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Hemostatic powder TC-325 treatment of malignancy-related upper gastrointestinal bleeds: International registry outcomes

Hussein, Mohamed; Alzoubaidi, Durayd; O'Donnell, Michael; de la Serna, Alvaro; Bassett, Paul; Varbobitis, Ioannis; Hengehold, Tricia; Ortiz Fernandez-Sordo, Jacobo; Rey, Johannes W; Hayee, Bu'Hussain; Despott, Edward J; Murino, Alberto; Graham, David; Latorre, Melissa; Moreea, Sulleman; Boger, Phillip; Dunn, Jason; Mainie, Inder; Mullady, Daniel; Early, Dayna; Ragunath, Krish; Anderson, John; Bhandari, Pradeep; Goetz, Martin; Kiesslich, Ralf; Coron, Emmanuel; Rodriguez de Santiago, Enrique; Gonda, Tamas; Gross, Seth A; Lovat, Laurence B; Haidry, Rehan
BACKGROUND AND AIM/OBJECTIVE:Upper gastrointestinal tumors account for 5% of upper gastrointestinal bleeds. These patients are challenging to treat due to the diffuse nature of the neoplastic bleeding lesions, high rebleeding rates, and significant transfusion requirements. TC-325 (Cook Medical, North Carolina, USA) is a hemostatic powder for gastrointestinal bleeding. The aim of this study was to examine the outcomes of upper gastrointestinal bleeds secondary to tumors treated with Hemospray therapy. METHODS:Data were prospectively collected on the use of Hemospray from 17 centers. Hemospray was used during emergency endoscopy for upper gastrointestinal bleeds secondary to tumors at the discretion of the endoscopist as a monotherapy, dual therapy with standard hemostatic techniques, or rescue therapy. RESULTS:One hundred and five patients with upper gastrointestinal bleeds secondary to tumors were recruited. The median Blatchford score at baseline was 10 (interquartile range [IQR], 7-12). The median Rockall score was 8 (IQR, 7-9). Immediate hemostasis was achieved in 102/105 (97%) patients, 15% of patients had a 30-day rebleed, 20% of patients died within 30 days (all-cause mortality). There was a significant improvement in transfusion requirements following treatment (P < 0.001) when comparing the number of units transfused 3 weeks before and after treatment. The mean reduction was one unit per patient. CONCLUSIONS:Hemospray achieved high rates of immediate hemostasis, with comparable rebleed rates following treatment of tumor-related upper gastrointestinal bleeds. Hemospray helped in improving transfusion requirements in these patients. This allows for patient stabilization and bridges towards definitive surgery or radiotherapy to treat the underlying tumor.
PMID: 34132412
ISSN: 1440-1746
CID: 4925582

The role of hemospray as a monotherapy treatment of gastrointestinal bleeds [Meeting Abstract]

Hussein, M; Alzoubaidi, D; O'Donnell, M; De, la Serna A; Varbobitis, I; Hengehold, T; Fernandez-Sordo, J O; W, Rey J; Hayee, B; Despott, E; Murino, A; Moreea, S; Boger, P; Dunn, J; Mainie, I; Graham, D; Mullady, D; Early, D; Latorre, M; Ragunath, K; Anderson, J; Bhandari, P; Goetz, M; Keisslich, R; Coron, E; De, Santiago E R; Gonda, T; Gross, S; Lovat, L; Haidry, R
Introduction Dual endoscopic therapy has been considered the standard of care for endoscopic management of GI bleeding. We aimed to look at the outcomes of Hemospray as a monotherapy treatment for GI bleeds. Methods Data was collected on patients with GI bleeds treated with Hemospray monotherapy in 18 centres. Haemostasis was defined as cessation of bleeding within 5 minutes of hemospray application. Results 62 patients with peptic ulcer bleeds were treated. There was an immediate haemostasis of 90% (56/62), re-bleed rate of 16% (7/44) (Table 1). 69% were Forrest 1a/1b ulcers. 72 patients with malignancy related bleeds. There was a haemostasis rate of 100% and a re-bleed rate of 18% (11/63). There was a haemostasis rate of 100% with post endoscopic therapy bleeds. 48% were post endoscopic mucosal resection. 22 patients with lower GI bleeds were treated. 36% secondary to colonic tumours. There was a haemostasis rate of 96% (21/22) and re-bleed of 26% (5/19). A 100% haemostasis was achieved in 5 patients treated for gastric angiodysplasia with one re-bleed. Conclusions Results show high haemostasis and comparable rebleed rates with Hemospray monotherapy treatment. It may play a potential role in actively bleeding peptic ulcers in difficult anatomical positions to help bridge towards definitive therapy. These data may represent the evolution of new treatment paradigms as experience with haemostatic powders increases
EMBASE:636541157
ISSN: 1468-3288
CID: 5082952

Does hemospray have a role to play as a combination treatment therapy for upper and lower gastrointestinal bleeds [Meeting Abstract]

Hussein, M; Alzoubaidi, D; O'Donnell, M; De, la Serna A; Hengehold, T; Varbobitis, I; Fraile, Lopez M; Ortiz, Fernando-Sordo J; W, Rey J; Hayee, B; Despott, E J; Murino, A; Moreea, S; Boger, P; Dunn, J M; Mainie, I; Graham, D G; Mullady, D; Early, D; Latorre, M; Ragunath, K; Anderson, J; Bhandari, P; Goetz, M; Keisslich, R; Coron, E; Rodriguez, De Santiago E; Gonda, T; Gross, S; Lovat, L; Haidry, R
Introduction: Combination endoscopic therapy is considered a gold standard treatment of upper gastrointestinal bleeding (UGIB). Endoscopic therapy reduces mortality in these patients. Hemospray is a haemostatic powder used for the endoscopic treatment of GI bleeds. We aimed to analyse the outcomes of Hemospray therapy in combination with standard endoscopic treatments. Aims & Methods: Data was collected on consecutive patients with GIB's and treated with Hemospray as part of a combination with standard endoscopic treatments from 18 centres (USA, UK, France, Germany, Spain). The decision to use Hemospray and what combination to use was at the discretion of the endoscopist.
Result(s): We analysed the outcomes of 230 patients (UGIB's - 134 peptic ulcers, 37 post endoscopic therapy, 29 UGI malignancies, 7 variceal, 6 angiodysplasia, 2 inflammation, 15 lower GI bleeds) (Table 1). 134/267 (50%) of the peptic ulcer cohort were treated with Hemospray combination therapy. Haemostasis rates of 92% were achieved relative to 89% in the overall peptic ulcer bleed cohort. 20/108 (19%) had a rebleed and 30-day mortality of 17% (20/119). The most common combination therapy was Hemospray with adrenaline injection therapy with a haemostasis rate of 93% (49/53). Hemospray was used as a second modality in 36/66 (55%) cases. In the remaining cases it was used as a 3rd modality, and a 4thmodality in one case. 58% of all patients had Forrest 1b ulcers where a haemostasis rate of 91% was achieved, re-bleeding in 12/69 (17%). 18% of patients had Forrest 1a ulcers with immediate haemostasis in 21/24 (88%) patients, re-bleed in 4/18 (22%) patients. In the post endoscopic therapy cohort, a 100% haemostasis rate was achieved with a 4% (1/26) re-bleed. Most of the cases were post endoscopic mucosal resection (22/37, 59%). The most common combination therapy was Hemospray and adrenaline injection (24% of patients). In malignancy related UGIB's an 86% (25/29) haemostasis rate was achieved, with a rebleed rate of 17% (4/23). The most common combination was Hemospray and adrenaline injection therapy (12/29, 41%) where a 92% haemostasis rate was achieved and one re-bleed. In variceal bleeds (5 oesophageal, 2 gastric) a haemostasis rate of 86% (6/7) was achieved, a rebleed rate of 29%. Hemospray was used as the second modality to banding/glue injection in the majority of cases.
Conclusion(s): High haemostasis rates were achieved following treatment with Hemospray in all the subgroups. In peptic ulcers high haemostasis and reasonable re-bleeding rates were achieved in Forrest 1a/1b ulcers. Results show that Hemospray combination therapy can have a role in lower GI bleeds. There is a shift towards use of Hemospray as part of standard combination therapy. Its role needs to be clearly defined within the GI bleed algorithm. Disclosure: M.H - Speaker fees (Cook Medical), R.H - Received research grant support from Pentax Medical, Cook Endoscopy, Fractyl Ltd, C2 therapeutics and Medtronic to support research infrastructure
EMBASE:636330211
ISSN: 2050-6414
CID: 5179982

Gastrostomy tubes in patients with COVID-19: Reduction of in-hospital mortality with a multidisciplinary team-based approach [Meeting Abstract]

Saltiel, J; Lee, B; Tran, J; Kumar, V; Grendell, J; Goodman, A; Petrilli, C; Bosworth, B; Latorre, M
Introduction: Critically-ill patients with COVID-19 often require long-term enteral access due to prolonged ventilator support and slow recovery from neurologic injury. The outcomes of hospitalized patients with SARS-CoV-2 who received gastrostomy tubes (GTs) are unknown and limited guidance exists on how to safely triage GT placement in this population. The Enteral Access Team (EAT) is a multidisciplinary team led by an attending gastroenterologist (GI) hospitalist with advanced practice providers who collaborate with Palliative Care, Geriatrics, Speech-Language Pathology, and Nutrition to reduce unnecessary feeding tube placements at the end-of-life. The EAT reviews the appropriateness of GT placement and triages each case to the indicated procedural service. The EAT's multidisciplinary approach was applied for patients with COVID-19.
Method(s): We performed a retrospective study of 135 hospitalized patients with positive PCR tests for SARS-CoV-2 who received GTs between 3/2020 and 4/2021. The GTs were placed by 3 services (gastroenterology, interventional radiology and surgery) at 3 hospitals within 1 health system in New York. One of the hospitals employed the multidisciplinary EAT approach to its triage of GT placement. Outcomes were compared between the EAT site and control sites where GT placement was decided through direct consultation by the primary team with one of the procedural services.
Result(s): Demographics for the two groups, including overall numbers of COVID-19 admissions, can be seen in Table 1. At the EAT site (n =43) 5% of patients expired prior to discharge following GT placement compared with 25% at the control sites (P <0.05). Patients at the EAT site were older with a mean age of 70 years compared to the control sites with a mean age of 63 years (P=0.01). There was no significant difference in the percentage of COVID-19 patients who received GTs, length-ofstay, or time from gastrostomy to discharge or death. Multivariable analysis showed the odds of in hospital mortality were 10.1 times greater with the standard workflow than with the EAT workflow (OR 10.1, [95% CI: 1.7-60.6], P <0.05).
Conclusion(s): The EAT's novel multidisciplinary team-based approach helps to appropriately select hospitalized patients with SARs-CoV-2 for long-term enteral access leading to reduced in-hospital mortality following GT placement. Additionally, this approach may help to mediate the national shortage of GTs and reduce the risk of exposure to providers involved in GT placement
EMBASE:636472602
ISSN: 1572-0241
CID: 5084322

A multicenter, prospective, inpatient feasibility study to evaluate the use of an intra-colonoscopy cleansing device to optimize colon preparation in hospitalized patients: the REDUCE study

Neumann, Helmut; Latorre, Melissa; Zimmerman, Tim; Lang, Gabriel; Samarasena, Jason; Gross, Seth; Brahmbhatt, Bhaumik; Pazwash, Haleh; Kushnir, Vladimir
BACKGROUND:High quality bowel preparation prior to colonoscopy can be difficult to achieve in the inpatient setting. Hospitalized patients are at risk for extended hospital stays and low diagnostic yield due to inadequate bowel preparation. The Pure-Vu System is a novel device intended to fit over existing colonoscopes to improve intra-colonoscopy bowel preparation. The objective of the REDUCE study was to conduct the first inpatient study to evaluate optimization of bowel preparation quality following overnight preparation when using the Pure-Vu System during colonoscopy. METHODS:This multicenter, prospective feasibility study enrolled hospitalized subjects undergoing colonoscopy. Subjects recorded the clarity of their last bowel movement using a 5-point scale prior to colonoscopy. After one night of preparation, all enrolled subjects underwent colonoscopy utilizing the Pure-Vu System. The primary endpoint was improvement of colon cleanliness from baseline to post-cleansing with the Pure-Vu System as assessed by the improvement in Boston Bowel Preparation Scale (BBPS). An exploratory analysis was conducted to assess whether the clarity of the last bowel movement could predict inadequate bowel preparation. RESULTS:Ninety-four subjects were included. BBPS analyses showed significant improvements in bowel preparation quality across all evaluable colon segments after cleansing with Pure-Vu, including left colon (1.74 vs 2.89; p < 0.0001), transverse colon (1.74 vs 2.91; p < 0.0001), and the right colon (1.41 vs 2.88; p < 0.0001). Prior to Pure-Vu, adequate cleansing (BBPS scores of ≥ 2) were reported in 60%, 62%, and 47% for the left colon, transverse colon, and right colon segments, respectively. After intra-colonoscopy cleansing with the Pure-Vu System, adequate colon preparation was reported in 100%, 99%, and 97% of the left colon, transverse colon, and right colon segments, respectively. Subjects with lower bowel movement clarity scores were more likely to have inadequate bowel preparation prior to cleansing with Pure-Vu. CONCLUSIONS:In this feasibility study, the Pure-Vu System appears to be effective in significantly improving bowel preparation quality in hospitalized subjects undergoing colonoscopy. Clarity of last bowel movement may be useful indicator in predicting poor bowel preparation. Larger studies powered to evaluate clinical outcomes, hospital costs, and blinded BBPS assessments are required to evaluate the significance of these findings. Trial registration Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System (NCT03503162).
PMCID:8140575
PMID: 34022813
ISSN: 1471-230x
CID: 4887362

A practical guide to establishing a gastroenterology hospitalist program

Latorre, Melissa; Gross, Seth A; Pochapin, Mark B
PMID: 33640479
ISSN: 1542-7714
CID: 4800982

Upper Gastrointestinal Bleeding Following Isolated Gastric Filiform Polyp Resection [Meeting Abstract]

Dornblaser, David W.; Latorre, Melissa; Liu, Shawn; Perelman, Alexander
ISI:000717526105229
ISSN: 0002-9270
CID: 5526522

Inpatient Capsule Endoscopy of Patients With Iron Deficiency Anemia Is Associated With Higher Therapeutic Yield and Shorter Time From Negative Endoscopy to Evaluation [Meeting Abstract]

Hong, Soonwook; Laljee, Saif; Levine, Irving; Bhakta, Dimpal; McNeill, Matthew; Gross, Seth A.; Latorre, Melissa
ISI:000717526102362
ISSN: 0002-9270
CID: 5325252

Dysphagia secondary to acute stroke masquerading as food impaction [Meeting Abstract]

Lopatin, S; Latorre, M
INTRODUCTION: Dysphagia is a commonly encountered symptom in gastroenterology, and esophageal food impaction is a common cause of acute onset dysphagia presenting in the emergency room. As such, gastroenterologists are often among the first to evaluate patients with a chief complaint of dysphagia. Here, we present a case of acute onset dysphagia concerning for food impaction, where the patient was then noted to have multiple neurologic deficits suggestive of acute stroke. CASE DESCRIPTION/METHODS: The patient is a 54 year-old male with history of hypertension who presented with acute onset dysphagia for two hours. His symptoms began with lightheadedness, and subsequently developed inability to swallow liquids. His symptoms did not develop acutely after ingestion of any solid foods. He then noted discomfort in his neck, prompting presentation to the emergency department. On arrival, he was hemodynamically stable. Initial labs were unremarkable. Physical exam at time of arrival notable for normal cardiovascular and neurologic exams. Oropharyngeal exam was abbreviated as he was wearing a mask due to the COVID-19 pandemic. GI was consulted for concern for food impaction. While plans were being made for urgent endoscopy, he developed a left facial droop, nystagmus and gait ataxia concerning for acute posterior circulation stroke. He underwent CTA which was notable for occlusion of right vertebral and proximal basilar arteries. He promptly received tPA and was admitted to the stroke service. His neurologic exam improved over the course of his hospitalization and tolerated pureed diet by time of discharge, though with some residual dysphagia. DISCUSSION: The differential diagnosis for dysphagia is commonly differentiated into oropharyngeal and esophageal pathologies. Within each of these categories, there are both neuromuscular and structural processes which can manifest with symptoms of dysphagia. As gastroenterologists, we are frequently exposed to common esophageal pathologies. However, maintaining a broad differential and avoiding anchoring bias is key for timely recognition of a multitude of diagnoses. Urgent diagnoses which can present with acute onset dysphagia include oropharyngeal infections, acute stroke, and food and/or foreign body impaction. This case highlights the importance of the gastroenterologist, who may be the first person to evaluate a patient with acute onset dysphagia, in maintaining a broad and appropriate differential diagnosis to ensure appropriately and timely treatment of the patient
EMBASE:633658938
ISSN: 1572-0241
CID: 4720452

Donning a new approach to the practice of gastroenterology: perspectives from the COVID-19 pandemic epicenter

Sethi, Amrita; Swaminath, Arun; Latorre, Melissa; Behin, Daniel S; Jodorkovsky, Daniela; Calo, Delia; Aroniadis, Olga; Mone, Anjali; Mendelsohn, Robin B; Sharaiha, Reem Z; Gonda, Tamas A; Khanna, Lauren G; Bucobo, Juan Carlos; Nagula, Satish; Ho, Sammy; Carr-Locke, David L; Robbins, David H
The COVID-19 pandemic is seemingly peaking now in New York City and has triggered significant changes to the standard management of gastrointestinal diseases. Priorities such as minimizing viral transmission, preserving (personal protective equipment) PPE, and freeing hospital beds have driven unconventional approaches to managing GI patients. Conversion of endoscopy units to COVID units and redeployment of gastroenterology (GI) fellows and faculty has profoundly changed the profile of most GI services. Meanwhile, consult and procedural volumes have been drastically reduced. In this review we share our collective experiences, how we have changed our practice of medicine, in response to the COVID surge. While we will review our management of specific consults and conditions, the overarching theme focuses primarily on non-invasive measures and maximizing medical therapies. Endoscopic procedures have been reserved for those timely interventions that are most likely to be therapeutic. The role of multidisciplinary discussion, while always important, has now become critical. And the support of our faculty and trainees remains essential. Local leadership can encourage well-being by frequent team check-ins and foster trainee development through remote learning. Advancing a clear vision and a transparent process for how to organize and triage care in the recovery phase will allow for a smooth transition to our "new normal."
PMID: 32330565
ISSN: 1542-7714
CID: 4397502