Abstract
Purpose
The second-generation cryoballoon (CBG2) is highly effective for pulmonary vein isolation (PVI) in paroxysmal atrial fibrillation (PAF). One-year outcome data are consistent among different research groups. First results suggest that a shortened application time might be equally effective. The objective of the study was to compare procedural and outcome data for a 240 and 180-s protocol.
Methods
Prospectively, consecutive patients with symptomatic PAF underwent initial PVI with CBG2. In succession, two groups were created: the application time was 240 s in group 1 and 180 s in group 2. In both groups, a bonus application was applied. Periprocedural data, complications, and freedom from atrial fibrillation (AF)/AT/symptoms were compared between the groups.
Results
From May 2012 to June 2013, 114 patients (57 per group, 38 % female) were included. The mean left atrial dwelling time decreased by 19 min (−16 %) in group 2 compared to group 1 (p = 0.005). Intraprocedural pulmonary vein (PV) reconduction occurred infrequently (0.4 % in both groups, p = 1.0). One persistent PNP occurred and resolved during the follow-up. Complications were without significant differences. One patient was lost to follow-up. The cumulative rates of freedom from recurrence at 12 months are 76.8 % in group 1 and 83.6 % in group 2. After a mean follow-up of 491 ± 208 days, the rates of freedom from AF/AT/symptoms at last visit were 38/57 (67 %) and 44/56 (78.6 %) in groups 1 and 2 (p = 0.14), respectively. Female sex was identified as a predictor for recurrence.
Conclusions
Compared to a protocol with cryoballoon applications of 240 s, a shortened application time to 180 s results in a faster procedure with comparable high rates of freedom from AF at 16 months. Female sex seems to be predictive for recurrences; this finding has to be reconfirmed in a larger population.
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Abbreviations
- AF:
-
Atrial fibrillation
- CB:
-
Cryoballoon
- CBG2:
-
Second-generation cryoballoon
- LA:
-
Left atrium
- PAF:
-
Paroxysmal atrial fibrillation
- PNP:
-
Phrenic nerve palsy
- PV:
-
Pulmonary vein
- PVI:
-
PV isolation
- RF:
-
Radiofrequency
- SD:
-
Standard deviation
References
Packer, D. L., Kowal, R. C., Wheelan, K. R., Irwin, J. M., Champagne, J., Guerra, P. G., et al. (2013). Cryoballoon ablation of pulmonary veins for paroxysmal atrial fibrillation: first results of the North American Arctic Front (STOP AF) pivotal trial. Journal of the American College of Cardiology, 61(16), 1713–1723.
Vogt, J., Heintze, J., Gutleben, K. J., Muntean, B., Horstkotte, D., & Nolker, G. (2013). Long-term outcomes after cryoballoon pulmonary vein isolation: results from a prospective study in 605 patients. Journal of the American College of Cardiology, 61(16), 1707–1712.
Straube, F., Dorwarth, U., Schmidt, M., Wankerl, M., Ebersberger, U., & Hoffmann, E. (2014). Comparison of the first and second cryoballoon: high-volume single-center safety and efficacy analysis. Circulation. Arrhythmia and Electrophysiology, 7(2), 293–299.
Straube, F., Dorwarth, U., Vogt, J., Kuniss, M., Heinz Kuck, K., Tebbenjohanns, J., et al. (2014). Differences of two cryoballoon generations: insights from the prospective multicentre, multinational FREEZE cohort substudy. Europace, 16(10), 1434–1442.
Gage, A. A., Guest, K., Montes, M., Caruana, J. A., & Whalen, D. A., Jr. (1985). Effect of varying freezing and thawing rates in experimental cryosurgery. Cryobiology, 22(2), 175–182.
Gage, A. A., Baust, J. M., & Baust, J. G. (2009). Experimental cryosurgery investigations in vivo. [Research Support, N.I.H., Extramural Review]. Cryobiology, 59(3), 229–243.
Chun, K. R., Furnkranz, A., Koster, I., Metzner, A., Tonnis, T., Wohlmuth, P., et al. (2012). Two versus one repeat freeze-thaw cycle(s) after cryoballoon pulmonary vein isolation: the alster extra pilot study. Journal of Cardiovascular Electrophysiology, 23(8), 814–819.
Furnkranz, A., Bordignon, S., Schmidt, B., Gunawardene, M., Schulte-Hahn, B., Urban, V., et al. (2013). Improved procedural efficacy of pulmonary vein isolation using the novel second-generation cryoballoon. Journal of Cardiovascular Electrophysiology, 24(5), 492–497.
Chierchia, G. B., Di Giovanni, G., Ciconte, G., de Asmundis, C., Conte, G., Sieira-Moret, J., et al. (2014). Second-generation cryoballoon ablation for paroxysmal atrial fibrillation: 1-year follow-up. Europace, 16(5), 639–644.
Bordignon, S., Furnkranz, A., Dugo, D., Perrotta, L., Gunawardene, M., Bode, F., et al. (2014). Improved lesion formation using the novel 28 mm cryoballoon in atrial fibrillation ablation: analysis of biomarker release. Europace, 16(7), 987–993.
Martins, R. P., Hamon, D., Cesari, O., Behaghel, A., Behar, N., Sellal, J. M., et al. (2014). Safety and efficacy of a second-generation cryoballoon in the ablation of paroxysmal atrial fibrillation. Heart Rhythm, 11(3), 386–393.
Metzner, A., Rausch, P., Lemes, C., Reissmann, B., Bardyszewski, A., Tilz, R., et al. (2014). The incidence of phrenic nerve injury during pulmonary vein isolation using the second-generation 28 mm cryoballoon. Journal of Cardiovascular Electrophysiology, 25(5), 466–470.
Metzner, A., Reissmann, B., Rausch, P., Mathew, S., Wohlmuth, P., Tilz, R., et al. (2014). One-year clinical outcome after pulmonary vein isolation using the second-generation 28-mm cryoballoon. Circulation. Arrhythmia and Electrophysiology, 7(2), 288–292.
Takami, M., Lehmann, H. I., Misiri, J., Parker, K. D., Sarmiento, R. I., Johnson, S. B., et al. (2015). The impact of freezing time and balloon size on the thermodynamics and isolation efficacy during pulmonary vein isolation using the 2nd generation cryoballoon. Circulation. Arrhythmia and Electrophysiology.
Chierchia, G. B., Di Giovanni, G., Sieira-Moret, J., de Asmundis, C., Conte, G., Rodriguez-Manero, M., et al. (2014). Initial experience of three-minute freeze cycles using the second-generation cryoballoon ablation: acute and short-term procedural outcomes. Journal of Interventional Cardiac Electrophysiology, 39(2), 145–151.
Ciconte, G., de Asmundis, C., Sieira, J., Conte, G., Di Giovanni, G., Mugnai, G., et al. (2015). Single 3-minute freeze for second-generation cryoballoon ablation: one-year follow-up after pulmonary vein isolation. Heart Rhythm, 12(4), 673–680.
Tebbenjohanns, J., Hofer, C., Bergmann, L., Dedroogh, M., Gaudin, D., von Werder, A., et al. (2015). Shortening of freezing cycles provides equal outcome to standard ablation procedure using second-generation 28 mm cryoballoon after 15-month follow-up. Europace.
Wissner, E., Heeger, C. H., Grahn, H., Reissmann, B., Wohlmuth, P., Lemes, C., et al. (2015). One-year clinical success of a 'no-bonus' freeze protocol using the second-generation 28 mm cryoballoon for pulmonary vein isolation. Europace.
Lakhani, M., Saiful, F., Bekheit, S., & Kowalski, M. (2012). Use of intracardiac echocardiography for early detection of phrenic nerve injury during cryoballoon pulmonary vein isolation. [Case Reports]. Journal of Cardiovascular Electrophysiology, 23(8), 874–876.
Peduzzi, P., Concato, J., Kemper, E., Holford, T. R., & Feinstein, A. R. (1996). A simulation study of the number of events per variable in logistic regression analysis. Journal of Clinical Epidemiology, 49(12), 1373–1379.
Metzner, A., Burchard, A., Wohlmuth, P., Rausch, P., Bardyszewski, A., Gienapp, C., et al. (2013). Increased incidence of esophageal thermal lesions using the second-generation 28-mm cryoballoon. Circulation. Arrhythmia and Electrophysiology, 6(4), 769–775.
Doll, N., Kornherr, P., Aupperle, H., Fabricius, A. M., Kiaii, B., Ullmann, C., et al. (2003). Epicardial treatment of atrial fibrillation using cryoablation in an acute off-pump sheep model. The Thoracic and Cardiovascular Surgeon, 51(5), 267–273.
Aupperle, H., Doll, N., Walther, T., Ullmann, C., Schoon, H. A., & Wilhelm Mohr, F. (2005). Histological findings induced by different energy sources in experimental atrial ablation in sheep. Interactive Cardiovascular and Thoracic Surgery, 4(5), 450–455.
Khairy, P., Rivard, L., Guerra, P. G., Tanguay, J. F., Mawad, W., Roy, D., et al. (2008). Morphometric ablation lesion characteristics comparing 4, 6, and 8 mm electrode-tip cryocatheters. [Comparative Study Evaluation Studies Research Support, Non-U.S. Gov't]. Journal of Cardiovascular Electrophysiology, 19(11), 1203–1207.
Lustgarten, D. L., Keane, D., & Ruskin, J. (1999). Cryothermal ablation: mechanism of tissue injury and current experience in the treatment of tachyarrhythmias. [Research Support, Non-U.S. Gov't Review]. Progress in Cardiovascular Diseases, 41(6), 481–498.
Markovitz, L. J., Frame, L. H., Josephson, M. E., & Hargrove, W. C., 3rd. (1988). Cardiac cryolesions: factors affecting their size and a means of monitoring their formation. [Research Support, U.S. Gov't, P.H.S.]. The Annals of Thoracic Surgery, 46(5), 531–535.
Chua, K. J., Chou, S. K., & Ho, J. C. (2007). An analytical study on the thermal effects of cryosurgery on selective cell destruction. Journal of Biomechanics, 40(1), 100–116.
Andrade, J. G., Dubuc, M., Guerra, P. G., Macle, L., Mondesert, B., Rivard, L., et al. (2012). The biophysics and biomechanics of cryoballoon ablation. [Research Support, Non-U.S. Gov't]. Pacing and Clinical Electrophysiology, 35(9), 1162–1168.
Stewart, G. J., Preketes, A., Horton, M., Ross, W. B., & Morris, D. L. (1995). Hepatic cryotherapy: double-freeze cycles achieve greater hepatocellular injury in man. [Research Support, Non-U.S. Gov't]. Cryobiology, 32(3), 215–219.
Reddy, V. Y., Sediva, L., Petru, J., Skoda, J., Chovanec, M., Chitovova, Z., et al. (2015). Durability of pulmonary vein isolation with cryoballoon ablation: results from the sustained PV isolation with arctic front advance (SUPIR) study. Journal of Cardiovascular Electrophysiology, 26(5), 493–500.
Kautzner, J., Neuzil, P., Lambert, H., Peichl, P., Petru, J., Cihak, R., et al. (2015). EFFICAS II: optimization of catheter contact force improves outcome of pulmonary vein isolation for paroxysmal atrial fibrillation. Europace, 17(8), 1229–1235.
Andrade, J. G., Dubuc, M., Guerra, P. G., Landry, E., Coulombe, N., Leduc, H., et al. (2013). Pulmonary vein isolation using a second-generation cryoballoon catheter: a randomized comparison of ablation duration and method of deflation. Journal of Cardiovascular Electrophysiology, 24(6), 692–698.
Dorwarth, U., Schmidt, M., Wankerl, M., Krieg, J., Straube, F., & Hoffmann, E. (2011). Pulmonary vein electrophysiology during cryoballoon ablation as a predictor for procedural success. Journal of Interventional Cardiac Electrophysiology, 32(3), 205–211.
Neumann, T., Wojcik, M., Berkowitsch, A., Erkapic, D., Zaltsberg, S., Greiss, H., et al. (2013). Cryoballoon ablation of paroxysmal atrial fibrillation: 5-year outcome after single procedure and predictors of success. Europace, 15(8), 1143–1149.
Avgil Tsadok, M., Gagnon, J., Joza, J., Behlouli, H., Verma, A., Essebag, V., et al. (2015). Temporal trends and sex differences in pulmonary vein isolation for patients with atrial fibrillation. Heart Rhythm
Bhave, P. D., Lu, X., Girotra, S., Kamel, H., & Vaughan Sarrazin, M. S. (2015). Race- and sex-related differences in care for patients newly diagnosed with atrial fibrillation. Heart Rhythm, 12(7), 1406–1412.
Jacobs, A. K. (2009). Coronary intervention in 2009: are women no different than men? Circulation Cardiovascular Interventions, 2(1), 69–78.
Acknowledgments
The authors are grateful to June Tomelden-Pade for helping with data acquisition and Armin Schwarz for assisting with the statistics and graphical design. Special thanks goes to our EP team supporting our work with a high degree of flexibility when introducing new technology or protocols to our lab.
Author contributions
All authors made substantial contributions to all of the following: (1) the conception and design of the study, or acquisition of data, or analysis and interpretation of data, (2) drafting the article or revising it critically for important intellectual content, (3) final approval of the version to be submitted: Dr. F. Straube performed the analysis and interpretation of the data, drafted the manuscript and is the corresponding author. Drs. F. Straube, Dorwarth, Bunz, Hartl and Wankerl were involved in data acquisition, patient recruitment, and revised the manuscript. Dr. Ebersberger performed the LA/PV imaging prior to the procedure including the data acquisition and critically revised the manuscript. Dr. Hoffmann was responsible for the concept of the study, supported the scientific activities as the head of the department, and revised and approved the manuscript.
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Dr. Straube received honoraria for lectures/travel expenses from Medtronic, Biotronik, Boehringer Ingelheim and Bristol-Myers-Squibb/Pfizer. Dr. Dorwarth received honoraria for lectures/travel expenses from Medtronic. Drs. Wankerl, Ebersberger: none. Drs. Bunz, Hartl received travel support from Medtronic. Dr. Hoffmann received honoraria for lectures from Boehringer Ingelheim, Boston Scientific, MSD SHARP&DOHME GmbH, and research funding from Biotronik, Edwards Corp, Medtronic, Philips, St. Jude Medical, Braun AG and Stentys Inc.
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Straube, F., Dorwarth, U., Hartl, S. et al. Outcome of paroxysmal atrial fibrillation ablation with the cryoballoon using two different application times: the 4- versus 3-min protocol. J Interv Card Electrophysiol 45, 169–177 (2016). https://doi.org/10.1007/s10840-015-0084-3
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DOI: https://doi.org/10.1007/s10840-015-0084-3