The first RCT to compare valve-in-valve vs redo surgery reassures, especially for regions where rheumatic valve disease is prevalent.

NEW ORLEANS, LA—Transcatheter mitral valve-in-valve (ViV) procedures are a safe, effective option for select patients who require treatment for failed mitral bioprostheses, data from the randomized SURViV trial suggest.

By 1 year, the ViV group had significantly less all-cause mortality and stroke in comparison to patients who underwent redo surgery. Both therapies led to improvements in symptoms and quality of life.

Dimytri A. Siqueira, MD, PhD (Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil), who presented the data at the American College of Cardiology 2026 Scientific Session, told the media that strategies for repeat mitral interventions are increasingly needed.

“Bioprosthetic mitral valve replacement has increased over the recent decades, but all [such devices] are prone to deterioration leading to clinically significant bioprosthetic valve dysfunction 10 to 15 years after surgery. This is a clinical challenge worldwide, especially in regions where rheumatic valve disease is still prevalent and leads to a first surgery at a younger age,” he said, noting that these individuals are typically underrepresented in trials.

Currently, redo surgical mitral valve replacement is the standard therapy for bioprosthetic valve dysfunction (BVD), though its 30-day mortality rates range from 7% to 22% depending on the etiology, Siqueira reported. “Transcatheter mitral valve-in-valve has emerged as a less-invasive alternative for patients considered at increased surgical risk, but no randomized trials have directly compared these treatment strategies.”

The findings from the trial are extremely encouraging . . . for both therapeutic strategies. David Rizik

SURViV is novel in this regard, though interventional cardiologist David Rizik, MD (Banner Health, Scottsdale, AZ), pointed out that the Brazilian trial’s participants, many of whom had rheumatic valve disease, diverge from the patients typically undergoing repeat mitral interventions in the United States. In the US, patients with failed mitral bioprostheses tend to be decades older, for instance. Moreover, the operators taking part in the trial were very experienced.

Even with this in mind, he said, “the findings from the trial are extremely encouraging . . . for both therapeutic strategies.”

Redo surgery “seems to entail a greater initial procedural burden [and] consistently yields superior valve hemodynamics,” Rizik commented. “However, the data further substantiate the beneficial role of valve-in-valve or transcatheter therapies, particularly for—but not limited to—older patients with more comorbid conditions, frail patient populations, women, and people over 70 for whom the surgical risk is heightened.”

He added: “It’s a win for catheter-based therapies but does underscore the clinical importance of the heart team, the multidisciplinary approach to optimizing patient selection and patient outcomes. . . . Individualize the therapy based on all of these pieces of data.”

Michael Reardon, MD  (Houston Methodist Hospital, TX), the discussant for SURViV yesterday in the Main Tent, agreed SURViV speaks to a clinically relevant issue.

“The US guidelines say we should use biologic valves in the mitral space starting at [age] 65, Europeans at 70,” he noted, citing a recent study that put the reintervention rate for mitral valve replacement at 9% by 12 years. “There wasn’t really a large inflection up until you got less than [age] 45, so we’re probably going to see more and more of these, particularly in countries that have a lot of rheumatic disease.”

One-Year Outcomes

The investigator-initiated SURViV trial enrolled 150 patients (mean age 57.9 years; 72% female) considered by a heart team to be candidates for either procedure across seven referral hospitals in Brazil, randomizing them to undergo repeat surgery or a transcatheter ViV procedure.

Siqueira, in an email to TCTMD, said it’s likely that a large proportion of the SURViV population has rheumatic heart disease. “This is indirectly reflected by the relatively young mean age, the predominance of women, and the advanced stage of cardiac disease, including pulmonary hypertension,” he wrote. “We did not include rheumatic etiology as a formal inclusion criterion, mainly because it is often very difficult to confirm this diagnosis many years after disease onset and after prior mitral valve replacement, especially without information on native valve morphology. Setting the minimum age at 18 years was, in part, intended to capture exactly this patient profile.”

At baseline, participants had a mean STS mortality score of 3.6 and a mean EuroSCORE II of 5.8, with 56.0% in NYHA functional class III or IV. Seventy percent had a systolic pulmonary artery pressure greater than 45 mm Hg, and half had atrial fibrillation. One-quarter had previously undergone at least two mitral valve surgeries (32% in the redo surgery group and 18.6% in the transcatheter group), and the mean time elapsed since the last surgery was 13.9 years.

All-cause death and disabling stroke at 1 year, the trial’s primary endpoint, was 5.3% with transcatheter ViV and 20.8% with redo surgery (HR 0.23; 0.07-0.68; P= 0.005).

The advantage of the transcatheter method was consistently seen across subgroups related to sex, age, body mass index, predicted surgical risk, the number of prior mitral surgeries, the time elapsed since those surgeries, NYHA class, LVEF, pulmonary artery pressure, and presence of tricuspid regurgitation.

The difference favoring ViV was driven mainly by events within the first 30 days. In-hospital deaths were more common after redo surgery (12.5%; P = 0.001), as were disabling strokes (8.3%; P = 0.012), with none occuring within 30 days of the transcatheter procedure. There also was less life-threatening, extensive, or major bleeding (1.3% vs 11.1%; P = 0.016) and acute kidney injury (0 vs 15.3%; P < 0.001) with transcatheter ViV, as well as a shorter median length of stay (4 vs 14 days; P < 0.001).

At 1 year, rehospitalizations due to cardiac causes were more common after ViV than after redo surgery (16% vs 2.8%; P = 0.02). NYHA class and quality-of-life measures did not differ between the two groups.

Valve performance over time favored surgery. The groups started out with similar mean mitral gradient between the transcatheter ViV and surgery groups (11.2 vs 10.9 mm Hg), with no difference at 3 months. By 12 months, however, the ViV-treated patients had a higher mean gradient than did the surgery-treated patients (6.7 vs 5.4 mm Hg; P = 0.007). Mean prosthetic valve area was 0.9 cm2 at baseline for both groups but was higher in surgery patients at 3 months (mean 1.8 vs 1.5 cm2; P < 0.001) and at 12 months (17 vs 1.4 cm2; P = 0.003).

Some Caveats

Siqueira cautioned that centers participating in the SURViV trial were highly experienced in mitral surgery, averaging 250-300 cases per year, and said that the COVID-19 pandemic could have affected perioperative care. Importantly, “the present study focuses on 1-year outcomes, and longer-term follow-up is ongoing to assess durability and inform optimal treatment sequencing,” he noted.

Overall, though, SURViV “supports the role of transcatheter valve-in-valve as a safe therapeutic option in selected patients undergoing repeat mitral intervention,” Siqueira concluded.

Longer-term follow-up is ongoing to assess durability and inform optimal treatment sequencing. Dimytri A. Siqueira

Michael Borger, MD, PhD (Leipzig Heart Center, Germany), a cardiac surgeon, told TCTMD that the “results are surprising in that the surgical outcomes were so poor,” with the perioperative mortality rate being more than twice as high as what was last reported by the Society of Thoracic Surgeons for redo mitral valve surgery in patients without endocarditis.

“The question is why the mortality was so high, because this was obviously a main driver of the statistically significant [difference] that the investigators found at the end of the 12-month follow-up period,” he said. Borger pointed to two possibilities: that the COVID era might indeed be a factor and that some patients in the surgery group had concomitant procedures (aortic valve replacement in 2.8%, tricuspid repair or replacement in 14%, and left atrial appendage closure in 26%).

“What’s also interesting is the somewhat catch-up that occurs near the end of the 12-month period and of course the increased gradients across the valve, which are not surprising, in the transcatheter group,” as well as the difference in rehospitalization, Borger added.

Despite those reservations, Borger said he already refers patients regularly for the ViV procedure. “The thing that really makes me tilt towards this is the age and comorbidities—so older and higher-risk patients—but also the size of the previously implanted valve,” he said, noting that “if you already had a small implanted bioprosthesis and now you’re going to do a valve-in-valve inside of that, that would give me cause for concern.

S. Chris Malaisrie, MD (Northwestern University, Chicago, IL), commenting on the results for the media, agreed that a trial is “much needed in this space,” though he highlighted the study population’s unique characteristics. Many had initially received a bioprosthetic mitral valve in their mid-40s, he pointed out, questioning why such young patients did not instead receive a mechanical valve.

Within the first year, it’s clear that all-cause mortality and stroke are less common with ViV than with redo surgery, said Malaisrie. “It’s going to be really interesting to see what happens with the long-term follow-up. Usually in these [transcatheter ViV] cases, we see short-term benefit be overshadowed by a long-term benefit [for] the surgery group.”

All that said, Malaisrie described himself as a “big fan of mitral valve-in-valve.”

“Give the patient a chance, because it could be a durable procedure for them,” he said, stressing the need for close follow-up thereafter to detect any cases of valve thrombosis or high mitral gradients.

Borger said more evidence is needed on the risk of leaflet thrombosis in the mitral setting. “I would say that the risk of leaflet thrombosis is probably even higher than in the aortic position, although that’s speculative at this stage. . . . But since the mitral position obviously has lower blood flow velocities in the left atrium, more risk of stagnation of blood flow, I would suspect that thrombosis [would be] more of an issue, but that needs to be further investigated.”

As discussant, Reardon asked Siqueira whether they were gathering data on valve thrombosis and oral anticoagulation. SURViV’s design left anticoagulation choices up to physician discretion but advised maintaining it for 3 months, he replied. “The majority of patients have atrial fibrillation, so they are already anticoagulated.”

Siqueira said they intend to do a serial CT evaluation, with data at baseline, 3 months, and 12 months, to check for signs of subclinical thrombosis.

What happens in the coming years with patients requiring repeat mitral procedures, said Reardon, is uncertain: whether the survival curves will later cross to favor redo surgery and whether the ViV strategy will prove durable. “What do you tell your patients,” he inquired, “since we really know nothing about the long term?”

“The clinical decision should remain individualized,” Siqueira stressed. “There are a lot of factors that play a role in deciding which treatment should be offered. This is a heart team decision.” For patients likely to need several mitral procedures over a lifetime, he said he tells them “that maybe with mitral valve-in-valve implantation we can skip one surgery and give them a chance to postpone another surgical intervention in the future.”