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1. Undertaking multi-centre randomised controlled trials in primary care: learnings and recommendations from the PULsE-AI trial researchers

Author

Pollock, Kevin G., Dickerson, Carissa, Kainth, Manjit, Lawton, Sarah, Hurst, Michael, Sugrue, Daniel M., Arden, Chris, Davies, D. Wyn, Martin, Anne-Céline, Sandler, Belinda, Gordon, Jason, Farooqui, Usman, Clifton, David, Mallen, Christian, Rogers, Jennifer, Hill, Nathan R., Camm, A. John, and Cohen, Alexander T.

Published
2024
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2. Combined atrial fibrillation ablation and left atrial appendage occlusion procedure in the United States: a propensity score matched analysis from 2016–2019 national readmission database

Author

Pasupula, Deepak Kumar, Malleshappa, Sudeep K Siddappa, Munir, Muhammad B, Bhat, Anusha Ganapati, Anandaraj, Antony, Jakkoju, Avaneesh, Spooner, Michael, Koranne, Ketan, Hsu, Jonathan C, Olshansky, Brian, and Camm, A John

Subjects
Patient Safety, Heart Disease, Cardiovascular, Clinical Research, Male, Humans, United States, Middle Aged, Aged, Aged, 80 and over, Female, Atrial Fibrillation, Patient Readmission, Atrial Appendage, Propensity Score, Retrospective Studies, Stroke, Catheter Ablation, Treatment Outcome, LAAO, Left Atrial Appendage Occlusion, CA, Percutaneous Catheter-directed Atrial Fibrillation Ablation, MACE, Major Adverse Cardiovascular Events, NRD, National Readmission Database, CA – Percutaneous Catheter-directed Atrial Fibrillation Ablation, LAAO – Left Atrial Appendage Occlusion, MACE – Major Adverse Cardiovascular Events, NRD – National Readmission Database, Clinical Sciences, Cardiovascular System & Hematology
Abstract

AimsThe safety and feasibility of combining percutaneous catheter ablation (CA) for atrial fibrillation with left atrial appendage occlusion (LAAO) as a single procedure in the USA have not been investigated. We analyzed the US National Readmission Database (NRD) to investigate the incidence of combined LAAO + CA and compare major adverse cardiovascular events (MACEs) with matched LAAO-only and CA-only patients.Methods and resultsIn this retrospective study from NRD data, we identified patients undergoing combined LAAO and CA procedures on the same day in the USA from 2016 to 2019. A 1:1 propensity score match was performed to identify patients undergoing LAAO-only and CA-only procedures. The number of LAAO + CA procedures increased from 28 (2016) to 119 (2019). LAAO + CA patients (n = 375, mean age 74 ± 9.2 years, 53.4% were males) had non-significant higher MACE (8.1%) when compared with LAAO-only (n = 407, 5.3%) or CA-only patients (n = 406, 7.4%), which was primarily driven by higher rate of pericardial effusion (4.3%). All-cause 30-day readmission rates among LAAO + CA patients (10.7%) were similar when compared with LAAO-only (12.7%) or CA-only (17.5%) patients. The most frequent primary reason for readmissions among LAAO + CA and LAAO-only cohorts was heart failure (24.6 and 31.5%, respectively), while among the CA-only cohort, it was paroxysmal atrial fibrillation (25.7%).ConclusionWe report an 63% annual growth (from 28 procedures) in combined LAAO and CA procedures in the USA. There were no significant difference in MACE and all-cause 30-day readmission rates among LAAO + CA patients compared with matched LAAO-only or CA-only patients.

Published
2023

3. Orally Inhaled Flecainide for Conversion of Atrial Fibrillation to Sinus Rhythm: INSTANT Phase 2 Trial

Author

Ruskin, Jeremy N., Camm, A. John, Dufton, Christopher, Woite-Silva, Anderson C., Tuininga, Ype, Badings, Erik, De Jong, Jonas S.S.G., Oosterhof, Thomas, Aksoy, Ismail, Kuijper, Aaf F.M., Van Gelder, Isabelle C., van Dijk, Vincent, Nuyens, Dieter, Schellings, Dirk, Lee, Mark Young, Kowey, Peter R., Crijns, Harry J.G.M., Maupas, Jean, and Belardinelli, Luiz

Published
2024
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8. Rationale and design of a randomized study comparing the Watchman FLX device to DOACs in patients with atrial fibrillation

Author

Kar, Saibal, Doshi, Shephal K., Alkhouli, Mohamad, Camm, A. John, Coylewright, Megan, Gibson, Michael C., Granger, Christopher B., Gurol, Mahmut E., Huber, Kenneth, Mansour, Moussa, Nair, Devi G., Natale, Andrea, Pocock, Stuart J., Reddy, Vivek R., Saliba, Walid, Christen, Thomas, Allocco, Dominic J., Ellenbogen, Kenneth A., and Leon, Martin B.

Published
2023
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9. Multicenter, Phase 2, Randomized Controlled Study of the Efficacy and Safety of Etripamil Nasal Spray for the Acute Reduction of Rapid Ventricular Rate in Patients With Symptomatic Atrial Fibrillation (ReVeRA-201)

Author

Camm, A. John, Piccini, Jonathan P., Alings, Marco, Dorian, Paul, Gosselin, Gilbert, Guertin, Marie-Claude, Ip, James E., Kowey, Peter R., Mondésert, Blandine, Prins, Fransisco J., Roux, Jean-Francois, Stambler, Bruce S., van Eck, JWM, Al Windy, Nadea, Thermil, Nathalie, Shardonofsky, Silvia, Bharucha, David B., and Roy, Denis

Published
2023
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10. A randomized controlled trial to investigate the use of acute coronary syndrome therapy in patients hospitalized with COVID-19: the COVID-19 Acute Coronary Syndrome trial

Author

Kanagaratnam, Prapa, Francis, Darrel P., Chamie, Daniel, Coyle, Clare, Marynina, Alena, Katritsis, George, Paiva, Patricia, Szigeti, Matyas, Cole, Graham, de Andrade Nunes, David, Howard, James, Esper, Rodrigo, Khan, Masood, More, Ranjit, Barreto, Guilherme, Meneguz-Moreno, Rafael, Arnold, Ahran, Nowbar, Alexandra, Kaura, Amit, Mariveles, Myril, March, Katherine, Shah, Jaymin, Nijjer, Sukhjinder, Lip, Gregory Y.H., Mills, Nicholas, Camm, A. John, Cooke, Graham S., Corbett, Simon J., Llewelyn, Martin J., Ghanima, Waleed, Toshner, Mark, Peters, Nicholas, Petraco, Ricardo, Al-Lamee, Rasha, Boshoff, Ana Sousa Marcelino, Durkina, Margarita, Malik, Iqbal, Ruparelia, Neil, Cornelius, Victoria, and Shun-Shin, Matthew

Published
2023
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11. 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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15. Blood-based cardiometabolic phenotypes in atrial fibrillation and their associated risk: EAST-AFNET 4 biomolecule study

Author

Fabritz, Larissa, primary, Chua, Winnie, additional, Cardoso, Victor R, additional, Al-Taie, Christoph, additional, Borof, Katrin, additional, Suling, Anna, additional, Krause, Linda, additional, Kany, Shino, additional, Magnussen, Christina, additional, Wegscheider, Karl, additional, Breithardt, Guenter, additional, Crijns, Harry J G M, additional, Camm, A John, additional, Gkoutos, George, additional, Ellinor, Patrick T, additional, Goette, Andreas, additional, Schotten, Ulrich, additional, Wienhues-Thelen, Ursula-Henrike, additional, Zeller, Tanja, additional, Schnabel, Renate B, additional, Zapf, Antonia, additional, and Kirchhof, Paulus, additional

Published
2024
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16. Oral anticoagulation in device-detected atrial fibrillation: effects of age, sex, cardiovascular comorbidities, and kidney function on outcomes in the NOAH-AFNET 6 trial

Author

Lip, Gregory Y H, primary, Nikorowitsch, Julius, additional, Sehner, Susanne, additional, Becher, Nina, additional, Bertaglia, Emanuele, additional, Blomstrom-Lundqvist, Carina, additional, Brandes, Axel, additional, Beuger, Vincent, additional, Calvert, Melanie, additional, Camm, A John, additional, Chlouverakis, Gregory, additional, Dan, Gheorghe-Andrei, additional, Dichtl, Wolfgang, additional, Diener, Hans Christoph, additional, Fierenz, Alexander, additional, Goette, Andreas, additional, de Groot, Joris R, additional, Hermans, Astrid, additional, Lubinski, Andrzej, additional, Marijon, Eloi, additional, Merkely, Béla, additional, Mont, Lluís, additional, Ozga, Ann-Kathrin, additional, Rajappan, Kim, additional, Sarkozy, Andrea, additional, Scherr, Daniel, additional, Schnabel, Renate B, additional, Schotten, Ulrich, additional, Simantirakis, Emmanuel, additional, Toennis, Tobias, additional, Vardas, Panos, additional, Wichterle, Dan, additional, Zapf, Antonia, additional, and Kirchhof, Paulus, additional

Published
2024
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19. Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry

Author

Sawhney, Jitendra PS, Kothiwale, Veerappa A, Bisne, Vikas, Durgaprasad, Rajashekhar, Jadhav, Praveen, Chopda, Manoj, Vanajakshamma, Velam, Meena, Ramdhan, Vijayaraghavan, Govindan, Chawla, Kamaldeep, Allu, Jagan, Pieper, Karen S, Camm, A John, Kakkar, Ajay K, Bassand, Jean-Pierre, Fitzmaurice, David A, Goldhaber, Samuel Z, Goto, Shinya, Haas, Sylvia, Hacke, Werner, Mantovani, Lorenzo G, Misselwitz, Frank, Turpie, Alexander GG, van Eickels, Martin, Verheugt, Freek WA, Kayani, Gloria, Fox, Keith AA, Gersh, Bernard J, Luciardi, Hector Lucas, Gibbs, Harry, Brodmann, Marianne, Cools, Frank, Barretto, Antonio Carlos Pereira, Connolly, Stuart J, Spyropoulos, Alex, Eikelboom, John, Corbalan, Ramon, Hu, Dayi, Jansky, Petr, Nielsen, Jørn Dalsgaard, Ragy, Hany, Raatikainen, Pekka, Le Heuzey, Jean-Yves, Darius, Harald, Keltai, Matyas, Kakkar, Sanjay, Sawhney, Jitendra Pal Singh, Agnelli, Giancarlo, Ambrosio, Giuseppe, Koretsune, Yukihiro, Díaz, Carlos Jerjes Sánchez, Cate, Hugo Ten, Atar, Dan, Stepinska, Janina, Panchenko, Elizaveta, Lim, Toon Wei, Jacobson, Barry, Oh, Seil, Viñolas, Xavier, Rosenqvist, Marten, Steffel, Jan, Angchaisuksiri, Pantep, Oto, Ali, Parkhomenko, Alex, Mahmeed, Wael Al, Fitzmaurice, David, Hu, DY, Chen, KN, Zhao, YS, Zhang, HQ, Chen, JZ, Cao, SP, Wang, DW, Yang, YJ, Li, WH, Yin, YH, Tao, GZ, Yang, P, Chen, YM, He, SH, Wang, Ying, Wang, Yong, Fu, GS, Li, X, Wu, TG, Cheng, XS, Yan, XW, Zhao, RP, Chen, MS, Xiong, LG, and Chen, P

Subjects
Hematology, Prevention, Cardiovascular, Clinical Research, Heart Disease, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Aged, Atrial Fibrillation, Electrocardiography, Female, Follow-Up Studies, Humans, Incidence, India, Male, Prevalence, Prognosis, Prospective Studies, Registries, Risk Assessment, Risk Factors, Survival Rate, Thromboembolism, Time Factors, Anticoagulant therapy, Arrhythmia, Atrial fibrillation, GARFIELD-AF, GARFIELD-AF Investigators, Cardiovascular System & Hematology
Abstract

BackgroundThe Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry.Methods and resultsA total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P

Published
2018

24. Anticoagulation in Patients With Device-Detected Atrial Fibrillation With and Without a Prior Stroke or Transient Ischemic Attack: The NOAH-AFNET 6 Trial.

Author

Diener, Hans Christoph, Becher, Nina, Sehner, Susanne, Toennis, Tobias, Bertaglia, Emanuele, Blomstrom Lundqvist, Carina, Brandes, Axel, Beuger, Vincent, Calvert, Melanie, Camm, A. John, Chlouverakis, Gregory, Dan, Gheorghe-Andrei, Dichtl, Wolfgang, Fierenz, Alexander, Goette, Andreas, de Groot, Joris R., Hermans, Astrid, Lip, Gregory Y. H., Lubinski, Andrzej, and Marijon, Eloi

Published
2024
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25. Treatment strategies of the thromboembolic risk in kidney failure patients with atrial fibrillation.

Author

Genovesi, Simonetta, Camm, A John, Covic, Adrian, Burlacu, Alexandru, Meijers, Björn, Franssen, Casper, Luyckx, Valerie, Liakopoulos, Vassilios, Alfano, Gaetano, Combe, Christian, and Basile, Carlo

Subjects
*LEFT atrial appendage closure, *ANTICOAGULANTS, *KIDNEY failure, *ATRIAL fibrillation, *ORAL medication
Abstract

The incidence and prevalence of atrial fibrillation (AF) in patients affected by kidney failure, i.e. glomerular filtration rate <15 ml/min/1.73 m2, is high and probably underestimated. Numerous uncertainties remain regarding how to prevent thromboembolic events in this population because both cardiology and nephrology guidelines do not provide clear recommendations. The efficacy and safety of oral anticoagulant therapy (OAC) in preventing thromboembolism in patients with kidney failure and AF has not been demonstrated for either vitamin K antagonists (VKAs) or direct anticoagulants (DOACs). Moreover, it remains unclear which is more effective and safer, because estimated creatinine clearance <25–30 ml/min was an exclusion criterion in the randomized controlled trials (RCTs). Three RCTs comparing DOACs and VKAs in kidney failure failed to reach the primary endpoint, as they were underpowered. The left atrial appendage is the main source of thromboembolism in the presence of AF. Left atrial appendage closure (LAAC) has recently been proposed as an alternative to OAC. RCTs comparing the efficacy and safety of LAAC versus OAC in kidney failure were terminated prematurely due to recruitment failure. A recent prospective study showed a reduction in thromboembolic events in haemodialysis patients with AF and undergoing LAAC compared with patients taking or not taking OAC. We review current treatment standards and discuss recent developments in managing the thromboembolic risk in kidney failure patients with AF. The importance of shared decision-making with the multidisciplinary team and the patient to consider individual risks and benefits of each treatment option is underlined. [ABSTRACT FROM AUTHOR]

Published
2024
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26. Causes of death in patients with atrial fibrillation anticoagulated with rivaroxaban: a pooled analysis of XANTUS.

Author

Kirchhof, Paulus, Haas, Sylvia, Amarenco, Pierre, Turpie, Alexander G G, Bach, Miriam, Lambelet, Marc, Hess, Susanne, and Camm, A John

Abstract

Aims Anticoagulation can prevent stroke and prolong lives in patients with atrial fibrillation (AF). However, anticoagulated patients with AF remain at risk of death. The aim of this study was to investigate the causes of death and factors associated with all-cause and cardiovascular death in the XANTUS population. Methods and results Causes of death occurring within a year after rivaroxaban initiation in patients in the XANTUS programme studies were adjudicated by a central adjudication committee and classified following international guidance. Baseline characteristics associated with all-cause or cardiovascular death were identified. Of 11 040 patients, 187 (1.7%) died. Almost half of these deaths were due to cardiovascular causes other than bleeding (n = 82, 43.9%), particularly heart failure (n = 38, 20.3%) and sudden or unwitnessed death (n = 24, 12.8%). Fatal stroke (n = 8, 4.3%), which was classified as a type of cardiovascular death, and fatal bleeding (n = 17, 9.1%) were less common causes of death. Independent factors associated with all-cause or cardiovascular death included age, AF type, body mass index, left ventricular ejection fraction, hospitalization at baseline, rivaroxaban dose, and anaemia. Conclusion The overall risk of death due to stroke or bleeding was low in XANTUS. Anticoagulated patients with AF remain at risk of death due to heart failure and sudden death. Potential interventions to reduce cardiovascular deaths in anticoagulated patients with AF require further investigation, e.g. early rhythm control therapy and AF ablation. Trial registration numbers NCT01606995, NCT01750788, NCT01800006 [ABSTRACT FROM AUTHOR]

Published
2024
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29. Longer and better lives for patients with atrial fibrillation: the 9th AFNET/EHRA consensus conference

Author

Linz, Dominik, primary, Andrade, Jason G, additional, Arbelo, Elena, additional, Boriani, Giuseppe, additional, Breithardt, Guenter, additional, Camm, A John, additional, Caso, Valeria, additional, Nielsen, Jens Cosedis, additional, De Melis, Mirko, additional, De Potter, Tom, additional, Dichtl, Wolfgang, additional, Diederichsen, Søren Zoega, additional, Dobrev, Dobromir, additional, Doll, Nicolas, additional, Duncker, David, additional, Dworatzek, Elke, additional, Eckardt, Lars, additional, Eisert, Christoph, additional, Fabritz, Larissa, additional, Farkowski, Michal, additional, Filgueiras-Rama, David, additional, Goette, Andreas, additional, Guasch, Eduard, additional, Hack, Guido, additional, Hatem, Stéphane, additional, Haeusler, Karl Georg, additional, Healey, Jeff S, additional, Heidbuechel, Hein, additional, Hijazi, Ziad, additional, Hofmeister, Lucas H, additional, Hove-Madsen, Leif, additional, Huebner, Thomas, additional, Kääb, Stefan, additional, Kotecha, Dipak, additional, Malaczynska-Rajpold, Katarzyna, additional, Merino, José Luis, additional, Metzner, Andreas, additional, Mont, Lluís, additional, Ng, Ghulam Andre, additional, Oeff, Michael, additional, Parwani, Abdul Shokor, additional, Puererfellner, Helmut, additional, Ravens, Ursula, additional, Rienstra, Michiel, additional, Sanders, Prashanthan, additional, Scherr, Daniel, additional, Schnabel, Renate, additional, Schotten, Ulrich, additional, Sohns, Christian, additional, Steinbeck, Gerhard, additional, Steven, Daniel, additional, Toennis, Tobias, additional, Tzeis, Stylianos, additional, van Gelder, Isabelle C, additional, van Leerdam, Roderick H, additional, Vernooy, Kevin, additional, Wadhwa, Manish, additional, Wakili, Reza, additional, Willems, Stephan, additional, Witt, Henning, additional, Zeemering, Stef, additional, and Kirchhof, Paulus, additional

Published
2024
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30. Practical Guide on Left Atrial Appendage Closure for the Non-implanting Physician. An International Consensus Paper

Author

Potpara, Tatjana, primary, Grygier, Marek, additional, Haeusler, Karl Georg, additional, Nielsen-Kudsk, Jens Erik, additional, Berti, Sergio, additional, Genovesi, Simonetta, additional, Marijon, Eloi, additional, Boveda, Serge, additional, Tzikas, Apostolos, additional, Boriani, Giuseppe, additional, Boersma, Lucas V A, additional, Tondo, Claudio, additional, De Potter, Tom, additional, Lip, Gregory Y H, additional, Schnabel, Renate B, additional, Bauersachs, Rupert, additional, Senzolo, Marco, additional, Basile, Carlo, additional, Bianchi, Stefano, additional, Osmancik, Pavel, additional, Schmidt, Boris, additional, Landmesser, Ulf, additional, Doehner, Wolfram, additional, Hindricks, Gerhard, additional, Kovac, Jan, additional, and Camm, A John, additional

Published
2024
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32. First Randomized, Multicenter, Placebo-Controlled Study of Self-Administered Intranasal Etripamil for Acute Conversion of Spontaneous Paroxysmal Supraventricular Tachycardia (NODE-301)

Author

Stambler, Bruce S., Plat, Francis, Sager, Philip T., Shardonofsky, Silvia, Wight, Douglas, Potvin, Diane, Pandey, A. Shekhar, Ip, James E., Coutu, Benoit, Mondésert, Blandine, Sterns, Laurence D., Bennett, Matthew, Anderson, Jeffrey L., Damle, Roger, Haberman, Ronald, and Camm, A. John

Published
2022
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35. Consumer wearable devices for evaluation of heart rate control using digoxin versus beta-blockers: the RATE-AF randomized trial

Author

Gill, Simrat K., Barsky, Andrey, Guan, Xin, Bunting, Karina V., Karwath, Andreas, Tica, Otilia, Stanbury, Mary, Haynes, Sandra, Folarin, Amos, Dobson, Richard, Kurps, Julia, Asselbergs, Folkert W., Grobbee, Diederick E., Camm, A. John, Eijkemans, Marinus J. C., Gkoutos, Georgios V., and Kotecha, Dipak

Abstract

Consumer-grade wearable technology has the potential to support clinical research and patient management. Here, we report results from the RATE-AF trial wearables study, which was designed to compare heart rate in older, multimorbid patients with permanent atrial fibrillation and heart failure who were randomized to treatment with either digoxin or beta-blockers. Heart rate (n= 143,379,796) and physical activity (n= 23,704,307) intervals were obtained from 53 participants (mean age 75.6 years (s.d. 8.4), 40% women) using a wrist-worn wearable linked to a smartphone for 20 weeks. Heart rates in participants treated with digoxin versus beta-blockers were not significantly different (regression coefficient 1.22 (95% confidence interval (CI) −2.82 to 5.27; P= 0.55); adjusted 0.66 (95% CI −3.45 to 4.77; P= 0.75)). No difference in heart rate was observed between the two groups of patients after accounting for physical activity (P= 0.74) or patients with high activity levels (≥30,000 steps per week; P= 0.97). Using a convolutional neural network designed to account for missing data, we found that wearable device data could predict New York Heart Association functional class 5 months after baseline assessment similarly to standard clinical measures of electrocardiographic heart rate and 6-minute walk test (F1 score 0.56 (95% CI 0.41 to 0.70) versus 0.55 (95% CI 0.41 to 0.68); P= 0.88 for comparison). The results of this study indicate that digoxin and beta-blockers have equivalent effects on heart rate in atrial fibrillation at rest and on exertion, and suggest that dynamic monitoring of individuals with arrhythmia using wearable technology could be an alternative to in-person assessment. ClinicalTrials.gov identifier: NCT02391337.

Published
2024
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36. Safety and efficacy of long-term sodium channel blocker therapy for early rhythm control: the EAST-AFNET 4 trial.

Author

Rillig, Andreas, Eckardt, Lars, Borof, Katrin, Camm, A John, Crijns, Harry J G M, Goette, Andreas, Breithardt, Günter, Lemoine, Marc D, Metzner, Andreas, Rottner, Laura, Schotten, Ulrich, Vettorazzi, Eik, Wegscheider, Karl, Zapf, Antonia, Heidbuchel, Hein, Willems, Stephan, Fabritz, Larissa, Schnabel, Renate B, Magnussen, Christina, and Kirchhof, Paulus

Abstract

Aims Clinical concerns exist about the potential proarrhythmic effects of the sodium channel blockers (SCBs) flecainide and propafenone in patients with cardiovascular disease. Sodium channel blockers were used to deliver early rhythm control (ERC) therapy in EAST-AFNET 4. Methods and results We analysed the primary safety outcome (death, stroke, or serious adverse events related to rhythm control therapy) and primary efficacy outcome (cardiovascular death, stroke, and hospitalization for worsening of heart failure (HF) or acute coronary syndrome) during SCB intake for patients with ERC (n = 1395) in EAST-AFNET 4. The protocol discouraged flecainide and propafenone in patients with reduced left ventricular ejection fraction and suggested stopping therapy upon QRS prolongation >25% on therapy. Flecainide or propafenone was given to 689 patients [age 69 (8) years; CHA2DS2-VASc 3.2 (1); 177 with HF; 41 with prior myocardial infarction, coronary artery bypass graft, or percutaneous coronary intervention; 26 with left ventricular hypertrophy >15 mm; median therapy duration 1153 [237, 1828] days]. The primary efficacy outcome occurred less often in patients treated with SCB [3/100 (99/3316) patient-years] than in patients who never received SCB [SCBnever 4.9/100 (150/3083) patient-years, P < 0.001]. There were numerically fewer primary safety outcomes in patients receiving SCB [2.9/100 (96/3359) patient-years] than in SCBnever patients [4.2/100 (135/3220) patient-years, adjusted P = 0.015]. Sinus rhythm at 2 years was similar between groups [SCB 537/610 (88); SCBnever 472/579 (82)]. Conclusion Long-term therapy with flecainide or propafenone appeared to be safe in the EAST-AFNET 4 trial to deliver effective ERC therapy, including in selected patients with stable cardiovascular disease such as coronary artery disease and stable HF. Clinical Trial Registration ISRCTN04708680, NCT01288352, EudraCT2010-021258-20, www.easttrial.org [ABSTRACT FROM AUTHOR]

Published
2024
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37. Direct Oral Anticoagulants for Stroke Prevention in Patients with Device-Detected Atrial Fibrillation: A Study-Level Meta-Analysis of the NOAH-AFNET 6 and ARTESiA Trials

Author

McIntyre, William F., primary, Benz, Alexander P., additional, Becher, Nina, additional, Healey, Jeffrey S., additional, Granger, Christopher B., additional, Rivard, Lena, additional, Camm, A. John, additional, Goette, Andreas, additional, Zapf, Antonia, additional, Alings, Marco, additional, Connolly, Stuart J., additional, Kirchhof, Paulus, additional, and Lopes, Renato D., additional

Published
2023
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38. Apixaban for Stroke Prevention in Subclinical Atrial Fibrillation

Author

Healey, Jeff S., primary, Lopes, Renato D., additional, Granger, Christopher B., additional, Alings, Marco, additional, Rivard, Lena, additional, McIntyre, William F., additional, Atar, Dan, additional, Birnie, David H., additional, Boriani, Giuseppe, additional, Camm, A. John, additional, Conen, David, additional, Erath, Julia W., additional, Gold, Michael R., additional, Hohnloser, Stefan H., additional, Ip, John, additional, Kautzner, Josef, additional, Kutyifa, Valentina, additional, Linde, Cecilia, additional, Mabo, Philippe, additional, Mairesse, Georges, additional, Benezet Mazuecos, Juan, additional, Cosedis Nielsen, Jens, additional, Philippon, Francois, additional, Proietti, Marco, additional, Sticherling, Christian, additional, Wong, Jorge A., additional, Wright, David J., additional, Zarraga, Ignatius G., additional, Coutts, Shelagh B., additional, Kaplan, Andrew, additional, Pombo, Marta, additional, Ayala-Paredes, Felix, additional, Xu, Lizhen, additional, Simek, Kim, additional, Nevills, Sandra, additional, Mian, Rajibul, additional, and Connolly, Stuart J., additional

Published
2023
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39. Anticoagulation with edoxaban in patients with long Atrial High-Rate Episodes ≥24 hours

Author

Becher, Nina, primary, Toennis, Tobias, additional, Bertaglia, Emanuele, additional, Blomström-Lundqvist, Carina, additional, Brandes, Axel, additional, Cabanelas, Nuno, additional, Calvert, Melanie, additional, Camm, A John, additional, Chlouverakis, Gregory, additional, Dan, Gheorghe-Andrei, additional, Dichtl, Wolfgang, additional, Diener, Hans Christoph, additional, Fierenz, Alexander, additional, Goette, Andreas, additional, de Groot, Joris R, additional, Hermans, Astrid N L, additional, Lip, Gregory Y H, additional, Lubinski, Andrzej, additional, Marijon, Eloi, additional, Merkely, Béla, additional, Mont, Lluís, additional, Ozga, Ann-Kathrin, additional, Rajappan, Kim, additional, Sarkozy, Andrea, additional, Scherr, Daniel, additional, Schnabel, Renate B, additional, Schotten, Ulrich, additional, Sehner, Susanne, additional, Simantirakis, Emmanuel, additional, Vardas, Panos, additional, Velchev, Vasil, additional, Wichterle, Dan, additional, Zapf, Antonia, additional, and Kirchhof, Paulus, additional

Published
2023
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40. A Multicenter, Phase 2, Randomized, Controlled Study of the Efficacy and Safety of Etripamil Nasal Spray for the Acute Reduction of Rapid Ventricular Rate in Patients with Symptomatic Atrial Fibrillation (ReVeRA-201)

Author

Camm, A. John, primary, Piccini, Jonathan P., additional, Alings, Marco, additional, Dorian, Paul, additional, Gosselin, Gilbert, additional, Guertin, Marie-Claude, additional, Ip, James E., additional, Kowey, Peter R., additional, Mondésert, Blandine, additional, Prins, Fransisco J., additional, Roux, Jean-Francois, additional, Stambler, Bruce S., additional, van Eck, J.W. Martijn, additional, Al Windy, Nadea, additional, Thermil, Nathalie, additional, Shardonofsky, Silvia, additional, Bharucha, David B., additional, and Roy, Denis, additional

Published
2023
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42. Clinical Outcomes in Older Patients with Atrial Fibrillation: Insights from the GARFIELD-AF Registry

Author

Goldhaber, Samuel Z., primary, Bassand, Jean-Pierre, additional, Camm, A. John, additional, Virdone, Saverio, additional, Pieper, Karen, additional, Cools, Frank, additional, Corbalan, Ramon, additional, Gersh, Bernard J., additional, Goto, Shinya, additional, Haas, Sylvia, additional, Misselwitz, Frank, additional, Parkhomenko, Alexander, additional, Steffel, Jan, additional, Stepinska, Janina, additional, Turpie, Alexander G.G., additional, Verheugt, Freek W.A., additional, Kayani, Gloria, additional, and Kakkar, Ajay K., additional

Published
2023
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48. Anticoagulation with edoxaban in patients with long atrial high-rate episodes ≥24 h.

Author

Becher, Nina, Toennis, Tobias, Bertaglia, Emanuele, Blomström-Lundqvist, Carina, Brandes, Axel, Cabanelas, Nuno, Calvert, Melanie, Camm, A John, Chlouverakis, Gregory, Dan, Gheorghe-Andrei, Dichtl, Wolfgang, Diener, Hans Christoph, Fierenz, Alexander, Goette, Andreas, Groot, Joris R de, Hermans, Astrid N L, Lip, Gregory Y H, Lubinski, Andrzej, Marijon, Eloi, and Merkely, Béla

Subjects
DISEASE risk factors, EDOXABAN, ATRIAL fibrillation, ORAL medication, ANTICOAGULANTS, P-waves (Electrocardiography)
Abstract

Background and Aims Patients with long atrial high-rate episodes (AHREs) ≥24 h and stroke risk factors are often treated with anticoagulation for stroke prevention. Anticoagulation has never been compared with no anticoagulation in these patients. Methods This secondary pre-specified analysis of the Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High-rate episodes (NOAH-AFNET 6) trial examined interactions between AHRE duration at baseline and anticoagulation with edoxaban compared with placebo in patients with AHRE and stroke risk factors. The primary efficacy outcome was a composite of stroke, systemic embolism, or cardiovascular death. The safety outcome was a composite of major bleeding and death. Key secondary outcomes were components of these outcomes and electrocardiogram (ECG)-diagnosed atrial fibrillation. Results Median follow-up of 2389 patients with core lab-verified AHRE was 1.8 years. AHRE ≥24 h were present at baseline in 259/2389 patients (11%, 78 ± 7 years old, 28% women, CHA2DS2-VASc 4). Clinical characteristics were not different from patients with shorter AHRE. The primary outcome occurred in 9/132 patients with AHRE ≥24 h (4.3%/patient-year, 2 strokes) treated with anticoagulation and in 14/127 patients treated with placebo (6.9%/patient-year, 2 strokes). Atrial high-rate episode duration did not interact with the efficacy (P -interaction =.65) or safety (P -interaction =.98) of anticoagulation. Analyses including AHRE as a continuous parameter confirmed this. Patients with AHRE ≥24 h developed more ECG-diagnosed atrial fibrillation (17.0%/patient-year) than patients with shorter AHRE (8.2%/patient-year; P <.001). Conclusions This hypothesis-generating analysis does not find an interaction between AHRE duration and anticoagulation therapy in patients with device-detected AHRE and stroke risk factors. Further research is needed to identify patients with long AHRE at high stroke risk. [ABSTRACT FROM AUTHOR]

Published
2024
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49. Anticoagulation with Edoxaban in Patients with Atrial High-Rate Episodes

Author

Kirchhof, Paulus, primary, Toennis, Tobias, additional, Goette, Andreas, additional, Camm, A. John, additional, Diener, Hans Christoph, additional, Becher, Nina, additional, Bertaglia, Emanuele, additional, Blomstrom Lundqvist, Carina, additional, Borlich, Martin, additional, Brandes, Axel, additional, Cabanelas, Nuno, additional, Calvert, Melanie, additional, Chlouverakis, Gregory, additional, Dan, Gheorghe-Andrei, additional, de Groot, Joris R., additional, Dichtl, Wolfgang, additional, Kravchuk, Borys, additional, Lubiński, Andrzej, additional, Marijon, Eloi, additional, Merkely, Béla, additional, Mont, Lluís, additional, Ozga, Ann-Kathrin, additional, Rajappan, Kim, additional, Sarkozy, Andrea, additional, Scherr, Daniel, additional, Sznajder, Rafał, additional, Velchev, Vasil, additional, Wichterle, Dan, additional, Sehner, Susanne, additional, Simantirakis, Emmanuel, additional, Lip, Gregory Y.H., additional, Vardas, Panos, additional, Schotten, Ulrich, additional, and Zapf, Antonia, additional

Published
2023
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50. Etripamil Nasal Spray for Conversion of Repeated Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia During Long‐Term Follow‐Up: Results From the NODE‐302 Study

Author

Ip, James E., primary, Coutu, Benoit, additional, Bennett, Matthew T., additional, Pandey, A. Shekhar, additional, Stambler, Bruce S., additional, Sager, Philip, additional, Chen, Michael, additional, Shardonofsky, Silvia, additional, Plat, Francis, additional, and Camm, A. John, additional

Published
2023
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