The powerlink bifurcated system for endovascular aortic aneurysm repair: Four-year results of the US multicenter trial

Jeffrey P. Carpenter, Kenneth Ouriel, Edward B. Dietrich, Peter Gloviczki, Kim Hodgson, James McKinsey, Amit Patel, Gregorio Sicard, Eugene Langan, James Skinner, Rodney White, James Williams, Robert Gayle, Michael Bacharach, Robert Kipperman

Research output: Contribution to journalReview article

30 Citations (Scopus)

Abstract

The aim of the study was to review the results of abdominal aortic aneurysm (AAA) repair with the Powerlink Bifurcated endovascular graft, when compared with open AAA repair. A prospective, controlled, multicenter trial of the Powerlink System for endovascular abdominal repair (EVAR) was conducted at 15 sites as part of a pivotal FDA trial. Between July 2000 and March 2003, 258 patients were enrolled (192 test and 66 control patients). Stent grafts were oversized by 10-20% relative to computed tomography (CT)-based diameter measurements. All repairs were performed in the operating room through one surgically exposed femoral artery and a contralateral 9 French sheath percutaneously placed. Results were assessed using contrast-enhanced CT and plain abdominal X-rays at 1, 6, and 12 months and annually postoperatively. Mean follow-up of 36 months was available. Technical success was achieved in 97.9% of patients, with 4 failed insertions: 3 early conversions for deployment issues and one access failure. There was a significant difference in 30-day mortality between Powerlink (1%) and control (6.1%) patients and only 1 death was procedure-related (P=0.0389). Blood loss (341 mL vs 1 583 mL, P<0.0001), operative time (136 min vs 222 min, P<0.0001), Intensive Care Unit (ICU) stay (0.78 days vs 4.1 days, P<0.0001) and hospital length of stay (3.3 days vs 9.5 days, P<0.0001) were significantly less in the Powerlink cohort compared with controls. Secondary procedures have been performed on 16 patients post-implant to 48 months follow-up. At the time of the first month CT scan, endoleaks were noted in 25 patients, yielding a 30-day endoleak rate of 22.3%. Type II endoleaks predominated and there were no type III or IV endoleaks. The 4-year endoleak-free survival rate was 73%. No Type I, III or IV endoleaks were reported at 48 months post-implant. There have been no ruptures, graft fabric defects or wire fractures. Sac regression was noted in 83% of patients. Significant reduction in mean AAA diameter and volume was noted over every follow-up interval. In comparison to the 1-month post-implant CT scan, 2 patients had an increase in AAA diameter 5 mm at 48 months. The Powerlink system appears to be safe, and effectively protects patients from AAA rupture over the follow-up period. The graft and stent materials are still free from failure and fatigue. Contralateral limb access (9 Fr) facilitates graft placement in patients with disadvantaged access routes. EVAR performed with the Powerlink produces significantly less early adverse events than open AAA repair. Continued follow-up over the longer term is necessary to assure the durability of these results.

Original languageEnglish (US)
Pages (from-to)239-243
Number of pages5
JournalJournal of Cardiovascular Surgery
Volume47
Issue number3
StatePublished - Jun 1 2006
Externally publishedYes

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Aortic Aneurysm
Multicenter Studies
Endoleak
Abdominal Aortic Aneurysm
Transplants
Tomography
Stents
Length of Stay
Aortic Rupture
Vulnerable Populations
Femoral Artery
Operating Rooms
Operative Time
Fatigue
Intensive Care Units
Rupture
Survival Rate
Extremities
X-Rays
Mortality

All Science Journal Classification (ASJC) codes

  • Surgery
  • Cardiology and Cardiovascular Medicine

Cite this

Carpenter, J. P., Ouriel, K., Dietrich, E. B., Gloviczki, P., Hodgson, K., McKinsey, J., ... Kipperman, R. (2006). The powerlink bifurcated system for endovascular aortic aneurysm repair: Four-year results of the US multicenter trial. Journal of Cardiovascular Surgery, 47(3), 239-243.
Carpenter, Jeffrey P. ; Ouriel, Kenneth ; Dietrich, Edward B. ; Gloviczki, Peter ; Hodgson, Kim ; McKinsey, James ; Patel, Amit ; Sicard, Gregorio ; Langan, Eugene ; Skinner, James ; White, Rodney ; Williams, James ; Gayle, Robert ; Bacharach, Michael ; Kipperman, Robert. / The powerlink bifurcated system for endovascular aortic aneurysm repair : Four-year results of the US multicenter trial. In: Journal of Cardiovascular Surgery. 2006 ; Vol. 47, No. 3. pp. 239-243.
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title = "The powerlink bifurcated system for endovascular aortic aneurysm repair: Four-year results of the US multicenter trial",
abstract = "The aim of the study was to review the results of abdominal aortic aneurysm (AAA) repair with the Powerlink Bifurcated endovascular graft, when compared with open AAA repair. A prospective, controlled, multicenter trial of the Powerlink System for endovascular abdominal repair (EVAR) was conducted at 15 sites as part of a pivotal FDA trial. Between July 2000 and March 2003, 258 patients were enrolled (192 test and 66 control patients). Stent grafts were oversized by 10-20{\%} relative to computed tomography (CT)-based diameter measurements. All repairs were performed in the operating room through one surgically exposed femoral artery and a contralateral 9 French sheath percutaneously placed. Results were assessed using contrast-enhanced CT and plain abdominal X-rays at 1, 6, and 12 months and annually postoperatively. Mean follow-up of 36 months was available. Technical success was achieved in 97.9{\%} of patients, with 4 failed insertions: 3 early conversions for deployment issues and one access failure. There was a significant difference in 30-day mortality between Powerlink (1{\%}) and control (6.1{\%}) patients and only 1 death was procedure-related (P=0.0389). Blood loss (341 mL vs 1 583 mL, P<0.0001), operative time (136 min vs 222 min, P<0.0001), Intensive Care Unit (ICU) stay (0.78 days vs 4.1 days, P<0.0001) and hospital length of stay (3.3 days vs 9.5 days, P<0.0001) were significantly less in the Powerlink cohort compared with controls. Secondary procedures have been performed on 16 patients post-implant to 48 months follow-up. At the time of the first month CT scan, endoleaks were noted in 25 patients, yielding a 30-day endoleak rate of 22.3{\%}. Type II endoleaks predominated and there were no type III or IV endoleaks. The 4-year endoleak-free survival rate was 73{\%}. No Type I, III or IV endoleaks were reported at 48 months post-implant. There have been no ruptures, graft fabric defects or wire fractures. Sac regression was noted in 83{\%} of patients. Significant reduction in mean AAA diameter and volume was noted over every follow-up interval. In comparison to the 1-month post-implant CT scan, 2 patients had an increase in AAA diameter 5 mm at 48 months. The Powerlink system appears to be safe, and effectively protects patients from AAA rupture over the follow-up period. The graft and stent materials are still free from failure and fatigue. Contralateral limb access (9 Fr) facilitates graft placement in patients with disadvantaged access routes. EVAR performed with the Powerlink produces significantly less early adverse events than open AAA repair. Continued follow-up over the longer term is necessary to assure the durability of these results.",
author = "Carpenter, {Jeffrey P.} and Kenneth Ouriel and Dietrich, {Edward B.} and Peter Gloviczki and Kim Hodgson and James McKinsey and Amit Patel and Gregorio Sicard and Eugene Langan and James Skinner and Rodney White and James Williams and Robert Gayle and Michael Bacharach and Robert Kipperman",
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Carpenter, JP, Ouriel, K, Dietrich, EB, Gloviczki, P, Hodgson, K, McKinsey, J, Patel, A, Sicard, G, Langan, E, Skinner, J, White, R, Williams, J, Gayle, R, Bacharach, M & Kipperman, R 2006, 'The powerlink bifurcated system for endovascular aortic aneurysm repair: Four-year results of the US multicenter trial', Journal of Cardiovascular Surgery, vol. 47, no. 3, pp. 239-243.

The powerlink bifurcated system for endovascular aortic aneurysm repair : Four-year results of the US multicenter trial. / Carpenter, Jeffrey P.; Ouriel, Kenneth; Dietrich, Edward B.; Gloviczki, Peter; Hodgson, Kim; McKinsey, James; Patel, Amit; Sicard, Gregorio; Langan, Eugene; Skinner, James; White, Rodney; Williams, James; Gayle, Robert; Bacharach, Michael; Kipperman, Robert.

In: Journal of Cardiovascular Surgery, Vol. 47, No. 3, 01.06.2006, p. 239-243.

Research output: Contribution to journalReview article

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T1 - The powerlink bifurcated system for endovascular aortic aneurysm repair

T2 - Four-year results of the US multicenter trial

AU - Carpenter, Jeffrey P.

AU - Ouriel, Kenneth

AU - Dietrich, Edward B.

AU - Gloviczki, Peter

AU - Hodgson, Kim

AU - McKinsey, James

AU - Patel, Amit

AU - Sicard, Gregorio

AU - Langan, Eugene

AU - Skinner, James

AU - White, Rodney

AU - Williams, James

AU - Gayle, Robert

AU - Bacharach, Michael

AU - Kipperman, Robert

PY - 2006/6/1

Y1 - 2006/6/1

N2 - The aim of the study was to review the results of abdominal aortic aneurysm (AAA) repair with the Powerlink Bifurcated endovascular graft, when compared with open AAA repair. A prospective, controlled, multicenter trial of the Powerlink System for endovascular abdominal repair (EVAR) was conducted at 15 sites as part of a pivotal FDA trial. Between July 2000 and March 2003, 258 patients were enrolled (192 test and 66 control patients). Stent grafts were oversized by 10-20% relative to computed tomography (CT)-based diameter measurements. All repairs were performed in the operating room through one surgically exposed femoral artery and a contralateral 9 French sheath percutaneously placed. Results were assessed using contrast-enhanced CT and plain abdominal X-rays at 1, 6, and 12 months and annually postoperatively. Mean follow-up of 36 months was available. Technical success was achieved in 97.9% of patients, with 4 failed insertions: 3 early conversions for deployment issues and one access failure. There was a significant difference in 30-day mortality between Powerlink (1%) and control (6.1%) patients and only 1 death was procedure-related (P=0.0389). Blood loss (341 mL vs 1 583 mL, P<0.0001), operative time (136 min vs 222 min, P<0.0001), Intensive Care Unit (ICU) stay (0.78 days vs 4.1 days, P<0.0001) and hospital length of stay (3.3 days vs 9.5 days, P<0.0001) were significantly less in the Powerlink cohort compared with controls. Secondary procedures have been performed on 16 patients post-implant to 48 months follow-up. At the time of the first month CT scan, endoleaks were noted in 25 patients, yielding a 30-day endoleak rate of 22.3%. Type II endoleaks predominated and there were no type III or IV endoleaks. The 4-year endoleak-free survival rate was 73%. No Type I, III or IV endoleaks were reported at 48 months post-implant. There have been no ruptures, graft fabric defects or wire fractures. Sac regression was noted in 83% of patients. Significant reduction in mean AAA diameter and volume was noted over every follow-up interval. In comparison to the 1-month post-implant CT scan, 2 patients had an increase in AAA diameter 5 mm at 48 months. The Powerlink system appears to be safe, and effectively protects patients from AAA rupture over the follow-up period. The graft and stent materials are still free from failure and fatigue. Contralateral limb access (9 Fr) facilitates graft placement in patients with disadvantaged access routes. EVAR performed with the Powerlink produces significantly less early adverse events than open AAA repair. Continued follow-up over the longer term is necessary to assure the durability of these results.

AB - The aim of the study was to review the results of abdominal aortic aneurysm (AAA) repair with the Powerlink Bifurcated endovascular graft, when compared with open AAA repair. A prospective, controlled, multicenter trial of the Powerlink System for endovascular abdominal repair (EVAR) was conducted at 15 sites as part of a pivotal FDA trial. Between July 2000 and March 2003, 258 patients were enrolled (192 test and 66 control patients). Stent grafts were oversized by 10-20% relative to computed tomography (CT)-based diameter measurements. All repairs were performed in the operating room through one surgically exposed femoral artery and a contralateral 9 French sheath percutaneously placed. Results were assessed using contrast-enhanced CT and plain abdominal X-rays at 1, 6, and 12 months and annually postoperatively. Mean follow-up of 36 months was available. Technical success was achieved in 97.9% of patients, with 4 failed insertions: 3 early conversions for deployment issues and one access failure. There was a significant difference in 30-day mortality between Powerlink (1%) and control (6.1%) patients and only 1 death was procedure-related (P=0.0389). Blood loss (341 mL vs 1 583 mL, P<0.0001), operative time (136 min vs 222 min, P<0.0001), Intensive Care Unit (ICU) stay (0.78 days vs 4.1 days, P<0.0001) and hospital length of stay (3.3 days vs 9.5 days, P<0.0001) were significantly less in the Powerlink cohort compared with controls. Secondary procedures have been performed on 16 patients post-implant to 48 months follow-up. At the time of the first month CT scan, endoleaks were noted in 25 patients, yielding a 30-day endoleak rate of 22.3%. Type II endoleaks predominated and there were no type III or IV endoleaks. The 4-year endoleak-free survival rate was 73%. No Type I, III or IV endoleaks were reported at 48 months post-implant. There have been no ruptures, graft fabric defects or wire fractures. Sac regression was noted in 83% of patients. Significant reduction in mean AAA diameter and volume was noted over every follow-up interval. In comparison to the 1-month post-implant CT scan, 2 patients had an increase in AAA diameter 5 mm at 48 months. The Powerlink system appears to be safe, and effectively protects patients from AAA rupture over the follow-up period. The graft and stent materials are still free from failure and fatigue. Contralateral limb access (9 Fr) facilitates graft placement in patients with disadvantaged access routes. EVAR performed with the Powerlink produces significantly less early adverse events than open AAA repair. Continued follow-up over the longer term is necessary to assure the durability of these results.

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Carpenter JP, Ouriel K, Dietrich EB, Gloviczki P, Hodgson K, McKinsey J et al. The powerlink bifurcated system for endovascular aortic aneurysm repair: Four-year results of the US multicenter trial. Journal of Cardiovascular Surgery. 2006 Jun 1;47(3):239-243.