Procedural Bleeding Research Articles

Underweight is associated with inferior short and long-term outcomes after MitraClip implantation: Results from the German TRAnscatheter mitral valve interventions (TRAMI) registry

Underweight and obesity represent classical risk factors for adverse outcome in patients treated for cardiovascular disease. The current analysis examines the impact of underweight, overweight and obesity on intra-hospital, short and long-term outcomes in patients treated by MitraClip therapy. From August 2010 until July 2013, 799 patients (age 75.3 ± 8.6 years, male gender 60.7%, median logistic EuroSCORE 20% [12; 31], functional mitral regurgitation (MR): 69.3%) were prospectively enrolled into the multicenter German Transcatheter Mitral Valve Interventions registry. Patients were stratified according to body mass index (BMI) into 4 groups: BMI <20 kg/m2 (underweight), BMI 20.0 to <25.0 kg/m2 (normal weight, reference group), BMI 25.0 to <30.0 kg/m2 (overweight) and BMI ≥30 kg/m2 (obese). Significant increased rates of procedural failure, transfusion/bleeding, sepsis or multiorgan failure and low cardiac output failure were found for underweight patients only. Kaplan-Meier survival curves demonstrated inferior survival for underweight patients, but comparable outcomes for all other patients (global log rank test, P < .01). Multivariable Cox-regression analysis (adjusted for age, gender, creatinine ≥1.5 mg/dL, diabetes, left ventricular ejection fraction <30% and chronic obstructive pulmonary disease) confirmed underweight (as compared to normal weight) as an independent risk factor of death (hazard ratio [HR]: 1.58, 95% confidence interval (CI): 1.01-2.46, P = .044) and overweight as protective against death (HR: 0.71; 95%-CI: 0.55-0.93; P = .011). Compared to other weight groups, underweight patients undergoing MitraClip implantation are exposed to increased rates of procedural failure, bleeding and low cardiac output as well as increased short- and long-term mortality rates and should therefore be carefully discussed in the heart-team.

Management of chronic liver disease-associated severe thrombocytopenia in Spain: a view from the experts.

chronic liver disease (CLD) patients often present thrombocytopenia (TCP) and when severe, it may prevent them from undergoing necessary invasive procedures due to an increased bleeding risk. The lack of scientific evidence makes it impossible to determine key aspects of the current management and associated healthcare burden of these patients in Spain. to gain insight into the current situation of patients with CLD-associated severe TCP undergoing invasive procedures in Spain, based on the experience of clinical experts. national Delphi study involving 32 medical experts. the estimated prevalence of CLD-associated severe TCP is approximately 5,967, with an annual incidence of 1,148 new patients. Patients undergo a median of 1 (0-3) invasive procedures/year. Platelet transfusions (PTs) are the standard option to raise platelet counts and are associated with significant burden. The achievement of target platelet levels (≥ 50 x 109/l) after a transfusion is not routinely measured. The lack of effectiveness and short life span of transfused platelets can lead to procedure cancellations and bleeding events, which potentially affect patient outcomes. Adverse events occur in 1-25 % of patients, including mild (febrile and allergic reactions) and severe events (e.g., transfusion-related acute lung injury). Between 5-15 % of patients are unfit to receive PTs and approximately 3 % are treated off-label with thrombopoietin receptor agonists. this study provides a snapshot of the current situation in Spain, highlighting that the current management is poorly standardized and suboptimal in some cases. The results suggest the benefit of developing a consensus document to address some of these shortcomings and to advance in the search for alternatives to PTs.

Rectal versus intramuscular diclofenac in prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis: experience of a Greek tertiary referral center.

Background:Independent patient-related and procedure-related factors increase the risk of pancreatitis after endoscopic retrograde cholangiopancreatography (post-ERCP pancreatitis [PEP]). Non-steroidal anti-inflammatory drugs (NSAIDs) have demonstrated efficacy in reducing the incidence of PEP. This study investigated the difference in the incidence of PEP between intramuscular and rectal prophylactic administration of diclofenac before ERCP.Methods:We performed a retrospective analysis of data from 516 patients who underwent ERCP during the period 2014-2017. The route of diclofenac administration (rectal or intramuscular), patient-related and procedure-related risk factors, as well as serum amylase levels 18 h after the endoscopic procedure and immediate bleeding during ERCP were recorded and evaluated.Results:The overall incidence of PEP was 4.5%, without significant differences between the rectal (5.2%) and intramuscular (3.9%) routes of administration. The factor that appeared to be of significance was pre-cut sphincterotomy, since patients who underwent that procedure showed a higher probability of PEP (P=0.05; odds ratio 2.67, 95% confidence interval). Intraprocedural bleeding was almost twice as frequent in the rectal compared to the intramuscular group. Pancreatic stent placement did not appear to be statistically significant in the prevention of PEP, either alone or in combination with diclofenac administration.Conclusions:The results of our study did not reveal any statistically significant difference between the rectal or intramuscular administration of diclofenac in the prevention of PEP, contradicting the results of the majority of studies and meta-analyses published so far. One of the known risk factors associated with increased risk of PEP was also confirmed.

Catheter Directed Thrombolytic Therapy for Pediatric Cerebral Sinus Vein Thrombosis

Background: Cerebral sinus vein thrombosis (CSVT) involves the thrombosis of the dural sinus and/or cerebral veins and it is considered a form of stroke. The estimated incidence of CSVT in children is 0.6 per 100,000 children per year. Poor outcomes, including death, happen in 9 to 29% of patients affected by CSVT. In addition, neurologic deficits, affecting primarily cognition and behavior, are seen in 50% of affected children. No randomized clinical trials have been conducted on pediatric CSVT so current guidelines for treatment have been extrapolated primarily from adult studies. Published guidelines by the American College of Chest Physicians, American Heart Association and American Society of Hematology, support the use of anticoagulation with unfractionated heparin (UFH) or low molecular weight heparin (LMWH). These same guidelines also suggest that catheter directed thrombolysis (CDT) with tissue plasminogen activator (tPA) and mechanical thrombectomy (MT) could be used when there has been clinical deterioration or no improvement (clot progression) despite anticoagulation. In all cases, these are based on uncontrolled case series and expert opinion. There is very little data on the safety and efficacy of CDT and/or MT for pediatric CSVT. Method: Pediatric patients with CSVT seen at Cook Children's Medical Center from January 1, 2008 to December 31, 2018 were identified by searching EMR using ICD-9 and ICD-10 codes. From this group, patients treated with MT and CDT in addition to anticoagulation were selected and reviewed. Results: Five children (4 to 14 y/o) were treated with MT and CDT after failing anticoagulation with UFH or LMWH. Diagnosis was made by MRI/MRV and all had CSVT of multiple sinuses. Four patients had more than one underlying disorders/factors that increased their risk for thrombosis including: Ulcerative Colitis in 2, severe anemia in 2, Systemic Lupus Erythematosus (SLE) in 1, use of oral contraceptives together with obesity and bacterial sepsis in 1. Two patients did have a thrombophilia: Protein S deficiency in 1 and Protein S and C deficiency in another. One patient with SLE had a positive hexagonal phase neutralization test but rest of evaluation was negative. Three patients had systemic bleeding prior initiation of UFH and MT/CDT. All children were treated with UFH, and due to clinical neurologic deterioration and/or worsening of imaging findings (4 comatose and 1 with persistent increased ICP), all underwent thromboaspiration and catheter directed infusion of tPA for 17 to 48 hours at a dose of 1 to 2 mg/hr. All patients continued anticoagulation with UFH during catheter directed tPA infusion and after the catheter was removed. All cases had partial resolution of the sinus vein thrombosis, although 1 had quick reocclusion. Post procedure bleeding happened in 1 patient who had also had an external ventricular drainage placed and developed parenchymal and intraventricular hemorrhage that led to discontinuation of tPA infusion, and 2 patients developed petechial brain hemorrhages. Four patients had great neurologic recovery and minimal deficits, but 1 had significant neurologic deficits. One patient died from lupus complications. (Table) Conclusion: Endovascular therapy including MT and CDT with tPA in conjunction with systemic UFH, may have a role in pediatric patients with CSVT who have deterioration despite initial anticoagulation. In our series, after procedures, all patients had partial resolution of their CSVT (but 1 had quick reocclusion) and 4 out of 5 patients had good neurologic outcomes despite bad predictor signs (coma, extensive CSVT). Further studies are needed to identify which patients would benefit from early endovascular treatment. Table Disclosures No relevant conflicts of interest to declare.

Tranexamic acid to reduce bleeding after dental extraction in patients treated with non-vitamin K oral anticoagulants: design and rationale of the EXTRACT-NOAC trial.

Bleeding after dental extraction in patients treated with non-vitamin K oral anticoagulants (NOAC) may lead to unplanned reinterventions and interruption of anticoagulation, thereby exposing patients to a risk of thromboembolism. We have designed a study (EXTRACT-NOAC) to investigate whether tranexamic acid (TXA) mouthwash decreases bleeding after extraction in such patients. The study is a randomised, double-blind, placebo-controlled trial. We plan to randomise 236 patients listed for dental extraction and treated with NOAC to 10% TXA mouthwash or placebo. Patients are instructed to use the mouthwash before the dental extraction, and three times a day for three days thereafter. The primary outcome is oral bleeding. Secondary outcomes include type of bleeding, procedural bleeding score, number of reinterventions after oral bleeding, and number of interruptions in NOAC treatment. Any bleeding from sources other than the mouth, and thrombotic events, are recorded as safety outcomes. Patients are followed-up for seven days. This study will provide evidence to guide the management of patients taking NOAC who need teeth extracted.

P4730Underweight is associated with unfavourable short- and long-term outcomes after MitraClip therapy: a body mass index derived subgroup analysis of the German Transcatheter Mitral Valve Interventions (

Abstract Background Underweight and obesity represent classical risk factors for patients undergoing cardiac surgery or interventional treatment. The multicentre German Transcatheter Mitral Valve Interventions (TRAMI) registry comprises a large and prospectively enrolled real-world cohort of patients treated by MitraClip implantation. Aims The current analysis examines the impact of underweight, overweight and obesity on intra-hospital, short and long-term outcomes in patients treated by MitraClip therapy. Methods and results From 08/2010 until 07/2013, 799 patients (age 75.3±8.6 years, male gender 60.7%, median logistic EuroSCORE 20% [12; 31], functional mitral regurgitation (MR): 69.3%) were prospectively enrolled into the multicentre, industry-independent German Transcatheter Mitral Valve Interventions registry. Patients were stratified according to body mass index (BMI) into four groups: BMI&lt;20 kg/m2 (underweight, n=49), BMI 20.0 to &lt;25.0 kg/m2 (normal weight, n=293), BMI 25.0 to &lt;30.0 kg/m2 (overweight, n=296) and BMI≥30 kg/m2 (obese, n=132). Procedure and radiation time were comparable among all groups. Significant increased rates of procedural failure (12.2% vs. 2.1 [normal weight], p&lt;0.001), transfusion/bleeding (20.8% vs. normal weight: 5.6%, obesity: 7.0%, p&lt;0.01), sepsis or multiorgan failure and low cardiac output failure were found for underweight patients only. Kaplan-Meier survival curves demonstrated inferior survival for underweight patients, but comparable outcomes for all other patients (global log rank test, p&lt;0.01). Multivariable Cox-regression analysis (adjusted for age, gender, creatinine≥1.5mg/dl, diabetes, left ventricular ejection fraction&lt;30% and chronic obstructive pulmonary disease) confirmed underweight (as compared to normal weight) as an independent risk factor of death (hazard ratio [HR]: 1.58, 95%-confidence interval (CI): 1.01–2.46, p=0.044) and overweight as protective against death (HR: 0.71; 95%-CI: 0.55–0.93; p=0.011). Conclusion Underweight patients are exposed to increased rates of procedural failure, bleeding and low cardiac output as well as increased short- and long-term mortality rates when undergoing MitraClip implantation and should therefore be carefully discussed within the heart team. Acknowledgement/Funding The TRAMI registry has been supported by proprietary means of IHF. Additional funding is provided by “Deutsche Herzstiftung” and a grant from Abbott.

P3123Enoxaparin versus unfractionated heparin in ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention

Abstract Background The use of intravenous enoxaparin (LBWH) in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) was upgraded in the latest European Guidelines to a class IIa recommendation. Purpose The authors aim to compare safety and prognostic impact of LMWH versus unfractionated heparin (UFH) use in STEMI patients undergoing primary PCI. Methods Retrospective study of 3875 STEMI patients who underwent pPCI between October 2010 and September 2017 and were included in a national multicenter registry. Group A consisted of patients managed only with LMWH, and Group B patients were treated with UFH regardless of eventual LMWH associated exposure. The groups were compared according to their demographic, clinical and laboratory characteristics. The primary endpoint (PE) results from a composite which included: procedural failure (pPCI failure or bailout use of GPIIb/IIIa inhibitors), in-hospital mortality, re-infarction or major bleeding (according to the registry criteria). The secondary endpoint (SE) included: in-hospital major bleeding, need for red blood cell transfusion, or haemoglobin drop ≥2g/dL. A 1:1 propensity score (PS) analysis was performed according to demographic variables, medical history and previous medication, physical examination, electrocardiogram characteristics and left ventricular function, matching 1558 of the 3875 patients for later comparison between groups. Results Overall, Group A included 1083 (27.9%) and Group B 2792 (72.1%) patients. The mean age was 63±14 years, and 33.5% of the cohort were female. Despite the baseline characteristics heterogeneity between groups, this phenomenon was not observed after PS matching. The PE was more frequent in Group A, without reaching statistical relevance (15.6% vs 13.3%, p=0.07). The SE was superior in Group A (34.4 vs 29.4%, p=0.01). According to the PS matching analysis, there were no differences beetween groups in terms of the PE (13.9% vs 12.0%, p=0.28), while the SE kept more frequent among Group A (34.9% vs 28.5%, p=0.02) [Figure]. Propensity score: group comparison Conclusion In this study based on a national multicentric registry of STEMI patients, the use of LMWH was not associated with better in-hospital prognosis in terms of major cardiovascular events and was related with higher rates of bleeding related events in the scenario of pPCI, compared to UFH. According to these results, further studies are required to support the widespread use of LMWH in this clinical scenario.

947 Lusutrombopag for Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Who Are Undergoing Planned Invasive Procedures: Pooled Safety Analysis of Bleeding-Related Adverse Events

INTRODUCTION: Thrombocytopenia is a common complication in patients with chronic liver disease. A low platelet count in chronic liver disease patients who require an invasive procedure is a serious condition that may be associated with an increased risk of bleeding during or after the procedure. Lusutrombopag is a thrombopoietin receptor agonist approved in Japan (2015) and the US (2018) for treatment of thrombocytopenia, and in the EU (2019) for severe thrombocytopenia, associated with chronic liver disease in patients undergoing a planned invasive procedure. A pooled safety analysis was performed to assess differences in bleeding events following treatment with lusutrombopag without platelet transfusion or placebo with platelet transfusion. METHODS: Safety data were pooled from 3 double-blind, placebo-controlled studies, in patients with thrombocytopenia associated with chronic liver disease undergoing a planned invasive procedure (Phase 2b: M0626 [Japan; JapicCTI-121944]; Phase 3: L-PLUS 1 [Japan; JapicCTI-132323], L-PLUS 2 [global; NCT02389621]). Patients enrolled in these studies were randomized to lusutrombopag 3 mg or placebo for up to 7 days prior to procedure. Platelet transfusion was administered if platelet count was &lt; 50 × 109/L no more than 2 days prior to procedure. Patients were classified into 1 of 4 subgroups: lusutrombopag alone or +platelet transfusion or placebo alone or +platelet transfusion. This analysis focused on patients in the lusutrombopag alone and placebo + platelet transfusion subgroups. Bleeding events were summarized pre-, during, and post-procedure. RESULTS: Lower bleeding event rates, regardless of severity and timing of onset, were observed for lusutrombopag alone vs placebo + platelet transfusion (Table 1). Percent of patients with bleeding events was numerically higher with placebo + platelet transfusion vs lusutrombopag alone, both during (4.8% vs 3.2%) and post-procedure (7.1% vs 4.0%). Percent of patients with procedural and post-procedural bleeding events in liver-related procedures was greater in the placebo + platelet transfusion (16.1%) vs lusutrombopag alone (11.1%) arm, and a larger difference was seen with gastrointestinal-related procedures in the placebo + platelet transfusion (8.9%) vs lusutrombopag alone (2.0%) arm. CONCLUSION: In this pooled analysis, a trend toward lower bleeding event rates was observed with lusutrombopag alone vs placebo + platelet transfusion, regardless of type of invasive procedure.

886 Underwater Endoscopic Mucosal Resection May Only Be Superior to Conventional Endoscopic Mucosal Resection for the Treatment of Colorectal Polyps 4 CM or Larger

INTRODUCTION: Underwater endoscopic mucosal resection (UEMR) is an alternative to conventional submucosal-lift EMR (CEMR) for removal of large non-pedunculated colorectal polyps. Retrospective studies have suggested that UEMR may be more effective at reducing lesion recurrence than CEMR, when performed by experts in this technique. The aim of this study was to compare the generalized safety and effectiveness of UEMR to CEMR for removal of large colorectal polyps when performed by expert endoscopists at a tertiary referral center. METHODS: Patients who had UEMR or CEMR performed by one of 7 experienced endoscopists (&gt;50 large polyp resections/year) at a single university-based health system between 3/2015 and 7/2018 were included. Each of the 7 endoscopists regularly performed CEMR but adopted UEMR before or during this study. Patients were identified retrospectively using CPT codes and data was collected from our electronic medical record. RESULTS: 186 patients who underwent 142 UEMR and 98 CEMR procedures were included (Table 1). Mean size of polyps removed was 30.7 mm (range: 15-120 mm) for UEMR and 25.3 mm (range: 15- 50 mm) for CEMR (P = 0.001). There were a significantly greater number of tubulovillous adenomas in the UEMR group (22% vs. 37%, P = 0.02). For polyps ≥4 cm, the residual polyp rate on the first follow-up colonoscopy was 26% for UEMR and 60% for CEMR (OR 4.2, P = 0.05), as confirmed by biopsies. However, there was no statistically significant difference between UEMR vs. CEMR for lesion recurrence for polyps &lt; 4 cm in size. For all polyp sizes, there was no difference in rates of complete macroscopic resection, en bloc resection, number of colonoscopies to reach clearance, and need for adjunctive resection techniques (i.e., argon plasma coagulation, hot biopsy avulsion) between the groups (Table 2). There were no instances of perforation. No significant differences in rates of intra-procedural or delayed procedural bleeding were found between groups (Table 3). CONCLUSION: When generalized across multiple endoscopists at a university-based health system, there was no observed benefit of UEMR compared to CEMR for colorectal polyps under 4 cm in size. However, for lesions 4 cm and greater, UEMR was superior in terms of reduced rates of residual lesion at the first follow-up colonoscopy. Prospective trials are required to further delineate the comparative impact of UEMR vs. CEMR with respect to rates of residual neoplasia.

275 A Case Study of Retinal Artery Occlusion Following Mechanical Thrombectomy via Direct Carotid Puncture.

Abstract Background This case study reviews the role of carotid puncture as arterial access in mechanical thrombectomy and an associated rare complication. Methods This case reviews the management of a 74-year-old gentleman who presented with a left MCA ischaemic stroke. On presentation NIHSS was 21 consistent with a left total anterior circulation stroke syndrome (TACS) with a very severe clinical deficit. He underwent IV thrombolysis and attempted mechanical thrombectomy via femoral puncture. However the intracranial middle cerebral artery (MCA) occlusion could not be reached as a near occlusion at the internal carotid artery (ICA) origin could not be passed. A carotid puncture was successfully attempted followed by mechanical thrombectomy with complete recanalization of occluded MCA. Despite carotid puncture occurring in the setting of IV thrombolysis there were no post procedure bleeding complications. On day 2 post-procedure, the NIHSS score was 1 (residual facial droop) representing remarkable neurological recovery. On day 4 post-procedure, acute left eye vision loss developed with subsequent diagnosis of left central retinal artery occlusion (CRAO). The mechanism of this retinal artery occlusion may have been a direct delayed complication of carotid artery puncture propagating clot into the ophthalmic artery, or may have been due to the underlying stroke mechanism such as new embolism from ICA origin or failure of collaterals. Results Persistent residual left eye blurred vision and right facial droop. Conclusion Proximal intracranial occlusion can effectively be treated with mechanical thrombectomy. Carotid puncture is a rarely used but effective alternative method of arterial access (11 out of 498 procedures between August 2016 and August 2018). Retinal artery occlusion is a possible complication from mechanical thrombectomy with carotid puncture.

Day care management of grade I and II bleeding hemorrhoids

Background: Hemorrhoids occur in up to 80% of the population, involving any age and affecting males and females equally1 First and second-degree hemorrhoids can be treated conveniently on an out-patient basis by sclerotherapy and rubber band ligation 2. This study aims at comparing outcomes of these modalities for the treatment of grade I and II bleeding hemorrhoids.Methods: In NKP Salve institute of Medical Sciences and Research Centre hospital based nonrandomized comparative study, patients clinically diagnosed as Grade I and II bleeding hemorrhoids were included. Subjects were divided in into two groups i.e Barron’s banding and Injection of Sclerosant. The post procedural complications for the first 24 hrs were recorded, follow up was taken at regular intervals and any complications were recorded.Results: A total of 50 patients were enrolled with mean age 42.01 years and a male preponderance, with 31 males and 19 females. Barron’s banding was carried out in 25 subjects and the 25 subjects were subjected to Injection of sclerosant the mean duration taken for Injection of sclerosant was 13.6 min and in Barron’s banding 16.4 min. In the first 24hrs post procedural bleeding was observed in 40% subjects in the Barron’s banding group and 52% in the injection of sclerosant group. For post procedural pain the mean VAS score in the Barron’s group was 1.84 and 0.96 in injection of sclerosant group, follow up at 3rd month showed 16% recurrence of bleeding and 32% in injection of sclerosant group.Conclusions: Injection of sclerosant is better than Barron’s banding procedure in terms of post procedural pain.

Clinical and procedural predictors and short-term survival of the patients with no reflow phenomenon after primary percutaneous coronary intervention

ObjectivesIn the present study, we analysed the incidence of no-reflow phenomenon, its clinical and procedural predictors, and associated in-hospital outcomes for the patients undergoing primary percutaneous coronary intervention (PCI). BackgroundNo-reflow phenomenon after primary PCI is a procedural complication associated with adverse post-procedure outcomes. MethodsData for this study were extracted from global registry, NCDR®, the site of National Institute of Cardiovascular Disease (NICVD), Karachi from July 2017 to March 2018. The demographic, clinical, and procedural characteristics, and in-hospital outcomes were analysed for the patients with and without no-reflow after primary PCI. ResultsOf total of 3255 patients, no-reflow phenomenon was found in 132 (4.1%) patients and it was associated with significantly higher in-hospitality mortality (6.8% vs. 2.9%; p = 0.01), cerebrovascular accident (1.5% vs. 0%; p < 0.001), post procedure bleeding (2.3% vs. 0.5%; p = 0.009), and cardiogenic shock (3.8% vs. 1.2%; p = 0.011). The multivariate analysis showed advanced age [odds ratio = 1.63, 95% confidence interval 1.09–2.44, p = 0.018], diabetes [1.66, 1.14–2.42, p = 0.009], prior history of CABG [8.70, 1.45–52.04, p = 0.018], low pre-procedure TIMI flow grade [2.04, 1.3–3.21, p = 0.002], longer length of target lesion [1.51, 1.06–2.16, p = 0.023], and 10 fold raised troponin I [1.55, 1.08–2.23, p = 0.018] were the independent predictors of no-reflow. ConclusionsIn this selected group of patients, the no-reflow phenomenon after primary percutaneous coronary intervention is not that uncommon. It is associated with an increased risk of adverse post-procedure hospital course including mortality. Pathophysiology of the no-reflow phenomenon is complex and opaque, however, it can be predicted based on certain clinical and procedural characteristics.

Tu2015 ENDOSCOPIC CLOSURE UTILIZING ENDOLOOP AND ENDOCLIPS AFTER GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR PATIENTS ON ANTITHROMBOTIC THERAPY

Antithrombotic therapy is a well-known independent risk factor for bleeding after gastric endoscopic submucosal dissection (ESD). A novel method of ulcer base closure using endoloop and endoclips to prevent post procedural bleeding has been reported. (Abe S, et al. Endoscopy 2015). The aims of this study was to evaluate the effectiveness of post-ESD endoloop-endoclip closure in bleeding prevention for patients on antithrombotic therapy.

Valvular Resistance and Bleeding Events Among Patients Undergoing Transcatheter Aortic Valve Replacement

ABSTRACT Background: Aortic valvular resistance (VR) may be a surrogate for shear stress in patients with aortic stenosis. Stenosis-induced shear stress is known to affect platelet function and bleeding tendency. The aim of this study is to assess the association between VR and bleeding events in patients undergoing transcatheter aortic valve replacement (TAVR). Methods: VR was calculated in 708 patients undergoing TAVR between August 2007 and December 2015. All subjects were stratified into a high VR (HVR; ≥238 dynes·cm−5) and a low VR (LVR; <238) group according to the median of VR. The primary endpoint was bleeding within 1 year after TAVR. Results: After adjustment for confounding factors, patients with HVR had a higher risk of bleeding events at 1 year (HRadj 2.09, 95% CI 1.56–2.80) than those with LVR. The difference emerged within the first month after intervention (HRadj 2.20, 95% CI 1.62–2.99) and was driven by procedural (HRadj 1.82, 95% CI 1.33–2.72) and non-procedural (HRadj 1.86, 95% CI 1.15–3.00) bleeding events. The effect was consistent across access sites and valve types. Of note, the unfavorable effect with regard to bleeding attenuated beyond 30 days post-TAVR (HR 1.01, 95% CI 0.32–3.14). In a multivariable analysis, HVR, renal failure at baseline, transapical approach, and moderate or greater post-TAVR aortic regurgitation were identified as independent predictors of bleeding within 1 year after TAVR. Conclusions: HVR at baseline was associated with bleeding events after TAVR; however, bleeding tendency in this setting improved within 30 days after releasing stenosis at the aortic position. Abbreviations: AR, aortic regurgitation; AS, aortic stenosis; AVA, aortic valve area; CI, confidence interval; MACCE, major adverse cardiac and cerebrovascular events; NYHA, New York Heart Association; RHC, right heart catheterization; TAVR, transcatheter aortic valve replacement; VARC, the Valve Academic Research Consortium; VR, valvular resistance

Trends and Predictors of Acute Kidney Injury in Patients with and without Chronic Kidney Disease Undergoing Left Ventricular Assist Device Implantation: A Nationwide Inpatient Sample Analysis

Purpose Acute Kidney Injury (AKI) is known to be associated with poor outcomes in patients undergoing Left ventricular assist device (LVAD) implantation. We sought to determine the trends and predictors of AKI in this patient population. Methods We queried the National Inpatient Sample (NIS) from Jan 2006 to Sept 2015 database for patients undergoing LVAD implantation using ICD-9 codes We excluded all the patients with end-stage renal disease . We divided the study sample into two cohorts 1. AKI with Chronic Kidney Disease (CKD) (A-CKD) 2. AKI without CKD (A-NCKD) and analyzed separately. Baseline characteristics and outcomes were identified using appropriate ICD-9 codes. Temporal trends of AKI were graphed, and regression analysis was done to identify comorbidities and social predictors of AKI in both the cohorts. Results There was significant uptrend in incidence of AKI in A-CKD cohort (from 41.7% in 2006 to 76.4% in 2015; p vasopressors use and infections are associated with increased risk of AKI regardless of baseline CKD (all p peripheral arterial disease , coronary artery disease , cardiogenic shock and post procedural bleeding requiring transfusion were additional risk factors for AKI (all p diabetes , chronic pulmonary disease , pulmonary hypertension, acute in-hospital stroke, ventricular fibrillation and cirrhosis increased risk of AKI (all p Conclusion In last decade, there has been a significant uptrend in AKI in patients with CKD. The rate of AKI in the patients without baseline CKD remained stable.

Abstract No. 605 Avatrombopag decreases need for platelet transfusion in patients with chronic liver disease and thrombocytopenia undergoing medical procedures with low to high associated bleeding risks

Thrombocytopenia (TCP) is common in patients with chronic liver disease (CLD). Because of the associated bleeding risks, patients may require prophylactic platelet transfusions before invasive procedures. Avatrombopag (AVA) is an oral thrombopoietin receptor agonist available as an alternative to platelet transfusions. Two randomized, double-blind, placebo (PBO)-controlled Phase 3 trials (ADAPT-1 and ADAPT-2) enrolled adults with CLD and PC <50x109/L, scheduled to undergo a procedure. Patients were divided into 2 cohorts by baseline PC (Cohort 1- <40x109/L; Cohort 2- 40 to <50x109/L),and were randomized 2:1 to once-daily oral AVA (Cohort 1- 60 mg; Cohort 2- 40 mg) or PBO for 5 days, with the procedure scheduled 5 to 8 days after the last dose. Patients were stratified by procedure bleeding risk (low, moderate, high). The primary efficacy endpoint was the proportion of patients not requiring platelet transfusion or any bleeding rescue procedure up to 7 days post-procedure. Overall, 435 patients were randomized. The primary endpoint was met by 66.9% of AVA-treated vs 28.6% of PBO-treated in Cohort 1 (p< 0.0001), and 88.0% of AVA-treated vs 35.8% of PBO-treated patients in Cohort 2 (p< 0.0001). The proportion of patients across all the pooled treatment groups in each bleeding risk category was: 60.8% in the low, 17.2% in the moderate, and 22.1% in the high bleeding risk categories. The primary efficacy endpoints in the low, moderate, and high risk of bleeding categories all favored AVA and were consistent with the overall study results. A positive AVA treatment effect was noted across the various bleeding risk subgroups in both Cohort 1 (AVA vs PBO: low risk- 78.1% vs 45.8%, moderate risk- 61.9% vs 17.6%, and high risk- 55.9% vs 6.7%, respectively), and Cohort 2 (AVA vs PBO: low risk- 92.4% vs 34.2%, moderate risk- 90.0% vs 50.0%, and high risk- 88.9% vs 35.7%, respectively). Subgroup analyses indicated that neither the type of procedure nor associated bleeding risk impacted the superiority of AVA to PBO in increasing PC and reducing platelet transfusions in patients with TCP and CLD undergoing a medical procedure.

Modified Distal Dunk Technique for Right Ventricle to Pulmonary Artery Shunt in Stage 1 Palliation

Although the use of a right ventricle to pulmonary artery shunt as a source of pulmonary blood flow in stage 1 Norwood palliation is common, there is no uniform agreement on the optimal surgical technique. We present a technique for creating the distal connection aimed at minimizing procedural bleeding, promoting distal patency, and facilitating second-stage palliation.

Thrombotic and Bleeding Outcomes Following Perioperative Interruption of Direct Oral Anticoagulants and Vitamin K Antagonists in Patients with Non-Valvular Atrial Fibrillation - a Comparative Analysis

Background: Atrial fibrillation (AF) is a common disorder that will affect up to 5.6 million patients in the U.S. by 2050. Both direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs), typically warfarin, are used for stroke prevention in AF and such patients frequently undergo invasive procedures requiring anticoagulant interruption. Temporary interruption of anticoagulants can be associated with significant morbidity and mortality in the form of thromboembolic and bleeding complications. DOACs have a short half-life and fast onset of action, thereby facilitating their perioperative management as compared to VKAs. Despite important differences in perioperative management and pharmacokinetics between DOACs and VKAs, there is a paucity of data comparing perioperative outcomes in DOAC and VKA-treated patients.Methods: We undertook a single-center, retrospective chart review that compared consecutive DOAC- or warfarin-treated patients with AF who underwent perioperative anticoagulant interruption for invasive procedures between January 2017 and March 2018. Perioperative warfarin interruption was done as per CHEST guidelines (Douketis et al. Chest 141,2 Suppl). Perioperative bridging with low-molecular-weight heparin was only used for patients with CHADS2 scores of 5-6 or in patients with stroke within the past 6 months. Perioperative interruption of DOACs was done as per Thrombosis Canada guidelines, with anticoagulation held for 3 half-lives prior to low bleeding risk procedures and 5 half-lives for high bleeding risk procedures. Primary outcomes included the 30-day post-operative thromboembolic and major bleeding rates. Secondary outcomes included the 30-day clinically relevant non-major bleeding (CRNMB) andl mortality rates. Major bleeding and CRNMB were defined according to ISTH definitions. Procedural bleeding risk was defined as per Schulman et al (Circulation 2015; 132(3)). Outcome events were independently adjudicated by two investigators. Outcomes from patients on DOACs and VKAs were compared. Demographic data was analyzed on a per-patient basis, p-values were calculated using independent T-Test, Chi-Square/Fisher's Exact Test where appropriate. Outcome data was analyzed on a per-interruption basis. P-values for unadjusted and adjusted comparisons were calculated using generalized estimating equations (GEE) to account for correlation between multiple procedures on the same patients.Results: 325 DOAC patients and 199 warfarin patients underwent 351 and 221 periprocedural interruptions, respectively. Warfarin patients had a significantly higher mean age, CHADS2 score, and proportion with renal dysfunction (Table 1). There was no statistically significant difference in 30-day post-operative rates of thromboembolism, CRNMB, and overall mortality, but warfarin patients had a significantly higher rate of major bleeding (Table 2). This latter result remained statistically significant following multivariate logistic regression correction for age, CHADS2 score and level of renal dysfunction. All bleeding events occurred post-procedure, with major bleeding events occurring from post-operative day 1 to post-operative day 25. None of the warfarin patients with major bleeding received perioperative bridging; the mean international normalized ratio (INR) at the time of major bleeding was 3.3. Most major bleeding events (7/8) in the VKA arm were surgical, with a single non-surgical major-bleed (spontaneous ICH on post-operative day 15 following urological surgery).Conclusions: The perioperative interruption of warfarin was associated with a higher 30-day rate of major bleeding as compared with DOAC interruption. Re-initiation of warfarin should be done judiciously following high bleeding risk procedures, and close INR monitoring may be warranted. [Display omitted] DisclosuresShaw:Portola Pharmaceuticals: Research Funding. Douketis:Janssen: Consultancy; Pfizer: Other: Advisory Board; Boehringer-Ingelheim: Consultancy, Other: Advisory Board, Research Funding; Portola: Other: Advisory Board; The Medicines Company: Other: Advisory Board; Daiichi-Sankyo: Other: Advisory Board; Biotie: Other: Advisory Board; Bayer: Other: Advisory Board; Sanofi: Consultancy, Other: Advisory Board; BMS: Other: Advisory Board; Astra-Zeneca: Other: Advisory Board. Carrier:Bayer: Honoraria; Pfizer: Honoraria; BMS: Honoraria, Research Funding; Leo Pharma: Research Funding.

Access and closure management of large bore femoral arterial access

Femoral and radial artery access continue to be the standard of care for percutaneous coronary interventions. Cardiac catheterization has progressed to encompass a wide range of diagnostic and interventional procedures including coronary, peripheral, endovascular, and structural heart disease interventions. Despite advanced technology to make these procedures safe, bleeding, and vascular complications continue to be a substantial source of morbidity, especially in patients undergoing large-bore access procedures. New variations of percutaneous devices have reduced complications associated with these procedures. However, safe vascular access with effective hemostasis requires special techniques which have not been well described in the literature. Large-bore femoral artery access is feasible, safe, and associated with low complication rates when a protocol is implemented. Wayne State University, Detroit Medical Center Heart Hospital is a tertiary care, high-volume center for endovascular, structural heart and complex high risk indicated procedures with more 150 procedures involving mechanical circulatory support (MCS) devices per year. In this manuscript, we describe our approach to femoral artery large-bore sheath insertion and management. Our protocol includes proper identification of the puncture site, device selection, insertion, assessment of limb perfusion while on prolong MCS support, and hemostasis techniques after sheath removal.

Chronic liver disease, thrombocytopenia and procedural bleeding risk; are novel thrombopoietin mimetics the solution?

Chronic liver disease (CLD) alters normal hemostatic and thrombotic systems via multiple mechanisms including reduced platelet function and number, leading to challenging peri-operative planning. Hepatic thrombopoietin (TPO) synthesis is reduced in CLD, leading to several recent randomized, placebo-controlled trials examining the utility of TPO-mimetics to increase platelet counts prior to surgery. While these trials do suggest that TPO-mimetics are efficacious at increasing platelet counts in patients with CLD and have led to several recent drug approvals in this space by the U.S. Food & Drug Administration, it remains unclear whether these results translate to the relevant clinical endpoint of reduced perioperative bleeding rate and severity. In this article, we review several recently-published, phase 3 trials on the TPO-mimetics eltrombopag, avatrombopag and lusutrombopag, and discuss the clinical significance of their results.