Incidence Of Bleeding Complications Research Articles

#1289 The effect of desmopressin in reducing post-kidney biopsy bleeding complication in patients with reduced renal function: a randomised control trial

Abstract Background and Aims Percutaneous kidney biopsy remains the gold standard for diagnosis of kidney disease. The incidence of bleeding complications following kidney biopsy ranges from 13 to 34%. This study aimed to evaluate the effect of prebiopsy administration of intranasal desmopressin on the incidence of post-biopsy bleeding complications in patients undergoing ultrasound-guided percutaneous native kidney biopsy with an estimated GFR of 60 ml/min/1.73 m2. Method It was a single-centre, double-blind, randomized controlled trial. Patients undergoing percutaneous ultrasound-guided biopsy of the native kidney in the department with age >18 years, BP before biopsy ≤140/90 mm Hg, and eGFR < 60 mL/min/1.73 m2. The patients were divided into experimental (intranasal desmopressin) and control group (intranasal normal saline), and block randomization was done by a computer-generated random number list prepared by an investigator with no clinical involvement in the study into an experimental and control group. The experimental group was treated using intranasal desmopressin acetate (dosage of 3 mcg/kg, each puff delivering 10 mcg) 1 hour before the kidney biopsy. The control group was treated with a placebo (equivalent dose of intranasal saline)(CTRI/2023/01/048812) Results A total of 152 patients were included (78 male and 74 female), the experimental group had 74 patients, and the control group had 78 patients. The mean age was 39.08 ± 15.03 yrs and 38.83 ± 15.67 yrs., respectively (p = 0.921). The experimental group had significantly less hematoma formation at 24 hrs. post kidney biopsy compared to the control group (p = 0.019). The hematoma volume at six hrs. (p = 0.342) and 24 hrs. (p = 0.698); post-kidney biopsy was not different between the two groups. Conclusion Intranasal desmopressin administration effectively reduces post-biopsy native kidney peri-renal hematoma formation at 24 hrs post-procedure. However, other bleeding complications were not different in the two groups of our studies.

Analysis of the safety, accuracy, and factors influencing bleeding complications in CT-guided puncture biopsy of brain occupying lesions

Objective: To investigate the safety and accuracy of CT-guided intracranial puncture biopsy and the possible influencing factors of postoperative bleeding complications. Methods: A case series study. A retrospective analysis was conducted on 101 patients who underwent CT-guided intracranial puncture biopsy at the First Affiliated Hospital of Zhengzhou University from January 2017 to December 2021. The basic data of patients and the safety and accuracy of CT-guided intracranial puncture biopsy were analyzed statistically. Univariate and multivariate logistic regression analysis were used to screen the influencing factors of bleeding complications in CT-guided intracranial puncture biopsy, and the bleeding complications in glioma subgroup were analyzed. Results: Among the 101 patients, 53 were males and 48 were females, aged (53.7±17.2) years. The average diameter of intracranial lesions was (3.5±1.4) cm, while the vertical distance from the lesion to the meninges was (2.4±1.7) cm. The needle's intracranial depth reached (3.2±1.8) cm, with adjustments averaging (3±1) occurrences and an average procedural duration of (40.2±12.9) minutes. Pathological diagnoses included glioma (36 cases), gliosis (3 cases), lymphoma (32 cases), metastatic tumors (7 cases), inflammatory lesions (13 cases), and 10 indeterminate cases. The positive rate of puncture pathology was 90.1% (91/101), and the diagnostic coincidence rate was 94.0% (78/83). The incidence of bleeding complications in CT-guided intracranial puncture biopsy was 26.7% (27/101), of which 23 cases had small intratoma or needle path bleeding, 4 cases had massive bleeding, and 2 cases died. The patients were divided into bleeding group (n=27) and no bleeding group (n=74), according to the presence or absence of bleeding. The results of univariate logistic regression analysis showed that thrombin time≥15 s and the number of needle adjustment were the factors affecting the occurrence of bleeding complications (both P<0.05), and the results of multivariate logistic regression showed that thrombin time≥15 s was the related factor for bleeding. Patients with thrombin time≥15 s had a 3.045 times higher risk of bleeding than those with thrombin time<15 s (OR=3.045,95%CI:1.189-7.799,P=0.020). Among the 101 patients, 36 cases of midbrain glioma were divided into low-grade glioma group (n=11) and high-grade glioma group (n=25) according to the pathological grade. Subgroup analysis showed that the risk of bleeding for high-grade gliomas was 9.231 times higher than that for low-grade gliomas (OR=9.231,95%CI:1.023-83.331,P=0.031). Conclusions: CT-guided intracranial puncture biopsy is safe and feasible with high accuracy. Complication rates are associated with thrombin time≥15 s, especially high-grade glioma, which increases the risk of postoperative bleeding.

Outcomes of Pleural Space Infections in Patients With Indwelling Pleural Catheters for Active Malignancies.

Pleural infections related to indwelling pleural catheters (IPCs) are an uncommon clinical problem. However, management decisions can be complex for patients with active malignancies due to their comorbidities and limited life expectancies. There are limited studies on the management of IPC-related infections, including whether to remove the IPC or use intrapleural fibrinolytics. We conducted a retrospective cohort study of patients with active malignancies and IPC-related empyemas at our institution between January 1, 2005 and May 31, 2021. The primary outcome was to evaluate clinical outcomes in patients with malignant pleural effusions and IPC-related empyemas treated with intrapleural tissue plasminogen activator (tPA) and deoxyribonuclease (DNase) compared with those treated with tPA alone or no intrapleural fibrinolytic therapy. The secondary outcome evaluated was the incidence of bleeding complications. We identified 69 patients with a malignant pleural effusion and an IPC-related empyema. Twenty patients received tPA/DNase, 9 received tPA alone, and 40 were managed without fibrinolytics. Those treated with fibrinolytics were more likely to have their IPCs removed as part of the initial management strategy ( P =0.004). The rate of surgical intervention and mortality attributable to the empyema were not significantly different between treatment groups. There were no bleeding events in any group. In patients with IPC-related empyemas, we did not find significant differences in the rates of surgical intervention, empyema-related mortality, or bleeding complications in those treated with intrapleural tPA/DNase, tPA alone, or no fibrinolytics. More patients who received intrapleural fibrinolytics had their IPCs removed, which may have been due to selection bias.

Abstract 14742: Clinical Predictors of Bleeding Complications Following Percutaneous Ventricular Assist Device Insertion: Insights From the J-PVAD (Japanese Registry for Percutaneous Ventricular Assist Device) Registry

Introduction: Bleeding complications are significant concerns in clinical use of percutaneous ventricular assist devices (PVAD). This study aimed to identify predictors of bleedings in PVAD use. Methods: We analyzed 3059 cases from the J-PVAD registry, a comprehensive national registry of PVAD use in Japan, excluding 53 cases without follow-up data. Patients were stratified based on whether they had acute coronary syndrome (ACS) on the onset or not, and incidence of bleeding was evaluated within each stratum, considering the clinically selected variables, including other mechanical circulatory support (MCS) use. Risk factors were explored through multivariate analyses. The primary outcome measure was any bleeding, while major bleeding was defined as a composite of cerebral bleeding, severe bleeding (defined as life-threatening, hospitalization-requiring, disability-causing, or congenital anomaly-inducing bleeding events), and blood transfusions. Results: The median follow-up period was 32 days. The cohort included 1459 patients with ACS and 1575 without ACS. The incidence of any bleeding did not differ significantly between the ACS and Non-ACS stratum (30-day incidence: 25.4% and 27.6%, P = 0.57, respectively). We observed the same trends for major bleeding. Most any bleeding or major bleeding occurred on the day of insertion of PVAD or within a few days. The groups with MCS had significantly more bleeding complications than those without MCS in each stratum (Figure). In a multivariate analysis using the Cox proportional hazards model, adding MCS on PVAD was the most potent predictor of any bleeding in both strata, with the effects of other variables being modest by comparison. Conclusions: Bleeding complications post-PVAD insertion are often severe and occur shortly after the procedure. Although the incidence of bleeding complications did not differ significantly according to the onset type, the MCS use strongly predicted bleeding complications.

Acquired von Willebrand disease in children undergoing extracorporeal membrane oxygenation: a prospective observational study

BackgroundExtracorporeal membrane oxygenation (ECMO) provides cardiopulmonary support for children with severe cardiac and/or pulmonary failure. The incidence of bleeding complications during ECMO support is high. Acquired von Willebrand disease (AVWD) might contribute to the development of bleeding complications. ObjectiveTo study the incidence and longitudinal profile of AVWD during the first 14 days of ECMO support in children and to investigate the association between AVWD and bleeding complications. MethodsThis prospective observational study included pediatric patients (0-17 years) receiving ECMO. Blood was sampled prior to and after ECMO start, daily and 12 to 24 hours after stopping ECMO. von Willebrand factor (VWF) parameters and multimer patterns were determined. Clinical data were collected for each patient. AVWD was defined as loss of high-molecular weight multimers (ie, decreased compared with baseline) or a VWF:collagen binding/VWF: antigen (Ag) ratio or VWF:activity/VWF:Ag ratio below 0.7. ResultsAll of 50 (100%) patients developed AVWD during ECMO. The VWF:collagen binding /VWF:Ag ratio, VWF:activity/VWF:Ag ratio, and high-molecular weight multimers decreased during the initial days and recovered to baseline level within 24 hours after stopping ECMO. The incidence and longitudinal profile of AVWD were similar in patients with and without major bleeding complications. ConclusionChildren receiving ECMO support commonly develop AVWD. AVWD develops rapidly after ECMO initiation and recovers quickly after ECMO cessation. Importantly, AVWD appears to be independent of major bleeding.

Weight-Based Dosing for Venous Thromboembolism Prophylaxis in Spinal Trauma Patients Appears Safe

IntroductionVenous thromboembolism (VTE) is a substantial cause of morbidity and mortality in trauma patients. VTE prophylaxis (VTEP) initiation is often delayed in certain patients due to the perceived risk of bleeding complications. Our VTEP guideline was changed from fixed-dosing to a weight-based dosing strategy using enoxaparin in June 2019. We investigated the rate of postoperative bleeding complications with a weight-based and a standard dosing protocol in traumatic spine injury patients requiring surgical stabilization. MethodsA retrospective pre-post cohort study using an institutional trauma database was conducted, comparing bleeding complications between fixed and weight-based VTEP protocols. Patients undergoing surgical stabilization of a spine injury were included. The preintervention cohort received fixed-dose thromboprophylaxis (30 mg twice daily or 40 mg daily); the postcohort received weight-based thromboprophylaxis (0.5 mg/kg q12 h with anti-factor Xa monitoring). All patients received VTEP 24-48 h after surgery. International Classification of Diseases codes were used to identify bleeding complications. ResultsThere were 68 patients in the pregroup and 68 in the postgroup with comparable demographics. Incidence of bleeding complications in the pre- and postgroups were 2.94% and 0% respectively. ConclusionsVTEP initiated 24-48 h after surgical stabilization of a spine fracture using a weight-based dosing strategy and has a similar rate of bleeding complications as a standard dose protocol. Our study is limited by the low overall incidence of bleeding complications and small sample size. These findings could be validated by a larger multicenter trial.

Venous thromboembolism: Exploring incidence and utility of screening in spinal cord injury

Objective To assess the incidence and possible risk factors for venous thromboembolism (VTE) in patients admitted to a SCI rehabilitation center. Design Retrospective review. Setting Acute neurorehabilitation hospital specializing in SCI. Methods Records of 228 consecutive admissions were reviewed. All patients received screening four limb ultrasounds on admission. Charts were reviewed to determine whether VTE was diagnosed at the acute care hospital or in the rehabilitation center; either on admission screening or later in the rehabilitation stay. Charts were reviewed to identify potential risk factors for VTE as well as the incidence of bleeding complications in patients on full anticoagulation. Results In this cohort, 115 deep venous thromboses (DVTs) were identified in the following settings: 27% in acute care [n = 31], 70% on admission to rehabilitation [n = 80], and 24% during the rehabilitation stay [n = 28]. Of those on therapeutic anticoagulation due to admission diagnosis of VTE [n = 63], 12.7% developed recurrent DVT and 9.5% had bleeding complications. Of those who were initiated and continued on therapeutic anticoagulation, there was zero incidence of PE. Risk factors for the development of VTE included age, body mass index (BMI), rehabilitation length of stay, injury etiology, spinal cord-related surgery, and history of inferior vena cava filter. Conclusions DVT was identified in 70% of this cohort with screening ultrasound on admission to rehabilitation and of those initiated and continued on therapeutic anticoagulation, none developed PE, while 9.5% had bleeding complications. Given the findings of this study, prospective research in noninvasive vascular ultrasound screening for VTE should be considered.

Efficacy and safety of recombinant human soluble thrombomodulin in patients with sepsis-induced disseminated intravascular coagulation - A meta-analysis

BackgroundRecombinant human soluble thrombomodulin (rhTM) is used to treat sepsis-induced disseminated intravascular coagulation (DIC). However, no consistent clinical guidelines exist regarding the administration of rhTM in patients with sepsis-induced DIC. Therefore, we conducted this meta-analysis to evaluate the efficacy and safety of rhTM therapy in patients with sepsis-induced DIC. MethodsEMBASE, PubMed, Scopus, Ichushi, and CINAHL databases were used to search for relevant articles that met the inclusion criteria of patients with sepsis-induced DIC treated with and without rhTM through November 2022. Mortality, DIC resolution, and incidence of bleeding complications were evaluated. DIC resolution was defined as the recovery from DIC after the start of DIC treatment. ResultsOf the 1697 citations identified for screening, 17 studies involving 2296 patients were included. Administering rhTM significantly reduced mortality (odds ratio (OR) 0.54, 95 % confidence interval (CI) 0.42–0.71) and improved DIC resolution (OR 2.88, 95 % CI 1.83–4.52). There were no significant differences in the incidence of bleeding complications between the rhTM and control groups (OR 0.92, 95 % CI 0.66–1.28). ConclusionsOur meta-analysis revealed that rhTM could reduce mortality and improve DIC resolution without increasing the risk of bleeding in patients with sepsis-induced DIC. Our findings suggest that rhTM is a relatively effective and safe anticoagulant for the treatment of sepsis-induced DIC. SummaryRecombinant human soluble thrombomodulin reduced mortality without increasing the bleeding risk in the treatment of sepsis-induced disseminated intravascular coagulation.

Patients with infective endocarditis undergoing cardiac surgery have distinct ROTEM profiles and more bleeding complications compared to patients without infective endocarditis.

The coagulation system is crucial in the pathogenesis of infective endocarditis and undergoes significant changes during course of the disease. However, little is known about the implications of those changes in the perioperative period. Aim of the present study was to delineate the specific coagulation patterns and their clinical consequence in patients undergoing cardiac surgery due to infective endocarditis. In this single-centre, exploratory, prospective observational study, we investigated the incidence and degree of coagulopathy in patients with (n = 31) and without infective endocarditis (n = 39) undergoing cardiac valve surgery. The primary outcome was the differences between these two groups in rotational thromboelastometry (ROTEM) results before, during and after surgery. The secondary outcomes were the differences between the groups in heparin sensitivity, bleeding complications, and transfusion requirements. Most ROTEM parameters in EXTEM, INTEM and FIBTEM assays were significantly altered in patients with infective endocarditis. Clotting time in the EXTEM assay was significantly prolonged in the endocarditis group at all time-points, while all clot firmness parameters (A5, A10 and MCF) were significantly increased. The heparin sensitivity index was significantly lower in the endocarditis group (median index 0.99 vs 1.17s. IU-1.kg-1, p = .008), indicating increased heparin resistance. Patients with infective endocarditis had more bleeding complications as assessed by the universal definition of perioperative bleeding score (OR 3.0, p = .018), and more patients with endocarditis underwent early re-exploration (p = .018). The findings of this exploratory investigation show significantly altered coagulation profiles in patients with infective endocarditis, with concomitant hyper- and hypocoagulability. Furthermore, the incidence of bleeding complications and transfusion requirements were increased in patients with endocarditis. These results show the potential of ROTEM to detect coagulation abnormalities in patients with infective endocarditis. Existing point-of-care coagulation testing guided algorithms for optimizing perioperative coagulation management possibly need to be adjusted for these high-risk patients undergoing cardiac surgery.

Duration of Initial Intensive Rivaroxaban Therapy for Patients With Venous Thromboembolism - Subanalysis of the J'xactly Study.

Background: Rivaroxaban, a direct oral anticoagulant, is used as a first-line treatment to prevent venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). However, whether 21 days is optimal for the initial treatment duration has not been investigated. Methods and Results: In this subanalysis of the prospective multicenter observational J'xactly study, which included 1,039 Japanese patients with acute symptomatic/asymptomatic DVT/PE who were prescribed rivaroxaban, the VTE recurrence rate and incidence of bleeding complications were assessed in 667 patients who underwent intensive rivaroxaban treatment (15 mg, twice daily) for a short (1-8 days), intermediate (9-16), or standard (17-24) duration. The short treatment duration group showed a tendency for increased VTE recurrence/aggravation compared with the standard treatment duration group (6.10% vs. 2.60% per patient-year). The intermediate treatment duration group showed a higher incidence of bleeding events than the standard treatment duration group (9.34% vs. 2.16% per patient-year), without major differences in patient characteristics between the groups. Conclusions: In this subanalysis of the real-world observational J'xactly study of VTE treatment and prevention in Japanese patients with acute symptomatic/asymptomatic DVT/PE, the standard initial intensive rivaroxaban treatment duration (17-24 days) appeared to be safe and effective, providing important insights into the clinical outcomes of the initial rivaroxaban treatment duration in this population.

Comparison of Efficacy of Biliverdin vs Heparin in Patients with Stable Ischemic Heart Disease Undergoing Percutaneous Coronary Intervention

Objective: To compare the efficacy and safety of biliverdin versus heparin in preventing thrombotic complications during percutaneous coronary intervention (PCI) in patients with stable ischemic heart disease. Methods: A total of 1000 patients were enrolled in the study, with 500 patients receiving biliverdin and 500 receiving heparin. The primary endpoint was the incidence of thrombotic complications during PCI, and the secondary endpoint was the incidence of bleeding complications. Results: Biliverdin was associated with a significantly lower incidence of thrombotic complications compared to heparin (5.6% versus 9.8%, respectively; p&lt;0.05). There was no significant difference in bleeding complications between the two groups (3.8% for biliverdin versus 3.2% for heparin; p=0.63). Logistic regression analysis found that biliverdin use was independently associated with a lower risk of thrombotic complications, even after adjusting for baseline demographic and clinical characteristics. Practical Implications: This study suggests that the use of biliverdin during percutaneous coronary intervention in patients with stable ischemic heart disease may provide a more effective alternative to heparin for preventing thrombotic complications without increasing the risk of bleeding complications. Conclusion: Biliverdin may be a more effective alternative to heparin for use during PCI in patients with stable ischemic heart disease, without increasing the risk of bleeding complications. Further studies are needed to confirm these findings and determine the long-term safety and efficacy of biliverdin in larger populations and over longer periods of follow-up. Keywords: Biliverdin, heparin, percutaneous coronary intervention, stable ischemic heart disease, thrombotic complications, bleeding complications.

Efficacy and safety of single versus dual antiplatelet therapy in carotid artery stenting

ObjectiveCurrent guidelines recommend dual antiplatelet (AP) therapy (DAPT) before carotid artery stenting (CAS); however, the true clinical effect of single AP therapy vs DAPT is unknown. We examined the efficacy and safety of preoperative single AP therapy vs DAPT in patients who had undergone transfemoral CAS (tfCAS) or transcarotid artery revascularization (TCAR). MethodsWe identified all patients who had undergone tfCAS or TCAR in the Vascular Quality Initiative database from 2016 to 2021. We stratified the patients by procedure and identified those who had received the following preoperative AP regimens: DAPT (acetylsalicylic acid [ASA] + P2Y12 inhibitor [P2Yi]), no AP therapy, ASA only, ASA + AP loading dose, P2Yi only, and P2Yi + AP loading dose. The AP loading dose was given within 4 hours of CAS. We generated propensity scores for each treatment regimen and assessed in-hospital outcomes using inverse probability weighted log binomial regression, with DAPT as the reference and adjusting for intraoperative protamine use. The primary efficacy outcome was a composite end point of stroke and death, and the primary safety outcome was access-related bleeding. ResultsOf the 18,570 tfCAS patients, 70% had received DAPT, 5.6% no AP therapy, 10% ASA only, 8.0% ASA + AP loading dose, 4.6% P2Yi only, and 2.9% P2Yi + AP loading dose. The corresponding unadjusted rates of stroke/death were 2.2%, 6.8%, 4.1%, 5.1%, 2.4%, and 2.3%. After adjustment, compared with DAPT, the incidence of stroke/death was higher with no AP therapy (relative risk [RR], 2.3; 95% confidence interval [CI], 1.7-3.2), ASA only (RR, 1.6; 95% CI, 1.2-2.1), and ASA + AP loading dose (RR, 2.0; 95% CI, 1.5-2.7) but was similar with P2Yi only (RR, 0.99; 95% CI, 0.58-1.7) and P2Yi + AP loading dose (RR, 1.1; 95% CI, 0.49-2.5). Of the 25,459 TCAR patients, 81% had received DAPT, 2.0% no AP therapy, 5.5% ASA only, 3.5% ASA + AP loading dose, 4.9% P2Yi only, and 2.4% P2Yi + AP loading dose. The corresponding unadjusted rates of stroke/death were 1.5%, 3.3%, 3.3%, 2.9%, 1.2%, and 1.1%. After adjustment, compared with DAPT, the incidence of stroke/death was higher with no AP therapy (RR, 2.0; 95% CI, 1.2-3.3) and ASA only (RR, 2.2; 95% CI, 1.5-3.1), with a trend toward a higher incidence with ASA + AP loading dose (RR, 1.6; 95% CI, 0.99-2.6), and was similar with P2Yi only (RR, 0.98; 95% CI, 0.54-1.8) and P2Yi + AP loading dose (RR, 0.66; 95% CI, 0.27-1.6). No differences were found in the incidence of access-related bleeding between the treatment groups after tfCAS or TCAR. ConclusionsCompared with DAPT, no AP therapy or ASA monotherapy was associated with higher rates of stroke/death after CAS and should be discouraged as unsafe practice. Meanwhile, P2Yi monotherapy was associated with similar rates of stroke/death. No differences were found in the incidence of bleeding complications, and adding an AP loading dose to ASA or P2Yi monotherapy within 4 hours of the procedure did not affect the outcomes. Overall, these findings support the current guidelines recommending DAPT before CAS but also suggest that P2Yi monotherapy might confer thromboembolic benefits similar to those with DAPT. However, an immediate preoperative AP loading dose might not provide additional thromboembolic benefits.

Current treatment strategies for primary upper extremity deep venous thrombosis; a retrospective observational multicenter case series.

Current treatment strategies for primary upper extremity deep venous thrombosis (pUEDVT) range from conservative treatment with anticoagulation therapy to invasive treatment with thoracic outlet decompression surgery (TOD), frequently combined with catheter directed thrombolysis, percutaneous transluminal angioplasty, or stenting. Due to a lack of large prospective series with uniform data collection or a randomized trial, the optimal treatment strategy is still under debate. We conducted a multicenter observational study to assess the efficacy and safety of both the conservative and invasive treatment strategies for patients with pUEDVT. We retrospectively collected data from patients treated in five vascular referral and teaching hospitals in the Netherlands between 2008 and 2019. Patients were divided into a conservative (Group 1), an invasive treatment group (Group 2) and a cross-over group (Group 3) of patients who received surgical treatment after initial conservative therapy. Follow-up consisted of outpatient clinic visits and an electronic survey. Primary outcome was symptom free survival defined as absence of any symptom of the affected arm reported at last follow-up regardless of severity, or extent of functional disability. Secondary outcomes were incidence of bleeding complications, recurrent venous thromboembolism, surgical complications, and reinterventions. A total of 115 patients were included (group 1 (N = 45), group 2 (N = 53) or group 3 (N = 27). The symptom free survival was 35.6%, 54.7% and 48.1% after a median follow-up of 36, 26 and 22 months in groups 1, 2 and 3 respectively. Incidence of bleeding complications was 8.6%, 3.8% and 18.5% and recurrent thrombosis occurred in 15.6%, 13.2% and 14.8% in groups 1-3 respectively. In this multicenter retrospective observational cohort analysis the conservative and direct invasive treatments for pUEDVT were deemed safe with low percentages of bleeding complications. Symptom free survival was highest in the direct surgical treatment group but still modest in all subgroups. Perioperative complications were infrequent with no related long term morbidity. Of relevance, pUEDVT patients with confirmed VTOS and recurrent symptoms after conservative treatment may still benefit from TOD surgery. However, symptom free survival of this delayed TOD seems lower than direct surgical treatment and bleeding complications seem to occur more frequently.

Significance of abnormal blood coagulation in patients with chronic myelomonocytic leukemia.

In aretrospective study, we analyzed the prevalence of subnormal prothrombin time (PT) values in 104patients with chronic myelomonocytic leukemia (CMML), their potential prognostic impact, and potential correlations with clinicolaboratory features. Reduced PT values (< 70%) were found in 45/104 (43%) patients. The median survival of patients with reduced PT values was significantly shorter than in patients with normal PT (19 vs. 49months, p = 0.006). Patients with reduced PT had higher leukocyte counts, ahigher proportion of circulating blast cells, and lower platelet counts. In patients for whom clinical information was available, there was no difference in the incidence of bleeding complications between patients with or without reduced PT. Our results show ahigh prevalence of plasmatic coagulation abnormalities in patients with CMML, which were associated with laboratory features of advanced disease. Moreover, subnormal PT values were identified as anew prognostic marker. Reduced PT values do not seem to have aclinical impact regarding bleeding complications.

Improved long-term outcomes with catheter-directed therapies over medical management in patients with submassive pulmonary embolism—a retrospective matched cohort study

BackgroundThe benefit of catheter-directed therapy (CDT) for submassive pulmonary embolism (sPE) has been the subject of debate. We sought to determine the short- and long-term mortality and outcomes of CDT compared with anticoagulation for patients with sPE. MethodsWe performed a single healthcare network, multihospital, retrospective cohort study of hospitalizations for sPE from 2012 to 2019. sPE was defined as the presence of right heart strain or elevated biomarkers (troponin I or B-type natriuretic peptide). Patients with massive PE and those who had undergone systemic thrombolysis were excluded. The sPE groups included therapeutic anticoagulation alone or anticoagulation plus CDT (ie, thrombolysis or suction thrombectomy). The primary outcome was mortality at 1, 3, and 5 years. The other measured outcomes included PE-related death, short term mortality (30 days and 3 and 6 months), 30-day treatment-related complications (eg, bleeding, transfusion, stroke), chronic thromboembolic pulmonary hypertension, and 6-minute walk test at 1 year. After 1:1 nearest-neighbor propensity score matching, Kaplan-Meier survival plots were generated, and the treatment groups were compared using log-rank testing. We used Cox multivariate analysis to evaluate the outcomes after clustering at the hospital level, generating matched hazard ratios (mHRs) with associated 95% confidence intervals (CIs). ResultsOf 6746 sPE hospitalizations, the patients who had received CDT were younger (age, 58.9 ± 15.5 years vs 61.5 ± 17.4 years; P = .004), were more frequently White (92.5% vs 85.7%; P < .001), and had presented with a higher mean heart rate (104.6 bpm vs 94.9 bpm; P < .001), lower median systolic blood pressure (129 mm Hg vs 135 mm Hg; P < .001), and a greater incidence of right heart strain (79.2% vs 20.3%; P < .001). A total of 470 patients were matched, with 235 in the CDT group and 235 in the anticoagulation-only group. CDT was associated with a lower risk of mortality compared with anticoagulation at 1 year (7.6% vs 9.8%; mHR, 0.77; 95% CI, 0.65-0.92; P = .004), 3 years (11.1% vs 16.6%; mHR, 0.64; 95% CI, 0.55-0.73; P < .001), and 5 years (14.5% vs 19.1%; mHR, 0.71; 95% CI, 0.66-0.77; P < .001). Anticoagulation alone resulted in a greater incidence of PE-related deaths at 1, 3, and 5 years. The mortality at 30 days and 3 months was similar; however, CDT had resulted in better survival at 6 months (mHR, 0.81; 95% CI, 0.68-0.97; P = .02). No differences were found between the two groups in the incidence of bleeding complications at 30 days, development of chronic thromboembolic pulmonary hypertension, or the mean walking distance at 1 year. ConclusionsCDT plus anticoagulation for sPE was associated with improved long-term survival compared with anticoagulation alone, with a lower incidence of PE-related death and a low complication rate. CDT should be considered for select patients with sPE given its survival benefit.

Bleeding complications in patients on new oral anticoagulants for venous thromboembolism in Kenya.

The incidence of bleeding complications in patients with venous thromboembolism (VTE) on new oral anticoagulants (NOACs) has not been widely studied in contemporary clinical practice in Africa. The purpose of this study was to determine the rates of major bleeding, clinically relevant non-major bleeding (CRNM) and minor bleeding associated with NOAC use. A retrospective review was carried out of patients diagnosed with venous thromboembolism and treated with NOACs at the Aga Khan University Hospital, Nairobi, from January 2014 to December 2019. Clinical and outcome data were collected from medical records and the hospital mortality database. All patients with VTE aged > 18 years and initiated on NOACS were recruited. Patients with missing information were excluded. They were followed up from the time of commencement of oral anticoagulation to completion of therapy, or to the time of the first major bleed, CRNM or minor bleeding. Data on bleeding were obtained from the hospital database and through telephone interviews. Unadjusted rates of the first major bleeding event or CRNM were calculated as the number of bleeding events per 100 person-years. Two hundred and forty-three patients with VTE were recruited and 222 (91.4%) were initiated on rivaroxaban, 12 (4.9%) on dabigatran and nine (3.7%) on apixaban, with a median follow up of 213 [interquartile range (IQR): 119-477] days. The median age of the patients was 57 (IQR: 45-71) years. A total of 64 bleeding events were identified in 50 (20.6%) patients. Overall, the incidence rate for bleeding events was 17.24 per 100 patient-years. The incidence rate of major bleeding was 3.79 per 100 person-years. Gastrointestinal bleeding was the most common major bleeding site. There were more females with bleeding events (70.7%) compared to males. Anaemia and the use of aspirin and other antiplatelets were associated with a higher incidence of major and CRNM bleeding [relative risk (RR) = 3.77, confidence interval (CI) = 1.37-10.39, p = 0.005 and RR = 8.89, CI = 2.06-38.33, p = 0.0003, respectively]. Most of these bleeds were minor, with the gastrointestinal tract being the most common source of major bleeding and menorrhagia being the commonest cause of bleeding. Anaemia and the use of aspirin were associated with a higher incidence of major bleeding.

Clinical study of heparin anticoagulation scheme during plasma adsorption therapy for liver failure

Objective: To investigate the reasonable dosage of heparin anticoagulation scheme during plasma adsorption (PA) therapy for liver failure. Methods: Patients with liver failure treated with PA therapy were retrospectively collected and divided according to the anticoagulation scheme into the first-dose heparin anticoagulation group and the first-dose plus maintenance heparin anticoagulation group. Clinical data and laboratory test results were compared before and after treatment between the two groups. Paired t-tests were used for comparison within the normally distributed groups. An independent two-sample t-test was used for inter group comparison. Wilcoxon rank-sum test was used for measurement data that did not conform to a normal distribution. Fisher's exact test was used to compare the count data between groups. Results: There were 138 cases with liver failure treated with PA therapy from October 2017 to September 2020. Among them, 83 and 55 cases were in the first-dose heparin anticoagulation and first-dose plus maintenance heparin anticoagulation group, respectively. Age, gender, and laboratory data before treatment were comparable between the two groups. PA treatment was successfully completed in both groups of patient, and there was no statistically significant difference in the determination of coagulation level with plasma separators (Z=-0.15, P=0.216). There were different degrees of bleeding complications in both groups. In the first-dose heparin anticoagulation group, there were two cases (2.4%) of central venous catheter bleeding and one case (1.2%) of epistaxis. In the first-dose plus maintenance heparin anticoagulation group, there were five cases (9.1%) of central venous catheter bleeding, two cases (3.6%) of skin bleeding, one case (1.8%) of epistaxis, and one case (1.8%) of upper gastrointestinal bleeding. The incidence of bleeding complications was lower in the first-dose of heparin anticoagulation than first-dose plus maintenance heparin anticoagulation group, and the difference was statistically significant (P<0.001). The activated partial thromboplastin time of the two groups was prolonged after therapy withdrawal than with therapy, and the difference was statistically significant (first-dose heparin anticoagulation group: t=3.850, P=0.022; first-dose plus maintenance heparin anticoagulation group: t=6.733, P=0.007). The activated partial thromboplastin time was prolonged in patients with first-dose plus maintenance heparin anticoagulation than first-dose heparin anticoagulation group, and the difference was statistically significant (P=0.025). The total bilirubin of the two groups before and after PA was significantly changed (the first-dose heparin anticoagulation group: Z=-2.455, P=0.017; the first-dose plus maintenance heparin anticoagulation group: Z=-2.307, P=0.024), and there was no statistically significant difference between the two groups (P=0.412). There was no statistically significant difference in platelet changes before and after PA therapy between the two groups (the first dose of heparin anticoagulation group: Z=-0.529, P=0.480; the first-dose plus maintenance heparin anticoagulation group: Z=-0.276, P=0.362). Conclusion: Anticoagulation scheme without maintenance medication is feasible with prothrombin activity before ≤20-40%, activated partial thromboplastin time of ≤87 s (2 times the upper normal value), platelet count before treatment (excluding contraindications to heparin) ≥50×109/L, and the first dose of heparin administration of 0.2 mg/kg during PA therapy in patients with liver failure.

Feasibility of open chest management with modified negative pressure wound therapy immediately after cardiac surgery.

OBJECTIVESTo evaluate the feasibility of open chest management with our modified negative pressure wound therapy immediately after cardiac surgery as a therapy for atypical tamponade.METHODSOpen chest with modified negative pressure wound therapy was performed immediately after cardiac surgery. The surface of the heart and the vessels were covered with non-adherent siliconized gauze. The sternal halves were stented using edge-cut disposable syringes to maintain a larger mediastinal cavity. Approximately 45 mm of distance was kept between the sternal edges. A trimmed sterile polyvinyl foam sponge was inserted into the mediastinum, the entire wound was sealed and negative pressure (−50 to −75 mmHg) was applied using a suction generator. Delayed chest closure was performed in a standard manner once the haemodynamic status was stabilizsed.RESULTSThe mortality rate was 3/15 (20%) patients. Deep sternal wound infection occurred in 1/15 (6.7%) patients. Five patients were extubated during the open chest management. Sternal closure was delayed for median of 3 days after the initial surgery. There was no incidence of bleeding complications or need for additional haemostatic procedures.CONCLUSIONSNegative pressure wound therapy performed immediately after cardiac surgery was feasible in our small number of patients.Clinical registration numberStudy ID: 2020-149.

Management of patients with inherited bleeding disorders in oral surgery: A 13-year experience

IntroductionThe management of patients with inherited bleeding disorders in oral surgery requires the systematic evaluation of bleeding risk and the setting up of an adequate treatment protocol by the referring haematologist, defining a replacement therapy and a recommended length of hospital stay. The purpose of this study was to determine the bleeding risk associated with oral surgery for each type of inherited bleeding disorder and to evaluate the efficacy of the treatment protocols set up in our tertiary care center. Materials and methodsWe included all patients with an inherited bleeding disorder, managed in our oral and maxillofacial surgery department with a treatment protocol set up by our local Haemophilia Treatment Centre for an oral surgical procedure. ResultsBetween January 2006 and December 2018, 295 treatment protocols were set up for the management of patients with haemorrhagic risk in oral surgical procedures. Of these, 203 were scheduled to take place in our department. A total of 180 oral surgical procedures for 147 patients were included. The incidence of bleeding complications in our study was 4.44% (8 out of 180) with a significantly higher risk in patients with haemophilia, the mean time to onset of bleeding was 11 days. DiscussionThe use of a treatment protocol for the management of patients with inherited bleeding disorders in oral surgery seems effective. Our rate of bleeding complications was comparable to data in the literature, and often lower.

Bleeding Complications in Relation to the International Normalized Ratio for Dental Extractions in Patients under Chronic Anticoagulant Therapy - An Evaluative Study.

Recent simple dental extraction protocols suggest that therapeutic levels of the anticoagulant drug should be maintained because bleeding complications could be managed with local haemostasis manoeuvres. The aim of the present study was to evaluate the association between bleeding complications and the international normalized ratio (INR) values in patients after dental extractions completed with a plug of bismuth subgallate, without interrupting anticoagulant administration. Patients undergoing oral Vitamin K antagonist chronic anticoagulant therapy requiring simple dental extractions were included in the study. INRs were recorded on the day of the surgery, and dental extractions were performed applying bismuth subgallate as a haemostatic agent. Patients took their anticoagulation drug normally. Bleeding complications were recorded. The study included 694 patients, of whom 11 (1.58%) presented mediate post-operative bleeding that was effectively controlled through local manoeuvres. No episode of thromboembolism or infectious endocarditis was observed. The incidence of bleeding complications was not related to the INR values (P > 0.05). INR values were not related to bleeding complications when simple dental extractions were performed applying bismuth subgallate as a haemostatic agent.