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INTRODUCTION: Previous studies report that patients of racial/ethnic minorities more frequently present with ruptured abdominal aortic aneurysms (rAAA) than their counterparts. The distribution of rAAA treatment modality, whether open aneurysm repair (OAR) or endovascular aneurysm repair (EVAR), by race/ethnicity classification remains uncertain. This study aims to investigate disparities, as represented by race/ethnic classification, median income, and insurance status, in the management of rAAA in a national cohort. METHODS: We conducted a retrospective analysis of patients admitted with rAAA managed with either OAR or EVAR from 2002 to 2020 using the National Inpatient Sample, comparing repair type by race/ethnicity group. Multilevel mixed effects logistic regression models, adjusted for patient- and system-level factors, were used to calculate difference in use of OAR or EVAR dependent on race/ethnicity classification. RESULTS: We identified 10,788 admissions for rAAA repairs, of which 9,506 (88.1%) were White, 605 (5.6%) were Black, 424 (3.9%) were Hispanic, and 253 (2.4%) were Asian/Native American. Asians/Native Americans underwent the highest frequency of OAR as compared to EVAR, (61.7% vs 38.3%). In the adjusted model, there was no statistically significant difference in use of OAR vs. EVAR by race/ethnicity classification. In total, primary payer and median income were also not statistically significant predictors of AAA treatment modality. CONCLUSIONS: Our study found no statistical evidence of disparities with respect to race, insurance, and median income and utilization of OAR or EVAR for the management of rAAA.
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OBJECTIVE: Observational studies demonstrate reduced mortality after endovascular (EVAR) compared with open aneurysm repair (OAR) for ruptured abdominal aortic aneurysms (rAAAs). We sought to determine national trends in repair type and in-hospital mortality rates for rAAAs. METHODS: We analyzed patients with rAAAs managed with OAR or EVAR from 2002 to 2020 in the National Inpatient Sample and evaluated annual trends in volume and in-hospital mortality by repair type. Multilevel mixed effects logistic regression model was fit for patient and system-level risk adjustment. We assessed interactions between time, sex, and Elixhauser index with repair type. RESULTS: We examined 13,376 patients with rAAAs. Of these, 8357 (62.5%) underwent OAR. Patients receiving EVAR were slightly older (73.7 vs 72.5 years; P < .001) with slightly higher mean Elixhauser index (4.0 vs 3.8; P < .001). Unadjusted in-hospital mortality was 37.4% vs 22.4% for OAR and EVAR, respectively. EVAR offered a risk-adjusted survival advantage (odds ratio [OR], 0.39; 95% confidence interval [CI], 0.32-0.46). There was a statistically significant reduction of in-hospital mortality over time in the EVAR group (interaction OR, 0.96; 95% CI, 0.95-0.98). The interaction between Elixhauser index and repair was not statistically significant (interaction OR, 0.95; 95% CI, 0.87-1.05). CONCLUSIONS: Survival rates for OAR and EVAR improved over time. EVAR persistently provided a substantial survival advantage over OAR in patients with rAAAs over the past 2 decades.
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INTRODUCTION: The influence of pack-year history and smoking cessation timing on postoperative morbidity and mortality in a highly comorbid cohort is uncertain. We examined whether the association between smoking and adverse postoperative events is modified by pack-year history and smoking cessation timing. METHODS: We collected single-institution, retrospective data from consecutive patients undergoing open operations for carotid, aortic, and infrainguinal arterial disease. Active smoking was defined as smoking on the day of the index surgical intervention. Duration of smoking cessation was calculated as the time between smoking cessation and index surgery. The primary outcome was a composite of 30-day mortality and morbidity. Logistic and time-to-event Cox regressions estimated associations with interactions between cessation duration and pack-year history for nonactive smokers. RESULTS: Between 2010 and 2019, 1087 patients underwent 1640 high-risk vascular interventions. Median pack-year history was 40.0 pack-years (interquartile range [IQR]: 20.0-60.0) among nonactive smokers and 46.0 pack-years (IQR: 31.0-61.0) among active smokers (P < 0.001). The median smoking cessation time was 15.5 y (IQR: 4.4-30.9). Smoking status did not independently predict an increased risk of postoperative mortality or morbidity (odds ratio [OR] = 0.99, P = 0.96). Among nonactive smokers, neither smoking cessation duration (OR = 0.99, P = 0.16) nor pack-year history (OR = 1.00, P = 0.88) were significantly associated with adverse events (interaction P = 0.11). CONCLUSIONS: After high-risk vascular interventions in a single institution, active smoking, cessation period, and pack-year history are not associated with an increased risk of postoperative morbidity or mortality-highlighting the benefit of cessation as independent of frequency or intensity.
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Postoperative Complications , Smoking Cessation , Vascular Surgical Procedures , Humans , Smoking Cessation/statistics & numerical data , Male , Female , Retrospective Studies , Middle Aged , Aged , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Vascular Surgical Procedures/adverse effects , Time Factors , Smoking/adverse effects , Smoking/epidemiology , Risk Factors , Treatment OutcomeABSTRACT
BACKGROUND: Transcatheter aortic valve replacement has become an accepted alternative to surgical aortic valve replacement. We examined the trends and predictors in inflation-adjusted costs of transcatheter aortic valve replacement and surgical aortic valve replacement. METHODS: National Inpatient Sample identified patients who underwent aortic valve replacement for severe aortic stenosis by International Classification of Diseases, Ninth and Tenth Revisions, codes. Hospitalization costs were inflation-adjusted using the Federal Reserve's consumer price index to reflect current valuation. Outcomes of interest were unadjusted trend in annual cost for each procedure and predictors of in-patient cost. Generalized linear models with a log link function identified predictors of adjusted costs. Interaction terms determined where cost predictors were different by operation type. RESULTS: Between 2011 and 2019, the mean annual inflation-adjusted cost of surgical aortic valve replacement increased from $62,853 to $63,743, in contrast to decreasing cost of transcatheter aortic valve replacement from $64,913 to $56,042 ($1,854 per year; P = .004). Significant independent predictors of patient-level cost included operation type (transcatheter aortic valve replacement associated with $9,625 increase; P < .001), incidence of in-hospital mortality ($28,836 increase; P < .001), elective status ($2,410 decrease; P < .001), Elixhauser Index ($995 increase; P < .001), and postoperative length of stay ($2,014 per day increase; P < .001). Compared to discharges with Medicare, discharges with private insurance and Medicaid paid $736 less (P = .004) and $1,863 less (P = .01), respectively. Increasing hospital volume was a significant predictor of decreasing patient level cost (P < .001). CONCLUSION: Annual cost of transcatheter aortic valve replacement has decreased significantly and has been a more cost-effective modality compared to surgical aortic valve replacement since 2017. Predictors of patient-level costs allow for mindful preparation of healthcare systems for aortic valve replacement.
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Aortic Valve Stenosis , Heart Valve Prosthesis Implantation , Transcatheter Aortic Valve Replacement , Humans , Female , Male , Transcatheter Aortic Valve Replacement/economics , Transcatheter Aortic Valve Replacement/statistics & numerical data , Transcatheter Aortic Valve Replacement/trends , Aged , United States , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/economics , Aged, 80 and over , Heart Valve Prosthesis Implantation/economics , Heart Valve Prosthesis Implantation/trends , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/statistics & numerical data , Hospital Costs/statistics & numerical data , Hospital Costs/trends , Aortic Valve/surgery , Retrospective Studies , Inflation, EconomicABSTRACT
BACKGROUND: The consequences of failed nonoperative management of appendicitis in older patients have not been described. METHODS: We used the 2004-2017 National Inpatient Sample to identify acute appendicitis patients managed nonoperatively (<65 years old: 32,469; ≥65 years old: 11,265). Outcomes included morbidity, length of stay (LOS), inpatient costs, and discharge to skilled facilities. Differences were estimated using propensity scores. RESULTS: For patients <65, nonoperative failure was associated with increased morbidity (7 â% [95 â% CI 6.9 â%-8.1 â%]), LOS (3 day [95 â% CI 3-4]), costs ($9015 [95 â% CI $8216- $9446]), and discharges to skilled facilities (1 â% [95 â% CI 0.9 â%-1.6 â%]) compared to successful nonoperative treatment. Patients ≥65 had differences in morbidity (14 â% [95 â% CI 13.6 â%-16.2 â%]), LOS (6 days [95 â% CI 5-6]), costs ($15,964 [95 â% CI $15,181- $17,708]), and discharges to skilled facilities (12 â% [95 â% CI: 10.0 â%-13.3]) compared to nonoperative success. CONCLUSIONS: Nonoperative management of appendicitis should be approached cautiously for older adults.
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Appendicitis , Length of Stay , Treatment Failure , Humans , Appendicitis/therapy , Appendicitis/economics , Aged , Male , Female , Middle Aged , Length of Stay/statistics & numerical data , United States , Age Factors , Adult , Appendectomy/economics , Aged, 80 and over , Retrospective Studies , Propensity Score , Patient Discharge/statistics & numerical dataABSTRACT
BACKGROUND: The purpose of this study was to (1) compare post-treatment outcomes of operative and nonoperative management of acute appendicitis in multi-morbid patients and (2) evaluate the generalizability of prior clinical trials by determining whether outcomes differ in multi-morbid patients compared to the young and healthy patients who resemble prior clinical trial participants. METHODS: We conducted a retrospective cohort study using the National Inpatient Sample from 2004 to 2017. We included 368,537 patients with acute, uncomplicated appendicitis who were classified as having 0 or 2+ comorbidities. We compared inpatient morbidity, mortality, length of stay, and costs using propensity scores. Unmeasured confounding was addressed with probabilistic sensitivity analysis. RESULTS: Overall, 5% of patients without comorbidities were treated nonoperatively versus 20% of multi-morbid patients. Compared to surgery, nonoperative management was associated with a 3.5% decrease in complications (95% confidence interval 3%-4%) for multi-morbid patients, but there was no significant difference for patients without comorbidity. However, nonoperative management was associated with a 1.5% increase in mortality for multimorbid patients (95% confidence interval 1.3%-1.7%). Costs and length of stay were lower for all patients treated with surgery. Probabilistic sensitivity analysis showed that results were robust to the effects of unmeasured confounding. CONCLUSION: Our results raise concerns about the generalizability of clinical trials that compared nonoperative and operative management of appendicitis because (1) those trials enrolled mostly young and healthy patients, and (2) results in multi-morbid patients differ from outcomes in younger and healthier patients.
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Appendicitis , Humans , Acute Disease , Appendicitis/therapy , Morbidity , Retrospective Studies , Treatment Outcome , Clinical Trials as TopicABSTRACT
OBJECTIVE: The objective of this study was to compare postoperative 90-day mortality between (1) fully vaccinated patients with COVID-19-positive and negative diagnosis, and (2) vaccinated and unvaccinated patients with COVID-19 positive diagnosis. BACKGROUND: Societal guidelines recommend postponing elective operations for at least 7 weeks in unvaccinated patients with preoperative coronavirus disease 2019 (COVID-19) infection. The role of vaccination in this infection-operation time risk is unclear. METHODS: We conducted a national US multicenter retrospective, matched cohort study spanning July 2021 to October 2022. Participants were included if they underwent a high-risk general, vascular, orthopedic, neurosurgery, or genitourinary surgery. All-cause mortality occurring within 90 days of the index operation was the primary outcome. Inverse probability treatment weighted propensity scores were used to adjust logistic regression models examining the independent and interactive associations between mortality, exposure status, and infection proximity. RESULTS: Of 3401 fully vaccinated patients in the 8-week preoperative period, 437 (12.9%) were COVID-19-positive. Unadjusted mortality rates were not significantly different between vaccinated patients with COVID-19 (22, 5.0%) and vaccinated patients without COVID-19 (99, 3.3%; P = 0.07). After inverse probability treatment weighted adjustment, mortality risk was not significantly different between vaccinated COVID-19-positive patients compared to vaccinated patients without COVID-19 (adjusted odds ratio = 1.38, 95% CI: 0.70, 2.72). The proximity of COVID-19 diagnosis to the index operation did not confer added mortality risk in either comparison cohort. CONCLUSIONS: Contrary to risks observed among unvaccinated patients, postoperative mortality does not differ between patients with and without COVID-19 when vaccinated against the severe acute respiratory syndrome coronavirus 2 virus and receiving a high-risk operation within 8 weeks of the diagnosis, regardless of operation timing relative to diagnosis.
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COVID-19 , Humans , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Testing , Cohort Studies , Retrospective Studies , Elective Surgical Procedures , VaccinationABSTRACT
BACKGROUND: There is substantial uncertainty regarding the effects of restrictive postoperative transfusion among patients who have underlying cardiovascular disease. The TOP Trial's objective is to compare adverse outcomes between liberal and restrictive transfusion strategies in patients undergoing vascular and general surgery operations, and with a high risk of postoperative cardiac events. METHODS: A two-arm, single-blinded, randomized controlled superiority trial will be used across 15 Veterans Affairs hospitals with expected enrollment of 1520 participants. Postoperative transfusions in the liberal arm commence when Hb is <10 g/ dL and continue until Hb is greater than or equal to 10 g/dL. In the restrictive arm, transfusions begin when Hb is <7 g/dL and continue until Hb is greater than or equal to 7 g/dL. Study duration is estimated to be 5 years including a 3-month start-up period and 4 years of recruitment. Each randomized participant will be followed for 90 days after randomization with a mortality assessment at 1 year. RESULTS: The primary outcome is a composite endpoint of all-cause mortality, myocardial infarction (MI), coronary revascularization, acute renal failure, or stroke occurring up to 90-days after randomization. Events rates will be compared between restrictive and liberal transfusion groups. CONCLUSIONS: The TOP Trial is uniquely positioned to provide high quality evidence comparing transfusion strategies among patients with high cardiac risk. Results will clarify the effect of postoperative transfusion strategies on adverse outcomes and inform postoperative management algorithms. TRIAL REGISTRATION: http://clinicaltrials.gov identifier: NCT03229941.
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Anemia , Myocardial Infarction , Humans , Anemia/etiology , Erythrocyte Transfusion/adverse effects , Erythrocyte Transfusion/methods , Blood Transfusion , Myocardial Infarction/epidemiology , Myocardial Infarction/etiology , Randomized Controlled Trials as Topic , Multicenter Studies as TopicABSTRACT
This Guide to Statistics and Methods outlines the key elements that need to be considered during the design phase of a surgical clinical trial.
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Research Design , HumansABSTRACT
The aim of this secondary analysis of ELIMIT (The Effect of Lipid Modification on Peripheral Artery Disease after Endovascular Intervention Trial) was to determine longitudinal changes over 24 months in skeletal thigh muscle volumes and individual muscle compartments in patients with peripheral artery disease (PAD) with and without diabetes. A total of 48 patients with available magnetic resonance imaging of the distal superficial femoral artery at baseline and 2 years were included in this analysis. Muscle volumes and superficial femoral artery wall, lumen, and total vessel volumes were quantified. Intrareader reproducibility of muscle tracings was assessed with the intraclass correlation coefficient using a 2-way model. Baseline characteristics were similar between patients with PAD with and without diabetes, except for smoking history (p = 0.049), cholesterol levels (p <0.050), and calf walking pain (p = 0.049). Interobserver reproducibility of the muscle volume tracings was excellent for all muscle groups (all intraclass correlation coefficients >0.86, confidence interval 0.69 to 0.94). Total muscle and total leg volumes increased significantly between baseline and 24 months among patients with PAD without diabetes (31 ± 6.4 cm3 vs 32 ± 7.0 cm3, p <0.001; 18 ± 4.4 cm3 vs 19 ± 4.8 cm3, p = 0.045), whereas there was no change in patients with PAD and diabetes. Total muscle volume was inversely associated with age and body mass index in patients with PAD both with and without diabetes (p <0.05). In conclusion, magnetic resonance imaging-quantified thigh muscle volumes are highly reproducible and may be of interest in assessing PAD patients with and without diabetes.
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Diabetes Mellitus , Peripheral Arterial Disease , Humans , Magnetic Resonance Imaging , Muscle, Skeletal/blood supply , Muscle, Skeletal/diagnostic imaging , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/diagnostic imaging , Reproducibility of Results , Thigh/diagnostic imaging , Thigh/pathologyABSTRACT
BACKGROUND: Studies indicate that coronavirus disease 2019 (COVID-19) infection before or soon after operations increases mortality, but they do not comment on the appropriate timing for interventions after diagnosis. OBJECTIVE: We sought to determine what the safest time would be for COVID-19 diagnosed patients to undergo major operative interventions. METHODS: High-risk operations, between January 2020 and May 2021, were identified from the Veterans Affairs COVID-19 Shared Data Resource. Current Procedural Terminology (CPT) codes were used to exact match COVID-19 positive cases (n=938) to negative controls (n=7235). Time effects were calculated as a continuous variable and then grouped into 2-week intervals. The primary outcome was 90-day, all-cause postoperative mortality. RESULTS: Ninety-day mortality in cases and controls was similar when the operation was performed within 9 weeks or longer after a positive test; but significantly higher in cases versus controls when the operation was performed within 7 to 8 weeks (12.3% vs 4.9%), 5 to 6 weeks (10.3% vs 3.3%), 3 to 4 weeks (19.6% vs 6.7%), and 1 to 2 weeks (24.7% vs 7.4%) from diagnosis. Among patients who underwent surgery within 8 weeks from diagnosis, 90-day mortality was 16.6% for cases versus 5.8% for the controls ( P <0.001). In this cohort, we assessed interaction between case status and any symptom ( P =0.93), and case status and either respiratory symptoms or fever ( P =0.29), neither of which were significant statistically. CONCLUSIONS: Patients undergoing major operations within 8 weeks after a positive test have substantially higher postoperative 90-day mortality than CPT-matched controls without a COVID-19 diagnosis, regardless of presenting symptoms.
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COVID-19 , COVID-19/diagnosis , COVID-19 Testing , Cohort Studies , Humans , Postoperative PeriodABSTRACT
OBJECTIVE: Patients can choose between open repair and endovascular repair (EVAR) of abdominal aortic aneurysm (AAA). However, the factors associated with patient preference for one repair type over another are not well-characterized. Here we assess the factors associated with preference of choice for open or endovascular AAA repair among veterans exposed to a decision aid to help with choosing surgical treatment. METHODS: Across 12 Veterans Affairs hospitals, veterans received a decision aid covering domains including patient information sources and understanding preference. Veterans were then given a series of surveys at different timepoints examining their preferences for open versus endovascular AAA repair. Questions from the preference survey were used in analyses of patient preference. Results were analyzed using χ2 tests. A logistic regression analysis was performed to assess factors associated with preference for open repair or preference for EVAR. RESULTS: A total of 126 veterans received a decision aid informing them of their treatment choices, after which 121 completed all preference survey questions; five veterans completed only part of the instruments. Overall, veterans who preferred open repair were typically younger (70 years vs 73 years; P = .02), with similar rates of common comorbidities (coronary disease 16% vs 28%; P = .21), and similar aneurysms compared with those who preferred EVAR (6.0 cm vs 5.7 cm; P = .50). Veterans in both preference categories (28% of veterans preferring EVAR, 48% of veterans preferring open repair) reported taking their doctor's advice as the top box response for the single most important factor influencing their decision. When comparing the tradeoff between less invasive surgery and higher risk of long-term complications, more than one-half of veterans preferring EVAR reported invasiveness as more important compared with approximately 1 in 10 of those preferring open repair (53% vs 12%; P < .001). Shorter recovery was an important factor for the EVAR group (74%) and not important in the open repair group (76%) (P = .5). In multivariable analyses, valuing a short hospital stay (odds ratio, 12.4; 95% confidence interval, 1.13-135.70) and valuing a shorter recovery (odds ratio, 15.72; 95% confidence interval, 1.03-240.20) were associated with a greater odds of preference for EVAR, whereas finding these characteristics not important was associated with a greater odds of preference for open repair. CONCLUSIONS: When faced with the decision of open repair versus EVAR, veterans who valued a shorter hospital stay and a shorter recovery were more likely to prefer EVAR, whereas those more concerned about long-term complications preferred an open repair. Veterans typically value the advice of their surgeon over their own beliefs and preferences. These findings need to be considered by surgeons as they guide their patients to a shared decision.
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Aortic Aneurysm, Abdominal , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Endovascular Procedures/adverse effects , Risk Factors , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/surgery , Odds Ratio , Patient Selection , Treatment Outcome , Retrospective Studies , Blood Vessel Prosthesis Implantation/adverse effectsABSTRACT
BACKGROUND: Screening identifies intact abdominal aortic aneurysms (iAAAs) before progression to ruptured AAAs (rAAAs). However, screening efforts have been limited by the low overall diagnostic yield and unequal screening among minority populations. The goal of the present study was to identify equitable AAA screening strategies for both majority and minority populations. METHODS: We performed epidemiologic and geospatial analyses of inpatient and outpatient procedures for iAAAs and rAAAs at Texas hospitals from 2006 through 2014 at all nonfederal hospitals and clinics in Texas. The data were aggregated by area (metropolitan statistical area vs rural region) and then supplemented by six additional data sources to estimate the AAA repair incidence rates, rates of AAA-related clinic and ultrasound visits, travel distance to providers, and the location and number of unrecognized AAAs. RESULTS: Most AAA repairs had occurred among men aged 65 to 84 years and categorized as White in large metropolitan areas. The area procedure rates for rAAAs and iAAAs were strongly correlated (R2 = 0.47). Two other variables-the proportions of persons categorized as White and those aged ≥65 years in a region-identified subgroups within the majority population with a high risk of iAAAs (R2 = 0.46). Lower rates of clinic visits and AAA ultrasound scans were seen among persons categorized as Black. Several areas with disproportionately higher rAAA/iAAA repair ratios were found, mainly affecting persons categorized as Black. CONCLUSIONS: Multiple focused AAA screening strategies could be required to address the disproportionately lower AAA identification among persons categorized as Black.
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Aortic Aneurysm, Abdominal , Aortic Rupture , Endovascular Procedures , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/epidemiology , Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/surgery , Hospitals , Humans , Male , Risk Factors , Texas/epidemiology , Treatment OutcomeABSTRACT
BACKGROUND: Peripheral vascular graft infections, a serious concern after open lower extremity interventions, are treated using multiple strategies. Yet, there is no consensus on the optimal treatment. This study summarizes the literature and compares aggregate effect sizes between graft preservation with antibiotic beads and total graft excision. METHODS: Manuscripts published between 1972 and 2019 were systematically queried using Ovid Medline and PubMed. Studies were included if they described early (≤4 months of the index procedure) infection-related outcomes after extracavitary and infrainguinal arterial graft infections that were managed with antibiotic-loaded beads or total excisions. Outcomes assessed included the prevalence of graft preservation failure, reinfection, and major amputation. To examine current preferences on this subject, a voluntary, anonymous survey was administered to practicing members of the Society for Clinical Vascular Surgery. RESULTS: Six graft preservation studies (n = 147 patients) were included in the meta-analysis, based on PRISMA guidelines. The meta-analytic pooled proportion of patients with: (1) graft preservation failure was 0.09 (95% CI: 0.00, 0.46, I2â¯=â¯88.8%), (2) reinfection was 0.04 (95% CI: 0.00, 0.18, I2â¯=â¯79.7%), and (3) major amputation was 0.00 (95% CI: 0.00, 0.04, I2â¯=â¯0%). Five studies addressing total excisions were identified via the systematic review however, their combined sample size (n = 28 patients) impeded use of a meta-analysis. Ninety (19%) licensed surgeons participated in the survey. In a hemodynamically stable, nonseptic patient, 67% (60) of respondents routinely excise the graft, while 31% (28) prefer preservation. CONCLUSIONS: Study design and patient characteristic-related heterogeneity limited our ability to generate robust, clinical evidence-level outcome estimates. A prospective study is necessary to definitively establish the efficacy of antibiotic beads in the treatment and preservation of vascular graft infections.
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Anti-Bacterial Agents/administration & dosage , Blood Vessel Prosthesis/adverse effects , Prosthesis-Related Infections/drug therapy , Surgical Wound Infection/drug therapy , Vascular Surgical Procedures/adverse effects , Amputation, Surgical , Anti-Bacterial Agents/therapeutic use , Drug Carriers , Humans , Lower Extremity/blood supply , Lower Extremity/surgery , Polymethyl Methacrylate , Surveys and Questionnaires , Treatment Failure , Vascular GraftingABSTRACT
BACKGROUND: Endovascular intervention is commonly pursued as first-line management of symptomatic, long-segment superficial femoral artery (SFA) disease. The relative effectiveness and comparative long-term outcomes among bare metal stents (BMS), covered stents (CS), and drug-eluting stents (DES) for long-segment SFA lesions remain uncertain. METHODS: A retrospective cohort study identified patients with symptomatic SFA lesions measuring at least 15 cm in length who successfully received an endovascular stent (BMS, CS, or DES). The outcomes were patency, patient presentation upon stent occlusion, amputation-free survival (AFS), and all-cause mortality. Proportional hazards regressions and a multinomial logistic regression model were used to control for significant confounders. RESULTS: A total of 226 procedures were analyzed (BMS: 95 [42%]; CS: 74 [33%]; DES: 57 [25%]). There were no significant differences among the 3 stent types with respect to age, prevalence of either diabetes or end-stage renal disease, or smoking history. The median length of the SFA lesion varied across the cohorts (BMS: 28 cm [interquartile range, IQR 20-30]; CS: 26 cm [IQR 20-30]; DES: 20 cm [IQR 16-25]; P = 0.002). The unadjusted primary patency of BMS at 12, 24, and 48 month following index stent placement was 57%, 47%, and 44%, respectively. This is compared to 62%, 49%, and 42% for CS, and 81%, 66%, and 53% for DES, respectively (log-rank P = 0.044). In adjusted models, however, there were no significant differences in primary patency among the stent types. Compared to CS however, DES was associated with improved primary-assisted patency (hazard ratio [HR] for patency loss: 0.35, P = 0.008) and secondary patency (HR: 0.32, P = 0.011). Across the entire follow-up period, stent occlusions occurred in 38 (40%) BMS cases, 42 (57%) CS, and 11 (19%) DES (P < 0.001). Of these, acute limb ischemia (ALI) occurred in 2 (5%) BMS cases, 14 (33%) CS, and 1 (9%) DES (P = 0.010). After adjustment, the relative risk of presenting with ALI as opposed to claudication was 27 times greater among patients re-presenting with occluded CS compared to BMS (P = 0.020). There were no significant differences in AFS or all-cause mortality across the 3 cohorts. CONCLUSIONS: For long-segment SFA lesions, DES is associated with improved primary-assisted and secondary patency over long-term follow-up. In the event of stent occlusion, CS is associated with an increased risk of ALI.
Subject(s)
Endovascular Procedures/instrumentation , Femoral Artery , Peripheral Arterial Disease/therapy , Stents , Aged , Amputation, Surgical , Comparative Effectiveness Research , Drug-Eluting Stents , Endovascular Procedures/adverse effects , Endovascular Procedures/mortality , Female , Femoral Artery/diagnostic imaging , Femoral Artery/physiopathology , Humans , Limb Salvage , Male , Metals , Middle Aged , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/mortality , Peripheral Arterial Disease/physiopathology , Prosthesis Design , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , Vascular PatencyABSTRACT
BACKGROUND: Transtibial amputations (TTAs) of the leg have been associated with high rates of wound complications. We assessed outcomes of TTAs to determine if bundled interventions implemented at our hospital had an impact on lowering wound complications, including surgical site infections. METHODS: We assessed the impact of a surgical site infection prevention bundle (negative-pressure wound therapy, minimizing the use of staples, and a decontamination protocol for methicillin-resistant Staphylococcus aureus) on 90-day wound complications. The year of implementation of the prevention bundle was excluded, and the pre-eras and posteras were defined as the four-year period before and after implementation. The study sample consisted of a single-center cohort, with TTA cases identified using operating room scheduling software. RESULTS: A total of 182 TTAs were performed: 110 in the pre-era and 72 in the postera. The wound complication rate decreased from 22 to 17% despite fewer two-stage operations, less imaging to identify peripheral artery disease, and an increased proportion of patients with end-stage renal disease. Wound complications and revision to a higher level of amputation were more associated with indication (especially no-option peripheral artery disease with ischemic rest pains) than with any particular aspect of surgical technique. The use of drains was associated with reoperations but not higher level revision. CONCLUSIONS: Higher rates of wound complications and revision to a higher level of amputations should be expected among patients with no-option peripheral artery disease with ischemic rest pains undergoing TTAs. Drains should be avoided.
Subject(s)
Amputation, Surgical/adverse effects , Intermittent Claudication/surgery , Ischemia/surgery , Leg/blood supply , Patient Care Bundles , Peripheral Arterial Disease/surgery , Surgical Wound Infection/surgery , Tibia/surgery , Aged , Female , Humans , Intermittent Claudication/diagnosis , Intermittent Claudication/physiopathology , Ischemia/diagnosis , Ischemia/physiopathology , Male , Middle Aged , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/physiopathology , Regional Blood Flow , Reoperation , Retrospective Studies , Risk Factors , Surgical Wound Infection/diagnosis , Surgical Wound Infection/microbiology , Time Factors , Treatment Outcome , Wound HealingABSTRACT
OBJECTIVE: Bypass graft preservation with wound sterilization using serial antibiotic bead exchange has been described in patients presenting with deep wound infections after extremity bypass. The long-term benefits of this approach remain poorly understood. We examined whether graft preservation and wound sterilization with antibiotic beads affect amputation rates and patient survival. METHODS: Patients who underwent operations for aortoiliac or infrainguinal aneurysmal or occlusive arterial disease were retrospectively analyzed. The Infection group included those with patent vascular grafts who developed Szilagyi class II or III deep wound infections within 90 days of index reconstruction and had no evidence of anastomotic or arterial bleeding. All patients in the infection group were managed with graft preservation using serial antibiotic bead exchange every 3 to 5 days until wound cultures became negative. This group was compared with a contemporary group of controls who underwent similar interventions but did not develop wound infections postoperatively. The primary outcome was amputation-free survival, defined as survival without major amputation. Secondary outcomes included major amputations and the occurrence of anastomotic pseudoaneurysms necessitating repair. Inverse propensity score weighting was used for risk adjustment between the groups. RESULTS: Over an 8-year period, we treated 701 patients (infection, 68; controls, 633). Compared with controls, patients in the infection group had a higher body mass index (mean, 28.5 vs 26.3, P = .002) and more prosthetic conduits placed during the index reconstruction. Amputation-free survival for the infection vs the control group was 78 vs 76% at 2 years, 61 vs 66% at 4 years, and 51 vs 57% at 6 years postoperatively (log-rank test, P = .516). Freedom from major amputation for the infection vs the control group was 82 vs 86% at 2 years, 80 vs 82% at 4 years, and 80 vs 76% at 6 years postoperatively (log-rank test, P = .568). In the risk-adjusted model, the presence of treated infection did not affect amputation-free survival (hazard ratio, 0.82; P = .440) or major amputation (hazard ratio, 1.02; P = .949). Anastomotic pseudoaneurysms occurred only in the Infection group (4.4%; P = .001), and were treated with interposition grafts without complications. CONCLUSIONS: Bypass graft preservation with wound sterilization using serial antibiotic bead exchange is associated with excellent limb salvage and survival rates, similar to those of noninfected wounds. With the use of this preservation strategy, close follow-up for timely detection of anastomotic pseudoaneurysms is recommended.