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First Results From Laser-Related Adverse Events Registry Reported


 

FROM ASLMS 2024

— A relatively new registry of complications from dermatologic surgery has posted its first results, showing that among laser and energy device treatments, the most common adverse events (AEs) were blistering, hypopigmentation, scars, and burns. But the process of reporting AEs to the registry needs to be made easier to attract more cases and provide a more complete picture of complications after dermatologic procedures, a researcher and observer said.

The Cutaneous Procedures Adverse Events Reporting Registry (CAPER) was established in 2021 to track AEs from dermatologic procedures. Since then, it has logged a total of 81 cases and 147 AEs from 27 unique procedures, Eric Koza, MD, a postdoctoral research fellow in the Department of Dermatology at Northwestern University, Chicago, reported at the annual conference of the American Society for Laser Medicine and Surgery.

Eric Koza, MD, a postdoctoral research fellow in the Department of Dermatology at Northwestern University, Chicago Richard Mark Kirkner/MDedge News

Dr. Eric Koza

“The takeaways from this project is that 20 laser and energy device treatments have been reported to the registry, half of which were nonablative laser treatments,” Dr. Koza said in presenting the results. “Of the adverse events reported, nonphysicians and non-dermatologic physicians were more likely to be associated with severe or persistent adverse events.”

The American Society for Dermatologic Surgery Association and the Northwestern University Department of Dermatology launched CAPER. Previously, Dr. Koza said, AEs were typically reported only through the Food and Drug Administration’s AE reporting system. He noted that CAPER is the only voluntary national reporting registry for AEs from dermatologic procedures.

What the Registry Shows So Far

The registry matched 72 of the 81 cases with type of provider, with dermatologist-conducted procedures (51, 70.8%) comprising the majority, followed by nonphysician-conducted procedures (14, 19.4%) and nondermatologist physician–conducted procedures (7, 9.7%).

Of the 81 total cases, the following reports were related to laser and energy device treatments: 12 (14.3%) from nonablative laser treatments, five (6%) from light treatments, and three (3.6%) from ablative laser treatments, Dr. Koza said.

Among nonablative laser treatments, the most common AE was blistering (six reports, 50%). Scar, pain, and hypopigmentation accounted for two cases each (16.67%). Dermatologists performed seven of these cases (58.3%); nonphysicians, four (33.3%); and a non-dermatologist physician, one (8.3%).

For intense pulsed-light treatments, burns were the most common AEs (three reports, 60%), with swelling and inflammation each accounting for one case (20%). Three of these cases (75%) were confirmed to have been performed by nonphysicians.

The ablative laser treatment AEs included one case each of hypopigmentation, scar, and erythema. Two of the three cases were confirmed to have been performed by dermatologists.

Dr. Koza acknowledged the low number of cases is a limitation of this analysis of registry reports. A future goal for CAPER is to publicize it more, he said. “The registry is only 3 years old,” he told this news organization. “Hopefully, we can get more data as time goes on. We’ve been getting more and more each year.” CAPER adapted data entry forms used in other registries.

Submitting a case to the registry takes about 15 minutes of the provider’s time, Dr. Koza said. “We can streamline that to make it easier for people to submit their adverse events,” he said in an interview.

Only registry staff have access to the reports, and when reported, the data “is de-identified and any identifying information pertaining to the patient or reporter is removed,” according to a statement on the CAPER website.

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