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 balloon cryoablation for pulmonary vein isolation in atrial fibrillation.
Atrial fibrillation is the irregular and rapid beating of the upper two chambers of the heart (the atria). This is caused by the disorganisation of the electrical impulses that control the heartbeat as a result of electrical triggers that may originate at the mouth of the pulmonary veins (large blood vessels that carry blood from the lungs to the left atrium). Typical symptoms can include palpitations, dizziness, shortness of breath and fatigue. Complications can include stroke. This procedure uses a probe attached to a balloon catheter to freeze tissue in one of the chambers on the left side of the heart. The aim is to produce scarring, which may interrupt the electrical signals and help regulate the heartbeat.
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.