Journal of Vascular Surgery
Volume 50, Issue 2 , Pages 299-304.e4, August 2009

Significant perioperative morbidity accompanies contemporary infrainguinal bypass surgery: An NSQIP report

Presented at the Annual Meeting of the Society of Vascular Surgery, June 4-8, 2008, San Diego, Calif.

  • Glenn M. LaMuraglia, MD

      Affiliations

    • The Division of Vascular and Endovascular Surgery, General Surgical Services, Massachusetts General Hospital and Harvard Medical School, Boston, Mass
    • Corresponding Author InformationReprint requests: Glenn M. LaMuraglia, MD, Harvard University, Massachusetts General Hospital, Division of Vascular Surgery, Boston, MA 02114
    • ,
  • Mark F. Conrad, MD

      Affiliations

    • The Division of Vascular and Endovascular Surgery, General Surgical Services, Massachusetts General Hospital and Harvard Medical School, Boston, Mass
    • ,
  • Tom Chung, MA

      Affiliations

    • The Division of Vascular and Endovascular Surgery, General Surgical Services, Massachusetts General Hospital and Harvard Medical School, Boston, Mass
    • ,
  • Matthew Hutter, MD

      Affiliations

    • The Codman Center of Clinical Effectiveness in Surgery, General Surgical Services, Massachusetts General Hospital and Harvard Medical School, Boston, Mass
    • ,
  • Michael T. Watkins, MD

      Affiliations

    • The Division of Vascular and Endovascular Surgery, General Surgical Services, Massachusetts General Hospital and Harvard Medical School, Boston, Mass
    • ,
  • Richard P. Cambria, MD

      Affiliations

    • The Division of Vascular and Endovascular Surgery, General Surgical Services, Massachusetts General Hospital and Harvard Medical School, Boston, Mass

Received 18 September 2008; accepted 21 January 2009.

Article Outline

Objectives

A variety of clinical and anatomic factors influence the choice between infrainguinal bypass surgery (BPG) and percutaneous endovascular procedures (PTA) to treat lower extremity vascular disease. The decision, in part, is dependant on periprocedural morbidity. The goal of this study was to document the contemporary morbidity and mortality of infrainguinal BPG, utilizing the previously validated National Surgical Quality Improvement Program (NSQIP) database.

Methods

Data from the private sector NSQIP, a prospectively validated systematic-sample database, using Current Procedural Terminology (CPT) codes for all infrainguinal BPG performed between January 1, 2005, and December 31, 2006, were analyzed. Study endpoints included 30-day death and NSQIP-defined major complications, including graft failure, differentiated between systemic vs operative-site related complications. Potentially associated clinical variables were assessed by univariate methods to create the multivariate models of factors associated with study endpoints.

Results

There were 2404 infrainguinal BPG (infrapopliteal distal anastomosis 42%, prosthetic 29%) performed in the study interval with patient variables: age 67 ± 12, male 66%, diabetes 44%, limb salvage indications 48%. The 30-day composite mortality/major morbidity was 19.5%. The overall mortality was 2.7% and correlated with (P value, odds ratio [OR]): patient age (<.001, 1.056), low body weight (.007, 0.988), significant preoperative dyspnea (.03, 1.97), dialysis (.003, 5.26), history transient ischemic attack (.03, 2.43), and bleeding disorder (.02, 2.01). Major complications occurred in 18.7% patients, including 7.4% graft thromboses, and 9.4% wound infections. Major systemic complications occurred in 5.9% and correlated with: age (.001, 1.03), history myocardial infarction (.02, 2.37), dialysis (<.001, 2.52), impaired sensorium (.005, 2.93), and general (vs regional) anesthesia (.04, 1.9). Major operative site-related complications occurred in 15.1% and correlated with: history chronic obstructive pulmonary disease (.04, 1.40), limb salvage indication (<.001, 1.71), impaired sensorium (.01, 2.26), non-independent preoperative functional status (.03, 1.37), and operative time (<.001, 1.002). The combination of dialysis and age >80 was identified as the most powerful high-risk composite for death (13.3-fold) and major complications (2.2-fold).

Conclusion

Infrainguinal BPG is accompanied by significant major morbidity and mortality in contemporary practice. These results reinforce the precept that stringent indications for BPG should be maintained, when considering the method of lower extremity revascularization.

 

The major objective in the management of patients with peripheral vascular disease is to maintain functional status, avoid amputation, and reduce overall mortality from cardiovascular disease.1 In addition to conservative measures of exercise, medical therapy, and aggressive risk factors modification, lower extremity revascularization is generally considered mandatory in patients with critical limb ischemia (CLI) and a matter of clinical judgment in those with disabling claudication.2 Although there is general agreement as to what constitutes successful lower extremity revascularization, there are no specific evidence-based criteria for choosing specific therapeutic options such as percutaneous therapy (PTA) or lower-extremity bypass surgery (BPG).3, 4 Randomized trials are few5, 6 and have not provided definitive guidelines with respect to the mode of revascularization.2

Multiple factors, such as anatomic extent and location of the disease, indication for revascularization, and patient demographic characteristics figure into the decision of method of revascularization. In addition, operator specialty, individual expertise, clinical experience, and patient preference also drive the choice between PTA and BPG when considering the specific patient goals.2, 7 In addition, the anatomic durability of the planned therapeutic option and the anticipated morbidity and mortality of the procedure will influence the decision whether to proceed in claudicants and the method of revascularization in CLI patients.3, 8, 9

An important component in the choice of revascularization is the associated periprocedural morbidity and mortality. Documentation of the short term results after BPG is limited to single institution retrospective reports,10, 11 large databases analyses with limited data variables,12 or prospective trials,5, 13 which may not reflect the cross-section of patients or accepted treatment in present practice. To overcome these factors, the perioperative outcomes of lower-extremity bypass were queried from the National Surgical Quality Improvement Program (NSQIP) for the private sector hospitals. The goal of this study was to delineate the contemporary perioperative morbidity and mortality of infrainguinal BPG and define the high-risk patient profiles in this patient cohort.

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Methods 

Database 

The private sector NSQIP is a validated, independently adjudicated, prospective database of a systematic sample of cases which provides detailed patient demographics and procedural data with 30-day mortality and major and minor morbidity.14 From 2005 through 2006, the number of hospitals contributing to the database increased from 37 to 121. Sixty-five percent and 60% were classified as academic/teaching institutions for each of the 2 years respectively, while the remainders were labeled as community hospitals. During the study, the average hospital sizes relative to patient beds were: 56% (>500), 27% (300-499), 14% (100-299), and 3% (<100).

The database was queried to provide detailed patient clinical and demographic data, periprocedural information, and 30-day specific outcome of mortality and morbidity as previously described. Approval was obtained from the Institutional Review Board of the Human Studies Committee.

Selected sample 

Patients were queried using the Current Procedural Terminology (CPT) for all infrainguinal bypass procedures that were done between January 1, 2005, and December 31, 2006, for procurement of the data. This comprised anonymous records from all participating private sector academic and nonacademic hospitals that were contributing to the program. Patient data was obtained per procedural code and included 30-day outcome. However, correlation of the specific index BPG procedure to any prior or subsequent operations or intervention on the same patient in the 30-day period was not possible.

Patient demographic clinical characteristics 

Patient demographic and clinical co-morbid conditions, available from the NSQIP database,15 were obtained for each of the patients and were cataloged as previously described.16 In addition, based on the CPT code and the NSQIP database data, the surgical details for each of the lower extremity bypass procedures were retrieved and used for outcome analysis. Laboratory data other than creatinine was not available for all patients and, therefore, not included in the data analysis.

Outcomes 

The 30-day mortality and major morbidity were the primary endpoints of the study. The individual major complications is a slight modification of the criteria that has been previously defined16 to also include bypass graft failure. The incidence of death and major complications was counted per patient who had one or more of these events occur, while the occurrence of the major complications were counted by the incidence of each event occurrence. To better identify the effect that the patient and procedural parameters may have on the outcomes, the complications were also divided and separately analyzed into those resulting in operative site-related or systemic events.

Statistical analysis 

Baseline characteristics were compared across groups using χ2 and Fisher's exact t test where appropriate. Multivariate analysis was performed using forward stepwise logistic regression and included univariate associations with a P < .05 of non-confounding variables. For outcomes with low event rates, multivariate modeling was limited to 10% of the number of events to control for overfitting. To identify a high-risk composite of patient variables, relative risk scores were computed from the most significant multivariate predictors of adverse events that had an incidence of at least 5% in the patient population. All statistical analyses were performed using SPSS version 15.0 (SPSS Inc, Chicago, Ill).

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Results 

During the study period, there were 2404 patients identified in the database who underwent an infrainguinal BPG and their demographic and clinical features are detailed in Table I. Prior coronary revascularization was noted in 45.8% of patients. There were 44.4% diabetics, approximately half of which were on insulin therapy. Of the 23.4% of patients whose baseline creatinine was over 1.5 mg/dL, 7.9% were on dialysis. The indication for surgery was CLI in 47.6% of patients with 37% having a non-healing wound. A vein conduit was used in 67.7% of patients and the infrapopliteal arteries were used for the distal anastomosis in 42.4% of cases. Detailed demographic, clinical, and procedural data is summarized in Table I, Table II.

Table I. Demographics and clinical features
DemographicsAll patients N = 2404
Age (excl. ‘90+' patients)67.0±11.8[17-89]{68}
Gender – Male65.9%(1585/2404)
Race – White70.3%(1691/2404)
Race – Black14.0%(336/2404)
BMI (kg/m2)27.7±6.4[10.7-92.9]{26.9}
Respiratory
Smoking (within 1 year)39.9%(959/2404)
Severe COPD12.0%(289/2404)
Cardiovascular
Hx CHF (within 1 month)3.4%(82/2404)
Hx MI (within 6 months)2.7%(66/2404)
Prior PCI19.5%(468/2404)
Prior CS26.3%(633/2404)
Critical limb ischemia47.6%(1144/2404)
Diabetes
Insulin24.1%(580/2404)
Oral agent20.3%(488/2404)
Dialysis7.9%(189/2404)
Preop creatinine ≥1.5 mg/dL23.4%(563/2404)
Neurological
Impaired sensorium2.1%(50/2404)
History TIA6.4%(154/2404)
Other
Open wound37.0%(890/2404)
Weight loss1.7%(41/2404)
Bleeding disorder21.5%(518/2404)
Independent functional status80.9%(1944/2404)

BMI, Body Mass Index; CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease; CS, cardiac surgery; Hx, history; MI, myocardial infarction; PCI, percutaneous cardiac intervention; TIA, transient ischemic attack.

Table II. Procedural detail
Interventional detailAll patients
Prior operation (within 30 days)8.6%(101/1178)
Total anesthesia time (minutes)311.5±116.9[54-888]{289}
Operative time (minutes)237.1±104.6[11-790]{218}
Anesthesia
General85.2%(2049/2404)
Spinal7.6%(183/2404)
Epidural7.2%(172/2404)
Inflow
Femoral86.6%(2082/2404)
Popliteal10.3%(248/2404)
Other (popliteal aneurysm)3.1%(74/2404)
Outflow
Popliteal54.5%(1311/2404)
Distal42.4%(1019/2404)
Other (popliteal aneurysm)3.1%(74/2404)
Graft
Vein55.2%(1328/2404)
Vein in situ12.5%(301/2404)
Non-vein29.2%(701/2404)
Other (popliteal aneurysm)3.1%(74/2404)

There were 65 patient deaths that occurred within 30 days for an incidence of 2.7%, a major complication rate of 18.7% for a composite major morbidity and mortality of 19.7% (Table III). There was a very significant and direct correlation of mortality and major systemic complications with increasing age (Table IV, online only), indeed there was a 10-fold increase in mortality and 3.5-fold increase in major systemic complications between the lowest and highest quartile of patient age. This age correlation did not hold true for all major complications nor with major operative site complications which had a threefold higher incidence than major systemic complications (Table V, online only).

Table III. Incidence of major postoperative occurrences
Postoperative occurrencesAll patients
Death2.7%(65/2404)
Major complications18.7%(450/2404)
Major complications – Operative site15.1%(364/2404)
Wound dehiscence1.7%(40/2404)
Wound infection3.3%(80/2404)
Organ space infection0.5%(11/2404)
Sepsis3.9%(93/2404)
Bleed1.6%(39/2404)
Graft failure7.4%(178/2404)
Major complications – Systemic5.9%(141/2404)
Failure to wean >48 hours1.7%(41/2404)
Unplanned re-intubation2.3%(55/2404)
Pneumonia2.1%(50/2404)
Acute renal failure0.5%(11/2404)
Pulmonary embolism0.0%(1/2404)
Stroke0.5%(12/2404)
Coma >24 hours0
Cardiac arrest1.0%(23/2404)
Deep venous thrombosis1.1%(26/2404)

As expected, there was a higher incidence of death (3.6% vs 2.0%, P < .023) and major complications (30.1% vs 16.3%, P < .0001) in patients who underwent lower extremity bypass for CLI. However, this difference was greater for the major operative site complications (23.9% vs 12.8%) as compared to the major systemic complications (7.1% vs 4.6%) between the CLI and claudication cohort of patients.

Univariate analysis was computed for each of the demographics and patient co-morbidities for the outcome of mortality and the major complications and its subsets (Table V, online only, Table VI, online only, Table VII, online only, Table VIII, online only). Diabetes and a recent history of myocardial infarction (MI) within the last 6 months surprisingly did not correlate with perioperative death, while any dyspnea, history of congestive heart failure, and renal insufficiency were strong markers for perioperative mortality. Of note, diabetes was not a predictor of major operative site or systemic complications, while impaired renal function or dialysis was not a significant predictor of major operative site complications.

From these univariate methods, multivariate logistic regression models were constructed to identify patient predictors for mortality (Table IX) and morbidity (Table X, Table XI, Table XII). With the creation of high-risk composites from these significant correlate variables for death and major complications, the composite that carried the highest predictive value was that of dialysis and age >80 years, which carried a 13.3-fold increase risk for mortality and a 2.2-fold increase in major complications.

Table IX. Multivariate analysis on death
VariableOR[95% CI]P value
Age1.056[1.02-1.09].0001
Weight1.011[1.00-1.02].012
Any dyspnea1.887[1.08-3.58].038
Dialysis8.40[1.79-15.4].0001
Hx TIA2.29[1.10-5.38].041
Bleeding disorder1.969[1.12-3.61].023

TIA, Transient ischemic attack.

Age, Weight – Continuous variables.

Table X. Multivariate analysis of all major complications
VariableOR[95% CI]P value
Critical limb ischemia1.62[1.30-2.03]<.001
Creatinine1.07[1.003-1.13].040
Impaired sensorium2.59[1.43-4.69].002
Operative time1.002[1.00-1.003].001
Infrapopliteal anastomosis1.30[1.03-1.64].029
Functional status: Non-independent1.77[1.37-2.29]<.001

OR, Odds ratio; CI, confidence interval.

Creatinine, Operative time – Continuous variables.

Table XI. Multivariate analysis of operative-site major complications
VariableOR[95% CI]P value
Severe COPD1.405[1.01-1.95]0.043
Impaired sensorium2.26[1.21-4.24]0.011
Functional status: Non-independent1.372[1.04-1.82]0.027
Operative time1.002[1.00-1.003]<0.001
Critical limb ischemia1.712[1.35-2.17]<0.001

COPD, Chronic obstructive pulmonary disease; OR, odds ratio; CI, confidence interval.

Operative Time – Continuous variable.

Table XII. Multivariate analysis for systemic major complications
VariableOdds ratioP value
Age1.033[1.02-1.05]<0.0001
Hx MI2.37[1.14-4.90]0.020
Dialysis2.52[1.56-4.07]<0.0001
Impaired sensorium2.93[1.37-6.25]0.005
General anesthesia1.901[1.03-3.52]0.040

MI, Myocardial infarction; Hx, history.

Age = Continuous variable.

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Discussion 

The initial Congressional mandate for the NSQIP program to provide the Veterans' Administration (VA) system with a prospective, accurate benchmark of the perioperative 30-day outcomes after surgical interventions14 has met with success in reducing complications and fostered other quality of care initiatives.17 Thus, this database provides a benchmark to document validated 30-day outcomes of contemporary infrainguinal BPG in an era with exponential rise of PTA procedures to treat infrainguinal disease.18, 19, 20 In addition, there is limited comprehensive data on this topic with retrospective single center studies10, 11 and recently published prospective multicenter studies, the Project of Ex-Vivo vein graft Engineering via Transfection III (PREVENT III),13 the Bypass vs Angioplasty in Severe Ischemia of the Leg (BASIL),5 and the Dutch trial.6 However, their drawback is the restrictive inclusion criteria for the patients to enter such a study resulting in a select cohort of patients that do not reflect the general population of patients in everyday practice undergoing infrainguinal BPG. Indeed, the BASIL randomized trial, designed to compare infrainguinal BPG vs PTA for first-“intention to treat” for CLI, identified a higher mortality (5.6% vs 2.7%), and cardiopulmonary complications (14.2% vs 3.1%) compared to the present study. However, this can be explained by the populations studied: BASIL trial vs this NSQIP study having only CLI (100% vs 46%) and an older population >70 years of age (65% vs 46%), both variables identified in this series to correlate with mortality and morbidity.

Lower extremity bypass is a very effective and durable method to revascularize the ischemic leg.10, 11 Prior publications focused on BPG patency, limb salvage rates, and amputation-free survival10, 21, 22 rather than perioperative complications since, until recently, there was little evidence of effective alternative procedures. In essence, the perioperative morbidity and mortality was regarded as the acknowledged risk for the patients to obtain the necessary lower extremity revascularization. With the recognition of PTA as an alternative for lower extremity reconstruction in selected circumstances,3, 19, 20 the perioperative outcomes of lower extremity BPG become more relevant in making the proper recommendations for lower extremity revascularization in an individual patient. This is especially true in lower extremity revascularization compared to other open vascular surgery procedures because of the acknowledged more limited longevity and high incidence of systemic cardiovascular co-morbidities in this patient population.23, 24 Thus, the data detailed in this study, by virtue of its broad inclusion criteria and multiple centers, represents the “real world” expectation of contemporary morbidity and mortality of infrainguinal BPG.

The 30-day mortality in this study was 2.7% and compared somewhat favorably to earlier studies of infrainguinal BPG: 3.7%,10 and was equivalent to more contemporary reports: 2.6%,11 2.7%,25 and 1.6%.26 Though the patient populations may not be totally comparable, this contrasts infrainguinal PTA periprocedural mortality reported from 0%3 to 0.5%4 in most studies and 3% in the BASIL trial.5 The two most powerful clinical variables that correlated with death in this study were dialysis and advanced patient age, which when combined as a high-risk composite, dialysis and patients over 80 years of age resulted in a significant increase risk of death (13.3-fold) and major complications (2.2-fold). With the reported 5-year survival of a dialysis patient undergoing infrainguinal BPG is only 5%,27 and with the dismal perioperative outcome for elderly dialysis patients identified in this study, it would follow that an infrainguinal BPG should rarely be considered in such a patient and only after all other options have been exhausted. The other alternative treatments that should be considered in this patient population include PTA,28 primary amputation,29 and wound care management.30

With the emergence of PTA as a less invasive alternative to BPG,9, 19 a focus in patient functional and postoperative recovery state after infrainguinal BPG has emerged.31 Although the goal of limb salvage remains paramount in determining functional outcome, several reports underlined the significant morbidity and importance of the functional outcome and recovery after infrainguinal BPG.31, 32 In the present study, the incidence of major complications was 18.7% with almost threefold the number of operative site complications compared to systemic complications, most of which would be expected to delay recovery. Essentially half of the operative site problems related to acute 30-day graft failure which was identified at 7.4%, while the remainder of these complications was related to bleeding and wound infections/dehiscence.

This rate of acute graft occlusion is somewhat higher in the present study when compared to other large, retrospective, single center reports including: 4.0%10 and 5.2%.13 There may be several reasons for this difference which include a higher capture with prospective data collection and multicenter outcomes and no available data of the surgeons' individual qualifications, training, or expertise. In this presented report, the only common correlate with a VA study which identified a 4.9% graft failure rate33 was infrapopliteal distal anastomosis, but not age, or race, despite similar percentages of African American race (14% vs 17%). Another study34 reported a fourfold higher significant incidence of acute infrainguinal BPG thrombosis with the use of general as compared to regional anesthesia. General anesthesia was not identified as an individual correlate with operative site complications which includes graft thrombosis in this study despite the over 85% utilization of general anesthesia in the present study. Other than graft failure and bleeding, local wound problems and infections comprised 8.8% of complications. This is the most difficult and subjective morbidity to quantify as reflected by the wide range of reported wound infections as: 11.4%35 and 39%5 likely with different definitions and inclusion criteria. However, the results are similar when comparing the present study results with a VA NSQIP report of 18,217 patients undergoing infrainguinal bypass with a wound infection rate of 12%.36 There was also agreement that renal dysfunction did not significantly correlate to wound infection or graft failure, but did significantly correlate to death.

An interesting finding was the few major cardiac complications (1.0%) in this study compared to others (3.9-7.9%) recently reported in the literature.5, 13, 35 This result may be underestimated, since routine EKG and cardiac enzymes were not routinely checked. In addition, over 45% of patients in this study had a prior coronary revascularization before their lower extremity bypass.37 Despite this, the history of having an MI within the last year was identified as a significant variable for the development of a systemic major complication, but not necessarily of a cardiac nature.

There are clearly multiple factors including: procedural indications, patient clinical variables, availability of conduit, and expected patient longevity that come into play to guide the recommendations for lower extremity revascularization. Appreciating this significant current mortality and morbidity with infrainguinal BPG even with contemporary improvements in healthcare,38 the results reported herein require a perspective with available alternatives. A consensus is emerging that PTA is a viable and effective initial therapy, when anatomically feasible, if one accepts an approximately 15-20% reintervention rate to achieve patency and a 5% surgical bailout rate.3, 4 This study reinforces such an approach owing to the significant morbidity and mortality of BPG and identifies patient subgroups at particularly high risk for whom every effort should be provided for an alternative therapeutic approach: percutaneous angioplasty alone,3, 4, 7 hybrid surgical and catheter-based procedures,39 or supportive care that may ultimately result in a primary amputation.29 Though infrainguinal BPG provides excellent durability to infrainguinal BPG, stringent indications should be maintained due to the significant associated perioperative morbidity.

Shortcomings 

A shortcoming of this study is that the patient database is based on CPT codes, and as such it is not known if these were primary or reoperative procedures. In addition, due to maintaining the confidentiality of the patients, the index case has no specific linked follow-up management information during or following the 30-day time period. In this NSQIP study, therefore, there can be no correlation of a complication, such as graft failure, with a specific procedure or clinical outcome, such as limb salvage. There are also no clinical guidelines for the treatment choices of these patients, or the qualifications of the surgeons performing the operations. As such, it is unknown how many patients were offered other treatment options, or treated conservatively without a bypass procedure. Though these factors are shortcomings to identify the ultimate patient outcome, these data still provide a very robust and complete reflection of the incidence of 30-day mortality and morbidity in contemporary practice for infrainguinal bypass.

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Author contributions 


Conception and design: GL, RC

Analysis and interpretation: GL, MC, TC, RC

Data collection: MH, TC

Writing the article: GL, TC, MW

Critical revision of the article: GL, MC, MH, MW, RC

Final approval of the article: GL, MC, MH, MW, RC

Statistical analysis: MC, TC

Obtained funding: GL, MH, RC

Overall responsibility: GL

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Tables, online only 

Table IV, online only. Perioperative death and major complications stratified by age quartile
Age: Less than 60 y60-69 y70-79 y80+ yP value
Perioperative death0.6%(4/618)2.5%(17/691)2.9%(20/692)6.0%(24/403)<.001
Major complications – ALL19.1%(118/618)17.4%(120/691)18.1%(125/692)21.6%(87/403).353
Major complications – operative site17.5%(108/618)13.7%(95/691)13.6%(94/692)16.6%(67/403).129
Major complications – systemic2.6%(16/618)5.8%(40/691)7.1%(49/692)8.9%(36/403)<.001
Table V, online only. Univariate analysis of death
DemographicsDeath rate for patients without comorbidity (Mean ± SD denote survivors)Death rates for patients with comorbidity (Mean ± SD denote deaths)P value
Age (excl. ‘90+' patients)66.8±11.8[17-89]{67}74.3±9.0[52-89]{76}<.001
Age ≥80 (incl. ‘90+' cases)2.0%(41/2001)6.0%(24/403)<.001
Gender - Female2.4%(38/1585)[male]3.3%(27/819)[female].198
BMI (kg/m2)27.7±6.4[10.7-82.9]24.5±23.7[15.7-43.0]<.001
Respiratory
Smoking (within 1 year)3.5%(49/1445)1.7%(16/959).011
Severe COPD2.5%(53/2115)4.2%(12/289).106
Any dyspnea2.3%(44/1924)4.4%(21/480).012
Cardiovascular
Hx CHF2.5%(58/2322)8.5%(7/82).001
Hx MI2.6%(61/2338)6.1%(4/66).101
Prior PCI2.6%(51/1936)3.0%(14/468).669
Prior CS2.5%(45/1771)3.2%(20/633).410
Critical limb ischemia2.0%(25/1260)3.5%(40/1144).022
Renal/metabolic
Diabetes – Insulin2.6%(47/1824)[none/oral]3.1%(18/580)[insulin].496
Dialysis1.9%(41/2215)12.7%(24/189)<.001
Preop creatinine1.52±1.52[0.3-14.1]{1.1}2.95±2.75[0.7-12.0]{1.5}<.001
Preoperative Cr ≥1.51.7%(32/1841)5.9%(33/563)<.001
Neurological
Impaired sensorium2.5%(60/2354)10.0%(5/50).010
Hx TIA2.4%(55/2250)6.5%(10/154).003
Other
Wound infection2.4%(36/1514)3.3%(29/890).199
Weight loss2.6%(62/2363)7.3%(3/41).097
Bleed disorder2.2%(42/1866)4.4%(23/518).006
Functional status non-independent1.9%(36/1944)6.3%(29/460)<.001
Interventional detail
Total anesthesia time310.8±116.4[54-888]336.5±130.9[125-714]<.001
Operative time236.5±217.0[11-790]259.6±117.1[90-617].079
Inflow – Femoral2.4%(6/248)[popliteal]2.8%(58/2082)[femoral].739
Outflow – Distal2.1%(28/1311)[popliteal]3.5%(36/1019)[distal].041
Graft material – Non-vein2.6%(43/1629)[vein]3.0%(21/701)[non-vein].630
Anesthesia – General vs other2.3%(8/355)2.8%(57/2049).571

BMI, Body Mass Index; COPD, chronic obstructive pulmonary disease; CHF, congestive heart failure; MI, myocardial infarction; PCI, percutaneous cardiac intervention; CS, cardiac surgery; TIA, transient ischemic attack; SD, standard deviation; Hx, history.

Table VI, online only. Univariate analysis of all major complications
DemographicsMajor comp. rate for patients w/o comorbidityMajor comp. rates for patients with comorbidityP
Age (excl. ‘90+' patients)67.0±11.7[17-89]67.2±12.1[20-89].714
Age ≥ 80 (incl. ‘90+' cases)18.1%(363/2001)21.6%(87/403).106
Gender - Female17.5%(277/1585)21.1%(173/819).030
BMI (kg/m2)27.7±6.4[10.7-92.9]{27.0}27.5±6.3[11.7-62.4]{26.6}.592
Respiratory
Smoking (within 1 year)19.0%(274/1445)18.4%(176/959).708
Severe COPD18.2%(384/2115)22.8%(66/289).056
Any dyspnea18.2%(351/1924)20.6%(99/480).231
Cardiovascular
Hx CHF18.3%(425/2322)30.5%(25/82).005
Hx MI18.3%(429/2338)31.8%(21/66).006
Prior PCI18.0%(349/1936)21.6%(101/468).077
Prior CS18.5%(328/1771)19.3%(122/633).677
Critical limb ischemia14.1%(178/1260)23.8%(272/1144)<.001
Renal/metabolic
Diabetes – Insulin17.8%(325/1824)21.6%(125/580).045
Dialysis17.9%(397/2215)28.0%(53/189).001
Preoperative creatinine16.7%(308/1841)25.2%(142/563)<.001
Preoperative Cr ≥1.51.50±1.52[0.3-14.1]{1.1}1.80±1.84[0.4-11.8]{1.1}<.001
Neurological
Impaired sensorium18.1%(427/2354)46.0%(23/50)<.001
Hx TIA18.5%(416/2250)22.1%(34/154).269
Other
Wound infection17.0%(257/1514)21.7%(193/890).004
Weight loss18.5%(437/2363)31.7%(13/41).032
Bleed disorder18.9%(357/1886)18.0%(93/518).614
Functional status non-independent16.0%(312/1944)30.0%(138/460)<.001
Interventional detail
Total anesthesia time306.2±113.8[54-858]334.2±126.8[85-888]<.001
Operative time232.4±101.7[11-776]257.9±114.1[47-790]<.001
Inflow – Femoral21.0%(52/248)[popliteal]18.8%(392/2082)[femoral].417
Outflow – Distal15.9%(209/1311)[popliteal]23.1%(235/1019)[distal]<.001
Graft material – Non-vein19.0%(310/1629)[vein]19.1%(134/701)[non-vein].962
Anesthesia – General vs other15.2%(54/355)[spinal/epid.]19.3%(396/2049)[general].066

BMI, Body Mass Index; COPD, chronic obstructive pulmonary disease; Hx, history; CHF, congestive heart failure; MI, myocardial infarction; PCI, percutaneous cardiac intervention; CS, cardiac surgery; TIA, transient ischemic attack; w/o, without.

Table VII, online only. Univariate analysis of major operative site complications
DemographicsMajor operative site comp. rate for patients w/o comorbidityMajor operative site comp. rates for patients with comorbidityP value
Age (excl. ‘90+' patients)67.1±11.7[17-89]66.4±12.3[20-88].305
Age ≥80 (incl. ‘90+' cases)14.8%(297/2001)16.6%(67/403).362
Gender - Female13.9%(221/1585)17.5%(143/819).023
BMI (kg/m2)27.6±6.4[10.7-92.9]27.8±6.4[11.7-62.4].724
Respiratory
Smoking (within 1 year)14.8%(214/1445)15.6%(150/959).578
Severe COPD14.6%(309/2115)19.0%(55/289).049
Any dyspnea14.9%(286/1924)16.3%(78/480).449
Cardiovascular
Hx CHF15.0%(348/2322)19.5%(16/82).261
Hx MI15.0%(350/2338)21.2%(14/66).163
Prior PCI14.6%(283/1936)17.3%(81/468).145
Prior CS14.9%(263/1771)16.0%(101/633).505
Critical limb ischemia11.3%(143/1260)19.3%(221/1144)<.001
Renal/metabolic
Diabetes – Insulin14.5%(264/1824)17.2%(100/580).105
Dialysis14.9%(330/2215)18.0%(34/189).255
Preoperative creatinine1.54±1.57[0.3-14.1]1.67±1.70[0.4-11.8].163
Preoperative Cr ≥1.514.2%(261/1841)18.3%(103/563).017
Neurological
Impaired sensorium14.7%(347/2354)34.0%(17/50)<.001
Hx TIA14.8%(334/2250)19.5%(30/154).120
Other
Wound infection13.7%(208/1514)17.5%(156/890).012
Weight loss15.0%(355/2363)22.0%(9/41).220
Bleed disorder15.3%(288/1886)14.7%(76/518).782
Functional status non-independent13.7%(266/1944)21.3%(98/460)<.001
Interventional detail
Total anesthesia time307.0±114.3[54-858]336.5±127.8[96-888]<.001
Operative time232.9±102.1[11-776]261.0±114.8[47-790]<.001
Inflow – Femoral16.1%(40/248)[popliteal]15.3%(318/2082)[femoral].724
Outflow – Distal12.7%(166/1311)[popliteal]18.8%(192/1019)[distal]<.001
Graft Material – Non-vein16.4%(115/701)14.9%(243/1629).361
Anesthesia – General vs other13.5%(48/355)15.4%(316/2049).356

BMI, Body Mass Index; COPD, chronic obstructive pulmonary disease; CHF, congestive heart failure; MI, myocardial infarction; PCI, percutaneous cardiac intervention; CS, cardiac surgery; TIA, transient ischemic attack; Hx, history; w/o, without.

Table VIII, online only. Univariate analysis of major systemic complications
DemographicsMajor systemic comp. rate for patients w/o comorbidityMajor systemic comp. rates for patients with comorbidityP value
Age (excl. ‘90+' patients)66.7±11.8[17-89]{67}71.1±10.3[36-89]{73}<.001
Age ≥80 (incl. ‘90+' cases)5.2%(105/2001)8.9%(36/403).004
Gender - Female5.6%(88/1585)6.5%(53/819).363
BMI (kg/m2)27.7±6.4[10.7-92.9]26.5±5.9[16.7-52.6].025
Respiratory
Smoking (within 1 year)6.8%(98/1445)4.5%(43/959).019
Severe COPD5.7%(120/2115)7.3%(21/289).280
Any dyspnea5.7%(109/1924)6.7%(32/480).404
Cardiovascular
Hx CHF5.6%(131/2322)12.2%(10/82).013
Hx MI5.6%(131/2338)15.2%(10/66).001
Prior PCI5.6%(109/1936)6.8%(32/468).318
Prior PCS5.7%(101/1771)6.3%(40/633).571
Critical limb ischemia4.8%(61/1260)7.0%(80/1144).025
Renal/metabolic
Diabetes – Insulin5.6%(103/1824)6.6%(38/580).419
Dialysis5.2%(115/2215)13.8%(26/189)<.001
Preoperative creatinine1.52±1.55[0.3-14.1]2.11±1.96[0.5-11.5]<.001
Preoperative Cr ≥1.54.5%(83/1841)10.3%(58/563)<.001
Neurological
Impaired sensorium5.6%(131/2354)20.0%(10/50)<.001
Hx TIA5.8%(130/2250)7.1%(11/154).486
Other
Wound infection5.5%(84/1514)6.4%(57/890).388
Weight loss5.8%(137/2363)9.8%(4/41).299
Bleed disorder5.9%(111/1886)5.8%(30/518).936
Functional status non-independent4.2%(82/1944)8.7%(59/460)<.001
Interventional detail
Total anesthesia time310.0±115.3[54-858]333.9±138.0[85-888].019
Operative time236.1±103.1[11-776]254.6±124.8[47-790].041
Inflow – Femoral6.5%(16/248)6.0%(124/2082).756
Outflow – Distal5.2%(68/1311)7.1%(72/1019).058
Graft material – Non-vein5.9%(96/1629)6.3%(44/701).721
Anesthesia – General vs other3.4%(12/355)6.3%(129/2049).031

BMI, Body Mass Index; COPD, chronic obstructive pulmonary disease; CHF, congestive heart failure; MI, myocardial infarction; PCI, percutaneous cardiac intervention; CS, cardiac surgery; TIA, transient ischemic attack; Hx, history; w/o, without.

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 This study was supported, in part, by grants from the Monte and Rita Goldman Foundation, John F. Murphy and the Bay State Federal Savings Foundation, James Esdale Fund, and the Harold and June Geneen Vascular Surgery Research Fund.

 Competition of interest: none.

 Additional material for this article may be found online at www.jvascsurg.org.

PII: S0741-5214(09)00070-6

doi:10.1016/j.jvs.2009.01.043

Journal of Vascular Surgery
Volume 50, Issue 2 , Pages 299-304.e4, August 2009

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