Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry

被引：185

作者：

Turagam, Mohit K. ^{[1
]}

Neuzil, Petr ^{[2
]}

Schmidt, Boris ^{[3
]}

Reichlin, Tobias ^{[4
]}

Neven, Kars ^{[5
,6
]}

Metzner, Andreas ^{[7
]}

Hansen, Jim ^{[8
]}

Blaauw, Yuri ^{[9
]}

Maury, Philippe ^{[10
,11
]}

Arentz, Thomas ^{[12
,13
]}

Sommer, Philipp ^{[14
]}

Anic, Ante ^{[15
]}

Anselme, Frederic ^{[16
]}

Boveda, Serge ^{[17
,18
]}

Deneke, Tom ^{[19
]}

Willems, Stephan ^{[20
]}

van der Voort, Pepijn ^{[21
]}

Tilz, Roland ^{[22
,23
]}

Funasako, Moritoshi ^{[2
,24
]}

Scherr, Daniel ^{[25
]}

Wakili, Reza ^{[26
]}

Steven, Daniel ^{[27
]}

Kautzner, Josef ^{[28
]}

Vijgen, Johan ^{[29
]}

Jais, Pierre ^{[30
]}

Petru, Jan ^{[2
]}

Chun, Julian ^{[3
]}

Roten, Laurent ^{[4
]}

Fueting, Anna ^{[5
,6
]}

Lemoine, Marc D. ^{[7
]}

Ruwald, Martin ^{[8
]}

Mulder, Bart A. ^{[9
]}

Rollin, Anne ^{[10
]}

Lehrmann, Heiko ^{[12
,13
]}

Fink, Thomas ^{[14
]}

Jurisic, Zrinka ^{[15
]}

Chaumont, Corentin ^{[16
]}

Adelino, Raquel ^{[17
,18
]}

Nentwich, Karin ^{[19
]}

Gunawardene, Melanie ^{[20
]}

Ouss, Alexandre ^{[21
]}

Heeger, Christian-Hendrik ^{[22
,23
]}

Manninger, Martin ^{[25
]}

Bohnen, Jan-Eric ^{[26
]}

Sultan, Arian ^{[27
]}

Peichl, Petr ^{[28
]}

Koopman, Pieter ^{[29
]}

Derval, Nicolas ^{[30
]}

Kueffer, Thomas ^{[4
]}

Rahe, Gilbert ^{[5
,31
]}

机构：

[1] Icahn Sch Med Mt Sinai, New York, NY USA

[2] Na Homolce Hosp, Cardiol Dept, Prague, Czech Republic

[3] MVZ CCB Frankfurt & Main Taunus GbR, Frankfurt, Germany

[4] Univ Bern, Bern Univ Hosp, Inselspital, Bern, Switzerland

[5] Witten Herdecke Univ, Dept Med, Witten, Germany

[6] Alfried Krupp Hosp, Dept Electrophysiol, Essen, Germany

[7] Univ Med Ctr Hamburg Eppendorf, Univ Heart & Vasc Ctr, Hamburg, Germany

[8] Copenhagen Univ Hosp, Copenhagen, Denmark

[9] Univ Groningen, Univ Med Ctr Groningen, Dept Cardiol, Groningen, Netherlands

[10] Univ Hosp Rangueil, Dept Cardiol, Toulouse, France

[11] INSERM, I2MC, UMR 1297, Toulouse, France

[12] Univ Freiburg, Med Ctr, Dept Cardiol & Angiol, Freiburg, Germany

[13] Univ Freiburg, Fac Med, Freiburg, Germany

[14] Ruhr Univ Bochum, Clin Electrophysiol Herz & Diabeteszentrum NRW, Bad Oeynhausen, Germany

[15] Univ Hosp Ctr Split, Dept Cardiovasc Dis, Split, Croatia

[16] Rouen Hosp, Dept Cardiol, Rouen, France

[17] Clin Pasteur, Heart Rhythm Dept, Toulouse, France

[18] Univ Ziekenhuis VUB, Brussels, Belgium

[19] Rhoen Clin Campus Bad Neustadt, Heart Ctr Bad Neustadt, Bad Neustadt An Der Saal, Germany

[20] Asklepios Hosp St Georg, Hamburg, Germany

[21] Catharina Ziekenhuis Eindhoven, Dept Cardiol, Eindhoven, Netherlands

[22] Univ Hosp Schleswig Holstein, Univ Heart Ctr Lubeck, Dept Rhythmol, Lubeck, Germany

[23] German Ctr Cardiovasc Res DZHK, Partner Site Hamburg Kiel Lubeck, Hamburg, Germany

[24] Neuron Med, Brno, Czech Republic

[25] Med Univ Graz, Graz, Austria

[26] Univ Duisburg Essen, West German Heart & Vasc Ctr Essen, Dept Cardiol & Vasc Med, Duisburg, Germany

[27] Univ Hosp Cologne, Dept Electrophysiol, Heart Ctr, Cologne, Germany

[28] IKEM Inst Clin & Expt Med, Prague, Czech Republic

[29] Jessa Hosp, Dept Cardiol, Hasselt, Belgium

[30] Univ Bordeaux, IHU LIRYC, CHU Bordeaux, Bordeaux, France

[31] Alfried Krupp Hosp, Dept Pulmonol Gastroenterol & Internal Med, Essen, Germany

来源：

CIRCULATION | 2023年 / 148卷 / 01期

关键词：

atrial fibrillation; catheter ablation; irreversible electroporation therapy; treatment outcome; EXPERT CONSENSUS STATEMENT; PULMONARY VEIN ISOLATION; SURGICAL ABLATION; END-POINTS; ELECTROPORATION; CATHETER; RECOMMENDATIONS; SPASM;

D O I：

10.1161/CIRCULATIONAHA.123.064959

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background:Pulsed field ablation is a novel nonthermal cardiac ablation modality using ultra-rapid electrical pulses to cause cell death by a mechanism of irreversible electroporation. Unlike the traditional ablation energy sources, pulsed field ablation has demonstrated significant preferentiality to myocardial tissue ablation, and thus avoids certain thermally mediated complications. However, its safety and effectiveness remain unknown in usual clinical care. Methods:MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a retrospective, multinational, patient-level registry wherein patients at each center were prospectively included in their respective center registries. The registry included all patients undergoing postapproval treatment with a multielectrode 5-spline pulsed field ablation catheter to treat atrial fibrillation (AF) between March 1, 2021, and May 30, 2022. The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of & GE;30 seconds on the basis of electrocardiographic data after a 3-month blanking period (on or off antiarrhythmic drugs). Safety outcomes included the composite of acute (<7 days postprocedure) and latent (>7 days) major adverse events. Results:At 24 European centers (77 operators) pulsed field ablation was performed in 1568 patients with AF: age 64.5 & PLUSMN;11.5 years, female 35%, paroxysmal/persistent AF 65%/32%, CHA(2)DS(2)-VASc 2.2 & PLUSMN;1.6, median left ventricular ejection fraction 60%, and left atrial diameter 42 mm. Pulmonary vein isolation was achieved in 99.2% of patients. After a median (interquartile range) follow-up of 367 (289-421) days, the 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was 78.1% (95% CI, 76.0%-80.0%); clinical effectiveness was more common in patients with paroxysmal AF versus persistent AF (81.6% versus 71.5%; P=0.001). Acute major adverse events occurred in 1.9% of patients. Conclusions:In this large observational registry of the postapproval clinical use of pulsed field technology to treat AF, catheter ablation using pulsed field energy was clinically effective in 78% of patients with AF.

引用

页码：35 / 46

页数：12

共 32 条

[1] HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: Recommendations for personnel, policy, procedures and follow-up [J].

Calkins, Hugh ;

Brugada, Josep ;

Packer, Douglas L. ;

Cappato, Riccardo ;

Chen, Shih-Ann ;

Crijns, Harry J. G. ;

Damiano, Ralph J., Jr. ;

Davies, D. Wyn ;

Haines, David E. ;

Haissaguerre, Michel ;

Lesaka, Yoshito ;

Jackman, Warren ;

Jais, Pierre ;

Kottkamp, Hans ;

Kuck, Karl Heinz ;

Lindsay, Bruce D. ;

Marchlinski, Francis E. ;

McCarthy, Patrick M. ;

Mont, J. Lluis ;

Morady, Fred ;

Nademanee, Koonlawee ;

Natale, Andrea ;

Pappone, Carlo ;

Prystowsky, Eric ;

Raviele, Antonio ;

Ruskin, Jeremy N. ;

Shemin, Richard J. .

EUROPACE, 2007, 9 (06) :335-379

[2]

Calkins H, 2017, HEART RHYTHM, V14, pE445, DOI [10.1093/europace/eux275, 10.1016/j.hrthm.2017.07.009, 10.1016/j.hrthm.2017.05.012]

[3]

Calkins H, 2012, HEART RHYTHM, V9, P632, DOI 10.1016/j.hrthm.2011.12.016

[4] Pulsed field ablation selectively spares the oesophagus during pulmonary vein isolation for atrial fibrillation [J].

Cochet, Hubert ;

Nakatani, Yosuke ;

Sridi-Cheniti, Soumaya ;

Cheniti, Ghassen ;

Ramirez, F. Daniel ;

Nakashima, Takashi ;

Eggert, Charles ;

Schneider, Christopher ;

Viswanathan, Raju ;

Derval, Nicolas ;

Duchateau, Josselin ;

Pambrun, Thomas ;

Chauvel, Remi ;

Reddy, Vivek Y. ;

Montaudon, Michel ;

Laurent, Francois ;

Sacher, Frederic ;

Hocini, Meleze ;

Haissaguerre, Michel ;

Jais, Pierre .

EUROPACE, 2021, 23 (09) :1391-1399

[5] Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study [J].

Duytschaever, Mattias ;

De Potter, Tom ;

Grimaldi, Massimo ;

Anic, Ante ;

Vijgen, Johan ;

Neuzil, Petr ;

Van Herendael, Hugo ;

Verma, Atul ;

Skanes, Allan ;

Scherr, Daniel ;

Puererfellner, Helmut ;

Rackauskas, Gediminas ;

Jais, Pierre ;

Reddy, Vivek Y. .

CIRCULATION-ARRHYTHMIA AND ELECTROPHYSIOLOGY, 2023, 16 (03) :E011780

[6] Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF) [J].

Ekanem, Emmanuel ;

Reddy, Vivek Y. ;

Schmidt, Boris ;

Reichlin, Tobias ;

Neven, Kars ;

Metzner, Andreas ;

Hansen, Jim ;

Blaauw, Yuri ;

Maury, Philippe ;

Arentz, Thomas ;

Sommer, Philipp ;

Anic, Ante ;

Anselme, Frederic ;

Boveda, Serge ;

Deneke, Tom ;

Willems, Stephan ;

van der Voort, Pepijn ;

Tilz, Roland ;

Funasako, Moritoshi ;

Scherr, Daniel ;

Wakili, Reza ;

Steven, Daniel ;

Kautzner, Josef ;

Vijgen, Johan ;

Jais, Pierre ;

Petru, Jan ;

Chun, Julian ;

Roten, Laurent ;

Fueting, Anna ;

Rillig, Andreas ;

Mulder, Bart A. ;

Johannessen, Arne ;

Rollin, Anne ;

Lehrmann, Heiko ;

Sohns, Christian ;

Jurisic, Zrinka ;

Savoure, Arnaud ;

Combes, Stephanes ;

Nentwich, Karin ;

Gunawardene, Melanie ;

Ouss, Alexandre ;

Kirstein, Bettina ;

Manninger, Martin ;

Bohnen, Jan-Eric ;

Sultan, Arian ;

Peichl, Petr ;

Koopman, Pieter ;

Derval, Nicolas ;

Turagam, Mohit K. ;

Neuzil, Petr .

EUROPACE, 2022, :1256-1266

[7] Coronary Spasm During Pulsed Field Ablation of the Mitral Isthmus Line [J].

Gunawardene, Melanie A. ;

Schaeffer, Benjamin N. ;

Jularic, Mario ;

Eickholt, Christian ;

Maurer, Tilman ;

Akbulak, Ruken Oe. ;

Flindt, Max ;

Anwar, Omar ;

Hartmann, Jens ;

Willems, Stephan .

JACC-CLINICAL ELECTROPHYSIOLOGY, 2021, 7 (12) :1618-1620

[8] 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS) [J].

Hindricks, Gerhard ;

Potpara, Tatjana ;

Dagres, Nikolaos ;

Arbelo, Elena ;

Bax, Jeroen J. ;

Blomstroem-Lundqvist, Carina ;

Boriani, Giuseppe ;

Castella, Manuel ;

Dan, Gheorghe-Andrei ;

Dilaveris, Polychronis E. ;

Fauchier, Laurent ;

Filippatos, Gerasimos ;

Kalman, Jonathan M. ;

La Meir, Mark ;

Lane, Deirdre A. ;

Lebeau, Jean-Pierre ;

Lettino, Maddalena ;

Lip, Gregory Y. H. ;

Pinto, Fausto J. ;

Thomas, G. Neil ;

Valgimigli, Marco ;

Van Gelder, Isabelle C. ;

Van Putte, Bart P. ;

Watkins, Caroline L. .

EUROPEAN HEART JOURNAL, 2021, 42 (05) :373-498

[9] Characterization of Phrenic Nerve Response to Pulsed Field Ablation [J].

Howard, Brian ;

Haines, David E. ;

Verma, Atul ;

Kirchhof, Nicole ;

Barka, Noah ;

Onal, Birce ;

Stewart, Mark T. ;

Sigg, Daniel C. .

CIRCULATION-ARRHYTHMIA AND ELECTROPHYSIOLOGY, 2022, 15 (06) :E010127

[10] Reduction in Pulmonary Vein Stenosis and Collateral Damage With Pulsed Field Ablation Compared With Radiofrequency Ablation in a Canine Model [J].

Howard, Brian ;

Haines, David E. ;

Verma, Atul ;

Packer, Douglas ;

Kirchhof, Nicole ;

Barka, Noah ;

Onal, Birce ;

Fraasch, Steve ;

Miklavcic, Damijan ;

Stewart, Mark T. .

CIRCULATION-ARRHYTHMIA AND ELECTROPHYSIOLOGY, 2020, 13 (09) :E008337

← 1 2 3 4 →