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Long-term outcomes of patients undergoing coronary sinus reducer implantation - A multicenter study
Maayan Konigstein1, Francesco Ponticelli2, Carlo Zivelonghi3
1Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv-Yafo, Israel.
Insights
Coronary sinus reducer implantation effectively treats refractory angina long-term. Angina symptom improvement and low mortality are maintained for over three years post-procedure.
Area of Science:
- Cardiology
- Interventional Cardiology
- Cardiac Surgery
Background:
- Coronary sinus (CS) narrowing via reducer implantation is a novel therapy for refractory angina.
- Long-term clinical benefit data for this intervention is limited.
Purpose of the Study:
- To evaluate the long-term efficacy and safety of coronary sinus reducer implantation.
- To assess the durability of angina symptom improvement in patients treated with a CS reducer.
Main Methods:
- Prospective enrollment of 99 patients undergoing successful CS reducer implantation across three centers.
- Follow-up data collected for a median of 3.38 years, including adverse events and Canadian Cardiovascular Society (CCS) class.
- Analysis focused on changes in angina severity and long-term clinical outcomes.
Main Results:
- No procedure-related complications were observed.
- Mean CCS class improved significantly from 3.1 at baseline to 1.7 at long-term follow-up (p < .001).
- Long-term mortality (15.1%) and rates of myocardial infarction (9%) or revascularization (21%) were comparable to stable coronary artery disease.
Conclusions:
- Coronary sinus reducer implantation demonstrates sustained efficacy in improving angina symptoms.
- Long-term mortality following reducer implantation aligns with that of stable coronary artery disease patients.
- The procedure offers a safe and effective long-term solution for refractory angina.
Background:
Coronary sinus (CS) narrowing by reducer implantation has emerged as a safe and effective therapy for patients suffering from refractory angina. However, data regarding the clinical benefit of this treatment over time is lacking.
Methods:
Patients undergoing successful reducer implantation were enrolled prospectively to clinical registries at three medical centers. Those with more than 2-years of follow-up were included in the present analysis. Peri-procedural data, data regarding adverse events, and current evaluation of angina severity (Canadian Cardiovascular Society [CCS] class) were collected.
Results:
Overall, 99 consecutive patients (77% males, mean age 69.8 ± 9.4) with severe angina were enrolled between September 2010 and October 2017 and included in the present analysis. No procedure-related complications were recorded. During a median follow up time of 3.38 years (IQR 2.95-4.40), 15.1% of the patients died, 9% experienced myocardial infarction (MI) and 21% underwent percutaneous coronary intervention (PCI). Mean CCS class was 3.1 ± 0.5 at baseline, improved to 1.66 ± 0.8 at 1 year (p < .001), and remained low through 2-years and at last follow up (1.72 ± 0.8 and 1.71 ± 0.8, p > 0.5 for both, in comparison to 1 year). At baseline 91% of patients reported severe disabling angina (CCS class 3-4), at 1 year only 17.9% suffered from disabling angina, p < .001, and this portion remained low overtime (19% at last follow up).
Conclusion:
Long-term mortality of patients undergoing reducer implantation is similar to that reported for patients with stable coronary artery disease. The previously reported short-term efficacy of the reducer, reflected by significant improvement of angina symptoms, is maintained over time.
