Prior TAVI Patients Needing Non-Aortic Valve Surgery Face Poor Outcomes

PHOENIX, AZ—Patients who require cardiac surgery on another valve after initially being treated with TAVI have very high operative morbidity and mortality, with a 30-day death rate exceeding 17%, according to results of a new analysis.

Cardiac surgery on the mitral or tricuspid valve is infrequent after an initial TAVI, but given the high risks associated with the subsequent operation, researchers say it’s paramount that all valvular pathologies be assessed so that all treatment options are on the table.

Lead investigator Austin Kluis, MD (Baylor Scott & White/The Heart Hospital, Plano, TX), said that for patients with multivalvular disease, it’s important to discuss the risks and benefits of two strategies: intervening simultaneously on both valves with surgery or treating aortic stenosis first and then “watching and waiting” to see how the secondary valve fares. “It’s really important to know all the options available and to convey them in a way that patients can make an informed decision based on the current literature,” Kluis told TCTMD.

Currently, surgery after TAVI is performed for reasons that include TAVI-related pathologies, such as aortic stenosis or regurgitation, paravalvular leak, or endocarditis. However, some patients may need surgery for non-TAVI-related diseases, such as a failing mitral or tricuspid valve or coronary artery disease, said Kluis. Given these patients’ high surgical risk at the time of TAVI, it’s not common to bring them to the operating room after going a noninvasive route with fixing their aortic stenosis.

Philippe Généreux, MD (Atlantic Health System/Morristown Medical Center, NJ), who moderated the TVT session where the new data were presented, highlighted the study’s time frame, noting that it spanned the earliest days of TAVI when the procedure was approved only for high-risk patients. At the time, mitral transcatheter edge-to-edge repair (TEER), transcatheter mitral valve replacement (TMVR), and percutaneous tricuspid interventions weren’t available options for people who needed these other valves fixed. 

“It’s very rare that we’d do TAVR and follow with a surgery of another valve,” he told TCTMD. “In current practice, when we evaluate the patient, we usually do the TAVR with the hope that mitral or tricuspid regurgitation will improve and we won’t have to intervene. I would say the vast majority of patients in whom we do a TAVR do have some degree of improvement in [mitral or tricuspid regurgitation]. Some patients, however, especially if the mechanism of mitral regurgitation is degenerative, won’t improve.”

Single-Center Surgical Experience

The indications, interventions, and outcomes among TAVI patients who later undergo cardiac surgery haven’t been well described, said Kluis. To date, there’s been one other published study based on experiences from the Cleveland Clinic. There, researchers retrospectively reviewed outcomes of 59 patients who needed surgery after TAVI and found that operative mortality was high at 8.5%, as was the risk of complications.

To get a better handle on outcomes, Kluis and colleagues retrospectively reviewed all patients treated with TAVI and then later required cardiac surgery at their center. Between 2015 and 2022, they identified 51 patients who were required surgery, 23 for reasons unrelated to the TAVI valve. Of these, six patients needed surgery for severe tricuspid regurgitation (TR), two for severe mitral regurgitation (MR), but the majority were treated for a mix of severe MR, TR, or mitral stenosis. Overall, 16 patients had a mitral-valve indication for surgery, with nine undergoing mitral valve replacement alone. One patient underwent CABG surgery for multivessel CAD.

All patients were classified as high risk—the mean STS-PROM score at the time of TAVI was 5.5%—and the surgery took place a median of 20 months after TAVI. Overall, 13 were minimally invasive surgical procedures and 10 were performed with a full sternotomy.

At 30 days, the mortality rate was 17.4%, with the cause of death a combination of events leading to multisystem organ failure. At 6 months and 1 year, the estimated Kaplan-Meier survival rates were 66.7% and 52.5%, respectively. Stratified by the type of operation, there was no significant difference in mortality in those who had a sternotomy and those treated with a minimally invasive approach. Although the numbers were small, Kluis said the data suggest that those who underwent tricuspid valve surgery had worse survival than the other interventions.

“It lends credence to how sick these [tricuspid] patients usually are,” he said, noting the surgery was often performed on compassionate grounds.

Généreux questioned whether the explanation is that operators didn’t fully appreciate the extent of mitral or tricuspid disease at the time of TAVI or they went ahead with the procedure in the hope these valves would get better after addressing the aortic stenosis. In response, Kluis said the majority of the patients had valvular disease that progressed over time, pointing out that 50% of patients went more than 2 years without symptoms severe enough to warrant cardiac surgery.

Paul Mahoney, MD (University of Pittsburgh Medical Center, PA), who co-moderated the TVT session, said the toughest question is about what to do with mitral valve disease in TAVI-eligible patients. “The mitral comes up a lot,” said Mahoney. “It’s not a terrible strategy to fix the aortic valve and then reassess. A lot of patients do get better and can avoid further interventions.” While a double-valve surgery upfront is an option, once operators go down the “catheter-based road that’s the road you’re going to want to follow based on these data,” said Mahoney.

To TCTMD, Généreux made a similar point, noting that a subsequent intervention would preferably be TEER or TMVR for severe MR in patients at such high surgical risk. “For me, it illustrates how TEER, TMVR, or [transcatheter tricuspid valve replacement] were not mature enough at the time to offer the treatment to patients and they were taken back to the operating room, to open-heart surgery, with very poor results,” he said.  

Kluis said deciding between a transcatheter or surgical approach in these TAVI-treated patients comes down to the heart team, who will factor in patient characteristics and physician skill sets available at the hospital. Manaf Assafin, MD (Montefiore Medical Center, New York), one of the TVT discussants, agreed, noting that lifetime management of aortic stenosis should also include thinking about other valvular disease and the need for future interventions.