Local Institutional Review Board Approval Research Articles

Improved catheter delivery for aspiration thrombectomy using Tenzing 7 ledge reducing catheter and FreeClimb 70.

Previous comparative mechanical thrombectomy device trials reported a substantial crossover rate from first-line aspiration to stent-retriever thrombectomy. A specialized delivery catheter may help track large-bore aspiration catheters to target occlusions. We report our multicenter experience of aspiration thrombectomy of intracranial large vessel occlusions using the FreeClimbTM 70 and Tenzing® 7 delivery catheter (Route 92, San Mateo, CA). After local Institutional Review Board approval, we retrospectively reviewed the clinical, procedural, and imaging data of patients who underwent mechanical thrombectomy with the FreeClimb 70 and Tenzing 7. FreeClimb 70 was successfully delivered using Tenzing 7 to target occlusion in 30/30 (100%) patients (18 M1, 6 M2, 4 ICA-terminus, and 2 basilar artery occlusions), without the use of a stent-retriever for anchoring. In 21/30 (70%) cases, a leading microwire was not needed to advance the Tenzing 7 to the target. Median (interquartile range) time from groin puncture to first pass was 12 (interquartile range 8-15) minutes. Overall first pass effect, or first pass effect (modified thrombolysis in cerebral ischemia 2C-3), was achieved 16/30 (53%). For M1 occlusions, first pass effect was 11/18 (61%). Successful reperfusion (modified thrombolysis in cerebral ischemia ≥ 2B) was achieved in 29/30 (97%) cases after a median of 1 pass (interquartile range 1-3). Median groin puncture to reperfusion time was 16 (interquartile range 12-26) minutes. There were no procedural complications or symptomatic intracranial hemorrhage. Average improvement in National Institutes of Health Stroke Scale at discharge was 6.6 ± 7.1. There were three patient deaths (renal failure, respiratory failure, and comfort care). Initial data support the use of Tenzing 7 with FreeClimb 70 catheter for reliable access to rapid, effective, and safe aspiration thrombectomy of large vessel occlusions.

Neovaginoplasty With Nile Tilapia Skin: Cytological and Microbiota Evaluation.

To study the clinical, cytological, and vaginal microbiota findings in patients with Mayer-Rokitansky-Küster-Hauser syndrome who underwent neovaginoplasty using Nile tilapia fish skin. This is a cross-sectional study with 7 cisgender women with Mayer-Rokitansky-Küster-Hauser syndrome who had previously undergone neovagina reconstruction using Nile tilapia fish skin at a university hospital. Local institutional review board approval and written permission from the patient were obtained. Between August 2019 and November 2021, within 12 to 24 months after surgery, vaginal specimens were obtained for conventional oncotic and hormonal cytology, and for Gram staining. The Nugent scores were calculated. Colposcopy was also performed. Squamous cells without atypia were found in all patients. Five patients had intermediate vaginal microbiota (Nugent score of 4), which was determined by the presence of few lactobacilli on Gram staining. In hormonal cytology, 4 patients presented with findings compatible with menacme. No colposcopic change was observed. When postsurgical dilation was performed correctly, a mean vaginal length of 8.3 cm was maintained after 1 year of follow-up. Squamous cells without atypia were present in neovaginas with Nile tilapia fish skin. Most vaginal contents revealed intermediate microbiota and hormonal results compatible with menacme. Studies with a greater number of patients are necessary for a more comprehensive understanding of the microbiome in neovaginas with this new technique, thereby providing support for the treatment and prevention of associated pathologies.

ReActiv8 Stimulation Therapy vs. Optimal Medical Management: A Randomized Controlled Trial for the Treatment of Intractable Mechanical Chronic Low Back Pain (RESTORE Trial Protocol).

Chronic low back pain (CLBP) is the leading cause of years lived with disability globally. The role of restorative neurostimulation in the treatment of patients with refractory mechanical CLBP and multifidus muscle dysfunction has been established in one randomized controlled trial (RCT) and several clinical studies that demonstrated both safety and clinical benefit. This post-market trial provides a direct comparison to optimized medical management to test the hypothesis that the addition of restorative neurostimulation to current care paradigms results in significant improvements in back pain-related disability. This trial will include people who have reported significant levels of back pain and back pain-related disability with symptoms that have persisted for longer than 6months prior to enrollment and resulted in pain on most days in the 12months prior to enrollment. Eligible patients will be randomized to either optimal medical management or optimal medical management plus ReActiv8® restorative neurostimulation therapy. Patient-reported outcomes will be collected at regular intervals out to the 1-year primary endpoint, at which time the patients in the control arm will be offered implantation with the ReActiv8 system. Assessment of each group will continue for an additional year. The RESTORE trial follows the principles of the Declaration of Helsinki. The WCG IRB acts as the Central Institutional Review Board (IRB) for most sites and some sites will receive local IRB approval prior to enrollment of patients. Each IRB assessed the protocol and related documentation. The protocol complies with Good Clinical Practice (GCP). All patients provide written informed consent to participate in the trial. Version C, 07 Sep 2022. gov registration number. NCT04803214 registered March 17, 2021.

The rate and predictors of healing of repaired lesser tuberosity osteotomy in reverse total shoulder arthroplasty.

Evidence is building that a functional subscapularis improves function-specifically internal rotation tasks-following reverse total shoulder arthroplasty (rTSA). However, the optimal method for subscapularis repair during rTSA remains unknown with variable healing rates reported. This study aims to investigate the rate of and predictors for healing a lesser tuberosity osteotomy (LTO) following rTSA. Following local institutional review board approval, patients with at least one-year follow-up for rTSA managed with an LTO and subsequent repair between March, 2017 and March, 2020 were retrospectively identified. Shoulders were selected for LTO repair based upon preoperative imaging and intraoperative assessment of subscapularis quality. All patients were implanted with a system consisting of a 150° or 155° (constrained) humeral neck-shaft angle and 2.5 to 4.5 millimeters (mm) of glenoid lateralization (Trabecular Metal Reverse Shoulder System; Zimmer Biomet, Warsaw, IN, USA). At a minimum of six months, radiographs were reviewed for an assessment of LTO healing by three independent reviewers. Healing was classified as displaced, fibrous union, or ossified union. For assessing predictors, the repair was considered intact if the LTO fragment was not displaced (fibrous union or ossified union). Sixty-five rTSA with LTO repair were performed in 64 patients. These patients had an average age of 67.2 years (range, 31-81) and 36 (55.4%; 36/65) were female. At an average follow-up of 15.2 months (range, 8-38), 50 cases (76.9%; 50/65) were classified as having an ossified union. The radiographic healing could not be assessed in a single case. Of the 14 cases without ossific union, 8 (12.3%; 8/65) were displaced and 6 (9.2%; 6/65) were classified as a fibrous union. In logistic regression, only combined humeral liner height predicted LTO displacement (odds ratio=1.4 [95% confidence interval=1.1-1.8]; P=.01). Humeral loosening was not found in any cases following LTO. This analysis demonstrates that radiographic healing of LTO repair is more favorable than published rates of healing after subscapularis tenotomy or peel in the setting of rTSA. Subscapularis management with LTO provides the ability to monitor repair integrity with plain radiographs and a predictable radiographic healing rate. The integrity of subscapularis repair may be influenced by the use of thicker humeral liners. Further investigation is needed to determine the functional impact of a healed subscapularis following rTSA.

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Disparities and implicit bias in the management of low-risk febrile infants: a mixed methods study protocol

IntroductionThe management of low-risk febrile infants presents a model population for exploring how implicit racial bias promotes inequitable emergency care for children who belong to racial, ethnic and language minority...

Safe Technical Innovation: Development and Implementation of a Robotic Breast Operation Program.

Safe Technical Innovation: Development and Implementation of a Robotic Breast Operation Program.

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A case of didelphys uterus: tackling the double trouble adenomyosis and infertility

To present a case of didelphys uterus with severe pelvic pain and primary infertility with focal adenomyosis of outer myometrium (FOAM) of the left hemiuterus and tips and tricks for hemihysterectomy as a fertility preserving surgery. Descriptive step-by-step video demonstration of a case of didelphys uterus with adenomyosis of the hemiuterus. Local institutional review board approval for publication was obtained. Endometriosis Centre, Apollo Hospitals, Hyderabad, India. Women with uterus didelphys with FOAM of the left hemiuterus with severe pelvic pain and infertility. A 30-year-old woman presented with chronic pelvic pain and severe progressive dysmenorrhea with primary infertility for 3 years. She was diagnosed with uterus didelphys and longitudinal vaginal septum 3 years back and underwent hysteroscopy for septal resection and diagnostic laparoscopy for pain in an outside setting; however, no laparoscopic intervention was performed. The patient was diagnosed with FOAM of the left hemiuterus involving 75% of the hemiuterus. After detailed discussion and counseling regarding different options, laparoscopic hemihysterectomy was performed as pelvic pain relief was a major expected outcome along with fertility preservation. Pain relief with improved quality of life and fertility preservation. The postoperative period was uneventful. The patient was discharged on the second postoperative day with no complaints. Her chronic pelvic pain and dysmenorrhea resolved. She was not prescribed any medication after the surgery. During the routine follow-up, she had a regular menstrual cycle with a visual analogue score of 0/10. The safe removal of a hemiuterus in case of a didelphys uterus with pathology of hemiuterus through a minimally invasive technique is possible, which cures the pain caused by adenomyosis and enables quick recovery while preserving future fertility.

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Conservative surgical repair in cervical atresia associated with partial or complete absence of the vagina

To describe the surgical technique of laparoscopically assisted uterovaginal/vestibular anastomosis in patients with cervical atresia associated with partial or complete absence of the vagina. Surgical video article. Local institutional review board approval and written permission from the patients were obtained. Tertiary referral center. The surgical video presents surgical correction in 3 different patients with cervical agenesis. The first patient, aged 14 years, had a normoconformed uterus and total absence of the vagina. The second patient, aged 12 years, demonstrated a left unicornuate uterus and partial absence of the vagina. The third patient, aged 13 years, displayed a right unicornuate uterus and total absence of the vagina. Laparoscopic time and perineal time. During laparoscopy, the entire abdominopelvic cavity was assessed to evaluate the uterine morphology and size to exclude anomalies such as hematometra. The adnexa and adhesions were evaluated and any endometrial flare-ups were treated appropriately. A laparoscopic ultrasound probe was used to evaluate the size and location of the endometrial cavity. In cases with total absence of vaginas, an H-shaped incision in the hymenal dimple allowed a larger area of available tissue for the anastomosis. A tunnel was then created by blunt finger dissection between the bladder and rectum. Simultaneously, the uterus was pushed caudally by an assistant while the operator grasped it from below using an internal probe. A circular myometrial incision at the uterine caudal body allowed to reach the endometrial cavity and open it. The edges of the uterine cavity were then anastomized with the edges of the hymenal incision. In cases with partial absence of vaginas, the creation of the tunnel between the vagina and rectum was not necessary and the open uterus was anastomosed with the margins of the vaginal dome, engraved on the guide of a metal dilator. All patients received broad-spectrum antibiotics (i.e., cephalosporins of the last available generation) on the day before surgery and on the day of surgery. Intraoperative anatomic and ultrasound data, neovaginal length, and recovery of menstrual function 180 days after surgery. The surgical procedure was successful in all cases. No major complications were recorded, and in particular, no bladder or rectal injuries occurred. No stenosis of the neocervix was recorded. The main hospital stay of the patients was 3.5 ± 1.5 days. In each case, the neovagina developed gradually over time after surgery because of the upward traction action exerted by the uterus through its natural ligament apparatus (cardinal ligaments and ovarian vessels). This fact eliminated the requirement for the use of a mold after surgery. At the 15-week follow-up, vaginoscopy was performed, with mucus observed at the site of uterovaginal anastomosis in all cases. None of the patients developed infection after surgery because of the avoidance of molds or pessaries and the natural mucus production. Six months after surgery, the length of the neovagina was >4 cm in all 3 cases. Laparoscopic-assisted uterovaginal/vestibular anastomosis may be considered the treatment of choice for patients with cervical atresia associated with partial or complete absence of the vagina.

Rationale and design of the SARCoidosis Outcomes in all respiratory Viral Infectious Diseases (SARCOVID) Study

IntroductionRespiratory infections are ubiquitous. The COVID-19 pandemic has refocused our attention on how morbid and potentially fatal they can be, and how host factors have an impact on the clinical...

Laparoscopic sclerotherapy for an endometrioma in 10 steps

To present 10 consecutive, standardized, and reproducible surgical steps for laparoscopic sclerotherapy of an endometrioma. Step-by-step video demonstration of the technique. Local institutional review board approval was not required for this video because patients cannot be identified. Endometriosis Center. Women with an endometrioma >50 mm with deep endometriosis lesions, symptomatic, and wishing to conceive. Ethanol sclerotherapy for an endometrioma may be performed following 10 steps. Step 1 takes place preoperatively and consists of a rigorous selection of the patient to eliminate malignant tumors. Step 2 consists of the preparation of the material by preparing the required volume of alcohol. Step 3 consists of an exploration of the peritoneal cavity to eliminate the presence of peritoneal carcinosis. Step 4 is the puncture of the cyst, which may be direct via a 5 mm trocar or after the intraabdominal opening of the cyst; then aspiration of its contents in Step 5. Step 6 is flushing the cyst with a Ringer's lactate solution. In Step 7, the surgeon fills the cavity with a 96% alcohol solution. Step 8 consists of exposure for 10 to 15 minutes while the surgeon continues to operate. In Step 9, the surgeon extracts out all the alcohol from the cyst and cleans the peritoneal cavity. Step 10 consists of removal of the area not exposed to alcohol to treat this portion and obtain a histologic diagnosis. Description of 10 successive surgical steps. A video presenting 10 surgical steps to perform sclerotherapy of an endometrioma during endometriosis surgery. Laparoscopic sclerotherapy for an endometrioma is a rapid and accessible method. The standardization of this technique by this 10-step video should allow the surgeon to consider it as an alternative to cystectomy to preserve the ovarian reserve.

Real World Survival Outcomes of CPX-351 Versus Venetoclax and Azacitadine for Initial Therapy in Adult Acute Myeloid Leukemia

Real World Survival Outcomes of CPX-351 Versus Venetoclax and Azacitadine for Initial Therapy in Adult Acute Myeloid Leukemia

MP47-17 NEDOSIRAN DRAMATICALLY REDUCES SERUM OXALATE IN DIALYSIS-DEPENDENT PRIMARY HYPEROXALURIA 1: A COMPASSIONATE USE CASE REPORT

You have accessJournal of UrologyPediatric Urology III (MP47)1 Sep 2021MP47-17 NEDOSIRAN DRAMATICALLY REDUCES SERUM OXALATE IN DIALYSIS-DEPENDENT PRIMARY HYPEROXALURIA 1: A COMPASSIONATE USE CASE REPORT Kevin Shee, Justin Ahn, Fadl Hamouche, Jorge Mena, Thomas Chi, and Marshall Stoller Kevin SheeKevin Shee More articles by this author , Justin AhnJustin Ahn More articles by this author , Fadl HamoucheFadl Hamouche More articles by this author , Jorge MenaJorge Mena More articles by this author , Thomas ChiThomas Chi More articles by this author , and Marshall StollerMarshall Stoller More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002068.17AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Primary hyperoxaluria 1 (PH1) is a rare but devastating condition, involving recurrent urolithiasis, nephrocalcinosis, early end-stage renal disease (ESRD), and multisystemic deposition of calcium oxalate crystals. Clinical management of PH1 typically involves conservative management, dialysis, and eventual combined kidney and liver transplant (CKLT). Emerging therapeutics for PH1 target key synthesis steps of oxalate production; for example, anti-LDH RNAi Nedosiran inhibits the conversion from glyoxylate to oxalate, the final step in the oxalate synthesis pathway. In this study we sought to determine whether Nedosiran could meaningfully impact the clinical course of a 17-year-old female patient with PH1 and resultant ESRD, awaiting CKLT. METHODS: An Emergency Investigational New Drug (EIND) application was filed and approved by the Food and Drug Administration (FDA). Local institutional review board (IRB) approval and patient consent were obtained. The patient received monthly abdominal subcutaneous injection from July 2020 to present. Plasma oxalate levels, drawn before and after each dialysis appointment and before each Nedosiran injection, were monitored. RESULTS: Monthly Nedosiran injections led to dramatically decreased plasma oxalate levels, from 55.5 μmol/L to 13.9 μmol/L between July and December 2020 (Figure 1). This resulted in decreased frequency of weekly hemodialysis sessions from six to three, and deferral of a combined kidney and liver transplant offer in favor of continued Nedosiran treatment. No adverse events were reported other than temporary injection site discomfort. Since starting Nedosiran, the patient has not had new nephrolithiasis events. CONCLUSIONS: Nedosiran treatment completely transformed the clinical outcome of our PH1 patient with ESRD. Rationally targeting the oxalate synthesis pathway with Nedosiran thus represents a novel and impactful treatment strategy for PH1 patients with advanced disease. These results warrant further exploration in a larger cohort of PH1 patients to determine generalizability and to identify clinical and molecular characteristics associated with response. Source of Funding: Drug doses were provided by Dicerna pharmaceuticals © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e830-e830 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kevin Shee More articles by this author Justin Ahn More articles by this author Fadl Hamouche More articles by this author Jorge Mena More articles by this author Thomas Chi More articles by this author Marshall Stoller More articles by this author Expand All Advertisement Loading ...

Computed tomography-guided transforaminal lumbar puncture using local anesthesia and a straight 22-gauge spinal needle for intrathecal nusinersen in adults: Findings in 77 procedures.

Intrathecal nusinersen is the first Food and Drug Administration-approved treatment for spinal muscular atrophy. Reliable intrathecal access is critical for initial and maintenance therapy; however, this can be challenging in older patients with spinal muscular atrophy many of whom have had prior lumbar instrumentation and osseous fusion. Transforaminal lumbar punctures have emerged as a technique for intrathecal access that avoids the hazards of cervical punctures. We describe our technique for transforaminal lumbar punctures under computed tomography guidance using local anesthesia and a straight 22-gauge needle. Following local institutional review board approval, medical records of all patients undergoing computed tomography-guided transforaminal lumbar puncture for intrathecal nusinersen injection were obtained and analyzed. The rate of technical success and immediate complications were recorded. Any delayed complications noted in a 3-day follow-up phone call and future office visit were also recorded. Data collation and analysis were performed using Excel. A total of 77 transforaminal lumbar punctures were performed with intrathecal administration of nusinersen, for a 100% technical success rate. Local anesthesia was used in 76 cases, with conscious sedation used in one case. General anesthesia was not used in any case. There were no major complications. One patient had a postdural puncture headache that resolved completely after a transforaminal epidural blood patch performed 4 days later. Intrathecal administration of nusinersen is critical for treatment of patients with spinal muscular atrophy. Our described technique allows for reliable access to the intrathecal space using local anesthesia and a straight 22-gauge spinal needle under computed tomography guidance, and is easily reproducible.

Salvianolic Acid B Suppresses ER Stress-Induced NLRP3 Inflammasome and Pyroptosis via AMPK/FoxO4 and Syndecan-4/Rac1 Signal Pathways in Human Endothelial Progenitor Cells

Increasing evidence demonstrates that uncontrolled endoplasmic reticulum (ER) stress responses can activate the inflammasome, which often leads to endothelial dysfunction that underlies the pathogenesis of chronic inflammatory diseases such as atherosclerosis. Salvianolic acid B (SalB), a bioactive compound isolated from Radix Salviae, has been reported to exert anti-oxidative and anti-inflammatory activities in various types of cells. However, the effect of SalB on ER stress-related inflammasome and endothelial dysfunction has not been studied. In the present study, we demonstrated that SalB substantially abrogated ER stress-induced cell death and reduction in capillary tube formation that was linked to declined intracellular reactive oxygen species (ROS) levels, restored mitochondrial membrane potential (MMP), and increased expression of HO-1 and SOD2 in bone marrow-derived endothelial progenitor cells (BM-EPCs). Inhibition of ER stress by CHOP or caspase-4 siRNA transfection attenuated the protective effect of SalB. Furthermore, SalB alleviates ER stress-mediated pyroptotic cell death via suppression of TXNIP/NLRP3 inflammasome activation, as evidenced by decrease in cleavage of caspase-1 and downstream mature interleukin (IL)-1β and IL-18 secretion. Furthermore, our results provide mechanistic evidence that modulation of AMPK/FoxO4/KLF2 and Syndecan-4/Rac1/ATF2 signaling pathways by SalB significantly protected BM-EPCs against cell injury caused by ER stress via reduction of intracellular ROS levels and NLRP3-dependent pyroptosis. In summary, our findings identify that ER stress-induced mitochondrial ROS release and NLRP3 assembly in BM-EPCs, while SalB inhibit NLRP3 inflammasome-mediated pyroptotic cell death via regulating novel AMPK/FoxO4/KLF2 and Syndecan-4/Rac1/ATF2 signaling pathways. These findings suggest SalB to be a potential new agent with applications in the fields of atherosclerotic heart disease. Funding Information: The project was supported by grants from the National Natural Science Foundation of China (No. 81503281), Natural Science Foundation of Guangdong Province (No. 2021A1515011257), Science and Technology Planning Project of Guangzhou (No. 201904010109), Joint Funds of Natural Science Foundation of Guangdong Province (No. 2020B1515120094), and the Talent Grant of Sun Yat-sen University (No. 18ykpy11). Declaration of Interests: The authors declare that there is no conflict of interest to reveal. Ethics Approval Statement: Informed consent for bone marrow collection was obtained from healthy volunteers. All procedures were performed in accordance with the guidance and approval of the local institutional review board (approval no. 2016[130]).

Laparoscopic Uterine Artery Occlusion Combined with Uterine-sparing Pelvic Plexus Block and Partial Adenomyomectomy for Adenomyosis: A Video Case Report

OBJECTIVE Adenomyosis usually causes dysmenorrhea and anemia. Clinically, it is difficult to be solved by medicine and traditional surgery, and hysterectomy is always performed for radical treatment. In this article, we introduce a new method which could control the dysmenorrhea and anemia through laparoscopic uterine artery occlusion (LUAO) combined with uterine-sparing pelvic plexus block, and partial adenomyomectomy for uterus perservation.