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    Overview

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    Safety summary

    Perioperative mortality

    Perioperative mortality was reported in 1 patient with Marfan syndrome in a case series of 317 patients who had a procedure to insert a personalised external aortic root support. The patient had severe pectus excavatum and died 5 days after surgery because of an injury to the left coronary artery. The support was not placed during the surgery (Nemec 2020). This patient was also described in the cohort studies of 30 and 200 patients (Treasure 2014, Van Hoof 2021).

    Vascular injury

    Injury to the left coronary artery was reported in 1 patient in the case series of 317 patients. This was successfully resolved with coronary artery bypass grafting (Nemec 2020). Coronary injury was reported in 3.0% (6/200) of patients in the cohort of 200 patients (Van Hoof 2021).

    Intraoperative aortic dissection was reported in 1 patient in the cohort study of 200 patients; this was treated conservatively (Van Hoof 2021).

    Ischaemic events

    Intraoperative ischaemic events and perioperative transient ischaemic attack related to atrial fibrillation were each reported in 2% (2/117) of patients in the cohort study of 117 patients (Pepper 2020).

    Cerebrovascular event with hemiparesis was reported in 1.0% (2/200) of patients in the cohort study of 200 patients; both patients recovered completely (Van Hoof 2021).

    Myocardial infarction

    Myocardial infarction was reported in 2.5% (5/200) of patients in the cohort study of 200 patients (Van Hoof 2021).

    Reoperation

    Reoperation because of hypotension while in the intensive care unit was reported in 1 patient in the case series of 317 patients who had a procedure to insert a personalised external aortic root support. The axial suture line of the mesh implant was partially released. After 6 years, aortic valve regurgitation developed, and the patient had surgery to correct dilation of the non-coronary sinus. The mesh-reinforced aortic wall was identified and could be cut and sewn safely. A second patient had a reoperation because of acute heart failure immediately after the procedure caused by occlusion of his circumflex coronary artery. The support was adjusted, and a stent was implanted in the artery (Nemec 2020).

    Blood transfusion

    Transfusion of red cells was needed in 5% (1/20) of patients who had external aortic root support and 50% (9/18) of patients who had aortic root replacement (p=0.002) in a non-randomised comparative study of 40 patients. None of the patients who had external aortic root support needed platelet or fresh frozen plasma transfusion compared with 50% (9/18) and 67% (12/18) of patients, respectively, who had aortic root replacement (p<0.001 for both) (Treasure 2012).

    Inflammatory characteristics

    The peak level of C-reactive protein after the procedure was 264.5 mg/L in patients who had personalised external aortic root support and 184.6 mg/L in patients who had standard prophylactic aortic root surgery (p=0.034) in a non-randomised comparative study of 27 patients. ST elevation after the procedure was reported in 85% (11/13) of patients who had personalised external aortic root support compared with 43% (6/14) of patients who had standard prophylactic surgery (p=0.024). The proportion of patients who had fever or pericarditis needing hospital readmission was also statistically significantly higher in patients who had external aortic root surgery compared with standard prophylactic surgery (Kockova 2019).

    Anecdotal and theoretical adverse events

    In addition to safety outcomes reported in the literature, professional experts are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never happened). For this procedure, professional experts listed the following anecdotal adverse events: short-lived postoperative pyrexia and seroma around the aorta, which resolves without intervention. They noted that if the sleeve does not cover the entire aortic root as far proximally as the aortic annulus, root dilatation will occur.