Key Points:
- Bioprosthetic mitral valve dysfunction is a growing problem, particularly in area where rheumatic heart disease is prevalent and patients undergo initial valve replacement at a younger age. Redo surgical mitral valve replacement (MVR) is the standard treatment but carries substantial perioperative risk. Transcatheter mitral valve-in-valve (mViV) has emerged as a less invasive alternative, but no randomized trial had previously compared the two strategies.
- The SURVIV trial randomized 150 patients with severe mitral bioprosthetic valve dysfunction at 7 centers in Brazil to mViV with a balloon-expandable Sapien 3 or re-do MVR, irrespective of surgical risk scores. SURVIV found that mViV was superior to MVR for the primary composite endpoint of all-cause death or disabling stroke. This difference was largely driven by a decrease in early mortality.
- SURVIV provides the first randomized evidence that transcatheter mViV may offer important short-term clinical benefits over redo surgery for failed mitral bioprostheses. However, the study was relatively small, conducted in a single country with a predominantly rheumatic population, and lacks long-term data on valve durability.
The use of bioprosthetic mitral valve replacement has increased substantially over the past two decades. Because bioprosthetic valves deteriorate over time, up to 30% of patients may require a repeat mitral valve intervention after approximately 10 years. Redo surgical mitral valve replacement remains the standard of care for failed mitral bioprostheses, but it carries considerably higher risk than a first operation, with contemporary series reporting 30-day mortality rates ranging from 7% to 22%. Transcatheter mitral valve-in-valve (mViV) has emerged as a minimally invasive alternative, in which a catheter is used to deploy a new prosthetic valve inside the failing bioprosthesis via a trans-septal approach. While registry data and observational studies have suggested favorable outcomes with mViV in high-risk patients, there is little randomized evidence directly comparing mViV with redo surgery.
On March 29th 2026, the results of “Redo-Surgery Versus Transcatheter Valve-In-Valve for Mitral Bioprosthetic Dysfunction: The SURVIV Trial” were presented at ACC Scientific Sessions 2026 in New Orleans, LA. The purpose of this trial was to compare the clinical outcomes of redo surgical mitral valve replacement and transcatheter mitral valve-in-valve in patients with failed mitral bioprostheses.
SURVIV was an investigator-initiated randomized trial conducted at 7 referral cardiovascular hospitals in Brazil. Patients 18 years or older with severe symptomatic mitral bioprosthetic valve dysfunction who were eligible for both redo surgery and mViV after heart team evaluation were enrolled. Importantly, surgical risk scores (STS and EuroSCORE II) were not used as eligibility criteria. Patients with concomitant aortic or complex coronary disease, severe left ventricular dysfunction (EF <20%), intracardiac thrombus or vegetations, or a predicted neo-left ventricular outflow tract area <170 mm² were excluded. Patients were randomized 1:1 to transseptal mViV with a balloon-expandable Sapien 3 (Edwards Lifesciences) or to redo surgical MVR. The primary endpoint was a composite of all-cause death and disabling stroke at 1 year. The primary analysis was a modified intention-to-treat, with outcomes assessed from the date of the procedure (rather than the date of randomization).
Between February 2020 and November 2023, 235 patients were screened and 150 were enrolled and randomized: 75 to mViV and 75 to MVR. In the MVR group, 2 patients refused surgery and 1 died before the procedure, leaving 72 who underwent surgery. In the mViV group, 1 patient required a transatrial rather than transseptal access. The mean age was 57.9 years, 72% were women, and the mean STS mortality score was 3.6%. Overall, 56% were in NYHA functional class III or IV, 50% had atrial fibrillation, 70% had pulmonary hypertension, and 25% had undergone more than one prior mitral valve surgery. The mean LVEF was 57.2% and the mean systolic pulmonary artery pressure was 57 mmHg. Baseline characteristics were well balanced between groups.
At 1 year, the primary composite endpoint of all-cause death or disabling stroke occurred in 5.3% of patients in the mViV group versus 20.8% in the MVR group (HR 0.23 [95% CI: 0.07–0.68]; p=0.005). This difference was driven predominantly by events in the early postoperative period. At 30 days, death occurred in 0% of the mViV group compared to 12.5% of the MVR group (p=0.001). At 30 days, life-threatening, extensive, or major bleeding was significantly higher in the MVR group (11.1% vs. 1.3%; p=0.016), as was acute kidney injury stage 2 or 3 (15.3% vs. 0%; p<0.001). The median index length of stay was 4 days after mViV compared to 14 days after MVR (p<0.001). Stroke rates were low in both groups. Results were consistent across prespecified subgroups with no significant interactions.
Both procedures resulted in substantial hemodynamic improvement, however the redo surgery group achieved a lower mean mitral gradient at 12 months (6.7 vs. 5.4 mmHg; p=0.007) and a larger prosthetic valve area at both 3 and 12 months. Both groups experienced significant improvements in NYHA functional class and quality of life, with no significant differences between the two strategies at 3 or 12 months. Cardiac rehospitalizations were higher in the mViV group (16% vs. 2.8%; p=0.02), with 4 rehospitalizations in the mViV group related to leaflet thrombosis.
Limitations of this study include its relatively small sample size and the fact that it was performed in a single country, limiting generalizability to populations with different underlying etiologies for mitral valve disease, different health care systems, and different surgical volumes. Pulmonary hypertension was common, which may have increased surgical risk. A proportion of patients were enrolled during the COVID-19 pandemic, which may have affected perioperative care. The study was not blinded, although outcomes were adjudicated by an independent blinded clinical events committee. Finally, only 1-year results are available; long-term data on valve durability and clinical outcomes are being collected with planned follow-up to 10 years.
Dimytri Siqueira, MD, PhD, Director of Interventions in Acquired Valvular Heart Disease at the Instituto Dante Pazzanese de Cardiologia in São Paulo, Brazil, concluded: “These results suggest that a transcatheter valve-in-valve procedure may offer an important short-term clinical benefit in selected high-risk patients. However, long-term follow-up of patient outcomes is essential to better understand durability and the overall role of this approach in clinical practice.”