Long-term patient-reported outcomes among patients undergoing revascularization vs medical therapy for intermittent claudication.

OBJECTIVE: Society for Vascular Surgery guidelines recommend revascularization for patients with intermittent claudication (IC) if it can improve patient function and quality of life. However, it is still unclear if patients with IC achieve a significant functional benefit from surgery compared with medical management alone. This study examines the relationship between IC treatment modality (operative vs nonoperative optimal medical management) and patient-reported outcomes for physical function (PROMIS-PF) and satisfaction in social roles and activities (PROMIS-SA). METHODS: We identified patients with IC who presented for index evaluation in a vascular surgery clinic at an academic medical center between 2016 and 2021. Patients were stratified based on whether they underwent a revascularization procedure during follow-up vs continued nonoperative management with medication and recommended exercise therapy. We used linear mixed-effect models to assess the relationship between treatment modality and PROMIS-PF, PROMIS-SA, and ankle-brachial index (ABI) over time, clustering among repeat patient observations. Models were adjusted for age, sex, diabetes, Charlson Comorbidity Index, Clinical Frailty Score, tobacco use, and index ABI. RESULTS: A total of 225 patients with IC were identified, of which 40% (n = 89) underwent revascularization procedures (42% bypass; 58% peripheral vascular intervention) and 60% (n = 136) continued nonoperative management. Patients were followed up to 6.9 years, with an average follow-up of 5.2 ± 1.6 years. Patients who underwent revascularization were more likely to be clinically frail (P = .03), have a lower index ABI (0.55 ± 0.24 vs 0.72 ± 0.28; P < .001), and lower baseline PROMIS-PF score (36.72 ± 8.2 vs 40.40 ± 6.73; P = .01). There were no differences in patient demographics or medications between treatment groups. Examining patient-reported outcome trends over time; there were no significant differences in PROMIS-PF between groups, trends over time, or group differences over time after adjusting for covariates (P = .07, P = .13, and P =.08, respectively). However, all patients with IC significantly increased their PROMIS-SA over time (adjusted P = .019), with patients managed nonoperatively more likely to have an improvement in PROMIS-SA over time than those who underwent revascularization (adjusted P = .045). CONCLUSIONS: Patient-reported outcomes associated with functional status and satisfaction in activities are similar for patients with IC for up to 7 years, irrespective of whether they undergo treatment with revascularization or continue nonoperative management. These findings support conservative long-term management for patients with IC.

Female patients have fewer limb amputations compared to male patients in the BEST-CLI trial.

OBJECTIVE: Female patients are less likely to be diagnosed with and treated for peripheral artery disease. When treated, there are also reported sex disparities in short- and long-term outcomes. We designed this study to compare outcomes after open and endovascular revascularization in the Best Endovascular vs best Surgical Therapy in patients with Critical Limb Ischemia (BEST-CLI) trial between females and males, and to examine outcomes of each revascularization type in an all-female cohort. METHODS: In a secondary analysis of cohorts 1 and 2 of the BEST-CLI Trial, patients with chronic limb-threatening ischemia (CLTI) undergoing open surgical bypass (with or without adequate conduit) and endovascular therapy were stratified by sex. In addition, in a female-only cohort, we evaluated differences in outcomes between treatment arm (combined all bypasses from cohorts 1 and 2 and compared with all endovascular treatment in cohorts 1 and 2). Outcomes included major amputation, reintervention, major adverse limb event (MALE, a composite of major amputation and reintervention), all-cause death, and composite outcome of MALE or all-cause death. Univariable and adjusted Cox regressions were used to assess outcome between males and females. Similar methods were used to assess differences in outcomes between treatment arm in females. RESULTS: Among 1830 patients, females were significantly underrepresented, comprising only 28% (n = 519) of the BEST-CLI cohort. Overall, the characteristics of females enrolled in the trial had some differences compared with males: females were more likely to have rest pain alone (72% vs 60%; P < .0001) and when presenting with an ischemic wound, were less likely to have a wound infection (38% vs 47%; P = .01). Females were less likely to have an adequate single-segment greater saphenous vein (SSGSV) available (82% vs 89%; P = .01). Controlled for baseline clinical factors, at 1 year, females had significantly lower rates of major limb amputation compared with males (hazard ratio [HR], 0.70; P = .023), which drove better amputation- and MALE-free survival rates. All-cause death at 1 year was not statistically different between sexes (11.8% vs 11.2%; P = .286). In the all-female cohort, results paralleled the overall trial; open surgical bypass (with any conduit) had significantly better outcomes compared with endovascular therapy. Specifically, among females undergoing endovascular therapy, the rate of major reintervention was particularly high compared with females undergoing open surgical bypass (24.8% vs 10.5%; P < .001). CONCLUSIONS: Despite being underrepresented in BEST-CLI, the primary results of the trial, namely, improved MALE-free survival with open surgical bypass with SSGSV, were mirrored in the all-female subset. Female patients enrolled in BEST-CLI had better amputation-free survival at 1 year compared with male patients. These findings suggest that in treating female patients with CLTI considered appropriate for both open and endovascular revascularization, surgical bypass with optimal conduit is the preferred treatment option and can potentially ameliorate poor limb preservation outcomes associated with sex.

Impact of Social Risk Screening on Discharge Care Processes and Postdischarge Outcomes: A Pragmatic Mixed-Methods Clinical Trial During the COVID-19 Pandemic.

BACKGROUND: Social risk screening during inpatient care is required in new CMS regulations, yet its impact on inpatient care and patient outcomes is unknown. OBJECTIVES: To evaluate whether implementing a social risk screening protocol improves discharge processes, patient-reported outcomes, and 30-day service use. RESEARCH DESIGN: Pragmatic mixed-methods clinical trial. SUBJECTS: Overall, 4130 patient discharges (2383 preimplementation and 1747 postimplementation) from general medicine and surgical services at a 528-bed academic medical center in the Intermountain United States and 15 attending physicians. MEASURES: Documented family interaction, late discharge, patient-reported readiness for hospital discharge and postdischarge coping difficulties, readmission and emergency department visits within 30 days postdischarge, and coded interviews with inpatient physicians. RESULTS: A multivariable segmented regression model indicated a 19% decrease per month in odds of family interaction following intervention implementation (OR=0.81, 95% CI=0.76-0.86, P<0.001), and an additional model found a 32% decrease in odds of being discharged after 2 pm (OR=0.68, 95% CI=0.53-0.87, P=0.003). There were no postimplementation changes in patient-reported discharge readiness, postdischarge coping difficulties, or 30-day hospital readmissions, or ED visits. Physicians expressed concerns about the appropriateness, acceptability, and feasibility of the structured social risk assessment. CONCLUSIONS: Conducted in the immediate post-COVID timeframe, reduction in family interaction, earlier discharge, and provider concerns with structured social risk assessments likely contributed to the lack of intervention impact on patient outcomes. To be effective, social risk screening will require patient/family and care team codesign its structure and processes, and allocation of resources to assist in addressing identified social risk needs.

Sex Differences in Patient-Reported Depression Following Vascular Surgery Procedures.

INTRODUCTION: Female patients frequently experience worse clinical outcomes than male patients after undergoing vascular surgery procedures. However, it is unclear whether these sex-based disparities also impact mental health outcomes. This study was designed to investigate sex differences in patient-reported outcome measures of depression for patients undergoing vascular surgery. METHODS: We retrospectively analyzed 107 patients (73 males and 34 females) who underwent vascular surgery procedures between January 2016 and April 2023. These patients completed a Patient-Reported Outcome Measurement Information System (PROMIS) Item Bank v1.0-Depression assessment 90 d before surgery and at least once after surgery. After stratifying patients by sex, we analyzed changes in PROMIS depression scores using a multiple mixed-effects linear regression model. Then, logistic regression was used to compare the proportion of patients who achieved a clinically meaningful difference in PROMIS depression score within 15 mo after surgery. RESULTS: There was no significant difference between female and male patients among rates of complications, length of hospital stay, or rates of nonhome discharge. However, female sex was associated with significantly improved PROMIS depression scores after surgery compared to male sex (P = 0.034). Furthermore, female patients were over 3-fold more likely than male patients to reach the minimal clinically important difference threshold for improvement in PROMIS depression scores (odds ratio 4.66, 95% confidence interval 1.39-15.61). CONCLUSIONS: These results suggest that female sex is associated with improved patient-reported measures of depression after undergoing vascular surgery. Clinicians should consider these mental health benefits when evaluating female patients for vascular interventions.

Use of Deep Learning to Identify Peripheral Arterial Disease Cases From Narrative Clinical Notes.

INTRODUCTION: Peripheral arterial disease (PAD) is the leading cause of amputation in the United States. Despite affecting 8.5 million Americans and more than 200 million people globally, there are significant gaps in awareness by both patients and providers. Ongoing efforts to raise PAD awareness among both the public and health-care professionals have not met widespread success. Thus, there is a need for alternative methods for identifying PAD patients. One potentially promising strategy leverages natural language processing (NLP) to digitally screen patients for PAD. Prior approaches have applied keyword search (KWS) to billing codes or unstructured clinical narratives to identify patients with PAD. However, KWS is limited by its lack of flexibility, the need for manual algorithm development, inconsistent validation, and an inherent failure to capture patients with undiagnosed PAD. Recent advances in deep learning (DL) allow modern NLP models to learn a conceptual representation of the verbiage associated with PAD. This capability may overcome the characteristic constraints of applying strict rule-based algorithms (i.e., searching for a disease-defining set of keywords or billing codes) to real-world clinical data. Herein, we investigate the use of DL to identify patients with PAD from unstructured notes in the electronic health record (EHR). METHODS: Using EHR data from a statewide health information exchange, we first created a dataset of all patients with diagnostic or procedural codes (International Classification of Diseases version 9 or 10 or Current Procedural Terminology) for PAD. This study population was then subdivided into training (70%) and testing (30%) cohorts. We based ground truth labels (PAD versus no PAD) on the presence of a primary diagnostic or procedural billing code for PAD at the encounter level. We implemented our KWS-based identification strategy using the currently published state-of-the-art algorithm for identifying PAD cases from unstructured EHR data. We developed a DL model using a BioMed-RoBERTa base that was fine-tuned on the training cohort. We compared the performance of the KWS algorithm to our DL model on a binary classification task (PAD versus no PAD). RESULTS: Our study included 484,363 encounters across 71,355 patients represented in 2,268,062 notes. For the task of correctly identifying PAD related notes in our testing set, the DL outperformed KWS on all model performance measures (Sens 0.70 versus 0.62; Spec 0.99 versus 0.94; PPV 0.82 versus 0.69; NPV 0.97 versus 0.96; Accuracy 0.96 versus 0.91; P value for all comparisons <0.001). CONCLUSIONS: Our findings suggest that DL outperforms KWS for identifying PAD cases from clinical narratives. Future planned work derived from this project will develop models to stage patients based on clinical scoring systems.

Increased Risk of Acute Aortic Events following COVID-19 and Influenza Respiratory Viral Infections.

BACKGROUND: Acute respiratory viral infections have been associated with an increased incidence of adverse cardiovascular events. However, it is unclear whether severe respiratory viral infections are associated with an increased risk of acute aortic syndromes (AAS). This study was designed to assess whether Coronavirus disease 2019 (COVID-19) and Influenza illnesses are associated with an increased incidence of subsequent AAS in the US population. METHODS: We used the MarketScan database (2011-2021) to identify patients 18-99 years of age without prior diagnosis of aortic pathology who were diagnosed with COVID-19 or Influenza. Identified patients were matched 1:1 by age and sex to control patients without COVID-19 or Influenza. The primary outcome was incidence of AAS (dissection, intramural hematoma, penetrating aortic ulcer, or aneurysm rupture) within 180-days of a viral infection. The association between infection and risk of developing an AAS was analyzed using multivariate Cox proportional hazards models. RESULTS: We identified 1,775,698 patients, including 779,229 (44%) with mild COVID-19, 42,141 (2%) with severe COVID-19, and 66,479 (4%) with Influenza that were matched to 887,849 (50%) control patients without COVID-19 or Influenza illnesses. A total of 164 patients experienced AAS within 6-months after diagnosis, which was highest among those after severe COVID-19. The predicted incidence of AAS was significantly higher among patients after severe COVID-19 (14.1 events/100,000 person-years), mild COVID-19 (13.3 events/100,000), and influenza (13.3 events/100,000) when compared to control patients (2.6 events/100,000). In risk-adjusted Cox regression models, severe COVID-19 (HR:5.4, 95% CI:2.8-10.4; P < 0.01), mild COVID-19 (HR:5.1, 95% CI:3.3-7.7; P < 0.01) and influenza (HR:5.1, 95% CI:2.6-9.7; P < 0.01) diagnoses were associated with a significantly increased risk of AAS within 180-days when compared to matched controls. CONCLUSIONS: There is an increased risk of developing acute aortic event in the months following illness with Influenza or COVID-19. These data highlight the need to closely monitor at-risk patients following a viral respiratory infection.

A transitional pain management program is associated with reduced opioid dependence after major shoulder surgery.

BACKGROUND: Overprescription of opioids in the United States increases risks of opioid dependence, overdose, and death. Increased perioperative and postoperative opioid use during orthopedic shoulder surgery is a significant risk factor for long-term opioid dependence. The authors hypothesized that a multidisciplinary perioperative pain management program (Transitional Pain Service [TPS]) for major shoulder surgery would lead to a reduced amount of opioids required postoperatively. METHODS: A TPS was implemented at a Veterans Affairs Medical Center focused on nonopioid pain management and cessation support. Opioid consumption during the implementation of the TPS was compared to a historical cohort. All patients undergoing total shoulder arthroplasty (TSA) or rotator cuff repair (RCR) were included. The primary outcome was the proportion of patients continuing opioid use at 90 days postoperatively. Secondary outcomes included postoperative pain scores, time to opioid cessation, and median opioid tablets consumed at 90 days. A multivariable model was developed to predict total opioid use at 90 days postoperatively. Kaplan-Meier curves were calculated for time to opioid cessation. RESULTS: The TPS group demonstrated decreased persistent opioid use at 90 days postdischarge (12.6% vs. 28.6%; P = .018). Independent predictors associated with increased total opioid tablet prescriptions at 90 days included length of stay (ß = 19.17), anxiety diagnosis (ß = 37.627), and number of tablets prescribed at discharge (ß = 1.353). TSA was associated with decreased 90-day opioid utilization (ß = -32.535) when compared to RCR. Median time to cessation was shorter in TSA (6 days) when compared with RCR (8 days). Pain scores were reduced compared with population mean by postdischarge day 2 for TSA and by postdischarge day 7 for RCR. Median number of postdischarge opioid tablets (oxycodone 5 mg) consumed under TPS management was 25 in both RCR and TSA surgery groups (180 morphine milligram equivalents). DISCUSSION AND CONCLUSIONS: This study demonstrates that a TPS reduces the amount of opioid use of patients undergoing shoulder arthroplasty or cuff repair at 90 days when compared with a historical control. Multivariable regression indicated that fewer opioid tablets at discharge was a modifiable factor that may aid in reducing opioid consumption and that anxiety diagnosis, increased length of stay, and cuff repair surgery were other factors independently associated with increased opioid consumption. These data will assist surgeons in counseling patients, setting narcotic use expectations, and minimizing overprescribing. Use of a similar multidisciplinary perioperative pain management program may greatly reduce opioid overprescriptions nationally.

Vascular Quality Initiative assessment of compliance with Society for Vascular Surgery clinical practice guidelines on the management of extracranial cerebrovascular disease.

OBJECTIVES: Compliance with Society for Vascular Surgery (SVS) clinical practice guidelines (CPGs) is associated with improved outcomes for the treatment of abdominal aortic aneurysm, but this has not been assessed for carotid artery disease. The Vascular Quality Initiative (VQI) registry was used to examine compliance with the SVS CPGs for the management of extracranial cerebrovascular disease and its impact on outcomes. METHODS: The 2021 SVS extracranial cerebrovascular disease CPGs were reviewed for evaluation by VQI data. Compliance rates by the center and provider were calculated, and the impact of compliance on outcomes was assessed using logistic regression with inverse probability-weighted risk adjustment for each CPG recommendation, allowing for clustering by the center. Our primary outcome was a composite end point of in-hospital stroke/death. As a secondary analysis, compliance with the 2021 SVS carotid implementation document recommendations and associated outcomes were also assessed. RESULTS: Of the 11 carotid CPG recommendations, 4 (36%) could be evaluated using VQI registry data. Median center-specific CPG compliance ranged from 38% to 95%, and median provider-specific compliance ranged from 36% to 100%. After adjustment, compliance with 2 of the recommendations was associated with lower rates of in-hospital stroke/death: first, the use of best medical therapy (antiplatelet and statin therapy) in low/standard surgical risk patients undergoing carotid endarterectomy for >70% asymptomatic stenosis (event rate in compliant vs noncompliant cases 0.59% vs 1.3%; adjusted odds ratio: 0.44, 95% confidence interval: 0.29-0.66); and second, carotid endarterectomy over transfemoral carotid artery stenting in low/standard surgical risk patients with >50% symptomatic stenosis (1.9% vs 3.4%; adjusted odds ratio: 0.55, 95% confidence interval: 0.43-0.71). Of the 132 implementation document recommendations, only 10 (7.6%) could be assessed using VQI data, with median center- and provider-specific compliance rates ranging from 67% to 100%. The impact of compliance on outcomes could only be assessed for 6 (4.5%) of these recommendations, and compliance with all 6 recommendations was associated with lower stroke/death. CONCLUSIONS: Few SVS recommendations could be assessed in the VQI because of incongruity between the recommendations and the VQI data variables collected. Although guideline compliance was extremely variable among VQI centers and providers, compliance with most of these recommendations was associated with improved outcomes after carotid revascularization. This finding confirms the value of guideline compliance, which should be encouraged for centers and providers. Optimization of VQI data to promote evaluation of guideline compliance and distribution of these findings to VQI centers and providers will help facilitate quality improvement efforts in the care of vascular patients.

The measurable impact of a diversity, equity, and inclusion editor on diversifying content, authorship, and peer review participation in the Journal of Vascular Surgery.

OBJECTIVE: Women and minorities remain under-represented in academic vascular surgery. This under-representation persists in the editorial peer review process which may contribute to publication bias. In 2020, the Journal of Vascular Surgery (JVS) addressed this by diversifying the editorial board and creating a new Editor of Diversity, Equity, and Inclusion (DEI). The impact of a DEI editor on modifying the output of JVS has not yet been examined. We sought to determine the measurable impact of a DEI editor on diversifying perspectives represented in the journal, and on contributing to changes in the presence of DEI subject matter across published journal content. METHODS: The authorship and content of published primary research articles, editorials, and special articles in JVS were examined from November 2019 through July 2022. Publications were examined for the year prior to initiation of the DEI Editor (pre), the year following (post), and from September 2021 to July 2022, accounting for the average 47-week time period from submission to publication in JVS (lag). Presence of DEI topics and women authorship were compared using χ2 tests. RESULTS: During the period examined, the number of editorials, guidelines, and other special articles dedicated to DEI topics in the vascular surgery workforce or patient population increased from 0 in the year prior to 4 (16.7%) in the 11-month lag period. The number of editorials, guidelines, and other special articles with women as first or senior authors nearly doubled (24% pre, 44.4% lag; P = .31). Invited commentaries and discussions were increasingly written by women as the study period progressed (18.7% pre, 25.9% post, 42.6% lag; P = .007). The number of primary research articles dedicated to DEI topics increased (5.6% pre, 3.3% post, 8.1% lag; P = .007). Primary research articles written on DEI topics were more likely to have women first or senior authors than non-DEI specific primary research articles (68.0% of all DEI vs 37.5% of a random sampling of non-DEI primary research articles; P < .001). The proportion of distinguished peer reviewers increased (from 2.8% in 2020 to 21.9% in 2021; P < .001). CONCLUSIONS: The addition of a DEI editor to JVS significantly impacted the diversification of topics, authorship of editorials, special articles, and invited commentaries, as well as peer review participation. Ongoing efforts are needed to diversify subject matter and perspective in the vascular surgery literature and decrease publication bias.

High-intensity statin therapy reduces risk of amputation and reintervention among patients undergoing lower extremity bypass for chronic limb-threatening ischemia.

OBJECTIVE: Statins are considered standard-of-care medical therapy for patients undergoing lower extremity bypass (LEB) procedures for chronic limb-threatening ischemia (CLTI). It is unclear, however, whether up-titrating and maintaining patients on higher-intensity statin medications following LEB improves limb salvage outcomes. This study was designed to evaluate whether high-intensity statin therapy impacts the risk of amputation and reintervention following LEB for patients with CLTI. METHODS: The IBM MarketScan database was used to identify adult patients (18-99 years old) who underwent a LEB for CLTI between 2008 and 2017. Patients lacking insurance covering drug reimbursement or those who already had undergone amputation before time of bypass were excluded. Using pharmacy claims and national drug codes to define statin intensity, patients were stratified into three groups: high-intensity, low-intensity, and limited statin therapy. The association between intensity of statin therapy and need for reintervention and/or major amputation after LEB was analyzed using Kaplan-Meier curves and risk-adjusted Cox proportional hazard models. RESULTS: A total of 25,907 patients who underwent LEB for CLTI were identified, of which 6696 (26%) were maintained on high-dose statins, 9297 (36%) were on low-dose statins, and 9914 (38%) had inconsistent pharmacy claims for statin therapy after surgery. Patients on high-intensity statins were, on average, younger and more likely to be male with comorbid disease (diabetes, hypertension, hyperlipidemia, obesity, renal insufficiency, ischemic heart disease, cerebrovascular disease, and tobacco abuse) than patients on low-intensity statins or limited statin therapy (P < .001 for all comparisons). Following LEB, 6649 patients (25.6%) required a reintervention, and 2550 patients (9.8%) went on to have a major amputation during follow-up. Patients maintained on high-intensity statins after LEB had a significantly lower likelihood of requiring a reintervention (hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.45-0.51; P < .001) or amputation (HR, 0.27; 95% CI, 0.24-0.30; P < .001) as compared with patients on limited statin therapy. Further, there was a dose-dependent effect for these outcomes relative to patients on low-intensity statins in risk-adjusted models, and it was independent of whether an autologous vein graft was used for the LEB. Finally, among patients who underwent a reintervention, high-dose statin therapy also significantly reduced the HR for subsequent amputation (HR, 0.21; 95% CI, 0.18-0.25; P < .001). CONCLUSIONS: Patients with CLTI on high-intensity therapy following LEB had a significantly lower risk of requiring subsequent reintervention and amputation when compared with patients on low-intensity statins or with limited statin use. These data suggest that patients with CLTI should be up-titrated and/or maintained on high-intensity statins following revascularization whenever possible.

Impact of frailty on risk of long-term functional decline following vascular surgery.

OBJECTIVE: Frailty is a clinical syndrome associated with slow recovery after vascular surgery. However, the degree and length of functional impairment frail patients experience after surgery is unclear. The objective of this study was to prospectively measure changes in functional status among frail and non-frail patients undergoing a spectrum of different vascular surgery procedures. METHODS: Patients consented to undergo elective minor and major vascular surgery procedures at an academic medical center between May 2018 and March 2019 were prospectively identified. Prior to surgery, all patients underwent provider assessment of frailty using the validated Clinical Frailty Scale (CFS), as well as baseline assessment of functional status using the Katz Activities of Daily Living (ADL) index and the Lawton Instrumental Activities of Daily Living (iADL) index. These same instruments were used to evaluate each patient's functional status at 2-weeks, 1-month, 1-year, and 2-year time points following surgery. Changes in iADL and ADL scores among frail (CFS ≥5) and non-frail patients were compared using paired Wilcoxon signed-rank tests and logistic regression models. RESULTS: A total of 126 patients were assessed before and after minor (55%) and major (45%) vascular procedures, of which 43 patients (34%) were determined to be frail prior to surgery. Frail patients were older and more likely than non-frail patients to have medical comorbidities including chronic kidney disease, chronic obstructive pulmonary disease, or diabetes (all P < .05). When compared with the non-frail cohort, frail patients had significantly lower ADL and iADL scores before surgery and experienced a greater decline in ability to independently complete ADL and iADL activities after surgery that was sustained at 2 years (P < .05 and P < .001, respectively). After risk-adjustment, frailty was associated with an increased likelihood of decline in ADLs (odds ratio, 5.4; 95% confidence interval, 1.9-15.4; P < .05) and iADLs (odds ratio, 6.3; 95% confidence interval, 2.6-15.1; P < .001) at 2 years following surgery. CONCLUSIONS: Frail patients experience a significant decline in ability to perform ADL and iADLs that persists 2 years following vascular surgery. These data highlight the degree of functional decline occurring immediately following surgery, as well as risk for long-term, sustained impairment that should be shared with frail patients before undergoing a procedure.

The Association Between Family History and Diverticulitis Recurrence: A Population-Based Study.

BACKGROUND: After initial nonoperative management of diverticulitis, individuals with a family history of diverticulitis may have increased risk of recurrent disease. OBJECTIVE: This study measured the association between family history and recurrent diverticulitis in a population-based cohort. DESIGN: This is a retrospective, population-based cohort study. SETTINGS: The cohort was identified from the Utah Population Database, a statewide resource linking hospital and genealogy records. PATIENTS: Individuals evaluated in an emergency department or hospitalized between 1998 and 2018 for nonoperatively managed diverticulitis were included. INTERVENTION: The primary predictor was a positive family history of diverticulitis, defined as diverticulitis in a first-, second-, or third-degree relative. MAIN OUTCOME MEASURES: This study measured the adjusted association between family history and the primary outcome of recurrent diverticulitis. A secondary outcome was elective surgery for diverticulitis. Additional analyses evaluated risk by degree of relation of the affected family member. RESULTS: The cohort included 4426 individuals followed for a median of 71 months. Median age was 64 years and 45% were male; 17% had complicated disease, 11% had recurrence, and 15% underwent elective surgery. After adjustment, individuals with a family history of diverticulitis had a similar risk of recurrence when compared to those without a family history (HR 1.0; 95% CI 0.8-1.2). However, individuals with a family history of diverticulitis were more likely to undergo elective surgery (HR 1.4; 95% CI 1.1-1.6). This effect was most pronounced in those with an affected first-degree family member (HR 1.7; 95% CI 1.4-2.2). LIMITATIONS: The use of state-specific data may limit generalizability. CONCLUSIONS: In this population-based analysis, individuals with a family history of diverticulitis were more likely to undergo elective surgery than those without a family history, despite similar risks of recurrence and complicated diverticulitis. Further work is necessary to understand the complex social, environmental, and genetic factors that influence diverticulitis treatment and outcomes. See Video Abstract at http://links.lww.com/DCR/B876 . ASOCIACIN ENTRE LOS ANTECEDENTES FAMILIARES Y LA RECURRENCIA DE LA DIVERTICULITIS UN ESTUDIO POBLACIONAL: ANTECEDENTES:Después del tratamiento inicial no quirúrgico de la diverticulitis, las personas con antecedentes familiares de diverticulitis pueden tener un mayor riesgo de enfermedad recurrente.OBJETIVO:Este estudio midió la asociación entre antecedentes familiares y diverticulitis recurrente en una cohorte poblacional.DISEÑO:Este es un estudio de cohorte retrospectivo de la población.ENTORNO CLÍNICO:La cohorte se identificó a partir de la Base de datos de población de Utah, un recurso estatal que vincula los registros hospitalarios y genealógicos.PACIENTES:Se incluyeron individuos evaluados en un departamento de emergencias u hospitalizados entre 1998 y 2018 por diverticulitis manejada de forma no quirúrgica.INTERVENCIÓN:El predictor principal fue un historial familiar positivo de diverticulitis, definida como diverticulitis en un familiar de primer, segundo o tercer grado.PRINCIPALES MEDIDAS DE VALORACIÓN:Este estudio midió la asociación ajustada entre los antecedentes familiares y el resultado primario de diverticulitis recurrente. Un resultado secundario fue la cirugía electiva por diverticulitis. Análisis adicionales evaluaron el riesgo por grado de parentesco del familiar afectado.RESULTADOS:La cohorte incluyó a 4.426 individuos seguidos durante una mediana de 71 meses. La mediana de edad fue de 64 años y el 45% eran varones. El 17% tenía enfermedad complicada, el 11% recidiva y el 15% se sometió a cirugía electiva. Después del ajuste, los individuos con antecedentes familiares de diverticulitis tenían un riesgo similar de recurrencia en comparación con aquellos sin antecedentes familiares (HR 1,0; IC del 95%: 0,8-1,2). Sin embargo, las personas con antecedentes familiares de diverticulitis tenían más probabilidades de someterse a una cirugía electiva (HR 1,4; IC del 95%: 1,1-1,6). Este efecto fue más pronunciado en aquellos con un familiar de primer grado afectado (HR 1,7; IC del 95%: 1,4-2,2).LIMITACIONES:El uso de datos específicos del estado puede limitar la generalización.CONCLUSIONES:En este análisis poblacional, los individuos con antecedentes familiares de diverticulitis tenían más probabilidades de someterse a una cirugía electiva que aquellos sin antecedentes familiares, a pesar de riesgos similares de recurrencia y diverticulitis complicada. Es necesario seguir trabajando para comprender los complejos factores sociales, ambientales y genéticos que influyen en el tratamiento y los resultados de la diverticulitis. Consulte Video Resumen en http://links.lww.com/DCR/B876 . (Traducción-Dr. Ingrid Melo ).

Exogenous Testosterone Replacement Therapy Is Associated with Increased Risk for Vascular Graft Infections Among Hypogonadal Men.

BACKGROUND: Vascular graft infections (VGIs) are a major source of morbidity following vascular bypass surgery. Hypogonadal men may be at increased risk for impaired wound healing and infections, but it is unclear if testosterone replacement therapy (TRT) mitigates this risk. We designed this study to evaluate the relationship between hypogonadism and the use of testosterone replacement therapy (TRT) with subsequent risk for developing a VGI. METHODS: We performed a retrospective analysis of claims in the MarketScan database identifying men greater than 18 years of age who underwent placement of a prosthetic graft in the peripheral arterial circulation from January 2009 to December 2020. Patients were stratified based on diagnosis of hypogonadism and use of TRT within 180 days before surgery. The primary outcome was VGI and the need for surgical excision. The association between hypogonadism and TRT use on risk of VGI was analyzed using Kaplan-Meier plots and multivariate Cox proportional hazards models. RESULTS: We identified 18,312 men who underwent a prosthetic bypass graft procedure in the upper and lower extremity during the study period, of which 802 (5%) had diagnosis of hypogonadism. Among men with hypogonadism, 251 (31%) were receiving TRT. Patients on TRT were younger, more likely to be diabetic, and more likely develop a VGI during follow-up (14% vs. 8%; P < 0.001) that was in the lower extremity. At 5 years, freedom from VGI was significantly lower for hypogonadal men on TRT than patients not on TRT or without hypogonadism (Log rank P < 0.001). In Cox regression models adjusted for age, diabetes, obesity, smoking, corticosteroid use, and procedure type, hypogonadal men on TRT were at a significantly increased risk of graft infection (hazard ratio (HR):1.94, 95% confidence interval (CI):1.4-2.7; P < 0.001) compared to controls. CONCLUSIONS: This study demonstrates TRT among hypogonadal men is associated with an increased risk of prosthetic VGIs. Temporary cessation of TRT should be considered for men undergoing prosthetic graft implants, particularly those in the lower extremity.

Predictors of Arteriovenous Fistula Maturation among Patients with Severe Obesity.

BACKGROUND: There is an increasing prevalence of obesity among patients who develop end-stage renal disease and require dialysis. While referrals for arteriovenous fistulas (AVFs) among patients with class 2-3 obesity (i.e., body mass index [BMI] ≥ 35) are increasing, it is unclear what type of autogenous access is most likely to mature in this patient population. This study was designed to evaluate factors that impact maturation of AVF among patients with class ≥2 obesity. METHODS: We retrospectively reviewed AVFs created at a single center from 2016 to 2019 for patients who had undergone dialysis within the same healthcare system. Ultrasound studies were used to evaluate factors that defined functional maturation, including diameter, depth, and volume flow rates through the fistula. Logistic regression models were used to evaluate the risk-adjusted association between class ≥2 obesity and functional maturation. RESULTS: A total of 202 AVFs [radiocephalic (24%), brachiocephalic (43%), and transposed brachiobasilic (33%)] were created during the study period, of which 53 (26%) patients had a BMI >35. Functional maturation was significantly lower among patients with class ≥2 obesity undergoing brachiocephalic (58% obese versus 82% normal-overweight; P = 0.017), but not radiocephalic or brachiobasilic AVFs. This was primarily a result of excessive AVF depth in severely obese patients (9.6 ± 4.0 mm obese versus 6.0 ± 2.7 mm normal-overweight; P < 0.001), whereas there was no significant difference found in average volume flow or AVF diameter between groups. In risk-adjusted models, a BMI ≥35 was associated with a significantly lower likelihood of achieving AVF functional maturation (odds ratio: 0.38; 95% confidence interval: 0.18-0.78; P = 0.009) after controlling for age, sex, socioeconomic status, and fistula type. CONCLUSIONS: Patients with a BMI >35 are less likely to mature AVFs after creation. This principally affects brachiocephalic AVFs and occurs because of increased fistula depth as opposed to diameter or volume flow parameters. These data can help guide decision-making when planning AVF placement in severely obese patients.

Hospital Costs Following Surgical Complications: A Value-driven Outcomes Analysis of Cost Savings Due to Complication Prevention.

OBJECTIVE: Surgical complications have substantial impact on healthcare costs. We propose an analysis of the financial impact of postoperative complications. SUMMARY OF BACKGROUND DATA: Both complications and preoperative patient risk have been shown to increase costs following surgery. The extent of cost increase due to specific complications has not been well described. METHODS: A single institution's American College of Surgeons National Surgical Quality Improvement Program data was queried from 2012 to 2018 and merged with institutional cost data for each encounter. A mixed effects multivariable generalized linear model was used to estimate the mean relative increase in hospital cost due to each complication, adjusting for patient and procedure-level fixed effects clustered by procedure. Potential savings were calculated based on projected decreases in complication rates and theoretical hospital volume. RESULTS: There were 11,897 patients linked between the 2 databases. The rate of any American College of Surgeons National Surgical Quality Improvement Program complication was 11.7%. The occurrence of any complication resulted in a 1.5-fold mean increase in direct hospital cost [95% confidence interval (CI) 1.49-1.58]. The top 6 most costly complications were postoperative septic shock (4.0-fold, 95% CI 3.58-4.43) renal insufficiency/failure (3.3-fold, 95% CI 2.91-3.65), any respiratory complication (3.1-fold, 95% CI 2.94-3.36), cardiac arrest (3.0-fold, 95% CI 2.64-3.46), myocardial infarction (2.9-fold, 95% CI 2.43-3.42) and mortality within 30 days (2.2-fold, 95% CI 2.01-2.48). Length of stay (6.5 versus 3.2 days, P < 0.01), readmission rate (29.1% vs 3.1%, P < 0.01), and discharge destination outside of home (20.5% vs 2.7%, P < 0.01) were significantly higher in the population who experienced complications. CONCLUSIONS: Decreasing complication rates through preoperative optimization will improve patient outcomes and lead to substantial cost savings.

Comparison of Patient Outcomes Among Integrated Residency Versus Fellowship-trained Vascular Surgeons.

OBJECTIVE: This study aims to evaluate whether graduates of integrated vascular surgery residency (IVSR) programs achieve similar surgical outcomes in clinical practice as compared to graduates of vascular surgery fellowships (VSF). SUMMARY OF BACKGROUND DATA: Early sub-specialization through IVSR programs decreases the total years of surgical training. However, it is unclear whether IVSR graduates achieve comparable outcomes to fellowship-trained surgeons once in clinical practice. METHODS: We identified all vascular surgeons who finished IVSR and VSF programs between 2013-2017 using American Board of Surgery data, which was linked to the Vascular Quality Initiative registry (2013-2019) to evaluate provider-specific clinical outcomes following carotid, lower extremity, and aortic aneurysm repair procedures. The association between training models and the composite outcome of 1-year mortality, major adverse cardiac events and/or other major complications were analyzed using mixed-effects logistic regression models. RESULTS: A total of 338 surgeons (31% IVSR, 69% VSF) submitted cases into the Vascular Quality Initiative registry, including 8155 carotid, 21,428 lower extremity, and 5800 aortic aneurysm repair procedures. Composite 1-year outcome rates were comparable between IVSR and VSF-trained surgeons following carotid endarterectomy (8%-IVSR vs 7%-VSF), lower extremity revascularization (19%-IVSR vs 16%-VSF), and aortic aneurysm repair (13%-IVSR vs 13%-VSF) procedures. These findings among IVSR-trained surgeons persisted following risk adjustment for severity of patient disease and indications for undertaking carotid [aOR: 1.04 (0.84-1.28)], lower extremity [aOR: 1.03 (0.84-1.26)], and aortic [aOR: 0.96 (0.76-1.21)] procedures when compared to VSF-trained surgeons. CONCLUSIONS: Despite fewer total years of training, graduates of IVSR programs achieve equivalent surgical outcomes as fellowship-trained vascular surgeons once in practice. These results suggest that concerns about differential competence among integrated residency graduates are not warranted.

Patient-reported physical function as a preoperative predictor of recovery after vascular surgery.

OBJECTIVE: Preoperative risk assessment in vascular surgery often relies on the clinical subjectivity of providers and assessment tools with poor discrimination. Patient-reported outcome measures (PROMs) may provide a more objective assessment of an individual's own health status before surgery and ability to recover after a vascular procedure. We designed this study to determine whether PROMs assessed for physical function (PROM-PF) prior to vascular surgery could be used to predict patient risk for postoperative complications and delayed recovery. METHODS: We identified all patients who completed a PROM-PF survey prior to undergoing a vascular surgery procedure captured in the Society for Vascular Surgery-Vascular Quality Initiative registry (carotid endarterectomy, abdominal aortic aneurysm, endovascular aneurysm repair, thoracic endovascular aneurysm repair, peripheral vascular intervention, infra-inguinal bypass, and supra-inguinal bypass) at a single academic institution between January 2016 and June 2020. PROM-PF assessment was obtained electronically using the validated Patient-Reported Outcome Measurement Information System short form (v1.2) instrument. All patient demographics and comorbidities were collected as part of the Society for Vascular Surgery-Vascular Quality Initiative registry. After stratifying patients based on high vs low preoperative PROM-PF, multivariable regression models were used to assess the risk-adjusted odds ratios (ORs) for perioperative complications, extended hospital length of stay (LOS), and discharge to a care facility. RESULTS: A total of 240 patients (mean age, 68 years; 69% male; and 88% Caucasian) completed a PROM-PF assessment <30 days before a vascular surgery intervention, of which 54% had low PF. Patients with high PF were more likely than those with low PF to undergo an open vascular procedure (43% high PF vs 42% low PF; P < .001). Rates of perioperative complications and/or mortality were similar between groups, although patients with low-PF were more likely to have an extended hospital LOS (48% low PF vs 33% high PF; P < .05) and/or be discharged to a care facility (17% low PF vs 7% high PF; P < .05). These results were confirmed in risk-adjusted models showing that patients with low PF scores were significantly more likely to have an extended LOS (adjusted OR, 1.86; 95% confidence interval, 1.06-3.28) and be discharged to a care facility (adjusted OR, 2.72; 95% confidence interval, 1.06-7.00). CONCLUSIONS: Low preoperative PROM-PF was associated with a higher risk of extended inpatient LOS and discharge to a care facility following vascular surgery. PROMs allow patients to provide valuable presurgical information about their own health status that can be used to anticipate postoperative recovery.

Rules of 6 criteria predict dialysis fistula maturation but not all rules are equal.

OBJECTIVE: The Rules of 6 (flow volume >600 mL/min, vein diameter >6 mm, vein depth <6 mm) are widely used to determine when an arteriovenous fistula (AVF) will support dialysis. Thus, we tested the utility of the Rules of 6 in clinical practice. METHODS: We retrospectively reviewed AVFs created at a single center from 2016 to 2019 for patients who had undergone dialysis within the same healthcare system. Clinical records and postoperative ultrasound studies were reviewed for the Rules of 6 criteria. Maturation was defined as use of the AVF with two needles for 75% of the dialysis sessions for a continuous 4-week period, with a mean flow of 300 mL/min or urea clearance (Kt/V) of 1.2. Predictors of maturation were assessed using logistic regression and receiver operating characteristic (ROC) curves. RESULTS: Five surgeons performed 202 AVFs of three types during 2016 to 2019 (radial-cephalic, n = 49; brachial-cephalic, n = 87; brachial-basilic, n = 66). Maturation occurred in 150 AVFs (74%; primary, n = 101 [50%]; assisted, n = 49 [24%]), while 52 (26%) failed to mature. Maturation did not vary by AVF type or patient sex or diabetes status. A higher body mass index was associated with failure to mature (P = .004). Only 16 mature AVFs (11%) met all three Rules of 6 using mean values for flow, diameter, and depth. However, 101 (67%) met all three Rules using the extreme, maximum or minimum, values. On multivariate analysis, each Rule of 6 was independently associated with maturation. If all three Rules were met, the AVF was nearly 10-fold more likely to have matured compared with an AVF satisfying no Rule. The body mass index correlated strongly with the vein depth (P < .001); however, both characteristics independently predicted maturation. The chance of maturation was highest if flow and depth Rules were met (positive predictive value [PPV], 93%); if all three rules were met, the PPV was 92%. The ROC area under curve (AUC) values for meeting flow volume and vein depth Rules together were higher than if all three Rules had been satisfied (0.784 vs 0.754). The PPV for diameter alone (78%) was the lowest of all PPVs for the three Rules and the ROC-AUC was only 0.588. If all three Rules together were not satisfied using extreme values, the negative predictive value was only 47%. CONCLUSIONS: The Rules of 6 predict AVF maturation, especially when using extreme, maximum or minimum, values to satisfy each Rule. Flow volume and vein depth together predict maturation equally as well as meeting all three Rules. Vein diameter seems less important. The Rules of 6 might be too stringent if used exclusively to predict for functional AVF maturation.

Expert consensus on the conceptual alignment of Accreditation Council for Graduate Medical Education competencies with patient outcomes after common vascular surgical procedures.

BACKGROUND: The quality and effectiveness of vascular surgery education should be evaluated based on patient care outcomes. To investigate predictive associations between trainee performance and subsequent patient outcomes, a critical first step is to determine the conceptual alignment of educational competencies with clinical outcomes in practice. We sought to generate expert consensus on the conceptual alignment of the Accreditation Council for Graduate Medical Education (ACGME) Vascular Surgery subcompetencies with patient care outcomes across different Vascular Quality Initiative (VQI) registries. METHODS: A national panel of vascular surgeons with expertise in both clinical care and education were recruited to participate in a modified Delphi expert consensus building process to map ACGME Vascular Surgery subcompetencies (educational markers of resident performance) to VQI clinical modules (patient outcomes). A master list of items for rating was created, including the 31 ACGME Vascular Surgery subcompetencies and 8 VQI clinical registries (endovascular abdominal aortic aneurysm repair, open abdominal aortic aneurysm, thoracic endovascular aortic repair, carotid endarterectomy, carotid artery stent, infrainguinal, suprainguinal, and peripheral vascular intervention). These items were entered into an iterative Delphi process. Positive consensus was reached when 75% or more of the participants ranked an item as mandatory. Intraclass correlations (ICCs) were used to evaluate consistency between experts for each Delphi round. RESULTS: A total of 13 experts who contributed to the development of the Vascular Surgery Milestones participated; 12 experts (92%) participated in both rounds of the Delphi process. Two rounds of Delphi were conducted, as suggested by excellent expert agreement (round 1, ICC = 0.79 [95% confidence interval, 0.74-0.84]; round 2, ICC = 0.97 [95% confidence interval, 0.960-.98]). Using the predetermined consensus cutoff threshold, the Delphi process reduced the number of subcompetencies mapped to patient care outcomes from 31 to a range of 9 to 15 across the 8 VQI clinical registries. Practice-based learning and improvement, and professionalism subcompetencies were identified as less relevant to patient outcome variables captured by the VQI registries after the final round, and the only the systems-based practice subcompetency that was identified as relevant was radiation safety in two of the endovascular registries. CONCLUSIONS: A national panel of vascular surgeon experts reported a high degree of agreement on the relevance of ACGME subcompetencies to patient care outcomes as captured in the VQI clinical registry. Systems-based practice, practice-based learning and improvement, and professionalism competencies were identified as less relevant to patient outcomes after specific surgical procedures.

A Vascular Quality Initiative frailty assessment predicts postdischarge mortality in patients undergoing arterial reconstruction.

BACKGROUND: Frailty assessment adds important prognostic information during preoperative decision-making but can be cumbersome to implement into routine clinical care. We developed and tested an abbreviated method of frailty assessment using variables routinely collected by the Vascular Quality Initiative (VQI) registry. METHODS: An abbreviated frailty score (the simple Vascular Quality Initiative-Frailty Score [VQI-FS]) was developed using 11 or fewer VQI variables (hypertension, congestive heart failure, coronary artery disease, peripheral vascular disease, diabetes, chronic obstructive pulmonary disease, renal impairment, anemia, underweight, nonhome residence, and nonambulatory status) that map to recognized frailty domains in the Comprehensive Geriatric Assessment and the literature. Nonemergent cases registered in the VQI from 2010 to 2017 (n = 265,632) in seven registries (carotid endarterectomy, n = 77,111; carotid artery stenting, n = 13,215; endovascular abdominal aortic aneurysm repair, n = 29,607; open abdominal aortic aneurysm repair, n = 7442; infrainguinal bypass, n = 33,128; suprainguinal bypass, n = 10,661; and peripheral vascular intervention, n = 94,468) were analyzed using logistic regression models to determine the predictive power of the VQI-FS for perioperative and longer term (9-month) mortality. Nomograms were created using weighted regression coefficients to assist in individualized frailty assessment and estimation of 9-month mortality. RESULTS: The VQI-FS, using equal weighting of these 11 VQI variables, effectively predicted 9-month mortality with an area under the curve of 0.724 by receiver operating characteristic curve analysis. However, differential weighting of the variables allowed simplification of the model to only seven variables (congestive heart failure, renal impairment, chronic obstructive pulmonary disease, not living at home, not ambulatory, anemia, and underweight status); hypertension, coronary artery disease, peripheral vascular disease, and diabetes had relatively low predictive power. Adding procedure-specific risk further improved performance of the model with a final area under the curve on receiver operating characteristic curve analysis of 0.758. Model calibration was excellent with predicted/observed regression line slope of 0.991 and intercept of 5.449e-04. CONCLUSIONS: A differentially weighted abbreviated VQI-FS using seven variables in addition to procedure-specific risk has strong correlation with 9-month mortality. Nomograms incorporating patient- and procedure-adjusted risk can effectively predict 9-month mortality. Reliable estimates of longer term mortality should assist in preoperative decision-making for vascular procedures that often carry substantial risk of mortality.