Comparing the Safety and Effectiveness of Five Leading New-Generation Devices for Transcatheter Aortic Valve Implantation: Twelve-Month Results From the RISPEVA Study

Objectives: The management of severe aortic stenosis has been revolutionized by the introduction of transcatheter aortic valve implantation (TAVI), especially in patients at intermediate, high, or prohibitive surgical risk. There is uncertainty, however, regarding the comparative effectiveness and safety of contemporary TAVI devices. Methods: We queried detailed data from the ongoing national Italian TAVI registry and compared baseline features, procedural details, and 12-month outcomes of Acurate Neo (Boston Scientific), Evolut Pro/R (Medtronic), Lotus (Boston Scientific), Portico (Abbott Vascular), and Sapien/ Sapien S3 Ultra (Edward Lifesciences) transcatheter aortic valves. Several endpoints were collected and appraised, including the composite of death, stroke, myocardial infarction (MI), major bleeding, major vascular complication, surgical aortic valve replacement and transcatheter aortic valve reimplantation, which were deemed major adverse events (MAEs). Results: A total of 1976 patients were included, with 234 treated with Acurate, 703 with Evolut, 151 with Lotus, 347 with Portico, and 541 with Sapien. Twelve-month events were not significantly different among the 5 devices, including death (P=.29) and MAE (P=.21), with the notable exception of major vascular complications, which were more common with Acurate and Sapien (P<.001) and permanent pacemaker implantation, which was more frequent with Lotus and Evolut (P<.001). Differences in MAE were more pronounced in women and subjects with prior cardiac surgery, with the lowest event rates in the Evolut group. Propensity-score adjusted analysis suggested that Acurate, Evolut, Portico, and Sapien were all associated with similarly favorable results, whereas adverse events were more evident with Lotus (P<.05). Conclusion: Leading current-generation TAVI devices offer similarly favorable results at mid-term follow-up.