JAMA surgery最新文献

Importance: Among cancer surgeries, patients requiring open radical cystectomy have the highest risk of red blood cell (RBC) transfusion. Prophylactic tranexamic acid (TXA) reduces blood loss during cardiac and orthopedic surgery, and it is possible that similar effects of TXA would be observed during radical cystectomy.

Objective: To determine whether TXA, administered before incision and for the duration of radical cystectomy, reduced the number of RBC transfusions received by patients up to 30 days after surgery.

Design, setting, and participants: The Tranexamic Acid During Cystectomy Trial (TACT) was a double-blind, placebo-controlled, randomized clinical trial with enrollment between June 2013 and January 2021. This multicenter trial was conducted in 10 academic centers. A consecutive sample of patients was eligible if the patients had a planned open radical cystectomy for the treatment of bladder cancer.

Intervention: Before incision, patients in the intervention arm received a loading dose of intravenous TXA, 10 mg/kg, followed by a maintenance infusion of 5 mg/kg per hour for the duration of the surgery. In the control arm, patients received indistinguishable matching placebo.

Main outcomes and measures: The primary outcome was receipt of RBC transfusion up to 30 days after surgery.

Results: A total of 386 patients were assessed for eligibility, and 33 did not meet eligibility. Of 353 randomized patients (median [IQR] age, 69 [62-75] years; 263 male [74.5%]), 344 were included in the intention-to-treat analysis. RBC transfusion up to 30 days occurred in 64 of 173 patients (37.0%) in the TXA group and 64 of 171 patients (37.4%) in the placebo group (relative risk, 0.99; 95% CI, 0.83-1.18). There were no differences in secondary outcomes among the TXA group vs placebo group including mean (SD) number of RBC units transfused (0.9 [1.5] U vs 1.1 [1.8] U; P = .43), estimated blood loss (927 [733] mL vs 963 [624] mL; P = .52), intraoperative transfusion (28.3% [49 of 173] vs 24.0% [41 of 171]; P = .08), or venous thromboembolic events (3.5% [6 of 173] vs 2.9% [5 of 171]; P = .57). Non-transfusion-related adverse events were similar between groups.

Conclusions and relevance: Results of this randomized clinical trial reveal that TXA did not reduce blood transfusion in patients undergoing open radical cystectomy for bladder cancer. Based on this trial, routine use of TXA during open radical cystectomy is not recommended.

Trial registration: ClinicalTrials.gov Identifier: NCT01869413.

Importance: Health care researchers, professionals, payers, and policymakers are increasingly relying on publicly available composite indices of area-level socioeconomic deprivation to address health equity. Implications of index selection, however, are not well understood.

Objective: To compare the performance of 2 frequently used deprivation indices using policy-relevant outcomes among Medicare beneficiaries undergoing 3 common surgical procedures.

Design, setting, and participants: This cross-sectional study examined outcomes among Medicare beneficiaries (65 to 99 years old) undergoing 1 of 3 common surgical procedures (hip replacement, knee replacement, or coronary artery bypass grafting) between 2016 and 2019. Index discriminative performance was compared for beneficiaries residing in tracts with high- and low-deprivation levels (deciles) according to each index. Analyses were conducted between December 2022 and August 2023.

Main outcomes and measures: Tract-level deprivation was operationalized using 2020 releases of the area deprivation index (ADI) and the social vulnerability index (SVI). Binary outcomes were unplanned surgery, 30-day readmissions, and 30-day mortality. Multivariable logistic regression models, stratified by each index, accounted for beneficiary and hospital characteristics.

Results: A total of 2 433 603 Medicare beneficiaries (mean [SD] age, 73.8 [6.1] years; 1 412 968 female beneficiaries [58.1%]; 24 165 Asian [1.0%], 158 582 Black [6.5%], and 2 182 052 White [89.7%]) were included in analyses. According to both indices, beneficiaries residing in high-deprivation tracts had significantly greater adjusted odds of all outcomes for all procedures when compared with beneficiaries living in low-deprivation tracts. However, compared to ADI, SVI resulted in higher adjusted odds ratios (adjusted odds ratios, 1.17-1.31 for SVI vs 1.09-1.23 for ADI), significantly larger outcome rate differences (outcome rate difference, 0.07%-5.17% for SVI vs outcome rate difference, 0.05%-2.44% for ADI; 95% CIs excluded 0), and greater effect sizes (Cohen d, 0.076-0.546 for SVI vs 0.044-0.304 for ADI) for beneficiaries residing in high- vs low-deprivation tracts.

Conclusions and relevance: In this cross-sectional study of Medicare beneficiaries, SVI had significantly better discriminative performance-stratifying surgical outcomes over a wider range-than ADI for identifying and distinguishing between high- and low-deprivation tracts, as indexed by outcomes for common surgical procedures. Index selection requires careful consideration of index differences, index performance, and contextual factors surrounding use, especially when informing resource allocation and health care payment adjustment models to address health equity.

Importance: Evaluating how social determinants of health (SDOH) influence veteran outcomes is crucial, particularly for quality improvement.

Objective: To measure associations between SDOH, care fragmentation, and surgical outcomes using a Desirability of Outcome Ranking (DOOR).

Design, setting, and participants: This was a cohort study of US veterans using data from the Veterans Affairs (VA) Surgical Quality Improvement Program (VASQIP; 2013-2019) limited to patients aged 65 years or older with inpatient stays between 2 and 30 days, merged with multiple data sources, including Medicare. Race and ethnicity data were retrieved from VASQIP, Medicare and Medicaid beneficiary summary files, the Veterans Health Administration Corporate Data Warehouse, and the United States Veterans Eligibility Trends and Statistics file. Data were analyzed between September 2023 and February 2024.

Exposure: Living in a highly deprived neighborhood (Area Deprivation Index >85), race and ethnicity used as a social construct, rurality, and care fragmentation (percentage of non-VA care days).

Main outcomes and measures: DOOR is a composite, patient-centered ranking of 26 outcomes ranging from no complication (1, best) to 90-day mortality or near-death complications (6, worst). A series of proportional odds regressions was used to assess the impact of SDOH and care fragmentation adjusted for clinical risk factors, including presentation acuity (presenting with preoperative acute serious conditions and urgent or emergent surgical procedures).

Results: The cohort had 93 644 patients (mean [SD] age, 72.3 [6.2] years; 91 443 [97.6%] male; 74 624 [79.7%] White). Veterans who identified as Black (adjusted odds ratio [aOR], 1.06; 95% CI, 1.02-1.10; P = .048) vs White and veterans with higher care fragmentation (per 20% increase in VA care days relative to all care days: aOR, 1.01; 95% CI, 1.01-1.02; P < .001) were associated with worse (higher) DOOR scores until adjusting for presentation acuity. Living in rural geographic areas was associated with better DOOR scores than living in urban areas (aOR, 0.93; 95% CI, 0.91-0.96; P < .001), and rurality was associated with lower presentation acuity (preoperative acute serious conditions: aOR, 0.88; 95% CI, 0.81-0.95; P = .001). Presentation acuity was higher in veterans identifying as Black, living in deprived neighborhoods, and with increased care fragmentation.

Conclusions and relevance: Veterans identifying as Black and veterans with greater proportions of non-VA care had worse surgical outcomes. VA programs should direct resources to reduce presentation acuity among Black veterans, incentivize veterans to receive care within the VA where possible, and better coordinate veterans' treatment and records between care sources.

Importance: Liberal oxygen (hyperoxia) is commonly administered to patients during surgery, and oxygenation is known to impact mechanisms of perioperative organ injury.

Objective: To evaluate the effect of intraoperative hyperoxia compared to maintaining normoxia on oxidative stress, kidney injury, and other organ dysfunctions after cardiac surgery.

Design, setting, and participants: This was a participant- and assessor-blinded, randomized clinical trial conducted from April 2016 to October 2020 with 1 year of follow-up at a single tertiary care medical center. Adult patients (>18 years) presenting for elective open cardiac surgery without preoperative oxygen requirement, acute coronary syndrome, carotid stenosis, or dialysis were included. Of 3919 patients assessed, 2501 were considered eligible and 213 provided consent. Of these, 12 were excluded prior to randomization and 1 following randomization whose surgery was cancelled, leaving 100 participants in each group.

Interventions: Participants were randomly assigned to hyperoxia (1.00 fraction of inspired oxygen [FiO2]) or normoxia (minimum FiO2 to maintain oxygen saturation 95%-97%) throughout surgery.

Main outcomes and measures: Participants were assessed for oxidative stress by measuring F2-isoprostanes and isofurans, for acute kidney injury (AKI), and for delirium, myocardial injury, atrial fibrillation, and additional secondary outcomes. Participants were monitored for 1 year following surgery.

Results: Two hundred participants were studied (median [IQR] age, 66 [59-72] years; 140 male and 60 female; 82 [41.0%] with diabetes). F2-isoprostanes and isofurans (primary mechanistic end point) increased on average throughout surgery, from a median (IQR) of 73.3 (53.1-101.1) pg/mL at baseline to a peak of 85.5 (64.0-109.8) pg/mL at admission to the intensive care unit and were 9.2 pg/mL (95% CI, 1.0-17.4; P = .03) higher during surgery in patients assigned to hyperoxia. Median (IQR) change in serum creatinine (primary clinical end point) from baseline to postoperative day 2 was 0.01 mg/dL (-0.12 to 0.19) in participants assigned hyperoxia and -0.01 mg/dL (-0.16 to 0.19) in those assigned normoxia (median difference, 0.03; 95% CI, -0.04 to 0.10; P = .45). AKI occurred in 21 participants (21%) in each group. Intraoperative oxygen treatment did not affect additional acute organ injuries, safety events, or kidney, neuropsychological, and functional outcomes at 1 year.

Conclusions: Among adults receiving cardiac surgery, intraoperative hyperoxia increased intraoperative oxidative stress compared to normoxia but did not affect kidney injury or additional measurements of organ injury including delirium, myocardial injury, and atrial fibrillation.

Trial registration: ClinicalTrials.gov Identifier: NCT02361944.