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Published on: December 11, 2017
Three-year outcomes after transcatheter aortic valve implantation with the CoreValve prosthesis
Michael Gotzmann1, Anna Czauderna1, Tobias Hehnen1
1BG-Kliniken Bergmannsheil, Department of Cardiology and Angiology, Ruhr-University Bochum, Bochum, Germany.
Insights
Transcatheter aortic valve implantation (TAVI) with the CoreValve prosthesis shows improved symptoms and outcomes after three years. However, complications like aortic regurgitation and prosthesis issues warrant consideration.
Area of Science:
- Cardiology
- Interventional Cardiology
- Prosthetic Heart Valves
Background:
- Long-term outcomes of the CoreValve prosthesis following transcatheter aortic valve implantation (TAVI) are not well-established.
- Severe aortic stenosis necessitates effective treatment options for improved patient survival and quality of life.
Purpose of the Study:
- To evaluate the 3-year clinical and hemodynamic results of the CoreValve prosthesis used in TAVI.
- To assess mortality, morbidity, and functional status following TAVI for severe aortic stenosis.
Main Methods:
- A prospective study involving 150 consecutive patients with severe aortic stenosis undergoing TAVI with the CoreValve prosthesis.
- Primary endpoint: all-cause mortality. Secondary endpoints: cardiovascular death, prosthesis-related mortality/morbidity, and New York Heart Association (NYHA) functional class.
Main Results:
- All-cause mortality at 1, 2, and 3 years was 25%, 32%, and 41%, respectively. Cardiovascular mortality was 14%, 21%, and 27% at the same time points.
- Significant improvement in NYHA class: from 95% in class III/IV pre-TAVI to 33-39% in surviving patients at 1-3 years.
- Moderate to severe aortic regurgitation (AR) occurred in 15% initially, with slight worsening in 13% by 3 years. No new severe AR. Prosthesis-related issues occurred in 1.5% annually.
Conclusions:
- TAVI with the CoreValve prosthesis demonstrates favorable 3-year effects on symptoms and outcomes in severe aortic stenosis.
- The benefits are tempered by the occurrence of side effects, including aortic regurgitation and prosthesis-related complications.
Abstract:
There is little known about the long-term results of the CoreValve prosthesis. The aim of this study was to assess the 3-year clinical and hemodynamic outcomes of the CoreValve prosthesis. One hundred fifty consecutive patients with severe aortic stenosis successfully underwent transcatheter aortic valve implantation (TAVI) with the CoreValve prosthesis. The primary study end point was death from any cause after TAVI. The secondary end points were defined as (1) cardiovascular death and (2) prosthesis-related mortality and morbidity. At 1 to 3 years, all-cause mortality rates were 25%, 32%, and 41%, respectively, and cardiovascular mortality rates were 14%, 21%, and 27%, respectively. Before TAVI, 95% of patients were in New York Heart Association class III or IV. Of the surviving patients, rates of New York Heart Association class III or IV at 1 to 3 years were 33%, 39%, and 38%, respectively. There was an annual decrease of the valve area of approximately 0.1 cm². Aortic restenosis occurred in 2 patients. Moderate or severe aortic regurgitation (AR) occurred in 15% of patients immediately after TAVI. Twenty patients (13%) had a slight worsening of AR within 3 years. New severe AR did not occur. The incidence of prosthesis-related endocarditis was 0.66% per year. Overall, 7 patients (incidence of 1.5% per year) had a clinically relevant problem of the prosthesis. In conclusion, TAVI with the CoreValve prosthesis had favorable effects on symptoms and outcomes even after 3 years. These results are clouded by side effects, such as AR and prosthesis-related mortality and morbidity.
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