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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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    Efficacy summary

    Remodelling in aorta and SAVs

    Aortic and SAV dimensions

    In a clinical trial of 46 patients with ATAD I, 35 patients had at least 1-year follow-up CT. When comparing with baseline (the first postoperative CT was used as a baseline), the total aortic diameter remained stable or decreased in 100% (35/35) of patients in zone A (aortic arch at the level of left common carotid artery), 77% (27/35) in zone B1 (2.5 cm distal to the left subclavian artery), 80% (28/35) in zone B2 (at the level of T6), 80% (28/35) in zone B3 (at the level of the distal end of the AMDS), and 74% (26/35) in zone C (proximal to the celiac trunk) at 1 year after procedure (Bozso 2021).

    In a case series of 16 patients with ATAD I and affected SAVs, the mean total lumen area changed from 214.82 mm2 before operation to 221.42 mm2 after operation in the innominate artery, from 67.12 mm2 to 54.84 mm2 in the right common carotid artery, from 57.13 mm2 to 62.60 mm2 in the left common carotid artery, from 749.75 mm2 to 728.00 mm2 in the proximal-descending aorta, and from 602.13 mm2 to 621.63 mm2 in the mid-descending aorta (Montager 2021).

    TL diameter

    In the clinical trial of 46 patients, when comparing with baseline the TL diameter remained stable or increased at 1 year postoperation in 100% (35/35) of patients in zone A, zone B1, zone B2, zone B3 and zone C (Bozso 2021).

    In the case series of 16 patients, the mean TL diameter increased from 9.15 mm before operation to 11.51 mm after operation in the innominate artery, from 4.24 mm to 5.98 mm in the right common carotid, from 5.91 mm to 7.51 mm in the left common carotid, from 18.34 mm to 23.91 mm in the proximal-descending aorta, and from 16.13 mm to 19.34 mm in the mid-descending aorta. For the indexed TL area (a percentage of the whole vessel area), there was a statistically significant increase from 32% before operation to 55% after operation (p=0.002) in the innominate artery, from 34% to 72% (p=0.01) in the right common carotid artery, from 37% to 64% (p<0.001) in the proximal-descending aorta and from 35% to 51% (p=0.002) in the mid-descending aorta. The increase in the left common carotid artery was not statistically significant (from 64% to 83%, p=0.13; Montagner 2021).

    FL diameter

    In the clinical trial of 46 patients, when comparing with baseline the FL diameter remained stable or decreased at 1-year follow-up in 100% (35/35) of patients in zone A, 97% (34/35) in zone B1, 74% (26/35) in zone B2, 86% (30/35) in zone B3 and 77% (27/35) in zone C. Complete obliteration or thrombosis of the FL was reported in 74% (29/39) of patients in zone A, 53% (20/38) in zone B1, 31% (11/36) in zone B2, 24% (8/34) in zone B3, and 15% (5/34) in zone C at 1 year. Partial thrombosis of the FL was described in 10% (4/39) of patients in zone A, 16% (6/38) in zone B1, 36% (13/36) in zone B2, 32% (11/34) in zone B3, and 44% (15/34) in zone C (Bozso 2021).

    In the case series of 16 patients, the mean FL diameter decreased from 13.67 mm before operation to 10.18 mm after operation in the innominate artery, from 7.04 mm to 3.21 mm in the right common carotid artery, from 3.89 mm to 2.37 mm in the left common carotid artery, from 24.30 mm to 16.36 mm in the proximal-descending aorta, and from 22.12 mm to 19.34 mm in the mid-descending aorta (Montager 2021).

    Resolving malperfusion

    In the clinical trial of 46 patients, 57% (26/46) of patients had clinical or radiographic malperfusion involving 66 individual vessels at baseline (Bozso 2021). In this malperfusion subgroup (n=26), malperfusion resolved in 95% (63/66) of the malperfused vessels at 1 year after operation, including 96% (21/22) supra-aortic, 93% (13/14) visceral, 94% (15/16) renal, and 100% (10/10) extremity (Bozso 2019).

    In the case series of 16 patients, elimination of antegrade FL perfusion in the aortic arch was reported in 88% of patients, with partial or full FL thrombosis of the descending aorta in 69% of patients. In the same study, the innominate artery presenting with dissection without impaired perfusion, subtotal occlusion or total occlusion decreased from 75%, 25% and 0% of patients before operation to 69%, 6% and 0% of patients after operation. There were also decreases in the right common carotid artery (from 25%, 38% and 19% to 19%, 19% and 0%) and the left common carotid artery (from 25%, 13% and 6% to 25%, 0% and 0%; Montagner 2021).

    Reintervention

    In the clinical trial of 46 patients, a secondary procedure was needed in 4 patients, including malperfusion-related (n=3) and aortic growth-related (n=1). No reintervention was done in the aortic arch (Bozso 2021). In the malperfusion subgroup (n=26) from the clinical trial, reintervention was carried out in 3 patients and all related to malperfusion (Bozso 2019).

    Length of stay

    In the clinical trial of 46 patients, the median lengths of stay were 6 days (IQR 4.0 to 12.0 days) in the intensive care unit and 13 days (IQR 8.0 to 18.0 days) in the hospital (Bozso 2021). In the malperfusion subgroup (n=26) from the clinical trial, the median lengths of stay in the intensive care unit and hospital were 9 days (IQR 5.8 to 13.3 days) and 14 days (IQR 9.0 to 19.5 days) respectively (Bozso 2019).

    In the case series of 16 patients, the mean length of stay in the intensive care unit was 11±8 days after operation (Montagner 2021).