A first-in-human prospective, open-label experience has shown that interatrial shunting with the V-Wave system was associated with improved clinical and functional status in 38 patients with heart failure (HF). The results of the V-Wave trial were presented Monday, March 12 in a Featured Clinical Research session at ACC.18 in Orlando, FL.

Led by Josep Rodés-Cabau, MD, the feasibility, safety and exploratory study enrolled 38 patients with HF (8 with preserved ejection fraction); median follow-up was 28 months. Most patients were men (n=35) and had NYHA class III HF (97 percent). The average age was 66 years.

The V-Wave shunt, an hourglass-shaped implant containing a one-way bioprosthetic valve, was implanted via transseptal catheterization. For the primary efficacy endpoint of procedural success, there was successful device implantation in all patients without any periprocedural deaths.

The primary safety outcome was device- and procedure-related major adverse cardiovascular and neurological events (MACNE), defined as death, stroke, device embolization, pericardial effusion requiring intervention, and re-intervention or surgery after three or 12 months. At both three and 12 months, the rate of MACNE was 2.6 percent. At 12-months, the rate of all-cause MACNE was 7.9 percent.

At three months, all shunts were patent. At 12 months, shunt occlusion occurred in five patients (14 percent) and 13 patients (36 percent) had shunt stenosis. Patients with widely patent shunts had lower long-term morbidity and mortality. 

Regarding clinical status, at three and 12 months there was a significant improvement in NYHA class, quality of life, and 6-minute walk distance, without changes in objective measures of left- or right-sided function.

The researchers concluded that interatrial shunting with the V-Wave system was feasible and safe for HF patients. They noted that device modification aimed at improving the durability of patency would be worthwhile before the launch of a randomized trial to confirm findings.

Kim A. Eagle, MD, MACC, editor-in-chief of ACC.org comments that while the study shows promise, it is very small. "It's clear that better devices are needed moving forward."

Keywords: ACC18, ACC Annual Scientific Session, Angiography, Propensity Score, Kaplan-Meier Estimate, Incidence, Pulmonary Artery, Standard of Care, Hypertension, Renal, Medicare, Nephritis, Comorbidity, Diabetes Mellitus, Arrhythmias, Cardiac, Heart Failure, Hospitalization, Lung Diseases

< Back to Listings