G C Flaker

University of Missouri, Columbia, Missouri, United States

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Publications (104)851.33 Total impact

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    ABSTRACT: Objectives The aim of this study was to determine the risk of major clinical and thromboembolic events after cardioversion for atrial fibrillation in subjects treated with apixaban, an oral factor Xa inhibitor, compared with warfarin. Background In patients with atrial fibrillation, thromboembolic events may occur after cardioversion. This risk is lowered with vitamin K antagonists and dabigatran. Methods Using data from the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial, we conducted a post-hoc analysis of patients undergoing cardioversion. Results A total of 743 cardioversions were performed in 540 patients: 265 first cardioversions in patients assigned to apixaban and 275 in those assigned to warfarin. The mean time to the first cardioversion for patients assigned to warfarin and apixaban was 243 ± 231 days and 251 ± 248 days, respectively; 75% of the cardioversions occurred by 1 year. Baseline characteristics were similar between groups. In patients undergoing cardioversion, no stroke or systemic emboli occurred in the 30-day follow-up period. Myocardial infarction occurred in 1 patient (0.2%) receiving warfarin and 1 patient receiving apixaban (0.3%). Major bleeding occurred in 1 patient (0.2%) receiving warfarin and 1 patient receiving apixaban (0.3%). Death occurred in 2 patients (0.5%) receiving warfarin and 2 patients receiving apixaban (0.6%). Conclusions Major cardiovascular events after cardioversion of atrial fibrillation are rare and comparable between warfarin and apixaban. (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation [ARISTOTLE]; NCT00412984)
    Journal of the American College of Cardiology 01/2014; 63(11):1082–1087. · 14.09 Impact Factor
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    ABSTRACT: Patients with atrial fibrillation who are vitamin K antagonist (VKA)-naive may have a higher risk of thrombosis and/or bleeding than VKA-experienced patients. Using data from ARISTOTLE, we assessed baseline characteristics and the treatment effect of apixaban versus warfarin in the VKA-naive and VKA-experienced cohorts. We compared rates of study drug discontinuation and time-in-therapeutic range. Overall, 7,800 (43%) were VKA naive, and 10,401 were VKA experienced. At baseline, both groups were similar with respect to age and congestive heart failure, hypertension, age, diabetes, stroke score (CHADS2). Fewer VKA-naive patients had a history of prior stroke (18% vs 21%) or prior bleeding (10% vs 22%) and were more often female (39% vs 33%). The effect of apixaban on the primary efficacy and safety outcomes was similar in VKA-naive (stroke/systemic embolism: hazard ratio [HR] 0.86, 95% CI 0.67-1.11 and major bleeding: HR 0.73, 95% CI 0.59-0.91) and VKA-experienced populations (stroke/systemic embolism: HR 0.73, 95% CI 0.57-0.95, P value for interaction = 0.39 and major bleeding: HR 0.66, 95% CI 0.55-0.80, P value for interaction = 0.50). Permanent study drug discontinuation was numerically less likely in patients receiving apixaban whether they were VKA naive (HR for discontinuation: 0.87, 95% CI 0.79-0.95) or VKA experienced (HR for discontinuation: 0.93, 95% CI 0.85-1.02). Among patients receiving warfarin, the mean/median times in therapeutic range were lower in the VKA-naive group (VKA-naive: 57.5/61.4, VKA-experienced: 66.0/69.1, P < .001). The treatment effects of apixaban (vs warfarin) were not modified by VKA naivety. The rates of stroke/systemic embolism and major bleeding were numerically lower among the patients assigned to apixaban, irrespective of prior VKA use.
    American heart journal 09/2013; 166(3):549-58. · 4.65 Impact Factor
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    ABSTRACT: BACKGROUND: During follow up of between 1 and 3 years in the RE-LY trial, two doses of dabigatran etexilate were shown to be effective and safe for prevention of stroke or systemic embolism in patients with atrial fibrillation (AF). There is a need for longer term follow up of patients on dabigatran and for further data comparing the two dabigatran doses. METHODS AND RESULTS: Patients randomized to dabigatran in RE-LY were eligible for RELY-ABLE if they had not permanently discontinued study medication at the time of their final RE-LY study visit. Enrolled patients continued to receive the double-blind dabigatran dose received in RE-LY, for up to 28 months of follow up after RE-LY (median follow up 2.3 years). There were 5851 patients enrolled, representing 48% of patients originally randomized to receive dabigatran in RE-LY and 86% of RELY-ABLE-eligible patients. Rates of stroke or systemic embolism were 1.46 and 1.60 %/year on dabigatran 150 and 110 mg bid, respectively (hazard ratio (HR) 0.91, 95% confidence interval (CI), 0.69-1.20). Rates of major hemorrhage were 3.74 and 2.99 %/year on dabigatran 150 and 110 mg (HR 1.26, 95% CI, 1.04-1.53). Rates of death were 3.02 and 3.10 %/year (HR 0.97; 95% CI 0.80-1.19). Rates of hemorrhagic stroke were; 0.13 and 0.14%/year. CONCLUSIONS: During 2.3 years continued treatment with dabigatran after RE-LY, there was a higher rate of major bleeding with dabigatran 150 mg twice daily compared to 110 mg, and similar rates of stroke and death. CLINICAL TRIAL REGISTRATION INFORMATION: Clinicaltrials.gov; Identifier: NCT00808067.
    Circulation 06/2013; · 15.20 Impact Factor
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    ABSTRACT: BACKGROUND: -The impact of apixaban versus aspirin on ischaemic stroke and major bleeding in relation to the CHADS(2) and CHA(2)DS(2)-VASc stroke risk scores in atrial fibrillation(AF) has not been investigated. METHODS AND RESULTS: -In this secondary analysis of the AVERROES trial, our principal objective was to assess the effect of treatment with aspirin or apixaban on ischemic stroke and major bleeding, in relation to the CHADS(2)/CHA(2)DS(2)-VASc scores. We found no significant heterogeneity for treatment efficacy on ischaemic stroke for apixaban when subdivided by stroke risk strata, based on CHADS(2)/CHA(2)DS(2)-VASc. Effects were consistent irrespective of baseline risk and thus, absolute benefits were greatest in the high risk groups. There was also no significant heterogeneity for apixaban vs aspirin with regard to major bleeding, when subdivided by CHADS(2)/CHA(2)DS(2)-VASc scores. In multivariable analysis, significant predictors of stroke on aspirin were age &[ge]75 years, prior stroke or TIA, estimated GFR<60 mL/min and non-paroxysmal AF. Proportions of the study cohort classified as low/moderate/high risk using the CHADS(2) and CHA(2)DS(2)-VASc scores were 0.3%/71.7%/28.1% and <0.1%/10.5%/89.5%, respectively. CONCLUSIONS: -In an AF population, apixaban was superior to aspirin for stroke prevention, with similar rates of major bleeding, in the presence of one or more stroke risk factors, with consistency of the treatment effect by CHADS(2)/CHA(2)DS(2)-VASc scores.
    Circulation Arrhythmia and Electrophysiology 02/2013; · 5.95 Impact Factor
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    ABSTRACT: BACKGROUND AND PURPOSE: Apixaban reduces stroke with comparable bleeding risks when compared with aspirin in patients with atrial fibrillation who are unsuitable for vitamin k antagonist therapy. This analysis explores patterns of bleeding and defines bleeding risks based on stroke risk with apixaban and aspirin. METHODS: The Apixaban versus Acetylsalicylic Acid to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin k Antagonist Treatment (AVERROES) trial randomized 5599 patients with atrial fibrillation and risk factors to receive either apixaban or aspirin. Bleeding events were defined as the first occurrence of either major bleeding or clinically relevant nonmajor bleeding. RESULTS: The rate of a bleeding event was 3.8%/year with aspirin and 4.5%/year with apixaban (hazard ratio with apixaban, 1.18; 95% CI, 0.92-1.51; P=0.19). The anatomic site of bleeding did not differ between therapies. Risk factors for bleeding common to apixaban and aspirin were use of nonstudy aspirin >50% of the time and a history of daily/occasional nosebleeds. The rates of both stroke and bleeding increased with higher CHADS(2) scores but apixaban compared with aspirin was associated with a similar relative risk of bleeding (P interaction 0.21) and a reduced relative risk of stroke (P interaction 0.37) irrespective of CHADS(2) category. CONCLUSIONS: Anatomic sites and predictors of bleeding are similar for apixaban and aspirin in these patients. Higher CHADS(2) scores are associated with increasing rates of bleeding and stroke, but the balance between risks and benefits of apixaban compared with aspirin is favorable irrespective of baseline stroke risk.Clinical Trial Registration Information-www.clinicaltrials.gov. Unique identifier: NCT 00496769.
    Stroke 10/2012; · 6.16 Impact Factor
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    Journal of the American College of Cardiology 02/2012; 59(9):854-5. · 14.09 Impact Factor
  • Rachel Littrell, Greg Flaker
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    ABSTRACT: Until recently, pharmaceutical options for stroke prevention in atrial fibrillation were restricted to aspirin or vitamin K antagonist therapy. In recent years development has been underway for alternatives. Apixaban, a direct Factor Xa inhibitor, is orally dosed, target selective and has few known drug or food interactions. As such, it is a member of a new generation of anticoagulants expected to revolutionize the way we approach anticoagulation for stroke prevention in atrial fibrillation. Apixaban has been studied in Phase II and Phase III trials for a variety of indications. The AVERROES trial established apixaban as superior to aspirin for stroke reduction in patients with atrial fibrillation for whom vitamin K antagonist therapy is unsuitable. The recent ARISTOTLE trial found apixaban to be superior to warfarin for stroke prevention in a wide range of patients with atrial fibrillation, with significantly lower bleeding risk, and lower risk of all-cause mortality.
    Expert Review of Cardiovascular Therapy 02/2012; 10(2):143-9.
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    Manish B Jhawar, Greg Flaker
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    ABSTRACT: Atrial fibrillation is the most common of the cardiac arrhythmias and is associated with high risk of stroke and systemic thromboembolism. Prevention of these complications is therefore a major component of clinical management in patients with this rhythm disorder. The choice of antithrombotic therapy in any given patient depends on his or her risk profile and needs to be carefully balanced against the risk of bleeding. In this review we discuss the pathophysiology of thrombogenesis in atrial fibrillation, risk factors for systemic thromboembolism in atrial fibrillation, patient risk stratification modules both for systemic thromboembolism and the risk of bleeding, current antithrombotic therapy strategies, clinicoepidemiological evidence that led to their evolvement, the challenges that plague them, recent developments in the field and how they could possibly affect our future clinical decision making.
    Hematology Research and Reviews 01/2012; 3:1-13.
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    ABSTRACT: Dronedarone restores sinus rhythm and reduces hospitalization or death in intermittent atrial fibrillation. It also lowers heart rate and blood pressure and has antiadrenergic and potential ventricular antiarrhythmic effects. We hypothesized that dronedarone would reduce major vascular events in high-risk permanent atrial fibrillation. We assigned patients who were at least 65 years of age with at least a 6-month history of permanent atrial fibrillation and risk factors for major vascular events to receive dronedarone or placebo. The first coprimary outcome was stroke, myocardial infarction, systemic embolism, or death from cardiovascular causes. The second coprimary outcome was unplanned hospitalization for a cardiovascular cause or death. After the enrollment of 3236 patients, the study was stopped for safety reasons. The first coprimary outcome occurred in 43 patients receiving dronedarone and 19 receiving placebo (hazard ratio, 2.29; 95% confidence interval [CI], 1.34 to 3.94; P=0.002). There were 21 deaths from cardiovascular causes in the dronedarone group and 10 in the placebo group (hazard ratio, 2.11; 95% CI, 1.00 to 4.49; P=0.046), including death from arrhythmia in 13 patients and 4 patients, respectively (hazard ratio, 3.26; 95% CI, 1.06 to 10.00; P=0.03). Stroke occurred in 23 patients in the dronedarone group and 10 in the placebo group (hazard ratio, 2.32; 95% CI, 1.11 to 4.88; P=0.02). Hospitalization for heart failure occurred in 43 patients in the dronedarone group and 24 in the placebo group (hazard ratio, 1.81; 95% CI, 1.10 to 2.99; P=0.02). Dronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in patients with permanent atrial fibrillation who were at risk for major vascular events. Our data show that this drug should not be used in such patients. (Funded by Sanofi-Aventis; PALLAS ClinicalTrials.gov number, NCT01151137.).
    New England Journal of Medicine 11/2011; 365(24):2268-76. · 51.66 Impact Factor
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    ABSTRACT: Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin. In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic embolism. The trial was designed to test for noninferiority, with key secondary objectives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause. The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.27% per year in the apixaban group, as compared with 1.60% per year in the warfarin group (hazard ratio with apixaban, 0.79; 95% confidence interval [CI], 0.66 to 0.95; P<0.001 for noninferiority; P=0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P<0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P=0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P<0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P=0.42). In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. (Funded by Bristol-Myers Squibb and Pfizer; ARISTOTLE ClinicalTrials.gov number, NCT00412984.).
    New England Journal of Medicine 08/2011; 365(11):981-92. · 51.66 Impact Factor
  • Greg Flaker, Richard Weachter
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    ABSTRACT: OPINION STATEMENT: Stroke is a dreaded complication of atrial fibrillation. In the past, preventive therapy included aspirin and oral anticoagulation. Selected patients who are not suitable for oral anticoagulation may benefit from the addition of clopidogrel with aspirin. This combination, when compared with aspirin, offers a reduced risk of stroke at a cost of more major bleeding. We use this therapy in patients with atrial fibrillation who have unstable coronary syndromes or in patients who receive coronary artery stents who are not good candidates for "triple therapy" with aspirin, clopidogrel, and warfarin. The duration of therapy is tempered by many variables. In the case of coronary stents, we ask the interventionalist to consider a bare metal stent to shorten the duration of need for clopidogrel plus aspirin. After several months of combination therapy, we stop this therapy and begin warfarin therapy. Dabigatran is commercially available in the United States. In patients who have difficult to control International Normalized Ratio (INR) values or who do not wish to have regular coagulation monitoring, dabigatran offers a huge advantage. The benefit seems less if the INR is consistently within range. We are impressed with the superior reduction in stroke and systemic embolism with 150 mg of dabigatran twice daily compared to warfarin and also its low risk of intracranial hemorrhage. The results of clinical trials involving factor Xa agents are now being presented. How these agents fit into the marketplace remains to be seen but they will offer clinicians additional therapy for stroke prevention in atrial fibrillation.
    Current Treatment Options in Cardiovascular Medicine 07/2011; 13(5):361-9.
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    ABSTRACT: INTRODUCTION: Atrial fibrillation is a common cardiac rhythm abnormality with a considerable cardiovascular disease burden worldwide. It is an independent major risk factor for stroke. Stroke prevention with anticoagulation or antiplatelet agents has been an important area of clinical research. Warfarin is the most widely used antithrombotic therapy for stroke prophylaxis for last several years, and now dabigatran (150 mg b.i.d.) is more effective than warfarin in stroke prevention in individuals at increased of stroke. In addition, several studies have evaluated the efficacy of clopidogrel for stroke prophylaxis either alone or in combination with aspirin. AREAS COVERED: This review summarizes the key findings of the trials looking at the efficacy of clopidogrel in stroke prevention. A literature search was performed using PubMed and Google Scholar. The trials that evaluated the efficacy of clopidogrel in preventing atherothrombotic events or stroke were also included. EXPERT OPINION: Clopidogrel prevents more vascular events, including stroke, in patients with a recent myocardial infarction, stroke or peripheral vascular disease than aspirin. Combination of clopidogrel and aspirin provides a greater reduction of stroke than aspirin or clopidogrel monotherapy, but at an increased risk of bleeding. Dual antiplatelet therapy (clopidogrel and aspirin) is inferior to warfarin in primary stroke prevention for patient with atrial fibrillation and thus should be considered for stroke prophylaxis only in patients ineligible for warfarin. However, with the advent of newer agents, like direct thrombin inhibitors and Factor Xa inhibitors, the role of antiplatelet therapy for stroke prevention in atrial fibrillation remains unclear.
    Expert Opinion on Pharmacotherapy 06/2011; 12(11):1781-7. · 2.86 Impact Factor
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    ABSTRACT: Vitamin K antagonists have been shown to prevent stroke in patients with atrial fibrillation. However, many patients are not suitable candidates for or are unwilling to receive vitamin K antagonist therapy, and these patients have a high risk of stroke. Apixaban, a novel factor Xa inhibitor, may be an alternative treatment for such patients. In a double-blind study, we randomly assigned 5599 patients with atrial fibrillation who were at increased risk for stroke and for whom vitamin K antagonist therapy was unsuitable to receive apixaban (at a dose of 5 mg twice daily) or aspirin (81 to 324 mg per day), to determine whether apixaban was superior. The mean follow up period was 1.1 years. The primary outcome was the occurrence of stroke or systemic embolism. Before enrollment, 40% of the patients had used a vitamin K antagonist. The data and safety monitoring board recommended early termination of the study because of a clear benefit in favor of apixaban. There were 51 primary outcome events (1.6% per year) among patients assigned to apixaban and 113 (3.7% per year) among those assigned to aspirin (hazard ratio with apixaban, 0.45; 95% confidence interval [CI], 0.32 to 0.62; P<0.001). The rates of death were 3.5% per year in the apixaban group and 4.4% per year in the aspirin group (hazard ratio, 0.79; 95% CI, 0.62 to 1.02; P=0.07). There were 44 cases of major bleeding (1.4% per year) in the apixaban group and 39 (1.2% per year) in the aspirin group (hazard ratio with apixaban, 1.13; 95% CI, 0.74 to 1.75; P=0.57); there were 11 cases of intracranial bleeding with apixaban and 13 with aspirin. The risk of a first hospitalization for cardiovascular causes was reduced with apixaban as compared with aspirin (12.6% per year vs. 15.9% per year, P<0.001). The treatment effects were consistent among important subgroups. In patients with atrial fibrillation for whom vitamin K antagonist therapy was unsuitable, apixaban reduced the risk of stroke or systemic embolism without significantly increasing the risk of major bleeding or intracranial hemorrhage. (Funded by Bristol-Myers Squibb and Pfizer; ClinicalTrials.gov number, NCT00496769.).
    New England Journal of Medicine 02/2011; 364(9):806-17. · 51.66 Impact Factor
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    ABSTRACT: The Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial compared dabigatran 110 mg BID (D110) and 150 mg BID (D150) with warfarin for stroke prevention in 18 113 patients with nonvalvular atrial fibrillation. Cardioversion on randomized treatment was permitted. Precardioversion transesophageal echocardiography was encouraged, particularly in dabigatran-assigned patients. Data from before, during, and 30 days after cardioversion were analyzed. A total of 1983 cardioversions were performed in 1270 patients: 647, 672, and 664 in the D110, D150, and warfarin groups, respectively. For D110, D150, and warfarin, transesophageal echocardiography was performed before 25.5%, 24.1%, and 13.3% of cardioversions, of which 1.8%, 1.2%, and 1.1% were positive for left atrial thrombi. Continuous treatment with study drug for ≥3 weeks before cardioversion was lower in D110 (76.4%) and D150 (79.2%) compared with warfarin (85.5%; P<0.01 for both). Stroke and systemic embolism rates at 30 days were 0.8%, 0.3%, and 0.6% (D110 versus warfarin, P=0.71; D150 versus warfarin, P=0.40) and similar in patients with and without transesophageal echocardiography. Major bleeding rates were 1.7%, 0.6%, and 0.6% (D110 versus warfarin, P=0.06; D150 versus warfarin, P=0.99). This study is the largest cardioversion experience to date and the first to evaluate a novel anticoagulant in this setting. The frequencies of stroke and major bleeding within 30 days of cardioversion on the 2 doses of dabigatran were low and comparable to those on warfarin with or without transesophageal echocardiography guidance. Dabigatran is a reasonable alternative to warfarin in patients requiring cardioversion.
    Circulation 01/2011; 123(2):131-6. · 15.20 Impact Factor
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    Journal of The American College of Cardiology - J AMER COLL CARDIOL. 01/2011; 57(14).
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    ABSTRACT: The aims of this study are to evaluate the cardiac safety of the Stinger S-200 Conducted Energy Weapon Device (CED) (Stinger Systems, Tampa, Fla) on a human-sized pig model and to test the effect of various commercially available CEDs, specifically the Stinger S-200, TASER M26 (Taser International, Scottsdale, Ariz), and TASER X26 on pacemaker function. Two groups of pigs, divided based on weight as group 1 (n = 3, 67.3 ± 4.7 kg) and group 2 (n = 3, 89.3 ± 1.2 kg), were used. In protocol 1, the Stinger S-200 was applied in multiple different orientations to simulate possible field scenarios across the heart. In protocol 2, a single-chamber bipolar lead connected to a pacemaker was placed in the right ventricle of the pig, and different CEDs were applied to test the pacemaker function during CED application. In protocol 1, the S-200 was applied a total of 216 times in the 6 pigs, and neither episodes of ventricular fibrillation nor episodes of sustained ventricular tachycardia were noted. In protocol 2, the CED discharges (1) were recognized by the pulse generator and sensed as either high-rate atrial or ventricular activity, (2) did not affect the native rhythm, (3) did not conduct down the lead systems to cause any extra systoles, and (4) had no effect on paced rhythm. In this model, the application of the S-200 in various orientations across the heart did not result in any sustained abnormal cardiac rhythms. None of the tested CEDs adversely affected the functioning of the tested pacemaker. Stinger Systems has now replaced the S-200 with the S-200T with a different output.
    The American journal of emergency medicine 10/2010; 29(9):1089-96. · 1.54 Impact Factor
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    ABSTRACT: The aim of cardiac resynchronization therapy (CRT) is to restore myocardial electromechanical synchrony. Achieving this in patients with chronic severe heart failure due to poor left ventricular (LV) systolic function and cardiac dyssynchrony on optimal medical therapy, is associated with improved clinical performance and outcomes. Up to one-third of patients undergoing CRT do not benefit from implantation. Ensuring LV capture is essential and can be at times difficult to confirm. Described herein, are six patients who underwent biventricular pacemaker implantation but failed to experience an improvement in LV systolic function or functional capacity. In each case, the 12-lead electrocardiogram (ECG) was helpful in unmasking loss of LV capture in patients who were presumed to have biventricular pacing. Despite the technical wizardry behind CRT and patient system analyzers, the surface ECG should continue to be an invaluable tool for evaluating patients who have undergone CRT.
    Annals of Noninvasive Electrocardiology 10/2010; 15(4):369-77. · 1.08 Impact Factor
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    ABSTRACT: Public access automatic external defibrillators (AEDs) can save lives, but most deaths from out-of-hospital sudden cardiac arrest occur at home. The Home Automatic External Defibrillator Trial (HAT) found no survival advantage for adding a home AED to cardiopulmonary resuscitation (CPR) training for 7,001 patients with a prior anterior wall myocardial infarction. Quality of life (QOL) outcomes for both the patient and spouse/companion were secondary end points. A subset of 1,007 study patients and their spouse/companions was randomly selected for ascertainment of QOL by structured interview at baseline and 12 and 24 months after enrollment. The primary QOL measures were the Medical Outcomes Study 36-Item Short-Form psychological well-being (reflecting anxiety and depression) and vitality (reflecting energy and fatigue) subscales. For patients and spouse/companions, the psychological well-being and vitality scales did not differ significantly between those randomly assigned an AED plus CPR training and controls who received CPR training only. None of the other QOL measures collected showed a clinically and statistically significant difference between treatment groups. Patients in the AED group were more likely to report being extremely or quite a bit reassured by their treatment assignment. Spouse/companions in the AED group reported being less often nervous about the possibility of using AED/CPR treatment than those in the CPR group. Adding access to a home AED to CPR training did not affect QOL either for patients with a prior anterior myocardial infarction or their spouse/companion but did provide more reassurance to the patients without increasing anxiety for spouse/companions.
    American heart journal 04/2010; 159(4):627-634.e7. · 4.65 Impact Factor
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    ABSTRACT: Many patients with atrial fibrillation (AF) at moderate or high risk for stroke are not treated with a vitamin K antagonist (VKA). Presently, the only alternative to a VKA with a labeled indication for AF is antiplatelet therapy with acetylsalicylic acid (ASA), which is much less effective than a VKA for prevention of stroke. The novel oral factor Xa inhibitor, apixaban, is being developed for prevention of stroke in AF. A noninferiority trial of apixaban versus a VKA (warfarin) is being conducted but does not address the large unmet need of AF patients at risk of stroke who are unsuitable for or unwilling to take a VKA. Apixaban may be an attractive alternative to ASA for prevention of stroke in patients with AF who cannot or will not take a VKA. AVERROES is a double-blind, double-dummy superiority trial of apixaban 5 mg twice daily (2.5 mg twice daily in selected patients) compared with ASA 81 to 324 mg once daily in patients with AF and at least 1 risk factor for stroke who have failed or are unsuitable for VKA therapy. The primary outcome is stroke or systemic embolism, and the primary safety outcome is major bleeding. The trial is event driven and is expected to enroll at least 5,600 patients. By evaluating the use of apixaban as a replacement for ASA in AF patients who are not treated with a VKA, the AVERROES study is addressing an important unmet clinical need. The results of AVERROES will be complementary to those of a parallel noninferiority trial comparing apixaban with VKA therapy in patients with AF who are able to receive a VKA.
    American heart journal 03/2010; 159(3):348-353.e1. · 4.65 Impact Factor

Publication Stats

6k Citations
851.33 Total Impact Points

Institutions

  • 1983–2014
    • University of Missouri
      • • Department of Internal Medicine
      • • School of Medicine
      • • Department of Surgery
      • • Department of Health Sciences
      Columbia, Missouri, United States
  • 2011
    • Louisiana State University Health Sciences Center New Orleans
      New Orleans, Louisiana, United States
  • 2008–2011
    • McMaster University
      • Population Health Research Institute (PHRI)
      Hamilton, Ontario, Canada
  • 2007
    • University of Ottawa
      Ottawa, Ontario, Canada
  • 2005
    • University of Pittsburgh
      • Division of General Internal Medicine
      Pittsburgh, PA, United States
  • 2004
    • Thomas Jefferson University Hospitals
      • Division of Cardiology
      Philadelphia, PA, United States
  • 1995–2004
    • Mount Sinai Medical Center
      New York City, New York, United States
    • Harvard Medical School
      Boston, Massachusetts, United States
  • 1992–2003
    • Brigham and Women's Hospital
      • Department of Medicine
      Boston, MA, United States
  • 1997
    • University of Pennsylvania
      • Department of Medicine
      Philadelphia, PA, United States