Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable,...

Area of Science:

• Cardiology
• Interventional Cardiology
• Medical Devices

Background:

• Transcatheter aortic valve replacement (TAVR) is established for high-risk severe aortic stenosis (AS) using first-generation devices.
• Limited prospective data exist for newer devices and lower-risk patient populations.

Purpose of the Study:

• To evaluate early outcomes of the next-generation SAPIEN 3 transcatheter heart valve (THV) in inoperable, high-risk (HR), and intermediate-risk (IR) patients with severe symptomatic AS.
• To assess safety and efficacy endpoints, including mortality, stroke, bleeding, vascular complications, and device performance.

Main Methods:

• A multicenter, non-randomized registry enrolled 1661 patients (583 HR/inoperable, 1078 IR) undergoing TAVR with the SAPIEN 3 system.
• Patients received transfemoral or transapical/transaortic access. Outcomes were assessed at 30 days, including mortality, stroke, bleeding, vascular complications, pacemaker requirement, and echocardiographic parameters.

Main Results:

• 30-day all-cause mortality was 2.2% in HR/inoperable and 1.1% in IR patients. Cardiovascular mortality was 1.4% and 0.9%, respectively.
• Low rates of major/disabling stroke (0.9-1.0%), moderate/severe paravalvular regurgitation (3.4%), and device gradients were observed.
• Significant improvements in quality of life (Kansas City Cardiomyopathy Questionnaire) were noted in both groups.

Conclusions:

• The SAPIEN 3 THV system demonstrated favorable early outcomes in HR/inoperable and IR patients with severe symptomatic AS.
• Low rates of mortality, major/disabling stroke, and paravalvular regurgitation support its use in these populations.
• The device effectively reduced transvalvular gradients and improved patient-reported outcomes.