Recommendations for empowering early career researchers to improve research culture and practice.

Early career researchers (ECRs) are important stakeholders leading efforts to catalyze systemic change in research culture and practice. Here, we summarize the outputs from a virtual unconventional conference (unconference), which brought together 54 invited experts from 20 countries with extensive experience in ECR initiatives designed to improve the culture and practice of science. Together, we drafted 2 sets of recommendations for (1) ECRs directly involved in initiatives or activities to change research culture and practice; and (2) stakeholders who wish to support ECRs in these efforts. Importantly, these points apply to ECRs working to promote change on a systemic level, not only those improving aspects of their own work. In both sets of recommendations, we underline the importance of incentivizing and providing time and resources for systems-level science improvement activities, including ECRs in organizational decision-making processes, and working to dismantle structural barriers to participation for marginalized groups. We further highlight obstacles that ECRs face when working to promote reform, as well as proposed solutions and examples of current best practices. The abstract and recommendations for stakeholders are available in Dutch, German, Greek (abstract only), Italian, Japanese, Polish, Portuguese, Spanish, and Serbian.

Clinical Impact of an Enhanced Recovery Program for Lower-extremity Bypass.

OBJECTIVE: To determine the association of Enhanced Recovery Program (ERP) implementation with length of stay (LOS) and perioperative outcomes after lower-extremity bypass (LEB). BACKGROUND: ERPs have been shown to decrease hospital LOS and improve perioperative outcomes, but their impact on patients undergoing vascular surgery remains unknown. METHODS: Patients undergoing LEB who received or did not receive care under the ERP were included; pre-ERP (January 1, 2016-May 13, 2018) and ERP (May 14, 2018-July 31, 2022). Clinicopathologic characteristics and perioperative outcomes were analyzed. RESULTS: Of 393 patients who underwent LEB [pre-ERP: n = 161 (41%); ERP: n = 232 (59%)], most were males (n = 254, 64.6%), White (n = 236, 60%), and government-insured (n = 265, 67.4%). Pre-ERP patients had higher Body Mass Index (28.8 ± 6.0 vs 27.4 ± 5.7, P = 0.03) and rates of diabetes (52% vs 36%, P = 0.002). ERP patients had a shorter total [6 (3-13) vs 7 (5-14) days, P = 0.01) and postoperative LOS [5 (3-8) vs 6 (4-8) days, P < 0.001]. Stratified by indication, postoperative LOS was shorter in ERP patients with claudication (3 vs 5 days, P = 0.01), rest pain (5 vs 6 days, P = 0.02), and tissue loss (6 vs 7 days, P = 0.03). ERP patients with rest pain also had a shorter total LOS (6 vs 7 days, P = 0.04) and lower 30-day readmission rates (32%-17%, P = 0.02). After ERP implementation, the average daily oral morphine equivalents decreased [median (interquartile range): 52.5 (26.6-105.0) vs 44.12 (22.2-74.4), P = 0.019], while the rates of direct discharge to home increased (83% vs 69%, P = 0.002). CONCLUSIONS: This is the largest single-center cohort study evaluating ERP in LEB, showing that ERP implementation is associated with shorter LOS and improved perioperative outcomes.

Investigating glycemic control in patients undergoing lower extremity bypass within an enhanced recovery pathway at a single institution.

BACKGROUND: Enhanced recovery pathways (ERPs) aim to lower perioperative stress to facilitate recovery. Limited fasting combined with carbohydrate loading is a common ERP element. The effect of limited fasting has not been elucidated in patients with diabetes. Given the known deleterious effects of poor glycemic control in the perioperative period, such as increased rates of surgical site infection, the associations of preoperative limited fasting with perioperative glycemic control and early outcomes after lower extremity bypass (LEB) were investigated. METHODS: A single institutional retrospective review of patients who underwent infrainguinal LEB from 2016 to 2022 was performed. The ERP was initiated in May 2018. Patients were stratified by diabetes diagnosis and preoperative hemoglobin A1C (HbA1C) levels. Perioperative glycemic control was compared between the limited fasting and traditional fasting patients (nil per os at midnight). Limited fasting was defined as a clear liquid diet until 2 hours before surgery with recommended carbohydrate loading consisting of 400 cc of a clear sports drink (approximately 30 g of carbohydrates). All limited fasting patients were within the ERP. Early perioperative hyperglycemia (EPH) was defined as blood glucose of >180 mg/dL within the first 24 hours of surgery. Perioperative outcomes such as surgical site infection, readmission, reinterventions, and complications were also compared. RESULTS: A total of 393 patients were included (limited fasting patients N = 135; traditional fasting patients N = 258). A trend toward EPH was seen in all limited fasting groups. Evaluating limited fasting within diabetic patients revealed that 74.5% of limited fasting-diabetic patients had EPH compared with 49.6% of traditional fasting-diabetic patients (P = .001). When stratified by the HbA1C level, a significantly higher rate of EPH was seen in the HbA1c >8.0% groups, with 90.5% in the limited fasting patients compared with 67.9% in traditional fasting patients (P = .05). Limited fasting-diabetic patients experience a longer postoperative length of stay at 5.0 days (interquartile range: 3, 9) vs 4.0 days (2, 6) in nondiabetic patients (P = .016). CONCLUSIONS: ERP limited fasting was associated with early perioperative hyperglycemia after LEB, particularly in patients with HbA1C >8.0%. Due to the high prevalence of diabetic patients undergoing LEB under ERP, the role of limited fasting and common glycemic elements of ERP may need to be re-evaluated in this subpopulation.

Risk of volume depletion events with concomitant use of sodium glucose co-transporter 2 inhibitors and loop diuretics: A self-controlled case series study.

BACKGROUND: Sodium glucose co-transporter 2 inhibitors (SGLT2is) are used to prevent cardiovascular complications in type 2 diabetes mellitus (T2DM) and newly indicated to treat heart failure (HF). Loop diuretics are commonly prescribed to manage volume overload in HF and may increase the risk of volume depletion in real-world practice. This study evaluated the risk of volume depletion following concomitant use of SGLT2is and loop diuretics in veterans. METHODS: Veterans with T2DM were included if they received concomitant loop diuretics and SGLT2is and experienced at least one volume depletion event between December 2012 and December 2019, utilizing a self-controlled case series design. Concomitant prescribing periods were divided into focal windows of 1 to 14 days, 14 to 28 days, and greater than 28 days. Incidence rate ratios (IRR) were estimated using multivariable Poisson regressions adjusted for age and renal function. RESULTS: 3352 patients experienced at least one volume depletion event and were concomitantly prescribed SGLT2is and loop diuretics at least once. The risk of volume depletion increased in the treatment versus control windows during the 1 to 14-day window (IRR = 1.82, 95% CI 1.63-2.02) the 15-to-28-day window (IRR = 1.46, 95% CI 1.28-1.67), and the greater than 28-day window (IRR = 1.22, 95% CI 1.21-1.34). CONCLUSIONS: Concomitant prescribing of SGLT2is and loop diuretics is associated with an increased risk of volume depletion, an effect that attenuates with longer therapy durations. Prescribers need to closely monitor fluid status in patients receiving concomitant therapy, especially those with advancing age or with eGFR below 60.

Heat Stress Management in the Military: Wet-Bulb Globe Temperature Offsets for Modern Body Armor Systems.

OBJECTIVE: The aim of this study was to model the effect of body armor coverage on body core temperature elevation and wet-bulb globe temperature (WBGT) offset. BACKGROUND: Heat stress is a critical factor influencing the health and safety of military populations. Work duration limits can be imposed to mitigate the risk of exertional heat illness and are derived based on the environmental conditions (WBGT). Traditionally a 3°C offset to WBGT is recommended when wearing body armor; however, modern body armor systems provide a range of coverage options, which may influence thermal strain imposed on the wearer. METHOD: The biophysical properties of four military clothing ensembles of increasing ballistic protection coverage were measured on a heated sweating manikin in accordance with standard international criteria. Body core temperature elevation during light, moderate, and heavy work was modeled in environmental conditions from 16°C to 34°C WBGT using the heat strain decision aid. RESULTS: Increasing ballistic protection resulted in shorter work durations to reach a critical core temperature limit of 38.5°C. Environmental conditions, armor coverage, and work intensity had a significant influence on WBGT offset. CONCLUSION: Contrary to the traditional recommendation, the required WBGT offset was >3°C in temperate conditions (<27°C WBGT), particularly for moderate and heavy work. In contrast, a lower WBGT offset could be applied during light work and moderate work in low levels of coverage. APPLICATION: Correct WBGT offsets are important for enabling adequate risk management strategies for mitigating risks of exertional heat illness.

The Effect of Saccharomyces boulardii Primary Prevention on Risk of Hospital-onset Clostridioides difficile Infection in Hospitalized Patients Administered Antibiotics Frequently Associated With C. difficile Infection.

BACKGROUND: Hospital-onset Clostridioides difficile infection (HO-CDI) is a costly problem leading to readmissions, morbidity, and mortality. We evaluated the effect of a single probiotic strain, Saccharomyces boulardii, at a standardized dose on the risk of HO-CDI within hospitalized patients administered antibiotics frequently associated with HO-CDI. METHODS: This retrospective cohort study merged hospital prescribing data with HO-CDI case data. The study assessed patients hospitalized from January 2016 through March 2017 who were administered at least 1 dose of an antibiotic frequently associated with HO-CDI during hospitalization. Associations between S. boulardii administration, including timing, and HO-CDI incidence were evaluated by multivariable logistic regression. RESULTS: The study included 8763 patients. HO-CDI incidence was 0.66% in the overall cohort. HO-CDI incidence was 0.56% and 0.82% among patients coadministered S. boulardii with antibiotics and not coadministered S. boulardii, respectively. In adjusted analysis, patients coadministered S. boulardii had a reduced risk of HO-CDI (odds ratio [OR], 0.57 [95% confidence interval {CI}, .33-.96]; P = .04) compared to patients not coadministered S. boulardii. Patients coadministered S. boulardii within 24 hours of antibiotic start demonstrated a reduced risk of HO-CDI (OR, 0.47 [95% CI, .23-.97]; P = .04) compared to those coadministered S. boulardii after 24 hours of antibiotic start. CONCLUSIONS: Saccharomyces boulardii administered to hospitalized patients prescribed antibiotics frequently linked with HO-CDI was associated with a reduced risk of HO-CDI.

An immediate or early invasive strategy in non-ST-elevation acute coronary syndrome: The OPTIMA-2 randomized controlled trial.

BACKGROUND: In intermediate- and high-risk non-ST elevated acute coronary syndrome (NSTE-ACS) patients, a routine invasive approach is recommended. The timing of coronary angiography remains controversial. To assess whether an immediate (<3 hours) invasive treatment strategy would reduce infarct size and is safe, compared with an early strategy (12-24 hours), for patients admitted with NSTE-ACS while preferably treated with ticagrelor. METHODS: In this single-center, prospective, randomized trial an immediate or early invasive strategy was randomly assigned to patients with NSTE-ACS. At admission, the patients were preferably treated with a combination of aspirin, ticagrelor and fondaparinux. The primary endpoint was the infarct size as measured by area under the curve (AUC) of CK-MB in 48 hours. Secondary endpoints were bleeding outcomes and major adverse cardiac events (MACE): composite of all-cause death, MI and unplanned revascularization. Interim analysis showed futility regarding the primary endpoint and trial inclusion was terminated. RESULTS: In total 249 patients (71% of planned) were included. The primary endpoint of in-hospital infarct size was a median AUC of CK-MB 186.2 ng/mL in the immediate group (IQR 112-618) and 201.3 ng/mL in the early group (IQR 119-479). Clinical follow-up was 1-year. The MACE-rate was 10% in the immediate and 10% in the early group (hazard ratio [HR] 1.13, 95% CI: 0.52-2.49). CONCLUSIONS: In NSTE-ACS patients randomized to either an immediate or an early-invasive strategy the observed median difference in the primary endpoint was about half the magnitude of the expected difference. The trial was terminated early for futility after 71% of the projected enrollment had been randomized into the trial.

Thoracofemoral bypass outcomes in the Vascular Quality Initiative.

OBJECTIVE: Thoracofemoral bypass (TFB) has been used infrequently but is an alternative for select patients with aortoiliac occlusive disease. Limited data are available in the reported data regarding TFB, with all studies small, single-center series. We aimed to describe the perioperative and long-term survival, patency, and rate of major perioperative complications after TFB in a large national registry. METHODS: The Vascular Quality Initiative suprainguinal bypass module was used to identify patients who had undergone TFB for occlusive disease from 2009 to 2019. A descriptive analysis was performed to provide the rates of survival, patency, major complications, and freedom from major amputation in the perioperative period and at 1 year of follow-up. Major complications were compared by procedure indication, with categorical variables analyzed using χ2 tests and continuous variables using analysis of variance. Kaplan-Meier curve analysis was used to estimate survival at the 1- and 5-year follow-up intervals and freedom from major amputation at 1 year. RESULTS: A total of 154 TFB procedures were identified. Of the 154 patients, 59 (38.3%) had undergone previous inflow bypass and 22 (14.2%) had undergone previous leg bypass. The procedure indications included claudication (n = 66; 42.9%), rest pain (n = 59; 38.3%), tissue loss (n = 19; 12.3%), and acute limb ischemia (n = 10; 6.5%). Major complications (eg, wound infection, respiratory, major stroke, new dialysis, cardiac, embolic, major amputation, occlusion) occurred in 31.2% of the cohort. When examined by indication, the acute limb ischemia and claudication cohorts had an increased rate of major complications (acute limb ischemia, 60.0%; claudication, 34.8%; critical limb ischemia, 24.4%; P = .05). The survival rate at 30 days was 95.5%, with a Kaplan-Meier estimated 1-year survival rate of 92.7% ± 2.2%. Primary patency at discharge from the index hospitalization was 92.9% and 89.0% at 1 year. Postoperative major amputation was required for 1 patient during the index hospitalization, for a Kaplan-Meier estimated freedom from major amputation at 1 year of 97.1% ± 2.2%. Two patients developed in-hospital bypass occlusion and three patients developed occlusion within 1 year, for an overall freedom from occlusion rate of 96.8% at 1 year. CONCLUSIONS: TFB is associated with a high rate of perioperative major complications; however, the long-term survival and patency after TFB remained acceptable when performed for limb salvage. The high perioperative complication rates of TFB procedures performed for claudication suggest TFB should be used rarely in this population. These data can be used to counsel patients and aid in decision making before operative intervention.

The association between preoperative length of stay and surgical site infection after lower extremity bypass for chronic limb-threatening ischemia.

OBJECTIVE: Surgical site infection (SSI) is an important complication of lower extremity bypass (LEB) and the rate of SSI after LEB varies widely in the existing literature, ranging from 4% to 31%. Prolonged length of stay (LOS) has been implicated in the occurrence of SSI across multiple surgical disciplines. The impact of preoperative LOS in patients with chronic limb-threatening ischemia (CLTI) undergoing LEB is unknown. We examined the association of preoperative LOS on SSI after LEB. METHODS: A retrospective analysis of the Society for Vascular Surgery Vascular Quality Initiative Infrainguinal Bypass Registry identified patients undergoing elective LEB for chronic limb-threatening ischemia from 2003 to 2019. Patients undergoing LEB for acute limb ischemia, urgent/emergent procedures, aneurysm, or who had concomitant suprainguinal bypass were excluded. The primary outcome measure was postoperative SSI. Multivariable forward stepwise logistic regression was then performed including all variables with a P value of less than .10 in both matched and unmatched cohorts to evaluate for demographic and perioperative predictors of SSI. Propensity score matching was used to create matched cohorts of patients for each LOS group. RESULTS: A total of 17,883 LEB procedures were selected for inclusion: 0 days (12,362 LEB), 1 to 2 days (1737 LEB), and 3 to 14 days (3784 LEB). Patients with the greatest preoperative LOS were more likely to have vein mapping (0 days preoperative LOS, 66.3%; 1-2 days, 65.2%; 3-14 days, 73.2%; P < .01) or computed tomography angiography/magnetic resonance angiography (0 days, 32.1%; 1-2 days, 34.4%; 3-14 days, 38.4%; P < .01). Patients with 3 or more days of preoperative LOS had longer procedure lengths (0 days, 244 minutes; 1-2 days, 243 minutes; 3-14 days, 255 minutes; P < .01) and were more likely to have completion angiogram (0 days, 27.1%; 1-2 days, 29.5%; 3-14 days, 31.6%; P = .02). Multivariable logistic regression demonstrated that preoperative LOS of 3 to 14 days was associated with increased rate of SSI (odds ratio [OR], 1.92; 95% confidence interval [CI], 1.20-3.07; P = .01). Transfusion of 3 or more units (OR, 2.87; 95% CI, 1.89-4.36; P < .01) and prolonged procedure length (>220 minutes; OR, 1.86; 95% CI, 1.26-2.73; P < .01) were also significantly associated with postoperative SSIs. CONCLUSIONS: Many factors including preoperative comorbidities and operative complexity covary with preoperative LOS as risk factors for SSI. However, when patients are matched based on comorbidities and factors that would predict overall clinical complexity, preoperative LOS remains important in predicting SSI.

Carotid endarterectomy with concomitant distal endovascular intervention is associated with increased rates of stroke and death.

OBJECTIVE: Carotid endarterectomy (CEA) with concomitant distal endovascular intervention (CEA+D) is infrequently necessary but has often been used as a salvage maneuver when complications occur during CEA. The present study aimed to determine whether preoperative risk factors associated with CEA requiring CEA+D exist and to evaluate the outcomes compared with isolated CEA. METHODS: The Vascular Quality Initiative CEA registry was used to identify patients who had undergone CEA or CEA+D for asymptomatic or symptomatic carotid stenosis from 2013 to 2019. Data regarding distal intervention included whether angioplasty or stenting of the distal internal carotid artery (ICA) and/or bifurcation had been required. However, information regarding the indication or whether the intervention had been planned was not included. The χ2 test and analysis of variance were used to evaluate the categorical and continuous perioperative variables. Variables with P < .20 on univariate analysis were included in the multivariable analysis to assess for preoperative predictors of the need for CEA+D and the association with perioperative stroke. RESULTS: From 2013 to 2019, 327 CEA+D cases were identified and compared with 105,192 isolated CEA cases. The CEA+D patients were more likely to have undergone previous ipsilateral CEA (CEA, 1.8%; CEA+D, 4.9%; P < .01) and contralateral ICA occlusion (CEA, 4.6%; CEA+D, 11.0%; P < .01) but were less likely to have had ipsilateral stenosis ≥70% (CEA, 88.3%; CEA+D, 80.6%; P < .01). The preoperative factors associated with the need for CEA+D on multivariable analysis included previous peripheral vascular intervention, American Society of Anesthesiologists class ≥4, contralateral ICA occlusion, low-volume surgeon, and previous ipsilateral CEA. CEA+D was associated with significantly increased rates of stroke in both asymptomatic (CEA+D, 3.9%; CEA, 0.9%; P < .01) and symptomatic (CEA+D, 9.4%; CEA, 1.9%; P < .01) patients. CEA+D was associated with decreased rates of 30-day survival in both asymptomatic (CEA+D, 98.3%; CEA, 99.4%; P = .02) and symptomatic (CEA+D, 94.8%; CEA, 99.1%; P < .01) cohorts. On multivariable analysis, CEA+D remained significantly associated with stroke (odds ratio, 3.17; 95% confidence interval, 1.80-5.60; P < .01). Other factors significantly associated with perioperative stroke included procedure length >135 minutes, diabetes, hypertension, shunt for indication, symptomatic status, previous ipsilateral CEA, contralateral ICA occlusion, urgent or emergent procedure, intravenous medications for hemodynamic instability, and re-exploration at the initial operation. CONCLUSIONS: Although markers of more significant cardiovascular disease burden were associated with the use of CEA+D, their power to predict CEA+D use was limited. In cases in which CEA+D was used, CEA+D was associated with significantly greater rates of perioperative stroke and mortality compared with isolated CEA for both asymptomatic and symptomatic patients, which could be useful for framing the expected outcomes after these procedures.

Association between thoracoabdominal aneurysm extent and mortality after complex endovascular repair.

OBJECTIVE: Traditional open surgical repair of thoracoabdominal aortic aneurysms (TAAAs) has historically resulted in 30-day mortality rates ranging from 6% to 20%, depending on the Crawford anatomic extent. Although short-term survival is important, long-term survival is essential for patients to benefit from these often elective and potentially morbid procedures. The aneurysm extent affects the long-term survival after open repair; however, effect on endovascular repair is unknown and could influence the decision process for repair. We evaluated the association between aneurysm extent and survival and identified patient and perioperative factors associated with mortality after endovascular repair. METHODS: A retrospective cohort of patients treated for TAAAs recorded in the Society for Vascular Surgery Vascular Quality Initiative thoracic and complex endovascular aneurysm repair registry were evaluated. All patients treated for asymptomatic degenerative aneurysms from 2010 to 2019 were included. Crawford extent I to V was defined according to the proximal and distal landing zones documented in the registry. Patients without extension into the visceral aorta were used for comparison and categorized as having extent 0a or 0b, depending on the distal landing zone in the thoracic aorta. Kaplan-Meier plots were used to estimate survival, and Cox proportional hazard regression models were created to identify the predictors of mortality. RESULTS: From 2010 to 2019, 15,333 patients were entered into the registry, of whom 2062 met the inclusion criteria. The Crawford extent was 0a for 379, 0b for 848, I for 81, II for 98, III for 130, IV for 454, and V for 72. Three groups were created in accordance with the similar outcomes noted on a preliminary analysis: (1) extent 0a and 0b; (2) extent I, II, and III; and (3) extent IV and V. The mean survival time for the extent 0a and 0b group was 70.7 ± 1.43 months and was 48.6 ± 1.65 months for the extent I, II, and III group and 57.6 ± 1.24 months for the extent IV and V group. The corresponding 1-year mortality was 8.4%, 18.4%, and 7.8%. Cox regression analysis identified the following preoperative factors were associated with mortality: chronic obstructive pulmonary disease (odds ratio [OR], 1.70; P < .001), Crawford extent I to III (OR, 1.64; P = .015), preexisting chronic kidney disease (OR, 1.37; P = .024), and age per year (OR, 1.03; P < .001). A number of postoperative factors were also associated with mortality. CONCLUSIONS: Similar to open TAAA repair, patients with more extensive aortic disease treated with endovascular repair had worse 1-year and long-term survival. The extent of aortic disease and anticipated postoperative survival should factor prominently into the surgical decision-making process for elective endovascular TAAA repair.

One-year mortality in NSTEMI patients is unaffected by timing of PCI within the first week of admission: Results of a real-world cohort analysis.

OBJECTIVES: We aimed to explore the impact of time to percutaneous coronary intervention (PCI) (T2P) on 1-year mortality in non-ST-elevation myocardial infarction (NSTEMI) patients. BACKGROUND: The current guidelines recommend an early invasive strategy for NSTEMI patients. However, impact of an early invasive strategy on mortality is a matter of debate. For that reason, real world data are of great value to determine the optimal treatment window. METHODS: This retrospective single center cohort study was performed in a high-volume PCI center in Amsterdam, The Netherlands. Intermediate- and high-risk NSTEMI patients undergoing PCI were included. The main discriminant was timing of PCI after admission (T2P), stratified according to different time windows (<24 h, 24-72 h, 72 h-7 days or >7 days). We analyzed 1-year mortality and the time distribution of overall survival. RESULTS: In total, 848 patients treated between January 1, 2016 and January 1, 2018 were included in the analysis. T2P was <24 h in 145 patients, 24-72 h in 192 patients, 72 h-7 days in 275 patients, and >7 days in 236 patients. The mean GRACE-risk score was 127.1 (SD 28.7), 130.0 (33.1), 133.8 (32.1), and 148.7 (34.6) respectively, p = <0.001. After adjusting for confounders, 1-year mortality in patients with T2P <24 h did not significantly differ when compared with T2P 24-72 h (OR = 1.08; 95% CI = 0.33-3.51) and T2P 72 h-7 days (OR 1.72; 95% CI = 0.57-5.21) but was significantly higher in T2P >7 days (OR = 3.20; 95% CI = 1.06-9.68). CONCLUSIONS: In an unselected cohort of patients with NSTEMI, treatment by PCI <24 h did not lead to improved survival as compared to aT2P <7 days strategy. Delay in PCI >7 days after admission resulted in worse outcome.

Working smarter, not harder: evaluating a population health approach to anticoagulation therapy management.

Inappropriate direct acting oral anti-coagulants (DOAC) prescribing increases the risk of adverse events. Population health management tools (PMTs) could help reduce adverse events through the early, efficient identification of questionable prescribing practices, but the impact of such a tool remains unknown. We evaluated the effect of PMT use on questionable DOAC dosing rates within 40 VHA medical centers and whether this effect differed by DOAC indication or agent. Medical centers were divided into PMT user or standard of care (SOC) groups based upon high or low tool access in the prior year. Questionable DOAC dosing rate was defined as the proportion of patients prescribed DOACs who were also flagged by the tool. Chi-square tests were used to determine if PMT user versus SOC groups differed with high (above 15.3%) versus low (below 15.3%) questionable dosing rates. T-tests were used to determine if mean questionable dosing rates significantly differed between the PMT user and SOC groups. DOAC PMT users were classified less frequently as being 'High" questionable dosage rate compared to SOCs (25% PMT vs. 75% SOC, respectively, p = 0.002). DOAC PMT utilization within the overall cohort was associated with a 4.3% absolute reduction in questionable DOAC dosing rates (13.2% PMT vs 17.5% SOC; p = 0.01). Tool use within the atrial fibrillation (AF) subgroup was associated with a 5.1% absolute reduction in questionable dosing rates (10.4% SOC vs. 5.3% PMT, p < 0.001). Tool use was also associated with lower questionable dosing rates in the apixaban (p < 0.001), dabigatran (p = 0.03) and AF plus venous thromboembolism (p < 0.001) subgroups. In our study, PMT use was associated with reduced questionable DOAC dosing, a difference most pronounced within AF patients. A population health approach has the potential to reduce adverse events among patients prescribed DOACs.

Describing Clinically Significant Arrhythmias in Postoperative Vascular Surgery Patients.

BACKGROUND: The American Heart Association guidelines instruct use of postoperative telemetry (POT) should be reserved for patients undergoing cardiac procedures and/or those with ischemic cardiac symptoms, but acknowledge that major vascular procedures deserve unique consideration. Telemetry remains a limited resource in many hospitals; however, it has been poorly defined which vascular patients have greatest need for POT. The purpose of this study is to define the rates of postoperative arrhythmias (POAs) after major vascular operations using the Society for Vascular Surgery Vascular Quality Initiative (VQI) registry, identify independent predictors of POA, and determine the effect of POA on mortality to guide the use of POT in vascular patients. METHODS: A retrospective cohort study was performed using the following VQI modules: open abdominal aortic aneurysm repair (oAAA), complex endovascular aneurysm repair (EVAR) (thoracic endovascular aortic repair [TEVAR]/c-EVAR), EVAR, suprainguinal bypass (SIB), and infrainguinal bypass (IIB). POA was defined in the VQI as a new rhythm disturbance requiring treatment with medication or cardioversion. The incidence of POA, preoperative risk factors, and demographics were determined for each procedure. RESULTS: A total of 121,652 procedures were identified with an overall POA event rate of 5.1% (n = 6,265). Procedure-specific event rates for POA among VQI registries are as follows: oAAA 14.4%, TEVAR/c-EVAR 8.5%, EVAR 2.7%, SIB 6.2%, and IIB 3.8%. Across all procedure types, POA was associated with emergent operations and increased procedure time. Procedure-specific multivariable regression revealed additional independent preoperative intraoperative factors associated with POA that were unique with each procedure. Across all procedural groups, the presence of POA was associated with increased rates of clinical myocardial infarction and decreased survival on Kaplan-Meier analysis. CONCLUSIONS: Rates of POA in patients undergoing vascular procedures appear higher than previously reported, and POA is associated with decreased survival. Our study elucidated patient- and procedure-specific predictor factors associated with POA that can be used to inform the use of POT.

Long-Term Trends in Preoperative Cardiac Evaluation and Myocardial Infarction after Elective Vascular Procedures.

BACKGROUND: Vascular surgery has seen rapid increase in the use of less invasive endovascular therapies along with advancements in cardiac perioperative optimization in the past 2 decades. However, a recent American College of Surgeons National Surgical Quality Improvement Program database study found no improvement in postoperative myocardial infarction (POMI) over a 10-year period in high-risk procedures. The national Society for Vascular Surgery Vascular Quality Initiative (VQI) registry provides a more in-depth characterization of vascular surgery procedures. Here, we sought to evaluate long-term trends in POMI using VQI registry data for patients undergoing carotid endarterectomy (CEA), thoracic endovascular aortic repair (TEVAR), endovascular aortic repair (EVAR), open abdominal aortic aneurysm repair (oAAA), suprainguinal bypass (SIB), and infrainguinal bypass (IIB). METHODS: A retrospective cohort study was performed using data on elective procedures from 2003 to 2017. Procedures were subdivided by date of operation into 3-year era consecutive groups for subanalysis (2003-05, 2006-08, 2009-11, 2012-14, and 2015-17). The incidence of POMI, preoperative risk factors (including individual patient VQI cardiac risk index (CRI)), and demographics were determined over time. RESULTS: A total of 227,837 elective procedures were identified: CEA (n = 88,805, 39.0%), TEVAR (n = 7,494, 3.3%), EVAR (n = 34,376, 15.1%), oAAA (n = 7,568, 3.3%), SIB (n = 11,354, 5.0%), and IIB (n = 34,661, 15.2%). Across all procedures, the overall rate of POMI was 1.3%. POMI rates from 2003-05 to 2015-17 for CEA decreased from 0.9% to 0.7% (P = 0.21), EVAR from 2.0% to 0.7%, P = 0.003, oAAA from 6.8% to 5.1% (P = 0.12), and IIB from 3.8% to 2.4% (P = 0.003). SIB POMI decreased from 3.06% to 2.95%, P = 0.85 from 2009 to 17. While POMI after TEVAR increased from 2.40% to 2.56% from 2009 to 17, P = 0.91. Over these same time periods, only EVAR and IIB had a reduction in CRIs (P = 0.059 and P < 0.001, respectively). CEA, EVAR, IIB, and oAAA all showed a significant (P < 0.001) increase in preoperative statin use. CONCLUSIONS: Except for TEVAR, the incidence of POMI has remained unchanged or decreased over the past 15 years in VQI registries. Patients undergoing IIB and EVAR demonstrated decreases in POMI rates that correspond with a reduction in CRIs and increased preoperative statin use. CEA and SIB had no significant change in POMI rates nor CRIs. The etiology of decreased POMI rate is uncertain, but increasing statin use, patient-specific factors, and patient selection for procedures may be important drivers of this improvement.

Prevalence and Outcomes of Endovascular Infrapopliteal Interventions for Intermittent Claudication.

BACKGROUND: Although endovascular peripheral vascular interventions (PVI) are typically limited to vessels above the knee in intermittent claudication (IC), some patients have concomitant or isolated infrapopliteal disease with IC. The benefits and risks of undergoing tibial intervention remain unclear in IC patients. The purpose of this study is to evaluate the prevalence and outcomes of infrapopliteal PVI for IC. METHODS: The Vascular Quality Initiative was queried for PVI procedures performed for IC between 2003 and 2018. Patients were divided into 3 groups: isolated femoropopliteal (FP), isolated infrapopliteal (IP), and combined above and below knee interventions (COM). Multivariable logistic regression models identified predictors of minor and major amputation, as well as freedom from reintervention. Kaplan-Meier plots estimate amputation-free survival. RESULTS: We identified 34,944 PVI procedures for IC. There were 31,110 (89.0%) FP interventions, 1,045 (3.0%) IP interventions, and 2,789 (8.0%) COM interventions. Kaplan-Meier plots of amputation-free survival revealed that patients with any IP intervention had significantly higher rates of both minor and major amputation (log rank <0.001). Freedom from reintervention at 1-year was 89.2% for the FP group, 91.3% for the IP group, and 85.3% for the COM group (P < 0.0001). In multivariable analysis, factors associated with an increased risk of major amputation included isolated IP intervention (OR 6.47, 95% CI, 6.45-6.49; P < 0.0001), COM interventions (OR 2.32, 95% CI, 2.31-2.33; P < 0.0001), dialysis dependence (OR 3.34, 95% CI, 3.33-3.35; P < 0.0001), CHF (OR 1.86, 95% CI, 1.85-1.86; P = 0.021) and, nonwhite race (OR 1.64, 95% CI, 1.63-1.64; P = 0.013). CONCLUSIONS: PVI in the infrapopliteal vessels for IC is associated with higher amputation rates. This observation may suggest the need for more careful patient selection when performing PVI in patients with IC where disease extends into the infrapopliteal level.

Predictors of Severity and Change in Emotion Dysregulation among Children and Adolescents with ASD.

OBJECTIVE: Emotion dysregulation problems are prevalent and disruptive for many with autism spectrum disorder (ASD). This study compared severity and perceived change in emotion dysregulation in youth with and without ASD and probed correlates of emotion dysregulation (including possible two-way interactions) among youth with ASD. METHOD: Participants were drawn from two large online samples (mean age = 12; range: 6-17) with (N = 1323) and without (N = 921) ASD. The study used the Emotion Dysregulation Inventory (EDI), a parent-report measure designed for youth with ASD. The EDI asks parents about current severity and perceived change (i.e. how current severity compares to lifetime severity) in emotion dysregulation, and includes two factors: Reactivity (rapidly escalating, intense negative affect) and Dysphoria (poorly upregulated positive affect, general unease). RESULTS: Results indicated that youth with ASD had greater Reactivity severity and also greater positive change in Reactivity than non-ASD peers. Furthermore, differences between youth with and without ASD in the relationship between Reactivity and Dysphoria suggest a distinct profile of emotion dysregulation in ASD. Within the ASD sample, age and severity of stereotyped behavior predicted Reactivity and Dysphoria severity and Reactivity change. Female gender, lower parent education, and fluent verbal ability were additional predictors of increased Reactivity severity, while intellectual disability predicted lower Dysphoria severity. CONCLUSIONS: This study provides new insight into predictors of emotion dysregulation in youth with ASD and represents a first step toward identifying which children with ASD may be most vulnerable to severe emotion dysregulation problems.

Effects of statin and antiplatelet therapy noncompliance and intolerance on patient outcomes following vascular surgery.

OBJECTIVE: Prior studies have evaluated the effects of statin and antiplatelet agent (APA) medications on patients with peripheral arterial disease. Although the benefits of statin and APA use are well-described, there is a paucity of research into the specific outcomes of patients who are not compliant or those who are unable to take the medication owing to intolerance. Here we examine the outcomes of patients intolerant to statin and APA and compare them with patients who are compliant or noncompliant with these therapies. METHODS: Patients treated from 2005 to 2018 in the Vascular Quality Initiative registry were included. Patients with missing data or deaths within 30 days of procedure were removed. Patients were considered noncompliant if they were previously prescribed a medication at discharge but were not taking it at 1-year follow-up or if the patient was reported to be noncompliant in the registry. Medication intolerance was defined if listed as "no, for medical reasons," and mortality data were ascertained using the Social Security Death Index, which is regularly cross-referenced to the Vascular Quality Initiative registry. RESULTS: We identified 105,628 patients who met our inclusion criteria. Statin intolerance was noted in 2.3% at discharge and 2.1% at the 1-year follow-up, with 0.7% listed as intolerant at all stages. Factors associated with increased risk of intolerance to statins included female gender (P = .001), discharge APA intolerance (P = .004), insurance status (non-U.S. insurance) (P < .001), discharge APA noncompliance (P = .019), and discharge angiotensin converting enzyme inhibitor noncompliance (P = .005). Patients who were compliant with statins showed a 91% survival at 5 years vs 87% survival in noncompliant patients and 87% in intolerant patients at 5 years (P < .001). Patients with statin intolerance have a similar survival curve as noncompliant patients across all registry cohorts. Noncompliance with statins was correlated with noncompliance with APA medications (R = 0.16, P < .001). Factors associated with increased risk of statin noncompliance included preoperative ambulatory status (requiring assistance) (P = .039), female sex (P < .001), peripheral vascular intervention (P < .001) or infrainguinal open bypass procedure surgery (P = .001), discharge status (to nursing home) (P = .006) and insurance (self-pay) (P < .001). CONCLUSIONS: Patients not taking statin and APA medications have a substantially decreased 5-year survival irrespective of the reason for not taking. Importantly, patients noted to be intolerant have a similar survival curve as noncompliant patients across all registry cohorts. Intolerant patients may benefit from attempts to alter statin dose, type (hydrophilic vs lipophilic), or from newer agents such as PCSK9 inhibitors.

Factors Associated with Amputation after Peripheral Vascular Intervention for Intermittent Claudication.

BACKGROUND: The natural history of intermittent claudication (IC) is that only 25% of patients will experience worsening of their claudication symptoms, and only approximately 1-3% will progress to major amputation. The impact of increasing use of endovascular therapies on the natural history of IC has not been well established. The purpose of this study is to evaluate the incidence and identify predictors of major and minor amputations after peripheral vascular intervention (PVI) for IC. METHODS: A retrospective cohort of patients treated for IC was derived from the national PVI Vascular Quality Initiative database evaluating both preoperative and intraoperative variables from 2003 to 2017. We examined rates of major or minor amputations after ipsilateral PVI for IC. Multivariable logistic regression models were created to identify predictors of amputation along with Kaplan-Meier (KM) plots to estimate amputation-free survival. RESULTS: We identified 11,887 PVI procedures for patients undergoing elective treatment for IC without a previous history of lower extremity PVI or bypass. Major and minor amputations occurred at a combined rate of 1.08% (n = 128). Minor amputations occurred in 0.56% (n = 67) of patients at 1 year, whereas major amputations were reported in 0.51% (n = 61) of cases. KM plots of amputation-free survival revealed that patients with preoperative ankle brachial indexes (ABIs) <0.2 or noncompressible ABIs (>1.3) had significantly higher rates of any amputation compared with subjects with ABIs between 0.20-0.49, 0.50-0.89, and 0.90-1.30 (log rank, <0.001). Multivariate analysis showed that patients with preoperative symptomatic congestive heart failure (CHF) (odds ratio [OR], 6.48; 95% confidence interval [95% CI], 2.43-17.20; P < 0.001), American Society of Anesthesiologists (ASA) class IV (OR, 9.34; 95% CI, 1.94-44.89; P = 0.005), and nonwhite race (OR, 3.32; 95% CI, 1.50-7.36; P = 0.003) had significant increase in risk of major amputation after PVI. Odds of major or minor amputation were increased when patients underwent only a tibial-level intervention (major: OR, 6.26; 95% CI, 1.50-26.10; P = 0.012 and minor: OR, 7.04; 95% CI, 1.02-8.51; P = 0.001). CONCLUSIONS: With relation to amputation, the natural history of IC does not appear to be impacted by PVI sicker patients with higher ASA or symptomatic CHF, and those with isolated tibial interventions are at higher risk for amputation, and we cannot determine if this is due to patient substrate, presentation, or the intervention itself. Importantly, there are key prognostic preoperative and intraoperative indicators that can assist the clinician with predicting patients who are at a higher risk of amputation.

Statin use improves limb salvage after intervention for peripheral arterial disease.

BACKGROUND: Statin use is recommended in all patients with peripheral arterial disease (PAD) owing to its morbidity and mortality benefits. However, the effect of statin use on limb salvage in patients with PAD after intervention is unclear. We examined the effect of statin use on limb salvage and survival among patients with PAD undergoing surgical or endovascular intervention. METHODS: A total of 488 patients with PAD were identified who underwent surgical (n = 297) or endovascular (n = 191) intervention between 2009 and 2010. Information was collected from electronic medical records and the Social Security Death Index. Predictors of ongoing statin use were identified first by univariate analysis and then via multivariable logistic regression. Survival and freedom from amputation were identified using Kaplan-Meier plots and adjusted hazard ratios by Cox regression. RESULTS: Of the 488 patients with PAD with intervention, 39% were non-whites, 44% were females, 41% received statins, 56% received antiplatelets, 26% received oral anticoagulants, 9% required a major amputation, and 11% died during follow-up of up to 88 months. Statin users were more often male (P = .03), white (P = .03), smokers (P < .01), and had higher comorbidities such as coronary artery disease (P < .01), hypertension (P < .01), and diabetes (P < .01). Antiplatelet use was not associated with limb salvage (P = .13), but did improve survival (P < .01). Dual antiplatelet therapy did not show any benefit over monotherapy for limb salvage (P = .4) or survival (P = .3). Statin use was associated with improved survival (P = .04), and improved limb salvage (hazard ratio, 0.3; 95% confidence interval, 0.1-0.7) after adjusting for severity of disease, traditional risk factors, and concurrent antiplatelet use. CONCLUSIONS: Statin use in patients with PAD with interventions was associated with improved limb salvage and survival. Despite existing guidelines, statin therapy was low in our PAD population, and efforts are ongoing to increase their use across the health care system.