Actual versus ideal body weight dosing of sugammadex in morbidly obese patients offers faster reversal of rocuronium- or vecuronium-induced deep or moderate neuromuscular block: a randomized clinical trial.

BACKGROUND: This randomized, double-blind trial evaluated sugammadex-mediated recovery time from rocuronium- or vecuronium-induced moderate (M-) or deep (D-) neuromuscular block in morbidly obese adults dosed by actual (ABW) or ideal body weight (IBW). METHODS: Adults with BMI ≥40 kg/m2 were randomized to 1 of 5 groups: M-neuromuscular block, sugammadex 2 mg/kg ABW; M-neuromuscular block, sugammadex 2 mg/kg IBW; M-neuromuscular block, neostigmine 5 mg, and glycopyrrolate 1 mg; D-neuromuscular block, sugammadex 4 mg/kg ABW; or D-neuromuscular block, sugammadex 4 mg/kg IBW. Supramaximal train of four (TOF) stimulation of the ulnar nerve (TOF-watch SX®) monitored recovery. Primary endpoint was time to TOF ratio ≥ 0.9 for ABW and IBW groups pooled across neuromuscular blocking agent (NMBA)/blocking depth, analyzed by log-rank test stratified for agent and depth. Prespecified safety outcomes included treatment-emergent bradycardia, tachycardia, and other arrhythmias, and adjudicated hypersensitivity and anaphylaxis. RESULTS: Of 207 patients randomized, 188 received treatment (28% male, BMI 47 ± 5.1 kg/m2, age 48 ± 13 years). Recovery was 1.5 min faster with ABW vs IBW dosing. The sugammadex 2 mg/kg groups recovered 9-fold faster [time 0.11-fold, 95% CI 0.08 to 0.14] than the neostigmine group. ABW (5.3%) and IBW (2.7%) groups had similar incidences of recovery time > 10 min (95% CI of difference: - 4.8 to 11.0%); 84% for neostigmine group. Re-curarization occurred in one patient each in the 2 mg/kg IBW and neostigmine groups. Prespecified safety outcomes occurred with similar incidences. CONCLUSIONS: ABW-based sugammadex dosing yields faster reversal without re-curarization, supporting ABW-based sugammadex dosing in the morbidly obese, irrespective of the depth of neuromuscular block or NMBA used. TRIAL REGISTRATION: Registered on November 17, 2017, at ClinicalTrials.gov under number NCT03346070 .

Blood pressure variability predicts adverse events and cardiovascular outcomes in SPRINT.

SPRINT (Systolic Blood Pressure Intervention Trial) highlighted the benefits of intensive targeted antihypertensive therapy but resulted in higher rates of treatment-related adverse events. Blood pressure (BP) variability has emerged as a significant predictor of outcomes over and above levels of BP. Using the SPRINT data set, we aimed to determine the relationship of BP variability with cardiovascular outcomes and side effects of antihypertensive therapy. The analyses included all participants randomized in SPRINT who reached the target systolic BP (SBP) for their respective groups (intensive < 120 mm Hg; standard < 140 mm Hg). Coefficients of variation (CV) for SBP, diastolic BP (DBP), and PP for each patient characterized variability. Student t test was used to compare treatment arms for each CV metric. Cox proportional hazards regression was used to identify independent predictors of the SPRINT primary outcome and adverse events. P < .15 on univariate analysis was required to enter the model and P < .05 to remain in it. A total of 8884 patients (4561 standard group; 4323 intensive group) met inclusion criteria. DBP CV differed between the groups (9.12 ± 3.20 standard group; 9.47 ± 3.49 intensive group [P < .0001]). DBP CV predicted a greater hazard for the primary outcome (hazard ratio [HR], 1.14) in the overall model as well as separate analyses by treatment arms (standard group HR, 1.15; intensive group HR, 1.19), each P < .0001. DBP CV also independently predicted a greater hazard for acute kidney injury (HR, 1.12) and hypotensive events (HR, 1.12). Visit-to-visit DBP variability independently predicted worse cardiovascular outcomes and hypoperfusion-related adverse events in SPRINT.

Blood Pressure Variability Predicts Adverse Events and Cardiovascular Outcomes in Chronic Kidney Disease: A Post-Hoc Analysis of the SPRINT Trial.

BACKGROUND: Visit-to-visit blood pressure variability has been associated with adverse cardiovascular outcomes. Using the SPRINT trial data set, we explored the relationship between blood pressure variability, cardiovascular outcomes, and hypoperfusion-related adverse events of antihypertensive therapy in patients with chronic kidney disease (CKD) enrolled in the study. METHODS: The analyses included patients with CKD randomized in SPRINT who reached the target systolic blood pressure for their respective groups (intensive <120 mm Hg; standard <140 mm Hg). Coefficients of variation (CV) for diastolic blood pressure (DBP) for each subject characterized variability. Cox proportional hazards regression was used to identify independent predictors of the SPRINT primary outcome (including acute coronary syndrome, stroke, acute heart failure, and death from cardiovascular causes) and the 3 major side effects of therapy-hypotension, syncope, and acute kidney injury (AKI). P <0.15 on univariate analysis was required to enter the model, and P <0.05 to remain in it. RESULTS: Overall, 2,488 subjects (1,273 standard; 1,124 intensive) met inclusion criteria. DBP CV predicted a greater hazard for primary outcome (hazard ratio [HR] 1.126, P < 0.0001) in the overall model as well as in separate analyses by treatment arms (standard group HR 1.107, P < 0.0001; intensive group HR 1.100, P = 0.0004). DBP CV also independently predicted a greater hazard for AKI (HR 1.117), syncope (HR 1.111), and hypotensive events (HR 1.104). CONCLUSION: Visit-to-visit DBP variability independently predicts worse cardiovascular outcomes and hypoperfusion-related adverse events in patients with CKD enrolled in SPRINT.

Prevalence and Clinical Significance of an E-Reversal Wave in the Left Ventricular Outflow Tract.

Diastolic waves are commonly seen in the left ventricular outflow tract on echocardiography. This work focuses on the E-reversal wave (Er) that occurs early in diastole, shortly after the mitral E wave. Factors associated with Er presence and velocity were investigated in a broad patient sample: 100 subjects with normal ejection fraction (EF >55%) and 100 subjects with reduced EF (<45%). Er presence was noted in 58% of the total cohort and correlated inversely with age. It was more common with normal EF (70% vs 45%, p = 0.0005) and was associated with higher mitral E velocity (78.3 ± 23.3 vs 68.4 ± 19.0 cm/s; p = 0.002) and septal e' velocity (6.7 ± 2.5 vs 5.3 ± 2.3 cm/s; p <0.0001). Er velocity was higher in the normal EF group (50 ± 18 vs 34 ± 13 cm/s, p <0.0001) and showed moderate correlation with septal e' velocity (r = 0.43; p <0.0001); 56 subjects experienced major adverse cardiovascular events (MACE) over 1.7 ± 0.3 years of follow-up. Those with an Er had less MACE (particularly heart failure), even after adjustment for multiple clinical and echocardiographic variables (OR 0.28, 95% CI 0.11 to 0.65; p = 0.003). When stratified by EF, the association between Er presence and MACE was significant only in the low EF group. Thus, Er occurs more commonly in younger subjects and those with preserved EF. It is associated with less MACE although this effect appears to be limited to patients with reduced EF.

Plantar talar head contusions and osteochondral fractures: associated findings on ankle MRI and proposed mechanism of injury.

OBJECTIVE: To evaluate the significance of plantar talar head injury (PTHI) in predicting osseous and soft tissue injuries on ankle MRI. MATERIALS AND METHODS: The IRB approved this HIPAA-compliant retrospective study. The study group consisted of 41 ankle MRIs with PTHI that occurred at our institution over a 5 ½ year period. Eighty MRIs with bone injuries in other locations matched for age, time interval since injury, and gender formed a control group. Injuries to the following structures were recorded: medial malleolus, lateral malleolus/distal fibula, posterior malleolus, talus, calcaneus, navicular, cuboid, lateral, medial and syndesmotic ligaments, spring ligament complex, and extensor digitorum brevis (EDB) muscle. Twenty separate logistic regressions determined which injuries PTHI predicted, using the Holm procedure to control for family-wise alpha at 0.05. RESULTS: PTHI strongly predicted the occurrence of injuries involving the anterior process of the calcaneus [24 % of cases, odds ratio (OR) 12.66], plantar components of the spring ligament (27 %, OR 9.43), calcaneal origin of the EDB and attachment of the dorsolateral calcaneocuboid ligament (22 %, OR 7.22), cuboid (51 %, OR 6.58), EDB (27 %, OR 5.49), anteromedial talus (66 %, OR 4.78), and posteromedial talus (49 %, OR 4.48). PTHI strongly predicted lack of occurrence of syndesmotic ligament injury (OR 19.6). The PTHI group had a high incidence of lateral ligamentous injury (78 %), but not significantly different from the control group (53 %). CONCLUSIONS: PTHI is strongly associated with injury involving the transverse tarsal joint complex. We hypothesize it results from talo-cuboid and/or talo-calcaneal impaction from a supination injury of the foot and ankle.

Persistent increase in red cell size distribution width after acute diseases: A biomarker of hypoxemia?

BACKGROUND: A biomarker of hypoxic exposure would be useful in clinical diagnosis and prognosis. Acute hypoxia stimulates large increases in serum erythropoietin (EPO), and EPO induces formation of characteristic enlarged red blood cells (RBCs). The presence of large RBCs perturbs red cell distribution width (RDW). METHODS: Using a >2M patient medical claims database, the human pathome was scanned for diseases where RDW rose 0-50days following a new diagnosis. The course of RDW after selected diagnoses was visualized by registering RDW measurements by diagnosis date. RESULTS: Acute hemorrhage, which provokes EPO-driven erythropoiesis, is followed by increases in RDW but not mean cell volume (MCV). Similar RDW increases follow many acute diseases with risk of hypoxia, including heart failure, pneumonia, atelectasis, pulmonary embolism, pneumothorax, and sepsis. Elevations reach maximum within 1month after onset and subside to pre-disease levels about 6months later. Unlike the case with iron-deficiency anemia (IDA), RDW elevations after hypoxia-associated diseases are unaccompanied by discernible change in average RBC size. CONCLUSIONS: As predicted by a model risk pathway linking hypoxia to formation of enlarged RBCs via EPO, acute hypoxemia-related disease episodes induce change in RBC size distribution. Further study is needed to explore whether a more sensitive and specific signal can be extracted from the fine structure of the RBC size distribution routinely measured in automated hemocytometers.

Percutaneous extraction of ePTFE-coated ICD leads: a single center comparative experience.

BACKGROUND: Percutaneous extraction of standard implantable cardioverter-defibrillator leads is often complicated by ingrowth of fibrotic tissue into the shocking coils. Leads with GORE™ expanded polytetrafluoroethylene (ePTFE) coating (W. L. Gore & Associates, Inc., Newark, DE, USA) designed to inhibit fibrosis are in use, but clinical data regarding their extraction are lacking. The study's purpose was to examine the feasibility, efficacy, and safety of percutaneous extraction involving defibrillator leads coated with ePTFE. METHODS: We analyzed our database to identify all percutaneously extracted leads with ePTFE-coated shocking coils. Lead and procedure characteristics were compared to a cohort of noncoated leads of similar implant duration. RESULTS: One hundred fifty-six leads were extracted from 145 patients; 57 ePTFE-coated leads, with a mean implant duration of 621 days, were extracted and compared to 99 noncoated leads, with a mean implant duration of 763 days (P = 0.0641). Mean extraction time was 5 minutes for coated leads versus 9.75 minutes for noncoated leads (P = 0.0001). Extraction time of less than 1 minute was more frequent with coated leads (61% vs 35%, P = 0.0025). Adjunct extraction tools were required less frequently with coated leads than noncoated leads (39% vs 63%, P = 0.0071). There was no fibrosis where ePTFE covered the shocking coils. Alternatively, 23 of 99 (23%) noncoated leads demonstrated fibrosis adherent to the shock coil. There were no procedure-related complications in either group. CONCLUSIONS: Compared to noncoated leads, ePTFE-coated leads are associated with shorter extraction times and are less likely to require extraction tools for removal. The difference is likely related to the absence of fibrosis over the ePTFE-coated high-energy coils.

Heart rate variability measures poorly predict atrial fibrillation after off-pump coronary artery bypass grafting.

STUDY OBJECTIVE: To investigate associations of heart rate variability (HRV) measurements with postoperative atrial fibrillation (AF) in patients undergoing off-pump coronary surgery. DESIGN: Prospective, observational, exploratory study. SETTING: Large university-affiliated community medical center. PATIENTS: 50 patients undergoing off-pump coronary artery bypass grafting (CABG). INTERVENTIONS: Preoperative recording of electrocardiograms (ECGs) with subsequent off-line HRV analysis. Monitored ECG telemetry for 5 days after operation. MEASUREMENTS: Frequency and time domain analyses, and additional non-linear HRV determinations. Multivariate regression analysis of predictors of postoperative AF. MAIN RESULTS: AF occurred in 23 (46%) patients. Only the low to high-frequency ratio was associated with AF (2.35 ± 1.8 v. 4.57 ± 5.0 for patients without AF, P < 0.05). CONCLUSIONS: The off-pump approach does not protect against AF, and nonlinear HRV analyses provide little value in predicting AF after off-pump CABG.

Prophylactic glycopyrrolate prevents bradycardia after spinal anesthesia for Cesarean section: a randomized, double-blinded, placebo-controlled prospective trial with heart rate variability correlation.

STUDY OBJECTIVE: To determine if prophylactic glycopyrrolate prevents bradycardia after spinal anesthesia. DESIGN: Prospective, randomized, double-blinded, placebo-controlled study. SETTING: Large university-affiliated community hospital. PATIENTS: 81 consecutive term parturients (not in active labor) who were scheduled for elective Cesarean section. INTERVENTIONS: Parturients received 1.0 to 1.5 L of intravenous Ringer's lactate and either glycopyrrolate 0.4 mg or an equal volume of saline, with caregivers blinded to the immediate sequelae of study drug. Each patient received intrathecal bupivacaine (12 to 14 mg) with morphine sulfate (0.1 to 0.2 mg). MEASUREMENTS: Continuous heart rate (HR) and blood pressure monitoring occurred for 20 minutes, with the minimum HR recorded for each 5-minute epoch. Heart rates < 60 beats per minute defined bradycardia. Heart rate variability (HRV) analysis occurred offline. MAIN RESULTS: None of 34 patients administered glycopyrrolate and 6 of 35 (17%) patients receiving saline experienced bradycardia (P = 0.02476). Time domain, frequency domain, and nonlinear and embedded spectrum entropy analyses all reflected the decrease in HRV accompanying administration of glycopyrrolate. CONCLUSION: Bradycardia after spinal anesthesia occurs commonly. Prophylactic glycopyrrolate may prevent the bradycardia, but not necessarily the hypotension.

The impact of immediate extubation in the operating room after cardiac surgery on intensive care and hospital lengths of stay.

OBJECTIVE: To determine if lengths of stay in intensive care and the hospital are associated with extubation in the operating room at the conclusion of cardiac surgery. DESIGN: A nonrandomized, observational study with propensity score-guided case-control matching of prospectively collected data. SETTING: Three interrelated, university-affiliated, community hospitals. PARTICIPANTS: Three thousand three hundred seventeen patients undergoing elective or urgent coronary artery, valve repair or replacement, or combined surgery between 2000 and 2006. INTERVENTIONS: Tracheal extubation occurred, based on history and intraoperative events, either immediately in the operating room or in the intensive care unit. MEASUREMENTS AND MAIN RESULTS: Of 3,317 patients in the institutions' Society of Thoracic Surgeons database, 3,089 were extubated within 24 hours, 69% of them in the operating room. Only 0.6% of patients extubated in the operating room required reintubation, compared with 5.9% extubated in the intensive care unit (p < 0.0001). By logistic regression, 12 of 25 preoperative and intraoperative factors generated a propensity score for each of the 2,595 patients with complete data, representing the likelihood of immediate extubation (c-statistic = 0.727). A "greedy 5 to 1" propensity score-matching technique created 713 matched pairs of patients by extubation pathway. Those undergoing immediate extubation had reductions in intensive care duration by 23 hours on average (median from 46 to 27 hours, p < 0.0001) and in hospital length of stay by 0.8 days on average (median = 6 for each, p < 0.0001). Cox regression, using matched pairs as strata, identified the following independent predictors of length of stay in the intensive care unit and hospital: immediate extubation in the operating room, need for reintubation, postoperative renal failure, and postoperative atrial fibrillation. CONCLUSIONS: Selection of patients for immediate extubation in the operating room by experienced clinicians was associated with shorter ICU and hospital stays. Immediate extubation rarely resulted in tracheal re-intubation.

Ventilatory management of the patient with hyperimmunoglobulinemia E (Job) syndrome.

Hyperimmunoglobulinemia E (Job syndrome) is a primary immunodeficiency that features abscesses of the skin, lung, and viscera; pneumonia; and elevated levels of serum immunoglobulin E. Pulmonary infections lead to lung abscesses, pneumatoceles, and bronchiectasis. We report the ventilatory management of a patient with Job syndrome.

Nonlinear heart rate variability analysis may predict atrial fibrillation after coronary artery bypass grafting.

BACKGROUND: Heart rate variability might predict arrhythmias after coronary artery bypass grafting. METHODS: Off-line processing of 10-min electrocardiogram recordings of consecutive patients provided R-R intervals for time domain, frequency domain, Poincaré, and point correlation analyses and subsequent association with postoperative atrial fibrillation by stepwise multivariate logistic regression. RESULTS: Of 88 patients who met entry criteria, 13 developed atrial fibrillation. Peak point correlation dimension (odds ratio 3.985/unit, P = 0.0096) and age (odds ratio 1.144/yr, P = 0.0019) were independently associated with atrial fibrillation (c-statistic = 0.839). CONCLUSIONS: Further study should confirm the ability of peak point correlation dimension to predict atrial fibrillation after coronary artery surgery with cardiopulmonary bypass.

Using heart rate variability to stratify risk of obstetric patients undergoing spinal anesthesia.

In this study, we evaluated whether point correlation dimension (PD2), a measure of heart rate variability, can predict hypotension accompanying spinal anesthesia for cesarean delivery. After the administration of spinal anesthesia with bupivacaine, hypotension was defined as systolic blood pressure

Does off-pump coronary artery bypass reduce the incidence of clinically evident renal dysfunction after multivessel myocardial revascularization?

In this prospective, observational trial, we determined whether off-pump coronary artery bypass (OPCAB) was associated with less postoperative renal dysfunction (RD) compared with coronary bypass surgery with cardiopulmonary bypass (CABG). All patients undergoing primary, isolated coronary surgery at our institution in the year 2000 participated. Data collected on each patient included demographics, preoperative risk factors for RD, perioperative events, and serum creatinine concentrations from date of admission until discharge or death. The criteria for RD was both a >or=50% increase from preoperative creatinine and an absolute postoperative creatinine >or=2.0 mg/dL (177 microM). Student's t-test or the Fisher's exact test was used to compare groups. Stepwise multiple logistic regression identified determinants of RD; P < 0.05 significant. The CABG group (n = 119) differed from the OPCAB group (n = 220) with respect to age (64 +/- 13 versus 67 +/- 10 yr, P = 0.0074) and number of distal grafts (median 4 versus 3, P = 0.0003). Type of operation did not associate with the presence of postoperative RD: 18 (8.2%) of 220 OPCAB patients versus 12 (10%) of 119 CABG patients (P = 0.55). Our data suggest that choice of operative technique (OPCAB versus CABG) is not associated with reduced renal morbidity.

Differentiation of perforated from nonperforated appendicitis at CT.

PURPOSE: To evaluate the sensitivity and specificity of five computed tomographic (CT) criteria in the differentiation of perforated from nonperforated appendicitis. MATERIALS AND METHODS: CT scans of 94 patients with surgically proven appendicitis were classified on review as showing perforation if one of five CT findings was present. The authors calculated the sensitivity and specificity for each finding by comparing the predicted outcome to the surgical and pathologic outcome. RESULTS: The perforated group comprised 39 patients and the nonperforated group comprised 55 patients. Sensitivity for abscess, phlegmon, extraluminal air, extraluminal appendicolith, and focal defect in enhancing appendiceal wall individually were 36%, 46%, 36%, 21%, and 64%, respectively. Sensitivity for any one of the five findings was 94.9%. Specificities were 100% for all findings except for phlegmon (95%). Groups differed with respect to age: 47 years +/- 19 (mean +/- SD) for perforated appendicitis and 30 years +/- 13 for nonperforated appendicitis (P <.001). Groups also differed with respect to appendiceal diameter: 15 mm +/- 4.9 for perforated appendicitis and 12 mm +/- 3.3 for nonperforated appendicitis (P =.049). CONCLUSION: A dedicated search for five specific CT findings allowed an overall sensitivity of 94.9% for perforated appendicitis. Among findings with 100% specificity, a focal defect in the enhancing appendiceal wall achieved the highest sensitivity.