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6. Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study

Author

Ekanem, Emmanuel, Neuzil, Petr, Reichlin, Tobias, Kautzner, Joseph, van der Voort, Pepijn, Jais, Pierre, Chierchia, Gian-Battista, Bulava, Alan, Blaauw, Yuri, Skala, Tomas, Fiala, Martin, Duytschaever, Mattias, Szeplaki, Gabor, Schmidt, Boris, Massoullie, Grégoire, Neven, Kars, Thomas, Olivier, Vijgen, Johan, Gandjbakhch, Estelle, Scherr, Daniel, Johannessen, Arne, Keane, David, Boveda, Serge, Maury, Philippe, García-Bolao, Ignacio, Anic, Ante, Hansen, Peter Steen, Raczka, Franck, Lepillier, Antoine, Guyomar, Yves, Gupta, Dhiraj, Van Opstal, Jurren, Defaye, Pascal, Sticherling, Christian, Sommer, Philipp, Kucera, Pavel, Osca, Joaquin, Tabrizi, Fariborz, Roux, Antoine, Gramlich, Michael, Bianchi, Stefano, Adragão, Pedro, Solimene, Francesco, Tondo, Claudio, Russo, Antonio Dello, Schreieck, Jürgen, Luik, Armin, Rana, Obaida, Frommeyer, Gerrit, Anselme, Frédéric, Kreis, Ingo, Rosso, Raphael, Metzner, Andreas, Geller, Laszlo, Baldinger, Samuel H., Ferrero, Angel, Willems, Stephan, Goette, Andreas, Mellor, Greg, Mathew, Shibu, Szumowski, Lukasz, Tilz, Roland, Iacopino, Saverio, Jacobsen, Peter Karl, George, Andrikopoulos, Osmancik, Pavel, Spitzer, Stefan, Balasubramaniam, Richard, Parwani, Abdul Shokor, Deneke, Thomas, Glowniak, Andrzej, Rossillo, Antonio, Pürerfellner, Helmut, Duncker, David, Reil, Peter, Arentz, Thomas, Steven, Daniel, Olalla, Juan José, de Jong, Jonas S. S. G., Wakili, Reza, Abbey, Selim, Timo, Gottschling, Asso, Antonio, Wong, Tom, Pierre, Bertrand, Ewertsen, Niels Christian, Bergau, Leonard, Lozano-Granero, Cristina, Rivero, Maximo, Breitenstein, Alexander, Inkovaara, Jaakko, Fareh, Samir, Latcu, Decebal Gabriel, Linz, Dominik, Müller, Patrick, Ramos-Maqueda, Javier, Beiert, Thomas, Themistoclakis, Sakis, Meininghaus, Dirk Grosse, Stix, Günter, Tzeis, Stylianos, Baran, Jakub, Almroth, Henrik, Munoz, Daniel Rodriguez, de Sousa, João, Efremidis, Michalis, Balsam, Pawel, Petru, Jan, Küffer, Thomas, Peichl, Petr, Dekker, Lukas, Della Rocca, Domenico G., Moravec, Ondrej, Funasako, Moritoshi, Knecht, Sebastien, Jauvert, Gael, Chun, Julian, Eschalier, Romain, Füting, Anna, Zhao, Alexandre, Koopman, Pieter, Laredo, Mikael, Manninger, Martin, Hansen, Jim, O’Hare, Daniel, Rollin, Anne, Jurisic, Zrinka, Fink, Thomas, Chaumont, Corentin, Rillig, Andreas, Gunawerdene, Melanie, Martin, Claire, Kirstein, Bettina, Nentwich, Karin, Lehrmann, Heiko, Sultan, Arian, Bohnen, Jan, Turagam, Mohit K., and Reddy, Vivek Y.

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.

Published
2024
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16. MACHINE LEARNING-BASED PREDICTION OF 1-YEAR ALL-CAUSE MORTALITY IN PATIENTS UNDERGOING VT ABLATION WITH TOPOLOGICAL DATA ANALYSIS

Author

Afshar, Ausa, primary, Nagy, Klaudia Vivien, additional, Vámosi, Péter, additional, Komlósi, Ferenc, additional, Tóth, Patrik, additional, Szegedi, Nandor, additional, Osztheimer, István, additional, Salló, Zoltán, additional, Tokodi, Marton, additional, Merkely, Bela, additional, and Geller, Laszlo A., additional

Published
2022
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21. B-PO03-043 LONG TERM EFFECTS OF CARDIAC NEUROMODULATION THERAPY ON SYSTOLIC BLOOD PRESSURE IN CONTROL PATIENTS AFTER CROSS OVER TO THERAPY

Author

Kalarus, Zbigniew, primary, Merkely, Bela, additional, Grabowski, Marcin, additional, Neuzil, Petr, additional, Marinskis, Germanas, additional, Mitkowski, Przemyslaw P., additional, Erglis, Andrejs, additional, Kazmierczak, Jaroslaw, additional, Pluta, Slawomir, additional, Geller, Laszlo, additional, Osztheimer, Istvan, additional, Lidia Chmielewska-Michalak, Libor Dujka, additional, Ieva Anasberga, Agnieska Kolodzinska, additional, Jurate Barysiene, Filip Malek, additional, Milosz Stepien, Diana Paskudzka, additional, and Sokal, Adam, additional

Published
2021
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25. Left atrial appendage size is a marker of atrial fibrillation recurrence after radiofrequency catheter ablation in patients with persistent atrial fibrillation

Author

Simon, Judit, primary, Mahdiui, Mohammed El, additional, Smit, Jeff, additional, Száraz, Lili, additional, Rosendael, Alexander van, additional, Herczeg, Szilvia, additional, Zsarnóczay, Emese, additional, Nagy, Anikó, additional, Kolossváry, Márton, additional, Szilveszter, Bálint, additional, Szegedi, Nandor, additional, Nagy, Klaudia Vivien, additional, Tahin, Tamás, additional, Geller, Laszlo, additional, Geest, Rob van der, additional, Bax, Jeroen, additional, Maurovich-Horvat, Pál, additional, and Merkely, Bela, additional

Published
2021
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27. TWO YEAR SAFETY AND EFFICACY OF CARDIAC NEUROMODULATION THERAPY IN HYPERTENSIVE PATIENTS INDICATED FOR A PACEMAKER

Author

Kalarus, Zbigniew, primary, Bela, Merkely P., additional, Neuzil, Petr, additional, Mitkowski, Przemyslaw, additional, Erglis, Andrejs, additional, Grawobski, Marcin, additional, Marinskis, Germanas, additional, Kazmierczak, Jaroslaw, additional, Pluta, Slawomir, additional, Geller, Laszlo, additional, Osztheimer, Istvan, additional, Malek, Filip, additional, Dujka, Libor, additional, Chmielewska-Michalak, Lidia, additional, Kolodzinska, Agnieska, additional, Anasberga, Ieva, additional, Barysiene, Jurate, additional, Paskusdzka, Diana, additional, Stepien, Milosz, additional, and Sokal, Adam, additional

Published
2021
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31. Preventive or Deferred Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy and Implantable Defibrillator (BERLIN VT) A Multicenter Randomized Trial

Author

Willems, Stephan, Tilz, Roland Richard, Steven, Daniel, Kaeaeb, Stefan, Wegscheider, Karl, Geller, Laszlo, Meyer, Christian, Heeger, Christian-Hendrik, Metzner, Andreas, Sinner, Moritz F., Schluter, Michael, Nordbeck, Peter, Eckardt, Lars, Bogossian, Harilaos, Sultan, Arian, Wenzel, Beate, Kuck, Karl-Heinz, Willems, Stephan, Tilz, Roland Richard, Steven, Daniel, Kaeaeb, Stefan, Wegscheider, Karl, Geller, Laszlo, Meyer, Christian, Heeger, Christian-Hendrik, Metzner, Andreas, Sinner, Moritz F., Schluter, Michael, Nordbeck, Peter, Eckardt, Lars, Bogossian, Harilaos, Sultan, Arian, Wenzel, Beate, and Kuck, Karl-Heinz

Abstract

Background: Catheter ablation for ventricular tachycardia (VT) reduces the recurrence of VT in patients with implantable cardioverter-defibrillators (ICDs). The appropriate timing of VT ablation and its effects on mortality and heart failure progression remain a matter of debate. In patients with life-threatening arrhythmias necessitating ICD implantation, we compared outcomes of preventive VT ablation (undertaken before ICD implantation to prevent ICD shocks for VT) and deferred ablation after 3 ICD shocks for VT. Methods: The BERLIN VT study (Preventive Ablation of Ventricular Tachycardia in Patients With Myocardial Infarction) was a prospective, open, parallel, randomized trial performed at 26 centers. Patients with stable ischemic cardiomyopathy, a left ventricular ejection fraction between 30% and 50%, and documented VT were randomly assigned 1:1 to a preventive or deferred ablation strategy. The primary outcome was a composite of all-cause death and unplanned hospitalization for either symptomatic ventricular arrhythmia or worsening heart failure. Secondary outcomes included sustained ventricular tachyarrhythmia and appropriate ICD therapy. We hypothesized that preventive ablation strategy would be superior to deferred ablation strategy in the intention-to-treat population. Results: During a mean follow-up of 396 +/- 284 days, the primary end point occurred in 25 (32.9%) of 76 patients in the preventive ablation group and 23 (27.7%) of 83 patients in the deferred ablation group (hazard ratio, 1.09 [95% CI, 0.62-1.92]; P=0.77). On the basis of prespecified criteria for interim analyses, the study was terminated early for futility. In the preventive versus deferred ablation group, 6 versus 2 patients died (7.9% versus 2.4%; P=0.18), 8 versus 2 patients were admitted for worsening heart failure (10.4% versus 2.3%; P=0.062), and 15 versus 21 patients were hospitalized for symptomatic ventricular arrhythmia (19.5% versus 25.3%; P=0.27). Among secondary outcomes, th

Published
2020

35. Biventricular pacing during cardiac magnetic resonance imaging

Author

Vago, Hajnalka, primary, Czimbalmos, Csilla, additional, Papp, Roland, additional, Szabo, Liliana, additional, Toth, Attila, additional, Dohy, Zsofia, additional, Csecs, Ibolya, additional, Suhai, Ferenc, additional, Kosztin, Annamaria, additional, Molnar, Levente, additional, Geller, Laszlo, additional, and Merkely, Bela, additional

Published
2019
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36. Clinical presentation at first heart failure hospitalization does not predict recurrent heart failure admission

Author

Kosztin, Annamaria, Costa, Jason, Moss, Arthur J., Biton, Yitschak, Nagy, Vivien Klaudia, Solomon, Scott D., Geller, Laszlo, McNitt, Scott, Polonsky, Bronislava, Merkely, Bela, and Kutyifa, Valentina

Subjects
Heart Failure, Male, Cardiac resynchronization therapy, Heart failure hospitalization, Prognosis, Patient Readmission, Risk Assessment, United States, Hospitalization, Survival Rate, Recurrence, Risk Factors, Original Research Articles, Humans, Female, Original Research Article, Recurrent hospitalization, Prospective Studies, Aged
Abstract

Aims There are limited data on whether clinical presentation at first heart failure (HF) hospitalization predicts recurrent HF events. We aimed to assess predictors of recurrent HF hospitalizations in mild HF patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy with defibrillator. Methods and results Data on HF hospitalizations were prospectively collected for patients enrolled in MADIT‐CRT. Predictors of recurrent HF hospitalization (HF2) after the first HF hospitalization were assessed using Cox proportional hazards regression models including baseline covariates and clinical presentation or management at first HF hospitalization. There were 193 patients with first HF hospitalization, and 156 patients with recurrent HF events. Recurrent HF rate after the first HF hospitalization was 43% at 1 year, 52% at 2 years, and 55% at 2.5 years. Clinical signs and symptoms, medical treatment, or clinical management of HF at first HF admission was not predictive for HF2. Baseline covariates predicting recurrent HF hospitalization included prior HF hospitalization (HR = 1.59, 95% CI: 1.15–2.20, P = 0.005), digitalis therapy (HR = 1.58, 95% CI: 1.13–2.20, P = 0.008), and left ventricular end‐diastolic volume >240 mL (HR = 1.62, 95% CI: 1.17–2.25, P = 0.004). Conclusions Recurrent HF events are frequent following the first HF hospitalization in patients with implanted implantable cardioverter defibrillator or cardiac resynchronization therapy with defibrillator. Neither clinical presentation nor clinical management during first HF admission was predictive of recurrent HF. Prior HF hospitalization, digitalis therapy, and left ventricular end‐diastolic volume at enrolment predicted recurrent HF hospitalization, and these covariates could be used as surrogate markers for identifying a high‐risk cohort.

Published
2017

41. Biventricular pacing during cardiac magnetic resonance imaging.

Author

Vago, Hajnalka, Czimbalmos, Csilla, Papp, Roland, Szabo, Liliana, Toth, Attila, Dohy, Zsofia, Csecs, Ibolya, Suhai, Ferenc, Kosztin, Annamaria, Molnar, Levente, Geller, Laszlo, and Merkely, Bela

Subjects
HEART failure treatment, LEFT heart ventricle, RESEARCH, LEFT ventricular dysfunction, RESEARCH methodology, MAGNETIC resonance imaging, MEDICAL cooperation, EVALUATION research, CARDIAC pacing, COMPARATIVE studies, HEART physiology, STROKE volume (Cardiac output), HEART failure
Abstract

Aims: We aimed to assess the effect of cardiac resynchronization on left ventricular (LV) function, volumes, geometry, and mechanics in order to demonstrate reverse remodelling using cardiac magnetic resonance (CMR) with resynchronization on.Methods and Results: New York Heart Association (NYHA) Class II-III patients on optimal medical therapy with LV ejection fraction (LVEF) ≤35%, and complete LBBB with broad QRS (>150 ms) were prospectively recruited. Cardiac magnetic resonance examination was performed at baseline and at 6-month follow-up, applying both biventricular and AOO pacing. The following data were measured: conventional CMR parameters, remodelling indices, global longitudinal, circumferential, radial strain, global dyssynchrony [mechanical dispersion (MD) defined as the standard deviation of time to peak longitudinal/circumferential strain in 16 LV segments], and regional dyssynchrony (maximum differences in time between peak septal and lateral transversal displacement). Thirteen patients (64 ± 7 years, 38% male) were enrolled. Comparing the baseline and follow-up CMR parameters measured during biventricular pacing, significant increase in LVEF, and decrease in LV end-diastolic volume index (LVEDVi) and LV end-systolic volume index (LVESVi) were found. Left ventricular remodelling indices, global longitudinal, circumferential, and radial strain values showed significant improvement. Circumferential MD decreased (20.5 ± 5.5 vs. 13.4 ± 3.4, P < 0.001), while longitudinal MD did not change. Regional dyssynchrony drastically improved (362 ± 96 vs. 104 ± 66 ms, P < 0.001). Applying AOO pacing resulted in an immediate deterioration in LVEF, LVESVi, circumferential strain, global and regional dyssynchrony.Conclusion: Cardiac magnetic resonance imaging during biventricular pacing is feasible and enables a more precise quantification of LV function, morphology, and mechanics. As a result, it may contribute to a better understanding of the effects of resynchronization therapy and might improve responder rate in the future. [ABSTRACT FROM AUTHOR]

Published
2020
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42. Quality of life predicting long-term outcomes in cardiac resynchronization therapy patients.

Author

Nagy, Klaudia Vivien, Merkely, Bela, Rosero, Spencer, Geller, Laszlo, Kosztin, Annamaria, McNitt, Scott, Polonsky, Bronislava, Goldenberg, Ilan, Zareba, Wojciech, and Kutyifa, Valentina

Subjects
MENTAL depression, HEART failure treatment, ANXIETY, DISEASE progression, ECHOCARDIOGRAPHY, RESEARCH, PAIN, MORTALITY, MULTIVARIATE analysis, RESEARCH methodology, PROGNOSIS, ACTIVITIES of daily living, EVALUATION research, MEDICAL cooperation, CARDIAC pacing, SEVERITY of illness index, COMPARATIVE studies, RANDOMIZED controlled trials, QUALITY of life, KAPLAN-Meier estimator, SYMPTOMS, STATISTICAL sampling, HEART failure, PROPORTIONAL hazards models, HEALTH self-care
Abstract

Aims: While improvement in quality of life (QoL) has been widely reported in cardiac resynchronization therapy (CRT) patients, its predictive value is not well-understood. We aimed to assess the predictive role of baseline QoL on long-term heart failure (HF) or death events in mild HF patients enrolled in Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT).Methods and Results: A total of 1791 of 1820 patients had their QoL evaluated at baseline, using the EuroQol-5 dimensions (EQ-5D) and the Kansas City Cardiomyopathy Questionnaires (KCCQ). Kaplan-Meier survival analyses and multivariate Cox models were utilized. Issues within any of the domains of the baseline EQ-5D questionnaire (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) were associated with long-term mortality (median follow-up 5.6 years) (all P < 0.05). Heart failure or death events were predicted by issues in baseline mobility [hazard ratio (HR) = 1.41, P < 0.001], usual activities (HR = 1.41, P < 0.001), and anxiety/depression (HR = 1.21, P = 0.035). The risk of HF events alone was significantly higher in patients with baseline mobility issues (HR = 1.42, P < 0.001) or usual activity (HR = 1.35, P = 0.003). Every 10% increase in the visual analogue scale (0-100) was associated with an 8% lower risk of all-cause mortality (P = 0.006), and a 6% lower risk of HF/death (P = 0.002). Mobility issues also predicted echocardiographic reverse remodelling (-33.08 mL vs. -31.17 mL, P = 0.043). Using the KCCQ, patients in the lower tertile of the clinical summary or physical limitations score had a significantly higher risk of long-term HF or death (P < 0.05).Conclusion: In mild HF patients enrolled in MADIT-CRT, multiple baseline QoL questionnaire domains were predictors of echocardiographic remodelling, long-term all-cause mortality, and HF events. [ABSTRACT FROM AUTHOR]

Published
2019
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48. Comparison of the Effects of Epicardial and Endocardial Cardiac Resynchronization Therapy on Transmural Dispersion of Repolarization

Author

Molnar, Levente, Szilagyi, Szabolcs, Osztheimer, Istvan, Szeplaki, Gabor, ÖZCAN, EMİN EVREN, Sallo, Zoltan, Geller, Laszlo, Merkely, Bela, Zima, Endre, and Ozturk, Ali

Abstract

BackgroundDespite significant improvements in cardiac output and functional capacity with cardiac resynchronization therapy (CRT), incidence of sudden cardiac death still remains high. Reversal of physiological myocardial activation sequence during epicardial pacing increases the transmural dispersion of repolarization (TDR). The aim of this study was to compare the effects of endocardial and epicardial biventricular pacing on repolarization parameters in the same patient group.

Published
2015

49. Reszinkronizációs terápia Primer implantáció és upgrade

Author

Nagy, Klaudia Vivien, Szegedi, Nandor, Szeplaki, Gabor, Kovacs, Atilla, Nemeth, Tamas, Valentina, Kutyifa, Molnar, Levente, Bela, Merkely, ÖZCAN, EMİN EVREN, Istvan, Osztheimer, Endre, Zima, Szilagyi, Szabolcs, and Geller, Laszlo

Published
2015

50. Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial

Author

Merkely, Bela, primary, Kosztin, Annamaria, additional, Roka, Attila, additional, Geller, Laszlo, additional, Zima, Endre, additional, Kovacs, Attila, additional, Boros, Andras Mihaly, additional, Klein, Helmut, additional, Wranicz, Jerzy K., additional, Hindricks, Gerhard, additional, Clemens, Marcell, additional, Duray, Gabor Z., additional, Moss, Arthur J., additional, Goldenberg, Ilan, additional, and Kutyifa, Valentina, additional

Published
2016
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