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The Allegra transcatheter heart valve: Short term results from a multicenter registry.
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.
Affiliation
  • Wolfrum M; Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland.
  • Moccetti F; Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland.
  • Piuhola J; Division of Cardiology, Department of Internal Medicine, University of Oulu, Oulu, Finland.
  • Lehtola H; Division of Cardiology, Department of Internal Medicine, University of Oulu, Oulu, Finland.
  • Baz JA; Department of Cardiology, Interventional Cardiology Unit, University Hospital Álvaro Cunqueiro of Vigo, Pontevedra, Spain.
  • Iñiguez A; Department of Cardiology, Interventional Cardiology Unit, University Hospital Álvaro Cunqueiro of Vigo, Pontevedra, Spain.
  • van Nunen LX; Department of Cardiology, Catharina Hospital, Eindhoven, Netherlands.
  • Tonino PAL; Department of Cardiology, Catharina Hospital, Eindhoven, Netherlands.
  • Niemelä M; Division of Cardiology, Department of Internal Medicine, University of Oulu, Oulu, Finland.
  • Toggweiler S; Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland.
Catheter Cardiovasc Interv ; 98(6): 1204-1209, 2021 11 15.
Article in En | MEDLINE | ID: mdl-34137483
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.
Subject(s)
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Full text: 1 Database: MEDLINE Main subject: Aortic Valve Stenosis / Heart Valve Prosthesis / Transcatheter Aortic Valve Replacement Type of study: Clinical_trials / Etiology_studies / Risk_factors_studies Limits: Aged / Aged80 / Animals / Female / Humans / Male Language: En Year: 2021 Type: Article

Full text: 1 Database: MEDLINE Main subject: Aortic Valve Stenosis / Heart Valve Prosthesis / Transcatheter Aortic Valve Replacement Type of study: Clinical_trials / Etiology_studies / Risk_factors_studies Limits: Aged / Aged80 / Animals / Female / Humans / Male Language: En Year: 2021 Type: Article