STS/ACC TVT Registry Reports on Initial Edwards Sapien TAVR Outcomes in the United States

November 17, 2013—Outcomes from the Society of Thoracic Surgeons/American College of Cardiology's Transcatheter Valve Therapy (STS/ACA TVT) Registry were presented by Michael J. Mack, MD, at the American Heart Association's Scientific Sessions 2013 in Dallas, Texas and were published by Dr. Mack et al in the Journal of the American Medical Association (JAMA; 2013;310:2069–2077).

The STS/ACA TVT Registry investigators reported on the initial commercial experience in the United States with transcatheter aortic valve replacement (TAVR).

This analysis describes the initial TAVR experience in the United States, including patient selection, procedural details, and in-hospital and 30-day outcomes after TAVR among patients enrolled in the TVT Registry.

The investigators concluded that among patients undergoing TAVR at United States centers in the STS/ACC TVT Registry, device implantation success was achieved in 92% of cases, the overall in-hospital mortality rate was 5.5%, and the stroke rate was 2%. Although these postmarket FDA-approval findings are comparable with previously published trial data and international experience, long-term follow-up is essential to assess continued efficacy and safety, noted the investigators.

As summarized in JAMA, the investigators obtained results from all eligible TAVR cases (n = 7,710) in the United States from 224 participating registry hospitals after the Edwards Sapien device commercialization (November 2011–May 2013).

The STS/ACC TVT Registry investigators' reported primary outcomes included all-cause in-hospital mortality and stroke after TAVR. Secondary analyses included procedural complications and outcomes by clinical indication and access site. Device implantation success was defined as successful vascular access, deployment of a single device in the proper anatomic position, appropriate valve function without either moderate or severe aortic regurgitation, and successful retrieval of the delivery system.

In JAMA, 30-day outcomes were presented for a representative 3,133 cases (40.6%) at 114 centers with at least 80% complete follow-up reporting.

The 7,710 patients who underwent TAVR included 1,559 cases (20%) that were inoperable and 6,151 cases (80%) that were high risk but operable. The median age was 84 years (interquartile range [IQR], 78–88 years), 3,783 patients (49%) were women, and the median STS-predicted risk of mortality was 7% (IQR, 5%–11%).

At baseline, 2,176 patients (75%) were either not at all satisfied (1,297 patients [45%]) or mostly dissatisfied (879 patients [30%]) with their symptom status; 2,198 (72%) had a 5-meter walk time of > 6 seconds (slow gait speed).

The most common vascular access approach was transfemoral (4,972 patients [64%]) followed by transapical (2,197 patients [29%]) and other alternative approaches (536 patients [7%]); successful device implantation occurred in 7,069 patients (92%; 95% confidence interval [CI], 91%–92%). The observed incidence of in-hospital mortality was 5.5% (95% CI, 5%–6.1%). Other major complications included stroke (2%; 95% CI, 1.7%–2.4%), dialysis-dependent renal failure (1.9%; 95% CI, 1.6%–2.2%), and major vascular injury (6.4%; 95% CI, 5.8%–6.9%). Median hospital stay was 6 days (IQR, 4–10 days), with 4,613 (63%) discharged home.

Among patients with available follow-up at 30 days (n = 3,133), the incidence of mortality was 7.6% (95% CI, 6.7%–8.6%; noncardiovascular cause, 52%); a stroke had occurred in 2.8% (95% CI, 2.3%–3.5%), new dialysis in 2.5% (95% CI, 2%–3.1%), and reintervention in 0.5% (95% CI, 0.3%–0.8%), reported the STS/ACC TVT Registry investigators.

In JAMA, the investigators noted that although the pivotal PARTNER trials demonstrated the efficacy of TAVR within a select cohort of patients and hospital centers, there are no data on dissemination and utilization patterns of this technology in routine clinical practice in the United States. Additionally, concerns persist regarding the safety and effectiveness of this novel technology as it moves beyond protocolized trial care and highly experienced centers and operators.

In 2011, the FDA approved the first TAVR device—the Edwards Sapien transcatheter heart valve (Edwards Lifesciences, Irvine, CA)—for the treatment of severe, symptomatic aortic stenosis and inoperable status. In 2012, the approved indication was expanded for high-risk but operable status patients. The national STS/ACC TVT Registry was initiated in December 2011 to meet a condition from the Centers for Medicare & Medicaid Services for coverage—which was granted in 2012—and to facilitate outcome assessment and comparison with other trials and international registries.