Phrenic Nerve Injury During Cryoballoon-Based Pulmonary Vein Isolation: Results of the Worldwide YETI Registry

Christian-H Heeger, Christian Sohns, Alexander Pott, Andreas Metzner, Osamu Inaba, Florian Straube, Malte Kuniss, Arash Aryana, Shinsuke Miyazaki, Serkan Cay, Joachim R Ehrlich, Ibrahim El-Battrawy, Martin Martinek, Ardan M Saguner, Verena Tscholl, Kivanc Yalin, Evgeny Lyan, Wilber Su, Giorgi Papiashvili, Maichel Sobhy Naguib Botros, Alessio Gasperetti, Riccardo Proietti, Erik Wissner, Daniel Scherr, Masashi Kamioka, Hisaki Makimoto, Tsuyoshi Urushida, Tolga Aksu, Julian K R Chun, Kudret Aytemir, Ewa Jędrzejczyk-Patej, Karl-Heinz Kuck, Tillman Dahme, Daniel Steven, Philipp Sommer, Roland Richard Tilz, Christian-H Heeger, Christian Sohns, Alexander Pott, Andreas Metzner, Osamu Inaba, Florian Straube, Malte Kuniss, Arash Aryana, Shinsuke Miyazaki, Serkan Cay, Joachim R Ehrlich, Ibrahim El-Battrawy, Martin Martinek, Ardan M Saguner, Verena Tscholl, Kivanc Yalin, Evgeny Lyan, Wilber Su, Giorgi Papiashvili, Maichel Sobhy Naguib Botros, Alessio Gasperetti, Riccardo Proietti, Erik Wissner, Daniel Scherr, Masashi Kamioka, Hisaki Makimoto, Tsuyoshi Urushida, Tolga Aksu, Julian K R Chun, Kudret Aytemir, Ewa Jędrzejczyk-Patej, Karl-Heinz Kuck, Tillman Dahme, Daniel Steven, Philipp Sommer, Roland Richard Tilz

Abstract

Background: Cryoballoon-based pulmonary vein isolation (PVI) has emerged as an effective treatment for atrial fibrillation. The most frequent complication during cryoballoon-based PVI is phrenic nerve injury (PNI). However, data on PNI are scarce.

Methods: The YETI registry is a retrospective, multicenter, and multinational registry evaluating the incidence, characteristics, prognostic factors for PNI recovery and follow-up data of patients with PNI during cryoballoon-based PVI. Experienced electrophysiological centers were invited to participate. All patients with PNI during CB2 or third (CB3) and fourth-generation cryoballoon (CB4)-based PVI were eligible.

Results: A total of 17 356 patients underwent cryoballoon-based PVI in 33 centers from 10 countries. A total of 731 (4.2%) patients experienced PNI. The mean time to PNI was 127.7±50.4 seconds, and the mean temperature at the time of PNI was -49±8°C. At the end of the procedure, PNI recovered in 394/731 patients (53.9%). Recovery of PNI at 12 months of follow-up was found in 97.0% of patients (682/703, with 28 patients lost to follow-up). A total of 16/703 (2.3%) reported symptomatic PNI. Only 0.06% of the overall population showed symptomatic and permanent PNI. Prognostic factors improving PNI recovery are immediate stop at PNI by double-stop technique and utilization of a bonus-freeze protocol. Age, cryoballoon temperature at PNI, and compound motor action potential amplitude loss >30% were identified as factors decreasing PNI recovery. Based on these parameters, a score was calculated. The YETI score has a numerical value that will directly represent the probability of a specific patient of recovering from PNI within 12 months.

Conclusions: The incidence of PNI during cryoballoon-based PVI was 4.2%. Overall 97% of PNI recovered within 12 months. Symptomatic and permanent PNI is exceedingly rare in patients after cryoballoon-based PVI. The YETI score estimates the prognosis after iatrogenic cryoballoon-derived PNI. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03645577. Graphic Abstract: A graphic abstract is available for this article.

Keywords: atrial fibrillation; catheter ablation; cryoballoon; incidence; phrenic nerve injury.

Figures

Figure 1.
Figure 1.
Time course of phrenic nerve injury (PNI) recovery. The Kaplan-Meier estimates demonstrate the relative proportion of patients recovered after periprocedural PNI.
Figure 2.
Figure 2.
Prognostic factors for phrenic nerve injury (PNI) recovery. Multivariate analysis on prognostic factors of 12-mo PNI recovery. Hazard rates have been reported on a logarithmic scale. AF indicates atrial fibrillation; BMI, body mass index; CMAP, compound motor action potential; and LA, left atrium.
Figure 3.
Figure 3.
YETI score: prediction of phrenic nerve injury (PNI) recovery. The YETI score has a numerical value that will directly represent the probability of a specific patient of recovering from PNI within 12 mo. The YETI Score is calculated as −0.0073833×age−0.0187482×temperature+0.2339744 if bonus freeze protocol was utilized, +0.6743827 if immediate stop by double-stop technique at PNI was performed, −0.2743813 if CMAP amplitude loss >30% was detected. An appropriate YETI score calculator will be available online.

References

    1. Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-Lundqvist C, Boriani G, Castella M, Dan G-A, Dilaveris PE, et al. . 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS)The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2020:ehaa612
    1. Heeger CH, Subin B, Wissner E, Fink T, Mathew S, Maurer T, Lemes C, Rillig A, Wohlmuth P, Reissmann B, et al. . Second-generation cryoballoon-based pulmonary vein isolation: Lessons from a five-year follow-up. Int J Cardiol. 2020;312:73–80. doi: 10.1016/j.ijcard.2020.03.062
    1. Aryana A, Kowalski M, O’Neill PG, Koo CH, Lim HW, Khan A, Hokanson RB, Bowers MR, Kenigsberg DN, Ellenbogen KA; Cryo-DOSING Investigators. Catheter ablation using the third-generation cryoballoon provides an enhanced ability to assess time to pulmonary vein isolation facilitating the ablation strategy: Short- and long-term results of a multicenter study. Heart Rhythm. 2016;13:2306–2313. doi: 10.1016/j.hrthm.2016.08.011
    1. Akkaya E, Berkowitsch A, Zaltsberg S, Greiss H, Hamm CW, Sperzel J, Kuniss M, Neumann T. Five-year outcome and predictors of success after second-generation cryoballoon ablation for treatment of symptomatic atrial fibrillation. Int J Cardiol. 2018;266:106–111. doi: 10.1016/j.ijcard.2018.03.069
    1. Reddy VY, Sediva L, Petru J, Skoda J, Chovanec M, Chitovova Z, Di Stefano P, Rubin E, Dukkipati S, Neuzil P. Durability of Pulmonary Vein Isolation with Cryoballoon Ablation: Results from the Sustained PV Isolation with Arctic Front Advance (SUPIR) Study. J Cardiovasc Electrophysiol. 2015;26:493–500. doi: 10.1111/jce.12626
    1. Bordignon S, Fürnkranz A, Perrotta L, Dugo D, Konstantinou A, Nowak B, Schulte-Hahn B, Schmidt B, Chun KR. High rate of durable pulmonary vein isolation after second-generation cryoballoon ablation: analysis of repeat procedures. Europace. 2015;17:725–731. doi: 10.1093/europace/euu331
    1. Heeger CH, Wissner E, Mathew S, Deiss S, Lemes C, Rillig A, Wohlmuth P, Reissmann B, Tilz RR, Ouyang F, et al. . Once Isolated, Always Isolated? Incidence and Characteristics of Pulmonary Vein Reconduction After Second-Generation Cryoballoon-Based Pulmonary Vein Isolation. Circ Arrhythm Electrophysiol. 2015;8:1088–1094. doi: 10.1161/CIRCEP.115.003007
    1. Kuck KH, Brugada J, Fürnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, et al. ; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016;374:2235–2245. doi: 10.1056/NEJMoa1602014
    1. Hoffmann E, Straube F, Wegscheider K, Kuniss M, Andresen D, Wu LQ, Tebbenjohanns J, Noelker G, Tilz RR, Chun JKR, et al. ; FREEZE Cohort Study Investigators. Outcomes of cryoballoon or radiofrequency ablation in symptomatic paroxysmal or persistent atrial fibrillation. Europace. 2019;21:1313–1324. doi: 10.1093/europace/euz155
    1. Abugattas JP, de Asmundis C, Iacopino S, Salghetti F, Takarada K, Coutiño HE, Ströker E, De Regibus V, de Greef Y, Brugada P, et al. . Phrenic nerve injury during right inferior pulmonary vein ablation with the second-generation cryoballoon: clinical, procedural, and anatomical characteristics. Europace. 2018;20:e156–e163. doi: 10.1093/europace/eux337
    1. Fürnkranz A, Bordignon S, Schmidt B, Perrotta L, Dugo D, De Lazzari M, Schulte-Hahn B, Nowak B, Chun JK. Incidence and characteristics of phrenic nerve palsy following pulmonary vein isolation with the second-generation as compared with the first-generation cryoballoon in 360 consecutive patients. Europace. 2015;17:574–578. doi: 10.1093/europace/euu320
    1. Metzner A, Rausch P, Lemes C, Reissmann B, Bardyszewski A, Tilz R, Rillig A, Mathew S, Deiss S, Kamioka M, 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. doi: 10.1111/jce.12358
    1. Miyazaki S, Kajiyama T, Watanabe T, Hada M, Yamao K, Kusa S, Igarashi M, Nakamura H, Hachiya H, Tada H, et al. . Characteristics of Phrenic Nerve Injury During Pulmonary Vein Isolation Using a 28-mm Second-Generation Cryoballoon and Short Freeze Strategy. J Am Heart Assoc. 2018;7:e008249. doi: 10.1161/JAHA.117.008249
    1. Casado-Arroyo R, Chierchia GB, Conte G, Levinstein M, Sieira J, Rodriguez-Mañero M, di Giovanni G, Baltogiannis Y, Wauters K, de Asmundis C, et al. . Phrenic nerve paralysis during cryoballoon ablation for atrial fibrillation: a comparison between the first- and second-generation balloon. Heart Rhythm. 2013;10:1318–1324. doi: 10.1016/j.hrthm.2013.07.005
    1. Su W, Kowal R, Kowalski M, Metzner A, Svinarich JT, Wheelan K, Wang P. Best practice guide for cryoballoon ablation in atrial fibrillation: the compilation experience of more than 3000 procedures. Heart Rhythm. 2015;12:1658–1666. doi: 10.1016/j.hrthm.2015.03.021
    1. Heeger CH, Wissner E, Wohlmuth P, Mathew S, Hayashi K, Sohns C, Reißmann B, Lemes C, Maurer T, Saguner AM, et al. . Bonus-freeze: benefit or risk? Two-year outcome and procedural comparison of a “bonus-freeze” and “no bonus-freeze” protocol using the second-generation cryoballoon for pulmonary vein isolation. Clin Res Cardiol. 2016;105:774–782. doi: 10.1007/s00392-016-0987-8
    1. Metzner A, Reissmann B, Rausch P, Mathew S, Wohlmuth P, Tilz R, Rillig A, Lemes C, Deiss S, Heeger C, et al. . One-year clinical outcome after pulmonary vein isolation using the second-generation 28-mm cryoballoon. Circ Arrhythm Electrophysiol. 2014;7:288–292. doi: 10.1161/CIRCEP.114.001473
    1. Ciconte G, de Asmundis C, Sieira J, Conte G, Di Giovanni G, Mugnai G, Saitoh Y, Baltogiannis G, Irfan G, Coutiño-Moreno HE, et al. . Single 3-minute freeze for second-generation cryoballoon ablation: one-year follow-up after pulmonary vein isolation. Heart Rhythm. 2015;12:673–680. doi: 10.1016/j.hrthm.2014.12.026
    1. Heeger CH, Wissner E, Mathew S, Hayashi K, Sohns C, Reißmann B, Lemes C, Maurer T, Fink T, Saguner AM, et al. . Short tip-big difference? First-in-man experience and procedural efficacy of pulmonary vein isolation using the third-generation cryoballoon. Clin Res Cardiol. 2016;105:482–488. doi: 10.1007/s00392-015-0944-y
    1. Chun KR, Stich M, Fürnkranz A, Bordignon S, Perrotta L, Dugo D, Bologna F, Schmidt B. Individualized cryoballoon energy pulmonary vein isolation guided by real-time pulmonary vein recordings, the randomized ICE-T trial. Heart Rhythm. 2017;14:495–500. doi: 10.1016/j.hrthm.2016.12.014
    1. Su W, Aryana A, Passman R, Singh G, Hokanson R, Kowalski M, Andrade J, Wang P. Cryoballoon Best Practices II: Practical guide to procedural monitoring and dosing during atrial fibrillation ablation from the perspective of experienced users. Heart Rhythm. 2018;15:1348–1355. doi: 10.1016/j.hrthm.2018.04.021
    1. Franceschi F, Koutbi L, Gitenay E, Hourdain J, Maille B, Trévisan L, Deharo JC. Electromyographic monitoring for prevention of phrenic nerve palsy in second-generation cryoballoon procedures. Circ Arrhythm Electrophysiol. 2015;8:303–307. doi: 10.1161/CIRCEP.115.002734
    1. Ghosh J, Singarayar S, Kabunga P, McGuire MA. Subclavian vein pacing and venous pressure waveform measurement for phrenic nerve monitoring during cryoballoon ablation of atrial fibrillation. Europace. 2015;17:884–890. doi: 10.1093/europace/euu341
    1. Tohoku S, Chen S, Last J, Bordignon S, Bologna F, Trolese L, Zanchi S, Bianchini L, Schmidt B, Chun KRJ. Phrenic nerve injury in atrial fibrillation ablation using balloon catheters: Incidence, characteristics, and clinical recovery course. J Cardiovasc Electrophysiol. 2020;31:1932–1941. doi: 10.1111/jce.14567
    1. Rottner L, Fink T, Heeger CH, Schlüter M, Goldmann B, Lemes C, Maurer T, Reißmann B, Rexha E, Riedl J, et al. . Is less more? Impact of different ablation protocols on periprocedural complications in second-generation cryoballoon based pulmonary vein isolation. Europace. 2018;20:1459–1467. doi: 10.1093/europace/eux219
    1. Andrade JG, Dubuc M, Ferreira J, Guerra PG, Landry E, Coulombe N, Rivard L, Macle L, Thibault B, Talajic M, et al. . Histopathology of cryoballoon ablation-induced phrenic nerve injury J Cardiovasc Electr. 2014;25:187–194. doi: 10.1111/jce.12296
    1. Heeger CH, Schuette C, Seitelberger V, Wissner E, Rillig A, Mathew S, Reissmann B, Lemes C, Maurer T, Fink T, et al. . Time-to-effect guided pulmonary vein isolation utilizing the third-generation versus second generation cryoballoon: one year clinical success. Cardiol J. 2019;26:368–374. doi: 10.5603/CJ.a2018.0056
    1. Andrade JG, Champagne J, Dubuc M, Deyell MW, Verma A, Macle L, Leong-Sit P, Novak P, Badra-Verdu M, Sapp J, et al. ; CIRCA-DOSE Study Investigators. Cryoballoon or radiofrequency ablation for atrial fibrillation assessed by continuous monitoring: a randomized clinical trial. Circulation. 2019;140:1779–1788. doi: 10.1161/CIRCULATIONAHA.119.042622

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever