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Effectiveness of coronary sinus reducer implantation in routine clinical practice: 12-month outcomes
Szymon Włodarczak1, Piotr Rola2,3, Artur Jastrzębski4
1Department of Cardiology, Copper Health Centre, Lubin, Poland. wlodarczak.szy@gmail.com
Insights
Coronary sinus reducer (CSR) implantation effectively treats refractory angina (RA) patients, improving symptoms and quality of life. One-year follow-up showed no adverse effects, indicating CSR is a safe and viable therapeutic option.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Refractory angina (RA) presents a significant challenge due to limited therapeutic options.
- Coronary sinus reducer (CSR) is a novel device for advanced coronary artery disease.
- Real-world clinical data on CSR efficacy are currently scarce.
Purpose of the Study:
- To evaluate the 12-month efficacy and safety of coronary sinus reducer (CSR) implantation in patients with refractory angina (RA).
- To assess changes in angina severity, exercise tolerance, and quality of life following CSR implantation.
Main Methods:
- The Lower Silesia Sinus Reducer Registry (NCT06288165) included 67 patients with chronic RA (CCS classes 2-4) receiving CSR.
- Primary endpoints included changes in angina severity (CCS class, SAQ-7), safety, exercise tolerance (6MWD), and quality of life (SF-36, EQ-5D VAS).
Main Results:
- 86.6% of patients experienced at least a one-class improvement in CCS class after 12 months (P <0.001).
- Significant improvements were observed in angina control (SAQ-7 score, P <0.001), quality of life (SF-36 score, P <0.001), and exercise tolerance (6MWD, P = 0.03).
Conclusions:
- CSR implantation is an effective treatment for patients suffering from refractory angina.
- One-year follow-up data indicate no long-term adverse effects associated with CSR device implantation.
Introduction:
Refractory angina (RA), due to a lack of therapeutic options, remains a significant health care challenge. Coronary sinus reducer (CSR) has been recently introduced as a therapeutic option for this advanced form of coronary artery disease. However, despite growing evidence of its efficacy, data from routine clinical practice are scarce.
Objectives:
We report 12‑month observation data on the efficacy and safety of CSR implantation based on the results from the Lower Silesia Sinus Reducer Registry (NCT06288165).
Patients And Methods:
The study included data from 67 consecutive patients diagnosed with chronic RA (Canadian Cardiovascular Society [CCS] classes 2-4) despite optimal medical therapy, who underwent CSR implantation. The study end points were defined as changes in angina severity (CCS class, the 7‑item Seattle Angina Questionnaire [SAQ‑7]), safety outcomes, exercise tolerance (6‑minute walking distance [6MWD]), and quality of life assessments (the 36‑item Short Form Health Survey [SF‑36], European Quality of Life 5-Dimension 5-Level Version, and EuroQol Visual Analog Scale).
Results:
A total of 86.6% of the patients showed improvement by at least 1 CCS class (P <0.001) over the 12 months of follow-up, as compared with the baseline. Significant improvement in 12‑month angina control was demonstrated, as measured by the SAQ‑7 total score (mean [SD], 39.9 [15.2] vs 54.6 [19.7]; P <0.001). A similar improvement in the 12‑month quality of life assessment measured by the SF‑36 total score (mean [SD], 112.7 [23.2] vs 98.4 [31.9]; P <0.001) was noticed. One year after CSR implantation, a significant improvement in exercise tolerance was also observed (mean [SD] 6MWD, 265.9 [136.9] m vs 234.9 [109.1] m; P = 0.03).
Conclusions:
One‑year data from the Lower Silesia Sinus Reducer Registry indicate that CSR implantation is an effective therapeutic option for patients with RA. Additionally, we did not observe any long‑term adverse effects associated with the device implantation.
