Endovascular Occlusion Balloon for Treatment of Superior Vena Cava Tears During Transvenous Lead Extraction

Abstract

Background: Superior vena cava (SVC) tears are one of the most lethal complications in transvenous lead extraction. An endovascular balloon can occlude the SVC in the event of a laceration, preventing blood loss and offering a more controlled surgical field for repair. An early study demonstrated that proper use of this device is associated with reduced mortality. Thereafter, high-volume extractors at the Eleventh Annual Lead Management Symposium developed a best practice protocol for the endovascular balloon. Methods: We collected data on adverse events in lead extraction from July 1, 2016, to July 31, 2018. Data were prospectively collected from both a US Food and Drug Administration–maintained database and physician reports of adverse events as they occurred. We gathered case details directly from extracting physicians. Confirmed SVC tears were analyzed for patient demographics, case details, and index hospitalization mortality. Results: From July 1, 2016, to July 31, 2018, 116 confirmed SVC events were identified, of which 44.0% involved proper balloon use and 56.0% involved no use or improper use. When an endovascular balloon was properly used, 45 of 51 patients (88.2%) survived in comparison to 37 of 65 patients (56.9%) when a balloon was not used or improperly used ( P =0.0002). Furthermore, multivariate regression modeling found that proper balloon deployment was an independent, negative predictor of in-hospital mortality for patients who experienced an SVC laceration (odds ratio, 0.13; 95% CI, 0.04–0.40; P <0.001). Conclusions: From July 1, 2016, through July 31, 2018, patients undergoing lead extraction were more likely to survive SVC tears when treatment included an endovascular balloon.

Results of the Patient-Related Outcomes of Mechanical lead Extraction Techniques (PROMET) study: a multicentre retrospective study on advanced mechanical lead extraction techniques

“…In real-world practice, this complication has clinical relevance, demonstrated by two published series of SVC events in the context of the use of compliant endovascular occlusion balloon: the initial series reported 35 surgically confirmed cases of laser-related SVC disruption in the USA during a 6-month period and the follow-up series reported 116 SVC events in a 25-month period. 15 , 16 Even the lower of these estimates implies an average of more than 4 SVC events per month.…”

Performance and outcomes of transvenous rotational lead extraction: Results from a prospective, monitored, international clinical study

“… 18 In 1 study reporting on the efficacy of the occlusion balloon that included 116 surgically confirmed SVC events, 90.5% of the SVC injuries occurred in patients who underwent TLE procedures involving a laser extraction sheath. 19 In this context, it is important to note that no isolated SVC injury occurred in the RELEASE study. These data are in line with the results of a MAUDE database analysis 11 and the PROMET study 6 suggesting that there is a lower risk of isolated SVC injury with use of rotational TLE tools compared with the use of laser sheaths.…”

Transvenous laser lead extraction in patients with congenital complete heart block

“…Furthermore, the adhesions noted in the SVC ensured that an endovascular balloon was advanced and tested prior to extraction attempts, a device associated with reduce mortality in those with SVC tears. 19 Also, intraprocedural imaging with intracardiac echocardiography, intravascular ultrasound, or TEE can characterize lead adherence locations and monitor real-time for perforations by rapidly assessing for pleural or pericardial effusions. 16,20 TEE was utilized in both patients, leading to rapid diagnosis and immediate surgical repair.…”