Fate of Transcatheter Tricuspid Devices: Will it Be Repair or Replacement?

CHICAGO -- Discussing their predictions on where transcatheter technologies in the tricuspid space are going, some experts said they favored the odds of replacement over repair when devices are ready to be commercialized.

Yet making the case for transcatheter tricuspid valve repair was Paul Sorajja, MD, of Minneapolis Heart Institute at Abbott Northwestern Hospital, who argued that this is "the number one option" for tricuspid regurgitation (TR) given its applicability to a broad anatomical range that even includes people with pacemaker leads.

Indeed, just days ago, a report from the Triluminate and bRIGHT TriClip single-arm studies suggested that TriClip and TriClip G4 repair have worked for pacemaker patients previously deemed poor candidates for transcatheter edge-to-edge repair (TEER). These devices were associated with high implant and procedural success, as well as at least a two-grade reduction in TR in 64% of cases.

These TriClip data, presented at the Transcatheter Valve Therapeutics (TVT) conference held by the Cardiovascular Research Foundation (CRF), were followed by a TVT debate on the future of tricuspid technologies.

"There are some patients who need replacement, there's no question about it. We've had hundreds who've benefited already, but thousands and thousands of patients treated with TriClip and they're doing well in registries," Sorajja said.

The repair versus replacement debate echoes the same discussion years ago when mitral valve technologies were still emerging. TriClip itself was adapted from the MitraClip, now FDA approved for treatment of both primary and secondary mitral regurgitation.

Besides TriClip, another tricuspid valve repair device under investigation is the Pascal Ace that is expected to have results from the CLASP IID pivotal trial reported later this year.

Sorajja stressed the safety of these devices, which leave behind no large prosthesis and its associated complications. The repair approach also avoids the enlargement and unnatural reshaping of the right ventricle (RV) that occurs after valve replacement, he stated.

Yet it might not matter if the RV ends up circular or stays a normal saddle shape, argued Rebecca Hahn, MD, of Columbia University Irving Medical Center in New York City. "Yes the RV may look a little worse [after tricuspid valve replacement], but if you have enough contractile reserve you actually still improve outcomes," she said as Sorajja's opposition during the debate.

"We've been gratified to see those ventricles actually doing better," agreed session panelist Ori Ben-Yehuda, MD, of the CRF Clinical Trials Center in New York City, who said that results so far with replacement have been better than expected.

Gorav Ailawadi, MD, of Michigan Medicine in Ann Arbor, also said that he's been "very surprised" to see how well replacement has fared compared with predictions based on the surgical data.

Ultimately, Hahn's main arguments for tricuspid valve replacement -- with the Intrepid and Evoque systems, for instance -- were ease of use and the TR reduction achieved.

Based on the available evidence, TEER cannot be expected to achieve the same resolution of severe TR. Ben-Yehuda remarked that taking TR down from severe to moderate with TEER is good, but that has to be reconciled with the epidemiological data that even moderate TR is not good in the long run.

"I think ultimately, once all devices commercialize, everyone's going to be talking about imaging and ease of use," said TVT panelist Gilbert Tang, MD, of Mount Sinai Health System in New York City, who cited the green-yellow-red zones for TEER. "Would you want to struggle with a yellow case in TEER or go for simple replacement?"

Tang also questioned what the treatment options are if a TEER patient returns with recurrent TR. He proposed that the initial operator "maybe just bite the bullet" and go for replacement.

Panelist Molly Szerlip, MD, of Baylor Scott & White Health in Plano, Texas, reminded attendees that surgery would be the treatment for recurrent TR.

Ultimately, the panel agreed it's too early to put all faith in one tricuspid technology versus another.

"I'm leaning toward replacement in my patients, but we need long-term data," said Ben-Yehuda, adding that he hoped the field would have head-to-head studies in the future.

"I believe we need a lot of tools in the toolbox," said Hahn. "I believe there's a role for all devices in this field where we know very little about a lot."

Correction: An earlier version of this story included an incorrect name for the upcoming CLASP IID trial.

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