Extracranial/Intracranial Vascular Bypass in the Treatment of Head and Neck Cancer - Related Carotid Blowout Syndrome.

OBJECTIVE/HYPOTHESIS: To investigate the endovascular intervention or extracranial/intracranial (EC/IC) vascular bypass in the management of patients with head and neck cancer-related carotid blowout syndrome (CBS). STUDY DESIGN: Retrospective case series. METHODS: Retrospective analysis of clinical data of patients with head and neck cancer-related CBS treated by endovascular intervention and/or EC/IC vascular bypass, analysis of its bleeding control, neurological complications, and survival results. RESULTS: Thrity-seven patients were included. Twenty-five were associated with external carotid artery (ECA); twelve were associated with internal or common carotid artery (ICA/CCA). All patients with ECA hemorrhage were treated with endovascular embolization. Of the 12 patients with ICA/CCA hemorrhage, 9 underwent EC/IC bypass, 1 underwent endovascular embolization, and 3 underwent endovascular stenting. For patients with ECA-related CBS, the median survival was 6 months, and the 90-day, 1-year, and 2-year survival rates were 67.1%, 44.7%, and 33.6%, respectively; the estimated rebleeding risk at 1-month, 6-month, and 2-year was 7.1%, 20.0%, and 31.6%, respectively. For patients with ICA/CCA-related CBS, the median survival was 22.5 months, and the 90-day, 1-year, and 2-year survival rates were 92.3%, 71.8%, and 41.0%, respectively; the estimated rebleeding risk at 1 month, 6 months, and 2 years is 7.7%,15.4%, and 15.4%, respectively. ICA/CCA-related CBS patients have significantly longer survival time and lower risk of rebleeding, which may be related to the more use of EC/IC vascular bypass as a definite treatment. CONCLUSIONS: For patients with ICA/CCA-related CBS, if there is more stable hemodynamics, longer expected survival, EC/IC vascular bypass is preferred. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:1548-1556, 2021.

Elastic intramedullary nail treatment of adolescent perihardware radius and ulna refracture.

A 13-year-old girl presented to the clinic with a midshaft refracture of both forearm bones adjacent to the site of a prior forearm fracture that had been treated with plating. She was treated with hardware removal and placement of elastic intramedullary nails. Flexible intramedullary nailing can be successful for a skeletally mature adolescent in treatment of refracture surrounding plate fixation of a midshaft forearm fracture. This technique allows for additional protection of the entire length of the affected bones, while avoiding the extensive dissection needed for extended plating.

Vicryl Mesh Coverage Reduced Recurrence After Bullectomy for Primary Spontaneous Pneumothorax.

BACKGROUND: Although thoracoscopic stapled bullectomy is a standard procedure for primary spontaneous pneumothorax (PSP), the postoperative recurrence rate is high. We investigated whether using a Vicryl (Ethicon, Somerville, NJ) mesh to cover the staple line after bullectomy reduces the postoperative recurrence rate. METHODS: Our single-blind, parallel-group, prospective, randomized controlled trial at 2 medical centers in Taiwan studied patients with PSP who were aged 15 to 50 years and required thoracoscopic bullectomy. On the day of operation, patients were randomly assigned (1:1) to receive Vicryl mesh (mesh group) or not (control group) after thoracoscopic bullectomy with linear stapling and mechanical apical pleural abrasion. Randomization was achieved using computer-generated random numbers in sealed envelopes. Our primary end point was the pneumothorax recurrence rate within 1 year after the operation (clinicaltrials.gov number, NCT01848860.) RESULTS: Between June 2013 and March 2016, 102 patients were assigned to the mesh group and 102 to the control group. Within 1 year after operation, recurrent pneumothorax was diagnosed in 3 patients (2.9%) in the mesh group compared with 16 (15.7%) in the control group (P = .005). The short-term postoperative results and hospitalization duration were comparable between the groups. CONCLUSIONS: For thoracoscopic bullectomy with linear stapling and mechanical apical pleural abrasion, the use of a Vicryl mesh to cover the staple line is effective for reducing the postoperative recurrence of pneumothorax. Vicryl mesh coverage can be considered an optimal adjunct to the standard surgical procedure for PSP.

Pediatric Spontaneous Pneumothorax: Does Initial Treatment Affect Outcomes?

BACKGROUND: Primary spontaneous pneumothorax (PSP) commonly occurs in adolescents, most commonly in males, and has recurrence rates between 20% and 60%. Surgical therapy has long been debated regarding its role in preventing recurrence, with no current consensus on guidelines for care. The purpose of this study is to examine the effect of treatment type on recurrence rates in pediatric PSP. METHODS: This is a single-institution, institutional review board-approved retrospective analysis of patients aged 1 to 18 diagnosed with their first occurrence of PSP between 2009 and 2017. Patient demographics, hospital course, and outcomes over a 2-y period were collected. Patients were divided into nonoperative (oxygen therapy only) management, chest tube placement, and surgical management. The primary outcome was the recurrence rate. RESULTS: Sixty-four patients diagnosed with PSP met inclusive criteria. The mean age was 15.5, and 48 (75%) of patients were men. Twenty-one patients (33%) underwent nonoperative treatment, 24 patients (37.5%) underwent operative treatment with video-assisted thoracoscopic surgery or open thoracotomy, and 19 patients (30%) underwent chest tube or pigtail placement alone. Fifteen patients (23.4%) experienced a recurrence within 2 y: 6 patients (29%) from the nonoperative treatment group, 4 (21%) who were treated with the chest tube only, and 5 (21%) who underwent video-assisted thoracoscopic surgery or open thoracotomy. No statistically significant difference in recurrence rates was found between treatment groups. Pneumothorax size was found to differ between treatment type; larger pneumothoraces were more likely to undergo surgical intervention (P = 0.0003). Smaller pneumothoraces were associated with higher rates of recurrence on multivariate logistic regression analysis (P = 0.046). CONCLUSIONS: Recurrence of PSP in adolescents was found to be 23.4% after 2-y follow-up. Smaller-sized pneumothoraces were associated with higher rates of recurrence, but treatment type did not significantly affect recurrence rates.

Chronic mesenteric ischemia: Clinical practice guidelines from the Society for Vascular Surgery.

BACKGROUND: Chronic mesenteric ischemia (CMI) results from the inability to achieve adequate postprandial intestinal blood flow, usually from atherosclerotic occlusive disease at the origins of the mesenteric vessels. Patients typically present with postprandial pain, food fear, and weight loss, although they can present with acute mesenteric ischemia and bowel infarction. The diagnosis requires a combination of the appropriate clinical symptoms and significant mesenteric artery occlusive disease, although it is often delayed given the spectrum of gastrointestinal disorders associated with abdominal pain and weight loss. The treatment goals include relieving the presenting symptoms, preventing progression to acute mesenteric ischemia, and improving overall quality of life. These practice guidelines were developed to provide the best possible evidence for the diagnosis and treatment of patients with CMI from atherosclerosis. METHODS: The Society for Vascular Surgery established a committee composed of vascular surgeons and individuals experienced with evidence-based reviews. The committee focused on six specific areas, including the diagnostic evaluation, indications for treatment, choice of treatment, perioperative evaluation, endovascular/open revascularization, and surveillance/remediation. A formal systematic review was performed by the evidence team to identify the optimal technique for revascularization. Specific practice recommendations were developed using the Grading of Recommendations Assessment, Development, and Evaluation system based on review of literature, the strength of the data, and consensus. RESULTS: Patients with symptoms consistent with CMI should undergo an expedited workup, including a computed tomography arteriogram, to exclude other potential causes. The diagnosis is supported by significant arterial occlusive disease in the mesenteric vessels, particularly the superior mesenteric artery. Treatment requires revascularization with the primary target being the superior mesenteric artery. Endovascular revascularization with a balloon-expandable covered intraluminal stent is the recommended initial treatment with open repair reserved for select younger patients and those who are not endovascular candidates. Long-term follow-up and surveillance are recommended after revascularization and for asymptomatic patients with severe mesenteric occlusive disease. Patient with recurrent symptoms after revascularization owing to recurrent stenoses should be treated with an endovascular-first approach, similar to the de novo lesion. CONCLUSIONS: These practice guidelines were developed based on the best available evidence. They should help to optimize the care of patients with CMI. Multiple areas for future research were identified.

Percutaneous transhepatic portal vein stenting as rescue treatment for recurrent oesophageal variceal bleeding in a 31-year-old woman with haepatocellular carcinoma in a non-cirrhotic liver.

A 31-year-old woman with hepatocellular carcinoma suffered from recurrent oesophageal variceal bleeding due to portal hypertension, which was caused by severe compression of the portal vein by metastatic lymph nodes. Endoscopic band ligation and pharmacological treatment did not suffice to prevent recurrence of variceal bleeding. Eventually, after the fifth variceal bleeding within 6 months, the patient was admitted to the intensive care unit in a haemodynamic shock. A Sengstaken-Blakemore tube was inserted and all treatment options were discussed, but only percutaneous transhepatic recanalisation of the portal vein with stent placement to reduce portal vein pressure was thought to be feasible with any chance to relieve portal vein pressure. After successful portal vein stenting, our patient did not have any recurrent bleeding in the remaining year of her life. We suggest that percutaneous transhepatic portal vein stenting may be a feasible and adequate last line treatment for complications of portal hypertension.

Treatment of Refractory Melasma in Asians With the Picosecond Alexandrite Laser.

BACKGROUND/OBJECTIVES: The picosecond Alexandrite laser was studied in our practice with the diffractive lens array and the flat optic to treat melasma. METHODS AND MATERIALS: Sixty patients with melasma were treated in a prospective investigation with the picosecond Alexandrite laser. Nineteen patients were treated with the flat optic and 41 patients were treated with the diffractive lens array. Treatments were performed with 1 pass at 2-week intervals for 6 treatments. The Melasma Severity Index (MSI) was used to evaluate the patients before treatment and 3 and 6 months after the final treatment session. RESULTS: At 6 months after the last treatment, there was an 18.5% difference between the groups with a 75.7% improvement in the MSI in patients with the diffractive lens array and a 57.2% improvement in the MSI score in patients with the flat optic. At 6 months, there was recurrence of melasma in 5% of the cases with no hyperpigmentation with the diffractive optic in contrast to recurrence in 16% of the cases in the flat optic group and a transient macular hyperpigmentation in 21% of the cases. CONCLUSION: This investigation highlights the utility of a picosecond Alexandrite laser with a flat and diffractive lens to successfully treat a large percentage of Asian patients in a sunny climate.

Preventing the recurrence of acute anorectal abscesses utilizing a loose seton: a pilot study.

INTRODUCTION: This pilot study aimed to document our results of treating anorectal abscesses with drainage plus loose seton for possible coexisting high fistulas or drainage plus fistulotomy for low tracts at the same operation. METHODS: Drainage plus fistulotomy were performed only in cases with subcutaneous mucosa, intersphincteric, or apparently low transsphincteric fistula tracts. For all other cases with high transsphincteric fistula or those with questionable sphincter involvement, a loose seton was placed through the tract. Drainage only was carried out in 17 patients. RESULTS: Twenty-three patients underwent drainage plus loose seton. Drainage plus fistulotomy were performed in four cases. None of the patients developed recurrent abscess during a follow-up of 12 months. Not surprisingly, the incontinence scores were similar pre and post-operatively (p=0.564). Only minor complications occurred in 4 cases (14.8 percent). Secondary interventions following loose seton were carried out in 13 patients (48.1 percent). At 12 months, drainage only was followed by 10 recurrences (58.8 percent; p<0.0001, compared with concomitant surgery). CONCLUSION: Concomitant loose seton treatment of high fistula tracts associated with anorectal abscess prevents abscess recurrence without significant complications or disturbance of continence. Concomitant fistulotomy for associated low fistulas also aids in the same clinical outcome. Concomitant fistula treatment with the loose seton may suffice in treating the whole disease process in selected cases. Even in patients with high fistula tracts, the loose seton makes fistula surgery simpler with a mature tract. Abscess recurrence is high after drainage only.

No-Touch Technique of Mesh Placement in Ventral Hernia Repair: Minimizing Postoperative Mesh Infections.

Synthetic mesh is commonly used in ventral hernia repairs to reinforce the abdominal closure and minimize hernia recurrence rates. However, the use of synthetic mesh is associated with certain risks, most notably infection requiring explantation. This study sought to evaluate the use of a "no-touch" technique with antibiotic solution during synthetic mesh placement in ventral hernia repairs and its impact on complication/infection rates. The authors retrospectively reviewed a prospectively maintained database of patients undergoing abdominal wall reconstruction with synthetic mesh from 2013 to 2018 by a single surgeon with a minimum 1-year follow-up. Data collected included demographic data, medical comorbidities, hernia history, and the type of antibiotics used in the no-touch technique. Complications were stratified into short-term (<30 days), medium-term (30 to 90 days), and long-term (91 to 365 days) complications. Results were compared to previously published rates in the literature. Eighty-eight patients met inclusion criteria. Fourteen patients (15.9 percent) experienced postoperative complications (two patients had multiple complications); six of these patients (6.8 percent) were readmitted to the hospital for management. Subsequently, three of the readmitted patients (3.4 percent) required reoperations related to abdominal infection and required removal of the synthetic mesh. A total of 16 complication events occurred in the cohort: 13 short-term complications (81.3 percent), three medium-term complications (18.7 percent), and zero long-term complications. The authors conclude that the no-touch technique for mesh placement in ventral hernia repairs appears to be efficacious in minimizing infectious complications with mesh placement, although further prospective studies are required to further define this relationship. CLINICAL QUESTION/LEVEL OF EVIDENCE:: Therapeutic, IV.

Normalization of Forefoot Supination After Tibialis Anterior Tendon Transfer for Dynamic Clubfoot Recurrence.

BACKGROUND: We aimed to evaluate the effect of tibialis anterior tendon transfer (TATT) on foot motion in children with clubfoot recurrence after initial Ponseti treatment. METHODS: Children with dynamic clubfoot recurrence after initial Ponseti treatment who underwent TATT between 2014 and 2017 were considered for inclusion. Exclusion criteria were neurological disease, split transfer of the tendon, additional bone or joint invasive surgery, and initial treatment abroad. Of 94 children (143 TATT), 36 met the inclusion criteria. Seventeen (47%) of the 36 children with 25 clubfeet and a mean age at the time of surgery of 6.8 years participated in the study. Gait analysis, including the Oxford foot model, was conducted preoperatively and postoperatively. Furthermore, kinematic and kinetic data were compared with those of age-matched healthy children (n=18). RESULTS: Forefoot supination in relation to the hindfoot and tibia was reduced during swing and at initial contact after TATT compared with preoperative values. Forefoot supination in relation to the tibia at initial contact decreased from 12.4 to 5.2 degrees after TATT (control group, 6.0 degrees). The heel showed less dynamic varus and adduction movement after TATT compared with preoperatively. Maximum ankle power was reduced preoperatively and postoperatively compared with controls. Maximum ankle dorsiflexion slightly increased after TATT. CONCLUSIONS: Gait analysis showed normalization of the main components of dynamic clubfoot recurrence after TATT. This joint-sparing surgery efficiently corrects recurrent dynamic deformity. LEVEL OF EVIDENCE: Level II-therapeutic.

Smartphone-based secondary prevention intervention for university students with unhealthy alcohol use identified by screening: study protocol of a parallel group randomized controlled trial.

BACKGROUND: Unhealthy alcohol use is a leading cause of morbidity and mortality among young people, including university students. Delivering secondary prevention interventions against unhealthy alcohol use is challenging. Information technology has the potential to reach large parts of the general population. The present study is proposed to test a proactive secondary prevention smartphone-based intervention against unhealthy alcohol use. METHODS: This is a parallel-group, randomized controlled trial (1:1 allocation ratio) among 1696 university students with unhealthy alcohol use, identified by screening and followed up at 3, 6, and 12 months. Participants will be randomized to receive access to a smartphone-based intervention or to a no intervention control condition. The primary outcome will be self-reported volume of alcohol drunk over the past 30 days, reported as the mean number of standard drinks per week over the past 30 days, measured at 6 months. Secondary outcomes will be number of heavy drinking days over the past 30 days, at 6 months. Additional outcomes will be maximum number of drinks on any day over the past 30 days, alcohol-related consequences (measured using the Short Inventory of Problems (SIP-2R), and academic performance. DISCUSSION: The aim of this trial is to close the evidence gap on the efficacy of smartphone-based secondary prevention interventions. If proven effective, smartphone-based interventions have the potential to reach a large portion of the population, completing what is available on the Internet. TRIAL REGISTRATION: ISRCTN, 10007691. Registered on 2 December 2019. Recruitment will start in April 2020.

Mesh fistula after ventral hernia repair: What is the optimal management?

BACKGROUND: A mesh-related intestinal fistula is an uncommon and challenging complication of ventral hernia repair. Optimal management is unclear owing to lack of prospective or long-term data. METHODS: We reviewed our prospective data for mesh-related intestinal fistulas from 2004 to 2017and compared suture repair versus ventral hernia repair with mesh at the time of mesh-related intestinal fistula takedown. RESULTS: Eighty-two mesh-related intestinal fistulas were treated; none of the fistulas had closed spontaneously, and all fistula persisted at the time of our treatment. Mean age was 61 ± 12 years with 33-month follow-up. Comorbidities were similar between groups. Defects were 2.5-times larger in ventral hernia repair with mesh (324 ± 392 cm2 vs 1301 ± 133 cm2; P = .044). Components separation (64% vs 21%; P = .0003) and panniculectomy (35% vs 7%; P = .0074) were more common in ventral hernia repair with mesh. Mortality occurred in 4 patients. Complications were similar. In patients undergoing ventral hernia repair with non-bridged, acellular, porcine dermal matrix, hernia recurrence was less than in patients without mesh (26% vs 66%; P = .0030). Only partial excision of the mesh involved with the fistula resulted in a substantial increase in developing another fistula (29% vs 6%; P < .05). CONCLUSION: Patients undergoing preperitoneal ventral hernia repair with mesh for mesh-related intestinal fistula had a lesser rate of hernia recurrence and similar complications compared to suture repair despite larger hernias. Complete mesh excision decreases the risk of fistula recurrence. We maintain that ventral hernia repair with mesh during mesh-related intestinal fistula takedown represents the best opportunity for a durable herniorrhaphy.

Hernia Repair Strength Enhanced With Antioxidants.

BACKGROUND: Incisional hernia is one of the most common complications of abdominal surgery, and repairs are associated with significant recurrence rates. Mesh repairs are associated with the best outcomes, but failures are not uncommon. Doxycycline has been demonstrated to enhance mesh hernia repair outcomes with associated increases in collagen deposition and improved tensiometric strength. This study compares the outcomes of incisional hernia repair with doxycycline administration and the antioxidant tempol. MATERIALS AND METHODS: Twenty-eight male Sprague Dawley rats underwent a midline hernia creation and an intraabdominal polypropylene mesh repair. The animals were administered saline, doxycycline, tempol, or both, daily for 8 wk. The abdominal wall was harvested at 8 wk and tensiometric strength and biochemical analysis was performed. RESULTS: The tensiometric strength of the repair was increased in all experimental groups. Collagen type 1 deposition was increased, and collagen type 3 deposition was decreased in each of the experimental groups relative to control. There was no difference in MMP-2 and MMP-9 levels between control and experimental groups. CONCLUSIONS: The hernia repair strength is equally enhanced with the administration of doxycycline or tempol. Dual therapy provided no benefit over treatment with either single agent. All treatment groups had an increase in collagen type 1:3 ratios, but the mechanism is not well understood. The benefits of antioxidant treatment following hernia repair are similar to treatment with doxycycline. Given the high frequency of incisional hernia repair failures, this study has implications for improving outcomes following ventral hernia repair through the use of either doxycycline or antioxidant therapy.

Minimising recurrence after primary femoral hernia repair; is mesh mandatory?

PURPOSE: The recent international hernia guidelines advocate laparoscopic pre-peritoneal mesh repair for primary femoral hernias. However, no randomised trial has demonstrated a lower recurrence rate compared to suture repair. This study aimed to determine the 5-year recurrence rate following femoral hernia repair, in elective and emergency settings, according to surgical approach (open or laparoscopic) and method (suture, suture + mesh, or mesh alone). METHODS: Consecutive patients undergoing primary femoral hernia repairs within a single health board, between 2007 and 2013, were identified from a prospective audit. Patients who had died or were uncontactable during the period of follow-up were excluded. Recurrence was defined as the clinical suspicion of an ipsilateral groin hernia at outpatient review or patient reported ipsilateral groin swelling. RESULTS: A total of 297 patients underwent primary femoral hernia repairs in the time period. Of the 138 cases with complete follow-up, 25 patients experienced recurrence at 5 years (18%), with 60% of recurrences evident within the first post-operative year. The median follow-up of the remaining 113 patients was 93 months (range 63-127). No difference could be detected in recurrence rates (P = 0.372, P = 0.353), or time to recurrence (P = 0.421, P = 0.295), according to repair type (suture only, suture and mesh, or mesh only) or surgical approach (high open, low open and laparoscopic pre-peritoneal), respectively. CONCLUSIONS: Use of different surgical approaches and types of repair for primary presentations of femoral hernia did not affect the recurrence rate or time to recurrence. Use of a pre-peritoneal mesh did not alter the recurrence rate or recurrence free survival, in either elective or emergency settings, compared to simple suture repair. Recurrence following primary femoral hernia repair tends to occur within the first post-operative year, suggesting that technical factors may be as important as suture or mesh failure.

Biomechanical Features of Reinforced Esophageal Hiatus Repair in a Porcine Model.

Recurrence rates in the laparoscopic repair of the hiatal hernia range from 12% to 59%. Limitation of reinforcement has been principally the risk of adverse events caused by synthetic materials. Biologic and resorbable synthetic materials are valid alternatives. This study compares the host response to all these materials after hiatal hernia repair. A total of 20 Landrace pigs, underwent laparoscopic primary hiatal hernia repair and reinforced with a polypropylene mesh (PROLENE: polypropylene [PP]), an absorbable synthetic scaffold (GOREBIO-A: polyglycolic acid [PGA]), a urinary bladder matrix scaffold, (Gentrix: urinary bladder matrix [UBM]), or without reinforcement, control group (C). Animals were survived for 3 months. Endpoints included gross morphology, biomechanical testing, and histology. Pigs in PP and PGA groups showed fibrosis at the repair site, with robust adhesions. In UBM and C groups, only mild adhesions were found. Load at failure (gr) and stiffness (gr/mm) of PP were higher than C group (PP:2103 ± 548.3 versus C:951.1 ± 372.7, P = 0.02; PP:643.3 ± 301 versus C:152.6 ± 142.7, P = 0.01). PGA and UBM values for both parameters were in between PP and C samples. However, stiffness in UBM was tended to be lower than PP group, and approached a significant difference (643.3 ± 301 versus 243 ± 122.1, P = 0.0536). In UBM group, the histology resembled native tissue. By contrast, PP and PGA groups showed mononuclear infiltrates, fibroencapsulation, necrosis, remnants of mesh, and disorganized tissue that was validated with a histologic score. In this setting, UBM scaffolds showed the most appropriate features for hiatal hernia repair, recovering the tissue properties that can help reduce the possibility of early failure and prevent complications associated with the implanted material.

Effect of balloon dilation eustachian tuboplasty combined with tympanic tube insertion in the treatment of chronic recurrent secretory otitis media.

PURPOSE: To investigate the long-term clinical effect of balloon dilation eustachian tuboplasty (BET) combined with tympanic tube insertion (TTI) in the treatment of chronic recurrent secretory otitis media (CRSOM). MATERIALS AND METHODS: A retrospective study of 30 cases of CRSOM treated with BET combined with TTI under general anesthesia between August 2014 and September 2016. Thirty cases of CRSOM treated with TTI in the same period were taken as the control group. All cases were followed over 24 months. The scores of eustachian tube (ET) function preoperation, 1 month, 6 months, 12 months, and 24 months postoperation were collected and analyzed, respectively. A satisfaction questionnaire was used to evaluate the therapy at 24-months postoperation. RESULTS: The symptoms were significantly improved and the ET score was obviously increased postsurgery in most cases treated with BET plus TTI compared with those treated with TTI alone. The highest ET score was obtained at 6 months post BET. Five (14%) cases (6 ears) of CRSOM recurred. The 24-month postoperation follow-up questionnaire showed that 84.6% of the patients were satisfied with the treatment, while ten cases (25%) in the TTI group recurred. CONCLUSION: BET combined with TTI surgery is an effective therapy for patients with CRSOM.

Surgical Experience and Complications in 50 Patients Treated with an Anular Closure Device Following Lumbar Discectomy.

OBJECTIVE: To examine the results of an anular closure device for prevention of lumbar disc reherniation in daily routine practice. METHODS: Fifty patients with large anular defects were treated with limited discectomy and a bone-anchored anular closure device. The device physically occludes the defect in the anulus fibrosus and is intended for prevention of lumbar disc reherniation. Pain scores on a visual analogue scale, back function on the Oswestry Disability Index, and neurological status were noted. Symptomatic reherniation and reoperation rates were assessed at each follow-up. Surgical findings and complications, device-related and/or procedure-related, were recorded. Follow-up was 6, 12, 26, and 52 weeks. RESULTS: Mean anular defect height/width was 4.6 mm/10.1 mm. The overall symptomatic reherniation and reoperation rate was 2%. During the 1-year follow-up period, mean back pain decreased from 43 to 8 (P < 0.001), leg pain decreased from 71 to 4 (P < 0.001), and the Oswestry Disability Index decreased from 46 to 5 (P < 0.001). Among 15 patients with preoperative neurological deficits, improvements in neurological function were noted in 14 (93%). There were no serious device-related complications. CONCLUSIONS: The presented study shows promising early results in using the anular closure device. The procedure is safe with significantly fewer reherniations than for patients with large anular defects without anular closure. Further studies with longer follow-up periods are warranted to prove these findings for long-term outcomes.

Two-year real-world results of lumbar discectomy with bone-anchored annular closure in patients at high risk of reherniation.

PURPOSE: To determine the safety and effectiveness of limited lumbar discectomy with additional implantation of an annular closure device (ACD) among patients at high risk of herniation recurrence treated in routine clinical practice. METHODS: This was a prospective, single-center study of lumbar discectomy for sciatica caused by intervertebral disc herniation with adjunctive ACD implantation to reduce herniation recurrence risk among high-risk patients with large annular defects. Patients returned for follow-up visits at 6 weeks, 12 weeks, 26 weeks, 1 year, and 2 years. Main outcomes included reoperation, herniation recurrence, back pain severity, leg pain severity, and Oswestry Disability Index (ODI). The minimum important difference was defined as ≥ 20 mm decrease relative to baseline for leg pain severity, ≥ 20 mm decrease for back pain severity, and ≥ 15-point decrease for ODI. RESULTS: Among 75 high-risk patients (mean age 45 years, 59% female), the cumulative event incidence through 2 years was 4.0% for reoperation and 1.4% for herniation recurrence. Mean leg pain severity decreased from 73 to 6 (p < 0.001), back pain severity decreased from 51 to 13 (p < 0.001), and ODI decreased from 49 to 7 (p < 0.001). The percentage of patients achieving the minimum important difference was 91% for leg pain, 65% for back pain, and 94% for ODI. CONCLUSION: In patients at high risk of herniation recurrence following limited lumbar discectomy in routine clinical practice, additional implantation of an ACD was safe and reherniation recurrence rates were low at 2-year follow-up, which is favorably compared to reported rates in high-risk patients.

Clinical evaluation of deep brain stimulation of nucleus accumbens/anterior limb of internal capsule for opioid relapse prevention: protocol of a multicentre, prospective and double-blinded study.

INTRODUCTION: Deep brain stimulation (DBS) is a new potential surgical treatment for opioid dependence. However, the implement of DBS treatment in addicted patients is currently controversial due to the significant associated risks. The aim of this study was mainly to investigate the therapeutic efficacy and safety of bilateral DBS of nucleus accumbens and the anterior limb of the internal capsule (NAc/ALIC-DBS) in patients with refractory opioid dependence (ROD). METHODS AND ANALYSIS: 60 patients with ROD will be enrolled in this multicentre, prospective, double-blinded study, and will be followed up for 25 weeks (6 months) after surgery. Patients with ROD (semisynthetic opioids) who meet the criteria for NAc/ALIC-DBS surgery will be allocated to either the early stimulation group or the late stimulation group (control group) based on the randomised ID number. The primary outcome was defined as the abstinence rate at 25 weeks after DBS stimulation on, which will be confirmed by an opiate urine tests. The secondary outcomes include changes in the Visual Analogue Scale (VAS) score for craving for opioid drugs, body weight, as well as psychological evaluation measured using the 17-item Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale, the Pittsburgh Sleep Quality Index, Fagerstrom test for nicotine dependence assessment, social disability screening schedule, the Activity of Daily Living Scale, the 36-item Short Form-Health Survey and safety profiles of both groups. ETHICS AND DISSEMINATION: The study received ethical approval from the medical ethical committee of Tangdu Hospital, The Fourth Military Medical University, Xi'an, China. The results of this study will be published in a peer-reviewed journal and presented at international conferences. TRIAL REGISTRATION NUMBER: NCT03424616; Pre-results.