WEDNESDAY, April 25 (HealthDay News) -- A Coronary Sinus Reducer device may help to reperfuse ischemic heart muscle in patients with chronic refractory angina pectoris who are not candidates for revascularization, according to the results of an open-label non-randomized trial published in the May 1 issue of the Journal of the American College of Cardiology.
Shmuel Banai, M.D., of Tel Aviv Medical Center in Tel Aviv, Israel, and colleagues electively treated 15 patients with coronary artery disease and severe angina, including reversible ischemia, with a Coronary Sinus Reducer device, which is an hourglass-shaped stainless steel stent. Clinical outcomes were measured before and up to six months after implantation. Narrowing the coronary sinus helps to redistribute blood from non-ischemic to ischemic tissue.
All procedures were successful and occurred without adverse events. Angina score and average Canadian Cardiovascular Society scores improved in most patients and stress-induced ST-segment depression was reduced or eliminated in six of nine patients studied. Computed tomography showed that the extent and severity of ischemia was also reduced.
"The use of percutaneous transvenous implantation of the Coronary Sinus Reducer in patients with refractory angina was found to be safe and feasible," the authors write. "These findings
support further evaluation of the Coronary Sinus Reducer in a randomized placebo-controlled trial, as an alternative tool for treating patients with refractory angina who are not candidates for or are at high risk for revascularization."
Some of the authors are consultants or employees of Neovasc Medical, Inc., the manufacturer of the Coronary Sinus Reducer.
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