Outcomes of Current-Generation Transfemoral Balloon-Expandable Versus Self-Expandable Transcatheter Aortic Valve Replacement

Abstract

Background: Transcatheter aortic valve replacement (TAVR) continues to gain momentum with current-generation balloon-expandable (BE) Edwards SAPIEN 3 (Edwards Lifesciences, Irvine, CA) and self-expandable (SE) Medtronic Evolut valves (Medtronic, Minneapolis, MN). Safety and efficacy of each device has been studied independently but head-to-head comparisons remain limited.

Methods: The institutional database was used to identify patients undergoing TAVR with BE and SE systems through transfemoral access between 2015 and 2018. Patients with an alternative access were excluded. Multivariable logistic and Cox proportional hazards regression was used to compare baseline risk-adjusted 30-day Valve Academic Research Consortium-2 variables and midterm outcomes, including survival, stroke, and readmission rates.

Results: A total of 294 BE (52.2%) and 269 SE (47.8%) valves were implanted. BE cohort was predominantly male (59.9% vs 33.1%, P < .001), with a larger body surface area (1.9 m² vs 1.8 m², P < .001), fewer prior aortic valve replacements (3.7% vs 10.0%, P = .003), and a lower Society of Thoracic Surgeons predicted risk of mortality score (4.9% vs 6.7%, P < .001). After risk adjustment, SE patients had a higher propensity of ischemic stroke at 30 days (6.0% vs 1.4%, P = .015) but were comparable in other Valve Academic Research Consortium-2 variables, including mortality (1.7% vs 3.4%, P = .474), pacemaker (12.7% vs 15.2%, P = .162), and moderate paravalvular leak (1.8% vs 3.2%, P = .165). Over the midterm, SE and BE were comparable in mortality (adjusted hazard ratio [aHR], 1.24; P = .269), all-cause readmission (aHR, 0.92; P = .576), and stroke rate (aHR, 1.97; P = .061).

Conclusions: Midterm outcomes of both valve types were comparable despite a higher risk of short-term stroke for the SE cohort. Select patients may benefit from one valve type over another based on clinical and anatomic risk factors.