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Novel coronary sinus device safely relieves symptoms in refractory angina
A novel device designed to treat chronic severe angina was implanted safely, effectively reduced angina symptoms and improved quality of life, according to the REDUCE study.
The prospective, single-arm, nonblinded registry included 141 consecutive patients who underwent implantation with the coronary sinus device (Reducer, Neovasc Inc.) at three high-volume centers in Milan; Tel Aviv, Israel; and Antwerp, Belgium.
All patients had severe angina refractory to optimal medical therapy and were deemed not amenable for further percutaneous or surgical revascularization procedures by the local heart team.
Device implantation was successful in 98.6% of patients, with two failures in patients with unfavorable coronary sinus anatomy. The mean procedural time was 50.4 minutes, the mean volume of contrast media used was 53.2 mL and the mean balloon inflation pressure was 4.2 atm.
During a median follow-up of 14 months, there was one case of device migration, which was treated without adverse clinical events, and no cases of coronary sinus perforation, cardiac tamponade, periprocedural MI or death. Three patients experienced minor complications, including periprocedural rapid atrial fibrillation with subsequent spontaneous cardioversion to sinus rhythm, dislocation of a pacemaker’s right atrial lead and bleeding at the access puncture site 10 days after implantation.
Patients who underwent successful implantation experienced a significant reduction in angina severity, as measured by Canadian Cardiovascular Society (CCS) class. From baseline to follow-up, the mean CCS score improved from 3.05 at baseline to 1.63 at follow-up (P < .001). Moreover, 81% of patients experienced an improvement of at least one CCS class, the researchers reported.
QOL, as measured by Seattle Angina Questionnaire scores, improved as well, according to the data. Specifically, physical limitation scores increased from 43.9 to 62.2 points, angina stability scores increased from 36.9 to 66.6 points and angina frequency scores improved from 45.6 to 66.7 points from baseline to follow-up. Treatment satisfaction scores also increased from 51.9 to 68.4 points and QOL scores increased from 26.6 to 52.2 points (P < .001 for all).
Additionally, the mean number of anti-ischemic drugs prescribed decreased from 2.37 to 2.17 (P = .003).
Of the 14 patients who had died at follow-up, two were due to fatal MI, one was due to advanced HF and one was due to refractory angina leading to anorexia and decubitus.
In patients for whom additional testing was available, the researchers found that limiting angina was less frequent during peak stress during an exercise treadmill stress test and there was significant improvement in distance walked during the 6-minute walk test. The researchers also found a significant reduction in ischemia extent after implantation as well as a reduction in inducible ischemia using dobutamine stress echocardiography.
“In this real-world experience, implantation of the Reducer was safe and effective in reducing angina symptoms, and improving quality of life,” the researchers wrote. “Therefore, Reducer implantation may offer a further complimentary intervention to optimal medical therapy.”
The stainless steel, balloon-expandable, hourglass-shaped device is implanted percutaneously through the jugular and is designed to create a focal narrowing in the lumen of the coronary sinus and generate a pressure gradient, the researchers noted. – by Melissa Foster
Disclosures: One author reports he is medical director of Neovasc Inc., and two authors report they are consultants for Neovasc Inc.
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Giannini F, et al. Int J Cardiol. 2018;doi:10.1016/j.ijcard.2018.06.116.