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GUIDELINES/RECOMMENDATIONS 
This observational study from the STS/ACC TVT Registry compares real-world outcomes of transcatheter aortic valve replacement (TAVR) in low-risk patients to published clinical trial data, revealing higher one-year mortality rates (3.1% vs 1%) despite identical STS Predicted Risk scores, suggesting that real-world patients may have important clinical differences beyond standard risk assessments.
⚕️Key Clinical Considerations⚕️
- Real-world low-risk TAVR patients showed higher one-year mortality (3.1%) compared to clinical trials (1%), despite matching STS Predicted Risk of Mortality scores.
- Among all registry patients deemed low-risk (n=108,407), only 38% would have met eligibility criteria for the landmark low-risk TAVR trials.
- 30-day outcomes in trial-eligible patients included 0.6% mortality, 1.4% stroke rate, and 8% requiring new pacemaker implantation.
- Higher rates of atrial fibrillation and lower baseline Kansas City Cardiomyopathy Questionnaire scores were identified as predictors of one-year mortality in the real-world cohort.
- At one year, 92% of trial-eligible patients met the “alive and well” criteria (alive with KCCQ score ≥60 and ≤10-point decrease from baseline).
🎯 Clinical Practice Impact 🎯
- Patient Communication: Discuss with patients that real-world outcomes may differ from published trial results, particularly regarding one-year mortality. Consider baseline functional status and comorbidities beyond standard risk calculators when counseling patients about expected outcomes.
- Practice Integration: Recognize that care fragmentation may contribute to worse outcomes; implement coordinated valve team approaches for pre-procedural evaluation and post-TAVR follow-up. Evaluate the presence of atrial fibrillation and baseline functional status as important prognostic factors when selecting patients for TAVR.
- Risk Management: Although real-world mortality is higher than in trials, the overall one-year mortality of 3.1% still represents excellent outcomes for a historically high-risk procedure. Understand that trial-ineligible low-risk patients (62% of those deemed low-risk) face even higher adverse event rates and require careful benefit-risk assessment.
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