TAVI (Transcatheter Aortic Valve Implantation) has proven to be beneficial and is currently performed in increasingly younger and lower-risk patients. However, as with surgical bioprostheses, structural deterioration, whether due to stenosis or regurgitation, is one of the challenges we must address.
While currently uncommon, this is an issue we will probably see more and more frequently in the future, and its resolution will become a challenge. It might require explant surgery or a new percutaneous valve implantation. Currently, we have very few reports on the latter strategy.
Researchers conducted an analysis of the STS/ACC TVT Registry, which included 350,591 patients who underwent TAVI with balloon-expandable valves (SAPIEN, SAPIEN XT, SAPIEN 3, and SAPIEN 3 Ultra). Of these patients, 1320 (0.37%) underwent TAVI-in-TAVI. About 36.8% of the previous TAVI procedures had been performed with self-expandable valves, while the rest had been conducted with balloon-expandable valves.
The primary endpoint (PEP) of this study was death and stroke at 30 days and one year.
Since patient populations were different, propensity score matching was used, resulting in 1320 patients in each group.
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The average patient age was 78 years, and 42% of subjects were women; 92% had hypertension, 39% had diabetes, 47% had atrial fibrillation, 30% had a permanent pacemaker, 25% had experienced an infarction, 24% had cardiac conduction disease, and the ejection fraction was 51%. The STS mortality score was 8%.
The mean time between the previous TAVI and TAVI-in-TAVI was 28 months.
Most procedures were performed via the transfemoral access route and were elective.
There were no significant differences in the PEP at 30 days or one year (4.7% vs. 4.0%; hazard ratio [HR], 1.19 [95% confidence interval (CI), 0.82–1.83]; p=0.36; and 17.5% vs. 19.0%; HR, 0.94 [95% CI, 0.77–1.16]; p=0.57, respectively). There were also no differences in death, stroke, the combination of death and stroke, rehospitalization, the need for a permanent pacemaker, infarction, new atrial fibrillation, life-threatening bleeding, functional class improvement, or quality of life improvement.
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The gradient at 30 days and one year was higher in those who underwent TAVI-in-TAVI (15.2 mm Hg [SD, 8.0] vs. 11.6 mm Hg [4.7], p<0.0001, and 15.1 mm Hg [8.2] vs. 11.8 mm Hg [5.8], p<0.0001, respectively), although there were no differences in the presence of moderate or severe paravalvular leak.
The analysis also looked at whether the type of valve (self-expandable or balloon-expandable) used in the initial TAVI procedure had an impact on outcomes at 30 days and one year. There were no differences in mortality, stroke, or paravalvular leak, but patients who had received a self-expandable valve had a lower gradient (16.6 mm Hg [SD, 8.6] vs. 14.2 mm Hg [7.5], p<0.0001, and 17.1 mm Hg [9.2] vs. 13.6 mm Hg [7.1], p=0.0001, respectively).
Conclusion
In conclusion, TAVI-in-TAVI with balloon-expandable valves proved to be effective in treating TAVI dysfunction, with a low rate of complications and similar rates of death and stroke compared with the initial TAVI procedure. Patients who underwent TAVI-in-TAVI had a clinical profile similar to that of patients who underwent TAVI for native aortic valve stenosis. Therefore, TAVI-in-TAVI with balloon-expandable valves could be considered a reasonable option for treating TAVI failure in a selected group of patients.
Dr. Carlos Fava.
Member of the Editorial Board of SOLACI.org.
Original Title: Outcomes of repeat transcatheter aortic valve replacement with balloon-expandable valves: a registry study.
Reference: Raj R Makkar, et al. The Lancet Published online August 31, 2023 https://doi.org/10.1016 S0140-6736(23)01636-7.
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