Surgical Bailout in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement: Incidence, Trends, and Clinical Outcomes.

Abstract

BACKGROUND Transcatheter aortic valve replacement (TAVR) harbors the risk of periprocedural complications that require emergent cardiac surgery, or "surgical bailout." Surgical bailout intends to be lifesaving but is associated with high mortality. This has given rise to discussion on the necessity of surgical backup during TAVR. Therefore, recent studies in contemporary TAVR patients are warranted. OBJECTIVES This study aimed to assess the incidence, trends, and clinical outcomes of surgical bailout in patients undergoing transfemoral TAVR. METHODS The CENTER2 (Cerebrovascular Events in Patients Undergoing Transcatheter Aortic Valve Implantation With Balloon-Expandable Valves Versus Self-Expandable Valves 2) study contains patient-level data from 10 clinical studies with patients undergoing TAVR between 2007 and 2022. RESULTS A total of 24,010 patients undergoing transfemoral TAVR were included. The mean age was 81.5 ± 6.7 years, and 56% were female. The median Society of Thoracic Surgeons Predicted Risk of Mortality declined over time (2007-2014: 7.1% [Q1-Q3: 4.3%-14.8%] vs 2015-2022: 3.9% [Q1-Q3: 2.6%-6.0%]; P < 0.001). Surgical bailout was reported in 125 (0.52%) patients, and its incidence decreased over time, from 0.84% in 2007 to 2010 to 0.25% in 2019 to 2022 (Ptrend < 0.001). Surgical bailout was more frequently observed in women compared with men (0.61% vs 0.41%; P = 0.03). Ventricular perforation was the most prevalent reason for surgical bailout (28.0%). Patients who underwent surgical bailout reported higher mortality rates during the 1-year follow-up compared with patients without surgical bailout (68.3% vs 15.3%; HR: 8.60; 95% CI: 6.74-10.97; P < 0.001). Interestingly, patients surviving the first 90 days reported a similar mortality risk (HR: 2.19; 95% CI: 0.91-5.27; P = 0.08). CONCLUSIONS The incidence of surgical bailout is very low in the contemporary TAVR population. Mortality rates remain high among patients requiring surgical bailout during transfemoral TAVR, but this risk diminishes in patients surviving the postprocedural period. (Cerebrovascular Events in Patients Undergoing Transcatheter Aortic Valve Implantation With Balloon-Expandable Valves Versus Self-Expandable Valves 2 [CENTER2]; NCT03588247).