Outcomes Following Transcatheter Aortic Valve Replacement in the United States

Abstract

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 PARTICIPANTSWe 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 MEASURESPrimary 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. RESULTSThe 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%,...

A Simplified Protocol for Transcatheter Aortic Valve Implantation that Reduces Procedure-Related Risk

“…TAVI has been widely accepted as a method to treat aortic stenosis in high-risk patients [1][2][3]. Experience has made the procedure safer, and the development of technology has led to the simplification of standard protocols.…”

“…Long-term results following the earliest intervention (TAVI) procedures have so far been convincing [3,4] and continuous technologic and material development has improved the technique. New options have been explored, and new procedures on mitral and tricuspid valves and valve-in-valve and valve-in-ring procedures developed.…”

“…There is no doubt, for instance, that high doses of contrast medium impair renal function, and patients may proceed to renal failure with anuria, uremia and death [7,8]. Vascular complications at the access site remain a problem, though rates seem to be decreasing [3,9]. Protocols that include one or more periods of rapid pacing can lead to acute hemodynamic problems in patients with impaired heart function.…”

Choice and Selection of Treatment Modalities for Cardiac Patients: An Interventional Cardiology Perspective

“…There have been several large national registries that have furthered our understanding of TAVR 16, 17, 18. The most recent addition to the series of large national registries has been the US Transcatheter Valve Therapy registry, which aims to collect outcomes following interventions on aortic as well as mitral valves 19. Registry‐based randomized trials represent a rather innovative style of answering important clinical questions by designing a randomized trial on the platform of an already existing high‐quality observational registry.…”

“…The next few years witnessed the publication of multiple large multicenter registries, which helped understand the utilization of this new technology and the outcomes in real‐world settings. For the growth and maturation of this technology, it is important that all sites in the United States should embrace meticulous data collection and participate in the national Transcatheter Valve Therapy registry 19. This registry would be crucial to benchmark performance standards, determine appropriateness of case selection, monitor device‐related complications, and provide the substrate for reimbursement decisions currently and in the future.…”