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DENVER -- Two tricuspid valve therapy systems were able to reduce regurgitation and improve the functional status of some patients with right-side heart failure, according to researchers.

A spacer-and-rail system was associated with improved symptoms for patients with severe tricuspid regurgitation, but shortcomings in its design require a new device iteration, according to the FORMA study presented at the (TCT) meeting here.

To be eligible to receive the Forma system from Edwards Lifesciences, patients had severe secondary tricuspid regurgitation and were considered at high surgical risk for tricuspid valve repair. After major complications -- two cases of right ventricular (RV) perforation, one device migration, and one device infection requiring explantation -- 25 study participants ended up having echocardiographic follow-up at 30 days.

By then, patients had a smaller effective regurgitant orifice area (EROA), assessed either as proximal isovelocity surface area (PISA; 1.1 to 0.6 cm², P=0.001) on 2D/3D quantitative analysis (2.1 to 1.1 cm², P=0.012), according to Martin Leon, MD, of Columbia University Medical Center/New York-Presbyterian Hospital.

At 30 days, 69% of patients were event-free. There were several deaths (6.9%), major bleeds (13.8%), cases of acute kidney injury (10.3%), and device-related cardiac surgeries (10.3%).

"The Forma tricuspid valve therapy system proved feasible, but was associated with infrequent distal anchor dislodgements and RV perforations," Leon admitted. "Next generation Forma devices are being developed to ensure predictable anchor capture without dislodgement or RV perforations."

The Forma is a a spacer tracked into transvalvar position by a rail anchored at the RV apex and subclavian vein.

Device recipients had a mean age of 75.9 years and 65.5% were women. The majority were in New York Heart Association (NYHA) class III or IV (86%), and another 82.8% had atrial fibrillation. A quarter of the patients had a pre-existing pacemaker.

Almost half of the participants had had a prior valve intervention, mainly for the mitral or aortic valves.

Baseline echocardiography showed tricuspid regurgitation jets averaging 129.0 mL. An estimated 65-80% of the population had torrential tricuspid regurgitation.

After transcatheter tricuspid valve repair, the distribution of heart failure classes showed more patients migrating to NYHA class I and II (72% by 30 days, P=0.0002). Patients also improved on the 6-minute walk test (+39 meters, P=0.012) and Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score (+29 points, P<0.001).

"The magnitude of tricuspid regurgitation reduction was proportional to the severity of baseline tricuspid regurgitation," Leon noted. "Forma may be especially useful in patients with the most severe tricuspid regurgitation."

Cardioband Tricuspid Repair System Shows Promise

In a separate TCT presentation, another Edwards device, the Cardioband Tricuspid Repair System, also proved promising for patients with functional tricuspid regurgitation.

TRI-REPAIR, the first-in-human study of the transcatheter repair system, showed that the device was associated with 100% technical success with access, deployment, and positioning of the device -- albeit with major safety events at 30 days: among 3o study participants, there were two deaths (one each from RV failure and bleeding unrelated to the device), one stroke, and three bleeds.

Author Georg Nickenig, MD, PhD, of University Hospital Bonn in Germany, noted that at discharge, there was an average 17% reduction in septolateral diameter (44.4 to 37 mm, P<0.01). By 30 days, PISA EROA was halved (0.8 cm² to 0.4 cm², P<0.001), the vena contracta had shrunk (1.3 versus 0.9 cm, P<0.001), and LV stroke volume trended toward improvement (60 versus 64.7 ml, P=0.06).

Edwards got hold of the Cardioband when it acquired manufacturer Valtech Cardio last year. The tricuspid repair system is similar to the Cardioband Mitral Repair System, allowing for a short learning curve in treating the tricuspid valve.

Functional improvement at 30 days came with the Cardioband's signals of benefit. Patients improved on the 6-minute walk test (+31 m, P<0.05), tended to move into a less severe NYHA class (P<0.05), and fewer patients had edema (P<0.05). Furthermore, KCCQ scores showed a trend towards improved quality of life as well (+7.1 points, P=0.06).

"NYHA functional status and KCCQ quality of life scores are left-sided heart failure clinical endpoints," Nickenig admitted. "Further study is needed to understand clinically important endpoints for patients with right-sided heart dysfunction."

Participants in TRI-REPAIR were high-risk patients with severe secondary tricuspid regurgitation who had never received tricuspid valve repair or replacement prior to enrollment. Mean age was 75.6 years and the group was 74% women. Like FORMA, the study had 86% patients going into the procedure with a baseline NYHA class III or IV.