Branched Endovascular Therapy of the Distal Aortic Arch: Preliminary Results of the Feasibility Multicenter Trial of the Gore Thoracic Branch Endoprosthesis

Himanshu J. Patel, Michael D. Dake, Joseph E. Bavaria, Michael J. Singh, Mark Filinger, Michael P. Fischbein, David M. Williams, Jon S. Matsumura, Gustavo Oderich

Research output: Contribution to journalArticle

30 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1190-1198
Number of pages9
JournalAnnals of Thoracic Surgery
Volume102
Issue number4
DOIs
StatePublished - Oct 1 2016

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Multicenter Studies
Thorax
Aneurysm
Aortic Aneurysm
Brachiocephalic Trunk
Endoleak
Subclavian Artery
Paraplegia
Therapeutics
Thoracic Aorta
Carotid Arteries
Angiography
Hospitalization
Arm
Survival Rate
Perfusion
Stroke
Clinical Trials
Transplants
Equipment and Supplies

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

Branched Endovascular Therapy of the Distal Aortic Arch : Preliminary Results of the Feasibility Multicenter Trial of the Gore Thoracic Branch Endoprosthesis. / Patel, Himanshu J.; Dake, Michael D.; Bavaria, Joseph E.; Singh, Michael J.; Filinger, Mark; Fischbein, Michael P.; Williams, David M.; Matsumura, Jon S.; Oderich, Gustavo.

In: Annals of Thoracic Surgery, Vol. 102, No. 4, 01.10.2016, p. 1190-1198.

Research output: Contribution to journalArticle

Patel, Himanshu J. ; Dake, Michael D. ; Bavaria, Joseph E. ; Singh, Michael J. ; Filinger, Mark ; Fischbein, Michael P. ; Williams, David M. ; Matsumura, Jon S. ; Oderich, Gustavo. / Branched Endovascular Therapy of the Distal Aortic Arch : Preliminary Results of the Feasibility Multicenter Trial of the Gore Thoracic Branch Endoprosthesis. In: Annals of Thoracic Surgery. 2016 ; Vol. 102, No. 4. pp. 1190-1198.
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abstract = "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.",
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T2 - Preliminary Results of the Feasibility Multicenter Trial of the Gore Thoracic Branch Endoprosthesis

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AU - Dake, Michael D.

AU - Bavaria, Joseph E.

AU - Singh, Michael J.

AU - Filinger, Mark

AU - Fischbein, Michael P.

AU - Williams, David M.

AU - Matsumura, Jon S.

AU - Oderich, Gustavo

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N2 - 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.

AB - 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.

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