Early Data Show Novel Catheter-Implanted Device Benefits Patients with Left Heart Failure

PARIS, France—A first-in-man study presented Tuesday, May 20, at EuroPCR 2014 introduced a new percutaneous treatment for heart failure.

Josep Rodés-Cabau, MD, of Laval University (Quebec City, Canada), shared details about the initial experience with the V-Wave device (V-Wave, Or Akiva, Israel), a permanent implant for heart failure patients with elevated left atrial filling pressure.

V-Wave is an hourglass-shaped nitinol frame device, he said, with 3 leaflets that serve as “a valve mechanism that avoids right-to-left shunt and creates a unidirectional left-to-right shunt at the level of the atrial septum.”

Starting in October 2013, Dr. Rodés-Cabau and colleagues treated 5 patients with chronic cardiomyopathy (80% ischemic) who were NYHA class III or ambulatory class IV heart failure despite optimal medical therapy as defined by American College of Cardiology/American Heart Association guidelines. Procedures were done in the cath lab via the transfemoral approach with general anesthesia and under transesophageal echocardiographic  (TEE) guidance.

Gains in Functional Status, Quality of Life

LVEF at baseline was 25 ± 6%, NTproBNP 4,396 ± 3,775 pg/mL, and mean pulmonary wedge pressure was 21 mm Hg.

Device implantation was successful in all cases. Procedural time was 58 minutes (range 43-65 minutes) but “reduced dramatically in the last 3 patients,” Dr. Rodés-Cabau said. Patients were discharged at 24 hours with no complications, and TEE verified permeability of the V-Wave device post-procedure and at 24 hours.

At 1 month, TEE showed device permeability with no thrombus or device embolization in any patient. By 3-month follow-up, all patients were in NYHA class II. Several measures including 6-minute walk test, Borg scale, and VO₂ max, Duke Activity Status Index (DASI), and Kansas City Cardiomyopathy Questionnaire (KCCQ) all improved, while there was a trend toward lower NTproBNP levels. There also were changes in pulmonary wedge pressure and the ratio of pulmonary to systemic flow (table 1).

Table 1. Changes in Median Values

^aRatio of pulmonary to systemic flow.

There were no significant changes between baseline and 3 months in LVEF, telediastolic LV diameter, left atrial volume, mitral regurgitation grade, or right arterial pressure.

No device-related adverse events occurred. One patient experienced GI bleeding related to warfarin at 2 months after the procedure, and another had symptomatic ventricular tachycardia requiring hospitalization and ablation at 5 weeks.

“The successful and uneventful first-in-man experience with the V-Wave device showed the feasibility of applying this new therapy in heart failure patients,” Dr. Rodés-Cabau concluded. “Confirmation of these results in a larger number of patients with longer follow-up may open a new avenue for the treatment of patients with heart failure.”

Two additional patients have received the V-Wave device at his institution within the past month, and a multicenter European registry is ongoing, he reported.

Rationale for Creating Left-to-Right Shunt

Dr. Rodés-Cabau made the case for innovation in heart failure treatment by pointing out that the disease affects up to 2% of the global population, amounting to approximately 1.2 million new patients in the United States and European Union each year. “Many patients with heart failure continue to deteriorate despite optimal medical treatment [which translates into] decline in quality of life, high rates of rehospitalization, and increased costs,” he said.

Earlier studies have shown that management of left atrial pressure is associated with improvement in NYHA functional class and increased LVEF, Dr. Rodés-Cabau reported.

“We know also that creating an interatrial shunt in patients with pulmonary hypertension usually improves functional status in this very sick group of patients,” he explained, adding that, conversely, closure of atrial septal defects in patients with left ventricular restriction can lead to a “deleterious hemodynamic situation with severe increase in left atrial pressure.” Additional case studies have suggested balloon atrial septostomy may be useful for treating ventricular dysfunction.

Panelist Ralf Mueller, MD, of HELIOS Heart Center (Siegburg, Germany), commented, “Many of us have tried something like this for a long time, but patency has been a problem. I’m very intrigued and surprised, although you don’t have long-term yet…. What do you think the secret is for this continued patency?”

Dr. Rodés-Cabau said that the valve is likely responsible. “There are no clear rules about [adjunctive medications.] We are treating these patients with anticoagulation. Most of them were anticoagulated already, and maybe this is one of the reasons for this [patency],” he observed.

Rodés-Cabau J. Left atrial decompression through unidirectional left-to-right shunt for the treatment of left cardiac failure: first-in-man experience with the V-Wave device. Presented at: EuroPCR; May 20, 2014; Paris, France.

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