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Published on: June 3, 2018
Cerebrovascular Events in Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation: A Pooled
Astrid C van Nieuwkerk1, Hugo M Aarts1, Kimberley I Hemelrijk1
1Department of Cardiology Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences Amsterdam the Netherlands.
Insights
Cerebrovascular events after transcatheter aortic valve implantation (TAVI) remain a significant concern, with a stable 30-day incidence of approximately 2.2% over 15 years. Post-stroke mortality remains high, underscoring the need for continued research and improved patient management strategies.
Area of Science:
- Cardiology
- Neurology
- Medical Interventions
Background:
- Cerebrovascular events are a major complication of transcatheter aortic valve implantation (TAVI).
- Limited real-world data exists on the longitudinal trends and outcomes of these events.
- This study aimed to analyze cerebrovascular events following transfemoral TAVI.
Purpose of the Study:
- To assess the incidence and temporal trends of cerebrovascular events after transfemoral TAVI.
- To identify predictors of these events.
- To evaluate the outcomes, including mortality, associated with cerebrovascular events post-TAVI.
Main Methods:
- Analysis of pooled patient-level data from 10 clinical studies (CENTER2 study).
- Inclusion of 24,305 patients undergoing transfemoral TAVI between 2007 and 2022.
- Assessment of 30-day and 1-year outcomes, including stroke incidence and mortality, stratified by risk categories and time periods.
Main Results:
- The 30-day stroke incidence was 2.2% (n=534), with rates remaining stable from 2007-2022 (P=0.28).
- Cerebrovascular event rates were similar across low, intermediate, and high Society of Thoracic Surgeon Predicted Risk of Mortality (STS-PROM) categories (P=0.21).
- Mortality was significantly higher in patients experiencing stroke at 30 days (20.3%) and 1 year (44.1%) compared to those without.
Conclusions:
- The 30-day incidence of cerebrovascular events after transfemoral TAVI has remained consistently around 2.2% from 2007 to 2022.
- Stroke rates did not vary significantly across different STS-PROM risk groups.
- Mortality rates following stroke post-TAVI remain high and have not shown a significant decline over time.
Background:
Cerebrovascular events remain one of the most devastating complications of transcatheter aortic valve implantation (TAVI). Data from real-world contemporary cohorts on longitudinal trends and outcomes remain limited. The aim of this study was to assess incidence, temporal trends, predictors, and outcomes of cerebrovascular events following transfemoral TAVI.
Methods And Results:
The CENTER2 (Cerebrovascular Events in Patients Undergoing Transcatheter Aortic Valve Implantation With Balloon-Expandable Valves Versus Self-Expandable Valves 2) study includes patients undergoing TAVI between 2007 and 2022. The database contains pooled patient-level data from 10 clinical studies. A total of 24 305 patients underwent transfemoral TAVI (mean age 81.5±6.7 years, 56% women, median Society of Thoracic Surgeon Predicted Risk of Mortality 4.9% [3.1%-8.5%]). Of these patients, 2.2% (n=534) experienced stroke in the first 30 days after TAVI, and 40 (0.4%) had a transient ischemic attack. Stroke rates remained stable during the treatment period (2007-2010: 2.1%, 2011-2014: 2.5%, 2015-2018: 2.1%, 2019-2022: 2.1%; Ptrend=0.28). Moreover, 30-day cerebrovascular event rates were similar across Society of Thoracic Surgeon Predicted Risk of Mortality risk categories: 2.1% in low-risk, 2.6% in intermediate-risk, and 2.5% in high-risk patients (P=0.21). Mortality was higher in patients with 30-day stroke than without at 30 days (20.3% versus 4.7%; odds ratio, 5.1 [95% CI, 4.1-6.5]; P<0.001) and at 1 year (44.1% versus 15.0%; hazard ratio, 3.5 [95% CI, 3.0-4.2]; P<0.001). One-year mortality rates for stroke did not decline over time (2007-2010: 46.9%, 2011-2014: 46.0%, 2015-2018: 43.0%, 2019-2022: 39.1%; Ptrend=0.32). At 1 year, 7.0% of patients undergoing TAVI had a stroke.
Conclusions:
In 24 305 patients who underwent transfemoral TAVI, 30-day cerebrovascular event incidence remained ≈ 2.2% between 2007 and 2022. Thirty-day stroke rates were similar throughout Society of Thoracic Surgeon Predicted Risk of Mortality risk categories. Mortality rates after stroke remain high.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03588247.
