Sex-Related Differences in Acuity and Postoperative Complications, Mortality and Failure to Rescue.

INTRODUCTION: Yentl syndrome describing sex-related disparities has been extensively studied in medical conditions but not after surgery. This retrospective cohort study assessed the association of sex, frailty, presenting with preoperative acute serious conditions (PASC), and the expanded Operative Stress Score (OSS) with postoperative complications, mortality, and failure-to-rescue. METHODS: The National Surgical Quality Improvement Program from 2015 to 2019 evaluating 30-d complications, mortality, and failure-to-rescue. RESULTS: Of 4,860,308 cases (43% were male; mean [standard deviation] age of 56 [17] y), 6.0 and 0.8% were frail and very frail, respectively. Frailty score distribution was higher in men versus women (P < 0.001). Most cases were low-stress OSS2 (44.9%) or moderate-stress OSS3 (44.5%) surgeries. While unadjusted 30-d mortality rates were higher (P < 0.001) in males (1.1%) versus females (0.8%), males had lower odds of mortality (adjusted odds ratio (aOR) = 0.92, 95% confidence interval [CI] = 0.90-0.94, P < 0.001) after adjusting for frailty, OSS, case status, PASC, and Clavien-Dindo IV (CDIV) complications. Males have higher odds of PASC (aOR = 1.33, CI = 1.31-1.35, P < 0.001) and CDIV complications (aOR = 1.13, CI = 1.12-1.15, P < 0.001). Male-PASC (aOR = 0.76, CI = 0.72-0.80, P < 0.001) and male-CDIV (aOR = 0.87, CI = 0.83-0.91, P < 0.001) interaction terms demonstrated that the increased odds of mortality associated with PASC or CDIV complications/failure-to-rescue were lower in males versus females. CONCLUSIONS: Our study provides a comprehensive analysis of sex-related surgical outcomes across a wide range of procedures and health care systems. Females presenting with PASC or experiencing CDIV complications had higher odds of mortality/failure to rescue suggesting sex-related care differences. Yentl syndrome may be present in surgical patients; possibly related to differences in presenting symptoms, patient care preferences, or less aggressive care in female patients and deserves further study.

Association of Frailty and the Expanded Operative Stress Score with Preoperative Acute Serious Conditions, Complications, and Mortality in Males Compared to Females: A Retrospective Observational Study.

OBJECTIVE: The aim of this study was to expand Operative Stress Score (OSS) increasing procedural coverage and assessing OSS and frailty association with Preoperative Acute Serious Conditions (PASC), complications and mortality in females versus males. SUMMARY BACKGROUND DATA: Veterans Affairs male-dominated study showed high mortality in frail veterans even after very low stress surgeries (OSS1). METHODS: Retrospective cohort using NSQIP data (2013-2019) merged with 180-day postoperative mortality from multiple hospitals to evaluate PASC, 30-day complications and 30-, 90-, and 180-day mortality. RESULTS: OSS expansion resulted in 98.2% case coverage versus 87.0% using the original. Of 82,269 patients (43.8% male), 7.9% were frail/very frail. Males had higher odds of PASC [adjusted odds ratio (aOR) = 1.31, 95% confidence interval (CI) = 1.21-1.41, P < 0.001] and severe/life-threatening Clavien-Dindo IV (CDIV) complications (aOR = 1.18, 95% CI = 1.09-1.28, P < 0.001). Although mortality rates were higher (all time-points, P < 0.001) in males versus females, mortality was similar after adjusting for frailty, OSS, and case status primarily due to increased male frailty scores. Additional adjustments for PASC and CDIV resulted in a lower odds of mortality in males (30-day, aOR = 0.81, 95% CI = 0.71-0.92, P = 0.002) that was most pronounced for males with PASC compared to females with PASC (30-day, aOR = 0.75, 95% CI = 0.56-0.99, P = 0.04). CONCLUSIONS: Similar to the male-dominated Veteran population, private sector, frail patients have high likelihood of postoperative mortality, even after low-stress surgeries. Preoperative frailty screening should be performed regardless of magnitude of the procedure. Despite males experiencing higher adjusted odds of PASC and CDIV complications, females with PASC had higher odds of mortality compared to males, suggesting differences in the aggressiveness of care provided to men and women.

Strategies to Promote ResiliencY (SPRY): a randomised embedded multifactorial adaptative platform (REMAP) clinical trial protocol to study interventions to improve recovery after surgery in high-risk patients.

INTRODUCTION: As the population ages, there is interest in strategies to promote resiliency, especially for frail patients at risk of its complications. The physiological stress of surgery in high-risk individuals has been proposed both as an important cause of accelerated age-related decline in health and as a model testing the effectiveness of strategies to improve resiliency to age-related health decline. We describe a randomised, embedded, multifactorial, adaptative platform (REMAP) trial to investigate multiple perioperative interventions, the first of which is metformin and selected for its anti-inflammatory and anti-ageing properties beyond its traditional blood glucose control features. METHODS AND ANALYSIS: Within a multihospital, single healthcare system, the Core Protocol for Strategies to Promote ResiliencY (SPRY) will be embedded within both the electronic health record (EHR) and the healthcare culture generating a continuously self-learning healthcare system. Embedding reduces the administrative burden of a traditional trial while accessing and rapidly analysing routine patient care EHR data. SPRY-Metformin is a placebo-controlled trial and is the first SPRY domain evaluating the effectiveness of three metformin dosages across three preoperative durations within a heterogeneous set of major surgical procedures. The primary outcome is 90-day hospital-free days. Bayesian posterior probabilities guide interim decision-making with predefined rules to determine stopping for futility or superior dosing selection. Using response adaptative randomisation, a maximum of 2500 patients allows 77%-92% power, detecting >15% primary outcome improvement. Secondary outcomes include mortality, readmission and postoperative complications. A subset of patients will be selected for substudies evaluating the microbiome, cognition, postoperative delirium and strength. ETHICS AND DISSEMINATION: The Core Protocol of SPRY REMAP and associated SPRY-Metformin Domain-Specific Appendix have been ethically approved by the Institutional Review Board and are publicly registered. Results will be publicly available to healthcare providers, patients and trial participants following achieving predetermined platform conclusions. TRIAL REGISTRATION NUMBER: NCT03861767.

Improved access to health care in Massachusetts after 2006 Massachusetts Healthcare Reform Law is associated with a significant decrease in mortality among vascular surgery patients.

BACKGROUND: Access to medical care, by adequate insurance coverage, has a direct impact on outcomes for patients undergoing vascular procedures. We evaluated in-hospital mortality for patients undergoing index vascular procedures before and after the Massachusetts Healthcare Reform Law (MHRL) in 2006, which mandated insurance for all Massachusetts residents, both in Massachusetts and throughout the United States. METHODS: The National Inpatient Sample was queried to identify patients undergoing interventions for peripheral arterial disease, carotid artery stenosis, and abdominal aortic aneurysms based on International Classification of Diseases, Ninth Revision, Clinical Modification procedural and diagnostic codes. The cohort was then divided into patients treated within Massachusetts (MA) and non-Massachusetts (NMA) hospitals. Two time intervals were examined: before (2003-2006, P1) and after the MHRL (2007-2011, P2). The primary outcome of interest included in-hospital mortality. Patients in MA and NMA hospitals were described in terms of demographics and presentation by time interval (P2 vs P1) compared using χ2 and t-tests. Weighted logistic regression with term modeling change in the odds ratio (OR) for P2 was performed to test and to estimate trends in mortality. Time (year of procedure) and region interactions were investigated by inclusion of time-region interactions in our analyses. Subgroup analysis was performed for P2 vs P1 among nonwhite, nonelderly, and low-income patients. RESULTS: We identified 306,438 patients who underwent repair of abdominal aortic aneurysm, lower extremity bypass, or carotid endarterectomy in MA and NMA hospitals. MA hospital patients had an increase in both Medicaid and private insurance status after the MHRL (P1 = 2.6% and 21% vs P2 = 3.3% and 21.7%, respectively; P = .034). In-hospital mortality trended down for all groups across the entire study. In comparing P2 vs P1 trends, MA hospital odds of mortality per year was lowered by 26% (OR, 0.74; 95% confidence interval [CI], 0.56-0.99; P = .042) not seen in NMA hospitals (OR, 1.03; 95% CI, 0.97-1.09; P = .405). Time and region interaction terms indicated significant time trend difference in both unadjusted (P = .031) and adjusted (P = .033) analysis in MA hospitals not observed in NMA hospitals. This pattern continued when the samples were stratified by procedure. Patients undergoing vascular procedures in MA hospitals had a significantly lowered OR of mortality, with fewer patients presenting at late disease stages in P2 vs P1. Nonelderly patients in Massachusetts, who benefit from the Medicaid expansion provided by the MHRL, had a profound 92% drop in odds of mortality in P2 vs P1 (OR, 0.08; 95% CI, 0.010-0.641; P = .017) compared with the 14% drop in NMA (OR, 0.86; 95% CI, 0.709-1.032; P = .103). CONCLUSIONS: The 2006 MHRL is associated with a decrease in mortality for patients undergoing index vascular surgery procedures in MA compared with NMA hospitals. This study suggests that governmental policy may play a key role in positively affecting the outcomes for patients.