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• W3111557218 abstract "HomeCirculation: Arrhythmia and ElectrophysiologyVol. 13, No. 12Novel Wide-Band Dielectric Imaging System and Occlusion Tool to Guide Cryoballoon-Based Pulmonary Vein Isolation Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyRedditDiggEmail Jump toFree AccessLetterPDF/EPUBNovel Wide-Band Dielectric Imaging System and Occlusion Tool to Guide Cryoballoon-Based Pulmonary Vein IsolationFeasibility and First Insights Andreas Rillig, MD, Laura Rottner, MD, Milena Nodorp, MD, Tina Lin, MBBS, BmedSci, Jessica Weimann, MSc, Paula Münkler, MD, Leon Dinshaw, MD, Ruben Schleberger, MD, Marc D. Lemoine, MD, Moritz Nies, MD, Tim Risius, MD, Stefan Blankenberg, MD, Paulus Kirchhof, MD, Christian Meyer, MD, Bruno Reissmann, MD and Andreas Metzner, MD Andreas RilligAndreas Rillig Correspondence to: Andreas Rillig, MD, Department of Cardiology, Universitäres Herzzentrum Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Email E-mail Address: [email protected] https://orcid.org/0000-0003-3457-0936 Department of Cardiology, University Heart Center Hamburg, Hamburg/Germany (A.R., L.R., M. Nodorp, J.W., P.M., L.D., R.S., M.D.L., M. Nies, T.R., S.B., P.K., C.M., B.R., A.M.). Search for more papers by this author , Laura RottnerLaura Rottner https://orcid.org/0000-0002-1389-8564 Department of Cardiology, University Heart Center Hamburg, Hamburg/Germany (A.R., L.R., M. Nodorp, J.W., P.M., L.D., R.S., M.D.L., M. Nies, T.R., S.B., P.K., C.M., B.R., A.M.). Search for more papers by this author , Milena NodorpMilena Nodorp https://orcid.org/0000-0002-3074-8541 Department of Cardiology, University Heart Center Hamburg, Hamburg/Germany (A.R., L.R., M. Nodorp, J.W., P.M., L.D., R.S., M.D.L., M. Nies, T.R., S.B., P.K., C.M., B.R., A.M.). Search for more papers by this author , Tina LinTina Lin Genesisare, Melbourne, Australia (T.L.). Search for more papers by this author , Jessica WeimannJessica Weimann Department of Cardiology, University Heart Center Hamburg, Hamburg/Germany (A.R., L.R., M. Nodorp, J.W., P.M., L.D., R.S., M.D.L., M. Nies, T.R., S.B., P.K., C.M., B.R., A.M.). Search for more papers by this author , Paula MünklerPaula Münkler Department of Cardiology, University Heart Center Hamburg, Hamburg/Germany (A.R., L.R., M. Nodorp, J.W., P.M., L.D., R.S., M.D.L., M. Nies, T.R., S.B., P.K., C.M., B.R., A.M.). Search for more papers by this author , Leon DinshawLeon Dinshaw Department of Cardiology, University Heart Center Hamburg, Hamburg/Germany (A.R., L.R., M. Nodorp, J.W., P.M., L.D., R.S., M.D.L., M. Nies, T.R., S.B., P.K., C.M., B.R., A.M.). Search for more papers by this author , Ruben SchlebergerRuben Schleberger Department of Cardiology, University Heart Center Hamburg, Hamburg/Germany (A.R., L.R., M. Nodorp, J.W., P.M., L.D., R.S., M.D.L., M. Nies, T.R., S.B., P.K., C.M., B.R., A.M.). Search for more papers by this author , Marc D. LemoineMarc D. Lemoine Department of Cardiology, University Heart Center Hamburg, Hamburg/Germany (A.R., L.R., M. Nodorp, J.W., P.M., L.D., R.S., M.D.L., M. Nies, T.R., S.B., P.K., C.M., B.R., A.M.). Search for more papers by this author , Moritz NiesMoritz Nies https://orcid.org/0000-0002-9384-4151 Department of Cardiology, University Heart Center Hamburg, Hamburg/Germany (A.R., L.R., M. Nodorp, J.W., P.M., L.D., R.S., M.D.L., M. Nies, T.R., S.B., P.K., C.M., B.R., A.M.). Search for more papers by this author , Tim RisiusTim Risius Department of Cardiology, University Heart Center Hamburg, Hamburg/Germany (A.R., L.R., M. Nodorp, J.W., P.M., L.D., R.S., M.D.L., M. Nies, T.R., S.B., P.K., C.M., B.R., A.M.). Search for more papers by this author , Stefan BlankenbergStefan Blankenberg Department of Cardiology, University Heart Center Hamburg, Hamburg/Germany (A.R., L.R., M. Nodorp, J.W., P.M., L.D., R.S., M.D.L., M. Nies, T.R., S.B., P.K., C.M., B.R., A.M.). Search for more papers by this author , Paulus KirchhofPaulus Kirchhof https://orcid.org/0000-0002-1881-0197 Department of Cardiology, University Heart Center Hamburg, Hamburg/Germany (A.R., L.R., M. Nodorp, J.W., P.M., L.D., R.S., M.D.L., M. Nies, T.R., S.B., P.K., C.M., B.R., A.M.). Institute of Cardiovascular Sciences, University of Birmingham, United Kingdom (P.K.). Search for more papers by this author , Christian MeyerChristian Meyer https://orcid.org/0000-0003-0217-3960 Department of Cardiology, University Heart Center Hamburg, Hamburg/Germany (A.R., L.R., M. Nodorp, J.W., P.M., L.D., R.S., M.D.L., M. Nies, T.R., S.B., P.K., C.M., B.R., A.M.). Search for more papers by this author , Bruno ReissmannBruno Reissmann Department of Cardiology, University Heart Center Hamburg, Hamburg/Germany (A.R., L.R., M. Nodorp, J.W., P.M., L.D., R.S., M.D.L., M. Nies, T.R., S.B., P.K., C.M., B.R., A.M.). Search for more papers by this author and Andreas MetznerAndreas Metzner Department of Cardiology, University Heart Center Hamburg, Hamburg/Germany (A.R., L.R., M. Nodorp, J.W., P.M., L.D., R.S., M.D.L., M. Nies, T.R., S.B., P.K., C.M., B.R., A.M.). Search for more papers by this author Originally published15 Dec 2020https://doi.org/10.1161/CIRCEP.120.009219Circulation: Arrhythmia and Electrophysiology. 2020;13:e009219Cryoballoon-based pulmonary vein (PV) isolation is an established treatment option for symptomatic atrial fibrillation1,2 and equally safe and effective as compared to point-by-point radiofrequency current guided by 3-dimensional mapping. Although cryoballoon ablation is associated with shorter procedure times, fluoroscopy times are usually longer compared to radiofrequency ablation.3Recently, KODEX-EPD (Philips, the Netherlands), a novel wide-band dielectric imaging system, was introduced offering high-resolution imaging based on both contact and noncontact mapping.4 The system takes advantage of the unique dielectric properties of biological tissue by inducing anisotropic electrical fields within the patients´ body and measuring the resultant subtle electrical field differences on the catheter electrodes as they move in the hearts´ chambers. This open platform works with any validated electrophysiology catheter and provides computed tomography like images of cardiac anatomy. Furthermore, its novel cryoballoon occlusion tool might support nonfluoroscopic guidance of the cryoballoon-based PV isolation in the near future.5In the current study, we sought to assess the feasibility and impact of the KODEX-EPD system for 3-dimensional imaging-guided cryoballoon-based PV isolation and the novel cryoballoon occlusion tool to detect PV occlusion without fluoroscopy.Data from consecutive patients with drug-refractory symptomatic paroxysmal or persistent atrial fibrillation who underwent cryoballoon-based atrial fibrillation ablation in combination with the KODEX-EPD system and its occlusion tool at University Heart and Vascular Center Hamburg between September 2019 and January 2020 were extracted. Data were analyzed to determine the usefulness of the system and the concordance of PV occlusion using the KODEX-EPD occlusion tool compared with PV-angiography. The study was approved by the ethic committee (WF-021/20). All patients gave informed consent.A 3-dimensional anatomic image of the left atrium including the PV ostia was taken in a standardized sequence via the Achieve catheter (Figure [A]; Medtronic, Inc, Minneapolis, MN). including the PANO-view, which is a world-map like endocardial view of the left atrium and its specific structures such as the PVs, the mitral valve, and the left atrial appendage. In addition, KODEX-EPD was used for nonfluoroscopic verification of PV occlusion (Figure [B]). An inflated, electrically nonconducting, large cryoballoon naturally represents a substantial spatial interference in the distribution of the electrical fields, enabling visualization of the catheter. Making use of that interference, the baseline anatomic recording was obtained while the cryoballoon catheter was inflated, but not yet occluding the vein. Advancing the cryoballoon and occlusion of the PV further change the distribution of the local dielectric properties and when compared to the baseline recording, as long as the Medtronic’s Achieve catheter remains approximately in the same proximal PV location, can effectively verify optimal cryoballoon apposition in the PV ostia. Different versions of KODEX-EPD were used during the study (version 1.4.6 and version 1.4.6a). The major differences between the initial KODEX-EPD occlusion software (version 1.4.6) and the latest version (1.4.6a) include an improvement of the algorithm for the occlusion detection based on clinical data collected with software version 1.4.6 and machine learning algorithms and the ability to mark a shadow position for the Achieve catheter to provide guidance for the optimal placement of the Achieve catheter for occlusion assessment.Download figureDownload PowerPointFigure. A novel wide-band dielectric imaging system and its occlusion tool to guide cryoballoon-based pulmonary vein (PV) isolation.A, Creation of left atrial (LA) and PV anatomic and bipolar imaging applying the KODEX-EPD system and the Achieve spiral mapping catheter. Imaging is started with the LA body followed by the PVs. B, KODEX-EPD imaging of the LA and the PV is shown as a LA shell and the panoramic view (left-sided). Occlusion quality of the target PV is color-coded: full red: not occluded, red/green: partially occluded, green: fully occluded, blue: freeze cycle in progress. The KODEX-EPD occlusion algorithm contains the following steps: B, A: After generation of a LA and PV imaging the Achieve mapping catheter is introduced into the target PV (here: left inferior PV [LIPV]). B, B The cryoballoon is inflated and the Achieve catheter is positioned in close proximity to the cryoballoon to record real-time potentials from the PV. A shadow is taken for the position of the Achieve catheter. B, C, The cryoballoon is then intentionally pulled back from the PV. A baseline analysis is performed by the KODEX-EPD system. KODEX-EPD analysis shows no occlusion (red ring). B, D, The cryoballoon is gently pushed against the target PV to achieve perfect occlusion at the PV/cryoballoon interface. Here KODEX-EPD analysis shows partial occlusion (red and green ring). B, E, By further pushing the cryoballoon against the PV complete PV occlusion is achieved (green ring). B, F, The freeze cycle is started (blue ring). C, Concordance of PV occlusion as assessed by occlusion angiography and KODEX- EPD. AP indicates anterior-posterior; LAA, LA appendage; LSPV, left superior PV; PA, posterior-anterior; RIPV, right inferior PV; and RSPV, right superior PV.Eighty-two patients (28 female, age 65 [57–72], 42 (51%) paroxysmal atrial fibrillation, left atrium diameter 44±9 mm) were studied, and 328 PVs were ablated using the fourth-generation cryoballoon. Both imaging modalities were analyzable in 317 out of 328 (97%) PVs. KODEX-EPD identified PV occlusion at the first attempt in 259 out of 317 PVs and angiography identified occlusion in 288 out of 317 PVs. PV occlusion verified by both KODEX-EPD and angiography was seen in 230 out of 288 (80%) PVs (right superior PV 52/69 [75%], right inferior PV 58/73 [79%], left superior PV 61/74 [82%], left inferior PV 59/72 [82%]). Perfect PV occlusion according to occlusion angiography but imperfect occlusion according to KODEX-EPD was assessed in 58 out of 288 (20%) PVs. Imperfect PV occlusion according to occlusion angiography but perfect occlusion according to KODEX-EPD was demonstrated in 29 out of 317 PVs. There was a trend towards higher concordance of PV occlusion as assessed by fluoroscopy and KODEX-EPD when comparing the latest KODEX-EPD software version to the index version (121/137 [88%] versus 109/151 [72%]; Figure [C]). All PVs were successfully isolated. Median procedure and fluoroscopy time were 87 (76–104) and 17 (14–21) minutes and mean dose area product 649 (438–1013) cGycm2. There were no major periprocedural complications.The workflow as described and evaluated is one of the two currently recommended workflows for PV occlusion assessment. A novel workflow implemented in the next version of KODEX-EP (1.4.7) is thought to be more accurate and potentially more straight-forward but performance in routine practice needs to be investigated. However, the novel workflow in 1.4.7 still requires contrast injections to verify PV occlusion.Although PV occlusion as assessed by KODEX-EPD was verified in all patients of this study cohort via angiography, the described KODEX-EPD workflow allows for PV occlusion assessment without the use of contrast.In conclusion, 3-dimensional KODEX-EPD imaging during cryoballoon ablation is feasible and can provide detailed left atrium visualization. Its novel, nonfluoroscopic KODEX-EPD cryoballoon PV occlusion tool has the potential to accurately assess PV occlusion by the cryoballoon.Nonstandard Abbreviations and AcronymsPVpulmonary veinSources of FundingNone.DisclosuresThe data that support the findings of this study are available from the corresponding author upon reasonable request. A. Metzner received speaker’s honoraria and travel grants from Medtronic, Biosense Webster, Bayer, Boehringer Ingelheim, EPD Solutions/Philips, and Cardiofocus. Dr Rillig received travel grants from Biosense, Medtronic, St. Jude Medical, Cardiofocus, EP Solutions, Ablamap and EPD Solutions/Philips and lecture and consultant fees from St. Jude Medical, Medtronic, Biosense, Cardiofocus, Novartis and Boehringer Ingelheim. Dr Reissmann received speaker’s honoraria and travel grants from Medtronic. Prof Kirchhof received research support for basic, translational, and clinical research projects from European Union, British Heart Foundation, Leducq Foundation, Medical Research Council (UK), and German Centre for Cardiovascular Research, from several drug and device companies active in atrial fibrillation (AF), and has received honoraria from several such companies in the past, but not in the last three years. Prof Kirchhof is listed as inventor on two patents held by University of Birmingham (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783).FootnotesFor Sources of Funding and Disclosures, see page 1504.Correspondence to: Andreas Rillig, MD, Department of Cardiology, Universitäres Herzzentrum Hamburg-Eppendorf, Martinistraße 52, 20246 Hamburg, Germany. Email a.[email protected]deReferences1. Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, et al.. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS.Europace. 2016; 18:1609–1678. doi: 10.1093/europace/euw295CrossrefMedlineGoogle Scholar2. Rottner L, Bellmann B, Lin T, Reissmann B, Tönnis T, Schleberger R, Nies M, Jungen C, Dinshaw L, Klatt N, et al.. Catheter ablation of atrial fibrillation: state of the art and future perspectives.Cardiol Ther. 2020; 9:45–58. doi: 10.1007/s40119-019-00158-2CrossrefMedlineGoogle Scholar3. 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/NEJMoa1602014CrossrefMedlineGoogle Scholar4. Maurer T, Mathew S, Schlüter M, Lemes C, Riedl J, Inaba O, Hashiguchi N, Reißmann B, Fink T, Rottner L, et al.. High-resolution imaging of LA anatomy using a novel wide-band dielectric mapping system: first clinical experience.JACC Clin Electrophysiol. 2019; 5:1344–1354. doi: 10.1016/j.jacep.2019.06.020CrossrefMedlineGoogle Scholar5. Rottner L, Sinning C, Reissmann B, Schleberger R, Dinshaw L, Münkler P, Meyer C, Blankenberg S, Rillig A, Metzner A. Wide-band dielectric imaging and the novel cryoballoon-occlusion tool to guide cryoballoon-based pulmonary vein isolation.Circ Arrhythm Electrophysiol. 2020; 13:e008507. doi: 10.1161/CIRCEP.120.008507LinkGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited ByRottner L, Moser F, Weimann J, Moser J, Schleberger R, Lemoine M, Münkler P, Dinshaw L, Risius T, Kirchhof P, Ouyang F, Reissmann B, Metzner A and Rillig A (2022) Accuracy and Acute Efficacy of the Novel Injection-Based Occlusion Algorithm in Cryoballoon Pulmonary Vein Isolation Guided by Dielectric Imaging, Circulation: Arrhythmia and Electrophysiology, 15:2, Online publication date: 1-Feb-2022. December 2020Vol 13, Issue 12Article InformationMetrics Download: 469 © 2020 American Heart Association, Inc.https://doi.org/10.1161/CIRCEP.120.009219PMID: 33320700 Originally publishedDecember 15, 2020 Keywordsatrial fibrillationmachine learningangiographycatheter ablationPDF download Advertisement SubjectsArrhythmiasAtrial FibrillationCatheter Ablation and Implantable Cardioverter-DefibrillatorElectrophysiologyImagingMachine Learning and Artificial Intelligence" @default.
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