Difference In Hemorrhagic Complications Research Articles

Efficacy and safety of intracoronary pro-urokinase combined with low-pressure balloon pre-dilatation during percutaneous coronary intervention in patients with anterior ST-segment elevation myocardial infarction

BackgroundThe efficacy and safety of low-pressure balloon pre-dilatation before intracoronary pro-urokinase (pro-UK) in preventing no-reflow during percutaneous coronary intervention (PCI) remains unknown. This study aimed to evaluate the clinical outcomes of intracoronary pro-UK combined with low-pressure balloon pre-dilatation in patients with anterior ST-segment-elevation myocardial infarction (STEMI).MethodsThis was a randomized, single-blind, investigator-initiated trial that included 179 patients diagnosed with acute anterior STEMI. All patients were eligible for PCI and were randomized into two groups: intracoronary pro-UK combined with (ICPpD group, n = 90) or without (ICP group, n = 89) low-pressure balloon pre-dilatation. The main efficacy endpoint was complete epicardial and myocardial reperfusion. The safety endpoints were major adverse cardiovascular events (MACEs), which were analyzed at 12 months follow-up.ResultsPatients in the ICPpD group presented significantly higher TIMI myocardial perfusion grade 3 (TMPG3) compared to those in the ICP group (77.78% versus 68.54%, P = 0.013), and STR ≥ 70% after PCI 30 min (34.44% versus 26.97%, P = 0.047) or after PCI 90 min (40.0% versus 31.46%, P = 0.044). MACEs occurred in 23 patients (25.56%) in the ICPpD group and in 32 patients (35.96%) in the ICP group. There was no difference in hemorrhagic complications during hospitalization between the groups.ConclusionPatients with acute anterior STEMI presented more complete epicardial and myocardial reperfusion with adjunctive low-pressure balloon pre-dilatation before intracoronary pro-UK during PCI.Trial registration2019xkj213.

Safety and efficacy of tailored antiplatelet therapy using prasugrel or ticagrelor based on clopidogrel responsiveness in endovascular treatment for intracranial aneurysms: a meta-analysis

BackgroundClopidogrel (CPG)-based dual antiplatelet therapy (DAPT) in combination with aspirin has been widely used before endovascular procedures for intracranial aneurysms to prevent procedural thromboembolic complication (TEC). However, the main drawback...

General Anesthesia Compared With Non-GA in Endovascular Thrombectomy for Ischemic Stroke: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Endovascular thrombectomy (EVT) for large vessel occlusion ischemic stroke is either performed under general anesthesia (GA) or with non-GA techniques such as conscious sedation or local anesthesia alone. Previous small meta-analyses have demonstrated superior recanalization rates and improved functional recovery with GA when compared with non-GA techniques. The publication of further randomized controlled trials (RCTs) could provide updated guidance when choosing between GA and non-GA techniques. A systematic search for trials in which stroke EVT patients were randomized to GA or non-GA was performed in Medline, Embase, and the Cochrane Central Register of Controlled Trials. A systematic review and meta-analysis using a random-effects model was performed. Seven RCTs were included in the systematic review and meta-analysis. These trials included a total of 980 participants (GA, N = 487; non-GA, N = 493). GA improves recanalization by 9.0% (GA 84.6% vs non-GA 75.6%; odds ratio [OR] 1.75, 95% CI 1.26-2.42, p = 0.0009), and the proportion of patients with functional recovery improves by 8.4% (GA 44.6% vs non-GA 36.2%; OR 1.43, 95% CI 1.04-1.98, p = 0.03). There was no difference in hemorrhagic complications or 3-month mortality. In patients with ischemic stroke treated with EVT, GA is associated with higher recanalization rates and improved functional recovery at 3 months compared with non-GA techniques. Conversion to GA and subsequent intention-to-treat analysis will underestimate the true therapeutic benefit. GA is established as effective in improving recanalization rates in EVT (7 Class 1 studies) with a high Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) certainty rating. GA is established as effective in improving functional recovery at 3 months in EVT (5 Class 1 studies) with a moderate GRADE certainty rating. Stroke services need to develop pathways to incorporate GA as the first choice for most EVT procedures in acute ischemic stroke with a level A recommendation for recanalization and level B recommendation for functional recovery.

Incidence and treatment of splanchnic vein thrombosis in patients with acute pancreatitis: A systematic review and meta-analysis.

This meta-analysis aimed to estimate the incidence of splanchnic vein thrombosis (SVT) in patients with acute pancreatitis and assess the effects of therapeutic anticoagulation. Systematic searches of the Medline, Embase, and Cochrane databases were undertaken to identify studies reporting the incidence and outcomes associated with SVT in patients with acute pancreatitis. The pooled incidence, odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using a random effects model. PROSPERO database registration no. CRD 42021230912. Only 18 of the 238 studies identified met the inclusion criteria. Of the 943 patients who had SVT, 264 (28.0%) received anticoagulation. The pooled incidence of SVT at first presentation of acute pancreatitis was 15% (95% CI 5 to 26%), but was 17% (95% CI 14 to 20%) in all studies. Recanalization was more likely to occur in the anticoagulation-treated than in the untreated group (OR 0.51, 95% CI 0.31 to 0.83, P=0.007). There were no differences in hemorrhagic complications (OR 2.27, 95% CI 0.81 to 6.37, P=0.12) or overall mortality (OR 2.37, 95% CI 0.86 to 6.52, P=0.10) in relation to the use of anticoagulation. The overall incidence of portal hypertension in patients was 60% (95% CI 55 to 65%). However, it was not possible to determine the incidence in each group. The incidence of SVT in patients with acute pancreatitis is significant. Treatment with anticoagulants improved the odds of recanalization but did not increase the risk of hemorrhagic complications or overall mortality.

Venous thromboembolic (VTE) prophylaxis in Cushing disease patients undergoing transsphenoidal surgery

IntroductionThe association between Cushing syndrome and a hypercoagulable state has been demonstrated in the literature. A standard venous thromboembolism (VTE) prophylaxis regimen has yet to be established for patients undergoing surgery for Cushing disease. Here we present outcomes associated with VTE prophylaxis in patients with Cushing disease undergoing endoscopic transsphenoidal surgery for pituitary tumor resection. MethodsA review of Cushing disease patients undergoing endoscopic transsphenoidal pituitary surgery between January 2010 and June 2020 was performed. Administration and type of VTE prophylaxis was recorded, and comparison was made between VTE and hemorrhagic complications before and after institution of a VTE prophylaxis protocol. ResultsA total of 65 patients were identified, 98.5% of which underwent VTE prophylaxis with either 5,000 units of subcutaneous heparin twice daily (n = 44) or 40 mg enoxaparin nightly (n = 20). VTE complications were not significantly different between the subcutaneous heparin and enoxaparin cohorts (4.5% v 0%; p = 0.61). The overall incidence of hemorrhagic complications requiring blood transfusion was 1.5%, and there was no significant difference in hemorrhagic complications between heparin and enoxaparin cohorts (0% v 5%; p = 0.32). ConclusionVTE prophylaxis in addition to sequential compression devices and early ambulation are critical in reducing VTE complications in patients with hypercortisolism from Cushing disease. Pharmacologic prophylaxis can be safely instituted in these patients with low risk of hemorrhagic complications.

Prevention of venous thromboembolism with rivaroxaban and apixaban in orthopedic surgery

Numerous limitations and side effects of standard anticoagulants require administering new anticoagulant drugs. New peroral anticoagulants of Factor Xa inhibitor group have more advantages, the key ones being: substantial reductions in specific nutrition limitations and drug interaction, no need for routine laboratory monitoring and greatly improved therapy predictability. Rivaroxaban, a selective peroral Factor Xa inhibitor is more effective compared with enoxaparin for venous thromboembolism (VTE) prophylaxis in major orthopedic interventions. Though several single trials demonstrated no difference in hemorrhagic complications, certain meta-analyses with rivaroxaban showed a higher incidence of hemorrhage. Apixaban, a peroral reversible inhibitor of factor Xa approved for the prevention of VTE, compared with European-approved doses of enoxaparin has the efficacy almost equal to the North-American-approved enoxaparin doses without a significant difference in bleeding rates, though ?DVANCE I study points towards lower bleeding rates in patients treated with apixaban. To clarify the contradictory results of the recent meta-analysis related to the comparison between the stated factor X inhibitors and various comparator enoxaparin regimens as well as related to the risk for symptomatic PTE and total bleeding events following major orthopedic surgery, new research will be required. Specificities of rivaroxaban and apixaban, already constituting, according to modern recommendations, an integral part of the VTE prophylaxis protocols after major orthopedic interventions, will enable the establishment of personalized protocols aimed at developing an improved safety profile of each individual patient.

03:00 PM Abstract No. 33 Evaluating blood product utilization and bleeding complications after implementation of single institution’s restrictive guidelines for periprocedural management of coagulation status in percutaneous image-guided interventions

Pre-procedure correction coagulopathy is of high priority in patients undergoing minimally invasive IR procedures. Unnecessary transfusion of blood products is associated with well-known infectious and non-infectious risks, however, uncorrected coagulopathy in the perioperative setting can be detrimental to the patient. Therefore, determining safe thresholds for administration of blood products is imperative, which in interventional radiology is mostly governed by the SIR consensus guidelines. The purpose of this study is to assess whether a single institution’s restrictive approach to pre-procedural transfusion of blood products can safely achieve outcomes similar to the established, more liberal guidelines. A total of 354 patients were enrolled in the study and a hypothetical comparison using Chi square method was made based on laboratory values that would have necessitated transfusion according to the SIR consensus guidelines (see table for transfusion cut-offs) Following our restrictive guidelines, high-risk group (n=119 patients), no FFP transfusion was required compared to 11 transfusions in the liberal group. Similarly, only 2 platelet transfusions were required in the restrictive group compared to 6 transfusions (p < 0.001) in the liberal group. In moderate-risk group (n=235 patients), there was statistically significant difference in the number of transfusions between the two strategies. Following our guidelines, only 1 FFP and 1 platelet transfusion were required compared to 26 FFP (p=0.004) and 7 platelet transfusions (p<0.003), respectively. Overall, in total of 354 patients, the number of FFP transfusion was only 1 in restrictive group compared to 37 in the liberal group (p = 0.003) and the number of platelet transfusion was only 3 compared to 13 in the liberal group (p<0.001). No difference in hemorrhagic complications was noted between patients receiving restrictive versus liberal transfusions. Restrictive transfusion strategy in patients undergoing IR procedures results in significant decrease in transfusions with no difference in hemorrhagic complications as well as drastic reduction in transfusion-related acquisition and activity-based costs.Tabled 1Transfusion Indications in Consensus GuidelinesTransfusion Indications in Restrictive Guidelines•Platelets ≤ 50,000•INR ≤ 1.5Non-cirrhotic Patients:•Platelets ≤ 30,000•INR ≤ 2.5Cirrhotic Patients:TIPS or Liver Biopsy = no•Platelets ≤ 30,000•INR ≤ 2.0TIPS or Liver Biopsy = YES•Platelets ≤ 50,000•INR ≤ 2.0 Open table in a new tab

Optimizating Clot Retrieval in Acute Stroke

We aimed to investigate the safety and efficacy of the Push and Fluff technique (PFT) as compared with the standard unsheathing technique for closed-cell stent retrievers in acute ischemic stroke. Acute ischemic stroke thrombectomy database was analyzed (September 2010 to January 2015) with the Trevo Retriever as a primary strategy. The PFT was compared with our internal standard unsheathing technique and with the Trevo Versus Merci Retrievers for Thrombectomy Revascularization of Large Vessel Occlusions in Acute Ischemic Stroke 2 (TREVO2) trial. Additionally, a silicon flow model was used to compare cell size/configuration, wall apposition/device diameter, and degree of foreshortening/device length across the 2 techniques. One hundred fifty-one out of 662 patients qualified for the study. The PFT (n=71) was associated with higher rates of first-pass reperfusion (54% versus 35%, P=0.03; 54% versus 32.6%, P<0.01), lower number of passes (1.3±0.8 versus 1.8±1.0, P<0.01; 1.7±1.0 versus 2.4±1.6, P<0.01), and higher rates of modified treatment in cerebral ischemia-3 reperfusion (58% versus 40%, P=0.03; 58% versus 14%, P<0.01) as compared with the standard unsheathing technique (n=81) and the TREVO2 Trevo arm (n=88), respectively. No differences in hemorrhagic complications were observed across the groups. The in vitro model indicated that, compared with standard unsheathing technique, PFT resulted in improved wall apposition (device diameter, 75% larger) and cell size (mean area, 51% larger) at the cost of a mild degree of foreshortening (25% length reduction). The PFT is safe and leads to optimization of wall apposition and cell size/configuration, resulting in higher chances of first-pass reperfusion, lower number of passes, and better rates of complete reperfusion.

Risk of hemorrhagic complication associated with ventriculoperitoneal shunt placement in aneurysmal subarachnoid hemorrhage patients on dual antiplatelet therapy

The use of an intracranial stent requires dual antiplatelet therapy to avoid in-stent thrombosis. In this study, the authors sought to investigate whether the use of dual antiplatelet therapy is a risk factor for hemorrhagic complications in patients undergoing permanent ventriculoperitoneal (VP) shunt for hydrocephalus following aneurysmal subarachnoid hemorrhage (aSAH). Patients were given 325 mg acetylsalicylic acid and 600 mg clopidogrel during the coil/stent procedure, and they were maintained on dual antiplatelet therapy with acetylsalicylic acid 325 mg daily and clopidogrel 75 mg daily during hospitalization and for 6 weeks posttreatment. Patients underwent placement of VP shunt at a later time during initial hospitalization, usually between 7 and 21 days following aSAH. Postoperative CT scans obtained in each study patient were reviewed for hemorrhages related to placement of the VP shunt. A total of 206 patients were admitted to the University of Iowa Hospitals and Clinics with aSAH between July 2009 and October 2010. Thirty-seven of these patients were treated with a VP shunt for persistent hydrocephalus. Twelve patients (32%) had previously undergone stent-assisted coiling and were on dual antiplatelet therapy with acetylsalicylic acid and clopidogrel. The remaining 25 patients (68%) had undergone surgical clipping or aneurysm coiling and were not receiving antiplatelet therapy at the time of surgery. Four cases (10.8%) of new intracranial hemorrhages associated with VP shunt placement were observed. All 4 hemorrhages (33%) occurred in patients on dual antiplatelet therapy for stent-assisted coiling. No new intracranial hemorrhages were observed in patients not receiving dual antiplatelet therapy. The difference in hemorrhagic complications between the 2 groups was statistically significant (4 [33%] of 12 vs 0 of 25, p = 0.0075]). All 4 hemorrhages occurred along the tract of the ventricular catheter. Only 1 hemorrhage (1 [8.3%] of 12) was clinically significant as it resulted in occlusion of the proximal shunt catheter and required revision of the VP shunt. The patient did not suffer any permanent morbidity related to the hemorrhage. The remaining 3 hemorrhages were not clinically significant. This small clinical series suggests that placement of a VP shunt in patients on dual antiplatelet therapy may be associated with an increased, but low, rate of symptomatic intracranial hemorrhage. It appears that in patients who are poor candidates for open surgical clipping and have aneurysms amenable to stent-assisted coiling, the risk of symptomatic hemorrhage may be an acceptable trade-off for avoiding risks associated with discontinuation of antiplatelet therapy. The authors' results are preliminary, however, and require confirmation in larger studies.

Abnormal Preprocedural International Normalized Ratio and Platelet Counts Are Not Associated With Increased Bleeding Complications After Ultrasound-Guided Thoracentesis

The objective of our study was to identify differences in hemorrhagic complications after ultrasound-guided thoracentesis on the basis of patient coagulation parameters. The records of consecutive patients who underwent ultrasound-guided thoracentesis between January 1, 2008 and April 30, 2010 were reviewed to document the international normalized ratio (INR) and platelet count obtained within 72 hours before thoracentesis and to identify bleeding complications that occurred after the procedure. The observed complication rates and 95% CIs for differences in complication rates were calculated. There were 1076 procedures performed during the study period with no hemorrhagic complications identified (0% complication rate; 95% CI, 0.00-0.34%). INR values before thoracentesis were available for 822 procedures: INR exceeded 2.0 in 139 cases (17%), 2.5 in 59 cases (7%), and 3.0 in 32 cases (4%). The 95% CI for the 0% difference in complications observed between two groups of patients determined by specific INR values was -0.008 to 0.014 (INR, 1.5), -0.007 to 0.026 (INR, 2.0), -0.007 to 0.061 (INR, 2.5), and -0.009 to 0.11 (INR, 3.0). Platelet values before thoracentesis were available for 953 procedures; the platelet count was less than 100,000/μL for 148 procedures (16%), less than 50,000/μL for 58 procedures (6%), and less than 25,000/μL for 12 procedures (1%). The 95% CI for the 0% difference in complications between two groups of patients determined by a platelet count threshold of 50,000/μL was -0.007 to 0.062. The risk of bleeding after ultrasound-guided thoracentesis performed by radiologists is low even if the preprocedural INR and platelet count are abnormal. An approach in which no coagulation testing or correction is performed before thoracentesis may be justified.

E0659 The effect and safety of tirofiban combined clopidogrel in AMI patients with PCI via transradial approach

ObjectiveTo evaluate the effect and safety of clopidogrel plus tirofiban in percutaneous coronary intervention (PCI) of acute myocardial infarction via transradial approach.MethodsA total of 104 patients with ST segment elevation...

Conscious Sedation Versus General Anesthesia During Endovascular Therapy for Acute Anterior Circulation Stroke

Patients undergoing intra-arterial therapy (IAT) for acute ischemic stroke receive either general anesthesia (GA) or conscious sedation. GA may delay time to treatment, whereas conscious sedation may result in patient movement and compromise the safety of the procedure. We sought to determine whether there were differences in safety and outcomes in GA patients before initiation of IAT. A cohort of 980 patients at 12 stroke centers underwent IAT for acute stroke between 2005 and 2009. Only patients with anterior circulation strokes due to large-vessel occlusion were included in the study. A binary logistic-regression model was used to determine independent predictors of good outcome and death. The mean age was 66+/-15 years and median National Institutes of Health Stroke Scale score was 17 (interquartile range, 13-20). The overall recanalization rate was 68% and the symptomatic hemorrhage rate was 9.2%. GA was used in 44% of patients with no differences in intracranial hemorrhage rates when compared with the conscious sedation group. The use of GA was associated with poorer neurologic outcome at 90 days (odds ratio=2.33; 95% CI, 1.63-3.44; P<0.0001) and higher mortality (odds ratio=1.68; 95% CI, 1.23-2.30; P<0.0001) compared with conscious sedation. Patients placed under GA during IAT for anterior circulation stroke appear to have a higher chance of poor neurologic outcome and mortality. There do not appear to be differences in hemorrhagic complications between the 2 groups. Future clinical trials with IAT can help elucidate the etiology of the differences in outcomes.

The Effect of Inhaled Nitric Oxide on the Course of Extracorporeal Membrane Oxygenation and the Occurrence of Hemorrhagic Complications

This study evaluated the relation between prior inhaled nitric oxide (iNO) and the time to initiation and duration of treatment with veno-arterial extracorporeal membrane oxygenation (ECMO) and the occurrence of hemorrhagic complications. A retrospective study was conducted in 59 human newborns treated for respiratory insufficiency with ECMO over a 5-year period. Patients received iNO before ECMO (iNO group) or not (control group). Both groups were compared for patient characteristics, postnatal age at the initiation of ECMO, duration of ECMO treatment, and hemorrhagic complications. There were no significant differences between the iNO group and the control group for patient characteristics and medication use before the ECMO treatment, except for norepinephrine. There was no significant difference for postnatal age at the initiation of ECMO and mean duration of ECMO treatment. We found no statistically significant difference in hemorrhagic complications between both groups. This persisted after correction for diagnosis and ECMO run-time in linear logistic regression analysis. Inhaled nitric oxide before ECMO did not result in a significant delay in the initiation of ECMO or longer duration of the ECMO. There was no significant relationship between the use of prior iNO and the occurrence of hemorrhagic complications during the ECMO treatment.

Interventional therapy of coronary artery disease in China: retrospective and perspective

Interventional therapy of coronary artery disease in China: retrospective and perspective

Clinical benefits of adjunctive tirofiban therapy in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention

There is continued debate as to whether a combined reperfusion regimen with platelet glycoprotein IIb/IIIa inhibitor-tirofiban provides additional benefit in optimal myocardial reperfusion for patients with acute ST-segment elevation myocardial infarction (STEMI). This study was conducted to investigate the clinical benefits of adjunctive tirofiban therapy combined with primary percutaneous coronary intervention (PCI) in patients with STEMI. One hundred and seventy-two consecutive patients with STEMI presented within 12 h of symptoms were randomly allocated to primary PCI combined with early (upstream group, n=57) or late administration of tirofiban (downstream group, n=57) or primary PCI treatment alone (control group, n=58). Clinical characteristics, angiographic findings, and in-hospital outcomes were compared between groups, as well as left ventricular ejection fraction (LVEF) and major adverse cardiac events (MACE, including death, reinfarction and target vessel revascularization) at 30-day and 6-month clinical follow-up. Despite comparable baseline clinical features among three groups, angiographic and procedural characteristics and outcomes differed significantly between patients receiving tirofiban treatment and controls, with respect to preprocedural (upstream: 28.1%, downstream: 7.0%, control: 5.2%, P<0.001) and postprocedural thrombolysis in myocardial infarction (TIMI) grade 3 flow of infarct-related artery (98.2, 94.7, 86.2%, P=0.03), TIMI myocardial perfusion grade 3 (75.4, 70.2, 53.4%, P=0.03), corrected TIMI frame count (20.4+/-5.0, 23.1+/-5.3, 32.2+/-6.7, P<0.001), resolution of the sum of ST-segment elevation (6.16+/-1.21, 6.02+/-1.09, 4.53+/-2.65 mm, P<0.001), peak value of creatine kinase-MB (218.0+/-72.5, 224.2+/-69.4, 255.3+/-77.0 ng/ml, P=0.02) and troponin I (76.0+/-21.5, 79.8+/-18.7, 86.4+/-11.0 ng/ml, P=0.007), and average hospital stay (10.6+/-5.4, 12.6+/-4.7, 14.5+/-6.5 days, P=0.001). The MACE rate at 30 days (3.5, 5.3, 15.5%, P=0.04) was reduced and LVEF (0.51+/-0.07, 0.50+/-0.07, 0.47+/-0.08, P=0.008) was higher in upstream and downstream groups than in controls. At 6-month follow-up, the MACE rate was not significantly different among groups (7.0, 8.8, 17.2%, P=0.17), but LVEF in upstream and downstream groups was significantly improved (0.59+/-0.06, 0.57+/-0.07, 0.54+/-0.07, P<0.001). Subgroup analysis demonstrated a statistically significant difference between upstream and downstream groups in preprocedural TIMI grade 3 flow (P=0.003) and postprocedural corrected TIMI frame count (P=0.007), which resulted in a shortened hospital stay (P=0.04), reduction of MACE rate at 30-day and 6-month follow-up by 34 and 20%, respectively. Multivariate logistic analysis revealed that age more than 65 years [odds ratio (OR)=3.42, P<0.01], tirofiban therapy (OR=0.56, P<0.05) and LVEF less than 0.5 during hospitalization (OR=2.56, P<0.01) were major independent predictors of MACE at 6-month clinical follow-up. No significant difference in hemorrhagic complications among three groups was noted (upstream: 10.5%, downstream: 12.3%, control: 6.9%, P=0.61). This prospective study indicates that adjunctive tirofiban therapy for patients with STEMI who undergo primary PCI can significantly improve reperfusion level in the infarct area, clinical outcomes at 30-day and 6-month follow-up, especially with upstream tirofiban therapy, and is safe.

Endoscopic Sphincterotomy Versus Endoscopic Papillary Balloon Dilatation for Choledocholithiasis in Liver Cirrhosis with Coagulopathy

Endoscopic Sphincterotomy Versus Endoscopic Papillary Balloon Dilatation for Choledocholithiasis in Liver Cirrhosis with Coagulopathy Do Hyun Park, Myung-Hwan Kim, Sung Koo Lee, Sang Soo Lee, Moon Hee Song, Jung Sik Choi, Dong Wan Seo, Young Il Min Background/Aim: To determine whether endoscopic papillary balloon dilatation (EPBD) actually decreases the risk of hemorrhage without increasing risk of acute pancreatitis, we compared the results of EPBD with those of endoscopic biliary sphincterotmy (EST) in cirrhotic patients with coagulopathy. Methods: Twentyone liver cirrhosis patients with coagulopathy were treated with EBPD for choledocholithiasis from January 2001 to September 2003. Twenty liver cirrhosis patients with coagulopathy who underwent EST from January 1998 to December 2000 served as a historical control group. Coagulopathy was defined as a prothrombin time below 50% of normal or a platelet count below 80,000 / mm3.Hemorrhagewas recorded onlywhen therewas clinical (not just endoscopic) evidence of bleeding such asmelena or hematemesis, with an associated decrease of at least 2 g per deciliter in the hemoglobin concentration, or the need for a blood transfusion. Results: Hemorrhage occurred in 6 (30%) of 20 patients in the EST group, but there was no case of hemorrhagic complications in the EPBD group (p = 0.009). With regard to the hemorrhagic rates according to Child-Pugh class in the EST group, the hemorrhagic complications mostly occurred in Child-Pugh class C patients. Moreover, three of five Child-Pugh class C cirrhotic patients with EST-related hemorrhage bled to death. In the EPBD group, however, there was not any hemorrhagic complication inChild-Pugh class C patients. Therefore, there was significant difference in the hemorrhagic complications of Child-Pugh class C patients between EST and EPBD group (5/14, 35.7% vs. 0/16, 0%; p = 0.014). On the contrary, in Child-Pugh class B, there was no significant difference in hemorrhagic complications between EST and EPBD groups (1/6, 16.6% vs. 0/4, 0%; p = NS). There was also no significant difference between EST and EPBD groups in the rate of procedure-related pancreatitis (2/20, 10 % vs. 1/21, 4.7 %; p = NS). Conclusions: EPBD may significantly reduce the risk of bleeding compared with EST in advanced cirrhotic patients with coagulopathy such as Child-Pugh class C. In these patients, EPBD should replace EST as a treatment modality for removal of choledocholithiasis. *T1476 ERCP with Sphincter of Oddi Manometry (SOM) at an Ambulatory Endoscopy Center (AEC): An Assessment of Complications Erik Springer, Yang K. Chen, Daus Mahnke, Mainor R. Antillon, Raj J. Shah BACKGROUND: Patients (pts) with suspected sphincter of Oddi dysfunction (SOD) are known to be at increased risk for post-ERCP pancreatitis. At our tertiary referral center, outpatients undergo ERCP at a multi-specialty AEC and recover in a post-anesthesia care unit.We assessed the safety of performingERCP/ SOM at an AEC. METHODS: Consecutive pts undergoing SOM over a one-yr period were identified by prospective collection and computer database. All pts had propofol administered by anesthesiology. The standard station pull-through technique was performed using the aspiration manometry catheter. Pts were transferred by ambulance to the hospital 6 miles away for 23hr observation. 30d complication rate was assessed by clinic/telephone contact and record review. Complications were defined by consensus (CONS) criteria, and by comprehensive (COMP) criteria which included unplanned ER/MDvisits,>23 hr observation, or admission for symptoms. SOD was defined by modified Milwaukee criteria. RESULTS: Between 10/02 and 10/03, 595 ERCPs were performed. 53 pts (7M, 46F, mean age 40) underwent 59 SOM procedures providing the cohort for this study. 31 SOMs were biliary, 11 were pancreatic, and 17 were biductal. SOM results: SOD Type II (29), SOD Type III (21), or normal (9). 48 pts had sphincterotomies: 32 biliary, 7 pancreatic, and 15 biductal. 31 pancreatic stents were placed prophylactically. CONS: Total 7 complications (11.9%); 6 pancreatitis, 1 bleed (mild). Pancreatitis severity: 1 mild (SOD III), 2 moderate (SOD II), and 3 severe (2 SOD II, 1 normal). COMP: Total 24 complications (41%) including 13 cases of pain requiring>23hr hospital admission, 1 abdominal pain requiring po analgesics, 1 IV site infiltration, and 2 infection. CONCLUSIONS: 1) SOM can be performed safely in an AEC provided there is on-site anesthesia support and mechanisms for hospital transfer. 2) Our pancreatitis rate is comparable to previously published series. 3) One-fifth of SOM pts without pancreatitis required >23 hr stay for pain management, thus, routine admission post-SOM is recommended. 4) Future studies reporting endoscopy-related complications should incorporate comprehensive criteria as defined for a more accurate assessment of morbidity.

Amrinone versus dopamine and nitroglycerin in neonates after arterial switch operation for transposition of the great arteries

Objective: To compare the efficacy and safety of amrinone and a combination of dopamine and nitroglycerin in neonates after reconstructive surgery for transposition of the great arteries. Design: A prospective, randomized, double-blind study. Setting: Pediatric intensive care unit in a university hospital. Participants: Thirty-five neonates with transposition of the great arteries. Interventions: A loading dose of amrinone, 2 mg/kg, followed by a maintenance infusion of 7.5 μg/kg/min, were administered to 16 neonates before separation from cardiopulmonary bypass. The remaining 19 patients were administered a combination of dopamine, 5 μg/kg/min, and nitroglycerin, 1 μg/kg/min. An open-label epinephrine infusion was administered in both groups as required. Measurements and Main Results: The circulatory state of the patients was evaluated from 4 to 18 hours after cardiopulmonary bypass. The systemic blood flow index, calculated using the Fick principle, was higher in the amrinone group (1.7 ± 0.5 L/min/m 2 (mean ± SD]) compared with the dopamine-nitroglycerin group (1.4 ± 0.4 L/min/m 2; p < 0.04). The systemic vascular resistance in the amrinone group was lower (26 ± 8 Wood units × m 2) than in the dopamine-nitroglycerin group (35 ± 12 Wood units × m 2; p < 0.02). The oxygen extraction ratio was higher in the dopamine-nitroglycerin group (0.34 ± 0.08) compared with the amrinone group (0.28 ± 0.06; p < 0.02). Lower platelet counts were observed in the amrinone group, but no difference in hemorrhagic complications was seen between the groups. Conclusion: With the dosage regimen used, supplemented with epinephrine, amrinone provides a higher cardiac output and more favorable oxygen dynamics than a combination of dopamine and nitroglycerin.

Anticoagulation Therapy and Ocular Surgery

It is not rare for patients receiving anticoagulant therapy to undergo ocular surgery; however, there are no clear guidelines with reference to the operative management of the eye. This study examines the complications in patients receiving anticoagulant therapy who undergo ocular operations and suggests a management regimen for these patients. The authors retrospectively analyzed 52 patients receiving anticoagulant therapy who underwent ocular surgery between 1993 and 1995. Data included sex, age, reason for anticoagulant therapy, operative procedure, complication rate, and length of time anticoagulant therapy was stopped or reduced prior to surgery. To show the base-line complication rate at their institution, data of patients not receiving anticoagulation therapy were added. Ticlopidine hydrochloride, an antiplatelet drug, was administered to 24 patients. Warfarin sodium was administered to 8 patients, heparin was administered to 8 patients, and other anticoagulants were administered to 20 patients. There were no significant differences in complications between the groups that stopped or reduced anticoagulant therapy and those that did not, but speech disturbance due to thrombotic complication occurred in 1 of 10 patients in whom ticlopidine hydrochloride was stopped or reduced. Hemorrhagic complications occurred in 50% of those who continued ticlopidine hydrochloride, but in none of those who discontinued it (P = .019). There was a significant difference in hemorrhagic complications after cataract surgery between the phacoemulsification, aspiration, and intraocular lens implantation (PEA + IOL) and the planned extracapsular cataract extraction and intraocular lens implantation (PECCE + IOL) groups that continued the drug (P = .0011). No patients showed visual acuity reduction due to hemorrhagic complications. To avoid life-threatening systemic complications, one need not always stop anticoagulant therapy before performing only cataract surgery. Cataract surgery in patients receiving ticlopidine hydrochloride should be performed with PEA + IOL via a small sclerocorneal or a corneal incision. In cataract surgery for patients receiving anticoagulant therapy, hemorrhagic complications are more frequent than in patients not receiving anticoagulant therapy.

Heparin and infarct coronary artery patency after streptokinase in acute myocardial infarction

Anticoagulant therapy is frequently used after thrombolytic agents in the treatment of acute myocardial infarction (AMI) although it is unclear that such therapy will prevent subsequent infarct vessel reocclusion. The role of duration of heparin therapy in maintaining infarct artery patency was studied retrospectively in 53 consecutive AMI patients who received streptokinase therapy and underwent coronary angiography acutely and at 14 ± 1 days. Of the 39 patients with initial infarct vessel patency, patency at follow-up angiography was observed in 100% (22 of 22) of those who received ≥4 days of intravenous heparin but in only 59% (10 of 17) of those patients who received <4 days of heparin (p < 0.05). Of the 14 patients not initially recanalized after streptokinase, patent infarct-related arteries at follow-up angiography were found in 3 of 8 (38%) treated with ≥4 days of heparin therapy but in none of the 6 patients treated for <4 days (difference not significant). No significant difference in hemorrhagic complications was noted between the short- and long-term heparin treatment groups. Thus, ≥4 days of intravenous heparin therapy after successful streptokinase therapy in AMI is more effective in maintaining short-term infarct vessel patency than a shorter duration of therapy and it may maintain the short-term patency of the infarct vessel in those patients who later spontaneously recanalize.

Ocular Surgery on Patients Receiving Long-Term Warfarin Therapy

We analyzed data of 50 patients receiving long-term warfarin sodium therapy who underwent ocular surgery between 1982 and 1986. The frequency of hemorrhagic and thrombotic complications was compared in patients in whom anticoagulants were continued, those in whom the anticoagulants were discontinued in the perioperative period, and a group of matched control patients. There were six perioperative hemorrhagic complications in the warfarin-treated group (12%) compared to none in the control group. This difference was significant (P less than .03). However, no significant difference in hemorrhagic complications was seen between patients in whom warfarin sodium was continued and those in whom it was discontinued.