Key result
In simulated redo-TAVR with a 3-mm initial Evolut depth, predicted coronary access was significantly higher with Sapien-3 outflow at node 4 compared to node 5 (84% vs 31%; P<0.001).
Why the study?
Coronary accessibility following redo-TAVR is increasingly important, particularly in younger low-risk patients, but requires prediction after redo-TAVR with a Sapien-3 within an Evolut valve.
Does the initial Evolut implant depth and Sapien-3 outflow position affect predicted coronary accessibility in simulated redo-TAVR?
Does the initial Evolut implant depth and Sapien-3 outflow position affect predicted coronary accessibility in simulated redo-TAVR?
Absolute Event Rate: 84% vs 31%
p-value: p=<0.001
CT simulation demonstrates that coronary accessibility after Sapien-3 in Evolut redo-TAVR is highly dependent on the initial Evolut implant depth and the Sapien-3 outflow position.
Simulated redo-TAVR coronary access depends on positioning; hypothesis-generating and should not yet change practice.
BACKGROUND: Coronary accessibility following redo–transcatheter aortic valve replacement (redo-TAVR) is increasingly important, particularly in younger low-risk patients. This study aimed to predict coronary accessibility after simulated Sapien-3 balloon-expandable valve implantation within an Evolut supra-annular, self-expanding valve using pre-TAVR computed tomography (CT) imaging. METHODS: A total of 219 pre-TAVR CT scans from the Evolut Low-Risk CT substudy were analyzed. Virtual Evolut and Sapien-3 valves were sized using CT-based diameters. Two initial Evolut implant depths were analyzed, 3 and 5 mm. Coronary accessibility was evaluated for 2 Sapien-3 in Evolut implant positions: Sapien-3 outflow at Evolut node 4 and Evolut node 5. RESULTS: With a 3-mm initial Evolut implant depth, suitable coronary access was predicted in 84% of patients with the Sapien-3 outflow at Evolut node 4, and in 31% of cases with the Sapien-3 outflow at Evolut node 5 ( P <0.001). Coronary accessibility improved with a 5-mm Evolut implant depth: 97% at node 4 and 65% at node 5 ( P <0.001). When comparing 3- to 5-mm Evolut implant depth, sinus sequestration was the lowest with Sapien-3 outflow at Evolut node 4 (13% versus 2%; P <0.001), and the highest at Evolut node 5 (61% versus 32%; P <0.001). CONCLUSIONS: Coronary accessibility after Sapien-3 in Evolut redo-TAVR relates to the initial Evolut implant depth, the Sapien-3 outflow position within the Evolut, and the native annular anatomy. This CT-based quantitative analysis may provide useful information to inform and refine individualized preprocedural CT planning of the initial TAVR and guide lifetime management for future coronary access after redo-TAVR. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02701283.
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Tang et al. (2023) studied Evolut failure requiring redo-TAVR (n=219). Sapien-3 outflow at Evolut node 4 vs. Sapien-3 outflow at Evolut node 5 was evaluated on Predicted suitable coronary access (3-mm initial Evolut implant depth) (p=<0.001). In simulated redo-TAVR with a 3-mm initial Evolut depth, predicted coronary access was significantly higher with Sapien-3 outflow at node 4 compared to node 5 (84% vs 31%; P<0.001).
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