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Beyond the five-year horizon: long-term outcome of high-risk and inoperable patients undergoing TAVR with
Marcus-André Deutsch1, Magdalena Erlebach, Melchior Burri
1Department of Cardiovascular Surgery, German Heart Center Munich, Technische Universität München, Munich, Germany.
Insights
Seven-year outcomes for high-risk patients show 23.2% survival after transcatheter aortic valve replacement (TAVR) using first-generation devices. Predictors of mortality and structural valve deterioration were identified for long-term TAVR success.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Transcatheter aortic valve replacement (TAVR) is a crucial treatment for high-risk patients with aortic stenosis.
- First-generation TAVR devices have been widely used, necessitating long-term outcome evaluation.
- Understanding predictors of mortality and valve durability is essential for optimizing patient selection and management.
Purpose of the Study:
- To determine the long-term (7-year) outcomes of high-risk patients undergoing TAVR with first-generation devices.
- To identify independent predictors of all-cause mortality after TAVR.
- To assess the durability of first-generation TAVR devices and the incidence of structural valve deterioration (SVD).
Main Methods:
- Retrospective analysis of a prospective single-center registry of 300 high-risk patients who received TAVR with first-generation CoreValve or SAPIEN devices (2007-2009).
- Kaplan-Meier survival estimates and Cox proportional hazards models were used to identify mortality predictors.
- Structural valve deterioration was assessed using the 2017 EAPCI/ESC/EACTS definition.
Main Results:
- Estimated 7-year survival rate was 23.2%.
- Independent predictors of mortality included patient factors (atrial fibrillation, impaired kidney function, peripheral artery disease, mitral regurgitation) and procedure-related factors (acute kidney injury, neurological events, vascular complications, bleeding).
- The crude cumulative incidence of SVD at 7 years was 14.9%, with higher rates for SAPIEN (22.6%) compared to CoreValve (11.8%).
Conclusions:
- Long-term survival after TAVR with first-generation devices remains limited, with both patient and procedural factors influencing outcomes.
- Structural valve deterioration may become increasingly relevant in longer-term follow-up, particularly with certain device types.
- These findings highlight the need for continued monitoring and potential device improvements for durable TAVR outcomes.
Aims:
We sought to determine the long-term outcome of high-risk patients who underwent transcatheter aortic valve replacement (TAVR) with first-generation devices with a focus on the identification of predictors for mortality and valve durability.
Methods And Results:
Consecutive patients in our prospective single-centre registry undergoing TAVR with first-generation devices (n=214 CoreValve; n=86 SAPIEN) between 06/2007 and 07/2009 were retrospectively analysed (n=300, mean age 81.43±6.55 years, mean STS score 6.5±4.5%). Kaplan-Meier estimates of survival and the Cox proportional hazards model were used to identify independent predictors of all-cause-mortality. At 1, 5, and 7 years, estimated survival rates were 76.0%, 40.2%, and 23.2%, respectively. Age-adjusted baseline predictors of mortality included atrial fibrillation, impaired kidney function, peripheral artery disease, and mitral regurgitation (≥moderate). Baseline risk-adjusted procedure-related predictors for all-cause mortality included acute kidney injury, neurological events, major vascular complications, and major/life-threatening bleeding. At both five and six years, 78.2% of surviving patients were in NYHA Class I or II. PVL was ≤mild in the majority of patients at discharge and throughout follow-up. At seven years, the overall crude cumulative incidence of structural valve deterioration according to the 2017 EAPCI/ESC/EACTS definition was 14.9% (CoreValve 11.8% vs. SAPIEN 22.6%; p=0.01).
Conclusions:
Seven years after TAVR, 23.2% of high-risk patients were still alive. Independent predictors of all-cause mortality included both patient- and procedure-related factors. With a cumulative incidence of 14.9% at seven years, there is some suggestion that SVD post TAVR may become increasingly relevant during longer-term follow-up.
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