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REDUCE LAP-HF: Interatrial shunt device lowers left atrial pressure in HFpEF

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Sanjiv J. Shah

ANAHEIM, Calif. — A transcatheter interatrial shunt device reduced pulmonary capillary wedge pressure during exercise in people with HF and preserved ejection fraction, according to data from the REDUCE LAP-HF I study.

Results from the study were presented at the American Heart Association Scientific Sessions.

“Patients with HFpEF are known to have left ventricular diastolic dysfunction. These abnormalities result in elevated [left atrial] pressure and volume overload with subsequent elevation in pulmonary venous pressures, particularly during exertion, resulting in symptoms of dyspnea and exercise intolerance,” Sanjiv J. Shah, MD, professor of medicine and director of the T1 Center for Cardiovascular Therapeutics at of Northwestern University Feinberg School of Medicine in Chicago, and colleagues wrote in a simultaneous publication in Circulation.

REDUCE LAP-HF was a phase 2, blinded, multicenter study of people with class III HF with ejection fraction of at least 40%. Participants were randomly assigned 1:1 to the transcatheter interatrial shunt device (IASD, Corvia Medical) vs. a sham procedure.

“The device has been studied previously in a nonrandomized, open-label single arm study of 64 patients. All patients had NYHA Class II to IV heart failure with EF  greater than or equal to 40%, and pulmonary capillary wedge pressure was elevated at rest or during exercise. Implantation of the interatrial shunt device was associated with improvement in exercise time and reduction in work-indexed pulmonary capillary wedge pressure. However, this prior study was subject to bias because of its nonrandomized, nonblinded study design,” Shah said during his presentation.

In the current study, efficacy was evaluated by pulmonary capillary wedge pressure during exercise at 1 month after randomization and safety was assessed by the number of adverse cardiac, cerebrovascular and renal events.

Of the 94 participants enrolled, 44 met inclusion criteria (mean age, 70 years; 50% women).

At 1 month, the shunt device reduced exercise pulmonary capillary wedge pressure compared with the sham procedure (P = .028).

Peak pulmonary capillary wedge pressure decreased by 3.5 mm Hg in the treatment group compared with 0.5 mm Hg in the control group (P = .14).

There were no major adverse CV, cerebrovascular or renal events reported in the treatment group, compared with one event (worsening renal function) in the control group (P = 1).

“We think these findings could have a beneficial clinical effect in heart failure with preserved EF and midrange EF,” Shah said. “A larger pivotal trial to examine the effects of this device on quality of life, exercise capacity and clinical outcomes is warranted. And, in fact, the REDUCE LAP-HF pivotal trial is already underway. It started earlier this year.”

Lynne Warner Stevenson

In a discussant presentation, Lynne Warner Stevenson, MD, Alice M. Jacobsen Professor of Medicine and director of cardiomyopathy at Vanderbilt University Medical Center, said, “This transcatheter interatrial shunt device is an ingenious new approach to address both the symptoms and the progression of this disease, inspired in part by interventions for the congenital heart disease population.

“Future investigation of this device for HFpEF should analyze carefully and perhaps choose patients for the HFpEF phenotypes, not only with and without obesity and in relation to baseline filling pressures but also in relation to ventricular dysfunction,” she said. “We greatly look forward to the ongoing trial to track the sustained benefit overtime. We’re interested in the exercise hemodynamics in clinical activity. … We also want to look very closely at the impact on renal function, which does relate to right atrial pressure.” – by Cassie Homer

References:

Shah SJ, et al. LBS.07. Innovative Therapies and Novel Applications. Presented at: American Heart Association Scientific Sessions; Nov. 11-15, 2017; Anaheim, California.

Feldman T, et al. Circulation. 2017;doi:10.1161/CIRCULATIONAHA.117.032094.

Disclosure: The study was funded by Corvia Medical. Shah reports he receives a research grant from Corvia Medical.