Compliant endovascular balloon reduces the lethality of superior vena cava tears during transvenous lead extractions.

BACKGROUND: Superior vena cava (SVC) lacerations have been identified as the most lethal complication encountered during cardiac implantable electronic device lead extraction. The case fatality rate of these events approximates 50% due to rapid exsanguination. A novel, compliant balloon specifically designed for use in the SVC may provide hemostasis in the event of endovascular perforation. By temporarily occluding the compromised vessel, the endovascular balloon should delay hemodynamic collapse, provide a more controlled surgical field for repair, and thereby reduce the mortality of SVC tears complicating transvenous lead extraction.

OBJECTIVE: To assess the early impact of the compliant endovascular balloon on the management of SVC tears and survival outcomes.

METHODS: We searched a publicly available, United States Food and Drug Administration-maintained database for adverse events from 1 manufacturer of lead extraction tools. Reports from July 1, 2016, to December 31, 2016 were reviewed by 2 physicians to identify instances of SVC tears. Extracting physicians were contacted for further case details. Confirmed SVC tears were analyzed for patient demographics, repair strategies, and index hospitalization mortality.

RESULTS: Of the complications reported, 35 cases of surgically confirmed SVC tears were identified. One hundred percent of patients (9/9) were discharged alive when the endovascular balloon was properly utilized, compared to 50% of patients (13/26) when the device was not used (P = .0131). Differences between all other variables analyzed were statistically insignificant.

CONCLUSION: During the study period, we observed a reduction in mortality in patients who suffered SVC tears while undergoing lead extraction when treatment included an endovascular balloon.