Real-world Evoque Data Reassure, but It’s Still Early Days With TTVR

Early US experience with transcatheter tricuspid valve replacement (TTVR) for patients with severe tricuspid regurgitation (TR) suggests that outcomes achieved in the real world are on par with, if not slightly better than, those achieved in the pivotal randomized trial, data from the Society of Thoracic Surgeons/American College of Cardiology TVT Registry show.

At 30 days, TR was almost completely eliminated in all patients and clinical outcomes, including all-cause mortality, stroke, and bleeding, were consistent with results from the TRISCEND II trial. The need for a new pacemaker was also markedly lower than in the randomized trial.

Aakriti Gupta, MD (Cedars-Sinai Medical Center, Los Angeles, CA), one of the study authors, said she and her colleagues remain “cautiously optimistic” about the safety and effectiveness of the Evoque device (Edwards Lifesciences) when used in real-world practice.

“We wanted to get these data out as soon as possible instead of waiting for 1-year outcomes, because this is a device that is actively being implanted in older patients and new centers are coming up every day,” she told TCTMD. “We are seeing outcomes that are reassuring in the real world, such that [physicians] can offer this in a more confident way to patients who are really suffering with symptoms.”

Azeem Latib, MD (Montefiore Medical Center, Bronx, NY), who wasn’t involved in the new study, said 30-day outcomes offer an important look at therapies as they start to roll out to centers and patients beyond the strictures of a randomized trial.

“When you commercialize a new technology, you are going to a large number of sites, and the indications are going to be wider with potentially sicker patients or patients who couldn’t be enrolled in the study,” he told TCTMD. “The first data that comes out is always very important to see how the technology can be generalized.”

Here, the data reassure: mortality rates are lower than in TRISCEND II and pacemaker rates have come down, which is one of the biggest concerns with TTVR, he said.

“The only thing I would say is we have to be cautious,” said Latib. “Overall, I think the data are good and I think Edwards [Lifesciences], in particular, has done a great job of bringing this technology to multiple new sites. But, if you look at the authors [of the new analysis], most were involved in TRISCEND II. They had experience. I’d love to know what the experience has been like in new sites versus those with experience in TRISCEND II.”

The analysis, with Raj Makkar, MD (Cedars-Sinai Medical Center), as lead author, was published this week in JAMA.

Lower Bleeding and Pacemaker Rates

The US Food and Drug Administration approved Evoque for the treatment of TR in early 2024 on the basis of TRISCEND II. The device is indicated for the improvement of health status, such as quality of life and NYHA functional class, but not for reducing clinical outcomes, such as mortality or heart failure hospitalizations. Recent data have hinted at improvements beyond health status, although that remains to be proven conclusively.

In the TVT Registry analysis, 1,034 patients (mean age 77.1 years; 69.1% female) with symptomatic, severe TR were treated at 82 centers. Nearly 75% of patients had NYHA class III/IV symptoms and the majority (83.8%) had atrial fibrillation or flutter. More than one-third had diabetes, and nearly half had been hospitalized in the past year for heart failure. Almost 80% were considered to have a high or extreme risk for surgery.

In-hospital all-cause mortality, stroke, and severe bleeding rates were 2.3%, 0.2%, and 6.9%, respectively. At 30 days, the rates were 3.1%, 0.2%, and 7.9%. For comparison, the rate of severe bleeding at 30 days was 10.4% with TTVR in TRISCEND II. In patients without a preexisting cardiac implantable electronic device (CIED), 15.9% of patients needed a new pacemaker or CIED, which was lower than the rate of 24.7% at 30 days in TRISCEND II.

“There’s no comparator arm—it’s not placebo-controlled—but we have to go with the data that we saw. I think we can say the early real-world results were consistent with the TRISCEND pivotal trial,” said Gupta. “And, descriptively, the rates of bleeding and new pacemaker implantation were lower in this registry.”

For the 747 patients with paired baseline and 30-day echocardiographic outcomes, 98.4% achieved mild or less TR (65.3% had none or trace TR) after TTVR. For the 626 patients with paired functional and quality-of-life data, 82.7% were in NYHA class I/II at 30 days compared with 25.6% at baseline. The Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score also improved significantly from baseline.

“In patients with a preexisting CIED or pacemaker, there was some debate [about whether] TTVR would perform as well,” said Gupta. “We did stratified analyses for several subgroups—patients with or without atrial fibrillation, with or without dialysis, and with or without preexisting baseline CIED. We did not find any real significant differences. This was reassuring in that patients who have a baseline device should not automatically be precluded from being evaluated for this procedure. If anatomically amenable, they have outcomes similar to those who don’t have a baseline device.”

Challenges of Registry Data

There is still more work to do, Gupta said, particularly when it comes to understanding the durability of the valve over time. Evoque is implanted in the low-pressure tricuspid space, so there is a need to better understand the long-term risks of thromboembolism and the appropriate anticoagulation strategy.  

“I think all of those are important questions that will inform the next wave of research, both from the real-world outcomes and also longer-term follow-up of the TRISCEND trial,” said Gupta.

Latib also highlighted long-term question marks around valve thrombosis and durability.

“I think we have to be open and honest that we don’t know yet and we have to continue to monitor that,” he said. “I find it surprising that zero patients had thrombosis at 30 days [in the registry]. I don’t believe that, to be very honest, because I’ve been doing this for long enough to know it would be too good to be true.”

Latib pointed out that the TVT Registry is site reported and often has incomplete data, which makes interpreting these and other results challenging. Postmarketing studies, he believes, are warranted for all new technologies as this step ensures data are well collected and monitored and properly adjudicated. The US Centers for Medicare & Medicaid Services (CMS) reimburses for TTVR with Evoque under coverage with evidence development. This means patients must be part of a CMS-approved study that reports clinical outcomes alongside functional improvements and quality of life. Such a study, said Latib, would be informative.

As a proponent of TTVR, Latib stressed that Evoque is an “incredible” technology with an ability to completely eliminate TR. It carries higher risks than transcatheter edge-to-edge repair (TEER), he said, adding, however, that TEER is not as effective at eliminating TR.