1. Redo-TAVR had low procedural complication rates and was comparable to native-TAVR in terms of risk of death and stroke at 30 days and 1 year.
2. Rates of moderate-to-severe aortic regurgitation were comparable between groups.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Transcatheter aortic valve replacement (TAVR) has become a standard treatment for aortic valve stenosis, raising concerns about the durability of bioprosthetic valves. Given the growing use of TAVR and its limited valve durability, data surrounding the clinical management of failed transcatheter heart valves is needed. This study aimed to assess the safety and efficacy of repeat TAVR in patients with failed TAVR using balloon-expandable valves. The primary outcome of this study was to compare procedural, echocardiographic, and clinical outcomes between patients undergoing redo-TAVR and those receiving native-TAVR. Findings from this study demonstrated that redo-TAVR with balloon-expandable valves effectively treated failed TAVR with a low procedural complication rate. The rates of stroke and death at 1-month and 1-year post-procedure were similar between groups. Although this study was well done, it was limited by data analysis from a registry, which may lack clinical details.
Click to read the study in The Lancet
Relevant Reading: Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years
In-depth [randomized-controlled trial]: This study evaluated data from patients who underwent TAVR with balloon-expandable valves between Nov 9, 2011, and Dec 30, 2022. Included were patients with balloon-expandable valves either in failed transcatheter heart valves (redo-TAVR) or native aortic valves (native-TAVR) and those who were part of the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Altogether, 350 591 patients were analyzed (1320 in redo-TAVR and 349 271 in native-TAVR). The mean patient age was 78 years (standard deviation [SD] 9) and the majority (57.7%) were male with a 30-day mortality risk of 8.1%. There was no significant difference between redo-TAVR and native-TAVR with respect to mortality at 30 days (4.7% vs. 4.0%, p=0.36) and 1 year (17.5% vs. 19.0%, p=0.57). This was also true for stroke at 30 days (2.0% in redo-TAVR vs. 1.9% in native-TAVR, p=0.84) and 1 year (3.2% vs. 3.5%, p=0.80). Overall, findings from this study suggest that redo-TAVR with balloon-expandable valves effectively treated TAVR dysfunction with low procedural complications compared to those with native aortic valve stenosis.
Image: PD
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