Transcatheter Aortic Valve Implantation with ACURATE neo : Results from the PROGRESS PVL Registry.

Objectives: The PROGRESS PVL registry evaluated transcatheter aortic valve implantation (TAVI) in patients treated with ACURATE neo , a supra-annular self-expanding bioprosthetic aortic valve.
Background: While clinical outcomes with TAVI are comparable with those achieved with surgery, residual aortic regurgitation (AR) and paravalvular leak (PVL) are common complications. The ACURATE neo valve has a pericardial sealing skirt designed to minimize PVL.
Methods: The primary endpoint was the rate of total AR over time, as assessed by a core echocardiographic laboratory. The study enrolled 500 patients (mean age: 81.8 ± 5.1 years; 61% female; mean baseline STS score: 6.0 ± 4.5%) from 22 centers in Europe and Canada; 498 patients were treated with ACURATE neo .
Results: The rate of ≥ moderate AR was 4.6% at discharge and 3.1% at 12 months; the rate of ≥ moderate PVL was 4.6% at discharge and 2.6% at 12 months. Paired analyses showed significant improvement in overall PVL between discharge and 12 months ( P < 0.001); 64.6% of patients had no change in PVL grade, 24.9% improved, and 10.5% worsened. Patients also exhibited significant improvement in transvalvular gradient ( P < 0.001) and effective orifice area ( P =0.01). The mortality rate was 2.2% at 30 days and 11.3% at 12 months. The permanent pacemaker implantation (PPI) rate was 10.2% at 30 days and 12.2% at 12 months.
Conclusions: Results from PROGRESS PVL support the sustained safety and performance of TAVI with the ACURATE neo valve, showing excellent valve hemodynamics, good clinical outcomes, and significant interindividual improvement in PVL from discharge to 12-month follow-up.
Competing Interests: Dr. Kim reports personal fees from Boston Scientific, Edwards Lifesciences, Abbott, Medtonic, and Meril, outside the submitted work. Dr. Thiele has nothing to disclose. Dr. Linke reports grants from Novartis and Edwards Lifesciences, personal fees from Medtronic, Abbott, Edwards Lifesciences, Boston Scientific, Astra Zeneca, Novartis, Pfizer, Abiomed, Bayer, and Boehringer, and other from Picardia, Transverse Medical, and Claret Medical, outside the submitted work. Dr. Kuntze reports grants from Edwards, outside the submitted work. Dr. Fichtlscherer has nothing to disclose. Dr. Webb reports personal fees from Edwards Lifesciences, outside the submitted work. Dr. Chu reports personal fees from Medtronic, Edwards Lifesciences, Boston Scientific, Abbott Vascular, Terumo Aortic, and Cryolife, outside the submitted work. Dr. Adam reports grants and personal fees from Medtronic and personal fees from Boston Scientific and Edwards Lifesciences, outside the submitted work. Dr Schymik has nothing to disclose. Dr. Geisler reports grants from Edwards Lifesciences and Medtronic, outside the submitted work. Dr. Kharbanda reports grants and personal fees from Boston Scientific, outside the submitted work. Drs. Christen and Allocco are employees and shareholders of Boston Scientific.
(Copyright © 2022 Won-Keun Kim et al.)