Minor Hemorrhagic Complications Research Articles

Early Hemorrhagic Complications after Holmium Laser Enucleation of the Prostate in Patients Undergoing Antithrombotic Therapy: A Retrospective Analysis from a High-Volume Centre.

Objectives: This study intends to evaluate early hemorrhagic complications after holmium laser enucleation of the prostate (HoLEP) in patients undergoing antithrombotic therapy. Methods: The data of patients undergoing HoLEP between January 2020 and February 2023 were retrospectively analysed. Patients were clustered into three groups: (1) no antithrombotic therapy; (2) antiplatelet (AP) therapy; and (3) anticoagulant (AC) therapy. Pre-, intra-, and post-operative variables were compared. A logistic regression model was built to identify predictors of post-operative hemorrhagic complications. Results: A total of 338 patients underwent HoLEP, including 212 who received no antithrombotic therapy (62.7%), 76 who received AP (22.5%), and 50 who received AC (14.8%). Intra-operative outcomes did not show any significant difference. A significant difference was observed in terms of catheterisation time (p = 0.001) and length of hospital stay (p < 0.001), favouring patients who did not receive antithrombotic therapy. Early post-operative hemorrhagic complications (<30 days) included re-admissions for macrohematuria (3.5%), transfusions (2.4%), and endoscopic re-interventions for bleeding (1.2%). A comparison between the groups showed significant differences for both re-admission (p < 0.001) and transfusion rates (p = 0.01), favouring patients who did not receive antithrombotic therapy. The re-intervention rate did not show any significant difference between the groups (p = 0.1). In multivariate analysis, AC therapy was identified as an independent predictor of those complications (OR 4.9, p = 0.005). Conclusions: HoLEP is a safe and effective procedure for patients undergoing antithrombotic therapy. Both AP and AC therapies are associated with longer catheterisation and hospitalisation times. AC therapy is shown to be a predictor of minor post-operative hemorrhagic complications.

Low-dose apixaban or rivaroxaban as secondary prophylaxis of upper extremity deep vein thrombosis.

Upper extremity deep vein thrombosis (UEDVT) may occur without inciting factor or may be secondary to malignancy, surgery, trauma, central venous catheter or related to thoracic outlet syndrome (TOS). International guidelines recommend anticoagulant treatment for at least three months, in particular the use of vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs). No data on extended anticoagulant therapy and reduced dose of DOACs have been reported in patients affected by UEDVT with persistent thrombotic risk (active cancer, major congenital thrombophilia) or without affected vein recanalization. In our retrospective observational study, including 43 patients, we treated secondary UEDVT with DOACs. In the acute phase of thrombosis (median time of 4 months), we used therapeutic dose of DOACs; the 32 patients with permanent thrombotic risk factors or without recanalization of the UEDVT were shifted to low-dose DOACs (apixaban 2.5mg twice daily or rivaroxaban 10mg daily). During therapy with full-dose DOACs, 1 patient presented recurrence of thrombosis; no thromboembolic events were observed during treatment with low-dose DOACs. During full-dose treatment, 3 patients presented minor hemorrhagic complications; no hemorrhagic events were observed during DOACs at low dose. We think our preliminary data could support the indication to extend the anticoagulation with dose reduction of DOACs in patients affected by UEDVT and no-transient thrombotic risk. These data should be confirmed in randomized controlled prospective study.

THROMBOLYSIS IN PULMONARY EMBOLISM TREATMENT.

The aim: To assess the effectiveness of thrombolytic therapy in treatment pulmonary embolism. Materials and methods: The work analyzed the results of the survey and conservative treatment of 284 patients with pulmonary embolism treated in cardiological department in «Uzhgorod Central City Clinical Hospital» during 2019-2022. Patients were divided into two groups: group I - 250 (88%) patients received anticoagulant therapy; group II - 34 (12%) patients received thrombolytic therapy that was then switched to new oral anticoagulants. Results: In I group, the first three days were carried out continuously intravenous infusion of heparin in a dose of 25-30 thousand units per day, on the fourth day switched to subcutaneous injection for 10-14 days with subsequent switching to rivaroxaban. 34 (12.0%) patients of the II group, was started with thrombolytic therapy. 32 (94.1%) patients were prescribed alteplase 100 mg/day, and 2 (5.9%) patients - streptokinase 1.5 million units/day. After thrombolysis, patients were prescribed rivaroxaban for prolonged period. Thrombolytic therapy made it possible to prevent fatal cases, and in monotherapy with anticoagulants - mortality was 4.8%. Minor hemorrhagic complications like hematuria, local hematomas at the injection site, bleeding gums were observed in 7.6% of patients during thrombolytic therapy. No cases of large hemorrhages were observed. Manifestations of chronic postembolic pulmonary hypertension in the distant period were found in 97.1% and 6.9% of patients of the I and II groups, respectively. Lethality in the remote period was 5.3% - all in the 1st group of patients due to PE recurrence and acute myocardial infarction. Conclusions: Implementation of thrombolytic therapy in patients with thromboembolism of the pulmonary artery allows effectively prevent recurrence with a fatal outcome, restore the lumen of the pulmonary arteries and prevent the development of chronic postembolic pulmonary hypertension in the immediate and remote period of observation compared to isolated anticoagulant therapy.

Regional catheter thrombolysis for late proximal deep vein thrombosis

To compare the efficacy of regional catheter thrombolysis with urokinase and alteplase for late proximal deep vein thrombosis. We analyzed safety and effectiveness of treatment of 38 patients with late proximal deep vein thrombosis divided into 2 statistically homogeneous groups by 19 people. In the first group, regional thrombolysis with urokinase was performed with injection of the drug into thrombosed popliteal, femoral and iliac veins. Alteplase was used in the second group. Patients received rivaroxaban in pre-, perioperative period and throughout 6 months after surgery. Complications of endovascular therapy were recorded. After 12 months, ultrasound and clinical examination were carried out to assess vein recanalization and venous outflow disorders. Vein recanalization was evaluated as follows: <50% - minimal, 50-99% - partial, 100% - complete. Minor hemorrhagic complications of endovascular treatment developed in 31.7 and 21% of patients, respectively. In the first group, complete vein recanalization occurred in 31.6%, partial - in 21%, minimal - in 47.4% of patients. In the second group, these values were 47.4%, 36.8% and 15.8%, respectively. In the first group, no signs of venous outflow disorders were observed in 31.6% of patients, mild disorders - in 15.8%, moderate disorders - in 31.6%, severe - in 21% of patients. In the second group, these values were 47.4%, 31.6%, 10.5% and 10.5%, respectively. Thrombolysis with alteplase is safer and more effective compared to urokinase.

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.

Особенности интраоперационного периода на фоне предварительного введения ингибитора ангиогенеза в хирургии пролиферативной диабетической ретинопатии

Purpose. To carry out a comparative analysis of the intraoperative period of vitrectomy against the background preliminary intravitreal injection inhibitor of angiogenesis performed at different times in patients with proliferative diabetic retinopathy. Material and methods. The study included 134 patients (134 eyes) with proliferative diabetic retinopathy (PDR) on the background of type II diabetes mellitus. 1 st group consisted of 30 patients (30 eyes) who underwent vitrectomy (VE) 1 month after intravitreal injection (IVI) inhibitor of angiogenesis (IA); 2 nd group included 104 patients (104 eyes) underwent VE 10–14 days after IVI IA, followed by a comparative assessment of intraoperative period and morphological and functional results of the eyes after 1 month. Results. In 1 st group of patients, moderate hemorrhagic complications were observed in 23.4 % of cases, severe – in 76.6 %, which significantly hampered visualization of surgical field during VE. In 2 nd group, minor hemorrhagic complications prevailed in 55.8 % of cases (p1-2 &lt;0.05). Moderate and severe – in 26 % and 18.2 % of cases, respectively (p1-2 &lt;0.05). Perfluorocarbon tamponade was used in 83.3 % of cases in 1 st group and in 22.1 % of cases in 2 nd group. Surgical intervention in 1 st group was ended with gas-air tamponade in 30 % of cases, with silicone oil in 70 % of cases, at patients of 2 nd group – in 63.4 % of cases with gas-air tamponade and 36.6 % of cases with silicone oil. Conclusion. The obtained clinical and morphological and functional results indicate the effectiveness of preliminary IVI IA before VE, minimally invasive, sparing nature of surgical intervention and uncomplicated course of the intraoperative period in patients with PDR. Keywords: proliferative diabetic retinopathy, vitrectomy, inhibitor of angiogenesis, intraoperative period, hemorrhagic complications, vitreous cavity tamponade.

Safety and Oncologic Outcomes of Percutaneous Cryoablation of Renal Cell Carcinoma Recurrences in the Ipsilateral Kidney Following Partial Nephrectomy.

To retrospectively investigate the safety and oncological outcomes of cryoablation performed on residual/recurring renal cell carcinoma (RCC) in the ipsilateral kidney following partial nephrectomy (PN). Data dealing with patients', RCC, procedure (including the length of the hospital stay), and follow-up (technical efficacy [TE], local tumor progression-free survival [LTPFS], disease-free survival [DFS], metastasis-free survival [MFS], cancer-specific survival (CSS), and overall survival [OS]) were retrospectively collected and analyzed. Between January 2008 and November 2020, 21 consecutive patients (17 [81%] men; 4 [19%] women; median age 68years; range 43-82) underwent cryoablation due to residual/recurring RCC in the PN site (15 patients) or de-novo RCC (6 patients) in the ipsilateral kidney. Median tumor size was 2.2cm (mean 2.3cm; range 0.8-4; interquartile range [IQR] 1.9-3). There were two (2/21; 10%) minor self-limiting hemorrhagic complications, both occurring in the group of patients with RCC in the PN site. Median hospital stay was 2days (mean 2.1; range 1-5; IQR 2-2). TE was 100% (21/21 patients), and 10-year estimates of LTPFS, MFS and DFS were 74.1% (95% confidence intervals [CI] 56.8-96.7%), 36.4% (95% CI 14.2-93.8%), and 43.5% (95% CI 21.9-86.4%), respectively. CSS and OS were 100% at the last available follow-up (median 56months; mean 67.4; range: 12-147; IQR:34-95). Cryoablation in patients with residual/recurring RCC following PN is safe and results in high 10-year estimates of LTPFS.

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.

Bleeding and antithrombotic therapy during pregnancy in women with poor aPL-related obstetric outcomes: A survey of 1075 cases from EUROAPS registry∗.

The combination of low-dose aspirin (LDA) and low-molecular-weight heparin (LMWH) until the end of gestation are the currently the accepted standard of care for the treatment of antiphospholipid-related obstetric disorders. In refractory cases, hydroxychloroquine (HCQ) can be added to this standard of care. To evaluate the haemostatic safety of LDA and LMWH (medium to high prophylactic doses) during pregnancy and the puerperium in women with both full-blown obstetric antiphospholipid syndrome (OAPS) (Sydney criteria) and noncriteria - incomplete - OAPS. Retrospective/prospective multicentre observational study. Obstetric background, laboratory categories, delivery mode, antithrombotic regimens and bleeding complications were compared. A total of 30 tertiary European hospitals. Mainly, Caucasian/Arian pregnant women were included. Other ethnicities were minimally present. Women were controlled throughout pregnancy and puerperium. The primary end-point was to evaluate the number of major and minor haemorrhagic complications in this cohort of women. Neuraxial anaesthetic bleeding complications were particularly assessed. Secondly, we aimed to compare local/general bleeding events between groups. We studied 1650 women, of whom 1000 fulfilled the Sydney criteria of the OAPS and 650 did not (noncriteria OAPS). Data on antithrombotic-related complications were available in 1075 cases (65.15%). Overall, 53 (4.93%) women had bleeding complications, with 34 being considered minor (3.16%) and 19 major (1.76%). Neither obstetric complications nor laboratory categories were bleeding-related. Assisted vaginal delivery and caesarean section were related to local haemorrhage. Heparin doses and platelet count were not associated with major bleeding. LDA and medium to high prophylactic LMWH during pregnancy in women with full-blown OAPS/noncriteria OAPS are safe. A slight increase in bleeding risk was noted in instrumental deliveries. No women who underwent spinal or epidural anaesthesia suffered bleeding complications. No haemorrhage was observed in cases where HCQ was added to standard therapy.

Diagnostic accuracy and safety of percutaneous MRI-guided biopsy of solid renal masses: single-center results after 4.5years.

To retrospectively evaluate diagnostic accuracy and complications of magnetic resonance imaging (MRI)-guided biopsy of radiologically indeterminate solid renal masses (RM). Electronic records of all consecutive patients undergoing MRI-guided biopsy of solid RM (using free-breathing T2-BLADE and BEAT-IRTTT sequences) between April 2014 and October 2018 were reviewed; 101 patients (69 men, 32 women; median age 68years; range 32-76) were included. Patient and RM characteristics, procedural details/complications, pathologic diagnosis, and clinical management were recorded. Diagnostic accuracy was calculated on an intention-to-diagnose basis. Diagnostic yield was also evaluated. Multi-variable analysis was performed for variables with p < .20, including patient age/sex; RM size/location/contact with vascular pedicle, RENAL score, number and total length of biopsy samples, and biopsy tract embolization, to determine factors associated with diagnostic samples, diagnostic accuracy, and complications. Median RM size was 2.4cm (range 1-8.4cm). There were 86 (85%; 95%CI 77-91%) diagnostic and 15 (15%; 95%CI 9-23%) non-diagnostic samples; 6/15 (40%) non-diagnostic biopsies were repeated with 50% malignancy rate. Sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy were 96% (95%CI 89-99%), 100% (95%CI 77-100%), 100% (95%CI 95-100%), 82% (95%CI 57-96%), and 97% (95%CI 90-99%), respectively. Primary and secondary diagnostic yields were 85% (95%CI 77-91%) and 91% (95%CI 84-96%), respectively. Seven (7%; 95%CI 1-10%) complications were observed. No tested variables were associated with diagnostic samples, diagnostic accuracy, or complications. MRI-guided biopsy of solid RM is associated with high diagnostic accuracy and low complication rate. The technique might be helpful for inaccessible tumors. • MRI-guided biopsy of radiologically indeterminate solid renal masses (RM) appears safe, with a low rate of minor self-limiting hemorrhagic complications. • Diagnostic accuracy and primary/secondary diagnostic yield are high and appear similar to reported estimates for US- and CT-guided RM biopsy. • MRI guidance may be particularly useful for RM with poor conspicuity on US and CT, for relatively inaccessible tumors (e.g., tumors requiring double-oblique steep-angled approaches), and for young patients or those with renal failure.

Evaluation of Complications in Postpartum Women Receiving Therapeutic Anticoagulation.

To evaluate complications associated with early postpartum therapeutic anticoagulation. A multicenter retrospective cohort study was done to evaluate the association between therapeutic anticoagulation postpartum and major complications (hemorrhagic and wound complications). Secondary outcomes included minor complications, risk factors associated with total complications (including the time to therapeutic anticoagulation resumption after delivery) and recurrent thrombotic events within 6 weeks postpartum. From 2003 to 2015, 232 consecutive women were treated with therapeutic anticoagulation within 96 hours postpartum; among those treated, 91 received unfractionated heparin, 138 received low-molecular-weight heparin, and three received other anticoagulants. The primary outcome, a composite of major hemorrhagic complications (requiring transfusion, hospitalization, volume resuscitation, transfer to intensive care unit, or surgery) and major wound complications, occurred in 7 of 83 (8.4%) for cesarean deliveries and 9 of 149 (6.0%) for vaginal deliveries (P=.490). Total complications (including major and minor hemorrhagic and wound complications) occurred in 13 of 83 (15.7%) for cesarean deliveries compared with 9 of 149 (6.0%) for vaginal deliveries (P=.016). When comparing cases associated with and without complications, the median delay before resuming anticoagulation was significantly shorter for both cesarean (12 vs 33 hours, P=.033) and vaginal deliveries (6 vs 19 hours, P=.006). For vaginal deliveries, 8 of 51 (15.7%) women had complications when anticoagulation was started before 9.25 hours postpartum, compared with 1 of 98 (1.0%) when started after 9.25 hours. For cesarean deliveries, 7 of 21 (33.3%) of women experienced complications compared with 6 of 62 (9.7%) if anticoagulation was started before or after 15.1 hours, respectively. Two (0.9%) episodes of venous thromboembolism occurred within 6 weeks postpartum. Among postpartum women who received early therapeutic anticoagulation, major complications occurred in 8.4% for cesarean deliveries and 6.0% for vaginal deliveries. Complications were associated with earlier resumption of therapeutic anticoagulation, particularly before 9.25 hours for vaginal deliveries and before 15.1 hours for cesarean deliveries.

Ultrasound-Accelerated, Catheter-Directed Thrombolysis for Submassive Pulmonary Embolism: Single-Center Retrospective Review with Intermediate-Term Outcomes

To evaluate ultrasound-accelerated, catheter-directed thrombolysis (CDT) for treatment of acute submassive pulmonary embolism (PE). This single-center, retrospective study included patients who underwent CDT for acute submassive PE (N= 113, 52% men/48% women) from 2013 to 2017. Baseline characteristics included history of deep venous thrombosis (12%), history of PE (6%), and history of cancer (18%). Of cohort patients, 88% (n=99) had a simplified PE severity index score of ≥ 1 indicating a high risk of mortality. A technical success rate of 100% was achieved with 84% of patients having bilateral catheter placements. Average tissue plasminogen activator (tPA) therapy duration was 20.7 hours ± 1.5, and median tPA dose was 21.5 mg. Three patients (2.6%) experienced minor hemorrhagic complications. Mean hospital length of stay was 6 days. Mean pulmonary arterial pressure decreased from 55 mm Hg on presentation to 37 mm Hg (P < .01) 1 day following initiation of thrombolytic therapy. All-cause mortality rate of 4% (n= 4) was noted on discharge, which increased to 6% (n= 7) at 6 months. At 6-month follow-up compared with initial presentation, symptom improvements (93%), physiologic improvements (heart rate 72 beats/min vs 106 beats/min, P < .01), oxygen requirement improvements (fraction of inspired oxygen 20% vs 28%, P < .01), and right ventricular systolic pressure improvements by echocardiography (30 mm Hg vs 47 mm Hg, P < .01) were observed. CDT for acute submassive PE was associated with low complications and mortality, decreased right ventricular systolic pressure, high rates of clinical improvement, and improved intermediate-term clinical outcomes.

Contributory Factors to Hemorrhage After Ultrasound-Guided Fine Needle Aspiration of Thyroid Nodules with an Emphasis on Patients Taking Antithrombotic or Anticoagulant Medications

Background: Thyroid nodules are a common clinical problem and ultrasound-guided fine needle aspiration (US-FNA) biopsy is widely used for evaluation of thyroid nodules. However, few studies have addressed the contributing factors to hemorrhage after US-FNA of thyroid nodules. Objectives: To assess the contributory factors related to patient characteristics, ultrasound (US) features of the thyroid nodules, and the US-FNA procedures to affect hemorrhage complications after US-FNA of thyroid nodules. Patients and Methods: Between March 2014 and April 2015, 366 consecutive patients who underwent US-FNA of thyroid nodules were enrolled in this retrospective study. The characteristics of hematomas, including the location, maximum size, and clinical course, were assessed. The relationships between hematomas and factors related to the medical characteristics of patients, US characteristics of the nodules, and FNA procedural factors were analyzed. Results: Data on 365 nodules in 321 patients who underwent US-FNA of thyroid nodules were analyzed. Minor hemorrhagic complications developed in 14 (3.8%) of the 365 nodules. There were no statistically significant differences between patients taking or not taking an anticoagulant or antithrombotic (P = 0.270). Factors related to increased risk of hematoma were male sex (P = 0.031), larger maximum size (P = 0.002), a cystic or predominantly cystic nodule (P < 0.0001), a probable benign nodule (P < 0.0001), thicker needle size (P < 0.0001), and a greater number of the needle passes (P = 0.005). Conclusion: US-FNA can be performed safely even in patients taking anticoagulant or antithrombotic agents. Factors related to hemorrhagic complications are male sex, larger nodules, cystic or predominantly cystic nodules, probably benign nodules, thicker needles and a greater number of needle passes.

Renal function in patients receiving long-term warfarin therapy: A five-year prospective follow-up

To investigate the prognostic value of renal function and to estimate glomerular filtration rate (GFR) changes during a 5-year follow-up of patients receiving warfarin therapy. 200 patients (124 men, 76 women) mainly from a group at high risk for thromboembolic events (mean CHA2DS2-VASc scores, 3.25±1.89) were examined. The patients' mean age was 62.3±9.4 years; the follow-up period was 5 years. 74% of the patients received warfarin monotherapy (international normalized ratio (INR) 2.0 to 3.0); 36% took vitamin K antagonists in combination with one or two antiplatelet agents. The CKD-EPI formula was used to estimate GFR in all the patients at baseline and throughout the investigation once a year. GFR less than 70.9 ml/min/1.73 m2 was found to be a predictor of fatal and nonfatal thrombotic events. The decreased GFR was unassociated with the development of major and clinically relevant hemorrhagic complications within 5 years of warfarin therapy. The initial decline in renal function (GFR <70.9 ml/min/1.73 m2) was associated only with an increased rate of recurrent minor hemorrhagic complications. During 5-year warfarin therapy, there was a significant decrease in GFR from 97.1±24.85 to 91.9±28.9 ml/min/1.73 m2; at the same time, a rapidly progressive loss of renal function (GFR ≥3 ml/min/1.73 m2/year) was recorded in 25.9% of the patients. Discriminant analysis showed that a baseline left ventricular ejection fraction of <40% was a predictor for the rapidly progressive loss of kidney function. Long-term warfarin therapy achieved the therapeutic range for INR is safe in the environment of the created patronage system. The initial decrease in GFR is a predictor of thrombotic events and is unassociated with an increased risk of bleeding.

SAFETY OF LONG-TERM THERAPY WITH WARFARIN: HEMORRHAGE FREQUENCY AND CLINICAL PREDICTORS (results of a prospective 15-year follow-up)

Despite the long-term clinical experience, bleeding remains the greatest danger for patients taking vitamin K antagonists. Moreover, even the presence of risk factors for hemorrhagic complications in a patient should not be the only reason for cancelling anticoagulant therapy. The challenge in assessing the frequency of hemorrhage is primarily explained by different approaches to hemorrhage classification. For patients receiving long-term anticoagulant therapy, along with fatal and life threatening hemorrhages, minor and clinically significant small hemorrhages should be taken into account to assess the safety of treatment. The 15-year prospective follow-up of patients receiving warfarin found that the frequency of all hemorrhagic complications was 8.66/100 patient-years, major hemorrhage — 2.98/100 patient-years, and clinically significant hemorrhage — 2.62/100 patient-years. According to the results of the discriminant analysis, the predictors for the development of major and clinically significant hemorrhagic complications in patients receiving long-term therapy with warfarin are administration of proton pump inhibitors, labile INR during therapy, recurrent minor hemorrhage in history and amiodarone therapy. The 15-year prospective follow-up of patients receiving warfarin demonstrated that minor hemorrhagic complications account for one third of all bleedings and are not associated with the subsequent development of clinically significant and major bleeding in patients. The prospective follow-up also found an increase in the frequency of hemorrhagic complications if one or two antiplatelet agents were added to warfarin therapy. The incidence of major and minor clinically significant hemorrhagic complications during triple antithrombotic therapy was 24/100 patient-years, which was higher than in the warfarin monotherapy subgroups and in the case of combining warfarin with an antiaggregant (4.4 and 8.47%, respectively). The localization of bleeding was analyzed to reveal that in triple antithrombotic therapy the greatest number of bleedings occurred in the upper or lower gastrointestinal tract. The relative risk was calculated to confirm that triple antithrombotic therapy significantly increased the risk of gastrointestinal bleeding by 3.02 times.

Use of enoxaparin in dogs with primary immune-mediated hemolytic anemia: 21 cases.

To describe the complications and frequency of thrombosis associated with the use of enoxaparin, a low molecular weight heparin, in dogs with primary immune-mediated hemolytic anemia (IMHA). Retrospective case series. Two privately owned veterinary referral hospitals. Twenty-one client-owned dogs with primary IMHA. Dogs were treated with enoxaparin (0.8 mg/kg subcutaneously every 6 h) as the sole anticoagulation therapy starting at admission to the hospital. Only 2 dogs had minor hemorrhagic complications associated with enoxaparin therapy. Frequency of thrombosis was not assessed. Long-term survival was comparable to other anticoagulation protocols reported for dogs with primary IMHA. The use of enoxaparin was safe in a small group of dogs with primary IMHA. Whether enoxaparin therapy can reduce mortality and thrombotic complications in dogs with primary IMHA compared with other anticoagulation protocols remains unknown.

Abstract W P52: Safety of Intravenous Thrombolysis (IVT) in Stroke Mimics: A Prospective Five-year Study and Comprehensive Meta-analysis of Reported Case Series

Background&amp;Purpose: Shortening door-to-needle time may lead to intravenous thrombolysis (IVT) administration in stroke mimics (SM). We sought to determine safety of IVT in SM using prospective, single-center data and by conducting a comprehensive meta-analysis of reported case series. Subjects&amp;Methods: We analyzed consecutive IVT-treated patients during a 5-year period (2009-2013) at a tertiary care stroke center. Non-contrast head CT, NIHSS pre-treatment and modified Rankin scores (mRS) at discharge were obtained as standard of care. SM was defined as no acute ischemic lesions on MRI and the final non-stroke diagnosis established by radiologists and treating physicians unaware of the purposes of this study. Symptomatic intracerebral hemorrhage (sICH) was defined as imaging evidence of ICH with NIHSS increase of 4 or more points. Functional independence (FI) was defined as mRS 0-1. We also conducted a comprehensive meta-analysis of all available case-series reporting safety of IVT in SM using PRISMA guidelines. Results: Of 516 consecutive IVT patients at our tertiary care center (50% men; mean age 60±14years; median NIHSS 11, range 3-22), SM comprised 75 cases (14.5%, 95%CI by adjusted wald method: 11.7%-17.9%). sICH occurred in one patient (1.3%; 95%CI:0%-7.9%), while we documented no cases of orolingual edema (OE) or major extracranial hemorrhagic complications (0%; 95%CI:0%-4.2%). Two patients experienced minor extra-cranial hemorrhagic complications (1 case of gingival &amp; 1 case of nose bleeding). Meta-analysis of 9 studies including 8,942 patients treated with IVT and reporting safety outcomes in 392 SM showed pooled rates of sICH and OE 0.5% (95%CI: 0%-2%) and 0.3% (95%CI: 0%-2%) respectively. We documented no heterogeneity between estimates of sICH (I squared statistic=0%; p=0.941 Cohran Q test), and OE (I squared statistic=0%; p=0.913 Cohran Q test). Conclusions: Our prospectively collected data coupled with the findings of the comprehensive meta-analysis underscore the safety of IVT in SM given the low prevalence of hemorrhagic and systemic complications and the lack of heterogeneity across reported case-series.

Treatment of ophthalmic segment carotid aneurysms using the pipeline embolization device: clinical and angiographic follow-up

Objectives: Aneurysms of the ophthalmic segment of the internal carotid artery (ICA) often present unique challenges to endovascular treatment due to their proximity to or involvement of the ophthalmic artery, and the subsequent risk of post-operative visual complications. The pipeline embolization device (PED) represents a paradigm shift and promising new therapy in the treatment of intracranial aneurysms. We reviewed the ophthalmic segment ICA aneurysms treated with the PED at Barrow Neurological Institute (BNI) to report outcome data, including patency of the ophthalmic artery and visual complications.Methods: The prospectively maintained BNI endovascular database was reviewed for all patients with ophthalmic segment ICA aneurysms treated with the PED since May 2011. Patient charts and digital subtraction angiograms were reviewed to report angiographic outcomes and visual complications. Only patients with at least 6 months of follow-up were included in the analysis.Results: Of 30 patients treated with ophthalmic segment aneurysms during the study period, sufficient follow-up was available for 29 patients with 38 aneurysms, all of which were treated electively. The PED was successfully deployed for all lesions, with 92·1% complete or near-complete obliteration rate at angiographic follow-up. All but one patient were found to have a patent ophthalmic artery at short-term follow-up and 100% of patients retained intact vision. Five patients had minor periprocedural hemorrhagic complications but no permanent morbidities. There were no intracranial hemorrhages, thromboembolic phenomena, vessel dissections, or mortalities.Conclusion: Treatment of ophthalmic segment ICA aneurysms with the PED is safe and effective at short-term follow-up.

Life-threatening gastrointestinal bleeding during targeted therapy for advanced renal cell carcinoma: a case report

BackgroundTemsirolimus has important clinical activity in both untreated and previously treated patients with advanced renal cell carcinoma. Targeted therapy–related stomatitis and mucositis have occurred during targeted therapies, but there is no consensus on which strategy is the most effective. We herein report a case in which several sessions of endoscopic hemostasis with argon plasma coagulation (APC) effectively resolved life-threatening gastrointestinal bleeding that had occurred during targeted therapy. This is the first case report of such an adverse drug reaction in the literature.Case presentationA 47-year-old female patient with advanced renal cell carcinoma was treated with temsirolimus. Eight weeks after starting targeted therapy, the patient was admitted to our hospital for worsened fatigue, pallor, and hematemesis. A complete blood count showed a marked drop in her hemoglobin level from 10.1 g/dl 4 days earlier to 2.9 g/dl. Esophagogastroduodenoscopy revealed diffuse mucosal bleeding of the antrum. Endoscopy revealed diffuse reddish spots that resembled gastric antral vascular ectasia (GAVE) extending from the pylorus into the antrum. One month after endoscopic hemostasis with APC and stopping temsirolimus, significant improvement was shown in the gastric erythema and GAVE like lesions.ConclusionMinor hemorrhagic events are relatively common in patients treated with targeted agents. Life-threatening hemorrhagic events are rarer than minor hemorrhagic complications. In the present case, endoscopic hemostasis with APC effectively prevented severe anemia and blood loss due to gastrointestinal bleeding.

Clopidogrel Hyper-Response and Bleeding Risk in Neurointerventional Procedures

Antiplatelet therapy is associated with decreased ischemic events after neurointerventional procedures. Antiplatelet resistance negates the protective effects of antiplatelet medication, leading to a higher incidence of ischemic events. A possible link between antiplatelet hyper-response and increased hemorrhagic complications has been inadequately investigated. We aimed to examine the correlation between antiplatelet hyper-response and the risk of hemorrhagic complications. Patients who were treated with antiplatelet medications and underwent neurointerventional procedures were prospectively recruited. We collected the following data: demographics, vascular risk factors, antiplatelet and anticoagulation treatment, antiplatelet responsiveness, coagulation profile, and hemorrhagic complications. P2Y12 receptor-mediated platelet inhibition was tested by using the VerifyNow assay device. The primary end points were postprocedural major and minor hemorrhagic complications. Receiver operator characteristic analysis was used to evaluate the percentage of platelet inhibition as a diagnostic tool for bleeding events. The association between hemorrhage and percentage of platelet inhibition was investigated by using logistic regression modeling. Forty-seven patients were enrolled. The mean age was 56±12 years, and 28% were men. Ten patients (21.3%) developed hemorrhagic complications. Clopidogrel response was higher in patients with a major bleeding complication compared with those with minor or no bleeding (median, 94% versus 24% platelet inhibition; P=.0084). Of the 7 patients (14.9%) defined as hyper-responders with ≥72% platelet inhibition, 42.8% had a major bleeding complication. Hyper-response to clopidogrel is associated with increased risk of hemorrhagic complications. Larger studies are urgently needed to validate a clinically useful threshold to define clopidogrel hyper-response and to examine the clinical effects of antiplatelet dosage adjustment.