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    Interventional procedure overview of aortic remodelling hybrid stent insertion during surgical repair of an acute type A aortic dissection

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    Safety summary

    Mortality

    30-day mortality was reported in 6 patients and 1-year mortality in 9 patients in the clinical trial of 46 patients. The causes of death included multisystem organ failure (n=3), myocardial infarction (n=2), hypoxemic encephalopathy (n=2), massive pulmonary embolism (n=1) and uncontrollable intraoperative haemorrhage (n=1). Of these deaths, 2 deaths related to malperfusion (Bozso 2021). In the malperfusion subgroup (n=26) from the clinical trial, 30-day mortality was reported in 2 patients. One patient died of multiorgan failure at postoperative day 4, and life-sustaining therapy was withdrawn from another patient after a severe stroke (Bozso 2019).

    30-day mortality was reported in 3 patients in the case series of 16 patients (Montagner 2021).

    Neurologic dysfunction

    Stroke

    New stroke was reported in 3 patients at 30 days after operation, with no new strokes between 30 days and 1 year, in the clinical trial of 46 patients. All new strokes happened in patients with dissection involving 1 or several SAVs (Bozso 2021).

    Postoperative stroke was reported in 6 patients in the case series of 16 patients (Montagner 2021).

    Neurologic deficit

    New neurologic deficit was identified in 2 patients at 30 days after operation in the malperfusion subgroup (n=26) from the clinical trial of the 46 patients (Bozso 2019).

    New postoperative neurological deficits were diagnosed in 3 patients during the perioperative period in the case series of 16 patients (Montagner 2021).

    Renal failure

    Acute renal failure needing dialysis was described in 5 patients in the clinical trial of 46 patients (Bozso 2021). These 5 patients had ATAD I complicated by clinical or radiographic malperfusion (Bozso 2019).

    Dialysis was needed in 2 patients in the case series of 16 patients (Montagner 2021).

    Rehospitalisation

    In the case series of 46 patients, rehospitalisation was reported in 8 patients at 1 year after operation. The causes were gastrointestinal bleed (n=1), epistaxis (n=1), low-flow alarm on LVAD (n=1), sternal re-wiring (n=1), pleural effusion drainage (n=1), implantation of AICD (n=1) and non-specific chest pain (n=2; Bozso 2021).

    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 theoretical adverse events: aortic injury, aortic branch obstruction, stent fracture and stent failure.