Post-operative Complication Rate Comparison Between Airway Surgery and Upper Airway Stimulation Using NSQIP and ADHERE
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ABSTRACT: Objective
Postoperative complication rates were compared between obstructive sleep
SUBMITTER: Van Daele D
PROVIDER: S-EPMC8512284 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Upper airway stimulation (UAS) has been shown to reduce severity of obstructive sleep apnoea. The aim of this study was to identify predictors of UAS therapy response in an international multicentre registry.Patients who underwent UAS implantation in the United States and Germany were enrolled in an observational registry. Data collected included patient characteristics, apnoea/hypopnoea index (AHI), Epworth sleepiness scale (ESS), objective adherence, adverse events and patient satisfaction measures. Post hoc univariate and multiple logistic regression were performed to evaluate factors associated with treatment success.Between October 2016 and January 2018, 508 participants were enrolled from 14 centres. Median AHI was reduced from 34 to 7?events·h-1, median ESS reduced from 12 to 7 from baseline to final visit at 12-month post-implant. In post hoc analyses, for each 1-year increase in age, there was a 4% increase in odds of treatment success. For each 1-unit increase in body mass index (BMI), there was 9% reduced odds of treatment success. In the multivariable model, age persisted in serving as statistically significant predictor of treatment success.In a large multicentre international registry, UAS is an effective treatment option with high patient satisfaction and low adverse events. Increasing age and reduced BMI are predictors of treatment response.
| S-EPMC6319796 | biostudies-literature
Project description:Objective/hypothesisThe ADHERE Registry is a multicenter prospective observational study following outcomes of upper airway stimulation (UAS) therapy in patients who have failed continuous positive airway pressure therapy for obstructive sleep apnea (OSA). The aim of this registry and purpose of this article were to examine the outcomes of patients receiving UAS for treatment of OSA.Study designCohort Study.MethodsDemographic and sleep study data collection occurred at baseline, implantation visit, post-titration (6 months), and final visit (12 months). Patient and physician reported outcomes were also collected. Post hoc univariate and multivariate analysis was used to identify predictors of therapy response, defined as ≥50% decrease in Apnea-Hypopnea Index (AHI) and AHI ≤20 at the 12-month visit.ResultsThe registry has enrolled 1,017 patients from October 2016 through February 2019. Thus far, 640 patients have completed their 6-month follow-up and 382 have completed the 12-month follow-up. After 12 months, median AHI was reduced from 32.8 (interquartile range [IQR], 23.6-45.0) to 9.5 (IQR, 4.0-18.5); mean, 35.8 ± 15.4 to 14.2 ± 15.0, P < .0001. Epworth Sleepiness Scale was similarly improved from 11.0 (IQR, 7-16) to 7.0 (IQR, 4-11); mean, 11.4 ± 5.6 to 7.2 ± 4.8, P < .0001. Therapy usage was 5.6 ± 2.1 hours per night after 12 months. In a multivariate model, only female sex and lower baseline body mass index remained as significant predictors of therapy response.ConclusionsAcross a multi-institutional study, UAS therapy continues to show significant improvement in subjective and objective OSA outcomes. This analysis shows that the therapy effect is durable and adherence is high.Level of evidence2 Laryngoscope, 130:1333-1338, 2020.
| S-EPMC7217178 | biostudies-literature
Project description:Purpose:Pathological metastatic fractures in lower-extremity weight bearing bones often require surgical reconstruction. Post-operative radiation is routinely recommended following surgical reconstruction. This study evaluated the clinical outcomes of patients that undergo surgical fixation of an established or an impending pathologic lower extremity fracture without post-operative radiation. Materials and methods:A retrospective chart review of patients at Sunnybrook Health Sciences Center between 2007 and 2019 was performed. Descriptive statistical analyses were performed. Results:A total of 161 surgical reconstruction procedures were identified. Among these cases, 86/161 (53.4%) received post-operative radiation, 75/161 (47%) did not receive post-operative radiation within 12 weeks of their index surgery. Of the 75 patients not receiving post-operative radiation, 40 patients had prior radiation to the surgical site and 35 patients were radiation naïve. 5 patients (6.7%) required a second operation to the index surgical site, with 4 patients (5.3%) requiring a second fixation surgery to stabilize hardware at a median of 6.0 months post-surgery. Post-surgical radiation to the surgical site (at >12 weeks) was administered to 12 patients (16.0%) at a median of 9.1 months post-surgery. Conclusions:The surgical revision rate was low despite absence of immediate post-operative radiation therapy and was similar to prior reports in patients receiving post-operative radiation.
| S-EPMC7262003 | biostudies-literature
Project description:BackgroundImplantation of deep brain stimulation (DBS) electrodes for the treatment of involuntary movement disorders, such as Parkinson's disease, routinely relies on the use of intraoperative electrophysiological confirmation to identify the optimal therapeutic target in the brain. However, only a few options exist to visualize the relative anatomic localization of intraoperative electrophysiological recordings with respect to post-operative imaging. We have developed a novel processing pipeline to visualize intraoperative electrophysiological signals registered to post-operative neuroanatomical imaging.New methodWe developed a processing pipeline built on the use of ITK-SNAP and custom MATLAB scripts to visualize the anatomical localization of intraoperative electrophysiological recordings mapped onto the post-operative MRI following implantation of DBS electrodes. This method combines the user-defined relevant electrophysiological parameters measured during the surgery with a manual segmentation of the DBS electrode from post-operative MRI; mapping the microelectrode recording (MER) depths along the DBS lead track.ResultsWe demonstrate the use of our processing pipeline on data from Parkinson's disease patients undergoing DBS implantation targeted to the subthalamic nucleus (STN). The primary processing components of the pipeline are: extrapolation of the lead wire and alignment of intraoperative electrophysiology.ConclusionWe describe the use of a processing pipeline to aid clinicians and researchers engaged in deep brain stimulation work to correlate and visualize the intraoperative recording data with the post-operative DBS trajectory.
| S-EPMC6205403 | biostudies-literature
Project description:OBJECTIVE:Hypoalbuminemia, a known marker for malnutrition, has been associated with an increased risk for perioperative morbidity and poor prognosis in patients with solid tumors. The aim of this study was to investigate the prognostic and predictive value of pre-treatment serum albumin levels for survival and postoperative complications in patients with vulvar cancer undergoing surgery. METHODS:Within in this retrospective study, we assessed data of 103 consecutive patients with vulvar cancer undergoing primary surgery into this study. Pre-treatment serum albumin levels were correlated with clinico-pathological parameters and complications. We performed univariate log-rank test and multivariable Cox regression models to evaluate the association between pre-treatment serum albumin and survival. RESULTS:We found hypoalbuminemia (< 35 mg/dl) in 9 of 103 (8.7%) patients. No difference in tumor characteristics was observed between patients with hypoalbuminemia and normal serum albumin levels. Difference in postoperative complications (55.6% and 37.8% of patients with hypoalbuminemia and normal serum albumin levels, respectively) was not statistically significant (p = 0.345). Shorter overall survival (OS) was observed in patients with hypoalbuminemia (5-year OS rate 17.1%) when compared to patients with normal serum albumin levels (5-year OS rate 58.6%, p = 0.004). In multivariable analysis, age (p = 0.017), FIGO stage (p = 0.011) and serum albumin levels (p = 0.013) were independently associated with OS. CONCLUSION:Pre-treatment hypoalbuminemia is an independent prognostic biomarker for OS in patients with vulvar cancer. We did not find an association between pre-treatment hypoalbuminemia and a higher risk for postoperative complications.
| S-EPMC6759670 | biostudies-other
Project description:ObjectiveThere is limited evidence to clarify the specific relationship between pre-operative blood urea nitrogen (BUN) and post-operative 30-day mortality in patients undergoing craniotomy for tumors. Therefore, we aimed to investigate this relationship in detail.MethodsElectronic medical records of 18,642 patients undergoing craniotomy for tumors in the ACS NSQIP from 2012 to 2015 were subjected to secondary retrospective analysis. The principal exposure was pre-operative BUN. Outcome measures were post-operative 30-day mortality. We used binary logistic regression modeling to evaluate the association between them and conducted a generalized additive model and smooth curve fitting (penalized spline method) to explore the potential relationship and its explicit curve shape. We also conducted sensitivity analyses to ensure the robustness of the results and performed subgroup analyses.ResultsA total of 16,876 patients were included in this analysis. Of these, 47.48% of patients were men. The post-operative 30-day mortality of the included cases was 2.49% (420/16,876), and the mean BUN was 16.874 ± 6.648 mg/dl. After adjusting covariates, the results showed that pre-operative BUN was positively associated with post-operative 30-day mortality (OR = 1.020, 95% CI: 1.004, 1.036). There was also a non-linear relationship between BUN and post-operative 30-day mortality, and the inflection point of the BUN was 9.804. For patients with BUN < 9.804 mg/dl, a 1 unit decrease in BUN was related to a 16.8% increase in the risk of post-operative 30-day mortality (OR = 0.832, 95% CI: 0.737, 0.941); for patients with BUN > 9.804 mg/dl, a 1 unit increase in BUN was related to a 2.8% increase in the risk of post-operative 30-day mortality (OR = 1.028, 95% CI: 1.011, 1.045). The sensitivity analysis proved that the results were robust. The subgroup analysis revealed that all listed subgroups did not affect the relationship between pre-operative BUN and post-operative 30-day mortality (P > 0.05).ConclusionOur study demonstrated that pre-operative BUN (mg/dl) has specific linear and non-linear relationships with post-operative 30-day mortality in patients over 18 years of age who underwent craniotomy for tumors. Proper pre-operative management of BUN and maintenance of BUN near the inflection point (9.804 mg/dl) could reduce the risk of post-operative 30-day mortality in these cases.
| S-EPMC9344969 | biostudies-literature
Project description:Obstructive sleep apnea (OSA) is characterized by recurrent upper airway obstruction during sleep. OSA leads to high cardiovascular morbidity and mortality. The pathogenesis of OSA has been linked to a defect in neuromuscular control of the pharynx. There is no effective pharmacotherapy for OSA. The objective of this study was to determine whether upper airway patency can be improved using chemogenetic approach by deploying designer receptors exclusively activated by designer drug (DREADD) in the hypoglossal motorneurons. DREADD (rAAV5-hSyn-hM3(Gq)-mCherry) and control virus (rAAV5-hSyn-EGFP) were stereotactically administered to the hypoglossal nucleus of C57BL/6J mice. In 6-8 weeks genioglossus EMG and dynamic MRI of the upper airway were performed before and after administration of the DREADD ligand clozapine-N-oxide (CNO) or vehicle (saline). In DREADD-treated mice, CNO activated the genioglossus muscle and markedly dilated the pharynx, whereas saline had no effect. Control virus treated mice showed no effect of CNO. Our results suggest that chemogenetic approach can be considered as a treatment option for OSA and other motorneuron disorders.
| S-EPMC5345079 | biostudies-literature
Project description:Study designRetrospective cohort study.ObjectiveTo determine the effects of operative time on postoperative complications in patients age 65 and older undergoing posterior lumbar fusion.MethodsAll patients age 65 and older undergoing posterior lumbar fusion were identified in the 2012 to 2015 American College of Surgeons National Surgical Quality Improvement Program database. The primary outcome measures were complications occurring up to 30 days postoperatively, including death, any complication, and complication subtypes. The primary independent variable was operative duration. Both bivariate and multivariate analyses utilized logistic regression and analyzed operative duration as a continuous variable. Statistical significance was considered P < .05.ResultsA total of 4947 patients age 65 and older undergoing posterior lumbar fusion were identified. The mean operative time was 3.3 hours (SD 1.7). The overall complication rate was 13.4% (n = 665). In multivariate analysis, each incremental hour of operative time was associated with increased risk of postoperative thromboembolism (odds ratio [OR] = 1.23; 95% confidence interval [CI] = 1.10-1.37), transfusion (OR= 1.25; 95% CI = 1.18-1.32), urinary tract infection (OR = 1.21; 95% CI = 1.10-1.32), and total postoperative complications (OR = 1.22; 95% CI = 1.16-1.27).ConclusionFor patients age 65 and older undergoing posterior lumbar fusion, longer operative time is associated with greater risk for thromboembolism, transfusion, intubation, kidney injury, urinary tract infection, surgical site infection, and overall postoperative complications. This data highlights several specific complications that are influenced by operative time in older patients, and further supports the need for future protocols that seek to safely minimize operative time for posterior lumbar fusion.
| S-EPMC6448197 | biostudies-literature
Project description:Study objectivesUpper airway stimulation (UAS) is an alternative treatment for obstructive sleep apnea that must be activated nightly. Although the implanted device offsets the mask- or pressure-related side effects often associated with continuous positive airway pressure therapy, some UAS recipients do not use the therapy consistently. This study qualitatively explored factors associated with UAS usage in obstructive sleep apnea patients.MethodsSemistructured interviews were conducted with 24 obstructive sleep apnea patients who received UAS treatment. Twelve patients were categorized as high users with mean usage of ≥ 4 hours/night and 12 were categorized as low users with < 4 hours/night or nonuse. Interviews explored patients' experiences regarding barriers and facilitators to UAS use and their advice for new UAS recipients. Demographic and clinical data including the Insomnia Severity Index and Generalized Anxiety Disorder Scale were collected.ResultsCompared to high users, low users had higher levels of insomnia (mean Insomnia Severity Index: 3.6 vs 15.2, respectively) and anxiety (mean Generalized Anxiety Disorder Scale: 3.4 vs 6.9). High users reported more positive experiences with UAS treatment, such as improvements in symptoms and convenience of treatment, as facilitators of use. Low users tended to focus on the negative aspects of treatment, particularly stimulation-related discomfort and associated sleep disturbance.ConclusionsInsomnia with or without anxiety contributes to differing patient-reported experiences in high vs low user groups, with increased insomnia symptoms among low users. Improved understanding of the specific barrier and facilitators of UAS adherence may drive better long-term use and more personalized management strategies, including concomitant insomnia treatment.Clinical trials registrationRegistry: ClinicalTrials.gov; Name: Stimulation Therapy for Apnea: Reporting Thoughts (START); URL: https://clinicaltrials.gov/ct2/show/NCT04768543; Identifier: NCT04768543.CitationLuyster FS, Ni Q, Lee K, et al. Factors affecting obstructive sleep apnea patients' use of upper airway stimulation treatment. J Clin Sleep Med. 2022;18(9):2207-2215.
| S-EPMC9435328 | biostudies-literature
Project description:Study objectivesUpper airway stimulation (UAS) is an innovative surgical treatment for obstructive sleep apnea; however, the treatment failure rate is approximately 22%. Easy arousability may limit the tolerability of stimulation and, by extension, its effectiveness. The odds ratio product (ORP) is a continuous electroencephalographic metric of arousal propensity (range: 0 [deep sleep] to 2.5 [full wakefulness]), and its rate of decline after arousal (ORP-9) is a risk factor for susceptibility to arousal in the presence of frequent arousal stimuli. We hypothesized that individuals with deeper sleep (low average ORP and low ORP-9) are more likely to respond to UAS.MethodsORP and ORP-9 were calculated from 126 baseline polysomnograms of participants in the STAR Trial. These values were compared between responders and nonresponders. Adjusted linear modeling was performed to determine the association between ORP-derived variables and treatment response.ResultsNo differences were found between responders and nonresponders in unadjusted comparisons of ORP-derived variables. On linear regression modeling, significant correlation was found between non-rapid eye movement ORP and reduction in apnea-hypopnea index (P = .004).ConclusionsNo significant difference in ORP was noted between responders and nonresponders to UAS therapy; however, contrary to our initial hypothesis, linear regression modeling trended toward a positive relationship between ORP and UAS response, suggesting that those who have lighter sleep are more likely to respond to therapy; however, these results are only exploratory, and future larger prospective studies are needed to confirm this relationship.Clinical trial registrationRegistry: ClinicalTrials.gov; Name: STAR Trial; Identifier: NCT01161420.
| S-EPMC8020691 | biostudies-literature