Incidence Of Gastrointestinal Bleeding Research Articles

Effectiveness and Safety of New and Traditional Oral Anticoagulants in a Population-Based Cohort of New Users with Atrial Fibrillation

To compare the effectiveness and safety of oral anticoagulants (OACs) -NOAC and VKA- in patients with atrial fibrillation (AF) in real-world clinical practice. Retrospective population-based cohort study. All new users of OAC from Nov2011 to Feb2014 with AF were included (N=21841). Data were obtained by linking diverse electronic databases of the Valencia Region, Spain. Incidence rates were estimated. Cox proportional hazards models adjusted for sociodemographic, clinical, healthcare use data, and propensity scores assessed the risk of several outcomes on effectiveness and safety of each NOAC compared with acenocumarol. Apixaban and warfarin patients were excluded because of few person-time observations The incidence of ischemic stroke was 12.5, 8.7 and 10.8 per 1000 person-years for acenocumarol, dabigatran and rivaroxaban. After adjustment no differences were found for NOAC in the risk of ischemic stroke compared to acenocumarol (HR:0.78, 95%CI:0.51-1.20 for dabigatran; HR:0.76, 95%CI:0.42-1.35 for rivaroxaban). Regarding the incidence of mortality (80.2, 65.1 and 91.7, respectively) no increased risk was found (HR:0.96, 95%CI:0.81-1.12 for dabigatran; HR: 1.16, 95%CI:0.95-1.42 for rivaroxaban). The incidence of gastrointestinal bleeding was 18.3, 21.4 and 14.4, respectively, being dabigatran associated with a higher risk (HR:1.44, 95%CI:1.08-1.92) but not rivaroxaban (HR: 0.72, 95%CI: 0.43-1.19). However, no differences were found for major gastrointestinal bleeding (HR: 1.01, 95%CI: 0.59-1.73 for dabigatran; HR:0.43, 95%CI:0.16-1.17 for rivaroxaban). Regarding the incidence of intracranial haemorrhage (8.8, 3.0 and 5.4, respectively), dabigatran was found to be associated with a decreased risk (HR:0.36, 95%CI:0.18-0.74), and no differences for rivaroxaban (HR: 0.56, 95%CI 0.25-1.27). NOAC were not associated with an increased risk of stroke or death compared with acenocumarol among newly treated patients with AF. Dabigatran was associated with lower risk of intracranial haemorrhage and higher risk of gastrointestinal bleeding. The risk of major gastrointestinal bleeding related to NOAC was similar to that for acenocumarol.

(577) - Incidence of Gastrointestinal Bleeds in Patients With Continuous-Flow Left Ventricular Assist Devices Prescribed Serotonergic Agents

Acquired von Willebrand disease, development of arteriovenous malformations, and requiring lifelong anticoagulation to prevent pump thrombosis are risk factors for gastrointestinal (GI) bleeding in patients with continuous-flow left ventricular assist devices (CF LVADs). In addition, depression is common in the heart failure population, and select serotonergic agents (SAs) are a first-line treatment. SAs have been associated with an increased incidence of GI bleeds. We hypothesized that SA use is associated with an increased risk of GI bleeds in patients implanted with CF LVADs.

Bleeding incidence and real-life prescribing practices with dabigatran use in an acute care setting.

Since dabigatran's emergence in the United States market for use in preventing stroke and systemic embolism in nonvalvular atrial fibrillation, the Food and Drug Administration has issued two safety alerts for serious bleeding events. The postmarketing findings, along with anecdotal clinician concerns, prompted this drug utilization evaluation for dabigatran. We included all adult patients administered dabigatran from January 1, 2011, to December 31, 2011, while admitted to a large university-affiliated medical center. Dabigatran is available on formulary with a dosing and monitoring policy developed by a multidisciplinary subcommittee of the formulary and therapeutics committee. This is an institutional review board-approved retrospective chart review of 172 patients administered dabigatran during hospitalization. Incidence of gastrointestinal bleeds and minor bleeds with the use of dabigatran. The incidence of gastrointestinal bleeds in our study was 2.3% and minor bleeds was 2.3%. Doses outside of the manufacturer's recommendations were not associated with overt bleeds while in the hospital. Our results demonstrate that the incidence of bleeds experienced with dabigatran was relatively low despite the reports received by FDA.

PO-0138 Stress Induced Gastrointestinal Bleeding In A Paediatric Intensive Care Unit : Which Risk Factors Should Necessitate Prophilaxis ?

<h3>Objective</h3> To determine the frequency and the risk factors of stress induced gastrointestinal bleeding (GIB) in critically ill children and to investigate the effect of prophilaxis. <h3>Setting</h3> 14-beded, tertiary care PICU <h3>Methods</h3> Records of 182 children admitted consecutively from December 2012 to May 2013 were retrospectively reviewed. 136 patients were eligible. The age ranged from 40 days to 18 years. Diagnosis, demographic data, risk factors, administration of prophilaxis, drugs used in medication, prescence and degree of GIB and complications were recorded. <h3>Results</h3> The male-female ratio was 1.3. Mean age was 5.9. Mean PRISM III score was 12.2 and 49.3% had PRISM score ≥ 10. Most frequent diagnosis was infectious diseases. Sixtyone (44.9%) children received prophylaxis in which antacids was used in 28(45.9%), sucralfate in 18(29.5%), proton pomp inhibitors (PPIs) in 51(83.6%) and 5 (8.2%) received H2 reseptor antagonist. The incidence of GIB was 15.4% (n = 21), in which 66.7% (n = 14) were mild, 23.8% (n = 5) were moderate, 4.8% (n = 1) was significant and 4.8% (n = 1) was massive. In children who received prophylaxis 17 (27.9%) cases developed GIB. Mechanical ventilation were found to be the only risk factor significantly associated with stress induced GIB. Also; mechanical ventilation and trauma was strongly significant (p &lt; 0.001) and coagulopathy/ thrombocytopenia, PRISM III ≥ 10, renal and hepatic failure, hypotension, and heart failure/ arrhythmia was found to be associated with the development of GIB in critically ill children (p &lt; 0.05). <h3>Conclusions</h3> GIB is a serious concern for PICU clinicians and intensivists are confused about the conflicting evidence supporting prophilaxis. We believe that prophylaxis could be beneficial for mechanically ventilated children. Also trauma, coagulopathy/thrombocytopenia, PRISM III ≥ 10, renal and hepatic failure, hypotension, and heart failure/arrhythmia must be kept in mind as risk factors requiring attention in PICU setting.

Gastrointestinal bleed after left ventricular assist device implantation: incidence, management, and prevention.

Continuous-flow left ventricular assist devices (CF-LVADs) have become the standard of care for patients with end-stage heart failure (HF). While these devices have improved durability compared to earlier generation left ventricular assist devices (LVADs), increased frequency in some complications has been seen, including gastrointestinal bleeding (GIB), pump thrombosis and hemolysis. We discuss the incidence, management and prevention of GIB after CF-LVAD implantation. We reviewed the current literature available on the incidence, management and prevention of GIB after CF-LVAD implantation with a focus on our experience at the University of Minnesota, with data on nearly 300 patients who received a CF-LVAD from 2005 to 2013. The incidence of GIB after CF-LVAD varies between 18-40% in numerous studies. At the University of Minnesota, out of 233 patients who underwent HeartMate II (HMII) implantation between 2005-2013, 60 GIB episodes occurred in 51 patients (22%), with an event rate of 0.17 gastrointestinal bleeds/patient-year of support. The etiology of GIB appears to be multifactorial. The main factors which have been identified include the need for chronic anticoagulation, acquired von Willebrand syndrome, platelet dysfunction and increased incidence of arteriovenous malformations due to chronic low pulse pressure. When managing an LVAD patient with GIB, a multi-disciplinary approach is needed. The main goals of treatment are evaluating the location and severity of the bleed, holding anti-coagulants and resuscitation to maintain stable hemodynamics. GIB is a complication with considerable morbidity. Future efforts to further understand the etiology of GIB and optimize anti-coagulation are needed to improve outcomes following CF-LVAD implantation.

Gastrointestinal bleeding in patients on long-term dialysis.

The epidemiology of gastrointestinal bleeding (GIB) in end-stage renal disease (ESRD) has not been adequately characterized. Using United States Renal Data System data we investigated the epidemiology of GIB in hospitalized patients receiving long-term dialysis. Medicare ESRD patients who began dialysis between 1996 and 2005 were followed from 90 days after starting dialysis to death, transplant, loss of Medicare, or December 31, 2006. GIB events were identified using claims data. Predictors of GIB incidence were analyzed using over-dispersed Poisson regression and Cox regression was used to evaluate the effect on survival. Repeat episodes were modeled using a partially conditional Cox regression model. 406,836 patients were followed for 832,131 person-years, during which 133,967 events were identified. The incidence of GIB was stable through year 2000 but steadily increased thereafter. Chronic gastric ulcer and colonic diverticulosis were the commonest defined causes of upper and lower GIB respectively. Age >49 years, female gender, hypertension as the cause of ESRD, and initiation on hemodialysis was associated with a greater risk of GIB. An episode of GIB conferred a increased hazard of death (hazard ratio 1.9, 95% CI 1.86-1.93). A previous episode of GIB was associated with greater hazard of another episode (hazard ratio 3.93, 95% CI 3.82-4.05). In ESRD patients incident to long-term dialysis the incidence of hospital-associated GIB is increasing, is associated with a greater hazard of death, and carries a great hazard of repeat episodes.

Poor Efficacy of Haemodiafiltration to Treat Dabigatran-Associated Coagulopathy

Dabigatran is a novel oral direct thrombin inhibitor, licensed for stroke prevention in atrial fibrillation and the primary prevention of venous thromboembolism in patients who have undergone hip or knee replacement. It has been shown to cause a lower rate of major life-threatening haemorrhage compared to warfarin, although the incidence of gastrointestinal bleeding is higher. When bleeds do occur, however, there is no immediate reversal agent available. In several case reports, haemodialysis has been successfully used to treat life-threatening bleeding associated with dabigatran. We present a case of a patient receiving dabigatran who suffered a severe gastrointestinal bleed where haemodiafiltration did not provide rapid normalisation of clotting parameters as previously reported.

Post-approval study of a highly pulsed, low-shear-rate, continuous-flow, left ventricular assist device, EVAHEART: A Japanese multicenter study using J-MACS

The EVAHEART left ventricular assist device was approved in 2010 by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for bridge to heart transplantation (BTT). However, its effectiveness has not been evaluated since approval. In this study we evaluated the EVAHEART device in a commercial setting in Japan. Ninety-six consecutive patients enrolled in the Japanese Registry for Mechanically Assisted Circulatory Support (J-MACS), who were listed for transplant or likely to be listed and who received an EVAHEART device, were enrolled from 2011 to 2013 at 14 Japanese centers. Patients' survival rates, adverse events and quality-of-life data were obtained from the J-MACS Registry. Patients' median age was 43 years (85% male). The Interagency Registry for Mechanically Assisted Circulatory Support profiles revealed 12 patients in Level 1, 45 in Level 2, 37 in Level 3 and 1 in Level 4. The mean support duration was 384.7 days, with a cumulative duration of 101.2 years. The Kaplan-Meier survival rate during support was 93.4% at 6 months, 87.4% at 1 year and 87.4% at 2 years. Seventy-seven patients (80.2%) currently remain on support, 7 received a transplant and 10 died during support. Major adverse events included drive-line infection (14.6%) and neurologic events such as ischemic stroke (17.7%), hemorrhage (13.5%), transient ischemic attack (3.1%), pump thrombosis (1%) and hemolysis (1%). There was no gastrointestinal (GI) bleeding or right heart failure requiring right ventricular assist device (RVAD). There was no pump exchange due to mechanical failure. The EVAHEART device provides safe, reliable and long-term circulatory support with improved survival in commercial settings of BTT in Japan, where the transplant waiting period is much longer. Incidences of GI bleeding, hemolysis, right ventricular failure, device thrombosis and mechanical failure were extremely rare in patients on EVAHEART devices.

Incidence of Gastrointestinal Bleeding After Percutaneous Coronary Intervention: A Single Center Experience.

BackgroundGastrointestinal (GI) bleeding is a hemorrhagic complication after percutaneous coronary intervention in patients with acute myocardial infarction. The purpose of the study is to determine predictors of GI bleeding and impact of GI bleeding on the patients undergoing percutaneous coronary intervention.MethodsGI bleeding occurred in 6 (7.1%) of 84 patients with STEMI/NSETMI (ST-segment elevated myocardial infarction/Non ST-segment elevated myocardial infarction) undergoing primary percutaneous coronary intervention.ResultsUnivariate analysis demonstrates that patients with GI bleeding had a significantly higher previous GI bleeding (16.66% vs. 8.6%, P < 0.001). Higher Killip classification at presentation was associated with higher incidence of GI bleeding (61% vs. 18%, P < 0.01). The use of proton pump inhibitors did not reduce the risk of GI bleeding. The GI bleeding in these patients was associated with higher mortality and morbidity in the post percutaneous coronary intervention period.ConclusionAlthough, GI bleeding in patients with MI significantly increases mortality and morbidity, previous GI bleeding and higher Killip class are associated with higher incidence of GI bleeding. High-risk patients for GI bleeding can be identified at presentation.

Upper gastrointestinal complications induced by anti-platelet agents.

Low-dose aspirin and thienopyridine are associated with gastrointestinal (GI) complications such as petechiae, erosion, ulcer, bleeding, and perforation. The incidence of GI bleeding in aspirin study groups was 0.82% in the hypertension optimal treatment (HOT) study and 0.76% in the primary prevention project (PPP) study. On the other hand, the incidence of GI bleeding by endoscopic evaluation was higher than in an observational study. In a study of 187 patients receiving low-dose aspirin for prevention of cardiovascular disease, the prevalence of endoscopically detected GI ulcers was 11% (95% CI 6.3-15.1%). Several risk factors for GI bleeding (history of peptic ulcer or GI bleeding, high aspirin dose, concomitant use of non-steroidal anti-inflammatory drugs and anti-platelet agents, advanced age and Helicobacter pylori infection) were reported for patients receiving aspirin. Prevention strategies for GI complications induced by anti-platelet agents are treatment with proton pump inhibitors, histamine-2 receptor antagonists, prostaglandin analogs, prostaglandin inducers and H. pylori eradication therapy. Further investigation is necessary to identify the strategies which are suitable for Japan.

Incidence and Risk Factors for Gastrointestinal Hemorrhage After Lumbar Fusion

Retrospective database analysis. To determine rates of gastrointestinal (GI) hemorrhage after lumbar fusions, a population-based database was analyzed to identify incidence, mortality, and risk factors associated with anterior (ALF), posterior (PLF), and simultaneous anterior/posterior (APLF) lumbar fusions. GI hemorrhage after lumbar surgery is a rare complication that can have devastating consequences. Incidences of GI bleeding after lumbar fusion are not well characterized in the current literature. Data from the Nationwide Inpatient Sample were obtained from 2002 to 2009. Patients undergoing ALF, PLF, and APLF for degenerative pathologies were identified and the incidence of GI hemorrhage was evaluated. Patient demographics, Charlson Comorbidity Index, length of stay, costs, and mortality were assessed. SPSS version 20 (IBM; Armonk, NY) was used to detect statistical differences between groups and perform logistic regression analyses to identify independent predictors of GI bleeding. A P value of <0.001 denoted significance. A total of 220,522 lumbar fusions were identified in the United States from 2002 to 2009. Of these, 19,762 were ALFs, 182,801 were PLFs, and 17,959 were APLFs. GI bleeding was noted in ALFs, with 1.1 events per 1000 cases, PLFs with 1.4 events, and APLFs with 1.7 events. Patients with GI bleeding demonstrated greater Charlson Comorbidity Index scores, length of stay, costs, and mortality (P < 0.001). Logistic regression analysis demonstrated independent predictors of GI hemorrhage including advanced age (>65 yr), male sex, blood loss anemia, fluid/electrolyte disorders, metastatic neoplasm, and weight loss (P < 0.001). The results of our study demonstrate very low complication rates of GI hemorrhage across ALFs, PLFs, and APLF cohorts. Across all surgical procedures, the presence of GI bleeding complications was associated with greater comorbidity, length of stay, cost, and mortality. We strongly advise physicians to perform stringent perioperative assessments of risk factors and to provide prompt medical attention to minimize the impact of GI bleeding complications. 3.

Phenotypic Variation and Long‐Term Outcome in Children With Congenital Hepatic Fibrosis

Congenital hepatic fibrosis (CHF) and Caroli syndrome are frequently associated with renal cystic diseases. They have a variable clinical course, and the natural history is not well defined despite molecular advances. Our study describes the clinical manifestations and long-term outcome in children with this disorder. A retrospective case review of children with CHF at a single centre diagnosed on the basis of clinical features, radiological and endoscopic evidence of portal hypertension (PHT), and compatible histopathological findings. Children were categorised based on hepatic phenotype-group 1 (Caroli syndrome) and group 2 (CHF). Hepatobiliary as well as renal manifestations were recorded at presentation, and their evolution followed up until transplant or last follow-up. There were 40 children (22 boys) with a median age of 1.3 years at clinical presentation. Fourteen of 40 (35%) children presented in the neonatal period with primarily renal disease, of whom 11 (78%) had Caroli syndrome (P = 0.02). Significant PHT with oesophageal varices was seen in 86%, with no difference in the incidence of gastrointestinal bleeding and varices between Caroli syndrome and CHF. Cholangitis developed in 10 of 40 (25%) and was more common in the Caroli syndrome group (P = 0.009). A higher proportion of children with Caroli syndrome developed chronic kidney disease (CKD) stage 3 and above as compared with CHF (85% vs 42%; P = 0.007). Twelve of 21 (57%) and 8 of 19 (42%) children in the Caroli syndrome and CHF groups required either combined liver-kidney or isolated liver transplant, with the most common indication for renal transplantation being end-stage renal disease (CKD5d) with or without advanced PHT or cholangitis. All 14 (100%) children with neonatal presentation developed CKD5d and required combined liver-kidney transplant before 14 years of age, whereas 77% of children presenting beyond the neonatal period survived without liver-kidney transplant (P < 0.001). Neonatal presentation was the best predictor of the need for transplant. Caroli syndrome is more likely to present in the neonatal period and these patients are more likely to develop CKD5d. CKD stage 3 or above with recurrent cholangitis is more common in Caroli syndrome presenting beyond the neonatal period and adds to the significant morbidity in these patients. Children presenting in the neonatal period have a more severe phenotype and should be considered early for combined liver-kidney transplant.

Proton-pump inhibitors can decrease gastrointestinal bleeding after percutaneous coronary intervention

Current medical therapies for patients who have an acute coronary syndrome (ACS) focus on the coagulation cascade and platelet inhibition. These, coupled with early use of cardiac catheterization and revascularization, have decreased morbidity and mortality rates in patients who have acute ischemic heart disease with risk of bleeding. The study aimed to determine the incidence of gastrointestinal bleeding after percutaneous coronary intervention (PCI). The effect of proton-pump inhibitor (PPI) treatment was also analyzed. This case-control study evaluated gastrointestinal bleeding within a year of PCI for stable angina and acute coronary syndromes at Nanjing First Hospital between 2008 and 2011. Cases were identified and outcomes assessed using linkage analysis of data from cardiology and gastroenterology department databases. Analysis of the case and control groups for both risk and protective factors was performed using independent two-sample Student's t-test with Fisher's exact P value and logistic regression. The incidence of gastrointestinal bleeding following PCI was 1.3% (35/2680 patients). The risk factors for gastrointestinal bleeding were advanced age, female gender, smoking, drinking, previous peptic ulcer and previous gastrointestinal bleeding. PPI use after PCI (P=0.000) was accompanied by a lower risk of gastrointestinal bleeding, with only a few cases of gastrointestinal bleeding events reported. The incidence of gastrointestinal bleeding associated with the combination of aspirin and clopidogrel therapy was estimated to be 1.3%. Advanced age, being female, smokers, drinkers, previous peptic ulcer and previous gastrointestinal bleeding were significant independent risk factors. PPI for the prevention and treatment of gastrointestinal bleeding induced by the combination of aspirin and clopidogrel in patients after PCI was safe and effective.

Gastrointestinal Bleeding Was Rare with Centrifugal Type Continuous Flow Left Ventricular Assist Device EVAHEART

Purpose Gastrointestinal (GI) bleeding is crucial issue in long-term management of continuous-flow (CF) left ventricular assist device (LVAD) patients, and it has been reported that lack of high-molecular-weight (HMW) von Willebrand factor (vWF) multimers is supposed to be one of the causes of GI bleeding. Aim of this study was to investigate a relationship between the prevalence of GI bleeding in our centrifugal type CF-LVAD and the effects on vWF. Methods and Materials An implantable centrifugal blood pump (EVAHEART, SunMedical Technology Research Co., Japan) has a very flat HQ curve to generate pulsed high systemic flow circulatory support. We performed EVAHEART implantation for 11 patients with advanced heart failure (INTERMACS profile I-III, eligible for heart transplantation, mean age 37). Coumadin sodium (PT-INR 2.5-3.0) and Aspirin (100-300mg) were given for anticoagulation therapy. Laboratory data of blood coagulation system, vWF antigen, and vWF ristocetin cofactor (Rco) activity were measured pre and post-operatively, while vWF multimer status was also analyzed. Results All patients survived, while 2 of them underwent heart transplantation. There was no active GI bleeding in all patients. The measurement of laboratory data were shown in Figure 1 .The patients had no signs of hemolytic anemia after implantation. The vWF multimers were well maintained in all patients. The values of vWF antigen and vWF Rco activity decreased gradually, but were kept within normal ranges (figure1 graph). Conclusions Centrifugal type CF-LVAD EVAHEART provided low incidence of GI bleeding with slight influences on the vWF.

Stress ulcer prophylaxis in the intensive care unit: is it indicated? A topical systematic review

Stress ulcer prophylaxis (SUP) is regarded as standard of care in the intensive care unit (ICU). However, recent randomized, clinical trials (RCTs) and meta-analyses have questioned the rationale and level of evidence for this recommendation. The aim of the present systematic review was to evaluate if SUP in the critically ill patients is indicated. MEDLINE including MeSH, EMBASE, and the Cochrane Library. patients in the ICU. pharmacological and non-pharmacological SUP. Risk of bias was assessed according to Grading of Recommendations Assessment, Development, and Evaluation, and risk of random errors in cumulative meta-analyses was assessed with trial sequential analysis. A total of 57 studies were included in the review. The literature on SUP in the ICU includes limited trial data and methodological weak studies. The reported incidence of gastrointestinal (GI) bleeding varies considerably. Data on the incidence and severity of GI bleeding in general ICUs in the developed world as of today are lacking. The best intervention for SUP is yet to be settled by balancing efficacy and harm. In essence, it is unresolved if intensive care patients benefit overall from SUP. The following clinically research questions are unanswered: (1) What is the incidence of GI bleeding, and which interventions are used for SUP in general ICUs today?; (2) Which criteria are used to prescribe SUP?; (3) What is the best SUP intervention?; (4) Do intensive care patients benefit from SUP with proton pump inhibitors as compared with other SUP interventions? Systematic reviews of possible interventions and well-powered observational studies and RCTs are needed.

Invited Commentary

Historically, mechanical assist devices were used as an emergency bridge to support patients until a suitable donor organ could be found [1Delgado D.H. Rao V. Ross H.J. Verma S. Smedira N. Mechanical circulatory assistance: state of art.Circulation. 2002; 106: 2046-2050Crossref PubMed Scopus (40) Google Scholar]. As such, a decade ago most devices were implanted for less than a year and were not designed to provide prolonged support. The presence of a valvular pathologic condition at the time of ventricular assist device (VAD) implantation dictated surgical strategy, and significant aortic insufficiency required intervention [2Rao V. Slater J.P. Edwards N.M. Naka Y. Oz M.C. Surgical management of valvular disease in patients requiring left ventricular assist device support.Ann Thorac Surg. 2001; 71: 1448-1453Abstract Full Text Full Text PDF PubMed Scopus (141) Google Scholar]. However, with increasing clinical experience and improved device technology, the concept of “destination” therapy became a reality, and prolonged support (>1 year) is now common. In many centers, including our own, the average support time, even in a bridge to transplantation population, exceeds 1 year. Often, clinical success breeds novel problems, and “acquired aortic insufficiency” (AI) has now become accepted among heart failure specialists. This report [2Rao V. Slater J.P. Edwards N.M. Naka Y. Oz M.C. Surgical management of valvular disease in patients requiring left ventricular assist device support.Ann Thorac Surg. 2001; 71: 1448-1453Abstract Full Text Full Text PDF PubMed Scopus (141) Google Scholar] from Advocate Christ Medical Center, a leading enroller in the Destination Therapy (DT) trial, describes their experience with almost 80 patients supported by a HeartMate 2 device. During their period of follow-up, over half of their patients experienced significant AI (defined as mild or greater). Of interest, advanced age and a closed aortic valve were found to be independent predictors of AI progression. Strikingly, the mean time to AI development was just over 6 months in this cohort of predominantly DT patients (69 of 79). Surprisingly, despite the finding that a closed aortic valve was associated with AI, there were no significant differences in pump speeds between the patients who experienced AI and those with a competent valve. Thus, the clinician remains somewhat confused over formulating a strategy to militate against AI. We have found that maintaining low pump speeds (8600 rpm vs the mean of 9200 rpm in this series) allows the aortic valve to open intermittently. We intentionally “ramp down” pump speeds at early follow-up (1 to 3 months) to achieve aortic valve opening every three cardiac cycles. Although we initially used this strategy to preserve the aortic valve, we have, surprisingly, found a dramatic decrease in the incidence of gastrointestinal bleeding (data published in abstract form). We have insufficient follow-up time to determine whether this strategy will lead to long-term aortic valve competence. Other clinicians have advocated for either formal aortic valve closure or a repair suture to maintain long-term aortic valve competence [3Aggarwal A. Raghuvir R. Eryazici P. et al.The development of aortic insufficiency in continuous-flow left ventricular assist device-supported patients.Ann Thorac Surg. 2013; 95: 493-499Abstract Full Text Full Text PDF PubMed Scopus (94) Google Scholar, 4Park S.J. Liao K.K. Segurola R. Madhu K.P. Miller L.W. Management of aortic insufficiency in patients with left ventricular assist devices: a simple coaptation stitch method (Park's stitch).J Thorac Cardiovasc Surg. 2004; 127: 264-266Abstract Full Text Full Text PDF PubMed Scopus (124) Google Scholar]. However, the impact of a permanently fused aortic valve on long-term clinical outcomes (especially gastrointestinal bleeding) has not been determined. The importance of the present report is to emphasize that aortic valve competence becomes an issue as early as 6 months after implantation, even in patients who had no aortic insufficiency at the time of VAD implantation. The long-term sequelae of either permanently fusing the aortic valve or lowering VAD support to facilitate intermittent aortic valve opening remains unknown and again will require vigilant clinical follow-up. The Development of Aortic Insufficiency in Continuous-Flow Left Ventricular Assist Device–Supported PatientsThe Annals of Thoracic SurgeryVol. 95Issue 2PreviewSignificant aortic insufficiency (AI) after left ventricular assist device (LVAD) placement affects device performance and end-organ perfusion. This study examined the development and progression of AI after implantation of continuous-flow LVAD. Full-Text PDF

Incidence and risk factors of gastrointestinal bleeding in patients on low-dose aspirin therapy after percutaneous coronary intervention in Japan

Background.Low-dose aspirin (LDA) is the most commonly prescribed antiplatelet agent for prevention of cardiovascular events following percutaneous coronary intervention (PCI). Long-term treatment with LDA has serious adverse effects, including gastrointestinal (GI) hemorrhage. Most studies have focused only on upper GI bleeding and few studies have evaluated the effect of LDA on total GI bleeding. Aims.The aims of this study were to investigate the incidence and risk factors of total GI bleeding within 30 days after PCI in Japanese patients taking LDA. Methods.A retrospective chart review was conducted for 364 patients undergoing LDA therapy following PCI at Osaka City University Hospital. A retrospective case-control study evaluated risk factors using the chi-squared test and logistic regression. Results. The incidence of total GI bleeding after PCI within 30 days was 4.3%. The source of the GI bleeding was located throughout the GI tract. Risk factors identified by univariate analysis were age ≥75 years, history of peptic ulcer disease, chronic renal failure, proton pump inhibitor use, and histamine H2 receptor antagonist use. By multivariate logistic regression only age ≥75 years (odds ratio = 5.26; 95% confidence interval: 1.13–24.51; p = 0.035) was found to be an independent risk factor of GI bleeding. Conclusions.The incidence of GI bleeding in patients undergoing LDA therapy following PCI is high. The bleeding episodes were located in the upper, middle, and lower GI tract. Age of ≥75 years was an independent risk factor for GI bleeding after PCI in patients on LDA therapy.

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Introduction: Dabigatran (Pradaxa®) is an oral direct thrombin inhibitor Food and Drug Administration (FDA) approved to prevent stroke and systemic embolism in nonvalvular atrial fibrillation. The purpose of this study is to examine prescribing patterns of dabigatran in a large teaching hospital and determine if we are meeting FDA approved guidelines for use. We also aim to examine bleeding incidence and the affect on bleeding assays. Hypothesis: We hypothesize that use of dabigatran is appropriate as indicated by the FDA label and incidence of bleeding will be as described in the package insert, around 6%. Methods: This was a medication use evaluation looking at 38 consecutive patients prescribed dabigatran during hospital admission. Parameters monitored included prescribing physician, dose prescribed, indication for use, and renal function. Further we evaluated the incidence of bleeding in these patients, the affect on measured INR and aPTT, and lastly pharmacist intervention on inappropriate use or dosing. The primary outcomes were incidence of appropriate use and dosing, incidence of bleeding, and the affect on INR and aPTT. Results: Demographics of patients in this study were an average age of 78, evenly male and female and 76% Caucasian. Prescribing was equally divided between housestaff, hospitalists, and cardiologist. Only 87% of patients were prescribed dabigatran for the FDA labeled indication of nonvalvular atrial fibrillation. Pharmacists intervened on 80% of patients prescribed dabigatran for the inappropriate indication as well as dose adjusted dabigatran for 24% of the prescribed dosages. The incidence of gastrointestinal (GI) bleeding with dabigatran was 10.5%. 74% of patients had an aPTT above the upper limit of normal and 64% had an INR above the upper limit of normal. Conclusions: Clinicians need to be aware of the appropriate use and renal dosing of dabigatran to prevent patient harm. The incidence of GI bleeding appears to be higher than reported in the package insert. Lastly, dabigatran does affect aPTT and INR, and these may be useful to determine medication adherence but not to determine the level of anticoagulation.

404 Identification of Risk Factors to Decrease the Incidence of Gastrointestinal Bleeding After Cardiac Surgery

404 Identification of Risk Factors to Decrease the Incidence of Gastrointestinal Bleeding After Cardiac Surgery

Gastrointestinal bleeding and blood transfusion in the elderly in Japan.

The incidence of gastrointestinal bleeding (GIB) increases with age and blood transfusion is frequently given for the management of GIB. In this report, we summarized our data of the patients with GIB and discussed the relationship between blood transfusion and age in patients with GIB. The patients were divided into two groups according to age, following elderly (≥75 years old) and younger (<75 years old) group. The causes and clinical outcome (blood transfusions, management) of each group were compared. One-hundred and twenty patients with GIB were hospitalized (59 men, 61 women) with a mean age of 72.0±15.8 years (range 16-96 years old). Thirty-one patients (25.8%) received blood transfusion. The mean pre-transfusion hemoglobin was 6.4±1.2g/dL (elderly 6.3±1.4, younger 6.6±1.0g/dL) and the mean amount of blood transfusion was 2.8±1.6U (elderly 3.2±1.8, younger 2.3±0.9U). The elderly patients using antithrombotic drugs need greater amounts of blood transfusion than younger patients using antithrombotic drugs. The hemoglobin level of the elder patients without antithrombotic drugs was significantly lower than that of younger patients without antithrombotic drugs. Our data suggest that our blood transfusion strategy seems to be in tolerance level with restrictive blood transfusion strategy.