FDA Approves First Transcatheter Tricuspid Valve Replacement Device

In a surprise early-morning announcement, Edwards Lifesciences said the US Food and Drug Administration has approved the company’s Evoque tricuspid valve replacement system for the treatment of tricuspid regurgitation (TR). The approval is the first in the United States for a transcatheter tricuspid device.

The announcement comes just about 3 months after the presentation of early, favorable data from the TRISCEND II trial. In patients with severe TR, the device significantly improved TR grade and led to meaningful improvements in functional status and symptoms.

In a press release announcing the approval, TRISCEND II lead investigator Susheel Kodali, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY), said the valve replacement can virtually eliminate TR in a wide range of patients.

“We see significant improvements in patients’ symptoms and quality of life, including not feeling short of breath and being able to care for themselves, which ranked highest on a patient preference survey conducted at baseline with TRISCEND II pivotal trial patients,” Kodali added.

Edwards Lifesciences says 1-year follow-up has been completed in 318 of the 392 randomized TRISCEND II patients and that there are “favorable trends in the device group compared to the control group in the primary composite endpoints, including all-cause mortality, tricuspid intervention, heart failure hospitalization, KCCQ, NYHA, and 6MWD.”

One-year data from the full cohort are expected to be presented later this year at TCT 2024.

Evoque received CE Mark approval in Europe several months ago but had not gone through the FDA’s advisory committee channels. Another transcatheter tricuspid valve device, TriClip (Abbott), also has CE Mark approval and is scheduled to go before an FDA advisory panel later this month. TriClip for transcatheter edge-to-edge repair (TEER) is being tested in the TRILUMINATE trial.

A Win for Patients

Speaking with TCTMD, TRISCEND II co-lead investigator Rebecca Hahn, MD (NewYork-Presbyterian/Columbia University Irving Medical Center), characterized today’s approval as a “tremendous” win for patients.

“The TRISCEND II and the TRILUMINATE pivotal trials are a testament to how many patients there are out there that are suffering and in need of therapy,” she said. “Going back to the earliest patients treated, we saw that they could not believe how much better they felt.”

In 2019, the FDA deemed Evoque a breakthrough therapy to help facilitate patient access, which Hahn said also allowed the agency early access to data that no one else has seen. Added to the earlier evidence, that likely pushed the FDA’s needle toward approval.

Neil Fam, MD (University of Toronto/St. Michael’s Hospital, Canada), who performed the first-in-human transcatheter tricuspid valve replacement (TTVR) with Evoque nearly 5 years ago, said the approval took him by surprise given that there had been no FDA advisory panel. However, he agreed that the body of evidence supports safety and predictable outcomes.

“There are some limitations to all TTVRs, including Evoque, which are well known, such as the risk of heart block and pacemaker. But, these things will be sorted out just as they were eventually for TAVI,” he said. “The other fascinating part about TRISCEND II is that there were so many centers, but the results were all pretty reproducible. So, that is speaking to the fact that it's a generalizable procedure.”

Like Hahn, Fam said patient testimonies are important to the story of TTVR.

“If the symptoms are from TR and you eliminate that, you can reduce their diuretics, which dramatically improves the quality of life because then they're not running to the bathroom all the time; they’re not afraid to leave the house. These are things that doctors don't talk about when we talk about trials, but when you see the patient in the clinic, this is what they tell you,” he noted.

Both Fam and Hahn said they suspect that the rollout of Evoque will be similar to the early commercial TAVI experience, with an emphasis on careful patient selection and proctorship for operators.

“The frustration, perhaps for many, is in how rapidly they can do that while maintaining the safety profile of this particular device,” Hahn added.

Also weighing in, Gilbert Tang, MD (Mount Sinai Health System, New York, NY), told TCTMD that while he agrees the approval is a big win for patients who otherwise don't have many treatment options for managing TR, he expected US regulators to follow Europe’s lead and give approval to TriClip before Evoque.

“I'm not sure how the decision-making took place internally, but that was probably the most surprising element to me,” he said. “Despite Evoque having a pacemaker rate of around 13% and bleeding rate of over 20%, versus TriClip in single digits, it was able to bypass the [FDA advisory] panel to get approval.”

Looking Ahead

With TriClip a strong contender for approval, Tang said, “now we have basically two different therapies available to treat these patients, beyond medical therapy and beyond surgery, which we know carries quite a significant risk due to underlying medical conditions and the [general] risks associated with surgery.”

Looking long-term, Tang said the most immediate concerns will be thrombosis and durability. Beyond that, there are still questions about the longer-term impact of the replacement valve on the conduction system and the contribution of that to pacemaker need.

Dee Dee Wang, MD (Henry Ford Hospital, Detroit, MI), called the approval a “milestone” in structural heart history, noting that it also puts the importance of imaging front and center.

“This is an interventional imaging physician-led procedure with imaging guidance as a 100% requirement for this device. But even now, we don't have adequate reimbursement to allow interventional imaging physicians across the nation, whether in a community hospital or an academic hospital, to justify their time to be able to support this procedure. So, a lot needs to be done,” she said. “When it comes down to healthcare economics, the limiting factor is not going to be access to the device, it’s going to be access to interventional imaging physicians.”

Hahn said she believes that all involved will work toward ensuring that the imaging piece is incorporated successfully as TTVR gains a foothold.

“The training of the imagers has been always a priority, particularly on the tricuspid side, [because] that is a key component of getting correct implantation and optimal procedural results from the device,” she added.