Endovascular repair for blunt thoracic aortic injury using the Zenith Alpha low-profile device

Joseph S. Giglia, Chyon Yeh, Amit Dwivedi, Benjamin Starnes, Karen Woo, John F. Angle, Arash Bornak, Francis Caputo, Jeffrey Slaiby, Carlos Timaran, Brajesh K. Lal, Vito Mantese, Ravi Rajani, Michael J. Wilderman, Zachary Baldwin, Nimesh Desai, Ali Khoynezhad, Mohammed Moursi

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Objective The objective of this study was to report 30-day results from a prospective, nonrandomized, multicenter trial that evaluated the safety and effectiveness of the Zenith Alpha thoracic endovascular graft (Cook Medical, Bloomington, Ind) for treatment of blunt thoracic aortic injuries (BTAIs). Methods Eligible patients with BTAIs (grade II to grade IV) in the descending thoracic aorta were treated with the Zenith Alpha device, which is available in smaller graft diameters (starting at 18 mm) and lower profile delivery systems (starting at 16F) than currently available thoracic endografts. The device (nitinol stents and polyester graft material) accommodates a tighter aortic curvature (radius of 20 mm) than the predicate Zenith TX2 Pro-Form. Follow-up clinical and imaging evaluations were performed at 30 days, at 6 and 12 months, and annually thereafter through 5 years. The primary end point was 30-day mortality. Results Between January 2013 and May 2014, 50 patients (44 men; mean age, 43 ± 19 years; range, 18-89 years) were treated with the Zenith Alpha device at 17 U.S. sites. The mean Injury Severity Score was 31 ± 14 (range, 3-66). Technical success was achieved in 100% of patients, with 0% intraoperative mortality. Device access was entirely percutaneous in 22 patients (44%). Smaller size grafts (18-24 mm) were used in 15 patients (30%). The mean procedure time was 85 ± 44 minutes (range, 34-278 minutes), and mean blood loss was 103 ± 145 mL (range, 0-1000 mL). The 30-day mortality rate was 2%; one patient died 24 days after the procedure of respiratory failure related to associated injuries and not to the device or procedure as adjudicated by an independent Clinical Events Committee (CEC). One patient experienced a stroke 7 days after the procedure (cause undetermined by the CEC), and one patient underwent reintervention for a site-reported proximal type I endoleak (core laboratory reported unknown endoleak type) at 30 days after the procedure. There have been no conversions to open surgical repair, paraplegia, or aortic rupture within 30 days. Conclusions Short-term results indicate that the Zenith Alpha thoracic endovascular graft appears safe and effective for the treatment of BTAIs. This low-profile device enables complete percutaneous repair in a large percentage of patients and can achieve high rates of technical success and very low rates of aortic injury-related mortality within 30 days.

Original languageEnglish (US)
Pages (from-to)1495-1503.e1
JournalJournal of Vascular Surgery
Volume62
Issue number6
DOIs
StatePublished - Dec 1 2015

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Thoracic Injuries
Nonpenetrating Wounds
Equipment and Supplies
Transplants
Endoleak
Thorax
Mortality
Thoracic Aorta
Aortic Rupture
Injury Severity Score
Polyesters
Paraplegia
Wounds and Injuries
Respiratory Insufficiency
Multicenter Studies
Stents
Stroke
Safety

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery

Cite this

Giglia, J. S., Yeh, C., Dwivedi, A., Starnes, B., Woo, K., Angle, J. F., ... Moursi, M. (2015). Endovascular repair for blunt thoracic aortic injury using the Zenith Alpha low-profile device. Journal of Vascular Surgery, 62(6), 1495-1503.e1. https://doi.org/10.1016/j.jvs.2015.07.098

Endovascular repair for blunt thoracic aortic injury using the Zenith Alpha low-profile device. / Giglia, Joseph S.; Yeh, Chyon; Dwivedi, Amit; Starnes, Benjamin; Woo, Karen; Angle, John F.; Bornak, Arash; Caputo, Francis; Slaiby, Jeffrey; Timaran, Carlos; Lal, Brajesh K.; Mantese, Vito; Rajani, Ravi; Wilderman, Michael J.; Baldwin, Zachary; Desai, Nimesh; Khoynezhad, Ali; Moursi, Mohammed.

In: Journal of Vascular Surgery, Vol. 62, No. 6, 01.12.2015, p. 1495-1503.e1.

Research output: Contribution to journalArticle

Giglia, JS, Yeh, C, Dwivedi, A, Starnes, B, Woo, K, Angle, JF, Bornak, A, Caputo, F, Slaiby, J, Timaran, C, Lal, BK, Mantese, V, Rajani, R, Wilderman, MJ, Baldwin, Z, Desai, N, Khoynezhad, A & Moursi, M 2015, 'Endovascular repair for blunt thoracic aortic injury using the Zenith Alpha low-profile device', Journal of Vascular Surgery, vol. 62, no. 6, pp. 1495-1503.e1. https://doi.org/10.1016/j.jvs.2015.07.098
Giglia, Joseph S. ; Yeh, Chyon ; Dwivedi, Amit ; Starnes, Benjamin ; Woo, Karen ; Angle, John F. ; Bornak, Arash ; Caputo, Francis ; Slaiby, Jeffrey ; Timaran, Carlos ; Lal, Brajesh K. ; Mantese, Vito ; Rajani, Ravi ; Wilderman, Michael J. ; Baldwin, Zachary ; Desai, Nimesh ; Khoynezhad, Ali ; Moursi, Mohammed. / Endovascular repair for blunt thoracic aortic injury using the Zenith Alpha low-profile device. In: Journal of Vascular Surgery. 2015 ; Vol. 62, No. 6. pp. 1495-1503.e1.
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T1 - Endovascular repair for blunt thoracic aortic injury using the Zenith Alpha low-profile device

AU - Giglia, Joseph S.

AU - Yeh, Chyon

AU - Dwivedi, Amit

AU - Starnes, Benjamin

AU - Woo, Karen

AU - Angle, John F.

AU - Bornak, Arash

AU - Caputo, Francis

AU - Slaiby, Jeffrey

AU - Timaran, Carlos

AU - Lal, Brajesh K.

AU - Mantese, Vito

AU - Rajani, Ravi

AU - Wilderman, Michael J.

AU - Baldwin, Zachary

AU - Desai, Nimesh

AU - Khoynezhad, Ali

AU - Moursi, Mohammed

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N2 - Objective The objective of this study was to report 30-day results from a prospective, nonrandomized, multicenter trial that evaluated the safety and effectiveness of the Zenith Alpha thoracic endovascular graft (Cook Medical, Bloomington, Ind) for treatment of blunt thoracic aortic injuries (BTAIs). Methods Eligible patients with BTAIs (grade II to grade IV) in the descending thoracic aorta were treated with the Zenith Alpha device, which is available in smaller graft diameters (starting at 18 mm) and lower profile delivery systems (starting at 16F) than currently available thoracic endografts. The device (nitinol stents and polyester graft material) accommodates a tighter aortic curvature (radius of 20 mm) than the predicate Zenith TX2 Pro-Form. Follow-up clinical and imaging evaluations were performed at 30 days, at 6 and 12 months, and annually thereafter through 5 years. The primary end point was 30-day mortality. Results Between January 2013 and May 2014, 50 patients (44 men; mean age, 43 ± 19 years; range, 18-89 years) were treated with the Zenith Alpha device at 17 U.S. sites. The mean Injury Severity Score was 31 ± 14 (range, 3-66). Technical success was achieved in 100% of patients, with 0% intraoperative mortality. Device access was entirely percutaneous in 22 patients (44%). Smaller size grafts (18-24 mm) were used in 15 patients (30%). The mean procedure time was 85 ± 44 minutes (range, 34-278 minutes), and mean blood loss was 103 ± 145 mL (range, 0-1000 mL). The 30-day mortality rate was 2%; one patient died 24 days after the procedure of respiratory failure related to associated injuries and not to the device or procedure as adjudicated by an independent Clinical Events Committee (CEC). One patient experienced a stroke 7 days after the procedure (cause undetermined by the CEC), and one patient underwent reintervention for a site-reported proximal type I endoleak (core laboratory reported unknown endoleak type) at 30 days after the procedure. There have been no conversions to open surgical repair, paraplegia, or aortic rupture within 30 days. Conclusions Short-term results indicate that the Zenith Alpha thoracic endovascular graft appears safe and effective for the treatment of BTAIs. This low-profile device enables complete percutaneous repair in a large percentage of patients and can achieve high rates of technical success and very low rates of aortic injury-related mortality within 30 days.

AB - Objective The objective of this study was to report 30-day results from a prospective, nonrandomized, multicenter trial that evaluated the safety and effectiveness of the Zenith Alpha thoracic endovascular graft (Cook Medical, Bloomington, Ind) for treatment of blunt thoracic aortic injuries (BTAIs). Methods Eligible patients with BTAIs (grade II to grade IV) in the descending thoracic aorta were treated with the Zenith Alpha device, which is available in smaller graft diameters (starting at 18 mm) and lower profile delivery systems (starting at 16F) than currently available thoracic endografts. The device (nitinol stents and polyester graft material) accommodates a tighter aortic curvature (radius of 20 mm) than the predicate Zenith TX2 Pro-Form. Follow-up clinical and imaging evaluations were performed at 30 days, at 6 and 12 months, and annually thereafter through 5 years. The primary end point was 30-day mortality. Results Between January 2013 and May 2014, 50 patients (44 men; mean age, 43 ± 19 years; range, 18-89 years) were treated with the Zenith Alpha device at 17 U.S. sites. The mean Injury Severity Score was 31 ± 14 (range, 3-66). Technical success was achieved in 100% of patients, with 0% intraoperative mortality. Device access was entirely percutaneous in 22 patients (44%). Smaller size grafts (18-24 mm) were used in 15 patients (30%). The mean procedure time was 85 ± 44 minutes (range, 34-278 minutes), and mean blood loss was 103 ± 145 mL (range, 0-1000 mL). The 30-day mortality rate was 2%; one patient died 24 days after the procedure of respiratory failure related to associated injuries and not to the device or procedure as adjudicated by an independent Clinical Events Committee (CEC). One patient experienced a stroke 7 days after the procedure (cause undetermined by the CEC), and one patient underwent reintervention for a site-reported proximal type I endoleak (core laboratory reported unknown endoleak type) at 30 days after the procedure. There have been no conversions to open surgical repair, paraplegia, or aortic rupture within 30 days. Conclusions Short-term results indicate that the Zenith Alpha thoracic endovascular graft appears safe and effective for the treatment of BTAIs. This low-profile device enables complete percutaneous repair in a large percentage of patients and can achieve high rates of technical success and very low rates of aortic injury-related mortality within 30 days.

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