Dysfunction of small surgical aortic bioprostheses represents a challenging scenario for transcatheter aortic valve replacement in the valve-in-valve setting, due to the higher incidence of elevated residual gradients and prosthesis–patient mismatch. Comparative evidence between balloon-expandable and self-expanding valves had primarily come from observational studies. The objective of this analysis of the randomized LYTEN trial was to compare hemodynamic performance and 3-year clinical outcomes between both types of prostheses in patients with dysfunctional small surgical bioprostheses undergoing valve-in-valve transcatheter aortic valve implantation.
The study was a prospective, randomized, open-label trial conducted at 11 centers in Canada, the United States, and Europe. A total of 102 patients were enrolled, of whom 98 ultimately underwent transcatheter valve implantation (46 with balloon-expandable valves and 52 with self-expanding valves). The mean age was 80±7 years, 47% were women, and the median surgical risk according to the Society of Thoracic Surgeons score was 5.0% (interquartile range 3.7–7.2). Surgical bioprostheses were ≤23 millimeters in size and included different models, with up to eight distinct valve types and no clear predominance. The cause of dysfunction was stenosis in approximately two-thirds of cases and regurgitation in the remaining third.
In the balloon-expandable group, SAPIEN 3 or SAPIEN ULTRA valves were implanted, while the self-expanding group received Evolut R, PRO, or PRO+ valves, with sizes ranging from 20 to 26 millimeters. Surgical ring fracture was performed more frequently in the balloon-expandable group (30% versus 13%; p=0.041). Device implantation was successful in 100% of cases, and there was no in-hospital mortality.
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The primary endpoint was the rate of severe prosthesis–patient mismatch or moderate-to-severe aortic regurgitation at 30 days. Secondary endpoints included clinical outcomes.
ViV-TAVI in Small Surgical Aortic Bioprostheses: Superior 3-Year Hemodynamic Performance with Self-Expanding Valves in the LYTEN Trial
At 3 years, hemodynamic performance was significantly better with self-expanding valves. Mean gradients were lower with self-expanding prostheses (13.12±8.56 mmHg versus 20.40±9.12 mmHg; p=0.002), as were peak gradients (23.0±16.2 mmHg versus 35.89±14.13 mmHg; p=0.001). Indexed effective orifice area was greater in the self-expanding group (0.93±0.32 versus 0.69±0.27 cm²/m²; p=0.002). A mean gradient ≥20 mmHg was observed in 17.6% of patients treated with self-expanding valves compared with 62.1% of those receiving balloon-expandable valves (p<0.001). Moderate aortic regurgitation was infrequent and similar between groups (0% versus 2.9%; p=0.582), and significant hemodynamic deterioration occurred in only one patient in the self-expanding group (2.9%).
Regarding clinical outcomes, no significant differences were observed between groups in any of the evaluated events. The composite endpoint of death, stroke, or hospitalization for heart failure occurred in 28.7% of patients (32.6% in the balloon-expandable group versus 25.5% in the self-expanding group; p=0.489). All-cause mortality at 3 years was 19.1% (23.3% versus 15.7%; p=0.375), hospitalizations for heart failure were 14.9% (16.3% versus 13.7%; p=0.716), and stroke occurred in 4.2% (2.3% versus 5.9%; p=0.407), with no statistically significant differences.
The need for permanent pacemaker implantation was low and similar between groups (2.3% versus 3.9%; p=0.665). Functional status and quality of life improved significantly in both groups from the early period and remained stable through 3 years, without differences according to valve type.
Conclusion: Hemodynamic Superiority of Self-Expanding Valves Without Impact on Major Clinical Events at Mid-Term Follow-Up
In patients with dysfunctional small surgical aortic bioprostheses treated with valve-in-valve transcatheter aortic valve replacement, self-expanding valves demonstrated superior hemodynamic performance at 3 years, with lower gradients and larger effective orifice area. However, this advantage did not translate into differences in major clinical events, functional status, or quality of life at mid-term follow-up. These findings suggest that the hemodynamic superiority of supra-annular prostheses does not necessarily result in a mid-term clinical benefit, although longer follow-up will be required to determine their definitive impact.
Original Title: Balloon- Versus Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses: 3-Year Results of the LYTEN Trial.
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