Radiofrequency ablation for Barrett's oesophagus related neoplasia with the 360 Express catheter: initial experience from the United Kingdom and Ireland-preliminary results.

BACKGROUND: Radio-frequency ablation (RFA) for Barrett's oesophagus (BE)-related neoplasia is currently used after endoscopic resection of visible neoplasia. The HALO 360 balloon has been used to ablate long segment BE. The Barrx™ 360 Express RFA self-sizing catheter ('RFA Express') may potentially allow quicker ablation times and improved treatment outcomes. The aim of this paper is to present real world data on the use of the 360 Express Device. METHODS: Centres in the UK and Ireland submitted cases where the RFA Express was used. The primary outcome was regression of BE at 3 months. Secondary outcomes were the rate of symptomatic stricture formation and resolution of intestinal metaplasia (CR-IM) and dysplasia (CR-D) at End of Treatment (EoT). RESULTS: 11 centres submitted 123 consecutive patients. 112 had a follow up endoscopy. The median age was 67 years (IQR 62-75). 3 dosimetries were used. The mean reduction in Circumferential (C) length was 78% ± 36 and mean reduction in Maximal length (M) was 55% ± 36. 17 patients (15%) developed strictures requiring dilation. There was a higher rate of stricture formation when the 12 J energy was used (p < 0.05). 47 patients had EoT biopsies, 40 (85%) had CR-D and 34(76%) had CR-IM. CONCLUSIONS: The RFA 360 Express catheter shows reduction in length of baseline BE at 3 months after index treatment, and eradication of intestinal metaplasia and dysplasia at 12 months similar to other studies with earlier devices. It appears that the symptomatic stricture rate is slightly higher than previous series with the HALO 360 catheter. This study was performed as part of the HALO registry and has been approved by the Research Ethics Committee - MREC Number 08/H0714/27 Local project reference 08/0104 Project ID 15,033 IRAS Number 54678 EudraCT 2009-015980-1. Registered on ISRCTN as below: ISRCTN93069556. https://doi.org/10.1186/ISRCTN93069556.

Endoscopic ultrasound-guided ethanol and radiofrequency ablation of pancreatic insulinomas: a systematic literature review.

BACKGROUND: Insulinoma is the most common neuroendocrine neoplasm of the pancreas, characterised by hypoglycaemic symptoms. Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) and ethanol ablation (EUS-EA) are novel methods for treating insulinoma.We aimed to perform a systematic review to assess the efficacy and safety of EUS-guided ablation techniques for pancreatic insulinomas. METHODS: We systematically searched for articles detailing EUS-guided ablations of insulinomas. We performed a qualitative analysis and summarised data on the efficacy and safety of EUS-RFA and EUS-EA techniques. RESULTS: In total, we identified 35 case reports and case series describing 75 patients with insulinomas treatment with EUS-guided ablation. Twenty-seven patients were treated with EUS-RFA, 47 patients with EUS-EA, and 1 patient received EUS-EA and EUS-RFA in the same session. In total, 84 insulinomas were ablated (EUS-RFA: 31, EUS-EA: 53). Most insulinomas were in the head of the pancreas (40%). The clinical success rate for EUS-guided ablation techniques was 98.5%. The median glucose level was 1.95 (Q1-Q3: 1.69-2.13) mmol/L before ablation compared to 6.20 (Q1-Q3: 5.30-7.05) mmol/L after treatment. The median insulin and C-peptide levels before and after RFA/EA were 230 (Q1-Q2: 120-257) pmol/L and 41 (Q1-Q2 35-42) pmol/L; 2077 (Q1-Q2 1644-2459) pmol/L and 819 (Q1-Q2 696-1072) pmol/L, respectively. There were eleven adverse events: seven abdominal pain, two mild acute pancreatitis, one necrotising acute pancreatitis and one local hematoma. All patients recovered, and there were no periprocedural deaths. CONCLUSIONS: EUS-guided ablation of insulinoma seems to be a safe and effective treatment and is an alternative to surgical resection in selected cases.

Quality indicators for Barrett's endotherapy (QBET): UK consensus statements for patients undergoing endoscopic therapy for Barrett's neoplasia.

INTRODUCTION: Endoscopic therapy for the management of patients with Barrett's oesophagus (BE) neoplasia has significantly developed in the past decade; however, significant variation in clinical practice exists. The aim of this project was to develop expert physician-lead quality indicators (QIs) for Barrett's endoscopic therapy. METHODS: The RAND/UCLA Appropriateness Method was used to combine the best available scientific evidence with the collective judgement of experts to develop quality indicators for Barrett's endotherapy in four subgroups: pre-endoscopy, intraprocedure (resection and ablation) and postendoscopy. International experts, including gastroenterologists, surgeons, BE pathologist, clinical nurse specialist and patient representative, participated in a three-round process to develop 15 QIs that fulfilled the RAND/UCLA definition of appropriateness. RESULTS: 17 experts participated in round 1 and 20 in round 2. Of the 24 proposed QIs in round 1, 20 were ranked as appropriate (put through to round 2) and 4 as uncertain (discarded). At the end of round 2, a final list of 15 QIs were scored as appropriate. CONCLUSIONS: This UK national consensus project has successfully developed QIs for patients undergoing Barrett's endotherapy. These QIs can be used by service providers to ensure that all patients with BE neoplasia receive uniform and high-quality care.

A Comparison of Clinical Outcomes between Early Cervical Spine Stabilizer Training and Usual Care in Individuals following Anterior Cervical Discectomy and Fusion.

OBJECTIVES: Early physical therapy (PT) with specific stabilization training has been shown to benefit individuals after lumbar spinal surgery but has not been studied in patients after cervical spine surgery. The primary purpose of this study was to compare clinical outcomes between early cervical spine stabilizer (ECS) training and usual care (UC) in patients after anterior cervical discectomy and fusion (ACDF) surgery. The secondary purpose was to determine test-retest reliability of strength and endurance tests of cervical spinal stabilizers in this patient population. METHODS: Forty participants who were scheduled for ACDF surgery were randomized into either the ECS group or the UC group. After surgery, participants received their assigned group intervention during their hospital stay and continued their assigned intervention for 12 weeks. All participants had phone follow-ups twice during the first 6 weeks to address questions or problems. Clinical outcome measures including pain level using the Numeric Pain Rating Scale (NPRS), disability level using the Neck Disability Index (NDI), Craniocervical Flexor Strength (CCF-S), and Craniocervical Flexor Endurance (CCF-E) were collected three times: before surgery and 6 and 12 weeks after surgery. Test-retest reliability was assessed in the first 10 participants. RESULTS: There was no significant interaction between the groups over time for any of the outcome measures. However, all participants made significant improvements in all four outcome measures at 6 and 12 weeks post surgery. The results showed good-to-excellent test-retest reliability for the CCF-S and CCF-E tests. CONCLUSIONS: Both ECS training and UC resulted in the same amount of improvement at 6 and 12 weeks; therefore, both therapy approaches appear to have similar and positive effects on patients in their first 3 months of recovery after ACDF. Both the CCF-S and CCF-E tests can be used reliably to assess the strength and endurance of the cervical spinal stabilizers for patients after ACDF surgery. The study was registered with the ClinicalTrials.gov (NIH, U.S. National Library of Medicine, identifier # NCT01519115) Protocol Registration system.

Radiofrequency ablation for patients with refractory symptomatic anaemia secondary to gastric antral vascular ectasia.

Background: Gastric antral vascular ectasia (GAVE) is a rare cause of gastrointestinal bleeding, often causing iron deficiency anaemia. Previous studies have looked at the management of this with argon plasma coagulation, laser therapy and endoscopic band ligation. Methods: This was a single-centre prospective study to evaluate the efficacy and safety of radiofrequency ablation (RFA) in patients with GAVE with persistent anaemia refractory to at least one session of first-line endoscopic therapy. Patients were treated with a through-the-scope (TTS) radiofrequency catheter at two endoscopic sessions six weeks apart. The primary outcome was change in haemoglobin at six months posttreatment. The secondary outcomes were reduction in blood or iron requirements, endoscopic surface area regression and complications. Results: Twenty patients were treated. The mean change in haemoglobin at six months was +12.6 g/l (95% confidence interval 11.7-24.3 g/l), paired t test p < 0.001. At six months, three of 14 individuals who had required blood transfusions had ongoing blood transfusions and five of 17 who had required iron had ongoing iron needs. Surface area regression was scored as 74% ± 25% but no correlation was seen between this and other outcomes. Three of 20 patients experienced pain which was managed with oral analgesia. Of the 14 patients who had reached 12-month follow-up, three required retreatment (21%). Discussion: This small study suggests that RFA is a safe and effective treatment for GAVE. Our study uses the TTS catheter compared to other studies, and demonstrates prolonged improvement in haemoglobin and reduction in blood and iron requirements with a novel assessment of surface area regression.

Hookworm exposure decreases human papillomavirus uptake and cervical cancer cell migration through systemic regulation of epithelial-mesenchymal transition marker expression.

Persistent infection with human papillomavirus (HPV) is responsible for nearly all new cervical cancer cases worldwide. In low- and middle-income countries (LMIC), infection with helminths has been linked to increased HPV prevalence. As the incidence of cervical cancer rises in helminth endemic regions, it is critical to understand the interaction between exposure to helminths and the progression of cervical cancer. Here we make use of several cervical cancer cell lines to demonstrate that exposure to antigens from the hookworm N. brasiliensis significantly reduces cervical cancer cell migration and global expression of vimentin and N-cadherin. Importantly, N. brasiliensis antigen significantly reduced expression of cell-surface vimentin, while decreasing HPV type 16 (HPV16) pseudovirion internalization. In vivo infection with N. brasiliensis significantly reduced vimentin expression within the female genital tract, confirming the relevance of these in vitro findings. Together, these findings demonstrate that infection with the hookworm-like parasite N. brasiliensis can systemically alter genital tract mesenchymal markers in a way that may impair cervical cancer cell progression. These findings reveal a possible late-stage treatment for reducing cervical cancer progression using helminth antigens.

Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc.

OBJECTIVE Seven cervical total disc replacement (TDR) devices have received FDA approval since 2006. These devices represent a heterogeneous assortment of implants made from various biomaterials with different biomechanical properties. The majority of these devices are composed of metallic endplates with a polymer core. In this prospective, randomized multicenter study, the authors evaluate the safety and efficacy of a metal-on-metal (MoM) TDR (Kineflex|C) versus anterior cervical discectomy and fusion (ACDF) in the treatment of single-level spondylosis with radiculopathy through a long-term (5-year) follow-up. METHODS An FDA-regulated investigational device exemption (IDE) pivotal trial was conducted at 21 centers across the United States. Standard validated outcome measures including the Neck Disability Index (NDI) and visual analog scale (VAS) for assessing pain were used. Patients were randomized to undergo TDR using the Kineflex|C cervical artificial disc or anterior cervical fusion using structural allograft and an anterior plate. Patients were evaluated preoperatively and at 6 weeks and 3, 6, 12, 24, 36, 48, and 60 months after surgery. Serum ion analysis was performed on a subset of patients randomized to receive the MoM TDR. RESULTS A total of 269 patients were enrolled and randomly assigned to undergo either TDR (136 patients) or ACDF (133 patients). There were no significant differences between the TDR and ACDF groups in terms of operative time, blood loss, or length of hospital stay. In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 60-month follow-up (both p < 0.01). Similarly, VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 60-month follow-up (both p < 0.01). There were no significant changes in outcomes between the 24- and 60-month follow-ups in either group. Range of motion in the TDR group decreased at 3 months but was significantly greater than the preoperative mean value at the 12- and 24-month follow-ups and remained significantly improved through the 60-month period. There were no significant differences between the 2 groups in terms of reoperation/revision surgery or device-/surgery-related adverse events. The serum ion analysis revealed cobalt and chromium levels significantly lower than the levels that merit monitoring. CONCLUSIONS Cervical TDR with an MoM device is safe and efficacious at the 5-year follow-up. These results from a prospective randomized study support that Kineflex|C TDR as a viable alternative to ACDF in appropriately selected patients with cervical radiculopathy. Clinical trial registration no.: NCT00374413 (clinicaltrials.gov).

Development and validation of a training module on the use of acetic acid for the detection of Barrett's neoplasia.

Background and study aims Acetic acid chromoendoscopy (AAC) enhances the ability to correctly identify Barrett's neoplasia, and is increasingly used by both expert and nonexpert endoscopists. Despite its increasing use, there is no validated training strategy to achieve competence. The aims of our study were to develop a validated training tool in AAC-assisted lesion recognition, to assess endoscopists' baseline knowledge of AAC-assisted lesion recognition, and to evaluate the efficacy and impact of this training tool. Methods A validated assessment of 40 images and 20 videos was developed. A total of 13 endoscopists with experience of Barrett's endoscopy but no formal training in AAC were recruited to the study. Participants underwent: baseline assessment 1, online training, assessment 2, interactive seminar, assessment 3. Results Baseline assessment demonstrated a sensitivity of 83 % and a negative predictive value (NPV) of 83 %. The online training intervention significantly improved sensitivity to 95 % and NPV to 94 % (P < 0.01). Further improvement was seen after a 1-day interactive seminar including live cases, with sensitivity increasing to 98 % and NPV to 97 %. Conclusions The data demonstrate the need for training in AAC-assisted lesion recognition as baseline performance, even by Barrett's experts, was poor. The online training and testing tool for AAC for Barrett's neoplasia was successfully developed and validated. The training intervention improved performance of endoscopists to meet ASGE PIVI standards. The training tool increases the endoscopist's degree of confidence in the use of AAC. The training tool also leads to shift in attitudes of endoscopists from Seattle protocol towards AAC-guided biopsy protocol for Barrett's surveillance.

Comparing outcome of radiofrequency ablation in Barrett's with high grade dysplasia and intramucosal carcinoma: a prospective multicenter UK registry.

BACKGROUND AND STUDY AIM: Mucosal neoplasia arising in Barrett's esophagus can be successfully treated with endoscopic mucosal resection (EMR) followed by radiofrequency ablation (RFA). The aim of the study was to compare clinical outcomes of patients with high grade dysplasia (HGD) or intramucosal cancer (IMC) at baseline from the United Kingdom RFA registry. PATIENTS AND METHODS: Prior to RFA, visible lesions and nodularity were removed entirely by EMR. Thereafter, patients underwent RFA every 3 months until all visible Barrett's mucosa was ablated or cancer developed (end points). Biopsies were taken at 12 months or when end points were reached. RESULTS: A total of 515 patients, 384 with HGD and 131 with IMC, completed treatment. Prior to RFA, EMR was performed for visible lesions more frequently in the IMC cohort than in HGD patients (77 % vs. 47 %; P < 0.0001). The 12-month complete response for dysplasia and intestinal metaplasia were almost identical in the two cohorts (HGD 88 % and 76 %, respectively; IMC 87 % and 75 %, respectively; P = 0.7). Progression to invasive cancer was not significantly different at 12 months (HGD 1.8 %, IMC 3.8 %; P = 0.19). A trend towards slightly worse medium-term durability may be emerging in IMC patients (P = 0.08). In IMC, EMR followed by RFA was definitely associated with superior durability compared with RFA alone (P = 0.01). CONCLUSION: The Registry reports on endoscopic therapy for Barrett's neoplasia, representing real-life outcomes. Patients with IMC were more likely to have visible lesions requiring initial EMR than those with HGD, and may carry a higher risk of cancer progression in the medium term. The data consolidate the approach to ensuring that these patients undergo thorough endoscopic work-up, including EMR prior to RFA when necessary.

Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior discectomy and fusion: a prospective, randomized, controlled multicenter clinical trial with 4-year follow-up results.

OBJECT: The purpose of this study was to evaluate the safety and effectiveness of 2-level total disc replacement (TDR) using a Mobi-C cervical artificial disc at 48 months' follow-up. METHODS: A prospective randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc was conducted at 24 centers in the U.S. Three hundred thirty patients with degenerative disc disease were randomized and treated with cervical total disc replacement (225 patients) or the control treatment, anterior cervical discectomy and fusion (ACDF) (105 patients). Patients were followed up at regular intervals for 4 years after surgery. RESULTS: At 48 months, both groups demonstrated improvement in clinical outcome measures and a comparable safety profile. Data were available for 202 TDR patients and 89 ACDF patients in calculation of the primary endpoint. TDR patients had statistically significantly greater improvement than ACDF patients for the following outcome measures compared with baseline: Neck Disability Index scores, 12-Item Short Form Health Survey Physical Component Summary scores, patient satisfaction, and overall success. ACDF patients experienced higher subsequent surgery rates and displayed a higher rate of adjacent-segment degeneration as seen on radiographs. Overall, TDR patients maintained segmental range of motion through 48 months with no device failure. CONCLUSIONS: Four-year results from this study continue to support TDR as a safe, effective, and statistically superior alternative to ACDF for the treatment of degenerative disc disease at 2 contiguous cervical levels. Clinical trial registration no.: NCT00389597 ( clinicaltrials.gov ).

Clinical outcomes of a polyaxial interspinous fusion system.

BACKGROUND: Early interspinous process fixation constructs utilize rigid fixation plates with immobile spikes which increase the difficulty of device implantation when anatomic variations are encountered. Second generation systems have been designed with polyaxial properties with the goal of accommodating natural osseous anatomic variations to achieve optimal implant placement and fixation integrity. The purpose of this study was to evaluate clinical outcomes in patients treated with this device to supplement the biomechanical data from previous studies. METHODS: A retrospective, non-randomized, single-center chart review at or beyond the one year postoperative time point was conducted to collect preoperative and perioperative data on patients treated with a polyaxial intraspinous fixation system. A postoperative numerical pain rating scale and modified MacNab classification score were obtained from each patient in the cohort via phone survey. RESULTS: A total of 53 patients were included in the study. Median hospital stay was 2 days (range 1-7 days). There were no reported perioperative blood transfusions or cases of radiographic fracture/migration of the device at the 6 week post-operative time point. There was a significant improvement in pain index score in the overall patient study group and a satisfactory (excellent or good) MacNab result was obtained in 48% of all patients. Patients with preoperative pain scores greater than 8/10 reported more pain improvement than patients with preoperative pain scores less than 5 (0 points, p = 0.96, n = 8). Patients with a BMI less than 30 had significantly better MacNab outcome classifications than patients with a BMI greater than 30. CONCLUSIONS: The polyaxial interspinous fusion system produces significant clinical improvement when employed to treat patients with stenosis, herniated disc, or low grade spondylolisthesis. This device can be implanted with a low complication rate and short postoperative hospital admission time. Patients with high pre-operative pain score and BMI under 30 can be predictors of better clinical outcome and should be considered prior to implantation.

Efficacy of vagus nerve stimulation as a treatment for medically intractable epilepsy in brain tumor patients. A case-controlled study using the VNS therapy Patient Outcome Registry.

PURPOSE: Vagus nerve stimulation (VNS) therapy is a procedure to control seizure frequency in patients with medically intractable epilepsy. However, there is no data on efficacy in the subset of these patients with brain tumors. The purpose of this study is to evaluate the efficacy of VNS therapy in patients with brain tumor-associated medically intractable epilepsy. METHODS: Data from the VNS therapy Patient Outcome Registry, maintained by the manufacturer of the device, Cyberonics Inc. (Houston, TX, USA), was queried to characterize the response of patients in whom a brain tumor was listed as the etiology of epilepsy. A case-control analysis was implemented and patient outcome was measured by Engel classification, median seizure response and responder rate (≥50% seizure reduction) using t-tests and chi-squared tests. RESULTS: In 107 patients with an epilepsy etiology related to a brain tumor, seizure reduction was 45% at 3 months and 79% at 24 months with a responder rate of 48% at 3 months and 79% at 24 months. There was no statistical difference in seizure reduction compared with 326 case-control patients from the registry without brain tumors. There was no significant difference in anti-epileptic drug (AED) usage from baseline to 24 months post implant in either group. CONCLUSIONS: VNS therapy is equally effective in patients who suffer seizures secondary to brain tumors as in patients without history of a brain tumor. VNS therapy is a viable treatment option for patients with brain tumor associated medically intractable epilepsy, assuming cytoreductive and other adjuvant therapies have been fully explored.

Radiofrequency ablation and endoscopic mucosal resection for dysplastic barrett's esophagus and early esophageal adenocarcinoma: outcomes of the UK National Halo RFA Registry.

BACKGROUND & AIMS: Patients with Barrett's esophagus (BE) and high-grade dysplasia (HGD) or early neoplasia increasingly receive endoscopic mucosal resection and radiofrequency ablation (RFA) therapy. We analyzed data from a UK registry that follows the outcomes of patients with BE who have undergone RFA for neoplasia. METHODS: We collected data on 335 patients with BE and neoplasia (72% with HGD, 24% with intramucosal cancer, 4% with low-grade dysplasia [mean age, 69 years; 81% male]), treated at 19 centers in the United Kingdom from July 2008 through August 2012. Mean length of BE segments was 5.8 cm (range, 1-20 cm). Patients' nodules were removed by endoscopic mucosal resection, and the patients then underwent RFA every 3 months until all areas of BE were ablated or cancer developed. Biopsies were collected 12 months after the first RFA; clearance of HGD, dysplasia, and BE were assessed. RESULTS: HGD was cleared from 86% of patients, all dysplasia from 81%, and BE from 62% at the 12-month time point, after a mean of 2.5 (range, 2-6) RFA procedures. Complete reversal dysplasia was 15% less likely for every 1-cm increment in BE length (odds ratio = 1.156; SE = 0.048; 95% confidence interval: 1.07-1.26; P < .001). Endoscopic mucosal resection before RFA did not provide any benefit. Invasive cancer developed in 10 patients (3%) by the 12-month time point and disease had progressed in 17 patients (5.1%) after a median follow-up time of 19 months. Symptomatic strictures developed in 9% of patients and were treated by endoscopic dilatation. Nineteen months after therapy began, 94% of patients remained clear of dysplasia. CONCLUSIONS: We analyzed data from a large series of patients in the United Kingdom who underwent RFA for BE-related neoplasia and found that by 12 months after treatment, dysplasia was cleared from 81%. Shorter segments of BE respond better to RFA; http://www.controlled-trials.com, number ISRCTN93069556.

Symptomatic adjacent segment disease after cervical total disc replacement: re-examining the clinical and radiological evidence with established criteria.

BACKGROUND CONTEXT: Although several publications in the last decade have proved equality in safety and efficacy of the total disc replacement (TDR) to the anterior fusion procedure in cervical spine, the claim that TDR may reduce the incidence of adjacent segment disease (ASD) has not been corroborated by clinical evidence. PURPOSE: We attempt to predict the true incidence of symptomatic ASD after TDR surgery in the cervical spine at one or two levels at a median follow-up period of 4 years. STUDY DESIGN: A total of 763 patients were screened to participate in four different Food and Drug Administration device exemption trials for artificial cervical disc replacement at three collaborating institutions. Two hundred seventy-one patients qualified and enrolled in the trials. One hundred seventy-three randomized to receive artificial disc replacement surgery, and 167 have completed a 4-year or longer follow-up. OUTCOME MEASURES: Patients experiencing cervical radiculopathy symptoms in the follow-up period were worked-up with clinical examinations, magnetic resonance imaging of the cervical spine, and other diagnostic studies. Once a clinical correlation was established with the imaging evidence of adjacent segment degeneration, a careful record was maintained to document the subsequent medical and/or surgical treatment received by these patients. Statistical analysis was performed to determine the true incidence of and factors affecting the ASD after cervical disc replacement in these patients. RESULTS: Twenty-six patients (15.2%) were identified to satisfy our criteria for ASD at the median follow-up of 51 months, with the annual incidence of 3.1% as calculated by life tables. The actuarial 5-year freedom from ASD rate was 71.6%±0.6%, and the mean period for freedom from ASD was 70.4±2.1 months. CONCLUSIONS: The incidence of symptomatic ASD after cervical TDR is 3.1% annually regardless of the patient's age, sex, smoking habits, and design of the TDR device. The presence of osteopenia and lumbar degenerative disease significantly increase the risk of developing ASD after anterior cervical surgery.

Consensus statements for management of Barrett's dysplasia and early-stage esophageal adenocarcinoma, based on a Delphi process.

BACKGROUND & AIMS: Esophageal adenocarcinoma (EA) is increasingly common among patients with Barrett's esophagus (BE). We aimed to provide consensus recommendations based on the medical literature that clinicians could use to manage patients with BE and low-grade dysplasia, high-grade dysplasia (HGD), or early-stage EA. METHODS: We performed an international, multidisciplinary, systematic, evidence-based review of different management strategies for patients with BE and dysplasia or early-stage EA. We used a Delphi process to develop consensus statements. The results of literature searches were screened using a unique, interactive, Web-based data-sifting platform; we used 11,904 papers to inform the choice of statements selected. An a priori threshold of 80% agreement was used to establish consensus for each statement. RESULTS: Eighty-one of the 91 statements achieved consensus despite generally low quality of evidence, including 8 clinical statements: (1) specimens from endoscopic resection are better than biopsies for staging lesions, (2) it is important to carefully map the size of the dysplastic areas, (3) patients that receive ablative or surgical therapy require endoscopic follow-up, (4) high-resolution endoscopy is necessary for accurate diagnosis, (5) endoscopic therapy for HGD is preferred to surveillance, (6) endoscopic therapy for HGD is preferred to surgery, (7) the combination of endoscopic resection and radiofrequency ablation is the most effective therapy, and (8) after endoscopic removal of lesions from patients with HGD, all areas of BE should be ablated. CONCLUSIONS: We developed a data-sifting platform and used the Delphi process to create evidence-based consensus statements for the management of patients with BE and early-stage EA. This approach identified important clinical features of the diseases and areas for future studies.

Factors affecting the incidence of symptomatic adjacent-level disease in cervical spine after total disc arthroplasty: 2- to 4-year follow-up of 3 prospective randomized trials.

STUDY DESIGN: Prospective randomized clinical trials. OBJECTIVE: To compare the outcome data with respect to clinical success rates and incidence of adjacent level disease (ALD) in patients after total disc arthroplasty (TDA) or anterior cervical fusion (ACDF) for 1- and 2-level cervical disc disease. SUMMARY OF BACKGROUND DATA: Previously published studies have provided evidence that ACDF procedure for cervical degenerative disc disease (DDD) may increase the stress on the nonoperated adjacent cervical segments, thus possibly increasing the risk of degeneration at these levels. The theoretical assumption that TDA may reduce the incidence of future ALD by preserving motion at the affected segments has, however, never been validated by clinical evidence. METHODS: One hundred seventy patients with established symptomatic cervical disc disease at 1 or 2 levels participated in 3 prospective randomized clinical trials at 2 institutions. Participating subjects were randomized to receive TDA (treatment; n = 113) or ACDF (control; n = 57) by 6 independent investigating surgeons. Visual analogue pain scores (0-100), Neck Disability Index, neurological examination, and cervical spine radiographs were collected at enrollment and then 6 weeks and 3, 6, 12, 24, 36, and 48 months after surgery. Patients with persistent symptoms during the follow-up period were investigated for adjacent segment disease (ASD) with computed tomography/magnetic resonance imaging of the cervical spine, neurophysiology, and subsequent active interventions. RESULTS: At the median follow-up of 42 months (range: 28-54 months), 9 (14.3%) ACDF and 19 (16.8%) TDA patients developed and were actively treated for ASD. Osteopenia dust energy x-ray absorptiometry T scores of -1.5 to -2.4) (P = 0.04; 95% confidence interval [CI]: 0.007-0.223) and concurrent lumbar degenerative disease (P = 0.02; 95% CI: 0.003-0.196) significantly increased the risk of ASD. CONCLUSION: The risk of developing adjacent segment degeneration was equivalent at median 38 months after both ACDF and TDA procedures in cervical DDD. Osteopenia and concurrent lumbar DDD significantly increase the risk of ALD.

Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up: clinical article.

OBJECT: Cervical total disc replacement (CTDR) represents a relatively novel procedure intended to address some of the shortcomings associated with anterior cervical discectomy and fusion (ACDF) by preserving motion at the treated level. This prospective, randomized, multicenter study evaluates the safety and efficacy of a new metal-on-metal CTDR implant (Kineflex|C) by comparing it with ACDF in the treatment of single-level spondylosis with radiculopathy. METHODS: The study was a prospective, randomized US FDA Investigational Device Exemption (IDE) pivotal trial conducted at 21 centers across the US. The primary clinical outcome measures included the Neck Disability Index (NDI), visual analog scale (VAS) scores, and a composite measure of clinical success. Patients were randomized to CTDR using the Kineflex|C (SpinalMotion, Inc.) cervical artificial disc or ACDF using structural allograft and an anterior plate. RESULTS: A total of 269 patients were enrolled and randomly assigned to either CTDR (136 patients) or to ACDF (133 patients). There were no significant differences between the CTDR and ACDF groups when comparing operative time, blood loss, length of hospital stay, or the reoperation rate at the index level. The overall success rate was significantly greater in the CTDR group (85%) compared with the ACDF group (71%) (p = 0.05). In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 24-month follow-up (p < 0.0001). Similarly, the VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 24-month follow-up (p < 0.0001). The range of motion (ROM) in the CTDR group decreased at 3 months but was significantly greater than the preoperative mean at 12- and 24-month follow-up. The ROM in the ACDF group was significantly reduced by 3 months and remained so throughout the follow-up. Adjacent-level degeneration was also evaluated in both groups from preoperatively to 2-year follow-up and was classified as none, mild, moderate, or severe. Preoperatively, there were no significant differences between groups when evaluating the different levels of adjacent-level degeneration. At the 2-year follow-up, there were significantly more patients in the ACDF group with severe adjacent-level radiographic changes (p < 0.0001). However, there were no significant differences between groups in adjacent-level reoperation rate (7.6% for the Kineflex|C group and 6.1% for the ACDF group). CONCLUSIONS: Cervical total disc replacement allows for neural decompression and clinical results comparable to ACDF. Kineflex|C was associated with a significantly greater overall success rate than fusion while maintaining motion at the index level. Furthermore, there were significantly fewer Kineflex|C patients showing severe adjacent-level radiographic changes at the 2-year follow-up. These results from a prospective, randomized study support that Kineflex|C CTDR is a viable alternative to ACDF in select patients with cervical radiculopathy.

Repeat planar white cell scanning to monitor short-term therapy of active inflammatory bowel disease: a methodological study and comparison with clinical scores and novel inflammatory markers.

OBJECTIVES: Radiolabelled white cell scans provide non-invasive quantification of inflammatory activity. Clinical activity scores measure severity of disease but are partly subjective. White cell scans may provide a suitable method of monitoring the treatment response of active inflammatory bowel disease. METHODS: Ten subjects with active ulcerative colitis and 13 subjects with active Crohn's disease were recruited. White cell scans were carried out before and 2 weeks after treatment. Prior to each scan, activity scores for ulcerative colitis or Crohn's disease were calculated and serum and faecal tumour necrosis factor-alpha and calprotectin measured. White cell scan activity at 1 h was calculated by using a validated visual grading system. RESULTS: Following anti-inflammatory treatment, 70% of white cell scans improved, 17% remained unchanged and 13% deteriorated. In the ulcerative colitis subgroup subjects there was modest agreement for change in scan score and activity scores. In the Crohn's disease subjects there was better agreement between change of white cell scan score and clinical scores. Planar white cell scans correlated with the van Hees activity index (r=0.68, P=0.002) and faecal calprotectin (r=0.58, P=0.0003). Changes in planar white cell scans correlated with changes in serum calprotectin (r=0.45, P=0.05). CONCLUSION: Non-invasive white cell scanning is a feasible and objective method to monitor the anti-inflammatory efficacy of treatments for active inflammatory bowel disease.