ObjectiveUsing a multisite, contemporary registry of 58 862 percutaneous coronary intervention (PCI) procedures in a national healthcare system, the present study compared radial access with femoral access on safety and efficacy outcomes.MethodsThis is a real-world, large-scale, retrospective study using clinical data from a 137-hopsital System and reported to a multisite clinical registry. All patients undergoing a cardiac catheterisation procedure were included in this database. The primary end points were major bleeding and radiation exposure. Multivariate logistic regression modelling was used to compare access groups.ResultsFemoral access (n=55 729) accounted for 94.7% and radial access (n=3137) for 5.3%. There were fewer bleeding events in the radial group (n=28, 0.9%) than those in the femoral group (n=1234, 2.2%) in the unadjusted analysis. For patients receiving bivalirudin, bleeding occurred in 337 patients (1.6%), and there was no difference in rates between radial access (n=13, 1.1%) and femoral access (n=327, 1.7%) (OR=0.65, CI 0.40 to 1.22, p=0.19). The radial technique resulted in higher radiation exposure in each case, but particularly for procedures involving prior coronary artery bypass graft history and non-ST-elevated myocardial infarction patients. The mean fluoroscopy time among femoral access procedures was 15.68 min (SD=11.7) versus 19.86 min (SD=13.8) for radial access procedures (p<0.0001).ConclusionsRadial access for PCI is associated with higher fluoroscopy times but not with less major bleeding when bivalirudin is used. Our analysis, combined with other study findings, suggest that the safest route for PCI may be the use of femoral access with bivalirudin.

P ulmonary artery perforation is a rare but often fatal complication of right heart catheterization that is due to Swan-Ganz catheter (Edward Lifesciences, Irvine, Calif) placement. [1][2][3] Treatment of a catheter-induced pulmonary artery rupture includes emergent intubation, lung resection, surgical pulmonary artery repair, and catheter-based pulmonary artery embolization. 4,5 This case demonstrates a new therapeutic approach of injecting topical Thrombin-JMI (GenTrac Inc, Middleton, Wisc) through the distal port of the Swan-Ganz catheter to effectively treat a pulmonary artery rupture during a right heart catheterization. Case PresentationThe patient was a 72-year-old woman with a past medical history of severe mitral valve regurgitation. Left heart catheterization was performed first with no complications. The coronary angiogram demonstrated minimal luminal irregularities in all 3 major coronary arteries. The left ventriculogram demonstrated ϩ3 mitral regurgitation with a 50% ejection fraction. Right heart catheterization was then performed using a 7.5Fr Swan-Ganz balloon-tipped catheter. The right atrial mean pressure was 8 mm Hg. Right ventricular pressure was 51/8 mm Hg. The pulmonary artery pressure was recorded at 51/20 mm Hg. The mean pulmonary capillary wedge pressure was 20 mm Hg.On inflation of the balloon, the pulmonary artery perforated. This was made evident by frank hemoptysis shortly after balloon inflation. Intubation was selective to the right bronchus then pulled back to a position just above the carina. With the Swan-Ganz catheter remaining in the pulmonary artery, a "pulmonary wedge" angiogram via the distal port of the Swan-Ganz was performed using Isovue 370 (Bracco Diagnostics, Princeton, NJ). The angiogram demonstrated formation of a pseudoaneurysm with extravasation of contrast (Figures 1 and 2). The tip of the catheter was retracted slightly, and the balloon was inflated to half its prior volume. Placement of the balloon at this location created a tamponade effect, stopping the hemoptysis.With each balloon deflation periodic pulmonary angiograms were performed through the distal port of the SwanGanz catheter. Mild hemoptysis was present with each deflation.The balloon was inflated for approximately an hour with periodic deflations and imaging to determine if the rupture would seal. The ruptured pulmonary artery failed to seal.A thrombin injection procedure was performed (topical US Pharmacopeia [bovine origin] Thrombin-JMI 20 000 IU/20 mL sterile saline). By angiography it was determined that 0.3 mL of contrast would fill the distal artery and the pseudoaneurysm. This measurement was obtained using a tuberculin syringe. Two injections of 0.2 mL each of thrombin were injected via the distal port of the Swan-Ganz catheter for a total dose of 400 IU thrombin delivered. Subsequent angiography demonstrated resolution and clotting of the affected pulmonary artery pseudoaneurysm. The adjacent pulmonary artery remained free from injury or clot (Figure 3).A follow-up high-resolution chest co...

ObjectiveAn accurate tool with good discriminative for bleeding would be useful to clinicians for improved management of all their patients. Bleeding risk models have been published but not externally validated in independent clinical data set. We chose the National Cardiovascular Data Registry (NCDR) percutaneous coronary intervention (PCI) score to validate within a large, multisite community data set. The aim of the study was validation of this Bleeding Risk Score (BRS) tool among a subgroup of patients based on body mass index.MethodsThis is a large-scale retrospective analysis of a current registry utilising data from a 37-hospital health system. The central repository of patients with coronary heart disease undergoing PCI between 1 June 2009 and 30 June 2012 was utilised to validate the NCDR PCI BRS among 4693 patients. The primary end point was major bleeding. Validation analysis calculating the receiver operating characteristic curve was performed.ResultsThere were 143 (3%) major bleeds. Mean BRS was 14.7 (range 3–42). Incidence of bleeding by risk category: low (0.5%), intermediate (1.7%) and high risk (7.6%). Tool accuracy was poor to fair (area-under-the curve (AUC) 0.78 heparin, 0.65 bivalirudin). Overall accuracy was 0.71 (CI 0.66 to 0.76). Accuracy did not improve when confined to just the intermediate risk group (AUC 0.58; CI 0.55 to 0.67). Tool accuracy was the lowest among the low BMI group (AUC 0.62) though they are at increased risk of bleeding following PCI.ConclusionsBleeding risk tools have low predictive value even among subgroups of patients at higher risk. Adjustment for anticoagulation use resulted in poor discrimination because bivalirudin differentially biases outcomes toward no bleeding. The current state of bleeding risk tools provide little support for diagnostic utility in regards to major bleeding and therefore have limited clinical applicability.

IntroductionStudies have demonstrated bivalirudin efficacy in some patients at increased risk of bleeding. The aim of this study was to determine the extent to which bleeding reduction is achieved among all patients using bivalirudin as compared with a heparin with or without 2B3A inhibitor strategy.MethodsThis is a real-world, large-scale retrospective study utilising the American College of Cardiology (ACC) data from a 37-hospital Ascension Health System. The registry represents routine clinical practice between 1 June 2009 and 30 June 2012. End points included major bleeding, major adverse cardiac events and death. Multivariate regression analysis modelled on predictors of end points.ResultsThis study included 58 862 PCI procedures. Major bleeding rates were lowest for bivalirudin plus closure device overall (OR=0.53, CI 0.21 to 0.84, p=0.001). The use of a device for access closure contributed to the greatest declines in major bleeding. Compared with heparin with device, bivalirudin with device had a significantly lower rate of bleeding (OR=0.37, CI 0.18 to 0.74, p=0.005). The use of device had a greater effect on decreasing bleeding among patients receiving bivalirudin compared with heparin, especially among women (p=0.001). After adjustment for 2B3A use, this advantage was no longer significant in ST segment elevation myocardial infarction patients (OR=1.8, CI 0.5 to 6.0, p=0.34).ConclusionsAll risk groups in this real world database representing current clinical practice benefited from the use of bivalirudin and device closure with lower risk groups benefiting the most. This robust analysis of real-world clinical data supports a combined treatment strategy of bivalirudin and closure device.