Incidence of postoperative opioid-induced respiratory depression episodes in patients on room air or supplemental oxygen: a post-hoc analysis of the PRODIGY trial.

BACKGROUND: Supplemental oxygen (SO) potentiates opioid-induced respiratory depression (OIRD) in experiments on healthy volunteers. Our objective was to examine the relationship between SO and OIRD in patients on surgical units. METHODS: This post-hoc analysis utilized a portion of the observational PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) trial dataset (202 patients, two trial sites), which involved blinded continuous pulse oximetry and capnography monitoring of postsurgical patients on surgical units. OIRD incidence was determined for patients receiving room air (RA), intermittent SO, or continuous SO. Generalized estimating equation (GEE) models, with a Poisson distribution, a log-link function and time of exposure as offset, were used to compare the incidence of OIRD when patients were receiving SO vs RA. RESULTS: Within the analysis cohort, 74 patients were always on RA, 88 on intermittent and 40 on continuous SO. Compared with when on RA, when receiving SO patients had a higher risk for all OIRD episodes (incidence rate ratio [IRR] 2.7, 95% confidence interval [CI] 1.4-5.1), apnea episodes (IRR 2.8, 95% CI 1.5-5.2), and bradypnea episodes (IRR 3.0, 95% CI 1.2-7.9). Patients with high or intermediate PRODIGY scores had higher IRRs of OIRD episodes when receiving SO, compared with RA (IRR 4.5, 95% CI 2.2-9.6 and IRR 2.3, 95% CI 1.1-4.9, for high and intermediate scores, respectively). CONCLUSIONS: Despite oxygen desaturation events not differing between SO and RA, SO may clinically promote OIRD. Clinicians should be aware that postoperative patients receiving SO therapy remain at increased risk for apnea and bradypnea. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02811302, registered June 23, 2016.

Incidence of Neuraxial and Non-Neuraxial Hematoma Complications From Spinal Cord Stimulator Surgery: Systematic Review and Proportional Meta-Analysis.

OBJECTIVE: The goal of this meta-analysis was to estimate the incidence of total hematomas, neuraxial hematomas, and non-neuraxial hematomas in patients who underwent temporary spinal cord stimulator (SCS) lead trial placement and permanent implantation of SCS leads and internal pulse generator (IPG). MATERIALS AND METHODS: A comprehensive search was conducted of databases of any publications before October 21, 2021. Eligible study designs included randomized control trials and prospective or retrospective observational studies with more than ten patients. The primary outcome variables were the incidences of total hematomas, neuraxial hematomas, and non-neuraxial hematomas in patients with SCS. These dichotomous categorical outcomes were abstracted from studies after Freeman-Tukey arcsine square root transformation using random-effects meta-analysis (DerSimonian and Laird method). Pooled incidence rates and 95% CIs were calculated for each outcome variable. RESULTS: A total of 40 studies met the inclusion criteria. Included in the neuraxial and non-neuraxial hematoma analyses were 4751 patients and 3862 patients, respectively. The pooled incidence of any hematoma in patients with SCS was 0.81% (95% CI, 0.45%-1.27%). The pooled incidence of neuraxial hematoma in patients with SCS was 0.32% (95% CI, 0.18%-0.50%). This included primarily epidural hematomas (11/4751) but also comprised an intracranial hemorrhage in a patient on enoxaparin bridge therapy from warfarin and one patient not on anticoagulation with an intracranial subdural hematoma that resulted in death. The pooled incidence of non-neuraxial hematomas in patients with SCS was 0.59% (95% CI, 0.29%-1.00%). CONCLUSION: The overall incidence of hematomas in patients with temporary SCS trial lead placement and permanent SCS/IPG implantations is less than 1%. Furthermore, the incidence of neuraxial hematomas is less than 0.5%, which is of particular interest given the potential devastating consequences of this complication. The results of this study can be used to inform patients and implanting physicians on hematoma complications from SCS and highlight that the benefits of SCS outweigh the hematoma risks if anticoagulation is appropriately managed perioperatively.

Frequency and Temporal Distribution of Postoperative Respiratory Depressive Events.

BACKGROUND: The frequency and temporal distribution of postoperative respiratory depression (RD) events are not completely understood. This study determined the temporal distribution and frequency of RD episodes in postsurgical patients continuously monitored by bedside capnography and pulse oximetry. METHODS: This was a post hoc study of a subset of postsurgical patients enrolled in The PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) trial from 2 sites in the United States. These patients had undergone continuous bedside monitoring on general care wards. These data were adjudicated for potential RD episodes. The number of RD episodes per patient and the time of each RD episode were determined. The first RD episode experienced by a patient was classified as an "initial" episode, and the initial and all subsequent RD episodes experienced by a patient were classified as "all" episodes. A PRODIGY risk score was calculated. RESULTS: Data analyzed from 250 patients contained 2539 RD episodes in 155 (62.0%, 95% confidence interval, 55.7-68.0) patients with median 2 [0-8], range of 0-545 RD episodes per patient, with a PRODIGY risk score distribution of 100 (40.0%) low, 79 (31.6%) intermediate, 70 (28.0%) high (missing data from 1 patient). Median time to the initial RD episode was 8.8 [5.1-18.0] hours postoperatively. There was a peak occurrence of initial RD events between 14:00 and 20:00 on the day of surgery, and these were associated with a large number of subsequent events in the same timeframe. The peak time of all RD episodes occurred from 02:00 to 06:00. Patients with high PRODIGY risk scores had higher incidence and greater number of RD episodes per patient (P < .001, overall comparisons between groups for both incidence [χ2] and number of episodes [Kruskal-Wallis test]). CONCLUSIONS: Continuous monitoring of surgical patients demonstrates that RD episodes are common, and risk increases with higher PRODIGY scores. In this patient cohort, the rate of initial RD episodes peaked in the afternoon to early evening, while peak rate of all RD episodes occurred in early morning. Further, among patients with RD episodes, the number of episodes increased with higher PRODIGY scores.

Comparison of expected and observed outcomes for septal myectomy in hypertrophic obstructive cardiomyopathy.

BACKGROUND: Septal myectomy remains the criterion standard for treatment of symptomatic, medically refractory hypertrophic cardiomyopathy (HCM). There is no specific surgical risk calculator for septal myectomy. METHODS: This study compares the outcomes of septal myectomy at a tertiary referral center with predicted outcomes of mitral valve (MV) repair and aortic valve replacement (AVR) using the Society of Thoracic Surgeons Adult Cardiac Surgery Risk Calculator (STS Calculator). A total of 298 consecutive patients with HCM underwent isolated septal myectomy from 2011 to 2014. Observed outcomes of septal myectomy were compared with the STS Calculator predicted risk of isolated MV repair and AVR predicted within this population using 1-sample tests of proportions. RESULTS: Thirty-day mortality for myectomy in this cohort was zero. STS Calculator predicted risk of mortality for MV repair was 0.7% (P = .14) and for AVR = 1.1% (P = .06). Follow-up for vital status was 6.0 ±â€¯0.7 years, at which 294 (98.7%) patients were alive. Hospital stay length was 4.9 ±â€¯1.9 days. One (0.3%) patient experienced a postoperative deep sternal wound infection, and 1 (0.3%) patient experienced a prolonged ventilated state. Postoperative atrial fibrillation occurred in 64 (21.5%) patients. During 30 days of follow-up, no patients experienced stroke, renal failure, or needed dialysis. CONCLUSIONS: Septal myectomy, performed in a tertiary referral center, had a 30-day mortality rate of 0% and low morbidity rate. There was no difference between observed myectomy mortality and STS Calculator predicted risk for AVR and MV repair. It is possible that a larger sample could reveal lower mortality than STS prediction.

Efficacy of Low-Dose Naltrexone and Predictors of Treatment Success or Discontinuation in Fibromyalgia and Other Chronic Pain Conditions: A Fourteen-Year, Enterprise-Wide Retrospective Analysis.

Current pharmacologic treatments may provide limited analgesia in fibromyalgia and other chronic pain disorders. Low-dose naltrexone (LDN) has emerged as a potential analgesic option that has been minimally explored. This study aims to describe current real-world prescribing practices of LDN, to investigate if patients have a perceived benefit of LDN in treating pain symptoms and to identify predictors associated with a perceived benefit or discontinuation of LDN. We evaluated all outpatient prescriptions for LDN prescribed for any pain indication in the Mayo Clinic Enterprise from 1 January 2009 to 10 September 2022. A total of 115 patients were included in the final analysis. The patients were 86% female, had a mean age of 48 ± 16 years, and 61% of prescriptions were for fibromyalgia-related pain. The final daily dose of oral LDN ranged from 0.8 to 9.0 mg, while the most common dose was 4.5 mg once daily. Of patients who reported follow-up data, 65% reported benefit in their pain symptoms while taking LDN. Adverse effects were reported in 11 (11%) patients and 36% discontinued taking LDN by the most recent follow-up. Concomitant analgesic medications were used by 60% of patients and were not associated with perceived benefit nor discontinuation of LDN, including concomitant opioids. LDN is a relatively safe pharmacologic option that may benefit patients with chronic pain conditions and warrants further investigation in a prospective, controlled, and well-powered randomized clinical trial.

Differences in Sedentary Time, Light Physical Activity, and Steps Associated with Better COPD Quality of Life.

INTRODUCTION: There is a knowledge gap about how much physical activity is recommended to patients with chronic obstructive pulmonary disease (COPD). We asked, what is the average difference in sedentary time and physical activity associated with clinically meaningful differences in symptoms in a large, well-characterized cohort of patients with advanced COPD? STUDY DESIGN AND METHODS: We conducted a cross-sectional analysis of daily activity data in 292 patients with stable COPD. Activity measure coefficients from multivariable linear models were used to predict the average difference in activity between patients with twice the minimal clinically important difference in reported symptoms. RESULTS: Symptoms were assessed with the Chronic Respiratory Disease Questionnaire subdomains - dyspnea, fatigue, mastery, and emotions. Daily steps, minutes in light physical activity, and sedentary time were measured by triaxial accelerometers. Average sedentary time, light physical activity, and steps were 767.6 minutes, 177.7 minutes, and 2960 steps, respectively. Individuals with 1-point better dyspnea scores averaged 24.5 (8.4-40.5) minutes less sedentary time per day. Individuals with 1-point better dyspnea and fatigue scores averaged 21.5 (10.9-32.3) minutes or 12.5 (2.0-23.2) minutes more light physical activity per day, respectively. Individuals with 1-point better dyspnea, fatigue, mastery, and emotions scores averaged 762 (546-984), 579 (351-814), 418 (207-636), and 392 (157-634) more steps per day, respectively. CONCLUSIONS: We provide guidance to clinicians counseling patients with severe COPD in activity-related goal setting on sedentary time, light physical activity, and steps associated with better symptoms.