- With transcatheter aortic valve replacement (TAVR) for symptomatic severe aortic stenosis (AS) in low-risk patients, no deaths or disabling strokes had occurred by 30 days.
Why this matters
- TAVR is standard of care for higher-risk severe AS patients.
- Increasingly, it is offered to surgical aortic valve replacement (SAVR)-eligible patients.
- Risk for subclinical leaflet thrombosis in low-risk TAVR patients was previously unknown.
- Mean patient age, 74 years.
- TAVR vs SAVR:
- All-cause mortality: 0.0% vs 1.7% (P=.079).
- In-hospital complications:
- Stroke: 0% vs 0.6% (P=.582);
- Major vascular complications, life-threatening/major bleeding: 2.5% vs 10.3% (P<.001>
- New permanent pacemaker: 5.0% vs 4.5% (P=.742);
- New-onset Afib: 3.0% vs 40.8% (P<.001>
- Length of stay: 2.0±1.1 vs 6.4±3.9 days (P<.001>
- Hypoattenuated leaflet thickening: 14.0%;
- Reduced leaflet motion: 11.2%;
- Hypoattenuation affecting motion: 7.4%.
- Randomized, multicenter, open-label trial (first Investigational Device Exemption trial enrolling low-risk US patients).
- Researchers compared outcomes in 200 prospective patients undergoing transfemoral TAVR with 719 historical SAVR control patients from Society of Thoracic Surgeons database.
- All participants had low surgical risk.
- Outcome: 30-day all-cause mortality.
- Funding: MedStar Health Research Institute.
- Some risk factors not captured in database.
- No data past 30 days.