Morbidity and mortality after thermal venous ablations

Area of Science:

• Vascular Surgery
• Medical Device Safety
• Health Informatics

Background:

• Saphenous vein reflux treatment has advanced with thermal ablation techniques.
• Endovenous ablation (EVA) is widely accepted but its risks are often underestimated.
• This study analyzes complications associated with EVA procedures.

Purpose of the Study:

• To analyze complications of endovenous ablation (EVA) using national database data.
• To identify patient-related injuries and device failures associated with EVLT and RFA.
• To assess the incidence and trends of adverse events following EVA.

Main Methods:

• Analysis of 349 adverse events from the MAUDE database (2000-2012).
• Included endovenous laser ablation (EVLT) and radiofrequency ablation (RFA) procedures.
• Outcomes assessed: pulmonary embolism (PE), deep vein thrombosis (DVT), death, and device failures.

Main Results:

• 58% of events were patient injuries, 42% were device failures.
• Radiofrequency ablation (RFA) had more reported complications than endovenous laser ablation (EVLT).
• Adverse event rates were low: 1-2 per 10,000 procedures for EVLT/RFA over 5 years.

Conclusions:

• EVA is effective but carries risks, including rare mortality from PE.
• Reported complications represent a fraction of actual events due to underreporting.
• A national registry is needed to accurately determine the magnitude of EVA complications.