- Email: [email protected]
Thirty-year trends in aortofemoral bypass for aortoiliac occlusive disease
From the Vascular and Endovascular Surgery Society
Thirty-year trends in aortofemoral bypass for aortoiliac occlusive disease Gaurav Sharma, MD, Rebecca E. Scully, MD, MPH, Samir K. Shah, MD, Arin L. Madenci, MD, MPH, Dean J. Arnaoutakis, MD, MBA, Matthew T. Menard, MD, C. Keith Ozaki, MD, and Michael Belkin, MD, Boston, Mass
ABSTRACT Objective: Endovascular intervention has supplanted open bypass as the most frequently used approach in patients with aortoiliac segment atherosclerosis. We sought to determine whether this trend together with changing demographic and clinical characteristics of patients undergoing aortobifemoral bypass (ABFB) for aortoiliac occlusive disease (AOD) have an association with postoperative outcomes. Methods: Using a prospectively maintained institutional database, we identified patients who underwent ABFB for AOD from 1985 to 2015. Patients were divided into two cohorts: the historical cohort (HC) included patients who underwent ABFB for AOD from 1985 to 1999 and the contemporary cohort (CC) who underwent ABFB for AOD from 2000 to 2015. Medical and demographic data, procedural information, postoperative complications, and follow-up data were extracted. Cox proportional hazards regression was used to evaluate associations with the end point of primary patency. A similar analysis was performed for major adverse limb events (MALEs; the composite of above-ankle amputation, major reintervention, graft revision, or new bypass graft of the index limb) in the subset of patients with critical limb ischemia. Results: There were a total of 359 cases: 226 in the HC and 133 in the CC. The CC had more women (56.4% vs 43.8%; P ¼ .02), smokers (87.2% vs 67.7%; P ¼ .001), and patients who failed prior aortoiliac endovascular intervention (17.3% vs 4.8%; P ¼ .0001), but fewer patients with coronary artery disease (32.3% vs 47.3%; P ¼ .005). Thirty-day mortality was less than 1% in both cohorts, but 10-year survival was higher in the CC (67.7% vs 52.6%; P ¼ .02). Five-year primary, primaryassisted, and secondary patency were higher in the HC (93.3% vs 82.2%; P ¼ .005; 93.8% vs 85.7%; P ¼ .02; 97.5% vs 90.4%; P ¼ .02, respectively). CC membership, decreasing age, prior aortic surgery, and decreasing graft diameter were significant independent predictors of loss of primary patency after adjustment (hazard ratio [HR], 7.03; 95% confidence interval [CI], 2.80-17.63; P < .0001; HR, 0.93; 95% CI, 0.90-0.96; P < .0001; HR, 18.80; 95% CI, 5.94-59.58; P < .0001; and HR, 0.73; 95% CI, 0.55-0.95; P ¼ .02, respectively). Similarly, CC membership, prior aortic surgery, and decreasing graft diameter were significant independent predictors of MALE in the critical limb ischemia cohort after adjustment (HR, 21.13; 95% CI, 4.20-106.40; P ¼ .0002; HR, 40.40; 95% CI, 3.23-505.61; P ¼ .004; and HR, 0.51; 95% CI, 0.30-0.86; P ¼ .01, respectively). Conclusions: Compared with the pre-endovascular era, demographic and clinical characteristics of patients undergoing ABFB for AOD in the CC have changed. Although long-term patency is slightly lower among patients in the CC during which a substantial subset of AOD patients are being treated primarily via the endovascular approach, durability remains excellent and limb salvage unchanged. After adjustment, the time period of index ABFB independently predicted primary patency and MALE, as did graft diameter and prior aortic surgery. These changing characteristics should be considered when counseling patients and benchmarking for reintervention rates and other outcomes. (J Vasc Surg 2018;-:1-9.) Keywords: Peripheral arterial disease; Aortobifemoral bypass
Aortobifemoral bypass (ABFB) has long been the gold standard therapy for aortoiliac occlusive disease (AOD). Historic studies reported surgical mortality ranging from 0.1% to 4.6%, and 5-year patency rates from 80%
to 97%.1-13 Endovascular interventions have experienced perhaps their greatest proliferation in the treatment of aortoiliac segment disease and now largely have supplanted ABFB as the first-line modality in AOD.14-19
From the Division of Vascular and Endovascular Surgery, Brigham and
and Vascular Center, 75 Francis St, Boston, MA 02115 (e-mail: mbelkin@
Women’s Heart and Vascular Center, Harvard Medical School. Author conflict of interest: none.
partners.org). The editors and reviewers of this article have no relevant financial
Presented at the 2017 Vascular and Endovascular Surgery Society Spring
relationships to disclose per the JVS policy that requires reviewers
Meeting Plenary Session at the 2017 Vascular Annual Meeting of the Society
to decline review of any manuscript for which they may have a
for Vascular Surgery, San Diego, Calif, May 31-June 3, 2017. Additional material for this article may be found online at www.jvascsurg.org. Correspondence: Michael Belkin, MD, Chief, Division of Vascular and Endovascular Surgery, Department of Surgery, Brigham and Women’s Heart
conflict of interest. 0741-5214 Copyright Ó 2018 by the Society for Vascular Surgery. Published by Elsevier Inc. https://doi.org/10.1016/j.jvs.2018.01.067
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This has raised concerns that outcomes of ABFB might decline as open surgical bypass becomes increasingly reserved for failures of endovascular therapy and for disease anatomy not amenable to catheter-based approaches.20 Concomitantly, substantial changes in patient demographics and clinical characteristics that may impact outcomes also have occurred.21-24 We sought to determine whether these trends were associated with a shift in the profile and outcomes of patients undergoing ABFB for AOD by leveraging a longitudinal institutional database spanning over 3 decades. We hypothesized that limb-related outcomes would be impacted negatively by these shifting characteristics.
2018
ARTICLE HIGHLIGHTS d
d
d
Type of Research: Retrospective study of a prospectively maintained database Take Home Message: In 359 patients who underwent aortobifemoral bypass for occlusive disease over 30 years, demographic and clinical characteristics have changed. Graft diameter and prior aortic surgery were independent predictors of patency and major adverse limb events after adjustment. Recommendation: The authors suggest to consider prior aortic surgery and graft diameter when counseling patients and benchmarking for reintervention rates and other outcomes.
METHODS Study participants, follow-up evaluation, and exposure variables. The study included all patients undergoing ABFB for AOD as determined by preoperative conventional aortography, computed tomographic imaging, or magnetic resonance angiography at a single academic medical center from 1985 to 2015. Demographic and clinical data, as well as procedural details and postoperative morbidity, mortality, and reinterventions were collected in a prospectively maintained registry. Previous work analyzing Medicare claims data from 1996 to 2010 has shown that the predominant therapeutic approach to lower-extremity revascularization for peripheral arterial disease shifted from open surgery to endovascular intervention in approximately 2000.15,25 Thus, participants were grouped into two cohorts, as follows: the historic cohort (HC), which underwent index ABFB between 1985 and 1999, and the contemporary cohort (CC), which underwent index ABFB between 2000 and 2015. Patients were followed up at 2 weeks, 6 months, 12 months, and annually thereafter. Patency was assessed by clinical history and physical examination, as well as arterial pressure measurements at annual visits. Depending on surgeon preference, a computed tomography arteriogram was obtained at 1 and 5 years after surgery. If there was any concern about graft patency, imaging with ultrasound or computed tomography arteriogram was obtained. Proximal and distal (limb) diameter was correlated consistently by a 2:1 ratio. Thus, proximal graft diameter was used for analyses and treated as an ordinal variable. The study protocol was approved by the Partners Human Research Committee Institutional Review Board, which determined that patients’ informed consent to participate was not required. Outcome measures. Our primary outcome of interest was primary patency. In addition, for the subset of patients with critical limb ischemia (CLI), we explored major adverse limb events (MALE) (the composite of above-ankle amputation or major reintervention such as thrombectomy/thrombolysis, graft revision, or new bypass graft of the index limb) based on recent
recommendations for efficacy end points.26 Secondary outcomes were complications such as surgical site infections and postoperative cardiovascular events, mortality, and quality metrics including readmissions. Statistical analysis. Baseline characteristics and postoperative outcomes of the two cohorts were compared using c2 testing for categorical variables, and the Student t-test vs Wilcoxon rank sum testing for continuous variables, based on normality of distribution. Kaplan-Meier analyses were used to examine patency and survival. These were compared between cohorts using the log-rank test. We then constructed a multivariable Cox proportional hazards regression model for the primary outcome in the complete cohort, as well as MALE in the subset of patients with CLI. In the multivariate analysis, patients in the contemporary and historic cohorts were aggregated. Variable selection proceeded by using a stepwise selection process of clinically relevant variables. Criteria for entry into the stepwise process had a P value <.30 and criteria for maintenance in the multivariable model was P < .05. Age and preoperative ankle-brachial index were treated as continuous variables whereas graft size was an ordinal variable. All statistical analyses were conducted using SAS software, version 9.4 (SAS Institute, Inc, Cary, NC). An a value #0.05 was considered statistically significant for all analyses.
RESULTS A total of 359 patients underwent ABFB: 226 in the HC and 133 in the CC. Both cohorts were similar in terms of mean age and prevalence of diabetes and chronic obstructive pulmonary disease (Table I). The CC had more women, smokers, patients on dialysis, and patients with hypertension (Table I). However there were fewer patients with coronary artery disease. Preoperative statin, b-blocker, and aspirin use was higher in the CC (Table I). CLI was more prevalent in the CC, accounting for the indication for ABFB in approximately 50% of cases. However, this difference between cohorts did not reach
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Table I. Background characteristics and indications for aortofemoral bypass in the historical cohort (HC; 1985-1999) vs contemporary cohort (CC; 2000-2015) Variable
HC 1985-1999 (n ¼ 226)
CC 2000-2015 (n ¼ 133)
P
Demographic characteristics Mean age, years (SD)
60.5 (12)
Female
99 (43.8)
60.2 (15) 75 (56.4)
.30 .02
Comorbidity Diabetes
47 (20.8)
28 (21.1)
.95
Smoking
153 (67.7)
116 (87.2)
.001
Hypertension
120 (53.1)
93 (69.9)
.002
Coronary artery disease
107 (47.3)
43 (32.3)
.005
Congestive heart failure
15 (6.6)
10 (7.5)
.75
Chronic obstructive pulmonary disease
42 (18.6)
27 (20.3)
.69
Chronic renal insufficiency
8 (3.5)
6 (4.5)
.65
Dialysis
0 (0.0)
4 (3.0)
.009
Preoperative medications Statin
48 (21.3)
92 (69.2)
.001
b-blocker
27 (11.9)
82 (61.7)
.001
Aspirin
66 (29.2)
92 (69.2)
.001
Intermittent claudication
134 (59.3)
66 (49.6)
.07
CLI
92 (40.7)
67 (50.4)
.07
Open abdominal aortic surgery
13 (5.8)
2 (1.5)
.05
Open iliofemoral surgery
13 (5.8)
15 (11.3)
.06
Prior aortoiliac endovascular intervention
11 (4.8)
23 (17.3)
.0001
Indication
Prior revascularization
CLI, Critical limb ischemia; SD, standard deviation. Data are shown as numbers, with percentages for categorical variables and SD for continuous variables in parentheses.
statistical significance (P ¼ .07). Patients in the CC were more likely to have undergone prior endovascular intervention, although differences in prior open surgical procedures were not significant (Table I). In terms of procedural characteristics, there were more end-to-side proximal anastomoses (53.4% vs 31%; P ¼ .001) in the CC compared with the HC. Fifty percent of patients who had undergone prior aortoiliac endovascular intervention underwent ABFB with end-to-side proximal anastomotic configuration vs 38% who had not undergone prior endovascular therapy. The mean estimated blood loss, distal anastomotic target vessel, and rates of concomitant visceral revascularization procedure were similar. There were more concomitant femoral endarterectomies and profundaplasties in the CC (Table II). Proximal graft diameter also was similar (mean 6 standard deviation, 16 6 1.51 mm vs 16 6 1.45 mm; P ¼ .07; Table II). The median follow-up period was 106.6 and 41.0 months in the HC and CC, respectively. In total, 176 (77.9%) patients in the HC and 59 (44.4%) patients in the CC had complete 5-year follow-up evaluation. Overall and major morbidity within 30 days of aortofemoral bypass were
similar in both cohorts (Table III). Thirty-day readmission and reintervention were significantly higher in the CC (Table III). Reasons for reintervention included thrombectomy for unilateral graft limb thrombosis within 24 hours of index ABFB (in three 16- 8-mm grafts and one 14- 7-mm graft), reoperation for retroperitoneal hemorrhage in one patient, and groin washout and tissue transfer in another patient. The most common reasons for readmission were groin wound complications in 14 of the 32 readmitted patients; other reasons included smallbowel obstruction vs ileus, graft-related complications (limb thrombosis or infection), abdominal pain of unclear etiology, and congestive heart failure exacerbation. Thirty-day mortality was similar and less than 1% in both cohorts and 5-year survival was similar, but 10-year survival was higher in the CC (67.7% vs 52.6%; P ¼ .02). At 5 years, secondary patency exceeded 90% in both cohorts, primary, primary-assisted, and secondary patency all were higher in the HC (Table III; Fig). Primary patency was 56% for 12- 6-mm grafts, 85% for 14- 7-mm grafts, 89% for 16- 8-mm grafts, and 100% for 18- 9-mm and larger grafts. The number of 14- 7-mm grafts was similar in patients with end-to-end configurations
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Table II. Procedural characteristics of aortofemoral bypass in the historical cohort (HC; 1985-1999) vs contemporary cohort (CC; 2000-2015) Variable
HC 1985-1999 (n ¼ 226)
CC 2000-2015 (n ¼ 133)
222 (98.2)
133 (100)
4 (1.8)
0 (0)
P
Conduit type Polyester, No. (SD) PTFE, No. (SD)
>.99
Proximal anastomotic configuration, No. (%) End-to-end
156 (69.0)
62 (46.6)
End-to-side
70 (31.0)
71 (53.4)
.001
Common femoral/common femoral
189 (83.7)
114 (85.7)
.60
Common femoral/profundal femoral
10 (4.4)
3 (2.2)
.29
Common femoral/superficial femoral
3 (1.3)
5 (3.8)
.13
Profunda femoral/profundal femoral
14 (6.2)
7 (5.3)
.72
Profunda femoral/superficial femoral
3 (1.3)
1 (0.8)
.62
Superficial femoral/superficial femoral
7 (3.1)
3 (2.2)
.64 .07
Distal anastomotic locations, No. (%)
Graft size, No. (%) 12 6 mm
8 (3.5)
8 (6.0)
14 7 mm
78 (34.5)
47 (35.3)
16 8 mm
121 (53.5)
73 (54.9)
18 9 mm
15 (6.6)
4 (3.0)
20 10 mm
2 (0.9)
22 11 mm
2 (0.9)
1 (0.8) 0 (0)
Concomitant visceral revascularization
18 (8.0)
7 (5.3)
Concomitant femoral endarterectomy or profundaplasty
69 (30.5)
69 (51.9)
.33 .001
PTFE, Polytetrafluoroethylene; SD, standard deviation.
(69/218; 32%) and end-to-side configurations (56/141; 39%; Table II). Limb salvage rates were similar in both groups and exceeded 98% (Table III). To control for differences in baseline patient and procedural characteristics in the two cohorts, we performed multivariate Cox proportional hazards regression analysis. Our primary outcome was primary patency. Multiple regression modeling showed that membership in the CC, younger age, prior aortic surgery history, and decreasing graft diameter were associated independently with loss of primary patency after adjustment (Table IV). Similar relationships were discovered between these predictors and loss of primary-assisted patency (Supplementary Table I, online only). In addition, non-white race was associated independently with loss of primary-assisted patency. Only membership in the CC was associated with loss of secondary patency after adjustment (Supplementary Table II, online only). Indication for surgery (claudication vs CLI) was not associated independently with patency end points (Table IV; Supplementary Tables I and II, online only). We also performed similar analysis of the end point of MALE in the subset of patients who underwent ABFB for CLI (Table V). As with primary and primary-assisted patency, membership in the contemporary cohort, prior
open aortic surgery, and decreased graft size all were independent predictors of MALE after adjustment (Table V).
DISCUSSION Here, we compared changing patient characteristics as well as short- and long-term postoperative outcomes in a prospectively maintained database of patients undergoing ABFB for AOD in the period before and after widespread proliferation of endovascular therapy. We found fewer total ABFB in the modern era, as well as shifts in patient demographics, clinical characteristics, and indications for surgery. Long-term patency was high in both cohorts. The era during which the index ABFB occurred, as well as graft diameter and a history of prior open aortic surgery, but not previous aortoiliac endovascular intervention, were associated with primary patency in the broader cohort of patients and MALE in CLI patients after adjustment by multivariate Cox proportional hazards regression. Surgery during the contemporary period, decreasing graft diameter, and a history of prior aortic surgery all independently predicted loss of primary patency and MALE. In addition, younger age was associated independently with loss of primary patency.
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Table III. Outcomes of aortofemoral bypass in the historical cohort (HC; 1985-1999) vs contemporary cohort (CC; 2000-2015) cohorts HC 1985-1999 (n ¼ 226)
CC 2000-2015 (n ¼ 133)
Overall
65 (28.8)
38 (28.6)
Major
18 (8.0)
14 (10.5)
.41
4 (1.8)
5 (3.8)
.24
Renal failure
7 (3.1)
3 (2.2)
.64
Surgical site infectiona
8 (3.5)
1 (0.8)
.26
Variable
P
Morbidity (within 30 days of aortofemoral bypass), No. (%)
Myocardial infarction
.14
Quality metrics, No. (%) 30-Day readmission 30-Day reintervention
12 (5.3) 1 (0.4)
20 (15)
.002
5 (3.8)
.02
Survival 30-Day mortality
0.4%
0.8%
.70
5-Year survival
80.5%
77.2%
.13
10-Year survival
52.6%
67.7%
.02
Primary
93.3%
82.2%
.005
Primary-assisted
93.8%
85.7%
.02
Secondary
97.5%
90.4%
.02
Limb salvage
99.5%
98.1%
.13
5-Year patency and limb salvage
SD, Standard deviation. a Only surgical site infections requiring surgical intervention were recorded prospectively.
Our findings are consistent with and extend those of previous investigators. Recent work has focused on comparison of open revascularization with alternative inflow procedures, such as a hybrid approach to AOD combining conventional open femoral endarterectomy with endovascular iliac interventions. A singleinstitution report of hybrid approaches found a 30-day mortality of 2.3%.27 Longitudinal data from registries and pooled analyses focused on open revascularization alone reported 2.7% to 3.6% 30-day mortality rates.20,28 Similarly, analysis of the American College of Surgeons National Surgical Quality Improvement Program database found a 30-day mortality rate of 2.7% for ABFB.29 This was significantly higher than alternative revascularization strategies after propensity-matched analysis.29 In contrast, in a retrospective analysis of the Veterans Affair population, McPhee et al30 reported that ABFB mortality at 30 and 90 days was 2.7% and 2.9%, respectively. At 90 days, this mortality rate was not significantly different than alternative inflow proceduresda group that included femoral endarterectomy with iliac angioplasty and stenting (90-day mortality, 2.1%).30 Here, we found that short-term mortality was less than 1% after ABFB in both contemporary and historic cohorts in our study. The differences in mortality found in other work may be owing in part to differences in patient selection. Although previous reports have shown increased American Society of Anesthesia scores in modern series of patients undergoing ABFB compared with those undergoing endovascular therapy,29 we found decreased rates
of cardiovascular disease in our CC compared with the HC. This, coupled with superior medical optimization as suggested by differences in preoperative medications between the cohorts in our study, may account for the lower 10-year mortality in the former. This also seems to reinforce the concept that in the contemporary era, the ability to offer patients a less-invasive, endovascular option has altered the risk-benefit balance of ABFB for higher-risk individuals. Although many of the aforementioned reports were restricted to patients with intermittent claudication, some have consisted wholly of patients with CLI.20 Our study included both CLI patients and claudicants. There was a trend toward more CLI in the CC, but no difference was found in mortality compared with the HC. In our unadjusted analyses, primary, primary-assisted, and secondary patency all were higher in the HC than the CC. This finding was borne out in our adjusted analyses; membership in the CC carried a five- to sevenfold hazard of loss of patency, and a 21-fold hazard of MALE in the CLI subgroup. Patency rates in the CC were consistent with those reported in a large pooled analysis comparing 3733 patients undergoing open surgical revascularization for AOD with 1625 patients undergoing endovascular intervention.28 The differences in patency may reflect increased complexity given the aforementioned trend toward CLI, the possibility of more extensive iliofemoral disease suggested by an increasing use of end-to-side aortic anastomoses in the modern era, increased rates of concomitant femoral
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Fig. Kaplan-Meier survival curves showing (A) primary patency, (B) primary assisted patency, (C) secondary patency, (D) major adverse limb event (MALE)-free survival in the historic cohort (HC; solid line) vs the contemporary cohort (CC; dashed line).
endarterectomies and profundaplasties, and the fact that more patientsdnearly one in fivedin the CC had failed prior endovascular aortoiliac intervention (although some of these differences may reflect differing provider preferences in the HC vs the CC). Such complexity also may account in part for the higher short-term reintervention rate and 30-day readmission rate among patients in the CC. However despite the need for more interventions and higher readmissions in the CC, limb salvage was similar in the two cohorts. In terms of patency rates in patients undergoing alternative inflow procedures, retrospective analysis of 171 patients who underwent intervention for 193 AOD lesions at a single institution showed excellent 5-year secondary patency of 98%.27 However, the median follow-up period for the study population was 24 months; the number at risk at the 5-year time point was not reported but was somewhere between 9% and 21%.27 Repeat interventions were required in 24% of patients.27 In adjusted analyses, we found that history of prior aortic surgery and decreasing graft diameter were independent predictors of loss of primary patency. Hertzer et al10 reported the results of a large, single-surgeon’s personal series of 355 direct anatomic open revascularizations for AOD over a 27-year period ending in 2002. Their
analyses included 181 additional patients undergoing extra-anatomic bypass, with significant baseline differences between these patients and the direct revascularization group as expected.10 In multivariate analyses they found that after adjustment for type of reconstruction (anatomic vs extra-anatomic), female sex was associated with an increased odds of short-term graft thrombosis and major amputation. Analysis of long-term end points in the single-surgeon series showed decreased age and prior inflow procedures as predictors of late graft failure.10 In addition, advanced ischemia was associated with an increased odds ratio of major amputation.10 Previous work also has shown decreased primary and secondary patency rates among patients younger than 50 years old, leading investigators to hypothesize that this younger cohort manifests AOD with a more virulent natural history.8,31,32 Age showed a similar association with loss of primary and primary-assisted patency after adjustment for other covariates in our study. As in the series by Hertzer et al,10 we also found that prior aortic surgery was a significant predictor of diminished primary and primary-assisted patency. Finally, Reed et al8 showed that smaller aortic diameter was linked independently to decreased long-term patency in patients undergoing ABFB. Here, we similarly report that increasing graft
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Table IV. Unadjusted univariate and adjusted Cox proportional hazards regression model for association of patient and procedure characteristics with loss of primary patency Unadjusted analysis Variable
HR (95% CI)
Adjusted analysis
P
HR (95% CI)
P
Cohort HC
Ref
CC
3.10 (1.66-5.79)
Increased age
0.93 (0.90-0.95)
Ref .0004
7.03 (2.80-17.63)
<.0001
<.0001
0.93 (0.90-0.96)
<.0001
18.80 (5.94-59.58)
<.0001
0.73 (0.55-0.95)
.02
Sex Male Female Non-white race
1.84 (1.01-3.32)
.05
0.54 (0.22-1.29)
.16
DM
1.30 (0.66-2.57)
.45
Smoking history
1.86 (0.83-4.17)
.13
Indication Claudication CLI Prior open aortic surgery
1.06 (0.59-1.90)
.85
5.95 (2.76-12.84)
<.0001
Prior open iliofemoral surgery
2.31 (1.03-5.17)
.04
Prior AI endovascular intervention
1.70 (0.74-3.87)
.21
Increased preoperative ABI
1.27 (0.25-6.37)
.77
Proximal anastomotic configuration End-to-end 2.17 (1.21-3.90)
.009
Increased graft size
End-to-side
0.71 (0.58-0.86)
.0006
Outflow procedure
0.82 (0.42-1.61)
.57
Major morbidity
0.86 (0.27-2.77)
.80
ABI, Ankle-brachial index; AI, aortoiliac; CC, contemporary cohort; CI, confidence interval; CLI, critical limb ischemia; DM, diabetes mellitus; HC, historical cohort; HR, hazard ratio.
diameter was protective of MALE, primary, and primaryassisted patency, even after adjustment for other potential predictors. Our findings must be interpreted within the context of the study design. We describe the experience of a single center, thus potentially limiting the external validity of our findings. Furthermore, although all analyses were based on prospectively collected data, the study itself was retrospective in nature; results therefore are associative and causal inferences cannot be made definitively. Although we adjusted for all clinically relevant confounders via multivariate regression analysis, such techniques cannot eliminate the effect of unmeasured covariates. Although all lesions were TransAtlantic Inter-Society Consensus C or D, the specific classification could not be determined for a significant percentage of patients and thus was omitted from analysis. Although the event-per-variable ratio of less than 10 held in the case of the primary outcome of primary patency and MALE, it did not in the case of primary-assisted patency data, potentially resulting in overfitting for that end point. For secondary patency,
only cohort membership independently predicted loss of patency; this may have resulted from the low event rate and/or collinearity of cohort and other variables as potentially suggested by the trend toward lower graft size in the CC. Finally, endovascular techniques and devices, as well as operator efficaciousness in their use, are in continual evolution. Thus, there may be heterogeneity in outcomes within the CC that obscure overall results.
CONCLUSIONS Demographic and clinical characteristics as well as a history of prior intervention and procedural details have shifted in patients undergoing ABFB in the endovascular era compared with those in the HC. This changing complexity should be considered as benchmarks used to assess the quality of revascularization in AOD are established. Performance on quality metrics, survival, and patency all have been affected in the modern era. Despite this increasing complexity, ABFB remains a durable option with high long-term patency. Increased patency is associated independently with increasing
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Table V. Unadjusted univariate and adjusted multivariate Cox proportional hazards regression model for association of critical limb ischemia (CLI) patient and procedure characteristics with major adverse limb event (MALE; composite of above-ankle amputation or major reintervention such as thrombectomy/thrombolysis, graft revision, or new bypass graft of the index limb) Unadjusted analysis Variable
HR (95% CI)
Adjusted analysis
P
P
HR (95% CI)
Cohort HC CC Increased age
Ref
Ref
5.88 (2.25-15.36)
.0003
0.97 (0.93-1.01)
.15
21.13 (4.20-106.40)
.0002
Sex Male Female Non-white race
3.00 (1.32-6.84)
.009
0.46 (0.14-1.56)
.21
DM
1.38 (0.57-3.36)
.48
Smoking history
3.34 (0.79-14.20)
.10
Prior open aortic surgery
6.43 (1.88-22.01)
.003
Prior open iliofemoral surgery
1.34 (0.31-5.77)
.69
Prior AI endovascular intervention
1.08 (0.25-4.66)
.92
Increased preoperative ABI
0.18 (0.02-1.49)
.11
40.40 (3.23-505.61)
.004
Proximal anastomotic configuration End-to-end End-to-side Increased graft size
1.92 (0.87-4.26)
.11
0.51 (0.37-0.70)
<.001
Outflow procedure
1.85 (0.81-4.23)
.15
Major morbidity
0.81 (0.19-3.46)
.78
0.51 (0.30-0.86)
.01
ABI, Ankle-brachial index; AI, aortoiliac; CC, contemporary cohort; CI, confidence interval; DM, diabetes mellitus; HC, historical cohort; HR, hazard ratio.
age at the time of surgery, as well as increasing graft diameter, and diminished by a history of prior open aortic surgery. The risk of MALE is associated independently with decreasing graft diameter. Thus, the identification of these at-risk patient groups should guide preoperative counseling and decision making, and may be considered when determining postoperative graft surveillance protocols. The patency and outcomes of ABFB in the CC highlights the importance of maintaining a pipeline of capable open-aortic surgeons.
AUTHOR CONTRIBUTIONS Conception and design: GS, SS, MM, CO, MB Analysis and interpretation: GS, RS, SS, DA, AM Data collection: Not applicable Writing the article: GS, DA Critical revision of the article: GS, RS, SS, DA, MM, CO, MB, AM Final approval of the article: GS, RS, SS, DA, MM, CO, MB, AM Statistical analysis: GS, RS, AM Obtained funding: Not applicable Overall responsibility: GS GS and RS contributed equally to this article and share co-first authorship.
REFERENCES 1. de Vries SO, Hunink MG. Results of aortic bifurcation grafts for aortoiliac occlusive disease: a meta-analysis. J Vasc Surg 1997;26:558-69. 2. McDaniel MD, Macdonald PD, Haver RA, Littenberg B. Published results of surgery for aortoiliac occlusive disease. Ann Vasc Surg 1997;11:425-41. 3. Ballard JL, Bergan JJ, Singh P, Yonemoto H, Killeen JD. Aortoiliac stent deployment versus surgical reconstruction: analysis of outcome and cost. J Vasc Surg 1998;28:94-101; discussion: 101-3. 4. Onohara T, Komori K, Kume M, Ishida M, Ohta S, Takeuchi K, et al. Multivariate analysis of long-term results after an axillobifemoral and aortobifemoral bypass in patients with aortoiliac occlusive disease. J Cardiovasc Surg (Torino) 2000;41:905-10. 5. Faries PL, LoGerfo FW, Hook SC, Pulling MC, Akbari CM, Campbell DR, et al. The impact of diabetes on arterial reconstructions for multilevel arterial occlusive disease. Am J Surg 2001;181:251-5. 6. Mingoli A, Sapienza P, Feldhaus RJ, Di Marzo L, Burchi C, Cavallaro A. Comparison of femorofemoral and aortofemoral bypass for aortoiliac occlusive disease. J Cardiovasc Surg (Torino) 2001;42:381-7. 7. Dimick JB, Cowan JA Jr, Henke PK, Wainess RM, Posner S, Stanley JC, et al. Hospital volume-related differences in aorto-bifemoral bypass operative mortality in the United States. J Vasc Surg 2003;37:970-5.
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8. Reed AB, Conte MS, Donaldson MC, Mannick JA, Whittemore AD, Belkin M. The impact of patient age and aortic size on the results of aortobifemoral bypass grafting. J Vasc Surg 2003;37:1219-25. 9. Back MR, Johnson BL, Shames ML, Bandyk DF. Evolving complexity of open aortofemoral reconstruction done for occlusive disease in the endovascular era. Ann Vasc Surg 2003;17:596-603. 10. Hertzer NR, Bena JF, Karafa MT. A personal experience with direct reconstruction and extra-anatomic bypass for aortoiliofemoral occlusive disease. J Vasc Surg 2007;45:527-35; discussion: 535. 11. Chiesa R, Marone EM, Tshomba Y, Logaldo D, Castellano R, Melissano G. Aortobifemoral bypass grafting using expanded polytetrafluoroethylene stretch grafts in patients with occlusive atherosclerotic disease. Ann Vasc Surg 2009;23:764-9. 12. Burke CR, Henke PK, Hernandez R, Rectenwald JE, Krishnamurthy V, Englesbe MJ, et al. A contemporary comparison of aortofemoral bypass and aortoiliac stenting in the treatment of aortoiliac occlusive disease. Ann Vasc Surg 2010;24:4-13. 13. Chiu KW, Davies RS, Nightingale PG, Bradbury AW, Adam DJ. Review of direct anatomical open surgical management of atherosclerotic aorto-iliac occlusive disease. Eur J Vasc Endovasc Surg 2010;39:460-71. 14. Bosch JL, Hunink MG. Meta-analysis of the results of percutaneous transluminal angioplasty and stent placement for aortoiliac occlusive disease. Radiology 1997;204: 87-96. 15. Upchurch GR, Dimick JB, Wainess RM, Eliason JL, Henke PK, Cowan JA, et al. Diffusion of new technology in health care: the case of aorto-iliac occlusive disease. Surgery 2004;136: 812-8. 16. Kashyap VS, Pavkov ML, Bena JF, Sarac TP, O’Hara PJ, Lyden SP, et al. The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction. J Vasc Surg 2008;48:1451-1457, 1457.e1-1457.e3. 17. Indes JE, Mandawat A, Tuggle CT, Muhs B, Sosa JA. Endovascular procedures for aortoiliac occlusive disease are associated with superior short-term clinical and economic outcomes compared with open surgery in the inpatient population. J Vasc Surg 2010;52:1173-9. 18. Jongkind V, Akkersdijk GJ, Yeung KK, Wisselink W. A systematic review of endovascular treatment of extensive aortoiliac occlusive disease. J Vasc Surg 2010;52:1376-83. 19. Farber A, Eberhardt RT. The current state of critical limb ischemia: a systematic review. JAMA Surg 2016;151:1070-7. 20. Bredahl K, Jensen LP, Schroeder TV, Sillesen H, Nielsen H, Eiberg JP. Mortality and complications after aortic bifurcated bypass procedures for chronic aortoiliac occlusive disease. J Vasc Surg 2015;62:75-82. 21. Nowygrod R, Egorova N, Greco G, Anderson P, Gelijns A, Moskowitz A, et al. Trends, complications, and mortality in peripheral vascular surgery. J Vasc Surg 2006;43:205-16.
22. Kwolek CJ, Clagett GP. Changing demographics in patients with vascular disease. J Vasc Surg 2009;49:528-31. 23. McGory ML, Kao KK, Shekelle PG, Rubenstein LZ, Leonardi MJ, Parikh JA, et al. Developing quality indicators for elderly surgical patients. Ann Surg 2009;250:338-47. 24. U.S. Department of Health and Human Services. The health consequences of smoking: 50 years of progress: a report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014. Available at: https://www.surgeongeneral.gov/library/reports/50-years-ofprogress/full-report.pdf. Accessed May 3, 2018. 25. Goodney PP, Tarulli M, Faerber AE, Schanzer A, Zwolak RM. Fifteen-year trends in lower limb amputation, revascularization, and preventive measures among Medicare patients. JAMA Surg 2015;150:84-6. 26. Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, et al. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg 2009;50:1462-73.e1-1473.e3. 27. Chang RW, Goodney PP, Baek JH, Nolan BW, Rzucidlo EM, Powell RJ. Long-term results of combined common femoral endarterectomy and iliac stenting/stent grafting for occlusive disease. J Vasc Surg 2008;48:362-7. 28. Indes JE, Pfaff MJ, Farrokhyar F, Brown H, Hashim P, Cheung K, et al. Clinical outcomes of 5358 patients undergoing direct open bypass or endovascular treatment for aortoiliac occlusive disease: a systematic review and metaanalysis. J Endovasc Ther 2013;20:443-55. 29. Madenci AL, Ozaki CK, Gupta N, Raffetto JD, Belkin M, McPhee JT. Perioperative outcomes of elective inflow revascularization for lower extremity claudication in the American College of Surgeons National Surgical Quality Improvement Program database. Am J Surg 2016;212: 461-7.e2. 30. McPhee JT, Madenci A, Raffetto J, Martin M, Gupta N. Contemporary comparison of aortofemoral bypass to alternative inflow procedures in the Veteran population. J Vasc Surg 2016;64:1660-6. 31. Kavanagh CM, Heidenreich MJ, Albright JJ, Aziz A. Hybrid external iliac selective endarterectomy surgical technique and outcomes. J Vasc Surg 2016;64:1327-34. 32. Mingoli A, Sapienza P, Feldhaus RJ, di Marzo L, Burchi C, Cavallaro A. Aortoiliofemoral bypass graft in young adults: long-term results in a series of sixty-eight patients. Surgery 1997;121:646-53. Submitted Jun 20, 2017; accepted Jan 22, 2018.
Additional material for this article may be found online at www.jvascsurg.org.
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Supplementary Table I (online only). Unadjusted univariate and adjusted Cox proportional hazards regression model for association of patient and procedure characteristics with loss of primary-assisted patency Unadjusted analysis Variable
HR (95% CI)
Adjusted analysis
P
HR (95% CI)
P
Cohort HC
Ref
CC
2.58 (1.33-5.04)
.005
6.61 (2.49-17.56)
.0002
0.92 (0.90-0.95)
<.0001
0.93 (0.90-0.97)
.0002
3.98 (1.39-11.33)
.01
26.54 (7.57-93.06)
<.0001
0.69 (0.52-0.93)
.01
Increased age
Ref
Sex Male Female Non-white race
1.60 (0.84-3.04)
.15
0.40 (0.17-0.98)
.045
DM
1.48 (0.72-3.06)
.29
Smoking history
2.24 (0.87-5.74)
.09
Indication Claudication 1.24 (0.66-2.35)
.50
Prior open aortic surgery
CLI
7.38 (3.36-16.21)
<.0001
Prior open iliofemoral surgery
2.82 (1.24-6.42)
.01
Prior AI endovascular intervention
1.79 (0.73-4.39)
.20
0.59 (0.10-3.39)
.55
Increased preoperative ABI Proximal anastomotic configuration End-to-end
2.43 (1.27-4.64)
.007
Increased graft size
End-to-side
0.67 (0.54-0.83)
.0002
Outflow procedure
0.93 (0.46-1.90)
.85
Major morbidity
1.02 (0.31-3.32)
.97
ABI, Ankle-brachial index; AI, aortoiliac; CC, contemporary cohort; CI, confidence interval; CLI, critical limb ischemia; DM, diabetes mellitus; HC, historical cohort; HR, hazard ratio.
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Supplementary Table II (online only). Unadjusted univariate and adjusted Cox proportional hazards regression model for association of patient and procedure characteristics with loss of secondary patency Unadjusted analysis Variable
HR (95% CI)
Adjusted analysis
P
HR (95% CI)
P
Cohort HC CC Increased age
Ref
Ref
3.75 (1.45-9.71)
.006
0.96 (0.92-1.01)
.10
5.09 (1.61-16.10)
.006
Sex Male Female Non-white race DM Smoking history
1.89 (0.73-4.88)
.19
0.56 (0.13-2.44)
.44
1.56 (0.56-4.40)
.40
13.41 (1.84-1708.3)
.80
Indication Claudication 3.01 (1.13-8.04)
.03
Prior open aortic surgery
CLI
3.74 (1.08-12.97)
.04
Prior open iliofemoral surgery
1.50 (0.34-6.53)
.59
Prior AI endovascular intervention
1.75 (0.49-6.19)
.39
0.27 (0.02-3.27)
.30
Increased preoperative ABI Proximal anastomotic configuration End-to-end End-to-side Increased graft size
2.11 (0.83-5.36) 0.57 (0.43-0.77)
.12 .0002
Outflow procedure
1.18 (0.43-3.19)
.75
Major morbidity
1.63 (0.38-7.12)
.51
ABI, Ankle-brachial index; AI, aortoiliac; CC, contemporary cohort; CI, confidence interval; CLI, critical limb ischemia; DM, diabetes mellitus; HR, hazard ratio.
Thirty-year trends in aortofemoral bypass for aortoiliac occlusive disease Gaurav Sharma, MD, Rebecca E. Scully, MD, MPH, Samir K. Shah, MD, Arin L. Madenci, MD, MPH, Dean J. Arnaoutakis, MD, MBA, Matthew T. Menard, MD, C. Keith Ozaki, MD, and Michael Belkin, MD, Boston, Mass
ABSTRACT Objective: Endovascular intervention has supplanted open bypass as the most frequently used approach in patients with aortoiliac segment atherosclerosis. We sought to determine whether this trend together with changing demographic and clinical characteristics of patients undergoing aortobifemoral bypass (ABFB) for aortoiliac occlusive disease (AOD) have an association with postoperative outcomes. Methods: Using a prospectively maintained institutional database, we identified patients who underwent ABFB for AOD from 1985 to 2015. Patients were divided into two cohorts: the historical cohort (HC) included patients who underwent ABFB for AOD from 1985 to 1999 and the contemporary cohort (CC) who underwent ABFB for AOD from 2000 to 2015. Medical and demographic data, procedural information, postoperative complications, and follow-up data were extracted. Cox proportional hazards regression was used to evaluate associations with the end point of primary patency. A similar analysis was performed for major adverse limb events (MALEs; the composite of above-ankle amputation, major reintervention, graft revision, or new bypass graft of the index limb) in the subset of patients with critical limb ischemia. Results: There were a total of 359 cases: 226 in the HC and 133 in the CC. The CC had more women (56.4% vs 43.8%; P ¼ .02), smokers (87.2% vs 67.7%; P ¼ .001), and patients who failed prior aortoiliac endovascular intervention (17.3% vs 4.8%; P ¼ .0001), but fewer patients with coronary artery disease (32.3% vs 47.3%; P ¼ .005). Thirty-day mortality was less than 1% in both cohorts, but 10-year survival was higher in the CC (67.7% vs 52.6%; P ¼ .02). Five-year primary, primaryassisted, and secondary patency were higher in the HC (93.3% vs 82.2%; P ¼ .005; 93.8% vs 85.7%; P ¼ .02; 97.5% vs 90.4%; P ¼ .02, respectively). CC membership, decreasing age, prior aortic surgery, and decreasing graft diameter were significant independent predictors of loss of primary patency after adjustment (hazard ratio [HR], 7.03; 95% confidence interval [CI], 2.80-17.63; P < .0001; HR, 0.93; 95% CI, 0.90-0.96; P < .0001; HR, 18.80; 95% CI, 5.94-59.58; P < .0001; and HR, 0.73; 95% CI, 0.55-0.95; P ¼ .02, respectively). Similarly, CC membership, prior aortic surgery, and decreasing graft diameter were significant independent predictors of MALE in the critical limb ischemia cohort after adjustment (HR, 21.13; 95% CI, 4.20-106.40; P ¼ .0002; HR, 40.40; 95% CI, 3.23-505.61; P ¼ .004; and HR, 0.51; 95% CI, 0.30-0.86; P ¼ .01, respectively). Conclusions: Compared with the pre-endovascular era, demographic and clinical characteristics of patients undergoing ABFB for AOD in the CC have changed. Although long-term patency is slightly lower among patients in the CC during which a substantial subset of AOD patients are being treated primarily via the endovascular approach, durability remains excellent and limb salvage unchanged. After adjustment, the time period of index ABFB independently predicted primary patency and MALE, as did graft diameter and prior aortic surgery. These changing characteristics should be considered when counseling patients and benchmarking for reintervention rates and other outcomes. (J Vasc Surg 2018;-:1-9.) Keywords: Peripheral arterial disease; Aortobifemoral bypass
Aortobifemoral bypass (ABFB) has long been the gold standard therapy for aortoiliac occlusive disease (AOD). Historic studies reported surgical mortality ranging from 0.1% to 4.6%, and 5-year patency rates from 80%
to 97%.1-13 Endovascular interventions have experienced perhaps their greatest proliferation in the treatment of aortoiliac segment disease and now largely have supplanted ABFB as the first-line modality in AOD.14-19
From the Division of Vascular and Endovascular Surgery, Brigham and
and Vascular Center, 75 Francis St, Boston, MA 02115 (e-mail: mbelkin@
Women’s Heart and Vascular Center, Harvard Medical School. Author conflict of interest: none.
partners.org). The editors and reviewers of this article have no relevant financial
Presented at the 2017 Vascular and Endovascular Surgery Society Spring
relationships to disclose per the JVS policy that requires reviewers
Meeting Plenary Session at the 2017 Vascular Annual Meeting of the Society
to decline review of any manuscript for which they may have a
for Vascular Surgery, San Diego, Calif, May 31-June 3, 2017. Additional material for this article may be found online at www.jvascsurg.org. Correspondence: Michael Belkin, MD, Chief, Division of Vascular and Endovascular Surgery, Department of Surgery, Brigham and Women’s Heart
conflict of interest. 0741-5214 Copyright Ó 2018 by the Society for Vascular Surgery. Published by Elsevier Inc. https://doi.org/10.1016/j.jvs.2018.01.067
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This has raised concerns that outcomes of ABFB might decline as open surgical bypass becomes increasingly reserved for failures of endovascular therapy and for disease anatomy not amenable to catheter-based approaches.20 Concomitantly, substantial changes in patient demographics and clinical characteristics that may impact outcomes also have occurred.21-24 We sought to determine whether these trends were associated with a shift in the profile and outcomes of patients undergoing ABFB for AOD by leveraging a longitudinal institutional database spanning over 3 decades. We hypothesized that limb-related outcomes would be impacted negatively by these shifting characteristics.
2018
ARTICLE HIGHLIGHTS d
d
d
Type of Research: Retrospective study of a prospectively maintained database Take Home Message: In 359 patients who underwent aortobifemoral bypass for occlusive disease over 30 years, demographic and clinical characteristics have changed. Graft diameter and prior aortic surgery were independent predictors of patency and major adverse limb events after adjustment. Recommendation: The authors suggest to consider prior aortic surgery and graft diameter when counseling patients and benchmarking for reintervention rates and other outcomes.
METHODS Study participants, follow-up evaluation, and exposure variables. The study included all patients undergoing ABFB for AOD as determined by preoperative conventional aortography, computed tomographic imaging, or magnetic resonance angiography at a single academic medical center from 1985 to 2015. Demographic and clinical data, as well as procedural details and postoperative morbidity, mortality, and reinterventions were collected in a prospectively maintained registry. Previous work analyzing Medicare claims data from 1996 to 2010 has shown that the predominant therapeutic approach to lower-extremity revascularization for peripheral arterial disease shifted from open surgery to endovascular intervention in approximately 2000.15,25 Thus, participants were grouped into two cohorts, as follows: the historic cohort (HC), which underwent index ABFB between 1985 and 1999, and the contemporary cohort (CC), which underwent index ABFB between 2000 and 2015. Patients were followed up at 2 weeks, 6 months, 12 months, and annually thereafter. Patency was assessed by clinical history and physical examination, as well as arterial pressure measurements at annual visits. Depending on surgeon preference, a computed tomography arteriogram was obtained at 1 and 5 years after surgery. If there was any concern about graft patency, imaging with ultrasound or computed tomography arteriogram was obtained. Proximal and distal (limb) diameter was correlated consistently by a 2:1 ratio. Thus, proximal graft diameter was used for analyses and treated as an ordinal variable. The study protocol was approved by the Partners Human Research Committee Institutional Review Board, which determined that patients’ informed consent to participate was not required. Outcome measures. Our primary outcome of interest was primary patency. In addition, for the subset of patients with critical limb ischemia (CLI), we explored major adverse limb events (MALE) (the composite of above-ankle amputation or major reintervention such as thrombectomy/thrombolysis, graft revision, or new bypass graft of the index limb) based on recent
recommendations for efficacy end points.26 Secondary outcomes were complications such as surgical site infections and postoperative cardiovascular events, mortality, and quality metrics including readmissions. Statistical analysis. Baseline characteristics and postoperative outcomes of the two cohorts were compared using c2 testing for categorical variables, and the Student t-test vs Wilcoxon rank sum testing for continuous variables, based on normality of distribution. Kaplan-Meier analyses were used to examine patency and survival. These were compared between cohorts using the log-rank test. We then constructed a multivariable Cox proportional hazards regression model for the primary outcome in the complete cohort, as well as MALE in the subset of patients with CLI. In the multivariate analysis, patients in the contemporary and historic cohorts were aggregated. Variable selection proceeded by using a stepwise selection process of clinically relevant variables. Criteria for entry into the stepwise process had a P value <.30 and criteria for maintenance in the multivariable model was P < .05. Age and preoperative ankle-brachial index were treated as continuous variables whereas graft size was an ordinal variable. All statistical analyses were conducted using SAS software, version 9.4 (SAS Institute, Inc, Cary, NC). An a value #0.05 was considered statistically significant for all analyses.
RESULTS A total of 359 patients underwent ABFB: 226 in the HC and 133 in the CC. Both cohorts were similar in terms of mean age and prevalence of diabetes and chronic obstructive pulmonary disease (Table I). The CC had more women, smokers, patients on dialysis, and patients with hypertension (Table I). However there were fewer patients with coronary artery disease. Preoperative statin, b-blocker, and aspirin use was higher in the CC (Table I). CLI was more prevalent in the CC, accounting for the indication for ABFB in approximately 50% of cases. However, this difference between cohorts did not reach
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Table I. Background characteristics and indications for aortofemoral bypass in the historical cohort (HC; 1985-1999) vs contemporary cohort (CC; 2000-2015) Variable
HC 1985-1999 (n ¼ 226)
CC 2000-2015 (n ¼ 133)
P
Demographic characteristics Mean age, years (SD)
60.5 (12)
Female
99 (43.8)
60.2 (15) 75 (56.4)
.30 .02
Comorbidity Diabetes
47 (20.8)
28 (21.1)
.95
Smoking
153 (67.7)
116 (87.2)
.001
Hypertension
120 (53.1)
93 (69.9)
.002
Coronary artery disease
107 (47.3)
43 (32.3)
.005
Congestive heart failure
15 (6.6)
10 (7.5)
.75
Chronic obstructive pulmonary disease
42 (18.6)
27 (20.3)
.69
Chronic renal insufficiency
8 (3.5)
6 (4.5)
.65
Dialysis
0 (0.0)
4 (3.0)
.009
Preoperative medications Statin
48 (21.3)
92 (69.2)
.001
b-blocker
27 (11.9)
82 (61.7)
.001
Aspirin
66 (29.2)
92 (69.2)
.001
Intermittent claudication
134 (59.3)
66 (49.6)
.07
CLI
92 (40.7)
67 (50.4)
.07
Open abdominal aortic surgery
13 (5.8)
2 (1.5)
.05
Open iliofemoral surgery
13 (5.8)
15 (11.3)
.06
Prior aortoiliac endovascular intervention
11 (4.8)
23 (17.3)
.0001
Indication
Prior revascularization
CLI, Critical limb ischemia; SD, standard deviation. Data are shown as numbers, with percentages for categorical variables and SD for continuous variables in parentheses.
statistical significance (P ¼ .07). Patients in the CC were more likely to have undergone prior endovascular intervention, although differences in prior open surgical procedures were not significant (Table I). In terms of procedural characteristics, there were more end-to-side proximal anastomoses (53.4% vs 31%; P ¼ .001) in the CC compared with the HC. Fifty percent of patients who had undergone prior aortoiliac endovascular intervention underwent ABFB with end-to-side proximal anastomotic configuration vs 38% who had not undergone prior endovascular therapy. The mean estimated blood loss, distal anastomotic target vessel, and rates of concomitant visceral revascularization procedure were similar. There were more concomitant femoral endarterectomies and profundaplasties in the CC (Table II). Proximal graft diameter also was similar (mean 6 standard deviation, 16 6 1.51 mm vs 16 6 1.45 mm; P ¼ .07; Table II). The median follow-up period was 106.6 and 41.0 months in the HC and CC, respectively. In total, 176 (77.9%) patients in the HC and 59 (44.4%) patients in the CC had complete 5-year follow-up evaluation. Overall and major morbidity within 30 days of aortofemoral bypass were
similar in both cohorts (Table III). Thirty-day readmission and reintervention were significantly higher in the CC (Table III). Reasons for reintervention included thrombectomy for unilateral graft limb thrombosis within 24 hours of index ABFB (in three 16- 8-mm grafts and one 14- 7-mm graft), reoperation for retroperitoneal hemorrhage in one patient, and groin washout and tissue transfer in another patient. The most common reasons for readmission were groin wound complications in 14 of the 32 readmitted patients; other reasons included smallbowel obstruction vs ileus, graft-related complications (limb thrombosis or infection), abdominal pain of unclear etiology, and congestive heart failure exacerbation. Thirty-day mortality was similar and less than 1% in both cohorts and 5-year survival was similar, but 10-year survival was higher in the CC (67.7% vs 52.6%; P ¼ .02). At 5 years, secondary patency exceeded 90% in both cohorts, primary, primary-assisted, and secondary patency all were higher in the HC (Table III; Fig). Primary patency was 56% for 12- 6-mm grafts, 85% for 14- 7-mm grafts, 89% for 16- 8-mm grafts, and 100% for 18- 9-mm and larger grafts. The number of 14- 7-mm grafts was similar in patients with end-to-end configurations
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Table II. Procedural characteristics of aortofemoral bypass in the historical cohort (HC; 1985-1999) vs contemporary cohort (CC; 2000-2015) Variable
HC 1985-1999 (n ¼ 226)
CC 2000-2015 (n ¼ 133)
222 (98.2)
133 (100)
4 (1.8)
0 (0)
P
Conduit type Polyester, No. (SD) PTFE, No. (SD)
>.99
Proximal anastomotic configuration, No. (%) End-to-end
156 (69.0)
62 (46.6)
End-to-side
70 (31.0)
71 (53.4)
.001
Common femoral/common femoral
189 (83.7)
114 (85.7)
.60
Common femoral/profundal femoral
10 (4.4)
3 (2.2)
.29
Common femoral/superficial femoral
3 (1.3)
5 (3.8)
.13
Profunda femoral/profundal femoral
14 (6.2)
7 (5.3)
.72
Profunda femoral/superficial femoral
3 (1.3)
1 (0.8)
.62
Superficial femoral/superficial femoral
7 (3.1)
3 (2.2)
.64 .07
Distal anastomotic locations, No. (%)
Graft size, No. (%) 12 6 mm
8 (3.5)
8 (6.0)
14 7 mm
78 (34.5)
47 (35.3)
16 8 mm
121 (53.5)
73 (54.9)
18 9 mm
15 (6.6)
4 (3.0)
20 10 mm
2 (0.9)
22 11 mm
2 (0.9)
1 (0.8) 0 (0)
Concomitant visceral revascularization
18 (8.0)
7 (5.3)
Concomitant femoral endarterectomy or profundaplasty
69 (30.5)
69 (51.9)
.33 .001
PTFE, Polytetrafluoroethylene; SD, standard deviation.
(69/218; 32%) and end-to-side configurations (56/141; 39%; Table II). Limb salvage rates were similar in both groups and exceeded 98% (Table III). To control for differences in baseline patient and procedural characteristics in the two cohorts, we performed multivariate Cox proportional hazards regression analysis. Our primary outcome was primary patency. Multiple regression modeling showed that membership in the CC, younger age, prior aortic surgery history, and decreasing graft diameter were associated independently with loss of primary patency after adjustment (Table IV). Similar relationships were discovered between these predictors and loss of primary-assisted patency (Supplementary Table I, online only). In addition, non-white race was associated independently with loss of primary-assisted patency. Only membership in the CC was associated with loss of secondary patency after adjustment (Supplementary Table II, online only). Indication for surgery (claudication vs CLI) was not associated independently with patency end points (Table IV; Supplementary Tables I and II, online only). We also performed similar analysis of the end point of MALE in the subset of patients who underwent ABFB for CLI (Table V). As with primary and primary-assisted patency, membership in the contemporary cohort, prior
open aortic surgery, and decreased graft size all were independent predictors of MALE after adjustment (Table V).
DISCUSSION Here, we compared changing patient characteristics as well as short- and long-term postoperative outcomes in a prospectively maintained database of patients undergoing ABFB for AOD in the period before and after widespread proliferation of endovascular therapy. We found fewer total ABFB in the modern era, as well as shifts in patient demographics, clinical characteristics, and indications for surgery. Long-term patency was high in both cohorts. The era during which the index ABFB occurred, as well as graft diameter and a history of prior open aortic surgery, but not previous aortoiliac endovascular intervention, were associated with primary patency in the broader cohort of patients and MALE in CLI patients after adjustment by multivariate Cox proportional hazards regression. Surgery during the contemporary period, decreasing graft diameter, and a history of prior aortic surgery all independently predicted loss of primary patency and MALE. In addition, younger age was associated independently with loss of primary patency.
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Table III. Outcomes of aortofemoral bypass in the historical cohort (HC; 1985-1999) vs contemporary cohort (CC; 2000-2015) cohorts HC 1985-1999 (n ¼ 226)
CC 2000-2015 (n ¼ 133)
Overall
65 (28.8)
38 (28.6)
Major
18 (8.0)
14 (10.5)
.41
4 (1.8)
5 (3.8)
.24
Renal failure
7 (3.1)
3 (2.2)
.64
Surgical site infectiona
8 (3.5)
1 (0.8)
.26
Variable
P
Morbidity (within 30 days of aortofemoral bypass), No. (%)
Myocardial infarction
.14
Quality metrics, No. (%) 30-Day readmission 30-Day reintervention
12 (5.3) 1 (0.4)
20 (15)
.002
5 (3.8)
.02
Survival 30-Day mortality
0.4%
0.8%
.70
5-Year survival
80.5%
77.2%
.13
10-Year survival
52.6%
67.7%
.02
Primary
93.3%
82.2%
.005
Primary-assisted
93.8%
85.7%
.02
Secondary
97.5%
90.4%
.02
Limb salvage
99.5%
98.1%
.13
5-Year patency and limb salvage
SD, Standard deviation. a Only surgical site infections requiring surgical intervention were recorded prospectively.
Our findings are consistent with and extend those of previous investigators. Recent work has focused on comparison of open revascularization with alternative inflow procedures, such as a hybrid approach to AOD combining conventional open femoral endarterectomy with endovascular iliac interventions. A singleinstitution report of hybrid approaches found a 30-day mortality of 2.3%.27 Longitudinal data from registries and pooled analyses focused on open revascularization alone reported 2.7% to 3.6% 30-day mortality rates.20,28 Similarly, analysis of the American College of Surgeons National Surgical Quality Improvement Program database found a 30-day mortality rate of 2.7% for ABFB.29 This was significantly higher than alternative revascularization strategies after propensity-matched analysis.29 In contrast, in a retrospective analysis of the Veterans Affair population, McPhee et al30 reported that ABFB mortality at 30 and 90 days was 2.7% and 2.9%, respectively. At 90 days, this mortality rate was not significantly different than alternative inflow proceduresda group that included femoral endarterectomy with iliac angioplasty and stenting (90-day mortality, 2.1%).30 Here, we found that short-term mortality was less than 1% after ABFB in both contemporary and historic cohorts in our study. The differences in mortality found in other work may be owing in part to differences in patient selection. Although previous reports have shown increased American Society of Anesthesia scores in modern series of patients undergoing ABFB compared with those undergoing endovascular therapy,29 we found decreased rates
of cardiovascular disease in our CC compared with the HC. This, coupled with superior medical optimization as suggested by differences in preoperative medications between the cohorts in our study, may account for the lower 10-year mortality in the former. This also seems to reinforce the concept that in the contemporary era, the ability to offer patients a less-invasive, endovascular option has altered the risk-benefit balance of ABFB for higher-risk individuals. Although many of the aforementioned reports were restricted to patients with intermittent claudication, some have consisted wholly of patients with CLI.20 Our study included both CLI patients and claudicants. There was a trend toward more CLI in the CC, but no difference was found in mortality compared with the HC. In our unadjusted analyses, primary, primary-assisted, and secondary patency all were higher in the HC than the CC. This finding was borne out in our adjusted analyses; membership in the CC carried a five- to sevenfold hazard of loss of patency, and a 21-fold hazard of MALE in the CLI subgroup. Patency rates in the CC were consistent with those reported in a large pooled analysis comparing 3733 patients undergoing open surgical revascularization for AOD with 1625 patients undergoing endovascular intervention.28 The differences in patency may reflect increased complexity given the aforementioned trend toward CLI, the possibility of more extensive iliofemoral disease suggested by an increasing use of end-to-side aortic anastomoses in the modern era, increased rates of concomitant femoral
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Fig. Kaplan-Meier survival curves showing (A) primary patency, (B) primary assisted patency, (C) secondary patency, (D) major adverse limb event (MALE)-free survival in the historic cohort (HC; solid line) vs the contemporary cohort (CC; dashed line).
endarterectomies and profundaplasties, and the fact that more patientsdnearly one in fivedin the CC had failed prior endovascular aortoiliac intervention (although some of these differences may reflect differing provider preferences in the HC vs the CC). Such complexity also may account in part for the higher short-term reintervention rate and 30-day readmission rate among patients in the CC. However despite the need for more interventions and higher readmissions in the CC, limb salvage was similar in the two cohorts. In terms of patency rates in patients undergoing alternative inflow procedures, retrospective analysis of 171 patients who underwent intervention for 193 AOD lesions at a single institution showed excellent 5-year secondary patency of 98%.27 However, the median follow-up period for the study population was 24 months; the number at risk at the 5-year time point was not reported but was somewhere between 9% and 21%.27 Repeat interventions were required in 24% of patients.27 In adjusted analyses, we found that history of prior aortic surgery and decreasing graft diameter were independent predictors of loss of primary patency. Hertzer et al10 reported the results of a large, single-surgeon’s personal series of 355 direct anatomic open revascularizations for AOD over a 27-year period ending in 2002. Their
analyses included 181 additional patients undergoing extra-anatomic bypass, with significant baseline differences between these patients and the direct revascularization group as expected.10 In multivariate analyses they found that after adjustment for type of reconstruction (anatomic vs extra-anatomic), female sex was associated with an increased odds of short-term graft thrombosis and major amputation. Analysis of long-term end points in the single-surgeon series showed decreased age and prior inflow procedures as predictors of late graft failure.10 In addition, advanced ischemia was associated with an increased odds ratio of major amputation.10 Previous work also has shown decreased primary and secondary patency rates among patients younger than 50 years old, leading investigators to hypothesize that this younger cohort manifests AOD with a more virulent natural history.8,31,32 Age showed a similar association with loss of primary and primary-assisted patency after adjustment for other covariates in our study. As in the series by Hertzer et al,10 we also found that prior aortic surgery was a significant predictor of diminished primary and primary-assisted patency. Finally, Reed et al8 showed that smaller aortic diameter was linked independently to decreased long-term patency in patients undergoing ABFB. Here, we similarly report that increasing graft
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Table IV. Unadjusted univariate and adjusted Cox proportional hazards regression model for association of patient and procedure characteristics with loss of primary patency Unadjusted analysis Variable
HR (95% CI)
Adjusted analysis
P
HR (95% CI)
P
Cohort HC
Ref
CC
3.10 (1.66-5.79)
Increased age
0.93 (0.90-0.95)
Ref .0004
7.03 (2.80-17.63)
<.0001
<.0001
0.93 (0.90-0.96)
<.0001
18.80 (5.94-59.58)
<.0001
0.73 (0.55-0.95)
.02
Sex Male Female Non-white race
1.84 (1.01-3.32)
.05
0.54 (0.22-1.29)
.16
DM
1.30 (0.66-2.57)
.45
Smoking history
1.86 (0.83-4.17)
.13
Indication Claudication CLI Prior open aortic surgery
1.06 (0.59-1.90)
.85
5.95 (2.76-12.84)
<.0001
Prior open iliofemoral surgery
2.31 (1.03-5.17)
.04
Prior AI endovascular intervention
1.70 (0.74-3.87)
.21
Increased preoperative ABI
1.27 (0.25-6.37)
.77
Proximal anastomotic configuration End-to-end 2.17 (1.21-3.90)
.009
Increased graft size
End-to-side
0.71 (0.58-0.86)
.0006
Outflow procedure
0.82 (0.42-1.61)
.57
Major morbidity
0.86 (0.27-2.77)
.80
ABI, Ankle-brachial index; AI, aortoiliac; CC, contemporary cohort; CI, confidence interval; CLI, critical limb ischemia; DM, diabetes mellitus; HC, historical cohort; HR, hazard ratio.
diameter was protective of MALE, primary, and primaryassisted patency, even after adjustment for other potential predictors. Our findings must be interpreted within the context of the study design. We describe the experience of a single center, thus potentially limiting the external validity of our findings. Furthermore, although all analyses were based on prospectively collected data, the study itself was retrospective in nature; results therefore are associative and causal inferences cannot be made definitively. Although we adjusted for all clinically relevant confounders via multivariate regression analysis, such techniques cannot eliminate the effect of unmeasured covariates. Although all lesions were TransAtlantic Inter-Society Consensus C or D, the specific classification could not be determined for a significant percentage of patients and thus was omitted from analysis. Although the event-per-variable ratio of less than 10 held in the case of the primary outcome of primary patency and MALE, it did not in the case of primary-assisted patency data, potentially resulting in overfitting for that end point. For secondary patency,
only cohort membership independently predicted loss of patency; this may have resulted from the low event rate and/or collinearity of cohort and other variables as potentially suggested by the trend toward lower graft size in the CC. Finally, endovascular techniques and devices, as well as operator efficaciousness in their use, are in continual evolution. Thus, there may be heterogeneity in outcomes within the CC that obscure overall results.
CONCLUSIONS Demographic and clinical characteristics as well as a history of prior intervention and procedural details have shifted in patients undergoing ABFB in the endovascular era compared with those in the HC. This changing complexity should be considered as benchmarks used to assess the quality of revascularization in AOD are established. Performance on quality metrics, survival, and patency all have been affected in the modern era. Despite this increasing complexity, ABFB remains a durable option with high long-term patency. Increased patency is associated independently with increasing
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Table V. Unadjusted univariate and adjusted multivariate Cox proportional hazards regression model for association of critical limb ischemia (CLI) patient and procedure characteristics with major adverse limb event (MALE; composite of above-ankle amputation or major reintervention such as thrombectomy/thrombolysis, graft revision, or new bypass graft of the index limb) Unadjusted analysis Variable
HR (95% CI)
Adjusted analysis
P
P
HR (95% CI)
Cohort HC CC Increased age
Ref
Ref
5.88 (2.25-15.36)
.0003
0.97 (0.93-1.01)
.15
21.13 (4.20-106.40)
.0002
Sex Male Female Non-white race
3.00 (1.32-6.84)
.009
0.46 (0.14-1.56)
.21
DM
1.38 (0.57-3.36)
.48
Smoking history
3.34 (0.79-14.20)
.10
Prior open aortic surgery
6.43 (1.88-22.01)
.003
Prior open iliofemoral surgery
1.34 (0.31-5.77)
.69
Prior AI endovascular intervention
1.08 (0.25-4.66)
.92
Increased preoperative ABI
0.18 (0.02-1.49)
.11
40.40 (3.23-505.61)
.004
Proximal anastomotic configuration End-to-end End-to-side Increased graft size
1.92 (0.87-4.26)
.11
0.51 (0.37-0.70)
<.001
Outflow procedure
1.85 (0.81-4.23)
.15
Major morbidity
0.81 (0.19-3.46)
.78
0.51 (0.30-0.86)
.01
ABI, Ankle-brachial index; AI, aortoiliac; CC, contemporary cohort; CI, confidence interval; DM, diabetes mellitus; HC, historical cohort; HR, hazard ratio.
age at the time of surgery, as well as increasing graft diameter, and diminished by a history of prior open aortic surgery. The risk of MALE is associated independently with decreasing graft diameter. Thus, the identification of these at-risk patient groups should guide preoperative counseling and decision making, and may be considered when determining postoperative graft surveillance protocols. The patency and outcomes of ABFB in the CC highlights the importance of maintaining a pipeline of capable open-aortic surgeons.
AUTHOR CONTRIBUTIONS Conception and design: GS, SS, MM, CO, MB Analysis and interpretation: GS, RS, SS, DA, AM Data collection: Not applicable Writing the article: GS, DA Critical revision of the article: GS, RS, SS, DA, MM, CO, MB, AM Final approval of the article: GS, RS, SS, DA, MM, CO, MB, AM Statistical analysis: GS, RS, AM Obtained funding: Not applicable Overall responsibility: GS GS and RS contributed equally to this article and share co-first authorship.
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8. Reed AB, Conte MS, Donaldson MC, Mannick JA, Whittemore AD, Belkin M. The impact of patient age and aortic size on the results of aortobifemoral bypass grafting. J Vasc Surg 2003;37:1219-25. 9. Back MR, Johnson BL, Shames ML, Bandyk DF. Evolving complexity of open aortofemoral reconstruction done for occlusive disease in the endovascular era. Ann Vasc Surg 2003;17:596-603. 10. Hertzer NR, Bena JF, Karafa MT. A personal experience with direct reconstruction and extra-anatomic bypass for aortoiliofemoral occlusive disease. J Vasc Surg 2007;45:527-35; discussion: 535. 11. Chiesa R, Marone EM, Tshomba Y, Logaldo D, Castellano R, Melissano G. Aortobifemoral bypass grafting using expanded polytetrafluoroethylene stretch grafts in patients with occlusive atherosclerotic disease. Ann Vasc Surg 2009;23:764-9. 12. Burke CR, Henke PK, Hernandez R, Rectenwald JE, Krishnamurthy V, Englesbe MJ, et al. A contemporary comparison of aortofemoral bypass and aortoiliac stenting in the treatment of aortoiliac occlusive disease. Ann Vasc Surg 2010;24:4-13. 13. Chiu KW, Davies RS, Nightingale PG, Bradbury AW, Adam DJ. Review of direct anatomical open surgical management of atherosclerotic aorto-iliac occlusive disease. Eur J Vasc Endovasc Surg 2010;39:460-71. 14. Bosch JL, Hunink MG. Meta-analysis of the results of percutaneous transluminal angioplasty and stent placement for aortoiliac occlusive disease. Radiology 1997;204: 87-96. 15. Upchurch GR, Dimick JB, Wainess RM, Eliason JL, Henke PK, Cowan JA, et al. Diffusion of new technology in health care: the case of aorto-iliac occlusive disease. Surgery 2004;136: 812-8. 16. Kashyap VS, Pavkov ML, Bena JF, Sarac TP, O’Hara PJ, Lyden SP, et al. The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction. J Vasc Surg 2008;48:1451-1457, 1457.e1-1457.e3. 17. Indes JE, Mandawat A, Tuggle CT, Muhs B, Sosa JA. Endovascular procedures for aortoiliac occlusive disease are associated with superior short-term clinical and economic outcomes compared with open surgery in the inpatient population. J Vasc Surg 2010;52:1173-9. 18. Jongkind V, Akkersdijk GJ, Yeung KK, Wisselink W. A systematic review of endovascular treatment of extensive aortoiliac occlusive disease. J Vasc Surg 2010;52:1376-83. 19. Farber A, Eberhardt RT. The current state of critical limb ischemia: a systematic review. JAMA Surg 2016;151:1070-7. 20. Bredahl K, Jensen LP, Schroeder TV, Sillesen H, Nielsen H, Eiberg JP. Mortality and complications after aortic bifurcated bypass procedures for chronic aortoiliac occlusive disease. J Vasc Surg 2015;62:75-82. 21. Nowygrod R, Egorova N, Greco G, Anderson P, Gelijns A, Moskowitz A, et al. Trends, complications, and mortality in peripheral vascular surgery. J Vasc Surg 2006;43:205-16.
22. Kwolek CJ, Clagett GP. Changing demographics in patients with vascular disease. J Vasc Surg 2009;49:528-31. 23. McGory ML, Kao KK, Shekelle PG, Rubenstein LZ, Leonardi MJ, Parikh JA, et al. Developing quality indicators for elderly surgical patients. Ann Surg 2009;250:338-47. 24. U.S. Department of Health and Human Services. The health consequences of smoking: 50 years of progress: a report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2014. Available at: https://www.surgeongeneral.gov/library/reports/50-years-ofprogress/full-report.pdf. Accessed May 3, 2018. 25. Goodney PP, Tarulli M, Faerber AE, Schanzer A, Zwolak RM. Fifteen-year trends in lower limb amputation, revascularization, and preventive measures among Medicare patients. JAMA Surg 2015;150:84-6. 26. Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, et al. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg 2009;50:1462-73.e1-1473.e3. 27. Chang RW, Goodney PP, Baek JH, Nolan BW, Rzucidlo EM, Powell RJ. Long-term results of combined common femoral endarterectomy and iliac stenting/stent grafting for occlusive disease. J Vasc Surg 2008;48:362-7. 28. Indes JE, Pfaff MJ, Farrokhyar F, Brown H, Hashim P, Cheung K, et al. Clinical outcomes of 5358 patients undergoing direct open bypass or endovascular treatment for aortoiliac occlusive disease: a systematic review and metaanalysis. J Endovasc Ther 2013;20:443-55. 29. Madenci AL, Ozaki CK, Gupta N, Raffetto JD, Belkin M, McPhee JT. Perioperative outcomes of elective inflow revascularization for lower extremity claudication in the American College of Surgeons National Surgical Quality Improvement Program database. Am J Surg 2016;212: 461-7.e2. 30. McPhee JT, Madenci A, Raffetto J, Martin M, Gupta N. Contemporary comparison of aortofemoral bypass to alternative inflow procedures in the Veteran population. J Vasc Surg 2016;64:1660-6. 31. Kavanagh CM, Heidenreich MJ, Albright JJ, Aziz A. Hybrid external iliac selective endarterectomy surgical technique and outcomes. J Vasc Surg 2016;64:1327-34. 32. Mingoli A, Sapienza P, Feldhaus RJ, di Marzo L, Burchi C, Cavallaro A. Aortoiliofemoral bypass graft in young adults: long-term results in a series of sixty-eight patients. Surgery 1997;121:646-53. Submitted Jun 20, 2017; accepted Jan 22, 2018.
Additional material for this article may be found online at www.jvascsurg.org.
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Supplementary Table I (online only). Unadjusted univariate and adjusted Cox proportional hazards regression model for association of patient and procedure characteristics with loss of primary-assisted patency Unadjusted analysis Variable
HR (95% CI)
Adjusted analysis
P
HR (95% CI)
P
Cohort HC
Ref
CC
2.58 (1.33-5.04)
.005
6.61 (2.49-17.56)
.0002
0.92 (0.90-0.95)
<.0001
0.93 (0.90-0.97)
.0002
3.98 (1.39-11.33)
.01
26.54 (7.57-93.06)
<.0001
0.69 (0.52-0.93)
.01
Increased age
Ref
Sex Male Female Non-white race
1.60 (0.84-3.04)
.15
0.40 (0.17-0.98)
.045
DM
1.48 (0.72-3.06)
.29
Smoking history
2.24 (0.87-5.74)
.09
Indication Claudication 1.24 (0.66-2.35)
.50
Prior open aortic surgery
CLI
7.38 (3.36-16.21)
<.0001
Prior open iliofemoral surgery
2.82 (1.24-6.42)
.01
Prior AI endovascular intervention
1.79 (0.73-4.39)
.20
0.59 (0.10-3.39)
.55
Increased preoperative ABI Proximal anastomotic configuration End-to-end
2.43 (1.27-4.64)
.007
Increased graft size
End-to-side
0.67 (0.54-0.83)
.0002
Outflow procedure
0.93 (0.46-1.90)
.85
Major morbidity
1.02 (0.31-3.32)
.97
ABI, Ankle-brachial index; AI, aortoiliac; CC, contemporary cohort; CI, confidence interval; CLI, critical limb ischemia; DM, diabetes mellitus; HC, historical cohort; HR, hazard ratio.
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Supplementary Table II (online only). Unadjusted univariate and adjusted Cox proportional hazards regression model for association of patient and procedure characteristics with loss of secondary patency Unadjusted analysis Variable
HR (95% CI)
Adjusted analysis
P
HR (95% CI)
P
Cohort HC CC Increased age
Ref
Ref
3.75 (1.45-9.71)
.006
0.96 (0.92-1.01)
.10
5.09 (1.61-16.10)
.006
Sex Male Female Non-white race DM Smoking history
1.89 (0.73-4.88)
.19
0.56 (0.13-2.44)
.44
1.56 (0.56-4.40)
.40
13.41 (1.84-1708.3)
.80
Indication Claudication 3.01 (1.13-8.04)
.03
Prior open aortic surgery
CLI
3.74 (1.08-12.97)
.04
Prior open iliofemoral surgery
1.50 (0.34-6.53)
.59
Prior AI endovascular intervention
1.75 (0.49-6.19)
.39
0.27 (0.02-3.27)
.30
Increased preoperative ABI Proximal anastomotic configuration End-to-end End-to-side Increased graft size
2.11 (0.83-5.36) 0.57 (0.43-0.77)
.12 .0002
Outflow procedure
1.18 (0.43-3.19)
.75
Major morbidity
1.63 (0.38-7.12)
.51
ABI, Ankle-brachial index; AI, aortoiliac; CC, contemporary cohort; CI, confidence interval; CLI, critical limb ischemia; DM, diabetes mellitus; HR, hazard ratio.