open access

Vol 28, No 6 (2021)
Original Article
Submitted: 2020-04-29
Accepted: 2021-01-25
Early publication date: 2021-08-17
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Transfermoral transcatheter aortic valve implantation using self-expanding Allegra bioprosthesis: One-year single-center outcomes

Joanna Milan1, Mirosław Gozdek234, Radosław Targoński5, Mariusz Kowalewski467, Aleksandra Stańska5, Marcin Fijałkowski1, Romuald Lango8, Miłosz Jaguszewski1, Dariusz Jagielak5
DOI: 10.5603/CJ.a2021.0093
·
Pubmed: 34490606
·
Cardiol J 2021;28(6):825-830.
Affiliations
  1. 1st Department of Cardiology, Medical University of Gdansk, Poland
  2. Department of Cardiology and Internal Medicine, Nicolaus Coper nicus University, Collegium Medicum in Bydgoszcz, Poland
  3. Department of Cardiac Surgery, Medinet Heart Center Ltd., Wroclaw, Poland
  4. Thoracic Research Center, Collegium Medicum, Nicolaus Copernicus University, Innovative Medical Forum, Bydgoszcz, Poland
  5. Department of Cardiac and Vascular Surgery, Medical University of Gdansk, Poland
  6. Clinical Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Center of Postgraduate Medical Education, Warsaw, Poland
  7. Department of Cardio-Thoracic Surgery, Heart and Vascular Center, Maastricht University Medical Center, Maastricht, The Netherlands
  8. Department of Cardiac Anesthesiology, Medical University of Gdansk, Poland

open access

Vol 28, No 6 (2021)
Original articles — Interventional cardiology
Submitted: 2020-04-29
Accepted: 2021-01-25
Early publication date: 2021-08-17

Abstract

Background: The NAUTILUS study aimed to evaluate the safety and performance of the Allegra bioprosthesis in high-risk recipients undergoing transcatheter aortic valve implantation and previously reported 30-day outcomes. In the current investigation 1-year results of the trial are presented.
Methods: Twenty-seven recipients with severe, symptomatic aortic valve stenosis at high surgical risk, who underwent treatment using the next-generation self-expanding Allegra via transfemoral approach were prospectively enrolled. Clinical endpoints assessed were: mortality, stroke, permanent pacemaker implantation, New York Heart Association class and re-hospitalizations. Prosthetic valve performance evaluation comprised of: mean gradient, effective orifice area and paravalvular leak.
Results: Patients were elderly (82.8 ± 4.2 years) and predominantly female (n = 19, 70.4%). All of them were deemed to be at high surgical risk with a mean logistic EuroSCORE of 12.5 ± 6.7. The bioprosthesis was successfully implanted in 92.6% of the cases (n = 25). At 1-year, all-cause mortality was 12.0% (n = 3) and stroke was 4.0% (n = 1). Three (12%) of patients developed complete atrioventricular block and received permanent pacemakers. 84% of patients were in New York Heart Association class II or lower. Need for subsequent hospitalization arose in 48% patients. The echocardiographic assessment confirmed an acceptable hemodynamic profile of the Allegra with low mean transprosthetic gradient (9.5 ± 3.4 mmHg), absence of severe paravalvular leak and a 20%-presence of moderate paravalvular leak.
Conclusions: The current follow-up observation study shows that the Allegra was associated with a satisfactory safety profile and hemodynamic performance at 1-year after implantation.

Abstract

Background: The NAUTILUS study aimed to evaluate the safety and performance of the Allegra bioprosthesis in high-risk recipients undergoing transcatheter aortic valve implantation and previously reported 30-day outcomes. In the current investigation 1-year results of the trial are presented.
Methods: Twenty-seven recipients with severe, symptomatic aortic valve stenosis at high surgical risk, who underwent treatment using the next-generation self-expanding Allegra via transfemoral approach were prospectively enrolled. Clinical endpoints assessed were: mortality, stroke, permanent pacemaker implantation, New York Heart Association class and re-hospitalizations. Prosthetic valve performance evaluation comprised of: mean gradient, effective orifice area and paravalvular leak.
Results: Patients were elderly (82.8 ± 4.2 years) and predominantly female (n = 19, 70.4%). All of them were deemed to be at high surgical risk with a mean logistic EuroSCORE of 12.5 ± 6.7. The bioprosthesis was successfully implanted in 92.6% of the cases (n = 25). At 1-year, all-cause mortality was 12.0% (n = 3) and stroke was 4.0% (n = 1). Three (12%) of patients developed complete atrioventricular block and received permanent pacemakers. 84% of patients were in New York Heart Association class II or lower. Need for subsequent hospitalization arose in 48% patients. The echocardiographic assessment confirmed an acceptable hemodynamic profile of the Allegra with low mean transprosthetic gradient (9.5 ± 3.4 mmHg), absence of severe paravalvular leak and a 20%-presence of moderate paravalvular leak.
Conclusions: The current follow-up observation study shows that the Allegra was associated with a satisfactory safety profile and hemodynamic performance at 1-year after implantation.

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Keywords

Allegra, NAUTILUS clinical study, transcatheter aortic valve implantation

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Title

Transfermoral transcatheter aortic valve implantation using self-expanding Allegra bioprosthesis: One-year single-center outcomes

Journal

Cardiology Journal

Issue

Vol 28, No 6 (2021)

Article type

Original Article

Pages

825-830

Early publication date

2021-08-17

Page views

2757

Article views/downloads

398

DOI

10.5603/CJ.a2021.0093

Pubmed

34490606

Bibliographic record

Cardiol J 2021;28(6):825-830.

Keywords

Allegra
NAUTILUS clinical study
transcatheter aortic valve implantation

Authors

Joanna Milan
Mirosław Gozdek
Radosław Targoński
Mariusz Kowalewski
Aleksandra Stańska
Marcin Fijałkowski
Romuald Lango
Miłosz Jaguszewski
Dariusz Jagielak

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