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Published on: June 3, 2018
Long-term results and durability of the CoreValve transcatheter aortic bioprosthesis: outcomes beyond five years
Roberta Antonazzo Panico1, Cristina Giannini, Marco De Carlo
1Vascular and CardioThoracic Department, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
Insights
The third-generation CoreValve device demonstrated good durability for high-risk patients undergoing transcatheter aortic valve implantation (TAVI) over seven years. Structural valve deterioration and bioprosthetic valve failure rates were low, indicating long-term efficacy.
Area of Science:
- Cardiology
- Interventional Cardiology
- Biomaterials Science
Background:
- Transcatheter aortic valve implantation (TAVI) is a key treatment for high-risk patients with severe aortic stenosis.
- Assessing long-term bioprosthetic valve durability is crucial for patient management and device development.
Purpose of the Study:
- To evaluate the seven-year durability of the third-generation CoreValve bioprosthesis in high-risk patients.
- To identify predictors of heart failure rehospitalisation and all-cause mortality post-TAVI.
Main Methods:
- Prospective single-centre registry of 278 high-risk TAVI patients (2007-2013).
- Utilized Cox proportional hazards model for survival analysis.
- Echocardiographic follow-up assessed valve function, paravalvular leak, and structural valve deterioration.
Main Results:
- Median follow-up of survivors was 6.8 years.
- Low cumulative incidences of structural valve deterioration (3.6%) and bioprosthetic valve failure (2.5%).
- Mild paravalvular leak and stable pressure gradients observed throughout follow-up.
Conclusions:
- The CoreValve bioprosthesis exhibits favorable durability up to seven years post-TAVI.
- Despite high overall mortality in this elderly cohort, the device provides a durable solution for aortic stenosis.
Aims:
The aim of this study was to determine the long-term outcomes of high-risk patients who underwent transcatheter aortic valve implantation (TAVI) with the third-generation CoreValve device, according to the 2017 EAPCI/ESC/EACTS definition of valve durability.
Methods And Results:
Between 2007 and 2013, 278 consecutive patients were enrolled in our prospective single-centre CoreValve registry (mean age 82±6 years, mean STS score 6.4±5.0%). The median follow-up of survivors was 6.8 years. The Cox proportional hazards model was used to identify independent predictors of HF rehospitalisation and all-cause mortality. Predictors of HF rehospitalisation were LVEF, MR and PVL at the last echocardiographic follow-up. The majority of patients were in NYHA Class I or II and showed mild/trivial paravalvular leak throughout follow-up. Mean pressure gradients remained stable over time. The overall crude cumulative incidences of structural valve deterioration and bioprosthetic valve failure were 3.6% and 2.5%, respectively.
Conclusions:
Although overall mortality was high in this elderly patient cohort, the CoreValve bioprosthesis showed good durability at seven-year follow-up.
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