Impact of Risk Stratification in Patients With Diabetes Mellitus in a Health System Specialty Pharmacy Setting.

Background: Integrated pharmacist care into health systems results in significant A1c reduction and improved outcomes in patients with diabetes. However, little is known about the adoption of Health System Specialty Pharmacy (HSSP) chronic disease management (CDM) services within diabetes clinics. Risk stratification is proven to enhance care in various patient populations. Objective: The objective of this study is to describe how the implementation of risk stratification in the HSSP setting results in optimized patient outcomes in diabetes. Method: This is a retrospective descriptive study reporting the results of expanding the HSSP care model to implement risk stratified CDM services for patients with diabetes. A total of 285 patients were enrolled in the HSSP CDM pharmacy services and were stratified into high- or low-risk groups. Results: Eighty-eight patients were stratified as high-risk with an average baseline A1c of 11.47% and a most recent average of 8.84%. The remaining 285 patients were stratified into the low-risk group. Their average baseline A1c was 7.48% and the last recorded average A1c was 7.15%. Patients not enrolled in HSSP CDM services (N = 100) had a lower reduction in average A1c compared to patients enrolled in the program. Conclusion: Patients stratified into high- and low-risk groups had greater reductions in A1c compared to patients who did not use HSSP CDM services. These results showcase the success of risk stratification and demonstrate the impact HSSP has on patients needing CDM services and outlines a strategy to provide the greatest impact in a high-volume patient population.

Analysis of Reported Adverse Events Related to Hemospray: An FDA MAUDE Database Study.

BACKGROUND: Topical hemostatic powder is a mineral powder that forms an adherent barrier and coagulates active bleeding in the gastrointestinal (GI) tract. Hemospray is the first hemostatic powder approved by the Food and Drug Administration (FDA) in the United States. Hemospray has been increasingly used to manage GI bleeding. However, data on the adverse events of hemostatic powders are lacking. Therefore, we aim to report and analyze adverse events associated with Hemospray using the FDA's "Manufacturer and User Facility Device Experience" database. METHODS: We analyzed the postmarketing surveillance data from the FDA's Manufacturer and User Facility Device Experience database for Hemospray, initially known as TC-325, from June 2018 through April 2022. Results of the search were classified into device-related technical issues, patient-related adverse events and health care staff-related adverse events. RESULTS: Five hundred two medical device reporting claims were identified from June 2018 through April 2022. Seven duplicate claims were identified, and some claims included more than one event type. Therefore, there were 558 device-related problems, 28 patient-related adverse events, and 2 adverse events in health care staff members. The most common device-related problems were activation failure or failure to fire (n = 385, 70.0%) and obstruction of carbon dioxide flow (n = 121, 21.7). The most common patient-related adverse events included tissue injury or bleeding (n = 21) and perforation (n = 5). CONCLUSION: Although Hemospray is a valuable tool in the armamentarium for endoscopists in managing GI bleeding, endoscopists must be mindful of deice-related problems and potential patient-related adverse events.

Intraoperative Endoscopic-Guided Bowel Resection for Persistent Gastrointestinal Bleeding Caused by Angiodysplasia: A Case Report and Literature Review.

Gastrointestinal angiodysplasia is an uncommon condition often associated with significant gastrointestinal bleeding that is resistant to medical therapy. We report the clinical outcomes of two patients who successfully underwent simultaneous intraoperative endoscopic and surgical interventions for the treatment of angiodysplasia. Intraoperative endoscopic guidance was found to be useful in managing hemorrhage caused by angiodysplasia in both patients. Additionally, we performed an analysis of cases reported in the literature. Our review focused on the anatomic location of the resected bowel and the clinical outcomes of patients ( n = 21) with angiodysplasia managed with intraoperative endoscopy reported in the literature.

Cold snare endoscopic mucosal resection for colon polyps: a systematic review and meta-analysis.

BACKGROUND: Cold snare endoscopic mucosal resection (CS-EMR) can reduce the risks associated with electrocautery during colon polyp resection. Data on efficacy are variable. This systematic review and meta-analysis aimed to estimate the pooled efficacy and safety rates of CS-EMR. METHODS: We conducted a comprehensive literature search of multiple databases, from inception to March 2023, for studies addressing outcomes of CS-EMR for colon polyps. The weighted pooled estimates with 95 %CIs were calculated using the random effects model. I2 statistics were used to evaluate heterogeneity. RESULTS: 4137 articles were reviewed, and 16 studies, including 2592 polyps in 1922 patients (51.4 % female), were included. Overall, 54.4 % of polyps were adenomas, 45 % were sessile serrated lesions (SSLs), and 0.6 % were invasive carcinomas. Polyp recurrence after CS-EMR was 6.7 % (95 %CI 2.4 %-17.4 %, I2  = 94 %). The recurrence rate was 12.3 % (95 %CI 3.4 %-35.7 %, I2  = 94 %) for polyps ≥ 20 mm, 17.1 % (95 %CI 4.6 %-46.7 %, I2  = 93 %) for adenomas, and 5.7 % (95 %CI 3.2 %-9.9 %, I2  = 50 %) for SSLs. The pooled intraprocedural bleeding rate was 2.6 % (95 %CI 1.5 %-4.5 %, I2  = 51 %), the delayed bleeding rate was 1.5 % (95 %CI 0.8 %-2.7 %, I2  = 18 %), and no perforations or post-polypectomy syndromes were reported, with estimated rates of 0.6 % (95 %CI 0.3 %-1.3 %, I2  = 0 %) and 0.6 % (95 %CI 0.3 %-1.4 %, I2  = 0 %), respectively. CONCLUSION: CS-EMR demonstrated an excellent safety profile for colon polyps, with variable recurrence rates based on polyp size and histology. Large prospective studies are needed to validate these findings.

Long-term outcomes following successful endoscopic treatment of T1 esophageal adenocarcinoma: a multicenter cohort study.

BACKGROUND AND AIMS: Endoscopic eradication therapy (EET) is guideline endorsed for management of early-stage (T1) esophageal adenocarcinoma (EAC). Patients with baseline high-grade dysplasia (HGD) and EAC are at highest risk of recurrence after successful EET, but limited data exist on long-term (>5 year) recurrence outcomes. Our aim was to assess the incidence and predictors of long-term recurrence in a multicenter cohort of patients with T1 EAC treated with EET. METHODS: Patients with T1 EAC achieving successful endoscopic cancer eradication with a minimum of 5 years' clinical follow-up were included. The primary outcome was neoplastic recurrence, defined as dysplasia or EAC, and it was characterized as early (<2 years), intermediate (2-5 years), or late (>5 years). Predictors of recurrence were assessed by time to event analysis. RESULTS: A total of 84 T1 EAC patients (75 T1a, 9 T1b) with a median 9.1 years (range, 5.1-18.3 years) of follow-up were included. The overall incidence of neoplastic recurrence was 2.0 per 100 person-years of follow-up. Seven recurrences (3 dysplasia, 4 EAC) occurred after 5 years of EAC remission. Overall, 88% of recurrences were treated successfully endoscopically. EAC recurrence-related mortality occurred in 3 patients at a median of 5.2 years from EAC remission. Complete eradication of intestinal metaplasia was independently associated with reduced recurrence (hazard ratio, .13). CONCLUSIONS: Following successful EET of T1 EAC, neoplastic recurrence occurred after 5 years in 8.3% of cases. Careful long-term surveillance should be continued in this patient population. Complete eradication of intestinal metaplasia should be the therapeutic end point for EET.

Outcomes of endoscopic retrograde cholangiopancreatography in patients with situs inversus viscerum.

BACKGROUND/AIMS: Situs inversus viscerum (SIV) is a congenital condition defined by left-to-right transposition of all visceral organs. This anatomical variant has caused technical challenges in endoscopic retrograde cholangiopancreatography (ERCP). Data on ERCP in patients with SIV are limited to case reports of unknown clinical and technical success rates. This study aimed to evaluate the clinical and technical success rates of ERCP in patients with SIV. METHODS: Data from patients with SIV who underwent ERCP were retrospectively reviewed. The data were collected by querying the nationwide Veterans Affairs Health System database for patients diagnosed with SIV who underwent ERCP. Patient demographics and procedural characteristics were collected. RESULTS: Eight patients with SIV who underwent ERCP were included. Choledocholithiasis was the most common indication for ERCP (62.5%). The technical success rate was 63%. Subsequent ERCP with interventional radiology-assisted rendezvous has increased the technical success rate to 100%. Clinical success was achieved in 63% of cases. Among cases of subsequent rendezvous ERCP after conventional ERCP failure, clinical success was achieved in 100%. CONCLUSION: The clinical and technical success rates of ERCP in patients with SIV were both 63%. In patients with SIV in whom ERCP fails, interventional radiology-assisted rendezvous ERCP can be considered.

Use of Endoscopic Suturing for the Treatment of Malignant Gastric Ulcer-Related Hemorrhage.

Gastrointestinal bleeding secondary to malignancy can be difficult to manage with traditional endoscopic therapies. Endoscopic suturing is a relatively new technology with limited data available regarding its use for bleeding related to peptic ulcer disease. We describe a case where endoscopic suturing was successfully used to control gastrointestinal hemorrhage from a previously known malignant ulceration that was refractory to traditional interventions.

Analysis of Reported Adverse Events Associated with Over-the-Scope Endoscopic Suturing System: an FDA MAUDE Database Study.

PURPOSE: The over-the-scope endoscopic suturing system (ESS) (OverStitch™) is one of the most widely utilized endoscopic suturing systems in current clinical practice; however, data on the adverse events associated with this device is scarce. Our study aims to evaluate the adverse events and complications associated with the over-the-scope ESS using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. MATERIALS AND METHODS: We analyzed the post-marketing surveillance data from the FDA MAUDE database for the over-the-scope ESS from January 2008 through June 2022. RESULTS: Eighty-three reports were filed from January 2008 to June 2022. Adverse events were classified as device-related complications and patient-related adverse events. Seventy-seven device-related issues and 87 patient adverse events were identified. The most common device-related issue was difficulty to remove after deployment (n=12, 15.58%) followed by mechanical problem (n=10, 12.99%), mechanical jam (n=9, 11.69%), or entrapment of device (n=9, 11.69%). Of the 87 patient-related adverse events, the most common was perforation (n=19; 21.84%), followed by device embedded in tissue or plaque (n=10; 11.49%), and abdominal pain (n=8; 9.20%). Of the 19 patients who experienced perforation, two required open surgical repair and one required laparoscopic surgical repair. CONCLUSION: The overall adverse events from the over-the-scope ESS remain acceptable as evidenced by the number of reported cases since 2008. However, it is important to note that adverse event rates might increase as the use of the device increases; therefore, it is essential for endoscopists to be aware of the potential common and rare adverse events associated with the use of the over-the-scope ESS device.

Endoscopic full-thickness resection for upper gastrointestinal tract lesions: a systematic review and meta-analysis.

INTRODUCTION: Endoscopic full-thickness resection (EFTR) is used to resect difficult superficial mucosal lesions and sub-epithelial lesions (SELs). We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of EFTR for upper gastrointestinal tract (GIT) lesions. METHODS: We conducted a comprehensive literature search of MEDLINE, EMBASE, Cochrane, ClinicalTrials.gov, and Scopus databases for studies published in the English language that addressed outcomes of EFTR for upper GIT lesions through November 2021. The weighted pooled rates with the 95% confidence interval (CI) were calculated. Cochran Q test and I statistics were used to calculate heterogeneity. RESULTS: We identify 740 articles on the initial search and six studies met the inclusion criteria. 140 patients (45.7% females) with 142 lesions were analyzed. Four studies used the full-thickness resection device (FTRD®). EFTR was performed for 26 adenomas, 97 SELs, six adenocarcinomas, and ten full-thickness biopsies. The overall technical success rate was 86.9% (CI 79.8-94%, I 2 = 38.9%), R0 resection was 80% (CI 67.6-92.3%, I 2 = 75.6%), and the overall adverse events rate was 18.6% (9.8-27.2%, I 2 = 49.4%). Major adverse events included six episodes of major bleeding, three micro-perforations, one large duodenal perforation, and one case of mucosal damage from FTRD®. At 3-6 months follow-up, there were only two cases of recurrence (R0 was not achieved in both). CONCLUSION: EFTR has a high technical and clinical success rate in managing upper GIT lesions with an acceptable safety profile. Large prospective studies comparing EFTR with conventional endoscopic resection techniques are needed.

Endoscopic full-thickness resection of gastric ulceration with persistent low-grade dysplasia using full-thickness resection device.

Video 1Endoscopic full-thickness resection of gastric ulceration with persistent low-grade dysplasia using full-thickness resection device.

Not every pancreatic mass is cancer: a case of a large intra-pancreatic splenule.

We report a case of a 72-year-old man who was referred to our tertiary medical center for endoscopic ultrasound (EUS) evaluation for an incidental 2-cm mass in the tail of the pancreas seen on computed tomography (CT). On EUS, a 22 mm by 13 mm, well-defined hypoechoic mass was identified within the pancreatic tail, and a fine-needle biopsy was performed. Histopathology revealed benign pancreatic parenchyma and the presence of lymphocytes. A technetium-99m sulfur colloid scan was performed, which demonstrated uptake in the pancreatic tail lesion consistent with an intra-pancreatic splenule. This case demonstrates that a splenule or accessory splenic tissue should remain in the differential diagnosis of a pancreatic mass. An accurate diagnosis of pancreatic splenule can preclude surgical resection.

Neuroendocrine Tumor Diagnosed Through Endoscopic Ultrasound-Guided Fine-Needle Biopsy of a Lung Mass.

Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) is an excellent modality for tissue acquisition and has been shown to be superior to EUS-fine-needle aspiration in several studies. Although tissue sampling of lung nodules using EUS-fine-needle aspiration has been reported in the literature, the use of EUS-FNB for tissue acquisition of parenchymal lung mass has rarely been reported in the literature. Our report highlights that EUS-FNB is safe and effective for lung lesions that are near the esophageal wall.

Jailbreaking a metal biliary stent through a duodenal stent.

Video 1.