Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study
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EKANEM, Emmanuel, Petr NEUZIL, Tobias REICHLIN, Joseph KAUTZNER, van der Voort PEPIJN, Pierre JAIS, Gian-Battista CHIERCHIA, Alan BULAVA, Yuri BLAAUW, Tomas SKALA (203 Česká republika), Martin FIALA (203 Česká republika, domácí), Mattias DUYTSCHAEVER, Gabor SZEPLAKI, Boris SCHMIDT, Gregoire MASSOULLIE, Kars NEVEN, Thomas OLIVIER, Johan VIJGEN, Estelle GANDJBAKHCH, Daniel SCHERR, Arne JOHANNESSEN, David KEANE, Serge BOVEDA, Philippe MAURY, Ignacio GARCIA-BOLAO, Ante ANIC, Peter Steen HANSEN, Franck RACZKA, Antoine LEPILLIER, Yves GUYOMAR, Dhiraj GUPTA, Van Opstal JURREN, Pascal DEFAYE, Christian STICHERLING, Philipp SOMMER, Pavel KUCERA (203 Česká republika), Joaquin OSCA, Fariborz TABRIZI, Antoine ROUX, Michael GRAMLICH, Stefano BIANCHI, Pedro ADRAGAO, Francesco SOLIMENE, Claudio TONDO, Antonio Dello RUSSO, Juergen SCHREIECK, Armin LUIK, Obaida RANA, Gerrit FROMMEYER, Frederic ANSELME, Ingo KREIS, Raphael ROSSO, Andreas METZNER, Laszlo GELLER, Samuel H BALDINGER, Angel FERRERO, Stephan WILLEMS, Andreas GOETTE, Greg MELLOR, Shibu MATHEW, Lukasz SZUMOWSKI, Roland TILZ, Saverio IACOPINO, Peter Karl JACOBSEN, Andrikopoulos GEORGE, Pavel OSMANCIK, Stefan SPITZER, Richard BALASUBRAMANIAM, Abdul Shokor PARWANI, Thomas DENEKE, Andrzej GLOWNIAK, Antonio ROSSILLO, Helmut PUERERFELLNER, David DUNCKER, Peter REIL, Thomas ARENTZ, Daniel STEVEN, Juan Jose OLALLA, Jonas S S G DE JONG, Reza WAKILI, Selim ABBEY, Gottschling TIMO, Antonio ASSO, Tom WONG, Bertrand PIERRE, Niels Christian EWERTSEN, Leonard BERGAU, Cristina LOZANO-GRANERO, Maximo RIVERO, Alexander BREITENSTEIN, Jaakko INKOVAARA, Samir FAREH, Decebal Gabriel LATCU, Dominik LINZ, Patrick MUELLER, Javier RAMOS-MAQUEDA, Thomas BEIERT, Sakis THEMISTOCLAKIS, Dirk Grosse MEININGHAUS, Guenter STIX, Stylianos TZEIS, Jakub BARAN, Henrik ALMROTH, Daniel Rodriguez MUNOZ, de Sousa JOAO, Michalis EFREMIDIS, Pawel BALSAM, Jan PETRU (203 Česká republika), Thomas KUEFFER, Petr PEICHL (203 Česká republika), Lukas DEKKER, Domenico G DELLA ROCCA, Ondrej MORAVEC (203 Česká republika), Moritoshi FUNASAKO, Sebastien KNECHT, Gael JAUVERT, Julian CHUN, Romain ESCHALIER, Anna FUETING, Alexandre ZHAO, Pieter KOOPMAN, Mikael LAREDO, Martin MANNINGER, Jim HANSEN, Daniel HARE, Anne ROLLIN, Zrinka JURISIC, Thomas FINK, Corentin CHAUMONT, Andreas RILLIG, Melanie GUNAWERDENE, Claire MARTIN, Bettina KIRSTEIN, Karin NENTWICH, Heiko LEHRMANN, Arian SULTAN, Jan BOHNEN, Mohit K TURAGAM a Vivek Y REDDY
Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for similar to 1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.
EKANEM, Emmanuel, Petr NEUZIL, Tobias REICHLIN, Joseph KAUTZNER, van der Voort PEPIJN, Pierre JAIS, Gian-Battista CHIERCHIA, Alan BULAVA, Yuri BLAAUW, Tomas SKALA, Martin FIALA, Mattias DUYTSCHAEVER, Gabor SZEPLAKI, Boris SCHMIDT, Gregoire MASSOULLIE, Kars NEVEN, Thomas OLIVIER, Johan VIJGEN, Estelle GANDJBAKHCH, Daniel SCHERR, Arne JOHANNESSEN, David KEANE, Serge BOVEDA, Philippe MAURY, Ignacio GARCIA-BOLAO, Ante ANIC, Peter Steen HANSEN, Franck RACZKA, Antoine LEPILLIER, Yves GUYOMAR, Dhiraj GUPTA, Van Opstal JURREN, Pascal DEFAYE, Christian STICHERLING, Philipp SOMMER, Pavel KUCERA, Joaquin OSCA, Fariborz TABRIZI, Antoine ROUX, Michael GRAMLICH, Stefano BIANCHI, Pedro ADRAGAO, Francesco SOLIMENE, Claudio TONDO, Antonio Dello RUSSO, Juergen SCHREIECK, Armin LUIK, Obaida RANA, Gerrit FROMMEYER, Frederic ANSELME, Ingo KREIS, Raphael ROSSO, Andreas METZNER, Laszlo GELLER, Samuel H BALDINGER, Angel FERRERO, Stephan WILLEMS, Andreas GOETTE, Greg MELLOR, Shibu MATHEW, Lukasz SZUMOWSKI, Roland TILZ, Saverio IACOPINO, Peter Karl JACOBSEN, Andrikopoulos GEORGE, Pavel OSMANCIK, Stefan SPITZER, Richard BALASUBRAMANIAM, Abdul Shokor PARWANI, Thomas DENEKE, Andrzej GLOWNIAK, Antonio ROSSILLO, Helmut PUERERFELLNER, David DUNCKER, Peter REIL, Thomas ARENTZ, Daniel STEVEN, Juan Jose OLALLA, Jonas S S G DE JONG, Reza WAKILI, Selim ABBEY, Gottschling TIMO, Antonio ASSO, Tom WONG, Bertrand PIERRE, Niels Christian EWERTSEN, Leonard BERGAU, Cristina LOZANO-GRANERO, Maximo RIVERO, Alexander BREITENSTEIN, Jaakko INKOVAARA, Samir FAREH, Decebal Gabriel LATCU, Dominik LINZ, Patrick MUELLER, Javier RAMOS-MAQUEDA, Thomas BEIERT, Sakis THEMISTOCLAKIS, Dirk Grosse MEININGHAUS, Guenter STIX, Stylianos TZEIS, Jakub BARAN, Henrik ALMROTH, Daniel Rodriguez MUNOZ, de Sousa JOAO, Michalis EFREMIDIS, Pawel BALSAM, Jan PETRU, Thomas KUEFFER, Petr PEICHL, Lukas DEKKER, Domenico G DELLA ROCCA, Ondrej MORAVEC, Moritoshi FUNASAKO, Sebastien KNECHT, Gael JAUVERT, Julian CHUN, Romain ESCHALIER, Anna FUETING, Alexandre ZHAO, Pieter KOOPMAN, Mikael LAREDO, Martin MANNINGER, Jim HANSEN, Daniel HARE, Anne ROLLIN, Zrinka JURISIC, Thomas FINK, Corentin CHAUMONT, Andreas RILLIG, Melanie GUNAWERDENE, Claire MARTIN, Bettina KIRSTEIN, Karin NENTWICH, Heiko LEHRMANN, Arian SULTAN, Jan BOHNEN, Mohit K TURAGAM a Vivek Y REDDY. Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study. Nature Medicine. BERLIN: Nature Research, 2024, roč. 30, č. 7, s. "2020"-"2029", 24 s. ISSN 1078-8956. Dostupné z: https://dx.doi.org/10.1038/s41591-024-03114-3.
@article{2421681, author = {Ekanem, Emmanuel and Neuzil, Petr and Reichlin, Tobias and Kautzner, Joseph and Pepijn, van der Voort and Jais, Pierre and Chierchia, GianandBattista and Bulava, Alan and Blaauw, Yuri and Skala, Tomas and Fiala, Martin and Duytschaever, Mattias and Szeplaki, Gabor and Schmidt, Boris and Massoullie, Gregoire and Neven, Kars and Olivier, Thomas and Vijgen, Johan and Gandjbakhch, Estelle and Scherr, Daniel and Johannessen, Arne and Keane, David and Boveda, Serge and Maury, Philippe and GarciaandBolao, Ignacio and Anic, Ante and Hansen, Peter Steen and Raczka, Franck and Lepillier, Antoine and Guyomar, Yves and Gupta, Dhiraj and Jurren, Van Opstal and Defaye, Pascal and Sticherling, Christian and Sommer, Philipp and Kucera, Pavel and Osca, Joaquin and Tabrizi, Fariborz and Roux, Antoine and Gramlich, Michael and Bianchi, Stefano and Adragao, Pedro and Solimene, Francesco and Tondo, Claudio and Russo, Antonio Dello and Schreieck, Juergen and Luik, Armin and Rana, Obaida and Frommeyer, Gerrit and Anselme, Frederic and Kreis, Ingo and Rosso, Raphael and Metzner, Andreas and Geller, Laszlo and Baldinger, Samuel H and Ferrero, Angel and Willems, Stephan and Goette, Andreas and Mellor, Greg and Mathew, Shibu and Szumowski, Lukasz and Tilz, Roland and Iacopino, Saverio and Jacobsen, Peter Karl and George, Andrikopoulos and Osmancik, Pavel and Spitzer, Stefan and Balasubramaniam, Richard and Parwani, Abdul Shokor and Deneke, Thomas and Glowniak, Andrzej and Rossillo, Antonio and Puererfellner, Helmut and Duncker, David and Reil, Peter and Arentz, Thomas and Steven, Daniel and Olalla, Juan Jose and de Jong, Jonas S S G and Wakili, Reza and Abbey, Selim and Timo, Gottschling and Asso, Antonio and Wong, Tom and Pierre, Bertrand and Ewertsen, Niels Christian and Bergau, Leonard and LozanoandGranero, Cristina and Rivero, Maximo and Breitenstein, Alexander and Inkovaara, Jaakko and Fareh, Samir and Latcu, Decebal Gabriel and Linz, Dominik and Mueller, Patrick and RamosandMaqueda, Javier and Beiert, Thomas and Themistoclakis, Sakis and Meininghaus, Dirk Grosse and Stix, Guenter and Tzeis, Stylianos and Baran, Jakub and Almroth, Henrik and Munoz, Daniel Rodriguez and Joao, de Sousa and Efremidis, Michalis and Balsam, Pawel and Petru, Jan and Kueffer, Thomas and Peichl, Petr and Dekker, Lukas and Della Rocca, Domenico G and Moravec, Ondrej and Funasako, Moritoshi and Knecht, Sebastien and Jauvert, Gael and Chun, Julian and Eschalier, Romain and Fueting, Anna and Zhao, Alexandre and Koopman, Pieter and Laredo, Mikael and Manninger, Martin and Hansen, Jim and Hare, Daniel and Rollin, Anne and Jurisic, Zrinka and Fink, Thomas and Chaumont, Corentin and Rillig, Andreas and Gunawerdene, Melanie and Martin, Claire and Kirstein, Bettina and Nentwich, Karin and Lehrmann, Heiko and Sultan, Arian and Bohnen, Jan and Turagam, Mohit K and Reddy, Vivek Y}, article_location = {BERLIN}, article_number = {7}, doi = {http://dx.doi.org/10.1038/s41591-024-03114-3}, keywords = {atrial fibrillation; pulsed field ablation}, language = {eng}, issn = {1078-8956}, journal = {Nature Medicine}, title = {Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study}, url = {https://www.nature.com/articles/s41591-024-03114-3}, volume = {30}, year = {2024} }
TY - JOUR ID - 2421681 AU - Ekanem, Emmanuel - Neuzil, Petr - Reichlin, Tobias - Kautzner, Joseph - Pepijn, van der Voort - Jais, Pierre - Chierchia, Gian-Battista - Bulava, Alan - Blaauw, Yuri - Skala, Tomas - Fiala, Martin - Duytschaever, Mattias - Szeplaki, Gabor - Schmidt, Boris - Massoullie, Gregoire - Neven, Kars - Olivier, Thomas - Vijgen, Johan - Gandjbakhch, Estelle - Scherr, Daniel - Johannessen, Arne - Keane, David - Boveda, Serge - Maury, Philippe - Garcia-Bolao, Ignacio - Anic, Ante - Hansen, Peter Steen - Raczka, Franck - Lepillier, Antoine - Guyomar, Yves - Gupta, Dhiraj - Jurren, Van Opstal - Defaye, Pascal - Sticherling, Christian - Sommer, Philipp - Kucera, Pavel - Osca, Joaquin - Tabrizi, Fariborz - Roux, Antoine - Gramlich, Michael - Bianchi, Stefano - Adragao, Pedro - Solimene, Francesco - Tondo, Claudio - Russo, Antonio Dello - Schreieck, Juergen - Luik, Armin - Rana, Obaida - Frommeyer, Gerrit - Anselme, Frederic - Kreis, Ingo - Rosso, Raphael - Metzner, Andreas - Geller, Laszlo - Baldinger, Samuel H - Ferrero, Angel - Willems, Stephan - Goette, Andreas - Mellor, Greg - Mathew, Shibu - Szumowski, Lukasz - Tilz, Roland - Iacopino, Saverio - Jacobsen, Peter Karl - George, Andrikopoulos - Osmancik, Pavel - Spitzer, Stefan - Balasubramaniam, Richard - Parwani, Abdul Shokor - Deneke, Thomas - Glowniak, Andrzej - Rossillo, Antonio - Puererfellner, Helmut - Duncker, David - Reil, Peter - Arentz, Thomas - Steven, Daniel - Olalla, Juan Jose - de Jong, Jonas S S G - Wakili, Reza - Abbey, Selim - Timo, Gottschling - Asso, Antonio - Wong, Tom - Pierre, Bertrand - Ewertsen, Niels Christian - Bergau, Leonard - Lozano-Granero, Cristina - Rivero, Maximo - Breitenstein, Alexander - Inkovaara, Jaakko - Fareh, Samir - Latcu, Decebal Gabriel - Linz, Dominik - Mueller, Patrick - Ramos-Maqueda, Javier - Beiert, Thomas - Themistoclakis, Sakis - Meininghaus, Dirk Grosse - Stix, Guenter - Tzeis, Stylianos - Baran, Jakub - Almroth, Henrik - Munoz, Daniel Rodriguez - Joao, de Sousa - Efremidis, Michalis - Balsam, Pawel - Petru, Jan - Kueffer, Thomas - Peichl, Petr - Dekker, Lukas - Della Rocca, Domenico G - Moravec, Ondrej - Funasako, Moritoshi - Knecht, Sebastien - Jauvert, Gael - Chun, Julian - Eschalier, Romain - Fueting, Anna - Zhao, Alexandre - Koopman, Pieter - Laredo, Mikael - Manninger, Martin - Hansen, Jim - Hare, Daniel - Rollin, Anne - Jurisic, Zrinka - Fink, Thomas - Chaumont, Corentin - Rillig, Andreas - Gunawerdene, Melanie - Martin, Claire - Kirstein, Bettina - Nentwich, Karin - Lehrmann, Heiko - Sultan, Arian - Bohnen, Jan - Turagam, Mohit K - Reddy, Vivek Y PY - 2024 TI - Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study JF - Nature Medicine VL - 30 IS - 7 SP - "2020"-"2029" EP - "2020"-"2029" PB - Nature Research SN - 10788956 KW - atrial fibrillation KW - pulsed field ablation UR - https://www.nature.com/articles/s41591-024-03114-3 N2 - Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for similar to 1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF. ER -
EKANEM, Emmanuel, Petr NEUZIL, Tobias REICHLIN, Joseph KAUTZNER, van der Voort PEPIJN, Pierre JAIS, Gian-Battista CHIERCHIA, Alan BULAVA, Yuri BLAAUW, Tomas SKALA, Martin FIALA, Mattias DUYTSCHAEVER, Gabor SZEPLAKI, Boris SCHMIDT, Gregoire MASSOULLIE, Kars NEVEN, Thomas OLIVIER, Johan VIJGEN, Estelle GANDJBAKHCH, Daniel SCHERR, Arne JOHANNESSEN, David KEANE, Serge BOVEDA, Philippe MAURY, Ignacio GARCIA-BOLAO, Ante ANIC, Peter Steen HANSEN, Franck RACZKA, Antoine LEPILLIER, Yves GUYOMAR, Dhiraj GUPTA, Van Opstal JURREN, Pascal DEFAYE, Christian STICHERLING, Philipp SOMMER, Pavel KUCERA, Joaquin OSCA, Fariborz TABRIZI, Antoine ROUX, Michael GRAMLICH, Stefano BIANCHI, Pedro ADRAGAO, Francesco SOLIMENE, Claudio TONDO, Antonio Dello RUSSO, Juergen SCHREIECK, Armin LUIK, Obaida RANA, Gerrit FROMMEYER, Frederic ANSELME, Ingo KREIS, Raphael ROSSO, Andreas METZNER, Laszlo GELLER, Samuel H BALDINGER, Angel FERRERO, Stephan WILLEMS, Andreas GOETTE, Greg MELLOR, Shibu MATHEW, Lukasz SZUMOWSKI, Roland TILZ, Saverio IACOPINO, Peter Karl JACOBSEN, Andrikopoulos GEORGE, Pavel OSMANCIK, Stefan SPITZER, Richard BALASUBRAMANIAM, Abdul Shokor PARWANI, Thomas DENEKE, Andrzej GLOWNIAK, Antonio ROSSILLO, Helmut PUERERFELLNER, David DUNCKER, Peter REIL, Thomas ARENTZ, Daniel STEVEN, Juan Jose OLALLA, Jonas S S G DE JONG, Reza WAKILI, Selim ABBEY, Gottschling TIMO, Antonio ASSO, Tom WONG, Bertrand PIERRE, Niels Christian EWERTSEN, Leonard BERGAU, Cristina LOZANO-GRANERO, Maximo RIVERO, Alexander BREITENSTEIN, Jaakko INKOVAARA, Samir FAREH, Decebal Gabriel LATCU, Dominik LINZ, Patrick MUELLER, Javier RAMOS-MAQUEDA, Thomas BEIERT, Sakis THEMISTOCLAKIS, Dirk Grosse MEININGHAUS, Guenter STIX, Stylianos TZEIS, Jakub BARAN, Henrik ALMROTH, Daniel Rodriguez MUNOZ, de Sousa JOAO, Michalis EFREMIDIS, Pawel BALSAM, Jan PETRU, Thomas KUEFFER, Petr PEICHL, Lukas DEKKER, Domenico G DELLA ROCCA, Ondrej MORAVEC, Moritoshi FUNASAKO, Sebastien KNECHT, Gael JAUVERT, Julian CHUN, Romain ESCHALIER, Anna FUETING, Alexandre ZHAO, Pieter KOOPMAN, Mikael LAREDO, Martin MANNINGER, Jim HANSEN, Daniel HARE, Anne ROLLIN, Zrinka JURISIC, Thomas FINK, Corentin CHAUMONT, Andreas RILLIG, Melanie GUNAWERDENE, Claire MARTIN, Bettina KIRSTEIN, Karin NENTWICH, Heiko LEHRMANN, Arian SULTAN, Jan BOHNEN, Mohit K TURAGAM a Vivek Y REDDY. Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study. \textit{Nature Medicine}. BERLIN: Nature Research, 2024, roč.~30, č.~7, s.~''2020''-''2029'', 24 s. ISSN~1078-8956. Dostupné z: https://dx.doi.org/10.1038/s41591-024-03114-3.