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1. Design and rationale of a pragmatic randomized clinical trial of early dronedarone versus usual care to change and improve outcomes in persons with first-detected atrial fibrillation – the CHANGE AFIB study

Author

Pokorney, Sean D., Nemeth, Hayley, Chiswell, Karen, Albert, Christine, Allyn, Nadine, Blanco, Rosalia, Butler, Javed, Calkins, Hugh, Elkind, Mitchell S.V., Fonarow, Gregg C., Fontaine, John M., Frankel, David S., Fermann, Gregory J., Gale, Rex, Kalscheur, Matthew, Kirchhof, Paulus, Koren, Andrew, Miller, Joseph B., Rashkin, Jason, Russo, Andrea M., Rutan, Christine, Steinberg, Benjamin A., and Piccini, Jonathan P.

Published
2025
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6. Self-administered intranasal etripamil using a symptom-prompted, repeat-dose regimen for atrioventricular-nodal-dependent supraventricular tachycardia (RAPID): a multicentre, randomised trial

Author

Ip, James E, Jones, Alonzo, Sr, Stambler, Bruce S, Schleinkofer, David E, Winters, Stephen, Lam, Wilson, Goldstein, Robert, Dor, Isaac Dor, Talwar, Sandeep, O'Neill, Padraig G, Koren, Michael J, Beinart, Sean C, Ambati, Srivani, Mazer, Sean P, Kinn, Robert M, Roy, Karine, Manshadi, Ramin, Kuk, Richard, Verma, Aditya, Phelan, Timothy, Stoian, Alexandru A, Ellenbogen, Kenneth, Jayachandran, J Vijay, Connelly, Terence P, Daccarett, Marcos, Gandhi, Gaurang, Mittal, Suneet, Abdel-Wahab, Amir, Augostini, Ralph, Ip, John H, Sorrentino, Denise, Roux, Jean-Francois, Brar, Ramandeep, Khoo, Clarence, Bennett, Matthew, Lo, Eric, Coutu, Benoit, Sterns, Laurence, Greer, Gerald S, Gujja, Pradeep, Gianfagna, Robert A, Swarup, Vijendra, Sogade, Felix, Wilton, Stephen, Ruisi, Christopher, Barbera, Saverio, Banchs, Javier E., Korley, Victoria, Schulze, Christopher, Damle, Roger, Healey, Jeffrey Sean, Pandey, A Shekhar, Anderson, Jeffrey L, Venkatachalam, K L, Noseworthy, Peter, Mondésert, Blandine, Verma, Atul, Friars, Douglas G, Kambur, Thomas R, Lockwood, Evan, Meininger, Glenn, Olsovsky, Greg, Jones Sr, Alonzo, Greer, Gerald, Mehta, Rohit, Akbar, Saleem, Salman, Malik, Rama, Bhola, Arora, Ramesh, Shah, Dhirenkumar, Shah, Rakesh, Cammarata, Michael, Owens, Andrew, Ludington, Katherine, Wharton, Marcus, Bagheri, Michael, Khan, Mohammed, Carr, Kenneth Warren, Siddique, Sultan, Parvathaneni, Sunthosh, Devabhaktuni, Subodh, Mouhaffel, Assad, Mark, George, Di Biase, Luigi, Rangappa, Sunil, Morton, Jared, Yarmohammadi, Hirad, Karim, Amin, Martinez Fleites, Aldo, Nero, Thomas, Shafiq, Qaiser, Pandey, Shekhar, Khaykin, Yaariv, Joza, Jacqueline, Gosselin, Gilbert, Skanes, Allen, Vyselaar, John, Savard, Daniel, Heidbuchel, Hein, Xhaet, Olivier, Catez, Emmanuel, Vijgen, Johan, Godart, Pascal, Casado, Ruben, Mairesse, Georges, Rossenbacker, Tom, Haemers, Peter, Hoffer, Etienne, Hausman, Pierre, Vertes, Andras, Duray, Gabor, Szolnoki, Erzsebet, Csanadi, Zoltan, Lakatos, Ferenc, Alings, Marco, Dorman, Reinhart, Tuininga, Y S, Jansen, W, Velthuis, Sebastiaan, van Bemmel, B, Bech, Gerhard Jan Willem, Pisters, Ron, Valk, Suzanne, Romer, Tjeerd, Luermans, Justin, Beelen, Driek, van Eck, Martijn, Houtgraaf, Jaco, Vet, Thijs, Shellings, Dirk, Oosterhof, T, Miekus, Pawel, Bebenek, Waldemar, Bielecka-Dabrowa, Agata, Gniot, Jacek, Zmuda, Witold, Kasprzak, Michal, Balak, Wojciech, Ptaszynski, Pawel, Nowak, Jacek, Prokopczuk, Janusz, Przybylski, Andrzej, Wozniak-Skowerska, Iwona, Derejko, Pawel, Czarnecka, Danuta, Janas, Adam, Merino Llorens, Jose Luis, Tercedor, Luis, Iniguez Romo, Andres, Ruiz Granell, Ricardo, Gonzalez Juanatey, Jose Ramon, Pascual-Figal, Domingo, Martinez-Selles, Manuel, Anguera Camos, Ignacio, Ibanez Criado, Alicia, Matrinez Basterra, Javier, Izquierdo, Alvaro, Rivas Gandara, Nuria, Alegret Colome, Josep M, Perez Diez, Diego, Martínez Hervás, Miguel Ángel, Medina, Maria, Segura Saint-Gerons, Jose María, Pedrote Leal, Alonso, Fernandez Lozano, Ignacio, Quesada, Aurelio, Guerra Ramos, Jose, Sarrias, Axel, Ramos Maqueda, Javier, Mansourati, Jacques, Defaye, Pascal, Guedon-Moreau, Laurence, Milhem, Antoine, De Guillebon, Maxime, Chevalier, Philippe, Badoz, Marc, Kriatselis, Charalampos, Simonis, Gregor, Lewalter, Thorsten, Zarse, Markus, Wilke, Andreas, Kraemer, Fabian, Al-Zoebi, Ayham, Camm, A John, Dorian, Paul, Kowey, Peter R, Merino, Jose L, Piccini, Jonathan P, Pokorney, Sean D, Sager, Philip T, Wharton, J Marcus, Bharucha, David B, Plat, Francis, Shardonofsky, Silvia, and Chen, Michael

Published
2023
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7. Shared decision-making in atrial fibrillation: patient-reported involvement in treatment decisions.

Author

Ali-Ahmed, Fatima, Pieper, Karen, North, Rebecca, Allen, Larry A, Chan, Paul S, Ezekowitz, Michael D, Fonarow, Gregg C, Freeman, James V, Go, Alan S, Gersh, Bernard J, Kowey, Peter R, Mahaffey, Kenneth W, Naccarelli, Gerald V, Pokorney, Sean D, Reiffel, James A, Singer, Daniel E, Steinberg, Benjamin A, Peterson, Eric D, Piccini, Jonathan P, and O’Brien, Emily C

Subjects
Health Services and Systems, Biomedical and Clinical Sciences, Health Sciences, Basic Behavioral and Social Science, Cardiovascular, Behavioral and Social Science, Clinical Research, Heart Disease, Aged, Atrial Fibrillation, Clinical Decision-Making, Disease Management, Female, Humans, Male, Middle Aged, Patient Participation, Patient Reported Outcome Measures, Stroke, Patient-reported involvement in treatment decisions, Quality of care, Shared decision-making, Stroke prevention, Cardiovascular medicine and haematology, Public health
Abstract

AimsTo determine the extent of shared decision-making (SDM), during selection of oral anticoagulant (OAC) and rhythm control treatments, in patients with newly diagnosed atrial fibrillation (AF).Methods and resultsWe evaluated survey data from 1006 patients with new-onset AF enrolled at 56 US sites participating in the SATELLITE substudy of the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT II). Patients completed surveys at enrolment and at 6-month follow-up. Patients were asked about who made their AF treatment decisions. Shared decision-making was classified as one that the patient felt was an autonomous decision or a shared decision with their healthcare provider (HCP). Approximately half of patients reported that their OAC treatment decisions were made entirely by their HCP. Compared with those reporting no SDM, patients reporting SDM for OAC were more often female (47.2% vs. 38.4%), while patients reporting SDM for rhythm control were more often male (62.2% vs. 57.6%). The most important factors cited by patients during decision-making for OAC were reducing stroke and bleeding risk, and their HCP's recommendations. After adjustment, patients with self-reported understanding of OAC, and rhythm control options, had higher odds of having participated in SDM [odds ratio (OR) 2.54, confidence interval (CI): 1.75-3.68 and OR 2.36, CI: 1.50-3.71, both P ≤ 0.001, respectively].ConclusionShared decision-making is not widely implemented in contemporary AF practice. Patient understanding about available therapeutic options is associated with a more than a two-fold higher likelihood of SDM, and may be a potential target for future interventions.

Published
2020

9. Residual stroke risk despite oral anticoagulation in patients with atrial fibrillation

Author

Carlisle, Matthew A., Shrader, Peter, Fudim, Marat, Pieper, Karen S., Blanco, Rosalia G., Fonarow, Gregg C., Naccarelli, Gerald V., Gersh, Bernard J., Reiffel, James A., Kowey, Peter R., Steinberg, Benjamin A., Freeman, James V., Ezekowitz, Michael D., Singer, Daniel E., Allen, Larry A., Chan, Paul S., Pokorney, Sean D., Peterson, Eric D., and Piccini, Jonathan P.

Published
2022
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14. Pharmacotherapy for Atrial Fibrillation in Patients With Chronic Kidney Disease: Insights From ORBIT‐AF

Author

Washam, Jeffrey B, Holmes, DaJuanicia N, Thomas, Laine E, Pokorney, Sean D, Hylek, Elaine M, Fonarow, Gregg C, Mahaffey, Kenneth W, Gersh, Bernard J, Kowey, Peter R, Ansell, Jack E, Go, Alan S, Reiffel, James A, Freeman, James V, Singer, Daniel E, Naccarelli, Gerald, Blanco, Rosalia, Peterson, Eric D, and Piccini, Jonathan P

Subjects
Clinical Research, Prevention, Kidney Disease, Stroke, Renal and urogenital, Cardiovascular, Good Health and Well Being, Administration, Oral, Aged, Aged, 80 and over, Anti-Arrhythmia Agents, Anticoagulants, Atrial Fibrillation, Dabigatran, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Registries, Renal Insufficiency, Chronic, Risk Factors, Time Factors, Treatment Outcome, Warfarin, antiarrhythmic, anticoagulation, atrial fibrillation, chronic kidney disease, Cardiorespiratory Medicine and Haematology
Abstract

Background Chronic kidney disease ( CKD ) is a common comorbidity in patients with atrial fibrillation. The presence of CKD complicates drug selection for stroke prevention and rhythm control. Methods and Results Patients enrolled in ORBIT AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation) with baseline renal function and follow-up data were included (N=9019). CKD was defined as an estimated creatinine clearance

Published
2018

15. Optimizing mechanically sensed atrial tracking in patients with atrioventricular-synchronous leadless pacemakers: A single-center experience

Author

Arps, Kelly, Piccini, Jonathan P., Yapejian, Rebecca, Leguire, Rhonda, Smith, Brenda, Al-Khatib, Sana M., Bahnson, Tristram D., Daubert, James P., Hegland, Donald D., Jackson, Kevin P., Jackson, Larry R., II, Lewis, Robert K., Pokorney, Sean D., Sun, Albert Y., Thomas, Kevin L., and Frazier-Mills, Camille

Published
2021
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16. Apixaban for Patients With Atrial Fibrillation on Hemodialysis: A Multicenter Randomized Controlled Trial

Author

Pokorney, Sean D., Chertow, Glenn M., Al-Khalidi, Hussein R., Gallup, Dianne, Dignacco, Pat, Mussina, Kurt, Bansal, Nisha, Gadegbeku, Crystal A., Garcia, David A., Garonzik, Samira, Lopes, Renato D., Mahaffey, Kenneth W., Matsuda, Kelly, Middleton, John P., Rymer, Jennifer A., Sands, George H., Thadhani, Ravi, Thomas, Kevin L., Washam, Jeffrey B., Winkelmayer, Wolfgang C., and Granger, Christopher B.

Published
2022
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22. Catheter ablation of atrial fibrillation in patients with diabetes mellitus

Author

Wang, Allen, Truong, Tracy, Black-Maier, Eric, Green, Cynthia, Campbell, Kristen B., Barnett, Adam S., Febre, Janice, Loring, Zak, Al-Khatib, Sana M., Atwater, Brett D., Daubert, James P., Frazier-Mills, Camille, Hegland, Donald D., Jackson, Kevin P., Jackson, Larry R., Koontz, Jason I., Lewis, Robert K., Pokorney, Sean D., Sun, Albert Y., Thomas, Kevin L., Bahnson, Tristam D., and Piccini, Jonathan P.

Published
2020
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27. Catheter ablation of ventricular tachycardia: Lessons learned from past clinical trials and implications for future clinical trials

Author

Pokorney, Sean D, Friedman, Daniel J, Calkins, Hugh, Callans, David J, Daoud, Emile G, Della-Bella, Paolo, Jackson, Kevin P, Shivkumar, Kalyanam, Saba, Samir, Sapp, John, Stevenson, William G, and Al-Khatib, Sana M

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Sciences, Clinical Trials and Supportive Activities, Patient Safety, Heart Disease, Cardiovascular, Rare Diseases, Clinical Research, Good Health and Well Being, Catheter Ablation, Clinical Trials as Topic, Humans, Recurrence, Tachycardia, Ventricular, Ventricular tachycardia, Catheter ablation, Implantable cardioverter-defibrillator, Clinical trials, Appropriate shock, Antitachycardia pacing, Mortality, Biomedical Engineering, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

Catheter ablation of ventricular tachycardia (VT) has evolved in recent years, especially in patients with ischemic heart disease. Data from prospective studies show that VT catheter ablation reduces the risk of recurrent VT; however, there is a paucity of data on the effect of VT catheter ablation on mortality and patient-centered outcomes such as quality of life. Performing randomized clinical trials of VT catheter ablation can be fraught with challenges, and, as a result, several prior trials of VT catheter ablation had to be stopped prematurely. The main challenges are inability to blind the patient to therapy to obtain a traditional control group, high crossover rates between the 2 arms of the study, patient refusal to participate in trials in which they have an equal chance of receiving a "pill" vs an invasive procedure, heterogeneity of mapping and ablation techniques as well as catheters and equipment, rapid evolution of technology that may make findings of any long trial less relevant to clinical practice, lack of consensus on what constitutes acute procedural and long-term success, and presentation of patients to electrophysiologists late in the course of their disease. In this article, a panel of experts on VT catheter ablation and/or clinical trials of VT catheter ablation review challenges faced in conducting prior trials of VT catheter ablation and offer potential solutions for those challenges. It is hoped that the proposed solutions will enhance the feasibility of randomized clinical trials of VT catheter ablation.

Published
2016

29. Digoxin Use and Subsequent Outcomes Among Patients in a Contemporary Atrial Fibrillation Cohort

Author

Allen, Larry A, Fonarow, Gregg C, Simon, DaJuanicia N, Thomas, Laine E, Marzec, Lucas N, Pokorney, Sean D, Gersh, Bernard J, Go, Alan S, Hylek, Elaine M, Kowey, Peter R, Mahaffey, Kenneth W, Chang, Paul, Peterson, Eric D, Piccini, Jonathan P, and Investigators, ORBIT-AF

Subjects
Heart Disease, Cardiovascular, Clinical Research, Aged, Aged, 80 and over, Atrial Fibrillation, Digoxin, Female, Heart Failure, Heart Rate, Humans, Male, Prospective Studies, Quality of Life, Registries, Time Factors, Treatment Outcome, heart failure, mortality, patient outcome assessment, safety, ORBIT-AF Investigators, Cardiorespiratory Medicine and Haematology, Public Health and Health Services, Cardiovascular System & Hematology
Abstract

BackgroundAlthough digoxin has long been used to treat atrial fibrillation (AF) and heart failure (HF), its safety remains controversial.ObjectivesThis study sought to describe digoxin use over time in patients with AF who were stratified by the presence or absence of HF, to characterize the predictors of digoxin use and initiation, and to correlate digoxin use with outcomes.MethodsLongitudinal patterns of digoxin use and its association with a variety of outcomes were assessed in a prospective outpatient registry conducted at 174 U.S. sites with enrollment from June 2010 to August 2011.ResultsAmong 9,619 patients with AF and serial follow-up every 6 months for up to 3 years, 2,267 (23.6%) received digoxin at study enrollment, 681 (7.1%) were initiated on digoxin during follow-up, and 6,671 (69.4%) were never prescribed digoxin. After adjusting for other medications, heart rate was 72.9 beats/min among digoxin users and 71.5 beats/min among nonusers (p < 0.0001). Prevalent digoxin use at registry enrollment was not associated with subsequent onset of symptoms, hospitalization, or mortality (in patients with HF, adjusted hazard ratio [HR] for death: 1.04; without HF, HR: 1.22). Incident digoxin use during follow-up was not associated with subsequent death in patients with HF (propensity adjusted HR: 1.05), but was associated with subsequent death in those without HF (propensity adjusted HR: 1.99).ConclusionsAfter adjustment for detailed clinical factors, digoxin use in registry patients with AF had a neutral association with outcomes under most circumstances. Because of the multiple conflicting observational reports about digoxin's safety and possible concerns in specific clinical situations, a large pragmatic trial of digoxin therapy in AF is needed.

Published
2015

30. Primary Prevention Implantable Cardioverter-Defibrillators in Older Racial and Ethnic Minority Patients

Author

Pokorney, Sean D, Hellkamp, Anne S, Yancy, Clyde W, Curtis, Lesley H, Hammill, Stephen C, Peterson, Eric D, Masoudi, Frederick A, Bhatt, Deepak L, Al-Khalidi, Hussein R, Heidenreich, Paul A, Anstrom, Kevin J, Fonarow, Gregg C, and Al-Khatib, Sana M

Subjects
Prevention, Clinical Research, Heart Disease, Cardiovascular, Good Health and Well Being, Age Factors, Aged, Aged, 80 and over, Comparative Effectiveness Research, Death, Sudden, Cardiac, Defibrillators, Implantable, Electric Countershock, Ethnicity, Healthcare Disparities, Humans, Medicare, Minority Groups, Primary Prevention, Racial Groups, Registries, Risk Factors, Time Factors, Treatment Outcome, United States, continental population groups, death, sudden, defibrillators, implantable ethnology, minority groups, primary prevention, defibrillators, implantable, ethnology, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Medical Physiology, Cardiovascular System & Hematology
Abstract

BackgroundRacial and ethnic minorities are under-represented in clinical trials of primary prevention implantable cardioverter-defibrillators (ICDs). This analysis investigates the association between primary prevention ICDs and mortality among Medicare, racial/ethnic minority patients.Methods and resultsData from Get With The Guidelines-Heart Failure Registry and National Cardiovascular Data Registry's ICD Registry were used to perform an adjusted comparative effectiveness analysis of primary prevention ICDs in Medicare, racial/ethnic minority patients (nonwhite race or Hispanic ethnicity). Mortality data were obtained from the Medicare denominator file. The relationship of ICD with survival was compared between minority and white non-Hispanic patients. Our analysis included 852 minority patients, 426 ICD and 426 matched non-ICD patients, and 2070 white non-Hispanic patients (1035 ICD and 1035 matched non-ICD patients). Median follow-up was 3.1 years. Median age was 73 years, and median ejection fraction was 23%. Adjusted 3-year mortality rates for minority ICD and non-ICD patients were 44.9% (95% confidence interval [CI], 44.2%-45.7%) and 54.3% (95% CI, 53.4%-55.1%), respectively (adjusted hazard ratio, 0.79; 95% CI, 0.63-0.98; P=0.034). White non-Hispanic patients receiving an ICD had lower adjusted 3-year mortality rates of 47.8% (95% CI, 47.3%-48.3%) compared with 57.3% (95% CI, 56.8%-57.9%) for those with no ICD (adjusted hazard ratio, 0.75; 95% CI, 0.67%-0.83%; P

Published
2015

31. Lead Extraction and Mortality Among Patients With Cardiac Implanted Electronic Device Infection

Author

Pokorney, Sean D., primary, Zepel, Lindsay, additional, Greiner, Melissa A., additional, Fowler, Vance G., additional, Black-Maier, Eric, additional, Lewis, Robert K., additional, Hegland, Donald D., additional, Granger, Christopher B., additional, Epstein, Laurence M., additional, Carrillo, Roger G., additional, Wilkoff, Bruce L., additional, Hardy, Chantelle, additional, and Piccini, Jonathan P., additional

Published
2023
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34. Self-administered intranasal etripamil using a symptom-prompted, repeat-dose regimen for atrioventricular-nodal-dependent supraventricular tachycardia (RAPID): a multicentre, randomised trial

Author

Stambler, Bruce S, primary, Camm, A John, additional, Alings, Marco, additional, Dorian, Paul, additional, Heidbuchel, Hein, additional, Houtgraaf, Jaco, additional, Kowey, Peter R, additional, Merino, Jose L, additional, Mondésert, Blandine, additional, Piccini, Jonathan P, additional, Pokorney, Sean D, additional, Sager, Philip T, additional, Verma, Atul, additional, Wharton, J Marcus, additional, Bharucha, David B, additional, Plat, Francis, additional, Shardonofsky, Silvia, additional, Chen, Michael, additional, Ip, James E, additional, Jones, Alonzo, additional, Stambler, Bruce S, additional, Schleinkofer, David E, additional, Winters, Stephen, additional, Lam, Wilson, additional, Goldstein, Robert, additional, Dor, Isaac Dor, additional, Talwar, Sandeep, additional, O'Neill, Padraig G, additional, Koren, Michael J, additional, Beinart, Sean C, additional, Ambati, Srivani, additional, Mazer, Sean P, additional, Kinn, Robert M, additional, Roy, Karine, additional, Manshadi, Ramin, additional, Kuk, Richard, additional, Verma, Aditya, additional, Phelan, Timothy, additional, Stoian, Alexandru A, additional, Ellenbogen, Kenneth, additional, Jayachandran, J Vijay, additional, Connelly, Terence P, additional, Daccarett, Marcos, additional, Gandhi, Gaurang, additional, Mittal, Suneet, additional, Abdel-Wahab, Amir, additional, Augostini, Ralph, additional, Ip, John H, additional, Sorrentino, Denise, additional, Roux, Jean-Francois, additional, Brar, Ramandeep, additional, Khoo, Clarence, additional, Bennett, Matthew, additional, Lo, Eric, additional, Coutu, Benoit, additional, Sterns, Laurence, additional, Greer, Gerald S, additional, Gujja, Pradeep, additional, Gianfagna, Robert A, additional, Swarup, Vijendra, additional, Sogade, Felix, additional, Wilton, Stephen, additional, Ruisi, Christopher, additional, Barbera, Saverio, additional, Banchs, Javier E., additional, Korley, Victoria, additional, Schulze, Christopher, additional, Damle, Roger, additional, Healey, Jeffrey Sean, additional, Pandey, A Shekhar, additional, Anderson, Jeffrey L, additional, Venkatachalam, K L, additional, Noseworthy, Peter, additional, Friars, Douglas G, additional, Kambur, Thomas R, additional, Lockwood, Evan, additional, Meininger, Glenn, additional, Olsovsky, Greg, additional, Jones Sr, Alonzo, additional, Greer, Gerald, additional, Mehta, Rohit, additional, Akbar, Saleem, additional, Salman, Malik, additional, Rama, Bhola, additional, Arora, Ramesh, additional, Shah, Dhirenkumar, additional, Shah, Rakesh, additional, Cammarata, Michael, additional, Owens, Andrew, additional, Ludington, Katherine, additional, Wharton, Marcus, additional, Bagheri, Michael, additional, Khan, Mohammed, additional, Carr, Kenneth Warren, additional, Siddique, Sultan, additional, Parvathaneni, Sunthosh, additional, Devabhaktuni, Subodh, additional, Mouhaffel, Assad, additional, Mark, George, additional, Di Biase, Luigi, additional, Rangappa, Sunil, additional, Morton, Jared, additional, Yarmohammadi, Hirad, additional, Karim, Amin, additional, Martinez Fleites, Aldo, additional, Nero, Thomas, additional, Shafiq, Qaiser, additional, Pandey, Shekhar, additional, Khaykin, Yaariv, additional, Joza, Jacqueline, additional, Gosselin, Gilbert, additional, Skanes, Allen, additional, Vyselaar, John, additional, Savard, Daniel, additional, Xhaet, Olivier, additional, Catez, Emmanuel, additional, Vijgen, Johan, additional, Godart, Pascal, additional, Casado, Ruben, additional, Mairesse, Georges, additional, Rossenbacker, Tom, additional, Haemers, Peter, additional, Hoffer, Etienne, additional, Hausman, Pierre, additional, Vertes, Andras, additional, Duray, Gabor, additional, Szolnoki, Erzsebet, additional, Csanadi, Zoltan, additional, Lakatos, Ferenc, additional, Dorman, Reinhart, additional, Tuininga, Y S, additional, Jansen, W, additional, Velthuis, Sebastiaan, additional, van Bemmel, B, additional, Bech, Gerhard Jan Willem, additional, Pisters, Ron, additional, Valk, Suzanne, additional, Romer, Tjeerd, additional, Luermans, Justin, additional, Beelen, Driek, additional, van Eck, Martijn, additional, Vet, Thijs, additional, Shellings, Dirk, additional, Oosterhof, T, additional, Miekus, Pawel, additional, Bebenek, Waldemar, additional, Bielecka-Dabrowa, Agata, additional, Gniot, Jacek, additional, Zmuda, Witold, additional, Kasprzak, Michal, additional, Balak, Wojciech, additional, Ptaszynski, Pawel, additional, Nowak, Jacek, additional, Prokopczuk, Janusz, additional, Przybylski, Andrzej, additional, Wozniak-Skowerska, Iwona, additional, Derejko, Pawel, additional, Czarnecka, Danuta, additional, Janas, Adam, additional, Merino Llorens, Jose Luis, additional, Tercedor, Luis, additional, Iniguez Romo, Andres, additional, Ruiz Granell, Ricardo, additional, Gonzalez Juanatey, Jose Ramon, additional, Pascual-Figal, Domingo, additional, Martinez-Selles, Manuel, additional, Anguera Camos, Ignacio, additional, Ibanez Criado, Alicia, additional, Matrinez Basterra, Javier, additional, Izquierdo, Alvaro, additional, Rivas Gandara, Nuria, additional, Alegret Colome, Josep M, additional, Perez Diez, Diego, additional, Martínez Hervás, Miguel Ángel, additional, Medina, Maria, additional, Segura Saint-Gerons, Jose María, additional, Pedrote Leal, Alonso, additional, Fernandez Lozano, Ignacio, additional, Quesada, Aurelio, additional, Guerra Ramos, Jose, additional, Sarrias, Axel, additional, Ramos Maqueda, Javier, additional, Mansourati, Jacques, additional, Defaye, Pascal, additional, Guedon-Moreau, Laurence, additional, Milhem, Antoine, additional, De Guillebon, Maxime, additional, Chevalier, Philippe, additional, Badoz, Marc, additional, Kriatselis, Charalampos, additional, Simonis, Gregor, additional, Lewalter, Thorsten, additional, Zarse, Markus, additional, Wilke, Andreas, additional, Kraemer, Fabian, additional, and Al-Zoebi, Ayham, additional

Published
2023
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36. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial

Author

Carbajales, Justo, Gómez, Javier Neri Ceferino, Principato, Mario Bruno, Von Wulffen, María Alejandra, Acunzo, Jorge Galperín Rafael Salvador, Bonato, Ricardo Renato, Ciampi, Natalia, Marani, Alberto Babil, Panigadi, Cristian Gustavo, Pastura, Silvia Gabriela, Onetto, Leonardo Martín, Moya, Cecilia Rafaela, Budassi, Nadia, Valle, Marisol, Camerini, Daniel, Monjes, Enrique, Zabala, Federico, Ricart, Juan Pablo, Medesani, Luis, Campos, Eduardo Noe Ortuño, Ferroni, Fabián, Torres, Mariana Foa, Fassi, Daniel Omar, Bosio, Fernando Javier Díaz, Baztarrica, Gabriel Edgardo Pérez, Infantas, Teresa Zúñiga, Perlo, Daniela, García, Celso Fernando, Durán, Rubén García, Durán, Luisina García, Pettinari, Cecilia Alejandra, Vico, Marisa Liliana, Lanchiotti, Paulina Virginia, Gómez, Mariela Soledad, Poy, Carlos Alberto, Grazziani, Franco Sebastián, Laspina, Marcela Julieta, Poy, María Laura, Bahit, María Cecilia, Tajer, Carlos, García, Marilia, Lopes, Renato D., de Barros e Silva, Pedro Gabriel Melo, Berwanger, Otavio, Egydio, Flávia, Restelli, Elissa, Kawakami, Anelise, Soares, Tamara Colaiácovo, Valois, Mayara Vioto, Duarte, Tauane Bello, Barbosa, Lilian Mazza, de Paola, Angelo Amato Vicenzo, Pimenta, Thiago Librelon, Jeronimo, Gabriela Dal Moro, da Costa, Bruna S. Fernandes, Coutinho, Enia Lucia, Guerrero, Andressa Zulmira A., Maia, Lilia Nigro, Nakazone, Marcelo Arruda, Lemos, Maria Angelica Teixeira, Costa, Osana Maria Coelho, Demore, Ana Paula, Brito, Roberta Parra, Melo, Camila Dal Bon, Góes, Nadielly Codonho, Lorenço, Osvaldo, Gonçalves, Luiz Otavio Maia, Nishiama, Kátia, de Lima, Tiago Aparecido Maschio, Backes, Luciano Marcelo, de Lima Deucher, Keyla Liliana Alves, Rodrigues, Milena Pozzatto, Baldissera, Dunnia Monisa, Reolão, José Basileu Caos, dos Santos, Tais Alves, Freisleben, Fernanda Michel Birck, da Silveira Kaross, Níncia Lucca, Montovani, Jéssika Tzervieczenski, Cantarelli, Maiara, Lucion, Aline, do Amarante, Luciano, Foscarini, Priscila, de Mello Perez, Claudia, França, Fernanda Ribeiro, Fialho, Lisa, Rey, Helena Cramer Veiga, God, Epotamenides Maria Good, Figueiredo, Estêvão Lanna, Werner, Gustavo Fonseca, de Faria Garcia, Jose Carlos, Azevedo, Bruna, Barbosa, Luiz Carlos Vianna, Pardi, Ernaldo, Oliveira, Márcia Domingos, Martinelli, Toshie, Cavalini, Roseli Gomes, de Moraes, Michele Santos Montoni, Filho, Adalberto Menezes Lorga, Palmegiani, Eduardo, Megid, Thiago Baccilli Cury, Queirantes, Clotildes S.P., Cruz, Thamyres Santini Arroyo, He, Pengkang, Zhou, Xiaolan, Zhou, Na, Zhao, Mingzhong, Yu, Juan, Cheng, Yong, Wang, Lijun, Liu, Lili, Liu, Shuwang, Li, Lei, Li, Aihua, Yuan, Xiaochen, Xia, Guangwei, Wang, Zhirong, Li, Chengzong, Chen, Wensu, Tang, Qiang, Tang, Qunzhong, Xu, Weiting, Zhu, Xinyi, Hou, Bin, Ma, Wenjian, Wang, Chongquan, Jin, Qiaoyun, Wang, Jianan, Xie, Xiaojie, Joseph, Johny, Davidson, Deepak, Thomas, Joby K., Kunjumon, Tony V., Stephen, Tibin, Fatania, Kamlesh, Rathi, Gaurav, Garala, Kinjal, Doshi, Dhruval, Varghese, Kiron, MA, Srilakshmi, Sheeba, Lumin, Kumar, Shantha, Rao, Malipeddi Bhaskara, Rao, Kodem Damodara, Vuriya, Anjan Kumar, Kumari, Mandula Padma, Khandelwal, Bidita, Dhakal, Mona, Srivastava, Nitin, Khatri, Dheeraj, Moktan, Shova, Gupta, Rajeev, Roy, Sanjeeb, Kumawat, Kapil, Sharma, Mukesh, Sharma, K.K., Jathappa, Narendra, Lokesh, B.H., Kariyappa, Shilpa, Leela, A.C., Someshwara, K.C., Desai, Soaham, Desai, Devangi, Patel, Kunj, Patel, Sujal, Bhartiya, Maulik, Mahanta, Bhupendra Narayan, Dutta, Dibya Jyoti, Rajkonwer, Ghanashyam, Gupta, Sandeep Kumar, Mishra, Ashok Kumar, Singh, Akansha, Kesarwani, Naveen, Kumar, Shivendra, Chioncel, Ovidiu, Balan, Adriana, Carstea, Nicolae, Chitoiu, Gabriel Tatu, Cornaciu, Stelian, Cinteza, Mircea, Rimbas, Roxana C., Dimulescu, Doina, Ionescu, Luminita, Fruntelata, Ana, Dumitru, Nicoleta, Gaita, Dan, Pleava, Roxana, Iliesiu, Adriana, Uscoiu, Gabriela, Lighezan, Daniel, Buzas, Roxana, Sinescu, Crina J., Avram, Ana-Maria, Baldea, Sorina, Galrinho, Ruxandra Dragoi, Magda, Stefania L., Matei, Lavinia, Vinereanu, Dragos, Lopes, Renato D, Bahit, M Cecilia, Xavier, Denis, Jiang, Jie, Al-Khalidi, Hussein R, He, Wensheng, Xian, Ying, Ciobanu, Andrea O, Kamath, Deepak Y, Fox, Kathleen A, Rao, Meena P, Pokorney, Sean D, de Barros e Silva, Pedro G M, Roettig, Mayme L, Huo, Yong, and Granger, Christopher B

Published
2017
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41. CI-452769-3 INAPPROPRIATE ICD SHOCKS IN PATIENTS WITH LVADS: PREVALENCE, ASSOCIATED FACTORS, AND ETIOLOGIES

Author

Andreae, Andrew E., primary, Black-Maier, Eric W., additional, Arps, Kelly, additional, Kobe, Elizabeth, additional, Towery, Emily, additional, Sun, Albert Y., additional, Friedman, Daniel J., additional, Koontz, Jason, additional, Schroder, Jacob, additional, Khouri, Michel, additional, Katz, Jason, additional, Patel, Chetan, additional, Pokorney, Sean D., additional, Daubert, James P., additional, and Piccini, Jonathan P., additional

Published
2023
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43. Early Lead Extraction for Infected Implanted Cardiac Electronic Devices

Author

Lakkireddy, Dhanunjaya R., primary, Segar, Douglas S., additional, Sood, Ami, additional, Wu, MaryAnn, additional, Rao, Archana, additional, Sohail, M. Rizwan, additional, Pokorney, Sean D., additional, Blomström-Lundqvist, Carina, additional, Piccini, Jonathan P., additional, and Granger, Christopher B., additional

Published
2023
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44. Early Lead Extraction for Infected Implanted Cardiac Electronic Devices JACC Review Topic of the Week

Author

Lakkireddy, Dhanunjaya R., Segar, Douglas S., Sood, Ami, Wu, MaryAnn, Rao, Archana, Sohail, Rizwan, Pokorney, Sean D., Blomström-Lundqvist, Carina, Piccini, Jonathan P., Granger, Christopher B., Lakkireddy, Dhanunjaya R., Segar, Douglas S., Sood, Ami, Wu, MaryAnn, Rao, Archana, Sohail, Rizwan, Pokorney, Sean D., Blomström-Lundqvist, Carina, Piccini, Jonathan P., and Granger, Christopher B.

Abstract

Infection remains a serious complication associated with the cardiac implantable electronic devices (CIEDs), leading to substantial clinical and economic burden globally. This review assesses the burden of cardiac implantable electronic device infection (CIED-I), evidence for treatment recommendations, barriers to early diagnosis and appropriate therapy, and potential solutions. Multiple clinical practice guidelines recommended complete system and lead removal for CIED-I when appropriate. CIED extraction for infection has been consistently reported with high success, low complication, and very low mortality rates. Complete and early extraction was associated with significantly better clinical and economic outcome compared with no or late extraction. However, significant gaps in knowledge and poor recommendation compliance have been reported. Barriers to optimal management may include diagnostic delay, knowledge gaps, and limited access to expertise. A multipronged approach, including education of all stakeholders, a CIED-I alert system, and improving access to experts, could help bring paradigm shift in the treatment of this serious condition. (J Am Coll Cardiol 2023;81:1283-1295)

Published
2023
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45. Self-Administered Intranasal Etripamil Using a Symptom-Prompted, Repeat-Dose Regimen for Atrioventricular-Nodal-Dependent Supraventricular Tachycardia (RAPID): A Multicentre, Randomised Trial

Author

Stambler, Bruce S, Camm, A John, Alings, Marco, Dorian, Paul, Heidbuchel, Hein, Houtgraaf, Jaco, Kowey, Peter R., Merino, Jose L, Mondésert, Blandine, Piccini, Jonathan P, Pokorney, Sean D, Sager, Philip T, Verma, Atul, Wharton, J Marcus, Bharucha, David B, Plat, Francis, Shardonofsky, Silvia, Chen, Michael, Ip, James E, Stambler, Bruce S, Camm, A John, Alings, Marco, Dorian, Paul, Heidbuchel, Hein, Houtgraaf, Jaco, Kowey, Peter R., Merino, Jose L, Mondésert, Blandine, Piccini, Jonathan P, Pokorney, Sean D, Sager, Philip T, Verma, Atul, Wharton, J Marcus, Bharucha, David B, Plat, Francis, Shardonofsky, Silvia, Chen, Michael, and Ip, James E

Abstract

BACKGROUND: Etripamil is a fast-acting, intranasally administered calcium-channel blocker in development for on-demand therapy outside a health-care setting for paroxysmal supraventricular tachycardia. We aimed to evaluate the efficacy and safety of etripamil 70 mg nasal spray using a symptom-prompted, repeat-dose regimen for acute conversion of atrioventricular-nodal-dependent paroxysmal supraventricular tachycardia to sinus rhythm within 30 min. METHODS: RAPID was a multicentre, randomised, placebo-controlled, event-driven trial, conducted at 160 sites in North America and Europe as part 2 of the NODE-301 study. Eligible patients were aged at least 18 years and had a history of paroxysmal supraventricular tachycardia with sustained, symptomatic episodes (≥20 min) as documented by electrocardiogram. Patients were administered two test doses of intranasal etripamil (each 70 mg, 10 min apart) during sinus rhythm; those who tolerated the test doses were randomly assigned (1:1) using an interactive response technology system to receive either etripamil or placebo. Prompted by symptoms of paroxysmal supraventricular tachycardia, patients self-administered a first dose of intranasal 70 mg etripamil or placebo and, if symptoms persisted beyond 10 min, a repeat dose. Continuously recorded electrocardiographic data were adjudicated, by individuals masked to patient assignment, for the primary endpoint of time to conversion of paroxysmal supraventricular tachycardia to sinus rhythm for at least 30 s within 30 min after the first dose, which was measured in all patients who administered blinded study drug for a confirmed atrioventricular-nodal-dependent event. Safety outcomes were assessed in all patients who self-administered blinded study drug for an episode of perceived paroxysmal supraventricular tachycardia. This trial is registered at ClinicalTrials.gov, NCT03464019, and is complete. FINDINGS: Between Oct 13, 2020, and July 20, 2022, among 692 patients randomly assigned

Published
2023

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