More Evidence That the MitraClip Might Be Useful in the Tricuspid Valve

SAN DIEGO, CA—Giving support to ongoing efforts to more systematically study use of the MitraClip (Abbott) to correct tricuspid regurgitation, an international registry study has shown that edge-to-edge repair using the device is associated with symptomatic improvements and reductions in adverse clinical outcomes.

Before undergoing the procedure, nearly all patients had tricuspid regurgitation (TR) grade 3+/4+, but by discharge, 77% had grade 1+/2+ regurgitation, Jörg Hausleiter, MD (Klinikum der Universität München, Munich, Germany), reported here at TCT 2018.

At baseline, most patients had NYHA class III/IV disease, but at the end of the year after the procedure, 69% had NYHA class I/II symptoms. There was also a reduction from baseline in the rate of peripheral edema (84% to 26%; P < 0.001).

Moreover, patients who had a successful result from MitraClip implantation were more likely to remain free from mortality or rehospitalization (70.1% vs 49.7%; P < 0.0001) during follow-up.

“We were able to demonstrate that this procedure can be performed very safely,” with a high procedural success rate, Hausleiter said at a press conference. “We were able to demonstrate that the TR reduction is durable and that this also improves the clinical outcome at 1 year.”

He pointed out during his presentation that “procedural failure was identified as an independent predictor for mortality, and this may suggest that the edge-to-edge tricuspid valve repair might also have an impact on survival in this high-risk patient population.”

During a panel discussion after Hausleiter’s talk, Rebecca Hahn, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY), said, “I want to emphasize to the audience how impactful this study is. We don’t have any data on concomitant surgical repair of the tricuspid and an impact on mortality. We have no studies. And now we have a study that actually shows a mortality benefit to reducing and fixing the tricuspid regurgitation.”

But Mayra Guerrero, MD (Evanston Hospital, IL), another panelist, remained more cautious.

“My take-home message is that it can be done and it can be done safely,” she told TCTMD. “What remains unanswered is, does it need to be done and does it really impact outcomes? I think there are confounders. Half of those patients received treatment of the mitral valve, and it’s hard to interpret if all of the benefit was due to the intervention of the tricuspid valve alone.

“So I think we need more data,” Guerrero continued, “but it’s encouraging to see that it can be done safely.”

TriValve Registry

Though the MitraClip was developed for use in the mitral valve, there is some preliminary evidence that the device can also be useful in the tricuspid valve. In a small series of 18 patients, for instance, MitraClip implantation in this setting was safe, feasible, and associated with a reduction in TR grade. In addition, a study of 64 patients with severe TR showed that the procedure was a success in 97% of cases, with 91% of patients seeing a reduction in TR of at least one grade.

These new data come from the TriValve registry, which is an international effort to collect information on interventional tricuspid repair for TR using any device. The current analysis was confined to 249 patients (mean age 77; 51% women) treated with the MitraClip under off-label/compassionate use programs at 14 centers. Patients had a high EuroSCORE II (mean 11.2%).

TR was secondary in 89.2% of patients. The most common predisposing factors were A-fib (74%) and left heart valve disease (68%). Mitral regurgitation (MR) grade 3+ or higher was observed in 43%. During the repair procedure, operators used an average of two clips (ranging from zero to five). Slightly more than half of patients (52%) underwent concomitant treatment for MR.

Nearly nine out of every 10 patients had a reduction of at least one TR grade by discharge. The results proved durable, with 72% maintaining TR grade ≤ 2+ at the end of follow-up.

The investigators identified four multivariate predictors for procedural failure: noncentral or nonanteroseptal TR jet location, larger TR effective regurgitant orifice area, larger tenting area, and larger coaptation gaps.

During a mean follow-up of 292 days, the overall mortality rate was 17.7%, which Hausleiter called “remarkably low” considering how sick and frail the patients were. Independent predictors of mortality included absence of sinus rhythm, reduced renal function, and procedural failure.

‘Just a Feasibility Study’

Hausleiter acknowledged that the study was limited by the lack of recommendations to operators on how to perform the procedure, of independent event adjudication, and of central echocardiographic core lab assessment.

For her part, Guerrero said the analysis should be considered the first step of many more to come in this line of research.

“This is just a very early feasibility trial,” she said. “It would have to be very rigorously studied. My prediction is that this will generate conduction of a more elaborate trial to answer the question, similar to COAPT.”

Hausleiter noted that there is an ongoing trial in this area, TRILUMINATE, which is a prospective, multicenter, single-arm study that has a planned enrollment of 85 patients with symptomatic TR treated with a tricuspid valve repair system from Abbott.

Hausleiter predicted CE Mark approval for the technology next year, and noted that a US study is currently being planned.