Adverse events associated with the bridge occlusion balloon for lead extraction: A MAUDE database study

Abstract

Transvenous lead extraction has evolved as an important procedure for the treatment of device infection and the removal of unnecessary leads but can result in complications including superior vena cava (SVC) injury that can be potentially fatal. 1 Brunner M.P. Cronin E.M. Wazni O. et al. Outcomes of patients requiring emergent surgical or endovascular intervention for catastrophic complications during transvenous lead extraction. Heart Rhythm. 2014; 11: 419-425 Abstract Full Text Full Text PDF PubMed Scopus (117) Google Scholar The bridge occlusion balloon (BOB; Philips, San Diego, CA) helps achieve prompt hemostasis and has been shown to reduce SVC injury–associated mortality. 2 Azarrafiy R. Tsang D.C. Wilkoff B.L. Carrillo R.G. Endovascular occlusion balloon for treatment of superior vena cava tears during transvenous lead extraction: a multiyear analysis and an update to best practice protocol. Circ Arrhythm Electrophysiol. 2019; 12e007266 Crossref PubMed Scopus (17) Google Scholar The safety profile of the BOB has not been previously evaluated, and we analyzed adverse events related to its use reported to the Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database.