Resumen de Outcomes Following Transcatheter Aortic Valve Replacement in the United States
M. J. Brennan, J. Matthew Mack, Ralph Brindis, Fred Edwards, Fred Grover, David Shahian, E. Murat Tuzcu, Eric D. Peterson, John S. Rumsfeld, Kathleen Hewitt, Cynthia Shewan, Joan Michaels, Barb Christensen, Alexander Christian, Sean O'Brien, David Holmes
Importance Transcatheter aortic valve replacement (TAVR) was approved by the US Food and Drug Administration for the treatment of severe, symptomatic aortic stenosis and inoperable status (in 2011) and high-risk but operable status (starting in 2012). A national registry (the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy [STS/ACC TVT] Registry) was initiated to meet a condition for Medicare coverage and also facilitates outcome assessment and comparison with other trials and international registries.
Objective To report the initial US commercial experience with TAVR.
Design, Setting, and Participants We obtained results from all eligible US TAVR cases (n=7710) from 224 participating registry hospitals following the Edwards Sapien device commercialization (November 2011�May 2013).
Main Outcomes and Measures 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 are presented for a representative 3133 cases (40.6%) at 114 centers with at least 80% complete follow-up reporting.
Results The 7710 patients who underwent TAVR included 1559 (20%) cases that were inoperable and 6151 (80%) cases that were high-risk but operable. The median age was 84 years (interquartile range [IQR], 78-88 years); 3783 patients (49%) were women and the median STS predicted risk of mortality was 7% (IQR, 5%-11%). At baseline, 2176 patients (75%) were either not at all satisfied (1297 patients [45%]) or mostly dissatisfied (879 patients [30%]) with their symptom status; 2198 (72%) had a 5-m walk time longer than 6 seconds (slow gait speed). The most common vascular access approach was transfemoral (4972 patients [64%]), followed by transapical (2197 patients [29%]) and other alternative approaches (536 patients [7%]); successful device implantation occurred in 7069 patients (92%; 95% 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 4613 (63%) discharged home. Among patients with available follow-up at 30 days (n=3133), 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 and Relevance 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%. Although these postmarket US approval findings are comparable with prior published trial data and international experience, long-term follow-up is essential to assess continued efficacy and safety.
Trial Registration clinicaltrials.gov Identifier: NCT01737528 In November 2011, the US Food and Drug Administration (FDA) approved use of a device for transcatheter aortic valve replacement (TAVR) using the transfemoral approach for the treatment of severe, symptomatic aortic stenosis in patients with inoperable status.1 The label for the device was expanded in September 2012 to include patients with high-risk but operable status by either a transfemoral or transapical approach.2 Since commercial approval, this first-to-US-market TAVR device has been introduced to nearly 250 US clinical sites. To meet Medicare insurance coverage requirements, facilities must comply with coverage criteria outlined by the Centers for Medicare & Medicaid Services (CMS) National Coverage Determination,3 including participation in a national procedural registry designed to answer outstanding evidentiary questions. To satisfy this requirement, the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) developed the STS/ACC Transcatheter Valve Therapy (TVT) Registry.4 Although the pivotal PARTNER trials demonstrated 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.5,6 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 this analysis, we describe the initial US TAVR experience, including patient selection, procedural details, and in-hospital and 30-day outcomes following TAVR among patients enrolled in the TVT Registry.
