An Emulated Target Trial Case Study of Real-World Overall Survival With Second-Line Maintenance Niraparib Versus Active Surveillance in Patients With Recurrent Ovarian Cancer.

PURPOSE: This retrospective real-world study compared overall survival (OS) between patients with BRCA wild-type (BRCAwt) recurrent epithelial ovarian cancer (OC) who received niraparib second-line maintenance (2LM) versus active surveillance (AS) using target trial emulation, cloning, inverse probability of censoring weighting (IPCW) methodology to minimize immortal time bias. METHODS: Eligible patients from a United States-based, deidentified, electronic health record-derived database were diagnosed with epithelial OC (January 1, 2011-May 31, 2021), were BRCAwt, and completed second-line (2L) therapy (January 1, 2017-March 2, 2022). Patient data were cloned at index (2L last treatment date), assigned to niraparib 2LM and AS cohorts, and censored when treatment deviated from clone assignment. Follow-up was measured from index to earliest of study end (May 31, 2022), last activity, or death. Median OS (mOS) and hazard ratios were estimated from stabilized IPCW Kaplan-Meier curves and Cox regression models. RESULTS: Overall, 199 patients received niraparib 2LM, and 707 had their care managed with AS. Key characteristics were balanced across cohorts after cloning and stabilized IPCW. Median follow-up was 15.6- and 9.3-months pre-cloning. IPCW mOS was 24.1 months (95% CI: 20.9-29.5) and 18.4 months (95% CI: 15.1-22.8) in niraparib 2LM and AS cohorts, respectively (hazard ratio, 0.77; 95% CI: 0.66-0.89). CONCLUSIONS: This real-world study provides supportive evidence of an OS benefit for patients with BRCAwt recurrent OC who received 2LM niraparib monotherapy compared with those whose care was managed with AS. The analytic strategies implemented were useful in minimizing immortal time bias and measured confounding.

Increasing Rates of RSV Hospitalization among Preterm Infants: A Decade of Data.

OBJECTIVE: In 2014, the American Academy of Pediatrics (AAP) changed its policy on the use of respiratory syncytial virus immunoprophylaxis (RSV-IP) so that RSV-IP was no longer recommended for use among infants without other medical conditions born >29 weeks of gestational age (wGA). This study examines 10-year trends in RSV-IP and RSV hospitalizations among term infants and preterm infants born at 29 to 34 wGA, including the 5 RSV seasons before and 5 RSV seasons after the AAP guidance change. STUDY DESIGN: A retrospective observational cohort study of a convenience sample of infants less than 6 months of age during RSV season (November-March) born between July 1, 2008, and June 30, 2019, who were born at 29 to 34 wGA (preterm) or >37 wGA (term) in the IBM MarketScan Commercial and Multi-State Medicaid databases. We excluded infants with medical conditions that would independently qualify them for RSV-IP. We identified RSV-IP utilization along with RSV and all-cause bronchiolitis hospitalizations during each RSV season. A difference-in-difference model was used to determine if there was a significant change in the relative rate of RSV hospitalizations following the 2014 policy change. RESULTS: There were 53,535 commercially insured and 85,099 Medicaid-insured qualifying preterm infants and 1,111,670 commercially insured and 1,492,943 Medicaid-insured qualifying term infants. Following the 2014 policy change, RSV-IP utilization decreased for all infants, while hospitalization rates tended to increase for preterm infants. Rate ratios comparing preterm to term infants also increased. The relative rate for RSV hospitalization for infants born at 29 to 34 wGA increased significantly for both commercially and Medicaid-insured infants (1.95, 95% CI: 1.67-2.27, p <0.001; 1.70, 95% CI: 1.55-1.86, p <0.001, respectively). Findings were similar for all-cause bronchiolitis hospitalizations. CONCLUSION: We found that the previously identified increase in RSV hospitalization rates among infants born at 29 to 34 wGA persisted for at least 5 years following the policy change. KEY POINTS: · Immunoprophylaxis rates decreased after the 2014 American Academy of Pediatrics guidelines update.. · Rate of RSV hospitalization increased among preterm infants after the 2014 AAP guidelines update.. · Increase in RSV hospitalization persisted for at least 5 years after AAP guidelines update..

Medically Attended Illness due to Respiratory Syncytial Virus Infection Among Infants Born in the United States Between 2016 and 2020.

BACKGROUND: Respiratory syncytial virus (RSV) is a leading cause of infant hospitalization in the United States. Preterm infants and those with select comorbidities are at highest risk of RSV-related complications. However, morbidity due to RSV infection is not confined to high-risk infants. We estimated the burden of medically attended (MA) RSV-associated lower respiratory tract infection (LRTI) among infants in the United States. METHODS: We analyzed commercial (MarketScan Commercial [MSC], Optum Clinformatics [OC]), and Medicaid (MarketScan Medicaid [MSM]) insurance claims data for infants born between April 2016 and February 2020. Using both specific and sensitive definitions of MA RSV LRTI, we estimated the burden of MA RSV LRTI during infants' first RSV season, stratified by gestational age, comorbidity status, and highest level of medical care associated with the MA RSV LRTI diagnosis. RESULTS: According to the specific definition 75.0% (MSC), 78.6% (MSM), and 79.6% (OC) of MA RSV LRTI events during infants' first RSV season occurred among term infants without known comorbidities. CONCLUSIONS: Term infants without known comorbidities account for up to 80% of the MA RSV LRTI burden in the United States during infants' first RSV season. Future prevention efforts should consider all infants.

Comparison of two-year treatment adherence, persistence, discontinuation, reinitiation, and switching between psoriasis patients treated with ixekizumab or secukinumab in real-world settings.

BACKGROUND: Real-world data on long-term treatment patterns associated with interleukin-17A inhibitors in plaque psoriasis are lacking. OBJECTIVE: To compare ixekizumab or secukinumab treatment patterns over a 24-month period among plaque psoriasis patients. METHODS: Adult patients with psoriasis who had 1 or more claims for ixekizumab or secukinumab between March 1, 2016, and October 31, 2019, and with 24 months of follow-up after starting treatment were identified from IBM MarketScan claims databases. Inverse probability of treatment weighting and multivariable models were employed to balance cohorts and estimate the risks of nonpersistence, discontinuation, and switching and odds of highly adherent treatment (proportion of days covered ≥ 80%). RESULTS: A total of 471 ixekizumab and 990 secukinumab users were included. Compared to secukinumab, ixekizumab use was associated with a 20% lower risk of nonpersistence (hazard ratio, 0.80; 95% CI, 0.70-0.92), a 17% lower risk of discontinuation (hazard ratio, 0.83; 95% CI, 0.72-0.96), and a 42% higher odds of being highly adherent to treatment (odds ratio, 1.42; 95% CI, 1.12-1.80). No difference in risk of switching was observed (hazard ratio, 0.83; 95% CI, 0.68-1.01). LIMITATIONS: Disease severity and clinical outcomes were unavailable. CONCLUSION: Over 24 months, ixekizumab users exhibited better persistence and adherence, and a lower risk of discontinuation than secukinumab users in real-world settings.

Long-Term Treatment Patterns Among Patients With Psoriasis Treated With Ixekizumab or Adalimumab: A Real-World Study.

BACKGROUND: There is a paucity of long-term real-world evidence comparing the effectiveness of ixekizumab (IXE) and adalimumab (ADA). We compared real-world treatment patterns of IXE-treated and ADA-treated patients with psoriasis over 24 months in the United States. METHODS: A retrospective observational study was conducted using IBM Watson Health MarketScan® databases. Adult patients with psoriasis having ≥1 claim for IXE or ADA from March 1, 2016 – October 31, 2019 were identified. Inverse probability of treatment weighting (IPTW) was used to address cohort imbalances. Cox proportional hazards models were used to estimate the risks of non-persistence, discontinuation, and switching. Logistic regression was used to estimate odds of high adherence. Persistence, adherence, discontinuation, reinitiation, and dosing and switching rates were also analyzed. RESULTS: The final cohorts comprised 475 IXE users and 3159 ADA users over 24 months. IXE users demonstrated higher adherence (36.3% vs 28.8%; P<0.001) and persistence rates (35.2% vs 28.8%; P=0.004), and a lower discontinuation rate (59.1% vs 65.3%; P=0.007) compared to ADA users. IXE users had a higher likelihood of being treatment-adherent compared to ADA users (OR=1.52, 95% CI: 1.24–1.87), a lower risk of non-persistence (HR=0.84, 95% CI: 0.75–0.95), and a lower risk of discontinuation (HR=0.83, 95% CI: 0.74–0.94), respectively. Switching rates were similar in both groups (31.2% vs 30.0%; P=0.608). CONCLUSION: IXE users had better treatment adherence and persistence, and a lower risk of discontinuation compared to ADA users over 24 months. There was no difference in the risk of switching between IXE and ADA. J Drugs Dermatol. 2022;21(4):399-407. doi:10.36849/JDD.6336.

Exploration of machine learning techniques to examine the journey to neuroendocrine tumor diagnosis with real-world data.

Aim: Machine learning reveals pathways to neuroendocrine tumor (NET) diagnosis. Patients & methods: Patients with NET and age-/gender-matched non-NET controls were retrospectively selected from MarketScan claims. Predictors (e.g., procedures, symptoms, conditions for which NET is misdiagnosed) were examined during a 5-year pre-period to understand presence of and time to NET diagnosis using conditional inference trees. Results: Among 3460 patients with NET, 70% had a prior misdiagnosis. 10,370 controls were included. Decision trees revealed combinations of factors associated with a high probability of being a patient with NET (e.g., abdominal pain, an endoscopic/biopsy procedure, vomiting) or longer times to diagnosis (e.g., asthma diagnosis with visits to >6 providers). Conclusion: Decision trees provided a unique examination of the journey to NET diagnosis.

Lay abstract We present the novel analytic approach of machine learning using real-world data to describe patient pathways to neuroendocrine tumor (NET) diagnosis. Due to the rarity and presentation of the disease, NET diagnosis is commonly inaccurate and delayed. We aimed to demonstrate the potential of analytics using conditional inference trees. Decision trees revealed specific combinations of characteristics associated with a high probability of being a patient with NET (e.g., abdominal pain, an endoscopic/biopsy procedure, vomiting) or longer times to diagnosis (e.g., asthma diagnosis with visits to >6 providers). Results from this study support prior literature and add advanced analyses that take initial steps toward developing tools aimed to help clinicians with early and accurate NET diagnosis. The methodology can be improved upon and translated to other diseases.

Effect of Aerobic Exercise on Cardiopulmonary Responses and Predictors of Change in Individuals With Parkinson's Disease.

OBJECTIVE: To determine the effect of aerobic exercise on maximal and submaximal cardiopulmonary responses and predictors of change in individuals with Parkinson's disease (PD). DESIGN: Single-center, parallel-group, rater-blind study. SETTING: Research laboratory. PARTICIPANTS: Individuals with mild to moderate PD (N=100). INTERVENTION: Participants were enrolled in a trial evaluating the effect of cycling on PD and randomized to either voluntary exercise (VE), forced exercise (FE), or a no exercise control group. The exercise groups were time and intensity matched and exercised 3×/wk for 8 weeks on a stationary cycle. MAIN OUTCOME MEASURES: Cardiopulmonary responses were collected via gas analysis during a maximal graded exercise test at baseline and post intervention. RESULTS: Exercise attendance was 97% and 93% for the FE and VE group, respectively. Average exercise heart rate reserve was 67%±11% for FE and 70%±10% for VE. No significant difference was present for change in peak oxygen consumption (VO2peak) post intervention, even though the FE group had a 5% increase in VO2peak. Both the FE and VE groups had significantly higher percentage oxygen consumption per unit time (V˙o2) at ventilator threshold (VT) than the control group compared with baseline values (P=.04). Mean V˙O2 at VT was 5% (95% CI, 0.1%-11%) higher in the FE group (P=.04) and 7% (2%, 12%) higher in VE group compared with controls. A stepwise linear regression model revealed that lower age, higher exercise cadence, and lower baseline VO2peak were most predictive of improved VO2peak. The overall model was found to be significant (P<.01). CONCLUSIONS: Peak and submaximal cardiopulmonary function may improve after aerobic exercise in individuals with PD. Lower age, higher exercise cadence, and lower baseline VO2peak were most predictive of improved VO2peak in this exercise cohort. The improvements observed in aerobic capacity were gained after a relatively short aerobic cycling intervention.

Comparison of real-world treatment patterns among patients with psoriasis prescribed ixekizumab or secukinumab.

BACKGROUND: Real-world data on treatment patterns associated with use of interleukin-17A inhibitors in psoriasis are lacking. OBJECTIVE: To compare treatment patterns between ixekizumab or secukinumab users in clinical practice. METHODS: A retrospective cohort study included patients with psoriasis aged ≥18 years treated with ixekizumab or secukinumab between March 1, 2016, and May 31, 2018 in IBM MarketScan (IBM Corp, Armonk, NY) databases. Inverse probability of treatment weighting and multivariable models were used to address cohort imbalances and estimate the risks of nonpersistence (60-day gap), discontinuation (≥90-day gap), switching, and the odds of adherence. RESULTS: The study monitored 645 ixekizumab users for 13.7 months and 1152 secukinumab users for 16.3 months. Ixekizumab users showed higher persistence rate (54.8% vs 45.1%, P < .001) and lower discontinuation rate (37.8% vs 47.5%, P < .001) than secukinumab. After multivariable adjustment, ixekizumab users had lower risks of nonpersistence (hazard ratio, 0.82; 95% confidence interval, 0.71-0.95) and discontinuation (hazard ratio, 0.82; 95% confidence interval, 0.70-0.96), and higher odds of high adherence to treatment measured by a medication possession ratio ≥80% (hazard ratio, 1.31; 95% confidence interval, 1.07-1.60). The risk of switching was similar between cohorts. LIMITATIONS: Disease severity and clinical outcomes were unavailable. CONCLUSION: Ixekizumab users demonstrated longer drug persistence, lower discontinuation rate and risk of discontinuation, higher likelihood of adherence, and similar risk of switching compared with secukinumab users in clinical practices.

Acute Postoperative Pain Is Associated With Myocardial Injury After Noncardiac Surgery.

BACKGROUND: Uncontrolled pain after noncardiac surgery activates the sympathetic nervous system, which causes tachycardia, hypertension, and increased cardiac contractility-all of which may increase myocardial oxygen demand. We therefore determined whether time-weighted average pain scores over the initial 72 postoperative hours are associated with myocardial injury after noncardiac surgery (MINS). METHODS: We conducted a retrospective cohort analysis of adults with routine postoperative troponin monitoring after noncardiac surgery under general, regional, or combined anesthesia at tertiary level centers in Cleveland from January 2012 to December 2015. Time-weighted average pain scores were calculated from all the available pain scores, typically at 4-hour intervals, until a troponin elevation was detected. MINS was defined as peak troponin T concentrations exceeding 0.03 ng/mL within 72 hours after surgery. We used a generalized linear mixed model to assess the association between pain and MINS with 3 hospitals as clusters, adjusting for potential confounders. RESULTS: Among 2892 eligible patients, 4.5% had myocardial injury within 72 hours after surgery. Higher time-weighted average pain scores were associated with increased hazard of myocardial injury. The estimated hazard ratio for a 1-unit increase in pain score was 1.12 (95% confidence interval [CI], 1.02-1.22; P = .013), adjusting for confounding variables. CONCLUSIONS: Among patients undergoing noncardiac surgery, time-weighted average pain scores within 72 hours after surgery were significantly associated with myocardial injury.

Combined Aerobic Exercise and Task Practice Improve Health-Related Quality of Life Poststroke: A Preliminary Analysis.

OBJECTIVE: The aim of this project was to determine the effects of lower extremity aerobic exercise coupled with upper extremity repetitive task practice (RTP) on health-related quality of life (HRQOL) and depressive symptomology in individuals with chronic stroke. DESIGN: Secondary analysis of data from 2 randomized controlled trials. SETTING: Research laboratory. PARTICIPANTS: Individuals (N=40) with chronic stroke. INTERVENTIONS: Participants received one of the following interventions: forced exercise+RTP (FE+RTP, n=16), voluntary exercise+RTP (VE+RTP, n=16), or stroke education+RTP (EDU+RTP, n=8). All groups completed 24 sessions, each session lasting 90 minutes. MAIN OUTCOME MEASURES: The Center for Epidemiological Studies-Depression Scale (CES-D) and Stroke Impact Scale (SIS) were used to assess depressive symptomology and HRQOL. RESULTS: There were no significant group-by-time interactions for any of the SIS domains or composite scores. Examining the individual groups following the intervention, those in the FE+RTP and VE+RTP groups demonstrated significant improvements in the following SIS domains: strength, mobility, hand function, activities of daily living, and the physical composite. In addition, the FE+RTP group demonstrated significant improvements in memory, cognitive composite, and percent recovery from stroke. The HRQOL did not change in the EDU+RTP group. Although CES-D scores improved predominantly for those in the FE+RTP group, these improvements were not statistically significant. Overall, results were maintained at the 4-week follow-up. CONCLUSION: Aerobic exercise, regardless of mode, preceding motor task practice may improve HRQOL in patients with stroke. The potential of aerobic exercise to improve cardiorespiratory endurance, motor outcomes, and HRQOL poststroke justifies its use to augment traditional task practice.

A Comparison of Global Longitudinal, Circumferential, and Radial Strain to Predict Outcomes After Cardiac Surgery.

OBJECTIVE: Myocardial strain measured by speckle-tracking echocardiography detects subtle regional and global left ventricular dysfunction. Myocardial strain is measured in the longitudinal, circumferential, and radial dimensions; however, it is unclear which dimension of strain is the best predictor of postoperative outcomes. DESIGN: A secondary analysis of prospectively collected data from a clinical trial (NCT01187329). SETTING: The cardiothoracic surgical operating rooms of an academic tertiary-care center. PARTICIPANTS: Cardiothoracic surgery patients with aortic stenosis having aortic valve replacement (AVR) with or without coronary artery bypass grafting enrolled in a clinical trial. INTERVENTIONS: Myocardial deformation analysis from standardized investigative transesophageal echocardiographic examinations performed after induction of anesthesia. MEASUREMENTS AND MAIN RESULTS: The authors compared the ability of intraoperative global longitudinal strain (GLS), global circumferential strain (GCS), and global radial strain (GRS) strain to predict adverse postoperative outcomes, including prolonged hospitalization and the need for pharmacologic hemodynamic support after cardiac surgery. The association of GLS, GCS, and GRS with prolonged hospitalization (>7 days) and the need for pharmacologic hemodynamic support, with epinephrine or norepinephrine after cardiopulmonary bypass, were assessed using separate multivariable logistic regression models with adjustment for multiple comparisons. Of 100 patients, 86 had acceptable measurements for GLS analysis, 73 for GCS, and 72 for GRS. Worse GLS was associated with prolonged hospitalization [odds ratio [OR] (98.3% confidence interval [CI]) of 1.21 (1.01-1.46) per-unit worsening in strain (p = 0.01, significance criterion <0.0167)] and the need for inotropic support with epinephrine [OR (99.2% CI) of 1.81 (1.10-2.97) per-unit worsening in strain (p = 0.002, significance criterion <0.0083)], but not norepinephrine. GCS and GRS were not associated with adverse outcomes. CONCLUSION: GLS, but not GCS or GRS, predicts prolonged hospitalization and the requirement for inotropic support with epinephrine after AVR.

Intra-operative tachycardia is not associated with a composite of myocardial injury and mortality after noncardiac surgery: A retrospective cohort analysis.

BACKGROUND: Myocardial injury after noncardiac surgery (MINS) is a major contributor to peri-operative morbidity and mortality with a reported incidence of about 8%. Tachycardia increases myocardial oxygen demand, and decreases oxygen supply, and is therefore a potential cause of MINS. OBJECTIVE: We tested the hypothesis that there is an association between intra-operative area above a heart rate (HR) of 90 bpm and a composite of MINS and in-hospital all-cause mortality. DESIGN: Retrospective analyses. SETTING: Major tertiary care hospital, Cleveland, USA. PATIENTS: Adults having elective or nonelective noncardiac surgery and scheduled troponin monitoring during the first 3 postoperative days between 2010 and 2015. MAIN OUTCOME MEASURES: All-or-none composite of myocardial injury (MINS), defined by a peak postoperative generation 4 troponin T concentration at least 0.03 ng ml, and in-hospital all-cause mortality. RESULTS: Among 2652 eligible patients, 123 (4.6%) experienced MINS within 7 days after surgery and 6 (0.2%) died before discharge. Intra-operative area above HR more than 90 bpm was not associated with the all-or-none composite of MINS and in-hospital mortality, with an estimated odds ratio (95% confidence interval) of 0.99 (0.97 to 1.01) per 1 h bpm increase in area above HR more than 90 bpm. Secondary outcomes were also unrelated to the composite, with estimated odds ratios (98.3% confidence interval) of 0.99 (0.98 to 1.00) for area above HR more than 80, 0.98 (0.92 to 1.04) for area above HR more than 100 bpm, and 0.96 (0.88 to 1.05) for maximum HR. CONCLUSION: There was no apparent association between various measures of tachycardia and a composite of MINS and death, a result that contradicts previously reported associations between other measures of intra-operative tachycardia and MINS/mortality.

Period-dependent Associations between Hypotension during and for Four Days after Noncardiac Surgery and a Composite of Myocardial Infarction and Death: A Substudy of the POISE-2 Trial.

BACKGROUND: The relative contributions of intraoperative and postoperative hypotension to perioperative morbidity remain unclear. We determined the association between hypotension and a composite of 30-day myocardial infarction and death over three periods: (1) intraoperative, (2) remaining day of surgery, and (3) during the initial four postoperative days. METHODS: This was a substudy of POISE-2, a 10,010-patient factorial-randomized trial of aspirin and clonidine for prevention of myocardial infarction. Clinically important hypotension was defined as systolic blood pressure less than 90 mmHg requiring treatment. Minutes of hypotension was the exposure variable intraoperatively and for the remaining day of surgery, whereas hypotension status was treated as binary variable for postoperative days 1 to 4. We estimated the average relative effect of hypotension across components of the composite using a distinct effect generalized estimating model, adjusting for hypotension during earlier periods. RESULTS: Among 9,765 patients, 42% experienced hypotension, 590 (6.0%) had an infarction, and 116 (1.2%) died within 30 days of surgery. Intraoperatively, the estimated average relative effect across myocardial infarction and mortality was 1.08 (98.3% CI, 1.03, 1.12; P < 0.001) per 10-min increase in hypotension duration. For the remaining day of surgery, the odds ratio was 1.03 (98.3% CI, 1.01, 1.05; P < 0.001) per 10-min increase in hypotension duration. The average relative effect odds ratio was 2.83 (98.3% CI, 1.26, 6.35; P = 0.002) in patients with hypotension during the subsequent four days of hospitalization. CONCLUSIONS: Clinically important hypotension-a potentially modifiable exposure-was significantly associated with a composite of myocardial infarction and death during each of three perioperative periods, even after adjustment for previous hypotension.

Patients at High Risk for Obstructive Sleep Apnea Are at Increased Risk for Atrial Fibrillation After Cardiac Surgery: A Cohort Analysis.

BACKGROUND: Patients with obstructive sleep apnea (OSA) experience intermittent hypoxia, hypercarbia, and sympathetic activation during sleep, which increases risk for paroxysmal atrial fibrillation and other cardiac arrhythmias. Whether patients with OSA experience increased episodes of atrial fibrillation after cardiac surgery is unclear. We examined whether patients at increased risk for OSA, assessed by the STOP-BANG (snoring, tired during the day, observed stop breathing during sleep, high blood pressure, body mass index more than 35 kg/m, age more than 50 years, neck circumference more than 40 cm, and male gender) questionnaire, had a higher incidence of new-onset postoperative atrial fibrillation after cardiac surgery. Because both postoperative atrial fibrillation and OSA increase resource utilization, we secondarily examined whether patients at increased OSA risk had longer duration of postoperative mechanical ventilation and intensive care unit (ICU) length of stay. METHODS: With institutional review board approval, this retrospective observational study evaluated adult patients who underwent elective cardiac surgery requiring cardiopulmonary bypass between 2014 and 2015 with preoperative assessment of OSA risk using the STOP-BANG questionnaire. Patients with a history of atrial fibrillation were excluded. The association between the STOP-BANG score and postoperative atrial fibrillation was examined using a multivariable logistic regression model. Secondarily, we estimated the association between the STOP-BANG score and duration of initial intubation using multivariable linear regression and ICU length of stay using Cox proportional hazards regression. We also descriptively summarized the percentage of patients requiring tracheal reintubation for mechanical ventilation. RESULTS: Of 4228 cardiac surgery patients, 1593 met inclusion and exclusion criteria. An increased STOP-BANG score was associated with higher odds of postoperative atrial fibrillation (odds ratio [95% confidence interval {CI}], 1.16 [1.09-1.23] per-point increase in the STOP-BANG score; P < .001). The STOP-BANG score was not associated with ICU length of stay (estimated hazard ratio [97.5% CI], 0.99 [0.96-1.03] per-point increase in the STOP-BANG score; P = .99) or duration of initial intubation (ratio of geometric means [97.5% CI], 1.01 [1.00-1.04]; P = .03; significance criterion [Bonferroni correction] < 0.025). One percent of patients required reintubation. DISCUSSION: Increasing risk for OSA, assessed by STOP-BANG, was associated with higher odds of postoperative atrial fibrillation, but not prolonged duration of mechanical ventilation or ICU length of stay.

Reduced Left Ventricular Global Longitudinal Strain Predicts Prolonged Hospitalization: A Cohort Analysis of Patients Having Aortic Valve Replacement Surgery.

BACKGROUND: Left ventricular ejection fraction (LVEF) is often preserved in patients with aortic stenosis and thus cannot distinguish between normal myocardial contractile function and subclinical dysfunction. Global longitudinal strain and strain rate (SR), which measure myocardial deformation, are robust indicators of myocardial function and can detect subtle myocardial dysfunction that is not apparent with conventional echocardiographic measures. Strain and SR may better predict postoperative outcomes than LVEF. The primary aim of our investigation was to assess the association between global longitudinal strain and serious postoperative outcomes in patients with aortic stenosis having aortic valve replacement. Secondarily, we also assessed the associations between global longitudinal SR and LVEF and the outcomes. METHODS: In this post hoc analysis of data from a randomized clinical trial (NCT01187329), we examined the association between measures of myocardial function and the following outcomes: (1) need for postoperative inotropic/vasopressor support; (2) prolonged hospitalization (>7 days); and (3) postoperative atrial fibrillation. Standardized transesophageal echocardiographic examinations were performed after anesthetic induction. Myocardial deformation was measured using speckle-tracking echocardiography. Multivariable logistic regression was used to assess associations between measures of myocardial function and outcomes, adjusted for potential confounding factors. The predictive ability of global longitudinal strain, SR, and LVEF was assessed as area under receiver operating characteristics curves (AUCs). RESULTS: Of 100 patients enrolled in the clinical trial, 86 patients with aortic stenosis had acceptable images for global longitudinal strain analysis. Primarily, worse intraoperative global longitudinal strain was associated with prolonged hospitalization (odds ratio [98.3% confidence interval], 1.22 [1.01-1.47] per 1% decrease [absolute value] in strain; P = .012), but not with other outcomes. Secondarily, worse global longitudinal SR was associated with prolonged hospitalization (odds ratio [99.7% confidence interval], 1.68 [1.01-2.79] per 0.1 second(-1) decrease [absolute value] in SR; P = .003), but not other outcomes. LVEF was not associated with any outcomes. Global longitudinal SR was the best predictor for prolonged hospitalization (AUC, 0.72), followed by global longitudinal strain (AUC, 0.67) and LVEF (AUC, 0.62). CONCLUSIONS: Global longitudinal strain and SR are useful predictors of prolonged hospitalization in patients with aortic stenosis having an aortic valve replacement.

Mild Perioperative Hypothermia and Myocardial Injury: A Retrospective Cohort Analysis.

BACKGROUND: We tested the primary hypothesis that final intraoperative esophageal temperature is associated with increased odds of a composite of in-hospital all-cause mortality and myocardial injury within 7 days after noncardiac surgery. Secondary exposures were time-weighted average intraoperative temperature and area <37°C threshold. METHODS: Myocardial injury was defined by postoperative fourth-generation troponin T ≥0.03 ng/mL apparently due to cardiac ischemia. Data were extracted for inpatients who had noncardiac surgery with general anesthesia at the Cleveland Clinic between 2012 and 2015. All had esophageal temperature monitoring and routine postoperative troponin monitoring. We estimated the confounder-adjusted association between final intraoperative esophageal temperature and the collapsed composite with multivariable logistic regression. We similarly estimated associations with time-weighted average intraoperative temperature and area <37°C. RESULTS: Two thousand two hundred ten patients were included. Nearly all final esophageal temperatures were 36°C-37°C. Ninety-seven patients (4.4%) had myocardial injury, and 7 (0.3%) died before discharge. Final intraoperative core temperature was not associated with the collapsed composite: odds ratio, 0.91 (95% confidence interval, 0.68-1.24) per 1°C decrease. Similarly, neither of the secondary exposures was associated with the composite outcome. CONCLUSIONS: We did not observe an association between mild perioperative hypothermia and mortality or myocardial injury in adults having noncardiac surgery. However, the range of final intraoperative temperatures was small and largely restricted to the normothermic range (36°C-37°C). Trials are needed to further assess the effect of temperature on myocardial injury.

Postoperative Hypotension and Surgical Site Infections After Colorectal Surgery: A Retrospective Cohort Study.

BACKGROUND: Hypotension compromises local tissue perfusion, thereby reducing tissue oxygenation. Hypotension might thus be expected to promote infection. Hypotension on surgical wards, while usually less severe than intraoperative hypotension, is common and often prolonged. In this retrospective cohort study, we tested the hypotheses that there is an association between surgical site infections and low postoperative time-weighted average mean arterial pressure and/or postoperative minimum mean arterial pressure. METHODS: We considered patients who had colorectal surgery lasting ≥1 hour at the Cleveland Clinic between 2009 and 2013. We defined blood pressure exposures as time-weighted average (primary) and minimum mean arterial pressure (secondary) within 72 hours after surgery. We assessed associations between continuous blood pressure exposures with a composite of deep and superficial surgical site infection using separate severity-weighted average relative effect generalized estimating equations models, each using an unstructured correlation structure and adjusting for potentially confounding variables. RESULTS: A total of 5896 patients were eligible for analysis. Time-weighted mean arterial pressure and surgical site infection were not significantly associated, with an estimated odds ratio (95% CI) of 1.03 (0.99-1.08) for a 5-mm Hg decrease (P = .16). However, there was a significant inverse association between minimum postoperative mean arterial pressure and infection, with an estimated odds ratio of 1.08 (1.03-1.12) per 5-mm Hg decrease (P = .001). CONCLUSIONS: Postoperative time-weighted mean arterial pressure was not associated with surgical site infection, but lowest postoperative mean arterial pressure was. Whether the relationship is causal remains to be determined.

Biochemically diagnosed hypothyroidism and postoperative complications after cardiac surgery: a retrospective cohort analysis.

PURPOSE: To determine whether hypothyroidism is associated with cardiovascular complications and surgical wound infections after cardiac surgery. METHODS: Patients were categorized as: (1) hypothyroid [patients with increased TSH concentrations (≧ 5.5 mIU/L) within 6 months prior to surgery]; (2) corrected hypothyroid [diagnosis of hypothyroidism any time before surgery or on preoperative thyroid supplementation and normal TSH concentration (0.4 [Formula: see text] TSH [Formula: see text] 5.5 mIU/L]; and (3) euthyroid [no hypothyroid diagnosis and not on preoperative thyroid supplementation and normal TSH concentrations (0.4-5.5 mIU/L)]. We conducted pairwise comparisons among the three groups using inverse probability of treatment weighting. We compared the groups on postoperative myocardial infarction, cardiac arrest, atrial fibrillation, and a composite of surgical wound infections and postoperative vasopressor use using multivariable logistic regression models. We compared the groups on ICU and hospital length of stay using Cox proportional hazards regression. RESULTS: Hypothyroidism was associated with a lower risk of atrial fibrillation than euthyroidism, with an estimated relative risk (99.4% CI) of 0.71 (0.56, 0.89); P < 0.001. However, none of the other pairwise comparisons on myocardial infarction, cardiac arrest, and atrial fibrillation were significant. Corrected hypothyroid patients were slightly more likely to be discharged from hospital at any given time than euthyroid patients (hazard ratios (99.6% CI), 1.18 (1.07, 1.30); P < 0.001), but no other pairwise comparisons for secondary outcomes were significant. CONCLUSIONS: Hypothyroidism was associated with lower risk of atrial fibrillation than euthyroidism, and corrected hypothyroidism was associated with a shorter length of stay than euthyroidism.

Systemic Lupus Erythematosus Is Associated With Increased Adverse Postoperative Renal Outcomes and Mortality: A Historical Cohort Study Using Administrative Health Data.

BACKGROUND: Systemic lupus erythematosus (SLE) is a common autoimmune connective tissue disease that mainly harms kidneys, heart, lungs, and nervous system. Effects of surgical stimulus and anesthesia combined with SLE-related pathologies may increase morbidity and mortality. Therefore, we aimed to evaluate the association between SLE (versus none) and postoperative renal, cardiac, and in-hospital mortality complications among patients undergoing major surgeries. METHODS: We obtained censuses of 2009 to 2011 inpatient hospital discharges across 7 states and conducted a retrospective cohort study by using International Classification of Diseases and Injuries, Version 9, diagnosis codes, procedure codes, and present-on-admission indicators. We included patients who had major surgery and matched each SLE discharge up to 4 control discharges for potential confounders. We assessed the association between matched SLE patients and controls on in-hospital renal complications, cardiovascular complications, and in-hospital mortality using separate logistic regression models. RESULTS: Among 8 million qualifying discharges, our sample contained 28,269 SLE patients matched with 13,269 controls. SLE was associated with a significantly higher risk of postoperative renal complications, with an estimated odds ratio (99% CI) of 1.33 (1.21, 1.46); P < .001. In addition, SLE was significantly associated with a higher risk of in-hospital mortality, with an estimated odds ratio (99% CI) of 1.27 (1.11, 1.47); P < .001. However, we found no significant association between SLE and cardiac complications, with an estimated odds ratio (99% CI) of 0.98 (0.83, 1.16), P = .79. CONCLUSIONS: This is, by far, the largest clinical study for postoperative outcomes of SLE patients with adequately powered statistical analyses. We concluded that SLE was associated with a higher risk of renal complications and in-hospital mortality but not cardiac events after major surgery. In SLE patients, more aggressive measures should be taken to prevent renal injury in the perioperative period.

Intravenous Acetaminophen Does Not Decrease Persistent Surgical Pain After Cardiac Surgery.

OBJECTIVE: The authors investigated the hypothesis that perioperative acetaminophen reduces incisional pain at 30 and 90 days. DESIGN: This was a prospective, randomized, double-blind trial. SETTING: Tertiary-care hospital (single center) cardiac surgery unit. PARTICIPANTS: Patients undergoing cardiac surgery via median sternotomy. INTERVENTIONS: Patients were assigned randomly to intravenous (IV) acetaminophen or IV placebo. Patients were given 4 doses of 1 g of IV acetaminophen or an equal volume of saline placebo over 15 minutes every 6 hours for 24 hours starting in the operating room after sternal closure. MEASUREMENTS AND MAIN RESULTS: Study participants were assessed by phone for incisional pain severity 30 and 90 days after surgery. Those reporting any incisional pain were asked to complete the Neuropathic Pain Questionnaire-Short Form and the modified Brief Pain Inventory. Patients were compared on 30- and 90-day incisional pain severity using separate multivariable linear regression models. IV acetaminophen had no effect on 30- and 90-day incisional pain, with an estimated difference in means (confidence interval) of 0.06 (-0.87 to 0.99) at 30 days (p = 0.88) and 0.07 (-0.71 to 0.86) at 90 days (p = 0.83). Low pain severity, neuropathic pain, and interference at both 30 and 90 days after surgery, regardless of treatment group, were observed. CONCLUSIONS: IV acetaminophen did not reduce the incidence or intensity of incisional pain at 30 days and 90 days after surgery.