Rates Of Gastrointestinal Bleeding Research Articles

Long-term outcomes of isolated mechanical versus bioprosthetic mitral valve replacement in different age groups of propensity-matched patients.

Prothesis choice in isolated mitral valve replacement for patients aged 75 years or younger remains debated as most studies comparing prothesis type have included large proportions of combined operations and benefits are influenced by concomitant procedures. This study compared long-term outcomes of isolated mechanical versus bioprosthetic mitral valves in different age groups of propensity-matched populations. This is a retrospective, multicentre, propensity-matched observational study. Baseline characteristics, operative details and long-term outcomes (mortality and freedom from surgical/transcatheter reintervention) were collected. Totally, 1536 isolated mitral valve replacements (806 mechanical, 730 bioprosthetic) were performed between 2000 and 2017. Over 90% of eligible patients successfully underwent propensity matching, yielding 226 each of mechanical and bioprosthetic valves in patients aged <65 years and 171 each of bioprosthetic and mechanical valves in patients aged 65-75 years with median follow-up of 13 years (maximum 20 years). In matched patients <65 years, 10-year survival was superior with mechanical valves versus bioprosthetic valves (78.2% vs 69.8%, P = 0.029), as was 10-year freedom from reintervention (96.2% vs 81.3%, P < 0.001). For matched patients between 65 and 75 years, there were no differences between mechanical and bioprosthetic valves in 10-year survival (64.6% vs 60.8%, P = 0.86) or 10-year freedom from reintervention (94.0% vs 97.2%, P = 0.23). Rates of post-operative stroke, gastrointestinal bleeding, renal failure and permanent pacemaker insertion were similar. In patients requiring isolated mitral valve replacement, mechanical valves confer significantly better long-term survival and freedom from reintervention for patients <65 years, while no benefit is observed at age 65-75 years compared to bioprosthetic valves.

Clinical features of inflammatory bowel disease unclassified: a case-control study

BackgroundApproximately 10-15% of inflammatory bowel disease (IBD) patients with overlapping features of ulcerative colitis (UC) and Crohn’s disease (CD) are termed as inflammatory bowel disease unclassified (IBDU). This study aimed to describe the clinical features of IBDU and evaluate the potential associated factors of reclassification.MethodsThe clinical data of 37 IBDU patients were retrospectively analyzed from November 2012 to November 2020. 74 UC and 74 CD patients were randomly selected and age- and sex-matched with the 37 IBDU patients. Clinical characteristics were compared between the three patient groups. Potential factors associated with the IBDU reclassification were evaluated.Results60% of IBDU patients displayed rectal-sparing disease, and 70% of them displayed segmental disease. In comparison to UC and CD, the IBDU group demonstrated higher rates of gastrointestinal bleeding (32.4%), intestinal perforation (13.5%), spontaneous blood on endoscopy (51.4%), and progression (56.8%). The inflammation proceeded relatively slowly, manifesting as chronic alterations like pseudopolyps (78.4%) and haustra blunt or disappearance (56.8%). 60% of IBDU patients exhibited crypt abscess, and 16.7% of them exhibited fissuring ulcers or transmural lymphoid inflammation. The proportions of IBDU patients receiving immunosuppressants, surgery, and infliximab were basically the same as those of CD patients. During the 79 (66, 91) months of follow-up, 24.3% of IBDU patients were reclassified as UC, while 21.6% were reclassified as CD. The presence of intestinal hemorrhaging was associated with CD reclassification, while hypoalbuminemia was associated with UC reclassification.ConclusionsIBDU may evolve into UC or CD during follow-up, and hemorrhage was associated with CD reclassification. Different from the other two groups, IBDU exhibited a more acute onset and a gradual progression. When an IBD patient presents with transmural inflammation or crypt abscess but lacks transmural lymphoid aggregates or fissuring ulcers, the diagnosis of IBDU should be considered.

Helicobacter pylori Infection and Complications of Cirrhosis.

Helicobacter pylori is a significant contributor to conditions such as peptic ulcer disease, gastric cancer, gastric mucosa-associated lymphoid tissue lymphoma, and colorectal cancer. Recent studies have suggested a potential link between H. pylori and cirrhosis. However, the impact of H. pylori on cirrhosis-related mortality, inpatient outcomes, and decompensating events remains unclear. Considering the widespread availability of H. pylori testing and effective treatment options, there is a potential rationale for eradicating H. pylori in cirrhotic patients to mitigate the morbidity and mortality associated with cirrhosis. This study aims to investigate the association between H. pylori and inpatient outcomes and complications related to cirrhosis. The National Inpatient Sample (NIS) database, a part of the Healthcare Cost & Utilization Project, was utilized for this study. Inpatient data from the years 2016 through 2019 were extracted for patients with a primary discharge diagnosis of cirrhosis and a concurrent diagnosis of H. pylori infection. The primary outcomes included inpatient mortality, length of stay, and cost of care. Secondary outcomes involved cirrhosis-related complications during hospitalization, such as gastrointestinal bleeding, hepatic encephalopathy, and hepatorenal syndrome. Over the years 2016 to 2019, 416,410 patients received a primary discharge diagnosis of cirrhosis. Among them, 990 patients (0.2%) had a secondary diagnosis of H. pylori infection. Those with both cirrhosis and H. pylori tended to be younger on average (mean age 54.25 vs. 57.18 years, p=0.01) and more frequently fell within the age range of 18-49 (33.84% vs. 24.71%, P=0.01). H. pylori-infected patients were also more likely to be male (70.71% vs. 63.11%, P<0.028), of Hispanic race (36.4% vs. 18.6%, p< 0.1), and of Black race (20.2% vs. 8.1%, p< 0.1). While H. pylori-exposed patients had lower in-hospital mortality (0.51% vs. 4.44%, p=0.007), their mean length of stay was higher (6.97 days vs. 5.75, p=0.002). The overall cost of care was comparable between the H. pylori-exposed and non-exposed groups (mean USD18,106.18 vs. $16,543.49, P=0.160). H. pylori-exposed patients had a higher overall rate of cirrhosis-related complications (84.85% vs. 67.59%, p< 0.001), gastrointestinal bleeding (48.48% vs. 27.34%, p< 0.001), and hepatorenal syndrome (70.71% vs. 46.99%, p< 0.001), and these differences persisted in multivariable analysis. Initially, rates of hepatic encephalopathy were higher in H. pylori non-exposed patients (21.57% vs. 15.66%, p=0.04), but this discrepancy was corrected after adjusting for potential confounders. While patients in this study were diagnosed with both H. pylori and cirrhosis by discharge, it cannot be definitively concluded that H. pylori was the direct cause of cirrhosis complications. Recognizing this uncertainty, further studies are needed better to understand the associations between cirrhosis and H. pylori complications. Distinguishing the causes of cirrhosis and its relationship with H. pylori may offer deeper insights into whether H. pylori is a causative factor or merely correlated in its effects on patients with cirrhosis.

Efficacy of robot‐assisted minimally invasive stereotactic puncture therapy for supratentorial hypertensive intracerebral hemorrhage

AbstractObjectiveTo evaluate the efficacy of robot‐assisted minimally invasive stereotactic puncture therapy (MISPT) for supratentorial hypertensive intracerebral hemorrhage (HICH).MethodsWe retrospectively analyzed 133 patients with supratentorial HICH treated using robot‐assisted MISPT (RM group; n = 77) or conventional craniotomy (CC group; n = 56). In our primary analysis, we evaluated the hematoma volume at discharge. In our secondary analyses, we evaluated the Glasgow Coma Scale (GCS) score at discharge; the operation time, intraparenchymal drainage catheter removal time, the length of hospital stay, and complications during hospitalization; the early and 6‐month postoperative mortality; and functional scores 6‐month postoperatively.ResultsThere were no statistical differences in the preoperative characteristics between the groups, such as age distribution (52.8 ± 9.6 vs. 55.3 ± 7.8 years), hematoma volume (38.4 ± 10.4 vs. 41.1 ± 11.0 mL), and GCS score (10.7 ± 2.2 vs. 9.8 ± 2.8). Hematoma volume at discharge did not significantly differ between the groups (2.6 ± 2.1 mL vs. 2.4 ± 2.1 mL). The GCS score at discharge was significantly higher in the RM group (13.5 ± 2.1 vs. 11.6 ± 3.1; p &lt; .001). Operation time (40.3 ± 7.0 min vs. 143.1 ± 61.3 min;p &lt; .001), intraparenchymal drainage catheter removal time (1.2 ± 0.4 vs. 2.1 ± 0.7 days; p &lt; .001), and length of hospital stay (9.3 ± 2.7 vs. 11.1 ± 4.8 days; p = .013) were significantly shorter in the RM group. The incidence rates of pneumonia, gastrointestinal bleeding, and intracranial infection were significantly lower in the RM group. Although the incidence of rebleeding was lower in the RM group (1.3% vs. 5.4%), the difference was not significant. Six months after surgery, the Barthel Index, Glasgow Outcome Scale, and Karnofsky performance status scores were significantly higher, whereas the modified Rankin scale score was significantly lower in the RM group (p = .002, p = .007, p = .001, and p = .018, respectively). Two RM group patients (3.1%) and six CC group patients (12.2%) died between hospital discharge and 6 months after surgery (p = .127).ConclusionThe main advantages of robot‐assisted MISPT for supratentorial HICH were shown in minimally invasive, precision, and low incidences of complications. In addition, it may improve the prognosis significantly. Thus, it has great potential to be popularized and clinically applied in the future.

Dispensing pharmacy chains and direct anticoagulants: Potential associations with patient outcomes.

Pharmacy chains can differ with respect to the characteristics of their patient populations as well as their nonprescription products, services, and practices, and thus may serve as a surrogate for potential unmeasured confounding in observational studies of prescription drugs. This study evaluates whether a single-source drug can have different patient outcomes based on the dispensing pharmacy chain. Separate analyses for two anticoagulant drugs, rivaroxaban and apixaban, were conducted using Medicare Fee-for-Service claims evaluating the association between dispensing pharmacy chain and outcomes of acute myocardial infarction, ischemic stroke, intracranial hemorrhage, gastrointestinal (GI) bleeding, all-cause mortality, and major GI bleeding. Inverse probability of treatment weighting (IPTW) was used to balance baseline covariates across pharmacy chain cohorts, and outcome association was assessed with a Cox Proportional Hazards model. We observed no differences in outcomes across pharmacy chains for apixaban recipients. Rivaroxaban recipients from pharmacy chain C, however, had lower rates of GI bleeding (adjusted HR 0.83; 95% CI 0.69-1.00) and ischemic stroke (adjusted HR 0.57; 95% CI 0.38-0.87) as compared to chain A in primary analyses with a 3-day grace period. The results moved closer to the null when 14- and 30-day grace periods were implemented. These results suggest that dispensing pharmacy chains may have the potential to act as a confounder of associations between drug exposure and outcome in some observational studies. Additional studies of potential confounding by pharmacy chain are needed. Further evaluation of potential pharmacy chain effects on safe use would be of value.

Inpatient outcomes of inflammatory bowel disease in hospitalized patients with COVID-19: analysis of a nationally representative sample

Purpose To compare the risks of adverse outcomes, including mortality, gastrointestinal bleeding, and venous thromboembolism, between COVID-19 patients with inflammatory bowel disease (IBD) and those without IBD. Methods We analyzed data from the National Inpatient Sample between January and December 2020. The study included adult patients with Crohn’s disease (CD) and ulcerative colitis (UC) who contracted COVID-19. Inpatient outcomes were compared between the IBD and non-IBD COVID-19 cohorts. Results Out of 1,050,045 COVID-19 hospitalizations, 0.28% had CD (2954 patients) and 0.26% had UC (2794 patients). After adjusting for confounding factors, UC patients had a significantly higher risk of deep vein thrombosis compared to non-IBD patients, with an adjusted odds ratio (aOR) of 2.55 (P < 0.001). However, CD patients did not show a significant association with deep vein thrombosis (aOR 1.29, P = 0.329). There were no significant associations between IBD patients (both UC and CD) and pulmonary embolism, nonvariceal gastrointestinal bleeding, or in-hospital mortality. UC patients had a longer average hospital stay (8.25 days) compared to non-IBD patients (adjusted mean difference 0.89, P = 0.007). Healthcare resource utilization was similar among the three groups. Conclusion Our national study on COVID-19 hospitalizations indicates that patients with IBD have comparable rates of gastrointestinal bleeding, pulmonary embolism, and mortality as those without IBD. However, patients with UC hospitalized with COVID-19 have a higher risk of deep vein thrombosis than COVID-19 patients hospitalized without UC. Further research is needed to better understand the relationship between COVID-19 and IBD.

Outcomes of SADI and OAGB Compared to RYGB from the Metabolic and Bariatric Surgery Quality Improvement Program: The North American Experience.

Rapid adoption of sleeve gastrectomy (SG) in the last decade aptly reflects the desire of patients and surgeons for alternatives to RYGB and DS. While SG provides good outcomes, other options that address specific patient needs are warranted. Recently approved by ASMBS, SADI, and OAGB have garnered increasing interest due to their single anastomosis technique. Using the Metabolic and Bariatric Surgery Quality Improvement Program database, we examined laparoscopic and robotic cases from 2018 to 2021 to understand the percentage of primary bariatric surgery cases that are SADI and OAGB. We used coarsened exact matching to match patients who underwent SADI or OAGB to patients who underwent Roux-en-Y gastric bypass (RYGB). We examined outcomes of matched patients using logistic regression. Of the 667,979 patients that underwent bariatric-metabolic surgery, 1326 (0.2%) underwent SADI, and 2541 (0.4%) underwent OAGB. SADI was not identified in the database until 2020. In 2020, there were 487 SADI procedures compared to 839 in 2021. From 2018 to 2021, OAGBs went from 149 to 940. Compared with RYGB, SADI was associated with higher rates of anastomotic or staple line leak (OR 2.21 (95% CI 1.08-4.53)) and sepsis (OR 3.62 (95% CI 1.62-8.12)). Compared with RYGB, OAGB was associated with lower rates of gastrointestinal bleeding (OR 0.29 (95% CI 0.12-0.71)) and bowel obstruction (OR 0.10 (95% CI 0.02-0.39)). Of note, there were no differences between these procedures and RYGB for 30-day mortality. More SADIs and OAGBs are being performed. However, there were higher complication rates associated with the SADI procedure. Further studies will be needed to better understand the key drivers for these outcomes.

Epidemiologic data on acute gastrointestinal bleeding in Albania: an overview of upper and lower GI bleeding

Abstract Background Acute gastrointestinal bleeding (GIB) is a significant medical condition that poses a considerable burden on healthcare systems worldwide. To effectively manage and improve outcomes for patients, it is essential to have comprehensive epidemiologic data on GIB, including its various aspects such as upper and lower GIB, treatment modalities, and overall mortality rates. Aim The objective of this study is to present the first epidemiological data on acute gastrointestinal bleeding in our country, which includes a comprehensive analysis of upper and lower AGIB, as well as the use of endoscopic and surgical treatments, and an assessment of overall mortality rates for the year 2015. Material and methods A retrospective analysis of medical records and databases was conducted to gather epidemiologic data related to acute GIB cases during the specified period. Patient demographics, clinical characteristics, diagnostic findings, treatment approaches (including endoscopic and surgical interventions), and overall mortality rates were evaluated and analyzed. Results The study included a total of 926 patients with acute gastrointestinal bleeding during 2015. Among them, 70% presented with upper gastrointestinal bleeding (UGIB), while 30% had lower gastrointestinal bleeding (LGIB). The remaining cases involved both upper and lower GIB. Regarding treatment modalities, 80% of patients with UGIB underwent endoscopic interventions, which included various techniques such as endoscopic hemostasis, band ligation, and sclerotherapy. On the other hand, 60% of patients with LGIB required surgical intervention due to the severity or complexity of their bleeding. The overall mortality rate for acute GIB during the study period was calculated to be 8%. Subgroup analysis revealed that patients with UGIB had a mortality rate of 5%, while patients with LGIB had a mortality rate of 10%. Conclusions This study provides important epidemiologic data on acute gastrointestinal bleeding, focusing on upper and lower GIB, endoscopic and surgical treatment approaches, and overall mortality rates during the year 2015 in Albania. It refers to the first data, not published and gathered on this therapeutic field, that can be used as a reference for comparison in the latest publications and reports. Our study results showed that the higher incidence of UGIB compared to LGIB highlights the need for focused attention on upper gastrointestinal pathologies as significant contributors to GIB cases. The utilization of endoscopic interventions as the primary treatment modality for UGIB indicates the effectiveness and importance of timely endoscopic evaluation and intervention in controlling bleeding and improving patient outcomes. Based on the findings of this initial study, our future research endeavors were primarily focused on investigating patients within the upper gastrointestinal bleeding (UGIB) cohort.

Clinical Predictors of Gastrointestinal Bleeding Source before Computed Tomography Angiography.

Acute gastrointestinal bleeding (GIB) is a commonly encountered medical emergency. In cases of negative endoscopic evaluations, computed tomography angiography (CTA) is usually the next diagnostic step. To date, data regarding positive CTA examinations are lacking. We aimed to assess the clinical and laboratory parameters that predict a positive CTA examination, as demonstrated by the extravasation of contrast material into the bowel lumen. We performed a single-center retrospective study, including all patients who were admitted with GIB and who underwent CTA. Analysis was performed to compare patients' characteristics, and logistic regression was used to explore parameters associated with a positive CTA. We included 154 patients. Of them, 25 patients (16.2%) had active GIB on CTA vs. 129 patients (83.8%) who did not. On univariate analysis, several parameters were positively associated with active GIB, including congestive heart failure (OR 2.47, 95% CI 1.04-5.86, p = 0.04), warfarin use (OR 4.76, 95% CI 1.49-15.21, p = 0.008), higher INR (OR 1.33, 1.04-1.69, p = 0.02), and low albumin level (OR 0.37, 95% CI 0.17-0.79, p = 0.01). On multivariate logistic regression analysis, only high INR (OR 1.34, 95% CI 1.02-1.76, p = 0.03) and low albumin (OR 0.3, 95% CI 0.12-0.7, p = 0.005) kept their positive association with active bleeding, while a high ASA score was negatively associated with an active GIB. We could identify high INR and low albumin as strong predictors of active GIB, as demonstrated by positive CTA. On the other hand, comorbid patients classified by a high ASA score did not experience a higher rate of active GIB.

Low screening rates and high prevalence of osteoporosis in cirrhosis: A real-world retrospective analysis.

Patients with cirrhosis are at increased risk for osteoporosis, and those who suffer a fracture are at high risk for mortality. Despite this, osteoporosis is often overlooked and undertreated. This study aimed to evaluate osteoporosis screening, management, and adverse osteoporosis medication events in patients with cirrhosis. We performed a retrospective chart review of adult outpatients with compensated and decompensated cirrhosis seen in single health system over a 6-year period. Patient demographics, liver and bone health comorbidities, DEXA scan results, and medications were abstracted. In total, 5398 patients met criteria. The cohort was predominately white (79.1%) and older (age 59). 44.4% were female. 64.6% had decompensated cirrhosis. Median MELD-Na score was 12.8. 23.5% had a DEXA scan ordered, approximately 50% completed this test. Patients who were older, female, white, with more severe liver disease, and other osteoporosis risk factors were more likely to have a DEXA scan ordered. 48.5% of patients had osteopenia and 30.2% had osteoporosis on DEXA scan. Only 22.6% of patients with osteoporosis received treatment, most commonly oral bisphosphonates. Oral bisphosphonate prescription was not associated with variceal bleeding (8.4% without vs. 4.8% with, p = 0.487). A minority of patients with cirrhosis were screened for osteoporosis. The majority screened had osteopenia or osteoporosis on DEXA scan. Less than a quarter of patients with osteoporosis were started on treatment. Real-world experience of oral bisphosphonate use did not reveal higher rates of gastrointestinal bleeding. There is room for improvement in all aspects of bone health care in cirrhosis.

Bleeding Risk Factors in Thrombocytopenic Patients with Hematologic Malignancies

Introduction Despite prophylactic platelet transfusions, World Health Organization (WHO) grade ≥ 2 bleeding occurs in 50 to 70% of patients with hematologic malignancies and hypoproliferative thrombocytopenia secondary to therapy and/or underlying disease (Gernsheimer et al, Blood 2022). Anemia (hematocrit, HCT ≤ 25%), coagulopathy (activated partial thromboplastin time ≥ 30s, international normalized ratio ≥ 1.2), and platelet count ≤ 5000/µl were independently associated with increased risk of bleeding in the PLADO (platelet dose) trial of 1272 patients with hypoproliferative thrombocytopenia treated between 2004 to 2007 (Uhl et al, Blood 2017). Updated data on bleeding outcomes and risk of bleeding is lacking. Methods We performed a post-hoc analysis of bleeding outcomes and bleeding risk factors in 330 patients with hematologic malignancy and hypoproliferative thrombocytopenia from therapy and/or underlying disease randomized at 3 institutions to receive either tranexamic acid (TXA) or placebo in the double-blinded, multicenter American Trial to Evaluate Tranexamic Acid Therapy in Thrombocytopenia (A-TREAT) (Gernsheimer et al, Blood 2022). Patients received prophylactic platelet transfusions for a platelet count of ≤ 10,000/µl and WHO grade bleeding was assessed daily for 30 days after a platelet count ≤ 30,000/µl and study drug was started. Study drug was discontinued when platelet count was ≥ 30,000/ul for 46 hours without platelet transfusion support or until a maximum of 30 days after treatment activation, whichever came first. Red blood cell (RBC) transfusion was given according to local standard of care. Cox proportional hazards regression with time-varying covariates was used to assess the association of patient characteristics with the risk of a first major (grade 2+) bleeding event. HCT, platelet count, inpatient vs. outpatient status, steroid treatment, and fever were recorded daily. Patients were censored at the first of time of withdrawal, death, or day 30. Results WHO grade ≥ 2 bleeding occurred in 46% of patients overall with no difference between the TXA and placebo groups (TXA 44% versus placebo 47%, p=0.66). Bleeding rates were highest in allogeneic stem cell transplant patients, followed by chemotherapy, followed by autologous stem cell transplant. Overall bleeding rates by organ system showed oral and nasal (18%), skin (17%), gastrointestinal (11%), and genitourinary (11%) bleeding (Table 1). WHO grade ≥ 2 vaginal bleeding occurred in 28% of patients of childbearing potential despite widespread use of hormonal suppression. In a proportional hazards regression model of time to first bleeding event, undergoing allogeneic stem cell transplant was associated with a non-significant increased hazard of bleeding vs chemotherapy (HR 1.32, 95% CI 0.92-1.89), whereas autologous transplant had significantly lower hazard of bleeding vs chemotherapy (HR 0.39, 95% CI 0.20-0.76) (Table 2). HCT &amp;lt; 21% was associated with increased bleeding risk even after adjusting for severe thrombocytopenia (HR 2.71, 29% CI 1.37, 5.36). Platelet count &amp;lt; 5000/µl was also associated with increased risk (HR 3.33, 95% CI 1.67-6.61). Inpatient status, presence of fever, and age did not significantly impact risk of first bleed. Conclusions The overall rate of WHO grade &amp;gt;2 bleeding was similar to historical literature with lower rates of gastrointestinal bleeding than previously reported (31% in PLADO). Vaginal bleeding was common despite standard use of hormonal suppression in patients of childbearing potential. Platelet count &amp;lt; 5000/µl remains a risk factor for bleeding. Regardless of platelet count, bleeding risk increased with HCT &amp;lt; 21% suggesting a red blood cell transfusion threshold higher than 21% is unlikely to mitigate bleeding. More investigation is needed on strategies to reduce bleeding in this patient population.

Long-term effectiveness and safety of edoxaban in patients with atrial fibrillation: 4-year follow-up of more than 13,000 patients from the ETNA-AF-Europe study

Abstract Background Direct, non-vitamin K antagonist oral anticoagulants (DOACs/NOACs) have become the first-choice therapy for stroke prevention in patients with atrial fibrillation (AF) at risk of stroke. Data on long-term effectiveness and safety of NOACs are scarce and not available from randomised clinical trials. Purpose We analysed 4-year outcome data in 13,632 European patients with AF treated with the NOAC, edoxaban. Methods This is the first report of the four-year follow-up information collected in the ETNA-AF-Europe (NCT02944019) study. It is a prospective registry, conducted in 825 centres enrolling edoxaban-treated patients in 10 European countries. Design and follow-up were agreed with the European Medicines Agency as part of the post-approval safety assessment of edoxaban. Key efficacy and safety outcomes were adjudicated. Results 13,164 patients (56.7% males) with AF treated with edoxaban (60 mg OD n=9617; 30 mg OD n=3042; missing dose n=505) were analysed: median (interquartile range [IQR]) age was 75 (68–80) years, weight 80 (70–90) kg, creatinine clearance (CrCl) 68.9 (52.7–87.9) mL/min, modified CHA2DS2-VASc and HAS-BLED scores 3 (2–4) and 2 (1–2), respectively in the overall population. Annualised all-cause and cardiovascular deaths in the overall population were 4.1%/year and 1.0%/year, respectively; higher in the edoxaban 30 mg vs 60 mg cohort (Figure 1). Annualised rates of stroke, transient ischaemic attack and systemic embolic events rates were &amp;lt;1% (0.6%/year, 0.3%/year and 0.1%/year, respectively); these proportions were similar between the two dose cohorts (Figure 1). The time-to-first event curves for all-cause death, stroke and major bleeding were almost linear throughout the 4-year follow-up (Figure 2), irrespective of dose cohort. Compared with patients receiving edoxaban 60 mg, those prescribed 30 mg were older (median [IQR] age: 80 [75–85] vs 73 [66–78] years), had greater frail proportion (27.0% vs 6.6%), a lower CrCl (46.1 [37.4–59.0] vs 75.9 [61.9–93.8] mL/min) and a higher CHA2DS2-VASc score (4 [3–5] vs 3 [2–4]). Annualised bleeding rate was 3.0%/year and higher in the 30 mg vs 60 mg cohort (Figure 1). Annualised major bleeding, intracranial haemorrhage (ICH) and major gastrointestinal (GI) bleeding rates were low (0.9%/year, 0.2%/year and 0.4%/year, respectively), with higher major bleeding and major GI bleeding rates in patients treated with edoxaban 30 mg OD (Figure 1). ICH rates were similar in both dose cohorts. Conclusion These findings illustrate the long-term effectiveness and safety of edoxaban. Treatment with edoxaban over 4 years in patients with AF is associated with a relatively low, linearly increasing rate of all-cause death and ischaemic stroke. Rates of bleeding and especially ICH rates were low.

Impact of systemic lupus erythematosus on outcomes in patients hospitalized with acute decompensated heart failure with reduced and preserved ejection fraction: a national inpatient sample study (2016)

Abstract Background Systemic lupus erythematosus (SLE) is known to have an impact on cardiovascular outcomes, but its effect on patients with acute decompensated heart failure (ADHF) with reduced and preserved ejection fraction is not well understood. This study aims to investigate the impact of SLE on in-hospital outcomes in patients with ADHF. Methods This retrospective cohort study analyzed data from the United States National Inpatient Sample Database from 2016 to 2020. Patients hospitalized with ADHF with reduced and preserved ejection fraction were identified using ICD-10 codes and then categorized based on SLE diagnosis. Mortality and in-hospital complications were analyzed using multivariate logistic regression. Results Out of 10,700,000 ADHF hospitalizations, 0.61% (65,270) were associated with SLE. Compared to patients without SLE, those with SLE were younger (61 vs 72 years old, p&amp;lt;0.001), more likely to be female (85% vs 48%, p&amp;lt;0.001), had longer lengths of stay (coefficient: 0.23; p 0.005), and lower total hospital charges (coefficient: -$5,207; p&amp;lt;0.001). Patients with SLE had lower rates of cardiogenic shock, acute MI, and ischemic stroke (Figure 1). However, they had higher odds of in-hospital mortality, gastrointestinal bleeding, blood transfusion, pericardial complications, and AKI. No significant differences were found in respiratory failure and intracranial hemorrhage rates between the two cohorts. Conclusions This study suggests that the presence of SLE in patients hospitalized with ADHF is associated with worse in-hospital outcomes, including higher rates of all-cause mortality, gastrointestinal bleeding, blood transfusion, pericardial complications, and AKI. However, patients with SLE had lower rates of cardiogenic shock, acute MI, and ischemic stroke compared to those without SLE. These findings highlight the importance of early recognition and aggressive management of SLE in patients with ADHF to improve outcomes. Further research is needed to identify potential interventions that could improve the outcomes of this high-risk population.

Abstract 15692: Clinical Outcomes in TAVR Patients Receiving Oral Anticoagulation Stratified by Baseline Creatinine Clearance Levels: A Subanalysis of the ENVISAGE-TAVI AF Trial

Introduction: The ENVISAGE-TAVI AF (NCT02943785) trial compared edoxaban (EDO) vs vitamin K antagonists (VKAs) in patients with atrial fibrillation (AF) after successful transcatheter aortic valve replacement (TAVR). The effect of baseline creatinine clearance (CrCl) on efficacy and safety of EDO vs VKA in these patients is not well understood. Hypothesis: The efficacy and safety of EDO vs VKA in patients with AF undergoing TAVR will vary across the range of baseline CrCl. Methods: In this post-hoc analysis from the ENVISAGE-TAVI AF trial, we stratified patients by oral anticoagulation (OAC) strategy (EDO vs VKA) and CrCl (CrCl ≥90 mL/min, CrCl 60-89 mL/min, CrCl 45-59 mL/min, CrCl 30-44 mL/min, CrCl ≤29 mL/min). Results: Of 1426 patients included, 46.3% (n = 676) had CrCl from 60 to 89 mL/min. Patients with lower CrCl trended older in age than those with higher CrCl ( Table 1 ). The annualized event rates for all outcomes tended to increase with decreasing CrCl ( Table 2 ). Across the range of CrCl, patients receiving EDO vs VKA had higher rates of major bleeding and major gastrointestinal bleeding but lower rates of non-cardiovascular death. Major bleeding did not translate into increased all-cause death. Rates of intracranial hemorrhage were higher with EDO vs VKA in patients with CrCl ≥90 mL/min but lower in all other patients. For all-cause death, differences between EDO and VKA were numerical and did not reach statistical significance. Conclusions: In this ENVISAGE-TAVI AF subanalysis, decrements of CrCl appeared to correlate with rates of adverse outcome parameters more than OAC strategy. Due to low event rates in some outcomes, these results should be interpreted with caution.

Association of timing of percutaneous left ventricular assist device insertion with outcomes in patients undergoing cardiac surgery

ObjectivesThe aim of this study was to explore the associations between percutaneous ventricular assist device (pVAD) insertion timing relative to cardiac surgery and patient outcomes. MethodsThe Nationwide Inpatient Sample was queried for patients undergoing cardiac surgery and pVAD insertion in the same admission from 2016 to 2019. Patients were stratified by timing of pVAD insertion. Preoperative characteristics, postoperative complications, and mortality were compared among groups. ResultsOverall, 3695 patients underwent cardiac surgery and pVAD insertion during the same hospitalization (pre: 1130, intra: 1690, and post: 875). The distribution of cardiac surgery procedures was similar across groups. Median Elixhauser Comorbidity Index was 13 for pre-, 15 for intra-, and 17 for postoperative pVAD patients (P = .021). Patients who received a postoperative pVAD were associated with increased mortality (pre: 18%, intra: 39%, and post: 54%; P < .01). Increased complication rates were also associated with postoperative pVAD insertion (pre: 61%, intra: 55%, and post: 75%; P < .01). Preoperative pVAD insertion was associated with increase rates of sepsis (pre: 18%, intra: 9.8%, and post: 17%; P = .01) and pneumonia (pre: 38%, intra: 23%, and post: 31%; P < .01). Postoperative pVAD insertion was associated with increased rates of gastrointestinal bleeding (pre: 2.2%, intra: 3.0%, and post: 7.4%; P = .01), renal failure (pre: 10%, intra: 9.2%, and post: 17%; P = .01), and prolonged ventilation (pre: 44%, intra: 41%, and post: 54%; P = .02). ConclusionsPostoperative pVAD insertion following cardiac surgery was associated with increased complications and mortality compared with preoperative or intraoperative insertion. Further studies should explore optimal utilization and timing of pVAD insertion in patients undergoing cardiac surgery.

Outcomes and Readmissions after Left Atrial Appendage Occlusion in Octogenarians: A Contemporary Analysis

Introduction and ObjectivesThe outcomes of left atrial appendage occlusion (LAAO) with the Watchman device in octogenarians are unknown as this population was underrepresented in major clinical trials. This study aims at examining the causes and outcomes of readmission after LAAO. DesignA retrospective cohort study based on the National Readmission Database in the United States. Settings and ParticipantPatients aged ≥80 years, admitted between January 2016 and December 2018, with the primary diagnosis of atrial fibrillation or flutter or who had LAAO were included in the study. Patients who died during index admission were excluded. MethodsWe used the National Readmission Database and International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes to identify study participants. Data analysis was performed through Stata, version 17. Univariate and multivariate aggression analysis was used to adjust for confounders using Student t tests and χ2 tests. ResultsWe identified 491,329 patients on anticoagulation (AC) and 2030 patients who underwent LAA closure. Neither group differed regarding hypertension, previous myocardial infarction, or valvular heart disease. All-cause readmissions were lower in the LAAO group at 45 days (adjusted P < .01). All-cause readmissions at 45 and 90 days were similar in both groups. There was an increase in gastrointestinal bleeding (GIB) readmissions in the LAAO at 45 (P < .01), 90 (P < .01), and 180 (P < .01) days. There was no difference in GIB readmission between the 2 groups. There was no also difference in stroke or intracranial hemorrhage rates between the 2 groups throughout the follow-up period. Conclusion and ImplicationsIn octogenarians who received LAAO, the rate of GIB increased during the first 6 months after the procedure; however, it was not different from that of AC after that. Special attention should be given to the antithrombotic regimens after LAAO to avoid bleeding in this vulnerable patient population.

Effect of Oral Anticoagulants in Atrial Fibrillation Patients with Polypharmacy: A Meta-analysis.

The aim of the present meta-analysis was to evaluate the effectiveness and safety of non-vitamin K antagonist oral anticoagulants (NOACs) versus vitamin K antagonists (VKAs) in atrial fibrillation (AF) patients with polypharmacy. Randomized controlled trials or observational studies reporting the data of NOACs versus VKAs among AF patients with polypharmacy were included. The search was performed in the PubMed and Embase databases up to November 2022. A total of 12 studies involving 767,544 AF patients were included. For the primary outcomes, the use of NOACs compared with VKAs was significantly associated with a reduced risk of stroke or systemic embolism in AF patients with moderate polypharmacy (hazard ratio [HR]: 0.77 [95% confidence interval [CI]: 0.69-0.86]) and severe polypharmacy (HR: 0.76 [95% CI: 0.69-0.82]), but there was no significant difference in major bleeding (moderate polypharmacy: HR: 0.87 [95% CI: 0.74-1.01]; severe polypharmacy: HR: 0.91 [95% CI: 0.79-1.06]) between the two groups. In secondary outcomes, there were no differences in the rates of ischemic stroke, all-cause death, and gastrointestinal bleeding between the NOAC- and VKA- users, but NOAC users had a reduced risk of any bleeding compared with VKA- users. Compared with VKAs, the risk of intracranial hemorrhage was reduced in NOAC- users with moderate polypharmacy but not severe polypharmacy. In patients with AF and polypharmacy, NOACs showed advantages over VKAs in stroke or systemic embolism and any bleeding, and were comparable to VKAs for major bleeding, ischemic stroke, all-cause death, intracranial hemorrhage, and gastrointestinal bleeding.

#4768 25 HYDROXYVITAMIN D ASSOCIATES WITH GASTROINTESTINAL BLEEDING IN DIALYSIS

Abstract Background and Aims The INSPIRE collaborative group built a prediction model that showed serum 25 hydroxyvitamin D concentration (25OH Vit D) may be a predictor of gastrointestinal bleeding (GIB) hospitalizations in dialysis patients [1]. Unexpectedly, 25OH Vit D levels in the target range (i.e., &amp;gt;30 ng/mL) were most associated with GIB hospitalization risk. We aimed to further investigate the association between GIB episodes and 25OH Vit D levels, considering the onset of a GIB comorbidity or a GIB hospitalization event in the next 180 days. Method Analysis used data from adult (age ≥18 years) dialysis patients in the United States who had one or more 25OH Vit D lab measurement between 01-Jan-2018 to 31-Mar-2021. We identified GIB episodes (comorbidity or hospitalization observations) that were within ≤180 days after a 25OH Vit D measurement. GIB episodes and types were based on ICD-10 diagnosis code clusters defined by the United States Healthcare Cost and Utilization Project [2]. We calculated the percent of GIB comorbidities that onset, or GIB hospitalizations that occurred, by categories of 25OH Vit D levels (&amp;lt;15, ≥15 to &amp;lt;30, ≥30 to &amp;lt;50, ≥50 to &amp;lt;100, or ≥100 ng/mL). Results Among 347,165 adult dialysis patients who had a 25OH Vit D lab measurement(s), 3.2% (n = 11,038) experienced ≥1 GIB comorbidity and 6.7% (n = 23,389) experienced ≥1 GIB hospitalization. In total, 16.5% (n = 4,873) of these patients had ≥1 GIB comorbidity and hospitalization. GIB episodes were within ≤180 days after a 25OH Vit D measurement for 5,558 GIB comorbidity and 21,862 GIB hospitalization observations. We found patients with 25OH Vit D levels that were &amp;lt;15 ng/mL or ≥50 ng/mL exhibited the lowest GIB comorbidity and GIB hospitalization rates (Figure 1A &amp; B). Patients with 25OH Vit D levels that were between ≥15 ng/mL and &amp;lt;50 ng/mL had the highest GIB comorbidity and GIB hospitalization rates. This observation was consistently observed for all GIB types, including upper, lower, and unspecified GIB episodes. Conclusion Findings showed serum 25OH Vit D levels are associated with 180-day GIB episodes in dialysis patients. The highest GIB rates were found in patients with a 25OH Vit D level between 15–50 ng/mL versus all other levels. This finding was consistent for the onset of a of GIB comorbidity and the occurrence of a GIB hospitalization, and in both cases was associated with 2-fold higher GIB rates. Outside the kidney failure population, 25OH vitamin D levels in the range of 30–100 ng/mL have been shown to be associated to higher GIB risk in warfarin users [3]. These findings may question recommendations in kidney disease that suggest repletion of 25OH Vit D levels to ≥30 ng/mL, which has been a controversy for more than a decade. Nonetheless, further analyses are needed and should consider adjustments for patient factors (e.g. age, sex, medications) and competing risks (non-GIB hospitalization events).

Outcomes of catheter-directed thrombolysis versus systemic thrombolysis in the treatment of pulmonary embolism: a meta-analysis.

To evaluate the safety and efficacy of catheter-directed thrombolysis (CDT) versus systemic thrombolysis (ST) in the treatment of pulmonary embolism (PE). The Cochrane Library, PubMed, and Embase databases were searched to collect the literature on the comparison of the results of CDT and ST in the treatment of PE from the beginning of their records to May 2020, and meta-analysis was performed by STATA software (version 15.1). Using standardized data-collection forms, the authors screened the studies and independently extracted data, and assessed the quality of the studies using the Newcastle-Ottawa Scale for cohort studies. Cohort studies that examined the following results were included in the current study: in-hospital mortality, all-cause bleeding rate, gastrointestinal bleeding rate, intracranial hemorrhage rate, the incidence of shock, and hospital length of stay. A total of eight articles, with 13,242 participants, involving 3962 participants in the CDT group and 9280 participants in the ST group were included. CDT compared with ST in the treatment of PE can significantly affect in-hospital mortality rate [odds ratio (OR) = 0.41, 95% CI: 0.30-0.56, P < 0.05], all-cause bleeding rate (OR = 1.20, 95% CI: 1.04-1.39, P = 0.012), gastrointestinal bleeding rate (OR = 1.43, 95% CI: 1.13-1.81, P = 0.003), the incidence of shock (OR = 0.46, 95% CI: 0.37-0.57, P < 0.05), and hospital length of stay [standard mean difference (SMD) = 0.16, 95% CI: 0.07-0.25, P < 0.05]. However, there was no significant effect on intracranial hemorrhage rate in patients with PE (OR = 0.70, 95% CI: 0.47-1.03, P = 0.070). CDT is a viable alternative to ST in the treatment of PE, as it can significantly reduce in-hospital mortality rate, all-cause bleeding rate, gastrointestinal bleeding rate, and incidence of shock. However, CDT may prolong hospital length of stay to a certain extent. Further research is needed to evaluate the safety and efficacy of CDT and ST in the treatment of acute PE and other clinical outcomes.

PREDICTIVE FACTORS OF MORBIDITY ASSOCIATED WITH ESOPHAGEAL VARICEAL BLEEDING IN CHILDREN WITH PORTAL HYPERTENSION.

•Most data on the natural history of portal hypertension come from studies in adults. •The morbidity rate of upper gastrointestinal bleeding in children with portal hypertension tend to be underestimated. •This study showed the relevance of morbidity rates after variceal hemorrhage in pediatric patients, especially those with cirrhosis. •Patients with hemodynamic instability requiring blood transfusion or expansion on admission are at increased risk of complications secondary to upper gastrointestinal bleeding and should be closely monitored. Background - Most data on the natural history of portal hypertension come from studies in adults. The morbidity rate of upper gastrointestinal bleeding (UGIB) in children with portal hypertension has not been systematically characterized. Objective - To describe the morbidity and mortality of UGIB in pediatric patients with portal hypertension and identify predictive factors for the occurrence of its main complications. Methods - This retrospective study included pediatric patients with cirrhotic portal hypertension or with extrahepatic portal vein obstruction (EHPVO). Mortality and UGIB complications within a period of up to 6 weeks of the bleeding were investigated. To determine the predictive factors of morbidity, a multivariate analysis was performed using logistic regression; all results were considered significant at P<0.05. Results - A total of 86 patients (51.2% with EHPVO and 48.8% with cirrhosis) had 174 bleeding events. Ascites was the most common complication (43.1% of all cases), being more prevalent in patients with cirrhosis (P<0.001). Cirrhosis was a predictor of the occurrence of any morbidity (OR 20.3). The need for blood transfusion was predictor of at least one complication (OR 5.8), ascites (OR 7.2) and infections (OR 3.8) in the general group and at least one complication (OR 11.3) and ascites (OR 5.8) in cirrhotic patients. The need for expansion was a predictor of any morbidity (OR 4.6) and infections (OR 3.9) in the general group, in addition to being predictor of infection in cirrhotic patients (OR 5.4). There were no deaths from UGIB in the six weeks post-bleeding. Conclusion - The study showed the relevance of morbidity after UGIB in pediatric patients with portal hypertension, especially in those with cirrhosis. The patients with hemodynamic instability requiring blood transfusion or expansion on admission are at increased risk of complications related to upper gastrointestinal bleeding and should be closely monitored.