Real-World Multiple Comparison of Transcatheter Aortic Valves: Insights From the Multicenter OBSERVANT II Study

Abstract

BACKGROUND: Head-to-head comparisons of devices for transcatheter aortic valve implantation (TAVI) are mostly limited to 2-arm studies so far. The aim of this study was to compare simultaneously outcomes of the most used, second- and third-generation transcatheter aortic valves in a real-world population. METHODS: A total of 2728 patients undergoing TAVI with different second- and third-generation devices, and enrolled in the multicenter, prospective OBSERVANT II study (Observational Study of Effectiveness of TAVI With New Generation Devices for Severe Aortic Stenosis Treatment) from December 2016 to September 2018 were compared according to the transcatheter aortic valve received. Outcomes were adjudicated through a linkage with administrative databases, and adjusted using inverse propensity of treatment weighting. The primary end point was the composite of all-cause death, stroke and rehospitalization for heart failure at 1-year. Rates were reported consecutively for Evolut R, Evolut PRO, SAPIEN 3, ACURATE neo, and Portico groups. RESULTS: The primary end point did not differ among groups (23.9% versus 24.7% versus 21.5% versus 23.7% versus 27.4%, respectively, P =0.56). Permanent pacemaker implantation was significantly lower for patients receiving SAPIEN 3 (19.9% versus 19.3% versus 12.5% versus 14.7% versus 22.1%, respectively, P <0.01) at 1 year. The SAPIEN 3 had lower rates of paravalvular regurgitation (moderate-to-severe grade 10.1% versus 5.0% versus 2.1% versus 13.1% versus 10.8%, respectively, P <0.01) but higher transprosthetic gradients (median mean gradients 7.0 versus 6.0 versus 10.0 versus 7.0 versus 8.0 mm Hg, respectively, P <0.01) after TAVI. CONCLUSIONS: Data from real-world practice showed low and comparable rates of complications after TAVI considering all the available devices. Patients receiving SAPIEN 3 valve had lower rates of paravalvular regurgitation and permanent pacemaker implantation, but higher transprosthetic gradients.

Advancing Transcatheter Aortic Valve Replacement to the Frontiers of Lifetime Valve Management: Deliberations From the OBSERVANT II Trial

“…They redemonstrated permanent pacemaker implantation (PPI), and new onset left bundle branch blocks were more prevalent with self-expandable valves (notably PPI was high among all groups, 16.0% versus 17.4% versus 9.6% versus 9.6% versus 18.2%) and intra-annular balloon-expandable SAPIEN 3 had lower rates of paravalvular leak (PVL) but higher residual transvalvular gradients. 1 This confirms prior investigation and may enable operators to provide patients reassuring data that any of the major TAVR platforms is equally safe, in terms of stroke, heart failure hospitalization, and death at 1 year.…”

“…In this issue of Circulation: Cardiovascular Interventions , Costa et al present real-world findings from the OBSERVANT II study (Observational Study of Effectiveness of TAVI With New Generation Devices for Severe Aortic Stenosis Treatment), 1 head-to-head comparisons of market-dominant TAVR platforms from 2016 to 2018: Evolut R, Evolut PRO, SAPIEN 3, ACCURATE Neo, and Portico. In their intermediate-risk (EuroSCORE II of 5.1% [3.1–8.0]) older (83 years [79–86]) patient population, the predominant valve implanted was Evolut R (41.2% [n=1125]), and access was mostly transfemoral (91.4% [n=2493]).…”

Comparison of 1-year Follow-up Echocardiographic Outcomes of Sapien 3 Versus Evolut R Bioprosthetic Transcatheter Aortic Valves: A Single-center Retrospective Iranian Cohort Study

“…A study by Hase et al 25 of 1-year follow-up after TAVI showed that patients undergoing the Evolut R had a lower mean gradient and a higher index effective orifice area (EOA) compared with the Sapien 3, which is consistent with the finding of this study. Furthermore, Costa et al 26 presented a real-world population comparison of the Evolut R, Evolut PRO, SAPIEN 3, ACURATE neo, and Portico groups. This study demonstrated that patients treated with Sapien 3 had higher transprosthetic gradients.…”