Major Hemorrhagic Complications Research Articles

Analysis of rescue strategies for acute thrombosis during STA-MCA bypass surgery and the literature review

Background and objectivesSTA-MCA bypass surgery is mainly used for Moyamoya disease, giant intracranial aneurysms, and resection of intracranial tumors requiring sacrifice of blood vessels. The intraoperative patency of the reconstructive vessels is critical to the efficacy of the procedure. This study aimed to evaluate the efficacy of intra-arterially infused tirofiban for the treatment of acute thrombosis during STA-MCA bypass surgery and countermeasures for acute thrombosis.MethodsThis study involved 209 patients (272 hemispheres) who underwent STA-MCA surgery between November 2020 and December 2023. Intraoperative acute thrombosis occurred in eight patients (3.83%,8 hemispheres). We retrospectively reviewed the clinical and imaging data, surgical procedure, and follow-up outcomes of eight patients. We implemented the different thrombolytic methods to evaluate the optimal thrombosis management during the bypass surgery. After three months, we assessed neurological functions using the modified Rankin Scale (mRS) and conducted a literature review using PubMed.ResultsEight patients (four male patients and four female patients) developed acute thrombosis during the bypass surgery. Of the eight patients, two underwent re-anastomosis after thrombus removal, three received local injections of tirofiban into the anastomosis or the branches of the superficial temporal artery, and three underwent superselective intra-arterial tirofiban infusion using a microcatheter. Thrombosis were resolved, and arteries were recanalized in all patients. The mRS score was 0 in all patients. No major ischemic or hemorrhagic complications occurred.ConclusionOur treatment methods were efficacious in the management of acute thrombosis. Intra-arterial tirofiban administration seems to be a simple and effective treatment option for acute thrombosis during STA-MCA bypass surgery.

Endovascular treatment of wide-neck bifurcation aneurysms using pCONUS2 HPC bridging device with single antiplatelet: A Case Series.

Wide neck bifurcation aneurysms (WNBA) are technically challenging for both surgical and endovascular treatments. Endovascular treatment for WNBA often requires dual antiplatelet therapy (DAPT) post stent insertion. Novel devices such as the pCONUS2 HPC neck bridging device have an HPC coating which reduces the device thrombogenicity. This theoretically allows for use of single antiplatelet therapy (SAPT), which would be advantageous, particularly in treating ruptured aneurysms. This case series aims to evaluate the safety of SAPT regimen only post stent insertion, by presenting our center early clinical experience in using pCONUS2 HPC neck bridging device in patients that are not suitable for DAPT. We report the cases of 3 patients (2 females, 1 male; range: 64-71 years old) who underwent coil embolization for WNBA using the pCONUS2 HPC device (2 unruptured WNBA, and 1 ruptured WNBA). As all 3 patients were allergic to Aspirin, they could only be started on SAPT post endovascular therapy. All 3 patients were diagnosed with WNBA on angiographic studies. Patient 1 had an unruptured left middle cerebral artery aneurysm; Patient 2 had a ruptured basilar tip aneurysm; Patient 3 had an unruptured anterior communicating artery (ACOM) aneurysm. All 3 WNBA were treated with pCONUS2 HPC neck bridging device. There were no immediate complications. The immediate angiographic result of aneurysm treatment in Patient 1 and Patient 2 demonstrated incomplete occlusions, with delayed complete occlusion of aneurysm in Patient 1 and growth of aneurysmal neck in Patient 2 on follow-up angiograms (range: 6-9 months). No major thrombo-embolic or hemorrhagic complications in the first 2 patients. For Patient 3, the immediate angiographic result of the treated aneurysm demonstrated complete occlusion. However, the patient readmitted 11 days post procedure with cerebral infarction, scoring 5 on the modified Rankin scale on discharge. pCONUS2 HPC as a neck bridging device in treating WNBA has yet to be shown superior to traditional techniques and devices. The theoretical advantage of HPC coating reducing its thrombogenicity requiring only SAPT is yet to be proven safe in clinical practice.

Lower Coated-platelet Potential is Associated with Major Hemorrhagic Complications After Discharge in Patients with Non-lacunar Brain Infarction (P2-5.030)

Lower Coated-platelet Potential is Associated with Major Hemorrhagic Complications After Discharge in Patients with Non-lacunar Brain Infarction (P2-5.030)

Impact of Premedication Prior to Platelet Transfusion on Platelet Increment Among Hemato-Oncological Patients

Introduction: Platelet transfusions have reduced the incidence of major hemorrhagic complications among hemato-oncological patients, however they are associated with potential complications, including transfusion reactions. The efficacy of premedication with steroids and/or antihistamines prior to platelet transfusion in preventing transfusion reactions has been studied. However, to the best of our knowledge, the effect of premedication on platelet increment has not been previously addressed. We aimed to assess the impact of premedication on platelet increment after platelet transfusion. Methods: We conducted a prospective study among adult patients admitted to the hemato-oncology and bone marrow transplantation (BMT) units in a tertiary medical center. Enrolled patients, who received a platelet transfusion during their admission, had a complete blood count taken 1-hour post platelet transfusion completion. The decision whether to administer premedication and the specific medications were left to the discretion of the attending physician. Single donor platelets or 5 pooled random donor platelets were provided by the blood bank interchangeably according to inventory level. The primary outcome was platelet recovery, defined as the difference between the 1-hour post- and pre- transfusion platelet counts. Adequate platelet recovery was considered >10,000/µL. Secondary outcome was platelet survival, defined as the difference between platelet count 18- to 24-hours post- and pre- transfusion. Rates of post-transfusion reactions and premedication complications were recorded. Association of other clinical variables with outcomes of interest was evaluated and variables significantly associated with adequate platelet recovery response (p<0.05) were entered into a multivariable analysis. Results: Overall, 68 patients were enrolled, with a median age of 58 years (interquartile range [IQR] 45-67) and 43 (63%) were males. The most common diagnoses were AML (n=24, 35%) and multiple myeloma (n=23, 34%). Most patients (72%) were admitted for a BMT (autologous 47%, allogeneic 25%). Outcomes were recorded in response to 217 platelet transfusions, with a median number of platelet transfusion per patient of 4 (IQR 3-5). Premedication was given prior to 64 transfusions (29%), consisting of steroids in 17 (27%), antihistamines in 4 (6%), or both in 43 (67%) platelet transfusions. In 153 (71%) platelet transfusions, no premedication was given. Patients who received premedication were younger, more often had a diagnosis of acute leukemia and were mostly admitted for non-transplant admissions. ( Table 1). Median platelet recovery and survival for all platelet transfusions were 15,000/µL (IQR 10,0000-22,500/µL) and 8,000/µL (IQR 4000-14,000/µL), respectively. There was no significant difference in median platelet recovery and survival between patients who received premedication and those who did not (15,000/µL in both cohorts, p=0.36 and 6,500 vs. 9,000/µL, p=0.69, respectively). The number of platelet transfusions leading to adequate platelet recovery was 150/213 (70.4%) overall, with no significant difference between patients who received premedication and those who did not [45/64 (70.3%) vs.105/153 (70.5%), p=1.0]. Female gender was associated with a higher rate of adequate platelet response in univariate analysis (81.7% vs. 63.4%, p=0.006), while splenomegaly was associated with a trend towards lower rates of adequate platelet recovery (55.2% vs. 71.4%, p=0.086). None of these variables was associated with adequate platelet recovery in multivariate analysis. Febrile non-hemolytic transfusion reaction (FNHTR) was significantly more common after platelet transfusions without premedication compared to platelet transfusions with premedication (7.8% vs. 0%, respectively, p=0.02). Among patients who received premedication, only one patient developed grade 2 asymptomatic hyperglycemia. Conclusions: To the best of our knowledge, this is the first prospective study to assess the impact of premedication prior to platelet transfusion on platelet recovery and survival. We did not observe an effect of premedication on various parameters of platelet increment, while use of premedication did reduce FNHTR. Our results suggest that premedication with steroids and/or antihistamines can be given prior to platelet transfusion without compromising platelet increment.

Platelet-Based Dose-Adjusted Low Molecular Weight Heparin Treatment Is Efficacious and Safe in Newly Diagnosed Acute Leukemia Patients with Catheter-Related Thrombosis

Introduction: Catheter-related thrombosis (CRT) is a major complication in patients with acute leukemia. Severe thrombocytopenia related to either the concomitant disease or therapy underscores the challenge of CRT management, resulting in the use of suboptimal anticoagulation, potentially leading to high rates of short-term complications, including recurrent thromboembolism and hemorrhage. Due to the paucity of data regarding the impact of reduced-dose anticoagulation on this clinical setting, the current study aimed to assess the safety and efficacy of this treatment approach to CRT management in this challenging patient population. Methods: In this retrospective, case-control study, all adult (age ≥18 years) acute leukemia patients, who had arrived at the Rambam Health Care Campus (RHCC, Haifa, Israel) between 1.11.2004-30.6.2022 to receive anti-leukemia therapy via a peripherally inserted central catheter (PICC) line were screened. The inclusion criteria were: patients with acute myeloid, promyelocytic and lymphoid leukemia (AML, APL, and ALL, respectively) and CRT confirmed by Doppler ultrasound within 3 months of leukemia diagnosis. Patients were divided into full- (i.e., 1 mg/kg bid) vs. partial-dose low molecular weight heparin (LMWH) groups. The LMWH dose was based on the platelet count with a cutoff of 50K/L, distinguishing between the selected doses. Primary endpoints: A record of venous thromboembolism (VTE; including pulmonary embolism (PE), deep vein thrombosis (DVT), and catheter-related thrombosis (CRT) recurrence within 12 months as well as a major hemorrhage (including intracranial, retinal and gastrointestinal hemorrhage) within 6 months. Secondary endpoints: blood product requirement (unit/day) before and after the CRT diagnosis (from leukemia diagnosis till CRT identification and 90 days or death (if prior) from the event, respectively) assessed in a self-controlled case series manner. Data were collected from the hospital electronic medical records. Chi-square and paired samples Wilcoxon tests were utilized for statistical analysis. Results: Overall,195 patients [aged 54±15 years; 103 (53%) males], diagnosed with CRT were included. The most frequent leukemia diagnosis was AML (n=149; 76%), with ALL and APL established in 23 (12%) patients each. CRT was diagnosed in the left upper limb in 136 (70%) patients, with 99 (46%) patients suffering from DVT. Eighty-eight (45%) patients were treated with full-dose LMWH. Recurrent VTE was identified in 11(12.5%) patients treated with full-dose LMWH vs. 9 (8.4%) receiving partial-dose LMWH (p-value 0.484), while major hemorrhage was diagnosed in 12 (13.6%) patients from the former group vs. 14 (13.0%) patients from the latter group (table 1). Similar results were documented upon stratification to deep vs. superficial CRT, and the leukemia type. The packed red blood cell (RBC) administration rate was lower in the post-CRT phase (0.12 units/day, IQR 0.06-0.20) compared to the pre-CRT phase (0.20 units/day, IQR 0-0.36; p-value <0.0001). Platelet utilization rates were similar in both the pre-CRT and post-CRT phases (0.05 units/day, IQR 0-0.24 and 0.06 units/day, IQR 0.01-0.16, respectively; p-value 0.126). Comparable results were observed in both full and partial-dose LMWH groups. Conclusion: LMWH dose adjustment based on platelet counts, in newly diagnosed acute leukemia patients with CRT, is not associated with higher rates of VTE recurrence. Moreover, this strategy does not result in major hemorrhagic complications even in patients with severe thrombocytopenia. Notably, RBC infusion requirements were lower in the post-CRT diagnosis phase, while platelet transfusion was similar during the pre- and post-CRT phases. This analysis, including a large number of patients, demonstrates that the adjusted therapy is safe and efficient in this challenging clinical scenario.

Comparison of intraoperative blood loss and perioperative complications between preoperative embolization and nonembolization combined with spinal tumor surgeries: a systematic review and meta-analysis.

The present study aimed to comparatively evaluate intraoperative blood loss (IBL) and perioperative complications between preoperative embolization (PE) and nonembolization (NE) combined with spinal tumor surgeries as well as to determine the subgroup of spinal tumor surgeries suitable for PE. A systematic search in PubMed and EMBASE and an additional search by reference lists of the retrieved studies were undertaken by two reviewers. The mean IBL and perioperative complication rate were employed as the effect size in the general quantitative synthesis through direct calculation. Meta-analysis was performed using standardized mean difference (SMD) and weighted mean difference (WMD) of IBL and the odds ratio (OR) of complications. Heterogeneity was assessed using the I2 statistic. The reviewers selected 17 published studies for the general quantitative synthesis and meta-analyses. The mean IBL of spinal tumor surgeries was 1786.3mL in the NE group and 1716.4mL in the PE group. The mean IBL between the two groups was similar. The pooled WMD and SMD of IBL in spinal tumor surgeries was 324.15mL (95% CI 89.50-1640.9, p = 0.007) and 0.398 (95% CI 0.114-0.682, p = 0.006), respectively. The reduction of the PE group compared with the NE group for the rates of major complications and major hemorrhagic complications were 7.80% and 5.71%, respectively. The risk of PE-related complications in the PE group was only 1.53% more than in the PE group. The pooled OR of major complications in spinal tumor surgeries was 1.426 (95% CI 0.760-2.674; p = 0.269). PE may be suitable for spinal tumor surgeries and some subgroups. From the perspective of complications, PE may also be a feasible option for spinal tumor surgeries.

Early Termination versus Standard Regimen Duration of Dual Antiplatelet Therapy in Intracranial Aneurysm Patients Treated With Pipeline Embolization Device Flex With Shield Technology: Preliminary Experience of 3 U.S. Centers

Pipeline Flex Embolization Device with Shield Technology (PED-Shield) is a third-generation flow diverter with reduced thromboembolic potential. However, safety profile and dual antiplatelet therapy (DAPT) recommendations with PED-Shield is not well -established. We aim to assess the safety and complication profile with early termination of DAPT with use of PED-Shield. Databases of 3 high-volume cerebrovascular centers were retrospectively reviewed. We identified patients with unruptured and ruptured intracranial aneurysms treated with PED-Shield. Patient demographics, aneurysm characteristics, complications, and angiographic outcomes were extracted. All patients who had early termination of DAPT, defined as <180 days, as well as standard duration were included. A total of 37 patients, totaling 37 aneurysms, had early termination of DAPT and 24 patients with 24 aneurysms received standard duration (>180 days) of DAPT. There was no difference in pre-procedural DAPT regimens between the groups (P= 0.503). Following DAPT termination, o1ne major thromboembolic complication was observed in the early termination group while no major or minor thromboembolic or hemorrhagic complication was noted in the standard duration group. Time of angiographic follow-up was not statistically different (P= 0.063) between the early termination (343 days, interquartile range [IQR] 114-371 days) and the standard duration (175 days, IQR 111-224.5 days) groups. There were no statistically significant differences in complete aneurysm occlusion (P= 0.857), residual neck (P= 0.582), and aneurysm remnant (P= 0.352) rates between the groups on angiography. Early termination of DAPT proves safe after PED-Shield treatment of intracranial aneurysms with comparable complete occlusion rates.

Comparison of Safety and Effectiveness of Bivalirudin Between Diabetic and Nondiabetic Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention

Background: Recurrent thrombotic events remain significantly high in spite of the currently recommended dual antiplatelet (DAPT) and conventional antithrombotic heparin (± GPI/ glycoprotein IIb/IIIa inhibitor) in diabetic ACS patients after PCI compared with non-diabetic even this drug eluting stent (DES) era. Therefore, more potent antithrombotic therapies are warranted for this group of high-risk patients.Comparison of safety and efficacy of newer anticoagulant bivalirudin between diabetic and non-diabetic ACS patients undergoing PCI using bivalirudin versus heparin (± GPI) is less well defined in Bangladeshi population. Objective: To determine and compare the incidence of 30-day major adverse cardiac events (MACEs), stent thrombosis and hemorrhagic complications between diabetic and non-diabetic ACS patients undergoing PCI. Impact of antithrombotic strategy (bivalirudin vs. heparin ± GPI) on the 30- day post PCI clinical outcome was also evaluated and compared between diabetic and non-diabetic subgroup. Methods: In this randomized controlled study, 500 ACS patients aged 18-75 years (200diabetic and 300 non-diabetics) who underwent PCI from November 2018 to October 2019 at the department of cardiology, BSMMU, were randomly assigned, in an open-label fashion to treatment with bivalirudin alone, heparin alone, or heparin plus eptifibatide (GPI) in a 1:1:1 ratio. Among them, 200 patients received Bivalirudin with a loading dose of 0.75 mg/kg, followed by an infusion of 1.75 mg/kg/h for up to 4 hours, 153 patients received UFH with a bolus of 70-100 U/kg (targeted ACT: 200-250 s) and 147 patients got heparin plus eptifibatide as 60 IU/kg heparin along with 180 μg/kg eptifibatide i.v. boluses, followed by a 2 μg /kg /min eptifibatide infusion for 18 hr consistent with current guidelines.Other pre- and post-procedural medications got under current guidelines. Both diabetic and non-diabetic subjects were subdivided into bivalirudin and control group (heparin ± GPI). In diabetic cohort, 100 patients were in bivalirudin and 100 patients were in control group. Among non -diabetic patients, 100 were in bivalirudin and 200 were in control group. The outcome measures were 30-day hemorrhagic complications, stent thrombosis, and MACCEs [death, MI, target lesion revascularization (TLR), and stroke] according to diabetic status. The diabetic and non-diabetic subgroup was also analyzed for the same outcome measure according to antithrombotic strategy. Peri and post PCI clinical follow-up comprised checking office visits and telephone contacts. Results: According to diabetic status, net adverse clinical events (NACEs) were significantly higher in diabetic in comparison to non-diabetic (diabetic vs. non-diabetic, 15% vs. 7.6 %, P=0.008) and was associated with higher incidence of MACCEs (10.5% vs. 4.0%, P=0.004), cardiac death (4 % vs. 1 %, P=0.02) and BARC 2,3,5 grade bleeding events (9% vs. 4 %, P=0.02). In diabetic cohort, incidence of 30-day NACEs was significantly lower in bivalirudin than control group(bivalirudin vs. UFH ± GPI, 6 % vs. 24 %, P=0.004) and was associated with lower incidence of MACCEs (2% vs. 8.5%, P=0.03) and bleeding events (3 % vs. 15 %, P=0.003) whereas incidence of stent thrombosis (2 % vs. 3%, P =0.651) was comparable between the bivalirudin and control groups. There was a significant advantage in favor of bivalirudin treatment among insulin-treated patients with regard to cardiac death at 30-day (bivalirudin vs. control group, 0% vs. 16.6%, p = 0.03) compared with non-insulin treat diabetic patients. However, subgroup analysis of the nondiabetic patients showed that there was no significant difference in the incidence of 30-Day NACEs (4% vs. 9.5%, P=0.09) according anticoagulant status. Multivariate analysis showed that bivalirudin (HR: 0. 202, 95% CI: 0.078 – 0.519, P=0.009) was independent protective factor of 30-day NACEs for diabetic patients. Conclusion: Bivalirudin monotherapy is safer and more efficacious for diabetic ACS patients compared with non-diabetic ACS patients undergoing PCI. J Dhaka Med Coll. 2022; 31(1) : 126-136

Lights and Shadows of Paracentesis: Is an Ultrasound Guided Approach Enough to Prevent Bleeding Complications?

Paracentesis is a validated procedure for diagnosing and managing ascites. Although paracentesis is a safe procedure with a 1–2% risk of complications such as bleeding, it is necessary to inform the patient about the possible adverse events. We would like to share our experience with two cases of bleeding after paracentesis. In our unit, two major hemorrhagic complications occurred in 162 procedures performed over the year 2020 (frequency of bleeding complications: 1.2%). We report two clinical cases of post-paracentesis abdominal wall hematomas. Despite a similar clinical presentation, the management approach was different: in the first case, embolization of the epigastric artery supplying the hematoma was performed. In the second case, conservative treatment was adopted. Our report aims to provide food for thought about a potentially challenging hemorrhagic complication, even with the risk of adverse outcomes.

Efficacy of the Hepcon System in Reducing Hemorrhagic and Thrombotic Complications in Antiphospholipid Syndrome Patients Undergoing Cardiac Surgery Requiring Cardiopulmonary Bypass

Introduction: Patients with Antiphospholipid Syndrome (APS) undergoing cardiopulmonary bypass (CPB) surgery are at increased risk for thrombotic and hemorrhagic complications. Heparin concentration during CPB is typically monitored by the activated clotting time (ACT), however, antiphospholipid antibodies have the potential to alter the baseline ACT. The Hepcon Hemostasis Management System (HMS) utilizes an individualized heparin dose-response curve to estimate free plasma heparin levels and has been shown to correlate well with anti-Xa levels. The purpose of this study is to evaluate the efficacy of Hepcon HMS in reducing thrombotic and hemorrhagic complications in APS patients undergoing cardiac surgery requiring CPB in a large cardiac surgery referral center. Herein, we report the largest cohort study to date of APS patients monitored with Hepcon HMS during CPB surgery. Methods: We performed a retrospective study of APS patients who underwent cardiac surgery requiring CPB at the Cleveland Clinic between April 2013 and July 2020. Two sets of antiphospholipid (APL) antibody labs spaced at least 12 weeks apart, or one set of APL labs in addition to historical elevated antibodies must have been present for inclusion. Vascular thrombosis or pregnancy morbidity (defined by revised Sapporo criteria) must have been documented for inclusion. The Hepcon HMS was utilized for intraoperative (intra-op) anticoagulation monitoring at the discretion of the cardiothoracic surgeon, anesthesiologist, and perfusionist. Data including blood product administration, thromboembolic, and major hemorrhagic complications were collected from the intra-op period through post-operative (post-op) day 30. Major hemorrhage was defined using the International Society on Thrombosis and Haemostasis criteria. The primary endpoint was the composite rate of thromboembolic or hemorrhagic complications per surgical case in patients monitored by Hepcon HMS vs. patients monitored by point-of-care-ACT. Secondary endpoints were median volume of chest tube output and packed red blood cell (PRBC) transfusion within the first 3 post-op days. Continuous and categorical variables were analyzed using Wilcoxon rank sum test and Fisher's exact test, respectively. Results: Of 201 screened patients, 43 met inclusion criteria. Of the 43 patients, 20 (47%) patients were monitored using Hepcon HMS during CPB surgery while 23 (53%) were monitored using point-of-care ACT. The two groups did not have a statistically significant difference in baseline characteristics including gender, comorbidities, age, and pre-op ACT, body mass index, creatinine, hemoglobin, and platelet count. The presence of triple positive APL antibody profile was statistically significant between the two groups with 11 such patients in the Hepcon HMS group and 2 such patients in the ACT group (p = .001). Surgical characteristics including total pump time, total cross clamp time, procedure type, and intra-op PRBC transfusion were not significantly different between the two groups. For the primary endpoint, there was no statistically significant difference between the Hepcon HMS and ACT groups (Hepcon HMS 6/20 [30%]; ACT 7/23 [30%]; p = >.99). For the secondary endpoints, there was no statistically significant difference in median post-op chest tube output (780mL vs. 850mL; p = .88) and median post-op PRBC transfusion (1 unit vs. 0 unit; p = .28) between the Hepcon HMS and ACT groups, respectively. Subgroup analysis of patients with triple positive APL antibody profile did not show a statistically significant difference in rate of complications between those monitored with Hepcon HMS vs. those monitored by ACT (27% vs. 50%, p = .54). Conclusion: In this largest to date cohort study of APS patients who underwent CPB surgery, there was no difference in the composite outcome of thrombotic or hemorrhagic complications in patients monitored by Hepcon HMS vs. those monitored by ACT. Both groups had a high rate of complications, which highlights the high-risk nature of this patient population. Prospective randomized trials are warranted to better define optimal heparin concentration monitoring during CPB surgery in APS patients. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Feasibility and safety of renal artery closure with advanced bipolar energy device during nephrectomy.

Many devices are available to control the renal pedicle during nephrectomy but the gold standard is still a matter of debate. Nanotechnology has evolved to include vessel-sealing systems; companies guarantee an efficacy for vessels until 7 mm. The aim of our study is to evaluate feasibility and safety of closure of the renal artery with radiofrequency energy during nephrectomy. We retrospectively evaluated consecutive patients undergoing nephrectomy between November 2016 and July 2020. Inclusion criteria were: renal artery diameter <7 mm and no significant arterial wall calcification. The EnSeal device was used in all cases for dissection, hemostasis and to secure the renal artery when feasible. Overall 101 patients underwent nephrectomy, in 68 cases the radiofrequency alone was used to close the renal artery; in 45 patients during a laparoscopic procedure and in 23 during an open surgery. Conversion to open surgery was never necessary. No patients had major hemorrhagic complications. Mean operative time was 75 min, mean intraoperative blood loss was 85 ml. Overall 11 patients had postoperative complications, according to Clavien-Dindo: five grade I, three grade II, three grade III. In our experience the closure of the renal artery with a radiofrequency energy device is a feasible and safe procedure. It allows a safe manipulation of the renal hilum, free from clips, which could limit surgeons' maneuvers and be dislocated. We believe that a deep knowledge of the available technologies is fundamental for the surgeon and guarantees the best achievable results.

Catheter-directed therapies for the treatment of high risk (massive) and intermediate risk (submassive) acute pulmonary embolism.

Catheter-directed therapies for the treatment of high risk (massive) and intermediate risk (submassive) acute pulmonary embolism.

Kidney Transplantation From Deceased Donors With Vaccine-induced Immune Thrombocytopenia and Thrombosis: An Updated Analysis of the UK Experience.

The emergence and attendant mortality of vaccine-induced immune thrombocytopenia and thrombosis (VITT) as a consequence of vaccination against severe acute respiratory syndrome coronavirus 2 have resulted in some patients with VITT being considered as deceased organ donors. Outcomes after kidney transplantation in this context are poorly described. Because the disease seems to be mediated by antiplatelet factor 4 antibodies, there is a theoretical risk of transmission via passenger leukocytes within the allograft. We analyzed the experience of kidney transplantation from donors with VITT in the United Kingdom between January and June 2021. We followed-up all recipients of kidney-only transplants from donors with VITT to detect major postoperative complications or features of disease transmission and assess graft survival and function. There were 16 kidney donors and 30 single kidney transplant recipients in our study period. Of 11 preimplantation biopsies, 4 showed widespread glomerular microthrombi. After a median of 5 mo, patient and graft survival were 97% and 90%, respectively. The median 3-mo estimated glomerular filtration rate was 51 mL/min/1.73 m 2 . Two recipients had detectable antiplatelet factor 4 antibodies but no evidence of clinical disease after transplantation. Major hemorrhagic complications occurred in 3 recipients, all of whom had independent risk factors for bleeding, resulting in the loss of 2 grafts. The involvement of VITT could not be completely excluded in one of these cases. The UK experience to date shows that favorable outcomes are possible after kidney transplantation from donors with VITT but highlights the need for ongoing vigilance for donor-related complications in these patients.

Bivalirudin or Unfractionated Heparin for Anticoagulation in Pediatric Patients on Continuous Flow Ventricular Assist Device Support: Single-Center Retrospective Cohort Study

Bivalirudin is a direct thrombin inhibitor that is being increasingly used for anticoagulation in children after ventricular assist device (VAD) implantation. While the data on bivalirudin use in pulsatile flow VADs are growing, reports on its use in patients on continuous flow (CF) VAD as well as comparisons of associated outcomes with unfractionated heparin (UFH) remain limited. Retrospective cohort study. Single tertiary-quaternary referral center. All patients less than 21 years old on CF-VAD support who received bivalirudin or UFH for anticoagulation between the years 2016 and 2020. Not applicable. Clinical characteristics compared between the cohorts included time to target range of anticoagulation, markers of hemolysis, and prevalence of hemocompatibility-related adverse events such as major hemorrhagic complications, ischemic stroke, and pump thrombosis. In 42 unique patients (41 HeartWare HVAD [Medtronic, Minneapolis, MN], one HeartMate 3 LVAD [Abbott Laboratories, Abbott Park, IL]) during the study period, a total of 67 encounters of IV anticoagulation infusions (29 UFH and 38 bivalirudin) were retrospectively reviewed. In comparison with use of UFH, bivalirudin was associated with lesser odds of major bleeding complications (odds ratio [OR], 0.29; 95% CI, 0.09-0.97; p = 0.038). We failed to identify any difference in odds of major thrombotic complications (OR, 2.53; 95% CI, 0.47-13.59; p = 0.450). Eight of the patients (28%) on UFH were switched to bivalirudin due to hemorrhagic or thrombotic complications or inability to achieve therapeutic anticoagulation, while two of the patients (5%) on bivalirudin were switched to UFH due to hemorrhagic complications. Bivalirudin was used for a "washout" in eight cases with concern for pump thrombosis-six had resolution of the pump thrombosis, while two needed pump exchange. Use of bivalirudin for anticoagulation in patients on CF-VAD support was associated with lesser odds of hemorrhagic complications compared with use of UFH. Bivalirudin "washout" was successful in medical management of six of eight cases of possible pump thrombosis.

Safety and Effectiveness of First-line Endovascular Management of Low-Grade Brain Arteriovenous Malformations : Single Center Experience in 145 Patients.

Spetzler-Martin grade (SMG) I-II (low-grade) brain arteriovenous malformations (BAVMs) are often considered safe for microsurgical resection; however, the role of endovascular treatment (EVT) remains to be clarified in this indication, especially for unruptured BAVMs. The purpose of our study was to assess the safety and effectiveness of endovascular treatment as the first-line treatment for low-grade BAVMs. From our local database, we retrospectively retrieved patients with low-grade BAVMs, either ruptured or unruptured, treated by embolization as first-line treatment in our department between January 2005 and January 2020. The primary endpoint was the total obliteration rate of BAVMs, and secondary endpoints were hemorrhagic complications and final clinical outcome, assessed through shift of the modified Rankin scale, and mortality rate secondary to BAVM embolization. A total of 145 patients meeting inclusion criteria and treated by EVT as first-line therapy were included in the study (82ruptured and 63unruptured BAVMs). Overall, complete exclusion of BAVMs was achieved in 110 patients (75.9%); 58patients (70.7%) with ruptured and52 (82.5%) unruptured BAVMs, including 37.9% BAVMs excluded by EVT alone (35.5% among ruptured and 44.4% among unruptured BAVMs) and 38% by combined treatment (EVT and surgery or EVT and SRS). There was no BAVM volume cut-off predictive for total obliteration by embolization alone. Early minor hemorrhagic complications were reported in 14patients (9.6%) and early major hemorrhagic complications were reported in 5patients (3.4%). No late hemorrhagic complications (0%) occurred; mortality rate was 0.7% (1/145 patients). Improved/unchanged mRS was reported in 137 patients (94.5%). Endovascular treatment alone or associated with others exclusion techniques, might be safe and effective for complete exclusion of low-grade brain arteriovenous malformations regardless of the volume.

Abstract 78: A Single Center Comparison Of Transradial And Transfemoral Approaches For Carotid Angioplasty And Stent Placement

Context: Transradial access has been increasingly utilized for neurointerventional procedures including carotid angioplasty and stent placement (CAS) over the past decade. At our center, we adopted transradial approach as the preferred approach in 2020. Objective: To compare the results of transradial approach with transfemoral approach for CAS as part of a quality assurance initiative. Methods: We analyzed data collected for all non-urgent CAS procedures performed at our institute in the last 24 months by same interventionalists to minimize inter-operator variability. We looked at the rates of technical failure; hemorrhagic complications classified as major (hemoglobin decrease &gt;5 g/dL or intracranial hemorrhage with deficits), minor (hemoglobin decreases 3-5 g/dL or intracranial hemorrhage without residual deficits), or insignificant; and any stroke and/or death within 1-month post procedure. Results: A total of 182 non-urgent CAS procedures were performed at our institution; 116 (64%) were initiated using transfemoral approach and 66 (36%) were initiated using transradial approach. The median age was similar between the two group (66.5 years versus 66.7 years). There were 6 (3%) CAS procedures initiated using transradial approach but later converted to transfemoral due to anatomical and/or technical difficulties. One (0.6%) CAS procedure initiated using transfemoral approach was converted to transradial approach due to severe iliofemoral atherosclerosis. The rates of any stroke and/or death were 1.6% (n=1) and 3.3%% (n-=4) in patients undergoing CAS using transradial and transfemoral approaches, respectively. The rate of major hemorrhagic complications were 1.6% (n=1) and 5.7% (n-=7) in patients undergoing CAS using transradial and transfemoral approaches, respectively. Conclusions: The rates of major hemorrhagic complications were lower among patients who underwent CAS via transradial approach compared with CAS using transfemoral approach although the rates of technical failure remain relatively high with transradial approach.

The impact of blood pressure on the risk of major bleeding complication after renal transplant biopsy.

To assess the impact of elevated blood pressure on the rate of major hemorrhagic complication after renal transplant biopsy. Pre-procedural systolic (SBP), diastolic (SBP), and mean arterial (MAP) blood pressure for consecutive patients undergoing US-guided renal transplant biopsies from 08/01/2015 to 7/31/2017 were retrospectively recorded. Patients who had a major bleeding complication were identified. The risk of complication as a function of SBP, DBP, and MAP was statistically analyzed, with significance set at p < 0.05. Of 1689 biopsies, there were 10 bleeding complications (10/1689, 0.59%). There was no statistically significant difference between biopsies with complication compared to those without complication based on SBP (p = 0.351), DBP (p = 0.088), or MAP (p = 0.132). Using risk dichotomization criteria, the odds ratio for hemorrhagic complication when the patient had SBP ≥ 180mmHg and DBP ≥ 95mmHg was 75.63 (95% CI 6.87-516.8, p = 0.002). The rate of hemorrhagic complication from renal transplant biopsy is low, and there is no statistically significant threshold for increased biopsy risk based on SBP, DBP, or MAP alone. The risk of complication was significantly higher only when both the SBP is ≥ 180mmHg and DBP is ≥ 95mmHg.

Severe gastrointestinal bleeding in patients with atrial fibrillation receiving oral anticoagulants (based on REGistry of long-term AnTithrombotic TherApy - REGATTA)

The rate of major bleeding in patients with atrial fibrillation receiving oral anticoagulants is 25% per year. Gastrointestinal bleedings are at least a half of major hemorrhagic complications. Currently, there is no optimal scale to calculate the risk of bleeding, and therefore the search for clinical predictors of gastrointestinal bleeding remains relevant. To assess the frequency and structure of large gastrointestinal bleeding, as well as to identify clinical predictors of their development based on long-term prospective observation of patients with atrial fibrillation receiving oral anticoagulants. Data were obtained from single center prospective REGistry of long-term AnTithrombotic TherApy (REGATTA NCT043447187). Investigation based on a 20-year follow-up with 510 patients with atrial fibrillation with a high thromboembolic risk (median CHA2DS2-VASc was 4 points). The REGATTA registry assessed the frequency and structure of major gastrointestinal bleeding. Predictors of the development of 32 large gastrointestinal bleeding were identified based on the analysis of pairs with univariate and multivariate analyses. The frequency of major gastrointestinal bleeding in patients with atrial fibrillation receiving oral anticoagulants at 1 year was 1.42 per 100 patients; the predominant localization was upper gastrointestinal tract. Predictors of the development of major gastrointestinal bleeding according to multiple regression data analysis were hemoglobin level 14.55 g/dL, body mass index 28.4 kg/m2, gastrointestinal ulcer or erosive lesion and major hemorrhagic complications in history of disease. In 1/2 cases the sourse of bleeding remained unclear. Searching for clinical predictors of gastrointestinal bleeding can identify patients receiving oral anticoagulants who is need of intensive monitoring risk factors to prevent the development of life-threatening bleeding and to provide with adequate anticoagulant therapy.

Comparison of clinical efficacy, subjective user experience, and safety for two different core biopsy needles, the Achieve® and Marquee®.

To compare clinical efficacy, subjective radiologist preference, and complication rates for two different core biopsy needles, the Achieve® and Marquee®. Retrospective review included consecutive patients who underwent 18 gauge non-targeted core liver biopsy, 30 with Achieve® (Merit Medical) and 30 with Marquee® (BD Bard) Pathologist (blinded to needle type) reviewed specimen total length, maximum width, and portal triad count. Sixteen radiologists subjectively rated (1 to 5(best)) each needle for cocking, firing, recoil, chamber exposure, handling, and overall. A medical records search of all (targeted and non-targeted) core liver biopsies 1/1/17-9/30/2020 compared rates of major (requiring transfusion and/or embolization) and minor (self-limited bleeding) hemorrhagic complications. Comparison between needle types was performed using t-test. For Achieve® and Marquee® needles, the respective mean (SD) for total length(mm) was 29.7(7.0) and 31.9(4.6), p = 0.1; max width(mm) was 0.78(0.1) and 0.85(0.1), p < 0.01; and number of portal triads was 15.3(5.3) and 17.3(5.3), p = 0.2. Radiologists subjectively preferred the Marquee® for several measures including cocking, chamber exposure, and overall (p < 0.02 for each), while the needles were rated similarly for firing, recoil, and handling. Review of 800 cases showed no difference in major (1.0% Achieve®, 1.9% Marquee®, p = 0.5) or minor (1.5% Achieve®, 0.5% Marquee®, p = 0.3) rates of hemorrhagic complications. Liver biopsy specimens were significantly wider with Marquee® compared to Achieve®. Radiologists preferred the Marquee® for multiple tactile measures, while the major complication rate was not significantly different. While both needles have a similar side-notch design, the Marquee® needle demonstrates better sample quality and higher user preference, without compromising safety.

Context-Responsive Anticoagulation Reduces Complications in Pediatric Extracorporeal Membrane Oxygenation.

Purpose: We sought to determine the impact of a comprehensive, context-responsive anticoagulation and transfusion guideline on bleeding and thrombotic complication rates and blood product utilization during extracorporeal membrane oxygenation (ECMO).Design: Single-center, observational pre- and post-implementation cohort study.Setting: Academic pediatric hospital.Patients: Patients in the PICU, CICU, and NICU receiving ECMO support.Interventions: Program-wide implementation of a context-responsive anticoagulation and transfusion guideline.Measurements: Pre-implementation subjects consisted of all patients receiving ECMO between January 1 and December 31, 2012, and underwent retrospective chart review. Post-implementation subjects consisted of all ECMO patients between September 1, 2013, and December 31, 2014, and underwent prospective data collection. Data collection included standard demographic and admission data, ECMO technical specifications, non-ECMO therapies, coagulation parameters, and blood product administration. A novel grading scale was used to define hemorrhagic complications (major, intermediate, and minor) and major thromboembolic complications.Main Results: Seventy-six ECMO patients were identified: 31 during the pre-implementation period and 45 in the post-implementation period. The overall observed mortality was 33% with no difference between groups. Compared to pre-implementation, the post-implementation group experienced fewer major hemorrhagic and major thrombotic complications and less severe hemorrhagic complications and received less RBC transfusion volume per kg.Conclusions: Use of a context-responsive anticoagulation and transfusion guideline was associated with a reduction in hemorrhagic and thrombotic complications and reduced RBC transfusion requirements. Further evaluation of guideline content, compliance, performance, and sustainability is needed.