Dexmedetomidine for reduction of atrial fibrillation and delirium after cardiac surgery (DECADE): a randomised placebo-controlled trial.

BACKGROUND: Atrial fibrillation and delirium are common consequences of cardiac surgery. Dexmedetomidine has unique properties as sedative agent and might reduce the risk of each complication. This study coprimarily aimed to establish whether dexmedetomidine reduces the incidence of new-onset atrial fibrillation and the incidence of delirium. METHODS: A randomised, placebo-controlled trial was done at six academic hospitals in the USA. Patients who had had cardiac surgery with cardiopulmonary bypass were enrolled. Patients were randomly assigned 1:1, stratified by site, to dexmedetomidine or normal saline placebo. Randomisation was computer generated with random permuted block size 2 and 4, and allocation was concealed by a web-based system. Patients, caregivers, and evaluators were all masked to treatment. The study drug was prepared by the pharmacy or an otherwise uninvolved research associate so that investigators and clinicians were fully masked to allocation. Participants were given either dexmedetomidine infusion or saline placebo started before the surgical incision at a rate of 0·1 µg/kg per h then increased to 0·2 µg/kg per h at the end of bypass, and postoperatively increased to 0·4 µg/kg per h, which was maintained until 24 h. The coprimary outcomes were atrial fibrillation and delirium occurring between intensive care unit admission and the earlier of postoperative day 5 or hospital discharge. All analyses were intention-to-treat. The trial is registered with ClinicalTrials.gov, NCT02004613 and is closed. FINDINGS: 798 patients of 3357 screened were enrolled from April 17, 2013, to Dec 6, 2018. The trial was stopped per protocol after the last designated interim analysis. Among 798 patients randomly assigned, 794 were analysed, with 400 assigned to dexmedetomidine and 398 assigned to placebo. The incidence of atrial fibrillation was 121 (30%) in 397 patients given dexmedetomidine and 134 (34%) in 395 patients given placebo, a difference that was not significant: relative risk 0·90 (97·8% CI 0·72, 1·15; p=0·34). The incidence of delirium was non-significantly increased from 12% in patients given placebo to 17% in those given dexmedetomidine: 1·48 (97·8% CI 0·99-2·23). Safety outcomes were clinically important bradycardia (requiring treatment) and hypotension, myocardial infarction, stroke, surgical site infection, pulmonary embolism, deep venous thrombosis, and death. 21 (5%) of 394 patients given dexmedetomidine and 8 (2%) of 396 patients given placebo, had a serious adverse event as determined by clinicians. 1 (<1%) of 391 patients given dexmedetomidine and 1 (<1%) of 387 patients given placebo died. INTERPRETATION: Dexmedetomidine infusion, initiated at anaesthetic induction and continued for 24 h, did not decrease postoperative atrial arrhythmias or delirium in patients recovering from cardiac surgery. Dexmedetomidine should not be infused to reduce atrial fibrillation or delirium in patients having cardiac surgery. FUNDING: Hospira Pharmaceuticals.

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.

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.

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.

Outcomes of physician patients after non-cardiac surgery: a registry analysis.

OBJECTIVES: When physicians become patients, they may expect special privileges, extra attention from caregivers, and non-routine treatments. Consequently, physician patients may not be treated per routine-which possibly worsens care rather than improving it. We thus tested the primary hypothesis that in-hospital mortality and major complications after non-cardiac surgery are more common in physician patients than in non-physician patients. PATIENTS AND METHODS: Perioperative data were extracted for patients who had non-cardiac surgery at the Cleveland Clinic between 2005 and 2013. We used propensity score matching to identify comparable groups of physician and non-physician patients. Matched physician and non-physician patients were compared on a composite of in-hospital mortality and major postoperative complications using a generalized equation average relative effects model. Secondly, the matched patients were also compared on reoperation using logistic regression and on duration of hospitalization using Kaplan-Meier analysis with the log-rank test and Cox proportional hazards regression. RESULTS: Among 21,173 qualifying patients, we matched 522 physician patients to 2448 non-physician controls. There were no significant differences between physician and non-physician patients in the composite of in-hospital mortality and major complications, with an estimated odds ratio across the outcome components (average relative effect) of 1.20 (95% confidence interval 0.77-1.87) for physicians vs. non-physicians, P = 0.41. There was also no difference in the risk of re-operation or duration of hospitalization. CONCLUSIONS: A variety of important outcomes were similar in physician patients and matched non-physician patients after non-cardiac surgery.