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1. Lack of Prognostic Value of T‐Wave Alternans for Implantable Cardioverter‐Defibrillator Benefit in Primary Prevention

Author

Ari Pelli, Tuomas V. Kenttä, M. Juhani Junttila, Cynthia Huber, Simon Schlögl, Markus Zabel, Marek Malik, Rik Willems, Marc A. Vos, Markus Harden, Tim Friede, Christian Sticherling, and Heikki V. Huikuri

Subjects
appropriate shock, heart failure, implantable cardioverter‐defibrillator, death, T‐wave alternans, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background New methods to identify patients who benefit from a primary prophylactic implantable cardioverter‐defibrillator (ICD) are needed. T‐wave alternans (TWA) has been shown to associate with arrhythmogenesis of the heart and sudden cardiac death. We hypothesized that TWA might be associated with benefit from ICD implantation in primary prevention. Methods and Results In the EU‐CERT‐ICD (European Comparative Effectiveness Research to Assess the Use of Primary Prophylactic Implantable Cardioverter‐Defibrillators) study, we prospectively enrolled 2327 candidates for primary prophylactic ICD. A 24‐hour Holter monitor reading was taken from all recruited patients at enrollment. TWA was assessed from Holter monitoring using the modified moving average method. Study outcomes were all‐cause death, appropriate shock, and survival benefit. TWA was assessed both as a contiguous variable and as a dichotomized variable with cutoff points

Published
2024
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2. 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

Author

Axel Bauer, ProfMD, Nikolay Sappler, MD, Lukas von Stülpnagel, PhD, Mathias Klemm, MD, Michael Schreinlechner, MD, Felix Wenner, MD, Johannes Schier, MD, Amani Al Tawil, MSc, Theresa Dolejsi, MD, Aresa Krasniqi, MD, Elodie Eiffener, MSc, Christa Bongarth, MD, Markus Stühlinger, MD, Martin Huemer, MD, Tommaso Gori, ProfMD, Reza Wakili, ProfMD, Riza Sahin, MD, Robert Schwinger, MD, Matthias Lutz, MD, Armin Luik, MD, Nele Gessler, MD, Peter Clemmensen, ProfMD, Axel Linke, ProfMD, Lars S Maier, ProfMD, Martin Hinterseer, MD, Mathias C Busch, MD, Florian Blaschke, MD, Stefan Sack, ProfMD, Carsten Lennerz, MSc, Manuela Licka, MD, Roland R Tilz, ProfMD, Christian Ukena, MD, Joachim R Ehrlich, ProfMD, Markus Zabel, ProfMD, Georg Schmidt, ProfMD, Ulrich Mansmann, Prof, Stefan Kääb, ProfMD, Konstantinos D Rizas, MD, Steffen Massberg, ProfMD, Andreas May, Peter Seitzer, Roland Schmidt, Dritan Keta, Viktoria Janke, Christian Schläger, Elisabeth André, Niels Brandt, Alexandra Schön, Alfred Zollner, Luisa Freyer, Wolfgang Hamm, Johannes Beil, Anna Katharina Strüven, Anja Loew, Stephanie Fichtner, Philipp Lange, Aresa Krasniqi, Ulrich Grabmeier, Heidi Estner, Philipp Bengel, Lars Lüthje, Aleksandra Kirova, Thomas Fischer, Leonard Bergau, Jonas Herting, Simon Schlögl, Helge Haarmann, Klaudia Schlögl (Illes), Ekrem Uecer, Sabine Sag, Maria Tafelmeier, Carsten Jungbauer, Sabine Fredersdorf-Hahn, Christina Strack, Benedikt Seither, Joachim Seegers, Dominic Millenaar, Jan Wintrich, Patrick Fischer, Axel Buob, Amjad Razouk, Thomas Demming, Johanne Frank, Constantin Kühl, Ulrike Ellendt, Sarah Sandrock, Julia Gänsbacher, Janosch Cupa, Daniel Sinnecker, Karl-Ludwig Laugwitz, Alexander Steger, Anna Berkefeld, Karin Schinke, Petra Barthel, Michael Dommasch, Maiwand Amadei, Gerhard Hindricks, Danilo Obradovic, Michael Döring, Kerstin Bode, Sebastian Hilbert, Susanne Löbe, Helge Knopp, Sebastian König, Silke John, Katharina Schöne, Philipp Hartung, Christian Binner, Christine Meyer-Zürn, Martin Duckheim, Christian Eick, Fabian Simpfle, Jürgen Schreieck, Lars Mizera, Verena Tscholl, Lisa Steinbeck, Nadija Güc, Anne-Sophie Schatz, Philipp Attanasio, Andrea Heuberger, Mattias Roser, Barbara Bellmann, Patrick Nagel, Sebastian Biewener, Saba Suhail, Benjamin Juri, Christian Meyer, Stephan Wiilems, Christiane Jungen, Susanne Schmitt, Paula Münkerer, Julia Vogler, Lukas Kaiser, Benjamin Schäffer, Moritz Nies, Tobias Tönnis, Nina Fluschnik, Hanno Grahn, Christoph Waldeyer, Shinwan Kany, Nils Arne Sörensen, Simon Winkelmann, Özge Akbulak, Nils Arne Gosau, Tilman Würger, Natalie Arnold, Nele Geßler, Alexander Jobs, Paula Münkler, Stefan Rausch, Jelena Köster, Ben Brüggemann, Amr Abdin, Christian Wacker, Philipp Grotherr, Bastian Fries, Maximilian Faust, Stefanie Steuer, Patrick Swojanowsky, Stephan Willems, Nathaniel Portz, Amar Ujeyl, Matthias Krüger, Robert Gramlich, Till Köhler, Armin Sause, Ina Nover, Athanasios-Panagiotis Ziakos, Veaceslav Ciobanu, Norman Spelsberg, Johannes Siebermair, Amir-Abbas Mahabadi, Miriam Köhler, Nadine Vonderlin, Lisa Riesinger, Edison Abdiu, Anja Bachmann, Marie Frenzel, Astrid Hummel, Kristin Lehnert, Anne Krüger, Franke Busse, Andreas Napp, Dirk Müller-Wieland, Simone Battermann, Philipp Lacour, Tobias Trippel, Nick Lasse Beetz, Leonhard Schleußner, Veronika Zach, Christina Rozados, Harald Mudra, Stephan Staubach, Alexander Illmann, Michael Joner, Matthias Bock, Christof Kolb, Tobias Koch, Rebecca Fröhlich, Carsten Lennerz, Tobias Lenz, Patrick Fuchs, Markus Freißmuth, Christian Grebmer, Jürgen Kuschyk, Malte Kranert, Fabian Fastenrath, Gökhan Yücel, Boris Rudic, Sarah Würfel, Albrecht Römer, Andreas Böhmer, Jörg Honold, Stamatis Georgopoulos, Lukas Gleirscher, Susanne Lederle, Artem Chaplygin, Matthias Pauschinger, Andrea Brinker-Paschke, Jana Kropacek, Lars Eckardt, Christian Ellermann, Niklas Bode, Florian Reinke, Hauke Engelke, Robert Höllriegel, Felix Woitek, Ephraim Winzer, Karim Ibrahim, Christian Pflücke, Georg Ende, Uwe Speiser, Stephan Haußig, Rolf Wachter, Tobias Uhe, Torsten Konrad, Edgar Zitron, Jeton Destani, Fangyi Fu, Samer Al Said, Ziya Kaya, Wilfried Schgör, and Thomas Senoner

Subjects
Computer applications to medicine. Medical informatics, R858-859.7
Abstract

Summary: 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 deg2) 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

Published
2022
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3. Remote magnetic navigation versus manual catheter ablation of atrial fibrillation: A single center long‐term comparison

Author

Gerd Hasenfuss, Klaudia Stella Schlögl, Markus Zabel, Helge Haarmann, Simon Schlögl, Philipp Bengel, Eva C.L. Rasenack, and Leonard Bergau

Subjects
Male, Reoperation, medicine.medical_treatment, Ablation of atrial fibrillation, Catheter ablation, 030204 cardiovascular system & hematology, Pericardial effusion, Pulmonary vein, Magnetics, 03 medical and health sciences, Postoperative Complications, 0302 clinical medicine, Recurrence, Risk Factors, Atrial Fibrillation, Humans, Medicine, Prospective Studies, 030212 general & internal medicine, business.industry, Remote magnetic navigation, Atrial fibrillation, General Medicine, Middle Aged, Ablation, medicine.disease, 3. Good health, Catheter, Fluoroscopy, Catheter Ablation, Female, Cardiology and Cardiovascular Medicine, business, Nuclear medicine
Abstract

BACKGROUND Data comparing remote magnetic catheter navigation (RMN) with manual catheter navigation (MCN) ablation of atrial fibrillation (AF) is lacking. The aim of the present prospective observational study was to compare the outcome of RMN versus (vs.) MCN ablation of AF with regards to AF recurrence. METHODS The study comprised 667 consecutive patients with a total of 939 procedures: 287 patients were ablated using RMN, 380 using MCN. RESULTS There was no significant difference between the groups at baseline. After 2.3 ± 2.3 years of follow-up, 23% of the patients in the MCN group remained free of AF recurrence compared to 13% in the RMN group (p

Published
2021

4. Impact of open-irrigated radiofrequency catheter with contact force measurement on the efficacy and safety of atrial fibrillation ablation: a single-center direct comparison

Author

Simon Schlögl, Klaudia Stella Schlögl, Philipp Bengel, Leonard Bergau, Helge Haarmann, Eva Rasenack, Gerd Hasenfuss, and Markus Zabel

Subjects
Physiology (medical), Cardiology and Cardiovascular Medicine
Abstract

Background In atrial fibrillation (AF) patients, catheter ablation of pulmonary veins (PVI) is the most effective therapeutic option to maintain sinus rhythm. To improve successful PVI, contact force–sensing (CF) catheters became routinely available. Previous studies did not clearly show superior clinical efficacy in comparison with non-CF catheters. Methods We investigated consecutive patients, who underwent index PVI for AF at our hospital between 2012 and 2018. Three hundred and fifty-four patients were ablated without CF. After availability of CF catheters in 2016, 317 patients were ablated using CF. In case of crossover between the groups, follow-up was censored. The primary endpoint was any documented atrial tachycardia (AT) or atrial fibrillation > 30 s after a 3-month blanking period. Secondary endpoints were procedural characteristics and periprocedural complications. Results There was no significant difference between the groups at baseline except hyperlipidemia. After 365 days of follow-up, 67% of patients in the CF group remained free from AF/AT recurrence compared to 59% in non-CF group (P = 0.038). In multivariable Cox regression analysis, non-CF ablation was an independent risk factor for AF recurrence besides age and persistent AF. Total fluoroscopy time (15 ± 7.6 vs. 28 ± 15.9 min) and total procedure time (114 ± 29.6 vs. 136 ± 38.5 min) were significantly lower for CF-guided PVI (P P = 0.661). Conclusions In our study, the AT/AF recurrence rate and pulmonary vein reconnection rate is lower after CF PVI with a similar complication rate but lower total procedure time and total fluoroscopy time compared to non-CF PVI.

Published
2022

5. Automated electrocardiographic quantification of myocardial scar in patients undergoing primary prevention implantable cardioverter-defibrillator implantation: Association with mortality and subsequent appropriate and inappropriate therapies

Author

Markus Zabel, Tobias Reichlin, Christian Sticherling, Babken Asatryan, Rik Willems, Simon Schlögl, Beat Schaer, Eu-Cert-Icd Investigators, Marc A. Vos, M. Juhani Junttila, Heikki V. Huikuri, Marek Malik, and Katerina Hnatkova

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Infarction, 030204 cardiovascular system & hematology, Risk Assessment, Sudden cardiac death, Cicatrix, Electrocardiography, 03 medical and health sciences, QRS complex, 0302 clinical medicine, Risk Factors, Interquartile range, Median QRS Duration, Physiology (medical), Internal medicine, Myocardial scarring, medicine, Humans, cardiovascular diseases, 030212 general & internal medicine, Aged, Retrospective Studies, Heart Failure, business.industry, Incidence, Myocardium, Middle Aged, medicine.disease, Implantable cardioverter-defibrillator, Defibrillators, Implantable, 3. Good health, Europe, Primary Prevention, Survival Rate, Death, Sudden, Cardiac, Heart failure, cardiovascular system, Cardiology, Female, medicine.symptom, Cardiology and Cardiovascular Medicine, business, circulatory and respiratory physiology
Abstract

Myocardial scarring from infarction or nonischemic fibrosis forms an arrhythmogenic substrate. The Selvester QRS score has been developed to estimate myocardial scar from the 12-lead electrocardiogram.; We aimed to assess the value of an automated version of the Selvester QRS score for the prediction of implantable cardioverter-defibrillator (ICD) therapy and death in patients undergoing primary prevention ICD implantation.; Unselected patients undergoing primary prevention ICD implantation were included in this retrospective, observational, multicenter study. The QRS score was calculated automatically from a digital standard preimplantation 12-lead electrocardiogram and was correlated to the occurrence of death and appropriate and inappropriate shocks during follow-up. Analyses were performed in groups defined by QRS duration < 130 ms vs ≥ 130 ms.; Overall, 1047 patients (872 [83%] men; median age 64 years IQR [55-71]) with ischemic (648, 62%) or nonischemic (399, 38%) cardiomyopathy were included. The median QRS duration was 123 ms (interquartile range [IQR] 111-157 ms), and the median QRS score was 5 (IQR 2-8). The QRS duration was

Published
2020

6. Rationale and design of the EU-CERT-ICD prospective study: comparative effectiveness of prophylactic ICD implantation

Author

Axel Bauer, Jarosław D. Kasprzak, Rajeeva Sritharan, Nikola Pavlović, Tomas Novotny, Panagiota Flevari, Jesper Hastrup Svendsen, Vassil Traykov, David Conen, Andrzej Lubiński, Tim Friede, Frieder Braunschweig, Georg Schmidt, Josep Brugada, Markus Zabel, Lars Lüthje, Stefan Kääb, Christian Sticherling, Tchavdar N. Shalganov, Anton E. Tuinenburg, Svetoslav Iovev, Gabriela Kaliska, Heikki V. Huikuri, Rik Willems, Janko Szavits Nossan, Gerd Hasenfuß, Robert Hatala, Stefan N. Willich, Simon Schlögl, Jim Hansen, Sandro Brusich, Milos Taborsky, Marc A. Vos, Béla Merkely, Vasil Velchev, Leonard Bergau, Marek Malik, and Iwona Cygankiewicz

Subjects
medicine.medical_specialty, business.industry, medicine.medical_treatment, Comparative effectiveness research, Guideline, 030204 cardiovascular system & hematology, medicine.disease, Implantable cardioverter-defibrillator, 3. Good health, Sudden cardiac death, 03 medical and health sciences, 0302 clinical medicine, Emergency medicine, medicine, Clinical endpoint, media_common.cataloged_instance, 030212 general & internal medicine, European union, Cardiology and Cardiovascular Medicine, business, Prospective cohort study, Cohort study, media_common
Abstract

Aims The clinical effectiveness of primary prevention implantable cardioverter defibrillator (ICD) therapy is under debate. The EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD) aims to assess its current clinical value. Methods and results The EU-CERT-ICD is a prospective investigator-initiated non-randomized, controlled, multicentre observational cohort study performed in 44 centres across 15 European Union countries. We will recruit 2250 patients with ischaemic or dilated cardiomyopathy and a guideline indication for primary prophylactic ICD implantation. This sample will include 1500 patients at their first ICD implantation and 750 patients who did not receive a primary prevention ICD despite having an indication for it (non-randomized control group). The primary endpoint is all-cause mortality; the co-primary endpoint in ICD patients is time to first appropriate shock. Secondary endpoints include sudden cardiac death, first inappropriate shock, any ICD shock, arrhythmogenic syncope, revision procedures, quality of life, and cost-effectiveness. At baseline (and prior to ICD implantation if applicable), all patients undergo 12-lead electrocardiogram (ECG) and Holter ECG analysis using multiple advanced methods for risk stratification as well as detailed documentation of clinical characteristics and laboratory values. Genetic biobanking is also organized. As of August 2018, baseline data of 2265 patients are complete. All subjects will be followed for up to 4.5 years. Conclusions The EU-CERT-ICD study will provide a necessary update about clinical effectiveness of primary prophylactic ICD implantation. This study also aims for improved risk stratification and patient selection using clinical and ECG risk markers.

Published
2018

7. Prediction of mortality benefit based on periodic repolarisation dynamics in patients undergoing prophylactic implantation of a defibrillator : a prospective, controlled, multicentre cohort study

Author

Axel Bauer, Mathias Klemm, Konstantinos D Rizas, Wolfgang Hamm, Lukas von Stülpnagel, Michael Dommasch, Alexander Steger, Andrezej Lubinski, Panagiota Flevari, Markus Harden, Tim Friede, Stefan Kääb, Bela Merkely, Christian Sticherling, Rik Willems, Heikki Huikuri, Marek Malik, Georg Schmidt, Markus Zabel, Béla Merkely, Peter Perge, Zoltan Sallo, Gabor Szeplaki, Lars Lüthje, Simon Schlögl, Helge Haarmann, Leonard Bergau, Joachim Seegers, Gerd Hasenfuß, Pascal Munoz-Exposito, Tobias Tichelbäcker, Aleksandra Kirova, Katerina Hnatkova, Marc Vos, Stefan N. Willich, Thomas Reinhold, Bert Vandenberk, Magdalena Klinika, Krapinske Toplice, Panayota Flevari, Andreas Katsimardos, Dimitrios Katsaras, Robert Hatala, Martin Svetlosak, Andrzej Lubinski, Tomasz Kuczejko, Jim Hansen, David Conen, Sestre Milosrdnice, Nikola Pavlović, Šime Manola, Ozren Vinter, Ivica Benko, Anton Tuinenburg, Christine Meyer-Zürn, Christian Eick, Jesper Hastrup, Josep Brugada, Elena Arbelo, Gabriela Kaliska, Jozef Martinek, Moritz F. Sinner, Konstantinos D. Rizas, Nikolay Vdovin, Iwona Cygankiewicz, Pawel Ptaszynski, Krzysztof Kaczmarek, Izabela Poddebska, Svetoslav Iovev, Tomáš Novotný, Milan Kozak, Tuomas Kenttä, Ari Pelli, Jaroslaw D. Kasprzak, Dariusz Qavoq, Sandro Brusich, Ervin Avdovic, Marina Klasan, Jan Galuszka, Milos Taborsky, Vasil Velchev, Rüdiger Dissmann, Przemysław Guzik, Dieter Bimmel, Christiane Lieberz, Stefan Stefanow, Norman Rüb, Christian Wolpert, Lars S. Maier, Steffen Behrens, Zrinka Jurisic, Frieder Braunschweig, Florian Blaschke, Burkert Pieske, Zoran Bakotic, Ante Anic, Robert H.G. Schwinger, and Pyotr Platonov

Subjects
Male, Death, Sudden, Cardiac/prevention & control, Cardiomyopathy, 030204 cardiovascular system & hematology, Arrhythmias, Cohort Studies, 0302 clinical medicine, Clinical endpoint, Controlled Clinical Trial, 030212 general & internal medicine, 11 Medical and Health Sciences, Medicine(all), Ejection fraction, Cardiac/prevention & control, Hazard ratio, General Medicine, Middle Aged, 3. Good health, Defibrillators, Implantable, Death, Europe, Multicenter Study, Cardiomyopathies/complications, Female, Implantable, Cardiomyopathies, Cohort study, medicine.medical_specialty, Arrhythmias, Cardiac/mortality, Comparative effectiveness research, Electric Countershock, 03 medical and health sciences, General & Internal Medicine, Internal medicine, medicine, Journal Article, Humans, Propensity Score, Aged, Cardiac/mortality, EU-CERT-ICD investigators, business.industry, Arrhythmias, Cardiac, Stroke Volume, Guideline, medicine.disease, Sudden, Death, Sudden, Cardiac, Propensity score matching, ICD sudden death cardiomyopathy, business, Defibrillators
Abstract

BACKGROUND: A small proportion of patients undergoing primary prophylactic implantation of implantable cardioverter defibrillators (ICDs) experiences malignant arrhythmias. We postulated that periodic repolarisation dynamics, a novel marker of sympathetic-activity-associated repolarisation instability, could be used to identify electrically vulnerable patients who would benefit from prophylactic implantation of ICDs by way of a reduction in mortality. METHODS: We did a prespecified substudy of EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD), a prospective, investigator-initiated, non-randomised, controlled cohort study done at 44 centres in 15 EU countries. Patients aged 18 years or older with ischaemic or non-ischaemic cardiomyopathy and reduced left ventricular ejection fraction (≤35%) were eligible for inclusion if they met guideline-based criteria for primary prophylactic implantation of ICDs. Periodic repolarisation dynamics from 24-h Holter recordings were assessed blindly in patients the day before ICD implantation or on the day of study enrolment in patients who were conservatively managed. The primary endpoint was all-cause mortality. Propensity scoring and multivariable models were used to assess the interaction between periodic repolarisation dynamics and the treatment effect of ICDs on mortality. FINDINGS: Between May 12, 2014, and Sept 7, 2018, 1371 patients were enrolled in our study. 968 of these patients underwent ICD implantation, and 403 were treated conservatively. During follow-up (median 2·7 years [IQR 2·0-3·3] in the ICD group and 1·2 years [0·8-2·7] in the control group), 138 (14%) patients died in the ICD group and 64 (16%) patients died in the control group. We noted a 43% reduction in mortality in the ICD group compared with the control group (adjusted hazard ratio [HR] 0·57 [95% CI 0·41-0·79]; p=0·0008). Periodic repolarisation dynamics significantly predicted the treatment effect of ICDs on mortality (adjusted p=0·0307). The mortality benefits associated with ICD implantation were greater in patients with periodic repolarisation dynamics of 7·5 deg or higher (n=199; adjusted HR 0·25 [95% CI 0·13-0·47] for the ICD group vs the control group; p

Published
2019

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