84 results on '"Wakili, R."'
Search Results
2. Role of BMI on radiation dose in patients undergoing pulmonary vein isolation by pulsed field, cryoballoon and high-power-short-duration radiofrequency ablation
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Kupusovic, J, primary, Avranas, K, additional, Schmidt, K, additional, Falagkari, A, additional, Luik, A, additional, Leistner, D, additional, Furnkranz, A, additional, and Wakili, R, additional
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- 2024
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3. Influence of audiovisual distraction on the feeling of stress, analgesic sedation and patient satisfaction during electrophysiological ablation procedures on the heart
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Kupusovic, J, primary, Raschke, R, additional, and Wakili, R, additional
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- 2024
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4. Role of mechanical circulatory support in VT ablation procedures: data from the German PROTECT VT registry
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Wakili, R, primary, Bogossian, H, additional, Falagkari, A, additional, Guckel, D, additional, Kupusovic, J, additional, Sommer, P, additional, Vacanti, G, additional, Zarse, M, additional, Luik, A, additional, and Sohns, C, additional
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- 2024
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5. Comparison of ultralow temperature cryoablation and classical cryoballoon ablation for pulmonary vein isolation in patients with atrial fibrillation
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Rudolph, I, primary, Bohnen, J, additional, Siebermair, J, additional, Rattka, M, additional, Rassaf, T, additional, and Wakili, R, additional
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- 2023
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6. High-density Mapping Guided Pulmonary Vein Isolation for Treatment of Atrial Fibrillation - Two-year clinical outcome of a single center experience
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Siebermair, J., Neumann, B., Risch, F., Riesinger, L., Vonderlin, N., Koehler, M., Lackermaier, K., Fichtner, S., Rizas, K., Sattler, S. M., Sinner, M. F., Kääb, S., Estner, H. L., and Wakili, R.
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- 2019
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7. Pulsed field ablation for atrial fibrillation: acute procedural efficacy and safety of an initial German multicenter experience
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Gunawardene, M A, primary, Lemoine, M, additional, Deneke, T, additional, Wakili, R, additional, Steven, D, additional, Schaeffer, B, additional, Rillig, A, additional, Nentwich, K, additional, Siebermair, J, additional, Filipovic, K, additional, Simu, G, additional, Riesinger, L, additional, Sultan, A, additional, Willems, S, additional, and Metzner, A, additional
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- 2022
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8. Role of catheter location on local impedance measurements and clinical outcome with the new direct sense technology in cardiac ablation procedures
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Pesch, E., primary, Riesinger, L., additional, Vonderlin, N., additional, Kupusovic, J., additional, Koehler, M., additional, Bruns, F., additional, Janosi, R.A., additional, Kochhäuser, S., additional, Dobrev, D., additional, Rassaf, T., additional, Wakili, R., additional, and Siebermair, J., additional
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- 2022
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9. Novel cryoballoon system for pulmonary vein isolation: multicenter assessment of efficacy and safety - The ANTARCTICA study
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Heeger, CH, primary, Pott, A, additional, Sohns, C, additional, Sommer, P, additional, Tondo, C, additional, Fassini, G, additional, Bohnen, J, additional, Dahme, T, additional, Rillig, A, additional, Wakili, R, additional, Metzner, A, additional, and Tilz, RR, additional
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- 2022
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10. Increased FDG uptake in AF individuals suggesting atrial inflammation visualized by FDG PET/CT with glucose uptake suppression protocols
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Kupusovic, J, primary, Weber, M, additional, Kessler, L, additional, Pesch, E, additional, Riesinger, L, additional, Wakili, R, additional, Dobrev, D, additional, Rischpler, C, additional, Rassaf, T, additional, and Siebermair, J, additional
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- 2021
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11. Concomitant real-time measurement and correlation of contact force to baseline local impedance and local impedance drops in RF ablation of left and right atrial procedures
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Riesinger, L, primary, Siebermair, J, additional, Kochhaeuser, S, additional, Pesch, E, additional, Popal, S R, additional, Rassaf, T, additional, and Wakili, R, additional
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- 2021
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12. Initial experience and follow up on the PolarX cryoablation system compared to the established Arctic Front cryoablation system in PVI ablations
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Riesinger, L, primary, Popal, S R, additional, Bohnen, J E, additional, Siebermair, J, additional, Pesch, E, additional, Rassaf, T, additional, Kochhaeuser, S, additional, and Wakili, R, additional
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- 2021
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13. Visualization of fibroblast activation after myocardial infarction using 68Ga-FAPI-PET
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Kupusovic, J, primary, Kessler, L, additional, Ferdinandus, J, additional, Hirmas, N, additional, Fendler, W, additional, Totzeck, M, additional, Herrmann, K, additional, Wakili, R, additional, Rischpler, C, additional, Rassaf, T, additional, and Siebermair, J, additional
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- 2021
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14. ECG scoring for the evaluation of therapy-naïve cancer patients to predict cardiotoxicity
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Pohl, J., Mincu, R.I., Mrotzek, S.M., Wakili, R., Mahabadi, A.A., Potthoff, S.K., Siveke, J.T., Keller, U., Landmesser, U., Rassaf, T., Anker, M.S., and Totzeck, M.
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Cancer Research - Abstract
OBJECTIVE: To evaluate a new electrocardiographic (ECG) score reflecting domains of electrical and structural alterations in therapy-naïve cancer patients to assess their risk of cardiotoxicity. METHODS: We performed a retrospective analysis of 134 therapy-naïve consecutive cancer patients in our two university hospitals concerning four ECG score parameters: Contiguous Q-waves, markers of left ventricular (LV) hypertrophy, QRS duration and JTc prolongation. Cardiotoxicity was assessed after a short-term follow-up (up to 12 months). RESULTS: Of all the patients (n = 25), 19% reached 0 points, 50% (n = 67) reached 1 point, 25% (n = 33) reached 2 points, 5% (n = 7) reached 3 points and 0.7% reached 4 or 5 points (n = 1 respectively). The incidence of cardiotoxicity (n = 28 [21%]) increased with the ECG score, with 0 points at 0%, 1 point 7.5%, 2 points 55%, 3 points 71% and ≥3 points 50%. In the ROC (Receiver operating curves) analysis, the best cut-off for predicting cardiotoxicity was an ECG score of ≥2 points (sensitivity 82%, specificity 82%, AUC 0.84, 95% CI 0.77-0.92, p < 0.0001) which was then defined as a high-risk score. High-risk patients did not differ concerning their age, LV ejection fraction, classical cardiovascular risk factors or cardiac biomarkers compared to those with a low-risk ECG score. CONCLUSION: ECG scoring prior to the start of anti-cancer therapies may help to identify therapy-naïve cancer patients at a higher risk for the development of cardiotoxicity. SIMPLE SUMMARY: Due to improved survival upon effective anti-cancer therapies, the management of treatment-related side-effects is of increasing interest and importance. Cardiovascular side-effects of chemo-, targeted- and/or immunotherapies are common and can be harmful. To date, the identification of patients who could experience those cardiovascular side-effects prior to the anti-cancer therapy start is difficult. We show that the use of a simple electrocardiographic (ECG) score can help to predict the occurrence of cardiovascular toxicity of anti-cancer therapies.
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- 2021
15. Stroke prevention of atrial fibrillation: Improving geographic under-use of contemporary antithrombotic approaches remains a challenge
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Riesinger, L., primary, Wakili, R., additional, and Dobrev, D., additional
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- 2021
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16. RNA-seq profiling of the atrial transcriptome reveals gender-specific patterns and interactions with atrial fibrillation and heart failure
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Balamurali, D, primary, Zeemering, S, additional, Sinner, MF, additional, Wakili, R, additional, Hatem, S, additional, Mont, L, additional, Guasch, E, additional, Batlle, M, additional, Kaab, S, additional, Fabritz, L, additional, Kirchhof, P, additional, Schotten, U, additional, Stoll, M, additional, and Isaacs, A, additional
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- 2021
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17. Triple therapy in the elderly patients and women – results from the MUNICH triple cohort in patients with AF undergoing PCI
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Riesinger, L, primary, Strobl, C.S, additional, Mehr, M, additional, Kellnar, A, additional, Opitz, K, additional, Siebermair, J, additional, Rassaf, T, additional, Massberg, S, additional, and Wakili, R, additional
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- 2020
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18. P2736Association between survival and non-selective prehospital acetylsalicylic acid and heparin administration in patients with out-of-hospital cardiac arrest
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Grabmaier, U, primary, Rizas, K, additional, Weckbach, L, additional, Wakili, R, additional, Huflaender, Y, additional, Berghof, J, additional, Wiegers, C, additional, Massberg, S, additional, and Brunner, S, additional
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- 2018
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19. Expert consensus document: Defining the major health modifiers causing atrial fibrillation: a roadmap to underpin personalized prevention and treatment
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Fabritz, L., Guasch, E., Antoniades, C., Bardinet, I., Benninger, G., Betts, T.R., Brand, E., Breithardt, G., Bucklar-Suchankova, G., Camm, A.J., Cartlidge, D., Casadei, B., Chua, W.W., Crijns, Harry, Deeks, J., Hatem, S., Hidden-Lucet, F., Kääb, S., Maniadakis, N., Martin, S., Mont, L., Reinecke, H., Sinner, M.F., Schotten, Ulrich, Southwood, T., Stoll, Monika, Vardas, P., Wakili, R., West, A., Ziegler, A., Kirchhof, P., RS: CARIM - R2.01 - Clinical atrial fibrillation, Cardiologie, MUMC+: MA Cardiologie (9), RS: CARIM - R2.11 - Experimental atrial fibrillation, Fysiologie, Biochemie, RS: FHML MaCSBio, and RS: CARIM - R1.06 - Genetic Epidemiology and Genomics of cardiovascular diseases
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CHRONIC KIDNEY-DISEASE ,Consensus ,LATE GADOLINIUM ENHANCEMENT ,Cardiology ,LONG-QT SYNDROME ,Risk Assessment ,EUROPEAN-SOCIETY ,RANDOMIZED CLINICAL-TRIAL ,CONSENSUS CONFERENCE ,LEFT-VENTRICULAR DYSFUNCTION ,Treatment Outcome ,RISK-FACTOR ,Predictive Value of Tests ,Risk Factors ,Atrial Fibrillation ,Preventive Health Services ,Animals ,Humans ,Precision Medicine ,PULMONARY VEIN ISOLATION ,NERVE-STIMULATION - Abstract
Despite remarkable advances in antiarrhythmic drugs, ablation procedures, and stroke-prevention strategies, atrial fibrillation (AF) remains an important cause of death and disability in middle-aged and elderly individuals. Unstructured management of patients with AF sharply contrasts with our detailed, although incomplete, knowledge of the mechanisms that cause AF and its complications. Altered calcium homeostasis, atrial fibrosis and ageing, ion-channel dysfunction, autonomic imbalance, fat-cell infiltration, and oxidative stress, in addition to a susceptible genetic background, contribute to the promotion, maintenance, and progression of AF. However, clinical management of patients with AF is currently guided by stroke risk parameters, AF pattern, and symptoms. In response to this apparent disconnect between the known pathophysiology of AF and clinical management, we propose a roadmap to develop a set of clinical markers that reflect the major causes of AF in patients. Thereby, the insights into the mechanisms causing AF will be transformed into a format that can underpin future personalized strategies to prevent and treat AF, ultimately informing better patient care.
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- 2015
20. Alteration of Endothelin 1, MCP-1 and Chromogranin A in patients with atrial fibrillation undergoing pulmonary vein isolation
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Lackermair, K., primary, Clauss, S., additional, Voigt, T., additional, Klier, I., additional, Summo, C., additional, Hildebrand, B., additional, Nickel, T., additional, Estner, H. L., additional, Kääb, S., additional, Wakili, R., additional, and Wilbert-Lampen, U., additional
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- 2017
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21. oVEMP detektieren Änderungen des intrakraniellen Druckes
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Gürkov, R, Wakili, R, Bartl, K, and Jerin, C
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ddc: 610 ,610 Medical sciences ,Medicine - Abstract
Einleitung: Okuläre vestibulär evozierte myogene Potentiale (oVEMP) repräsentieren extraokuläre Muskelaktivität als Antwort auf vestibuläre Reize. In dieser Studie wird die Hypothese geprüft, ob oVEMP durch einen erhöhten intrakraniellen Druck moduliert werden.[for full text, please go to the a.m. URL], 85. Jahresversammlung der Deutschen Gesellschaft für Hals-Nasen-Ohren-Heilkunde, Kopf- und Hals-Chirurgie
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- 2014
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22. Role of constitutively active acetylcholine-mediated potassium current in atrial contractile dysfunction caused by atrial tachycardia remodelling
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Koo, S.-H., primary, Wakili, R., additional, Heo, J.-H., additional, Chartier, D., additional, Kim, H.-S., additional, Kim, S.-J., additional, Lee, J.-W., additional, Qi, X. Y., additional, Nattel, S., additional, and Cha, T.-J., additional
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- 2010
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23. 578 Evaluation of pulmonary vein diameter after impedance-controlled ostial catheter ablation for paroxysmal atrial fibrillation by multislice computed tomography
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Wakili, R., primary, Remp, T., additional, Matis, T., additional, Becker, A., additional, Becker, C.H.R., additional, Reithmann, C.H., additional, and Steinbeck, G., additional
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- 2005
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24. Drug therapy and catheter ablation for management of arrhythmias in continuous flow left ventricular assist device's patients: a Clinical Consensus Statement of the European Heart Rhythm Association and the Heart Failure Association of the ESC.
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Peichl P, Bayes-Genis A, Deneke T, Chioncel O, deRiva M, Crespo-Leiro MG, Frontera A, Gustafsson F, Martins RP, Pagnesi M, Maury P, Petrie MC, Sacher F, Amir O, Di Biase L, Deisenhofer I, Gasparetti A, Hocini M, Costa FM, Moura B, Skouri H, Tocchetti CG, Volterrani M, and Wakili R
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- Humans, Consensus, Treatment Outcome, Risk Factors, Tachycardia, Ventricular therapy, Tachycardia, Ventricular surgery, Tachycardia, Ventricular physiopathology, Ventricular Function, Left, Europe, Heart-Assist Devices, Catheter Ablation methods, Heart Failure therapy, Heart Failure physiopathology, Anti-Arrhythmia Agents therapeutic use, Arrhythmias, Cardiac therapy, Arrhythmias, Cardiac physiopathology, Arrhythmias, Cardiac diagnosis
- Abstract
Left ventricular assist devices (LVADs) are an increasingly used strategy for the management of patients with advanced heart failure. Although these devices effectively improve survival, atrial and ventricular arrhythmias are common with a prevalence of 20-50% at one year after LVAD implantation. Arrhythmias predispose these patients to additional risk and are associated with considerable morbidity from recurrent implantable cardioverter-defibrillator shocks, progressive failure of the unsupported right ventricle, and herald an increased risk of mortality. Management of patients with arrhythmias and LVAD differs in many aspects from the general population heart failure patients. These include ruling out the reversible causes of arrhythmias that in LVAD patients may include mechanical irritation from the inflow cannula and suction events. For patients with symptomatic arrhythmias refractory to medical treatment, catheter ablation might be relevant. There are specific technical and procedural challenges perceived to be unique to LVAD-related ventricular tachycardia (VT) ablation such as vascular and LV access, signal filtering, catheter manoeuvrability within decompressed chambers, and electroanatomic mapping system interference. In some patients, the arrhythmogenic substrate might not be readily accessible by catheter ablation after LVAD implantation. In this regard, the peri-implantation period offers a unique opportunity to surgically address arrhythmogenic substrate and suppress future VT recurrences. This document aims to address specific aspects of the management of arrhythmias in LVAD patients focusing on anti-arrhythmic drug therapy and ablations., Competing Interests: Conflict of interest: O.A. serves as an advisor for Novartis, Boehringer Ingelheim, AstraZeneca, Merck Sharp & Dohme, Sanofi, Bayer, Pfizer, Amgen, Bristol Myers Squibb, Eli Lilly and reports consulting fees from Medical Consults: Restore -Medical, Cordio-Medical, and Boehringer Ingelheim. A.B-G. serves as an advisor for Abbott, AstraZeneca, Boehringer-Ingelheim, Bayer, Medtronic, Novartis, Roche Diagnostics, and Vifor. F.G. serves as an advisor for Abbott, FineHeart, AdjuCor, Corwave, Bayer, Astra-Zeneca, Ionis, Alnylam, and Roche. M.PE. reports research funding from Boehringer Ingelheim, Roche, SQ Innovations, Astra Zeneca, Novartis, Novo Nordisk, Medtronic, Boston Scientific, Pharmacosmos, and consultancy for Abott, Akero, Applied Therapeutics, Amgen, AnaCardio, Biosensors, Boehringer Ingelheim, Corteria, Novartis, Astra Zeneca, Novo Nordisk, Abbvie, Bayer, Horizon Therapeutics, Foundry, Takeda, Cardiorentis, Pharmacosmos, Siemens, Eli Lilly, Vifor, New Amsterdam, Moderna, Teikoku, LIB Therapeutics, 3R Lifesciences, Reprieve, FIRE 1, Corvia, Regeneron. M.PA. reports fees from Abbott Vascular, AstraZeneca, Boehringer Ingelheim, Novartis, Roche Diagnostics, and Vifor Pharma. P.P. reports speakers’ honoraria from Boston Scientific, Abbott, Medtronic, Biosense Webster, and Biotronik. F.S. reports speakers’ honoraria from Abbott, Biosense Webster, Boston Scientific, and Medtronic, and consulting fees from Inheart. Others report no relevant conflicts of interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2024
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25. Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study.
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Ekanem E, Neuzil P, Reichlin T, Kautzner J, van der Voort P, Jais P, Chierchia GB, Bulava A, Blaauw Y, Skala T, Fiala M, Duytschaever M, Szeplaki G, Schmidt B, Massoullie G, Neven K, Thomas O, Vijgen J, Gandjbakhch E, Scherr D, Johannessen A, Keane D, Boveda S, Maury P, García-Bolao I, Anic A, Hansen PS, Raczka F, Lepillier A, Guyomar Y, Gupta D, Van Opstal J, Defaye P, Sticherling C, Sommer P, Kucera P, Osca J, Tabrizi F, Roux A, Gramlich M, Bianchi S, Adragão P, Solimene F, Tondo C, Russo AD, Schreieck J, Luik A, Rana O, Frommeyer G, Anselme F, Kreis I, Rosso R, Metzner A, Geller L, Baldinger SH, Ferrero A, Willems S, Goette A, Mellor G, Mathew S, Szumowski L, Tilz R, Iacopino S, Jacobsen PK, George A, Osmancik P, Spitzer S, Balasubramaniam R, Parwani AS, Deneke T, Glowniak A, Rossillo A, Pürerfellner H, Duncker D, Reil P, Arentz T, Steven D, Olalla JJ, de Jong JSSG, Wakili R, Abbey S, Timo G, Asso A, Wong T, Pierre B, Ewertsen NC, Bergau L, Lozano-Granero C, Rivero M, Breitenstein A, Inkovaara J, Fareh S, Latcu DG, Linz D, Müller P, Ramos-Maqueda J, Beiert T, Themistoclakis S, Meininghaus DG, Stix G, Tzeis S, Baran J, Almroth H, Munoz DR, de Sousa J, Efremidis M, Balsam P, Petru J, Küffer T, Peichl P, Dekker L, Della Rocca DG, Moravec O, Funasako M, Knecht S, Jauvert G, Chun J, Eschalier R, Füting A, Zhao A, Koopman P, Laredo M, Manninger M, Hansen J, O'Hare D, Rollin A, Jurisic Z, Fink T, Chaumont C, Rillig A, Gunawerdene M, Martin C, Kirstein B, Nentwich K, Lehrmann H, Sultan A, Bohnen J, Turagam MK, and Reddy VY
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- Humans, Female, Male, Middle Aged, Aged, Treatment Outcome, Postoperative Complications epidemiology, Postoperative Complications etiology, Atrial Fibrillation surgery, Atrial Fibrillation therapy, Catheter Ablation adverse effects, Catheter Ablation methods
- Abstract
Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF., (© 2024. The Author(s).)
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- 2024
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26. Efficacy and safety of pulsed field ablation compared to cryoballoon ablation in the treatment of atrial fibrillation: a meta-analysis.
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Rudolph I, Mastella G, Bernlochner I, Steger A, von Olshausen G, Hahn F, Wakili R, Laugwitz KL, Martens E, and Rattka M
- Abstract
Aims: Pulmonary vein isolation (PVI) represents the gold standard in the treatment of atrial fibrillation (AF) and the use of single-shot techniques, such as cryoballoon ablation (CBA) and pulsed field ablation (PFA) using a pentaspline catheter, has gained prominence. Recent studies hypothesize that PFA might be superior to CBA, although procedural efficacy and safety data are inconsistent. A meta-analysis was conducted to compare both energy sources for the treatment of AF., Methods and Results: A structured systematic database search and meta-analysis were performed on studies investigating outcomes, periprocedural complications, and/or procedural parameters of AF patients treated by either CBA or PFA. Eleven studies reporting data from 3805 patients were included. Pulmonary vein isolation by PFA was associated with a significantly lower recurrence of atrial fibrillation/atrial tachycardia [odds ratio (OR) = 0.73, 95% confidence interval (CI) = 0.54-0.98, I
2 = 20%] and fewer periprocedural complications (OR = 0.62, 95% CI = 0.40-0.96, I2 = 6%) compared to CBA. The lower complication rate following PFA was mainly driven by fewer phrenic nerve injuries (OR = 0.19, 95% CI = 0.08-0.43, I2 = 0%). However, there were more cases of cardiac tamponades after PFA (OR = 2.56, 95% CI = 1.01-6.49, I2 = 0%). Additionally, using PFA for PVI was associated with shorter total procedure times [mean difference (MD) = -9.68, 95% CI = -14.92 to -4.43 min, I2 = 92%] and lower radiation exposure (MD = -148.07, 95% CI = -276.50 to -19.64 µGy·mI2 = 7%)., Conclusion: Our results suggest that PFA for PVI, compared to CBA, enables shorter procedure times with lower arrhythmia recurrence and a reduced risk of periprocedural complications. Randomized controlled trials need to confirm our findings., Competing Interests: Conflict of interest: R.W. received honoraria for lectures and advisory board activities and research funding from Boston Scientific. Otherwise, there are no conflicts of interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)- Published
- 2024
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27. Risk of Cardiac Implantable Electronic Device Infection after Early versus Delayed Lead Repositioning.
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Schvartz N, Haidary A, Wakili R, Hecker F, Kupusovic J, Zsigmond EJ, Miklos M, Saghy L, Szili-Torok T, Erath JW, and Vamos M
- Abstract
(1) Background: Early reintervention increases the risk of infection of cardiac implantable electronic devices (CIEDs). Some operators therefore delay lead repositioning in the case of dislocation by weeks; however, there is no evidence to support this practice. The aim of our study was to evaluate the impact of the timing of reoperation on infection risk. (2) Methods: The data from consecutive patients undergoing lead repositioning in two European referral centers were retrospectively analyzed. The odds ratio (OR) of CIED infection in the first year was compared among patients undergoing early (≤1 week) vs. delayed (>1 week to 1 year) reoperation. (3) Results: Out of 249 patients requiring CIED reintervention, 85 patients (34%) underwent an early (median 2 days) and 164 (66%) underwent a delayed lead revision (median 53 days). A total of nine (3.6%) wound/device infections were identified. The risk of infection was numerically lower in the early (1.2%) vs. delayed (4.9%) intervention group yielding no statistically significant difference, even after adjustment for typical risk factors for CIED infection (adjusted OR = 0.264, 95% CI 0.032-2.179, p = 0.216). System explantation/extraction was necessary in seven cases, all being revised in the delayed group. (4) Conclusions: In this bicentric, international study, delayed lead repositioning did not reduce the risk of CIED infection.
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- 2024
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28. Longer and better lives for patients with atrial fibrillation: the 9th AFNET/EHRA consensus conference.
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Linz D, Andrade JG, Arbelo E, Boriani G, Breithardt G, Camm AJ, Caso V, Nielsen JC, De Melis M, De Potter T, Dichtl W, Diederichsen SZ, Dobrev D, Doll N, Duncker D, Dworatzek E, Eckardt L, Eisert C, Fabritz L, Farkowski M, Filgueiras-Rama D, Goette A, Guasch E, Hack G, Hatem S, Haeusler KG, Healey JS, Heidbuechel H, Hijazi Z, Hofmeister LH, Hove-Madsen L, Huebner T, Kääb S, Kotecha D, Malaczynska-Rajpold K, Merino JL, Metzner A, Mont L, Ng GA, Oeff M, Parwani AS, Puererfellner H, Ravens U, Rienstra M, Sanders P, Scherr D, Schnabel R, Schotten U, Sohns C, Steinbeck G, Steven D, Toennis T, Tzeis S, van Gelder IC, van Leerdam RH, Vernooy K, Wadhwa M, Wakili R, Willems S, Witt H, Zeemering S, and Kirchhof P
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- Humans, Risk, Hemorrhage, Anticoagulants therapeutic use, Atrial Fibrillation complications, Atrial Fibrillation diagnosis, Atrial Fibrillation epidemiology, Stroke etiology, Stroke prevention & control
- Abstract
Aims: Recent trial data demonstrate beneficial effects of active rhythm management in patients with atrial fibrillation (AF) and support the concept that a low arrhythmia burden is associated with a low risk of AF-related complications. The aim of this document is to summarize the key outcomes of the 9th AFNET/EHRA Consensus Conference of the Atrial Fibrillation NETwork (AFNET) and the European Heart Rhythm Association (EHRA)., Methods and Results: Eighty-three international experts met in Münster for 2 days in September 2023. Key findings are as follows: (i) Active rhythm management should be part of the default initial treatment for all suitable patients with AF. (ii) Patients with device-detected AF have a low burden of AF and a low risk of stroke. Anticoagulation prevents some strokes and also increases major but non-lethal bleeding. (iii) More research is needed to improve stroke risk prediction in patients with AF, especially in those with a low AF burden. Biomolecules, genetics, and imaging can support this. (iv) The presence of AF should trigger systematic workup and comprehensive treatment of concomitant cardiovascular conditions. (v) Machine learning algorithms have been used to improve detection or likely development of AF. Cooperation between clinicians and data scientists is needed to leverage the potential of data science applications for patients with AF., Conclusions: Patients with AF and a low arrhythmia burden have a lower risk of stroke and other cardiovascular events than those with a high arrhythmia burden. Combining active rhythm control, anticoagulation, rate control, and therapy of concomitant cardiovascular conditions can improve the lives of patients with AF., Competing Interests: Conflict of interest The 9th AFNET/EHRA consensus conference was partially supported by the European Union MAESTRIA project (grant agreement 965286) to AFNET. The following participants and authors are employees of companies active in cardiovascular health as indicated in their affiliations: M.D.M., E.D., C.E., G.H., L.H.H., T.H., R.H.v.L., M.W., and H.W. P.K. was partially supported by the European Union AFFECT-AF (grant agreement 847770) and MAESTRIA (grant agreement 965286), German Center for Cardiovascular Research supported by the German Ministry of Education and Research (DZHK, grant numbers DZHK FKZ 81X2800182, 81Z0710116, and 81Z0710110), German Research Foundation (Ki 509167694), and Leducq Foundation. He receives research support for basic, translational, and clinical research projects from several drug and device companies active in AF and has received honoraria from several such companies in the past, but not in the last 3 years. He is listed as an inventor on two issued patents held by the University of Hamburg (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783). J.G.A. was partially supported by the Canadian Arrhythmia Network and the Michael Smith Foundation for Health Research, Baylis Medical. He receives consulting fees/honoraria from Bayer, BMS/Pfizer Alliance, Servier, and Medtronic Inc. E.A. receives consulting fees/honoraria from Biosense Webster and Bayer. G.B. receives consulting fees/honoraria from Bayer, BMS, Boston Scientific, Daiichi Sankyo, Sanofi, and Janssen. A.J.C. receives consulting fees/honoraria from Bayer, Pfizer/BMS, Daiichi Sankyo, Menarini, Sanofi, Boston Scientific, Biosense Webster, Abbott, Acesion Pharma, Huya Bio, and Milestone. V.C. receives consulting fees/honoraria from Bayer, Boehringer Ingelheim, and Ever Pharma (paid to the institution of employment). W.D. receives consulting fees/honoraria from Reata and research grants from MicroPort, Boston Scientific, and Abbott. S.Z.D. receives consulting fees from BMS/Pfizer, Cortrium, and Acesion Pharma and speaker fees from MS/Pfizer and Bayer. He is listed as a medical advisor for Vital Beats. Dobromir D. receives consulting fees/honoraria from Elsevier, Springer Healthcare Ltd, and Daiichi Sankyo and research grants as follows: four NIH grants (partially) from Baylor College of Medicine, Houston; one NIH grant from UC Davis, one NIH grant from the University of Minnesota, and one EU-Project H2020. David D. receives consulting fees/honoraria from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Boston Scientific, BMS/Pfizer, CVRx, Medtronic, MicroPort, and Zoll and research grants from Roche, CVRx, and Zoll. L.E. has received lecture fees from various companies in AF in the past but none related to the present work. L.F. receives consulting fees/honoraria from Roche (paid to the institution of employment). She is currently employed at the UKE and previously at the University of Birmingham. She was partially supported by the European Union AFFECT-EU (grant agreement 847770), MAESTRIA (grant agreement 965286), CATCH ME (grant agreement 633196), and the British Heart Foundation (AA/18/2/3218). D.F.-R. receives research grants from Abbott. He is listed as an inventor on two issued patents: EP3636147A1 (method for the identification of cardiac fibrillation drivers and/or the footprint of rotational activations) and PCT/EP2022/071364 (system and method of assessment of electromechanical remodelling). A.G. receives consulting fees/honoraria from Daiichi Sankyo, Bayer, BMS/Pfizer, Medtronic, Abbott, and Boston Scientific and was partially supported by the European Union MAESTRIA (grant agreement 965286). K.G.H. receives consulting fees/honoraria from Abbott, Alexion, Amarin, Astra Zeneca, Bayer Healthcare, Biotronik, Boehringer Ingelheim, Boston Scientific, BMS/Pfizer, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novaris, Portola, Premier Research, Sanofi, SUN Pharma, and W. L. Gore and Associates. J.S.H. receives speaking fees from BMS/Pfizer, Bayer, Servier, and Boston Scientific and consulting fees from Bayer and Boston Scientific. He receives research grants from BMS/Pfizer, Servier, Novartis, Boston Scientific, and Medtronic. H.H. receives lecture and consulting fees from Bayer, Biotronik, BMS/Pfizer, Daiichi Sankyo, Milestone Pharmaceuticals, Centrix India, C.T.I. Germany, ESC, Medscape, and Springer Healthcare Ltd. He receives research grants (paid to the institution of employment, University of Antwerp and/or University of Hasselt) from Abbott, Bayer, Biosense Webster, Boston Scientific, Daiichi Sankyo, Fibricheck/Qompium, Medtronic, and BMS/Pfizer. Z.H. receives consulting fees/honoraria from Boehringer Ingelheim, BMS/Pfizer, and Roche Diagnostics. He was partially supported by The Swedish Society for Medical Research (S17-0133), Hjärt-Lungfonden (The Swedish Heart-Lung Foundation, 20200722), and the institution he is currently employed at (Uppsala University Hospital). L.H.-M. receives research grants from the Spanish Ministry of Science and Innovation (PID2020-116927RB-C21) and Fondo Europeo de Desarrollo Regional (FEDER). D.K. receives consulting fees/honoraria from Bayer, Amomed, and Protherics Medicines Development. He receives research grants from the National Institute for Health Research (NIHR CDF-2015-08-074 RAE-AF; NIHR130280 DaRe2THINK; NIHR13274 D2T-NeuroVascular; and NIHR203326 Biomedical Research Centre), the British Heart Foundation (PG/17/55/33087, AA/182/3218, and FS/CDRF/21/21032), the EU/EFPIA Innovative Medicines Initiative (BigData@Heart 116074), EU Horizon and UKRI (HYPERMARKER 101095480) UK National Health Service—Data for R&D-Subnational Secure Data Environment programme, UK Department for Business, Energy Industrial Strategy Regulators Pioneer Fund, the Cook & Wolstenholme Charitable Trust, and the European Society of Cardiology supported by educational grants from Boehringer Ingelheim, BMS/Pfizer, Alliance, Bayer, Daiichi Sankyo, Boston Scientific, the NIHR/University of Oxford Biomedical Research Centre, and the British Hear Foundation, the University of Birmingham Accelerator Award (STEEER-AF). J.L.M. receives consulting fees/honoraria from Biotronik, Medtronic, MicroPort, and Milestone Pharmaceuticals. A.M. receives consulting fees/honoraria from Medtronic, Biosense Webster, and Boston Scientific and lecture fees from Medtronic, Boston Scientific, Biosense Webster, BMS, and Bayer. L.M. receives consulting fees/honoraria from Abbott, Medtronic, Boston Scientific, and Johnson & Johnson. G.A.N. receives lecture fees from AliveCor, consultant fees from Biosense Webster, and research grants from Abbott and Biosense Webster. H.P. receives consulting fees/honoraria from Abbott, Boston Scientific, Biosense Webster, Medtronic, Daiichi Sankyo, Bayer, and Pfizer. P.S. receives consulting fees/honoraria from Medtronic, Boston Scientific, Abbott, CathRx, and PaceMate (paid to the institution of employment). He is currently employed at the University of Adelaide, which receives research grants from Medtronic, Boston Scientific, and Becton-Dickenson. R.B.S. receives consulting fees/honoraria from BMS/Pfizer. She was partially supported by the European Union Horizon 2020 research and innovation programme (grant agreement 648131 and 847770), German Center for Cardiovascular Research supported by the German Ministry of Education and Research (DZHK, grant numbers 81Z1710103 and 81Z0710114), German Ministry of Research and Education (BMBF 01ZX1408A), ERACoSysMed3 (031L0239), Wolfgang Seefried project funding German Heart Foundation. U.S. receives consulting fees/honoraria from University Svizzerra Italiana, Stanford, and Johnson & Johnson and research grants from the European Union, Dutch Heart Foundation, Roche, and EP Solution. He is a shareholder of YourRhythmics B.V. T.T. receives consulting fees/honoraria from Boston Scientific and Medtronic. I.C.v.G. receives consulting fees/honoraria from Bayer (paid to the institution of employment). She is currently employed at the University of Groningen. K.V. receives consulting fees/honoraria from Abbott, Philips, Medtronic, Biosense Webster, and Boston Scientific and research grants from Medtronic and Biosense Webster. R.W. receives consulting fees/honoraria from Boehringer Ingelheim, BMS/Pfizer, Daiichi Sankyo, Boston Scientific, Biotronik, Abiomed, and Zoll and a research grant from Boston Scientific, BMS/Pfizer, and Abiomed. S.W. receives consulting fees/honoraria from Boehringer Ingelheim, Boston Scientific, Abbott, and Bayer Vital and a research grant from Boston Scientific. All remaining authors (G.B., J.C.N., T.D.P., N.D., M.F., E.G., S.H., S.K., D.L., K.M.-R., M.O., A.S.P., U.R., M.R., D.S., C.S., G.S., D.S., S.T., R.H.v.L., and S.Z.) have declared no conflicts of interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2024
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29. Delayed 68 Ga-FAPI-46 PET/MR imaging confirms ongoing fibroblast activation in patients after acute myocardial infarction.
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Kupusovic J, Kessler L, Kazek S, Chodyla MK, Umutlu L, Zarrad F, Nader M, Fendler WP, Varasteh Z, Hermann K, Dobrev D, Wakili R, Rassaf T, Siebermair J, and Rischpler C
- Abstract
Purpose of the Report: Combined cardiac
68 Ga-Fibroblast-Activation Protein-alpha inhibitor (FAPI) positron-emission tomography (PET) and cardiac magnetic resonance imaging (MRI) constitute a novel diagnostic tool in patients for the assessment of myocardial damage after an acute myocardial infarction (AMI). Purpose of this pilot study was to evaluate simultaneous Ga-68-FAPI-46-PET/MR imaging in the delayed phase after AMI., Material and Methods: Eleven patients underwent hybrid68 Ga-FAPI-46 PET/MRI post AMI. Standardized uptake values and fibroblast activation volume (FAV) were calculated and correlated with serum biomarkers and MRI parameters., Results: Significant68 Ga-FAPI-46 uptake could be demonstrated in 11 (100 %) patients after a mean period of 30.9 ± 22.0 days. FAV significantly exceeded the infarction size in MRI and showed a good correlation to MRI parameters as well as to serum biomarkers of myocardial damage., Conclusions:68 Ga-FAPI-46 PET/MRI offers molecular and morphological imaging of affected myocardium after AMI. This study demonstrates ongoing fibroblast activation in a delayed phase after AMI and generates hypotheses for future studies while aiming for a better understanding of myocardial remodeling following ischemic tissue damage., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors.)- Published
- 2024
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30. Heart Failure, Female Sex, and Atrial Fibrillation Are the Main Drivers of Human Atrial Cardiomyopathy: Results From the CATCH ME Consortium.
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Winters J, Isaacs A, Zeemering S, Kawczynski M, Maesen B, Maessen J, Bidar E, Boukens B, Hermans B, van Hunnik A, Casadei B, Fabritz L, Chua W, Sommerfeld L, Guasch E, Mont L, Batlle M, Hatem S, Kirchhof P, Wakili R, Sinner M, Stoll M, Goette A, Verheule S, and Schotten U
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- Humans, Female, Male, Aged, Sex Factors, Middle Aged, Heart Atria pathology, Europe epidemiology, Atrial Remodeling, Myocytes, Cardiac pathology, Myocytes, Cardiac metabolism, Phenotype, Atrial Appendage pathology, Atrial Fibrillation etiology, Atrial Fibrillation physiopathology, Atrial Fibrillation pathology, Heart Failure etiology, Heart Failure pathology, Cardiomyopathies pathology, Cardiomyopathies etiology, Fibrosis
- Abstract
Background: Atrial cardiomyopathy (atCM) is an emerging prognostic factor in cardiovascular disease. Fibrotic remodeling, cardiomyocyte hypertrophy, and capillary density are hallmarks of atCM. The contribution of etiological factors and atrial fibrillation (AF) to the development of differential atCM phenotypes has not been quantified. This study aimed to evaluate the association between histological features of atCM and the clinical phenotype., Methods and Results: We examined left atrial (LA, n=95) and right atrial (RA, n=76) appendages from a European cohort of patients undergoing cardiac surgery. Quantification of histological atCM features was performed following wheat germ agglutinin/CD31/vimentin staining. The contributions of AF, heart failure, sex, and age to histological characteristics were determined with multiple linear regression models. Persistent AF was associated with increased endomysial fibrosis (LA: +1.13±0.47 μm, P =0.038; RA: +0.94±0.38 μm, P =0.041), whereas total extracellular matrix content was not. Men had larger cardiomyocytes (LA: +1.92±0.72 μm, P <0.001), while women had more endomysial fibrosis (LA: +0.99±0.56 μm, P =0.003). Patients with heart failure showed more endomysial fibrosis (LA: +1.85±0.48 μm, P <0.001) and extracellular matrix content (LA: +3.07±1.29%, P =0.016), and a higher capillary density (LA: +0.13±0.06, P =0.007) and size (LA: +0.46±0.22 μm, P =0.044). Fuzzy k-means clustering of histological features identified 2 subtypes of atCM: 1 characterized by enhanced endomysial fibrosis (LA: +3.17 μm, P <0.001; RA: +2.86 μm, P <0.001), extracellular matrix content (LA: +3.53%, P <0.001; RA: +6.40%, P <0.001) and fibroblast density (LA: +4.38%, P <0.001), and 1 characterized by cardiomyocyte hypertrophy (LA: +1.16 μm, P =0.008; RA: +2.58 μm, P <0.001). Patients with fibrotic atCM were more frequently female (LA: odds ratio [OR], 1.33, P =0.002; RA: OR, 1.54, P =0.004), with persistent AF (LA: OR, 1.22, P =0.036) or heart failure (LA: OR, 1.62, P <0.001). Hypertrophic features were more common in men (LA: OR=1.33, P =0.002; RA: OR, 1.54, P =0.004)., Conclusions: Fibrotic atCM is associated with female sex, persistent AF, and heart failure, while hypertrophic features are more common in men.
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- 2023
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31. Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry.
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Turagam MK, Neuzil P, Schmidt B, Reichlin T, Neven K, Metzner A, Hansen J, Blaauw Y, Maury P, Arentz T, Sommer P, Anic A, Anselme F, Boveda S, Deneke T, Willems S, van der Voort P, Tilz R, Funasako M, Scherr D, Wakili R, Steven D, Kautzner J, Vijgen J, Jais P, Petru J, Chun J, Roten L, Füting A, Lemoine MD, Ruwald M, Mulder BA, Rollin A, Lehrmann H, Fink T, Jurisic Z, Chaumont C, Adeliño R, Nentwich K, Gunawardene M, Ouss A, Heeger CH, Manninger M, Bohnen JE, Sultan A, Peichl P, Koopman P, Derval N, Kueffer T, Rahe G, and Reddy VY
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- Humans, Female, Middle Aged, Aged, Retrospective Studies, Stroke Volume, Ventricular Function, Left, Treatment Outcome, Registries, Recurrence, Atrial Fibrillation diagnosis, Atrial Fibrillation surgery, Atrial Fibrillation drug therapy, Atrial Flutter etiology, Catheter Ablation adverse effects, Catheter Ablation methods, Pulmonary Veins
- Abstract
Background: Pulsed field ablation is a novel nonthermal cardiac ablation modality using ultra-rapid electrical pulses to cause cell death by a mechanism of irreversible electroporation. Unlike the traditional ablation energy sources, pulsed field ablation has demonstrated significant preferentiality to myocardial tissue ablation, and thus avoids certain thermally mediated complications. However, its safety and effectiveness remain unknown in usual clinical care., Methods: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a retrospective, multinational, patient-level registry wherein patients at each center were prospectively included in their respective center registries. The registry included all patients undergoing postapproval treatment with a multielectrode 5-spline pulsed field ablation catheter to treat atrial fibrillation (AF) between March 1, 2021, and May 30, 2022. The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of ≥30 seconds on the basis of electrocardiographic data after a 3-month blanking period (on or off antiarrhythmic drugs). Safety outcomes included the composite of acute (<7 days postprocedure) and latent (>7 days) major adverse events., Results: At 24 European centers (77 operators) pulsed field ablation was performed in 1568 patients with AF: age 64.5±11.5 years, female 35%, paroxysmal/persistent AF 65%/32%, CHA
2 DS2 -VASc 2.2±1.6, median left ventricular ejection fraction 60%, and left atrial diameter 42 mm. Pulmonary vein isolation was achieved in 99.2% of patients. After a median (interquartile range) follow-up of 367 (289-421) days, the 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was 78.1% (95% CI, 76.0%-80.0%); clinical effectiveness was more common in patients with paroxysmal AF versus persistent AF (81.6% versus 71.5%; P =0.001). Acute major adverse events occurred in 1.9% of patients., Conclusions: In this large observational registry of the postapproval clinical use of pulsed field technology to treat AF, catheter ablation using pulsed field energy was clinically effective in 78% of patients with AF., Competing Interests: Disclosures Dr Reddy reports receiving consulting fees (and equity—now divested) from Farapulse Inc. and is a consultant for Boston Scientific Inc; unrelated to this manuscript, Dr Reddy also serves as a consultant for and has equity in Ablacon, Acutus Medical, Affera-Medtronic, Apama Medical-Boston Scientific, Anumana, APN Health, Aquaheart, Atacor, Autonomix, Axon Therapies, Backbeat, BioSig, CardiaCare, CardioNXT/ AFTx, Circa Scientific, CoRISMA, Corvia Medical, Dinova-Hangzhou DiNovA EP Technology, East End Medical, EPD-Philips, EP Frontiers, Epix Therapeutics-Medtronic, EpiEP, Eximo, Field Medical, Focused Therapeutics, HRT, Intershunt, Javelin, Kardium, Keystone Heart, LuxMed, Medlumics, Middlepeak, Neutrace, Nuvera-Biosense Webster, Oracle Health, Restore Medical, Sirona Medical, SoundCath, Valcare; unrelated to this work, has served as a consultant for AtriAN, Biosense-Webster, BioTel Heart, Biotronik, Cairdac, Cardiofocus, Cardionomic, CoreMap, Fire1, Gore & Associates, Impulse Dynamics, Medtronic, Novartis, Philips, Pulse Biosciences; and has equity in Manual Surgical Sciences, Newpace, Nyra Medical, Surecor, and Vizaramed. Dr Schmidt reports receiving speaker’s fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. Dr Reichlin reports research grants from the Swiss National Science Foundation, the Swiss Heart Foundation, and the sitem insel Support Fund. Speaker/consulting honoraria or travel support from Abbott/SJM, Bayer, Biosense Webster, Biotronik, Boston Scientific, Daiichi Sankyo, Medtronic, and Pfizer-BMS. Support for his institution’s fellowship programme from Abbott/SJM, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. Dr Roten reports receiving speaker honoraria from Abbott/SJM, consulting honoraria from Medtronic, and research funding to the institution from Medtronic. Dr Neven reports speaker’s fees from Farapulse, Inc. Dr Metzner reports research grant and fees from Farapulse. Dr Rollin reports receiving research grant from Farapulse. Dr Lemoine reports receiving research grant from Farapulse. Dr Hansen reports receiving speaker fees and grant support from Biosense Webster, and Medtronic. Dr Blaauw reports receiving research grants from Medtronic and Atricure and consulting fees from Abbott, Biosense Webster, Boston Scientific. Dr Sommer reports member of the advisory board for Abbott, Biosense Webster, Boston Scientific, and Medtronic. Dr Anic reports receiving consultant fees from Farapulse Inc., Boston Scientific Inc., Galaxy Medical Inc., Biosense Webster, and performs contracted research for Farapulse Inc., Boston Scientific Inc., Galaxy Medical Inc., and Biosense Webster. Dr Anselme reports receiving consulting fees from Boston Scientific, Medtronic, and Microport CRM. Dr Boveda reports receiving consulting fees from Medtronic, Boston Scientific, Microport, Zoll, and BMS. Dr Deneke reports receiving speaker honoraria from Galaxy Medical, Abbott, and Biotronik, being a consultant to Farapulse, and serving on a Clinical Events Committee for Boston Scientific. Dr Willems reports receiving grants and personal fees from Abbott, Boston Scientific, Medtronic, and personal fees from Boehringer Ingelheim, Brystol Myers Squibb, Bayer Vital, Accutus, Daiichi, and Farapulse Inc. Dr Gunawardene reports grants from Farapulse Inc. and Abbott. Dr Tilz reports receiving consulting fees from Boston Scientific, Abbott Medical, Biotronik, Biosense Webster and speaker honorarium from Boston Scientific, Abbott Medical, Biotronik, and Biosense Webster. Dr Heeger received travel grants and research grants by Boston Scientific, Lifetech, Biosense Webster, and Cardiofocus and Speaker´s Honoraria from Boston Scientific, Lifetech. Biosense Webster, Bayer, and Cardiofocus. He is a consultant of Medtronic, Lifetech, Boston Scientific, Biosense Webster, and Cardiofocus. Dr Scheer reports receiving an educational grant from Farapulse Inc. and is a consultant for Boston Scientific Inc. Dr Wakili reports receiving consultant fees and travel expenses from Boston Scientific and Biotronik; investigator-initiated funding for research projects (initiated by him) from Bristol-Myers Squibb, Pfizer, and Boston Scientific; and speaking honoraria from Boston Scientific, Biotronik, and Medtronic. Dr Steven reports receiving speaking fees from Pfizer, Bayer, Abbott, Johnson & Johnson, and Medtronic; grants from Abbott, Johnson & Johnson, and Boston Scientific; and consulting fees from Boston Scientific and Johnson & Johnson. Dr Sultan reports receiving lecture and consulting honoraria from Medtronic, Abbott, and Bayer. Dr Kautzner reports personal fees from Bayer, Biosense Webster, Boehringer Ingelheim, Medtronic, and Abbott for participation in scientific advisory boards, and has received speaker honoraria from Bayer, Biosense Webster, Biotronik, Boehringer Ingelheim, CathVision, Medtronic, Mylan, Pfizer, ProMed, and Abbott. Dr Jais reports receiving equity from Farapulse and consulting fees and grant from Boston Scientific. Dr Derval reports receiving consulting fees from Boston scientific. Dr Chun reports receiving speaker’s fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. Dr Neuzil reports receiving grants from the Ministry of Health, Czech Republic, DRO (NHH, 00023884). Dr Manninger reports receiving speaker fees from Bayer, Biosense Webster, Biotronik, Amomed, AOP Orphan, Boston Scientific, Daiichi Sankyo, BMS/Pfizer and research grants from Biosense Webster and Abbott. All remaining authors have declared no conflict of interest.- Published
- 2023
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32. Characterization of temporal electrical activity patterns for detection of critical isthmus regions of recurrent atypical atrial flutter.
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Vonderlin N, Siebermair J, Mahabadi A, Pesch E, Koehler M, Dobrev D, Janosi RA, Rassaf T, and Wakili R
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- Humans, Retrospective Studies, Treatment Outcome, Tachycardia, Atrial Flutter diagnosis, Atrial Flutter surgery, Tachycardia, Supraventricular, Catheter Ablation adverse effects, Catheter Ablation methods
- Abstract
Introduction: Identifying the critical isthmus region (CIR) of atrial re-entry tachycardias (AT) is challenging. The Lumipoint® (LP) software, developed for the Rhythmia® mapping system, aims to facilitate the successful ablation of ATs by identifying the CIR., Objective: The objective of this study was to evaluate the quality of LP regarding the percentage of arrhythmia-relevant CIR in patients with atypical atrial flutter (AAF)., Methods: In this retrospective study, we analyzed 57 AAF forms. Electrical activity (EA) was mapped over tachycardia cycle length resulting in a two-dimensional EA pattern. The hypothesis was that EA minima suggest potential CIRs with slow-conduction-zone., Results: A total of n = 33 patients were included, with the majority of patients being already preablated (69.7%). LP algorithm identified a mean of 2.4 EA minima and 4.4 suggested CIRs per AAF form. Overall, we observed a low probability of identifying only the relevant CIR (POR) at 12.3% but a high probability that at least one CIR is detected (PALO) at 98.2%. Detailed analysis revealed EA minima depth (≤20%) and width (>50 ms) as the best predictors of relevant CIRs. Wide minima occurred rarely (17.5%), while low minima were more frequently present (75.4%). Minima depth of EA ≤ 20% showed the best PALO/POR overall (95% and 60%, respectively). Analysis in recurrent AAF ablations (five patients) revealed that CIR in de novo AAF was already detected by LP during the index procedure., Conclusion: The LP algorithm provides an excellent PALO (98.2%), but poor POR (12.3%) to detect the CIR in AAF. POR improved by preselection of the lowest and widest EA minima. In addition, there might be the role of initial bystander CIRs becoming relevant for future AAFs., (© 2023 The Authors. Clinical Cardiology published by Wiley Periodicals, LLC.)
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- 2023
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33. Early diagnosis and better rhythm management to improve outcomes in patients with atrial fibrillation: the 8th AFNET/EHRA consensus conference.
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Schnabel RB, Marinelli EA, Arbelo E, Boriani G, Boveda S, Buckley CM, Camm AJ, Casadei B, Chua W, Dagres N, de Melis M, Desteghe L, Diederichsen SZ, Duncker D, Eckardt L, Eisert C, Engler D, Fabritz L, Freedman B, Gillet L, Goette A, Guasch E, Svendsen JH, Hatem SN, Haeusler KG, Healey JS, Heidbuchel H, Hindricks G, Hobbs FDR, Hübner T, Kotecha D, Krekler M, Leclercq C, Lewalter T, Lin H, Linz D, Lip GYH, Løchen ML, Lucassen W, Malaczynska-Rajpold K, Massberg S, Merino JL, Meyer R, Mont L, Myers MC, Neubeck L, Niiranen T, Oeff M, Oldgren J, Potpara TS, Psaroudakis G, Pürerfellner H, Ravens U, Rienstra M, Rivard L, Scherr D, Schotten U, Shah D, Sinner MF, Smolnik R, Steinbeck G, Steven D, Svennberg E, Thomas D, True Hills M, van Gelder IC, Vardar B, Palà E, Wakili R, Wegscheider K, Wieloch M, Willems S, Witt H, Ziegler A, Daniel Zink M, and Kirchhof P
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- Humans, Artificial Intelligence, Early Diagnosis, Consensus, Cognition, Atrial Fibrillation complications, Atrial Fibrillation diagnosis, Atrial Fibrillation therapy, Stroke prevention & control
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Despite marked progress in the management of atrial fibrillation (AF), detecting AF remains difficult and AF-related complications cause unacceptable morbidity and mortality even on optimal current therapy. This document summarizes the key outcomes of the 8th AFNET/EHRA Consensus Conference of the Atrial Fibrillation NETwork (AFNET) and the European Heart Rhythm Association (EHRA). Eighty-three international experts met in Hamburg for 2 days in October 2021. Results of the interdisciplinary, hybrid discussions in breakout groups and the plenary based on recently published and unpublished observations are summarized in this consensus paper to support improved care for patients with AF by guiding prevention, individualized management, and research strategies. The main outcomes are (i) new evidence supports a simple, scalable, and pragmatic population-based AF screening pathway; (ii) rhythm management is evolving from therapy aimed at improving symptoms to an integrated domain in the prevention of AF-related outcomes, especially in patients with recently diagnosed AF; (iii) improved characterization of atrial cardiomyopathy may help to identify patients in need for therapy; (iv) standardized assessment of cognitive function in patients with AF could lead to improvement in patient outcomes; and (v) artificial intelligence (AI) can support all of the above aims, but requires advanced interdisciplinary knowledge and collaboration as well as a better medico-legal framework. Implementation of new evidence-based approaches to AF screening and rhythm management can improve outcomes in patients with AF. Additional benefits are possible with further efforts to identify and target atrial cardiomyopathy and cognitive impairment, which can be facilitated by AI., Competing Interests: Conflict of interest: RBS has received lecture fees and advisory board fees from BMS/Pfizer outside this work and has received funding from the European Research Council (ERC) under the European Union's Horizon 2020 research and innovation programme under the grant agreement No 648131, from the European Union's Horizon 2020 research and innovation programme under the grant agreement No 847770 (AFFECT-EU) and German Center for Cardiovascular Research (DZHK e.V.) (8121710103); German Ministry of Research and Education (BMBF 01ZX1408A) and ERACoSysMed3 (031L0239).EAM is employee of Daiichi Sankyo Europe GmbH producing and marketing an oral anticoagulant (edoxaban). EA has received consulting / speaker fees for Biosense Webster. GB has received speaker's fees of small amount from Boston, Bayer, Daiichi, Boehringer. SB is consultant for Medtronic, Boston Scientific, Microport, and Zoll. JC has received consulting fees / honoraria fees from Acesion, Allergan, Alta Thera, Arca, lncarda, Menarini, Milestone, Sanofi, Bayer, Daiichi Sankyo, Pfizer, Abbott, Biosense Webster, Biotronik, Boston Scientific, Lilly, Medtronic, Johnson and Johnson. BC has received in kind contribution for research Support from iRhythm. WC has received advisory board fees for Roche Diagnostics AG. MDM is employee of Medtronic. SZB has received fees as member of Advisory Board in Bristol Myers Squibb-Pfizer. DD has received fees from Abbott, Astra Zenica, Bayer, Bosten Scientific, Bristol Myers Squibb-Pfizer, Medtonic, Zoll. LE has received lecture Honoria from Medtronic, Biotronik, Boston Scientific, Boehringer Ingelheim, Daiichy Sankyo, Bayer, MMS, Pfizer, Sanofi and received research grants from DFG and DGK. CE is employee of Preventicus GmbH. LF has received institutional research grants and non-financial support from European Union, DFG, British Heart Foundation, Medical Research Council (UK), NIHR, and several biomedical companies. The Institute of Cardiovascular Research, University of Birmingham, has received an Accelerator Award by the British Heart Foundation M/18/2/34218. LF is listed as inventor of two patents held by University of Birmingham (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783). BF receiving fees from Bristol-Myers Squibb and Pfizer Alliance, Bayer, Daiichi Sankyo, Omron. (largely speaker fees and travel support for speaking at session or official satellites of large international/continental society meetings) and investigator-initiated research grants to the institution from Bristol-Myers and Squibb and Pfizer Alliance and Ownership / Employee of Nil. LG and AZ are employees of Roche Diagnostics International Ltd. AG has received funding from Daiichi Sankyo, Astra Zenica, Bayer, Bristol Myers Squibb-Pfizer, Viola, Medtonic, Berlin Charitè. JHS has received Advisory board fees in Medtronic and Speaker fee from Medtronic. KGH has received fees from Abbott, Alexion, AMARIN, AstraZeneca, Bayer, Biotronik, Boehringer Ingelheim, Bristol-Myers-Squibb, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Pfizer, Premier Research, SUN Pharma and W. L. Gare & Associates and Research Grants from Bayer Vital, Sanofi-Aventis. JSH received fees from Boston Scientific, Servier, Bayer, Myokardia, Bristol-Myers-Squibb, Pfizer, and research grants from Medtronic, Boston Scientific, Bristol-Myers-Squibb, Abbott. HH has received lecture and consultancy fees from Abbott, Biotronik, Bristol-Myers-Squibb- Pfizer, Medscape, Daiichi Sankyo, Springer Healthcare Ltd and receive un conditional research grants through the Univerity of Antwerp and/or University of Hasselt from Abbott, Bayer, Biotronik, Biosense-Webster, Fibrickeck/Qompium, Medtronic, Bristol-Myers-Squibb- Pfizer, Boston Scientific, Daiichi Sankyo and Boehringer Ingelheim. RH has received speacker fees from BI, Bayer and Bristol-Myers-Squibb- Pfizer and AZ. TH is CEO of Preventicus GmbH. DK has received funding from Bayer, AtriCure, Protherics Medicines Development and Myokardia and Research grant from rants from the National Institute for Health Research (NIHR CDF-2015-08-074 RATE-AF; NIHR HTA-130280 DaRe2THINK; NIHR EME- 132974 D2T-NV), the British Heart Foundation (PG/17/55/33087 and AA/18/2/34218), EU/EFPIA IMI (BigData@Heart 116074),the European Society of Cardiology supported by educationalgrants from Boehringer Ingelheim/BMS-Pfizer Alliance/Bayer/Daiichi Sankyo/Boston Scientific, the NIHR/the University of Ox- ford Biomedical Research Centre, and British Heart Foundation/ the University of Birmingham Accelerator Award (STEEER-AF NCT04396418), Amomed Pharma, and IRCCS San Raffaele/Menarini (beta-blockers in Heart Failure Collaborative Group NCT0083244). MK is employee of Bristol-Myers and Squibb. CL has received fees from medtonic, Boston Scientific, Biotronik and Bristol-Myers and Squibb- Pfizer and research grants from Rennes Univerity, Metronik, Biotonik and Boston Scientific. DL has received research grant for EHRA-PATHS, NovoNordisk Young Investigator Award. MLL has received lecture fees from Bristol-Myers and Squibb and research grant from H2020 AFFECT-EU (grant No. 847770). SM has received research grant from Daiichi Sankyo (EPDAURUS IIT) and Bristol-Myers and Squibb (APPROACH ACS AF IIT). JLM has received Abbott, Boston Scientific, Biotronik, Boehringer Ingelheim, Sanofi, Microport and received research grants from Medtronic, Abbott, Microport, Biosense. RM is employee of Medtronic. LM is Stockholder for Galgomedical and Corify and receiving consuting fees from Abbott, Biosense-Webster, Bosten Scientific, Medtronik and receiving research grants from Abbott, Biosense-Webster, Bosten Scientific, Medtronik. LN has received consulting fees from Bristol-Myers and Squibb- Pfizer. GP is employee of Bayer AG. HP has received consulting fees from Abbott, Biosense-Webster, Bosten Scientific, Medtronik and receiving research grants from Abbott, Bayer, Biosense-Webster, Bosten Scientific, Medtronik, Bristol-Myers and Squibb- Pfizer. MR has received consulting fees for Medtonic, Arca BiopharmaInc, Roche and received research grants from Dutch Heart Foundation: RACE V, RED-CVD, CVON-AI, DECISION studies; grant from SJM/Abbott to institution: VIP-HF study; Grant for Medtronic to institution: Cryoballoon AF registry/biobank study. The other authors declare that there is no conflict of interest.LR has received research grants from Canadian Insititute of Health research and Byer Inc. U.S. received consultancy fees or honoraria from Università della Svizzera Italiana (USI, Switzerland), Roche Diagnostics (Switzerland), EP Solutions Inc. (Switzerland), Johnson & Johnson Medical Limited, (United Kingdom), Bayer Healthcare (Germany). U.S. is co-founder and shareholder of YourRhythmics BV, a spin-off company of the University Maastricht and Research grant from the Dutch Heart Foundation (CVON RACE V, CVON2014–09) European Union's Horizon 2020 Research and Innovation Program granted to MS under the Marie Sklodowska-Curie grant agreement #813716 (TRAIN-HEART Innovative Training Network), and various other programs of the European Union granted to US (ITN Network Personalize AF: Personalized Therapies for Atrial Fibrillation: a translational network – grant #860974; CATCH ME: Characterizing Atrial fibrillation by Translating its Causes into Health Modifiers in the Elderly – grant #633196; MAESTRIA: Machine Learning Artificial Intelligence Early Detection Stroke Atrial Fibrillation – grant #965286; REPAIR: Restoring cardiac mechanical function by polymeric artificial muscular tissue – grant #952166). DS has received consultation fees from Biosense Webster, Abbott, Boston Scientific, Consultant with stock option: SentiAR, Arga Medtech. RS is employee of Daiichi Sankyo Europe GmbH. DS has received consultation fees from Boston Scientific, Abbott and Research grant from Biosense Webster. ES has received lecture fees from Bayer, Bristol-Myers and Squibb- Pfizer, Boehringer Ingelheim, Johnson & Johnson, Merck Sharp & Dohme and Sanofi. DT has received lecture fees from Bayer Vital, Bristol-Myers and Squibb- Pfizer, Daiichi Sankyo, Medtonic, Zoll CMS, Sanofi, St. Jude Medical and research grant from Daiichi Sankyo. MTH is employee/owner of American Foundation of women's Health /StopAfib.org and employee/owner of True Hills Inc.. BV is employee of Bayer AG. RW has received consultation fees from Boston Scientific, Biotronic, Pfizer, Daiichi Sankyo, Bayer, Adagio Medical and Research grant from Bristol-Myers and Squibb- Pfizer, Boston Scientific. CW has received consulation fees from Biotronik, Boston Scientific, Novartis and research grant from BMBF, AFNET, DZHK, Biotronik. MW is employee and shareholder of Sanofi. SW has received Consulting fees from Boston Scientific, Abbott, Bayer, Bristol-Myers and Squibb- Pfizer, Boehringer Ingelheim and research grant from Boston Scientific. HW is employee and stockholder of Pfizer Germany. MDZ has received advisory and speaker fee from Bristol-Myers and Squibb- Pfizer. PK reports grants and non-financial support from BMBF (German Ministry of Education and Research), grants from Sanofi and Abbott, grants and non-financial support from EHRA (European Heart Rhythm Association), and grants from German Heart Foundation and DZHK (German Center for Cardiovascular Research), during the conduct of the study, and grants from European Union, British Heart Foundation, Leducq Foundation, Medical Research Council (UK), and non-financial support from German Centre for Heart Research, outside the submitted work; in addition, P.K. has a patent Atrial Fibrillation Therapy WO 2015140571 issued to University of Birmingham and a patent Markers for Atrial Fibrillation WO 2016012783 issued to University of Birmingham., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology.)
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- 2023
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34. In Silico Study of Local Electrical Impedance Measurements in the Atria - Towards Understanding and Quantifying Dependencies in Human.
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Unger LA, Anton CM, Stritt M, Wakili R, Haas A, Kircher M, Dossel O, and Luik A
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- Humans, Electric Impedance, Electric Conductivity, Catheters, Computer Simulation, Heart Atria, Catheter Ablation methods
- Abstract
Background: Electrical impedance measurements have become an accepted tool for monitoring intracardiac radio frequency ablation. Recently, the long-established generator impedance was joined by novel local impedance measurement capabilities with all electrical circuit terminals being accommodated within the catheter., Objective: This work aims at in silico quantification of distinct influencing factors that have remained challenges due to the lack of ground truth knowledge and the superposition of effects in clinical settings., Methods: We introduced a highly detailed in silico model of two local impedance enabled catheters, namely IntellaNav MiFi OI and IntellaNav Stablepoint, embedded in a series of clinically relevant environments. Assigning material and frequency specific conductivities and subsequently calculating the spread of the electrical field with the finite element method yielded in silico local impedances. The in silico model was validated by comparison to in vitro measurements of standardized sodium chloride solutions. We then investigated the effect of the withdrawal of the catheter into the transseptal sheath, catheter-tissue interaction, insertion of the catheter into pulmonary veins, and catheter irrigation., Results: All simulated setups were in line with in vitro experiments and in human measurements and gave detailed insight into determinants of local impedance changes as well as the relation between values measured with two different devices., Conclusion: The in silico environment proved to be capable of resembling clinical scenarios and quantifying local impedance changes., Significance: The tool can assists the interpretation of measurements in humans and has the potential to support future catheter development.
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- 2023
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35. Novel cryoballoon ablation system for pulmonary vein isolation: multicenter assessment of efficacy and safety-ANTARCTICA study.
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Heeger CH, Pott A, Sohns C, Riesinger L, Sommer P, Gasperetti A, Tondo C, Fassini G, Moser F, Lucas P, Weinmann K, Bohnen JE, Dahme T, Rillig A, Kuck KH, Wakili R, Metzner A, and Tilz RR
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- Humans, Middle Aged, Aged, Prospective Studies, Treatment Outcome, Pulmonary Veins surgery, Cryosurgery, Catheter Ablation methods, Atrial Fibrillation diagnosis, Atrial Fibrillation surgery, Atrial Fibrillation etiology
- Abstract
Aims: Pulmonary vein isolation (PVI) either by balloon devices or radiofrequency forms the cornerstone of invasive atrial fibrillation (AF) treatment. Although equally effective cryoballoon (CB)-based PVI offers shorter procedure duration and a better safety profile. Beside the worldwide established Arctic Front Advance system, a novel CB device, POLARx, was recently introduced. This CB incorporates unique features, which may translate into improved efficacy and safety. However, multicentre assessment of periprocedural efficacy and safety is lacking up to date., Methods and Results: A total of 317 patients with paroxysmal or persistent AF were included and underwent POLARx CB-based PVI in 6 centres from Germany and Italy. Acute efficacy and safety were assessed in this prospective multicenter observational study. In 317 patients [mean age: 64 ± 12 years, 209 of 317 (66%) paroxysmal AF], a total of 1256 pulmonary veins (PVs) were identified and 1252 (99,7%) PVs were successfully isolated utilizing mainly the short tip POLARx CB (82%). The mean minimal CB temperature was -57.9 ± 7°C. Real-time PVI was registered in 72% of PVs. The rate of serious adverse events was 6.0% which was significantly reduced after a learning curve of 25 cases (9.3% vs. 3.0%, P = 0.018). The rate of recurrence-free survival after mean follow-up of 226 ± 115 days including a 90-day blanking period was 86.1%., Conclusion: In this large multicentre assessment, the novel POLARx CB shows a promising efficacy and safety profile after a short learning curve., Competing Interests: Conflict of interest: C.-H.H. received travel grants and research grants by Boston Scientific, Biosense Webster and Cardiofocus and Speaker’s Honoraria from Boston Scientific, Biosense Webster, Bayer and Cardiofocus. He is a consultant of Medtronic, Boston Scientific, Biosense Webster and Cardiofocus. R.R.T. is a consultant of Boston Scientific, Biotronik and Biosense Webster and received Speaker’s Honoraria from Biosense Webster, Medtronic, Boston Scientific and Abbot Medical. K.-H.K. reports grants and personal fees from Abbott Vascular, Medtronic, Biosense Webster outside submitted work. A.M. received speaker's honoraria and travel grants from Medtronic, Biosense Webster and Cardiofocus. A.P. received speaker’s honoraria and consulting fees from Medtronic, Biosense Webster, Daiichi-Sankyo, Bayer and is invited fellow of the Boston Scientific EP training programme. T.D. received speaker’s honoraria and consulting fees from Medtronic, Biosense Webster, Boerhringer-Ingelheim, Bayer, Daiichi-Sankyo. C.T. received Speaker’s and Proctor’s fees from Boston Scientific, Medtronic, Abbott and Biosense Webster. He serves in the Advisory Board of Medtronic, Boston Scientific. All remaining authors have declared no conflicts of interest., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2022
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36. Role of catheter location on local impedance measurements and clinical outcome with the new direct sense technology in cardiac ablation procedures.
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Pesch E, Riesinger L, Vonderlin N, Kupusovic J, Koehler M, Bruns F, Janosi RA, Kochhäuser S, Dobrev D, Rassaf T, Wakili R, and Siebermair J
- Abstract
Background: A novel catheter technology (direct sense, DS) enables periprocedural local impedance (LI) measurement for estimation of tissue contact during radiofrequency ablation (RFA) for real-time assessment of lesion generation. This measure reflects specific local myocardial conduction properties in contrast to the established global impedance (GI) using a neutral body electrode. Our study aimed to assess representative LI values for the cardiac chambers, to evaluate LI drop in response to RF delivery and to compare those values to established GI measures in patients undergoing RFA procedures., Methods and Results: Seventy-three patients undergoing RFA with the DS technology were included. Within the cardiac chambers, baseline LI was significantly different, with the highest values in the left atrium (LA 107.5 ± 14.3 Ω; RV 104.6 Ω ± 12.9 Ω; LV 100.7 Ω ± 11.7 Ω, and RA 100.5 Ω ± 13.4 Ω). Baseline LI was positively correlated to the corresponding LI drop during RF delivery (R
2 = 0.26, p = 0.01) representing a promising surrogate of lesion generation. The observed mean LI drop (15.6 ± 9.5 Ω) was threefold higher as GI drop (4.9 ± 7.4 Ω), p < 0.01. We evaluated the clinical outcome in a subgroup of patients undergoing DS-guided pulmonary vein isolation, which was comparable regarding arrhythmia recurrence to a conventional ablation cohort (57 % vs 50 %, p = 0.2)., Conclusion: We provide detailed information on LI measures in electrophysiological procedures with significant differences within the cardiac chambers highlighting that RFA-related LI drop can serve as a promising surrogate for real-time assessment of lesion generation. Guiding the electrophysiologist in RFA procedures, this additional information promises to improve safety profile and success rates in the interventional treatment of arrhythmias., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2022 The Authors.)- Published
- 2022
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37. Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF).
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Ekanem E, Reddy VY, Schmidt B, Reichlin T, Neven K, Metzner A, Hansen J, Blaauw Y, Maury P, Arentz T, Sommer P, Anic A, Anselme F, Boveda S, Deneke T, Willems S, van der Voort P, Tilz R, Funasako M, Scherr D, Wakili R, Steven D, Kautzner J, Vijgen J, Jais P, Petru J, Chun J, Roten L, Füting A, Rillig A, Mulder BA, Johannessen A, Rollin A, Lehrmann H, Sohns C, Jurisic Z, Savoure A, Combes S, Nentwich K, Gunawardene M, Ouss A, Kirstein B, Manninger M, Bohnen JE, Sultan A, Peichl P, Koopman P, Derval N, Turagam MK, and Neuzil P
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- Adult, Aged, Aged, 80 and over, Female, Humans, Middle Aged, Retrospective Studies, Treatment Outcome, Young Adult, Atrial Fibrillation diagnosis, Atrial Fibrillation etiology, Atrial Fibrillation surgery, Catheter Ablation methods, Pulmonary Veins surgery, Stroke etiology
- Abstract
Aims: Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical trials. In the MANIFEST-PF survey, we investigated the 'real world' performance of the only approved PFA catheter, including acute effectiveness and safety-in particular, rare oesophageal effects and other unforeseen PFA-related complications., Methods and Results: This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7-291), full cohort included 1758 patients: mean age 61.6 years (range 19-92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9-100%). Procedure time was 65 min (38-215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each)., Conclusion: In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of 'generic' catheter complications (tamponade, stroke) underscores the need for improvement., Competing Interests: Conflict of interest: V.Y.R. reports receiving consulting fees and equity (stock) from Farapulse Inc. and is a consultant for Boston Scientific Inc.; he also has additional disclosures unrelated to this manuscript that are listed in the Supplementary material online. B.S. reports receiving speaker’s fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. T.R. reports research grants from the Swiss National Science Foundation, the Swiss Heart Foundation, and the sitem insel support fund. Speaker/consulting honoraria or travel support from Abbott/SJM, Bayer, Biosense Webster, Biotronik, Boston Scientific, Daiichi Sankyo, Medtronic, and Pfizer-BMS. Support for his institution’s fellowship programme from Abbott/SJM, Biosense Webster, Biotronik, Boston Scientific, and Medtronic. L.R. reports receiving speaker honoraria from Abbott/SJM and consulting honoraria from Medtronic. K.N. reports speaker’s Fees from Farapulse, Inc. A.M. reports research grant and fees from Farapulse. A.R. reports receiving research grant from Farapulse. J.H. reports receiving speaker fees and grant support from Biosense Webster and Medtronic. Y.B.: reports receiving Research grant from Medtronic and Atricure and consulting fees from Abbott, Biosense Webster, Boston Scientific. P.S. reports member of the advisory board for Abbott, Biosense Webster, Boston Scientific, and Medtronic. C.S. reports receiving modest honoraria from Medtronic. A.A. reports receiving consultant fees from Farapulse Inc., Boston Scientific Inc., Galaxy Medical Inc., Biosense Webster, and performs contracted research for Farapulse Inc., Boston Scientific Inc., Galaxy Medical Inc., Biosense Webster. F.A. reports receiving consulting fees from Boston Scientific, Medtronic and Microport CRM. S.B. reports receiving consulting fees for Medtronic, Boston Scientific, Microport, Zoll, and BMS. T.D. reports receiving speaker honoraria from Galaxy Medical, Abbott and Biotronik, being a consultant to Farapulse, and serving on a Clinical Events Committee for Boston Scientific. S.W. reports receiving grants and personal fees from Abbott, Boston Scientific, Medtronic, and personal fees from Boehringer Ingelheim, Brystol Myers Squibb, Bayer Vital, Accutus, Daiichi, Farapulse Inc. M.G. reports grant from Farapulse Inc. and Abbott. R.T. reports receiving consulting fees from Boston Scientific, Abbot Medical, Biotronik, and speakers honorarium from Boston Scientific, Abbot Medical, Biotronik, Biosense Webster. B.K. reports receiving Travel and Congress Sponsoring from Biotronik, Abbott, Impulse Dynamics, DGK AG EP, EHRA, Pfizer; she also received fellowship sponsoring from Johnson & Johnson, Boston Scientific and Lecture Honorary from Biotronik, Impulse Dynamics, C.T.I. GmbH, Doctrina Med. D.S. reports receiving an educational grant from Farapulse Inc., and is a consultant For Boston Scientific Inc. R.W. reports receiving consultant fees and travel expenses from Boston Scientific and Biotronik; investigator-initiated funding for research projects (initiated by him) from Bristol-Myers Squibb, Pfizer, and Boston Scientific; and speaking honoraria from Boston Scientific, Biotronik, and Medtronic. D.S. reports receiving speaking fees from Pfizer, Bayer, Abbott, Johnson & Johnson, and Medtronic; grant from Abbott, Johnson & Johnson, and Boston Scientific; and consulting fees from Boston Scientific and Johnson & Johnson. A.S. reports receiving lecture and consulting honoraria from Medtronic, Abbott, and Bayer. J.K. reports personal fees from Bayer, Biosense Webster, Boehringer Ingelheim, Medtronic, and Abbott for participation in scientific advisory boards, and has received speaker honoraria from Bayer, Biosense Webster, Biotronik, Boehringer Ingelheim, CathVision, Medtronic, Mylan, Pfizer, ProMed, and Abbott. P.J. reports receiving equity from Farapulse and consulting fees and grant from Boston Scientific. N.D. reports receiving consulting fees from Boston scientific. J.C. reports receiving speaker’s fees and research grants from Boston Scientific/Farapulse, Medtronic, Biosense Webster, and Abbott. P.N. reports receiving grant from the Ministry of Health, Czech Republic, DRO (NHH, 00023884). All the remaining authors have declared no conflict of interest., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2022
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38. Clinical features and predictors of atrial fibrillation in patients with light-chain or transthyretin cardiac amyloidosis.
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Papathanasiou M, Jakstaite AM, Oubari S, Siebermair J, Wakili R, Hoffmann J, Carpinteiro A, Hagenacker T, Thimm A, Rischpler C, Kessler L, Rassaf T, and Luedike P
- Subjects
- Aged, Female, Humans, Male, Prealbumin genetics, Prospective Studies, Retrospective Studies, Stroke Volume, Ventricular Function, Left, Amyloidosis, Atrial Appendage, Atrial Fibrillation diagnosis, Atrial Fibrillation epidemiology, Atrial Fibrillation etiology, Brain Ischemia, Immunoglobulin Light-chain Amyloidosis complications, Immunoglobulin Light-chain Amyloidosis diagnosis, Immunoglobulin Light-chain Amyloidosis epidemiology, Stroke
- Abstract
Aims: The study aimed to investigate the prevalence, phenotypic characteristics, and predictors of atrial fibrillation (AF) in patients presenting with cardiac amyloidosis (CA) of light-chain (AL) or transthyretin (ATTR) type., Methods and Results: Clinical, biochemical, and echocardiographic data of patients presenting with CA between 2005 and 2020 were retrospectively collected. CA staging was based on established biomarker systems. Binomial logistic regression was run to analyse the effects of clinical variables on the likelihood of AF. The study included 133 patients [53% AL, 41% wild-type (wt) ATTR-CA, & 6% hereditary ATTR-CA]. Mean age was 71 years, and 80% were male patients. AF was diagnosed in 64 (48%) patients (28% in AL-CA, 80% in wtATTR, 13% in hATTR, P < 0.001). Patients with AF were older (74 vs. 69 years, P < 0.001), more likely to have wtATTR-CA (67 vs. 16%, P < 0.001), exhibited more often New York Heart Association ≥ III symptoms (66 vs. 45%, P = 0.02) and carried a higher burden of comorbidities. AF patients had lower left ventricular ejection fraction (47 vs. 53%, P < 0.005), higher left atrial volume index (54 vs. 46 mL/m
2 , P = 0.007), higher pulmonary artery pressure (42 vs. 31 mmHg, P = 0.008), and worse tricuspid annular plane systolic excursion values (17 vs. 20 mm, P = 0.01). Mitral regurgitation ≥ Grade 2 was more frequent in AF (56 vs. 25%, P < 0.001). Higher ATTR-CA stage was associated with higher AF prevalence (47% vs. 74% vs. 94%, P < 0.001, for Stages I, II, & III, respectively). Higher AL-CA stage was associated with lower AF prevalence (0% vs. 40% vs. 31% vs. 18%, P < 0.001, for Stages I, II, IIIa, & IIIb, respectively). Three independent predictors for AF were identified in a multivariate logistic regression model with 81.5% classification accuracy: AL type [odds ratio (OR) 0.1, confidence interval (CI) 0.01-0.29, P = 0.001], estimated glomerular filtration rate (OR 0.9, CI 0.93-0.99, P = 0.03), and body mass index (OR 1.3, CI 1.07-1.66, P = 0.01). ATTR amyloidosis was associated with a 10-fold higher risk of AF. During 1 year follow-up, only one episode of ischaemic stroke was reported., Conclusions: Atrial fibrillation affects nearly half of all patients with CA. Patients presenting with AF have more severe symptoms and higher burden of comorbidities. ATTR type of amyloidosis is the strongest predictor of AF. Prospective screening for occult AF may be considered in ATTR-CA., (© 2022 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)- Published
- 2022
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39. Telemedical cardiac risk assessment by implantable cardiac monitors in patients after myocardial infarction with autonomic dysfunction (SMART-MI-DZHK9): a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial.
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Bauer A, Sappler N, von Stülpnagel L, Klemm M, Schreinlechner M, Wenner F, Schier J, Al Tawil A, Dolejsi T, Krasniqi A, Eiffener E, Bongarth C, Stühlinger M, Huemer M, Gori T, Wakili R, Sahin R, Schwinger R, Lutz M, Luik A, Gessler N, Clemmensen P, Linke A, Maier LS, Hinterseer M, Busch MC, Blaschke F, Sack S, Lennerz C, Licka M, Tilz RR, Ukena C, Ehrlich JR, Zabel M, Schmidt G, Mansmann U, Kääb S, Rizas KD, and Massberg S
- Subjects
- Aged, Austria, Female, Germany, Humans, Male, Middle Aged, Prospective Studies, Arrhythmias, Cardiac diagnosis, Monitoring, Physiologic methods, Myocardial Infarction complications, Myocardial Infarction physiopathology, Risk Assessment methods, Telemedicine methods
- Abstract
Background: Cardiac autonomic dysfunction after myocardial infarction identifies patients at high risk despite only moderately reduced left ventricular ejection fraction. We aimed to show that telemedical monitoring with implantable cardiac monitors in these patients can improve early detection of subclinical but prognostically relevant arrhythmic events., Methods: We did a prospective investigator-initiated, randomised, multicentre, open-label, diagnostic trial at 33 centres in Germany and Austria. Survivors of acute myocardial infarction with left ventricular ejection fraction of 36-50% had biosignal analysis for assessment of cardiac autonomic function. Patients with abnormal periodic repolarisation dynamics (≥5·75 deg
2 ) or abnormal deceleration capacity (≤2·5 ms) were randomly assigned (1:1) to telemedical monitoring with implantable cardiac monitors or conventional follow-up. Primary endpoint was time to detection of serious arrhythmic events defined by atrial fibrillation 6 min or longer, atrioventricular block class IIb or higher and fast non-sustained (>187 beats per min; ≥40 beats) or sustained ventricular tachycardia or fibrillation. This study is registered with ClinicalTrials.gov, NCT02594488., Findings: Between May 12, 2016, and July 20, 2020, 1305 individuals were screened and 400 patients at high risk were randomly assigned (median age 64 years [IQR 57-73]); left ventricular ejection fraction 45% [40-48]) to telemedical monitoring with implantable cardiac monitors (implantable cardiac monitor group; n=201) or conventional follow-up (control group; n=199). During median follow-up of 21 months, serious arrhythmic events were detected in 60 (30%) patients of the implantable cardiac monitor group and 12 (6%) patients of the control group (hazard ratio 6·33 [IQR 3·40-11·78]; p<0·001). An improved detection rate by implantable cardiac monitors was observed for all types of serious arrhythmic events: atrial fibrillation 6 min or longer (47 [23%] patients vs 11 [6%] patients; p<0·001), atrioventricular block class IIb or higher (14 [7%] vs 0; p<0·001) and ventricular tachycardia or ventricular fibrillation (nine [4%] patients vs two [1%] patients; p=0·054)., Interpretation: In patients at high risk after myocardial infarction and cardiac autonomic dysfunction but only moderately reduced left ventricular ejection fraction, telemedical monitoring with implantable cardiac monitors was highly effective in early detection of subclinical, prognostically relevant serious arrhythmic events., Funding: German Centre for Cardiovascular Research (DZHK) and Medtronic Bakken Research Center., Competing Interests: Declaration of interests AB received funding from Medtronic Bakken Research Center as co-funding for the SMART-MI trial (providing implantable cardiac monitors and staff cost for implantable cardiac monitors core lab); and speaker honoraria from Bayer, Boerhinger Ingelheim, Edwards, Medtronic, and Novartis. MSt received consulting fees, speaker honoraria, and travel expenses from Medtronic. RW received grants from German Centre for Cardiovascular Research, Bristol Myers Squibb–Pfizer, and Grant Boston Scientific; speaker honoraria from Biotronik, Boston Scientific, Medtronic, Abiomed, Bristol Myers Squibb–Pfizer, Boehringer Ingelheim, Daiichi Sankyo, Bayer, and Novartis; and travel expenses from Boston Scientific, Bristol Myers Squibb–Pfizer, Boehringer Ingelheim, Daiichi Sankyo, and Bayer. RW participated on advisory boards for Biotronik, Philips, Boehringer Ingelheim, and Daiichi Sankyo. ALu received grants and consulting fees from Boston Scientific and Biosense Webster; speaker honoraria from Boston Scientific, Biosense Webster, and Medtronic; travel expenses from Boston Scientific; and participated on data safety monitoring boards and societies for Boston Scientific. NG received grants from Boston Scientific and Medtronic and travel expenses from Bayer Vital. PC received research grants from Philips. LSM received grants from the German Research Foundation and the EU; speaker honoraria from Bayer, Astra Zeneca, Pfizer, Bristol Myers Squibb, Daiichi Sankyo, and Boehringer Ingelheim; travel expenses from Servier, Boehringer Ingelheim, and Vifor; and participated on data safety monitoring boards for Else Kröner-Fresenius-Stiftung. LSM is stock holder of Bayer and Fresenius Medical Care. MCB received consulting fees from Medtronic and Boston Scientific; speaker honoraria from Medtronic, Boston Scientific, and St Jude Medical; travel expenses from Medtronic, Jonhson & Johnson, Boston Scientific, and St Jude Medical; and participated on advisory boards for Medtronic. CL is member of the Expert Panel for medical devices for the European Commission. CU received consulting fees and speaker honoraria from Medtronic. JRE received consulting fees and speaker honoraria from Medtronic, Abbott, and Boston Scientific. UM received grants from German Centre for Cardiovascular Research (DZHK). All other authors declare no competing interests., (Copyright © 2022 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)- Published
- 2022
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40. Early Pacemaker Implantation after Transcatheter Aortic Valve Replacement: Impact of PlasmaBlade™ for Prevention of Device-Associated Bleeding Complications.
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Lind A, Ahsan M, Kaya E, Wakili R, Rassaf T, and Jánosi RA
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- Aged, Aged, 80 and over, Aortic Valve surgery, Female, Hemorrhage epidemiology, Humans, Male, Retrospective Studies, Risk Factors, Treatment Outcome, Hemorrhage prevention & control, Pacemaker, Artificial, Transcatheter Aortic Valve Replacement adverse effects
- Abstract
Background and Objectives : Permanent pacemaker implantation (PPI) is frequently required following transcatheter aortic valve replacement (TAVR). Dual antiplatelet therapy (DAPT) or oral anticoagulation therapy (OAK) is often necessary in these patients since they are at higher risk of thromboembolic events due to TAVR implantation, high incidence of coronary artery diseases (CAD) with the necessity of coronary intervention, and high rate of atrial fibrillation with the need of stroke prevention. We sought to evaluate the safety, efficiency, and clinical outcomes of early PPI following TAVR using the PlasmaBlade™ (Medtronic Inc., Minneapolis, MN, USA) pulsed electron avalanche knife (PEAK) for bleeding control in patients under DAPT or OAK. Materials and Methods : This retrospective single-center study included patients who underwent PPI after transfemoral TAVR (TF) at our center between December 2015 and May 2020. All PPI were performed using the PlasmaBlade™ Device. Results : The overall PPI rate was 14.1% (83 of 587 patients; 82.5 ± 4.6 years; 45.8% male). The PPI procedures were used to treat high-grade atrioventricular block (81.9%), severe sinus node dysfunction (13.3%), and alternating bundle branch block (4.8%). At the time of the procedure, 35 (42.2%) patients received DAPT, and 48 (57.8%) patients received OAK (50% with vitamin K antagonist (VKA) and 50% with novel oral anticoagulants (NOAK)). One device-pocket hematoma treated conservatively occurred in a patient (1.2%) receiving NOAK. Two re-operations were necessary in patients due to immediate lead dislocation (2.4%). Conclusions : The results of this study illustrate that the use of PlasmaBlade™ for PPI in patients after a TAVR who require antithrombotic treatment is feasible and might result into lower rates of severe bleeding complications compared to rates reported in the literature. Use of the PlasmaBlade device may be considered in this specific group of patients because of their high risk of bleeding.
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- 2021
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41. Central retinal artery occlusion as a first sign of atrial fibrillation: A 3-year retrospective single-center analysis.
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Vonderlin N, Kortuem K, Siebermair J, Köhrmann M, Rassaf T, Massberg S, Priglinger S, Kääb S, and Wakili R
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- Anticoagulants therapeutic use, Humans, Retrospective Studies, Risk Assessment, Risk Factors, Atrial Fibrillation diagnosis, Atrial Fibrillation epidemiology, Retinal Artery Occlusion diagnosis, Retinal Artery Occlusion epidemiology, Stroke
- Abstract
Background: Central retinal artery occlusion ((C)RAO) is known to be associated with stroke and/or atrial fibrillation (AF). Nevertheless, patients often present at the ophthalmologist initially and it is unknown how many of these receive an adequate cardiological/neurological work-up (CWU/NWU), including a 24 h-Holter-ECG., Hypothesis: Hypothesis of this study was that patients with (C)RAO do not undergo CWU on regular basis and that new-onset AF is more often detected in patients with CWU., Methods and Results: We performed a retrospective analysis of n = 292 consecutive patients who presented at an ophthalmology department with the diagnosis of (C)RAO during a 3-year period. After excluding patients with known AF, meeting exclusion criteria, inability to comply with the protocol, missed land phoneline, or death during follow-up a total of 174 patients were enrolled; mean follow-up was 20 ± 12 months. The CHA
2 DS2 -VASc score of the cohort was 5.3 ± 1.4. Our analysis revealed that only 50.6% of patients received a CWU including a single Holter-ECG after the index-event. In 12.6% cases new-onset AF was diagnosed, while the rate was higher in patients with CWU compared to patients without CWU (18.2 vs. 7.0%; p = 0.26). Evaluation of oral anticoagulation (OAC) therapy showed that only 66% of patients with AF were treated according to guidelines., Conclusion: Only half of patients with (C)RAO underwent CWU. Despite minimal monitoring, rate of new diagnosed AF was high. Our results confirm that (C)RAO identifies a high-risk population for AF. These results illustrate the importance to implement standardized CWU in (C)RAO patients presenting at the ophthalmologist., (© 2021 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.)- Published
- 2021
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42. Case report: incessant ventricular fibrillation in a conscious left ventricular assist device patient.
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Jakstaite AM, Luedike P, Wakili R, Kochhäuser S, Ruhparwar A, Rassaf T, and Papathanasiou M
- Abstract
Background: Ventricular arrhythmia in left ventricular assist device (LVAD) recipients represents a challenging clinical scenario and the optimal treatment strategy in this unique patient population still needs to be defined., Case Summary: We report on a 61-year-old LVAD patient with incessant ventricular fibrillation (VF) despite multiple unsuccessful attempts to restore normal rhythm with external defibrillation and antiarrhythmic medication. He remained initially stable as an outpatient and subsequently developed secondary organ failure., Discussion: This case demonstrates that under LVAD support long-term haemodynamic stability is possible even in case of VF, a situation that resembles Fontan circulation. However, ventricular arrhythmias are associated with a high risk of secondary organ damage due to right heart failure if left untreated. In case of refractory ventricular tachycardia or electrical storm listing for heart transplantation with high priority status should be pursued when possible. Alternatively, catheter ablation may be considered in selected cases and be performed in experienced centres in close collaboration with all involved specialists., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2021
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43. Apixaban versus PhenpRocoumon: Oral AntiCoagulation plus antiplatelet tHerapy in patients with Acute Coronary Syndrome and Atrial Fibrillation (APPROACH-ACS-AF): Rationale and design of the prospective randomized parallel-group, open-label, blinded-endpoint, superiority, multicenter-trial of a triple therapy versus a dual therapy in patients with Atrial Fibrillation and Acute Coronary Syndrome undergoing coronary stenting.
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Riesinger L, Strobl C, Leistner DM, Gori T, Akin I, Mehr M, Kellnar A, Mahabadi AA, Bogossian H, Block M, Edelmann F, Sarafoff N, Sibbing D, Ince H, Rassaf T, Mansmann U, Mehilli J, Kääb S, Hausleiter J, Massberg S, and Wakili R
- Abstract
Background: A regimen of dual (DAT) vs. triple (TAT) antithrombotic therapy reduces bleeding in patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI). However, recent evidence suggests that DAT may be associated with an increased ischemic risk. This raises the question whether DAT rather than TAT should be recommended to AF patients that undergo PCI for acute coronary syndrome (ACS), carrying a particularly high risk of both bleeding and ischemic events, studied only as subgroups of previous trials., Methods and Design: The APPROACH-ACS-AF-(DZHK-7) trial is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE) trial which will include patients presenting with an ACS managed by PCI and requiring oral anticoagulation (OAC) due to AF. The trial will test, whether a DAT-regimen comprising clopidogrel plus the non-Vitamin-K-antagonist oral anticoagulant (NOAC) apixaban is superior to a TAT-regimen of vitamin-K-antagonist (VKA) plus dual anti-platelet therapy (APT) with respect to bleeding. A total of 400 patients will be randomized 1:1 to a control-arm with guideline-recommended TAT with VKA plus clopidogrel and acetylsalicylic-acid and a study arm receiving DAT comprising apixaban plus clopidogrel. Patients will be followed-up for 6 months. The primary endpoint of the study is the cumulative incidence of BARC type ≥2 bleeding, secondary endpoints include a composite clinical ischemic outcome and net clinical outcome., Conclusions: APPROACH-ACS-AF is the first trial dedicated to ACS patients, testing whether in terms of bleeding a DAT with NOAC is superior to a TAT regimen with VKA in high-risk ACS patients with AF., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: D.M.L reports grants from Deutsches Zentrum für Herz-Kreislaufforschung (DZHK), Bayer AG, AstraZeneca, Novartis, Abbott Vascular, Biotronik and Sahajanand Medical Technologies Pvt Ltd. (SMT) and personal fees from Bayer AG, Daiichi Sankyo, Amgen, B.Braun, Abbott Vascular, Boehringer Ingelheim, Boston, Sahajanand Medical Technologies Pvt Ltd. (SMT), Medtronik, Bayer AG, Vifor, Novartis and AstraZeneca; T.G. reports a research grant from Abbott Vascular and neovasc, lecture/consulting fees from Abbott Vascular, Neovasc, Boston Scientific, Daiichi-Sankyo, Bayer, Astra Zeneca, BMS, SMT, Eli Lilly, Pfizer, all outside the submitted work; I.A. reports personal fees from Daiichi Sankyo, Pfizer/BMS, Boston Scientific, GORE Medical; A.A.M. reports personal fees from AMGEN, AtraZeneca, BAYER, Berlin Chemie, Daiichi Sankyo outside the submitted work; M.B. received personal fees from Bayer, Boehringer-Ingelheim, Boston-Scientific, Daiichi-Sankyo, Medtronic, ZOLL CMS; F.E. reports grants from German Research Foundation (DFG), grants from German Ministry of Education and Research, during the conduct of the study; personal fees and non-financial support from Novartis, grants and personal fees from Boehringer Ingelheim, personal fees from CVRx, Pfizer, Medtronic, grants and personal fees from Servier, personal fees from MSD/Bayer, personal fees from Bayer, personal fees from Resmed, personal fees from Berlin Chemie, grants from Thermo Fischer, personal fees from Vifor Pharma, personal fees from PharmaCosmos, personal fees from Merck, outside the submitted work; N.S. received travel grants from BMS/Pfizer outside the submitted work; D.S. reports grants from Roche Diagnostics, grants from Daiichi Sankyo, personal fees from Bayer, personal fees from Astra Zeneca, personal fees from Daiichi Sankyo, personal fees from Eli Lilly, personal fees from MSD, personal fees from Pfizer, and personal fees from Sanofi, outside the submitted work; H.I. reports lecture fees from Bayer, Boehringer, Daichi Sankyo, Pfizer, Bristol-Myers-Squibb, outside the submitted work; T.R reports personal fees from Astra Zeneca, Bayer, Boehringer, Daichi Sankyo, Bristol-Myers-Squibb, Medtronic outside the submitted work; J.M. reports an institutional grant from Boston Scientific, lecture fees from Boston Scientific, Edwards LifeScience, Medtronic, Biotronik, Astra Zeneca, BMS and Terumo, Siemens outside the submitted work; J.H. reports speaker and advisory board activities for Abbott Vascular and Edwards Lifesciences and institutional research support from Abbott Vascular and Edwards Lifesciences outside the submitted work; S.M. received research grants from Roche (Tropical ACS trial) and Pfizer/BMS (APPROACH-ACS-AF trial). S.M. also reports grants from Deutsches Zentrum für Herz-Kreislaufforschung, during the conduct of the study; grants from Pfizer, from Roche, outside the submitted work; R.W. reports grants from Deutsches Zentrum für Herz-Kreislaufforschung, during the conduct of the study. R.W. reports grants from Boston Scientific (MULTASA trial). R.W. reports personal fees from Bayer, Boehringer, Daichi Sankyo, Pfizer, Bristol-Myers-Squibb, Boston Scientific, Biotronik outside the submitted work; L.R., C.S., M.M., A.K., H.B. and U.M. do not have any conflicts of interest., (© 2021 The Authors.)
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- 2021
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44. Stroke prevention of atrial fibrillation: Improving geographic under-use of contemporary antithrombotic approaches remains a challenge.
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Riesinger L, Wakili R, and Dobrev D
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- 2021
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45. Gender Differences in Anger Among Hospital Medical Staff Exposed to Patients with COVID-19.
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Wesemann U, Hadjamu N, Wakili R, Willmund G, Vogel J, Rassaf T, and Siebermair J
- Abstract
Purpose: Occupational exposure to patients with COVID-19 is a stress factor. The aim of this study was to assess gender differences in anger among medical hospital staff. Methods: N =78 hospital employees with direct or indirect contact to patients with COVID-19 completed State-Trait Inventory-2. Results: Female personnel showed higher scores in the main "trait anger" scale and its subscale "anger temperament," whereas "anger control-out" was significant lower. Direct patient contact had no influence. Conclusion: More specific training for female hospital staff could achieve health-related equity. Focusing on anger as a leading indicator could lead to better prevention and self-monitoring. Registered at Clinicaltrials.gov (NCT04368312)., Competing Interests: No competing financial interests exist., (© Ulrich Wesemann et al., 2021; Published by Mary Ann Liebert, Inc.)
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- 2021
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46. ECG Scoring for the Evaluation of Therapy-Naïve Cancer Patients to Predict Cardiotoxicity.
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Pohl J, Mincu RI, Mrotzek SM, Wakili R, Mahabadi AA, Potthoff SK, Siveke JT, Keller U, Landmesser U, Rassaf T, Anker MS, and Totzeck M
- Abstract
Objective: To evaluate a new electrocardiographic (ECG) score reflecting domains of electrical and structural alterations in therapy-naïve cancer patients to assess their risk of cardiotoxicity., Methods: We performed a retrospective analysis of 134 therapy-naïve consecutive cancer patients in our two university hospitals concerning four ECG score parameters: Contiguous Q-waves, markers of left ventricular (LV) hypertrophy, QRS duration and JTc prolongation. Cardiotoxicity was assessed after a short-term follow-up (up to 12 months)., Results: Of all the patients ( n = 25), 19% reached 0 points, 50% ( n = 67) reached 1 point, 25% ( n = 33) reached 2 points, 5% ( n = 7) reached 3 points and 0.7% reached 4 or 5 points ( n = 1 respectively). The incidence of cardiotoxicity ( n = 28 [21%]) increased with the ECG score, with 0 points at 0%, 1 point 7.5%, 2 points 55%, 3 points 71% and ≥3 points 50%. In the ROC (Receiver operating curves) analysis, the best cut-off for predicting cardiotoxicity was an ECG score of ≥2 points (sensitivity 82%, specificity 82%, AUC 0.84, 95% CI 0.77-0.92, p < 0.0001) which was then defined as a high-risk score. High-risk patients did not differ concerning their age, LV ejection fraction, classical cardiovascular risk factors or cardiac biomarkers compared to those with a low-risk ECG score., Conclusion: ECG scoring prior to the start of anti-cancer therapies may help to identify therapy-naïve cancer patients at a higher risk for the development of cardiotoxicity.
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- 2021
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47. Dynamic risk assessment to improve quality of care in patients with atrial fibrillation: the 7th AFNET/EHRA Consensus Conference.
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Fabritz L, Crijns HJGM, Guasch E, Goette A, Häusler KG, Kotecha D, Lewalter T, Meyer C, Potpara TS, Rienstra M, Schnabel RB, Willems S, Breithardt G, Camm AJ, Chan A, Chua W, de Melis M, Dimopoulou C, Dobrev D, Easter C, Eckardt L, Haase D, Hatem S, Healey JS, Heijman J, Hohnloser SH, Huebner T, Ilyas BS, Isaacs A, Kutschka I, Leclercq C, Lip GYH, Marinelli EA, Merino JL, Mont L, Nabauer M, Oldgren J, Pürerfellner H, Ravens U, Savelieva I, Sinner MF, Sitch A, Smolnik R, Steffel J, Stein K, Stoll M, Svennberg E, Thomas D, Van Gelder IC, Vardar B, Wakili R, Wieloch M, Zeemering S, Ziegler PD, Heidbuchel H, Hindricks G, Schotten U, and Kirchhof P
- Subjects
- Anticoagulants adverse effects, Consensus, Humans, Risk Assessment, Risk Factors, Treatment Outcome, Atrial Fibrillation diagnosis, Atrial Fibrillation epidemiology, Atrial Fibrillation therapy, Stroke diagnosis, Stroke epidemiology, Stroke prevention & control
- Abstract
Aims: The risk of developing atrial fibrillation (AF) and its complications continues to increase, despite good progress in preventing AF-related strokes., Methods and Results: This article summarizes the outcomes of the 7th Consensus Conference of the Atrial Fibrillation NETwork (AFNET) and the European Heart Rhythm Association (EHRA) held in Lisbon in March 2019. Sixty-five international AF specialists met to present new data and find consensus on pressing issues in AF prevention, management and future research to improve care for patients with AF and prevent AF-related complications. This article is the main outcome of an interactive, iterative discussion between breakout specialist groups and the meeting plenary. AF patients have dynamic risk profiles requiring repeated assessment and risk-based therapy stratification to optimize quality of care. Interrogation of deeply phenotyped datasets with outcomes will lead to a better understanding of the cardiac and systemic effects of AF, interacting with comorbidities and predisposing factors, enabling stratified therapy. New proposals include an algorithm for the acute management of patients with AF and heart failure, a call for a refined, data-driven assessment of stroke risk, suggestions for anticoagulation use in special populations, and a call for rhythm control therapy selection based on risk of AF recurrence., Conclusion: The remaining morbidity and mortality in patients with AF needs better characterization. Likely drivers of the remaining AF-related problems are AF burden, potentially treatable by rhythm control therapy, and concomitant conditions, potentially treatable by treating these conditions. Identifying the drivers of AF-related complications holds promise for stratified therapy., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)
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- 2021
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48. Mapping and Removing the Ventricular Far Field Component in Unipolar Atrial Electrograms.
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Frisch D, Oesterlein TG, Unger LA, Lenis G, Wakili R, Schmitt C, Luik A, Dossel O, and Loewe A
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- Algorithms, Electrocardiography, Endocardium, Humans, Signal Processing, Computer-Assisted, Electrophysiologic Techniques, Cardiac, Heart Atria
- Abstract
Objective: Unipolar intracardiac electrograms (uEGMs) measured inside the atria during electro-anatomic mapping contain diagnostic information about cardiac excitation and tissue properties. The ventricular far field (VFF) caused by ventricular depolarization compromises these signals. Current signal processing techniques require several seconds of local uEGMs to remove the VFF component and thus prolong the clinical mapping procedure. We developed an approach to remove the VFF component using data obtained during initial anatomy acquisition., Methods: We developed two models which can approximate the spatio-temporal distribution of the VFF component based on acquired EGM data: Polynomial fit, and dipole fit. Both were benchmarked based on simulated cardiac excitation in two models of the human heart and applied to clinical data., Results: VFF data acquired in one atrium were used to estimate model parameters. Under realistic noise conditions, a dipole model approximated the VFF with a median deviation of 0.029 mV, yielding a median VFF attenuation of 142. In a different setup, only VFF data acquired at distances of more than 5 mm to the atrial endocardium were used to estimate the model parameters. The VFF component was then extrapolated for a layer of 5 mm thickness lining the endocardial tissue. A median deviation of 0.082 mV (median VFF attenuation of 49x) was achieved under realistic noise conditions., Conclusion: It is feasible to model the VFF component in a personalized way and effectively remove it from uEGMs., Significance: Application of our novel, simple and computationally inexpensive methods allows immediate diagnostic assessment of uEGM data without prolonging data acquisition.
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- 2020
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49. ECG Changes in Melanoma Patients Undergoing Cancer Therapy-Data From the ECoR Registry.
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Pohl J, Mincu RI, Mrotzek SM, Hinrichs L, Michel L, Livingstone E, Zimmer L, Wakili R, Schadendorf D, Rassaf T, and Totzeck M
- Abstract
We aimed to evaluate whether therapy with immune checkpoint inhibitors (ICI) leads to changes in electrocardiogram (ECG) parameters in melanoma patients. We retrospectively examined 41 patients (46% women, age 61 ± 12years) with advanced melanoma (stage III/IV) before and during ICI treatment from our "Essen Cardio-oncology Registry" (ECoR). ECGs were analyzed before and 4-12 weeks after therapy started (follow-up, 90 ± 51 days). Heart rate, PR time, QRS duration and duration of the corrected QT (QTc) interval were recorded. QT dispersion (QTd) was calculated. Heart rate, PR time, QRS and QTc did not differ when comparing values before and after therapy started. QTd was prolonged after therapy started (32 ± 16 ms vs. 47 ± 19 ms, n = 41, p < 0.0001). Subgroup analyses revealed prolonged QTd in patients that received a combination immunotherapy with ipilimumab and nivolumab (31 ± 14 ms vs. 50 ± 14 ms, n = 21, p < 0.0001), while QTd in patients with anti-programmed death 1 (PD-1) inhibitor monotherapy did not change after therapy started. QTd is prolonged in patients under ICI combination therapy, potentially signaling an increased susceptibility to ventricular arrhythmias.
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- 2020
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50. Impact of diabetes on clinical outcome of patients with heart failure undergoing ICD and CRT procedures: results from the German Device Registry.
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Kaya E, Senges J, Hochadel M, Eckardt L, Andresen D, Ince H, Spitzer SG, Kleemann T, Maier SSK, Jung W, Stellbrink C, Rassaf T, and Wakili R
- Subjects
- Humans, Proportional Hazards Models, Registries, Retrospective Studies, Cardiac Resynchronization Therapy, Defibrillators, Implantable, Diabetes Mellitus epidemiology, Heart Failure complications, Heart Failure epidemiology, Heart Failure therapy
- Abstract
Aims: Diabetes mellitus (DM) has a negative impact on prognosis in patients with heart failure (HF). The role impact of DM in HF patients with implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) devices might differ and remains unclear. The aim of our study was to investigate the impact of DM on periprocedural complications and clinical outcome in HF patients undergoing ICD or CRT implantation., Methods and Results: Within the German Device Registry, data from 50 German centres were collected between January 2007 and February 2014. A retrospective analysis of n = 5329 patients undergoing ICD implantation was conducted. Patients' characteristics, procedural data, periprocedural complications, and post-procedural clinical outcome, including a composite clinical endpoint of all-cause mortality, stroke, and myocardial infarction (MACCE), were analysed. Subgroup analysis were performed for ICD and CRT implantations. Median follow-up was 15.7 (12.9; 20.0) and 16.2 (12.8; 21.2) months in DM and non-DM patients. Of 5329 patients enrolled, n = 1448 (27.2%) had a diagnosis of DM. Within the cohort, 94% of DM and 90% of non-DM patients had a diagnosis of HF. Patients with DM were older, had higher body mass index, and higher rate of cardiovascular comorbidities compared with non-DM patients. Unadjusted and adjusted analyses revealed similar all-over intrahospital periprocedural complication rates in both groups (4.1% vs 3.9%). Unadjusted Kaplan-Meier survival analysis showed higher all-cause mortality after 1 year (9.0% vs 6.3%; log-rank P = 0.001) with higher MACCE rates (10.0% vs 7.3%; P < 0.001) in the DM group versus non-DM patients. After multivariable adjustment for relevant covariates, the association of DM to MACCE disappeared [HR 1.11 (0.89-1.38)]. Because chronic kidney disease (CKD) was clearly associated with increased 1 year MACCE after multivariate adjustment [odds ratio (OR) 2.11 (1.68-2.64)], a subgroup analysis was performed showing a strong trend towards more perioperative complications in DM patients with CKD [OR 2.16 (0.9-5.21)], while no effect of DM was observed in patients without CKD [OR 0.73 (0.42-1.28)]., Conclusions: The overall risk of periprocedural complications and short-term (1 year) clinical outcome in patients with DM and HF undergoing ICD or CRT defibrillator (CRT-D) implantation was not increased. In contrast, CKD was associated with an increased risk of 1 year MACCE in HF patients undergoing ICD/CRT-D implantation., (© 2020 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.)
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- 2020
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