V-Wave Device Offers Functional, Hemodynamic Gains for Patients With Systolic HF
A novel percutaneously implanted unidirectional shunt for the treatment of systolic HF showed promising safety and efficacy outcomes at 3 months, according to new findings presented at TCT 2015. The results were maintained out to 1 year in evaluable patients.
Maria Del Trigo, MD, of Quebec Heart and Lung Institute, Quebec City, Canada, and colleagues implanted the V-Wave (V-Wave Ltd) device in 10 patients (mean age, 62 years; 90% men), all of whom had NYHA class III/IV symptoms, left ventricular ejection fraction (LVEF) > 15% and ≤ 40%, and pulmonary capillary wedge pressure ≥ 15 mm Hg. Mean LVEF was 27% at baseline.
V-Wave is intended to regulate left atrial filling pressures by creating a low-volume, left-to-right shunt.
All patients underwent successful femoral transseptal shunt implantation without complications. Procedures lasted an average of 59 minutes, without contrast injection. At 3 months, functional and hemodynamic results were promising, but data were available only for the first eight patients. Importantly, all were NYHA class I/II after treatment (see Table).
DASI: Duke Activity Status Index; KCCQ: Kansas City Cardiomyopathy Questionnaire; PCWP: pulmonary capillary wedge pressure; QOL: quality of life
At 1 month after implantation, all shunts were patent on transesophageal echocardiography, and there was no evidence of thrombus or device migration. Del Trigo told TCT Daily that the results were maintained out to 1 year in six evaluable patients, and no adverse events related to the device were reported. One death due to “ventricular tachycardia storm” occurred at 2 months in a patient with a history of severe ventricular arrhythmia.
“Creating a left-to-right unidirectional shunt in patients with [HF and reduced EF] under optimal maximal therapy was associated with significant improvements in functional status, exercise capacity, quality of life and hemodynamic parameters,” Del Trigo noted, adding that her group was somewhat surprised by the degree and rapidity of the effects. “In fact, the vast majority of patients spontaneously expressed a significant improvement in dyspnea symptoms within the hours following the procedure,” she said.
Del Trigo reported that several registries using the V-Wave device are planned, to be followed by a pivotal randomized trial in North America and Europe. “These trials should provide definitive evidence on the efficacy of the V-Wave device for the treatment of chronic HF with reduced and preserved EF,” she concluded.
- Del Trigo reports no relevant conflicts of interest.