The Allegra transcatheter heart valve: Short term results from a multicenter registry. Issue 6 (17th June 2021)

• Record Type: Journal Article
• Authors: Wolfrum, Mathias; Moccetti, Federico; Piuhola, Jarkko; Lehtola, Heidi; Baz, José Antonio; Iñiguez, Andrés; van Nunen, Lokien X.; Tonino, Pim A. L.; Niemelä, Matti; Toggweiler, Stefan
• Is Part Of: Catheterization and cardiovascular interventions. Volume 98:Issue 6(2021)
• Page Start: 1204
• Page End: 1209
• Publication Date: 2021-06-17
• Subjects: Allegra -- aortic stenosis -- transcatheter aortic valve -- TAVR -- transcatheter aortic valve replacement -- outcomes; Heart -- Diseases -- Diagnosis -- Periodicals; Cardiac catheterization -- Periodicals; 616.1207572
• DOI: 10.1002/ccd.29833
• Languages: English
• ISSNs: 1522-1946

Abstract

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 cm 2, 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.