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.
