Percutaneous insertion of a closure device to repair a paravalvular leak around a replaced mitral or aortic valve

Evidence on the safety of percutaneous insertion of a closure device to repair a paravalvular leak around a replaced mitral or aortic valve shows that this procedure can cause potentially serious but well-recognised complications. Evidence on its efficacy is limited in 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 wishing to do percutaneous insertion of a closure device to repair a paravalvular leak around a replaced mitral or aortic valve 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.

• Review local clinical outcomes and enter details about all patients having percutaneous insertion of a closure device to repair a paravalvular leak around a replaced mitral or aortic valve into the British Cardiovascular Intervention Society database managed by the National Institute for Cardiovascular Outcomes Research. Contact bartshealth.nicor-generalenquiries@nhs.net for details.

• 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 experienced in managing the condition including interventional cardiologists with specific training in the procedure, cardiac surgeons, specialists in cardiovascular imaging and cardiac anaesthetists.

This is a technically challenging procedure, and it should only be done in specialised centres by a multidisciplinary team including clinicians with training and experience in this procedure. Clinicians should only do their initial procedures with an experienced mentor.

Further research should report details of patient selection, device selection, procedural outcomes, long-term outcomes including quality of life, the need for repeat interventions or surgery, and complication rates.