Randomized, Controlled Trial of the Safety and Effectiveness of a Contact Force-Sensing Irrigated Catheter for Ablation of Paroxysmal Atrial Fibrillation: Results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) Study

Circulation

Volumn 132, Issue 10, 2015, Pages 907-915

  Reddy, Vivek Y ^a   Dukkipati, Srinivas R ^a   Neuzil, Petr ^b   Natale, Andrea ^c   Albenque, Jean Paul ^d   Kautzner, Josef ^e   Shah, Dipen ^f   Michaud, Gregory ^g   Wharton, Marcus ^h   Harari, David ⁱ   Mahapatra, Srijoy ⁱ   Lambert, Hendrik ⁱ   Mansour, Moussa ^j  

^a MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^b NA HOMOLCE HOSPITAL   (Czech Republic)

^c Texas Cardiac Arrhythmia Research   (United States)

^d CLINIQUE PASTEUR   (France)

^e INSTITUTE FOR CLINICAL AND EXPERIMENTAL MEDICINE   (Czech Republic)

^f GENEVA UNIVERSITY HOSPITALS   (Switzerland)

^g BRIGHAM AND WOMEN S HOSPITAL   (United States)

^h MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

ⁱ St Jude Medical Inc USA   (United States)

^j MASSACHUSETTS GENERAL HOSPITAL   (United States)

more..

Author keywords

ablation techniques; atrial fibrillation; catheter ablation

Indexed keywords

ANTIARRHYTHMIC AGENT;

ABLATION CATHETER; ADULT; ARTICLE; CATHETER ABLATION; CLINICAL EFFECTIVENESS; CONTACT FORCE; CONTROLLED STUDY; FEMALE; HEART ATRIUM ARRHYTHMIA; HEART LEFT VENTRICLE EJECTION FRACTION; HEART PERFORATION; HEART TAMPONADE; HUMAN; LUNG EDEMA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PAROXYSMAL ATRIAL FIBRILLATION; PATIENT SAFETY; PERICARDITIS; PRIORITY JOURNAL; PROSPECTIVE STUDY; PULMONARY VEIN; PULMONARY VEIN OBSTRUCTION; QUALITY OF LIFE; RADIOFREQUENCY ABLATION; RANDOMIZED CONTROLLED TRIAL; ADVERSE EFFECTS; AGED; ARRHYTHMIAS, CARDIAC; ATRIAL FIBRILLATION; CLINICAL TRIAL; CONGENITAL MALFORMATION; FOLLOW UP; HEART CATHETERIZATION; HEART MUSCLE CONDUCTION SYSTEM; MIDDLE AGED; PROCEDURES; TREATMENT OUTCOME;

AGED; ARRHYTHMIAS, CARDIAC; ATRIAL FIBRILLATION; CARDIAC CATHETERIZATION; CATHETER ABLATION; FEMALE; FOLLOW-UP STUDIES; HEART CONDUCTION SYSTEM; HUMANS; MALE; MIDDLE AGED; PERICARDITIS; PROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 84941343767     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.114.014092     Document Type: Article

References (21)

1. Morillo CA, Verma A, Connolly SJ, Kuck KH, Nair GM, Champagne J, Sterns LD, Beresh H, Healey JS, Natale A; RAAFT-2 Investigators. Radiofrequency Ablation vs Antiarrhythmic Drugs as First-Line Treatment of Paroxysmal Atrial Fibrillation (RAAFT-2): a randomized trial. JAMA. 2014;311:692-700. doi: 10.1001/jama.2014.467.
2. Wazni OM, Marrouche NF, Martin DO, Verma A, Bhargava M, Saliba W, Bash D, Schweikert R, Brachmann J, Gunther J, Gutleben K, Pisano E, Potenza D, Fanelli R, Raviele A, Themistoclakis S, Rossillo A, Bonso A, Natale A. Radiofrequency Ablation vs Antiarrhythmic Drugs as First-Line Treatment of Symptomatic Atrial Fibrillation: a randomized trial. JAMA. 2005;293:2634-2640. doi: 10.1001/jama.293.21.2634.
3. Wilber DJ, Pappone C, Neuzil P, De Paola A, Marchlinski F, Natale A, Macle L, Daoud EG, Calkins H, Hall B, Reddy V, Augello G, Reynolds MR, Vinekar C, Liu CY, Berry SM, Berry DA; ThermoCool AF Trial Investigators. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA. 2010;303:333-340. doi: 10.1001/jama.2009.2029.
4. Packer DL, Kowal RC, Wheelan KR, Irwin JM, Champagne J, Guerra PG, Dubuc M, Reddy V, Nelson L, Holcomb RG, Lehmann JW, Ruskin JN; STOP AF Cryoablation Investigators. Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: first results of the North American Arctic Front (STOP AF) pivotal trial. J Am Coll Cardiol. 2013;61:1713-1723. doi: 10.1016/j.jacc.2012.11.064.
5. Arujuna A, Karim R, Caulfield D, Knowles B, Rhode K, Schaeffter T, Kato B, Rinaldi CA, Cooklin M, Razavi R, O'Neill MD, Gill J. Acute pulmonary vein isolation is achieved by a combination of reversible and irreversible atrial injury after catheter ablation: evidence from magnetic resonance imaging. Circ Arrhythm Electrophysiol. 2012;5:691-700. doi: 10.1161/CIRCEP.111.966523.
6. Ouyang F, Tilz R, Chun J, Schmidt B, Wissner E, Zerm T, Neven K, Köktürk B, Konstantinidou M, Metzner A, Fuernkranz A, Kuck KH. Long-term results of catheter ablation in paroxysmal atrial fibrillation: lessons from a 5-year follow-up. Circulation. 2010;122:2368-2377. doi: 10.1161/CIRCULATIONAHA.110.946806.
7. Weerasooriya R, Khairy P, Litalien J, Macle L, Hocini M, Sacher F, Lellouche N, Knecht S, Wright M, Nault I, Miyazaki S, Scavee C, Clementy J, Haissaguerre M, Jais P. Catheter ablation for atrial fibrillation: are results maintained at 5 years of follow-up? J Am Coll Cardiol. 2011;57:160-166. doi: 10.1016/j.jacc.2010.05.061.
8. Tzou WS, Marchlinski FE, Zado ES, Lin D, Dixit S, Callans DJ, Cooper JM, Bala R, Garcia F, Hutchinson MD, Riley MP, Verdino R, Gerstenfeld EP. Long-term outcome after successful catheter ablation of atrial fibrillation. Circ Arrhythm Electrophysiol. 2010;3:237-242. doi: 10.1161/CIRCEP.109.923771.
9. Avitall B, Mughal K, Hare J, Helms R, Krum D. The effects of electrode-tissue contact on radiofrequency lesion generation. Pacing Clin Electrophysiol. 1997;20(pt 1):2899-2910.
10. Strickberger SA, Vorperian VR, Man KC, Williamson BD, Kalbfleisch SJ, Hasse C, Morady F, Langberg JJ. Relation between impedance and endocardial contact during radiofrequency catheter ablation. Am Heart J. 1994;128:226-229.
11. Zheng X, Walcott GP, Hall JA, Rollins DL, Smith WM, Kay GN, Ideker RE. Electrode impedance: an indicator of electrode-tissue contact and lesion dimensions during linear ablation. J Interv Card Electrophysiol. 2000;4:645-654.
12. Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jaïs P, Hindricks G, Peichl P, Yulzari A, Lambert H, Neuzil P, Natale A, Kuck KH. The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart Rhythm. 2012;9:1789-1795. doi: 10.1016/j.hrthm.2012.07.016.
13. Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H, Zhang B, Stagg RB, Boo LM, Marchlinski FE. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014;64:647-656. doi: 10.1016/j.jacc.2014.04.072.
14. Yokoyama K, Nakagawa H, Shah DC, Lambert H, Leo G, Aeby N, Ikeda A, Pitha JV, Sharma T, Lazzara R, Jackman WM. Novel contact force sensor incorporated in irrigated radiofrequency ablation catheter predicts lesion size and incidence of steam pop and thrombus. Circ Arrhythm Electrophysiol. 2008;1:354-362. doi: 10.1161/CIRCEP.108.803650.
15. Shah DC, Lambert H, Nakagawa H, Langenkamp A, Aeby N, Leo G. Area under the real-time contact force curve (force-time integral) predicts radiofrequency lesion size in an in vitro contractile model. J Cardiovasc Electrophysiol. 2010;21:1038-1043. doi: 10.1111/j.1540-8167.2010.01750.x.
16. Neuzil P, Reddy VY, Kautzner J, Petru J, Wichterle D, Shah D, Lambert H, Yulzari A, Wissner E, Kuck KH. Electrical reconnection after pulmonary vein isolation is contingent on contact force during initial treatment: results from the EFFICAS I study. Circ Arrhythm Electrophysiol. 2013;6:327-333. doi: 10.1161/CIRCEP.113.000374.
17. Thiagalingam A, D'Avila A, Foley L, Guerrero JL, Lambert H, Leo G, Ruskin JN, Reddy VY. Importance of catheter contact force during irrigated radiofrequency ablation: evaluation in a porcine ex vivo model using a force-sensing catheter. J Cardiovasc Electrophysiol. 2010;21:806-811. doi: 10.1111/j.1540-8167.2009.01693.x.
18. Kuck KH, Reddy VY, Schmidt B, Natale A, Neuzil P, Saoudi N, Kautzner J, Herrera C, Hindricks G, Jaïs P, Nakagawa H, Lambert H, Shah DC. A novel radiofrequency ablation catheter using contact force sensing: TOCCATA study. Heart Rhythm. 2012;9:18-23. doi: 10.1016/j.hrthm.2011.08.021.
19. Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Packer D, Skanes A. Worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circulation. 2005;111:1100-1105. doi: 10.1161/01.CIR.0000157153.30978.67.
20. Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Natale A, Packer D, Skanes A, Ambrogi F, Biganzoli E. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010;3:32-38. doi: 10.1161/CIRCEP.109.859116.
21. Nakagawa H, Ikeda A, Lambert H, Shah D, Fonck E, Yulzari A, Sharma T, Pitha J, Lazzara R, Jackman W. Relationship between catheter contact force and radiofrequency lesion size and incidence of steam pop in the beating canine heart: electrode amplitude, impedance and electrode temperature are poor predictors of electrode-tissue contact force and lesion size. Circ Arrhythm Electrophysiol. 2014;7:1174-1180.