Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Safety and Effectiveness of Coronary Sinus Reducer in the Therapy of Refractory Angina Pectoris - Mid-Term Results of the Real-Life Cohort

Version 1 : Received: 20 May 2024 / Approved: 20 May 2024 / Online: 20 May 2024 (20:18:17 CEST)

How to cite: Włodarczak, S.; Rola, P.; Jastrzębski, A.; Turkiewicz, K.; Korda, A.; Włodarczak, P.; Barycki, M.; Kulczycki, J. J.; Furtan, Ł.; Włodarczak, A.; Lesiak, M. Safety and Effectiveness of Coronary Sinus Reducer in the Therapy of Refractory Angina Pectoris - Mid-Term Results of the Real-Life Cohort. Preprints 2024, 2024051305. https://doi.org/10.20944/preprints202405.1305.v1 Włodarczak, S.; Rola, P.; Jastrzębski, A.; Turkiewicz, K.; Korda, A.; Włodarczak, P.; Barycki, M.; Kulczycki, J. J.; Furtan, Ł.; Włodarczak, A.; Lesiak, M. Safety and Effectiveness of Coronary Sinus Reducer in the Therapy of Refractory Angina Pectoris - Mid-Term Results of the Real-Life Cohort. Preprints 2024, 2024051305. https://doi.org/10.20944/preprints202405.1305.v1

Abstract

Background: Despite continuous improvements in revascularization techniques, refractory angina without potential revascularization options remains a relevant clinical issue with significant impact on patient’s quality of life. Recently, a novel device, the Coronary Sinus Reducer (CSR), has been introduced into clinical practice as a therapeutic option for patients with disabling angina pectoris. In this single-center, observational study, we evaluated the mid-term (3-month) safety and efficacy of the CSR in a real-world cohort. Methods: The study population consisted of 55 patients with refractory angina without potential revascularization options, predominantly men (87.3%) with a high cardiovascular risk factor burden and advanced angina (baseline CCS angina class 3.15 ± 0.6). In terms of procedure safety, all patients underwent successful device deployment with only one periprocedural complication. Results: At the 3-month follow-up we observed statistically significant improvement in angina control measured CCS class and SAQ-7 Total questionnaire along with increased abolition of physical limitation – 6-MWT (233.3 ± 107.1 vs 305.2 ± 126.8; p<0.0001). Additionally, we observed significant improvement in terms of quality of life measurements SF-36, the EQ-5D-5L questionnaire, and the EQ-VAS. Conclusions: Our real-world data suggest that CSR implantation is a relatively safe procedure and appears to be particularly effective in relieving angina symptoms and improving quality of life in subjects with refractory angina.

Keywords

Refractory angina pectoris (RA); Coronary Artery Disease (CAD); Percutaneous Coronary Intervention (PCI); Coronary Artery Bypass Grafting (CABG); Coronary Sinus Reducer (CSR); Quality of Life (QoL)

Subject

Medicine and Pharmacology, Cardiac and Cardiovascular Systems

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