Opioid Injection-Associated Bacterial Infections in England, 2002-2021: A Time Series Analysis of Seasonal Variation and the Impact of Coronavirus Disease 2019.

BACKGROUND: Bacterial infections cause substantial pain and disability among people who inject drugs. We described time trends in hospital admissions for injecting-related infections in England. METHODS: We analyzed hospital admissions in England between January 2002 and December 2021. We included patients with infections commonly caused by drug injection, including cutaneous abscesses, cellulitis, endocarditis, or osteomyelitis, and a diagnosis of opioid use disorder. We used Poisson regression to estimate seasonal variation and changes associated with coronavirus disease 2019 (COVID-19) response. RESULTS: There were 92 303 hospital admissions for injection-associated infections between 2002 and 2021. Eighty-seven percent were skin, soft-tissue, or vascular infections; 72% of patients were male; and the median age increased from 31 years in 2002 to 42 years in 2021. The rate of admissions reduced from 13.97 per day (95% confidence interval [CI], 13.59-14.36) in 2003 to 8.94 (95% CI, 8.64-9.25) in 2011, then increased to 18.91 (95% CI, 18.46-19.36) in 2019. At the introduction of COVID-19 response in March 2020, the rate of injection-associated infections reduced by 35.3% (95% CI, 32.1-38.4). Injection-associated infections were also seasonal; the rate was 1.21 (95% CI, 1.18-1.24) times higher in July than in February. CONCLUSIONS: This incidence of opioid injection-associated infections varies within years and reduced following COVID-19 response measures. This suggests that social and structural factors such as housing and the degree of social mixing may contribute to the risk of infection, supporting investment in improved social conditions for this population as a means to reduce the burden of injecting-related infections.

Guidance on take-home naloxone distribution and use by community overdose responders in Canada.

BACKGROUND: The increasing toxicity of opioids in the unregulated drug market has led to escalating numbers of overdoses in Canada and worldwide; takehome naloxone (THN) is an evidence-based intervention that distributes kits containing naloxone to people in the community who may witness an overdose. The purpose of this guidance is to provide policy recommendations for territorial, provincial and federal THN programs, using evidence from scientific and grey literature and community evidence that reflects 11 years of THN distribution in Canada. METHODS: The Naloxone Guidance Development Group - a multidisciplinary team including people with lived and living experience and expertise of drug use - used the Appraisal of Guidelines for Research & Evaluation (AGREE II) instrument to inform development of this guidance. We considered published evidence identified through systematic reviews of all literature types, along with community evidence and expertise, to generate recommendations between December 2021 and September 2022. We solicited feedback on preliminary recommendations through an External Review Committee and a public input process. The project was funded by the Canadian Institutes of Health Research through the Canadian Research Initiative in Substance Misuse. We used the Guideline International Network principles for managing competing interests. RECOMMENDATIONS: Existing evidence from the literature on THN was of low quality. We incorporated evidence from scientific and grey literature, and community expertise to develop our recommendations. These were in 3 areas: routes of naloxone administration, THN kit contents and overdose response. Take-home naloxone programs should offer the choice of both intramuscular and intranasal formulations of naloxone in THN kits. Recommended kit contents include naloxone, a naloxone delivery device, personal protective equipment, instructions and a carrying case. Trained community overdose responders should prioritize rescue breathing in the case of respiratory depression, and conventional cardiopulmonary resuscitation in the case of cardiac arrest, among other interventions. INTERPRETATION: This guidance development project provides direction for THN programs in Canada in the context of limited published evidence, with recommendations developed in collaboration with diverse stakeholders.

Opioid agonist treatment and risk of death or rehospitalization following injection drug use-associated bacterial and fungal infections: A cohort study in New South Wales, Australia.

BACKGROUND: Injecting-related bacterial and fungal infections are associated with significant morbidity and mortality among people who inject drugs (PWID), and they are increasing in incidence. Following hospitalization with an injecting-related infection, use of opioid agonist treatment (OAT; methadone or buprenorphine) may be associated with reduced risk of death or rehospitalization with an injecting-related infection. METHODS AND FINDINGS: Data came from the Opioid Agonist Treatment Safety (OATS) study, an administrative linkage cohort including all people in New South Wales, Australia, who accessed OAT between July 1, 2001 and June 28, 2018. Included participants survived a hospitalization with injecting-related infections (i.e., skin and soft-tissue infection, sepsis/bacteremia, endocarditis, osteomyelitis, septic arthritis, or epidural/brain abscess). Outcomes were all-cause death and rehospitalization for injecting-related infections. OAT exposure was classified as time varying by days on or off treatment, following hospital discharge. We used separate Cox proportional hazards models to assess associations between each outcome and OAT exposure. The study included 8,943 participants (mean age 39 years, standard deviation [SD] 11 years; 34% women). The most common infections during participants' index hospitalizations were skin and soft tissue (7,021; 79%), sepsis/bacteremia (1,207; 14%), and endocarditis (431; 5%). During median 6.56 years follow-up, 1,481 (17%) participants died; use of OAT was associated with lower hazard of death (adjusted hazard ratio [aHR] 0.63, 95% confidence interval [CI] 0.57 to 0.70). During median 3.41 years follow-up, 3,653 (41%) were rehospitalized for injecting-related infections; use of OAT was associated with lower hazard of these rehospitalizations (aHR 0.89, 95% CI 0.84 to 0.96). Study limitations include the use of routinely collected administrative data, which lacks information on other risk factors for injecting-related infections including injecting practices, injection stimulant use, housing status, and access to harm reduction services (e.g., needle exchange and supervised injecting sites); we also lacked information on OAT medication dosages. CONCLUSIONS: Following hospitalizations with injection drug use-associated bacterial and fungal infections, use of OAT is associated with lower risks of death and recurrent injecting-related infections among people with opioid use disorder.

Society for Vascular Surgery appropriate use criteria for management of intermittent claudication.

The Society for Vascular Surgery appropriate use criteria (AUC) for the management of intermittent claudication were created using the RAND appropriateness method, a validated and standardized method that combines the best available evidence from medical literature with expert opinion, using a modified Delphi process. These criteria serve as a framework on which individualized patient and clinician shared decision-making can grow. These criteria are not absolute. AUC should not be interpreted as a requirement to administer treatments rated as appropriate (benefit outweighs risk). Nor should AUC be interpreted as a prohibition of treatments rated as inappropriate (risk outweighs benefit). Clinical situations will occur in which moderating factors, not included in these AUC, will shift the appropriateness level of a treatment for an individual patient. Proper implementation of AUC requires a description of those moderating patient factors. For scenarios with an indeterminate rating, clinician judgement combined with the best available evidence should determine the treatment strategy. These scenarios require mechanisms to track the treatment decisions and outcomes. AUC should be revisited periodically to ensure that they remain relevant. The panelists rated 2280 unique scenarios for the treatment of intermittent claudication (IC) in the aortoiliac, common femoral, and femoropopliteal segments in the round 2 rating. Of these, only nine (0.4%) showed a disagreement using the interpercentile range adjusted for symmetry formula, indicating an exceptionally high degree of consensus among the panelists. Post hoc, the term "inappropriate" was replaced with the phrase "risk outweighs benefit." The term "appropriate" was also replaced with "benefit outweighs risk." The key principles for the management of IC reflected within these AUC are as follows. First, exercise therapy is the preferred initial management strategy for all patients with IC. Second, for patients who have not completed exercise therapy, invasive therapy might provide net a benefit for selected patients with IC who are nonsmokers, are taking optimal medical therapy, are considered to have a low physiologic and technical risk, and who are experiencing severe lifestyle limitations and/or a short walking distance. Third, considering the long-term durability of the currently available technology, invasive interventions for femoropopliteal disease should be reserved for patients with severe lifestyle limitations and a short walking distance. Fourth, in the common femoral segment, open common femoral endarterectomy will provide greater net benefit than endovascular intervention for the treatment of IC. Finally, in the infrapopliteal segment, invasive intervention for the treatment of IC is of unclear benefit and could be harmful.

Priority setting for Canadian Take-Home Naloxone best practice guideline development: an adapted online Delphi method.

BACKGROUND: Take-Home Naloxone (THN) is a core intervention aimed at addressing the toxic illicit opioid drug supply crisis. Although THN programs are available in all provinces and territories throughout Canada, there are currently no standardized guidelines for THN programs. The Delphi method is a tool for consensus building often used in policy development that allows for engagement of stakeholders. METHODS: We used an adapted anonymous online Delphi method to elicit priorities for a Canadian guideline on THN as a means of facilitating meaningful stakeholder engagement. A guideline development group generated a series of key questions that were then brought to a 15-member voting panel. The voting panel was comprised of people with lived and living experience of substance use, academics specializing in harm reduction, and clinicians and public health professionals from across Canada. Two rounds of voting were undertaken to score questions on importance for inclusion in the guideline. RESULTS: Nine questions that were identified as most important include what equipment should be in THN kits, whether there are important differences between intramuscular and intranasal naloxone administration, how stigma impacts access to distribution programs, how effective THN programs are at saving lives, what distribution models are most effective and equitable, storage considerations for naloxone in a community setting, the role of CPR and rescue breathing in overdose response, client preference of naloxone distribution program type, and what aftercare should be provided for people who respond to overdoses. CONCLUSIONS: The Delphi method is an equitable consensus building process that generated priorities to guide guideline development.

Fatal opioid overdoses during and shortly after hospital admissions in England: A case-crossover study.

BACKGROUND: Hospital patients who use illicit opioids such as heroin may use drugs during an admission or leave the hospital in order to use drugs. There have been reports of patients found dead from drug poisoning on the hospital premises or shortly after leaving the hospital. This study examines whether hospital admission and discharge are associated with increased risk of opioid-related death. METHODS AND FINDINGS: We conducted a case-crossover study of opioid-related deaths in England. Our study included 13,609 deaths between January 1, 2010 and December 31, 2019 among individuals aged 18 to 64. For each death, we sampled 5 control days from the period 730 to 28 days before death. We used data from the national Hospital Episode Statistics database to determine the time proximity of deaths and control days to hospital admissions. We estimated the association between hospital admission and opioid-related death using conditional logistic regression, with a reference category of time neither admitted to the hospital nor within 14 days of discharge. A total of 236/13,609 deaths (1.7%) occurred following drug use while admitted to the hospital. The risk during hospital admissions was similar or lower than periods neither admitted to the hospital nor recently discharged, with odds ratios 1.03 (95% CI 0.87 to 1.21; p = 0.75) for the first 14 days of an admission and 0.41 (95% CI 0.30 to 0.56; p < 0.001) for days 15 onwards. 1,088/13,609 deaths (8.0%) occurred in the 14 days after discharge. The risk of opioid-related death increased in this period, with odds ratios of 4.39 (95% CI 3.75 to 5.14; p < 0.001) on days 1 to 2 after discharge and 2.09 (95% CI 1.92 to 2.28; p < 0.001) on days 3 to 14. 11,629/13,609 deaths (85.5%) did not occur close to a hospital admission, and the remaining 656/13,609 deaths (4.8%) occurred in hospital following admission due to drug poisoning. Risk was greater for patients discharged from psychiatric admissions, those who left the hospital against medical advice, and those leaving the hospital after admissions of 7 days or more. The main limitation of the method is that it does not control for time-varying health or drug use within individuals; therefore, hospital admissions coinciding with high-risk periods may in part explain the results. CONCLUSIONS: Discharge from the hospital is associated with an acute increase in the risk of opioid-related death, and 1 in 14 opioid-related deaths in England happens in the 2 weeks after the hospital discharge. This supports interventions that prevent early discharge and improve linkage with community drug treatment and harm reduction services.

JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study.

PURPOSE: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). MATERIALS AND METHODS: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR (ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI). RESULTS: Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively. CONCLUSION: JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR.

Implementation and evaluation of a novel, unofficial, trainee-organized hospital addiction medicine consultation service.

Background: To evaluate a novel, unofficial, trainee-organized, hospital addiction medicine consultation service (AMCS), we aimed to assess whether it was (1) acceptable to hospital providers and patients, (2) feasible to organize and deliver, and (3) impacted patient care. Methods: We performed a retrospective descriptive study of all AMCS consultations over the first 16 months. We determined acceptability via the number of referrals received from admitting services, and the proportion of referred patients who consented to consultation. We evaluated feasibility via continuation/growth of the service over time, and the proportion of referrals successfully completed before hospital discharge. As most referrals related to opioid use disorder, we determined impact through the proportion of eligible patients offered and initiated on opioid agonist therapy (OAT) in hospital, and the proportion of patients who filled their outpatient prescription or attended their first visit with their outpatient OAT prescriber. Results: The unofficial AMCS grew to involve six hospital-based residents and five supervising community-based addiction physicians. The service received 59 referrals, primarily related to injection opioid use, for 50 unique patients from 12 different admitting services. 90% of patients were seen before discharge, and 98% agreed to addiction medicine consultation. Among 34 patients with active moderate-severe opioid use disorder who were not already on OAT, 82% initiated OAT in hospital and 89% of these patients continued after discharge. Conclusions: Established in response to identified gaps in patient care and learning opportunities, a novel, unofficial, trainee-organized AMCS was acceptable, feasible, and positively impacted patient care over the first 16 months. This trainee-organized, unofficial AMCS could be used as a model for other hospitals that do not yet have an official AMCS.

Real-world cost analysis of endovascular repair versus open repair in patients with nonruptured abdominal aortic aneurysms.

BACKGROUND: The aim of this study was to provide a nationwide, all-payer, real-world cost analysis of endovascular aortic aneurysm repair (EVAR) versus open aortic aneurysm repair (OAR) in patients with nonruptured abdominal aortic aneurysms (non-rAAA). METHODS: All non-rAAA patients registered between July 2009 and March 2015 in the Premier Healthcare Database were analyzed. The Student t-test and the χ2 test were used for continuous and categorical variables, respectively; median value comparisons were done with the Wilcoxon-Mann-Whitney rank-sum test. The in-hospital absolute mean total cost (sum of fixed cost and variable cost) and subcategories were analyzed after adjustment for inflation at July 2015. Fixed costs included all overhead costs while variables costs included in-hospital services including procedures, room and board, services provided by hospital staff, and pharmacy costs. Total cost was stratified based on admission type (emergency vs nonemergency), 75th percentile of length of hospital stay among individual procedures (expected vs extended stay), mortality, and complications. Student t-test and Fisher's analysis of variance were used for comparing mean cost. Year-wise comparison of mean cost was done with analysis of variance to look for a trend over time. RESULTS: Our study cohort included 38,809 non-rAAA patients (33,171 EVAR and 5638 OAR). The mean total cost of index admission was lower in EVAR in comparison with OAR ($32,052 vs $36,091; P < .001), with lower fixed costs ($11,309 vs $16,818; P < .001) and higher variable costs ($20,743 vs $19,272; P < .001). Cost of pharmacy, labor, operating room, room and board and other costs were significantly higher with OAR, whereas the supply cost was higher with EVAR. The expected hospital length of stay of patients who underwent EVAR was associated with a higher total cost ($27,271 vs $25,680; P < .001) and a higher variable cost ($18,186 vs $13,671; P < .001) than OAR patients. However, the extended hospital stay of patients who underwent EVAR had lower costs in all categories compared with the extended length of stay of those who underwent OAR. Mortality associated with EVAR was costlier than OAR associated mortality (mean $72,483 vs $59,804; P = .017). From 2009 to 2014, the mean total cost of EVAR increased significantly by 18.5% ($28,745 vs $34,049; P < .001) owing to a 7.8% increase in fixed costs ($10,931 vs $11,789; P < .001) and a 25.0% increase in variable costs ($17,804 vs $22,257; P < .001). The mean total cost OAR remained stable over time. CONCLUSIONS: Overall hospitalization costs associated with EVAR of non-rAAA was lower than the hospitalization cost of OAR. Interestingly, we found that, among patients who had an expected hospital length of stay, the hospitalization cost after OAR was significantly lower than after EVAR. The average hospitalization cost of OAR was stable during the 5 years study period, whereas the hospitalization cost of EVAR increased significantly over time. Further studies are required to identify reasons for increased costs associated with EVAR.

Previous thoracic aortic repair is not associated with adverse outcomes after thoracic endovascular aortic repair.

BACKGROUND: As many as 20% of patients who have undergone previous thoracic aortic repair will require reintervention, which could entail thoracic endovascular aortic repair (TEVAR). A paucity of data is available on mortality and the incidence of spinal cord ischemia (SCI) and other postoperative complications associated with TEVAR after previous aortic repairs exclusive to the thoracic aorta. The aim of the present study was to assess the effect of previous thoracic aortic repair on the 30-day mortality and SCI outcomes for patients after TEVAR. METHODS: The Society for Vascular Surgery Vascular Quality Initiative database was queried for all cases of TEVAR from 2012 to 2018. Patients were excluded if they had undergone previous abdominal aortic repair, the TEVAR had extended beyond aortic zone 5, or SCI data were missing. The 3 cohorts compared were TEVAR with previous ascending aortic or aortic arch repair (group 1), TEVAR with previous descending thoracic aortic repair (group 2), and TEVAR without previous repair (group 3). The primary outcomes of interest were 30-day mortality and SCI. The secondary outcomes included stroke, myocardial infarction, cardiac complications, respiratory complications, postoperative length of stay, and reintervention. The patient variables were compared using χ2 tests, analysis of variance, or Kruskal-Wallis tests, as appropriate. Logistic regression analysis was performed to identify the predictors of 30-day mortality and SCI. RESULTS: A total of 4010 patients met the inclusion criteria, with 470 in group 1, 132 in group 2, and 3408 in group 3. The 30-day mortality was 4% (19 of 470) in group 1, 6% (8 of 132) in group 2, and 6% (213 of 3408) in group 3 (P = .17). The incidence of SCI was 3% (14 of 470) in group 1, 3% (4 of 132) in group 2, and 3.8% (128 of 3408) in group 3 (P = .65). Stroke, reintervention, myocardial infarction, and cardiac complications were not significantly different among the 3 groups. The incidence of respiratory complications was greatest for group 3 (11%; 360 of 3408) compared with groups 1 (9%; 44 of 470) and 2 (4%; 5 of 132; P = .034). Similarly, the postoperative length of stay was longest for group 3 (9.6 ± 19.4 days vs 8.2 ± 18.3 days for group 1 and 5.9 ± 8.6 days for group 2; P = .038). The independent predictors of 30-day mortality for all TEVAR patients included units of packed red blood cells transfused intraoperatively, urgent or emergent repairs, older age, increasing serum creatinine level, inability to perform self-care, total procedure time, occlusion of the left subclavian artery intraoperatively, distal endograft landing zone 5, and diabetes. The predictors of SCI included the total procedure time, urgent and emergent repairs, and increasing serum creatinine level. CONCLUSIONS: TEVAR after previous thoracic aortic repair was not associated with an increased risk of SCI or 30-day mortality compared with TEVAR without previous aortic repair.

Case Series: Limited Opioid Withdrawal With Use of Transdermal Buprenorphine to Bridge to Sublingual Buprenorphine in Hospitalized Patients.

BACKGROUND: Prerequisite opioid withdrawal symptoms prior to buprenorphine induction are unacceptable to many patients. We assessed whether transdermal buprenorphine minimized withdrawal while bridging to sublingual therapy among hospital inpatients. METHODS: Retrospective chart review of (n = 23) inpatients with opioid use disorder or opioid dependence due to chronic pain. RESULTS: Of 23 inpatients, 65% transitioned without symptoms, while 35% experienced mild withdrawal. Ninety-six percent completed planned hospitalizations, with 83% engaged in treatment 4 weeks post-discharge. DISCUSSION AND CONCLUSIONS: Bridging to sublingual therapy with transdermal buprenorphine patches was feasible without withdrawal symptoms. SCIENTIFIC SIGNIFICANCE: This strategy may facilitate buprenorphine therapy in hospital inpatients. (Am J Addict 2019;00:1-4).

Occlusion of the Celiac Artery during Endovascular Thoracoabdominal Aortic Aneurysm Repair Is associated with Increased Perioperative Morbidity and Mortality.

BACKGROUND: Some studies suggest that celiac artery coverage during elective endovascular thoracoabdominal aortic aneurysm (TAAA) repair is safe given sufficient collateralization of visceral organ perfusion from the superior mesenteric artery. However, there is concern that celiac artery coverage may lead to increased risk of foregut or spinal cord ischemia with an attendant increased risk of mortality. We sought to investigate rates of bowel ischemia, spinal cord ischemia, and 30-day mortality associated with celiac artery coverage during TEVAR and complex EVAR. METHODS: The Society for Vascular Surgery Vascular Quality Initiative database was queried for TEVAR and complex EVAR cases from 2012 to 2018. Inclusion criteria included TAAA pathology and endograft extension to aortic zone 6. Patients with aortic rupture, trauma, prior thoracic aortic surgery, known preoperative occlusion of the left subclavian superior mesenteric, or celiac arteries were excluded. Cases with intraoperative celiac artery occlusion (CAO) were compared retrospectively to cases with celiac artery preservation (CAP). Primary outcomes included 30-day mortality and a composite end point of 30-day mortality, spinal cord ischemia (transient or permanent lower extremity neurologic deficit), and bowel ischemia (colonoscopic evidence of ischemia, bloody stools in a patient who dies prior to colonoscopy or laparotomy, or other documented clinical diagnosis). Univariable comparisons were performed using chi-squared tests and Student's t-tests, as appropriate. Multivariable logistic regression analyses were employed to identify independent predictors of outcome. RESULTS: There were 628 cases identified for inclusion in the study. Patients undergoing CAO (n = 44) were more likely to be female or to have higher rates of preoperative spinal drain use, American Society of Anesthesiologists score ≥3, low preop hemoglobin, and/or symptomatic presentation, but fewer mean number of aortic zones covered. CAO was associated with higher 30-day mortality (5 of 44, 11%) compared to CAP (23 of 584, 4%), P = 0.039. The composite end point occurred at a significantly greater proportion for those who had CAO (10 of 44, 23%) compared to CAP (53 of 584, 9%, P = 0.008), driven by higher rates of 30-day mortality and bowel ischemia (9% vs. 2%, P = 0.026). By multivariate analysis, CAO was predictive of 30-day mortality (odds ratio [OR] = 3.9, 95% confidence interval [CI] = 1.1-13.8, P = 0.04) and the composite endpoint (OR = 3.0, 95% CI = 1.1-8.5, P = 0.03). Increasing procedure time was also associated with 30-day mortality (OR = 1.4, 95% CI = 1.1-1.7, P < 0.001) and the composite end point (OR = 1.4, 95% CI = 1.1-1.6, P < 0.001). CONCLUSIONS: For those treated for TAAAs, CAO was independently predictive of increased 30-day mortality and a composite end point of perioperative mortality, spinal cord ischemia, and bowel ischemia. When treating patients with extensive aortic aneurysmal disease, physicians should attempt to preserve the celiac artery, by revascularization or avoiding ostium coverage, whenever feasible.

Discharge to a Post-Acute Care Facility after Emergent Femoral Artery Repair is Not Protective Against Wound Complications.

BACKGROUND: Access site complication is the most common adverse event after endovascular intervention, and when emergent operative repair of the common femoral artery (CFA) is needed, patient morbidity can be significantly increased. The intent of this project was to identify predictors of wound events after emergent operative repair of the CFA due to an access site complication. It was hypothesized that patients discharged to a facility would benefit from an ongoing relationship with healthcare professionals as evidenced by more consistent follow-up and lower wound complication rates. METHODS: Patients who had a percutaneous CFA access complication and required emergent open CFA repair at an academic medical institution between 2015 and 2018 were included, and the charts were reviewed retrospectively. Primary outcomes included wound complication and outpatient compliance with vascular surgery clinic visit. Dichotomous groups were evaluated by the chi-squared test, and continuous variables were evaluated by Student's t-test. Univariate and multivariate regression analyses were completed to assess risk factors contributing to wound event or failure of clinic follow-up. RESULTS: Forty-four patients were identified with emergent CFA repair due to an access complication between July 2015 and June 2018. Among this population, 33% of patients had wound complications and 27% were discharged to a facility. Among those discharged to a facility, the rate of follow-up to the vascular surgeon's clinic was significantly lower than those discharged to home (40% vs. 85%, P < 0.05), and the incidence of wound complications appeared greater but did not reach statistical significance (50% vs. 27%, P = 0.11). Univariate analysis indicated that kidney disease, albumin <3 g/dL, and current smoking were predictive of wound complication, whereas on multivariate analysis, only kidney disease remained predictive (P < 0.05, odds ratio = 22). The modified frailty index (mFI) was not predictive of wound complications or compliance with follow-up. However, mFI did approach statistical significance when predicting discharge to a facility. CONCLUSIONS: Despite the availability of medical personnel to arrange transportation and provide wound care in post-acute care facilities, patients who were discharged to a facility after CFA injury requiring emergent repair experienced lower compliance with clinic follow-up and may have suffered more wound complications. Strategies to improve compliance with patient follow-up and wound healing in patients sent to post-acute care facilities are warranted.

Limitations of Vascular Quality Initiative-derived models to predict the outcomes of intervention for infrapopliteal limb-threatening ischemia.

OBJECTIVE: The purpose of this study was to validate published Society for Vascular Surgery Vascular Quality Initiative (VQI) prediction models for patients with limb-threatening ischemia (LTI) undergoing open or endovascular revascularization for infrapopliteal occlusive disease. METHODS: We sought to validate our prior VQI LTI models for major adverse limb events (MALEs) and amputation-free survival (AFS) in a VQI new cohort undergoing open or percutaneous interventions from September 2014 through August 2016. Receiver operating characteristic curves were generated including the C statistic, and the predicted vs actual outcomes were correlated. The Hosmer-Lemeshow (HL) statistic was calculated to determine goodness of fit, and the Tjur R2 statistic was derived to demonstrate the degree to which the observed outcomes were accurately predicted by the models. RESULTS: Of 15,576 open infrainguinal and 34,679 percutaneous interventions collected in the VQI during the 24-month interval, 8852 and 17,124, respectively, were performed for LTI, among which 4410 and 5116 specifically targeted the infrapopliteal vessels. MALEs and AFS were identified for 400 of 927 (43.1%) and 576 of 982 (58.7%) open procedures and 197 of 855 (23.0%) and 658 of 1115 (59.0%) percutaneous procedures, respectively. For open operation, the predictive ability of the model was poor for MALEs (C = 0.59; HL = 107; R2 = 0.03) and only marginally better for AFS (C = 0.69; HL = 130; R2 = 0.10). Similarly, for endovascular intervention, the model performed poorly for MALEs (C = 0.62; HL = 183; R2 = 0.06) and slightly better for AFS (C = 0.68; HL = 68; R2 = 0.11). Breaking AFS into its component determinants, the predictive ability of the open operation model for patient survival (C = 0.77; HL = 70; R2 = 0.15) surpassed that for limb salvage (C = 0.64; HL = 54; R2 = 0.05). For endovascular interventions, the survival model (C = 0.71; HL = 94; R2 = 0.11) also outperformed the limb salvage model (C = 0.67; HL = 28; R2 = 0.07). For both types of intervention, the actual MALE rate was lower and AFS was higher than predicted by the models. CONCLUSIONS: The ability of reported VQI-derived models to accurately predict major outcomes for infrapopliteal LTI is limited and cannot be advocated for clinical decision-making at this time. Further study would be necessary to determine whether this is due to intraoperative and postoperative variables not accounted for in our models, absence of pertinent data points from the registry, or incomplete follow-up.

Outcomes for peripheral vascular intervention and lower extremity bypass in kidney transplant recipients are superior to outcomes of patients remaining on dialysis.

BACKGROUND: Improved survival is reported for patients with end-stage renal disease who are kidney transplant recipients (KTRs) compared with dialysis-dependent patients (DDPs). Whether amputation-free survival (AFS) and freedom from major adverse limb events (MALEs) after peripheral vascular intervention (PVI) or lower extremity bypass (LEB) are superior after renal transplantation remains incompletely defined. METHODS: A retrospective cohort study was undertaken of KTRs and DDPs undergoing infrainguinal PVI or LEB for symptoms of limb-threatening ischemia recorded in the Vascular Quality Initiative from 2003 to 2017. Primary outcomes were AFS and freedom from MALEs along with their components of assisted primary patency, limb salvage, and patient survival. The χ2 tests and independent samples t-tests were used to compare demographic variables. Kaplan-Meier survival analyses were used to estimate outcomes, and Cox regression analyses were used to confirm independent predictors of outcome. RESULTS: There were 2707 PVI (351 KTRs and 2356 DDPs) and 1444 LEB (198 KTRs and 1246 DDPs) procedures performed for limb-threatening ischemia. Chronic obstructive pulmonary disease, congestive heart failure, female patients, and African Americans were more common among the DDP group, as were lower preoperative hemoglobin values and older age. After PVI, KTRs had better AFS than DDPs (42% vs 66% at 1 year, 15% vs 26% at 2 years; hazard ratio [HR], 1.91; 95% confidence interval [CI], 1.38-2.64; P < .001) and fewer MALEs (53% vs 64% at 1 year, 35% vs 49% at 18 months; HR, 1.71; 95% CI, 1.25-2.34; P = .001). PVI outcomes, AFS, and freedom from MALEs were driven primarily by differences in limb salvage and patient survival but not assisted primary patency. After LEB, KTRs also displayed improved AFS compared with DDPs (44% vs 65% at 1 year, 10% vs 36% at 3 years; HR, 2.32; 95% CI, 1.41-3.81; P = .001), driven by patient survival but not limb salvage, whereas differences in freedom from MALEs did not attain statistical significance (67% vs 58%; P = .08). CONCLUSIONS: For patients with end-stage renal disease, subsequent kidney transplantation was associated with better AFS and freedom from MALEs after PVI but only improved AFS after LEB. Open or endovascular revascularization can be advocated in patients with limb-threatening ischemia who have received kidney transplantation to a greater degree than in those who remain dialysis dependent.

Errors in Reporting Significant Figures in Surgical and Medical Journals in 2017.

BACKGROUND: The present study was undertaken to ascertain the prevalence of published data with errors in the numerical significant figures in established surgical and medical journals in 2017. The frequency of errors was not only summarized but was also correlated to the published journal impact factor for the seven journals reviewed. METHODS: All original investigations and other analysis reporting quantitative statistical results published in seven surgical and medical journals in 2017 were electronically reviewed for errors in reporting significant figures of the published statistical findings. Errors in significant figures were placed into one of three author defined categories: calculated significant figure errors, interval precision errors, and P value reporting errors. Tests for intraobserver and interobserver reproducibility were conducted blindly to ensure validity and reproducibility between different readers. RESULTS: A total of 1675 articles published in 2017 were identified and reviewed. In total, 730 articles (44%) were reported to have an error in one category, with error rates ranging from 25% to 68% depending on publishing journal. The error rate for each journal were easily reproduced by different observers (κ coefficient range: 0.55-0.81) and correlated with its 2016 impact factor (r = 0.97, R2 = 0.95, P < 0.001). CONCLUSIONS: Published findings are frequently reported incorrectly in the surgical and medical literature and can be potentially misleading. The pervasiveness of errors correlates to fewer citations as measured by the lower impact factor.

The impact of current smoking on outcomes after infrainguinal bypass for claudication.

OBJECTIVE: Although smoking cessation is a benchmark of medical management of intermittent claudication, many patients require further revascularization. Currently, revascularization among smokers is a controversial topic, and practice patterns differ institutionally, regionally, and nationally. Patients who smoke at the time of revascularization are thought to have a poor prognosis, but data on this topic are limited. The purpose of this study was to evaluate the impact of smoking on outcomes after infrainguinal bypass for claudication. METHODS: Data from the national Vascular Quality Initiative from 2004 to 2014 were used to identify infrainguinal bypasses performed for claudication. Patients were categorized as former smokers (quit >1 year before intervention) and current smokers (smoking within 1 year of intervention). Demographic and comorbid differences of categorical variables were assessed. Significant predictors were included in adjusted Cox proportional hazards models to calculate hazard ratios (HRs) and 95% confidence intervals (CIs) by smoking status for outcomes of major adverse limb event (MALE), amputation-free survival, limb loss, death, and MALE or death. Cumulative incidence curves were created using competing risks modeling. RESULTS: We identified 2913 patients (25% female, 9% black) undergoing incident infrainguinal bypass grafting for claudication. There were 1437 current smokers and 1476 former smokers in our study. Current smoking status was a significant predictor of MALE (HR, 1.27; 95% CI, 1.00-1.60; P = .048) and MALE or death (HR, 1.22; 95% CI, 1.03-1.44; P = .02). Other factors found to be independently associated with poor outcomes in adjusted models included black race, below-knee bypass grafting, use of prosthetic conduit, and dialysis dependence. CONCLUSIONS: Current smokers undergoing an infrainguinal bypass procedure for claudication experienced more MALEs than former smokers did. Future studies with longer term follow-up should address limitations of this study by identifying a data source with long-term follow-up examining the relationship of smoking exposure (pack history and duration) with outcomes.

Document d'orientation sur la distribution et l'utilisation de trousses de naloxone à emporter par les intervenants et intervenantes communautaires en cas de surdose au Canada.

CONTEXTE: La toxicité croissante des opioïdes dans le marché illicite des drogues a fait exploser le nombre de surdoses au Canada et ailleurs dans le monde; le programme de naloxone à emporter (NàE) est une intervention fondée sur des données probantes qui consiste à distribuer des trousses contenant de la naloxone aux membres de la communauté susceptibles d'être témoins d'une surdose. L'objectif du présent document d'orientation est de formuler des recommandations stratégiques à l'intention des programmes fédéraux, provinciaux et territoriaux de NàE, en s'appuyant sur des données probantes issues de la documentation scientifique, de la littérature grise et des communautés, à la lumière de 11 années de distribution de NàE au Canada. MÉTHODES : Le groupe d'élaboration des documents d'orientation sur la naloxone, une équipe multidisciplinaire composée de personnes ayant une expertise et une expérience vécue en matière de toxicomanie, a appliqué l'outil AGREE II (Appraisal of Guidelines for Research & Evaluation) afin d'éclairer l'élaboration du présent document d'orientation. En vue de l'élaboration de nos recommandations, nous avons procédé entre décembre 2021 et septembre 2022 à une revue systématique de tous les types d'ouvrages dans le but de recueillir les données probantes publiées, ainsi que les données probantes et l'expertise issues de la communauté. Nous avons sollicité des commentaires sur nos recommandations préliminaires par le biais d'un comité de révision externe et d'un processus de participation du public. Le projet a été financé par les Instituts de recherche en santé du Canada dans le cadre de l'Initiative canadienne de recherche sur l'abus de substances (ICRAS). Nous avons appliqué les principes du Réseau international en matière de lignes directrices (Guidelines International Network) pour gérer les intérêts concurrents. RECOMMANDATIONS: Les données probantes existantes issues de la documentation sur la NàE étaient de faible qualité. Pour élaborer nos recommandations, nous avons incorporé des données probantes tirées de la documentation scientifique et de la littérature grise, ainsi que l'expertise de la communauté. Nos recommandations portent sur 3 volets : les voies d'administration de la naloxone, le contenu des trousses de NàE et les interventions en cas de situations de surdose. Les trousses distribuées par les programmes de naloxone à emporter doivent offrir le choix entre les préparations intramusculaire et intranasale. Le contenu recommandé de la trousse comprend la naloxone, un dispositif d'administration de la naloxone, un équipement de protection individuelle, des instructions et un étui de transport. Les intervenants et intervenantes communautaires formés à la réponse aux surdoses doivent prioriser la respiration artificielle en cas de dépression respiratoire, et la réanimation cardiorespiratoire (RCR) conventionnelle en cas d'arrêt cardiaque, entre autres interventions. INTERPRÉTATION : Ce projet d'élaboration d'un document d'orientation vise à guider les programmes de NàE au Canada dans un contexte où les données probantes publiées sont rares; les recommandations ont été élaborées en collaboration avec diverses parties prenantes.