Safety of wireless capsule endoscopy in patients with implantable cardiac devices.

BACKGROUND AND AIM: Wireless capsule endoscopy (WCE) has become an increasingly utilized imaging modality for the evaluation of gastrointestinal bleeding. There is a paucity of data evaluating the safety and use of WCE in patients with implantable cardiac devices. METHODS: A retrospective chart review of all patients who had a WCE at Loyola University Medical Center in Maywood, IL, USA completed between January 2007 and December 2016 identified patients with internal cardiac devices and obscure gastrointestinal bleeding. Patient WCE footage was viewed in its entirety before creating a final report to ensure no gaps in footage and video quality. RESULTS: No patient complaints were documented during the 8-h procedure duration, and there were no cardiac abnormalities noted on telemetry. There were no device-related complications documented in the 30-day postprocedure time period. Postprocedure analysis of the WCE recordings demonstrated no interference in WCE image quality (loss of images or gaps in video) or duration. CONCLUSIONS: There is no significant interference between WCE and implantable cardiac devices, and it appears to be safe to use.

A multicenter evaluation of a new EUS core biopsy needle: Experience in 200 patients.

BACKGROUND AND OBJECTIVES: We present a multicenter study of a new endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) needle (Acquire, Boston Scientific, Natick, MA). The aim of the study was to analyze the needle's clinical performance when sampling solid lesions and to assess the safety of this device. METHODS: We performed a multicenter retrospective study of patients undergoing EUS-FNB during July 1-November 15, 2016. RESULTS: Two hundred patients (121 males and 79 females) underwent EUS-FNB of solid lesions with the Acquire needle. Lesions included solid pancreatic masses (n = 109), adenopathy (n = 45), submucosal lesions (n = 34), cholangiocarcinoma (n = 8), liver lesions (n = 6), and other (n = 8). Mean lesion size was 30.6 mm (range: 3-100 mm). The mean number of passes per target lesion was 3 (range: 1-7). Rapid onsite cytologic evaluation (ROSE) by a cytologist was performed in all cases. Tissue obtained by EUS-FNB was adequate for evaluation and diagnosis by ROSE in 197/200 cases (98.5%). Data regarding the presence or absence of a core of tissue obtained after EUS-FNB were available in 145/200 procedures. In 131/145 (90%) of cases, a core of tissue was obtained. Thirteen out of 200 patients (6.5%) underwent some form of repeat EUS-based tissue acquisition after EUS-FNB with the Acquire needle. There were no adverse events. CONCLUSION: Overall, this study showed a high rate of tissue adequacy and production of a tissue core with this device with no adverse events seen in 200 patients. Comparative studies of different FNB needles are warranted in the future to help identify which needle type and size is ideal in different clinical settings.

Are gastroenterologists willing to implement imaging-guided surveillance for Barrett's esophagus? Results from a national survey.

INTRODUCTION: The American Society for Gastrointestinal Endoscopy (ASGE) has published a Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) statement on incorporating an imaging-guided surveillance protocol to replace the current practice of four-quadrant biopsies every two centimeters for Barrett's esophagus (BE) surveillance. We sought to determine if current gastroenterologists would be willing to apply these changes to their practice and identify any barriers to implementation. METHODS: We collected data using surveys that were distributed at two national meetings and using a random selection process emailed surveys to members listed in the American Gastroenterological Association directory. Physicians from a variety of practice settings participated. Primary outcomes of our study included determining whether clinicians would be willing to accept an imaging-based surveillance protocol, their reasons for not doing so, and whether a financial incentive would be persuade them to implement the protocol. Continuous variables were reported as mean ± standard deviation. Categorical variables were summarized with percentages and 95 % confidence intervals. RESULTS: Gastroenterologists (172) completed the survey; and 140 (81.4 %) of them stated they would implemented the PIVI recommendations into practice. Using a multivariate analysis of the data, physicians who reported a financial incentive for submitting biopsy specimens to pathology were less likely to implement the PIVI recommendations. The two main barriers to implementation of the protocol were medical-legal and financial reasons. Of the 32 gastroenterologists who were not willing to implement the imaging-guided surveillance protocol, 20 (62.5 %) stated that they would implement it if there were a financial incentive. DISCUSSION: The PIVI statement focuses on re-evaluating our current method of surveillance for BE. The results of our survey show that gastroenterologists may be willing to implement an imaging-guided surveillance program, but concerns regarding financial compensation and proper training in advanced imaging techniques remain.

A rapid and accurate method to detect active small bowel gastrointestinal bleeding on video capsule endoscopy.

BACKGROUND: Video capsule endoscopy (VCE) is indicated to evaluate for suspected small bowel bleeding, but "standard view" (SV) evaluation is time-consuming. Rapid Reader 6.0 software (Given Imaging, Duluth GA) contains two computer algorithmic systems: (1) "Quickview" (QV) which automatically skips similar images and (2) a pixel analysis program that identifies suspected blood (SBI). Combining the two modalities (QV + SBI) may provide a faster modality to assess for active small bowel bleeding. AIMS: This study was designed to assess the accuracy of QV + SBI for small bowel bleeding compared to SV findings. METHODS: This is a retrospective, case-control study at a single tertiary care referral hospital including all patients with VCE performed for suspected small bowel bleeding from 4/2007 to 3/2011. All studies were previously read using SV by one of two experienced faculty (CS, DR). The primary outcome was diagnostic accuracy of QV + SBI in assessing for active small bowel bleeding compared to SV. RESULTS: A total of 116 VCE were included, 28 with active small bowel bleeding identified by original SV. Using QV + SBI, all 28 VCEs with active small bowel bleeding were identified. The sensitivity of QV + SBI to detect active bleeding was 100%, while the specificity was 93-94%. The mean time to identify landmarks and read the entire study was 3 min 20 s. CONCLUSIONS: The QV + SBI reading format of VCE is an efficient, highly sensitive modality to assess for potential small bowel bleeding.

Risk factors for inadequate colonoscopy bowel preparations in African Americans and whites at an urban medical center.

OBJECTIVES: Poor bowel preparation leads to inadequate examinations and shorter surveillance intervals for colorectal cancer screening. Previous studies regarding risk factors for inadequate preparation have not included large numbers of African Americans. Our aim was to determine the prevalence of inadequate bowel preparation on initial and follow-up colonoscopy in a large, racially diverse patient population. METHODS: Colonoscopies performed during a 1-year period were analyzed retrospectively. Factors including age, sex, race, and start time were recorded. Patient ZIP codes were linked to census data to estimate education and income. For examinations with inadequate bowel preparations, we collected data on recommendations and the preparation quality of follow-up procedures. RESULTS: We included 3741 patients (40.2% African American). Of these, 66.9% had adequate bowel preparation and 33.1% had inadequate bowel preparation. African Americans had the highest prevalence of inadequate preparations at 43.0%. African American race was a predictor of inadequate bowel preparation, despite controlling for education and income. Age, male sex, and procedure taking place after 12 pm also were risk factors for inadequate preparation. Receipt of specific preparation instructions on the endoscopy report did not affect preparation quality on follow-up examination. Our study found a high rate (33.1%) of inadequate bowel preparations, and African American race was found to be an independent risk factor for inadequate preparation. We validated previously reported risk factors including age, male sex, and later procedure time. Finally, we noted high rates of inadequate preparation on follow-up examinations. CONCLUSIONS: Improving the quality of colonoscopy bowel preparation is important for colorectal cancer prevention, especially in high-risk populations such as African Americans.

Co-management between hospitalist and hepatologist improves the quality of care of inpatients with chronic liver disease.

BACKGROUND AND GOALS: Our institution shifted the care of patients with chronic liver disease (CLD) from Internal Medicine faculty, house staff, and consulting hepatology service to a co-managed unit staffed by academic hospitalists and hepatologists. The effect of co-management between hospitalists and hepatologists on the care of patients hospitalized with complications of CLD such as spontaneous bacterial peritonitis (SBP) is unknown. STUDY: A retrospective chart review of 56 adult patients admitted with CLD and SBP from July 1, 2004 to June 30, 2010 was performed. Adherence rates to current management guidelines were measured along with costs and outcomes of care. RESULTS: Patients admitted under the 2 models of care were similar; however, they consistently underwent paracentesis within 24 hours (100% vs. 79%, P=0.013), had appropriate avoidance of fresh-frozen plasma use (75% vs. 43%, P=0.05), received albumin (97% vs. 65%, P=0.002), and were discharged on SBP prophylaxis (91% vs. 37%, P<0.001) under the co-managed model compared with the conventional model. Costs of care were similar between the 2 groups. We note a trend toward improved outcomes of care under the co-management model as measured by transfer rates to the intensive care unit, inpatient mortality, 30-day readmission, and mortality rates. CONCLUSIONS: These results support co-management between hospitalists and hepatologists as a superior model of care for hospitalized patients with SBP. Furthermore, this study adds to the growing literature indicating that efforts are needed to improve the quality of care delivered to CLD patients.

Coccydynia.

Coccydynia is a term that refers to pain in the region of the coccyx. Most cases are associated with abnormal mobility of the coccyx which may trigger a chronic inflammatory process leading to degeneration of this structure. In some patients this instability may be detected on dynamic radiographs. Nonsurgical management remains the gold standard treatment for coccydynia, consisting of decreased sitting, seat cushioning, coccygeal massage, stretching, manipulation, local injection of steroids or anesthetics, and postural adjustments. Those patients who fail these conservative modalities may potentially benefit from coccygectomy. However, surgical intervention is typically reserved for patients with evidence of advanced coccygeal instability (e.g., subluxation or hypermobility) or spicule formation, as this population appears to exhibit the greatest improvement postoperatively.

The safety and efficacy of OP-1 (rhBMP-7) as a replacement for iliac crest autograft for posterolateral lumbar arthrodesis: minimum 4-year follow-up of a pilot study.

BACKGROUND CONTEXT: Although autogenous bone is still considered to be the gold standard graft material for promoting spinal fusion, other bone graft substitutes have been developed in an attempt to improve arthrodesis rates and avoid the complications associated with the procurement of autograft. The bone morphogenetic proteins (BMPs) represent a family of osteoinductive growth factors that are known to stimulate the osteoblastic differentiation of stem cells. Osteogenic protein-1 (OP-1) Putty is a commercially available BMP preparation that is already approved for use in humans. Previous clinical studies involving patients with degenerative spondylolisthesis have reported that the efficacy and safety of OP-1 Putty is comparable to that of autograft at both 1- and 2-year follow-up. PURPOSE: The purpose of this study was to evaluate the intermediate-term efficacy and safety of OP-1 Putty as an alternative to autogenous bone by comparing the 4-year radiographic, clinical, and safety data of these same patients who underwent decompression and uninstrumented fusion with either OP-1 Putty or iliac crest autograft. STUDY DESIGN/SETTING: A prospective, randomized, controlled, multicenter clinical pilot study. PATIENT SAMPLE: Thirty-six patients undergoing decompressive laminectomy and single-level uninstrumented fusion for degenerative spondylolisthesis and symptomatic spinal stenosis were randomized in a 2:1 fashion to receive either OP-1 Putty (24 patients) or autogenous iliac crest bone graft (12 patients). OUTCOME MEASURES: Patient-reported outcome measures consisting of Oswestry Disability Index and Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) scores were used to evaluate clinical efficacy. Perioperative data including operative time, estimated blood loss, and duration of hospital stay were also recorded for each surgery. Postoperatively, a neurological examination and an assessment of donor-site pain (if applicable) were performed at every follow-up visit. Radiographic fusion success was defined as the presence of continuous bridging bone formation between the transverse processes at the level of the spondylolisthesis with minimal motion evident on dynamic lateral x-ray films. The primary efficacy endpoint was the overall success rate, a composite measure derived from both radiographic and clinical parameters. The safety of OP-1 Putty was confirmed by comparing the nature and frequency of all adverse events and complications that were prospectively observed in either of the groups. METHODS: Thirty-six patients with degenerative spondylolisthesis and symptoms of neurogenic claudication underwent decompressive laminectomy and single-level uninstrumented fusion with either OP-1 Putty or autograft. All patients were evaluated at 6 weeks and 3, 6, 9, 12, and 24 months, after which time they were instructed to return on a yearly basis. Multiple neuroradiologists blinded to the assigned treatment reviewed static and dynamic X-ray films with digital calipers to assess fusion status according to the presence of continuous bridging bone across the transverse processes as well as the amount of residual motion evident at the level of interest. Oswestry Disability Index surveys and SF-36 questionnaires were used to assess clinical outcomes. RESULTS: At the 48-month time point, complete radiographic and clinical data were available for 22 of 36 patients (16 OP-1 Putty and 6 autograft) and 25 of 36 patients (18 OP-1 Putty and 7 autograft), respectively. Radiographic evidence of a solid arthrodesis was present in 11 of 16 OP-1 Putty patients (68.8%) and 3 of 6 autograft patients (50%). Clinically successful outcomes defined as at least a 20% improvement in preoperative Oswestry scores were experienced by 14 of 19 OP-1 Putty patients (73.7%) and 4 of 7 autograft patients (57.1%); these clinical findings were corroborated by similar increases in SF-36 scores. The respective overall success rates of the OP-1 Putty and autograft group were 62.5% and 33.3%. In this study, there were no incidents of local or systemic toxicity, ectopic bone production, or other adverse events directly related to the use of OP-1 Putty. CONCLUSION: Despite the challenges associated with obtaining a solid uninstrumented fusion in patients with degenerative spondylolisthesis, the rates of radiographic fusion, clinical improvement, and overall success associated with the use of OP-1 Putty were at least comparable to that of the autograft controls for at least 48 months after surgery. These results appear to validate the short-term results previously reported for OP-1 Putty and suggest that this material may potentially represent a viable bone graft substitute for certain fusion applications.