A recent analysis published in Circulation revealed that low-risk patients undergoing transcatheter aortic valve replacement (TAVR) in real-world settings experience a higher risk of mortality compared to those treated in clinical trials. While the outcomes for these real-world patients were still considered “excellent,” the study highlighted the importance of understanding survival odds post-treatment.
Key Findings:
- Mortality Rates: In the real-world setting, 1-year mortality for low-risk TAVR patients was 4.6%, higher than the 3.1% seen in clinical trial participants from the PARTNER 3 and Evolut Low-Risk trials.
- Stroke & Pacemaker Rates: The rates of stroke and permanent pacemaker implantation were also higher in the real-world cohort compared to trial participants.
- Eligibility Differences: Only 62% of real-world patients would have qualified for the PARTNER 3 or Evolut Low-Risk trials, with exclusion criteria including higher mortality risk scores and recent cardiovascular events.
Key Factors:
- Comorbidities: Real-world patients exhibited higher rates of atrial fibrillation and lower Kansas City Cardiomyopathy Questionnaire (KCCQ) scores.
- Care Fragmentation: Variations in patient care, including fragmented treatment, may contribute to worse outcomes compared to the more controlled clinical trial environments.
While real-world low-risk TAVR patients generally achieve positive outcomes, the higher incidence of adverse events emphasizes the need for cardiologists and patients to be informed about potential risks, particularly in terms of long-term survival and the need for pacemakers post-treatment.
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