Effects of Preoperative Use of Povidone-Iodine-Impregnated Dressing on Postoperative Rate of Surgical Site Infection in Patients Undergoing Posterolateral Lumbar Spinal Fusion Surgery: A Randomized, Nonblinded, Active-Controlled Trial.

BACKGROUND AND OBJECTIVES: No study has evaluated the efficacy of using preoperative antiseptic dressings in reducing the rate of surgical site infection (SSI) in spine surgery thus far. To investigate the efficacy of the use of preoperative povidone-iodine-impregnated antiseptic dressings in patients undergoing instrumented posterolateral lumbar spinal fusion. METHODS: This was a randomized, nonblinded, active-controlled, parallel-group clinical trial. Patients were randomly assigned to the 2 study groups, including treatment and control. Patients in the treatment group received povidone-iodine-impregnated antiseptic dressing applied to the anticipated incision site 12 hours before the operation. The control group merely received the standard perioperative care with no additional intervention or placebo. Patients were followed up for 90 days, and SSIs were recorded. RESULTS: A total of 200 patients were included in this study (100 in each arm). Three cases of SSI were observed in the treatment group compared with 12 in the control one. A significant reduction in the postoperative rate of SSI was observed in the treatment group compared with the control one (P = .029). In addition to study intervention (P = .029), body mass index (P = .005), smoking status (P = .005), duration of the procedure (P = .003), American Society of Anesthesiologists class (P = .002), and diabetes mellitus (P < .001) were significantly associated with the postoperative rate of SSI. CONCLUSION: To the best of our knowledge, this study for the first time showed that preoperative use of antiseptic dressings is significantly effective in reducing the rate of SSI in instrumented posterior lumbar spinal fusion surgery. Future studies are warranted to evaluate the efficacy of different preparations or the effectiveness of the present one in patients undergoing spine procedures with other surgical characteristics.

Microfluidic integrated gas sensors for smart analyte detection: a comprehensive review.

The utilization of gas sensors has the potential to enhance worker safety, mitigate environmental issues, and enable early diagnosis of chronic diseases. However, traditional sensors designed for such applications are often bulky, expensive, difficult to operate, and require large sample volumes. By employing microfluidic technology to miniaturize gas sensors, we can address these challenges and usher in a new era of gas sensors suitable for point-of-care and point-of-use applications. In this review paper, we systematically categorize microfluidic gas sensors according to their applications in safety, biomedical, and environmental contexts. Furthermore, we delve into the integration of various types of gas sensors, such as optical, chemical, and physical sensors, within microfluidic platforms, highlighting the resultant enhancements in performance within these domains.

Suicide gene therapy using allogeneic adipose tissue-derived mesenchymal stem cell gene delivery vehicles in recurrent glioblastoma multiforme: a first-in-human, dose-escalation, phase I clinical trial.

BACKGROUND: Glioblastoma multiforme (GBM) is associated with remarkably poor prognosis, and its treatment is challenging. This investigation aimed to evaluate the safety of suicide gene therapy using allogeneic adipose tissue-derived mesenchymal stem cells (ADSCs) carrying herpes simplex virus-thymidine kinase (HSV-TK) gene for the first time in patients with recurrent GBM. METHODS: This study was a first-in-human, open-label, single-arm, phase I clinical trial with a classic 3 + 3 dose escalation design. Patients who did not undergo surgery for their recurrence were included and received this gene therapy protocol. Patients received the intratumoral stereotactic injection of ADSCs according to the assigned dose followed by prodrug administration for 14 days. The first dosing cohort (n = 3) received 2.5 × 105 ADSCs; the second dosing cohort (n = 3) received 5 × 105 ADSCs; the third dosing cohort (n = 6) received 10 × 105 ADSCs. The primary outcome measure was the safety profile of the intervention. RESULTS: A total of 12 patients with recurrent GBM were recruited. The median follow-up was 16 (IQR, 14-18.5) months. This gene therapy protocol was safe and well tolerated. During the study period, eleven (91.7%) patients showed tumor progression, and nine (75.0%) died. The median overall survival (OS) was 16.0 months (95% CI 14.3-17.7) and the median progression-free survival (PFS) was 11.0 months (95% CI 8.3-13.7). A total of 8 and 4 patients showed partial response and stable disease, respectively. Moreover, significant changes were observed in volumetric analysis, peripheral blood cell counts, and cytokine profile. CONCLUSIONS: The present clinical trial, for the first time, showed that suicide gene therapy using allogeneic ADSCs carrying the HSV-TK gene is safe in patients with recurrent GBM. Future phase II/III clinical trials with multiple arms are warranted to validate our findings and further investigate the efficacy of this protocol compared with standard therapy alone. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT), IRCT20200502047277N2. Registered 8 October 2020, https://www.irct.ir/ .

The prevalence of permanent pacemaker implantation after open-heart surgeries; eight years of experience in Tehran heart center.

BACKGROUND: We aimed to evaluate the prevalence of permanent pacemaker implantation (PPI) among open-heart surgery patients. METHODS: We reviewed data from 23 461 patients undergoing open-heart surgeries between 2009 and 2016 in our heart center in Iran. A total of 18 070 patients (77%) had coronary artery bypass grafting (CABG), 3 598 (15.3%) valvular surgeries, and 1 793 (7.6%) congenital repair procedures. Finally, 125 patients who received PPI following open-heart surgeries were enrolled in our study. We defined the demographic and clinical characteristics of all these patients. RESULTS: PPI was required in 125 (0.53%) patients with an average age of 58 ± 15.3 years. The average hospitalization time after surgery and waiting time for PPI were 19.7 ± 10.2 and 11.4 ± 6.5 days, respectively. Atrial fibrillation was the dominant pre-operative cardiac conduction abnormality (29.6%). Also, the primary indication for PPI was complete heart block in 72 patients (57.6%). Patients in the CABG group were significantly older (P = 0.002) and were more likely to be male (P = 0.030). The valvular group longer bypass and cross-clamp times and had more left atrial abnormalities. In addition, the congenital defect group was younger and had longer ICU stay times. CONCLUSIONS: Based on our study findings, PPI was required in 0.53% of patients following open-heart surgery due to damage to the cardiac conduction system. The current study paves the way for future investigations to identify possible predictors of PPI in patients undergoing open-heart surgeries.

Safety and Potential Efficacy of Selective Dorsal Rhizotomy in Adults with Spinal Cord Injury-Induced Spasticity: An Open-Label, Non-Randomized, Single-Arm Trial.

BACKGROUND: Despite the abundant literature on the use of selective dorsal rhizotomy (SDR) in spastic cerebral palsy, no investigation has evaluated its use in adult patients with chronic spinal cord injury (SCI)-induced spasticity. The present investigation aimed to evaluate the safety and potential efficacy of SDR in chronic SCI-induced spasticity for the first time. METHODS: In this open-label, single-arm, non-randomized clinical trial, all patients were assigned to the single study intervention arm and underwent SDR. The primary outcome measure was the safety profile of SDR. Secondary outcome measures were Modified Ashworth Scale, Penn Spasm Frequency Scale, visual analog scale for spasticity, Spinal Cord Injury Spasticity Tool, Spinal Cord Independence measure version III, and Short Form 36 Health Survey Questionnaire. RESULTS: Six patients with cervical SCI and 4 with thoracic SCI were allocated to the single study intervention arm. No adverse event attributable to the SDR was found. Moreover, all secondary outcome measures of the study improved significantly over the study period (P < 0.001). Multiple regression analysis also found a significant association between level of injury and changes in average Modified Ashworth Scale scores (P = 0.041), Spinal Cord Injury Spasticity Tool score (P = 0.013), and Spinal Cord Independence measure version III total (P = 0.002) and mobility domain scores (P = 0.004) at 12-month postoperatively. CONCLUSIONS: This clinical trial indicated that SDR is a safe and potentially effective procedure in patients with severe and intractable SCI-induced spasticity. However, future clinical trials with larger sample sizes and adequate power are required to validate our findings regarding efficacy.

Effects of local intraoperative epidural use of triamcinolone acetonide-soaked Gelfoam on postoperative outcomes in patients undergoing posterolateral lumbar spinal fusion surgery: a randomized, placebo-controlled, double-blind trial.

OBJECTIVE: Prior evidence has supported the use of local intraoperative epidural steroids in lumbar discectomy for improvements in postoperative pain and outcomes. However, currently there is a paucity of data regarding the efficacy of local epidural steroids in spinal fusion procedures. The present investigation aimed to evaluate the impact of local epidural administration of triamcinolone acetonide-soaked Gelfoam on postoperative pain and patient-reported outcomes in patients undergoing instrumented posterolateral lumbar spinal fusion. METHODS: In this randomized, double-blind, placebo-controlled trial, patients were randomly divided into two groups (treatment and control). Patients in the treatment group received a Gelfoam carrier soaked in 1 ml of triamcinolone acetonide (40 mg), which was placed over the nerve roots in the epidural space before the closure. Patients in the control group received a Gelfoam carrier soaked in normal saline in a similar fashion to the treatment group. Patients were followed up during their hospital stay and at 4 and 12 weeks postoperatively. The primary outcome measure was early postoperative visual analog scale (VAS) scores for pain both at rest and with movement. RESULTS: A total of 100 patients were recruited in this study and were randomly allocated to the treatment or control group. No significant difference was found in baseline demographic, clinical, and surgical characteristics between the two groups. Postoperative VAS scores for pain both at rest and with movement were comparable between the treatment and control groups. Cumulative morphine consumption, length of hospital stay, and incidence of postoperative complications such as surgical site infection were also similar between the two groups. There was no significant difference in patient-reported outcomes including VAS scores for back and leg pain as well as the Oswestry Disability Index at 4 and 12 weeks postoperatively. The proportion of patients who achieved a minimum clinically important difference for patient-reported outcomes were also similar between the two groups. CONCLUSIONS: In contrast to the existing literature on the beneficial use of local intraoperative epidural steroids in conventional lumbar discectomy, the present study did not demonstrate such significant efficacy for the use of local epidural steroids in instrumented posterolateral lumbar spinal fusion. However, there is still a lack of evidence in this regard and further high-quality clinical trials are required to evaluate the efficacy of local epidural steroids in this group of patients.

Analgesic Effects of Preoperative Combination of Oral Pregabalin and Intravenous Magnesium Sulfate on Postoperative Pain in Patients Undergoing Posterolateral Spinal Fusion Surgery: A 4-arm, Randomized, Double-blind, Placebo-controlled Trial.

BACKGROUND: Multimodal perioperative pain management including nonopioid analgesia is a major pillar of enhanced recovery after surgery programs. The aim of this study was to investigate the analgesic efficacy of the preoperative combination of 2 nonopioid drugs, oral pregabalin and intravenous magnesium sulfate, in patients undergoing posterolateral lumbar spinal fusion. METHODS: This 4-arm, randomized, double-blind, placebo-controlled trial included 104 patients randomly allocated to receive: magnesium sulfate and pregabalin (MP), magnesium sulfate and oral placebo (M), 0.9% saline and oral pregabalin (P), and 0.9% saline and oral placebo (C). The study drugs were administered 1 hour preoperatively. The primary outcome was the cumulative morphine consumption on postoperative day 1. Secondary outcomes included visual analog scale scores for leg pain at rest and with movement, and postoperative nausea and vomiting (PONV) in the first 48 hours after surgery. RESULTS: Cumulative morphine consumption on postoperative day 1 was lower in group MP (19.6±8.0 mg) compared with group M (32.6±9.5 mg; P <0.001), group P (28.9±9.4 mg; P =0.001), or group C (38.8±10.3 mg; P <0.001). Multiple linear regression demonstrated a significant association between group MP and cumulative morphine consumption (B=-5.4 [95% CI, -7.1, -3.7], P <0.001). Visual analog scale scores for leg pain at rest and with movement were lower in group MP compared with other groups ( P =0.006 and <0.001). The incidence of PONV was also lowest in group MP ( P =0.032). CONCLUSIONS: Preoperative administration of oral pregabalin and intravenous magnesium sulfate resulted in reduced morphine consumption and greater analgesic effect than the use of each drug individually or placebo in patients undergoing posterolateral lumbar spinal fusion.

The Impact of the Coronavirus Disease 2019 Pandemic on Neurosurgical Practice and Feasibility of Safe Resumption of Elective Procedures During this Era in a Large Referral Center in Tehran, Iran: An Unmatched Case-Control Study.

OBJECTIVE: The coronavirus disease 2019 (COVID-19) pandemic has considerably affected surgical practice. The present study aimed to investigate the effects of the pandemic on neurosurgical practice and the safety of the resumption of elective procedures through implementing screening protocols in a high-volume academic public center in Iran, as one of the countries severely affected by the pandemic. METHODS: This unmatched case-control study compared 2 populations of patients who underwent neurosurgical procedures between June 1, 2019 and September 1, 2019 and the same period in 2020. In the prospective part of the study, patients who underwent elective procedures were tested for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection postoperatively to evaluate the viability of our screening protocol. RESULTS: Elective and emergency procedures showed significant reduction during the pandemic (59.4%, n = 168 vs. 71.3%, n = 380) and increase (28.7%, n = 153 vs. 40.6%, n = 115, respectively; P = 0.003). The proportional distribution of neurosurgical categories remained unchanged during the pandemic. Poisson regression showed that the reduction in total daily admissions and some categories, including spine, trauma, oncology, and infection were significantly correlated with the pandemic. Among patients who underwent elective procedures, 0 (0.0%) and 26 (16.25%) had positive test results on days 30 and 60 postoperatively, respectively. Overall mortality was comparable between the pre-COVID-19 and COVID-19 periods, yet patients with concurrent SARS-CoV-2 infection showed substantially higher mortality (65%). CONCLUSIONS: By implementing safety and screening protocols with proper resource allocation, the emergency care capacity can be maintained and the risk minimized of hospital-acquired SARS-CoV-2 infection, complications, and mortality among neurosurgical patients during the pandemic. Similarly, for elective procedures, according to available resources, hospital beds can be allocated for patients with a higher risk of delayed hospitalization and those who are concerned about the risk of hospital-acquired infection can be reassured.

Changed pattern of hospital admission in stroke during COVID-19 pandemic period in Iran: a retrospective study.

BACKGROUND: Some previous reports have shown a reduced number of admission in stroke cases during the coronavirus disease 2019 (COVID-19) pandemic period. The present study aimed to investigate this changing pattern and the potential causes behind it at an academic neurology and neurosurgery center in Iran. METHODS: Patients admitted to our center with the diagnosis of ischemic and hemorrhagic stroke, between March 1, 2019, Jun 1, 2019, and the similar 3-month period in 2020 (COVID-19 pandemic period), were compared in terms of clinical characteristics and outcome. Poisson regression was also conducted to assess the correlation between daily admissions and the COVID-19 pandemic period. RESULTS: A total of 210 patients with stroke (ischemic and hemorrhagic) in 2019 were compared with 106 patients in 2020. COVID-19 pandemic period was significantly associated with the decline in the number of daily admissions in ischemic stroke (IRR, 0.51 [95% CI, 0.4-0.64]). A significant reduction (P = 0.003) in time from onset to arrival at hospital from median 12 h [IQR, 5-32] in 2019 to median 6 h [IQR, 4-16] in 2020 was found in ischemic stroke cases. National Institute of Health Stroke Scale (NIHSS) was significantly increased (P < 0.001) from median 4 [IQR, 2-7] in 2019 to median 9 [IQR, 4-14] in 2020. Glasgow coma scale (GCS) was significantly decreased from 13.9 (SD, 2) in 2019 to 12.8 (SD, 2.9) in 2020 (P < 0.001). CONCLUSIONS: The present study provided new pieces of evidence regarding the changed pattern of hospital admission in stroke especially the possible reasons for its decline.

Percutaneous left atrial appendage occlusion with the Amulet device: The impact of device disc position upon periprocedural and long-term outcomes.

OBJECTIVE: To investigate the effect of left atrial appendage (LAA) occlusion device positioning upon periprocedural and long-term outcomes. BACKGROUND: The Amulet device is designed to cover the ostium of the LAA. Prolapse of the device into the neck of the LAA is not uncommon resulting in incomplete coverage of the ostium. The clinical consequences of this remain uncertain. METHODS: Outcomes of 87 patients with successful LAA closure were analyzed according to Amulet disc position: group A (n = 45) had complete LAA ostium coverage; group B (n = 42) had incomplete ostium coverage because of disc prolapse. Periprocedural major adverse events (MAE) (composite of all cause death, tamponade, device/air embolization, cerebrovascular events, myocardial infarction, and major bleeding not related to vascular access complications) and total device-related periprocedural adverse events (defined as MAE and pericardial effusion) were evaluated. All patients were followed up longitudinally with long-term events defined as a composite of: cardiovascular death, cerebrovascular events, systemic embolization, and major bleeding requiring transfusion or intervention. RESULTS: Median follow-up was 234 days (IQR 150-436 days). There was a trend toward more periprocedural MAE in group B (P = 0.07) with deep implantation of the Amulet device associated with significantly more periprocedural adverse events (P = 0.03). There were no differences in reposition attempts (P = 0.9) or long-term events (P = 0.57). CONCLUSIONS: Our data suggest that suboptimal device positioning may be associated with worse periprocedural outcomes but no difference in long-term clinical outcomes. The results of this relatively small cohort does not seem to be affected by repositioning attempts during the index procedure.

Upper Limb Deep Vein Thrombosis: A Case Report of an Increasingly Common Condition.

Upper limb deep vein thrombosis (DVT) is a less common phenomenon than lower limb DVT. Repeated trauma secondary to sport- or job-related arm movements and positions has been recognized as the predisposing factor for upper limb DVT. We describe a 38-year-old male computer programmer admitted with swelling and pain in his left upper limb. Venous duplex ultrasound confirmed the presence of axillary vein thrombosis. Coagulation studies for secondary thrombosis were unremarkable. The patient was treated with full anticoagulation using low molecular weight heparin and warfarin. On subsequent follow-up at 3 months, the patient was symptom free and duplex sonography showed no evidence of thrombosis.