Increasing incidence of midterm and long-term complications after endovascular graft repair of abdominal aortic aneurysms

A note of caution based on a 9-year experience

Takao Ohki, Frank J. Veith, Palma Shaw, Evan C. Lipsitz, William D. Suggs, Reese A. Wain, Maseer Bade, Manish Mehta, Neal Cayne, Jacob Cynamon, Jennifer Valldares, Jamie McKay

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Abstract

Objective: To analyze the late complications after endovascular graft repair of elective abdominal aortic aneurysms (AAAs) at the authors' institution since November 1992. Summary Background Data: Recently, the use of endovascular grafts for the treatment of AAAs has increased dramatically. However, there is little midterm or long-term proof of their efficacy. Methods: During the past 9 years, 239 endovascular graft repairs were performed for nonruptured AAAs, many (86%) in high-risk patients or in those with complex anatomy. The grafts used were Montefiore (n = 97), Ancure/EVT (n = 14), Vanguard (n = 16), Talent (n = 47), Excluder (n = 20), AneuRx (n = 29), and Zenith (n = 16). All but the AneuRx and Ancure repairs were performed as part of a U.S. phase 1 or phase 2 clinical trial under a Food and Drug Administration investigational device exemption. Procedural outcomes and follow-up results were prospectively recorded. Results: The major complication and death rates within 30 days of endovascular graft repair were 17.6% and 8.5%, respectively. The technical success rate with complete AAA exclusion was 88.7%. During follow-up to 75 months (mean ± standard deviation, 15.7 ± 6.3 months), 53 patients (22%) died of unrelated causes. Two AAAs treated with endovascular grafts ruptured and were surgically repaired, with one death. Other late complications included type 1 endoleak (n = 7), aortoduodenal fistula (n = 2), graft thrombosis/stenosis (n = 7), limb separation or fabric tear with a subsequent type 3 endoleak (n = 1), and a persistent type 2 endoleak (n = 13). Secondary intervention or surgery was required in 23 patients (10%). These included deployment of a second graft (n = 4), open AAA repair (n = 5), coil embolization (n = 6), extraanatomic bypass (n = 4), and stent placement (n = 3). Conclusion: With longer follow-up, complications occurred with increasing frequency. Although most could be managed with some form of endovascular reintervention, some complications resulted in a high death rate. Although endovascular graft repair is less invasive and sometimes effective in the long term, it is often not a definitive procedure. These findings mandate long-term surveillance and prospective studies to prove the effectiveness of endovascular graft repair.

Original languageEnglish (US)
Pages (from-to)323-335
Number of pages13
JournalAnnals of Surgery
Volume234
Issue number3
DOIs
StatePublished - 2001

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Abdominal Aortic Aneurysm
Transplants
Incidence
Endoleak
Aptitude
Mortality
United States Food and Drug Administration
Tears
Fistula
Stents
Anatomy
Pathologic Constriction
Thrombosis
Extremities
Clinical Trials
Prospective Studies
Equipment and Supplies

ASJC Scopus subject areas

  • Surgery

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Increasing incidence of midterm and long-term complications after endovascular graft repair of abdominal aortic aneurysms : A note of caution based on a 9-year experience. / Ohki, Takao; Veith, Frank J.; Shaw, Palma; Lipsitz, Evan C.; Suggs, William D.; Wain, Reese A.; Bade, Maseer; Mehta, Manish; Cayne, Neal; Cynamon, Jacob; Valldares, Jennifer; McKay, Jamie.

In: Annals of Surgery, Vol. 234, No. 3, 2001, p. 323-335.

Research output: Contribution to journalArticle

Ohki, Takao ; Veith, Frank J. ; Shaw, Palma ; Lipsitz, Evan C. ; Suggs, William D. ; Wain, Reese A. ; Bade, Maseer ; Mehta, Manish ; Cayne, Neal ; Cynamon, Jacob ; Valldares, Jennifer ; McKay, Jamie. / Increasing incidence of midterm and long-term complications after endovascular graft repair of abdominal aortic aneurysms : A note of caution based on a 9-year experience. In: Annals of Surgery. 2001 ; Vol. 234, No. 3. pp. 323-335.
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title = "Increasing incidence of midterm and long-term complications after endovascular graft repair of abdominal aortic aneurysms: A note of caution based on a 9-year experience",
abstract = "Objective: To analyze the late complications after endovascular graft repair of elective abdominal aortic aneurysms (AAAs) at the authors' institution since November 1992. Summary Background Data: Recently, the use of endovascular grafts for the treatment of AAAs has increased dramatically. However, there is little midterm or long-term proof of their efficacy. Methods: During the past 9 years, 239 endovascular graft repairs were performed for nonruptured AAAs, many (86{\%}) in high-risk patients or in those with complex anatomy. The grafts used were Montefiore (n = 97), Ancure/EVT (n = 14), Vanguard (n = 16), Talent (n = 47), Excluder (n = 20), AneuRx (n = 29), and Zenith (n = 16). All but the AneuRx and Ancure repairs were performed as part of a U.S. phase 1 or phase 2 clinical trial under a Food and Drug Administration investigational device exemption. Procedural outcomes and follow-up results were prospectively recorded. Results: The major complication and death rates within 30 days of endovascular graft repair were 17.6{\%} and 8.5{\%}, respectively. The technical success rate with complete AAA exclusion was 88.7{\%}. During follow-up to 75 months (mean ± standard deviation, 15.7 ± 6.3 months), 53 patients (22{\%}) died of unrelated causes. Two AAAs treated with endovascular grafts ruptured and were surgically repaired, with one death. Other late complications included type 1 endoleak (n = 7), aortoduodenal fistula (n = 2), graft thrombosis/stenosis (n = 7), limb separation or fabric tear with a subsequent type 3 endoleak (n = 1), and a persistent type 2 endoleak (n = 13). Secondary intervention or surgery was required in 23 patients (10{\%}). These included deployment of a second graft (n = 4), open AAA repair (n = 5), coil embolization (n = 6), extraanatomic bypass (n = 4), and stent placement (n = 3). Conclusion: With longer follow-up, complications occurred with increasing frequency. Although most could be managed with some form of endovascular reintervention, some complications resulted in a high death rate. Although endovascular graft repair is less invasive and sometimes effective in the long term, it is often not a definitive procedure. These findings mandate long-term surveillance and prospective studies to prove the effectiveness of endovascular graft repair.",
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T1 - Increasing incidence of midterm and long-term complications after endovascular graft repair of abdominal aortic aneurysms

T2 - A note of caution based on a 9-year experience

AU - Ohki, Takao

AU - Veith, Frank J.

AU - Shaw, Palma

AU - Lipsitz, Evan C.

AU - Suggs, William D.

AU - Wain, Reese A.

AU - Bade, Maseer

AU - Mehta, Manish

AU - Cayne, Neal

AU - Cynamon, Jacob

AU - Valldares, Jennifer

AU - McKay, Jamie

PY - 2001

Y1 - 2001

N2 - Objective: To analyze the late complications after endovascular graft repair of elective abdominal aortic aneurysms (AAAs) at the authors' institution since November 1992. Summary Background Data: Recently, the use of endovascular grafts for the treatment of AAAs has increased dramatically. However, there is little midterm or long-term proof of their efficacy. Methods: During the past 9 years, 239 endovascular graft repairs were performed for nonruptured AAAs, many (86%) in high-risk patients or in those with complex anatomy. The grafts used were Montefiore (n = 97), Ancure/EVT (n = 14), Vanguard (n = 16), Talent (n = 47), Excluder (n = 20), AneuRx (n = 29), and Zenith (n = 16). All but the AneuRx and Ancure repairs were performed as part of a U.S. phase 1 or phase 2 clinical trial under a Food and Drug Administration investigational device exemption. Procedural outcomes and follow-up results were prospectively recorded. Results: The major complication and death rates within 30 days of endovascular graft repair were 17.6% and 8.5%, respectively. The technical success rate with complete AAA exclusion was 88.7%. During follow-up to 75 months (mean ± standard deviation, 15.7 ± 6.3 months), 53 patients (22%) died of unrelated causes. Two AAAs treated with endovascular grafts ruptured and were surgically repaired, with one death. Other late complications included type 1 endoleak (n = 7), aortoduodenal fistula (n = 2), graft thrombosis/stenosis (n = 7), limb separation or fabric tear with a subsequent type 3 endoleak (n = 1), and a persistent type 2 endoleak (n = 13). Secondary intervention or surgery was required in 23 patients (10%). These included deployment of a second graft (n = 4), open AAA repair (n = 5), coil embolization (n = 6), extraanatomic bypass (n = 4), and stent placement (n = 3). Conclusion: With longer follow-up, complications occurred with increasing frequency. Although most could be managed with some form of endovascular reintervention, some complications resulted in a high death rate. Although endovascular graft repair is less invasive and sometimes effective in the long term, it is often not a definitive procedure. These findings mandate long-term surveillance and prospective studies to prove the effectiveness of endovascular graft repair.

AB - Objective: To analyze the late complications after endovascular graft repair of elective abdominal aortic aneurysms (AAAs) at the authors' institution since November 1992. Summary Background Data: Recently, the use of endovascular grafts for the treatment of AAAs has increased dramatically. However, there is little midterm or long-term proof of their efficacy. Methods: During the past 9 years, 239 endovascular graft repairs were performed for nonruptured AAAs, many (86%) in high-risk patients or in those with complex anatomy. The grafts used were Montefiore (n = 97), Ancure/EVT (n = 14), Vanguard (n = 16), Talent (n = 47), Excluder (n = 20), AneuRx (n = 29), and Zenith (n = 16). All but the AneuRx and Ancure repairs were performed as part of a U.S. phase 1 or phase 2 clinical trial under a Food and Drug Administration investigational device exemption. Procedural outcomes and follow-up results were prospectively recorded. Results: The major complication and death rates within 30 days of endovascular graft repair were 17.6% and 8.5%, respectively. The technical success rate with complete AAA exclusion was 88.7%. During follow-up to 75 months (mean ± standard deviation, 15.7 ± 6.3 months), 53 patients (22%) died of unrelated causes. Two AAAs treated with endovascular grafts ruptured and were surgically repaired, with one death. Other late complications included type 1 endoleak (n = 7), aortoduodenal fistula (n = 2), graft thrombosis/stenosis (n = 7), limb separation or fabric tear with a subsequent type 3 endoleak (n = 1), and a persistent type 2 endoleak (n = 13). Secondary intervention or surgery was required in 23 patients (10%). These included deployment of a second graft (n = 4), open AAA repair (n = 5), coil embolization (n = 6), extraanatomic bypass (n = 4), and stent placement (n = 3). Conclusion: With longer follow-up, complications occurred with increasing frequency. Although most could be managed with some form of endovascular reintervention, some complications resulted in a high death rate. Although endovascular graft repair is less invasive and sometimes effective in the long term, it is often not a definitive procedure. These findings mandate long-term surveillance and prospective studies to prove the effectiveness of endovascular graft repair.

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