Novel treatment for severe tricuspid regurgitation demonstrates safety, reduction of symptoms

SAN FRANCISCO — A novel transcatheter-based treatment appears to be safe and efficacious in patients with severe tricuspid regurgitation, according to results presented at the annual TCT Scientific Symposium.

“… Alternative minimally invasive surgical and percutaneous transcatheter treatment alternatives were recently developed in an attempt to improve the prognosis and quality of life of patients with severe [tricuspid regurgitation],” the researchers wrote. “Novel treatment options include percutaneous annular rings, transcatheter suture bicuspidization, valved stents or heterotopic placement of transcatheter aortic valves in the vena cava.”

Francisco Campelo-Parada, MD, of the Quebec Heart and Lung Institute in Quebec City, and colleagues evaluated the novel transcatheter Forma Repair System (Edwards Lifesciences) in seven participants. Patients had severe tricuspid regurgitation and symptoms of HF. Only patients with functional tricuspid regurgitation who did not have a pacemaker, implantable cardioverter defibrillator leads or a history of tricuspid surgery were included. Device implantation was performed to improve tricuspid leaflet coaptation, thereby decreasing tricuspid regurgitation.

Participants underwent transcatheter treatment with the Forma Repair System in a cardiac cath lab or a hybrid operating room. The procedure was performed under general anesthesia with transesophageal echocardiographic guidance, and vascular access was acquired through the left axillary vein. The researchers prospectively collected baseline characteristics as well as procedural and in-hospital outcomes and 30-day follow-up data.

Patients ranged from NYHA class II to IV. Mean age was 76 ± 13 years; mean logistic EuroSCORE was 25.7 ± 17.4%. Device implantation was completed in all patients without procedural complications, with significant reductions in tricuspid regurgitation severity (moderate in three patients and mild in four). Median hospital length of stay was 4 days.

At the 30-day follow-up point, all patients except one had better NYHA functional status (to class II) with “pronounced” decreases in the existence and severity of peripheral edema. All patients were determined to have moderate tricuspid regurgitation severity via transthoracic echocardiography at the 30-day follow-up point. No complications related to the device or vascular access were noted during follow-up.

“In patients with severe, symptomatic secondary tricuspid regurgitation at high surgical risk, transcatheter reduction therapy can be performed with a low short-term risk of complications and may represent an acceptable alternative strategy,” the researchers wrote. “Further studies are necessary to establish the long-term efficacy of transcatheter interventions to improve right [HF], functional status and quality of life in patients with severe secondary [tricuspid regurgitation].”

In an accompanying editorial in the Journal of the American College of Cardiology, Alec Vahanian, MD, and Jean Michel Juliard, MD, of the cardiology department at Bichat Hospital and the University Paris Diderot, both in Paris, noted the short-term improvement in clinical outcomes regardless of the incomplete decrease in tricuspid regurgitation.

“This is a significant achievement in inoperable patients in whom quality of life and reduction of rehospitalization and medical treatment are important,” they wrote.

Vahanian and Juliard also commented on the implications of the findings from Campelo-Parada and colleagues.

“We should now follow what has been done successfully in the field of [transcatheter aortic valve replacement],” they wrote. “The field of application of transcatheter tricuspid valve therapy will certainly be high-risk or inoperable patients. In the future, if both tricuspid and mitral transcatheter interventions prove to be effective and durable, they could potentially be combined in patients at lower risk in the same way as in surgery.” – by Julia Ernst, MS

References:

Campelo-Parada F, et al. Session II: The FDA EFS/Innovation Pathway: Percutaneous tricuspid and mitral valve intervention technologies. Presented at: TCT Scientific Symposium; Oct. 11-15, 2015; San Francisco.

Vahanian A, Juliard JM. J Am Coll Cardiol. 2015;doi:10.1016/j.jacc.2015.09.067.

Disclosures: Two of the researchers report consulting for and receiving research grants from Edwards Lifesciences. Vahanian reports consulting for Abbott Vascular and Edwards Lifesciences and has received honoraria from Abbott Vascular, Edwards Lifesciences and Valtech.