Percutaneous thrombectomy for acute limb ischemia is associated with equivalent limb and mortality outcomes compared with open thrombectomy.

BACKGROUND: Acute limb ischemia (ALI) carries a 15% to 20% risk of combined death or amputation at 30 days and 50% to 60% at 1 year. Percutaneous mechanical thrombectomy (PT) is an emerging minimally invasive alternative to open thrombectomy (OT). However, ALI thrombectomy cases are omitted from most quality databases, limiting comparisons of limb and survival outcomes between PT and OT. Therefore, our aim was to compare in-hospital outcomes between PT and OT using the National Inpatient Sample. METHODS: We analyzed survey-weighted National Inpatient Sample data (2015-2020) to include emergent admissions of aged adults (50+ years) with a primary diagnosis of lower extremity ALI undergoing index procedures within 2 days of hospitalization. We excluded hospitalizations with concurrent trauma or dissection diagnoses and index procedures using catheter-directed thrombolysis. Our primary outcome was composite in-hospital major amputation or death. Secondary outcomes included in-hospital major amputation, death, in-hospital reintervention (including angioplasty/stent, thrombolysis, PT, OT, or bypass), and extended length of stay (eLOS; defined as LOS >75th percentile). Adjusted odds ratios (aORs) with 95% confidence intervals (95% CIs) were generated by multivariable logistic regression, adjusting for demographics, frailty (Risk Analysis Index), secondary diagnoses including atrial fibrillation and peripheral artery disease, hospital characteristics, and index procedure data including the anatomic thrombectomy level and fasciotomy. A priori subgroup analyses were performed using interaction terms. RESULTS: We included 23,795 survey-weighted ALI hospitalizations (mean age: 72.2 years, 50.4% female, 79.2% White, and 22.3% frail), with 7335 (30.8%) undergoing PT. Hospitalization characteristics for PT vs OT differed by atrial fibrillation (28.7% vs 36.5%, P < .0001), frequency of intervention at the femoropopliteal level (86.2% vs 88.8%, P = .009), and fasciotomy (4.8% vs 6.9%, P = .006). In total, 2530 (10.6%) underwent major amputation or died. Unadjusted (10.1% vs 10.9%, P = .43) and adjusted (aOR = 0.96 [95% CI, 0.77-1.20], P = .74) risk did not differ between the groups. PT was associated with increased odds of reintervention (aOR = 2.10 [95% CI, 1.72-2.56], P < .0001) when compared with OT, but this was not seen in the tibial subgroup (aOR = 1.31 [95% CI, 0.86-2.01], P = .21, Pinteraction < .0001). Further, 79.1% of PT hospitalizations undergoing reintervention were salvaged with endovascular therapy. Lastly, PT was associated with significantly decreased odds of eLOS (aOR = 0.80 [95% CI, 0.69-0.94], P = .005). CONCLUSIONS: PT was associated with comparable in-hospital limb salvage and mortality rates compared with OT. Despite an increased risk of reintervention, most PT reinterventions avoided open surgery, and PT was associated with a decreased risk of eLOS. Thus, PT may be an appropriate alternative to OT in appropriately selected patients.

The association between frailty and outcomes following ruptured abdominal aortic aneurysm repair.

OBJECTIVE: Endovascular aortic repair (EVAR) is a less invasive method than the more physiologically stressful open surgical repair (OSR) for patients with anatomically appropriate abdominal aortic aneurysms (AAAs). Early postoperative outcomes are associated with both patients; physiologic reserve and the physiologic stresses of the surgical intervention. Among frail patients with reduced physiologic reserve, the stress of an aortic rupture in combination with the stress of an operative repair are less well tolerated, raising the risk of complications and mortality. This study aims to evaluate the difference in association between frailty and outcomes among patients undergoing minimally invasive EVAR and the physiologically more stressful OSR for ruptured AAAs (rAAAs). METHODS: Our retrospective cohort study included adults undergoing rAAA repair in the Vascular Quality Initiative from 2010 to 2022. The validated Risk Analysis Index (RAI) (robust, ≤20; normal, 21-29; frail, 30-39; very frail, ≥40) quantified frailty. The association between the primary outcome of 1-year mortality and frailty status as well as repair type were compared using multivariable Cox models generating adjusted hazard ratios (aHRs) with 95% confidence intervals (CIs). Interaction terms evaluated the association's moderation. RESULTS: We identified 5806 patients (age, 72 ± 9 years; 77% male; EVAR, 65%; robust, 6%; normal, 48%; frail, 36%; very, frail 10%) with a 53% observed 1-year mortality rate following rAAA repair. OSR (aHR, 1.43; 95% CI, 1.19-1.73) was associated with increased 1-year mortality when compared with EVAR. Increasing frailty status (frail aHR, 1.26; 95% CI, 1.00-1.59; very frail aHR, 1.64; 95% CI, 1.26-2.13) was associated with increased 1-year mortality, which was moderated by repair type (P-interaction < .05). OSR was associated with increased 1-year mortality in normal (aHR, 1.49; 95% CI, 1.20-1.87) and frail (aHR, 1.51; 95% CI, 1.20-1.89), but not among robust (aHR, 0.88; 95% CI, 0.59-1.32) and very frail (aHR, 1.29; 95% CI, 0.97-1.72) patients. CONCLUSIONS: Frailty and OSR were associated with increased adjusted risk of 1-year mortality following rAAA repair. Among normal and frail patients, OSR was associated with an increased adjusted risk of 1-year mortality when compared with EVAR. However, there was no difference between OSR and EVAR among robust patients who can well tolerate the stress of OSR and among very frail patients who are unable to withstand the surgical stress from rAAA regardless of repair type.

The Role of Integrated Air Transport System in Managing Patients with Abdominal Aortic Aneurysm Rupture.

OBJECTIVE: Ruptured abdominal aortic aneurysms (rAAAs) are highly morbid emergencies. Not all hospitals are equipped to repair them, and an air ambulance network may aid in regionalising specialty care to quaternary referral centres. The association between travel distance by air ambulance and rAAA mortality in patients transferred as an emergency for repair was examined. METHODS: A retrospective review of institutional data. Adults with rAAA (2002 - 2019) transferred from an outside hospital (OSH) to a single quaternary referral centre for repair via air ambulance were identified. Patients who arrived via ground transport or post-repair at an OSH for continued critical care were excluded. Patients were divided into near and far groups based on the 75th percentile of the straight line travel distance (> 72 miles) between hospitals. The primary outcome was 30 day mortality. Multivariable logistic regression was used to assess the association between distance and mortality after adjusting for age, sex, ethnicity, cardiovascular comorbidities, and repair type. RESULTS: A total of 290 patients with rAAA were transported a median distance of 40.4 miles (interquartile range 25.5, 72.7) with 215 (74.1%) near and 75 (25.9%) far patients. Both the near and far groups had similar ages, sex, and ethnicity. There was no difference in pre-operative loss of consciousness, intubation, or cardiac arrest between groups. Endovascular aneurysm repair utilisation and intra-operative aortic occlusion balloon use were also similar. Neither the observed (26.8% vs. 23.9%, p = .61) nor the adjusted odds ratio (0.70, 95% confidence interval 0.36 - 1.39, p = .32) 30 day mortality rate differed significantly between the near and far groups. CONCLUSION: Increasing distance travelled during transfer by air ambulance was not associated with worse outcomes in patients with rAAA. The findings support the regionalisation of rAAA repair to large quaternary centres via an integrated and robust air ambulance network.

Prophylactic defunctioning stomas improve clinical outcomes of anastomotic leak following rectal cancer resections: An analysis of the US Rectal Cancer Consortium.

PURPOSE: Anastomotic leak (AL) is a complication of low anterior resection (LAR) that results in substantial morbidity. There is immense interest in evaluating immediate postoperative and long-term oncologic outcomes in patients who undergo diverting loop ileostomies (DLI). The purpose of this study is to understand the relationship between fecal diversion, AL, and oncologic outcomes. METHODS: This is a retrospective multicenter cohort study using patient data obtained from the US Rectal Cancer Consortium database compiled from six academic institutions. The study population included patients with rectal adenocarcinoma undergoing LAR. The primary outcome was the incidence of AL among patients who did or did not receive DLI during LAR. Secondary outcomes included risk factors for AL, receipt of adjuvant therapy, 3-year overall survival, and 3-year recurrence. RESULTS: Of 815 patients, 38 (4.7%) suffered AL after LAR. Patients with AL were more likely to be male, have unintentional preoperative weight loss, and are less likely to undergo DLI. On multivariable analysis, DLI remained protective against AL (p < 0.001). Diverted patients were less likely to undergo future surgical procedures including additional ostomy creation, completion proctectomy, or pelvic washout for AL. Subgroup analysis of 456 patients with locally advanced disease showed that DLI was correlated with increased receipt of adjuvant therapy for patients with and without AL on univariate analysis (SHR:1.59; [95% CI 1.19-2.14]; p = 0.002), but significance was not met in multivariate models. CONCLUSION: Lack of DLI and preoperative weight loss was associated with anastomotic leak. Fecal diversion may improve the timely initiation of adjuvant oncologic therapy. The long-term outcomes following routine diverting stomas warrant further study.

Contemporary National Incidence and Outcomes of Acute Limb Ischemia.

INTRODUCTION: Acute Limb Ischemia (ALI) is a morbid and deadly diagnosis. However, existing epidemiologic studies describing ALI predate the introduction of the Affordable Care Act in 2010 and direct oral anticoagulants in 2011. Thus, we synergized the National Inpatient Sample (NIS) and United States (U.S.) Census to define contemporary trends in the incidence, treatment, and outcomes of ALI in the US. METHODS: We included emergent admissions of adults with primary diagnosis of lower extremity ALI in survey-weighted NIS data (2005-2020). Mann-Kendal trend test evaluated ALI incidence (primary outcome), anticoagulation usage, insurance coverage, revascularization type, and in-hospital amputation/death. Multivariable logistic regression quantified covariate associations with in-hospital amputation/death. RESULTS: Of 582,322,862 estimated hospitalizations in the NIS, 227,440 met inclusion criteria (mean age 68.80 years, 49.94% women, 76.66% White). ALI incidence peaked in 2006 (7.16/100,000 person-years) but has declined since 2015 to 4.16/100,000 person-years in 2020 (ptrend=.008). Endovascular revascularization, anticoagulation, and Medicaid coverage increased, while self-pay insurance decreased (ptrend<.05). Amputation rates significantly decreased from 8.04% to 6.54% (ptrend=.01) while death rate remained at 5.59% (ptrend=.16) over the study period. Pre-hospitalization anticoagulation was associated with decreased amputation (aOR=0.74 [95%CI 0.65-0.84]) and death (aOR=0.50 [95%CI 0.43-0.57]). When controlling for covariates, women had a higher risk of death (aOR=1.17 [95%CI 1.07-1.27], p<.0001), while Black patients had a higher risk of amputation (aOR=1.24 [95%CI 1.10-1.41], p<.0001). CONCLUSIONS: Our U.S. population based epidemiological study demonstrates that ALI incidence and in-hospital amputation rates are decreasing, while mortality remains unchanged. We further highlight the ongoing need for ALI investigation specifically as it relates to access to care, antithrombotic therapy use, treatment strategy, and strategies to combat gender and racial disparities.

Incidental AVF creation during unrelated hospitalization is associated with worse outcomes compared with outpatient AVF creation.

INTRODUCTION: Arteriovenous fistula (AVF) creation during an inpatient hospitalization is often performed for patient convenience and to ensure compliance. We sought to evaluate whether this approach has comparable outcomes to outpatient AVF creation. METHODS: We identified patients undergoing index AVF creation from the United States Renal Data System dataset (2012-2017). Patients were grouped into outpatient and inpatient. Outpatient included patients that were operated in either an outpatient setting, ambulatory surgical center or were admitted inpatient on the day of AVF creation. Inpatient included only patients with claims for an inpatient visit before access creation. Multiple safety outcomes were compared between groups using unadjusted and adjusted logistic regression methods generating odds ratios and 95% confidence intervals (95% CI). One-year maturation rates were compared using competing-risks regression methods generating sub-hazard ratios (sHR) and 95% CI. Outcomes were also compared after 1:1 propensity score matching. RESULTS: We identified 68,872 patients undergoing AVF creation, 4855 (7.1%) of which were created during inpatient hospitalization. Patients in the inpatient group were older (65.8 ± 13.8 vs 65.2 ± 13.8, p = 0.002), more likely to be of Black race (28.1% vs 26.8%, p = 0.02), and have cardiovascular comorbidities (all p < 0.05). Patients in the inpatient groups were more likely to be dialyzed at for-profit (88.1% vs 85.9%, p < 0.01) and freestanding (94.8% vs 92.9%, p < 0.01) dialysis centers. On both unadjusted and adjusted analysis, inpatient group was more likely to experience 30-day adverse events (e.g. pneumonia, COPD exacerbation, stroke, myocardial infarction), any complication, and all-cause mortality. On competing risks analysis, successful two-needle cannulation at 1 year was significantly less likely in the inpatient group (68.1% vs 76.8%, p < 0.01; sHR = 0.68 [95% CI, 0.65-0.71], p < 0.01). These trends were robust on 1:1 propensity matching. CONCLUSION: Incidental AVF creation in hospitalized patients is associated with worse outcomes, ranging from mortality to postoperative complications to fistula maturation, compared with outpatient AVF creation.

Association between timing of operative interventions and mortality in emergency general surgery.

Background: Emergency general surgery (EGS) often demands timely interventions, yet data for triage and timing are limited. This study explores the relationship between hospital arrival-to-operation time and mortality in EGS patients. Study design: We performed a retrospective cohort study using an EGS registry at four hospitals, enrolling adults who underwent operative intervention for a primary American Association for the Surgery of Trauma-defined EGS diagnosis between 2021 and 2023. We excluded patients undergoing surgery more than 72 hours after admission as non-urgent and defined our exposure of interest as the time from the initial vital sign capture to the skin incision timestamp. We assessed the association between operative timing quintiles and in-hospital mortality using a mixed-effect hierarchical multivariable model, adjusting for patient demographics, comorbidities, organ dysfunction, and clustering at the hospital level. Results: A total of 1199 patients were included. The median time to operating room (OR) was 8.2 hours (IQR 4.9-20.5 hours). Prolonged time to OR increased the relative likelihood of in-hospital mortality. Patients undergoing an operation between 6.7 and 10.7 hours after first vitals had the highest odds of in-hospital mortality compared with operative times <4.2 hours (reference quintile) (adjusted OR (aOR) 68.994; 95% CI 4.608 to 1032.980, p=0.002). A similar trend was observed among patients with operative times between 24.4 and 70.9 hours (aOR 69.682; 95% CI 2.968 to 1636.038, p=0.008). Conclusion: Our findings suggest that prompt operative intervention is associated with lower in-hospital mortality rates among EGS patients. Further work to identify the most time-sensitive populations is warranted. These results may begin to inform benchmarking for triaging interventions in the EGS population to help reduce mortality rates. Level of evidence: IV.

Outcomes of Women Undergoing Noncardiac Surgery in Veterans Affairs Compared With Non-Veterans Affairs Care Settings.

Importance: Recent legislation facilitates veterans' ability to receive non-Veterans Affairs (VA) surgical care. Although veterans are predominantly male, the number of women receiving care within the VA has nearly doubled to 10% over the past decade and recent data comparing the surgical care of women in VA and non-VA care settings are lacking. Objective: To compare postoperative outcomes among women treated in VA hospitals vs private-sector hospitals. Design, Setting, and Participants: This coarsened exact-matched cohort study across 9 noncardiac specialties in the Veterans Affairs Surgical Quality Improvement Program (VASQIP) and American College of Surgeons National Surgical Quality Improvement Program (NSQIP) took place from January 1, 2016, to December 31, 2019. Multivariable Poisson models with robust standard errors were used to evaluate the association between VA vs private-sector care settings and 30-day mortality. Hospitals participating in American College of Surgeons NSQIP and VASQIP were included. Data analysis was performed in January 2023. Participants included female patients 18 years old or older. Exposures: Surgical care in VA or private-sector hospitals. Main Outcomes and Measures: Postoperative 30-day mortality and failure to rescue (FTR). Results: Among 1 913 033 procedures analyzed, patients in VASQIP were younger (VASQIP: mean age, 49.8 [SD, 13.0] years; NSQIP: mean age, 55.9 [SD, 16.9] years; P < .001) and although most patients in both groups identified as White, there were significantly more Black women in VASQIP compared with NSQIP (29.6% vs 12.7%; P < .001). The mean risk analysis index score was lower in VASQIP (13.9 [SD, 6.4]) compared with NSQIP (16.3 [SD, 7.8]) (P < .001 for both). Patients in the VA were more likely to have a preoperative acute serious condition (2.4% vs 1.8%: P < .001), but cases in NSQIP were more frequently emergent (6.9% vs 2.6%; P < .001). The 30-day mortality, complications, and FTR were 0.2%, 3.2%, and 0.1% in VASQIP (n = 36 762 procedures) as compared with 0.8%, 5.0%, and 0.5% in NSQIP (n = 1 876 271 procedures), respectively (all P < .001). Among 1 763 540 matched women (n = 36 478 procedures in VASQIP; n = 1 727 062 procedures in NSQIP), these rates were 0.3%, 3.7%, and 0.2% in NSQIP and 0.1%, 3.4%, and 0.1% in VASQIP (all P < .01). Relative to private-sector care, VA surgical care was associated with a lower risk of death (adjusted risk ratio [aRR], 0.41; 95% CI, 0.23-0.76). This finding was robust among women undergoing gynecologic surgery, inpatient surgery, and low-physiologic stress procedures. VA surgical care was also associated with lower risk of FTR (aRR, 0.41; 95% CI, 0.18-0.92) for frail or Black women and inpatient and low-physiologic stress procedures. Conclusions and Relevance: Although women comprise the minority of veterans receiving care within the VA, in this study, VA surgical care for women was associated with half the risk of postoperative death and FTR. The VA appears better equipped to meet the unique surgical needs and risk profiles of veterans, regardless of sex and health policy decisions, including funding, should reflect these important outcome differences.

Adaptation of the Risk Analysis Index for Frailty Assessment Using Diagnostic Codes.

Importance: Frailty is associated with adverse outcomes after even minor physiologic stressors. The validated Risk Analysis Index (RAI) quantifies frailty; however, existing methods limit application to in-person interview (clinical RAI) and quality improvement datasets (administrative RAI). Objective: To expand the utility of the RAI utility to available International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) administrative data, using the National Inpatient Sample (NIS). Design, Setting, and Participants: RAI parameters were systematically adapted to ICD-10-CM codes (RAI-ICD) and were derived (NIS 2019) and validated (NIS 2020). The primary analysis included survey-weighed discharge data among adults undergoing major surgical procedures. Additional external validation occurred by including all operative and nonoperative hospitalizations in the NIS (2020) and in a multihospital health care system (UPMC, 2021-2022). Data analysis was conducted from January to May 2023. Exposures: RAI parameters and in-hospital mortality. Main Outcomes and Measures: The association of RAI parameters with in-hospital mortality was calculated and weighted using logistic regression, generating an integerized RAI-ICD score. After initial validation, thresholds defining categories of frailty were selected by a full complement of test statistics. Rates of elective admission, length of stay, hospital charges, and in-hospital mortality were compared across frailty categories. C statistics estimated model discrimination. Results: RAI-ICD parameters were weighted in the 9 548 206 patients who were hospitalized (mean [SE] age, 55.4 (0.1) years; 3 742 330 male [weighted percentage, 39.2%] and 5 804 431 female [weighted percentage, 60.8%]), modeling in-hospital mortality (2.1%; 95% CI, 2.1%-2.2%) with excellent derivation discrimination (C statistic, 0.810; 95% CI, 0.808-0.813). The 11 RAI-ICD parameters were adapted to 323 ICD-10-CM codes. The operative validation population of 8 113 950 patients (mean [SE] age, 54.4 (0.1) years; 3 148 273 male [weighted percentage, 38.8%] and 4 965 737 female [weighted percentage, 61.2%]; in-hospital mortality, 2.5% [95% CI, 2.4%-2.5%]) mirrored the derivation population. In validation, the weighted and integerized RAI-ICD yielded good to excellent discrimination in the NIS operative sample (C statistic, 0.784; 95% CI, 0.782-0.786), NIS operative and nonoperative sample (C statistic, 0.778; 95% CI, 0.777-0.779), and the UPMC operative and nonoperative sample (C statistic, 0.860; 95% CI, 0.857-0.862). Thresholds defining robust (RAI-ICD <27), normal (RAI-ICD, 27-35), frail (RAI-ICD, 36-45), and very frail (RAI-ICD >45) strata of frailty maximized precision (F1 = 0.33) and sensitivity and specificity (Matthews correlation coefficient = 0.26). Adverse outcomes increased with increasing frailty. Conclusion and Relevance: In this cohort study of hospitalized adults, the RAI-ICD was rigorously adapted, derived, and validated. These findings suggest that the RAI-ICD can extend the quantification of frailty to inpatient adult ICD-10-CM-coded patient care datasets.

A Prospective Cohort Protocol for the Remnant Investigation in Sepsis Study.

BACKGROUND: Sepsis is a common and deadly syndrome, accounting for more than 11 million deaths annually. To mature a deeper understanding of the host and pathogen mechanisms contributing to poor outcomes in sepsis, and thereby possibly inform new therapeutic targets, sophisticated, and expensive biorepositories are typically required. We propose that remnant biospecimens are an alternative for mechanistic sepsis research, although the viability and scientific value of such remnants are unknown. METHODS AND RESULTS: The Remnant Biospecimen Investigation in Sepsis study is a prospective cohort study of 225 adults (age ≥ 18 yr) presenting to the emergency department with community sepsis, defined as sepsis-3 criteria within 6 hours of arrival. The primary objective was to determine the scientific value of a remnant biospecimen repository in sepsis linked to clinical phenotyping in the electronic health record. We will study candidate multiomic readouts of sepsis biology, governed by a conceptual model, and determine the precision, accuracy, integrity, and comparability of proteins, small molecules, lipids, and pathogen sequencing in remnant biospecimens compared with paired biospecimens obtained according to research protocols. Paired biospecimens will include plasma from sodium-heparin, EDTA, sodium fluoride, and citrate tubes. CONCLUSIONS: The study has received approval from the University of Pittsburgh Human Research Protection Office (Study 21120013). Recruitment began on October 25, 2022, with planned release of primary results anticipated in 2024. Results will be made available to the public, the funders, critical care societies, laboratory medicine scientists, and other researchers.