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Antibiotic prophylaxis may lower SSIs in skin cancer surgery
Delivering s, compared with not using incision site antibiotics.
The rate of postoperative SSIs was 2.1% in the clindamycin arm, vs. 5.7% in the control arm and 5.3% in the flucloxacillin arm.
“Based on these results, we recommend the routine adoption of incisional microdosed clindamycin for patients undergoing skin cancer surgery,” Maple Goh, MBChB, of the Auckland Regional Plastic and Reconstructive Surgery Unit, Auckland, New Zealand, and the coauthors conclude. “This strategy appears suitable for widespread implementation because of the magnitude of the effect observed and the absence of adverse events.”
The study was published online in JAMA Surgery.
Skin cancer surgery carries a high risk of SSIs, which represent costly yet largely preventable complications of surgery. Despite the risk, there’s a lack of evidence from randomized clinical trials of the role of antibiotic prophylaxis in reducing SSI rates among patients undergoing skin cancer surgery. Previous studies have investigated incisional antibiotic prophylaxis to reduce SSIs with Mohs micrographic surgery, but these surgeries represent a relatively small proportion of overall skin cancer surgeries.
To understand whether this benefit extends to more general skin cancer surgeries, investigators recruited patients from a high-volume skin cancer center in New Zealand who were treated from February to July 2019. In the double-blind, prospective PICASSo trial, patients were randomly assigned to receive an incision site injection of buffered local anesthetic alone (control group), buffered local anesthetic with microdoses of flucloxacillin (500 mcg/mL), or buffered local anesthetic with microdoses of clindamycin (500 mcg/mL). The most common surgery type was excision and direct closure (approximately 80% in all arms), and the mean volume injected per length of direct closure was 1.5 mL/cm.
The primary endpoint was the rate of postoperative SSIs, defined as a postoperative wound infection score of 5 or more. The SSI rate was calculated as the number of lesions with SSIs per total number of lesions in the group.
Overall, 681 patients with 1,133 total lesions were included in the study. Compared with the control arm, the rate of postoperative SSIs was nearly threefold lower among patients who received clindamycin, –2.1% (9 of 422) vs. 5.7% (22 of 388) in the control arm (P = .01 for clindamycin vs. control).
However, flucloxacillin did not demonstrate the same effectiveness. The flucloxacillin arm and the control arm demonstrated similar postoperative SSI rates – 5.3% (17 of 323) vs. 5.7%.
The results were similar after adjusting for baseline differences and lesion ulceration.
The researchers also found that the proportion of lesions that required postoperative systemic antibiotics was four times higher among the control arm, in comparison with the clindamycin arm (8% vs. 2.1%; P < .001). It was two times higher than in the flucloxacillin arm (8% vs. 4%; P = .03).
Treatment with microdoses of incisional flucloxacillin and clindamycin was safe and well tolerated.
The researchers speculated that clindamycin’s greater effectiveness may come down to its slightly broader coverage of commonly cultured bacteria in skin and soft tissue infections, including community-associated methicillin-resistant Staphylococcus aureus. Clindamycin is known to have more efficacy against anaerobic bacteria that may be lurking in chronically ulcerated skin lesions and is associated with less local tissue inflammation, compared with flucloxacillin.
Overall, “clindamycin was significantly more effective at preventing SSI than flucloxacillin in our study,” the authors conclude. They note that the use of clindamycin as a first-line prophylaxis agent against SSIs for patients undergoing skin cancer surgery is a practical option.
“These results establish evidence-based guidelines for antibiotic prophylaxis in one of the most common surgical interventions performed worldwide, where they have been previously absent,” the researchers say.
The authors of an editorial published with the study underscore other advantages of incisional microdosing with antibiotics.
“One advantage of cutaneous antibiotic administration is improved drug delivery to poorly perfused tissue, which would have limited reach by the systemic circulation,” wrote Amanda R. Sergesketter, MD, of Duke University, Durham, N.C., and Scott T. Hollenbeck, MD, of the University of Virginia, Charlottesville.
“While not evaluated in this study, local antibiotic delivery may be especially relevant to larger and more complex wounds,” the editorialists say. They note that the next step for future studies should be to evaluate prophylaxis in more complex situations.
“Such studies should be considered enthusiastically, given the clearly favorable impact on surgical site infections demonstrated in the PICASSo trial,” Dr. Sergesketter and Dr. Hollenbeck said.
The study was supported by a grant from the New Zealand Health Research Council. Dr. Hollenbeck reported educational grants to Duke University from Allergan, Acelity, Synovis, Integra, Smith & Nephew, Stryker, Cook, KLs Martin, Bard, VOptix, Scanlan, True Digital Surgery, Nautilus, Mitaka, Checkpoint Surgical, and Omniguide, and he is a founder and equity holder for InSoma Bio, a premarket company focused on tissue regeneration.
A version of this article first appeared on Medscape.com.
Delivering s, compared with not using incision site antibiotics.
The rate of postoperative SSIs was 2.1% in the clindamycin arm, vs. 5.7% in the control arm and 5.3% in the flucloxacillin arm.
“Based on these results, we recommend the routine adoption of incisional microdosed clindamycin for patients undergoing skin cancer surgery,” Maple Goh, MBChB, of the Auckland Regional Plastic and Reconstructive Surgery Unit, Auckland, New Zealand, and the coauthors conclude. “This strategy appears suitable for widespread implementation because of the magnitude of the effect observed and the absence of adverse events.”
The study was published online in JAMA Surgery.
Skin cancer surgery carries a high risk of SSIs, which represent costly yet largely preventable complications of surgery. Despite the risk, there’s a lack of evidence from randomized clinical trials of the role of antibiotic prophylaxis in reducing SSI rates among patients undergoing skin cancer surgery. Previous studies have investigated incisional antibiotic prophylaxis to reduce SSIs with Mohs micrographic surgery, but these surgeries represent a relatively small proportion of overall skin cancer surgeries.
To understand whether this benefit extends to more general skin cancer surgeries, investigators recruited patients from a high-volume skin cancer center in New Zealand who were treated from February to July 2019. In the double-blind, prospective PICASSo trial, patients were randomly assigned to receive an incision site injection of buffered local anesthetic alone (control group), buffered local anesthetic with microdoses of flucloxacillin (500 mcg/mL), or buffered local anesthetic with microdoses of clindamycin (500 mcg/mL). The most common surgery type was excision and direct closure (approximately 80% in all arms), and the mean volume injected per length of direct closure was 1.5 mL/cm.
The primary endpoint was the rate of postoperative SSIs, defined as a postoperative wound infection score of 5 or more. The SSI rate was calculated as the number of lesions with SSIs per total number of lesions in the group.
Overall, 681 patients with 1,133 total lesions were included in the study. Compared with the control arm, the rate of postoperative SSIs was nearly threefold lower among patients who received clindamycin, –2.1% (9 of 422) vs. 5.7% (22 of 388) in the control arm (P = .01 for clindamycin vs. control).
However, flucloxacillin did not demonstrate the same effectiveness. The flucloxacillin arm and the control arm demonstrated similar postoperative SSI rates – 5.3% (17 of 323) vs. 5.7%.
The results were similar after adjusting for baseline differences and lesion ulceration.
The researchers also found that the proportion of lesions that required postoperative systemic antibiotics was four times higher among the control arm, in comparison with the clindamycin arm (8% vs. 2.1%; P < .001). It was two times higher than in the flucloxacillin arm (8% vs. 4%; P = .03).
Treatment with microdoses of incisional flucloxacillin and clindamycin was safe and well tolerated.
The researchers speculated that clindamycin’s greater effectiveness may come down to its slightly broader coverage of commonly cultured bacteria in skin and soft tissue infections, including community-associated methicillin-resistant Staphylococcus aureus. Clindamycin is known to have more efficacy against anaerobic bacteria that may be lurking in chronically ulcerated skin lesions and is associated with less local tissue inflammation, compared with flucloxacillin.
Overall, “clindamycin was significantly more effective at preventing SSI than flucloxacillin in our study,” the authors conclude. They note that the use of clindamycin as a first-line prophylaxis agent against SSIs for patients undergoing skin cancer surgery is a practical option.
“These results establish evidence-based guidelines for antibiotic prophylaxis in one of the most common surgical interventions performed worldwide, where they have been previously absent,” the researchers say.
The authors of an editorial published with the study underscore other advantages of incisional microdosing with antibiotics.
“One advantage of cutaneous antibiotic administration is improved drug delivery to poorly perfused tissue, which would have limited reach by the systemic circulation,” wrote Amanda R. Sergesketter, MD, of Duke University, Durham, N.C., and Scott T. Hollenbeck, MD, of the University of Virginia, Charlottesville.
“While not evaluated in this study, local antibiotic delivery may be especially relevant to larger and more complex wounds,” the editorialists say. They note that the next step for future studies should be to evaluate prophylaxis in more complex situations.
“Such studies should be considered enthusiastically, given the clearly favorable impact on surgical site infections demonstrated in the PICASSo trial,” Dr. Sergesketter and Dr. Hollenbeck said.
The study was supported by a grant from the New Zealand Health Research Council. Dr. Hollenbeck reported educational grants to Duke University from Allergan, Acelity, Synovis, Integra, Smith & Nephew, Stryker, Cook, KLs Martin, Bard, VOptix, Scanlan, True Digital Surgery, Nautilus, Mitaka, Checkpoint Surgical, and Omniguide, and he is a founder and equity holder for InSoma Bio, a premarket company focused on tissue regeneration.
A version of this article first appeared on Medscape.com.
Delivering s, compared with not using incision site antibiotics.
The rate of postoperative SSIs was 2.1% in the clindamycin arm, vs. 5.7% in the control arm and 5.3% in the flucloxacillin arm.
“Based on these results, we recommend the routine adoption of incisional microdosed clindamycin for patients undergoing skin cancer surgery,” Maple Goh, MBChB, of the Auckland Regional Plastic and Reconstructive Surgery Unit, Auckland, New Zealand, and the coauthors conclude. “This strategy appears suitable for widespread implementation because of the magnitude of the effect observed and the absence of adverse events.”
The study was published online in JAMA Surgery.
Skin cancer surgery carries a high risk of SSIs, which represent costly yet largely preventable complications of surgery. Despite the risk, there’s a lack of evidence from randomized clinical trials of the role of antibiotic prophylaxis in reducing SSI rates among patients undergoing skin cancer surgery. Previous studies have investigated incisional antibiotic prophylaxis to reduce SSIs with Mohs micrographic surgery, but these surgeries represent a relatively small proportion of overall skin cancer surgeries.
To understand whether this benefit extends to more general skin cancer surgeries, investigators recruited patients from a high-volume skin cancer center in New Zealand who were treated from February to July 2019. In the double-blind, prospective PICASSo trial, patients were randomly assigned to receive an incision site injection of buffered local anesthetic alone (control group), buffered local anesthetic with microdoses of flucloxacillin (500 mcg/mL), or buffered local anesthetic with microdoses of clindamycin (500 mcg/mL). The most common surgery type was excision and direct closure (approximately 80% in all arms), and the mean volume injected per length of direct closure was 1.5 mL/cm.
The primary endpoint was the rate of postoperative SSIs, defined as a postoperative wound infection score of 5 or more. The SSI rate was calculated as the number of lesions with SSIs per total number of lesions in the group.
Overall, 681 patients with 1,133 total lesions were included in the study. Compared with the control arm, the rate of postoperative SSIs was nearly threefold lower among patients who received clindamycin, –2.1% (9 of 422) vs. 5.7% (22 of 388) in the control arm (P = .01 for clindamycin vs. control).
However, flucloxacillin did not demonstrate the same effectiveness. The flucloxacillin arm and the control arm demonstrated similar postoperative SSI rates – 5.3% (17 of 323) vs. 5.7%.
The results were similar after adjusting for baseline differences and lesion ulceration.
The researchers also found that the proportion of lesions that required postoperative systemic antibiotics was four times higher among the control arm, in comparison with the clindamycin arm (8% vs. 2.1%; P < .001). It was two times higher than in the flucloxacillin arm (8% vs. 4%; P = .03).
Treatment with microdoses of incisional flucloxacillin and clindamycin was safe and well tolerated.
The researchers speculated that clindamycin’s greater effectiveness may come down to its slightly broader coverage of commonly cultured bacteria in skin and soft tissue infections, including community-associated methicillin-resistant Staphylococcus aureus. Clindamycin is known to have more efficacy against anaerobic bacteria that may be lurking in chronically ulcerated skin lesions and is associated with less local tissue inflammation, compared with flucloxacillin.
Overall, “clindamycin was significantly more effective at preventing SSI than flucloxacillin in our study,” the authors conclude. They note that the use of clindamycin as a first-line prophylaxis agent against SSIs for patients undergoing skin cancer surgery is a practical option.
“These results establish evidence-based guidelines for antibiotic prophylaxis in one of the most common surgical interventions performed worldwide, where they have been previously absent,” the researchers say.
The authors of an editorial published with the study underscore other advantages of incisional microdosing with antibiotics.
“One advantage of cutaneous antibiotic administration is improved drug delivery to poorly perfused tissue, which would have limited reach by the systemic circulation,” wrote Amanda R. Sergesketter, MD, of Duke University, Durham, N.C., and Scott T. Hollenbeck, MD, of the University of Virginia, Charlottesville.
“While not evaluated in this study, local antibiotic delivery may be especially relevant to larger and more complex wounds,” the editorialists say. They note that the next step for future studies should be to evaluate prophylaxis in more complex situations.
“Such studies should be considered enthusiastically, given the clearly favorable impact on surgical site infections demonstrated in the PICASSo trial,” Dr. Sergesketter and Dr. Hollenbeck said.
The study was supported by a grant from the New Zealand Health Research Council. Dr. Hollenbeck reported educational grants to Duke University from Allergan, Acelity, Synovis, Integra, Smith & Nephew, Stryker, Cook, KLs Martin, Bard, VOptix, Scanlan, True Digital Surgery, Nautilus, Mitaka, Checkpoint Surgical, and Omniguide, and he is a founder and equity holder for InSoma Bio, a premarket company focused on tissue regeneration.
A version of this article first appeared on Medscape.com.
FROM JAMA SURGERY
Teledermatology follow-up after Mohs surgery gets a thumbs up from patients
SEATTLE – The , according to new findings.
In addition, nearly all patients surveyed (91.4%) were willing to go through electronic follow-up again.
“A big takeaway from our study is that streamlining this process is really essential for successful implementation,” said study author Laura Rezac, MD, a PGY IV dermatology resident at the University of Mississippi, Jackson. “This study demonstrated the flexibility and convenience for both patients and surgeons and can serve as a prototype for future innovation.”
The study results were presented at the annual meeting of the American College of Mohs Surgery.
The role of telehealth has rapidly expanded over the past decade, with its use accelerating during the COVID-19 pandemic and transforming into an indispensable resource. It can be synchronous, Dr. Rezac explained, which is when telehealth happens in live, real-time settings where the patient interacts with a clinician. This usually occurs via phone or video, and providers and patients communicate directly.
Conversely, asynchronous telehealth, also known as “store-and-forward,” is often used for patient intake or follow-up care. For example, in dermatology, a patient can send a photo of a skin condition that is then reviewed by a dermatologist later.
“A pilot survey regarding the adoption of telemedicine in Mohs surgery found that, although most dermatologic surgeons felt that it can play a role, most said that they didn’t plan on using it after the pandemic,” said Dr. Rezac.
The survey, which was reported by this news organization, found that 80% of surveyed surgeons said that they turned to telemedicine during the pandemic, compared with just 23% who relied on the technology prior to the pandemic.
There were numerous perceived barriers to the use of telemedicine, and the one most commonly cited was the uncertainty of how telemedicine fits in the workflow of clinical practice. Other limitations reported were for physical exams (88%), patient response and training (57%), reimbursement concerns (50%), implementation of the technology (37%), regulations such as HIPAA (24%), training of staff (17%), and licensing (8%).
“The survey did identify one key use of telemedicine in Mohs and that was for [postoperative] visits,” she said. “But thus far, a postoperative evaluation after Mohs via an integrated asynchronous ‘store and forward’ teledermatology platform has not yet been evaluated.”
In the study, Dr. Rezac and colleagues sought to evaluate feasibility and efficacy, as well as patient attitudes, using a telemedicine platform for postoperative follow-up. A total of 163 patients who were treated with Mohs at a single academic institution during the 9-month study period (December 2021 through August 2022) responded to a survey and elected to participate in postoperative follow-up using telemedicine.
Dr. Rezac explained how their procedure was implemented for the patient. “On the day of the follow-up, the patient receives a text with a link that takes them to the MyChart website or app on their phone,” she said. “Once they log in, they see that they have a message telling them that they have a teledermatology message waiting for them. When they view it, they are taken to the curated message with instructions and a phone call if they need assistance, and then at the bottom, it shows they have a task to complete, which is the questionnaire.”
The patient will then be prompted to upload photos, which can be taken with their phone camera. The next step is to answer questions regarding the surgical site or pain concerns, and finally, patients are asked to respond to a few short questions about this type of follow-up. Once submitted, then they wait to be contacted by the surgeon.
On the surgeon’s side, these answers come into their EPIC inbox, and they can respond via a MyChart message.
Patient response was overwhelmingly positive, Dr. Rezac noted. Of the patients, 80.4% found the electronic surgery follow-up process to be “easy” or “very easy,” while only 4% found it “difficult” or “very difficult,” she said. “Also, 75.5% preferred electronic follow-up while 17.2% preferred in-person follow-up.”
There were limitations to this study, primarily that the asynchronous method does reduce live interaction, which could be an issue, depending on person’s needs, she pointed out. “But it is easy to schedule a phone call or video call or office visit.”
“The universal barrier is how to adopt it into the workflow, which includes training of staff,” she continued, “But this was a very streamlined process and gave very detailed instructions to the staff. Additionally, widespread use is limited to dermatological proficiency and access, and patients have to be amenable to it, so there is a selection bias since these patients chose to participate.”
Asked to comment on the study, Vishal Patel, MD, director of cutaneous oncology at George Washington University in Washington, said: “The COVID pandemic changed how practices and providers considered follow-up visits for small routine matters. Postoperative visits are often simple and do not require an in-depth, in-person evaluation.” Dr. Patel was not involved with this research.
“This study highlights the comfort of the vast majority of patients to have follow-up postoperative visits conducted via teledermatology – an approach that can help cut overall costs and also increase access for patients who are more in need of in-office care,” he added.
No external funding of the study was reported. Dr. Rezac reported no relevant financial relationships. Dr. Patel is a consultant for Sanofi, Regeneron, and Almirall.
A version of this article originally appeared on Medscape.com.
SEATTLE – The , according to new findings.
In addition, nearly all patients surveyed (91.4%) were willing to go through electronic follow-up again.
“A big takeaway from our study is that streamlining this process is really essential for successful implementation,” said study author Laura Rezac, MD, a PGY IV dermatology resident at the University of Mississippi, Jackson. “This study demonstrated the flexibility and convenience for both patients and surgeons and can serve as a prototype for future innovation.”
The study results were presented at the annual meeting of the American College of Mohs Surgery.
The role of telehealth has rapidly expanded over the past decade, with its use accelerating during the COVID-19 pandemic and transforming into an indispensable resource. It can be synchronous, Dr. Rezac explained, which is when telehealth happens in live, real-time settings where the patient interacts with a clinician. This usually occurs via phone or video, and providers and patients communicate directly.
Conversely, asynchronous telehealth, also known as “store-and-forward,” is often used for patient intake or follow-up care. For example, in dermatology, a patient can send a photo of a skin condition that is then reviewed by a dermatologist later.
“A pilot survey regarding the adoption of telemedicine in Mohs surgery found that, although most dermatologic surgeons felt that it can play a role, most said that they didn’t plan on using it after the pandemic,” said Dr. Rezac.
The survey, which was reported by this news organization, found that 80% of surveyed surgeons said that they turned to telemedicine during the pandemic, compared with just 23% who relied on the technology prior to the pandemic.
There were numerous perceived barriers to the use of telemedicine, and the one most commonly cited was the uncertainty of how telemedicine fits in the workflow of clinical practice. Other limitations reported were for physical exams (88%), patient response and training (57%), reimbursement concerns (50%), implementation of the technology (37%), regulations such as HIPAA (24%), training of staff (17%), and licensing (8%).
“The survey did identify one key use of telemedicine in Mohs and that was for [postoperative] visits,” she said. “But thus far, a postoperative evaluation after Mohs via an integrated asynchronous ‘store and forward’ teledermatology platform has not yet been evaluated.”
In the study, Dr. Rezac and colleagues sought to evaluate feasibility and efficacy, as well as patient attitudes, using a telemedicine platform for postoperative follow-up. A total of 163 patients who were treated with Mohs at a single academic institution during the 9-month study period (December 2021 through August 2022) responded to a survey and elected to participate in postoperative follow-up using telemedicine.
Dr. Rezac explained how their procedure was implemented for the patient. “On the day of the follow-up, the patient receives a text with a link that takes them to the MyChart website or app on their phone,” she said. “Once they log in, they see that they have a message telling them that they have a teledermatology message waiting for them. When they view it, they are taken to the curated message with instructions and a phone call if they need assistance, and then at the bottom, it shows they have a task to complete, which is the questionnaire.”
The patient will then be prompted to upload photos, which can be taken with their phone camera. The next step is to answer questions regarding the surgical site or pain concerns, and finally, patients are asked to respond to a few short questions about this type of follow-up. Once submitted, then they wait to be contacted by the surgeon.
On the surgeon’s side, these answers come into their EPIC inbox, and they can respond via a MyChart message.
Patient response was overwhelmingly positive, Dr. Rezac noted. Of the patients, 80.4% found the electronic surgery follow-up process to be “easy” or “very easy,” while only 4% found it “difficult” or “very difficult,” she said. “Also, 75.5% preferred electronic follow-up while 17.2% preferred in-person follow-up.”
There were limitations to this study, primarily that the asynchronous method does reduce live interaction, which could be an issue, depending on person’s needs, she pointed out. “But it is easy to schedule a phone call or video call or office visit.”
“The universal barrier is how to adopt it into the workflow, which includes training of staff,” she continued, “But this was a very streamlined process and gave very detailed instructions to the staff. Additionally, widespread use is limited to dermatological proficiency and access, and patients have to be amenable to it, so there is a selection bias since these patients chose to participate.”
Asked to comment on the study, Vishal Patel, MD, director of cutaneous oncology at George Washington University in Washington, said: “The COVID pandemic changed how practices and providers considered follow-up visits for small routine matters. Postoperative visits are often simple and do not require an in-depth, in-person evaluation.” Dr. Patel was not involved with this research.
“This study highlights the comfort of the vast majority of patients to have follow-up postoperative visits conducted via teledermatology – an approach that can help cut overall costs and also increase access for patients who are more in need of in-office care,” he added.
No external funding of the study was reported. Dr. Rezac reported no relevant financial relationships. Dr. Patel is a consultant for Sanofi, Regeneron, and Almirall.
A version of this article originally appeared on Medscape.com.
SEATTLE – The , according to new findings.
In addition, nearly all patients surveyed (91.4%) were willing to go through electronic follow-up again.
“A big takeaway from our study is that streamlining this process is really essential for successful implementation,” said study author Laura Rezac, MD, a PGY IV dermatology resident at the University of Mississippi, Jackson. “This study demonstrated the flexibility and convenience for both patients and surgeons and can serve as a prototype for future innovation.”
The study results were presented at the annual meeting of the American College of Mohs Surgery.
The role of telehealth has rapidly expanded over the past decade, with its use accelerating during the COVID-19 pandemic and transforming into an indispensable resource. It can be synchronous, Dr. Rezac explained, which is when telehealth happens in live, real-time settings where the patient interacts with a clinician. This usually occurs via phone or video, and providers and patients communicate directly.
Conversely, asynchronous telehealth, also known as “store-and-forward,” is often used for patient intake or follow-up care. For example, in dermatology, a patient can send a photo of a skin condition that is then reviewed by a dermatologist later.
“A pilot survey regarding the adoption of telemedicine in Mohs surgery found that, although most dermatologic surgeons felt that it can play a role, most said that they didn’t plan on using it after the pandemic,” said Dr. Rezac.
The survey, which was reported by this news organization, found that 80% of surveyed surgeons said that they turned to telemedicine during the pandemic, compared with just 23% who relied on the technology prior to the pandemic.
There were numerous perceived barriers to the use of telemedicine, and the one most commonly cited was the uncertainty of how telemedicine fits in the workflow of clinical practice. Other limitations reported were for physical exams (88%), patient response and training (57%), reimbursement concerns (50%), implementation of the technology (37%), regulations such as HIPAA (24%), training of staff (17%), and licensing (8%).
“The survey did identify one key use of telemedicine in Mohs and that was for [postoperative] visits,” she said. “But thus far, a postoperative evaluation after Mohs via an integrated asynchronous ‘store and forward’ teledermatology platform has not yet been evaluated.”
In the study, Dr. Rezac and colleagues sought to evaluate feasibility and efficacy, as well as patient attitudes, using a telemedicine platform for postoperative follow-up. A total of 163 patients who were treated with Mohs at a single academic institution during the 9-month study period (December 2021 through August 2022) responded to a survey and elected to participate in postoperative follow-up using telemedicine.
Dr. Rezac explained how their procedure was implemented for the patient. “On the day of the follow-up, the patient receives a text with a link that takes them to the MyChart website or app on their phone,” she said. “Once they log in, they see that they have a message telling them that they have a teledermatology message waiting for them. When they view it, they are taken to the curated message with instructions and a phone call if they need assistance, and then at the bottom, it shows they have a task to complete, which is the questionnaire.”
The patient will then be prompted to upload photos, which can be taken with their phone camera. The next step is to answer questions regarding the surgical site or pain concerns, and finally, patients are asked to respond to a few short questions about this type of follow-up. Once submitted, then they wait to be contacted by the surgeon.
On the surgeon’s side, these answers come into their EPIC inbox, and they can respond via a MyChart message.
Patient response was overwhelmingly positive, Dr. Rezac noted. Of the patients, 80.4% found the electronic surgery follow-up process to be “easy” or “very easy,” while only 4% found it “difficult” or “very difficult,” she said. “Also, 75.5% preferred electronic follow-up while 17.2% preferred in-person follow-up.”
There were limitations to this study, primarily that the asynchronous method does reduce live interaction, which could be an issue, depending on person’s needs, she pointed out. “But it is easy to schedule a phone call or video call or office visit.”
“The universal barrier is how to adopt it into the workflow, which includes training of staff,” she continued, “But this was a very streamlined process and gave very detailed instructions to the staff. Additionally, widespread use is limited to dermatological proficiency and access, and patients have to be amenable to it, so there is a selection bias since these patients chose to participate.”
Asked to comment on the study, Vishal Patel, MD, director of cutaneous oncology at George Washington University in Washington, said: “The COVID pandemic changed how practices and providers considered follow-up visits for small routine matters. Postoperative visits are often simple and do not require an in-depth, in-person evaluation.” Dr. Patel was not involved with this research.
“This study highlights the comfort of the vast majority of patients to have follow-up postoperative visits conducted via teledermatology – an approach that can help cut overall costs and also increase access for patients who are more in need of in-office care,” he added.
No external funding of the study was reported. Dr. Rezac reported no relevant financial relationships. Dr. Patel is a consultant for Sanofi, Regeneron, and Almirall.
A version of this article originally appeared on Medscape.com.
AT ACMS 2023
Mohs surgery workforce continues to increase
SEATTLE – At least for now, and that has been the case for the past 5 years.
Using CMS billing codes as a surrogate, the researchers found that there was a steady increase in the number of physicians who billed from 2015 to 2020. With the exception of 2020, which was the height of the COVID-19 pandemic, the number of times that a specific code was billed for increased on average by 4.7% annually.
“Thus, if the attrition rate remains stable, even with changes in board certification and potential payer eligibility restrictions, the number of physicians will continue to increase,” study author Ji Won Ahn, MD, who specializes in dermatology and Mohs surgery at University of Pittsburgh Medical Center, said at the annual meeting of the American College of Mohs Surgery, where she presented the results.
The growth in the number of Mohs surgeons has been fueled by several factors, including a rising incidence of skin cancer as well as the superior cure rates and cosmetic outcomes with the procedure. Reimbursement has been favorable and training pathways have expanded. A 2019 retrospective study reported that there were 2,240 dermatologists who performed Mohs surgery in the United States, with nearly all of them (94.6%) residing in metropolitan areas.
Dr. Ahn explained that it was important to define the workforce because of several new factors that will be affecting it in the future. “With the establishment of Micrographic Surgery and Dermatologic Oncology [MSDO] board certification that went into effect 2 years ago, potential future payer eligibility restrictions may be coming,” she said. “The adequacy of the Mohs surgery workforce is an important consideration.”
Another issue is that new board certification will be limited to fellowship-trained physicians after the first 5 years. “We wanted to compare these numbers with the fellowship numbers,” she said. “Although fellowship numbers are something that the college potentially has the power to change.”
Dr. Ahn and colleagues used the Centers for Medicare & Medicaid Services database to evaluate the use of the Current Procedural Terminology (CPT) code 17311, which is one of the most common billing codes for Mohs micrographic technique. Looking at data from 2015-2020, they found that there was an annual increase in the number of unique national provider identifiers (NPIs) billing for 17311, at an average rate of 75.6 per year.
The total number of times that 17311 was billed also increased from 2015 to 2019 at an average rate of 4.7% per year but declined in 2020 by 8.4%. “Overall, there was an average of 135 new NPIs that appeared and an average of 59.4 NPIs that stopped billing for 17311,” thus, an attrition rate of 59 surgeons, Dr. Ahn explained.
She emphasized that notably, the number of approved MSDO fellowship spots has remained stable since 2016 and is about 92 to 93 per year. “There are about 135 new surgeons and about two-thirds are new fellowship graduates,” she said.
The researchers were also interested in seeing how saturated each surgeon was and looked at the approximate number of cases that they were handling.
Of the physicians who billed 17311 through CMS, over 26% billed less than 100 times and more than 45% billed less than 200 times, and over 80% billed less than 500 times.
“One might be able to conclude that there might be some potential flexibility depending on the future need for surgeons,” she said.
The study was limited by several factors, one being that the researchers looked only at CPT code 17311 and not other designated codes for Mohs surgery. Other factors such as staff and space limitations were not accounted for since only billing data were used.
Dr. Ahn and her team are going to continue their work, and the next steps are to look at geographic trends and monitor for insurance network eligibility changes. “We are currently doing a workforce survey so we can better understand our current workforce rather than just historical data,” she concluded.
Asked to comment on the results, Vishal Patel, MD, assistant professor of dermatology and director of the cutaneous oncology program at George Washington University, Washington, who was not involved with the study, noted that the increase in the “billing rates of the first stage of Mohs micrographic surgery highlights not only the growing skin cancer epidemic, but also the number of providers who are providing these services. This underscores the importance of standardized training guidelines and board certifications of Mohs micrographic surgeons to assure high levels of patient care and the appropriate use of Mohs micrographic surgery,” he said.
No external funding of the study was reported. Dr. Ahn reported no relevant financial relationships. Dr. Patel is a consultant for Sanofi, Regeneron, and Almirall.
A version of this article originally appeared on Medscape.com.
SEATTLE – At least for now, and that has been the case for the past 5 years.
Using CMS billing codes as a surrogate, the researchers found that there was a steady increase in the number of physicians who billed from 2015 to 2020. With the exception of 2020, which was the height of the COVID-19 pandemic, the number of times that a specific code was billed for increased on average by 4.7% annually.
“Thus, if the attrition rate remains stable, even with changes in board certification and potential payer eligibility restrictions, the number of physicians will continue to increase,” study author Ji Won Ahn, MD, who specializes in dermatology and Mohs surgery at University of Pittsburgh Medical Center, said at the annual meeting of the American College of Mohs Surgery, where she presented the results.
The growth in the number of Mohs surgeons has been fueled by several factors, including a rising incidence of skin cancer as well as the superior cure rates and cosmetic outcomes with the procedure. Reimbursement has been favorable and training pathways have expanded. A 2019 retrospective study reported that there were 2,240 dermatologists who performed Mohs surgery in the United States, with nearly all of them (94.6%) residing in metropolitan areas.
Dr. Ahn explained that it was important to define the workforce because of several new factors that will be affecting it in the future. “With the establishment of Micrographic Surgery and Dermatologic Oncology [MSDO] board certification that went into effect 2 years ago, potential future payer eligibility restrictions may be coming,” she said. “The adequacy of the Mohs surgery workforce is an important consideration.”
Another issue is that new board certification will be limited to fellowship-trained physicians after the first 5 years. “We wanted to compare these numbers with the fellowship numbers,” she said. “Although fellowship numbers are something that the college potentially has the power to change.”
Dr. Ahn and colleagues used the Centers for Medicare & Medicaid Services database to evaluate the use of the Current Procedural Terminology (CPT) code 17311, which is one of the most common billing codes for Mohs micrographic technique. Looking at data from 2015-2020, they found that there was an annual increase in the number of unique national provider identifiers (NPIs) billing for 17311, at an average rate of 75.6 per year.
The total number of times that 17311 was billed also increased from 2015 to 2019 at an average rate of 4.7% per year but declined in 2020 by 8.4%. “Overall, there was an average of 135 new NPIs that appeared and an average of 59.4 NPIs that stopped billing for 17311,” thus, an attrition rate of 59 surgeons, Dr. Ahn explained.
She emphasized that notably, the number of approved MSDO fellowship spots has remained stable since 2016 and is about 92 to 93 per year. “There are about 135 new surgeons and about two-thirds are new fellowship graduates,” she said.
The researchers were also interested in seeing how saturated each surgeon was and looked at the approximate number of cases that they were handling.
Of the physicians who billed 17311 through CMS, over 26% billed less than 100 times and more than 45% billed less than 200 times, and over 80% billed less than 500 times.
“One might be able to conclude that there might be some potential flexibility depending on the future need for surgeons,” she said.
The study was limited by several factors, one being that the researchers looked only at CPT code 17311 and not other designated codes for Mohs surgery. Other factors such as staff and space limitations were not accounted for since only billing data were used.
Dr. Ahn and her team are going to continue their work, and the next steps are to look at geographic trends and monitor for insurance network eligibility changes. “We are currently doing a workforce survey so we can better understand our current workforce rather than just historical data,” she concluded.
Asked to comment on the results, Vishal Patel, MD, assistant professor of dermatology and director of the cutaneous oncology program at George Washington University, Washington, who was not involved with the study, noted that the increase in the “billing rates of the first stage of Mohs micrographic surgery highlights not only the growing skin cancer epidemic, but also the number of providers who are providing these services. This underscores the importance of standardized training guidelines and board certifications of Mohs micrographic surgeons to assure high levels of patient care and the appropriate use of Mohs micrographic surgery,” he said.
No external funding of the study was reported. Dr. Ahn reported no relevant financial relationships. Dr. Patel is a consultant for Sanofi, Regeneron, and Almirall.
A version of this article originally appeared on Medscape.com.
SEATTLE – At least for now, and that has been the case for the past 5 years.
Using CMS billing codes as a surrogate, the researchers found that there was a steady increase in the number of physicians who billed from 2015 to 2020. With the exception of 2020, which was the height of the COVID-19 pandemic, the number of times that a specific code was billed for increased on average by 4.7% annually.
“Thus, if the attrition rate remains stable, even with changes in board certification and potential payer eligibility restrictions, the number of physicians will continue to increase,” study author Ji Won Ahn, MD, who specializes in dermatology and Mohs surgery at University of Pittsburgh Medical Center, said at the annual meeting of the American College of Mohs Surgery, where she presented the results.
The growth in the number of Mohs surgeons has been fueled by several factors, including a rising incidence of skin cancer as well as the superior cure rates and cosmetic outcomes with the procedure. Reimbursement has been favorable and training pathways have expanded. A 2019 retrospective study reported that there were 2,240 dermatologists who performed Mohs surgery in the United States, with nearly all of them (94.6%) residing in metropolitan areas.
Dr. Ahn explained that it was important to define the workforce because of several new factors that will be affecting it in the future. “With the establishment of Micrographic Surgery and Dermatologic Oncology [MSDO] board certification that went into effect 2 years ago, potential future payer eligibility restrictions may be coming,” she said. “The adequacy of the Mohs surgery workforce is an important consideration.”
Another issue is that new board certification will be limited to fellowship-trained physicians after the first 5 years. “We wanted to compare these numbers with the fellowship numbers,” she said. “Although fellowship numbers are something that the college potentially has the power to change.”
Dr. Ahn and colleagues used the Centers for Medicare & Medicaid Services database to evaluate the use of the Current Procedural Terminology (CPT) code 17311, which is one of the most common billing codes for Mohs micrographic technique. Looking at data from 2015-2020, they found that there was an annual increase in the number of unique national provider identifiers (NPIs) billing for 17311, at an average rate of 75.6 per year.
The total number of times that 17311 was billed also increased from 2015 to 2019 at an average rate of 4.7% per year but declined in 2020 by 8.4%. “Overall, there was an average of 135 new NPIs that appeared and an average of 59.4 NPIs that stopped billing for 17311,” thus, an attrition rate of 59 surgeons, Dr. Ahn explained.
She emphasized that notably, the number of approved MSDO fellowship spots has remained stable since 2016 and is about 92 to 93 per year. “There are about 135 new surgeons and about two-thirds are new fellowship graduates,” she said.
The researchers were also interested in seeing how saturated each surgeon was and looked at the approximate number of cases that they were handling.
Of the physicians who billed 17311 through CMS, over 26% billed less than 100 times and more than 45% billed less than 200 times, and over 80% billed less than 500 times.
“One might be able to conclude that there might be some potential flexibility depending on the future need for surgeons,” she said.
The study was limited by several factors, one being that the researchers looked only at CPT code 17311 and not other designated codes for Mohs surgery. Other factors such as staff and space limitations were not accounted for since only billing data were used.
Dr. Ahn and her team are going to continue their work, and the next steps are to look at geographic trends and monitor for insurance network eligibility changes. “We are currently doing a workforce survey so we can better understand our current workforce rather than just historical data,” she concluded.
Asked to comment on the results, Vishal Patel, MD, assistant professor of dermatology and director of the cutaneous oncology program at George Washington University, Washington, who was not involved with the study, noted that the increase in the “billing rates of the first stage of Mohs micrographic surgery highlights not only the growing skin cancer epidemic, but also the number of providers who are providing these services. This underscores the importance of standardized training guidelines and board certifications of Mohs micrographic surgeons to assure high levels of patient care and the appropriate use of Mohs micrographic surgery,” he said.
No external funding of the study was reported. Dr. Ahn reported no relevant financial relationships. Dr. Patel is a consultant for Sanofi, Regeneron, and Almirall.
A version of this article originally appeared on Medscape.com.
AT ACMS 2023
Mohs surgery improves survival in early-stage Merkel cell carcinoma
SEATTLE – The use of
Compared with conventional wide local excision, survival was significantly improved among patients treated with Mohs, and a subgroup analysis showed that the survival benefit remained for patients with risk factors.
“At 10 years, overall survival was about 21% higher for those treated with Mohs surgery versus those treated with conventional surgery,” said lead author Shayan Cheraghlou, MD, a dermatology resident at the New York University School of Medicine. “On multivariable analysis, which controlled for tumor and patient factors, Mohs was associated with an over 40% reduction in the hazard for death.”
The findings were presented at the annual meeting of the American College of Mohs Surgery.
MCC is a rare, aggressive, neuroendocrine cutaneous malignancy that carries a high mortality rate. The estimated 5-year survival for patients with localized disease is about 50%, Dr. Cheraghlou noted. “That extrapolates to about 55% for T1 tumors and down to about 30% for T4 tumors.”
Although it’s considered to be a rare cancer, the incidence of MCC has been rapidly rising, and in fact it doubled during the period from the 1990s to the 2010s.
Most commonly treated with wide local excision with or without adjuvant radiation therapy, Mohs as monotherapy may offer an alternative treatment option for patients with MCC. It is generally accepted that the optimal treatment for tumors without regional lymph node involvement is surgical, but the data regarding the optimal surgical approach are mixed. Current National Comprehensive Cancer Network guidelines state that either Mohs surgery or wide local excision can be used.
“However, these guidelines do not indicate a preference for one modality over the other,” said Dr. Cheraghlou, “and present them as interchangeable treatment options.”
A growing body of literature supports Mohs surgery for many types of rare tumors, including MCC. For example, as previously reported at the 2021 ACMS meeting, one study found that Mohs surgery compared favorably with the standard treatment approach when it came to recurrence rates for patients with MCC. The 5-year disease-specific survival rate was 91.2% for patients with stage I disease and 68.6% for patients with stage IIa. These rates were comparable with rates for historical control patients who were treated with wide local excision, with or without radiation (81%-87% for stage I disease, and 63%-67% for stage II).
Study details
In the current study, Dr. Cheraghlou and colleagues sought to evaluate the association of the type of surgical approach with patient survival after excision of early-stage MCC. They conducted a retrospective cohort study using the National Cancer Database to identify cases of MCC with T1/T2 tumors. A total of 2,313 patients who were diagnosed from 2004 to 2018 with pathologically confirmed negative lymph node involvement and who were treated with Mohs surgery or wide lesion excision were included in the analysis.
“About 90% were T1 tumors, about 40% were located on the head and neck, and the vast majority – about 60% – were treated with wide local excision,” he explained. “Only about 5% received Mohs surgery for treatment of the primary tumor.”
But when the researchers assessed survival outcomes, they found that treatment with Mohs surgery was associated with significantly improved overall survival.
The unadjusted 3-, 5-, and 10-year survival rates for patients treated with Mohs was 87.4% (SE: 3.4%), 84.5% (SE: 3.9%), and 81.8% (SE: 4.6%), respectively, while for wide lesion excision, the rates were 86.1% (SE: 0.9%), 76.9% (SE: 1.2%), and 60.9% (SE: 2.0%), respectively.
For patients who underwent treatment with narrow margin excision, survival rates were similar as for those treated with wide lesion excision, with 3-, 5-, and 10-year survival rates of 84.8% (SE: 1.4%), 78.3% (SE: 1.7%), and 60.8% (SE: 3.6%), respectively.
On multivariable survival analysis, Mohs surgery was associated with significantly improved survival, compared with wide lesion excision (hazard ratio, 0.594; P = .038). This was also true after multivariable analysis for patients who had one or more NCCN risk factors, for whom improved survival was also seen with Mohs (HR, 0.530; P = .026).
The results did not differ after a sensitivity analysis that included T3 and T4 tumors.
Given that the use of Mohs was so infrequent, compared with standard surgery, the researchers investigated the factors that were associated with the use of Mohs. High-volume MCC centers were significantly more likely to utilize Mohs than wide lesion excision (odds ratio, 1.993; P < .001), compared with other facilities.
“This study has important implications going forward,” Dr. Cheraghlou concluded. “We think it’s important how few patients were treated with Mohs for Merkel cell, and it was slightly more likely to happen in a high-volume center.”
The reasoning for that may be that high-volume centers are more likely to have a surgeon trained to perform Mohs surgery for MCC. “Or perhaps they are more attuned to the benefits of this procedure,” he said. “We can’t tell that from our data, but its notable that it’s such a small proportion of patients – especially when we consider that it is associated with improved survival for the patients who receive it.”
He added that efforts to increase the utilization of Mohs may yield improved local control and overall survival for these patients. “And perhaps with more data, future versions of guidelines may indicate a preference for Mohs over conventional incisions.”
No changes to current practice
Asked to comment on the study, Anthony J. Olszanski, RPh, MD, associate professor, department of hematology/oncology, Fox Chase Cancer Center, Philadelphia, noted that while the results are intriguing, they must be interpreted with caution.
“This study was retrospective in nature, and unrecognized biases can influence results,” he said. “Additionally, given the relative rarity of Merkel cell carcinoma, the sample size is expectantly small.”
But importantly, Dr. Olszanski emphasized, Mohs may more often have been recommended for patients with lesions that appear less aggressive. “Many patients undergoing wide lesion excision may have been referred by Mohs surgeons secondary to features or characteristics of lesions which were worrisome,” he explained. “The results of this study do not opine on why Mohs would impact overall survival over wide lesion excision, a point worthy of consideration. Presently, both modalities can be considered for patients with T1/T2 MCC. The results of this study should not change current practice and would lend themselves to a more robust study.”
No external funding of the study was reported. Dr. Cheraghlou has disclosed no relevant financial relationships. Dr. Olszanski has received financial support from Merck and BMS for participated on advisory boards.
A version of this article originally appeared on Medscape.com.
SEATTLE – The use of
Compared with conventional wide local excision, survival was significantly improved among patients treated with Mohs, and a subgroup analysis showed that the survival benefit remained for patients with risk factors.
“At 10 years, overall survival was about 21% higher for those treated with Mohs surgery versus those treated with conventional surgery,” said lead author Shayan Cheraghlou, MD, a dermatology resident at the New York University School of Medicine. “On multivariable analysis, which controlled for tumor and patient factors, Mohs was associated with an over 40% reduction in the hazard for death.”
The findings were presented at the annual meeting of the American College of Mohs Surgery.
MCC is a rare, aggressive, neuroendocrine cutaneous malignancy that carries a high mortality rate. The estimated 5-year survival for patients with localized disease is about 50%, Dr. Cheraghlou noted. “That extrapolates to about 55% for T1 tumors and down to about 30% for T4 tumors.”
Although it’s considered to be a rare cancer, the incidence of MCC has been rapidly rising, and in fact it doubled during the period from the 1990s to the 2010s.
Most commonly treated with wide local excision with or without adjuvant radiation therapy, Mohs as monotherapy may offer an alternative treatment option for patients with MCC. It is generally accepted that the optimal treatment for tumors without regional lymph node involvement is surgical, but the data regarding the optimal surgical approach are mixed. Current National Comprehensive Cancer Network guidelines state that either Mohs surgery or wide local excision can be used.
“However, these guidelines do not indicate a preference for one modality over the other,” said Dr. Cheraghlou, “and present them as interchangeable treatment options.”
A growing body of literature supports Mohs surgery for many types of rare tumors, including MCC. For example, as previously reported at the 2021 ACMS meeting, one study found that Mohs surgery compared favorably with the standard treatment approach when it came to recurrence rates for patients with MCC. The 5-year disease-specific survival rate was 91.2% for patients with stage I disease and 68.6% for patients with stage IIa. These rates were comparable with rates for historical control patients who were treated with wide local excision, with or without radiation (81%-87% for stage I disease, and 63%-67% for stage II).
Study details
In the current study, Dr. Cheraghlou and colleagues sought to evaluate the association of the type of surgical approach with patient survival after excision of early-stage MCC. They conducted a retrospective cohort study using the National Cancer Database to identify cases of MCC with T1/T2 tumors. A total of 2,313 patients who were diagnosed from 2004 to 2018 with pathologically confirmed negative lymph node involvement and who were treated with Mohs surgery or wide lesion excision were included in the analysis.
“About 90% were T1 tumors, about 40% were located on the head and neck, and the vast majority – about 60% – were treated with wide local excision,” he explained. “Only about 5% received Mohs surgery for treatment of the primary tumor.”
But when the researchers assessed survival outcomes, they found that treatment with Mohs surgery was associated with significantly improved overall survival.
The unadjusted 3-, 5-, and 10-year survival rates for patients treated with Mohs was 87.4% (SE: 3.4%), 84.5% (SE: 3.9%), and 81.8% (SE: 4.6%), respectively, while for wide lesion excision, the rates were 86.1% (SE: 0.9%), 76.9% (SE: 1.2%), and 60.9% (SE: 2.0%), respectively.
For patients who underwent treatment with narrow margin excision, survival rates were similar as for those treated with wide lesion excision, with 3-, 5-, and 10-year survival rates of 84.8% (SE: 1.4%), 78.3% (SE: 1.7%), and 60.8% (SE: 3.6%), respectively.
On multivariable survival analysis, Mohs surgery was associated with significantly improved survival, compared with wide lesion excision (hazard ratio, 0.594; P = .038). This was also true after multivariable analysis for patients who had one or more NCCN risk factors, for whom improved survival was also seen with Mohs (HR, 0.530; P = .026).
The results did not differ after a sensitivity analysis that included T3 and T4 tumors.
Given that the use of Mohs was so infrequent, compared with standard surgery, the researchers investigated the factors that were associated with the use of Mohs. High-volume MCC centers were significantly more likely to utilize Mohs than wide lesion excision (odds ratio, 1.993; P < .001), compared with other facilities.
“This study has important implications going forward,” Dr. Cheraghlou concluded. “We think it’s important how few patients were treated with Mohs for Merkel cell, and it was slightly more likely to happen in a high-volume center.”
The reasoning for that may be that high-volume centers are more likely to have a surgeon trained to perform Mohs surgery for MCC. “Or perhaps they are more attuned to the benefits of this procedure,” he said. “We can’t tell that from our data, but its notable that it’s such a small proportion of patients – especially when we consider that it is associated with improved survival for the patients who receive it.”
He added that efforts to increase the utilization of Mohs may yield improved local control and overall survival for these patients. “And perhaps with more data, future versions of guidelines may indicate a preference for Mohs over conventional incisions.”
No changes to current practice
Asked to comment on the study, Anthony J. Olszanski, RPh, MD, associate professor, department of hematology/oncology, Fox Chase Cancer Center, Philadelphia, noted that while the results are intriguing, they must be interpreted with caution.
“This study was retrospective in nature, and unrecognized biases can influence results,” he said. “Additionally, given the relative rarity of Merkel cell carcinoma, the sample size is expectantly small.”
But importantly, Dr. Olszanski emphasized, Mohs may more often have been recommended for patients with lesions that appear less aggressive. “Many patients undergoing wide lesion excision may have been referred by Mohs surgeons secondary to features or characteristics of lesions which were worrisome,” he explained. “The results of this study do not opine on why Mohs would impact overall survival over wide lesion excision, a point worthy of consideration. Presently, both modalities can be considered for patients with T1/T2 MCC. The results of this study should not change current practice and would lend themselves to a more robust study.”
No external funding of the study was reported. Dr. Cheraghlou has disclosed no relevant financial relationships. Dr. Olszanski has received financial support from Merck and BMS for participated on advisory boards.
A version of this article originally appeared on Medscape.com.
SEATTLE – The use of
Compared with conventional wide local excision, survival was significantly improved among patients treated with Mohs, and a subgroup analysis showed that the survival benefit remained for patients with risk factors.
“At 10 years, overall survival was about 21% higher for those treated with Mohs surgery versus those treated with conventional surgery,” said lead author Shayan Cheraghlou, MD, a dermatology resident at the New York University School of Medicine. “On multivariable analysis, which controlled for tumor and patient factors, Mohs was associated with an over 40% reduction in the hazard for death.”
The findings were presented at the annual meeting of the American College of Mohs Surgery.
MCC is a rare, aggressive, neuroendocrine cutaneous malignancy that carries a high mortality rate. The estimated 5-year survival for patients with localized disease is about 50%, Dr. Cheraghlou noted. “That extrapolates to about 55% for T1 tumors and down to about 30% for T4 tumors.”
Although it’s considered to be a rare cancer, the incidence of MCC has been rapidly rising, and in fact it doubled during the period from the 1990s to the 2010s.
Most commonly treated with wide local excision with or without adjuvant radiation therapy, Mohs as monotherapy may offer an alternative treatment option for patients with MCC. It is generally accepted that the optimal treatment for tumors without regional lymph node involvement is surgical, but the data regarding the optimal surgical approach are mixed. Current National Comprehensive Cancer Network guidelines state that either Mohs surgery or wide local excision can be used.
“However, these guidelines do not indicate a preference for one modality over the other,” said Dr. Cheraghlou, “and present them as interchangeable treatment options.”
A growing body of literature supports Mohs surgery for many types of rare tumors, including MCC. For example, as previously reported at the 2021 ACMS meeting, one study found that Mohs surgery compared favorably with the standard treatment approach when it came to recurrence rates for patients with MCC. The 5-year disease-specific survival rate was 91.2% for patients with stage I disease and 68.6% for patients with stage IIa. These rates were comparable with rates for historical control patients who were treated with wide local excision, with or without radiation (81%-87% for stage I disease, and 63%-67% for stage II).
Study details
In the current study, Dr. Cheraghlou and colleagues sought to evaluate the association of the type of surgical approach with patient survival after excision of early-stage MCC. They conducted a retrospective cohort study using the National Cancer Database to identify cases of MCC with T1/T2 tumors. A total of 2,313 patients who were diagnosed from 2004 to 2018 with pathologically confirmed negative lymph node involvement and who were treated with Mohs surgery or wide lesion excision were included in the analysis.
“About 90% were T1 tumors, about 40% were located on the head and neck, and the vast majority – about 60% – were treated with wide local excision,” he explained. “Only about 5% received Mohs surgery for treatment of the primary tumor.”
But when the researchers assessed survival outcomes, they found that treatment with Mohs surgery was associated with significantly improved overall survival.
The unadjusted 3-, 5-, and 10-year survival rates for patients treated with Mohs was 87.4% (SE: 3.4%), 84.5% (SE: 3.9%), and 81.8% (SE: 4.6%), respectively, while for wide lesion excision, the rates were 86.1% (SE: 0.9%), 76.9% (SE: 1.2%), and 60.9% (SE: 2.0%), respectively.
For patients who underwent treatment with narrow margin excision, survival rates were similar as for those treated with wide lesion excision, with 3-, 5-, and 10-year survival rates of 84.8% (SE: 1.4%), 78.3% (SE: 1.7%), and 60.8% (SE: 3.6%), respectively.
On multivariable survival analysis, Mohs surgery was associated with significantly improved survival, compared with wide lesion excision (hazard ratio, 0.594; P = .038). This was also true after multivariable analysis for patients who had one or more NCCN risk factors, for whom improved survival was also seen with Mohs (HR, 0.530; P = .026).
The results did not differ after a sensitivity analysis that included T3 and T4 tumors.
Given that the use of Mohs was so infrequent, compared with standard surgery, the researchers investigated the factors that were associated with the use of Mohs. High-volume MCC centers were significantly more likely to utilize Mohs than wide lesion excision (odds ratio, 1.993; P < .001), compared with other facilities.
“This study has important implications going forward,” Dr. Cheraghlou concluded. “We think it’s important how few patients were treated with Mohs for Merkel cell, and it was slightly more likely to happen in a high-volume center.”
The reasoning for that may be that high-volume centers are more likely to have a surgeon trained to perform Mohs surgery for MCC. “Or perhaps they are more attuned to the benefits of this procedure,” he said. “We can’t tell that from our data, but its notable that it’s such a small proportion of patients – especially when we consider that it is associated with improved survival for the patients who receive it.”
He added that efforts to increase the utilization of Mohs may yield improved local control and overall survival for these patients. “And perhaps with more data, future versions of guidelines may indicate a preference for Mohs over conventional incisions.”
No changes to current practice
Asked to comment on the study, Anthony J. Olszanski, RPh, MD, associate professor, department of hematology/oncology, Fox Chase Cancer Center, Philadelphia, noted that while the results are intriguing, they must be interpreted with caution.
“This study was retrospective in nature, and unrecognized biases can influence results,” he said. “Additionally, given the relative rarity of Merkel cell carcinoma, the sample size is expectantly small.”
But importantly, Dr. Olszanski emphasized, Mohs may more often have been recommended for patients with lesions that appear less aggressive. “Many patients undergoing wide lesion excision may have been referred by Mohs surgeons secondary to features or characteristics of lesions which were worrisome,” he explained. “The results of this study do not opine on why Mohs would impact overall survival over wide lesion excision, a point worthy of consideration. Presently, both modalities can be considered for patients with T1/T2 MCC. The results of this study should not change current practice and would lend themselves to a more robust study.”
No external funding of the study was reported. Dr. Cheraghlou has disclosed no relevant financial relationships. Dr. Olszanski has received financial support from Merck and BMS for participated on advisory boards.
A version of this article originally appeared on Medscape.com.
AT ACMS 2023
Controlled hyperthermia: Novel treatment of BCCs without surgery continues to be refined
PHOENIX – .
“For 2,000 years, it’s been known that heat can kill cancers,” an apoptotic reaction “rather than a destructive reaction coming from excessive heat,” Christopher B. Zachary, MD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the study was presented during an abstract session.
Dr. Zachary, professor and chair emeritus of the department of dermatology at the University of California, Irvine, and colleagues, evaluated a novel, noninvasive technique of controlled hyperthermia and mapping protocol (CHAMP) designed to help clinicians with margin assessment and treatment of superficial and nodular BCCs. For this prospective study, which was first described at the 2022 ASLMS annual conference and is being conducted at three centers, 73 patients with biopsy-proven superficial and nodular BCCs have been scanned with the VivoSight Dx optical coherence tomography (OCT) device to map BCC tumor margins.
The BCCs were treated with the Sciton 1,064-nm Er:YAG laser equipped with a 4-mm beam diameter scan pattern with no overlap and an 8-millisecond pulse duration, randomized to either standard 120-140 J/cm2 pulses until tissue graying and contraction was observed, or the CHAMP controlled hyperthermia technique using repeated 25 J/cm2 pulses under thermal camera imaging to maintain a consistent temperature of 55º C for 60 seconds. Patients were rescanned by OCT at 3 to 12 months for any signs of residual tumor and if positive, were retreated. Finally, lesions were excised for evidence of histological clearance.
To date, 48 patients have completed the study. Among the 26 patients treated with the CHAMP method, 22 (84.6%) were histologically clear, as were 19 of the 22 (86.4%) in the standard treatment group. Ulceration was uncommon with the CHAMP method, and patients healed with modest erythema, Dr. Zachary said.
Pretreatment OCT mapping of BCCs indicated that tumors extended beyond their 5-mm clinical margins in 11 cases (15%). “This will be of interest to those who treat BCCs by Mohs or standard excision,” he said. Increased vascularity measured by dynamic OCT was noted in most CHAMP patients immediately after irradiation, which suggests that apoptosis was the primary mechanism of tumor response instead of vascular destruction.
“The traditional technique for using the long pulsed 1,064-nm Er:YAG laser to cause damage and destruction of BCC is 120-140 J/cm2 at one or two passes until you get to an endpoint of graying and contraction of tissue,” Dr. Zachary said. “That’s opposed to the ‘Low and Slow’ approach [where you use] multiple pulses at 25 J/cm2 until you achieve an optimal time and temperature. If you treat above 60º C, you tend to get epidermal blistering, prolonged healing, and interestingly, absence of pain. I think that’s because you kill off the nerve fibers. With the low fluence multiple scan technique, you’re going for an even flat-top heating.”
Currently, he and his colleagues consider 55 degrees at 60 seconds as “the optimal parameters,” he said, but “it could be 45 degrees at 90 seconds or two minutes. We don’t know yet.”
In an interview at the meeting, one of the abstract session moderators, Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said that he was encouraged by the study results as investigations into effective, noninvasive treatment of BCC continue to move forward. “Details matter such as the temperature [of energy delivery] and noninvasive imaging to delineate the appropriate margins,” said Dr. Avram, who has conducted research on the 1,064-nm long-pulsed Nd:YAG laser as an alternative treatment for nonfacial BCCs in patients who are poor surgical candidates.
“Hopefully, at some point,” he said, such approaches will “become the standard of care for many BCCs that we are now treating surgically. I don’t think this will happen in the next 3 years, but I think in the long term, it will emerge as the treatment of choice.”
The study is being funded by Michelson Diagnostics. Sciton provided the long-pulsed 1,064-nm lasers devices being used in the trial. Dr. Zachary reported having no relevant disclosures. Dr. Avram disclosed that he has received consulting fees from Sciton.
PHOENIX – .
“For 2,000 years, it’s been known that heat can kill cancers,” an apoptotic reaction “rather than a destructive reaction coming from excessive heat,” Christopher B. Zachary, MD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the study was presented during an abstract session.
Dr. Zachary, professor and chair emeritus of the department of dermatology at the University of California, Irvine, and colleagues, evaluated a novel, noninvasive technique of controlled hyperthermia and mapping protocol (CHAMP) designed to help clinicians with margin assessment and treatment of superficial and nodular BCCs. For this prospective study, which was first described at the 2022 ASLMS annual conference and is being conducted at three centers, 73 patients with biopsy-proven superficial and nodular BCCs have been scanned with the VivoSight Dx optical coherence tomography (OCT) device to map BCC tumor margins.
The BCCs were treated with the Sciton 1,064-nm Er:YAG laser equipped with a 4-mm beam diameter scan pattern with no overlap and an 8-millisecond pulse duration, randomized to either standard 120-140 J/cm2 pulses until tissue graying and contraction was observed, or the CHAMP controlled hyperthermia technique using repeated 25 J/cm2 pulses under thermal camera imaging to maintain a consistent temperature of 55º C for 60 seconds. Patients were rescanned by OCT at 3 to 12 months for any signs of residual tumor and if positive, were retreated. Finally, lesions were excised for evidence of histological clearance.
To date, 48 patients have completed the study. Among the 26 patients treated with the CHAMP method, 22 (84.6%) were histologically clear, as were 19 of the 22 (86.4%) in the standard treatment group. Ulceration was uncommon with the CHAMP method, and patients healed with modest erythema, Dr. Zachary said.
Pretreatment OCT mapping of BCCs indicated that tumors extended beyond their 5-mm clinical margins in 11 cases (15%). “This will be of interest to those who treat BCCs by Mohs or standard excision,” he said. Increased vascularity measured by dynamic OCT was noted in most CHAMP patients immediately after irradiation, which suggests that apoptosis was the primary mechanism of tumor response instead of vascular destruction.
“The traditional technique for using the long pulsed 1,064-nm Er:YAG laser to cause damage and destruction of BCC is 120-140 J/cm2 at one or two passes until you get to an endpoint of graying and contraction of tissue,” Dr. Zachary said. “That’s opposed to the ‘Low and Slow’ approach [where you use] multiple pulses at 25 J/cm2 until you achieve an optimal time and temperature. If you treat above 60º C, you tend to get epidermal blistering, prolonged healing, and interestingly, absence of pain. I think that’s because you kill off the nerve fibers. With the low fluence multiple scan technique, you’re going for an even flat-top heating.”
Currently, he and his colleagues consider 55 degrees at 60 seconds as “the optimal parameters,” he said, but “it could be 45 degrees at 90 seconds or two minutes. We don’t know yet.”
In an interview at the meeting, one of the abstract session moderators, Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said that he was encouraged by the study results as investigations into effective, noninvasive treatment of BCC continue to move forward. “Details matter such as the temperature [of energy delivery] and noninvasive imaging to delineate the appropriate margins,” said Dr. Avram, who has conducted research on the 1,064-nm long-pulsed Nd:YAG laser as an alternative treatment for nonfacial BCCs in patients who are poor surgical candidates.
“Hopefully, at some point,” he said, such approaches will “become the standard of care for many BCCs that we are now treating surgically. I don’t think this will happen in the next 3 years, but I think in the long term, it will emerge as the treatment of choice.”
The study is being funded by Michelson Diagnostics. Sciton provided the long-pulsed 1,064-nm lasers devices being used in the trial. Dr. Zachary reported having no relevant disclosures. Dr. Avram disclosed that he has received consulting fees from Sciton.
PHOENIX – .
“For 2,000 years, it’s been known that heat can kill cancers,” an apoptotic reaction “rather than a destructive reaction coming from excessive heat,” Christopher B. Zachary, MD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the study was presented during an abstract session.
Dr. Zachary, professor and chair emeritus of the department of dermatology at the University of California, Irvine, and colleagues, evaluated a novel, noninvasive technique of controlled hyperthermia and mapping protocol (CHAMP) designed to help clinicians with margin assessment and treatment of superficial and nodular BCCs. For this prospective study, which was first described at the 2022 ASLMS annual conference and is being conducted at three centers, 73 patients with biopsy-proven superficial and nodular BCCs have been scanned with the VivoSight Dx optical coherence tomography (OCT) device to map BCC tumor margins.
The BCCs were treated with the Sciton 1,064-nm Er:YAG laser equipped with a 4-mm beam diameter scan pattern with no overlap and an 8-millisecond pulse duration, randomized to either standard 120-140 J/cm2 pulses until tissue graying and contraction was observed, or the CHAMP controlled hyperthermia technique using repeated 25 J/cm2 pulses under thermal camera imaging to maintain a consistent temperature of 55º C for 60 seconds. Patients were rescanned by OCT at 3 to 12 months for any signs of residual tumor and if positive, were retreated. Finally, lesions were excised for evidence of histological clearance.
To date, 48 patients have completed the study. Among the 26 patients treated with the CHAMP method, 22 (84.6%) were histologically clear, as were 19 of the 22 (86.4%) in the standard treatment group. Ulceration was uncommon with the CHAMP method, and patients healed with modest erythema, Dr. Zachary said.
Pretreatment OCT mapping of BCCs indicated that tumors extended beyond their 5-mm clinical margins in 11 cases (15%). “This will be of interest to those who treat BCCs by Mohs or standard excision,” he said. Increased vascularity measured by dynamic OCT was noted in most CHAMP patients immediately after irradiation, which suggests that apoptosis was the primary mechanism of tumor response instead of vascular destruction.
“The traditional technique for using the long pulsed 1,064-nm Er:YAG laser to cause damage and destruction of BCC is 120-140 J/cm2 at one or two passes until you get to an endpoint of graying and contraction of tissue,” Dr. Zachary said. “That’s opposed to the ‘Low and Slow’ approach [where you use] multiple pulses at 25 J/cm2 until you achieve an optimal time and temperature. If you treat above 60º C, you tend to get epidermal blistering, prolonged healing, and interestingly, absence of pain. I think that’s because you kill off the nerve fibers. With the low fluence multiple scan technique, you’re going for an even flat-top heating.”
Currently, he and his colleagues consider 55 degrees at 60 seconds as “the optimal parameters,” he said, but “it could be 45 degrees at 90 seconds or two minutes. We don’t know yet.”
In an interview at the meeting, one of the abstract session moderators, Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at Massachusetts General Hospital, Boston, said that he was encouraged by the study results as investigations into effective, noninvasive treatment of BCC continue to move forward. “Details matter such as the temperature [of energy delivery] and noninvasive imaging to delineate the appropriate margins,” said Dr. Avram, who has conducted research on the 1,064-nm long-pulsed Nd:YAG laser as an alternative treatment for nonfacial BCCs in patients who are poor surgical candidates.
“Hopefully, at some point,” he said, such approaches will “become the standard of care for many BCCs that we are now treating surgically. I don’t think this will happen in the next 3 years, but I think in the long term, it will emerge as the treatment of choice.”
The study is being funded by Michelson Diagnostics. Sciton provided the long-pulsed 1,064-nm lasers devices being used in the trial. Dr. Zachary reported having no relevant disclosures. Dr. Avram disclosed that he has received consulting fees from Sciton.
AT ASLMS 2023
Best practices document outlines genitourinary applications of lasers and energy-based devices
PHOENIX –
“Even a cursory review of PubMed today yields over 100,000 results” on this topic, Macrene R. Alexiades, MD, PhD, associate clinical professor of dermatology at Yale University, New Haven, Conn., said at the annual conference of the American Society for Laser Medicine and Surgery. “Add to that radiofrequency and various diagnoses, the number of publications has skyrocketed, particularly over the last 10 years.”
What has been missing from this hot research topic all these years, she continued, is that no one has distilled this pile of data into a practical guide for office-based clinicians who use lasers and energy-based devices for genitourinary conditions – until now. Working with experts in gynecology and urogynecology, Dr. Alexiades spearheaded a 2-year-long effort to assemble a document on optimal protocols and best practices for genitourinary application of lasers and energy-based devices. The document, published soon after the ASLMS meeting in Lasers in Medicine and Surgery, includes a table that lists the current Food and Drug Administration approval status of devices in genitourinary applications, as well as individual sections dedicated to fractional lasers, radiofrequency (RF) devices, and high-intensity focused electromagnetic technology. It concludes with a section on the current status of clearances and future pathways.
“The work we did was exhaustive,” said Dr. Alexiades, who is also founder and director of Dermatology & Laser Surgery Center of New York. “We went through all the clinical trial data and compiled the parameters that, as a consensus, we agree are best practices for each technology for which we had rigorous published data.”
The document contains a brief background on the history of the devices used for genitourinary issues and it addresses core topics for each technology, such as conditions treated, contraindications, preoperative physical assessment and preparation, perioperative protocols, and postoperative care.
Contraindications to the genitourinary use of lasers and energy-based devices are numerous and include use of an intrauterine device, active urinary tract or genital infection, vaginal bleeding, current pregnancy, active or recent malignancy, having an electrical implant anywhere in the body, significant concurrent illness, and an anticoagulative or thromboembolic condition or taking anticoagulant medications 1 week prior to the procedure. Another condition to screen for is advanced prolapse, which was considered a contraindication in all clinical trials, she added. “It’s important that you’re able to do the speculum exam and stage the prolapse” so that a patient with this contraindication is not treated.
Dr. Alexiades shared the following highlights from the document’s section related to the use of fractional CO2 lasers:
Preoperative management. Schedule the treatment one week after the patient’s menstrual period. Patients should avoid blood thinners for 7 days and avoid intercourse the night before the procedure. Reschedule in the case of fever, chills, or vaginal bleeding or discharge.
Preoperative physical exam and testing. A normal speculum exam and a recent negative PAP smear are required. For those of child-bearing potential, a pregnancy test is warranted. Obtain written and verbal consent, including discussion of all treatment options, risks, and benefits. No topical or local anesthesia is necessary internally. “Externally, we sometimes apply topical lidocaine gel, but I have found that’s not necessary in most cases,” Dr. Alexiades said. “The treatment is so quick.”
Peri-operative management. In general, device settings are provided by the manufacturer. “For most of the studies that had successful outcomes and no adverse events, researchers adhered to the mild or moderate settings on the technology,” she said. Energy settings were between 15 and 30 watts, delivered at a laser fluence of about 250-300 mJ/cm2 with a spacing of microbeams 1 mm apart. Typically, three treatments are done at 1-month intervals and maintenance treatments are recommended at 6 and 12 months based on duration of the outcomes.
Vulvovaginal postoperative management. A 3-day recovery time is recommended with avoidance of intercourse during this period, because “re-epithelialization is usually complete in 3 days, so we want to give the opportunity for the lining to heal prior to introducing any friction, Dr. Alexiades said.” Rarely, spotting or discharge may occur and there should be no discomfort. “Any severe discomfort or burning may potentially signify infection and should prompt evaluation and possibly vaginal cultures. The patient can shower, but we recommend avoiding seated baths to decrease any introduction of infectious agents.”
Patients should be followed up monthly until three treatments are completed, and a maintenance treatment is considered appropriate between 6 and 12 months. “I do recommend doing a 1-month follow-up following the final treatment, unless it’s a patient who has already had a series of three treatments and is coming in for maintenance,” she said.
In a study from her own practice, Dr. Alexiades evaluated a series of three fractional CO2 laser treatments to the vulva and vagina with a 1-year follow-up in postmenopausal patients. She used the Vaginal Health Index (VHI) to assess changes in vaginal elasticity, fluid volume, vaginal pH, epithelial integrity, and moisture. She and her colleagues discovered that there was improvement in every VHI category after treatment and during the follow-up interval up to 6 months.
“Between 6 and 12 months, we started to see a return a bit toward baseline on all of these parameters,” she said. “The serendipitous discovery that I made during the course of that study was that early intervention improves outcomes. I observed that the younger, most recently postmenopausal cohort seemed to attain normal or near normal VHI quicker than the more extended postmenopausal cohorts.”
In an editorial published in 2020, Dr. Alexiades reviewed the effects of fractional CO2 laser treatment of vulvar skin on vaginal pH and referred to a study she conducted that found that the mean baseline pH pretreatment was 6.32 in the cohort of postmenopausal patients, and was reduced after 3 treatments. “Postmenopausally, the normal acidic pH becomes alkaline,” she said. But she did not expect to see an additional reduction in pH following the treatment out to 6 months. “This indicates that, whatever the wound healing and other restorative effects of these devices are, they seem to continue out to 6 months, at which point it turns around and moves toward baseline [levels].”
Dr. Alexiades highlighted two published meta-analyses of studies related to the genitourinary use of lasers and energy-based devices. One included 59 studies of 3,609 women treated for vaginal rejuvenation using either radiofrequency or fractional ablative laser therapy. The studies reported improvements in symptoms of GSM/VVA and sexual function, high patient satisfaction, with minor adverse events, including treatment-associated vaginal swelling or vaginal discharge.
“Further research needs to be completed to determine which specific pathologies can be treated, if maintenance treatment is necessary, and long-term safety concerns,” the authors concluded.
In another review, researchers analyzed 64 studies related to vaginal laser therapy for GSM. Of these, 47 were before and after studies without a control group, 10 were controlled intervention studies, and 7 were observational cohort and cross-sectional studies.
Vaginal laser treatment “seems to improve scores on the visual analogue scale, Female Sexual Function Index, and the Vaginal Health Index over the short term,” the authors wrote. “Safety outcomes are underreported and short term. Further well-designed clinical trials with sham-laser control groups and evaluating objective variables are needed to provide the best evidence on efficacy.”
“Lasers and energy-based devices are now considered alternative therapeutic modalities for genitourinary conditions,” Dr. Alexiades concluded. “The shortcomings in the literature with respect to lasers and device treatments demonstrate the need for the consensus on best practices and protocols.”
During a separate presentation at the meeting, Michael Gold, MD, highlighted data from Grand View Research, a market research database, which estimated that the global women’s health and wellness market is valued at more than $31 billion globally and is expected to grow at a compound annual growth rate of 4.8% from 2022 to 2030.
“Sales of women’s health energy-based devices continue to grow as new technologies are developed,” said Dr. Gold, a Nashville, Tenn.–based dermatologist and cosmetic surgeon who is also editor-in-chief of the Journal of Cosmetic Dermatology. “Evolving societal norms have made discussions about feminine health issues acceptable. Suffering in silence is no longer necessary or advocated.”
Dr. Alexiades disclosed that she has conducted research for Candela Lasers, Lumenis, Allergan/AbbVie, InMode, and Endymed. She is also the founder and CEO of Macrene Actives. Dr. Gold disclosed that he is a consultant to and/or an investigator and a speaker for Joylux, InMode, and Alma Lasers.
PHOENIX –
“Even a cursory review of PubMed today yields over 100,000 results” on this topic, Macrene R. Alexiades, MD, PhD, associate clinical professor of dermatology at Yale University, New Haven, Conn., said at the annual conference of the American Society for Laser Medicine and Surgery. “Add to that radiofrequency and various diagnoses, the number of publications has skyrocketed, particularly over the last 10 years.”
What has been missing from this hot research topic all these years, she continued, is that no one has distilled this pile of data into a practical guide for office-based clinicians who use lasers and energy-based devices for genitourinary conditions – until now. Working with experts in gynecology and urogynecology, Dr. Alexiades spearheaded a 2-year-long effort to assemble a document on optimal protocols and best practices for genitourinary application of lasers and energy-based devices. The document, published soon after the ASLMS meeting in Lasers in Medicine and Surgery, includes a table that lists the current Food and Drug Administration approval status of devices in genitourinary applications, as well as individual sections dedicated to fractional lasers, radiofrequency (RF) devices, and high-intensity focused electromagnetic technology. It concludes with a section on the current status of clearances and future pathways.
“The work we did was exhaustive,” said Dr. Alexiades, who is also founder and director of Dermatology & Laser Surgery Center of New York. “We went through all the clinical trial data and compiled the parameters that, as a consensus, we agree are best practices for each technology for which we had rigorous published data.”
The document contains a brief background on the history of the devices used for genitourinary issues and it addresses core topics for each technology, such as conditions treated, contraindications, preoperative physical assessment and preparation, perioperative protocols, and postoperative care.
Contraindications to the genitourinary use of lasers and energy-based devices are numerous and include use of an intrauterine device, active urinary tract or genital infection, vaginal bleeding, current pregnancy, active or recent malignancy, having an electrical implant anywhere in the body, significant concurrent illness, and an anticoagulative or thromboembolic condition or taking anticoagulant medications 1 week prior to the procedure. Another condition to screen for is advanced prolapse, which was considered a contraindication in all clinical trials, she added. “It’s important that you’re able to do the speculum exam and stage the prolapse” so that a patient with this contraindication is not treated.
Dr. Alexiades shared the following highlights from the document’s section related to the use of fractional CO2 lasers:
Preoperative management. Schedule the treatment one week after the patient’s menstrual period. Patients should avoid blood thinners for 7 days and avoid intercourse the night before the procedure. Reschedule in the case of fever, chills, or vaginal bleeding or discharge.
Preoperative physical exam and testing. A normal speculum exam and a recent negative PAP smear are required. For those of child-bearing potential, a pregnancy test is warranted. Obtain written and verbal consent, including discussion of all treatment options, risks, and benefits. No topical or local anesthesia is necessary internally. “Externally, we sometimes apply topical lidocaine gel, but I have found that’s not necessary in most cases,” Dr. Alexiades said. “The treatment is so quick.”
Peri-operative management. In general, device settings are provided by the manufacturer. “For most of the studies that had successful outcomes and no adverse events, researchers adhered to the mild or moderate settings on the technology,” she said. Energy settings were between 15 and 30 watts, delivered at a laser fluence of about 250-300 mJ/cm2 with a spacing of microbeams 1 mm apart. Typically, three treatments are done at 1-month intervals and maintenance treatments are recommended at 6 and 12 months based on duration of the outcomes.
Vulvovaginal postoperative management. A 3-day recovery time is recommended with avoidance of intercourse during this period, because “re-epithelialization is usually complete in 3 days, so we want to give the opportunity for the lining to heal prior to introducing any friction, Dr. Alexiades said.” Rarely, spotting or discharge may occur and there should be no discomfort. “Any severe discomfort or burning may potentially signify infection and should prompt evaluation and possibly vaginal cultures. The patient can shower, but we recommend avoiding seated baths to decrease any introduction of infectious agents.”
Patients should be followed up monthly until three treatments are completed, and a maintenance treatment is considered appropriate between 6 and 12 months. “I do recommend doing a 1-month follow-up following the final treatment, unless it’s a patient who has already had a series of three treatments and is coming in for maintenance,” she said.
In a study from her own practice, Dr. Alexiades evaluated a series of three fractional CO2 laser treatments to the vulva and vagina with a 1-year follow-up in postmenopausal patients. She used the Vaginal Health Index (VHI) to assess changes in vaginal elasticity, fluid volume, vaginal pH, epithelial integrity, and moisture. She and her colleagues discovered that there was improvement in every VHI category after treatment and during the follow-up interval up to 6 months.
“Between 6 and 12 months, we started to see a return a bit toward baseline on all of these parameters,” she said. “The serendipitous discovery that I made during the course of that study was that early intervention improves outcomes. I observed that the younger, most recently postmenopausal cohort seemed to attain normal or near normal VHI quicker than the more extended postmenopausal cohorts.”
In an editorial published in 2020, Dr. Alexiades reviewed the effects of fractional CO2 laser treatment of vulvar skin on vaginal pH and referred to a study she conducted that found that the mean baseline pH pretreatment was 6.32 in the cohort of postmenopausal patients, and was reduced after 3 treatments. “Postmenopausally, the normal acidic pH becomes alkaline,” she said. But she did not expect to see an additional reduction in pH following the treatment out to 6 months. “This indicates that, whatever the wound healing and other restorative effects of these devices are, they seem to continue out to 6 months, at which point it turns around and moves toward baseline [levels].”
Dr. Alexiades highlighted two published meta-analyses of studies related to the genitourinary use of lasers and energy-based devices. One included 59 studies of 3,609 women treated for vaginal rejuvenation using either radiofrequency or fractional ablative laser therapy. The studies reported improvements in symptoms of GSM/VVA and sexual function, high patient satisfaction, with minor adverse events, including treatment-associated vaginal swelling or vaginal discharge.
“Further research needs to be completed to determine which specific pathologies can be treated, if maintenance treatment is necessary, and long-term safety concerns,” the authors concluded.
In another review, researchers analyzed 64 studies related to vaginal laser therapy for GSM. Of these, 47 were before and after studies without a control group, 10 were controlled intervention studies, and 7 were observational cohort and cross-sectional studies.
Vaginal laser treatment “seems to improve scores on the visual analogue scale, Female Sexual Function Index, and the Vaginal Health Index over the short term,” the authors wrote. “Safety outcomes are underreported and short term. Further well-designed clinical trials with sham-laser control groups and evaluating objective variables are needed to provide the best evidence on efficacy.”
“Lasers and energy-based devices are now considered alternative therapeutic modalities for genitourinary conditions,” Dr. Alexiades concluded. “The shortcomings in the literature with respect to lasers and device treatments demonstrate the need for the consensus on best practices and protocols.”
During a separate presentation at the meeting, Michael Gold, MD, highlighted data from Grand View Research, a market research database, which estimated that the global women’s health and wellness market is valued at more than $31 billion globally and is expected to grow at a compound annual growth rate of 4.8% from 2022 to 2030.
“Sales of women’s health energy-based devices continue to grow as new technologies are developed,” said Dr. Gold, a Nashville, Tenn.–based dermatologist and cosmetic surgeon who is also editor-in-chief of the Journal of Cosmetic Dermatology. “Evolving societal norms have made discussions about feminine health issues acceptable. Suffering in silence is no longer necessary or advocated.”
Dr. Alexiades disclosed that she has conducted research for Candela Lasers, Lumenis, Allergan/AbbVie, InMode, and Endymed. She is also the founder and CEO of Macrene Actives. Dr. Gold disclosed that he is a consultant to and/or an investigator and a speaker for Joylux, InMode, and Alma Lasers.
PHOENIX –
“Even a cursory review of PubMed today yields over 100,000 results” on this topic, Macrene R. Alexiades, MD, PhD, associate clinical professor of dermatology at Yale University, New Haven, Conn., said at the annual conference of the American Society for Laser Medicine and Surgery. “Add to that radiofrequency and various diagnoses, the number of publications has skyrocketed, particularly over the last 10 years.”
What has been missing from this hot research topic all these years, she continued, is that no one has distilled this pile of data into a practical guide for office-based clinicians who use lasers and energy-based devices for genitourinary conditions – until now. Working with experts in gynecology and urogynecology, Dr. Alexiades spearheaded a 2-year-long effort to assemble a document on optimal protocols and best practices for genitourinary application of lasers and energy-based devices. The document, published soon after the ASLMS meeting in Lasers in Medicine and Surgery, includes a table that lists the current Food and Drug Administration approval status of devices in genitourinary applications, as well as individual sections dedicated to fractional lasers, radiofrequency (RF) devices, and high-intensity focused electromagnetic technology. It concludes with a section on the current status of clearances and future pathways.
“The work we did was exhaustive,” said Dr. Alexiades, who is also founder and director of Dermatology & Laser Surgery Center of New York. “We went through all the clinical trial data and compiled the parameters that, as a consensus, we agree are best practices for each technology for which we had rigorous published data.”
The document contains a brief background on the history of the devices used for genitourinary issues and it addresses core topics for each technology, such as conditions treated, contraindications, preoperative physical assessment and preparation, perioperative protocols, and postoperative care.
Contraindications to the genitourinary use of lasers and energy-based devices are numerous and include use of an intrauterine device, active urinary tract or genital infection, vaginal bleeding, current pregnancy, active or recent malignancy, having an electrical implant anywhere in the body, significant concurrent illness, and an anticoagulative or thromboembolic condition or taking anticoagulant medications 1 week prior to the procedure. Another condition to screen for is advanced prolapse, which was considered a contraindication in all clinical trials, she added. “It’s important that you’re able to do the speculum exam and stage the prolapse” so that a patient with this contraindication is not treated.
Dr. Alexiades shared the following highlights from the document’s section related to the use of fractional CO2 lasers:
Preoperative management. Schedule the treatment one week after the patient’s menstrual period. Patients should avoid blood thinners for 7 days and avoid intercourse the night before the procedure. Reschedule in the case of fever, chills, or vaginal bleeding or discharge.
Preoperative physical exam and testing. A normal speculum exam and a recent negative PAP smear are required. For those of child-bearing potential, a pregnancy test is warranted. Obtain written and verbal consent, including discussion of all treatment options, risks, and benefits. No topical or local anesthesia is necessary internally. “Externally, we sometimes apply topical lidocaine gel, but I have found that’s not necessary in most cases,” Dr. Alexiades said. “The treatment is so quick.”
Peri-operative management. In general, device settings are provided by the manufacturer. “For most of the studies that had successful outcomes and no adverse events, researchers adhered to the mild or moderate settings on the technology,” she said. Energy settings were between 15 and 30 watts, delivered at a laser fluence of about 250-300 mJ/cm2 with a spacing of microbeams 1 mm apart. Typically, three treatments are done at 1-month intervals and maintenance treatments are recommended at 6 and 12 months based on duration of the outcomes.
Vulvovaginal postoperative management. A 3-day recovery time is recommended with avoidance of intercourse during this period, because “re-epithelialization is usually complete in 3 days, so we want to give the opportunity for the lining to heal prior to introducing any friction, Dr. Alexiades said.” Rarely, spotting or discharge may occur and there should be no discomfort. “Any severe discomfort or burning may potentially signify infection and should prompt evaluation and possibly vaginal cultures. The patient can shower, but we recommend avoiding seated baths to decrease any introduction of infectious agents.”
Patients should be followed up monthly until three treatments are completed, and a maintenance treatment is considered appropriate between 6 and 12 months. “I do recommend doing a 1-month follow-up following the final treatment, unless it’s a patient who has already had a series of three treatments and is coming in for maintenance,” she said.
In a study from her own practice, Dr. Alexiades evaluated a series of three fractional CO2 laser treatments to the vulva and vagina with a 1-year follow-up in postmenopausal patients. She used the Vaginal Health Index (VHI) to assess changes in vaginal elasticity, fluid volume, vaginal pH, epithelial integrity, and moisture. She and her colleagues discovered that there was improvement in every VHI category after treatment and during the follow-up interval up to 6 months.
“Between 6 and 12 months, we started to see a return a bit toward baseline on all of these parameters,” she said. “The serendipitous discovery that I made during the course of that study was that early intervention improves outcomes. I observed that the younger, most recently postmenopausal cohort seemed to attain normal or near normal VHI quicker than the more extended postmenopausal cohorts.”
In an editorial published in 2020, Dr. Alexiades reviewed the effects of fractional CO2 laser treatment of vulvar skin on vaginal pH and referred to a study she conducted that found that the mean baseline pH pretreatment was 6.32 in the cohort of postmenopausal patients, and was reduced after 3 treatments. “Postmenopausally, the normal acidic pH becomes alkaline,” she said. But she did not expect to see an additional reduction in pH following the treatment out to 6 months. “This indicates that, whatever the wound healing and other restorative effects of these devices are, they seem to continue out to 6 months, at which point it turns around and moves toward baseline [levels].”
Dr. Alexiades highlighted two published meta-analyses of studies related to the genitourinary use of lasers and energy-based devices. One included 59 studies of 3,609 women treated for vaginal rejuvenation using either radiofrequency or fractional ablative laser therapy. The studies reported improvements in symptoms of GSM/VVA and sexual function, high patient satisfaction, with minor adverse events, including treatment-associated vaginal swelling or vaginal discharge.
“Further research needs to be completed to determine which specific pathologies can be treated, if maintenance treatment is necessary, and long-term safety concerns,” the authors concluded.
In another review, researchers analyzed 64 studies related to vaginal laser therapy for GSM. Of these, 47 were before and after studies without a control group, 10 were controlled intervention studies, and 7 were observational cohort and cross-sectional studies.
Vaginal laser treatment “seems to improve scores on the visual analogue scale, Female Sexual Function Index, and the Vaginal Health Index over the short term,” the authors wrote. “Safety outcomes are underreported and short term. Further well-designed clinical trials with sham-laser control groups and evaluating objective variables are needed to provide the best evidence on efficacy.”
“Lasers and energy-based devices are now considered alternative therapeutic modalities for genitourinary conditions,” Dr. Alexiades concluded. “The shortcomings in the literature with respect to lasers and device treatments demonstrate the need for the consensus on best practices and protocols.”
During a separate presentation at the meeting, Michael Gold, MD, highlighted data from Grand View Research, a market research database, which estimated that the global women’s health and wellness market is valued at more than $31 billion globally and is expected to grow at a compound annual growth rate of 4.8% from 2022 to 2030.
“Sales of women’s health energy-based devices continue to grow as new technologies are developed,” said Dr. Gold, a Nashville, Tenn.–based dermatologist and cosmetic surgeon who is also editor-in-chief of the Journal of Cosmetic Dermatology. “Evolving societal norms have made discussions about feminine health issues acceptable. Suffering in silence is no longer necessary or advocated.”
Dr. Alexiades disclosed that she has conducted research for Candela Lasers, Lumenis, Allergan/AbbVie, InMode, and Endymed. She is also the founder and CEO of Macrene Actives. Dr. Gold disclosed that he is a consultant to and/or an investigator and a speaker for Joylux, InMode, and Alma Lasers.
AT ASLMS 2023
What are the main reasons patients sue dermatologists?
PHOENIX – , and the defendants were more likely to be male.
Those are among key findings from a study that aimed to determine the reasons patients pursue litigation against dermatologists.
“The number of lawsuits against physicians continues to climb annually,” Young Lim, MD, PhD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the results were presented during an abstract session. “Depending on the study, anywhere between 75 to 99 percent of physicians will face a lawsuit by age 65. A clear understanding of prior litigations will help mitigate similar errors in future practice and promote safer, higher quality care.”
Dr. Lim, a dermatology resident at Massachusetts General Hospital and Harvard Medical School, Boston, along with Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at MGH, and H. Ray Jalian, MD, a cosmetic dermatologist who practices in Los Angeles, used two large national database repositories, WestlawNext and LexisNexis, to retrospectively analyze legal documents following a query using “dermatology” and “dermatologist” as search terms to capture all variety of litigations. They excluded cases in which litigation did not involve patient care as well as those in which the dermatologist was the plaintiff and those in which the dermatologist was involved as a third party.
The final analysis consisted of 54 claims, comprising 43 state and 11 federal cases. Of the 54 cases, 35 involved a male defendant, 12 involved a female defendant, and 7 cases either did not specify the gender of the defendant or involved multiple defendants. Of the 35 cases involving a male defendant, 23 (66%) were brought by female plaintiffs.
Most cases (49, or 91%) involved a defendant dermatologist in private practice while the remaining 5 involved a defendant dermatologist in an academic setting.
The most common reason for litigation was accidental injury (27 cases, or 50%), followed by incorrect or delayed diagnoses (22 cases, or 41%). Five cases resulted from the dermatologist failing to communicate important information, such as postop care instructions or obtaining informed consent.
Of all 54 cases 30 (56%) were dismissed prior to trial, while 24 (44%) resulted in a judgment for the plaintiff. According to Dr. Lim, payout information was available for only five cases, and ranged from $15,000 (injury from laser) to $1,950,000 (delayed diagnosis of malignant melanoma).
“While lawsuits from patients against dermatologists largely involve injury from elective procedures, clinicians should practice caution regarding missed or delayed diagnoses when practicing medical dermatology,” the authors concluded in their abstract. “Ensuring that critical information is shared with patients and obtaining proper written consent will also safeguard against easily-avoidable litigations.”
Christopher B. Zachary, MBBS, professor and chair emeritus of the department of dermatology at the University of California, Irvine, who was asked to comment on the study, said that the findings are a reminder that lack of attention to the most simply performed aspects of care can be the reasons patients will seek medical malpractice redress.
“Consent requires careful and thoughtful explanation of a planned procedure, which should then be recorded in the chart to avoid future confusion,” Dr. Zachary told this news organization. “A patient’s signature on a consent form obtained by a staff member is clearly inadequate if not accompanied by a clear and understandable preoperative discussion. Words, images, video are all elements that aid patients’ comprehension of a planned procedure. And postoperative instructions given to the patients while on the laser table are commonly forgotten by the patient and must be accompanied by written advice summary. Patients will frequently misremember instructions and can be overwhelmed by medical jargon.”
Neither the researchers nor Dr. Zachary reported having relevant financial disclosures.
PHOENIX – , and the defendants were more likely to be male.
Those are among key findings from a study that aimed to determine the reasons patients pursue litigation against dermatologists.
“The number of lawsuits against physicians continues to climb annually,” Young Lim, MD, PhD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the results were presented during an abstract session. “Depending on the study, anywhere between 75 to 99 percent of physicians will face a lawsuit by age 65. A clear understanding of prior litigations will help mitigate similar errors in future practice and promote safer, higher quality care.”
Dr. Lim, a dermatology resident at Massachusetts General Hospital and Harvard Medical School, Boston, along with Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at MGH, and H. Ray Jalian, MD, a cosmetic dermatologist who practices in Los Angeles, used two large national database repositories, WestlawNext and LexisNexis, to retrospectively analyze legal documents following a query using “dermatology” and “dermatologist” as search terms to capture all variety of litigations. They excluded cases in which litigation did not involve patient care as well as those in which the dermatologist was the plaintiff and those in which the dermatologist was involved as a third party.
The final analysis consisted of 54 claims, comprising 43 state and 11 federal cases. Of the 54 cases, 35 involved a male defendant, 12 involved a female defendant, and 7 cases either did not specify the gender of the defendant or involved multiple defendants. Of the 35 cases involving a male defendant, 23 (66%) were brought by female plaintiffs.
Most cases (49, or 91%) involved a defendant dermatologist in private practice while the remaining 5 involved a defendant dermatologist in an academic setting.
The most common reason for litigation was accidental injury (27 cases, or 50%), followed by incorrect or delayed diagnoses (22 cases, or 41%). Five cases resulted from the dermatologist failing to communicate important information, such as postop care instructions or obtaining informed consent.
Of all 54 cases 30 (56%) were dismissed prior to trial, while 24 (44%) resulted in a judgment for the plaintiff. According to Dr. Lim, payout information was available for only five cases, and ranged from $15,000 (injury from laser) to $1,950,000 (delayed diagnosis of malignant melanoma).
“While lawsuits from patients against dermatologists largely involve injury from elective procedures, clinicians should practice caution regarding missed or delayed diagnoses when practicing medical dermatology,” the authors concluded in their abstract. “Ensuring that critical information is shared with patients and obtaining proper written consent will also safeguard against easily-avoidable litigations.”
Christopher B. Zachary, MBBS, professor and chair emeritus of the department of dermatology at the University of California, Irvine, who was asked to comment on the study, said that the findings are a reminder that lack of attention to the most simply performed aspects of care can be the reasons patients will seek medical malpractice redress.
“Consent requires careful and thoughtful explanation of a planned procedure, which should then be recorded in the chart to avoid future confusion,” Dr. Zachary told this news organization. “A patient’s signature on a consent form obtained by a staff member is clearly inadequate if not accompanied by a clear and understandable preoperative discussion. Words, images, video are all elements that aid patients’ comprehension of a planned procedure. And postoperative instructions given to the patients while on the laser table are commonly forgotten by the patient and must be accompanied by written advice summary. Patients will frequently misremember instructions and can be overwhelmed by medical jargon.”
Neither the researchers nor Dr. Zachary reported having relevant financial disclosures.
PHOENIX – , and the defendants were more likely to be male.
Those are among key findings from a study that aimed to determine the reasons patients pursue litigation against dermatologists.
“The number of lawsuits against physicians continues to climb annually,” Young Lim, MD, PhD, said at the annual conference of the American Society for Laser Medicine and Surgery, where the results were presented during an abstract session. “Depending on the study, anywhere between 75 to 99 percent of physicians will face a lawsuit by age 65. A clear understanding of prior litigations will help mitigate similar errors in future practice and promote safer, higher quality care.”
Dr. Lim, a dermatology resident at Massachusetts General Hospital and Harvard Medical School, Boston, along with Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at MGH, and H. Ray Jalian, MD, a cosmetic dermatologist who practices in Los Angeles, used two large national database repositories, WestlawNext and LexisNexis, to retrospectively analyze legal documents following a query using “dermatology” and “dermatologist” as search terms to capture all variety of litigations. They excluded cases in which litigation did not involve patient care as well as those in which the dermatologist was the plaintiff and those in which the dermatologist was involved as a third party.
The final analysis consisted of 54 claims, comprising 43 state and 11 federal cases. Of the 54 cases, 35 involved a male defendant, 12 involved a female defendant, and 7 cases either did not specify the gender of the defendant or involved multiple defendants. Of the 35 cases involving a male defendant, 23 (66%) were brought by female plaintiffs.
Most cases (49, or 91%) involved a defendant dermatologist in private practice while the remaining 5 involved a defendant dermatologist in an academic setting.
The most common reason for litigation was accidental injury (27 cases, or 50%), followed by incorrect or delayed diagnoses (22 cases, or 41%). Five cases resulted from the dermatologist failing to communicate important information, such as postop care instructions or obtaining informed consent.
Of all 54 cases 30 (56%) were dismissed prior to trial, while 24 (44%) resulted in a judgment for the plaintiff. According to Dr. Lim, payout information was available for only five cases, and ranged from $15,000 (injury from laser) to $1,950,000 (delayed diagnosis of malignant melanoma).
“While lawsuits from patients against dermatologists largely involve injury from elective procedures, clinicians should practice caution regarding missed or delayed diagnoses when practicing medical dermatology,” the authors concluded in their abstract. “Ensuring that critical information is shared with patients and obtaining proper written consent will also safeguard against easily-avoidable litigations.”
Christopher B. Zachary, MBBS, professor and chair emeritus of the department of dermatology at the University of California, Irvine, who was asked to comment on the study, said that the findings are a reminder that lack of attention to the most simply performed aspects of care can be the reasons patients will seek medical malpractice redress.
“Consent requires careful and thoughtful explanation of a planned procedure, which should then be recorded in the chart to avoid future confusion,” Dr. Zachary told this news organization. “A patient’s signature on a consent form obtained by a staff member is clearly inadequate if not accompanied by a clear and understandable preoperative discussion. Words, images, video are all elements that aid patients’ comprehension of a planned procedure. And postoperative instructions given to the patients while on the laser table are commonly forgotten by the patient and must be accompanied by written advice summary. Patients will frequently misremember instructions and can be overwhelmed by medical jargon.”
Neither the researchers nor Dr. Zachary reported having relevant financial disclosures.
AT ASLMS 2023
Ten-year analysis finds relatively low complication rate from fractional resurfacing lasers
PHOENIX – over a decade showed.
To investigate, Dr. Hashemi, a third-year dermatology resident at Harvard University and Massachusetts General Hospital, Boston, and Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at MGH, drew from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, which compiles medical device reports for suspected injuries from device use or malfunction and represents the largest repository of device adverse effects. Medical device reports are submitted by manufacturers, clinicians, patients, and others.
The researchers limited their query to MDRs related to ablative and nonablative fractional resurfacing lasers over the 10-year period from 2013 to 2022. The query was performed in January 2023 using a comprehensive list of product names and manufacturers.
The initial search yielded 240 MDRs, which were individually reviewed for duplicate records or insufficient data, and the final analysis included 165 MDRs. The 10 most reported adverse events were burns (30%), followed by dyspigmentation (14%), scarring (12%), other (11%), postoperative infection (8%), blisters (6%), pain (5%), hypertrophic scar (4%), post-treatment inflammation (4%), and textural changes (3%). Within the 10-year period analyzed, 56% of MDRs occurred between 2016 and 2019, with a disproportionately low percentage of MDRs occurring in 2022 (5%).
“Adverse events due to ablative and nonablative fractional resurfacing lasers are rare but potentially serious,” Dr. Hashemi concluded. “Care must be taken with counseling, patient selection, and treatment settings to optimize safety, informed consent, and patient satisfaction. Given the relatively low number of adverse events seen with fractional resurfacing lasers, factors driving their safety should be further explored.”
He added that he was surprised by the relatively low number of reported issues, referring to the total of 165 cases over 10 years. By comparison, he said, body contouring had 660 cases reported over a 7-year period in one recent study.
According to the MAUDE website, submitting MDRs to MAUDE is mandatory for manufacturers, importers, and device user facilities, and are voluntary for other groups, such as health care professionals, patients, and consumers.
Dr. Hashemi disclosed that he is a consultant for Castle Biosciences. He is also an entrepreneur in residence for Gore Range Capital.
PHOENIX – over a decade showed.
To investigate, Dr. Hashemi, a third-year dermatology resident at Harvard University and Massachusetts General Hospital, Boston, and Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at MGH, drew from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, which compiles medical device reports for suspected injuries from device use or malfunction and represents the largest repository of device adverse effects. Medical device reports are submitted by manufacturers, clinicians, patients, and others.
The researchers limited their query to MDRs related to ablative and nonablative fractional resurfacing lasers over the 10-year period from 2013 to 2022. The query was performed in January 2023 using a comprehensive list of product names and manufacturers.
The initial search yielded 240 MDRs, which were individually reviewed for duplicate records or insufficient data, and the final analysis included 165 MDRs. The 10 most reported adverse events were burns (30%), followed by dyspigmentation (14%), scarring (12%), other (11%), postoperative infection (8%), blisters (6%), pain (5%), hypertrophic scar (4%), post-treatment inflammation (4%), and textural changes (3%). Within the 10-year period analyzed, 56% of MDRs occurred between 2016 and 2019, with a disproportionately low percentage of MDRs occurring in 2022 (5%).
“Adverse events due to ablative and nonablative fractional resurfacing lasers are rare but potentially serious,” Dr. Hashemi concluded. “Care must be taken with counseling, patient selection, and treatment settings to optimize safety, informed consent, and patient satisfaction. Given the relatively low number of adverse events seen with fractional resurfacing lasers, factors driving their safety should be further explored.”
He added that he was surprised by the relatively low number of reported issues, referring to the total of 165 cases over 10 years. By comparison, he said, body contouring had 660 cases reported over a 7-year period in one recent study.
According to the MAUDE website, submitting MDRs to MAUDE is mandatory for manufacturers, importers, and device user facilities, and are voluntary for other groups, such as health care professionals, patients, and consumers.
Dr. Hashemi disclosed that he is a consultant for Castle Biosciences. He is also an entrepreneur in residence for Gore Range Capital.
PHOENIX – over a decade showed.
To investigate, Dr. Hashemi, a third-year dermatology resident at Harvard University and Massachusetts General Hospital, Boston, and Mathew M. Avram, MD, JD, director of laser, cosmetics, and dermatologic surgery at MGH, drew from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, which compiles medical device reports for suspected injuries from device use or malfunction and represents the largest repository of device adverse effects. Medical device reports are submitted by manufacturers, clinicians, patients, and others.
The researchers limited their query to MDRs related to ablative and nonablative fractional resurfacing lasers over the 10-year period from 2013 to 2022. The query was performed in January 2023 using a comprehensive list of product names and manufacturers.
The initial search yielded 240 MDRs, which were individually reviewed for duplicate records or insufficient data, and the final analysis included 165 MDRs. The 10 most reported adverse events were burns (30%), followed by dyspigmentation (14%), scarring (12%), other (11%), postoperative infection (8%), blisters (6%), pain (5%), hypertrophic scar (4%), post-treatment inflammation (4%), and textural changes (3%). Within the 10-year period analyzed, 56% of MDRs occurred between 2016 and 2019, with a disproportionately low percentage of MDRs occurring in 2022 (5%).
“Adverse events due to ablative and nonablative fractional resurfacing lasers are rare but potentially serious,” Dr. Hashemi concluded. “Care must be taken with counseling, patient selection, and treatment settings to optimize safety, informed consent, and patient satisfaction. Given the relatively low number of adverse events seen with fractional resurfacing lasers, factors driving their safety should be further explored.”
He added that he was surprised by the relatively low number of reported issues, referring to the total of 165 cases over 10 years. By comparison, he said, body contouring had 660 cases reported over a 7-year period in one recent study.
According to the MAUDE website, submitting MDRs to MAUDE is mandatory for manufacturers, importers, and device user facilities, and are voluntary for other groups, such as health care professionals, patients, and consumers.
Dr. Hashemi disclosed that he is a consultant for Castle Biosciences. He is also an entrepreneur in residence for Gore Range Capital.
AT ASLMS 2023
Study compares noninvasive treatments of cutaneous neurofibromas
PHOENIX – after only one treatment, according to preliminary results of an ongoing prospective trial that compared several treatment modalities.
“Neurofibromatosis type 1 is the most common single-gene disease of mankind, but there is so much we have yet to learn about it,” study author Patricia Richey, MD, who practices Mohs surgery and cosmetic dermatology in Washington, D.C., said in an interview in advance of the annual conference of the American Society for Laser Medicine and Surgery, where she presented the results during an abstract session. Dr. Richey also conducts research for the Wellman Center for Photomedicine and the Dermatology Laser and Cosmetic Center at Massachusetts General Hospital, Boston, and is working with R. Rox Anderson, MD, director of the Wellman Center, on this project. In his words, she said, “the lack of better treatments for cNF is a ‘problem worth solving.’ ”
“The accepted and widely available treatments for cNF result in scars and hypopigmentation. Our treatments do not,” she added. Since the epidermis overlying cNF is normal, “there is no reason to use nonselective or surgical methods and destroy a perfectly good epidermis when you don’t need to.”
Four treatments vs. controls
For the study, Dr. Richey and colleagues enrolled 19 adults with a total of 307 cNFs measuring 2-4 mm in size to receive one of four treatments: electrocautery with an insulated radiofrequency needle; 755-nm alexandrite laser with negative pressure (8-mm spot size, 100 J/cm2 fluence, 3-ms pulse duration); 980-nm diode laser (delivered via 8-mm sapphire skin-contact window), and intratumoral injection of 10 mg/mL deoxycholic acid at a volume approximately equal to that of the tumor. The average age of the participants was 49 years and 15 were female.
The investigators applied 5% lidocaine/prilocaine for 40 minutes to treatment sites before randomizing the tumors to treatment or to the control arm (no treatment). They compared safety, tolerability (including pain scores), and efficacy of each modality as measured by the change in cNF volume/height via three-dimensional imaging and clinical improvement via physician assessment at 6 months. All 19 participants have completed the 6-month assessment.
All modalities reduced or eliminated some of the cNFs by 6 months after treatment, with statistically significant reductions in height and volume across all four treatments. A wide variation of responses was observed. Specifically, the mean tumor volume changes for each modality, compared with controls, were –33.4% versus –5.1% among those treated with the 755-nm alexandrite laser; –24.9% versus –9.2% among those treated with the 980-nm diode laser, –23.3% versus –0.8% among those treated with insulated-needle radiofrequency coagulation, and –29.4% versus –3.7% among those treated with deoxycholic acid.
The variation in responses “may be due to histologic diversity of cNF or may indicate a need for more fine-tuned dosimetry, or a combination,” Dr. Richey said. “Our future trials will address this. We will also be treating all skin types in our upcoming trials.”
No adverse events categorized as higher than grade 2 occurred in any of the treatment groups, and no signs of regrowth or growth stimulation have been observed to date.
Tolerability of treatments
As for general tolerability, the 980-nm laser treatment caused moderate to severe pain; the alexandrite laser caused mild pain; insulated-needle radiofrequency coagulation caused mild pain, though more than deoxycholic acid injections or alexandrite laser, and pain associated with the deoxycholic acid injections was minimal.
When residual neurofibroma tumor was present histologically, its appearance was similar to that of untreated tumors in controls. There was no evidence of atypia, mitosis, or tumor inflammation, and mild fibrosis was present at the sites of prior tumor.
“It was surprising that all four modalities did work to some extent,” Dr. Richey said, noting that the lack of ulceration with deoxycholic acid injection “was pleasantly surprising.” Treatment with the 980-nm diode laser “was a bit more painful than we anticipated.”
The positive results of this trial has raised “more questions for us to answer. We have three additional trials in the works to fine tune these treatments and optimize dose/delivery, with the end goal of treating younger people.”
Dr. Richey said that she was “amazed” by how motivated the enrollees were to participate in the trial, noting that many patients with cNF undergo general anesthesia to have dozens of tumors surgically removed at once. “They pay $10,000-$20,000 on average out of pocket, as this surgery is considered cosmetic,” she said.
“This very important study could lead to effective, relatively noninvasive, therapy for small neurofibromas,” said Jeffrey S. Dover, MD, codirector of SkinCare Physicians in Chestnut Hill, Mass., who was not involved with the study and was asked to comment on the results.
“Remarkably, all four treatments worked to varying degrees, but of all the treatments, the selective alexandrite laser appeared to achieve the best results. Further study will be needed to see just how effective these treatments are, and to determine the best and safest treatment parameters. Given how common this autosomal dominant disease is, and how disfiguring neurofibromas become as they enlarge, a well-tolerated noninvasive nonsurgical treatment with limited side effects is highly sought after.”
The study, which was named the best clinical abstract at the meeting, was supported by the Neurofibromatosis Therapeutic Acceleration Program. Dr. Anderson is supported in part as the Lancer Endowed Chair in Dermatology at MGH. Dr. Dover reported having no relevant disclosures.
PHOENIX – after only one treatment, according to preliminary results of an ongoing prospective trial that compared several treatment modalities.
“Neurofibromatosis type 1 is the most common single-gene disease of mankind, but there is so much we have yet to learn about it,” study author Patricia Richey, MD, who practices Mohs surgery and cosmetic dermatology in Washington, D.C., said in an interview in advance of the annual conference of the American Society for Laser Medicine and Surgery, where she presented the results during an abstract session. Dr. Richey also conducts research for the Wellman Center for Photomedicine and the Dermatology Laser and Cosmetic Center at Massachusetts General Hospital, Boston, and is working with R. Rox Anderson, MD, director of the Wellman Center, on this project. In his words, she said, “the lack of better treatments for cNF is a ‘problem worth solving.’ ”
“The accepted and widely available treatments for cNF result in scars and hypopigmentation. Our treatments do not,” she added. Since the epidermis overlying cNF is normal, “there is no reason to use nonselective or surgical methods and destroy a perfectly good epidermis when you don’t need to.”
Four treatments vs. controls
For the study, Dr. Richey and colleagues enrolled 19 adults with a total of 307 cNFs measuring 2-4 mm in size to receive one of four treatments: electrocautery with an insulated radiofrequency needle; 755-nm alexandrite laser with negative pressure (8-mm spot size, 100 J/cm2 fluence, 3-ms pulse duration); 980-nm diode laser (delivered via 8-mm sapphire skin-contact window), and intratumoral injection of 10 mg/mL deoxycholic acid at a volume approximately equal to that of the tumor. The average age of the participants was 49 years and 15 were female.
The investigators applied 5% lidocaine/prilocaine for 40 minutes to treatment sites before randomizing the tumors to treatment or to the control arm (no treatment). They compared safety, tolerability (including pain scores), and efficacy of each modality as measured by the change in cNF volume/height via three-dimensional imaging and clinical improvement via physician assessment at 6 months. All 19 participants have completed the 6-month assessment.
All modalities reduced or eliminated some of the cNFs by 6 months after treatment, with statistically significant reductions in height and volume across all four treatments. A wide variation of responses was observed. Specifically, the mean tumor volume changes for each modality, compared with controls, were –33.4% versus –5.1% among those treated with the 755-nm alexandrite laser; –24.9% versus –9.2% among those treated with the 980-nm diode laser, –23.3% versus –0.8% among those treated with insulated-needle radiofrequency coagulation, and –29.4% versus –3.7% among those treated with deoxycholic acid.
The variation in responses “may be due to histologic diversity of cNF or may indicate a need for more fine-tuned dosimetry, or a combination,” Dr. Richey said. “Our future trials will address this. We will also be treating all skin types in our upcoming trials.”
No adverse events categorized as higher than grade 2 occurred in any of the treatment groups, and no signs of regrowth or growth stimulation have been observed to date.
Tolerability of treatments
As for general tolerability, the 980-nm laser treatment caused moderate to severe pain; the alexandrite laser caused mild pain; insulated-needle radiofrequency coagulation caused mild pain, though more than deoxycholic acid injections or alexandrite laser, and pain associated with the deoxycholic acid injections was minimal.
When residual neurofibroma tumor was present histologically, its appearance was similar to that of untreated tumors in controls. There was no evidence of atypia, mitosis, or tumor inflammation, and mild fibrosis was present at the sites of prior tumor.
“It was surprising that all four modalities did work to some extent,” Dr. Richey said, noting that the lack of ulceration with deoxycholic acid injection “was pleasantly surprising.” Treatment with the 980-nm diode laser “was a bit more painful than we anticipated.”
The positive results of this trial has raised “more questions for us to answer. We have three additional trials in the works to fine tune these treatments and optimize dose/delivery, with the end goal of treating younger people.”
Dr. Richey said that she was “amazed” by how motivated the enrollees were to participate in the trial, noting that many patients with cNF undergo general anesthesia to have dozens of tumors surgically removed at once. “They pay $10,000-$20,000 on average out of pocket, as this surgery is considered cosmetic,” she said.
“This very important study could lead to effective, relatively noninvasive, therapy for small neurofibromas,” said Jeffrey S. Dover, MD, codirector of SkinCare Physicians in Chestnut Hill, Mass., who was not involved with the study and was asked to comment on the results.
“Remarkably, all four treatments worked to varying degrees, but of all the treatments, the selective alexandrite laser appeared to achieve the best results. Further study will be needed to see just how effective these treatments are, and to determine the best and safest treatment parameters. Given how common this autosomal dominant disease is, and how disfiguring neurofibromas become as they enlarge, a well-tolerated noninvasive nonsurgical treatment with limited side effects is highly sought after.”
The study, which was named the best clinical abstract at the meeting, was supported by the Neurofibromatosis Therapeutic Acceleration Program. Dr. Anderson is supported in part as the Lancer Endowed Chair in Dermatology at MGH. Dr. Dover reported having no relevant disclosures.
PHOENIX – after only one treatment, according to preliminary results of an ongoing prospective trial that compared several treatment modalities.
“Neurofibromatosis type 1 is the most common single-gene disease of mankind, but there is so much we have yet to learn about it,” study author Patricia Richey, MD, who practices Mohs surgery and cosmetic dermatology in Washington, D.C., said in an interview in advance of the annual conference of the American Society for Laser Medicine and Surgery, where she presented the results during an abstract session. Dr. Richey also conducts research for the Wellman Center for Photomedicine and the Dermatology Laser and Cosmetic Center at Massachusetts General Hospital, Boston, and is working with R. Rox Anderson, MD, director of the Wellman Center, on this project. In his words, she said, “the lack of better treatments for cNF is a ‘problem worth solving.’ ”
“The accepted and widely available treatments for cNF result in scars and hypopigmentation. Our treatments do not,” she added. Since the epidermis overlying cNF is normal, “there is no reason to use nonselective or surgical methods and destroy a perfectly good epidermis when you don’t need to.”
Four treatments vs. controls
For the study, Dr. Richey and colleagues enrolled 19 adults with a total of 307 cNFs measuring 2-4 mm in size to receive one of four treatments: electrocautery with an insulated radiofrequency needle; 755-nm alexandrite laser with negative pressure (8-mm spot size, 100 J/cm2 fluence, 3-ms pulse duration); 980-nm diode laser (delivered via 8-mm sapphire skin-contact window), and intratumoral injection of 10 mg/mL deoxycholic acid at a volume approximately equal to that of the tumor. The average age of the participants was 49 years and 15 were female.
The investigators applied 5% lidocaine/prilocaine for 40 minutes to treatment sites before randomizing the tumors to treatment or to the control arm (no treatment). They compared safety, tolerability (including pain scores), and efficacy of each modality as measured by the change in cNF volume/height via three-dimensional imaging and clinical improvement via physician assessment at 6 months. All 19 participants have completed the 6-month assessment.
All modalities reduced or eliminated some of the cNFs by 6 months after treatment, with statistically significant reductions in height and volume across all four treatments. A wide variation of responses was observed. Specifically, the mean tumor volume changes for each modality, compared with controls, were –33.4% versus –5.1% among those treated with the 755-nm alexandrite laser; –24.9% versus –9.2% among those treated with the 980-nm diode laser, –23.3% versus –0.8% among those treated with insulated-needle radiofrequency coagulation, and –29.4% versus –3.7% among those treated with deoxycholic acid.
The variation in responses “may be due to histologic diversity of cNF or may indicate a need for more fine-tuned dosimetry, or a combination,” Dr. Richey said. “Our future trials will address this. We will also be treating all skin types in our upcoming trials.”
No adverse events categorized as higher than grade 2 occurred in any of the treatment groups, and no signs of regrowth or growth stimulation have been observed to date.
Tolerability of treatments
As for general tolerability, the 980-nm laser treatment caused moderate to severe pain; the alexandrite laser caused mild pain; insulated-needle radiofrequency coagulation caused mild pain, though more than deoxycholic acid injections or alexandrite laser, and pain associated with the deoxycholic acid injections was minimal.
When residual neurofibroma tumor was present histologically, its appearance was similar to that of untreated tumors in controls. There was no evidence of atypia, mitosis, or tumor inflammation, and mild fibrosis was present at the sites of prior tumor.
“It was surprising that all four modalities did work to some extent,” Dr. Richey said, noting that the lack of ulceration with deoxycholic acid injection “was pleasantly surprising.” Treatment with the 980-nm diode laser “was a bit more painful than we anticipated.”
The positive results of this trial has raised “more questions for us to answer. We have three additional trials in the works to fine tune these treatments and optimize dose/delivery, with the end goal of treating younger people.”
Dr. Richey said that she was “amazed” by how motivated the enrollees were to participate in the trial, noting that many patients with cNF undergo general anesthesia to have dozens of tumors surgically removed at once. “They pay $10,000-$20,000 on average out of pocket, as this surgery is considered cosmetic,” she said.
“This very important study could lead to effective, relatively noninvasive, therapy for small neurofibromas,” said Jeffrey S. Dover, MD, codirector of SkinCare Physicians in Chestnut Hill, Mass., who was not involved with the study and was asked to comment on the results.
“Remarkably, all four treatments worked to varying degrees, but of all the treatments, the selective alexandrite laser appeared to achieve the best results. Further study will be needed to see just how effective these treatments are, and to determine the best and safest treatment parameters. Given how common this autosomal dominant disease is, and how disfiguring neurofibromas become as they enlarge, a well-tolerated noninvasive nonsurgical treatment with limited side effects is highly sought after.”
The study, which was named the best clinical abstract at the meeting, was supported by the Neurofibromatosis Therapeutic Acceleration Program. Dr. Anderson is supported in part as the Lancer Endowed Chair in Dermatology at MGH. Dr. Dover reported having no relevant disclosures.
AT ASLMS 2023
Study suggests narrow excision margins safe in early melanoma resection
Current U.S., European, and Australian or melanoma-specific mortality (MSM), results of a retrospective study suggest.
Among 1,179 patients with stage T1a melanomas near the face, scalp, external genitalia, or other critical areas, the weighted 10-year local recurrence rate for patients who underwent resection with 10-mm margins was 5.7%, compared with 6.7% for those who had resections with 5-mm margins, a nonsignificant difference.
Weighted 10-year melanoma-specific mortality was 1.8% for patients treated with wide margins, vs. 4.2% for those treated with narrow margins, also a nonsignificant difference. Patients treated with narrow margins did have significantly fewer reconstructive surgeries than patients treated with wide margins, reported Andrea Maurichi, MD, and colleagues at the National Cancer Institute of Italy in Milan.
“Because this association was found in melanomas of the head and neck, acral, and genital sites, there is no plausible reason why it could not be extrapolated to other locations. The findings also support the need for prospective randomized clinical trials to definitively answer the important question about appropriate excision margins for T1a melanoma,” they wrote in the study, published online in JAMA Dermatology.
The authors also found, however, that Breslow thickness greater than 0.4 mm and mitotic rate greater than 1/mm2 were associated with worse MSM, and that acral lentiginous melanoma, lentigo maligna melanoma, and increasing Breslow thickness were associated with a higher incidence of local recurrence.
A melanoma expert who was not involved in the study said that despite these findings, wider margins are always preferable.
“There is always a conversation around these general [critical] areas, but as a rule we try to get larger margins,” said Ryan J. Sullivan, MD, of Mass General Cancer Center in Boston.
In an interview, Dr. Sullivan said that the finding about lower frequency of reconstructive procedures in the narrow margins groups may be more of a concern for younger patients than for the elderly.
Study design
The investigators conducted a retrospective cohort study of consecutive patients aged 18 or older at the National Cancer Institute of Milan who were diagnosed with T1a cutaneous melanoma close to critical areas from 2001 through 2020.
Patients with primary cutaneous melanoma of the head and face areas with functional or cosmetic considerations, acral areas (plantar, palmar, digital and interdigital areas), external genitalia, or periumbilical and perineal areas were eligible for inclusion.
The cohort comprised 1,179 patients with a median age of 50 and equal sex distribution. Of these patients, 626 (53%) had a wide excision, of whom 434 had a linear repair, and 192 had a flap of graft reconstruction. The remaining 553 patients had narrow excisions, 491 with linear repair, and 62 with flap or graft reconstruction.
Analyses were adjusted to account for imbalances between the surgical groups.
The study was supported by the nonprofit foundation Emme Rouge. The authors and Dr. Sullivan reported having no relevant conflicts of interest to disclose.
Current U.S., European, and Australian or melanoma-specific mortality (MSM), results of a retrospective study suggest.
Among 1,179 patients with stage T1a melanomas near the face, scalp, external genitalia, or other critical areas, the weighted 10-year local recurrence rate for patients who underwent resection with 10-mm margins was 5.7%, compared with 6.7% for those who had resections with 5-mm margins, a nonsignificant difference.
Weighted 10-year melanoma-specific mortality was 1.8% for patients treated with wide margins, vs. 4.2% for those treated with narrow margins, also a nonsignificant difference. Patients treated with narrow margins did have significantly fewer reconstructive surgeries than patients treated with wide margins, reported Andrea Maurichi, MD, and colleagues at the National Cancer Institute of Italy in Milan.
“Because this association was found in melanomas of the head and neck, acral, and genital sites, there is no plausible reason why it could not be extrapolated to other locations. The findings also support the need for prospective randomized clinical trials to definitively answer the important question about appropriate excision margins for T1a melanoma,” they wrote in the study, published online in JAMA Dermatology.
The authors also found, however, that Breslow thickness greater than 0.4 mm and mitotic rate greater than 1/mm2 were associated with worse MSM, and that acral lentiginous melanoma, lentigo maligna melanoma, and increasing Breslow thickness were associated with a higher incidence of local recurrence.
A melanoma expert who was not involved in the study said that despite these findings, wider margins are always preferable.
“There is always a conversation around these general [critical] areas, but as a rule we try to get larger margins,” said Ryan J. Sullivan, MD, of Mass General Cancer Center in Boston.
In an interview, Dr. Sullivan said that the finding about lower frequency of reconstructive procedures in the narrow margins groups may be more of a concern for younger patients than for the elderly.
Study design
The investigators conducted a retrospective cohort study of consecutive patients aged 18 or older at the National Cancer Institute of Milan who were diagnosed with T1a cutaneous melanoma close to critical areas from 2001 through 2020.
Patients with primary cutaneous melanoma of the head and face areas with functional or cosmetic considerations, acral areas (plantar, palmar, digital and interdigital areas), external genitalia, or periumbilical and perineal areas were eligible for inclusion.
The cohort comprised 1,179 patients with a median age of 50 and equal sex distribution. Of these patients, 626 (53%) had a wide excision, of whom 434 had a linear repair, and 192 had a flap of graft reconstruction. The remaining 553 patients had narrow excisions, 491 with linear repair, and 62 with flap or graft reconstruction.
Analyses were adjusted to account for imbalances between the surgical groups.
The study was supported by the nonprofit foundation Emme Rouge. The authors and Dr. Sullivan reported having no relevant conflicts of interest to disclose.
Current U.S., European, and Australian or melanoma-specific mortality (MSM), results of a retrospective study suggest.
Among 1,179 patients with stage T1a melanomas near the face, scalp, external genitalia, or other critical areas, the weighted 10-year local recurrence rate for patients who underwent resection with 10-mm margins was 5.7%, compared with 6.7% for those who had resections with 5-mm margins, a nonsignificant difference.
Weighted 10-year melanoma-specific mortality was 1.8% for patients treated with wide margins, vs. 4.2% for those treated with narrow margins, also a nonsignificant difference. Patients treated with narrow margins did have significantly fewer reconstructive surgeries than patients treated with wide margins, reported Andrea Maurichi, MD, and colleagues at the National Cancer Institute of Italy in Milan.
“Because this association was found in melanomas of the head and neck, acral, and genital sites, there is no plausible reason why it could not be extrapolated to other locations. The findings also support the need for prospective randomized clinical trials to definitively answer the important question about appropriate excision margins for T1a melanoma,” they wrote in the study, published online in JAMA Dermatology.
The authors also found, however, that Breslow thickness greater than 0.4 mm and mitotic rate greater than 1/mm2 were associated with worse MSM, and that acral lentiginous melanoma, lentigo maligna melanoma, and increasing Breslow thickness were associated with a higher incidence of local recurrence.
A melanoma expert who was not involved in the study said that despite these findings, wider margins are always preferable.
“There is always a conversation around these general [critical] areas, but as a rule we try to get larger margins,” said Ryan J. Sullivan, MD, of Mass General Cancer Center in Boston.
In an interview, Dr. Sullivan said that the finding about lower frequency of reconstructive procedures in the narrow margins groups may be more of a concern for younger patients than for the elderly.
Study design
The investigators conducted a retrospective cohort study of consecutive patients aged 18 or older at the National Cancer Institute of Milan who were diagnosed with T1a cutaneous melanoma close to critical areas from 2001 through 2020.
Patients with primary cutaneous melanoma of the head and face areas with functional or cosmetic considerations, acral areas (plantar, palmar, digital and interdigital areas), external genitalia, or periumbilical and perineal areas were eligible for inclusion.
The cohort comprised 1,179 patients with a median age of 50 and equal sex distribution. Of these patients, 626 (53%) had a wide excision, of whom 434 had a linear repair, and 192 had a flap of graft reconstruction. The remaining 553 patients had narrow excisions, 491 with linear repair, and 62 with flap or graft reconstruction.
Analyses were adjusted to account for imbalances between the surgical groups.
The study was supported by the nonprofit foundation Emme Rouge. The authors and Dr. Sullivan reported having no relevant conflicts of interest to disclose.
FROM JAMA DERMATOLOGY