The use of coronary sinus reducer for refractory angina in the U.S.: A case series

Abstract Background Coronary sinus Reducer device (CSF) implantation is a novel therapeutic option to relieve symptoms in patients with refractory angina (RA). There is limited real-world data describing its use outside of clinical trials. Aim To assess the safety and efficacy of this procedure in a real-world setting. Methods This is a report of a single centre prospective registry of consecutive patients with RA (CCS II-IV) deemed unsuitable for revascularization. Between May 2017 and August 2019, 17 patients were referred to CSF implantation. Baseline and follow-up evaluation consisted of clinical assessment, including completion of the short version of the Seattle Angina Questionnaire (SAQ-7) and CCS class evaluation and objective evaluation by transthoracic echocardiography and cardiopulmonary exercise test (CPET). Results A total of 13 patients (70,6±6,5 years, 76,9% male) underwent CSF implantation with a procedural success of 84.6%. No cases of periprocedural serious adverse events were reported. At 12-month follow-up, any reduction in CCS Class was achieved in 72.7% of cases, with 27.2% reducing 2 CCS classes. Baseline CCS score was reduced from 2.8±0.4 to 1.7±0.8 (p=0.009). Quality of life (QoL) was significantly improved as assessed by the improvement seen in all items of SAQ-7 (p<0.017 for all). CPET duration was significantly increased (p=0.034), but no change was noted in the remainder CPET variables. During follow-up, 3 patients suffered myocardial infarction, resulting in 1 death. Conclusion CSF implantation in patients with RA was safe and led to a significant reduction of the angina burden and improvement of QoL at 12-month follow-up. FUNDunding Acknowledgement Type of funding sources: None.

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Left ventricular lead fixation during biventricular pacemaker implantation by coronary sinus branch stenting – case series presentation

Cardiologia Croatica ◽

10.15836/ccar.2014.369 ◽

2014 ◽

Vol 9 (9-10) ◽

pp. 369-369

Author(s):

Zorislav Susak ◽

Ante Anic ◽

Zoran Bakotic ◽

Albino Jovic

Keyword(s):

Coronary Sinus ◽

Pacemaker Implantation ◽

Case Series ◽

Left Ventricular ◽

Left Ventricular Lead ◽

Biventricular Pacemaker ◽

Ventricular Lead ◽

Lead Fixation

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A novel method to interpret early phase trials shows how the narrowing of the coronary sinus concordantly improves symptoms, functional status and quality of life in refractory angina

Heart ◽

10.1136/heartjnl-2020-316644 ◽

2020 ◽

Vol 107 (1) ◽

pp. 41-46

Author(s):

E Marc Jolicoeur ◽

Stefan Verheye ◽

Timothy D Henry ◽

Lawrence Joseph ◽

Serge Doucet ◽

...

Keyword(s):

Quality Of Life ◽

Coronary Sinus ◽

Early Phase ◽

Exercise Duration ◽

Control Group ◽

Refractory Angina ◽

Group Level ◽

Early Phase Trials ◽

Level Analysis

BackgroundReduction of the coronary sinus was shown to improve angina in patients unsuitable for revascularisation. We assessed whether a percutaneous device that reduces the diameter of the coronary sinus improved outcomes across multiple endpoints in a phase II trial.MethodsWe conducted a novel analysis performed as a post hoc efficacy analysis of the COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) trial, which enrolled patients with Canadian Cardiovascular Society (CCS) class 3–4 refractory angina. We used four domains: symptoms (CCS Angina Scale), functionality (total exercise duration), ischaemia (imaging) and health-related quality of life. For all domains, we specified a meaningful threshold for change. The primary endpoint was defined as a probability of ≥80% that the reducer exceeded the meaningful threshold on two or more domains (group-level analysis) or that the average efficacy score in the reducer group exceeded the sham control group by at least two points (patient-level analysis).ResultsWe randomised 104 participants to either a device that narrows to coronary sinus (n=52) or a sham implantation (n=52). The reducer group met the prespecified criteria for concordance at the group level and demonstrated improvement in symptoms (0.59 CCS grade, 95% credible interval (CrI)=0.22 to 0.95), total exercise duration (+27.9%, 95% CrI=2.8% to 59.8%) and quality of life (stability +11.2 points, 95% CrI=3.3 to 19.1; perception +11.0, 95% CrI=3.3 to 18.7).ConclusionsThe reducer concordantly improved symptoms, functionality and quality of life compared with a sham intervention in patients with angina unsuitable for coronary revascularisation. Concordant analysis such as this one can help interpret early phase trials and guide the decision to pursue a clinical programme into a larger confirmatory trial.Trail registration numberClinicalTrials.gov identifier: NCT01205893.

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