19 April 2018

Positive Real-World Results for Neovasc Coronary Sinus Reducer in Patients With Refractory Angina

An implantable device that narrows the coronary sinus appears to be a good option for patients with refractory angina who are not candidates for further revascularization, real-world results from a single-center study suggest.

The Reducer (Neovasc) is a stainless-steel, balloon-expandable, hourglass-shaped device that is implanted percutaneously to narrow the coronary sinus. Its use “ultimately leads to an increase in coronary venous pressure, capillary and arteriolar dilatation, lower resistance to flow, and restoration of the normal endocardial/epicardial blood flow ratio, which is impaired in the ischemic myocardium,” researchers led by Francesco Giannini, MD (IRCCS San Raffaele Scientific Institute, Milan, Italy), explain.

Patients implanted with the device, which is available in Europe but has not been approved for use in the United States, had improvements in angina symptoms and quality of life that were sustained out to 1 year, with additional positive effects on exercise tolerance and dyspnea severity, the investigators report in a study published in the April 23, 2018, issue of JACC: Cardiovascular Interventions.

Despite use of conventional reperfusion techniques and optimal medical therapy, a subset of patients with angina will remain symptomatic, Giannini pointed out, adding that other nonpharmacological treatments are only partially effective at addressing the problem of refractory angina.

“The Reducer device provides an additional, effective option for these patients,” he said.

The current 50-patient study, though not randomized, “describes the largest available group of real-world patients, selected among both genders, a wide range of ages, and very different medical backgrounds,” and includes the longest available clinical follow-up, he said. In addition, the paper includes a detailed description of the technical aspects of the procedure that operators can use to ensure safe implantation, covering areas like coronary sinus sizing, implant site evaluation, guidewire selection, and alternative techniques to be used for challenging anatomy.

Suzanne Arnold, MD (Saint Luke’s Mid America Heart Institute, Kansas City, MO), said this is “an important study to show the real-world efficacy of this procedure.”

April 23, 2018, JACC: Cardiovascular Interventions