Polish archives of internal medicine · 2025
Effectiveness of coronary sinus reducer implantation in routine clinical practice: 12-month outcomes.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Włodarczak Szymon, Rola Piotr, Jastrzębski Artur, Barycki Mateusz, Furtan Łukasz, Włodarczak Piotr, Kulczycki Jan J, Korda Andrzej, Turkiewicz Karol, Włodarczak Adrian, Lesiak Maciej
Аннотация
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.
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.