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Clinical research

Transcatheter treatment for refractory angina with the coronary sinus Reducer

1. Department of Cardiology, Tel Aviv Medical Center, Tel Aviv, Israel, and the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; 2. Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium; 3. Neovasc, Inc., Richmond, BC, Canada

Aims: To evaluate the clinical efficacy of the coronary sinus (CS) Reducer in attenuating angina severity in patients suffering from severe refractory angina.

Methods and results: Patients with refractory angina, objective evidence of myocardial ischaemia and no option for revascularisation were treated with CS Reducer implantation at two medical centres. Six-month follow-up evaluation consisted of clinical assessment of angina severity. Objective assessment of ischaemia at six-month follow-up was performed in one of the two centres. Successful CS Reducer implantation was achieved in 21 of 23 eligible patients, at both centres. No device-related adverse effects were observed during the procedure or the follow-up period. Canadian Cardiovascular Society (CCS) score diminished from a mean of 3.3 at baseline to 2.0 at six months (n=20, p<0.01), exercise duration was prolonged from 3:16 to 5:16 min (min:sec; n=8, p=0.05). Thallium SPECT summed stress score and summed difference score were both reduced (n=9, 21.5±10 vs.13.2±9, p=0.01, and 11.1±6 vs. 4.7±4, p=0.007, respectively). Wall motion score index at peak dobutamine infusion was also significantly improved (n=8, 1.9±0.4 vs. 1.4±0.4, p=0.046).

Conclusions: CS Reducer implantation was safe and resulted in significant improvement of angina class. The results of the ongoing randomised sham-control trial will address the concern regarding the possible placebo effect, and hopefully further support our encouraging observations.

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