Effectiveness of Closed Incision Negative Pressure Wound Therapy for Infrainguinal Bypass in the Vascular Quality Initiative.

BACKGROUND: To analyze surgical site infections (SSIs) after infrainguinal bypass for standard dressings versus closed incision negative pressure wound therapy (ciNPWT) in the Society for Vascular Surgery's Vascular Quality Initiative (VQI). METHODS: We retrospectively analyzed SSI after infrainguinal bypass procedures in the VQI from December 2019 to December 2021 comparing ciNPWT and standard dressings. The primary outcome of any superficial or deep wound infection at 30 days was analyzed in a subset of procedures with 30-day follow-up data (cohort A, n = 1,575). Secondary outcomes including in-hospital SSI, return to the operating room (OR) for infection, and length of stay (LOS) were analyzed for all procedures (cohort B, n = 9,288). Outcomes were analyzed in propensity-matched cohorts. RESULTS: Patients who received ciNPWT (n = 1,389) were more likely to be female (34% vs. 32%, P = 0.04) with a higher rate of smoking history (90% vs. 86%, P = 0.003), diabetes (54% vs. 50%, P = 0.007), obesity (34% vs. 26%, P < 0.001), prior peripheral vascular intervention (57% vs. 51%, P < 0.001), and to prosthetic conduit (55% vs. 48%, P < 0.001) compared to patients with standard dressings (n = 7,899). After propensity matching of cohort A (n = 1,256), the 30-day SSI rate was 4% (12/341) in the ciNPWT and 6% (54/896) in the standard dressing group (P = 0.07, 95% CI 0.03-1.06). In the propensity-matched in-hospital cohort B (n = 5,435), SSI was 3% (35/1,371) in the ciNPWT group and 2% (95/4,064) in the standard dressing group (P = 0.66). There was no difference in the rate of return to the OR for infection, 1% (36/4,064) vs. 1% (19/1,371) (P = 0.13) or LOS, 9.0 vs. 9.0 days (P = 0.86) for the standard versus ciNPWT groups. CONCLUSIONS: In this analysis of the VQI registry, the use of ciNPWT after infrainguinal bypass did not result in a statistically significant decrease in 30-day SSI. We recommend that surgeons consider the use of ciNPWT as part of a bundled process of care for high risk rather than all patients, as it may reduce SSI after infrainguinal bypass.

Integration of palliative care consultation into the management of patients with chronic limb-threatening ischemia.

OBJECTIVE: We assessed the feasibility of integrating palliative care consultation into the routine management of patients with chronic limb-threatening ischemia (CLTI). Additionally, we sought to describe patient-reported outcomes from the palliative care and vascular literature in patients with CLTI receiving a palliative care consultation at our institution. METHODS: This was a single-institution, prospective, observational study that aimed to assess feasibility of incorporating palliative care consultation into the management of patients admitted to our tertiary academic medical center with CLTI by looking at utilization of palliative care before and after implementation of a protocol-based palliative care referral system. A survey comprised of patient-reported outcomes from the palliative care literature was administered to patients before and after palliative consultation. Length of stay and mortality were compared between our study cohort and a historic cohort of patients admitted with CLTI. RESULTS: Over a 14-month enrollment period, 44% of patients (n = 39) with CLTI (rest pain, 36%; tissue loss, 64%) admitted to the vascular service received palliative care consultation, compared with 5% of patients (n = 4) who would have met criteria over the preceding 14 months before our protocol was instituted. The mean age was 69 years, 23% were female, 92% were white, and 49% were able to ambulate independently. Revascularization included bypass (46%), peripheral vascular intervention (23%), and femoral endarterectomy (21%). Additional procedures included minor amputation or wound debridement (26%) and major amputation (15%). No patients received medical management alone. After receiving palliative care consultation, patients reported experiencing less emotional distress than before consultation (P = .03). They also reported being less bothered by uncertainty regarding what to expect from the course of their illness (P = .002). Fewer patients reported being unsure of the purpose of their medical care after palliative care consultation (8%) vs before (18%), although this was not statistically significant (P = .10). Median length of stay was longer in the study group compared with the historic cohort (8 vs 7 days; P = .02). There was no difference in 30-day mortality (3% vs 8%; P = .42) between the study group and the historic cohort (n = 77). CONCLUSIONS: Integrating inpatient palliative care consultation into the routine management of patients with CLTI is feasible and may improve emotional domains of health-related quality of life. This study laid the foundation for future studies on longer term outcomes of patients with CLTI undergoing palliative care consultation as well as the benefit of outpatient palliative care consultation in patients with CLTI.

Defining Risk and Risk Factors for Unplanned ICU Admission of Trauma Patients.

BACKGROUND: Unplanned ICU admissions (up-ICUad) are associated with poor outcomes. It is difficult to identify who is at risk for up-ICUad in trauma patients. This study aimed to identify injury patterns and comorbidities associated with up-ICUad and develop a predictive tool for who is at risk. METHODS: A retrospective study compared trauma patients admitted to the floor who experienced an up-ICUad to similar patients without an up-ICUad. Univariate analysis and multivariate logistic regression identified independent risk factors associated with up-ICUad. Based on those factors, a Risk Score (RS) was created and compared between the two groups. RESULTS: 2.15% of the 7206 patients experienced an up-ICUad. The up-ICUad group was older, experienced longer length of stay, and had higher mortality. Age, congestive heart failure, COPD, peptic ulcer disease, mild liver disease, CKD, and significant injuries to the thorax, spine, and lower extremities were independently associated with up-ICUad. A RS equation was created and was used for each patient. CONCLUSIONS: Trauma patients are at increased risk for up-ICUad based on specific factors. These factors can be used to calculate a RS to determine who is at greatest risk for an up-ICUad which may be helpful for preventing up-ICUad.

Intranasal Fentanyl for On-the-Hill Analgesia by Ski Patrol.

INTRODUCTION: Intranasal fentanyl offers a means for safe and effective pain management in austere environments. Prehospital analgesia traditionally involves intravenous or intramuscular medication. However, for wilderness rescuers, these methods are often impractical. METHODS: We conducted a retrospective review of health records to evaluate the safety and efficacy of intranasal fentanyl administered by EMT-Basic certified ski patrollers. Our primary aim was to measure the reduction in initial pain scores to subsequent measurements at 5, 10, and 15 min using the pain numeric rating scale (0-10). Clinically significant reduction in severe pain has been established as ≥1.8 points. We used paired t-tests and multilevel modeling to measure statistical significance and potential interactions and reviewed patient charts for adverse events, including respiratory depression or the use of naloxone. RESULTS: We compiled the results from the winter seasons for 2007 through 2012 and 2016 through 2020. A total of 247 patients were included. The initial pain score was 8.6±1.5 (mean±SD). The decrease in pain scores from 0 to 5, 10, and 15 min, respectively, was -1.8, -2.4, and -2.9 (P<0.0001), which demonstrated a clinically and statistically significant decrease in pain scores. There were no adverse events. CONCLUSIONS: Traditional standard of care analgesics are invasive, elongate scene times, and increase the risk of environmental exposure and provider needlestick. Intranasal fentanyl offers a safe, noninvasive, and rapid analgesia that is well-suited for austere winter environments, such as those encountered at ski resorts. This study demonstrates the safety and efficacy of the administration of intranasal fentanyl by EMT-Basic certified providers.

Tobacco and Nicotine Use Among US Adult "Never Smokers" in Wave 4 (2016-2018) of the Population Assessment of Tobacco and Health Study.

INTRODUCTION: A common criterion for being labeled a "never smoker" is having smoked <100 lifetime cigarettes. This category is often used as an unexposed reference group to estimate the relative harm from cigarettes. We examined the amount of current and past cigarette and non-cigarette tobacco/nicotine use among adults who met this "never smoker" criterion. METHODS: We analyzed cross-sectional data from 17 179 adult "never smokers" (ie, reported <100 lifetime cigarettes) in Wave 4 (2016-2018) of the Population Assessment of Tobacco and Health (PATH) Study, a United States nationally representative sample. We used PATH-derived variables to describe "never smokers'" demographics as well as cigarette and non-cigarette tobacco/nicotine use. RESULTS: Approximately half of "never smokers" were young adults (49.3%). Most were white (68.6%) with some college or more (64.4%). Most "never smokers" had tried any cigarette or non-cigarette tobacco/nicotine in their lifetime (66.7%), 8.5% smoked cigarettes in the past 30 days, and 5.3% were current experimental (ie, some days or every day) cigarette smokers. By definition, "never smokers" reported smoking <100 lifetime cigarettes. One fifth (22.8%) had a lifetime history of established regular non-cigarette tobacco/nicotine use and 8.6% were current established regular non-cigarette tobacco/nicotine users. In total, 9.4% of "never smokers" were current experimental or established regular users of combustible tobacco. CONCLUSIONS: The 100-cigarette lifetime threshold includes substantial amounts of current and past tobacco use and thus does not represent lack of exposure to cigarette or non-cigarette tobacco. "Never smoker" reference groups may produce underestimates of the relative harms from cigarettes. IMPLICATIONS: The <100 lifetime cigarettes criterion may not capture what many would consider true "never smokers." Relying on the current definition of "never smokers" as a reference group will include a substantial number of those currently and recently using combustible tobacco and thus produce data that may underestimate the relative harm from cigarettes. Prospective longitudinal research is needed to compare how the 100-cigarette lifetime threshold versus other definitions of regular cigarette smoking differ in predictive validity of clinically meaningful outcomes and health harms to determine the optimal criteria to define established cigarette smoking.

Possible New Symptoms of Tobacco Withdrawal III: Reduced Positive Affect-A Review and Meta-analysis.

INTRODUCTION: Most descriptions of tobacco withdrawal have not changed in >30 years despite new research. This meta-analysis tested whether abstinence leads to decreased positive affect (PA) because abstinence-induced symptom changes are a core feature of the tobacco withdrawal syndrome. In addition, we examined whether reduced PA was due to withdrawal (ie, temporary decrease in a "U-shaped" curve) or offset (ie, return to baseline) effect. METHODS: Our main inclusion criterion was a prospective within-participant test of change in PA during abstinence conditions among people who smoke cigarettes daily who were not using a cessation medication. Our search of PubMed, PsycINFO, and personal libraries yielded a total of 32 tests with 2054 participants. RESULTS: There was a medium effect size indicating an overall decrease in PA following abstinence from cigarettes (Cohen's d = -0.40, 95% CI = -0.30 to -0.49). There was large heterogeneity (I2 = 70.7%). Most (79%) of the 24 trials that conducted significance tests reported that reduction in PA was significant. Seven tests were adequately designed to detect a withdrawal versus offset effect. Over half (57%) displayed a U-shaped curve for abstinence-induced change in PA indicative of a withdrawal symptom rather than offset effect. CONCLUSIONS: Abstinence from cigarettes is associated with a decrease in PA. Whether low PA should be added to withdrawal measures and diagnostic criteria requires replication of the time-course of change in PA and tests of whether abstinence-induced changes in PA and negative affect occur independently. IMPLICATIONS: Though there was substantial heterogeneity among trials, our findings suggest that (1) abstinence from cigarettes decreases positive affect and (2) this decrease may represent a withdrawal effect (vs. an offset effect). However, it is unclear whether abstinence-induced losses in positive affect are independent from increased negative affect.

Outcomes of Peripheral Vascular Interventions via Retrograde Pedal Access for Chronic Limb-Threatening Ischemia in a Multicenter Registry.

Purpose: To describe the use and 1-year outcomes of retrograde pedal access during peripheral vascular interventions (PVI) for chronic limb-threatening ischemia (CLTI). Materials and Methods: From October 2016 to September 2017, 159 patients (mean age 71±10 years; 112 men) undergoing PVI via retrograde pedal access were enrolled in the multicenter Vascular Quality Initiative (VQI) registry. The pedal access approach included retrograde femoral (40%), antegrade femoral (26%), retrograde to antegrade femoral (22%), and pedal only (11%). A comparator group of 1972 patients (mean age 69±12 years; 1129 men) having a contralateral retrograde femoral access was established for propensity matching, which resulted in 156 patients per group. Procedure characteristics, technical success, and access site complications were compared. Major adverse limb events (MALE) and amputation-free survival (AFS) at 1 year were analyzed using the Kaplan-Meier method and Cox proportional hazard models to calculate hazard ratios (HR) and 95% confidence intervals (CI). Results: Technical failure was similar for retrograde femoral and pedal access (7% vs 13%, p=0.07). Complications were rare and included access site hematoma (2 vs 5, p=0.32) and target artery thrombosis (0 vs 2) for the femoral vs pedal access groups, respectively. The rates of MALE at 1 year were significantly lower after retrograde femoral access (24%) compared with pedal access (38%; log-rank p=0.01; HR 1.95, 95% CI 1.15 to 3.30). AFS estimates at 1 year were similar: 86% for retrograde femoral and 83% for pedal access (log-rank p=0.37; HR 1.32, 95% CI 0.73 to 2.39), as were major amputation estimates: 10% for retrograde femoral access and 13% for pedal access group (log-rank p=0.21; HR 1.58, 95% CI 0.77 to 3.26). Conclusion: In this analysis of multicenter registry data, retrograde pedal access in patients with CLTI had similar technical success and early complications in comparison with traditional contralateral retrograde femoral access. The rates of MALE were higher after pedal access but AFS was similar, indicating a tradeoff between limb salvage and repeat interventions.

Lipoprotein(a) and Risk of Ischemic Stroke in the REGARDS Study.

Objective- Increased Lp(a) [lipoprotein(a)] is associated with coronary heart disease risk, but links with stroke are less consistent. Blacks have higher Lp(a) levels and stroke incidence than whites but have been underrepresented in studies. We hypothesized that Lp(a) is a risk factor for ischemic stroke and that risk differs by race. Approach and Results- REGARDS (Reasons for Geographic and Racial Differences in Stroke) recruited 30 239 black and white US adults aged ≥45 in 2003-2007 to study regional and racial differences in stroke mortality. We measured baseline Lp(a) by immunonephelometric assay in 572 cases of incident ischemic stroke and a 967-person cohort random sample. The hazard ratio of stroke by baseline Lp(a) was calculated using Cox proportional hazards models, stratified by race. Lp(a) was modeled in sex- and race-specific quartiles, given known differences in distributions by race and sex. Interactions were tested by including interaction terms in the proportional hazards models, with P<0.10 considered statistically significant. After adjustment for age, sex, and stroke risk factors, being in the fourth versus the first Lp(a) quartile was weakly associated with ischemic stroke overall, hazard ratio, 1.45 (95% CI, 0.96-2.19). In blacks, the hazard ratio was 1.96 (95% CI, 1.10-3.46), whereas in whites HR was 1.14 (95% CI, 0.64-2.04); P interaction=0.12. Lp(a) was lower in men than women, but associations with stroke in men and women were similar. Conclusions- We confirm that Lp(a) is a risk factor for ischemic stroke. Further research is needed to confirm the role of racial differences of the Lp(a) risk multiplier in ischemic stroke.

Withdrawal Symptoms From E-Cigarette Abstinence Among Adult Never-Smokers: A Pilot Experimental Study.

INTRODUCTION: Use of e-cigarettes among never-smokers has substantially increased; yet there are few descriptions of the consequences of such use. We assessed whether adult never-smokers can have withdrawal from cessation of e-cigarettes. METHODS: In an un-blinded pre-post clinical trial, 30 never-smoker daily e-cigarette users used their own nicotine-containing e-cigarette for 7 days followed by 6 days of biologically confirmed abstinence. Participants monitored symptoms of nicotine withdrawal nightly via an Interactive Voice Response system. They attended three lab visits/week to provide expired carbon monoxide and urine samples to determine compliance. FINDINGS: Abstinence increased all the DSM5 symptoms of tobacco withdrawal and this occurred in the majority of participants. The increase in severity of withdrawal was small and rarely impaired functioning. CONCLUSIONS: Our finding suggests that withdrawal symptoms can occur in never-smokers who stop e-cigarettes abruptly. However, the severity of withdrawal appears to be small and may not be of clinical or regulatory significance. Although our sample size was small and thus replication tests of our results are indicated, it may be prudent to warn never-smokers that withdrawal symptoms may occur. IMPLICATIONS: This study indicates that withdrawal symptoms can occur in never-smokers who are daily e-cigarette users. However, the severity of withdrawal from e-cigarette abstinence in never-smokers appears to be small and may not be of clinical or regulatory significance. Given our small sample size, replication of our results is warranted. Nevertheless, it might be prudent to warn never-smokers of addiction to e-cigarettes.Clinical Trial Registration = NCT02825459.

Withdrawal Symptoms From E-Cigarette Abstinence Among Former Smokers: A Pre-Post Clinical Trial.

INTRODUCTION: The major aim of this study was to test whether abstinence from e-cigarettes causes withdrawal symptoms in former smokers. METHODS: We conducted an unblinded, within-participants, pre-post clinical trial in which 109 former smokers who were current daily electronic cigarette (e-cigarette) users used their own e-cigarette for 7 days followed by 6 days of biologically confirmed abstinence engendered via an escalating contingency payment system. Participants monitored symptoms of nicotine withdrawal daily via an Interactive Voice Response system. They also attended three laboratory visits per week for carbon monoxide and cotinine testing to verify abstinence. RESULTS: Half of participants completely abstained for a week. All the Diagnostic and Statistical Manual, Fifth Edition (DSM-5) tobacco withdrawal symptoms, craving for e-cigarettes, craving for tobacco cigarettes, and the four possible new withdrawal symptoms (anhedonia, impulsivity, mood swings, and positive affect) increased during abstinence. Weight increased and heart rate decreased with abstinence. Symptoms showed the prototypical inverted U time pattern of a withdrawal state. The magnitude of withdrawal appeared to be somewhat less than that in a prior study of abstinent daily tobacco cigarette smokers. More severe withdrawal on the first 2 days of abstinence did not predict abstinence on the last day of the study. CONCLUSIONS: Former smokers who are daily e-cigarette users transfer physical dependence on tobacco cigarettes to dependence on e-cigarettes. The severity of withdrawal from e-cigarettes appears to be only somewhat less than that from daily tobacco cigarette use. Replication tests that include placebo controls, testing for pharmacological specificity, and including never-smokers, non-daily e-cigarette users and dual users are indicated. IMPLICATIONS: Our results indicate e-cigarettes can maintain physical dependence. This adverse effect should be included in any risk vs. benefit calculation. Also, potential and current e-cigarette users should be informed that abrupt cessation of e-cigarettes can cause withdrawal symptoms. TRIAL REGISTRATION: NCT02825459.

Increasing Quit Attempts by Transitioning to Very Low Nicotine Content Cigarettes Versus Reducing Number of Cigarettes Per Day: A Secondary Analysis of an Exploratory Randomized Trial.

INTRODUCTION: The Food and Drug Administration (FDA) has proposed reducing nicotine with very low nicotine content (VLNC) cigarettes. In contrast, reducing nicotine by reducing number of cigarettes per day (CPD) is common. Our prior findings demonstrate that VLNC cigarettes decreased dependence more and were more acceptable than reducing CPD. This secondary analysis explored which reduction strategy increased quit attempts (QA), self-efficacy, or intention to quit more. METHODS: This is a secondary analysis of 68 adult daily smokers not ready to quit randomized to smoke VLNC cigarettes versus reduce CPD over 5 weeks. All participants smoked study cigarettes with nicotine yield similar to most commercial cigarettes ad lib for 1 week (baseline). Participants were then randomized to gradually reduce to 70%, 35%, 15%, and 3% of baseline nicotine over 4 weeks by either (1) transitioning to lower nicotine VLNC cigarettes or (2) reducing the number of full nicotine CPD. All participants received nicotine patches to aid reduction. We assessed (1) QAs using nightly and weekly self-reports, (2) Velicer's Self-Efficacy to Quit measure weekly, and (3) the Intention-to-Quit Ladder nightly. RESULTS: More CPD (41%) than VLNC (17%) participants made any QA (odds ratio = 3.4, 95% confidence interval = 1.1, 10.5). There was no difference in QAs ≥24 h. Self-efficacy increased for VLNC but not CPD participants (interaction: F = 3.7, p < .01). The condition by time interaction for intention-to-quit was not significant. CONCLUSIONS: Reducing number of CPD increased QAs more than reducing nicotine via switching to VLNC cigarettes. The lack of difference in longer QAs suggests replication tests are needed. IMPLICATIONS: Reducing the frequency of smoking behavior (ie, CPD) could be a more effective strategy to increase QAs than reducing the magnitude of nicotine in each cigarette (ie, VLNC) per se.

Surveillance and Management of Troponin Elevation after Vascular Surgery.

BACKGROUND: Postopertive troponin elevation may occur without typical or atypical cardiac symptoms and is associated with an increased 30-day morbidity and mortality. The objective of the study was to implement a quality improvement initiative of postoperative troponin surveillance algorithm aimed at intensifying medical management after vascular surgery. METHODS: We conducted a single-center study of postoperative troponin surveillance after vascular surgery (n = 201) at a tertiary care, academic medical center from January to December 2016. Troponin surveillance was performed on postoperative days 1-3 after carotid endarterectomy, endovascular aortic repair, infrainguinal bypass, open abdominal aortic aneurysm repair, peripheral vascular intervention, and suprainguinal bypass, regardless of cardiac symptoms. Patients with troponin I elevation (>0.034 ng/mL) were managed with a treatment algorithm which included single or dual antiplatelet (AP) agent, high-intensity statin therapy, smoking cessation consultation, and outpatient cardiology consultation and stress testing. Patients with troponin elevation ≥1.0 ng/mL received inpatient cardiology consultation. We assessed adherence to the protocol for intensification of best medical therapy defined as high-dose statin therapy, increase in AP therapy, and smoking cessation consultation according to the established algorithm. RESULTS: Troponin elevation was recorded in 17% (34/201) of patients and was associated with cardiac symptoms in 8 patients (24%), while 26 (76%) patients had an asymptomatic abnormal troponin on postoperative surveillance. One patient was excluded due to death immediately after SUPRA, resulting in 200 patients. Troponin elevation ≥1.0 ng/mL occurred in 11 asymptomatic patients (5.5%). Any intensification of medical therapy was instituted in 76% of patients with elevated troponin and included high-intensity statin therapy (58%), increase in AP therapy (18%), and smoking cessation consultation (66%). Once an elevated troponin level was recognized, 52% of our patients received cardiology consultation with an increased likelihood (100%) in patients with troponin ≥1 ng/mL (P < 0.001). Adherence to outpatient stress testing was 66%. Intensification of medical therapy was not significantly different between patients with abnormal troponin values, >0.034-1.0 (n = 23) versus ≥1.0 ng/mL (n = 10); statin therapy (P = 1.0), AP (P = 0.34), and smoking cessation (P = 1.0). One-year mortality was higher in patients with postoperative troponin elevation than those with normal postoperative troponin levels (12% vs. 2.4%; P = 0.03). CONCLUSIONS: Routine postoperative troponin surveillance results in intensification of statin therapy in patients with asymptomatic troponin elevation. Further study is needed to determine if this approach reduces long-term cardiovascular morbidity and mortality.

Underutilization of antiplatelet and statin therapy after postoperative myocardial infarction following vascular surgery.

OBJECTIVE: The objective of this study was to investigate adherence to practice guidelines for antiplatelet and statin use after postoperative myocardial infarction (POMI) and its effect on late mortality following vascular surgery in a multicenter registry. METHODS: Antiplatelet and statin use was examined in 1749 vascular surgery procedures with POMI within the Vascular Quality Initiative (VQI) from 2005 to 2015. Our primary aim was to assess cardiac medication (CM) use at discharge, defined as (1) single antiplatelet therapy (SAPT; aspirin or P2Y12 inhibitor) or dual antiplatelet therapy (DAPT; aspirin and P2Y12 inhibitor) and (2) statin therapy. Long-term mortality in patients with POMI was analyzed on the basis of discharge CM. A proportional hazards model was developed to control for factors associated with mortality. Regional differences in CM use at discharge after POMI were compared. RESULTS: Overall discharge CM use after POMI included aspirin (81%), P2Y12 inhibitor (38%), statin therapy (76%), and combined antiplatelet and statin (74%). At discharge, 26% of patients were not receiving combined antiplatelet and statin therapy. SAPT (50%) was more common than DAPT (35%; P < .001). Patients with POMI undergoing carotid endarterectomy were more likely to be discharged on CM (80%) compared with patients undergoing infrainguinal bypass (78%), suprainguinal bypass (72%), endovascular aneurysm repair (71%), and open abdominal aortic aneurysm repair (59%; P < .001). Patients receiving SAPT or DAPT plus statin therapy had improved survival (79%) compared with those receiving noncombination or no therapy (69%) with mean follow-up of 5.5 years and 4.9 years, respectively (log-rank, P = .001). After adjustment for covariates including preoperative medications, treatment with SAPT or DAPT plus statin at discharge was associated with lower late mortality compared with noncombination or no therapy (hazard ratio, 0.72; 95% confidence interval, 0.56-0.93; P = .01). Regional variation in CM at discharge following POMI was also observed with a range of 33% to 100% (P = .05). CONCLUSIONS: Within the VQI, regional and procedure-specific variation exists in CM regimen after POMI following vascular surgery. Absence of combined antiplatelet and statin therapy at discharge after POMI was associated with higher late mortality and represents an area for quality improvement in the care of these patients.

Three decades later: investigating the rate of and risks for conversion from laparoscopic to open cholecystectomy.

INTRODUCTION: Recent data suggest a wide range of conversion (4.9-20%) from laparoscopic (LC) to open cholecystectomy (OC) despite increasing surgeon familiarity and superior equipment. Previously identified risk factors for conversion include increased age, male gender, diabetes, and emergent surgeries. Recent studies also suggest that formal minimally invasive surgical training (MIST) reduces conversion rates. We sought to determine conversion rates in our population, a rural academic medical center, and identify any significant risks for conversion. METHODS: We conducted a single-center retrospective review of 2810 cholecystectomies performed over a seven-year period (2009-2016). RESULTS: Our study included 837 (29.8%) males and 1973 (70.2%) females with a mean age of 49.2 years. Forty-two percent of cases were done by surgeons with MIST. A total of 139 (4.95%) cases were converted to OC. Univariate predictors of conversion to OC included male gender, age ≥65, urgent and emergent admissions, and MIST of the surgeon. In multivariate modeling, which included significant univariate predictors of conversion, independent predictors of conversion to OC included urgent or emergent admission, male gender, and age ≥65. MIST status was no longer a significant predictor. CONCLUSION: Our conversion rate from LC to OC falls within the lower range of recently published rates. This is likely multifactorial, and reflects increasing familiarity of the laparoscopic technique, improved quality of laparoscopic equipment, and/or prior knowledge of preoperative risk factors for conversion. Our results, consistent with previous literature, show a reduced conversion rate among surgeons with MIST. This finding, albeit not significant on multivariate analysis, may offer insight into a potential alterable preoperative risk factor for conversion and warrants further research. Further knowledge about the impact MIST has on conversion may provide a feasible preoperative approach to reducing conversion to OC, thereby reducing costs and overall patient morbidity.

Measures of Kidney Disease and the Risk of Venous Thromboembolism in the REGARDS (Reasons for Geographic and Racial Differences in Stroke) Study.

BACKGROUND: Kidney disease has been associated with venous thromboembolism (VTE) risk, but results conflict and there is little information regarding blacks. STUDY DESIGN: Prospective cohort study. SETTING & PARTICIPANTS: 30,239 black and white adults 45 years or older enrolled in the REGARDS (Reasons for Geographic and Racial Differences in Stroke) Study 2003 to 2007. PREDICTORS: Estimated glomerular filtration rate (eGFR) using the combined creatinine-cystatin C (eGFRcr-cys) equation and urinary albumin-creatinine ratio (ACR). OUTCOMES: The primary outcome was adjudicated VTE, and secondary outcomes were provoked and unprovoked VTE, separately. Mortality was a competing-risk event. RESULTS: During 4.6 years of follow-up, 239 incident VTE events occurred over 124,624 person-years. Cause-specific HRs of VTE were calculated using proportional hazards regression adjusted for age, sex, race, region of residence, and body mass index. Adjusted VTE HRs for eGFRcr-cys of 60 to <90, 45 to <60, and <45 versus ≥90mL/min/1.73m2 were 1.28 (95% CI, 0.94-1.76), 1.30 (95% CI, 0.77-2.18), and 2.13 (95% CI, 1.21-3.76). Adjusted VTE HRs for ACR of 10 to <30, 30 to <300, and ≥300 versus <10mg/g were 1.14 (95% CI, 0.84-1.56), 1.15 (95% CI, 0.79-1.69), and 0.64 (95% CI, 0.25-1.62). Associations were similar for provoked and unprovoked VTE. LIMITATIONS: Single measurement of eGFR and ACR may have led to misclassification. Smaller numbers of events may have limited power. CONCLUSIONS: There was an independent association of low eGFR (<45 vs ≥90mL/min/1.73m2) with VTE risk, but no association of ACR and VTE.

Transanal Endoscopic Microsurgery for Early Rectal Cancer: A Single-Center Experience.

BACKGROUND: There is debate regarding the appropriate use of transanal endoscopic microsurgery for rectal cancer. OBJECTIVE: This study analyzed our single-center experience with transanal endoscopic microsurgery for early rectal cancer. DESIGN: Medical charts of patients who underwent transanal endoscopic microsurgery were reviewed to determine lesion characteristics, as well as operative and treatment characteristics. Complications and recurrences were recorded. SETTINGS: The study was conducted at a single academic medical center. PATIENTS: Patients with early stage cancer (T1 or T2, N0, and M0) of the rectum were included. MAIN OUTCOME MEASURES: Local and overall recurrence and disease-specific survival were measured. RESULTS: A total of 92 patients were analyzed. Median follow-up was 4.6 years. Negative margins were obtained in 98.9%. Length of stay was 1 day for 95.4% of patients. The complication rate was 10.9% (n = 10), including urinary retention at 4.3% (n = 4) and postoperative bleeding at 4.3% (n = 4). Preoperative staging included 54 at T1 (58.7%) and 38 at T2 (41.3%). Adjuvant therapy was recommended for all of the T2 and select T1 lesions with adverse features on histology. The final pathologic stages of tumors were ypT0 at 8.7% (n = 8), pT1 at 58.7% (n = 54), pT2 at 23.9% (n = 22), and ypT2 at 8.7% (n = 8). The 3-year local recurrence risk was 2.4% (SE = 1.7), and overall recurrence was 6.7% (SE = 2.9). There were no recurrences among patients with complete pathologic response to neoadjuvant therapy. Mean time to recurrence was 2.5 years (SD = 1.43). A total of 89.2% of patients with very low tumors underwent curative resection without a permanent stoma (33/37). The 3-year disease-specific survival rate was 98.6% (95% CI, 90.4%-99.8%), and overall survival rate was 89.4% (95% CI, 79.9%-94.6%). LIMITATIONS: The study was limited by its single-center retrospective experience. CONCLUSIONS: Transanal endoscopic microsurgery provides comparable oncologic outcomes to radical resection in properly selected patients with early rectal cancer. Sphincter preservation rates approach 90% even in patients with very distal rectal cancer.

A Mediation Analysis of Motivational, Reduction, and Usual Care Interventions for Smokers Who Are Not Ready to Quit.

INTRODUCTION: We recently conducted a large randomized controlled trial (RCT) (N = 560) that failed to replicate our initial RCT's findings that brief motivational and reduction interventions increased quit attempts (QA) and point-prevalence abstinence (PPA) in smokers not ready to quit. The present study aimed to test why our interventions were ineffective. METHODS: A secondary analysis of a 3-arm RCT tested (1) whether telephone-based motivational or reduction interventions changed the following hypothesized mediators more than usual care: cigarettes per day (CPD), dependence, pros of smoking, cons of smoking, self-efficacy, or intention to quit; (2) whether changes in these hypothesized mediators predicted QAs and PPA at a 6-month follow-up, and (3) whether the interventions affected QAs and PPA via the hypothesized mediators. RESULTS: In comparison to usual care, the motivational intervention did not significantly influence the hypothesized mediators. The reduction intervention resulted in a significantly greater decrease in CPD and pros of smoking and increase in self-efficacy and intention to quit than usual care. Decreases in CPD and dependence and increases in self-efficacy and intention to quit were associated with increased QAs. The reduction intervention's influence on QAs was mediated by decreases in CPD and increases in self-efficacy and intention to quit. Findings regarding PPA were similar. CONCLUSION: Our failure to replicate may be due, in part, to the fact that, compared to usual care, (1) the motivational intervention had no effect on the hypothesized mediators, and (2) the reduction intervention had a statistically significant but clinically insignificant effect on the hypothesized mediators. IMPLICATIONS: This study demonstrates that mediation analysis may be useful to understand why an intervention is not more effective than usual care. We identified reductions in CPD and dependence and increases in self-efficacy and intention to quit as predictors of quitting. Further research should focus on developing more effective interventions to target these constructs, and cause clinically significant changes among smokers who are not ready to quit.

Development of a Self-Report Measure of Reward Sensitivity:A Test in Current and Former Smokers.

INTRODUCTION: Tobacco use or abstinence may increase or decrease reward sensitivity. Most existing measures of reward sensitivity were developed decades ago, and few have undergone extensive psychometric testing. METHODS: We developed a 58-item survey of the anticipated enjoyment from, wanting for, and frequency of common rewards (the Rewarding Events Inventory-REI). The current analysis focuses on ratings of anticipated enjoyment. The first validation study recruited current and former smokers from Internet sites. The second study recruited smokers who wished to quit and monetarily reinforced them to stay abstinent in a laboratory study and a comparison group of former smokers. In both studies, participants completed the inventory on two occasions, 3-7 days apart. They also completed four anhedonia scales and a behavioral test of reduced reward sensitivity. RESULTS: Half of the enjoyment ratings loaded on four factors: socializing, active hobbies, passive hobbies, and sex/drug use. Cronbach's alpha coefficients were all ≥0.73 for overall mean and factor scores. Test-retest correlations were all ≥0.83. Correlations of the overall and factor scores with frequency of rewards and anhedonia scales were 0.19-0.53, except for the sex/drugs factor. The scores did not correlate with behavioral tests of reward and did not differ between current and former smokers. Lower overall mean enjoyment score predicted a shorter time to relapse. DISCUSSION: Internal reliability and test-retest reliability of the enjoyment outcomes of the REI are excellent, and construct and predictive validity are modest but promising. The REI is comprehensive and up-to-date, yet is short enough to use on repeated occasions. Replication tests, especially predictive validity tests, are needed. IMPLICATIONS: Both use of and abstinence from nicotine appear to increase or decrease how rewarding nondrug rewards are; however, self-report scales to test this have limitations. Our inventory of enjoyment from 58 rewards appears to be reliable and valid as well as comprehensive and up-to-date, yet is short enough to use on repeated occasions. Replication tests, especially of the predictive validity of our scale, are needed.

Does Tobacco Abstinence Decrease Reward Sensitivity? A Human Laboratory Test.

INTRODUCTION: Animal studies report abstinence from nicotine makes rewards less rewarding; however, the results of human tests of the effects of cessation on reward sensitivity are mixed. The current study tested reward sensitivity in abstinent smokers using more rigorous methods than most prior studies. METHODS: A human laboratory study compared outcomes for 1 week prior to quitting to those during 4 weeks postquit. The study used smokers trying to quit, objective and subjective measures, multiple measures during smoking and abstinence, and monetary rewards to increase the prevalence of abstinence. Current daily smokers (n = 211) who were trying to quit completed an operant measure of reward sensitivity and a survey of pleasure from various rewards as well as self-reports of anhedonia, delay discounting, positive affect, and tobacco withdrawal twice each week. A comparison group of long-term former smokers (n = 67) also completed the tasks weekly for 4 weeks. Primary analyses were based on the 61 current smokers who abstained for all 4 weeks. RESULTS: Stopping smoking decreased self-reported pleasure from rewards but did not decrease reward sensitivity on the operant task. Abstinence also decreased self-reported reward frequency and increased the two anhedonia measures. However, the changes with abstinence were small for all outcomes (6%-14%) and most lasted less than a week. CONCLUSIONS: Abstinence from tobacco decreased most self-report measures of reward sensitivity; however, it did not change the objective measure. The self-report effects were small. IMPLICATIONS: Animal research suggests that nicotine withdrawal decreases reward sensitivity. Replication tests of this in humans have produced inconsistent results. We report what we believe is a more rigorous test. We found smoking abstinence slightly decreases self-reports of reward sensitivity but does not do so for a behavioral measure of reward sensitivity.

Increased risk organ transplantation in the pediatric population.

IRD organs are classified by the Public Health Service to be at above-average risk for harboring human immunodeficiency virus, hepatitis C, and hepatitis B. Traditionally underutilized, there exists even greater reluctance for their use in pediatric patients. We performed a retrospective analysis via the United Network for Organ Sharing database of all pediatric renal and hepatic transplants performed from 2004 to 2008 in the United States. Primary outcomes were patient and graft survival. Proportional hazards regression was performed to control for potentially confounding factors. Waitlist time, organ acceptance rates, and infectious transmissions were analyzed. There were 1830 SRD renal, 92 IRD renal, 1695 SRD hepatic, and 59 IRD hepatic transplants. There were no statistically significant differences in allograft or patient survival in either group. Acceptance rates of IRD organs were lower for kidney (1.5% IRD vs 4.82% SRD) and liver (1.99% IRD vs 4.51% SRD). One transmission of a bloodborne pathogen involving a pediatric recipient out of 7797 unique transplants was reported from 2008 to 2015. IRD organs appear to have equivalent outcomes. Increasing their utilization may improve access to transplant while decreasing wait times and circumventing waitlist morbidity and mortality.