Author + information
- Received September 22, 2006
- Revision received January 2, 2007
- Accepted January 2, 2007
- Published online May 1, 2007.
- Shmuel Banai, MD⁎,1,⁎ (, )
- Shmuel Ben Muvhar†,1,
- Keyur H. Parikh, MD‡,
- Aharon Medina, MD§,
- Horst Sievert, MD‖,
- Ashok Seth, MD¶,
- Jonathan Tsehori, MD⁎,
- Yoav Paz, MD⁎,
- Ami Sheinfeld, MD# and
- Gad Keren, MD⁎,1
- ↵⁎Reprint requests and correspondence:
Dr. Shmuel Banai, Interventional Cardiology, Tel Aviv Medical Center, 6 Weizman Street, Tel Aviv, Israel.
Objectives This study sought to evaluate the safety of the Coronary Sinus Reducer (Neovasc Medical, Inc., Or Yehuda, Israel) as a potential alternate therapy for patients with refractory angina who are not candidates for conventional revascularization procedures.
Background Increased coronary sinus (CS) pressure can reduce myocardial ischemia by redistribution of blood from nonischemic to ischemic territories. The Coronary Sinus Reducer is a percutaneous implantable device designed to establish CS narrowing and to elevate CS pressure. In preclinical experiments, implantation of the Reducer was safe and was associated with improved ischemic parameters. In the present study, the safety and feasibility of the Coronary Sinus Reducer was evaluated in patients with refractory angina who were not candidates for revascularization.
Methods Fifteen coronary artery disease patients with severe angina and reversible ischemia were electively treated with the Reducer. Clinical evaluation, dobutamine echocardiography, thallium single-photon emission computed tomography, and administration of an angina questionnaire were performed before and 6 months after implantation. Cardiac computed tomography was performed 2 days and 6 months after implantation.
Results All procedures were completed successfully. No procedure-related adverse events occurred during the periprocedural and the follow-up periods. Angina score improved in 12 of 14 patients. Average Canadian Cardiovascular Society score was 3.07 at baseline and 1.64 at follow-up (n = 14, p < 0.0001). Stress-induced ST-segment depression was reduced in 6 of 9 patients and was eliminated in 2 of these 6 (p = 0.047). The extent and severity of myocardial ischemia by dobutamine echocardiography and by thallium single-photon emission computed tomography was reduced (p = 0.004 [n = 13] and p = 0.042 [n = 10], respectively).
Conclusions Implantation of the Coronary Sinus Reducer is feasible and safe. These findings, along with the clinical improvement observed, support further evaluation of the Reducer as an alternative treatment for patients with chronic refractory angina who are not candidates for coronary revascularization.
↵1 Drs. Banai and Keren are active consultants and Shmuel Ben Muvhar is the Chief Executive Officer of Neovasc Medical, Inc.
The research and development of the Coronary Sinus Reducer stent were done by Neovasc Medical, Inc.
- Received September 22, 2006.
- Revision received January 2, 2007.
- Accepted January 2, 2007.
- American College of Cardiology Foundation