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ABSTRACT: Objective
To describe the feasibility and outcomes of endovascular repair of distal aortic arch aneurysms using a patient-specific stent graft with a pre-loaded single retrograde left subclavian artery (LSA) branch stent graft.Methods
We reviewed the clinical data and outcomes of consecutive patients enrolled in an ongoing prospective, non-randomized physician-sponsored investigational device exemption study to evaluate the outcomes of endovascular aortic arch repair using patient-specific arch branch stent grafts (William Cook Europe, Bjaeverskov, Denmark) between 2019 and 2022. All patients received a design with triple-wide scallop and a single retrograde LSA branch with a pre-loaded catheter.Results
There were five male patients with median age of 77 years old (72-80) treated using the single LSA branch stent graft. Technical success was achieved in all patients. Median operating time, fluoroscopy time, and total radiation dose area product were 103 (78-134) minutes, 26 (19-39) minutes, and 123 (71-270) mGy.cm2, respectively. There were no 30-day or in-hospital mortality, neurological or other major adverse events (MAEs). During median follow-up of 21 (20-27) months, all patients were alive with patent LSA branches, except for one who died of COVID-19 complications. There was no branch instability or secondary interventions.Conclusion
This early feasibility study demonstrates successful endovascular repair of distal aortic arch aneurysms using a patient-specific stent graft with single retrograde LSA branch without technical failures, mortality or neurological events. Larger clinical experience and longer follow-up are needed to determined effectiveness of this approach in patients who need endovascular repair with proximal extension into Zone 2.
SUBMITTER: Wong J
PROVIDER: S-EPMC9628377 | biostudies-literature | 2023 Feb
REPOSITORIES: biostudies-literature
Cardiovascular and interventional radiology 20221101 2
<h4>Objective</h4>To describe the feasibility and outcomes of endovascular repair of distal aortic arch aneurysms using a patient-specific stent graft with a pre-loaded single retrograde left subclavian artery (LSA) branch stent graft.<h4>Methods</h4>We reviewed the clinical data and outcomes of consecutive patients enrolled in an ongoing prospective, non-randomized physician-sponsored investigational device exemption study to evaluate the outcomes of endovascular aortic arch repair using patien ...[more]