The Allegra transcatheter heart valve: Short term results from a multicenter registry
- 17 June 2021
- journal article
- research article
- Published by Wiley in Catheterization and Cardiovascular Interventions
- Vol. 98 (6), 1204-1209
- https://doi.org/10.1002/ccd.29833
Abstract
Objectives We aimed to determine the safety and efficacy of the Allegra transcatheter heart valve (THV) for the treatment of severe aortic valve stenosis in a large patient population treated under real-world conditions. Background The Allegra is a novel self-expanding THV with supra-annular bovine leaflets. The valve is available in three different sizes (23, 27, and 31 mm), all are delivered through an 18F sheath. Methods Consecutive patients undergoing TAVR with the Allegra THV were enrolled in a multicenter-registry. Data were collected throughout initial hospital-stay and at 30-day follow-up. Clinical endpoints were defined according to the updated definitions of the Valve-Academic-Research-Consortium. Results This registry included 255 patients (mean age 83 ± 6 years, 48% women) from four European centers. Median European System for Cardiac Operative Risk Evaluation II score (EuroSCORE II) was 3.3% (IQR 1.9–5.8%). Acute device success was 95.7%. The remaining 11 patients had either moderate paravalvular regurgitation immediately after the procedure (7 patients) or the device could not be optimal positioned requiring implantation of a second THV (4 patients). Major vascular complications and major/life-threatening bleedings occurred in 10 (3.9%) and 12 (4.7%) patients, respectively. At 30 day follow-up, mean effective orifice area was 2.2 ± 0.5 cm2, mean gradient was 6.9 ± 3.8 mmHg, 7 (3.3%) patients had more than mild paravalvular leakage, 3 patients (1.2%) had died, 6 patients (2.4%) had a stroke and 30 (12.8%) patients had required implantation of a new permanent pacemaker. Conclusions Transfemoral implantation of the Allegra THV resulted in favorable clinical and echocardiographic outcomes during hospitalization and short-term follow up.Keywords
This publication has 13 references indexed in Scilit:
- Use of a Repositionable and Fully Retrievable Aortic Valve in Routine Clinical PracticeJACC: Cardiovascular Interventions, 2019
- Individual Operator Experience and Outcomes in Transcatheter Aortic Valve ReplacementJACC: Cardiovascular Interventions, 2018
- 1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic ValveJACC: Cardiovascular Interventions, 2018
- The SAVI-TF RegistryJACC: Cardiovascular Interventions, 2018
- Real-world experience using the ACURATE neo prosthesis: 30-day outcomes of 1,000 patients enrolled in the SAVI TF registryEuroIntervention, 2018
- SOURCE 3: 1-year outcomes post-transcatheter aortic valve implantation using the latest generation of the balloon-expandable transcatheter heart valveEuropean Heart Journal, 2017
- SOURCE 3 RegistryJournal of the American College of Cardiology, 2017
- Transcatheter aortic valve implantation with the NVT Allegra transcatheter heart valve system: first-in-human experience with a novel self-expanding transcatheter heart valveEuroIntervention, 2016
- Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE StudyEuropean Heart Journal, 2014
- Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document†European Heart Journal, 2012