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The Coronary Sinus Reducer; 5-year Dutch experience
M J M Silvis1, M Dekker2,3, C Zivelonghi4
1Department of Cardiology, University Medical Centre Utrecht, Utrecht, The Netherlands.
Insights
The Coronary Sinus Reducer (CSR) offers a safe and effective treatment for refractory angina, improving symptoms in many patients. Further research is needed to identify non-responders for optimized therapy selection.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Refractory angina affects millions globally, posing a significant healthcare challenge.
- The Coronary Sinus Reducer (CSR) is an innovative device aimed at alleviating refractory angina symptoms.
- CSR functions by increasing venous pressure, promoting arteriolar dilation and reducing sub-endocardial vascular resistance.
Purpose of the Study:
- To evaluate the 5-year safety and efficacy of the Coronary Sinus Reducer (CSR) in Dutch patients.
- To assess the impact of CSR implantation on Canadian Cardiovascular Society (CCS) class in refractory angina patients.
Main Methods:
- A cohort of 132 patients with refractory angina received CSR treatment.
- Efficacy was measured by CCS class improvement at 6-month follow-up.
- Safety was assessed by successful CSR implantation and absence of device-related events.
Main Results:
- Significant improvement in CCS class was observed, with 67% of patients showing at least a one-class improvement and 34% showing at least a two-class improvement.
- Mean CCS class decreased from 3.17 to 2.12 (P < 0.001).
- Successful CSR implantation was achieved in 99% of patients with only minor complications reported.
Conclusions:
- The Coronary Sinus Reducer (CSR) presents a simple, safe, and effective therapeutic option for the majority of refractory angina patients.
- Approximately 30% of patients did not experience benefits from CSR implantation.
- Future research should investigate the mechanisms of action and reasons for non-response to optimize patient selection for CSR therapy.
Background:
Refractory angina is a growing and major health-care problem affecting millions of patients with coronary artery disease worldwide. The Coronary Sinus Reducer (CSR) is a device that may be considered for the relief of symptoms of refractory angina. It causes increased venous pressure leading to a dilatation of arterioles and reduced arterial vascular resistance in the sub-endocardium. This study describes the 5‑year Dutch experience regarding safety and efficacy of the CSR.
Methods:
One hundred and thirty-two patients with refractory angina were treated with the CSR. The primary efficacy endpoint of the study was Canadian Cardiovascular Society (CCS) class improvement between baseline and 6‑month follow-up. The primary safety endpoint was successful CSR implantation in the absence of any device-related events.
Results:
Eighty-five patients (67%) showed improvement of at least 1 CCS class and 43 patients (34%) of at least 2 classes. Mean CCS class improved from 3.17 ± 0.61 to 2.12 ± 1.07 after implantation (P < 0.001). The CSR was successfully implanted in 99% of the patients and only minor complications during implantation were reported.
Conclusion:
The CSR is a simple, safe, and effective option for most patients with refractory angina. However, approximately thirty percent of the patients showed no benefit after implantation. Future studies should focus on the exact underlying mechanisms of action and reasons for non-response to better identify patients that could benefit most from this therapy.
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