Outcomes of current generation Transfemoral Balloon-Expandable versus Self-Expandable TAVR.

BACKGROUND Transcatheter Aortic Valve Replacement (TAVR) continues to gain momentum with current generation Balloon-Expandable (BE) Edwards SAPIEN 3 and Self-Expandable (SE) Medtronic Evolut valves. Safety and efficacy of each device has been studied independently but head-to-head comparisons remain limited. METHODS Institutional database was used to identify patients undergoing TAVR with BE and SE systems via transfemoral access between 2015 and 2018. Alternative access patients were excluded. Multivariable logistic and Cox proportional-hazards regression was used to compare baseline risk-adjusted 30-day Valve Academic Research Consortium (VARC-2) parameters and mid term 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<0.001), with a larger BSA (1.9m2 vs. 1.8m2,p<0.001), fewer prior aortic valve replacements (3.7% vs. 10.0%,p=0.003) and a lower STS predicted risk of mortality score (4.9% vs. 6.7%,p<0.001). After risk adjustment, SE patients had a higher propensity of ischemic stroke at 30 days (6.0% vs. 1.4%,p=0.015) but were comparable in other VARC-2 parameters including mortality (1.7% vs. 3.4%, p=0.474), pacemaker (12.7% vs. 15.2%, p=0.162) and moderate paravalvular leak (1.8% vs. 3.2%, p=0.165). Over mid term, SE and BE were comparable in mortality (adjusted HR [aHR], 1.24;p=0.269), all-cause readmission (aHR,0.92;p=0.576) and stroke rate (aHR,1.97;p=0.061). CONCLUSIONS Mid-term 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.