Initial Results With V-Wave's Interatrial Shunt Published

March 28, 2016—V-Wave Ltd. announced that the results of the first human implants of the company’s investigational interatrial shunt device for patients with advanced heart failure (HF) were published by Maria Del Trigo, MD, et al in The Lancet (2016;367:1290–1297). The study was led by structural heart disease expert Josep Rodés-Cabau, MD, and performed at the Quebec Heart and Lung Institute, Laval University in Quebec, Canada.

The V-Wave unidirectional shunt system is under clinical investigation in the European Union and is not available in the United States. The system consists of an implantable shunt, a loading system, and a transcatheter delivery system. It is introduced via a transseptal puncture procedure.

According to the company, the first 10 consecutive patients had class III symptoms, despite being treated with maximally tolerated HF medications, and had poor left ventricular function. All were successfully implanted with the shunt during a minimally invasive procedure that generally took < 1 hour and were discharged home the next morning. There were no device-related adverse effects. 

After 3 months, patients had significant improvements in symptoms, exercise capacity, and quality-of-life assessments. Catheter measurements showed lowering of left atrial pressure without deterioration of right heart function. These findings are consistent with the shunt diverting just the right amount of blood from the left side to the right side of the heart.

In the company’s press release, William Abraham, MD, Steering Committee Chairman for the study, commented, “Studies in larger populations with longer-term follow-up are ongoing, and a pivotal, randomized controlled trial targeting patients in North America, the European Union, and Israel is being planned. From these data, we hope to understand the safety, efficacy, and patient populations most likely to benefit from interatrial shunting. There is good reason to expect the V-Wave shunt will be helpful not only in patients with reduced left ventricular function, but also in the nearly one-half of HF patients where it is preserved.” Dr. Abraham is Director of Cardiovascular Medicine at The Ohio State University Wexner Medical Center in Columbus, Ohio.

V-Wave also announced four coprincipal investigators who will guide the company’s future clinical trials program. In addition to Josep Rodés-Cabau, who has the most experience implanting the V-Wave shunt, they are Gregg Stone, MD; Joann Lindenfeld, MD; and Stefan D. Anker, MD. Dr. Stone, who is an interventional cardiologist and structural heart disease specialist, is Professor of Medicine at Columbia University in New York, New York. Dr. Lindenfeld, who is current President of the Heart Failure Society of America, is Professor of Medicine at Vanderbilt University in Nashville, Tennessee. Dr. Anker, who is Councilor of the Board of the European Society of Cardiology, is Professor of Innovative Clinical Trials at University Medicine Göttingen, Germany.