The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on transcatheter endovascular closure of perimembranous ventricular septal defect.
It replaces the previous guidance on Endovascular closure of perimembranous ventricular septal defect (NICE interventional procedures guidance 172, May 2006).
Ventricular septal defect (sometimes shortened to VSD) is one or more holes in the partition called the septum that separates the left and right ventricles, which are the two lower chambers of the heart. This defect is the most common heart defect that is present when babies are born (congenital) but it is not known what causes it. A ventricular septal defect lets blood leak back from the left ventricle to the right ventricle.
Endovascular closure of a perimembranous ventricular septal defect involves inserting a small blocking device (called an occluder) into the heart. This is inserted via a blood vessel so that there is no need for open heart surgery. A fine wire is put into a blood vessel at the top of the leg and a second wire into either a different blood vessel at the top of the leg or in the neck. These two wires are used to form a loop, which passes through the heart via the defect. The blocking device is moved along the loop into place to block the hole.
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.