Evidence on the safety of coronary sinus narrowing device implantation for refractory angina shows well-recognised complications. Evidence on efficacy is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. Find out what special arrangements mean on the NICE interventional procedures guidance page.
Clinicians wanting to do coronary sinus narrowing device implantation for refractory angina should:
Inform the clinical governance leads in their healthcare organisation.
Give patients (and their families and carers as appropriate) clear written information to support shared decision making, including NICE's information for the public.
Ensure that patients (and their families and carers as appropriate) understand the procedure's safety and efficacy, and any uncertainties about these.
Audit and review clinical outcomes of all patients having the procedure. The main efficacy and safety outcomes identified in this guidance can be entered into NICE's interventional procedure outcomes audit tool (for use at local discretion).
Discuss the outcomes of the procedure during their annual appraisal to reflect, learn and improve.
Healthcare organisations should:
Ensure systems are in place that support clinicians to collect and report data on outcomes and safety for every patient having this procedure.
Regularly review data on outcomes and safety for this procedure.
Patient selection should be done by a multidisciplinary team.
The procedure should only be done in specialist centres by interventional cardiologists with specific training in the technique.
Report any problems with a medical device using the Medicines and Healthcare products Regulatory Agency's Yellow Card Scheme.
NICE encourages further research into coronary sinus narrowing device implantation for refractory angina. This should report details of patient selection and long-term patient outcomes, including survival.