Greater Proportion Of Patients Research Articles

Abstract 13134: Comparative Analysis of Implantable Loop Recorder Devices

Implantable loop recorders ILR are used for diagnosis and evaluation of Atrial fibrillation and Syncope. The devices mainly utilize RR variability to determine an episode of AF.Diagnosis of bradycardia is based on rate and absence of any R wave. Presence of a P wave is not a prerequisite.In this Retrospective study we used recorded electrogram characteristics obtained with two ILRs. Hypothesis-The R wave amplitude and clarity of P wave facilitates correct diagnosis of AF and any heart block .This would also infuence any undersensing and oversensing Methods-The two ILRs were Medtronic Reveal I & Biomonitor III.The Biomonitor is 77.5x8.6 x4.4 mm whereas LINQ I is 44.8x7.2x4 mm. Main difference in the two is that BioMonitor III has larger sensing area ( 77.5 vs 44.8). Results 106 patients were included in this analysis 53 patients had Medtronic Reveal I and the remaining 53 patients had a BioMonitor III. We compared the amplitude of the R wave, presence of P wave, Undersensing and Oversensing of recorded events. Group I = patients who had Medtronic reveal I, 19 Males, 34 Females, mean age 74+11 BMI=28.83±6.8 Indication was AF in 38 & syncope in 15. Mean R wave was 0.48 mV±0.38, Clear P waves were noted in 16/53. Oversensing noted in 8/53, Undersensing in 4/53. Group I I = patients with BioMonitor III 27 Males, 26 Females,Mean age 73+10 Mean BMI 29.20±5.35. Indication was AF in 37 & syncope in 16.Mean R wave was 0.65 mV±0.37. Clear P waves noted in 33/53. Oversensing noted in 8/53, Undersensing in 0/53. Group II( BM III) had significantly greater R wave amplitude (p=0.02), the presence of a P wave in sinus rhythm was in significanly greater number of patients (p=0.009) There was no significant difference in proportion of patients with oversensing in the two groups ( p=0.09 ) However undersensing was seen in significanly less No of patients in Group II as compared to Group I ( p= 0.04). The two groups are matched for age sex, BMI , indication for implantation. Conclusions 1 In ILRs the recordings obtained with a Biomonitor III ( larger recording area ) had significantly greater amplitude of R wave and a greater proportion of patients with a clear P wave as compared to a Medtronic Reveal 1 ILR 2. Undersensing is also less seen with the Biomonitor ILR which may be related to the R wave amplitude.

Use of Ultrasound-Guided Tendon Fenestration and Injection Procedures for Treatment of Tendinosis

Introduction. Overuse injuries such as tendinosis are a common complaint at sports medicine clinics. When conservative management for tendinosis has failed, ultrasound-guided tendon fenestration and injection procedures such as dry needling, needling tenotomy, autologous whole blood injections, and prolotherapy can be utilized for treatment. This study examined the effectiveness of these procedures for pain improvement and ability to return to activity for patients with tendinosis. Methods. This study included patients 15 years or older who underwent at least one treatment for tendinosis at a sports medicine clinic between January 1, 2014 through April 17, 2019. A CPT code query was used to screen patient charts for study inclusion. Results. In total, 680 patients’ data were reviewed, and 343 patients met inclusion criteria. Patients underwent a total of 598 unique procedures. Dry needling represented most procedures (62.8%, n=375). Most patients reported diminished pain at follow up (73.0%, n=268). Prolotherapy had the highest percentage of patients reporting diminished pain (81.0%, n=17). Most patients were able to return to activity (47.4%, n=172) at follow-up. A greater proportion of patients with autologous whole blood injection were able to return to activity (60.7%, n=85). Conclusions. Most patients with tendinosis who underwent tendon fenestration or injection procedures reported diminished pain at follow-up. Autologous whole blood injection may be more likely to diminish patient pain and allow return to activity than other procedure types. More research is needed across all anatomical sites to compare the generalized effectiveness of these procedures.

The effect of complex therapy on the quality of life in patients with arterial hypertension on the background of gout

Abstract. Gout remains the most common type of inflammatory arthritis worldwide. Hypertension (AH) prevails in the structure of comorbid diseases in gout. In patients with hypertension in combination with gout, the problem of choosing treatment tactics remains quite relevant. Aim. To assess the effectiveness of the combination of basic therapy drugs for the treatment of patients with hypertension in combination with gout on quality of life indicators at the primary level of medical care. Materials and methods. Two groups of patients were formed. The first group, 36 patients who received losartan, allopurinol, atorvastatin. The second group, 36 people who received ramipril, allopurinol, atorvastatin. Quality of life was assessed using the SF-36 standardized questionnaire. The patient's functional status was assessed using the HAQ-DI health status questionnaire. Statistical analysis was performed using Statistica 6.1. Results. In the studied groups of patients, the quality of life of patients before and after treatment was evaluated. It was established that before the appointment of treatment, no significant difference was found between the groups according to the SF-36, HAQ-DI questionnaires. In patients of both groups, the indicators of the physical component of health (PCH) and the psychological component of health (PsCH) on the SF-36 scale were reduced, and a greater proportion of patients with minimal and moderate impairment of vital activity according to the HAQ-DI was registered. According to the results of the analysis, it was established that the level of quality of life according to the PCH indicator increased by 21.7 % in the first group and by 20.4 % in the second group (p < 0.01), according to the PsCH indicator – by 18.4 % and 17.5 % (p < 0.01), respectively. A probable decrease in the HAQ-DI indicator was found only in patients who received ramipril compared to the initial data before treatment by 33.3 % (р < 0.05). In patients of the I group, the share of patients with minimal disorders is increasing, and the proportion of patients with moderate disorders is decreasing, and in the II group, the prevalence of minimal and moderate disorders is increasing, which indicates the effectiveness of the prescribed therapy. Conclusions. Complex therapy (losartan or ramipril, allopurinol, atorvastatin) for 6 months in patients with hypertension in combination with gout is accompanied by a significant improvement in the quality of life according to the indicators of PCH (25.1 %, p < 0.01) and PsCH (17.7 %, p < 0.01) and degree of vital activity (25.0 %, p < 0.01).

Low plasma renin activity is associated with “Apparently” idiopathic atrial fibrillation

BackgroundPrevious studies have reported the direct or indirect relationship between the renin-angiotensin-aldosterone system (RAAS) and atrial fibrillation (AF). However, in patients with “apparently” idiopathic AF without possible external influence, whether RAAS is dysregulated at an early stage of AF and its relationship with the recurrence of AF after ablation have not been studied. MethodsThis single-center, prospective, case-control study included apparently healthy individuals with AF (the case group) or paroxysmal supraventricular tachycardia (PSVT, the control group) referred for catheter ablation at the same period. The primary outcome was RAAS activation in these two groups. The secondary outcome was the 1-year recurrence of AF after ablation. ResultsThis study included 51 “apparently” idiopathic AF and 91 patients with PSVT. A greater proportion of patients in the case group had plasma renin activity (PRA) levels < 1 ng/ml/h compared to the control group (25.5 % vs. 7.7 %, P = 0.003). PRA < 1 ng/ml/h was the only factor found to be associated with the diagnose of AF in both the univariate model (odds ratio [OR] 4.11, 95 % confidence interval [CI] 1.52–11.11, P = 0.005) and the model adjusted for age and sex (OR 3.98, 95 % CI 1.20–13.25, P = 0.024). A similar pattern was seen with paroxysmal AF. No significant difference in the components of RAAS was observed between 11 patients with the recurrence of AF and 40 without the recurrence at the 1-year follow-up. ConclusionsThis observational study revealed an association between low renin activity and the diagnosis of “apparently” idiopathic AF, particularly paroxysmal AF.

Prevalence of Metabolic Syndrome in Patients with Type2 Diabetes in Japan: A Retrospective Cross-Sectional Study.

Recent data on the prevalence of metabolic syndrome in Japanese patients with type2 diabetes (T2D) are limited. This retrospective, cross-sectional, observational study investigated the prevalence of metabolic syndrome in patients with T2D using a Japanese administrative claims database. Patients with a T2D diagnosis, prescription of a hypoglycemic agent, and one or more annual health checkups in 2020 were included. Trends in the prevalence of metabolic syndrome by sex and body mass index (BMI) subgroup were assessed. The study cohort consisted of 155,653 patients (men, 81.6%; mean age 54.6 ± 8.5years). Patients with metabolic syndrome had a higher mean BMI (29.1 ± 4.5kg/m2 versus 25.2 ± 4.5kg/m2) and mean waist circumference (98.3 ± 10.0cm versus 87.9 ± 11.2cm) compared to those without metabolic syndrome. Overall, the prevalence of metabolic syndrome was 43.0% in patients with T2D, with prevalence higher in men (46.6%) than women (27.0%). The prevalence increased across BMI subgroups from 17.3% in the < 25kg/m2 subgroup, to 54.6% and 66.1% in the 25 to < 30 and ≥ 30kg/m2 subgroups, respectively. A greater proportion of patients with metabolic syndrome had cardiovascular or renal comorbidities (BMI < 25, 0.3-2.0%; BMI 25 to < 30, 0.7-6.2%; BMI ≥ 30kg/m2, 0.7-6.8%) and cardiovascular drug usage (BMI < 25, 1.3-9.0%; BMI 25 to < 30, 3.8-31.1%; BMI ≥ 30kg/m2, 3.5-37.0%) in the higher BMI subgroups compared to the BMI < 25kg/m2 subgroup. The prevalence of metabolic syndrome in Japanese patients with T2D was 43.0% and increased with higher BMI. In patients with T2D and metabolic syndrome, cardiovascular drug usage and comorbidities increased in patients with a higher BMI. These data highlight the importance of managing metabolic parameters in addition to glycemic control in Japanese patients with T2D, particularly in patients with metabolic syndrome and BMI ≥ 25kg/m2.

Baseline characteristics may impact treatment duration of cabazitaxel in patients with mCRPC: a subanalysis of data from a post-marketing surveillance.

Cabazitaxel has demonstrated improvements in overall survival among patients with metastatic castration-resistant prostate cancer (mCRPC) in the pivotal comparison clinical trials TROPIC, PROSELICA and CARD. However, these trials include mCRPC patients with similar characteristics, and there are limited data on how baseline characteristics affect treatment discontinuation in the patient population. To assess individual factors that may impact the discontinuation rate of cabazitaxel treatment, we conducted a post hoc analysis of data from a nationwide all-case, post-marketing surveillance of cabazitaxel in Japan. Patients were grouped according to the number of cabazitaxel treatment cycles received (1-2 and≥3cycles). Predictive factors were identified through multivariate logistic regression analysis. Across 660 patients with metastatic castration-resistant prostate cancer, 70.2% received ≥3cycles of cabazitaxel treatment. Those receiving 1-2cycles of cabazitaxel had a greater proportion of patients with poorer Eastern Cooperative Oncology Group Performance Status, presence of lung and liver metastases, higher prostate-specific antigen level and prior radiation therapy at baseline. Regardless of the number of cabazitaxel cycles received, the primary reason for discontinuation was progression of disease rather than adverse events. Compared with those receiving 1-2cycles, a lower proportion of patients receiving 3-10 and≥11cycles of cabazitaxel treatment experienced adverse events. Multivariate analysis showed a significant association between early discontinuation and presence of liver lesions, poorer Eastern Cooperative Oncology Group Performance Status and higher prostate-specific antigen level at baseline. Post-marketing surveillance data suggest physicians should individualize cabazitaxel treatment based on certain patient characteristics at baseline.

Epidemiology and survival factors of appendicular myxofibrosarcoma: a SEER-retrospective study.

The low incidence of myxofibrosarcoma (MFS) makes high power studies difficult to perform. Demographic and prognostic factors for MFS and how they differ from all extremity soft tissue sarcomas (STS) are not well understood. The purpose of this study was to characterize a large cohort of patients with MFS and evaluate epidemiologic and survival factors when compared to all STS. We performed a retrospective review of the Surveillance, Epidemiology, and End Results (SEER) database from 2000 to 2015 to identify 1,440 patients diagnosed with MFS and 12,324 with STS. Survival curves were creased using Kaplan-Meier, and Cox regression analyses were performed to identify hazard ratios (HRs). Overall survival was greater for STS than MFS (79% vs. 67%). Patients with MFS had a higher average age at diagnosis than STS (62 vs. 56), and older age was strongly associated with decreased survivorship for MFS (HR = 7.94). A greater proportion of patients under 30 diagnosed with MFS were female when compared to STS (49.6% vs. 45.4%). The incidence of MFS and STS increased over the 15-year period, with MFS increasing at a greater rate than STS (1.25% vs. 2.59%). Survival increased for patients diagnosed after 2008 for both STS (9.4%) and MFS (13.2%). There are differences between patient demographics and survival factors when comparing MFS to all STS. Monitoring changes in demographic and survival trends for rare STS subtypes like MFS is important to improve diagnostic algorithms and treatment options.

SAT132 Isolated Elevated Hemoglobin A1c At Early Diagnosis Of Gestational Diabetes Does Not Predict Need For Hypoglycemic Agents

Abstract Disclosure: E.S. Markovic: None. J. Rios: None. S. Scarpelli-Shchur: None. E. Kaplowitz: None. T.S. Strauss: None. L. Brustman: None. Introduction: ACOG recommends universal screening for gestational diabetes (GDM) at 24 - 28 weeks, as well as screening at the initiation of prenatal care for patients with risk factors. While HbA1c ≥5.7% signifies impaired glucose regulation, data is limited regarding its prognostic utility in patients with early diagnosis of GDM (&amp;lt;24 weeks). We hypothesized that HbA1c &amp;gt;5.7% at diagnosis predicts worse disease as measured by need for hypoglycemic medication. We also compared neonatal outcomes between patients HbA1c &amp;gt; and &amp;lt; 5.7%. Methods: An IRB approved retrospective cohort study from 2016 - 2021 of patients in our Diabetes in Pregnancy Program diagnosed with GDM &amp;lt;24 weeks by Carpenter-Coustan criteria or fingerstick paneling. We compared those with HbA1c &amp;gt;5.7% to those with HbA1c &amp;lt;5.7% with regard to demographics, need for hypoglycemic medication in pregnancy and neonatal outcomes including birth weight, Apgar scores, hypoglycemia, respiratory distress, jaundice, stillbirth and NICU admission. Results: 113 out of 1,520 patients had early onset GDM with HbA1c drawn at time of diagnosis. HbA1c range 4.5 - 7.5% (median 5.5%). Gestational age at diagnosis range 6.4 - 23 weeks (median 15.6 weeks). 72 (64%) had a HbA1c &amp;lt;5.7% while 41 (36%) had a HbA1c ≥5.7%. Larger BMI (p&amp;lt;0.0001), higher fasting GTT (p&amp;lt;0.0001), larger number of abnormal GTT values (p=0.009), Hispanic ethnicity (p=0.003) or Black race (p=0.004), and hyperlipidemia (p=0.016) were significantly associated with HbA1c &amp;gt;5.7%. A greater proportion of patients with HbA1c ≥5.7% required hypoglycemic medication [37 (90%) vs. 51 (71%), p= 0.032]. Patients with HbA1c &amp;gt;5.7% were 3.9 times more likely to require hypoglycemic agents compared to patients with HbA1c &amp;lt;5.7% (p=0.042). The odds of receiving medication were 8.5 times greater for each percent increase in HbA1c (p=0.004). After adjusting for confounders, HbA1c ≥5.7% at early GDM diagnosis was not significantly associated with increased likelihood of needing hypoglycemic agents (OR=3.4; p=0.304). Only fasting GTT was associated with needing hypoglycemic agents (OR=1.2; 95% CI: 1.0, 1.3; p=0.023). HbA1c &amp;gt;5.7% was associated with lower Apgar score at 1 minute (p=0.039) and earlier gestational age at delivery (p=0.009) but these were not significant after adjusting for confounders. Conclusion: The premise of our study was that HbA1c &amp;gt;5.7% in early diagnosed GDM would be associated with impaired glucose tolerance and therefore more significant disease. Counterintuitively, our data do not suggest this. An isolated HbA1c &amp;gt;5.7% was not predictive of the need for hypoglycemic agents or adverse neonatal outcomes. Future directions should include large prospective studies to clarify if HbA1c &amp;gt;5.7% is associated with more severe disease, adverse neonatal outcomes, and the development of type 2 diabetes. Presentation: Saturday, June 17, 2023

Comparison of Outcomes After Reverse Total Shoulder Arthroplasty in Patients With Proximal Humerus Fractures Versus Rotator Cuff Arthropathy.

Indications for reverse total shoulder arthroplasty (rTSA) has expanded to encompass complex proximal humerus fractures (PHFs) in recent years. The purpose of this study was to report and assess whether PHF patients treated with rTSA could achieve similar functional outcomes and short-term survivorship to patients who underwent rTSA for rotator cuff arthropathy (RTCA). All consecutive patients with a preoperative diagnosis of PHF or RTCA, 18 years or older, treated with rTSA at a single academic institution between 2018 and 2020 with a minimum 2-year follow-up were retrospectively reviewed. Primary outcomes were survivorship defined as revision surgery or implant failure analyzed using the Kaplan-Meier survival curve, and functional outcomes, which included Quick Disabilities of the Arm, Shoulder, and Hand, and range of motion (ROM) were compared at multiple follow-up time points up to 2 years. Secondary outcomes were patient demographics, comorbidities, surgical data, length of hospital stay, and discharge disposition. A total of 48 patients were included: 21 patients (44%) were diagnosed with PHF and 27 patients (56%) had RTCA. The Kaplan-Meier survival rate estimates at 3 years were 90.5% in the PHF group and 85.2% in the RTCA group. No differences in revision surgery rates between the two groups (P = 0.68) or survivorship (P = 0.63) were found. ROM was significantly lower at subsequent follow-up time points in multiple planes (P < 0.05). A greater proportion of patients in the PHF group received cement for humeral implant fixation compared with the RTCA group (48% versus 7%, P = 0.002). The mean length of hospital stay was longer in PHF patients compared with RTCA patients (2.9 ± 3.8 days versus 1.6 ± 1.8 days, P = 0.13), and a significantly lower proportion of PHF patients were discharged home (67% versus 96%, P = 0.015). The rTSA implant survivorship at 3 years for both PHF and RTCA patients show comparable results. At the 2-year follow-up, RTCA patients treated with rTSA were found to have better ROM compared with PHF patients.

Prevalence and Predictors of Postoperative Depression and Anxiety After Anterior Cruciate Ligament Reconstruction.

Preoperative mood disorders influence postoperative outcomes after anterior cruciate ligament (ACL) reconstruction (ACLR), but the prevalence and risk factors associated with postoperative depression/anxiety development remain unknown. The purposes of this study were to quantify the prevalence of postoperative diagnoses of depression or anxiety following ACLR in patients under the age of 25 and assess the interplay between patient sex and ACL reoperation on the prevalence of a depression or anxiety diagnosis following ACLR. ACLR patients under the age of 25 years old were identified in the Truven Healthcare Marketscan database. Patients with incomplete coverage +/- one year of the index surgical procedure were excluded. Patients were categorized by the presence of preoperative, postoperative, or no depression/anxiety using the International Classification of Diseases, Ninth Revision (ICD-9) codes. We compared patient demographics and reoperation rates following the index ACLR between the depression and anxiety categories. Additionally, logistic regression was fit to assess the interaction between sex and either ipsilateral or contralateral ACL surgery on postoperative depression/anxiety diagnosis. Of the 42,174 patients, 10.7% had a new depression/anxiety diagnosis after ACLR. Postoperative depression/anxiety was nearly twice as prevalent for females (F: 14.4%, M: 7.6%) despite having similar rates of secondary ACLR (F: 15.5%, M: 13.0%). Those with postoperative depression/anxiety had a considerably greater prevalence of reoperation (18.8%) than those without depression/anxiety (13.7%) and those with pre-existing preoperative depression/anxiety (12.9%). Sex and reoperation were independently associated with postoperative depression/anxiety diagnosis. Female sex and secondary ACL surgery are independently associated with an increased prevalence of postoperative depression/anxiety. Nearly one in seven young females are diagnosed with depression/anxiety after ACLR. Similarly, a greater proportion of patients who suffer a secondary ACL surgery are subsequently diagnosed with depression/anxiety. The orthopedic community must be cognizant of the increased risk of postoperative depression/anxiety for females and those who suffer a secondary ACL surgery, and screening for depression/anxiety in these at-risk populations with referrals to mental health professionals may be warranted.

The Predictive Utility of MammaPrint and BluePrint in Identifying Patients with Locally Advanced Breast Cancer Who are Most Likely to Have Nodal Downstaging and a Pathologic Complete Response After Neoadjuvant Chemotherapy

BackgroundNeoadjuvant chemotherapy (NCT) increases the feasibility of surgical resection by downstaging large primary breast tumors and nodal involvement, which may result in surgical de-escalation and improved outcomes. This subanalysis from the Multi-Institutional Neo-adjuvant Therapy MammaPrint Project I (MINT) trial evaluated the association between MammaPrint and BluePrint with nodal downstaging.Patients and MethodsThe prospective MINT trial (NCT01501487) enrolled 387 patients between 2011 and 2016 aged ≥ 18 years with invasive breast cancer (T2–T4). This subanalysis includes 146 patients with stage II–III, lymph node positive, who received NCT. MammaPrint stratifies tumors as having a Low Risk or High Risk of distant metastasis. Together with MammaPrint, BluePrint genomically (g) categorizes tumors as gLuminal A, gLuminal B, gHER2, or gBasal.ResultsOverall, 45.2% (n = 66/146) of patients had complete nodal downstaging, of whom 60.6% (n = 40/66) achieved a pathologic complete response. MammaPrint and combined MammaPrint and BluePrint were significantly associated with nodal downstaging (p = 0.007 and p < 0.001, respectively). A greater proportion of patients with MammaPrint High Risk tumors had nodal downstaging compared with Low Risk (p = 0.007). When classified with MammaPrint and BluePrint, more patients with gLuminal B, gHER2, and gBasal tumors had nodal downstaging compared with HR+HER2−, gLuminal A tumors (p = 0.538, p < 0.001, and p = 0.013, respectively).ConclusionsPatients with genomically High Risk tumors, defined by MammaPrint with or without BluePrint, respond better to NCT and have a higher likelihood of nodal downstaging compared with patients with gLuminal A tumors. These genomic signatures can be used to select node-positive patients who are more likely to have nodal downstaging and avoid invasive surgical procedures.

Three-level ACDF versus 3-level laminectomy and fusion: are there differences in outcomes? An analysis of the Quality Outcomes Database cervical spondylotic myelopathy cohort.

The authors sought to compare 3-level anterior with posterior fusion surgical procedures for the treatment of multilevel cervical spondylotic myelopathy (CSM). The authors analyzed prospective data from the 14 highest enrolling sites of the Quality Outcomes Database CSM module. They compared 3-level anterior cervical discectomy and fusion (ACDF) and posterior cervical laminectomy and fusion (PCF) surgical procedures, excluding surgical procedures crossing the cervicothoracic junction. Rates of reaching the minimal clinically important difference (MCID) in patient-reported outcomes (PROs) were compared at 24 months postoperatively. Multivariable analyses adjusted for potential confounders elucidated in univariable analysis. Overall, 199 patients met the inclusion criteria: 123 ACDF (61.8%) and 76 PCF (38.2%) patients. The 24-month follow-up rates were similar (ACDF 90.2% vs PCF 92.1%, p = 0.67). Preoperatively, ACDF patients were younger (60.8 ± 10.2 vs 65.0 ± 10.3 years, p < 0.01), and greater proportions were privately insured (56.1% vs 36.8%, p = 0.02), actively employed (39.8% vs 22.8%, p = 0.04), and independently ambulatory (14.6% vs 31.6%, p < 0.01). Otherwise, the cohorts had equivalent baseline modified Japanese Orthopaedic Association (mJOA), Neck Disability Index (NDI), numeric rating scale (NRS)-arm pain, NRS-neck pain, and EQ-5D scores (p > 0.05). ACDF patients had reduced hospitalization length (1.6 vs 3.9 days, p < 0.01) and a greater proportion had nonroutine discharge (7.3% vs 22.8%, p < 0.01), but they had a higher rate of postoperative dysphagia (13.5% vs 3.5%, p = 0.049). Compared with baseline values, both groups demonstrated improvements in all outcomes at 24 months (p < 0.05). In multivariable analyses, after controlling for age, insurance payor, employment status, ambulation status, and other potential clinically relevant confounders, ACDF was associated with a greater proportion of patients with maximum satisfaction on the North American Spine Society Patient Satisfaction Index (NASS) (NASS score of 1) at 24 months (69.4% vs 53.7%, OR 2.44, 95% CI 1.17-5.09, adjusted p = 0.02). Otherwise, the cohorts shared similar 24-month outcomes in terms of reaching the MCID for mJOA, NDI, NRS-arm pain, NRS-neck pain, and EQ-5D score (adjusted p > 0.05). There were no differences in the 3-month readmission (ACDF 4.1% vs PCF 3.9%, p = 0.97) and 24-month reoperation (ACDF 13.5% vs PCF 18.6%, p = 0.36) rates. In a cohort limited to 3-level fusion surgical procedures, ACDF was associated with reduced blood loss, shorter hospitalization length, and higher routine home discharge rates; however, PCF resulted in lower rates of postoperative dysphagia. The procedures yielded comparably significant improvements in functional status (mJOA score), neck and arm pain, neck pain-related disability, and quality of life at 3, 12, and 24 months. ACDF patients had significantly higher odds of maximum satisfaction (NASS score 1). Given comparable outcomes, patients should be counseled on each approach's complication profile to aid in surgical decision-making.

Clinical characteristics and treatment patterns of patients with episodic cluster headache: results from the United States, United Kingdom and Germany

Objective To describe clinical characteristics and regional treatment patterns of episodic cluster headache (CH). Methods A point-in-time survey of physicians and their patients with CH was conducted in the United States, United Kingdom and Germany in 2017. Results Overall, 1012 patients with episodic CH were analyzed. Demographic and clinical findings were generally consistent across regions. Most patients were men (66.6%) and the mean age was 40.9 years. The greatest proportion of patients (38.3%) had ≤1 attack per day. The mean number of attacks per day (APD) was 2.4 and mean number of cluster periods per year was 2.6; the mean cluster period duration was 30.8 days. Most patients (69.3%) did not report a specific or predicable time when cluster periods occurred. Acute treatment was prescribed for 47.6% of patients, 10.3% of patients received preventive treatment, and 37.9% of patients received combined acute and preventive treatment; 4.2% of patients were not receiving treatment. Frequently prescribed acute treatments were sumatriptan, oxygen, and zolmitriptan; oxygen use varied considerably across countries and was prescribed least often in the United States. Frequently prescribed preventive treatments were verapamil, topiramate, and lithium. Lack of efficacy and tolerability were the most common reasons for discontinuing preventive treatment. Conclusions We observed high use of acute treatments, but only half of patients used preventive treatments despite experiencing several cluster periods per year with multiple cluster APD. Further studies about the need for and benefits of preventive treatment for episodic CH are warranted.

Assessing the duration of EDSS improvement after a therapy start: A novel approach applied to the long-term extension of the PRISMS study

In a chronic and progressive disease such as multiple sclerosis (MS), the improvement on Expanded Disability Status Scale (EDSS) can be a transient event. Therefore, estimating the prevalence of disability improvement over time, accounting both for improvement incidence and duration, is of interest. The aim of this study was to show the application of a simple estimator for the proportion of patients with sustained improvement over time using data from the long-term extension of the PRISMS trial. A total of 534 relapsing-remitting MS (RRMS) patients from the PRISMS trial were included. Patients with a baseline EDSS of 0 were excluded. Patients were randomized to placebo (n=178), subcutaneous interferon beta-1a (sc IFN β-1a) 22µg (n=181) or sc IFN β-1a 44µg (n=175). At Year 2, patients receiving placebo were re-randomized to sc IFN β-1a 22µg or 44µg (delayed sc IFN β-1a) while patients receiving sc IFN β-1a 22µg or 44µg continued their initial regimen. Patients were followed up for over 7 years post-randomization. Disability improvement was defined as a 1-point decrease in EDSS from baseline confirmed at 6 months. Prevalence of improvement was estimated as difference of Kaplan-Meier (KM) estimators while the cumulative incidence of improvement was calculated using the standard KM curves. No significant differences in cumulative incidence of EDSS improvement at 3 years between delayed sc IFN β-1a (20.3%) and sc IFN β-1a 22µg (20.8%; p=0.49) or 44µg (21.3%; p=0.33). When taking duration of improvement into account, the proportion of patients showing an improved condition after 3 years was 10.1% with delayed sc IFN β-1a, 11.3% with sc IFN β-1a 22µg (p=0.17) and 15.4% with sc IFN β-1a 44µg (p=0.037) that was substantially maintained over the long term. With the use of this new statistical methodology, it is possible to estimate the time to improvement as well as the duration of improvement, information that is better suited to describing a non-final outcome like disability improvement. In this case, early sc IFN β-1a 44µg initiation had a greater proportion of patients with a sustained disability improvement over a long period of follow-up as compared to patients who had initially been randomized to placebo. In contrast, no significant differences on the cumulative incidence of improvement were observed.

Esketamine versus placebo on time to remission in major depressive disorder with acute suicidality

BackgroundEsketamine (ESK) nasal spray, taken with oral antidepressant therapy, is approved for the treatment of depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. In pooled analyses of two pivotal phase 3 studies, ASPIRE I and II, remission rates were consistently higher among patients with MDD with active suicidality who were treated with ESK + standard of care (SOC) versus placebo (PBO) + SOC at all time points in the double-blind and most time points in the follow-up phases. The current analysis of the ASPIRE data sets assessed the effect of ESK + SOC versus PBO + SOC on additional remission-related endpoints: time to achieving remission and consistent remission, proportion of patients in remission and consistent remission, and days in remission.MethodsPost hoc analysis of pooled data from ASPIRE I and II (N = 451). Remission and consistent remission were defined as Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≤ 12 at any given visit or two consecutive visits, respectively. Combined endpoints utilizing Clinical Global Impression-Severity of Suicidality-revised version [CGI-SS-r] ≤ 1 (i.e., not suicidal/questionably suicidal) along with the remission and consistent remission definitions (i.e., MADRS total score ≤ 12) were also examined.ResultsThe median times to remission and consistent remission of MDD were significantly shorter in ESK + SOC versus PBO + SOC (15 versus 23 [p = 0.005] and 23 versus 50 days [p = 0.007], respectively) and a greater proportion of patients in ESK + SOC achieved remission and consistent remission by Day 25 (65.2% versus 55.5% and 54.2% versus 39.8%, respectively). Similar results were obtained using the combined endpoint for both remission definitions. The median percent of days in remission during the double-blind treatment phase was significantly greater in ESK + SOC (27.1% or 5 days) versus PBO + SOC (8.3% or 2 days; p = 0.006), and the significant difference was maintained during follow-up.ConclusionTreatment with ESK + SOC versus PBO + SOC resulted in significantly shorter time to remission, greater proportion of patients in remission, and greater percent of days in remission using increasingly rigorous definitions of remission. These findings underscore the clinical benefits of ESK for adults with MDD with suicidality.Trial registrationClinicalTrials.gov registry NCT03039192 (registered February 1, 2017) and NCT03097133 (registered March 31, 2017).

The Burden of Anabolic Androgenic Steroid-Induced Gynecomastia.

Introduction Gynecomastia is benign proliferation of male breast tissue that can be idiopathic or secondary to hormonal imbalance. Consumption of steroids plays a major role in the development of gynecomastia. The increased consumption of anabolic androgenic steroid (AAS) in youngsters to boost the physical strength and improve appearance is associated with increased prevalence of gynecomastia. True estimation of AAS-associated gynecomastia is difficult to calculate and prone to underestimation because of low social acceptance. Accurate estimation is required to assess future healthcare, for prevention and to give appropriate treatment. Aims and Objectives The aim of this study was to calculate the steroid consumption in gynecomastia patients accurately so that appropriate treatment can be given and their response to treatment could be analysed. Methods This is a prospective study done in a tertiary care hospital from June 2019 to June 2022. All the gynecomastia patients treated during this period in Burns & Plastic Surgery Department of PGIMS Rohtak were included in the study. Patient's detailed history was recorded and also after 3 months of surgery patients were again enquired about their history to record any change. Results Real prevalence of AAS-associated gynecomastia (39.19%) was much higher than that recorded in preoperative period (4.05%). Also, AAS users were having higher body mass index and a greater proportion of patients were bodybuilders. Conclusion Patients with high body mass index, athletic body, and history of recent weight gain should raise the suspicion of anabolic steroid intake. Surgery is not always indicated in AAS-associated gynecomastia. If gynecomastia persisted, surgery necessitates and it involves meticulous intraoperative hemostasis and careful glandular excision to minimize recurrence and achieve low complication rates.

Durable multimodal and holistic response for physiologic closed-loop spinal cord stimulation supported by objective evidence from the EVOKE double-blind randomized controlled trial

IntroductionChronic pain patients may experience impairments in multiple health-related domains. The design and interpretation of clinical trials of chronic pain interventions, however, remains primarily focused on treatment effects on pain...

Risk factors for in-hospital patient falls: a retrospective analysis

Background/Aims Falls are a key patient safety concern because of the associated physical injuries, emotional impact and financial burden on patients and the healthcare system. This study aimed to describe the characteristics of falls and assess the potential risk factors among hospitalised patients in a medium-sized acute care hospital in Queensland, Australia. Methods This was a retrospective descriptive study using routinely collected information. The study was conducted in a medium-sized public hospital in Queensland, Australia. Characteristics of patients, their fall risk classification and circumstances of patient falls were extracted from the incident report provided by the hospital. Data were analysed using descriptive statistics. Results A total of 677 patient fall incidents were documented on the hospital's electronic incident system from 2015–17. The majority of falls (98%) occurred in inpatient units and caused no or minimal harm to patients. Older age groups (75–84 years and 85–94 years) made up the greatest proportion of patients who fell. Falls were largely related to toileting activities. The most common locations for inpatient falls were the bed, bedside trolley or treatment chair. Conclusions Intervention studies are needed to develop and evaluate procedures to prevent falls, particularly for activities with a high risk of falls, such as toileting, and for older patients.

Preoperative Glucose Predicts Postoperative Complications After Complex Abdominal Wall Reconstruction.

Despite advances in surgical methods, complication rates after complex abdominal wall reconstruction (CAWR) remain high. Identification of preoperative risk factors can assist surgeons with risk stratification and patient counseling. The deleterious effects of hyperglycemia on wound healing are well established. With the increasing prevalence of diabetes (diabetes mellitus) and prediabetes, a greater proportion of patients are likely to have increased blood glucose levels that may contribute to poor surgical outcomes. The primary aim of this study was to determine whether preoperative hyperglycemia predicted surgical outcome. The secondary aim was to establish glucose thresholds to assist with surgical risk stratification. All patients who underwent CAWR by the senior author at a single institution from 2002 to 2021 were retrospectively reviewed. Patients were stratified into 4 groups based on preoperative blood glucose: <100 mg/dL (n = 184), 100-140 mg/dL (n = 207), 140-180 mg/dL (n = 41), and >180 mg/dL (n = 16). Patient demographics, risk factors, surgical techniques, complications, and outcomes were recorded and compared. The study cohort comprised of 478 patients. Mean age was 53.9 ± 12.3 years. Mean body mass index was 32.1 ± 7.8 kg/m2. Higher age (P = 0.0085), higher body mass index (P = 0.0005), the presence of diabetes (P < 0.0001), and hypertension (P = 0.0004) were significantly associated with higher glucose. Overall complication rates ranged from 26% (glucose <100 mg/dL) to 94% (glucose >180 mg/dL), whereas recurrence rates ranged from 10% (glucose <100 mg/dL) to 37% (glucose 140-180 mg/dL). Multivariate logistic regression analysis revealed preoperative glucose to have a significant, independent effect on overall complication rate (P < 0.0001), major complication rate (P < 0.0001), and recurrence rate (P < 0.0031). Preoperative hyperglycemia is an important predictor of postoperative complications and recurrence after CAWR. Point-of-care glucose levels are routinely gathered before surgery and may help to establish thresholds for which elective CAWR might be deferred. Strategies to lower preoperative glucose should be part of an optimization protocol for improving outcomes.

Fracture blisters: predictors for time to definitive fixation in pilon fractures.

Fracture blisters, a common soft-tissue complication of pilon fractures, are associated with post-operative wound infections, delays in definitive fixation, and alterations in surgical plan. The purpose of this study was to (1) identify the delay in surgery attributable to the presence fracture blisters and (2) investigate the relationship of fracture blisters to comorbidities and fracture severity. Patients with pilon fractures at an urban level 1 Trauma center from 2010 to 2021 were identified. The presence or absence of fracture blisters was noted, along with location. Demographic information, time from injury to external fixator placement, and time to definitive open reduction internal fixation (ORIF) were collected. Pilon fractures were classified according to AO/OTA guidelines using CT imaging and plain radiographs. 314 patients with pilon fractures were available for analysis, eighty (25%) of whom were found to have fracture blisters. Patients with fracture blisters had longer time to surgery compared to those without fracture blisters (14.2days vs 7.9days, p < 0.001). A greater proportion of patients with fracture blisters had AO/OTA 43C fracture patterns, compared with those without fracture blisters (71.3% vs 53.8%, p = 0.03). Fractures blisters were less likely to be localized over the posterior ankle (12%, p = 0.007). The presence of fracture blisters in pilon fractures are associated with significant delays in time to definitive fixation and higher energy fracture patterns. Fracture blisters are less commonly located over the posterior ankle which may support the implementation of a staged posterolateral approach when managing these injures.