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

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  • Christian-H. Heeger
    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.).
  • Christian Sohns
    Herz-und Diabeteszentrum NRW, Bad Oeynhausen, Germany (C.S., P.S.).
  • Alexander Pott
    Department of Cardiology, University of Ulm, Germany (A.P., T.D.).
  • Andreas Metzner
    Asklepios Klinik St. Georg, Hamburg, Germany (C.-H.H., A.M., K.-H.K.).
  • Osamu Inaba
    Japanese Red Cross Saitama Hospital, Saitama, Japan (O.I.).
  • Florian Straube
    München Klinik Bogenhausen und Schwabing, Klinik für Kardiologie und Internistische Intensivmedizin, München, Germany (F.S.).
  • Malte Kuniss
    Kerckhoff Klinik, Bad Nauheim, Germany (M.K.).
  • Arash Aryana
    Mercy General Hospital and Dignity Health Heart and Vascular Institute, Sacramento, CA (A.A.).
  • Shinsuke Miyazaki
    Tsuchiura Kyodo Hospital, Ibaraki, Japan (S.M.).
  • Serkan Cay
    Department of Cardiology, Division of Arrhythmia and Electrophysiology, University of Health Sciences, Ankara City Hospital, Turkey (S.C.).
  • Joachim R. Ehrlich
    St. Josefs-Hospital, Wiesbaden, Germany (J.R.E.).
  • Ibrahim El-Battrawy
    Department of Cardiology and Angiology, Bergmannsheil University Hospitals, Ruhr University of Bochum, Germany (I.E.-B.)
  • Martin Martinek
    Ordensklinikum Linz Elisabethinen, Austria (M.M.).
  • Ardan M. Saguner
    Department of Cardiology, University Heart Center Zurich, University Hospital Zurich, Switzerland (A.M.S.).
  • Verena Tscholl
    Charité Campus Benjamin Franklin, Berlin, Germany (V.T.).
  • Kivanc Yalin
    İstanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, İstanbul, Turkey (K.Y.).
  • Evgeny Lyan
    Herzzentrum Bad Bevensen, Germany (E.L.).
  • Wilber Su
    University of Arizona, Phoenix (W.S.).
  • Giorgi Papiashvili
    Helsicore, Israeli-Georgian Medical Research Clinic, Tbilisia (G.P.).
  • Maichel Sobhy Naguib Botros
    Critical care department Cairo University, Cairo, Egypt (M.S.N.B.).
  • Alessio Gasperetti
    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.).
  • Riccardo Proietti
    Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom (R.P.).
  • Erik Wissner
    Division of Cardiology, University of Illinois at Chicago (E.W.).
  • Daniel Scherr
  • Masashi Kamioka
    Department of Cardiovascular Medicine, Fukushima Medical University, Japan (M.K.).
  • Hisaki Makimoto
    Universitätsklinik Düsseldorf, Abteilung für Kardiologie, Germany (H.M.).
  • Tsuyoshi Urushida
    Hamamatsu University School of Medicine, Japan (T.U.).
  • Tolga Aksu
    Kocaeli Derince Training and Research, Turkey (T.A.).
  • Julian K.R. Chun
    CCB/Med. Klinik III, Kardiologie, Markuskrankenhaus, Frankfurt am Main, Germany (J.K.R.C.).
  • Kudret Aytemir
    Arrhythmia and Electrophysiology Unit, Department of Cardiology, Hacettepe University, Ankara, Turkey (K.A.).
  • Ewa Jędrzejczyk-Patej
    Department of Cardiology, Congenital Heart Diseases and Electrotherapy, Zabrze, Poland (E.J.-P.).
  • Karl-Heinz Kuck
    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.).
  • Tillman Dahme
    Department of Cardiology, University of Ulm, Germany (A.P., T.D.).
  • Daniel Steven
    Universität zu Köln, Abteilung für Elektrophysiologie, Köln, Germany (D.S.).
  • Philipp Sommer
    Herz-und Diabeteszentrum NRW, Bad Oeynhausen, Germany (C.S., P.S.).
  • Roland Richard Tilz
    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.).

Description

<jats:sec> <jats:title>Background:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Results:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Registration:</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov">https://www.clinicaltrials.gov</jats:ext-link> ; Unique identifier: NCT03645577. </jats:p> </jats:sec> <jats:sec> <jats:title>Graphic Abstract:</jats:title> <jats:p>A graphic abstract is available for this article.</jats:p> </jats:sec>

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