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Outcomes Following Transcatheter Aortic Valve Replacement in the United States
Study Questions:
What is the initial US commercial experience with transcatheter aortic valve replacement (TAVR)?
Methods:
The investigators obtained results from all eligible US TAVR cases (n = 7,710) from 224 participating hospitals in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry, following the Edwards Sapien XT device commercialization (November 2011–May 2013). Primary outcomes included all-cause in-hospital mortality and stroke following 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 AR, and successful retrieval of the delivery system. Thirty-day outcomes were presented for a representative 3,133 cases (40.6%) at 114 centers with at least 80% complete follow-up reporting.
Results:
The 7,710 patients who underwent TAVR included 1,559 (20%) cases that were inoperable and 6,151 (80%) cases 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-minute walk time longer than 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, 5.0%-6.1%). Other major complications included stroke (2.0%; 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, 2.0%-3.1%), and reintervention in 0.5% (95% CI, 0.3%-0.8%).
Conclusions:
The authors concluded that among patients undergoing TAVR at US 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 2.0%.
Perspective:
This analysis reported that post-approval commercial introduction of this new TAVR technology with an early-generation device has yielded success rates and complication patterns that are similar to those documented in carefully performed randomized trials. Furthermore, the outcomes of procedures even with this early-generation approved device are similar to the global experience of TAVR, which now is based on second- and third-generation improved devices. These findings are very encouraging, but longer-term follow-up is essential to assess continued safety and efficacy, as well as patient quality of life.
Keywords: Heart Valve Prosthesis, Stroke, Follow-Up Studies, Hospital Mortality, Heart Valve Prosthesis Implantation, Angioplasty, Balloon, Coronary, Vascular System Injuries, Prostheses and Implants, Renal Dialysis, Incidence, Renal Insufficiency, Urinary Incontinence, Stress, United States
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