Long‐term outcomes of patients undergoing coronary sinus reducer implantation ‐ A multicenter study

Abstract

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.

A budget impact model and a cost–utility analysis of reducer device (Neovasc) in patients with refractory angina

“…The cost-effectiveness of the reducer was expressed as an ICER, defined as the differential in the cumulative costs relative to the difference in cumulative QALYs of the reducer and SoC. Contrary to the assumptions made by Gallone et al ( 13 ), which anticipated a decline in effectiveness over time, our analysis supports the sustained and consistent efficacy of the device, as previously documented in the efficacy section and corroborated by literature ( 14 – 17 ). For this reason, a decrease in effectiveness over the time horizon considered is not assumed in the model.…”

“…While this study holds significant relevance for its insights into the cost-effectiveness of introducing new technologies within the Italian national healthcare system, it is not without limitations. In contrast to the findings presented by Gallone et al in 2019 ( 13 ), subsequent research ( 14 – 17 , 19 , 21 ) has suggested that the efficacy of the reducer may remain stable over an extended period. Additionally, the implantation of the reducer has been shown not to affect blood pressure and heart rate metrics pre and post-procedure, further supporting the notion that its beneficial impacts are directly linked to the device itself rather than alterations in medical treatment.…”

“…New evidence has been recently published both regarding the device mechanism of action (MOA) and the long-term results: Palmisano et al showed a significant increase in perfusion and reduction of ischemia with MRI, which addresses both MOA and impact on ischemia; REDUCER 1 ( 17 ) study and FIM 12 ( 26 ) study include a mean follow-up of 3.38 years and provide evidence that results can be maintained over time. Moreover, the reducer improves myocardial longitudinal and circumferential strain, without microstructural remodeling and impact on diastolic proprieties.…”

“…With a median follow-up of 502 days, it reported a significant improvement in angina symptoms, with 39.7% of patients achieving a ≥2 CCS class improvement and a procedural success rate of 96.7%. The median follow-up in the RESOURCE study ( 17 ) was 502 days. Konigstein et al ( 17 ) conducted a prospective single-arm registry in 2021 involving 99 patients, which examined the long-term effects (>2 years) of CSR implantation in patients with RA.…”

“…The median follow-up in the RESOURCE study ( 17 ) was 502 days. Konigstein et al ( 17 ) conducted a prospective single-arm registry in 2021 involving 99 patients, which examined the long-term effects (>2 years) of CSR implantation in patients with RA. With a median follow-up of 3.38 years, it reported no procedure-related complications, a significant improvement in CCS class from baseline to 1 year (maintained through to the last follow-up), and outcomes indicating safety and sustained efficacy of CSR for angina relief over time.…”