The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on Percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction.
This document replaces previous guidance on percutaneous pulmonary valve implantation for right ventricular outflow tract dysfunction (NICE interventional procedure guidance 237, November 2007).
Right ventricular outflow tract (RVOT) dysfunction is the term given to abnormalities of the pulmonary valve (one of the valves in the heart) and the right ventricular outflow tract. It causes blood to flow abnormally between the heart and the lungs and is often congenital (present from birth). If left untreated right ventricular outflow tract dysfunction can reduce life expectancy. Faulty heart valves are usually replaced during open heart surgery, but with time the replacements can degenerate and fail. Using a catheter to implant an artificial valve is an alternative to further open heart surgery – it is a less invasive procedure, because it does not involve opening up the chest. In this procedure, the replacement valve is implanted through a catheter (a narrow tube), which is inserted through the skin and into a large vein in the groin and then into the pulmonary artery. The replacement valve is implanted within a wire mesh tube called a stent.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.