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Coronary sinus Reducer device for the treatment of refractory angina: A multicenter initial experience
João Ferreira Reis1, Catarina Brízido2, Sérgio Madeira2
1Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar e Universitário de Lisboa Central, Lisbon, Portugal.
Insights
The Coronary Sinus Reducer (CSR) effectively treats refractory angina in patients ineligible for revascularization. This real-world study shows CSR implantation improves angina symptoms and quality of life.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Refractory angina (RA) significantly impacts quality of life in patients with severe coronary artery disease.
- Optimal medical therapy and revascularization are not suitable for all RA patients.
- The Coronary Sinus Reducer (CSR) offers a complementary therapeutic option for these challenging cases.
Purpose of the Study:
- To evaluate the safety and efficacy of the Coronary Sinus Reducer (CSR) device in a real-world clinical setting.
- To assess improvements in angina symptoms, quality of life, and medication use post-CSR implantation.
Main Methods:
- A multicenter study included 26 patients with refractory angina unsuitable for revascularization.
- The Coronary Sinus Reducer (CSR) device was implanted between May 2017 and July 2019.
- Safety endpoints included procedural success and complications; efficacy was assessed at six months via CCS class, SAQ-7 quality of life scores, and antianginal therapy reduction.
Main Results:
- Procedural success was achieved in 23 of 26 patients, with low complication rates.
- At six-month follow-up, 75% of patients experienced a reduction in Canadian Cardiovascular Society (CCS) class, with 16.7% becoming asymptomatic.
- Significant improvements were observed in quality of life (SAQ-7 domains) and a reduction in anti-ischemic drug use.
Conclusions:
- Real-world implantation of the Coronary Sinus Reducer (CSR) is safe and effective for patients with refractory angina.
- CSR therapy leads to substantial improvements in angina symptoms and overall quality of life.
- The CSR device represents a valuable therapeutic option for refractory angina patients not amenable to traditional revascularization.
Introduction:
The coronary sinus Reducer (CSR) device has emerged as a complementary therapy in patients with severe angina refractory to optimal medical therapy and not amenable to revascularization. Our aim was to assess the safety and efficacy of the CSR in a real-world setting.
Methods:
Twenty-six patients with refractory angina (RA) and evidence of myocardial ischemia attributable to the left coronary artery considered unsuitable for revascularization were treated with the CSR at two centers between May 2017 and July 2019. Safety endpoints were procedural success and complications. Efficacy endpoints, assessed at six-month follow-up, were reduction in CCS class, improvement in quality of life (QoL) assessed using the short version of the Seattle Angina Questionnaire (SAQ-7), and reduction in antianginal therapy.
Results:
Twenty-three patients had end-stage coronary artery disease without revascularization targets and three had microvascular disease without epicardial stenosis. Procedural success was achieved in 23 patients, with two device/procedure-related complications and one anatomically-related failure to deliver the device. A total of 24 patients had the device implanted and entered the efficacy analysis. Eighteen patients (75.0%) had a reduction of at least one CCS class, 41.7% had a reduction of at least two classes, and 16.7% became asymptomatic, with a mean reduction in CCS class of 1.3±0.2 (p=0.001) at six-month follow-up. All SAQ-7 domains improved, notably physical limitation (p=0.001), angina frequency (p=0.005) and QoL (p=0.006). There was a mean reduction in anti-ischemic drugs from 3.4±1.1 to 2.9±1.2 (p=0.010).
Conclusion:
In this real-world, multicenter experience, implantation of the CSR was associated with improvement in angina and QoL in patients with RA.
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