Background: Transvenous lead extraction (TLE) procedures are complex with increased risk of superior vena cava (SVC) tear. The bridge balloon, FDA-approved since February 2016, was designed to temporarily occlude the SVC in SVC tears and facilitate surgical repair.
Objective: To evaluate the impact of introducing the bridge balloon into clinical practice in reducing periprocedural mortality during TLE.
Methods: We analyzed 4,946 patients who underwent TLE at our center between 1996 and 2022 using a prospectively maintained registry. Patients were grouped based on whether extraction occurred before (n=3,577) or after (n=1,369) February 2016. Outcomes of interest included sternotomy rates and periprocedural mortality. Practice patterns, in terms of factors associated with prophylactic bridge balloon placement, were identified for the post-2016 cohort.
Results: Among 1,369 patients in the bridge balloon era, prophylactic placement occurred in 794 (58%) and rescue activation in 21 (1.5%). Predictors of prophylactic placement included older lead age (OR 1.12; p<0.001), higher combined age of leads (OR 1.04; p=0.003), and the presence of defibrillator leads (OR 1.50; p<0.001). Patients in the balloon era had older leads and required more rescue sternotomies (2.3% vs. 1.0%; p<0.001) but had no procedure-related deaths, compared to 12 (0.3%) before (p=0.03). This benefit was most notable in procedures performed in electrophysiology labs (intra-procedural death 0.9% vs. 0%, p=0.007; 7-day mortality 1.36% vs. 0.1%, p=0.005).
Conclusion: Introduction of the bridge balloon was associated with reduced TLE mortality, particularly in electrophysiology lab procedures, despite more complex cases. These findings support its role in enhancing procedural safety.
Keywords: Bridge occlusion balloon; Cardiac implantable electronic device; Periprocedural mortality; Sternotomy; Superior Vena Cava tear; Transvenous lead extraction.
Copyright © 2025. Published by Elsevier Inc.