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

doi:10.1161/CIRCEP.121.010516

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

Circ Arrhythm Electrophysiol. 2022 Jan;15(1):e010516. doi: 10.1161/CIRCEP.121.010516. Epub 2021 Dec 28.

Authors

Christian-H Heeger^{1

2

3}, Christian Sohns⁴, Alexander Pott⁵, Andreas Metzner^{2

6

7}, Osamu Inaba⁸, Florian Straube^{9

10}, Malte Kuniss¹¹, Arash Aryana¹², Shinsuke Miyazaki¹³, Serkan Cay¹⁴, Joachim R Ehrlich¹⁵, Ibrahim El-Battrawy¹⁶, Martin Martinek¹⁷, Ardan M Saguner¹⁸, Verena Tscholl¹⁹, Kivanc Yalin²⁰, Evgeny Lyan²¹, Wilber Su²², Giorgi Papiashvili²³, Maichel Sobhy Naguib Botros²⁴, Alessio Gasperetti^{1

25

26}, Riccardo Proietti²⁷, Erik Wissner²⁸, Daniel Scherr, Masashi Kamioka²⁹, Hisaki Makimoto³⁰, Tsuyoshi Urushida³¹, Tolga Aksu³², Julian K R Chun³³, Kudret Aytemir³⁴, Ewa Jędrzejczyk-Patej³⁵, Karl-Heinz Kuck^{1

2

36}, Tillman Dahme⁵, Daniel Steven^{37

38}, Philipp Sommer⁴, Roland Richard Tilz^{1

3}

Affiliations

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.

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

Publication types

Multicenter Study

MeSH terms

Aged
Atrial Fibrillation / diagnosis
Atrial Fibrillation / epidemiology
Atrial Fibrillation / surgery*
Cryosurgery / adverse effects*
Female
Humans
Iatrogenic Disease*
Incidence
Male
Middle Aged
Peripheral Nerve Injuries / diagnosis
Peripheral Nerve Injuries / epidemiology*
Phrenic Nerve / injuries*
Pulmonary Veins / surgery*
Registries
Retrospective Studies
Risk Assessment
Risk Factors
Time Factors
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT03645577