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

Author:

Heeger Christian-H.123ORCID,Sohns Christian4ORCID,Pott Alexander5,Metzner Andreas267,Inaba Osamu8ORCID,Straube Florian910ORCID,Kuniss Malte11ORCID,Aryana Arash12ORCID,Miyazaki Shinsuke13ORCID,Cay Serkan14ORCID,Ehrlich Joachim R.15ORCID,El-Battrawy Ibrahim16ORCID,Martinek Martin17ORCID,Saguner Ardan M.18ORCID,Tscholl Verena19ORCID,Yalin Kivanc20ORCID,Lyan Evgeny21ORCID,Su Wilber22ORCID,Papiashvili Giorgi23ORCID,Botros Maichel Sobhy Naguib24ORCID,Gasperetti Alessio12526ORCID,Proietti Riccardo27,Wissner Erik28,Scherr Daniel,Kamioka Masashi29ORCID,Makimoto Hisaki30,Urushida Tsuyoshi31,Aksu Tolga32ORCID,Chun Julian K.R.33ORCID,Aytemir Kudret34ORCID,Jędrzejczyk-Patej Ewa35ORCID,Kuck Karl-Heinz1236ORCID,Dahme Tillman5ORCID,Steven Daniel3738,Sommer Philipp4ORCID,Richard Tilz Roland13ORCID

Affiliation:

1. University Heart Center Lübeck, Medical Clinic II, Department of Cardiology, Angiology and Intensive Care Medicine, Germany (C.-H.H., A.G., K.-H.K., R.R.T.).

2. Asklepios Klinik St. Georg, Hamburg, Germany (C.-H.H., A.M., K.-H.K.).

3. German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Germany (C.-H.H., R.R.T.).

4. Herz-und Diabeteszentrum NRW, Bad Oeynhausen, Germany (C.S., P.S.).

5. Department of Cardiology, University of Ulm, Germany (A.P., T.D.).

6. Asklepios Klinik Harburg, Hamburg, Germany (A.M.).

7. University Heart Center Hamburg, Germany (A.M.).

8. Japanese Red Cross Saitama Hospital, Saitama, Japan (O.I.).

9. München Klinik Bogenhausen und Schwabing, Klinik für Kardiologie und Internistische Intensivmedizin, München, Germany (F.S.).

10. Ludwig-Maximilians-University, Faculty Munich University Clinic, Germany (F.S.).

11. Kerckhoff Klinik, Bad Nauheim, Germany (M.K.).

12. Mercy General Hospital and Dignity Health Heart and Vascular Institute, Sacramento, CA (A.A.).

13. Tsuchiura Kyodo Hospital, Ibaraki, Japan (S.M.).

14. Department of Cardiology, Division of Arrhythmia and Electrophysiology, University of Health Sciences, Ankara City Hospital, Turkey (S.C.).

15. St. Josefs-Hospital, Wiesbaden, Germany (J.R.E.).

16. Department of Cardiology and Angiology, Bergmannsheil University Hospitals, Ruhr University of Bochum, Germany (I.E.-B.)

17. Ordensklinikum Linz Elisabethinen, Austria (M.M.).

18. Department of Cardiology, University Heart Center Zurich, University Hospital Zurich, Switzerland (A.M.S.).

19. Charité Campus Benjamin Franklin, Berlin, Germany (V.T.).

20. İstanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, İstanbul, Turkey (K.Y.).

21. Herzzentrum Bad Bevensen, Germany (E.L.).

22. University of Arizona, Phoenix (W.S.).

23. Helsicore, Israeli-Georgian Medical Research Clinic, Tbilisia (G.P.).

24. Critical care department Cairo University, Cairo, Egypt (M.S.N.B.).

25. Department of Cardiology, Johns Hopkins University, Baltimore (A.G.).

26. Cardiology and Arrhythmology Clinic, Department of Biomedical Sciences and Public Health, University Hospital “Umberto I-Lancisi-Salesi”, Marche Polytechnic University, Ancona, IT, Italy (A.G.).

27. Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom (R.P.).

28. Division of Cardiology, University of Illinois at Chicago (E.W.).

29. Department of Cardiovascular Medicine, Fukushima Medical University, Japan (M.K.).

30. Universitätsklinik Düsseldorf, Abteilung für Kardiologie, Germany (H.M.).

31. Hamamatsu University School of Medicine, Japan (T.U.).

32. Kocaeli Derince Training and Research, Turkey (T.A.).

33. CCB/Med. Klinik III, Kardiologie, Markuskrankenhaus, Frankfurt am Main, Germany (J.K.R.C.).

34. Arrhythmia and Electrophysiology Unit, Department of Cardiology, Hacettepe University, Ankara, Turkey (K.A.).

35. Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Zabrze, Poland (E.J.-P.).

36. LANS Cardio, Hamburg, Germany (K.-H.K.).

37. Universität zu Köln, Abteilung für Elektrophysiologie, Köln, Germany (D.S.).

38. University Hospital Graz, Austria (D.S.).

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

Reference28 articles.

1. 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.;Hindricks G;Eur Heart J,2020

2. Second-generation cryoballoon-based pulmonary vein isolation: Lessons from a five-year follow-up

3. 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

4. Five-year outcome and predictors of success after second-generation cryoballoon ablation for treatment of symptomatic atrial fibrillation

5. Durability of Pulmonary Vein Isolation with Cryoballoon Ablation: Results from the Sustained PV Isolation with Arctic Front Advance (SUPIR) Study

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