Role of the Bridge balloon in improving the safety of transvenous lead extraction procedures.

Background: Transvenous lead extraction (TLE) procedures are complex and carry an increased risk of superior vena cava (SVC) tears. Approved by the US Food and Drug Administration in February 2016, the Bridge balloon was designed to temporarily occlude the SVC in cases of SVC tears and facilitate surgical repair.

Objective: The purpose of this study was to evaluate the impact of introducing the Bridge balloon into clinical practice on reducing periprocedural mortality during TLE.

Methods: We analyzed 4946 patients who underwent TLE at our center between 1996 and 2022 using a prospectively maintained registry. Patients were grouped on the basis of whether extraction occurred before (n = 3577) or after (n = 1369) February 2016. The 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 the 1369 patients in the Bridge balloon era, prophylactic placement occurred in 794 (58%) and rescue activation in 21 (1.5%). Predictors of prophylactic placement included an older lead age (odds ratio [OR] 1.12; P < .001), a higher combined age of leads (OR 1.04; P = .003), and the presence of defibrillator leads (OR 1.50; P < .001). Patients in the balloon era had older leads and required more rescue sternotomies (2.3% vs 1.0%; P < .001) but experienced no procedure-related deaths, compared with 12 (0.3%) in the pre-balloon era (P = .03). This benefit was most notable in procedures performed in electrophysiology laboratories (intraprocedural death: 0.9% vs 0%; P = .007; 7-day mortality: 1.36% vs 0.1%; P = .005).

Conclusion: Introduction of the Bridge balloon was associated with reduced TLE mortality, particularly in electrophysiology laboratory procedures, despite more complex cases. These findings support its role in enhancing procedural safety.