Variations in early outcomes of endovascular aneurysm repair with alternate endograft configurations (original) (raw)
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Cureus, 2021
Background Endovascular aneurysm repair (EVAR) has become the treatment modality of choice in patients with abdominal aortic aneurysms. This has resulted in endograft utilization within instructions for use (IFU) and in cases with proximal neck anatomy outside of IFU. Purpose To identify whether graft selection influences outcomes following EVAR outside of IFU. Methodology A retrospective analysis was conducted from previously published data for 636 patients, collated from the Endurant Stent Graft Natural Selection Global Post-Market Registry (ENGAGE) and the Global Registry for Endovascular Aortic Treatment (GREAT). Patients were recruited into the ENGAGE registry between 2009 and 2011 and into the GREAT registry between August 2010 and October 2016. In ENGAGE, they received the Medtronic Endurant stent graft (Medtronic Vascular Inc, Dublin, Ireland) for infrarenal AAA repair while patients analyzed in GREAT received the Gore Excluder stent-graft (W. L. Gore & Associates, Flagstaff...
Journal of Vascular Surgery, 2004
Objective: We compared the effectiveness and clinical outcome of open repair versus endovascular aortic aneurysm repair (EVAR) in achieving prevention of abdominal aortic aneurysm (AAA)-related death and graft-related complications. Methods: Over 7 years from 1997 to 2003, 1119 consecutive patients underwent elective treatment of infrarenal AAAs, 585 with open repair and 534 with EVAR. Patients were regularly followed up at 1, 6, 12 months, and every 6 months thereafter, in EVAR group, and at 3 and 12 months, and yearly thereafter after open repair. Preoperative, intraoperative, and follow-up data were stored in a prospective database. Results: Median follow-up was similar in the 2 groups: 33 months (interquartile range [IQR], 13-50 months) in the EVAR group vs 35 months (IQR, 15-54 months) in the open repair group. EVAR group patients were older than patients in the open repair group: 73 years vs 72 years (P ؍ .04). There were statistical significant differences between the EVAR group and the open repair group with respect to AAA median diameter (52 mm vs 56 mm), coronary disease rate (46% vs 37%; P ؍ .001), pulmonary disease rate (56% vs 38%; P < .0001), and American Society of Anesthesiologists IV score rate (16% vs 6%; P < .0001). Thirty-day mortality in the EVAR group was 0.9% (5 of 534 patients), compared with 4.1% (24 of 585 patients; P ؍ .001) in the open repair group, and major morbidity was 9.1% (49 of 534 patients) vs 18.6% (109 of 585 patients; P < .0001), respectively. The incidence of secondary procedures in the EVAR group was 15.7%, compared with 3% in the open repair group (P < .0001). There were no deaths related to secondary procedures in either group. Six AAAs (1.1%) ruptured after EVAR, 3 of which were fatal; in the open repair group 1 patient (0.2%) underwent successful repeat operatation to treat iliac pseudoaneurysm rupture 5 years after the original procedure. Kaplan-Meier estimates for freedom from aneurysm-related death at 84 months were 97.5% in the EVAR group and 95.9% in the open repair group (log rank test, P ؍ .008). Kaplan-Meier survival estimates at 84 months were 67.1% in the open repair group and 66.9% in the EVAR group (P ؍ NS). At the same interval the risk for secondary procedures was 49.4% for the EVAR group and 7.1% for the open repair group. Of the 11 variables analyzed with logistic analysis, open surgery (hazard ratio [HR], 11; 95% confidence interval [CI], 2.5-54.2; P ؍ .002), American Society of Anesthesiologists IV score (HR, 7.1; 95% CI, 2.7-18.8; P ؍ .0001), and age (HR, 1.06; 95% CI, 1.04-1.13; P ؍ .04) were positive independent predictors of perioperative mortality. Conclusion: Our data suggest that at a maximum follow-up of 7 years, patients who undergo EVAR show lower perioperative and late aneurysm-related mortality compared with a younger and substantially healthier group of patients with aneurysms treated with open repair. The higher need for secondary procedures in the endovascular group did not affect superiority of the overall performance of EVAR in the early and late intervals. ( J Vasc Surg 2004;40:841-8.)
Annals of Surgery, 2001
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 ϭ 97), Ancure/EVT (n ϭ 14), Vanguard (n ϭ 16), Talent (n ϭ 47), Excluder (n ϭ 20), AneuRx (n ϭ 29), and Zenith (n ϭ 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 Ϯ standard deviation, 15.7 Ϯ 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 ϭ 7), aortoduodenal fistula (n ϭ 2), graft thrombosis/stenosis (n ϭ 7), limb separation or fabric tear with a subsequent type 3 endoleak (n ϭ 1), and a persistent type 2 endoleak (n ϭ 13). Secondary intervention or surgery was required in 23 patients (10%). These included deployment of a second graft (n ϭ 4), open AAA repair (n ϭ 5), coil embolization (n ϭ 6), extraanatomic bypass (n ϭ 4), and stent placement (n ϭ 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. Since the Food and Drug Administration (FDA)'s approval of the Guidant Ancure graft (Guidant, San Jose, CA) and the AneuRx graft (Medtronic, Inc., Minneapolis, MN) for the treatment of abdominal aortic aneurysms (AAAs), interest in and use of endovascular grafts (EVGs) have increased dramatically in the United States as well as in Europe. However, FDA approval was made based on procedural safety with a follow-up of only 12 months, and there is little midterm or long-term proof of their efficacy. 1 EVGs can fail in a number of ways, including graft migration, infection, deterioration, or component separation, all of which
Midterm durability of abdominal aortic aneurysm endograft repair: A word of caution
Journal of Vascular Surgery, 2001
Purpose: Endograft technology for abdominal aortic aneurysm (AAA) repair is being applied more liberally. There is little information about the midterm performance of these grafts. This study is focused on follow-up interventions after endograft repair for AAA. Methods: Prospective follow-up analysis of a consecutive patient series (n = 173 patients) at a single center who underwent endovascular AAA repair up to 50 months after operation. Seventeen percent of the patients were regarded unfit for open surgery. Four types of commercially available grafts were used. The Society for Vascular Surgery/International Society for Cardiovascular Surgery guidelines were applied for endograft implantation and data preparation. Results: In two patients, the procedure was converted to open surgery. In one procedure, emergency repair for iliac artery rupture was performed. The 30-day mortality rate was 2.8% (n = 5 patients). An early second procedure to correct type I endoleaks was necessary in 8 cases (4.6%; 3-10 days). The following midterm results were obtained: median follow-up of the 166 remaining patients was 18 months (range, 1-50 months); 50 additional procedures were necessary in 37 patients (22.3%) for the treatment of leaks (n = 45 interventions) or to maintain graft patency (n = 5 grafts; four patients with concomitant graft segment disconnection); and 46% of the reinterventions were performed within the first year of followup and 74% of the reinterventions were performed within the second year of follow-up. One patient died after emergency surgery for rupture as the result of a secondary endoleak at 1 year. Although seven interventions (14%) were performed for type II endoleak, no serious complications were related to patent sidebranches. There was no statistically significant difference between the need for maintenance in different graft configurations (tubular, bifurcated, aorto-uniiliac), or number of graft segments . New generation grafts (after 1996) performed better than early generation grafts (P = 0.04, chi-squared test) with regard to endoleak development. Conclusion: Endograft repair for AAA is safe but, with current technology, not as durable as open repair. Our data suggest that the use of endograft repair for AAA is becoming safer as endograft design improves. Nevertheless in 26.6% of the patients, there is need for reintervention within midterm follow-up. Close follow-up is crucial because late leaks may develop after more than 2 years after the initial procedure. Endoluminal repair should therefore be applied with caution, strict indication, and only if a tight follow-up is warranted. These findings may also affect health care reimbursement policies. J Vasc Surg 2001;33:S46-54.) JOURNAL OF VASCULAR SURGERY Volume 33, Number 2 * Rutherford R, Flannigan D, Gupta S, et al. Suggested standards for reports dealing with lower extremity ischemia. J Vasc Surg 1986;4:80-94.
Outcomes of secondary interventions after abdominal aortic aneurysm endovascular repair
Journal of Vascular Surgery, 2004
We assessed the distribution of secondary interventions after aortic stent grafting (EVAR) performed to treat infrarenal abdominal aortic aneurysm (AAA), and evaluated clinical success and survival in patients who underwent a secondary procedure (group 2) compared with patients who did not undergo a secondary procedure (group 1). Methods: Two hundred fifty patients (mean age, 71.3 years) with asymptomatic AAAs (mean aneurysm diameter, 54.5 mm) underwent treatment with commercially available stent grafts. Mean follow-up was 28 months (median, 25 months). Secondary procedures were defined as any additional procedures performed after initial graft placement to treat endoleak, migration, kinking, stenosis, or occlusion. Overall clinical success was defined according to reporting standards of the Society for Vascular Surgery/American Association for Vascular Surgery. Results: Sixty-eight patients (27%) required 112 secondary procedures, with a mean time from initial graft placement of 18.2 months. Patients who received grafts since removed from the market required more secondary procedures (59%, procedure:patient ratio) compared with patients who received devices still on the market (21%; P ؍ .001). Thirty-six patients (53%) required a single secondary procedure, 24 patients (35%) required two procedures, 5 patients (10%) required three procedures, 2 patients (3%) required four procedures, and 1 patient required five secondary procedures. Ninety-eight procedures (87%) were performed with endovascular methods, including placement of 42 additional covered stent grafts (36 iliac, 6 aortic), with a success rate of 85%; 35 embolization procedures (21 lumbar, 9 internal iliac artery, 5 mesenteric), with only 23 (65%) successful; 14 angioplasty procedures, with 85% successful; 4 thrombolysis procedures, 2 of them successful (50%); and 3 successfully placed new endografts within a previous endovascular graft. Surgical secondary operations included nine femorofemoral bypass procedures and three femoral thromboendarterectomies, all of which remain patent; one cerclage of an external iliac limb; and one laparoscopic repair of a type II endoleak, which was successful. Overall clinical success rate for EVAR was 84% (211 of 250) in this series. Clinical success rate in groups 1 and 2 was 91% (166 of 182) versus 66% (45 of 68; P ؍ .001) if all endoleaks on the most recent computed tomography scans are taken into account, and 94% (171 of 182) versus 76% (52 of 68; P ؍ .001) if type II endoleak without aneurysm growth is not considered failure. The survival rate and rupture-free survival in groups 1 and 2 were, respectively, 97.7% ؎ 1.0% and 98.5% ؎ 1.4% at 1 month, 95.9% ؎ 1.5% and 96.9% ؎ 2.1% at 6 months, 94.4% ؎ 2.0% and 93.2% ؎ 3.4% at 1 year, and 80.8% ؎ 5.2% and 88.5% ؎ 5.0% at 3 years (P ؍ .273, log-rank test). Conclusion: With close follow-up and a significant number of secondary operations, this 8-year experience has not included any aneurysm ruptures to date. Secondary operations did not lead to increased mortality, but were associated with more surgical conversions and with a higher clinical failure rate.
European Journal of Vascular and Endovascular Surgery, 2006
Objective. To evaluate frequency, causes and results of conversion to Open repair (OR) after endovascular repair (EVAR) in a single centre during an 8-year period. Design. Six hundred and forty-nine consecutive patients undergoing EVAR were followed up prospectively for endograftrelated complications. Outcomes. Early conversion was any OR during or within 30 days from the primary EVAR. Late conversion was any OR with removal of the endograft after 30 days since a completed EVAR procedure. Results. Median patient follow-up was 38 months (1-93 months). Conversion to OR was performed in 38 patients; nine early and 29 late. Most (7/9) early conversions were due to extensive vessel calcification. Peri-operative mortality was 22% (2/9). Late conversions occurred at a median of 33 months after primary EVAR: 29 were elective and 4 urgent. During the same interval, 79 secondary endovascular interventions were performed, 7 of which failed. The risk of conversion to OR was 9% at 6 years. At multivariate logistic regression analysis, no single factor (short, large or angulated neck, suprarenal fixation, large pre-operative diameter, iliac aneurysms, ASA score risk) was associated with the risk of late failure requiring conversion to OR. Conclusion. The risk of death after early conversion should be recognized, to avoid forcing morphological indications for primary EVAR. Occurrence of late conversion after EVAR is not negligible, affecting almost 1 out of 10 patients after 6 years. In the presence of an expanding aneurysm after EVAR, especially after a failed secondary endovascular correction, an aggressive attitude in fit patients allows outcomes at similar to those of primary OR.
Journal of Vascular Surgery, 2011
Objective: This study assessed the long-term outcome of patients with abdominal aortic and aortoiliac aneurysms treated with the Cook Zenith endovascular graft (Cook Inc, Bloomington, Ind). Methods: Between September 1998 and October 2003, 143 patients underwent elective endovascular aneurysm repair (EVAR) using the Cook Zenith endograft. Data from these patients were reviewed from a prospective database in October 2008. Primary outcome measures were overall survival, intervention-free survival, and freedom from aneurysm rupture. Secondary outcome measures were early and late postoperative complications, including endoleaks. Results: Mean follow-up was 66.4 months (range, 1.9-121.0 months). Overall survival was 72.1% at the 5-year follow-up and 50.9% at the 8-year follow-up. Intervention-free survival was 77.1% at 5 years and 63.8% at 8 years. There were no reintervention-related deaths. Six patients had a late aneurysm rupture, which was fatal in three. Freedom from aneurysm rupture was 98.1% at 5 years and 91.0% at 8 years. Late complications occurred throughout the follow-up period, with a tendency for aneurysm rupture and surgical conversion to occur at a later stage in the follow-up period. Aneurysm sac enlargement during follow-up was associated with late aneurysm rupture and with the need for reintervention. Conclusion: Elective EVAR using the Cook Zenith endograft provides excellent results through a mean follow-up of >5 years. There is a low aneurysm-related mortality and an acceptable rate of postoperative complications and reinterventions. The occurrence of late complications throughout the follow-up period stresses the need for continued postoperative surveillance in EVAR patients. ( J Vasc Surg 2011;54:48-57.)
Journal of Vascular Surgery, 2000
Objective: To review early results of endovascular repair of abdominal aortic aneurysms (AAAs). • Patients and Methods: The first 100 patients who underwent endovascular repair of AAA (EVAR) between June 26, 1996, and October 31, 2001, at the Mayo Clinic in Rochester, Minn, were studied retrospectively to evaluate technical success, freedom from reinterventions, and early clinical outcome.
Journal of Vascular Surgery, 2009
This study evaluated the feasibility, efficacy, and durability of a specific aortomonoiliac endograft for the treatment of abdominal aortic aneurysm (AAA) during a midterm follow-up. Methods: From January 2002 until November 2008, 106 patients (6 women; mean age, 73.37 ؎ 7.39 years) were treated for an AAA using an EndoFit aortomonoiliac graft (LeMaitre Vascular, Burlington, Mass). All procedures were elective. Results: Mean follow-up was 34.9 months (SD, 20.08; range, 2-81 months). Long-term data (follow-up >60 months) were available for nine patients, none of which reported any vascular or procedure related complications. Three of the 106 patients (2.83%) died during early follow-up (<30 days); eight died during late follow-up (7.54%). Endograft infection developed in two patients (1.88%), and an aortoduodenal fistula developed in two (1.88%). Also observed were 15 type II (14.15%) and three type I (2.83%) endoleaks. Femorofemoral bypass thrombosis was detected in two patients (1.88%). Conclusion: In this retrospective analysis, the aortomonoiliac configuration for elective AAA repair was proven to be safe and efficacious. Midterm and long-term follow-up results in this series compare well with previously reported results for AAA endografting using both bifurcated and aortomonoiliac endoprostheses. (
Journal of Endovascular Therapy, 2010
Objective. To evaluate frequency, causes and results of conversion to Open repair (OR) after endovascular repair (EVAR) in a single centre during an 8-year period. Design. Six hundred and forty-nine consecutive patients undergoing EVAR were followed up prospectively for endograftrelated complications. Outcomes. Early conversion was any OR during or within 30 days from the primary EVAR. Late conversion was any OR with removal of the endograft after 30 days since a completed EVAR procedure. Results. Median patient follow-up was 38 months (1-93 months). Conversion to OR was performed in 38 patients; nine early and 29 late. Most (7/9) early conversions were due to extensive vessel calcification. Peri-operative mortality was 22% (2/9). Late conversions occurred at a median of 33 months after primary EVAR: 29 were elective and 4 urgent. During the same interval, 79 secondary endovascular interventions were performed, 7 of which failed. The risk of conversion to OR was 9% at 6 years. At multivariate logistic regression analysis, no single factor (short, large or angulated neck, suprarenal fixation, large pre-operative diameter, iliac aneurysms, ASA score risk) was associated with the risk of late failure requiring conversion to OR. Conclusion. The risk of death after early conversion should be recognized, to avoid forcing morphological indications for primary EVAR. Occurrence of late conversion after EVAR is not negligible, affecting almost 1 out of 10 patients after 6 years. In the presence of an expanding aneurysm after EVAR, especially after a failed secondary endovascular correction, an aggressive attitude in fit patients allows outcomes at similar to those of primary OR.