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No full textComparison of Local and General Anesthesia on 30-Day Outcomes of Emergency Infrainguinal Endovascular Revascularization for Patients with Chronic Limb-Threatening Ischemia
No full textBackgroundInfrainguinal endovascular interventions can be the first-choice treatment for suitable patients with peripheral artery disease (PAD). However, the choice of anesthesia for infrainguinal endovascular procedures, particularly in emergency situations, remains underexplored. This study aimed to conduct a retrospective analysis based on a multi-institutional nationwide registry to compare the 30-day outcomes of patients with chronic limb-threatening ischemia (CLTI) who received either local anesthesia (LA) or general anesthesia (GA) during emergency infrainguinal endovascular interventions.MethodsPatients who underwent emergency infrainguinal endovascular revascularization for CLTI (tissue loss or rest pain) were selected from the ACS-NSQIP database from 2012-2022. Multivariable logistic regression was used to compare 30-day outcomes between patients under GA and LA, where demographics, baseline characteristics, and symptomatology were adjusted.ResultsAmong 703 patients, 292 (41.54%) were under LA, and 411 (58.46%) were under GA. Patients under LA had lower bleeding requiring transfusion (aOR = 0.428, 95 CI = 0.281-0.653, P \u3c 0.01), lower postoperative wound complications (aOR = 0.289, 95 CI = 0.137-0.612, P \u3c 0.01), and shorter operative time (102.00 ± 72.38 vs 150.70 ± 105.40 minutes, P \u3c 0.01). All other 30-day outcomes, including mortality, organ system complications, and limb-specific outcomes, were comparable between patients under LA and GA.ConclusionLA and GA can be considered equivalent options for eligible CLTI patients undergoing emergency infrainguinal endovascular revascularization, with close monitoring of wound and bleeding complications recommended for GA patients. Further studies are necessary to evaluate long-term outcomes in these patients
Quality Verification in Surgical Subspecialty Programs
No full textIn 2001, the Institute of Medicine defined 6 domains in quality health care: safe, effective, patient-centered, timely, efficient, and equitable. In 2010, the Affordable Care Act (ACA) or Obamacare, was passed into law. In addition to the well-known health insurance reform, it introduced delivery system redesign based on quality performance. Basically, it heralded a transition of reimbursement from payment for service and volume to payment for quality and value. Defining value is rather elusive; but if one considers that value equals quality divided by cost, payers aim to increase the value of a service either by improving quality, decreasing cost, or, preferably for them, both. The question is who defines value and quality of surgical services. Surgical specialists and their professional organizations should. Such organizations have the knowledge in their specialty but usually lack the infrastructure necessary to do so; but quality verification programs can be established in collaboration with the American College of Surgeons (ACS). ACS has had a long history of establishing quality verification programs; it has the infrastructure and the experienced personnel to do so. All ACS verification programs are based on four guiding principles: Setting standards based on evidence based guidelines, building the right infrastructure based on the standards, collecting the appropriate outcome data, and verifying compliance with the standards by site visit by outside experts. In this article, I outline the reasons for establishing verification programs, the process used to establish and maintain such programs, and their implications using the ACS/SVS (Society for Vascular Surgery) Vascular Verification Program as an example
The Intersection of Race, Ethnicity, and Sex on Postoperative Complications in Otolaryngology
No full textOBJECTIVE: Racial and ethnic patient health disparities are well-documented within surgical specialties; however, an intersectional lens studying the combined impact of multiple identities has not been evaluated in this context. We aim to explore the multiplicative effect of race, ethnicity, and sex on postoperative complications across a variety of otolaryngologic procedures. STUDY DESIGN: Cross-sectional analysis of retrospective data. SETTING: A multi-institutional cohort using National Surgical Quality Improvement Program (NSQIP) data from 2010 to 2021. METHODS: The 100 most common NSQIP cases conducted by otolaryngologists between 2010 and 2021 were included. Primary outcomes included 30-day surgical complications and medical complications. Propensity-weighted data were fitted to logistic regression models, and pairwise post hoc comparisons were performed for each race and ethnicity contrast within each sex. RESULTS: Of 146,461 patients included in the final analysis, the majority identified as white (82.6%) and non-Hispanic (NH; 92.35%). Black NH males had 2.15 times higher odds of experiencing any complication than Asian NH males (OR = 2.15, 95% confidence interval [CI] [2.05, 2.26], P \u3c .001). White Hispanic males were half as likely to experience complications compared to black Hispanic males (OR = 0.50, 95% CI [0.37, 0.70], P = .002). White Hispanic females were 68% less likely to experience surgical complications compared to black Hispanic females (OR = 0.32, 95% CI [0.23, 0.46], P \u3c .001). CONCLUSION: We demonstrate that black male patients experience increased adverse surgical outcomes despite accounting for multiple relevant comorbidities. These findings contribute to the growing literature on intersectionality, providing a strong argument for prospective strategies to address inequities of surgical care in otolaryngology
Safety and efficacy of chronic weekly rozanolixizumab in generalized myasthenia gravis: the randomized open-label extension MG0004 study
No full textBACKGROUND: In the Phase 3 MycarinG study (NCT03971422), six once-weekly subcutaneous infusions of rozanolixizumab significantly improved myasthenia gravis (MG)-specific outcomes versus placebo in patients with acetylcholine receptor or muscle-specific tyrosine kinase autoantibody-positive generalized MG (gMG). Following completion of MycarinG, patients could enroll in the open-label extension MG0004 study (NCT04124965) to receive chronic weekly rozanolixizumab. METHODS: Patients were re-randomized 1:1 to once-weekly rozanolixizumab 7 or 10 mg/kg for up to 52 infusions. The primary endpoints were the occurrence of treatment-emergent adverse events (TEAEs) and TEAEs leading to rozanolixizumab discontinuation. After ≥6 visits/infusions patients could switch to the MG0007 study (NCT04650854) to receive cyclic rozanolixizumab treatment. RESULTS: In MG0004, 70 patients received rozanolixizumab 7 mg/kg (n = 35) or 10 mg/kg (n = 35). Mean treatment duration was 22.9 and 23.7 weeks, respectively, due to rollover into MG0007. TEAEs were reported in 60/70 (85.7%) patients; most were mild/moderate. The most frequently reported TEAEs were headache (25/70 [35.7%]), diarrhea (13/70 [18.6%]) and decreased blood immunoglobulin G (11/70 [15.7%]). There were no opportunistic, serious or severe infections, serious or severe hypersensitivity or injection-site reactions, any anaphylactic reactions or albumin or lipid abnormalities. Maximum mean reduction from baseline in MG Activities of Daily Living score was 3.1 in the 7 mg/kg group and 4.1 in the 10 mg/kg group. CONCLUSION: Chronic weekly rozanolixizumab for up to 52 infusions was generally well tolerated, and clinically relevant improvements across MG-specific outcomes were maintained, supporting the long-term use of rozanolixizumab in patients with gMG. TRIAL REGISTRATION: NCT04124965 (registered October 11, 2019)
Expanding choices of antiretroviral treatment regimens for pregnant and breastfeeding persons with HIV
No full textThirty-Day Endovascular Repair Outcomes of Stanford Type B Aortic Dissection in Patients With Diabetes Mellitus: A Propensity-Score-Matched Study From the ACS-NSQIP Database
No full textBACKGROUND: The surgical intervention for Stanford type B aortic dissection (TBAD) has been revolutionized by thoracic endovascular aortic repair (TEVAR). While diabetes mellitus (DM) is associated with increased risks of short-term mortality and infectious complications after major surgeries, previous studies present conflicting findings regarding the outcomes of TEVAR in DM patients. This study aimed to assess the 30-day postoperative outcomes for DM patients who have undergone TEVAR for TBAD using a dataset from a multi-institutional national registry. METHODS: Patients who underwent TEVAR for TBAD were selected from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database from 2005 to 2022. A 1:4 propensity-score matching was used to balance demographics and preoperative characteristics between patients with and without DM. Thirty-day postoperative outcomes were compared. RESULTS: There were 160 (8.89%) DM and 1640 (91.11%) non-DM patients who underwent TEVAR for TBAD. After propensity-score matching, all DM patients were matched to 594 non-DM patients. DM patients had a higher rate of mortality that was trending toward significance (10.19% vs 5.89%, p = 0.07). All 30-day complications were comparable between DM and non-DM patients. CONCLUSION: TEVAR can generally be safe for DM patients in terms of short-term outcomes, but the potential for higher perioperative mortality rates in these patients may warrant careful consideration. Further large-scale studies may be necessary to fully understand the impact of DM on both short-term and long-term outcomes following TEVAR for TBAD.Clinical ImpactThis study assessed the 30-day postoperative outcomes for diabetes mellitus (DM) patients who have undergone thoracic endovascular aortic repair (TEVAR) for Stanford type B aortic dissection (TBAD) using the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database. After propensity-score matching, DM patients had a higher rate of mortality that was trending toward significance but all 30-day complications were comparable between DM and non-DM patients. Therefore, TEVAR can generally be safe for DM patients in terms of short-term outcomes, but the potential for higher perioperative mortality rates in these patients may warrant careful consideration. Further large-scale studies may be necessary to fully understand the impact of DM on both short-term and long-term outcomes following TEVAR for TBAD
Evaluation of Department of Defense hospital antimicrobial stewardship programs (ASPs) using a novel Core Elements scoring approach and modeling Core Elements scores with metrics related to ASP outcomes
No full textOBJECTIVE: Evaluate Department of Defense (DoD) antimicrobial stewardship programs (ASPs) by assessing the relationship between key clinical outcome metrics (antibiotic use, incidence of resistant pathogens, and incidence of Clostridioides difficile infections) and CDC Core Element (CE) adherence. DESIGN: Retrospective, cross-sectional study of DoD hospitals in 2018 and 2021. METHODS: National Healthcare Safety Network Standardized Antimicrobial Administration Ratios (SAARs) were used to measure antibiotic use and microbiology results to evaluate four types of pathogen incidence. A novel CE scoring approach used scores to quantitatively assess relationships with CE adherence and outcome metrics using correlation and regression models. Assessments were repeated with 2021 data for Priority CE adherence and to conduct adjusted regressions for CEs and Priority CEs controlling for categorical bed size. RESULTS: Compared to 2022 national data, DoD hospitals in 2021 had a similar proportion of facilities with a SAAR statistically significantly \u3e 1.0. Leadership, Action, and Tracking CEs followed a more normal score distribution, while Reporting and Education were somewhat left-skewed. Unadjusted models often showed a positive relationship with higher CE scores associated with worse outcomes for the SAAR and pathogen incidence. Adjusted models indicated that procedural CEs, particularly Priority Reporting, were associated with better ASP-related outcomes. CONCLUSIONS: CEs should be more quantitatively assessed. Results provide initial evidence to prioritize procedural CE implementation within the DoD; however, additional investigation for structural CEs is needed. Patient outcome data should be collected as an important indicator of ASP performance