"Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients". The New England Journal of Medicine. 2011. 364(23):2187-2198. PubMed•Full
Links to original sources: Wiki Journal Post Full Journal Article
Contents
1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9 Criticisms 10 Funding 11 Further Reading
In high-risk patients with severe aortic stenosis, how does transcatheter aortic-valve replacement (TAVR) compare with surgical aortic-valve replacement (SAVR) in terms of mortality and morbidity?
In high-risk patients with severe aortic stenosis, TAVR is comparable to SAVR in terms of survival at 1 year with differences in periprocedural risks.
The PARTNER (Placement of Aortic Transcatheter Valves) trial included a cohort of high-risk patients with severe aortic stenosis, for whom SAVR was applicable but with substantial risk. This study demonstrated that TAVR, delivered either by the transfemoral or transapical approach, was a viable alternative to SAVR, showing similar rates of survival at 1 year.
Current guidelines for the treatment of aortic stenosis have incorporated results from the PARTNER trial, including recommendations for TAVR in patients at high risk for surgical complications.
- Multicenter, randomized, controlled trial - N=699 high-risk patients with severe aortic stenosis - Randomized to TAVR (n=348) or SAVR (n=351) - Intention-to-treat analysis - Primary end point: Death from any cause at 1 year
Inclusion Criteria - Severe aortic stenosis with cardiac symptoms (NYHA class II or worse) - High risk for operative complications or death with predicted 30-day mortality of at least 15%
Exclusion Criteria - Bicuspid or noncalcified valve - Severe left ventricular dysfunction (ejection fraction <20%) - Need for revascularization - Severe valvular regurgitation - Recent neurologic event - Severe renal insufficiency
Baseline Characteristics - Balanced between groups - High STS score indicating operative risk
- Patients were randomized to undergo either TAVR via transfemoral or transapical access or SAVR. - Heparin administered during the procedure and dual antiplatelet therapy for 6 months post-procedure.
Primary Outcome - 1-year mortality: 24.2% in TAVR group vs. 26.8% in SAVR group (P=0.44)
- Major stroke at 1 year: 5.1% in TAVR group vs. 2.4% in SAVR group (P=0.07) - Differences in periprocedural complications with more vascular complications in TAVR and more bleeding and atrial fibrillation in SAVR. - Improvement in functional class and 6-minute walk distance at 1-year with no significant difference between groups.
- Withdrawals and decisions against the procedure were more frequent in SAVR group, affecting early procedure-related outcomes assessment. - Long-term valve durability data pending. - Increased stroke rate associated with the TAVR procedure. - Trial used an early device version and included centers with no prior experience with the procedure.
Funded by Edwards Lifesciences.
The full text of the article with supplementary material is available at NEJM.org.