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Michael D Ezekowitz - One of the best experts on this subject based on the ideXlab platform.
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edoxaban therapy increases treatment satisfaction and reduces utilization of healthcare resources an analysis from the edoxaban vs warfarin in subjects undergoing Cardioversion of atrial fibrillation ensure af study
Europace, 2018Co-Authors: Andreas Goette, Michael D Ezekowitz, Gregory Y.h. Lip, Winghan Jacqueline Kwong, Maciej Banach, Soren Pihlkjaer Hjortshoj, Dmitry ZamoryakhinAbstract:Aims The EdoxabaN vs. warfarin in subjectS UndeRgoing Cardioversion of atrial fibrillation (ENSURE-AF) (NCT02072434) study was a multicentre prospective, randomized, open-label, blinded-endpoint evaluation (PROBE) trial comparing edoxaban with enoxaparin/warfarin followed by warfarin alone in 2199 non-valvular atrial fibrillation patients undergoing electrical Cardioversion and showed comparable rates of bleeding and thromboembolism between treatments. This prespecified ancillary analysis investigated the impact of edoxaban therapy on treatment satisfaction and utilization of healthcare services. Methods and results The Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) was completed by study patients on Day 28 post-Cardioversion. Higher scores represent greater satisfaction. Healthcare resource utilizations were collected from randomization to Day 28 post-Cardioversion. Data from patients who received at least one dose of study drugs were analysed. Patients treated with edoxaban were more satisfied than enoxaparin/warfarin in both PACT-Q treatment satisfaction and convenience scores (P < 0.001 for both). Differences in treatment satisfaction scores were greater in patients who underwent non-transoesophageal echocardiography (TOE)-guided Cardioversion than in patients who underwent TOE-guided Cardioversion. Edoxaban was associated with fewer clinic visits (4.75 visits vs. 7.60 visits; P < 0.001) and fewer hospital days (3.43 days vs. 5.41 days; P < 0.05). Rates of hospitalizations and emergency room visits were not significantly different. Overall, edoxaban therapy was estimated to reduce healthcare costs by €107.73, €437.92, €336.75, and $246.32 per patient in German, Spanish, Italian, and US settings, respectively. Conclusions The convenience of edoxaban therapy over warfarin in patients undergoing Cardioversion may provide greater treatment satisfaction and cost savings to the healthcare system.
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apixaban compared to heparin vitamin k antagonist in patients with atrial fibrillation scheduled for Cardioversion the emanate trial
European Heart Journal, 2018Co-Authors: Michael D Ezekowitz, Charles V Pollack, Jonathan L Halperin, Richard D England, Sandra Vanpelt Nguyen, Judith Spahr, Maria Sudworth, Nilo B Cater, Andrei BreaznaAbstract:Aim The primary objective was to compare apixaban to heparin/vitamin K antagonist (VKA) in patients with atrial fibrillation (AF) and ≤48 h anticoagulation prior to randomization undergoing Cardioversion. Methods One thousand five hundred patients were randomized. The apixaban dose of 5 mg b.i.d. was reduced to 2.5 mg b.i.d. in patients with two of the following: age ≥ 80 years, weight ≤ 60 kg, or serum creatinine ≥ 133 µmol/L. To expedite Cardioversion, at the discretion of the investigator, imaging and/or a loading dose of 10 mg (down-titrated to 5 mg) was allowed. The endpoints for efficacy were stroke, systemic embolism (SE), and death. The endpoints for safety were major bleeding and clinically relevant non-major (CRNM) bleeding. Results There were 1038 active and 300 spontaneous Cardioversions; 162 patients were not cardioverted. Imaging was performed in 855 patients, and 342 received a loading dose of apixaban. Comparing apixaban to heparin/VKA in the full analysis set, there were 0/753 vs. 6/747 strokes [relative risk (RR) 0; 95% confidence interval (95% CI) 0-0.64; nominal P = 0.015], no SE, and 2 vs. 1 deaths (RR 1.98; 95% CI 0.19-54.00; nominal P > 0.999). In the safety population, there were 3/735 vs. 6/721 major (RR 0.49; 95% CI 0.10-2.07; nominal P = 0.338) and 11 vs. 13 CRNM bleeding events (RR 0.83; 95% CI 0.34-1.89; nominal P = 0.685). On imaging, 60/61 with thrombi continued randomized treatment; all (61) were without outcome events. Conclusions Rates of strokes, systemic emboli, deaths, and bleeds were low for both apixaban and heparin/VKA treated AF patients undergoing Cardioversion. Clinical trials.gov number NCT02100228.
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apixaban compared with parenteral heparin and or vitamin k antagonist in patients with nonvalvular atrial fibrillation undergoing Cardioversion rationale and design of the emanate trial
American Heart Journal, 2016Co-Authors: Michael D Ezekowitz, Charles V Pollack, Jonathan L Halperin, Judith Spahr, Nilo B Cater, Andrei Breazna, Paul Sanders, William Petkun, Paulus KirchhofAbstract:Background Stroke prevention in anticoagulation-naive patients with atrial fibrillation undergoing Cardioversion has not been systematically studied. Objective To determine outcomes in anticoagulation-naive patients (defined as those receiving an anticoagulant for Methods This is a randomized, prospective, open-label, real-world study comparing apixaban to heparin plus warfarin. Early image-guided Cardioversion is encouraged. For apixaban, the usual dose is 5 mg BID with a dose reduction to 2.5 mg BID if 2 of the following are present: age >80 years, weight 1.5 mg/dL. If Cardioversion is immediate, a single starting dose of 10 mg (or 5 mg if the dose is down-titrated) of apixaban is administered. Cardioversion may be attempted up to 90 days after randomization. Patients are followed up for 30 days after Cardioversion or 90 days postrandomization if Cardioversion is not performed within that timeframe. Outcomes are stroke, systemic embolization, major bleeds, clinically relevant nonmajor bleeding, and death, all adjudication-blinded. Statistics The warfarin-naive cohort from the ARISTOTLE study was considered the closest data set to the patients being recruited into this study. The predicted incidence of stroke, systemic embolism, and major bleeding within 30 days after randomization was approximately 0.75%. To adequately power for a noninferiority trial, approximately 48,000 participants would be needed, a number in excess of feasibility. The figure of 1,500 patients was considered clinically meaningful and achievable. Clinical context This first prospective Cardioversion study of a novel anticoagulant in anticoagulation-naive patients should influence clinical practice.
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rivaroxaban vs vitamin k antagonists for Cardioversion in atrial fibrillation
European Heart Journal, 2014Co-Authors: Riccardo Cappato, Michael D Ezekowitz, Allan L Klein, John A Camm, Jeanyves Le Heuzey, Mario TalajicAbstract:Aims X-VeRT is the first prospective randomized trial of a novel oral anticoagulant in patients with atrial fibrillation undergoing elective Cardioversion. Methods and results We assigned 1504 patients to rivaroxaban (20 mg once daily, 15 mg if creatinine clearance was between 30 and 49 mL/min) or dose-adjusted vitamin K antagonists (VKAs) in a 2:1 ratio. Investigators selected either an early (target period of 1–5 days after randomization) or delayed (3–8 weeks) Cardioversion strategy. The primary efficacy outcome was the composite of stroke, transient ischaemic attack, peripheral embolism, myocardial infarction, and cardiovascular death. The primary safety outcome was major bleeding. The primary efficacy outcome occurred in 5 (two strokes) of 978 patients (0.51%) in the rivaroxaban group and in 5 (two strokes) of 492 patients (1.02%) in the VKA group [risk ratio 0.50; 95% confidence interval (CI) 0.15–1.73]. In the rivaroxaban group, four patients experienced primary efficacy events following early Cardioversion (0.71%) and one following delayed Cardioversion (0.24%). In the VKA group, three patients had primary efficacy events following early Cardioversion (1.08%) and two following delayed Cardioversion (0.93%). Rivaroxaban was associated with a significantly shorter time to Cardioversion compared with VKAs ( P < 0.001). Major bleeding occurred in six patients (0.6%) in the rivaroxaban group and four patients (0.8%) in the VKA group (risk ratio 0.76; 95% CI 0.21–2.67). Conclusion Oral rivaroxaban appears to be an effective and safe alternative to VKAs and may allow prompt Cardioversion. Name of the trial registry Clinicaltrials.gov; Trial registration number: [NCT01674647][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01674647&atom=%2Fehj%2F35%2F47%2F3346.atom
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rationale and design of the explore the efficacy and safety of once daily oral rivaroxaban for the prevention of cardiovascular events in patients with nonvalvular atrial fibrillation scheduled for Cardioversion trial a comparison of oral rivaroxaban once daily with dose adjusted vitamin k antagonists in patients with nonvalvular atrial fibrillation undergoing elective Cardioversion
American Heart Journal, 2014Co-Authors: Michael D Ezekowitz, Riccardo Cappato, Allan L Klein, John A Camm, Jeanyves Le Heuzey, Mario Talajic, Chang Sheng, Mauricio Scanavacca, Panos E Vardas, Paulus KirchhofAbstract:Background Anticoagulation before, during, and after Cardioversion is effective in reducing stroke risk in patients with atrial fibrillation. Objective The objective of this study is to explore the efficacy and safety of rivaroxaban 20 mg once daily (15 mg if creatinine clearance is 30-49 mL/min) compared with dose-adjusted vitamin K antagonists (VKAs; international normalized ratio 2.0-3.0) in patients scheduled for elective Cardioversion. Methods This is a prospective, randomized, open-label, parallel group comparison of approximately 1,500 patients from 17 countries with hemodynamically stable nonvalvular atrial fibrillation of >48 hours or unknown duration. Patients will be randomized 2:1 (rivaroxaban:VKA) using 2 Cardioversion strategies: the first approach is early Cardioversion with the preCardioversion anticoagulation goal of 1 to 5 days using rivaroxaban or usual therapy (heparin + VKA). In these patients, transesophageal echocardiography will be encouraged to exclude atrial thrombi. The alternative approach is delayed Cardioversion. Rivaroxaban or VKA will be administered for 21 to 56 days before Cardioversion. All patients will receive study treatment for 6 weeks postCardioversion. The primary efficacy end point is a composite of all strokes, transient ischemic attacks, noncentral nervous system systemic emboli, myocardial infarctions, and cardiovascular deaths. Each primary end point component will be evaluated separately, and additional composites will be investigated. The principal safety end point is major bleeding. Clinical context This will be the first prospective study of a novel oral anticoagulant in the setting of Cardioversion. It will provide important information regarding the use of rivaroxaban in the periods preceding and after Cardioversion in a broad patient population.
Gregory Y.h. Lip - One of the best experts on this subject based on the ideXlab platform.
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role for machine learning in sex specific prediction of successful electrical Cardioversion in atrial fibrillation
Open heart, 2020Co-Authors: Nicklas Vinter, Gregory Y.h. Lip, Anne Sofie Frederiksen, Andi Eie Albertsen, Morten Fengergron, Ludovic Trinquart, Lars Frost, Dorthe Svenstrup MollerAbstract:Objective Electrical Cardioversion is frequently performed to restore sinus rhythm in patients with persistent atrial fibrillation (AF). However, AF recurs in many patients and identifying the patients who benefit from electrical Cardioversion is difficult. The objective was to develop sex-specific prediction models for successful electrical Cardioversion and assess the potential of machine learning methods in comparison with traditional logistic regression. Methods In a retrospective cohort study, we examined several candidate predictors, including comorbidities, biochemistry, echocardiographic data, and medication. The outcome was successful Cardioversion, defined as normal sinus rhythm immediately after the electrical Cardioversion and no documented recurrence of AF within 3 months after. We used random forest and logistic regression models for sex-specific prediction. Results The cohort comprised 332 female and 790 male patients with persistent AF who underwent electrical Cardioversion. Cardioversion was successful in 44.9% of the women and 49.9% of the men. The prediction errors of the models were high for both women (41.0% for machine learning and 48.8% for logistic regression) and men (46.0% for machine learning and 44.8% for logistic regression). Discrimination was modest for both machine learning (0.59 for women and 0.56 for men) and logistic regression models (0.60 for women and 0.59 for men), although the models were well calibrated. Conclusions Sex-specific machine learning and logistic regression models showed modest predictive performance for successful electrical Cardioversion. Identifying patients who will benefit from Cardioversion remains challenging in clinical practice. The high recurrence rate calls for thoroughly informed shared decision-making for electrical Cardioversion.
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clinical factors related to successful or unsuccessful Cardioversion in the edoxaban versus warfarin in subjects undergoing Cardioversion of atrial fibrillation ensure af randomized trial
Journal of Arrhythmia, 2020Co-Authors: Gregory Y.h. Lip, Maciej Banach, Jose L Merino, Naab Alsaady, James Jin, Michael Melino, Shannon M Winters, Monika Koziel, Andreas GoetteAbstract:Background EdoxabaN versus warfarin in subjectS UndeRgoing Cardioversion of Atrial Fibrillation evaluated use of nonvitamin K antagonist oral anticoagulant edoxaban vs enoxaparin-warfarin in patients with nonvalvular atrial fibrillation undergoing electrical Cardioversion. Hypothesis To assess clinical factors related to successful or unsuccessful Cardioversion. To evaluate whether differences in adverse events based on anticoagulation strategy may exist. Methods In this multicenter prospective randomized open-label blinded end-point evaluation trial, 2199 patients were randomized to edoxaban 60 mg once daily (30 mg for creatinine clearance 15-50 mL/min, weight ≤ 60 kg, and/or concomitant use of P-glycoprotein inhibitor) or enoxaparin-warfarin. Successful Cardioversion was confirmed by 12-lead electrocardiography-documented sinus rhythm. Results Cardioversion was successful in 1578 patients; in 355 patients, Cardioversion was unsuccessful. Male, high body weight, high body mass index (BMI), coronary artery disease, concomitant aspirin, or prior statins use were more common in patients with unsuccessful Cardioversion; international normalized ratio control did not differ by Cardioversion success. On multivariate analysis, gender (P < .05), body weight (P = .0196) and BMI (P = .0377) emerged as independent predictors of successful Cardioversion. There were no significant differences in primary efficacy (a composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular death during overall study period) regardless of Cardioversion success. There were no significant differences in bleeding rates, regardless of Cardioversion outcome; notwithstanding low numbers, edoxaban and enoxaparin-warfarin did not differ. Conclusions Male gender, higher mean weight and higher mean BMI were associated with unsuccessful Cardioversion. Efficacy and safety outcomes were low and did not differ by Cardioversion success.
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Clinical factors related to successful or unsuccessful Cardioversion in the EdoxabaN versus warfarin in subjectS UndeRgoing Cardioversion of Atrial Fibrillation (ENSURE-AF) randomized trial.
'Wiley', 2020Co-Authors: Gregory Y.h. Lip, Banach Maciej, Al‐saady Naab, Jin James, Melino Michael, Winters, Shannon M., Kozieł Monika, Merino, Jose L, Goette AndreasAbstract:BackgroundEdoxabaN versus warfarin in subjectS UndeRgoing Cardioversion of Atrial Fibrillation evaluated use of nonvitamin K antagonist oral anticoagulant edoxaban vs enoxaparin-warfarin in patients with nonvalvular atrial fibrillation undergoing electrical Cardioversion.HypothesisTo assess clinical factors related to successful or unsuccessful Cardioversion. To evaluate whether differences in adverse events based on anticoagulation strategy may exist.MethodsIn this multicenter prospective randomized open-label blinded end-point evaluation trial, 2199 patients were randomized to edoxaban 60 mg once daily (30 mg for creatinine clearance 15-50 mL/min, weight ≤ 60 kg, and/or concomitant use of P-glycoprotein inhibitor) or enoxaparin-warfarin. Successful Cardioversion was confirmed by 12-lead electrocardiography-documented sinus rhythm.ResultsCardioversion was successful in 1578 patients; in 355 patients, Cardioversion was unsuccessful. Male, high body weight, high body mass index (BMI), coronary artery disease, concomitant aspirin, or prior statins use were more common in patients with unsuccessful Cardioversion; international normalized ratio control did not differ by Cardioversion success. On multivariate analysis, gender (P P = .0196) and BMI (P = .0377) emerged as independent predictors of successful Cardioversion. There were no significant differences in primary efficacy (a composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular death during overall study period) regardless of Cardioversion success. There were no significant differences in bleeding rates, regardless of Cardioversion outcome; notwithstanding low numbers, edoxaban and enoxaparin-warfarin did not differ.ConclusionsMale gender, higher mean weight and higher mean BMI were associated with unsuccessful Cardioversion. Efficacy and safety outcomes were low and did not differ by Cardioversion success
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edoxaban therapy increases treatment satisfaction and reduces utilization of healthcare resources an analysis from the edoxaban vs warfarin in subjects undergoing Cardioversion of atrial fibrillation ensure af study
Europace, 2018Co-Authors: Andreas Goette, Michael D Ezekowitz, Gregory Y.h. Lip, Winghan Jacqueline Kwong, Maciej Banach, Soren Pihlkjaer Hjortshoj, Dmitry ZamoryakhinAbstract:Aims The EdoxabaN vs. warfarin in subjectS UndeRgoing Cardioversion of atrial fibrillation (ENSURE-AF) (NCT02072434) study was a multicentre prospective, randomized, open-label, blinded-endpoint evaluation (PROBE) trial comparing edoxaban with enoxaparin/warfarin followed by warfarin alone in 2199 non-valvular atrial fibrillation patients undergoing electrical Cardioversion and showed comparable rates of bleeding and thromboembolism between treatments. This prespecified ancillary analysis investigated the impact of edoxaban therapy on treatment satisfaction and utilization of healthcare services. Methods and results The Perception of Anticoagulant Treatment Questionnaire (PACT-Q2) was completed by study patients on Day 28 post-Cardioversion. Higher scores represent greater satisfaction. Healthcare resource utilizations were collected from randomization to Day 28 post-Cardioversion. Data from patients who received at least one dose of study drugs were analysed. Patients treated with edoxaban were more satisfied than enoxaparin/warfarin in both PACT-Q treatment satisfaction and convenience scores (P < 0.001 for both). Differences in treatment satisfaction scores were greater in patients who underwent non-transoesophageal echocardiography (TOE)-guided Cardioversion than in patients who underwent TOE-guided Cardioversion. Edoxaban was associated with fewer clinic visits (4.75 visits vs. 7.60 visits; P < 0.001) and fewer hospital days (3.43 days vs. 5.41 days; P < 0.05). Rates of hospitalizations and emergency room visits were not significantly different. Overall, edoxaban therapy was estimated to reduce healthcare costs by €107.73, €437.92, €336.75, and $246.32 per patient in German, Spanish, Italian, and US settings, respectively. Conclusions The convenience of edoxaban therapy over warfarin in patients undergoing Cardioversion may provide greater treatment satisfaction and cost savings to the healthcare system.
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EPWIRE Cardioversion for atrial fibrillation in current European practice: results of the European Heart
2013Co-Authors: Rhythmassociation Survey, Jesper Hastrup Svendsen, Gregory Y.h. LipAbstract:This survey was conducted to provide an insight into the current clinical practice regarding the use of Cardioversion for atrial fibrillation (AF) in Europe. Responses were received from 57 centres across Europe, 71.9 % of which were university hospitals. For electrical Cardioversion, general anaesthesia was managed by an anaesthesiologist in 73.9 % of centres and by a cardiologist in 37%. In the majority of centres, electrical cardiover-sion was performed using a biphasic defibrillator (85.1%). Antiarrhythmic drugs were routinely prescribed prior to electrical Cardioversion by 54.3 % of hospitals. For pharmacological Cardioversion in patients with no or minimal heart disease, the majority of centres (63.1%) chose intra-venous flecainide or propafenone, whereas vernakalant was used by 35 % of centres in patients with no or minimal-to-moderate structural heart disease. Most centres (71.7%) used a mandatory strategy of 3 weeks of oral anticoagulation prior to elective Cardioversion in patients AF. 48 h, but 28.3 % performed immediate Cardioversion after a transoesophageal echocardiogram. Many centres are now performing electrical cardiover
John A Camm - One of the best experts on this subject based on the ideXlab platform.
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rivaroxaban vs vitamin k antagonists for Cardioversion in atrial fibrillation
European Heart Journal, 2014Co-Authors: Riccardo Cappato, Michael D Ezekowitz, Allan L Klein, John A Camm, Jeanyves Le Heuzey, Mario TalajicAbstract:Aims X-VeRT is the first prospective randomized trial of a novel oral anticoagulant in patients with atrial fibrillation undergoing elective Cardioversion. Methods and results We assigned 1504 patients to rivaroxaban (20 mg once daily, 15 mg if creatinine clearance was between 30 and 49 mL/min) or dose-adjusted vitamin K antagonists (VKAs) in a 2:1 ratio. Investigators selected either an early (target period of 1–5 days after randomization) or delayed (3–8 weeks) Cardioversion strategy. The primary efficacy outcome was the composite of stroke, transient ischaemic attack, peripheral embolism, myocardial infarction, and cardiovascular death. The primary safety outcome was major bleeding. The primary efficacy outcome occurred in 5 (two strokes) of 978 patients (0.51%) in the rivaroxaban group and in 5 (two strokes) of 492 patients (1.02%) in the VKA group [risk ratio 0.50; 95% confidence interval (CI) 0.15–1.73]. In the rivaroxaban group, four patients experienced primary efficacy events following early Cardioversion (0.71%) and one following delayed Cardioversion (0.24%). In the VKA group, three patients had primary efficacy events following early Cardioversion (1.08%) and two following delayed Cardioversion (0.93%). Rivaroxaban was associated with a significantly shorter time to Cardioversion compared with VKAs ( P < 0.001). Major bleeding occurred in six patients (0.6%) in the rivaroxaban group and four patients (0.8%) in the VKA group (risk ratio 0.76; 95% CI 0.21–2.67). Conclusion Oral rivaroxaban appears to be an effective and safe alternative to VKAs and may allow prompt Cardioversion. Name of the trial registry Clinicaltrials.gov; Trial registration number: [NCT01674647][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01674647&atom=%2Fehj%2F35%2F47%2F3346.atom
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rationale and design of the explore the efficacy and safety of once daily oral rivaroxaban for the prevention of cardiovascular events in patients with nonvalvular atrial fibrillation scheduled for Cardioversion trial a comparison of oral rivaroxaban once daily with dose adjusted vitamin k antagonists in patients with nonvalvular atrial fibrillation undergoing elective Cardioversion
American Heart Journal, 2014Co-Authors: Michael D Ezekowitz, Riccardo Cappato, Allan L Klein, John A Camm, Jeanyves Le Heuzey, Mario Talajic, Chang Sheng, Mauricio Scanavacca, Panos E Vardas, Paulus KirchhofAbstract:Background Anticoagulation before, during, and after Cardioversion is effective in reducing stroke risk in patients with atrial fibrillation. Objective The objective of this study is to explore the efficacy and safety of rivaroxaban 20 mg once daily (15 mg if creatinine clearance is 30-49 mL/min) compared with dose-adjusted vitamin K antagonists (VKAs; international normalized ratio 2.0-3.0) in patients scheduled for elective Cardioversion. Methods This is a prospective, randomized, open-label, parallel group comparison of approximately 1,500 patients from 17 countries with hemodynamically stable nonvalvular atrial fibrillation of >48 hours or unknown duration. Patients will be randomized 2:1 (rivaroxaban:VKA) using 2 Cardioversion strategies: the first approach is early Cardioversion with the preCardioversion anticoagulation goal of 1 to 5 days using rivaroxaban or usual therapy (heparin + VKA). In these patients, transesophageal echocardiography will be encouraged to exclude atrial thrombi. The alternative approach is delayed Cardioversion. Rivaroxaban or VKA will be administered for 21 to 56 days before Cardioversion. All patients will receive study treatment for 6 weeks postCardioversion. The primary efficacy end point is a composite of all strokes, transient ischemic attacks, noncentral nervous system systemic emboli, myocardial infarctions, and cardiovascular deaths. Each primary end point component will be evaluated separately, and additional composites will be investigated. The principal safety end point is major bleeding. Clinical context This will be the first prospective study of a novel oral anticoagulant in the setting of Cardioversion. It will provide important information regarding the use of rivaroxaban in the periods preceding and after Cardioversion in a broad patient population.
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initial energy setting outcome and efficiency in direct current Cardioversion of atrial fibrillation and flutter
Journal of the American College of Cardiology, 2001Co-Authors: Mark M Gallagher, Xiaohua Guo, Jan Poloniecki, Yee Guan Yap, David E Ward, John A CammAbstract:OBJECTIVES The purpose of this study was to design a more efficient protocol for the electrical Cardioversion of atrial arrhythmias. BACKGROUND Guidelines for electrical Cardioversion of atrial arrhythmias recommend starting with low energy shocks, which are often ineffective. METHODS We recorded the sequence of shocks in 1,838 attempts at Cardioversion for atrial fibrillation (AF) and 678 attempts at Cardioversion for atrial flutter. These data were used to calculate the probability of success for each shock of a standard series and the probability of success with a single shock at each intensity. In 150 cases, a rhythm strip with the time of each shock allowed us to calculate the time expended on unsuccessful shocks. RESULTS We analyzed the effects of 5,152 shocks delivered to patients for AF and 1,238 shocks delivered to patients for atrial flutter. The probability of success on the first shock in AF of >30 days duration was 5.5% at 30 days duration, shocks of 180 days. In those with AF for >180 days, the initial use of a 360 J shock was associated with the eventual use of less electrical energy than with an initial shock of ≤100 J (581 ± 316 J vs. 758 ± 433 J, p < 0.01, Mann-Whitney Utest). CONCLUSIONS An initial energy setting of ≥360 J can achieve Cardioversion of AF more efficiently in patients than traditional protocols, particularly with AF of longer duration.
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initial energy setting outcome and efficiency in direct current Cardioversion of atrial fibrillation and flutter
Journal of the American College of Cardiology, 2001Co-Authors: Mark M Gallagher, Xiaohua Guo, Jan Poloniecki, Yee Guan Yap, David E Ward, John A CammAbstract:AbstractOBJECTIVESThe purpose of this study was to design a more efficient protocol for the electrical Cardioversion of atrial arrhythmias.BACKGROUNDGuidelines for electrical Cardioversion of atria...
Amit Parekh - One of the best experts on this subject based on the ideXlab platform.
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dabigatran versus warfarin in patients with atrial fibrillation an analysis of patients undergoing Cardioversion
Circulation, 2010Co-Authors: Rangadham Nagarakanti, Michael D Ezekowitz, Greg C Flaker, Jonas Oldgren, Sean Yang, Michael R Chernick, Timothy H Aikens, Josep Brugada, Gabriel Kamensky, Amit ParekhAbstract:Background–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. Methods and Results–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 emboli...
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dabigatran versus warfarin in patients with atrial fibrillation an analysis of patients undergoing Cardioversion
Circulation, 2010Co-Authors: Rangadham Nagarakanti, Michael D Ezekowitz, Greg C Flaker, Jonas Oldgren, Sean Yang, Michael R Chernick, Timothy H Aikens, Josep Brugada, Gabriel Kamensky, Amit ParekhAbstract:Background-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. Methods and Results-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). Conclusions-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.
Paulus Kirchhof - One of the best experts on this subject based on the ideXlab platform.
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apixaban compared with parenteral heparin and or vitamin k antagonist in patients with nonvalvular atrial fibrillation undergoing Cardioversion rationale and design of the emanate trial
American Heart Journal, 2016Co-Authors: Michael D Ezekowitz, Charles V Pollack, Jonathan L Halperin, Judith Spahr, Nilo B Cater, Andrei Breazna, Paul Sanders, William Petkun, Paulus KirchhofAbstract:Background Stroke prevention in anticoagulation-naive patients with atrial fibrillation undergoing Cardioversion has not been systematically studied. Objective To determine outcomes in anticoagulation-naive patients (defined as those receiving an anticoagulant for Methods This is a randomized, prospective, open-label, real-world study comparing apixaban to heparin plus warfarin. Early image-guided Cardioversion is encouraged. For apixaban, the usual dose is 5 mg BID with a dose reduction to 2.5 mg BID if 2 of the following are present: age >80 years, weight 1.5 mg/dL. If Cardioversion is immediate, a single starting dose of 10 mg (or 5 mg if the dose is down-titrated) of apixaban is administered. Cardioversion may be attempted up to 90 days after randomization. Patients are followed up for 30 days after Cardioversion or 90 days postrandomization if Cardioversion is not performed within that timeframe. Outcomes are stroke, systemic embolization, major bleeds, clinically relevant nonmajor bleeding, and death, all adjudication-blinded. Statistics The warfarin-naive cohort from the ARISTOTLE study was considered the closest data set to the patients being recruited into this study. The predicted incidence of stroke, systemic embolism, and major bleeding within 30 days after randomization was approximately 0.75%. To adequately power for a noninferiority trial, approximately 48,000 participants would be needed, a number in excess of feasibility. The figure of 1,500 patients was considered clinically meaningful and achievable. Clinical context This first prospective Cardioversion study of a novel anticoagulant in anticoagulation-naive patients should influence clinical practice.
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rationale and design of the explore the efficacy and safety of once daily oral rivaroxaban for the prevention of cardiovascular events in patients with nonvalvular atrial fibrillation scheduled for Cardioversion trial a comparison of oral rivaroxaban once daily with dose adjusted vitamin k antagonists in patients with nonvalvular atrial fibrillation undergoing elective Cardioversion
American Heart Journal, 2014Co-Authors: Michael D Ezekowitz, Riccardo Cappato, Allan L Klein, John A Camm, Jeanyves Le Heuzey, Mario Talajic, Chang Sheng, Mauricio Scanavacca, Panos E Vardas, Paulus KirchhofAbstract:Background Anticoagulation before, during, and after Cardioversion is effective in reducing stroke risk in patients with atrial fibrillation. Objective The objective of this study is to explore the efficacy and safety of rivaroxaban 20 mg once daily (15 mg if creatinine clearance is 30-49 mL/min) compared with dose-adjusted vitamin K antagonists (VKAs; international normalized ratio 2.0-3.0) in patients scheduled for elective Cardioversion. Methods This is a prospective, randomized, open-label, parallel group comparison of approximately 1,500 patients from 17 countries with hemodynamically stable nonvalvular atrial fibrillation of >48 hours or unknown duration. Patients will be randomized 2:1 (rivaroxaban:VKA) using 2 Cardioversion strategies: the first approach is early Cardioversion with the preCardioversion anticoagulation goal of 1 to 5 days using rivaroxaban or usual therapy (heparin + VKA). In these patients, transesophageal echocardiography will be encouraged to exclude atrial thrombi. The alternative approach is delayed Cardioversion. Rivaroxaban or VKA will be administered for 21 to 56 days before Cardioversion. All patients will receive study treatment for 6 weeks postCardioversion. The primary efficacy end point is a composite of all strokes, transient ischemic attacks, noncentral nervous system systemic emboli, myocardial infarctions, and cardiovascular deaths. Each primary end point component will be evaluated separately, and additional composites will be investigated. The principal safety end point is major bleeding. Clinical context This will be the first prospective study of a novel oral anticoagulant in the setting of Cardioversion. It will provide important information regarding the use of rivaroxaban in the periods preceding and after Cardioversion in a broad patient population.
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targeted pharmacological reversal of electrical remodeling after Cardioversion rationale and design of the flecainide short long flec sl trial
American Heart Journal, 2005Co-Authors: Paulus Kirchhof, Peter Hanrath, Thomas Meinertz, Gerhard Steinbeck, Thomas Fetsch, Walter Lehmacher, Gunter BreithardtAbstract:Persistent atrial fibrillation (AF) causes relevant mortality and cardiovascular and noncardiovascular morbidity. Therefore, maintenance of sinus rhythm is an important clinical goal, especially when the patient is symptomatic, despite the fact that current treatment strategies are not sufficient to completely prevent recurrent AF. In addition to underlying atrial disease that predisposes to AF, AF in itself induces structural and electrical adaptations ("electrical remodeling" and "structural remodeling"). Underlying disease processes and parts of structural remodeling are not always reversible. Electrical remodeling, in contrast, is reversed by a few weeks of maintenance of sinus rhythm under experimental conditions. This corresponds to the period when most of the recurrent episodes of AF occur after Cardioversion. Antiarrhythmic drugs that prolong the atrial action potential can assist in the prevention of recurrent AF by promoting the reversal of electrical remodeling. Such drugs, which are currently used over long periods after Cardioversion, may only be needed until the physiological action potential duration is restored, for example, during the first few weeks after Cardioversion of persistent AF. This treatment concept that we call "targeted pharmacological reversal of electrical remodeling" would limit both cost and drug-induced side effects of antiarrhythmic drug therapy after Cardioversion. The Flec-SL trial, ISECTN62728743, therefore tests the main hypothesis that targeted pharmacological reversal of electrical remodeling by short-term antiarrhythmic drug therapy for 4 weeks after Cardioversion is not inferior to standard long-term antiarrhythmic drug therapy for the prevention of recurrent AF after Cardioversion in a parallel group, randomized, multicenter, open, blinded end point analysis design. Based on its effectiveness and pharmacokinetic profile, flecainide is used to test the study hypothesis. The trial uses daily transtelephonic electrocardiographic monitoring for all patients and will be conducted within the German Atrial Fibrillation Competence NETwork (AFNET) to facilitate inclusion of patients from electrophysiologically oriented cardiology centers, ordinary hospitals, and office-based physicians.