The National Institute for Health and Clinical Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on radiofrequency valvotomy for pulmonary atresia.
Radiofrequency valvotomy is used to treat pulmonary atresia, a congenital malformation of the pulmonary valve in which the valve orifice fails to develop. The valve is completely closed thereby obstructing the outflow of blood from the heart to the lungs. Babies with this type of cyanotic congenital heart disease survive only for the first few days of life while the normal fetal shunts between left and right circulations remain patent. Without an operation in that period to open the pulmonary valve or to make a shunt between the aorta and the pulmonary arteries, the condition is fatal.
The standard treatment for pulmonary atresia is open heart surgery which includes the Fontan procedure (the surgical creation of a right ventricular bypass by directly connecting either the right atrium or the superior or inferior vena cava and the pulmonary artery) and the Blalock-Taussig shunt (a palliative procedure where a shunt is created to allow blood to pass from the aorta to the pulmonary artery by dividing the left subclavian artery and connecting it to the left pulmonary artery). Further open heart surgery may include open surgical valvotomy.
Radiofrequency valvotomy is a minimally invasive cardiac catheterisation procedure which involves creating an opening in the blocked pulmonary valve followed by dilation using balloon angioplasty. It avoids open surgery but some children will later need a permanent shunt procedure.
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.
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