Clip-Based Tricuspid Repair Improves Regurgitation, Function, and Quality of Life: TRILUMINATE

The transcatheter approach offers promise for the valve long neglected by interventional cardiologists due to a lack of options.

Clip-Based Tricuspid Repair Improves Regurgitation, Function, and Quality of Life: TRILUMINATE

PARIS, France—Percutaneous edge-to-edge repair with a clip device appears to offer some hope for patients with tricuspid regurgitation, according to new results from the TRILUMINATE study.

At 30 days, clip-based transcatheter tricuspid valve repair significantly reduced tricuspid regurgitation by at least one grade in the vast majority of patients and led to significant improvements in quality of life and NYHA functional class.

Lead investigator Georg Nickenig, MD (University Hospital Bonn, Germany), who presented the results at EuroPCR 2019, said the findings from this early feasibility study—specifically the improvement in heart failure symptoms and quality of  life—suggest the procedure is “clinically effective.” Edge-to-edge repair may be a “promising treatment option, obviously to be tested in larger, randomized studies with hard clinical endpoints” for patients with symptomatic severe tricuspid regurgitation.

“The tricuspid valve is a forgotten valve, if you will,” said Nickenig. “Tricuspid regurgitation is a very prevalent disease, as prevalent as mitral valve disease some people have estimated, and it’s associated with a pretty poor outcome. We don’t have very many therapeutic options available. We have diuretics and we have a high-risk surgical approach.”

TRILUMINATE tested the TriClip, a transcatheter tricuspid valve repair system which is a modification of the percutaneous MitraClip NT device (both Abbott) used for mitral valve repair.

“It’s more or less the same,” said Nickenig, referring to the MitraClip. “[TriClip] has some additional features, in bending and guiding the catheter. Of note, it’s important to emphasize we had to use the smaller clip in this trial. Of course, we would have loved to use the XTR clip in these patients with huge coaptation defects in the tricuspid space.”

High-risk Patients with Previous Procedures

The prospective, single-arm study was conducted at 21 sites in the United States and Europe and employed a team of heart failure specialists, echocardiographers, interventional cardiologists, and cardiac surgeons to assess patients for eligibility.

In total, 85 patients with moderate or greater tricuspid regurgitation and no indication for left-sided/pulmonary valve correction were included in the study. The average age of patients was 78 years, 33% had a prior intervention on the mitral valve, and 75% had NYHA class III/IV heart failure. Nickenig noted the patients were “pretty sick,” with significantly impaired right ventricular end-diastolic dimensions, but preserved left ventricular ejection fraction.

“Most of these patients would have been ‘redo’ patients,” Nickenig told TCTMD. “They already had procedures, such as CABG or mitral valve repair, and in these redo patients open-heart surgery for tricuspid regurgitation is associated with very high mortality risks, as high as 20%. If it is a primary, isolated tricuspid regurgitation, the risk is lower, [but] surgery is not a good option in [our] types of patients.” 

All devices were successfully implanted and the average time for implantation was 75 minutes. The majority of clips were placed in the anterior-septal commissure, which makes anatomic sense since the lateral wall typically pulls the leaflets apart, said Nickenig. In total, 20.0%, 47.1%, 28.2%, and 4.7% were treated with one, two, three, and four clips, respectively. “The implant success rate and the acute device success rate in this very early study of this very novel treatment was 100%, meaning we were able to place the clip where we wanted to place the clip in every patient,” Nickenig said.

At 30 days, 86.6% of patients had at least a one-grade improvement in tricuspid regurgitation, with the study meeting the primary effectiveness endpoint. At baseline, 94% of patients had severe or greater tricuspid regurgitation, including 37% with torrential regurgitation. At 30 days, 25% had tricuspid regurgitation considered moderate and 28% had regurgitation considered mild. In total, 4% of patients had no tricuspid regurgitation, 39% had severe or massive regurgitation, and 5% had torrential regurgitation.

In terms of echocardiographic findings, percutaneous treatment with the TriClip reduced regurgitant volume and tricuspid annular diameters and improved the mean tricuspid valve gradient. There was a reduction in tricuspid annular diameters and an improvement in cardiac output. Subsequently, there were significant improvements in NYHA functional class, with more than 80% of patients in NYHA functional class I/II at 30 days. There were also significant improvements in quality of life.

There was one major adverse cardiovascular event, a case of new-onset renal failure, at 30 days. An increase in the tricuspid valve mean gradient ≥ 5 mm Hg was observed in four patients. Single leaflet device attachment was observed in five patients, but there were no clinical consequences or sequelae, said Nickenig.

Who Benefits Most From Tricuspid Repair?

Francesco Maisano, MD (University Heart Centre/University Hospital Zürich, Switzerland), who moderated the late-breaking clinical trials session, said one of the more critical issues facing the tricuspid field is patient selection. “Who should we send for this type of therapy?” he asked.

Nickenig said that it’s far too early to identify responders to transcatheter tricuspid valve repair, but stressed that patients with tricuspid regurgitation often have limited therapeutic options. While the field needs to sort out who will fare best with treatment, other hurdles need to be cleared before that happens. “First of all, what we need to do is compare this treatment to medical therapy,” said Nickenig. “[TRILUMINATE] sets the stage for a randomized trial and there we can hopefully have some answers about patient selection.”

David Hildick-Smith, MD (Brighton Cardiac Center/Sussex University Hospitals, Brighton, England), one of the session panelists, agreed that the TriClip technology is promising, but clipping three leaflets will likely present technical challenges for operators. Like Maisano, Hildick-Smith said patient selection for transcatheter tricuspid repair is important, although this is difficult because tricuspid regurgitation is often secondary to other conditions.

“Identifying a patient who will benefit with having something done for their tricuspid regurgitation without necessarily fixing other conditions upstream is a challenge,” he told TCTMD. “There are lots of technologies vying for attention in this area and initially doing exploratory work to see if we can diminish—objectively and echocardiographically—how much tricuspid regurgitation there is and whether it makes a difference clinically. The interesting thing [about TRILUMINATE] is the extent to which patients felt better.”

While it’s early days still for the percutaneous tricuspid valve repair, Simon Redwood, MBBS (King’s College London, England), told TCTMD the TRILUMINATE data are “very exciting” given that most cardiologists had no choice but to ignore severe tricuspid regurgitation due to the lack of effective treatments. With the high rate of technical success, and low rate of complications, the TriClip offers promise, but there is still a long way to go in the field, he said.

                                                               

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Sources
  • Nickenig G, Lurz P, von Bardeleben S, et al. Percutaneous edge-to-edge repair for tricuspid regurgitation: primary outcomes from the TRILUMINATE clinical trial. Presented at: EuroPCR 2019. May 21, 2019. Paris, France.

Disclosures
  • TRILUMINATE was sponsored by Abbott.
  • Nickenig reports receiving honoraria for lectures and advisory boards and research funding from Abbott, AGA, AstraZeneca, Bayer, Berlin Cardiovalve, Chemie, Biosensus, Biotronik, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi Aventis, and St. Jude Medical.

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