Branched Endovascular Therapy of the Distal Aortic Arch: Preliminary Results of the Feasibility Multicenter Trial of the Gore Thoracic Branch Endoprosthesis.
BACKGROUND
Endovascular treatment for aortic arch aneurysms often requires adjunctive use of hybrid debranching procedures to maintain branch vessel perfusion. This study describes early results with a novel branched arch endograft for total endovascular repair of distal arch aneurysms.


METHODS
This US feasibility multicenter clinical trial evaluated 22 patients (mean age, 74.1 ± 10.5 years; 54.5% male) undergoing branched thoracic endovascular aortic repair in Ishimaru zone 2. This endograft was designed with a single side branch designed to facilitate aortic coverage proximal to the left subclavian artery while maintaining branch vessel patency. The pathologic features treated included fusiform (n = 10) and saccular (n = 12) aneurysms, with a mean aortic diameter of 5.7 ± 1.1 cm. The mean preoperative left-to-right brachial index was 1.0 ± 0.1.


RESULTS
The mean total treatment length was 17.6 ± 8.9 cm; 8 patients were treated with a single 10-cm graft for isolated arch disease. The primary endpoint of device delivery and branch vessel patency was achieved in 100% of patients, without 30-day death, stroke, or permanent paraplegia. The median duration of hospitalization was 4.0 days. Type I endoleaks at completion angiography were observed in 4 patients, and all resolved by 1 month without reintervention. All side branches were patent at 1 month. The Kaplan-Meier survival rate at 6 months was 94.7%.


CONCLUSIONS
Total endovascular repair of distal zone 2 arch aortic aneurysms can be achieved with a novel branched arch endograft. Future studies will evaluate the feasibility of this approach for aneurysms encompassing the brachiocephalic trunk and left carotid artery.
Department of Cardiac Surgery, University of Michigan Frankel Cardiovascular Center, Ann Arbor, Michigan. Electronic address: hjpatel@med.umich.edu.
Himanshu J
HJ
Patel
Department of Cardiothoracic Surgery, Stanford University Hospitals, Palo Alto, California.
Michael D
MD
Dake
Department of Surgery, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania.
Joseph E
JE
Bavaria
Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Michael J
MJ
Singh
Department of Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Mark
M
Filinger
Department of Cardiothoracic Surgery, Stanford University Hospitals, Palo Alto, California.
Michael P
MP
Fischbein
Department of Radiology, University of Michigan Frankel Cardiovascular Center, Ann Arbor, Michigan.
David M
DM
Williams
Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.
Jon S
JS
Matsumura
Department of Surgery, Mayo Clinic, Rochester, Minnesota.
Gustavo
G
Oderich
D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D001013:Aorta, Thoracic / Q000503:physiopathology / Q000601:surgery; D017545:Aortic Aneurysm, Thoracic / Q000000981:diagnostic imaging / Q000401:mortality* / Q000601:surgery*; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000379:methods; D000072226:Computed Tomography Angiography / Q000379:methods*; D057510:Endovascular Procedures / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D017052:Hospital Mortality / Q000639:trends*; D006801:Humans; D021621:Imaging, Three-Dimensional; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000401:mortality / Q000503:physiopathology / Q000628:therapy; D011474:Prosthesis Design; D018570:Risk Assessment; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome