The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial.

BACKGROUND: Multimodal analgesic strategies that reduce perioperative opioid consumption are well-supported in Enhanced Recovery After Surgery (ERAS) literature. However, the optimal analgesic regimen has not been established, as the contributions of each individual agent to the overall analgesic efficacy with opioid reduction remains unknown. Perioperative ketamine infusions can decrease opioid consumption and opioid-related side effects. However, as opioid requirements are drastically minimized within ERAS models, the differential effects of ketamine within an ERAS pathway remain unknown. We aim to pragmatically investigate through a learning healthcare system infrastructure how the addition of a perioperative ketamine infusion to mature ERAS pathways affects functional recovery. METHODS: The IMPAKT ERAS trial (IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery) is a single center, pragmatic, randomized, blinded, placebo-controlled trial. 1544 patients undergoing major abdominal surgery will be randomly allocated to receive intraoperative and postoperative (up to 48 h) ketamine versus placebo infusions as part of a perioperative multimodal analgesic regimen. The primary outcome is length of stay, defined as surgical start time until hospital discharge. Secondary outcomes will include a variety of in-hospital clinical end points derived from the electronic health record. DISCUSSION: We aimed to launch a large-scale, pragmatic trial that would easily integrate into routine clinical workflow. Implementation of a modified consent process was critical to preserving our pragmatic design, permitting an efficient, low-cost model without reliance on external study personnel. Therefore, we partnered with leaders of our Investigational Review Board to develop a novel, modified consent process and shortened written consent form that would meet all standard elements of informed consent, yet also allow clinical providers the ability to recruit and enroll patients during their clinical workflow. Our trial design has created a platform for subsequent pragmatic studies at our institution. TRIAL REGISTRATION: NCT04625283, Pre-results.

Electrocardiogram changes as predictors for new imaging findings in repeat transthoracic echocardiography.

Aim: To determine if electrocardiogram (EKG) findings may be a useful tool to predict changes in repeat transthoracic echocardiogram (TTE). Methods: We evaluated patients who underwent TTE during hospitalization and their EKGs, and whether findings differed between studies. Results: Of 229 hospitalized patients who underwent repeat TTE, 183 (80%) were abnormal. Each minor and major EKG abnormality resulted in a 1.8 (1.2 to 2.6; p = 0.002) and 2.1 (1.3 to 3.3; p < 0.001) increased odds of abnormal imaging on TTE, respectively. The negative likelihood ratio for an unchanged EKG to predict an unchanged TTE was 0.68 (95% CI = 0.62 to 0.73). Conclusion: Among hospitalized patients with prior imaging results, an unchanged EKG predicts an unchanged TTE.

The IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery (IMPAKT ERAS): protocol for a pragmatic, randomized, double-blinded, placebo-controlled trial.

BACKGROUND: Multimodal analgesic strategies that reduce perioperative opioid consumption are well-supported in Enhanced Recovery After Surgery (ERAS) literature. However, the optimal analgesic regimen has not been established, as the contributions of each individual agent to the overall analgesic efficacy with opioid reduction remains unknown. Perioperative ketamine infusions can decrease opioid consumption and opioid-related side effects. However, as opioid requirements are drastically minimized within ERAS models, the differential effects of ketamine within an ERAS pathway remain unknown. We aim to pragmatically investigate through a learning healthcare system infrastructure how the addition of a perioperative ketamine infusion to mature ERAS pathways affects functional recovery. METHODS: The IMPAKT ERAS trial (IMpact of PerioperAtive KeTamine on Enhanced Recovery after Abdominal Surgery) is a single center, pragmatic, randomized, blinded, placebo-controlled trial. 1544 patients undergoing major abdominal surgery will be randomly allocated to receive intraoperative and postoperative (up to 48 hours) ketamine versus placebo infusions as part of a perioperative multimodal analgesic regimen. The primary outcome is length of stay, defined as surgical start time until hospital discharge. Secondary outcomes will include a variety of in-hospital clinical end points derived from the electronic health record. DISCUSSION: We aimed to launch a large-scale, pragmatic trial that would easily integrate into routine clinical workflow. Implementation of a modified consent process was critical to preserving our pragmatic design, permitting an efficient, low-cost model without reliance on external study personnel. Therefore, we partnered with leaders of our Investigational Review Board to develop a novel, modified consent process and shortened written consent form that would meet all standard elements of informed consent, yet also allow clinical providers the ability to recruit and enroll patients during their clinical workflow. Our trial design has created a platform for subsequent pragmatic studies at our institution. TRIAL REGISTRATION NUMBER: NCT04625283, Pre-results Protocol Version 1.0, 2021.

Assessment of Awake Prone Positioning in Hospitalized Adults With COVID-19: A Nonrandomized Controlled Trial.

Importance: Awake prone positioning may improve hypoxemia among patients with COVID-19, but whether it is associated with improved clinical outcomes remains unknown. Objective: To determine whether the recommendation of awake prone positioning is associated with improved outcomes among patients with COVID-19-related hypoxemia who have not received mechanical ventilation. Design, Setting, and Participants: This pragmatic nonrandomized controlled trial was conducted at 2 academic medical centers (Vanderbilt University Medical Center and NorthShore University HealthSystem) during the COVID-19 pandemic. A total of 501 adult patients with COVID-19-associated hypoxemia who had not received mechanical ventilation were enrolled from May 13 to December 11, 2020. Interventions: Patients were assigned 1:1 to receive either the practitioner-recommended awake prone positioning intervention (intervention group) or usual care (usual care group). Main Outcomes and Measures: Primary outcome analyses were performed using a bayesian proportional odds model with covariate adjustment for clinical severity ranking based on the World Health Organization ordinal outcome scale, which was modified to highlight the worst level of hypoxemia on study day 5. Results: A total of 501 patients (mean [SD] age, 61.0 [15.3] years; 284 [56.7%] were male; and most [417 (83.2%)] were self-reported non-Hispanic or non-Latinx) were included. Baseline severity was comparable between the intervention vs usual care groups, with 170 patients (65.9%) vs 162 patients (66.7%) receiving oxygen via standard low-flow nasal cannula, 71 patients (27.5%) vs 62 patients (25.5%) receiving oxygen via high-flow nasal cannula, and 16 patients (6.2%) vs 19 patients (7.8%) receiving noninvasive positive-pressure ventilation. Nursing observations estimated that patients in the intervention group spent a median of 4.2 hours (IQR, 1.8-6.7 hours) in the prone position per day compared with 0 hours (IQR, 0-0.7 hours) per day in the usual care group. On study day 5, the bayesian posterior probability of the intervention group having worse outcomes than the usual care group on the modified World Health Organization ordinal outcome scale was 0.998 (posterior median adjusted odds ratio [aOR], 1.63; 95% credibility interval [CrI], 1.16-2.31). However, on study days 14 and 28, the posterior probabilities of harm were 0.874 (aOR, 1.29; 95% CrI, 0.84-1.99) and 0.673 (aOR, 1.12; 95% CrI, 0.67-1.86), respectively. Exploratory outcomes (progression to mechanical ventilation, length of stay, and 28-day mortality) did not differ between groups. Conclusions and Relevance: In this nonrandomized controlled trial, prone positioning offered no observed clinical benefit among patients with COVID-19-associated hypoxemia who had not received mechanical ventilation. Moreover, there was substantial evidence of worsened clinical outcomes at study day 5 among patients recommended to receive the awake prone positioning intervention, suggesting potential harm. Trial Registration: ClinicalTrials.gov Identifier: NCT04359797.

Allometric model improves scaling of left atrial size in obese population: the use of body weight containing variables is challenged.

BACKGROUND: Scaling left atrial (LA) size remains a challenge. An allometric model using body weight (BW) as scaling variable was recently proposed. We sought to examine the performance of this model in an obese population. METHODS: A total of 266 consecutive overweight (110) and obese subjects (class I, II, and III obese 81, 47, and 28, respectively) were studied; 46 normal subjects with normal body mass index (BMI) served as controls. LA dimension (LAD) was scaled to BW, body surface area (BSA), BMI and height, respectively, using both isometric and allometric models. RESULTS: There were no significant differences in age, gender, or height among the five groups. The prevalence of comorbid conditions, wall thickness, E/E' and LAD measures increased significantly with increasing weight group (P < 0.01-0.001). With the isometric model, LAD corrected by BW, BSA, and BMI significantly but paradoxically decreased across the groups (P < 0.05-0.001). With the allometric model, LAD overcorrection by BM, BSA, and BMI was improved, but remained in the class III obese group. In contrast, scaling LAD to height showed significant and graded increase across the five groups in accordance with the increases of BMI, E/E' and the prevalence of comorbid conditions. CONCLUSION: All isometric models that correct LAD by BW or BW containing variables underestimate LA size in overweight and obese groups. The allometric model using height provides more consistent results and should be preferred to models using BW or BW containing variables in scaling LAD in obese population.

Ankle-Brachial Index in Addition to Stress Testing in Patients Who Presented With Chest Pain and 1-Year Major Cardiovascular Events.

BACKGROUND: Chest pain is a common presentation to the emergency department, and the best approach for risk stratification with long-term outcomes is limited. Our goal was to assess the utility of ankle-brachial index (ABI) in addition to stress testing among patients (males >40 and females >50 years old) who presented with chest pain, undetectable biomarkers, and unchanged electrocardiogram. METHODS: A total of 348 consecutive patients were enrolled in a prospective cohort study and completed an ABI and cardiovascular stress test. RESULTS: Patients with an abnormal ABI were twice as likely to have an abnormal stress test (odds ratio = 2.03; 95% confidence interval [CI], 1.11-3.70). At 1 year, the incidence of adjusted major cardiovascular events (MCE) was lowest (8.2%) among those with a normal ABI and normal stress test. When compared with this low-risk group, the adjusted risk of 1-year MCE was 8.4% higher (95% CI, -1.0% to 17.8%; P = 0.080) in the normal ABI with abnormal stress test group; 5.3% higher (95% CI, -4.5% to 15.1%; P = 0.291) in the abnormal ABI with normal stress test group; and finally, 12.1% higher (95% CI, -2.5% to 26.6%; P = 0.105) in the abnormal ABI with abnormal stress test group. CONCLUSIONS: Although additional research needs to be conducted, either an abnormal stress test or abnormal ABI suggested an increase of MCE at 1 year with abnormal stress test and ABI demonstrating the highest risk. The addition of ABI to patients undergoing stress testing may enhance risk stratification in patients who present with chest pain.

Association Between Inpatient Echocardiography Use and Outcomes in Adult Patients With Acute Myocardial Infarction.

IMPORTANCE: Guidelines recommend that patients with acute myocardial infarction (AMI) undergo echocardiography for assessment of cardiac structure and ejection fraction, but little is known about the association between echocardiography as used in routine clinical management of AMI and patient outcomes. OBJECTIVE: To examine the association between risk-standardized hospital rates of transthoracic echocardiography and outcomes. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study of data from 397 US hospitals that contributed to the Premier Healthcare Informatics inpatient database from January 1, 2014, to December 31, 2014, used International Classification of Diseases, Ninth Revision (ICD-9) codes to identify 98 999 hospital admissions for patients with AMI. Data were analyzed between October 2017 and January 2019. EXPOSURES: Rates of transthoracic echocardiography. MAIN OUTCOMES AND MEASURES: Inpatient mortality, length of stay, total inpatient costs, and 3-month readmission rate. RESULTS: Among the 397 hospitals with more than 25 admissions for AMI in 2014, a total of 98 999 hospital admissions for AMI were identified for analysis (38.2% women; mean [SD] age, 66.5 [13.6] years), of which 69 652 (70.4%) had at least 1 transthoracic echocardiogram performed. The median (IQR) hospital risk-standardized rate of echocardiography was 72.5% (62.6%-79.1%). In models that adjusted for hospital and patient characteristics, no difference was found in inpatient mortality (odds ratio [OR], 1.02; 95% CI, 0.88-1.19) or 3-month readmission (OR, 1.01; 95% CI, 0.93-1.10) between the highest and lowest quartiles of echocardiography use (median risk-standardized echocardiography use rates of 83% vs 54%, respectively). However, hospitals with the highest rates of echocardiography had modestly longer mean lengths of stay (0.23 days; 95% CI, 0.04-0.41; P = .01) and higher mean costs ($3164; 95% CI, $1843-$4485; P < .001) per admission compared with hospitals in the lowest quartile of use. Multiple sensitivity analyses yielded similar results. CONCLUSIONS AND RELEVANCE: In patients with AMI, hospitals in the quartile with the highest rates of echocardiography showed greater hospital costs and length of stay but few differences in clinical outcomes compared with hospitals in the quartile with the lowest rates of echocardiography. These findings suggest that more selective use of echocardiography might be used without adversely affecting clinical outcomes, particularly in hospitals with high rates of echocardiography use.

Fatal pheochromocytoma crisis precipitated by dobutamine stress echocardiography.

The safety of dobutamine stress echocardiography (DSE) has been demonstrated in multiple studies with a major complication rate of <1%. Specifically, ventricular tachycardia during DSE has a reported incidence of 0.3%, and has been bound to be of no prognostic significance in patients without obstructive coronary artery disease. We report a unique case of fatal pheochromocytoma crisis precipitated by DSE in a patient with heretofore unknown adrenal disease. We are once again reminded that no diagnostic modality is absolutely without risk; however, minimal they might be.

Ruptured Sinus of Valsalva Aneurysm Associated with Situs Ambiguus, Isolated Levocardia, and Polysplenia.

Aneurysm of the sinus of Valsalva, a rare cardiac condition, results from dilation of an aortic sinus. Sudden aneurysm rupture can trigger rapidly progressive heart failure. We discuss the case of a 57-year-old woman with situs ambiguus, isolated levocardia, and polysplenia who presented with acute-onset heart failure. Transesophageal echocardiograms revealed an aneurysm of the right coronary sinus of Valsalva that had ruptured into the right atrial cavity. The patient underwent successful surgical repair. To our knowledge, this is the first report of a sinus of Valsalva aneurysm in a patient with this combination of congenital abnormalities. We briefly review the association between congenital heart disease, situs ambiguus, and ciliary dysfunction.

Nonobstructive membranes of the left atrial appendage cavity: report of three cases.

A membranous structure causing functional stenosis at the mouth of the left atrial appendage (LAA) has been reported. In this study we describe the presence of nonobstructive membranes traversing the cavity of the LAA found incidentally on transesophageal echocardiography (TEE).

Cardio-embolic stroke following remote blunt chest trauma.

A cardio-embolic stroke as a sequela of remote blunt chest trauma is a rare clinical presentation. Blunt chest trauma can cause various acute cardiac complications like arrhythmias, cardiac contusion etc. However, delayed consequences such as left ventricular thrombus resulting in thromboembolic phenomena are reported infrequently. A 30-year-old healthy man presented to an outside facility with transient neurological deficits. An MRI brain showed lesions suggestive of embolic etiology. A trans-thoracic echocardiogram (TTE) showed a 1.5 × 1.5 cm mass present in the left ventricular (LV) apex. Patient was transferred to our institution for cardiac surgery evaluation. On detailed questioning, he reported an incident of blunt chest trauma during a martial arts exhibition fight that took place 2 years back. Given this history, a cardiac catheterization was done, which showed 30% stenosis in mid-left anterior descending artery (LAD) without any other significant obstructive lesion. A trans-esophageal echocardiogram (TEE) showed akinesis of the LV apex and confirmed TTE finding of a mass, consistent with an apical thrombus. Surgery was deferred and patient was started on anticoagulation. A cardiac MRI done 2 weeks later showed evidence of apical infarction in the LAD territory. LAD is the most commonly affected coronary vessel by blunt traumatic injuries, likely due to its vulnerable anatomical position on the anterior aspect of the heart. A variety of mechanisms including intimal tear, rupture and spasm have been implicated in the pathogenesis of myocardial infarction after blunt chest trauma.

Outcomes of patients admitted for observation of chest pain.

BACKGROUND: Low-risk chest pain is a common cause of hospital admission; however, to our knowledge, there are no guidelines regarding the appropriate use of stress testing in such cases. METHODS: We performed a retrospective cohort study of patients 21 years and older who were admitted to our tertiary care center with chest pain in 2007 and 2008. Using electronic records and chart review, we sought (1) to identify differences in the use of stress testing based on patient demographics and comorbidities, pretest probability of coronary artery disease, and house staff coverage and (2) to describe the results of stress testing and patient outcomes, including revascularization procedures and 30-day readmissions for myocardial infarction. RESULTS: Of 2107 patients, 1474 (69.9%) underwent stress tests, and the results were abnormal in 184 patients (12.5%). Within 30 days, 22 patients (11.6%) with abnormal test results underwent cardiac catheterization, 9 (4.7%) underwent revascularization, and 2 (1.1%) were readmitted for myocardial infarction. In a multivariable model, stress test ordering was positively associated with age younger than 70 years (RR [relative risk], 1.12; 95% CI, 1.02-1.23), private insurance (vs Medicare/Medicaid: RR, 1.19; 95% CI, 1.11-1.27), and no house staff coverage (RR, 1.39; 95% CI, 1.28-1.50). Of patients with low (<10%) pretest probability, 68.0% underwent stress testing, but only 4.5% of these had abnormal test results. CONCLUSIONS: Most patients who are admitted with low-risk chest pain undergo stress testing, regardless of pretest probability, but abnormal test results are uncommon and rarely acted on. Ordering stress tests based on pretest probability could improve efficiency without endangering patients.