Guidance
1 Recommendations
1 Recommendations
1.1 Evidence is adequate on the short-term safety and efficacy of personalised external aortic root support (PEARS) using mesh to prevent aortic root expansion and aortic dissection in people with Marfan syndrome. Evidence on long-term outcomes is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research. Find out what special arrangements mean on the NICE interventional procedures guidance page.
1.2 Clinicians wanting to do PEARS using mesh to prevent aortic root expansion and aortic dissection in people with Marfan syndrome should:
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Inform the clinical governance leads in their healthcare organisation.
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Give patients (and their families and carers as appropriate) clear written information to support shared decision making, including NICE's information for the public.
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Ensure that patients (and their families and carers as appropriate) understand the procedure's safety and efficacy, and any uncertainties about these.
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Audit and review clinical outcomes of all patients having the procedure. The main efficacy and safety outcomes identified in this guidance can be entered into NICE's interventional procedure outcomes audit tool (for use at local discretion).
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Discuss the outcomes of the procedure during their annual appraisal to reflect, learn and improve.
1.3 Healthcare organisations should:
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Ensure systems are in place that support clinicians to collect and report data on outcomes and safety for everyone having this procedure.
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Regularly review data on outcomes and safety for this procedure.
1.4 Patient selection should be done by a multidisciplinary team.
1.5 The procedure should only be done in specialist centres with experience of managing this condition, by surgeons trained and experienced in aortic root surgery.
1.6 Further research should report details of patient selection, including aortic diameter, and long-term outcomes, including evidence of disease progression, such as dilation and dissection of the aortic root.