Clinical Experience with the first 100 Implantations of the New Type A Arch Remodeling Stent for DeBakey I Acute Aortic Dissection

Background: A new hybrid non-covered stent for surgical repair of DeBakey I acute aortic dissection (AAD) was developed as an adjunct to the standard hemiarch procedure to induce positive vascular remodeling of the arch and downstream aorta. The present study analyzes the performance of the device in a total of 100 implantations.

Method: Between 2018 and 2021, a total of 100 patients underwent surgical repair of a DeBakey I AAD with the implantation of a non-covered stent in the arch and descending aorta. Clinical data were collected retrospectively. Endpoints of the study were 30-day mortality, neurologic outcome in terms of new operation-related deficit and need of reinterventions due to persisting malperfusion.

Results: Mean age was 63 years (SD: 12) and 32 (32%) patients were female. Pain-to-cut time was less than 24 hours in the majority of patients (89%). Preoperative malperfusion was present in 41 (41%) patients, with acute neurologic deficit in 36 (36%) cases. A total of 11 surgeons were trained with the device. Primary arterial cannulation strategy was the right axillary artery and an open distal anastomosis was performed under unilateral (81%), bilateral (17%) or retrograde (2%) selective cerebral perfusion. The device could be successfully deployed in 96 (96%) patients. During the available follow-up, no device related complication (i.e., aortic rupture, stent-related new entry) was observed, as well as no re-operation due to negative remodeling in the arch. The 30-day mortality was 17% and the rate of operation-related new postoperative neurologic deficit was 7%. Persisting malperfusion led to additional endovascular interventions in 14 (14%) cases.

Operative data and outcome, mean (SD), N (%)	Total population, N = 100
Operation time (min)	387 (SD: 128)
Selective cerebral perfusion time (min)	44.9 (SD: 19.9)
Device sizing
40 tubular	25 (25)
40–30 tapered	16 (16)
55 tubular	11 (11)
55–40 tapered	48 (48)
Revision for malperfusion	14 (14)
New operation-related postoperative neurological deficit	7 (7)
30-day mortality	17 (17)

Conclusion: The novel hybrid stent for arch remodeling in De Bakey I AAD is a safe and reproducible adjunct to the standard of care. Further investigations with head-to-head comparison to hemiarch alone and imaging based follow-up is warranted to draw firm conclusion regarding the long-term clinical benefit of the device.

No conflict of interest has been declared by the author(s).

Publication History

Article published online:
03 February 2022