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

Autor: Kim WK; Department of Cardiology and Cardiac Surgery, Kerckhoff Heart Center, Bad Nauheim, Germany., Thiele H; Department of Cardiology, Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany., Linke A; Department of Internal Medicine and Cardiology, Herzzentrum Dresden at Technische Universität Dresden, Dresden, Germany., Kuntze T; Department of Cardiology, Heart Centre, Central Clinic in Bad Berka, Bad Berka, Germany., Fichtlscherer S; Department of Internal Medicine, Division of Cardiology, Johann W. Goethe University, Frankfurt, Germany., Webb J; Centre for Heart Valve Innovation, St. Paul's and Vancouver General Hospitals, University of British Columbia, Vancouver, British Columbia, Canada., Chu MWA; Division of Cardiac Surgery, Department of Surgery, Western University, London Health Sciences Centre, London, Ontario, Canada., Adam M; Clinic for Cardiology, University Hospital Cologne, Cologne, Germany., Schymik G; Medical Clinic IV, Department of Cardiology, Municipal Hospital Karlsruhe, Karlsruhe, Baden-Württemberg, Germany., Geisler T; Department of Cardiology and Angiology, University Hospital Tübingen, Tübingen, Germany., Kharbanda R; Oxford Heart Centre, John Radcliffe Hospital, Oxford, UK., Christen T; Boston Scientific, Marlborough, MA, USA., Allocco D; Boston Scientific, Marlborough, MA, USA.
Jazyk: angličtina
Zdroj: Journal of interventional cardiology [J Interv Cardiol] 2022 Jun 25; Vol. 2022, pp. 9138403. Date of Electronic Publication: 2022 Jun 25 (Print Publication: 2022).
DOI: 10.1155/2022/9138403
Abstrakt: 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.)
Databáze: MEDLINE
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