Association Between Coronavirus Disease 2019 Vaccination and Mortality After Major Operations.

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.

Association Between Pack-Years and Smoking Cessation on Outcomes After Vascular Interventions.

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.

Timing of a Major Operative Intervention After a Positive COVID-19 Test Affects Postoperative Mortality: Results From a Nationwide, Procedure-matched Analysis.

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.

Treatment of Early Deep Wound Infections after Arterial Reconstructions: A Meta-Analysis and Survey.

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, I2 = 88.8%), (2) reinfection was 0.04 (95% CI: 0.00, 0.18, I2 = 79.7%), and (3) major amputation was 0.00 (95% CI: 0.00, 0.04, I2 = 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.

Outcomes after Endovascular Stent Placement for Long-Segment Superficial Femoral Artery Lesions.

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.

Long-term outcomes of lower extremity graft preservation using antibiotic beads in patients with early deep wound infections after major arterial reconstructions.

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.

Leg Amputations Among Texans Remote From Experienced Surgical Care.

BACKGROUND: Surgical outcomes may differ between low-volume and experienced hospitals. We sought to identify characteristics of remote patients-those living more than 50 miles from an experienced center-who underwent leg amputations for peripheral artery disease (PAD) and foot complications at low-volume and experienced hospitals and identify regions of Texas where such patients live. MATERIALS AND METHODS: Publicly available Texas hospitalization data from 2004 through 2009 were used to identify patients with PAD who underwent leg amputation for foot complications, including foot ulcers, foot infections, and gangrene. Geocoding was used to further identify a subset of remote patients and to estimate distances from zip code of residence to hospital in which care was received. RESULTS: Among all leg amputations, 850 (18.6%) were performed on patients classified as remote, and 3723 (81.4%) were performed on patients classified as nonremote. Compared with nonremote patients, remote patients were more often categorized as white and more frequently received Medicare and/or Medicaid. Of the subset of remote patients, those at low-volume hospitals were older, were less often categorized as Hispanic, more often had Medicaid coverage, were also more frequently admitted through the emergency department, and often had a foot infection compared with those at experienced centers. Geospatial analysis identified five concentrated geographic areas of remote patients who live more than 50 miles from an experienced center. CONCLUSIONS: These findings suggest travel distance may at least influence, if not constrain, the choice of hospital for patients with PAD and foot complications. Efforts to decrease leg amputations among remote patients should be focused on five specific geographic areas of Texas.

A Statistical Model-driven Surgical Case Scheduling System Improves Multiple Measures of Operative Suite Efficiency: Findings From a Single-center, Randomized Controlled Trial.

OBJECTIVE: We sought to determine whether a data-driven scheduling approach improves Operative Suite (OS) efficiency. BACKGROUND: Although efficient use of the OS is a critical determinant of access to health care services, OS scheduling methodologies are simplistic and do not account for all the available characteristics of individual surgical cases. METHODS: We randomly scheduled cases in a single OS by predicting their length using either the historical mean (HM) duration of the most recent 4 years; or a regression modeling (RM) system that accounted for operative and patient characteristics. The primary endpoint was the imprecision in prediction of the end of the operative day. Secondary endpoints included measures of OS efficiency; personnel burnout captured by the Maslach Burnout Inventory; and a composite endpoint of 30-day mortality, myocardial infarction, wound infection, bleeding, amputation, or reoperation. RESULTS: Two hundred and seven operative days were allocated to scheduling with either the RM or the HM methodology. Mean imprecision in predicting the end of the operative day was higher with the HM approach (30.8 vs 7.2 minutes, P = 0.024). RM was associated with higher throughput (379 vs 356 cases scheduled over the course of the study, P = 0.04). The composite rate of adverse 30-day events was similar (2.2% vs 3.2%, P = 0.44). The mean depersonalization score was higher (3.2 vs 2.0, P = 0.044), and mean personal accomplishment score was lower during HM weeks (37.5 vs 40.5, P = 0.028). CONCLUSIONS: Compared to the HM scheduling approach, the proposed data-driven RM scheduling methodology improves multiple measures of OS efficiency and OS personnel satisfaction without adversely affecting clinical outcomes.

Health Care Resource Distribution of Texas Counties With High Rates of Leg Amputations.

BACKGROUND: Lower extremity amputation rates associated with peripheral arterial disease in Texas are high and vary disproportionately among different populations. We sought to assess the impact of socioeconomic status and health care resource distribution on the geographic prevalence of lower extremity amputation in Texas counties. MATERIALS AND METHODS: We collated 2005-2009 data on all 254 Texas counties. The primary outcome was the number of nontraumatic lower extremity amputations. Population-adjusted regressions identified factors that could explain increasing amputation rates. RESULTS: We identified 33 counties with population-weighted amputation rates in the highest 25%. These counties had higher rates of diabetes, larger populations of people categorized as black, fewer health care resources, and lower health care utilization. In the presence of more emergency room visits, dual Medicare/Medicaid eligibility decreased total amputations. In counties with more than 70% rural communities, additional primary care providers also significantly decreased amputations per 100,000 residents (mean difference = -0.12, 95% confidence interval: -0.23, -0.0008). CONCLUSIONS: Policy-driven strategic health care resource allocation at the local level may benefit patients in high-need, low-resource areas and promote a reduction in amputations.

Delayed gratification and adherence to exercise among patients with claudication.

Few studies have explicitly identified factors that explain an individual's willingness to engage in community-based exercise for claudication. Identifying the unique characteristics of those inclined toward physical activity would inform interventions that encourage walking. We examined the utility of behavioral economics-related concepts in understanding walking among Veterans with claudication. Patients who received care at the Michael E. DeBakey Veterans Affairs Medical Center in Houston, Texas, were surveyed on symptom severity, behavioral economics, stress, and depression. The primary outcome was a binary variable measuring current walking for exercise and defined as walking for at least 30 minutes every day. Multivariable logistic regression models were used to identify variables, both clinically and statistically significant, at a p-value < 0.05. Between April 2017 and March 2018, we received 148 (30%) responses. A total of 35% (n = 51) of respondents indicated that they walked recreationally for exercise compared to 65% (n = 94) who did not. Characteristics that were significantly associated with walking included regularly saving money (adjusted odds ratio (aOR) = 10.7, p = 0.001), seeking complex problem-solving (aOR = 0.12, p = 0.002), and severe symptoms (aOR = 0.24, p = 0.017). Individuals describing a preference for the future rather than immediate benefit also reported currently walking for exercise. Defining the characteristics of those who exercise may help inform strategies designed to increase walking among those who do not adhere to recommendations.

Successful Smoking Cessation Associated with Walking Behavior in Patients with Claudication.

BACKGROUND: Behavioral economics theories suggest that a preference for delayed benefits promotes positive behavioral change, a concept relevant to both smoking cessation and community-based exercise regimens for claudication. Given the high rate of smoking among older veterans, we were interested in examining the association between smoking cessation, exercise regimen adherence, and preferences for delayed versus immediate benefits. METHODS: Between April 2017 and March 2018, patients with claudication at the Michael E. DeBakey Veterans Affairs Medical Center in Houston, Texas, received questionnaires collecting information on social, behavioral, and psychological characteristics. A dual validation system, via the electronic medical record and survey data, measured the primary outcome-smoking cessation versus current smoking. Self-reported physical activity was measured through the validated Ainsworth's compendium of Physical Activities and binary survey questions. The Walking Impairment and Barratt's Impulsivity Questionnaires measured subjective symptom severity and behavioral economics factors, respectively. Multivariable, logistic regression models identified significant associations. RESULTS: The survey was mailed to 500 patients who met the eligibility criteria. We received responses from 148 individuals (30%), and 67 of 141 (48%) indicated that they had successfully quit smoking. In unadjusted comparisons, the median cognitive complexity score in the smoking cessation group was higher than that in the current smoking group. A greater proportion of patients who reported walking for exercise (n = 46) also reported successful smoking cessation (28/46, 61%). Among those who were not walking for exercise (n = 88), more individuals reported current smoking (49/88, 56%). In the multivariable model, individuals who had successfully stopped smoking were older (odds ratio [OR]: 7.59, P < 0.001), more likely to walk for exercise (OR: 3.94, P = 0.009), more interested in the future than in the present (OR: 1.73, P = 0.030), and more likely to regularly save money (OR: 3.49, P = 0.046). CONCLUSIONS: We found that participants who reported successful smoking cessation were more likely to report walking for exercise. Our findings suggest that adherence to walking may be less challenging for patients who have already successfully implemented and continue to implement another beneficial health behavior (smoking cessation). Patients with claudication who are current smokers may be less likely to adopt exercise recommendations.

Missing Data in Surgical Data Sets: A Review of Pertinent Issues and Solutions.

Incomplete data is a common problem in research studies. Methods to address missing observations in a data set have been extensively researched and described. Disseminating these methods to the greater research community is an ongoing effort. In this article, we describe some of the basic principles of missing data and identify practical, commonly used methods of adjustment relevant to surgical data sets. Through an example data set, we compare models generated through complete case analysis, single imputation (SI), and multiple imputation (MI). We also provide information on the steps to conduct MI using Stata IC. In our comparisons, we found that differences in odds ratios were greatest between the results from complete case analysis compared to the SI and MI models indicating that in this case the reduction in statistical power has a non-negligible effect on the parameter estimates. Odds ratio estimates from the SI and MI methods were largely similar. In some instances, when compared to the MI method, the SI method tended to overestimate effect sizes. While in this example the differences in odds ratios do not vary greatly between the SI and MI methods, there are clear indications supporting the use of MI over SI. By describing the issues surrounding missing data and the available options for adjustment, we hope to encourage the use of robust imputation methods for missing observations.

The influence of pain-related beliefs on physical activity and health attitudes in patients with claudication: A pilot study.

We examined how pain beliefs are related to symptom severity, expectations of risk/benefits, and baseline physical activity among claudicants. Eligible patients at the Michael E DeBakey Veterans Affairs Medical Center were administered questionnaires that measured: fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire [FABQ]), walking impairment, baseline physical activity, claudication type, and risk/benefit attitudes. Among 20 participants, the median age was 69 years (IQR: 66-75). In our efforts to understand how fear-avoidance beliefs influenced physical activity among people with claudication, we found that 12 out of 19 participants (63%) thought that the primary etiology of their pain was walking, while 18 (out of 20) (90%) people thought that walking would exacerbate their leg symptoms - suggesting that there was some confusion regarding the effects of walking on claudication. Those who expected that walking would benefit their symptoms more than surgery reported fewer fear-avoidance beliefs ( p=0.01), but those who believed that walking would make their leg pain worse expected greater benefit from surgery ( p=0.02). As symptom severity increased, fear-avoidance beliefs also increased ( p=0.001). The association between symptom severity and fear-avoidance beliefs indicates that as pain or impairment increases, the likelihood of avoiding behaviors that are thought to cause pain might also increase. Accounting for pain-related beliefs when recommending physical activity for claudication should be considered.

The impact of clinical, psychological, behavioral, social, and environmental factors on self-perceived symptom severity in a male cohort with intermittent claudication.

OBJECTIVE: To understand the relationship between self-perceived severity of intermittent claudication and various associated nonclinical factors, we examined how correlates in domains of physical activity (ie, clinical, psychological, behavioral, social, and environmental factors) relate to exertional limb symptoms. METHODS: A survey was administered to individuals with intermittent claudication during their initial outpatient assessment. The subjects' self-reported exertional limb symptom severity and classic-versus-atypical claudication classification was based on the Walking Impairment Questionnaire (WIQ) and San Diego Claudication Questionnaire (SDCQ), respectively. We evaluated psychosocial and environmental factors, osteoarthritis symptoms, health, behaviors, and beliefs. Logistic and linear regressions identified factors with a strong independent association with total WIQ scores and the SDCQs. RESULTS: A cohort of 102 subjects (99.0% male) was enrolled in the study. The median age was 65 years with a median ankle-brachial index of 0.69. Forty-three subjects (43%) had "typical" claudication per SDCQs. Individuals with atypical claudication were more likely to report higher Aberdeen Clinical Back Pain Questionnaire scores (odds ratio, 1.04; P = .04) and no depressive symptoms (odds ratio, 8.30; P = .03). Exertional limb symptom severity among the entire cohort was significantly associated with increasing osteoarthritis symptoms (P <.001), age (P = .02), a reserved personality (P = .008), and the belief that an exercise regimen would not improve symptoms (P = .005), self-perceived levels of boredom (P = .002), and the belief that exercise (P = .002) was the best way to improve symptoms were associated with decreased symptom severity. When restricted to those with atypical pain, significant factors associated with increasing exertional symptom severity included age greater than 60 years (P = .005), osteoarthritis (P = .02), alcohol use (P = .01), belief that exercise would not improve walking (P = .03), and difficulty walking around the neighborhood (P = .02). When restricted to those with classic claudication, significant factors associated with increasing exertional limb symptom severity included frequent pain or aching in the calves while walking or sitting (P = .03 [walking]; P = .01 [sitting]) and occasional morning joint stiffness (P = .007). Exertional limb symptom severity was also associated with high limitations at home (P = .003) and a belief that exercise would not improve walking (P = .005) among those with classic claudication. CONCLUSIONS: Symptom severity and type of pain are associated with a number of nonclinical factors. A multidomain approach, as indicated by the models above, would benefit the continuum of care for intermittent claudication, where management is integrated and coordinated among multiple lines of care.

Percutaneous intervention for carotid in-stent restenosis does not improve outcomes compared with nonoperative management.

BACKGROUND: The appropriateness of percutaneous intervention for moderate to severe carotid in-stent restenosis (C-ISR) is unclear. We therefore sought to compare stroke/death/myocardial infarction (MI) rates between percutaneous interventions and nonoperative management for ≥50% C-ISR. METHODS: We performed a single-center retrospective review of consecutive patients presenting with ≥50% C-ISR to the vascular surgery service. Demographics, comorbidities, and intraoperative and postoperative variables were obtained. The degree of stenosis was verified by review of digital subtraction or computed tomography angiograms. The primary outcome was stroke/death/MI after the diagnosis of ≥50% C-ISR. χ2, Kruskal-Wallis, and Kaplan-Meier analysis was used to quantify outcomes of the patients treated percutaneously vs nonoperatively. RESULTS: During a 13-year period, 59 patients (75 C-ISRs) presented with ≥50% C-ISRs (n = 58 male [98%]; n = 57 C-ISRs asymptomatic [76%]) with a median age of 67.5 years (62.8-74.6). The initial pathologic process underlying the original stent was atherosclerosis in 33 (70%), radiation induced in 10 (21%), prior carotid endarterectomy in 4 (9%), and unknown in 28 (37%). Forty C-ISRs underwent a percutaneous intervention (19 percutaneous angioplasty only [48%]; 21 repeated stent and percutaneous angioplasty [52%]). Median follow-up for the entire cohort was 948 days (283-2322) and similar between the intervention and nonintervention arms. There were no significant differences between the arms with respect to age (P = .16), medical comorbidities (P > .05), original stent type (P = .46), or clopidogrel use (P = .74). At 30 days, there was one stroke and subsequent death in the intervention arm and none in the nonintervention arm. During the follow-up period, a median of 1.0 procedure was required to maintain patency. By Kaplan-Meier analysis, there were no statistically significant differences between the intervention and nonintervention arms with respect to stroke/death/MI as a composite or any of the individual components at last follow-up (P = .82). Kaplan-Meier estimated patency was not significantly superior in the intervention vs the nonintervention arm (8.0 years ± 1.1 vs 5.3 years ± 0.7; P = .14). CONCLUSIONS: Over 13 years, percutaneous interventions for ≥50% C-ISR were safe and durable. However, interventions fail to improve long-term stroke/death/MI or patency rates relative to nonintervention. Intervention for C-ISR may not be necessary, although future appropriately powered, prospective trials will be necessary to confirm these findings and to determine the appropriateness of interventions for C-ISR.

Trends and predictors of inflation-adjusted costs in transcatheter and surgical aortic valve replacement in a nationally representative sample.

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.

A Multi-Component Strategy to Decrease Wound Complications after Open Infra-Inguinal Re-Vascularization.

BACKGROUND: Wound complications remain a significant source of morbidity for patients undergoing open infra-inguinal re-vascularization. The purpose of this study was to determine the impact of several infection-control strategies on post-operative wound complications after open infra-inguinal re-vascularization. METHODS: A retrospective cohort study was conducted among all patients who underwent an open infra-inguinal re-vascularization procedure before and after 2014. Since 2014, we have implemented strategies to reduce post-operative wound complications, including: (1) Decreasing the use of incisional skin staples, (2) increasing the use of negative pressure wound therapy (NPWT) dressings, and (3) implementing an outpatient elective decontamination protocol for methicillin-resistant Staphylococcus aureus. "Pre-era" is defined as the period between January 2012 and December 2013, before the implementation of infection control strategies; "Post-era" is between January 2015 and August 2016, after implementation. The primary outcome of interest is 30-day wound complications (infection or dehiscence). Multi-variable logistic regression analysis was used to identify significant predictors of wound-related complications between the two cohorts. Propensity score adjustment controlled for baseline patient characteristics, peri-operative variables, and surgeon experience. RESULTS: A total of 338 open infra-inguinal procedures were performed: 175 in the pre-era and 163 in the post-era. Chlorhexidine skin preparation was used in the majority (321 [95%]) of cases. Comparing the periods, the post-era is characterized by a significant decrease in the use of groin staples (118 [67%] vs. 51 [31%], p < 0.001), and an increased application of NPWT dressings (6 [4%] vs. 66 [43%], p < 0.001). Thirty-five (37%) outpatient elective cases received the pre-operative decontamination protocol in the post-era. Compared with the pre-era, there was a decrease in the 30-day rate of wound complications (68 [39%] to 42 [26%], p = 0.011), and infection-related re-admissions (31 [17.7%] to 21 [12.9%], p = 0.220). When adjusting for patient characteristics, operative variables, and surgeon experience, post-era had significantly lower wound complications (odds ratio [OR] 0.33, p = 0.002) and re-operations (OR 0.16, p = 0.007). Among outpatient elective cases, the decontamination protocol was also independently associated with these two outcomes (wound complications: OR 0.05, p = 0.006; re-operations: 0.06, p = 0.002). The use of groin staples was an independent predictor of deep groin infections (OR 248, p < 0.001) and re-operations (OR 8.16, p = 0.032). CONCLUSIONS: Wound complications after open infra-inguinal re-vascularization have decreased significantly after the implementation of several infection-control strategies. Findings suggest that skin staples should be avoided in groin wounds, and anti-staphylococcal decontamination protocols decrease wound complications and prevent re-operations.