The National Institute for Health and Clinical Excellence (NICE) issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on percutaneous laser therapy for fetal tumours in June 2006. In accordance with the Interventional Procedures Programme Process Guide, guidance on procedures with special arrangements are reviewed 3 years after publication and the procedure is reassessed if important new evidence is available.
The guidance was considered for reassessment in June 2009 and it was concluded that NICE will not be updating this guidance at this stage. However, if you believe there is new evidence which should warrant a review of our guidance, please contact us via the email address below.
This guidance has considered the following types of fetal tumours: sacrococcygeal teratomas, cervical teratomas, cystic hygromas and congenital cystic adenomatoid malformations (CCAM). These tumours are usually benign, although teratomas may also be malignant. The tumours can become very large and highly vascularised, causing stress on the fetal heart, leading to the development of heart failure. Fetal mortality is high and a poor prognosis is associated with non-immune hydrops fetalis, placentomegaly, cardiomegaly, large tumour size and high tumour growth rate.
Percutaneous laser therapy for fetal tumours involves using laser energy to destroy tumour tissues and to coagulate blood vessels within the tumour. The procedure is performed under maternal local anaesthesia and light sedation by inserting a needle into the uterine cavity through the mother's abdomen under ultrasonographic guidance. An analgesic is then injected subcutaneously or intramuscularly into the fetus before advancing the needle to the site of the fetal tumour. Colour-Doppler imaging is used to guide placement of the needle. A laser fibre is passed through the needle lumen and laser energy is then delivered in pulses causing destruction of tumour tissues and coagulation of blood vessels within the tumour.
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.