Significant Bleeding Episodes Research Articles

Optimizing the safety and efficacy of the awake venovenous extracorporeal membrane oxygenation in patients with COVID-19-related ARDS.

Maintaining the patient awake and not intubated during the venovenous extracorporeal membrane oxygenation (VV ECMO) reduces the risk of ventilation-induced lung injury in patients with ARDS. Currently, there is a lack of data on outcomes and complications associated with the awake ECMO approach. To evaluate outcomes and the occurrence of complications of awake ECMO approach guided by local safety protocol comprising ultrasound-guided cannulation, argatroban-based anticoagulation, respiratory support, and routine sedation targeted to reduce respiratory effort and keeping nurse-to-patient ratio of 1:1. A single-center retrospective case series analysis. Consecutive patients with COVID-19-related acute respiratory distress syndrome (ARDS) (CARDS) treated by full awake VV ECMO approach from April 2019 to December 2023 were eligible. Our center treated 10 patients (mean age 54.7 ± 11.6 years) with CARDS with an awake ECMO approach. The reasons for awake ECMO included the presence of barotrauma in six patients, a team consensus to prefer awake ECMO instead of mechanical ventilation in three patients, and the patient's refusal to be intubated in one case. Before ECMO, patients were severely hypoxemic, with a mean value of Horowitz index of 48.9 ± 9.1 mmHg and a mean respiratory rate of 28.8 ± 7.3 breaths per minute on high-flow nasal cannula or noninvasive ventilation support. The mean duration of awake VV ECMO was 558.0 ± 173.6 h. Seven patients (70%) were successfully disconnected from ECMO and fully recovered. Intubation from respiratory causes was needed in three patients (30%), all of whom died eventually. In total, three episodes of delirium, two episodes of significant bleeding, one pneumothorax requiring chest tube insertion, and one oxygenator acute exchange occurred throughout the 5580 h of awake ECMO. No complications related to cannula displacement or malposition occurred. The awake ECMO strategy guided by safety protocol appears to be a safe approach in conscious, severely hypoxemic, non-intubated patients with COVID-19-related ARDS.

Real-World Management Strategies of Anticoagulated Atrial Fibrillation Patients After a Clinically Significant Bleeding Episode

BackgroundSystemic anticoagulation for stroke prevention in patients with atrial fibrillation (AF) carries inherent bleeding risks, and determining whether and when to resume anticoagulation after significant bleeding is a common dilemma. We aimed to describe the clinical characteristics of AF patients discharged after a bleeding event, document real-life thromboembolic prevention strategy (TPS), and analyse their associated clinical outcomes. MethodsWe retrospectively reviewed the charts of anticoagulated AF patients admitted for bleeding from 2017 to 2019. ResultsA total of 140 patients were included, with a mean age of 78.6 years. Four discharge groups were defined: 75 patients (53.5%) had optimal anticoagulation (OA), 37 (26.4%) had a suboptimal antithrombotic regimen (SAR; low-dose direct oral anticoagulants without dose-reduction criteria or antiplatelet therapy), 10 (7.1%) were referred for left atrial appendage occlusion (LAAO), and 18 (12.9%) left without any TPS. All-cause mortality at 2 years was high (28.6%) but not statistically different between groups (P = 0.71). Patients discharged with a TPS (OA/SAR/LAAO referral) were more likely to be readmitted for bleeding at 2 years (34% vs 0%; P = 0.002), and those discharged without a TPS had higher rates of stroke (16.6% vs 1.4%; P = 0.003). SAR yielded readmission rates for bleeding similar to resumption of OA (27% vs 34.7%; P = 0.41) but was associated with high rates of death or readmission at 2 years. ConclusionsThis real-life cohort reveals that clinicians frequently downgrade or discontinue long-term thromboembolic protection after a bleeding event despite current guideline recommendations to the contrary, and downgrading resulted in bleeding risk similar to OA.

The benefits of early continuous renal replacement therapy in critically ill patients with acute kidney injury at high-altitude areas: a retrospective multi-center cohort study

Severe hypoxia would aggravate the acute kidney injury (AKI) in high-altitude areas and continuous renal replacement therapy (CRRT) has been used to treat critically ill patients with AKI. However, the characteristics and outcomes of CRRT in critically ill patients at AKI in high altitudes and the optimal timing of CRRT initiation remain unclear. 1124 patients were diagnosed with AKI and treated with CRRT in the ICU, comprising a high-altitude group (n = 648) and low-altitude group (n = 476). Compared with the low-altitude group, patients with AKI at high altitude showed longer CRRT (4.8 vs. 3.7, P = 0.036) and more rapid progression of AKI stages (P < 0.01), but without any significant minor or major bleeding episodes (P > 0.05). Referring to the analysis of survival and kidney recovery curves, a higher mortality but a lower possibility of renal recovery was observed in the high-altitude group (P < 0.001). However, in the high-altitude group, the survival rate of early CRRT initiation was significantly higher than that of delayed CRRT initiation (P < 0.001). The findings showed poorer clinical outcomes in patients undergoing CRRT for AKI at high altitudes. CRRT at high altitudes was unlikely to increase the adverse events. Moreover, early CRRT initiation might reduce the mortality and promote renal recovery in high-altitude patients.

Ультразвуковая эндоназальная дакриоцисториностомия в лечении рецидивирующего дакриоцистита новорожденного

Purpose. To evaluate early and long-term functional and anatomic results of surgical treatment of lacrimal pathways obstruction (LPO) in children with endonasal dacryocystorhinostomy (EDCR) method using ultrasound bone tissue dissector for the formation of nasolacrimal anastomosis. Material and methods. Surgical treatment of recurrent dacryocystitis of newborn (DN) after repeated unsuccessful «blind»lacrimal pathways probing in children with nasolacrimal duct obstruction, including cases of congenital nasolacrimal duct atresia. Bone «window» of the nasolacrimal anastomosis during endoscopic EDCR was formed using SONOCA 185 piezoelectric ultrasound dissector. In total, 14 children, 8 girls and 6 boys aged from 3 to 11 years (mean, 6 years) were operated with follow-up period of 6 months. Results. It was found that in all the children an adequate nasolacrimal anastomosis was formed without significant bleeding episodes both intraoperatively and in the early post-op period. No cases of destruction of the medial wall of the lacrimal sac were marked. Functional success was achieved in 92.8% (13 of14 cases). In 7.2% (1 of 14cases) there was a postoperative granuloma of the mucous in the rhinostoma region which was a partial obstacle for tear flow. Conclusions. Controlled low temperature process of nasal bones ultrasound dissection during EDCR in children allows formation of an adequate bone «window»and, therefore, a valuable nasolacrimal anastomosis in narrow nasal passages, makes the surgical procedure much easier and quicker, enables better healing of soft tissues in a shorter period. Key words: recurrent dacryocystitis of newborns, endonasal endoscopic dacryocystorhinostomy, ultrasound dissection of bone tissue

#4894 EFFICIENCY AND SAFETY OF AN ASSISTED HOME HEMODIALYSIS PROGRAM IN THE STATE OF QATAR: A RETROSPECTIVE STUDY

Abstract Background and Aims Home hemodialysis (HHD) usually done as self-care by patient themselves through a portable haemodialysis (HD) machine under training and monitoring by dialysis team. HHD offers greater patient autonomy, cost benefits, treatment-related flexibility, and improved quality of life compared to traditional in-centre HD. Uptake of HHD is limited by patient motivation, cognitive and/or physical barriers, as well as lack of support of family and community. Assisted HHD (AHHD) is a new concept where dialysis team provides HD at home. Usually, it is done by a visiting dialysis nurse using mobile HD machine. Its use is limited due to financial and logistical restriction. We like to present our unique experience in providing AHHD in the State of Qatar. Planning for our AHHD program started in July 2020. Because of COVID-19 pandemic, it faced many challenges and delays. We started first patient in July of 2021. In our program, we use traditional HD machine (not portable) with connection set up in the house in a dedicated room. Special training was provided to AHHD staff regarding the special care needed for home setting (including social, complication of home dialysis settings, decision making, follow up of protocols and policies, etc.) Method We performed a retrospective study between July 1st, 2021 - December 31st, 2022. Our primary objectives were efficiency and safety of AHHD, and secondary objective was cost effectiveness. We included adult chronic HD patients (on HD &amp;gt;3 months) using ambulance (or eligible for it) with functional dialysis access. We excluded patients who are not suitable for home environment (psychiatric illness, aggressive behaviour, etc.). Data were collected from our national electronic health record system. Results 946 patients screened for the program. 237 were eligible (exclusion mostly due to lack of national insurance coverage or not meeting mobility/transport criteria). 121 patients refused to participate (mostly for feeling safer in the clinic setting or improper home environment), 40 patients were undecided, and 76 patients accepted and started AHHD. Age was 73+/-11 years. We had 32 males and 44 females. Mean follow up period were 7 months. 12 patients died and 2 patients returned to dialysis centre during follow up period. Only 15 out of the total 126 hospitalizations were related to dialysis (mostly due to volume overload and non-compliance with dialysis schedule and time). We had 55 patients with permcath and 21 with AV fistulas. We had 8 incidents of dialysis catheter malfunction (6 required tissue plasminogen activator installation in the house setting and only two needed catheter exchange (one had catheter related infection)). No reported significant access bleeding or hypotension episodes. We had 20 technical incidents during the study related to electricity or water supply failures. All incidents were resolved without much interruption of treatment. The program overall was cost effective and reduced cost by over 25% (mostly related to saving of ambulance cost). Patients and their families were very satisfied with the program overall. Conclusion We present a unique successful program related to providing AHHD. Targeting certain dialysis population showed great care, safety, cost saving, better QOL and satisfaction.

Clinical Trial Comparing the Efficacy and Safety of Regional Citrate Anticoagulation Versus Heparin in CRRT.

Heparin continues to be the most common modality of anticoagulation in CRRT. The increased risk of hemorrhagic complications associated with its use led to the emergence of regional citrate anticoagulation (RCA) as an alternative. However, the perceived complexities associated with its use and the risk of metabolic derangements have prevented it from being adopted on a larger scale. Thus, we conducted a prospective study to compare the efficacy and safety of RCA versus heparin. Adult patients admitted to our ICU (November 2018-November 2019) with renal insufficiency and requiring CRRT were included in the study. It was an open-label study with 25 patients each being allotted to the heparin and citrate groups. Our primary outcome was the filter life span. Secondary outcomes included metabolic derangements, bleeding episodes, and patient survival. The starting dose of citrate was 2.0 mmol/L. The mean filter life span was 32.84 h in the citrate group and 30.40 h in the heparin group (p-value = 0.47). In a significant proportion of the cases, CRRT was terminated for non-filter clotting-related reasons (64% in citrate vs. 32% in heparin). Kaplan-Meir analysis was done to overcome this confounder; the filter lifespan was estimated to be 46.94 h in citrate and 40.05 h for the heparin group (p-value = 0.29). No significant metabolic derangements or bleeding episodes were noted in either group. Overall patient survival was higher in the citrate group at 52% versus 32% (p-value = 0.15) in the heparin group. No significant difference in filter lifespan or risk of metabolic derangements was noted. A trend toward higher patient survival rates in the citrate group was noted, which warrants further evaluation in future trials.

Clinical Profile and Management of Prosthetic Valve Thrombosis in Tertiary Cardiac Centre

Background and Aim: Prosthetic valve thrombosis is a potentially fatal outcome of valve replacement surgery. A proportion of patients suffer with thrombotic problems, mostly as a result of inadequate anticoagulation status and irregular INR checks. The present study aimed to investigate the clinical profile and prosthetic valve thrombosis management in tertiary cardiac centers. Patients and Methods: This prospective study was carried out on 58 prosthetic valve thrombosis patients in AFIC, Rawalpindi and Punjab Institute of Cardiology, Lahore from January 2022 to June 2022. The study protocol was approved by the institutional research and ethical committee. All the enrolled patients provided informed written consent. Patients’ demographic details, clinical profile, in-hospital complications, and outcome during one year follow-up were recorded. SPSS version 28 was used for data analysis. Results: Of the total 58 PVT patients, there were 22 (37.9%) male and 36 (62.1%) females. The overall mean age was 32.84± 8.4 years with an age range 10-65 years. About 34 (58.6%) patients had sub-therapeutic INR values during admission time whereas 28 (48.3%) patients had atrial fibrillation. Breathing difficulties was the predominant complaint in 54 (92.8%) of the patients who came within one week after the beginning of symptoms. Approximately 51 patients (88.4%) had streptokinase thrombolysis, while four required surgery. Valve thrombosis was most prevalent in 49 (84.5%) of the individuals. In-hospital mortality was 9.8% (n=6), with no significant bleeding episodes or new strokes seen. Conclusion: The present study concluded that PV thrombosis is a medical emergency associated with a high mortality rate. Low socio-economic level leads to poor adherence to anticoagulation medication. The prosthetic valve thrombosis patients had poor compliance and sub-therapeutic INR. Prosthetic valve thrombosis can be effectively treated with thrombolysis. Keywords: Prosthetic valve thrombosis, Clinical profile, Thrombosis

P1659: UNIQUE GENOTYPE-PHENOTYPE RELATIONSHIP IN VON WILLEBRAND DISEASE: A SINGLE CENTRE EXPERIENCE

Background: von Willebrand Disease (VWD) is the most common hereditary coagulation disorder. Generally, coagulation disorders are more prevalent in communities with high rate of consanguinity. Due to segregation of multiple alleles, combinations of abnormal variants causing unique clinical presentations can occur. Aims: We aim to present our single centre experience of VWD in pediatrics. Methods: Retrospective data analysis of all pediatric patients diagnosed with (VWD) throughout a period of 10 years, dating from January 2012 till December 2021. In addition, molecular testing using next generation sequencing (NGS) of a family, with a spectrum of bleeding phenotypes was done. Results: Out of 455 cases with hereditary coagulation disorders, 219 (48%) were diagnosed with VWD throughout the study period (141 girls and 78 boys), with an age of presentation ranging from 18 months to 14 years. Significant bleeding episodes were encountered in 42/219 patients (19%). History of consanguinity was documented in 175 cases (80%). The most common presenting feature was mucocutaneous bleeding, followed by menorrhagia and then post-traumatic/post-surgical hemorrhage. Factor replacement therapy was used in 34 cases and desmopressin (DDAVP) in 22 cases. Hormonal therapy was offered to 18 girls presenting with menorrhagia. However, only 7 of them were compliant. The index case is a 4-year-old girl, presented with profuse post-adenotonsillectomy hemorrhage. Her past history was negative for any significant bleeding, but no previous surgical challenges. Parents are cousins, and family history was irrelevant. Routine preoperative investigations didn’t reveal any abnormalities apart from raised mean platelet volume (14 fL), and a platelet count of 180 × 10ˆ9/L. Bleeding didn’t respond optimally to FFP, but controlled with multiple platelet transfusions and recombinant activated factor VII. Molecular studies using NGS revealed two different heterozygous variants in the CD36 gene. The first heterozygous variant was NM_001001547.2:c338_339del (p.Ser113Phefs*20), a frameshift variant which results in loss of function of the protein product of CD36 gene. The second was deletion of exons 2 and 3 (NM_001001547.2:c.1_120del), which results in loss of a significant portion of the coding region of CD36 gene. To our knowledge, both novel variants have not been reported in the literature. Biallelic mutations in CD36 are associated with platelet glycoprotein IV deficiency (PG4D), characterized by macrothrombocytopenia with variable bleeding phenotype (PubMed: 7533783; OMIM: 173510). In addition, A heterozygous variant in the VWF gene, NM_000552.4:c.3692A>G (p.Asn1231Ser), was identified. This heterozygous variant was reported in a case with von Willebrand disease type 1 (PubMed: 28971901). The distinctive combination of these three variants explains the severe bleeding phenotype. NGS identified the same heterozygous frameshift variant of CD36 in the mother, while the father carries both the deletional variant of CD36 and the missense variant of VWF gene. Two sisters (ages: 8 & 15 years) harbor the heterozygous VWF gene variant. On further enquiries, the eldest was found to have mild to moderate menorrhagia, that didn’t require any medical advice. Family pedigree is shown in figure 1. Image:Summary/Conclusion: Genotype-phenotype correlation is mandatory in coagulation disorders, presenting with significant bleeding episodes.

Post-operative Anticoagulation Strategy Following Comprehensive Stage 2 Procedure for Single Ventricle Physiology.

Thrombosis, especially thrombosis of the pulmonary artery, is a large contributor to morbidity and mortality following comprehensive stage 2 procedure for single ventricle cardiac physiology. A peri-operative management protocol was implemented at our institution in March 2010. It includes 6weeks of therapeutic anticoagulation post-operatively to mitigate the thrombotic risks in this patient population. This is a retrospective study of hospitalized children who received post-operative anticoagulation following a comprehensive stage 2 procedure for single ventricle cardiac physiology at a free-standing children's hospital. The primary objectives are to describe our institution's anticoagulation strategy and report on the number of thromboses and major bleeding episodes in the 6weeks post-operatively. Secondary objectives include the dose of enoxaparin required to obtain a therapeutic low-molecular weight anti-factor-Xa (AFXaLMWH) level, and the number of patients outside of the therapeutic range. A total of 71 infants were included in the final analysis. Four patients experienced a thrombosis episode and three patients experienced clinically significant bleeding. The mean dose of enoxaparin required to obtain a therapeutic AFXaLMWH level between 0.5-1 unit/mL was 1.23mg/kg SQ every 12h and 37% of patients achieved goal AFXaLMWH levels with the initial starting dose of enoxaparin 1mg/kg SQ every 12h. We describe a 9-year experience of anticoagulation after single ventricle palliation. Anticoagulation with therapeutic AFXaLMWH goals of 0.5-1 unit/mL may reduce the rates of clinically significant thrombosis post-operatively in this population and appears safe without increase in significant bleeding episodes when compared to a historical cohort. Further studies comparing this population to those who do not receive post-operative anticoagulation are warranted.

Correction of Anticoagulant Therapy in Patients with Severe COVID-19 Virus Infection Using a Thrombodynamics Coagulation Assay.

The average frequency of thrombosis in patients with COVID-19 is still high despite low molecular weight heparin (LMWH) prophylactic. Global hemostasis assays, particularly thrombodynamics (TD), known to be sensitive to both hypercoagulation and heparin effects, could potentially be useful for individual management of anticoagulant therapy. A total of 74 patients with lung involvement >50% were randomized into two groups: Group A (44 patients) received weight-based dosing of LMWH, and Group B (30 patients) received the first LMWH dose by a weight-based dosing protocol and then received an adjusted dose based on TD daily results. The endpoints of the study were thrombosis and bleeding as well as discharge or death of the patient. The incidence of thrombosis was 3 times lower in Group B under TD control compared to Group A without TD control: 7% versus 23 respectively (p = .05). The relative risk of thrombosis if the average clot growth rate V in TD exceeded the threshold value of 25 μm/min was 14.3 (p = .0005, 95% confidence interval 3.2-63.7). There were no clinically significant bleeding episodes in Group B while there were 7% in unregulated Group A. Mortality in Group B under TD control was lower than that in Group A without control: 27% versus 36%, respectively (p = .13). The dosing LMWH under thrombodynamics control in severe patients with COVID-19 allows for a significant reduction in thrombotic complications. Long-term hypercoagulation revealed by thrombodynamics (3 and more days) is a strong predictor of thrombosis (AUC = 0.83).

Port removal in patients receiving emicizumab prophylaxis: A single centre experience and review of the literature.

Treatment of patients with Haemophilia A has improved significantly in recent years since the advent of novel therapeutic agents such as emicizumab. The low annualised bleeding rates associated with emicizumab have liberated many patients from the need for central venous access devices (CVAD). Optimal peri-operative management of CVAD removal is not currently known and there are no specific formal recommendations available. We reviewed outcomes in a paediatric cohort in our centre undergoing CVAD removal without pre-operative factor or bypassing agent and reviewed the literature regarding port removal in patients on Emicizumab. Ten male patients with severe Haemophilia A underwent CVAD removal without planned administration of factor concentrate or bypassing agent. Patients were monitored in hospital for 24h with routine laboratory testing pre- and post-operatively. No significant bleeding episodes occurred in any patient, no patient required factor concentrate or bypassing agent and no patients were readmitted due to bleeding within 7 days of surgery. We propose that, in the era of emicizumab, prophylactic factor administration pre-operatively for elective CVAD removal is not required in the majority of cases.

Incidence of Pediatric Eosinophilic Esophagitis and Characterization of the Stricturing Phenotype in Alberta, Canada.

We retrospectively identified all new cases of EoE at our center from 2015 to 2018 using esophageal biopsy reports, EoE clinic lists, and a local OR database of esophageal dilatations. Electronic medical records (EMRs) were reviewed to confirm EoE diagnosis. Clinical data were captured from the outpatient EMR and gastroscopy/pathology reports. Scope adverse event data were captured from multiple sources. The 2016 census data were used to calculate incidence rates. One hundred eighty-five new cases of EoE were diagnosed during the study period. For patients <15 years old living in Edmonton, the incidence over the 4 years was 11.1 cases per 100,000 person years. Eight of 185 (4%) patients had endoscopically confirmed esophageal strictures, 4 of which required mechanical dilation. Eleven of 185 (5.9%) patients had more subtle signs of esophageal narrowing, but no focal strictures. No perforations or episodes of significant bleeding were reported. Pain was reported after 15% of all scopes, including 50% of the 28 scopes with focal strictures. No unexpected admissions or emergency department visits occurred within 72 hours of a gastroscope with esophageal narrowing. Edmonton zone has one of the highest incidences of pediatric EoE reported. In this cohort, 4% had focal esophageal strictures, and 6% had more subtle narrowing. Mechanical dilation of esophageal strictures was associated with no significant adverse events.

SHAPE-SENSING ROBOTIC ASSISTED BRONCHOSCOPY FOR THE DIAGNOSIS OF PERIPHERAL PULMONARY LESIONS

TOPIC: Lung Cancer TYPE: Original Investigations PURPOSE: To assess the real-world performance characteristics of a shape-sensing robotic platform for the diagnosis of peripheral pulmonary nodules. METHODS: This is a retrospective, single center, single operator cohort of consecutive cases performed utilizing shape-sensing robotic assisted bronchoscopy (SSRAB) with integrated 3.5mm robotic catheter (Ion Endoluminal System, Intuitive Surgical, Sunnyvale, CA). Cases were performed between January 2020 and April 2021. A specific anesthesia protocol was used in all patients to prevent atelectasis. Radial endobronchial ultrasound (rEBUS) was used in all cases. Cone-beam CT (CBCT, Philips Allura Xper FD20 with Lung Suite, Best, Netherlands) was used at the discretion of the physician. A procedure was considered diagnostic if there was a malignant or specific benign result. Biopsies with inflammation were considered indeterminate, followed with CT imaging and considered diagnostic if there was significant improvement or resolution of the lesion. Specimens noted to be “atypical” were considered non-diagnostic. RESULTS: A total of 230 lesions, biopsied in 192 consecutive patients were included (56% female). Multiple lesions were biopsied (maximum = 3) in a single procedure in 38 patients (20%). Bilateral lesions were biopsied in 13 patients (7%). Most lesions (64%) were in the upper lobes (n= 144, 40% RUL, 24% LUL). Median lesion size was 15mm (IQR: 10, 21). A bronchus sign was present in 38% of lesions. Lesions biopsied were solid (78%), semi-solid (12%), ground glass (7%) or cavitary (3%). Diagnostic yield was 92.2% for all lesions and 89.3% for lesions 10mm or less (n=56, smallest = 5mm). CBCT was used for 75% of lesions (n=174). Malignancy was noted in 74% (n=170) of lesions. A specific benign diagnosis was noted in 16% (n=37), and 8% (n=15) of lesions were non-diagnostic. There were 8 lesions where biopsy results were indeterminate. These patients underwent serial CT scans for follow-up: 5 lesions resolved, improved significantly or were stable for 12 months. Three lesions have follow-up pending and are considered non-diagnostic in this analysis. All indeterminate lesions had tool-in-lesion confirmation on intraprocedural CBCT scan. Sensitivity for malignancy ranges from 90.4% to 91.9% considering pending follow-up of 3 lesions. Pneumothorax was noted in 2 patients (1%), 1 of which required a chest tube (0.5%). There were no episodes of respiratory failure or significant bleeding that required intervention (including removal of the robotic catheter). CONCLUSIONS: This represents the largest cohort of patients to date using any robotic bronchoscopy technology and shows that SSRAB, when combined with CBCT and rEBUS, is safe with a high diagnostic yield. CLINICAL IMPLICATIONS: The use of SSRAB may increase the diagnostic yield for peripheral pulmonary nodules. Larger, prospective multicenter trials are forthcoming. DISCLOSURES: My spouse/partner as a Employee relationship with Medtronic Please note: >$100000 by Michael Pritchett, source=Web Response, value=Salary Consultant relationship with Medtronic Please note: $5001 - $20000 by Michael Pritchett, source=Web Response, value=Consulting fee Consultant relationship with Johnson & Johnson Please note: $5001 - $20000 by Michael Pritchett, source=Web Response, value=Consulting fee Consultant relationship with AstraZeneca Please note: $20001 - $100000 by Michael Pritchett, source=Web Response, value=Consulting fee Consultant relationship with Intuitive Please note: $20001 - $100000 by Michael Pritchett, source=Web Response, value=Consulting fee Consultant relationship with BodyVision Please note: $5001 - $20000 by Michael Pritchett, source=Web Response, value=Consulting fee Consultant relationship with Boston Scientific Please note: $1001 - $5000 by Michael Pritchett, source=Web Response, value=Consulting fee Research relationship with Philips Please note: $5001 - $20000 by Michael Pritchett, source=Web Response, value=Grant/Research Support Consultant relationship with Biodesix Please note: $5001 - $20000 by Michael Pritchett, source=Web Response, value=Consulting fee Speaker relationship with Intuitive Please note: 2 years Added 06/23/2021 by Michael Pritchett, source=Web Response, value=Speaking fees Consultant relationship with Medtronic Please note: 5 years Added 06/23/2021 by Michael Pritchett, source=Web Response, value=Consulting fee Consultant relationship with Intuitive Please note: 2 years Added 06/23/2021 by Michael Pritchett, source=Web Response, value=Consulting fee Advisory Committee Member relationship with AstraZeneca Please note: 4 years Added 06/23/2021 by Michael Pritchett, source=Web Response, value=Honoraria Advisory Committee Member relationship with Pfizer Please note: 4 years Added 06/23/2021 by Michael Pritchett, source=Web Response, value=Honoraria Advisory Committee Member relationship with Biodesix Please note: 4 years Added 06/23/2021 by Michael Pritchett, source=Web Response, value=Honoraria Consultant relationship with BodyVision Please note: 3 years Added 06/23/2021 by Michael Pritchett, source=Web Response, value=Consulting fee Consultant relationship with Philips Please note: 2 years Added 06/23/2021 by Michael Pritchett, source=Web Response, value=Consulting fee Consultant relationship with Johnson & Johnson Please note: 3 years Added 06/23/2021 by Michael Pritchett, source=Web Response, value=Consulting fee No relevant relationships by Charles Schirmer, source=Web Response

Bleeding after suction rectal biopsy with Rbi2: identification of the root cause through a multi-staged approach

IntroductionSuction rectal biopsy (SRB) is a key diagnostic tool in Hirschsprung’s disease. The original Noblett device has been superseded by modern alternatives including the Rbi2 rectal biopsy gun. We describe...

Retrospective Study of Hematologic Complications in Vascular Malformation Patients with Localized Intravascular Coagulopathy Undergoing Surgical Intervention

BACKGROUNDSlow-flow vascular malformations such as multifocal or extensive venous (VM), venous-lymphatic (VLM), capillary-venous (CVM) and capillary-lymphatic-venous malformations (CLVM), are commonly associated with spontaneous thrombosis and thrombolysis, a phenomenon termed localized intravascular coagulopathy (LIC). LIC is characterized by elevated D-dimer, low fibrinogen, and/or mild thrombocytopenia and may progress to disseminated intravascular coagulopathy. Individuals with LIC are at an increased risk for hematological complications, particularly when undergoing surgical procedures on or near the vascular malformation. The pathogenesis of this coagulopathy is unknown but thought to be secondary to slow blood flow, consumption of coagulation factors, abnormal endothelium and loss of protective anticoagulant factors. The exact mechanism of dysregulation of the coagulation pathway and the resultant hematologic complications remains largely unstudied. Furthermore, many institutions are empirically using peri-procedural LMWH in attempt to decrease morbidity in individuals with LIC despite supportive evidence. This work will be the largest retrospective study investigating post-procedural hematologic complications in children and young adults with vascular malformations as only case reports and series have been published to date. METHODRetrospective chart review was conducted of medical records of adult and pediatric patients with slow-flow vascular malformations with LIC who underwent a surgical intervention and/or sclerotherapy procedure at Cincinnati Children's Hospital Medical Center from 7/1/2008 to 12/31/2016. LIC was defined by high D-dimer (5 times upper limit of normal), fibrinogen <150mg/dL and/or platelet count <150K/mcL. Hematologic complications included any clinically relevant bleeding or clotting abnormality that occurred intra-operatively, 2 weeks post-procedure and/or while on LMWH prophylaxis, up to 2 weeks, prior to surgery. Use of LMWH including dose, frequency and course length was evaluated. RESULTSThirty-nine patients with slow-flow vascular malformations with associated LIC (24 with extensive VM/VLM, 9 with multiple VM/VLM, 4 with CLVM, 2 with localized VM/VLM) underwent a total of 236 sclerotherapy procedures with 86% occurring in individuals under 18 years of age. At our institution, LMWH was administered at 0.5mg/kg/dose once daily for 2 weeks before and after sclerotherapy in 87% of sclerotherapy cases. No thrombotic complications occurred in children. One adult patient on LMWH at treatment dosing developed pulmonary emboli (PE), presumably from deep vein thrombosis (DVT) of the treated extremity; the patient was a known smoker with a history of DVT/PE. In 5 patients fibrinogen levels dropped below 100 mg/dL post-sclerotherapy for which cryoprecipitate was administered and no bleeding complications occurred. No intra-op bleeding or thrombotic events occurred.Total of 104 patients with slow flow malformations underwent 265 procedures represented by all major surgical subspecialties, excluding sclerotherapy. Twenty-seven (26%) of these patients had evidence of LIC prior to surgery. Eight significant bleeding episodes and 3 thrombotic events occurred; seven (64%) of which occurred in patients with known LIC. Two patients had both a clotting and hemorrhagic event. Although complications occurred similarly in both children and adults, 100% of the hematogic complications occurred in patients with extensive combined vascular malformations , most with venous ectasias. The dosing, course length and frequency of LMWH use was highly variable among patients undergoing surgery. CONCLUSIONSProphylactic LMWH use was common in this patient population and did not appear to increase the risk of significant bleeding before, during or after sclerotherapy. Thrombotic events after sclerotherapy appear rare but may still occur. In patients with known LIC, attempts to correct coagulation abnormalities should be made prior to undergoing major surgical interventions. Further studies evaluating peri-procedural LMWH are needed to determine benefit and optimal dosing. Collaborative plans exist to combine data with Boston Children's Hospital so that future studies will allow for comparative effectiveness analysis of LMWH use at different doses in this patient population. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

2021 John N. Insall Award: Aspirin is effective in preventing propagation of infrapopliteal deep venous thrombosis following total knee arthroplasty.

The optimal management of an infrapopliteal deep venous thrombosis (IDVT) following total knee arthroplasty (TKA) remains unknown. The risk of DVT propagation and symptom progression must be balanced against potential haemorrhagic complications associated with administration of anticoagulation therapy. The current study reports on a cohort of patients diagnosed with IDVT following TKA who were treated with aspirin, followed closely for development of symptoms, and scanned with ultrasound to determine resolution of IDVT. Among a cohort of 5,078 patients undergoing TKA, 532 patients (695 TKAs, 12.6%) developed an IDVT between 1 January 2014 to 31 December 2019 at a single institution, as diagnosed using Doppler ultrasound at the first postoperative visit. Of the entire cohort of 532 patients with IDVT, 91.4% (486/532) were treated with aspirin (325 mg twice daily) and followed closely. Repeat lower limb ultrasound was performed four weeks later to evaluate the status of IDVT. Follow-up Doppler ultrasound was performed on 459/486 (94.4%) patients and demonstrated resolution of IDVT in 445/459 cases (96.9%). Doppler diagnosed propagation of IDVT to the popliteal vein had occurred in 10/459 (2.2%) cases. One patient with an IDVT developed a pulmonary embolus six weeks postoperatively. The results of this study demonstrate a low rate of IDVT propagation in patients managed with aspirin. Additionally, no significant bleeding episodes, wound-related complications, or other adverse events were noted from aspirin therapy. Cite this article: Bone Joint J2021;103-B(6 Supple A):18-22.

Complete Treatment of a Case of Medically Refractory Ulcerative Colitis with Adoption of the Health Triangle Methods for Lifestyle Modification

Ulcerative colitis (UC) is an inflammatory disease affecting the mucosa in the colon. Despite significant progress and expansion of the therapeutic armamentarium for UC, there are currently no curative medications available and some cases require colectomy. In this communication, we report the case of a 38 years old male patients with a five-year history of UC who had involvement of the entire colon and was medically refractory. The patient had received treatment with steroids, mesalazine, infliximab, and adalimumab, but failed to achieve remission in the process. He had non-remitting symptoms with endoscopic and histologic evidence of severe disease, and experienced episodes of significant lower gastrointestinal bleeding. Ultimately, the patient was advised to undergo colectomy, but he refused; instead, he adopted a lifestyle modification approach—the health triangle method. In short, this approach emphasizes three aspects of nutrition, use of herbal medicines, and interventions (called aamal-e-yadavi in Traditional Iranian Medicine) like oiling, cupping, and phlebotomy (hejamat). These interventions can improve the cellular energy balance and truly cure the autoimmune disease if adopted over the long term. After three years, the patient reported substantial improvement in symptoms, and the colonoscopy and histology showed evidence of remission. This case indicated the potential efficacy and safety of complementary and alternative approaches in patients with UC; however, the health triangle method needs to be investigated in randomized controlled trials.

Safety and Feasibility of Same-session Endoscopic Ultrasound-guided Biopsy and Fiducial Placement in Pancreatic Cancer

ABSTRACT Background In patients with pancreas adenocarcinoma (PDAC), performing endoscopic ultrasound (EUS)-guided fiducial placement at the time of initial EUS-guided biopsies may obviate a second procedure, streamline care, and improve resource utilization. However, the safety of this combined approach is understudied. Methods We retrospectively identified and reviewed cases at a single institution in which patients with PDAC underwent EUS-guided biopsy and same session fiducial placement. Patient and procedural characteristics were abstracted. Intraprocedural and postprocedural adverse events were classified according to the American Society for Gastrointestinal Endoscopy Lexicon for Adverse Events. The percentage of and adverse events occurring within 14 days of the procedure was calculated. Results Thirty-three patients were included in this series (median age 64, 42% male). The median numbers of biopsies performed and fiducials placed were 3 (range 2-7) and 4 (range 1-4), respectively, per patient. A 22-gauge needle was used for the majority of biopsies (81.8%) and all fiducial placements (100%). No definite and one probable adverse event of mild postprocedural pain was noted (3.0%, 1/33). There were no episodes of significant bleeding, pancreatitis or infection. Fiducials were successfully used in the administration of radiation to all patients. Conclusion We report a low risk of adverse events in the setting of combined EUS-guided biopsy and fiducial placement. In the appropriate setting, this approach may streamline care for patients with PDAC while avoiding time, cost, and risks associated with an additional procedure or impacting radiation therapy. Larger, controlled studies are needed to validate the safety and efficacy of this combined approach.

A196 INCIDENCE OF PEDIATRIC EOSINOPHILIC ESOPHAGITIS IN EDMONTON ZONE AND RISK OF STRICTURING AT DIAGNOSIS

Abstract Background Eosinophilic esophagitis (EoE) is a common cause of esophageal dysfunction in children. A subset of children have a more severe phenotype of EoE, complicated by esophageal stricturing. Limited work has been done to characterize this phenotype. Aims To determine the incidence of EoE, and the frequency of esophageal stricturing in pediatric EoE. Methods We retrospectively identified all new cases of EoE at the Stollery Children’s Hospital from 2015–2018 using esophageal biopsy reports for the province of Alberta (CoPath database), EoE clinic lists and an OR database for esophageal dilatation at the Stollery. Electronic medical records (EMR) were reviewed to confirm EoE diagnosis. For each confirmed case, clinical data was captured from the outpatient EMR and gastroscopy/pathology reports. A review of peri-endoscopy OR/nursing charts was performed on a subset of patients (n=75) to capture scope adverse event. Statistics Canada 2016 census data was used to calculate incidence rates. Results 185 new cases of EoE were diagnosed at our center during the study period (see table). For patients &amp;lt; 15 years old living in Edmonton zone (n=73), the incidence over the 4 years was 11.1 cases per 100,000 person years {8.7 (0–4 year-old), 7.6 (5–9 year old), and 18.1 (10–14 year old)}. There was limited variation in incidence in the 4 years (9.1–12.1 per 100,000 person years). 8 of 185 (4%) patients had endoscopically confirmed esophageal strictures, 4 of which required mechanical dilation (mean 3.75 dilations per patient, range 1–6). 11/185 (5.9%) patients had more subtle signs of esophageal narrowing, but no strictures. No perforations or episodes of significant bleeding were reported in peri-endoscopy charts reviewed for 239 gastroscopes, including 16 dilations. Pain was reported after 15% of all scopes, including 50% of the 28 scopes with strictures and 63% of the 16 scopes involving dilations. Conclusions Edmonton zone has one of the highest incidences of EoE reported in children. In this cohort, 4% had esophageal stricture (half required dilatation) and 5.9% had more subtle narrowing. Patients with strictures were older, had more frequent food impaction and longer duration of symptoms (Table). This data will be included in an ongoing multicenter case-control study across Canada. Funding Agencies CAGWomen and Children’s Health Research Institute (Univ. Alberta)

Abstract WMP119: Short Term Use of Direct Oral Anticoagulants is Not Associated With Decreased Bleeding in High Risk Patients Following Percutaneous Left Atrial Appendage Closure

Introduction: Percutaneous left atrial appendage closure is well established as an alternative to anticoagulation therapy for stroke prophylaxis among patients with non-valvular atrial fibrillation (NVAF) with relative or absolute contraindications to anticoagulation. Only the Watchman® (BSC) device has FDA approval for this indication. There are no current guidelines on the choice of short term antithrombotic therapy following placement of the Watchman® device. The landmark Watchman® clinical trials utilized warfarin and aspirin in the first 45 days to facilitate endothelialization; however these studies were started prior to direct oral anticoagulants (DOAC) becoming widely available. Our main objective was to compare bleeding outcomes with warfarin vs. DOACs following Watchman® device placement. Methods: We conducted a retrospective chart review of all patients who received a Watchman® device at all three Mayo Clinic sites (MN, FL, AZ) between January 2010 and December 2018 with follow up for outcomes at 45 days or 6 weeks following procedure. We conducted bivariate analysis using t-tests and chi-square tests as appropriate. A logistic regression model was constructed to evaluate the effect of anticoagulant choice on bleeding and thromboembolic outcomes. Clinically significant bleeding was defined as bleeding leading to interruption of anticoagulation regimen or requiring transfusion. Results: 232 patients were identified (33% female), mean age in years, CHADS2VASC score and HASBLED scores were 77, 5 and 4 respectively. Overall, 39% were initiated on non-warfarin therapies and 11% had a significant bleeding episode during follow up. There was no difference in clinically significant bleeding events (11% vs. 12%; OR 0.92, 95% CI: 0.32 – 2.65) with short term DOAC use compared to warfarin. Patients who received a Watchman® due to GI bleeding were more likely to have a bleeding event in the first 6 weeks following Watchman® (OR: 4.08, 95% CI: 1.30 – 12.75). Conclusion: This observational study demonstrates no significant difference in bleeding episodes with DOACs compared to warfarin during the first 6 weeks following Watchman® device placement in patients at high risk for bleeding. Larger prospective studies are needed.