Registry Evaluates Transcatheter Tricuspid Valve-in-Ring Implantation to Treat Tricuspid Regurgitation
January 9, 2017—A study of transcatheter tricuspid valve-in-ring (TVIR) implantation for the treatment of tricuspid regurgitation (TR) demonstrated that TVIR implantation using commercially available transcatheter prostheses is technically feasible and clinically effective in reducing TR; however, paravalvular regurgitation is common and may necessitate further interventions. The findings were published by Jamil Aboulhosn, MD, et al online in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.
The investigators noted that this international multicenter registry was developed to collect data on TVIR implantation. The background of the study is that off-label use of transcatheter valves within surgically placed tricuspid annuloplasty prostheses has only been described in small reports. Data were collected from 13 sites on 22 patients (5–69 years of age) with TR who underwent catheterization with the intent to perform TVIR implantation.
As summarized in JACC: Cardiovascular Interventions, TVIR implantation was performed in 20 patients (91%). Most patients were severely impaired (86% in New York Heart Association functional class III or IV); TR was severe in 86% of patients. Seventeen patients received a Sapien valve (Edwards Lifesciences) and three patients received a Melody valve (Medtronic).
The investigators found that there were no procedural deaths. There was one valve embolization requiring retrieval and placement of a second TVIR implant and one valve malposition with severe paravalvular regurgitation requiring a second TVIR implantation.
Over a median follow-up of 12 months, one patient died and two underwent repeat TVIR implantation, one of whom subsequently underwent surgical valve replacement. Significant paravalvular leak (PVL) was treated at the time of TVIR implantation in four patients: three underwent device occlusion and one received a second TVIR implant.
On follow-up echocardiography, 15 patients had PVL (75%), the majority of which (n = 10) were trivial or mild and did not require treatment. PVL intervention was performed in three patients during follow-up. Functional capacity improved in most patients (70%), reported the investigators in JACC: Cardiovascular Interventions.