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The influence of gender on functional outcomes of lower extremity bypass.

ABSTRACT: Our aim was to evaluate the effect of gender on early and late procedural and functional outcomes of lower extremity bypass (LEB).We reviewed the records of 2576 patients (828 women; 32%) who underwent LEB for claudication or critical limb ischemia (CLI) in the Vascular Study Group of New England from 2003 to 2010. Logistic regression and proportional hazards models were used to adjust for potential confounding differences between genders. Morbidity, mortality, graft patency, freedom from major amputation, ambulation, and living status were analyzed postoperatively and over 1 year.Women were older (70 vs 68 years; P < .001), had more hypertension (89% vs 85%; P = .006), less coronary artery disease (35% vs 39%; P = .03), smoking (73% vs 88%; P < .001), and preoperative statin use (60% vs 64%; P = .04). Women were more likely to have CLI (76% vs 71%; P = .003), and ambulate with assistance at presentation (19% vs 16%; P = .02). Morbidity was similar except women had higher rates of reoperation for thrombosis (4% vs 2%; P < .001) without differences in major amputation (2% vs 1%; P = .13) or in-hospital mortality (1.7% vs 1.7%; P = .96). Women and men with claudication had similar 1-year graft patency rates. Women with CLI had lower rates of primary (hazard ratio [HR], 1.24; 95% confidence interval [CI], 1.03-1.48; P = .02), assisted primary (HR, 1.42; 95% CI, 1.15-1.76; P = .001) and secondary patency (HR, 1.40; 95% CI, 1.10-1.77; P = .006) during the first year compared with men. Freedom from amputation was similar for men and women with CLI (HR, 1.17; 95% CI, 0.84-1.63; P = .36). There were no differences in late survival between women and men with claudication (HR, 0.89; 95% CI, 0.60-1.31; P = .36) or CLI (HR, 0.94; 95% CI, 0.81-1.09; P = .39). More female claudicants were not independently ambulatory at discharge (30% vs 19%; P = .002) and were discharged to a nursing home (15% vs 5%; P < .001) but these differences did not persist at 1 year. Women with CLI were more likely to be nonambulatory at discharge (13% vs 9%; P = .006) and at 1 year (13% vs 8%; P < .001). More women with CLI were discharged to a nursing home (44% vs 35%; P = .01) and resided there at 1 year (11% vs 7%; P = .02).Women have complication rates similar to men with inferior early and late functional outcomes after LEB. The reduced patency rates in women with CLI did not translate into differences in limb salvage. These findings might help define physician and patient expectations for women before revascularization.

SUBMITTER: Duffy RP

PROVIDER: S-EPMC4283108 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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The influence of gender on functional outcomes of lower extremity bypass.

Duffy Reshma P RP Adams Julie E JE Callas Peter W PW Schanzer Andres A Goodney Philip P PP Ricci Michael A MA Cronenwett Jack L JL Bertges Daniel J DJ

Journal of vascular surgery 20140919 5

<h4>Objective</h4>Our aim was to evaluate the effect of gender on early and late procedural and functional outcomes of lower extremity bypass (LEB).<h4>Methods</h4>We reviewed the records of 2576 patients (828 women; 32%) who underwent LEB for claudication or critical limb ischemia (CLI) in the Vascular Study Group of New England from 2003 to 2010. Logistic regression and proportional hazards models were used to adjust for potential confounding differences between genders. Morbidity, mortality, ...[more]

PMID: 25242270

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Project description:BackgroundIsolated common femoral endarterectomy was recently reported to have a 30-day mortality of 3.4%. The effect of adjunctive femoral endarterectomy at the time of lower extremity bypass is not well described, and therefore, the purpose of this study was to determine its associated perioperative and long-term risk.MethodsVascular Study Group of New England registry data were used to identify patients undergoing initial lower extremity bypass from 2003 to 2015. After univariate analysis, multivariable logistic regression was used to identify the independent association of endarterectomy with adverse perioperative events. Kaplan-Meier and Cox hazard models were used for the 1-year analysis.ResultsAfter exclusions, 4496 patients were identified as undergoing infrainguinal bypass (33% with endarterectomy). There was no difference in the proportion with chronic limb-threatening ischemia (CLI; 68% vs 67%; P = .24) or tissue loss of those with CLI (65% vs 63%; P = .34) between the adjunctive endarterectomy group and bypass alone, respectively. Patients undergoing adjunctive endarterectomy were older (mean 68 years vs 67 years; P = .02), more likely white (95% vs 93%; P = .02), smokers (91% vs 87%; P = .001), and more often had prior coronary artery bypass grafting/percutaneous coronary intervention (34% vs 31%; P = .02). The endarterectomy cohort had similar 30-day mortality (CLI: 2.6% vs 2.9%; P = .60; claudication: 0.2% vs 0.4%; P = 1.0) despite a longer operative time (median, 268 minutes vs 210 minutes; P < .001) and increased blood loss (median, 250 mL vs 180 mL; P < .001). Patients with CLI undergoing adjunctive endarterectomy had more in-hospital myocardial infarctions (MIs; 6.2% vs 3.8%; P = .003) and transfusions (11% vs 6.8%; P < .001). At 1-year, this group had a suggestion of improved freedom from major amputation (91% vs 87%; P = .049) and amputation-free survival (80% vs 76%; P = .03) that did not reach significance after adjustment. For patients with claudication and adjunctive endarterectomy, rates of MI (2.4% vs 0.9%; P = .02), renal dysfunction (3.6% vs 1.4%; P = .01), surgical site infection (SSI; 5.0% vs 2.6%; P = .02), and transfusion (4.6% vs 1.8%; P = .002) were higher. After adjustment, all patients undergoing adjunctive endarterectomy were at increased risk of MI (odds ratio [OR], 1.6; 95% confidence interval [CI], 1.1-2.2), SSI (OR, 1.5; 95% CI, 1.1-2.0), and bleeding requiring transfusion (OR, 1.8; 95% CI, 1.4-2.3). There were no differences in 1-year survival for CLI or claudication groups and no difference in all 1-year end points for patients with claudication.ConclusionsAdjunctive femoral endarterectomy with bypass is safe, with no difference in perioperative or 1-year mortality compared with bypass. However, surgeons should be aware that adjunctive endarterectomy is associated with an increased risk of bleeding, SSI, and MI, likely from these patients' disease burden and presumed more extensive atherosclerosis.

Project description:Infrainguinal bypass (IB) surgery is an effective means of improving arterial circulation to the lower extremity for patients with critical limb ischemia (CLI). However, wound complications (WC) of the surgical incision following IB can impart significant morbidity.A retrospective analysis of WC from the 1404 patients enrolled in a multicenter clinical trial of vein bypass grafting for CLI was performed. Univariate and multivariable regression models were used to determine WC predictors and associated outcomes, including graft patency, limb salvage, quality of life (QoL), resource utilization (RU), and mortality.A total of 543 (39%) patients developed a reported WC within 30 days of surgery, with infections (284, 52%) and hematoma/hemorrhage (121, 22%) being the most common type. Postoperative anticoagulation (odds ratio [OR], 1.554; 95% confidence interval [CI] 1.202 to 2.009; P = .0008) and female gender (OR, 1.376; 95% CI, 1.076 to 1.757; P = .0108) were independent factors associated with WC. Primary, primary-assisted, and secondary graft patency rates were not influenced by the presence of WC; though, patients with WC were at increased risk for limb loss (hazard ratio [HR], 1.511; 95% CI 1.096 to 2.079; P = .0116) and higher mortality (HR, 1.449; 95% CI 1.098 to 1.912; P = .0089). WC was not significantly associated with lower QoL at 3 months (4.67 vs 4.79, P = .1947) and 12 months (5.02 vs 5.13, P = .2806). However, the subset of patients with serious WC (SWC) demonstrated significantly lower QoL at 3 months compared with patients without WC, (4.43 vs 4.79, respectively, P = .0166), though this difference was not seen at 12 months (4.94 vs 5.13, P = .2411). Patients with WC had higher RU than patients who did not have WC. Mean index length of hospital stay (LOS) was 2.3 days longer, mean cumulative 1-year LOS was 8.1 days longer, and mean number of hospitalizations was 0.5 occurrences greater for patients with WC compared with patients without WC (all P < .0001).WC is a frequent complication of IB for CLI, associated with increased risk for major amputation, mortality, and greater RU. Further detailed investigation into the link between female gender and oral anticoagulation use with WC may help identify causes of WC and perhaps prevent or lessen their occurrence.

Project description:Optimal patient selection for lower extremity revascularization remains a clinical challenge among the hemodialysis-dependent (HD). The purpose of this study was to examine contemporary real world open and endovascular outcomes of HD patients to better facilitate patient selection for intervention.A regional multicenter registry was queried between 2003 and 2013 for HD patients (N = 689) undergoing open surgical bypass (n = 295) or endovascular intervention (n = 394) for lower extremity revascularization. Patient demographics and comorbidities were recorded. The primary outcome was overall survival. Secondary outcomes included graft patency, freedom from major adverse limb events, and amputation-free survival (AFS). Multivariate analysis was performed to identify independent risk factors for death and amputation.Among the 689 HD patients undergoing lower extremity revascularization, 66% were male, and 83% were white. Ninety percent of revascularizations were performed for critical limb ischemia and 8% for claudication. Overall survival at 1, 2, and 5 years survival remained low at 60%, 43%, and 21%, respectively. Overall 1- and 2-year AFS was 40% and 17%. Mortality accounted for the primary mode of failure for both open bypass (78%) and endovascular interventions (80%) at two years. Survival, AFS, and freedom from major adverse limb event outcomes did not differ significantly between revascularization techniques. At 2 years, endovascular patency was higher than open bypass (76% vs 26%; 95% confidence interval [CI], 0.28-0.71; P = .02). Multivariate analysis identified age ?80 years (hazard ratio [HR], 1.9; 95% CI, 1.4-2.5; P < .01), indication of rest pain or tissue loss (HR, 1.8; 95% CI, 1.3-2.6; P < .01), preoperative wheelchair/bedridden status (HR, 1.5; 95% CI, 1.1-2.1; P < .01), coronary artery disease (HR, 1.5; 95% CI, 1.2-1.9; P < .01), and chronic obstructive pulmonary disease (HR, 1.4; 95% CI, 1.1-1.8; P = .01) as independent predictors of death. The presence of three or more risk factors resulted in predicted 1-year mortality of 64%.Overall survival and AFS among HD patients remains poor, irrespective of revascularization strategy. Mortality remains the primary driver for these findings and justifies a prudent approach to patient selection. Focus for improved results should emphasize predictors of survival to better identify those most likely to benefit from revascularization.

Project description:Context? The extent to which lower extremity lean mass (LELM) relative to total body mass influences one's ability to maintain safe landing biomechanics during prolonged exercise when injury incidence increases is unknown.Objectives? To examine the influence of LELM on (1) pre-exercise lower extremity biomechanics and (2) changes in biomechanics during an intermittent exercise protocol (IEP) and (3) determine whether these relationships differ by sex. We hypothesized that less LELM would predict higher-risk baseline biomechanics and greater changes toward higher-risk biomechanics during the IEP.Design? Cohort study.Setting? Controlled laboratory.Patients or other participants? A total of 59 athletes (30 men: age = 20.3 ± 2.0 years, height = 1.79 ± 0.05 m, mass = 75.2 ± 7.2 kg; 29 women: age = 20.6 ± 2.3 years, height = 1.67 ± 0.08 m, mass = 61.8 ± 9.0 kg) participated.Intervention(s)? Before completing an individualized 90-minute IEP designed to mimic a soccer match, participants underwent dual-energy x-ray absorptiometry testing for LELM.Main outcome measure(s)? Three-dimensional lower extremity biomechanics were measured during drop-jump landings before the IEP and every 15 minutes thereafter. A previously reported principal components analysis reduced 40 biomechanical variables to 11 factors. Hierarchical linear modeling analysis then determined the extent to which sex and LELM predicted the baseline score and the change in each factor over time.Results? Lower extremity lean mass did not influence baseline biomechanics or the changes over time. Sex influenced the biomechanical factor representing knee loading at baseline (P = .04) and the changes in the anterior cruciate ligament-loading factor over time (P = .03). The LELM had an additional influence only on women who possessed less LELM (P = .03 and .02, respectively).Conclusions? Lower extremity lean mass influenced knee loading during landing in women but not in men. The effect appeared to be stronger in women with less LELM. Continually decreasing knee loading over time may reflect a strategy chosen to avoid injury. A minimal threshold of LELM may be needed to safely perform landing maneuvers, especially during prolonged exercise when the injury risk increases.

Project description:Controversy persists surrounding the perceived bleeding risk associated with perioperative clopidogrel use in patients undergoing lower extremity bypass (LEB). The purpose of this study was to examine the LEB bleeding risk and clinical sequelae associated with clopidogrel.All LEBs in the Vascular Quality Initiative (VQI) from 2008 to 2014 were studied. The exposure was perioperative clopidogrel. Primary outcomes were blood transfusion, estimated blood loss ?500 mL, and reoperation for bleeding. Secondary outcomes included mean operative time, major cardiac events, respiratory complications, infectious complications, and in-hospital mortality. Univariate and multivariable analyses were used to analyze patients on the basis of clopidogrel use and its association with outcomes. Nonparametric test for trend and Mantel-Haenszel methods were used to analyze association of clopidogrel use with blood transfusion and secondary outcomes.Among the LEB cohort (N = 9179), 28% (n = 2544) were taking clopidogrel and 72% (n = 6635) were not. Patients taking clopidogrel were more likely to have coronary disease, prior coronary intervention, abnormal findings on stress test, and aspirin use (P < .001 for all). Patients taking clopidogrel were more likely to receive blood transfusion (38% vs 24%; P < .001) and to have estimated blood loss ?500 mL (21% vs 12%; P < .001). Reoperation for bleeding rates were similar (0.9% vs 1.1%; P = .9). Clopidogrel use was also associated with increased mean operative times (244 minutes vs 232 minutes; P < .001) as well as with cardiac complications (8.8% vs 6.5%; P = .001), respiratory complications (2.5% vs 1.6%; P = .007), and in-hospital mortality (1.3% vs 0.8%; P = .03). Multivariable analysis demonstrated that clopidogrel was associated with increased risk of 1- or 2-unit blood transfusion (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.5-2.1; P < .001) and >2-unit blood transfusion (OR, 2.0; 95% CI, 1.7-2.5; P < .001). Major cardiac events (OR, 1.2; 95% CI, 1.0-1.5; P = .05) and respiratory complications (OR, 1.4; 95% CI, 1.0-2.0; P = .03) were also independently associated with clopidogrel use. Weighted Mantel-Haenszel ORs controlling for blood transfusion amount revealed no remaining effect of clopidogrel on major cardiac events (OR, 1.1; P = .4) or respiratory complications (OR, 1.0; P = .8).Perioperative clopidogrel use in LEB surgery is associated with increased blood loss and blood transfusion. Associated clinical sequelae include increased cardiac and pulmonary complications. Accordingly, surgeons should consider discontinuation of perioperative clopidogrel when it is clinically appropriate unless it is strongly indicated at the time of LEB.

Project description:Despite poor long-term patency, acceptable limb salvage has been reported with cryopreserved saphenous vein bypass (CVB) for various indications. However, utility of CVB in patients with critical limb ischemia (CLI) remains undefined. The purpose of this analysis was to determine the role of CVB in CLI patients and to identify predictors of successful outcomes.A retrospective review of all lower extremity bypass (LEB) procedures at a single institution was completed, and CVB in CLI patients were further analyzed. The primary end point was amputation-free survival. Secondary end points included primary patency and limb salvage. Life tables were used to estimate occurrence of end points. Cox regression analysis was used to determine predictors of limb salvage.From 2000 to 2012, 1059 patients underwent LEB for various indications, of whom 81 received CVB for either ischemic rest pain or tissue loss. Mean age (± standard deviation) was 66 ± 10 years (male, 51%; diabetes, 51%; hemodialysis dependence, 12%), and 73% (n = 59) had history of failed ipsilateral LEB or endovascular intervention. None had sufficient autogenous conduit for even composite vein bypass. Infrainguinal CVB (infrapopliteal target, 96%; n = 78) was completed for multiple indications including Rutherford class 4 (42%; n = 34), class 5 (40%; n = 32), and class 6 (18%; n = 15). Eleven (14%) had CLI and concomitant graft infection (n = 8) or acute on chronic ischemia (n = 3). Intraoperative adjuncts (eg, profundaplasty, suprainguinal stent or bypass) were completed in 49% (n = 40) of cases. Complications occurred in 36% (n = 29), with 30-day mortality of 4% (n = 3). Median follow-up for CLI patients was 11.8 (interquartile range, 0.4-28.4) months with corresponding 1- and 3-year actuarial estimated survival (± standard error mean) of 84% ± 4% and 62% ± 6%. Primary patency of CVB for CLI was 27% ± 6% and 17% ± 6% at 1 and 3 years, respectively. Amputation-free survival was 43% ± 6% and 23% ± 6% at 1 and 3 years, respectively, and significantly higher for rest pain (59% ± 9%, 36% ± 10%) compared with tissue loss (31% ± 7%, 14% ± 7%; log-rank, P = .04). Freedom from major amputation after CVB for CLI was 57% ± 6% and 43% ± 7% at 1 and 3 years. Multivariable predictors of limb salvage for the CVB CLI cohort included postoperative warfarin (hazard ratio [HR], 0.4; 95% confidence interval [CI], 0.2-0.8), dyslipidemia (HR, 0.4; 95% CI, 0.2-0.9), and rest pain (HR, 0.4; 95% CI, 0.2-0.9). Predictors of major amputation included graft infection (HR, 3.1; 95% CI, 1.1-9.0).In CLI patients with no autologous conduit and prior failed infrainguinal bypass, CVB outcomes are disappointing. CVB performs best in patients with rest pain, particularly those who can be anticoagulated with warfarin. However, it may be an acceptable option in patients with minor tissue loss or concurrent graft infection, but consideration should be weighed against the known natural history of nonrevascularized CLI and nonbiologic conduit alternatives, given potential cost implications.

Dataset Information

The influence of gender on functional outcomes of lower extremity bypass.

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The influence of gender on functional outcomes of lower extremity bypass.

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