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Transfermoral transcatheter aortic valve implantation using self-expanding Allegra bioprosthesis: One-year single-center outcomes
Affiliations- 1st Department of Cardiology, Medical University of Gdansk, Poland
- Department of Cardiology and Internal Medicine, Nicolaus Coper nicus University, Collegium Medicum in Bydgoszcz, Poland
- Department of Cardiac Surgery, Medinet Heart Center Ltd., Wroclaw, Poland
- Thoracic Research Center, Collegium Medicum, Nicolaus Copernicus University, Innovative Medical Forum, Bydgoszcz, Poland
- Department of Cardiac and Vascular Surgery, Medical University of Gdansk, Poland
- Clinical Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Center of Postgraduate Medical Education, Warsaw, Poland
- Department of Cardio-Thoracic Surgery, Heart and Vascular Center, Maastricht University Medical Center, Maastricht, The Netherlands
- Department of Cardiac Anesthesiology, Medical University of Gdansk, Poland
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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.
Keywords
Allegra, NAUTILUS clinical study, transcatheter aortic valve implantation
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About this articleTitle
Transfermoral transcatheter aortic valve implantation using self-expanding Allegra bioprosthesis: One-year single-center outcomes
Journal
Issue
Article type
Original Article
Pages
825-830
Published online
2021-08-17
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6062
Article views/downloads
558
DOI
Pubmed
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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