Outcomes Following Transcatheter Aortic Valve Replacement in the United States
What is the initial US commercial experience with transcatheter aortic valve replacement (TAVR)?
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.
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%).
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%.
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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