Branched stented anastomosis frozen elephant trunk repair: Early results from a physician-sponsored investigational device exemption study

Eric E Roselli; Patrick R Vargo; Faisal Bakaeen; Marijan Koprivanac; Daniel Burns; Yuki Kuramochi; Marc Gillinov; B-SAFER Investigators

doi:10.1016/j.jtcvs.2023.09.069

Branched stented anastomosis frozen elephant trunk repair: Early results from a physician-sponsored investigational device exemption study

J Thorac Cardiovasc Surg. 2023 Oct 5:S0022-5223(23)00895-4. doi: 10.1016/j.jtcvs.2023.09.069. Online ahead of print.

Authors

Eric E Roselli¹, Patrick R Vargo², Faisal Bakaeen², Marijan Koprivanac², Daniel Burns², Yuki Kuramochi³, Marc Gillinov²; B-SAFER Investigators⁴

Affiliations

¹ Aortic Center, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio; Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address: RosellE@ccf.org.
² Aortic Center, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio; Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio.
³ Aortic Center, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio.
⁴ Aortic Center, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio; Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio; Department of Cardiology, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio; Department of Vascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio.

PMID: 37802330
DOI: 10.1016/j.jtcvs.2023.09.069

Abstract

Background: Multisegment thoracic aortic disease typically requires total aortic arch replacement, affects a heterogenous population, and carries a high risk even at centers of excellence. Risk has been associated with the duration of operation and complexity of repair. A novel branched stented anastomosis frozen elephant trunk repair (B-SAFER) technique has been developed at our center and is currently being studied as a physician-sponsored investigation device exemption (PS-IDE).

Objective: This study aimed to assess the early safety of using this investigational technique to treat the proximal aorta in subjects with aortic disease involving multiple segments.

Methods: This prospective, single center, nonrandomized study enrolled patients undergoing B-SAFER for acute aortic syndrome (n = 73), aortic aneurysm with chronic aortic dissection (n = 68), degenerative aortic aneurysm (n = 33), or congenital aortic arch disease (n = 4). Devices are delivered antegrade under hypothermic circulatory arrest, and the arch reconstruction is performed as a single anastomosis single stent (SASS; n = 70), single anastomosis multiple stent (SAMA; n = 68), multiple anastomosis single stent (MASS; n = 21), or multiple anastomosis multiple stent (MAMS; n = 16) reconstruction. The primary safety endpoints were operative mortality, disabling stroke, and paraparesis/paralysis.

Results: Between May 27, 2021, and December 31, 2022, 178 patients underwent B-SAFER in the configurations and for the indications as described above. The median patient age was 65 years (range, 21 to 85 years), and 52 (29%) were female. The median cardiopulmonary bypass time was 188 minutes (interquartile range [IQR], 155 to 226 minutes), and 97% of the patients underwent repair with antegrade brain perfusion for a median of 46 minutes (IQR, 38 to 61 minutes). Operative mortality occurred in 10 patients (5.6%, including 6 [8.2%] with acute dissection, 2 [2.9%] with chronic dissection, 2 [6.1%] with degenerative aneurysm, and 0 with a congenital disorder), disabling stroke in 5 patients (2.9%), and paraparesis in 1 patient. Other serious complications included respiratory failure (n = 20; 11.4%) and acute kidney injury (n = 18; 10%). Thirty-two patients (18%) had undergone second-stage repairs (28 endovascular and 4 open), with 1 operative mortality after that procedure due to distal rupture. Estimated survival was 95% at 30 days, 88% at 90 days, 84% at 6 months, and 79% at 1 year. One-year survival differed by indication (72% for acute dissection, 91% for chronic dissection, 71% for degenerative aneurysm, and 100% for congenital disorders).

Conclusions: The B-SAFER technique for total arch replacement in a complex cohort of patients with various indications for surgery is a safe and reproducible operation, as demonstrated by the early results from a very inclusive PS-IDE study. Further follow-up and analysis will help refine the technique. Novel devices to perform this procedure should be developed.

Keywords: aortic aneurysm; aortic arch; aortic dissection; frozen elephant trunk repair; hybrid arch repair.