Safety and efficacy of cryoballoon ablation for paroxysmal atrial fibrillation in Japan-results from the japanese prospective post-market surveillance study –

Circulation Journal

Volumn 80, Issue 8, 2016, Pages 1744-1749

  Okumura, Ken ^a   Matsumoto, Kazuo ^b   Kobayashi, Yoshinori ^c   Nogami, Akihiko ^d   Hokanson, Robert B ^e   Kueffer, Fred ^e  

^a HIROSAKI UNIVERSITY   (Japan)

^b SAITAMA MEDICAL UNIVERSITY INTERNATIONAL MEDICAL CENTER   (Japan)

^c TOKAI UNIVERSITY HACHIOJI HOSPITAL   (Japan)

^d UNIVERSITY OF TSUKUBA   (Japan)

^e MEDTRONIC INC   (United States)

Author keywords

Atrial fibrillation; Catheter ablation; Cryoballoon; Japanese; Pulmonary vein isolation

Indexed keywords

CONTRAST MEDIUM;

ABLATION CATHETER; ADULT; ARTICLE; CATHETERIZATION; CRYOBALLOON ABLATION; CRYOTHERAPY; FEMALE; FLUOROSCOPY; FOLLOW UP; GUIDE WIRE; HEART TAMPONADE; HEMATOMA; HUMAN; JAPAN; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; NERVE INJURY; OBSERVATIONAL STUDY; PAROXYSMAL ATRIAL FIBRILLATION; PERICARDIAL EFFUSION; PLEURA EFFUSION; PROSPECTIVE STUDY; PULMONARY VEIN OBSTRUCTION; TREATMENT FAILURE; TREATMENT OUTCOME; ADVERSE EFFECTS; AGED; ASIAN CONTINENTAL ANCESTRY GROUP; ATRIAL FIBRILLATION; CLINICAL TRIAL; CRYOSURGERY; MULTICENTER STUDY; PATHOPHYSIOLOGY; POSTMARKETING SURVEILLANCE; PROCEDURES; SAFETY;

AGED; ASIAN CONTINENTAL ANCESTRY GROUP; ATRIAL FIBRILLATION; CRYOSURGERY; FEMALE; FOLLOW-UP STUDIES; HUMANS; JAPAN; MALE; MIDDLE AGED; PRODUCT SURVEILLANCE, POSTMARKETING; PROSPECTIVE STUDIES; SAFETY;

EID: 84982278682     PISSN: 13469843     EISSN: 13474820     Source Type: Journal    
DOI: 10.1253/circj.CJ-16-0285     Document Type: Article

References (17)

1. January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol 2014; 64: e1-e76, doi:10.1016/j.jacc.2014.03.022.
2. Stefansdottir H, Aspelund T, Gudnason V, Arnar DO. Trends in the incidence and prevalence of atrial fibrillation in Iceland and future projections. Europace 2011; 13: 1110-1117.
3. Ohlmeier C, Mikolajczyk R, Haverkamp W, Garbe E. Incidence, prevalence, and antithrombotic management of atrial fibrillation in elderly Germans. Europace 2013; 15: 1437-1444.
4. Inoue H, Fujiki A, Origasa H, Ogawa S, Okumura K, Kubota I, et al. Prevalence of atrial fibrillation in the general population of Japan: An analysis based on periodic health examination. Int J Cardiol 2009; 137: 102-107.
5. Packer DL, Kowal RC, Whelan KR, Irwin JM, Champagne J, Guerra PG, et al. 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.
6. Di Giovanni GD, Wauters K, Chierchia GB, Sieira J, Levinstein M, Conte G, et al. One-year follow-up after single procedure cryoballoon ablation: A comparison between first and second generation balloon. J Cardiovasc Electrophysiol 2014; 25: 834-839.
7. Fürnkranz A, Bordignon S, Dugo D, Perotta L, Gunawardene M, Schulte-Hahn B, et al. Improved one-year clinical success rate of pulmonary vein isolation with the second-generation cryoballoon in patients with paroxysmal atrial fibrillation. J Cardiovasc Electrophysiol 2014; 25: 840-844.
8. Aytemir K, Gurses KM, Yalcin MU, Kocyigit D, Dural M, Evranos B, et al. Safety and efficacy outcomes in patients undergoing pulmonary vein isolation with second-generation cryoballoon. Europace 2015; 17: 379-387.
9. Aryana A, Morkoch S, Bailey S, Lim HW, Sara R, d’Avila A, et al. Acute procedural and cryoballoon characteristics from cryoablation of atrial fibrillation using the first- and second-generation cryoballoon: A retrospective comparative study with follow-up outcomes. J Interv Card Electrophysiol 2014; 41: 177-186.
10. Greiss H, Berkowitsch A, Wojcik M, Zaltsberg S, Pajitnev D, Deubner N, et al. The impact of left atrial surface area and the second generation cryoballoon on clinical outcome of atrial fibrillation cryoablation. Pacing Clin Electrophysiol 2015; 38: 815-824.
11. Chierchia GB, Di Giovanni G, Ciconte G, de Asmundis C, Conte G, Sieira-Moret J, et al. Second-generation cryoballoon ablation for paroxysmal atrial fibrillation: 1-year follow-up. Europace 2014; 16: 639-644.
12. Kumar N, Blaauw Y, Timmermans C, Pison L, Vernooy K, Crijns H. Adenosine testing after second-generation balloon devices (cryothermal and laser) mediated pulmonary vein ablation for atrial fibrillation. J Interv Card Electrophysiol 2014; 41: 91-97.
13. Jourda F, Providencia R, Marijon E, Bouzeman A, Hireche H, Khoueiry Z, et al. Contact-force guided radiofrequency vs. second-generation balloon cryotherapy for pulmonary vein isolation in patients with paroxysmal atrial fibrillation-a prospective evaluation. Europace 2015; 17: 225-231.
14. Ciconte G, Ottaviano L, de Asmundis C, Baltogiannis G, Conte G, Sieira J, et al. Pulmonary vein isolation as index procedure for persistent atrial fibrillation: One-year clinical outcome after ablation using the second-generation cryoballoon. Heart Rhythm 2014; 12: 60-66.
15. Wissner E, Heeger CH, Grahn H, Reissmann B, Wohlmuth P, Lemes C, et al. One-year clinical success of a ‘no-bonus’ freeze protocol using the second-generation 28 mm cryoballoon for pulmonary vein isolation. Europace 2015; 17: 1236-1240.
16. Su W, Kowal R, Kowalski M, Metzner A, Svinarich JT, Wheelan K, et al. Best practice guide for cryoballoon ablation in atrial fibrillation: The compilation experience of more than 3000 procedures. Heart Rhythm 2015; 12: 1658-1666.
17. Metzner A, Rausch P, Lemes C, Reissmann B, Bardyszewski A, Tilz R, et al. The incidence of phrenic nerve injury during pulmonary vein isolation using the second-generation 28 mm cryoballoon. J Cardiovasc Electrophysiol 2014; 25: 466-470.