The transcatheter valve-in-valve (ViV) procedure appears to be a safe option for select patients requiring repeat surgery after failed mitral bioprostheses, according to findings from the randomized controlled SURViV trial presented at ACC.26. However, it is still early days for the ViV approach.
Researchers compared the ViV strategy with redo surgery in 150 patients (mean age 57.9 years, 72 percent female) with mitral bioprosthetic valve dysfunction who were deemed suitable candidates for either procedure by a heart team at seven referral hospitals in Brazil. A quarter had undergone at least 2 prior mitral valve surgeries. Approximately 70 percent had pulmonary hypertension, 50 percent had atrial fibrillation, and many had rheumatic heart disease. Patients were randomly assigned to redo surgery or transcatheter ViV. [ACC 2026, LBCT 5, abstract 110-07]
At 1 year, the trial’s primary endpoint of all-cause death or disabling stroke was 5.3 percent with transcatheter ViV and 20.8 percent with redo surgery (hazard ratio [HR], 0.23; p=0.005).
In the sub-analysis, the ViV advantage was consistently observed across subgroups defined by age, sex, BMI, predicted surgical risk, the number of prior mitral surgeries, the time since those surgeries, NYHA class, left ventricular ejection fraction, pulmonary artery pressure, and the presence of tricuspid regurgitation.
Reporting at ACC.26 on behalf of the investigators, Dr Dimytri Siqueira, an interventional cardiologist at the Instituto Dante Pazzanese de Cardiologia in São Paulo, Brazil, said the study provides “first randomized evidence to inform treatment selection for mitral bioprosthetic dysfunction.”
Early clinical adverse events
Clinical adverse events at 30 days were significantly lower for the ViV group, Siqueira reported. In-hospital deaths were higher after redo surgery (12.5 percent; p=0.001), as were disabling strokes (8.3 percent; p=0.012), whereas none occurred within 30 days of the transcatheter procedure.
Additionally, there was less life-threatening, extensive, or major bleeding (1.3 percent vs 11.1 percent; p=0.016) and a lower incidence of acute kidney injury (0 percent vs 15.3 percent; p<0.001) with transcatheter ViV. Median hospital stay was 4 days for ViV vs 14 days for redo surgery (p<0.001).
Valve performance
At 3 months, the mean mitral gradient was 5.9 mm Hg in the ViV group and 5.3 mm Hg in the redo surgery group. By 1 year, however, patients treated with ViV had a higher mean gradient than those who underwent redo surgery (6.7 vs 5.4 mm Hg; p=0.007). Mean prosthetic valve area was larger in the surgery group (1.7 cm2 vs 1.4 cm2; (p=0.003).
At 1 year, rehospitalizations for cardiac causes were more common after ViV (four were related to leaflet thrombosis) than after redo surgery (16 percent vs 2.8 percent; p=0.02). New York Heart Association class and quality-of-life measures (mean EuroQoL 5D-Visual Analogue Scale) did not differ between the two groups.
Valve deterioration: A time-dependent drawback
Siqueira said that bioprosthetic mitral valve replacement (MVR) has become increasingly common. However, structural valve deterioration remains an inevitable, time-dependent limitation of these devices, often necessitating redo surgery.
“Bioprosthetic valve dysfunction can occur 10–15 years after surgery. This is a clinical challenge worldwide, especially in regions where rheumatic heart disease remains prevalent and leads to a first surgery at a younger age,” he added.
Redo surgical MVR has traditionally been the standard of care for bioprosthetic valve dysfunction (BVD), but it carries significant surgical risks.
“Transcatheter mitral ViV implantation has emerged as a less invasive alternative for patients at increased surgical risk,” said Siqueira. It is less risky than open-heart redo surgery and is often performed via catheters in the groin, with faster recovery. However, no randomized trials have directly compared these treatment strategies, added Siqueira.
Practical and clinically relevant
Discussant for SURViV, Dr Michael Reardon of Houston Methodist Hospital in Texas, US, agreed that the trial addresses a practical and clinically relevant issue.
“The US guidelines recommend using biologic valves in the mitral space from age 65, whereas in Europe, from age 70,” he said. “A recent study reported a 9 percent reintervention rate for MVR by 12 years. There wasn’t a large inflection until you got below [age] 45, so we’re probably going to see more of these, particularly in countries with a high prevalence of rheumatic disease.”
Reardon added that, in the long run, “we are uncertain whether the survival curves will cross in favour of redo surgery or whether the ViV strategy will prove durable over time. What do you tell your patients, since we know nothing about the long term?” he asked Siqueira.
Siqueira said the clinical decision should remain individualized. “A lot of factors play a role in deciding which treatment to offer. This is a heart team decision.”