1. Transfermoral transcatheter aortic valve implantation using self-expanding Allegra bioprosthesis: One-year single-center outcomes
- Author
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Radosław Targoński, Romuald Lango, Aleksandra Stańska, Joanna Milan, Marcin Fijałkowski, Miłosz Jaguszewski, Dariusz Jagielak, Mirosław Gozdek, and Mariusz Kowalewski
- Subjects
medicine.medical_specialty ,New York Heart Association Class ,Transcatheter aortic ,Hemodynamics ,Prosthesis Design ,Single Center ,Transcatheter Aortic Valve Replacement ,Internal medicine ,Clinical endpoint ,Humans ,Medicine ,Allegra ,Stroke ,transcatheter aortic valve implantation ,Aged ,Bioprosthesis ,business.industry ,Aortic Valve Stenosis ,General Medicine ,medicine.disease ,Interventional Cardiology ,Treatment Outcome ,Aortic Valve ,Heart Valve Prosthesis ,Aortic valve stenosis ,Cardiology ,Original Article ,Female ,NAUTILUS clinical study ,Terfenadine ,Cardiology and Cardiovascular Medicine ,business ,Atrioventricular block - 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.
- Published
- 2021
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