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Abstract Background Radiofrequency catheter ablation of atrial fibrillation (AF) has been proved to be effective and to prevent progressive left atrial (LA) remodeling. Cryoballoon catheter ablation (CCA), using a different energy source, was developed to simplify the ablation procedure. Our hypothesis was that successful CCA can also prevent progressive LA remodeling. Methods 36 patients selected for their first CCA because of nonvalvular paroxysmal AF had echocardiography before and 3, 6 and 12 months after CCA. LA diameters, volumes (LAV) and LA volume index (LAVI) were evaluated. LA function was assessed by: early diastolic velocities of the mitral annulus (Aasept, Aalat), LA filling fraction (LAFF), LA emptying fraction (LAEF) and the systolic fraction of pulmonary venous flow (PVSF). Detailed left ventricular diastolic function assessment was also performed. Results Excluding recurrences in the first 3-month blanking period, the clinical success rate was 64%. During one-year of follow-up, recurrent atrial arrhythmia was found in 21 patients (58%). In the recurrent group at 12 months after ablation, minimal LAV (38 ± 19 to 44 ± 20 ml; p < 0.05), maximal LAV (73 ± 23 to 81 ± 24 ml; p < 0.05), LAVI (35 ± 10 to 39 ± 11 ml/m2; p = 0.01) and the maximal LA longitudinal diameter (55 ± 5 to 59 ± 6 mm; p < 0.01) had all increased. PVSF (58 ± 9 to 50 ± 10%; p = 0.01) and LAFF (36 ± 7 to 33 ± 8%; p = 0.03) had decreased. In contrast, after successful cryoballoon ablation LA size had not increased and LA function had not declined. In the recurrent group LAEF was significantly lower at baseline and at follow-up visits. Conclusions In patients whose paroxysmal atrial fibrillation recurred within one year after cryoballoon catheter ablation left atrial size had increased and left atrial function had declined. In contrast, successful cryoballoon catheter ablation prevented progressive left atrial remodeling.

Background: Limited information is available on the safety and efficacy of cryoballoon ablation (CBA) in elderly patients with atrial fibrillation (AF). Moreover, global utilization of CBA in this population (≥ 80 years old) has not been reported. This study's objectives were to determine the use, efficacy, and safety of CBA to treat octogenarians suffering from AF., Methods: In this sub-analysis of the Cryo Global Registry, 12-month outcomes of treating AF via CBA in octogenarians were compared to patients < 80 years old. Efficacy was evaluated as time to a ≥ 30 s atrial arrhythmia (AA) recurrence. Healthcare utilization was determined via repeat ablations and hospitalizations. Improvement upon disease burden was evaluated through patient reporting of symptoms and the EQ-5D-3L quality of life (QoL) survey., Results: The octogenarian cohort (n = 101) had a higher prevalence of females (51.5% vs 35.7%) and CHA 2 DS 2 -VASc scores (4.2 ± 1.3 vs 2.0 ± 1.5) compared to the control cohort (n = 1573, both p < 0.01). Even when adjusting for baseline characteristics and antiarrhythmic drug usage, freedom from AA recurrence at 12 months (80.6% vs 78.9%, HR adj :0.97 [95% CI:0.59-1.58], p = 0.90) was comparable between octogenarians and control, respectively. Similar serious adverse event rates were observed between octogenarians (5.0%) and control (3.2%, p = 0.38). The groups did not differ in healthcare utilization nor reduction of AF-related symptoms from baseline to follow-up, but both experienced an improvement in QoL at 12 months., Conclusions: Despite more age-related comorbidities, CBA is a safe and effective treatment for AF in octogenarians, with efficacy and adverse events rates akin to ablations performed in younger patients., Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT02752737., (© 2023. The Author(s).)

Aims: Recommendations on cardiac resynchronization therapy (CRT) in patients with atrial fibrillation or flutter (AF) are based on less robust evidence than those in sinus rhythm (SR). We aimed to assess the efficacy of CRT upgrade in the BUDAPEST-CRT Upgrade trial population by their baseline rhythm., Methods and Results: Heart failure patients with reduced ejection fraction (HFrEF) and previously implanted pacemaker (PM) or implantable cardioverter defibrillator (ICD) and ≥20% right ventricular (RV) pacing burden were randomized to CRT with defibrillator (CRT-D) upgrade (n = 215) or ICD (n = 145). Primary [HF hospitalization (HFH), all-cause mortality, or <15% reduction of left ventricular end-systolic volume] and secondary outcomes were investigated. At enrolment, 131 (36%) patients had AF, who had an increased risk for HFH as compared with those with SR [adjusted hazard ratio (aHR) 2.99; 95% confidence interval (CI) 1.26-7.13; P = 0.013]. The effect of CRT-D upgrade was similar in patients with AF as in those with SR [AF adjusted odds ratio (aOR) 0.06; 95% CI 0.02-0.17; P < 0.001; SR aOR 0.13; 95% CI 0.07-0.27; P < 0.001; interaction P = 0.29] during the mean follow-up time of 12.4 months. Also, it decreased the risk of HFH or all-cause mortality (aHR 0.33; 95% CI 0.16-0.70; P = 0.003; interaction P = 0.17) and improved the echocardiographic response (left ventricular end-diastolic volume difference -49.21 mL; 95% CI -69.10 to -29.32; P < 0.001; interaction P = 0.21)., Conclusion: In HFrEF patients with AF and PM/ICD with high RV pacing burden, CRT-D upgrade decreased the risk of HFH and improved reverse remodelling when compared with ICD, similar to that seen in patients in SR., Competing Interests: Conflict of interest: B.M. reports grants from Boston Scientific, NRDIF Hungary, and National Heart Program during the conduct of the study; personal fees from Biotronik, Abbott, AstraZeneca, Novartis, and Boehringer Ingelheim; and grants from Medtronic outside the submitted work. I.O. reports lecture and advisory fees from Abbott, Biotronik, Boston Scientific, Medtronic, and Vitatron and travel grants from Abbott, Biotronik, Boston Scientific, and Medtronic. Attila K. reports grants from Bolyai Research Scholarship and FK ‘OTKA’ Research Grant from NKFIH outside the submitted work, stock from CardioSight, Inc. and stock option from Argus Cognitive, Inc. outside the submitted work, and personal fees from Argus Cognitive, Inc. and CardioSight Hungary LLC outside the submitted work. G.D. reports research grants to institution from Medtronic and Biotronik and lecture and advisory fees from Medtronic, Biotronik, and Abbott. C.F. reports support from the Semmelweis University, grants from Medtronic, consulting fees from Medtronic and Biotronik Hungary, and payment or honoraria for lectureures from Johnson and Johnson Co., Abbott Laboratories and Boehringer Ingelheim RCV GmbH and Co. L.G. reports support for the present manuscript from Vitatron Medical, Boston Scientific, Abbott Laboratories, Medtronic Hungary, and Biotronik Hungary; consulting fees from Medtronic Hungary and Abbott Hungary; honoraria; travel grants; participation on a data safety monitoring board or advisory board; and role in other board and committee (FESC, FEHRA, President of the Scientific Committee of the Hungarian Society of Cardiology, Past President of the Working Group on Cardiac Arrhythmias and Pacing, and EHRA Scientific Programme Board). Annamária K. reports grants from Bolyai Research Scholarship outside the submitted work; consulting fees from Medtronic; honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Biotronik, and Novartis; payment for expert testimony from Boehringer Ingelheim and Boston Scientific; travel grants from AstraZeneca and Novartis; participation on a data safety monitoring board or advisory board for Boehringer Ingelheim and Boston Scientific; and role in other board and committee (committee member of Hungarian Society of Cardiology and secretary of the Working Group on Cardiac Arrhythmias and Pacing, Hungarian Society of Cardiology). S.D.S. reports grants to institution from Actelion, Alnylam, Amgen, AstraZeneca, Bellerophon, Bayer, BMS, Celladon, Cytokinetics, Eidos, Gilead, GSK, Ionis, Lilly, Mesoblast, MyoKardia, NIH/NHLBI, NeuroTronik, Novartis, Novo Nordisk, Respicardia, Sanofi Pasteur, Theracos, and US2.AI and consulting fees outside the scope of the current work from Abbott, Action, Akros, Alnylam, Amgen, Arena, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Cardior, Cardurion, Corvia, Cytokinetics, Daiichi Sankyo, GSK, Lilly, Merck, MyoKardia, Novartis, Roche, Theracos, Quantum Genomics, Cardurion, Janssen, Cardiac Dimensions, Tenaya, Sanofi Pasteur, Dinaqor, Tremeau, CellProthera, Moderna, American Regent, Sarepta, Lexicon, AnaCardio, Akros, and Valo. R.H. reports institutional grants from Abbott, Biotronik, and Slovak Research and Development Agency; honoraria from Abbott and Medtronic; and travel grants from the European Society of Cardiology and Pfizer. He is also the president of the Slovak Heart Rhythm Association. E.M. reports grants from Novartis, Boehringer Ingelheim, and Biotronik Hungary. V.K. reports grants from Boston Scientific, ZOLL, Biotronik, Spire Inc., and NIH, consulting fees from Biotronik and Zoll, and payment or honoraria for lectures from Abbott Medical and Medtronic. The other authors declare no conflict of interest for this contribution., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Cryoballoon ablation is a well-established anatomical approach for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Although widely adopted, regional variations in standards of care have not been well characterized., Methods: Patients with AF were enrolled in the Cryo Global Registry (NCT02752737) from May 2016 to Sept 2021 at 128 sites in 37 countries and treated with cryoballoon ablation according to local clinical practice. Baseline patient and procedural characteristics were summarized for 8 regions (Central Asia & Russia, East Asia, Europe, Middle East, North America, South Africa, South America, and Southeast Asia). Serious procedure-related adverse events (SAEs) were evaluated in a subset of patients with ≥ 7 days of follow-up., Results: A total of 3,680 patients undergoing initial PVI for AF were included. Cryoballoon ablation was commonly performed in patients with paroxysmal AF. Mean age ranged from 47 ± 12 years in the Middle East to 64 ± 11 years in East Asia. Mean procedure time was ≤ 95 min in all regions. Average freeze duration ranged from 153 ± 41 s in Southeast Asia to 230 ± 29 s in Central Asia & Russia. Acute procedural success was ≥ 94.7% in all geographies. In 3,126 subjects with ≥ 7 days of follow-up, 122 procedure-related SAEs were reported in 111 patients (3.6%) and remained low in all regions. One procedure-related death was reported during data collection., Conclusions: Despite regional variations in patient selection and procedural characteristics, PVI using cryoballoon ablation was performed with high acute success and short procedural times around the world., Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT02752737., (© 2023. The Author(s).)

Background: Cryoballoon ablation for treatment of atrial fibrillation (AF) reduces procedure times, but limited data is available about its impact on electrophysiology (EP) lab efficiency in Central and Eastern Europe (CEE). Using CEE-specific procedure data, the present study modeled cryoballoon ablation procedures on EP lab resource consumption to improve efficiency., Methods: A discrete event simulation model was developed to assess EP efficiency with cryoballoon ablation. Model inputs were taken from CEE sites within the Cryo Global Registry, namely Czech Republic, Hungary, Poland, Serbia, and Slovakia. The main endpoints were percentage of days that resulted in overtime and percentage of days with time for one extra simple EP procedure. Use of the 'figure of 8' (Fo8) closure technique to reduce procedure time was also examined., Results: The mean lab occupancy time across all CEE sites was 133 ± 47 minutes (min: 104 minutes, max:181 minutes). Cryoballoon ablation in the base-case scenario resulted in 14.6% of days with overtime and 64.8% of days with time for an extra simple EP procedure. Use of the Fo8 closure technique enhanced these values to 5.5% and 85.3%, respectively. Model endpoints were most sensitive to changes in lab occupancy times and overtime start time., Conclusions: In this CEE-specific analysis of EP lab efficiency it was found that 3 cryoballoon ablation procedures could be performed in 1 lab day, leaving time for a 4th simple EP procedure on most days. As such, use cryoballoon ablation for PVI is an effective way to improve EP lab efficiency.

Background and Aims: De novo implanted cardiac resynchronization therapy with defibrillator (CRT-D) reduces the risk of morbidity and mortality in patients with left bundle branch block, heart failure and reduced ejection fraction (HFrEF). However, among HFrEF patients with right ventricular pacing (RVP), the efficacy of CRT-D upgrade is uncertain., Methods: In this multicentre, randomized, controlled trial, 360 symptomatic (New York Heart Association Classes II-IVa) HFrEF patients with a pacemaker or implantable cardioverter defibrillator (ICD), high RVP burden ≥ 20%, and a wide paced QRS complex duration ≥ 150 ms were randomly assigned to receive CRT-D upgrade (n = 215) or ICD (n = 145) in a 3:2 ratio. The primary outcome was the composite of all-cause mortality, heart failure hospitalization, or <15% reduction of left ventricular end-systolic volume assessed at 12 months. Secondary outcomes included all-cause mortality or heart failure hospitalization., Results: Over a median follow-up of 12.4 months, the primary outcome occurred in 58/179 (32.4%) in the CRT-D arm vs. 101/128 (78.9%) in the ICD arm (odds ratio 0.11; 95% confidence interval 0.06-0.19; P < .001). All-cause mortality or heart failure hospitalization occurred in 22/215 (10%) in the CRT-D arm vs. 46/145 (32%) in the ICD arm (hazard ratio 0.27; 95% confidence interval 0.16-0.47; P < .001). The incidence of procedure- or device-related complications was similar between the two arms [CRT-D group 25/211 (12.3%) vs. ICD group 11/142 (7.8%)]., Conclusions: In pacemaker or ICD patients with significant RVP burden and reduced ejection fraction, upgrade to CRT-D compared with ICD therapy reduced the combined risk of all-cause mortality, heart failure hospitalization, or absence of reverse remodelling., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Catheter ablation is a rarely used procedure to treat arrhythmias during pregnancy., Hypothesis: In the case of maternal arrhythmia during pregnancy, zero-fluoroscopic catheter ablation is preferable to medical treatment., Methods: Between April 2014 and September 2021, we examined the demographic data, procedural parameters, and fetal and maternal outcomes in pregnant women undergoing ablation at the Gottsegen National Cardiovascular Center and University of Pécs Medical School, Heart Institute., Results: Fourteen procedures (14 electrophysiological studies [EPS], 13 ablations) performed on 13 pregnant women (age 30.3 ± 5.2 years, primipara n = 6) were studied. During EPS, 12 patients had inducible arrhythmias. Atrial tachycardia was confirmed in three, atrioventricular re-entry tachycardia via manifest accessory pathway (AP) in three, and via concealed AP in one case. Atrioventricular nodal re-entry tachycardia was confirmed in three and sustained monomorphic ventricular tachycardia in two cases. Eleven radiofrequency ablation (84.6%) and two cryoablation (15.4%) were performed. The electroanatomical mapping system was used in all cases. Transseptal puncture was performed in two cases (15.4%) due to left lateral APs. The mean procedure time was 76.0±33.0 minutes. All procedures were performed without fluoroscopy. No complications occurred. During the follow-up, arrhythmia-free survival was achieved in all cases, but in two patients, we used antiarrhythmic drugs (AADs) to achieve it. APGAR score was within the normal range in all cases [median (interquartile range), 9.0/10.0 (9.0-10.0/9.3-10.0)]., Conclusions: Zero-fluoroscopic catheter ablation was an effective and safe treatment option for our 13 pregnant patients. Catheter ablation may have less side effects on fetal development than the use of AADs during pregnancy., (© 2023 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.)

Background: Cryoballoon ablation (CBA) is an effective first-line treatment for symptomatic atrial fibrillation (AF), as recently demonstrated by three randomized trials. This sub-analysis of the Cryo Global Registry aims to examine current clinical practices of first-line CBA., Methods: AF patients treated with first-line CBA were compared to CBA in antiarrhythmic drug (AAD)-refractory patients at 12 months. Efficacy was examined using time-to-first atrial arrhythmia recurrence following a 90-day blanking period. Healthcare utilization was evaluated by repeat ablations and hospitalizations. Disease burden was examined by assessing quality of life (QOL) and patients' reporting of symptoms., Results: Of 1394 patients, 433 (31.1%) were treated with first-line CBA, which was more frequent in high-volume centers. Serious procedure-related adverse event rates were similar. Efficacy at 12 months was higher in the first-line group (87.8 vs. 81.6%, HR unadj 0.64 (95% CI 0.47-0.88); p < 0.01) regardless of the centers' CBA experience; when controlling for baseline characteristics, the difference was not significant (HR adj 0.87 (95% CI 0.56-1.37); p = 0.55). No difference was observed in repeat ablations and hospitalizations between cohorts. First-line patients experienced a larger mean reduction in symptoms and were prescribed AADs at a lower rate at 12-month follow-up (9.7 vs. 29.9%). QOL improved in both cohorts from baseline to 12 months with no significant difference between groups (p = 0.29)., Conclusions: In this global real-world experience, first-line CBA in patients with symptomatic AF is effective, with a larger symptom reduction compared with CBA after AAD failure and without a difference in healthcare utilization at mid-term follow-up., Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT02752737., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction: Left common pulmonary vein is the most common anatomical variant of pulmonary veins that may affect the outcome of pulmonary vein isolation., Objective: Our aim was to compare procedural data and outcomes in patients with common trunk versus normal left atrial anatomy for radiofrequency and cryoballoon catheter ablation., Method: Data from patients who underwent pulmonary vein isolation for atrial fibrillation and had a preprocedural cardiac CT scan at our Institution between 01. 10. 2019 and 10. 03. 2022 were retrospectively evaluated. We defined a common trunk where the left superior and inferior pulmonary vein merged at least 5 mm before the left atrial ostium., Results: From the study population (n = 210), data from 42 patients with a left common trunk (LCPV group) and 60 patients with normal left atrial anatomy (control group) were examined. No significant differences were found between the common trunk and the control group in terms of demographic data. There was no significant difference between the two groups in procedural data for radiofrequency and cryoballoon ablation (procedure time, fluoroscopy time, left atrial dwelling time, radiation dose). After radiofrequency ablation, the success rate at 1-year follow-up was 72.0% in the common trunk group and 76.2% in the control group (p = 0.659). For cryoballoon ablation, the success rate was 64.7% and 69.2% for common trunk and normal anatomy, respectively (p = 0.641)., Conclusion: There was no significant difference in the procedural parameters and clinical outcome between patients with left common pulmonary vein and those with normal left atrial anatomy. Both radiofrequency and cryoballoon ablation techniques are well suited for this population. Orv Hetil. 2023; 164(4): 140-147.

Aims: The BUDAPEST-CRT Upgrade study is the first prospective, randomized, multicentre clinical trial investigating the outcomes after cardiac resynchronization therapy (CRT) upgrade in heart failure (HF) patients with intermittent or permanent right ventricular (RV) pacing with wide paced QRS. This report describes the baseline clinical characteristics of the enrolled patients and compares them to cohorts from previous milestone CRT studies., Methods and Results: This international multicentre randomized controlled trial investigates 360 patients having a pacemaker (PM) or implantable cardioverter defibrillator (ICD) device for at least 6 months prior to enrolment, reduced left ventricular ejection fraction (LVEF ≤35%), HF symptoms (New York Heart Association [NYHA] functional class II-IVa), wide paced QRS (&gt;150 ms), and ≥20% of RV pacing burden without having a native left bundle branch block. At enrolment, the mean age of the patients was 73 ± 8 years; 89% were male, 97% were in NYHA class II/III functional class, and 56% had atrial fibrillation. Enrolled patients predominantly had conventional PM devices, with a mean RV pacing burden of 86%. Thus, this is a patient cohort with advanced HF, low baseline LVEF (25 ± 7%), high N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (2231 pg/ml [25th-75th percentile 1254-4309 pg/ml]), and frequent HF hospitalizations during the preceding 12 months (50%)., Conclusion: When compared with prior CRT trial cohorts, the BUDAPEST-CRT Upgrade study includes older patients with a strong male predominance and a high burden of atrial fibrillation and other comorbidities. Moreover, this cohort represents an advanced HF population with low LVEF, high NT-proBNP, and frequent previous HF events., Clinical Trial Registration: ClinicalTrials.gov NCT02270840., (© 2022 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background Heart failure (HF) and atrial fibrillation (AF) often coexist; yet, outcomes of ablation in patients with AF and concomitant HF are limited. This analysis assessed outcomes of cryoablation in patients with AF and HF. Methods and Results The Cryo AF Global Registry is a prospective, multicenter registry of patients with AF who were treated with cryoballoon ablation according to routine practice at 56 sites in 26 countries. Patients with baseline New York Heart Association class I to III (HF cohort) were compared with patients without HF. Freedom from atrial arrhythmia recurrence ≥30 seconds, safety, and health care utilization over 12-month follow-up were analyzed. A total of 1303 patients (318 HF) were included. Patients with HF commonly had preserved left ventricular ejection fraction (81.6%), were more often women (45.6% versus 33.6%) with persistent AF (25.8% versus 14.3%), and had a larger left atrial diameter (4.4±0.9 versus 4.0±0.7 cm). Serious procedure-related complications occurred in 4.1% of patients with HF and 2.6% of patients without HF ( P =0.188). Freedom from atrial arrhythmia recurrence was not different between cohorts with either paroxysmal AF (84.2% [95% CI, 78.6-88.4] versus 86.8% [95% CI, 84.2-89.0]) or persistent AF (69.6% [95% CI, 58.1-78.5] versus 71.8% [95% CI, 63.2-78.7]) ( P =0.319). After ablation, a reduction in AF-related symptoms and antiarrhythmic drug use was observed in both cohorts (HF and no-HF), and freedom from repeat ablation was not different between cohorts. Persistent AF and HF predicted a post-ablation cardiovascular rehospitalization ( P =0.032 and P =0.001, respectively). Conclusions Cryoablation to treat patients with AF is similarly effective at 12 months in patients with and without HF. Registration URL: https://www.clinicaltrials.gov; Unique Identifier: NCT02752737.

Background: Cryoballoon ablation for the treatment of patients with atrial fibrillation (AF) has been utilized in Europe for >15 years., Objectives: Report patient and procedural characteristics that influence the safety of cryoablation for the treatment of AF., Methods: Patients enrolled in the prospective, multicenter Cryo AF Global Registry were treated at 38 European centers. Freedom from a ≥30s episode of AF/atrial flutter (AFL)/atrial tachycardia (AT) at 12-months and serious complications were analyzed. Univariate and multivariable models identified baseline patient and procedural characteristics that predicted a procedure-related complication., Results: Of the 1418 subjects who completed an index procedure, the cohort was 62 ± 11 years of age, 37.7% female, and 72.2% paroxysmal AF (PAF). The mean procedure, left atrial dwell, and fluoroscopy times were 81 ± 34, 54 ± 25, and 14 ± 13 min, respectively. Among the 766 patients with 12-month follow-up, freedom from a ≥30 s AF/AFL/AT recurrence was 83.3% (95% CI: 79.8%-86.3%) and 71.6% (95% CI: 64.6%-77.4%) in patients with PAF and persistent AF. The serious procedure- and device-related adverse event rates were 4.7% and 2.0%. No baseline patient characteristic independently predicted a procedure-related adverse event; however, prolonged procedure duration (OR = 1.01 [95% CI: 1.00-1.01]), use of general anesthesia (OR = 1.71 [95% CI: 1.01-2.92]), and delivery of a cavotricuspid isthmus line (OR = 3.04 [95% CI: 1.01-9.20]) were each independently associated with the occurrence of a serious procedural safety event (all p < .05)., Conclusions: Cryoballoon ablation is safe and effective in real-world use across a broad cohort of patients with AF., (© 2021 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

Background: Cryoballoon ablation is a commonly used approach to treat patients with atrial fibrillation (AF)., Objectives: Report on the safety and efficacy of cryoballoon ablation for the treatment of AF in the largest global cohort of cryoablated patients prospectively studied within a single registry., Methods: The Cryo AF Global Registry is a prospective, multi-center registry. Patients with paroxysmal AF (PAF) or persistent AF (PsAF) were treated with the cryoballoon catheter according to routine practices at 93 sites across 36 countries. Primary efficacy endpoints included freedom from AF and freedom from AF/atrial flutter (AFL)/atrial tachycardia (AT) ≥30 seconds. The primary safety endpoint was serious device- or procedure-related adverse events over 12 month follow-up., Results: During this evaluation window, 2922 subjects completed an index cryoballoon procedure, and 1440 completed 12 month follow-up. The cohort was 61 ± 12 years of age, 36.3% female, and 78.7% PAF. Serious device- and procedure-related adverse event rates were 1.5% and 3.4%, respectively. Freedom from AF/AFL/AT after the 90 day blanking period was 86.4% (95% CI: 84.3%-88.3%) in patients with PAF and 70.9% (95% CI: 64.6%-76.4%) in patients with PsAF. Freedom from AF/AFL/AT in first-line PAF and PsAF was 90.0% (95% CI: 86.4%-92.7%) and 72.9% (95% CI: 58.6%-83.0%) at 12 months, respectively., Conclusions: The Cryo Global AF Registry is the largest evaluation to demonstrate cryoablation is an efficient, safe, and effective treatment for patients with AF worldwide. Cryoablation was commonly used to treat patients prior to an AAD failure and may facilitate earlier therapy for patients on the AF disease continuum., Competing Interests: This study was sponsored by Medtronic, Inc, Minneapolis, MN. FJ Kueffer and KM Braegelmann are employees of Medtronic. Dr Földesi has received compensation for teaching and proctoring from Medtronic, The Johnson & Johnson Co., Abbott Laboratories, and Biotronik SE & Co. The remaining authors declare no conflict of interests for this article., (© 2021 The Authors. Journal of Arrhythmia published by John Wiley & Sons Australia, Ltd on behalf of the Japanese Heart Rhythm Society.)

Összefoglaló. Bevezetés: Az inadekvát, aránytalan sinuscsomó-tachycardia a szív nomotop ingerképzési zavarával járó, nem ritka klinikai szindróma. A szívritmuszavar-entitást a nem paroxysmalis, magas nyugalmi sinusfrekvencia, a fizikai/pszichés stresszre adott aránytalan sinustachycardia, valamint főként palpitációs panaszok jellemzik. Célkitűzés: Az aránytalan sinuscsomó-tachycardiás betegeink gyógyszeres kezelésével szerzett tapasztalataink ismertetése. Módszerek: 2008 és 2018 között 104 beteget (92 nő, 12 férfi; átlagéletkor 31 ± 10 év) kezeltünk ezzel a szívritmuszavarral. A betegek kivizsgálásuk után 12 elvezetéses EKG-, terheléses EKG-, valamint 24 órás Holter-monitoros EKG-megfigyeléseken vettek részt a gyógyszeres kezelés előtt és után (bizoprolol: 2 × 5 mg/nap; ivabradin: 2 × 5 mg/nap). Az életminőség változását a European Heart Rhythm Association (EHRA) tüneti skálája szerint állapítottuk meg. Eredmények: Mindkét gyógyszer jelentősen csökkentette a nyugalmi sinusfrekvenciát (kontroll: 102 ± 10/min; bizoprolol: 78 ± 6/min; ivabradin: 74 ± 8/min, mindkettő: p<0,0001). A gyógyszeres kezelés nélküli, 24 órás Holter-monitoros EKG-felvételek során mért szívfrekvenciák (minimum-maximum [átlag] sinusfrekvencia/min) a kontrollértékekről (58 ± 8-159 ± 14 [94 ± 6]/min) mindkét gyógyszerre egyaránt szignifikánsan csökkentek (bizoprolol: 53 ± 7-132 ± 13 [77 ± 9]/min [mindhárom: p<0,0001]; ivabradin 51 ± 6-134 ± 18 [77 ± 8]/min [mindhárom: p<0,0001]). A terheléses EKG-vizsgálatok előtt (kontroll: 99 ± 13/min; bizoprolol 81 ± 11/min [p<0,0001]; ivabradin: 84 ± 10/min [p<0,0001]) és a terhelés csúcspontján mért sinusfrekvenciák (kontroll: 164 ± 15/min; bizoprolol: 140 ± 16/min [p<0,0001]; ivabradin: 142 ± 14/min [p<0,0001]) is jelentősen mérséklődtek. Az azonos dózisban adott két gyógyszer szívfrekvencia-csökkentő hatásai között számottevő különbséget nem tapasztaltunk. Az életminőséget tükröző EHRA tüneti skálán (kontroll: 2,3 ± 0,7) mind a bizoprolol (1,4 ± 1,4; p<0,0001), mind az ivabradin (1,1 ± 0,2; p<0,0001) egyformán csökkentette a betegek tüneteit, panaszait. Számottevő cardiovascularis mellékhatás egyik betegcsoportban sem jelentkezett. Következtetések: Vizsgálati eredményeink alapján megállapítható, hogy az aránytalan sinuscsomó-tachycardiás betegek gyógyszeres kezelésére: (1) a kardiospecifikus adrenerg béta-blokkoló bizoprolol és az If-csatorna-gátló ivabradin egyaránt hatékonynak és biztonságosnak bizonyult; (2) az azonos adagban adott két gyógyszer hatékonysága között számottevő különbség nem volt; (3) a gyógyszeres kezelés nemcsak a sinusfrekvenciát csökkentette, hanem a betegek panaszait, tüneteit is mérsékelte. Orv Hetil. 2020; 161(46): 1953-1958., Introduction: The inadequate, inappropriate sinus-node tachycardia is not a rare clinical syndrome, defined as a disturbance of the nomotopic impulse formation of the heart. This cardiac arrhythmic entity is characterized by a non-paroxismal, increased sinus rate at rest, and/or inadequate response to physical and/or emotional stress and palpitations., Objective: The aim of this study was to describe our experiences with pharmacological therapy of patients with inappropriate sinus tachycardia syndrome., Methods: Between 2008 and 2018, 104 patients (92 women, 12 men, mean age: 31 ± 10 years) were treated with this cardiac arrhythmia entity. All patients underwent 12-lead ECG, 24-hour Holter-ECG monitoring and standard bicycle dynamic exercise tests before and after drug treatment (bisoprolol: 5 mg bid; ivabradine: 5 mg bid). Changes in the quality of life were estimated by using the European Heart Rhythm Association (EHRA) score., Results: Both drugs decreased significantly the resting heart rate (control: 102 ± 10/min; bisoprolol 78 ± 6/min (p<0.0001), ivabradine: 74 ± 8/min (p<0.0001). The results of the parameters of the 24-hour Holter ECG recordings (expressed as minimal-maximal [average] heart rate/min) with drug therapy showed a significant decrease from control values in all three parameters: control 58 ± 8-159 ± 14 (94 ± 6)/min; bisoprolol 53 ± 7-132 ±13 (77 ± 9)/min (all three: p<0.0001); ivabradine: 51 ± 6-134 ± 18 (77 ± 8)/min (all three: p<0.0001). The sinus rate reduced significantly both before the bicycle dynamic exercise tests (control: 99 ± 13/min; bisoprolol: 81 ± 11/min [p<0.0001]; ivabradine: 84 ± 10/min [p<0.0001]) and at the peaks of the exercise test (control: 164 ± 15/min; bisoprolol: 140 ± 16/min [p<0.0001]; ivabradine 142 ± 14/min [p<0.0001]). The heart rate reducing effects of the two drugs did not differ significantly. The EHRA quality of life score was equally improved by the two drugs (control: 2.3 ± 0.7; bisoprolol: 1.4 ± 1.4 [p<0.0001]; ivabradine: 1.1 ± 0.2 [p<0.0001]). No cardiovascular side effects were observed while taking bisoprolol or ivabradine., Conclusions: Based on our clinical results, it can be pointed out that in the drug therapy of patients with inappropriate sinus node tachycardia: (1) bisoprolol (5 mg bid) and ivabradine (5 mg bid) proved to be equally effective and safe; (2) the heart rate reducing effect of the two drugs - given in the same dosage - did not differ considerably; (3) the pharmacological therapy significantly decreased not only the sinus frequency, but also reduced the symptoms of the patients. Orv Hetil. 2020; 161(46): 1953-1958.

Introduction: The inadequate, inappropriate sinus-node tachycardia is not a rare clinical syndrome, defined as a non-paroxysmal, increased sinus-rate at rest, and/or inadequate response to physical and/or emotional stress, and palpitations. Aim: The aim of this study was to describe our experiences with the investigations of our inappropriate sinus-node tachycardia patients. Method: In the last years, 104 patients (92 women, 12 men, mean age: 31 ± 10 years) were treated with this cardiac arrhythmia entity. All patients underwent 12 leads ECG, chest X-ray, echocardiography, Holter-monitoring and transtelephonic ECG observations. The quality of life score was estimated by using the European Heart Rhythm Association scale. Results: Patients had no structural heart disease (physical examination ECG, chest X-ray, echocardiography were normal), the laboratory values (TSH, blood count) were within normal limits, but the resting heart rates were repeatedly high (102 ± 8/min). The results of Holter recording (expressed as minimal-maximal [average] heart rate/min) without drug therapy showed high heart rate values (59 ± 8, 160 ± 14 [94 ± 6]/min). The standard bicycle ergometry showed an average loading capacity of 124 ± 23 watt (heart rate: control: 99 ± 12/min, top: 167 ± 13/min) with early, inadequate sinus tachycardia. To disclose the episodes of paroxysmal supraventricular tachycardia, beside the Holter-monitoring transtelephonic ECG system was used. This diagnostic modality was very useful for the exclusion of paroxysmal supraventricular tachycardia episodes during the palpitation symptoms. Out of 104 patients, 4 patients (3.8%) showed familiar occurrence, another 16 patients (15.2%) had previous slow-pathway radiofrequency ablation due to atrioventricular nodal reentry tachycardia. Conclusions: Based on our clinical observations, it can be pointed out that inappropriate sinus-node tachycardia syndrome (1) occurs mainly in young women, mostly in students, inducing decreased quality of life scores (EHRA score: 2.3 ± 0.4); (2) the prevalence in our outpatient clinic was 0.7%; (3) the patient population is not homogeneous: familiar or postablation occurrence is possible in some patients; (4) transtelephonic ECG has been proved to be very useful to disclose episodes of paroxysmal supraventricular tachycardia in these patients. Orv Hetil. 2019; 160(37): 1464-1470.

Introduction: Contact force sensing radiofrequency ablation and the new generation cryoballoon ablation are prevalent techniques for the treatment of paroxysmal atrial fibrillation., Aim: The authors aimed to compare the procedural and 1-year outcome of patients after radiofrequency and cryoballoon ablation., Method: 96 patients with paroxysmal atrial fibrillation (radiofrequency ablation: 58, cryoballoon: 38 patients; 65 men and 31 women aged 28-70 years) were enrolled. At postprocedural 1, 3, 6 and 12 months ECG, Holter monitoring and telephone interviews were performed., Results: Procedure and fluorosocopy time were: radiofrequency ablation, 118.5 ± 15 min and 15.8 ± 6 min; cryoballoon, 73.5 ± 16 min (p<0.05) and 13.8 ± 4.,1 min (p = 0.09), respectively. One year later freedom from atrial fibrillation was achieved in 76.5% of patients who underwent radiofrequency ablation and in 81% of patients treated with cryoballoon. Temporary phrenic nerve palsy occurred in two patients and pericardial tamponade developed in one patient., Conclusions: In this single center study freedom from paroxysmal atrial fibrillation was similar in the two groups with significant shorter procedure time in the cryoballoon group.

Objectives: The objective of this study was to compare evidence requirements for health technology assessment of pharmaceuticals by national agencies across Europe responsible for reimbursement decisions focusing specifically on relative effectiveness assessment., Methods: Evidence requirements from thirty-three European countries were requested and twenty-nine national agencies provided documents to review. Data were extracted from national documents (manufacturer's submission templates and associated guidance) into a purpose-made framework with categories covering information about the health condition, the technology, clinical effectiveness and safety., Results: The level of detail in the required evidence varies considerably across countries. Some countries include specific questions while others request information under general headings. Some countries include all information in a single document, which may or may not include guidance on how to complete the template. Others have specific guidance documents or methods and process manuals that help with the completion of the submission templates. Despite differences in quantity and detail, the content of the evidence requirements is broadly similar. All countries ask for information on the health technology, target disease, and clinical effectiveness and safety. However, one country only requests clinical effectiveness information as part of cost-effectiveness analyses. We found twenty-six evidence requirements for which generic answers may apply across borders and nineteen in which countries requested nationally specific information., Conclusions: This work suggests that it would be possible to put together a minimum set of evidence requirements for HTA to support reimbursement decisions across Europe which could facilitate collaboration between jurisdictions.

The "gold standard" of the prevention of atrial fibrillation related thromboembolic events is anticoagulation therapy with oral vitamin K antagonists. A certain proportion of high-risk patients with atrial fibrillation are not receiving effective antithrombotic therapy because of problems associated with its use. Resolution of subsequent left atrial appendage thrombi is quite a great challenge in patients who are not tolerating "standard" antithrombotic drugs. According to the knowledge of the authors, this is the first report of a patient with non-valvular persistent atrial fibrillation and high stroke risk, who was intolerant to "standard" anticoagulant therapy and had persistent left atrial appendage thrombi following the use of a wide variety of "standard" anticoagulants. Successful resolution of left atrial appendage thrombi with dabigatran and successful percutaneous left atrial appendage closure were performed in this case.

Aims: Cardiac resynchronization therapy (CRT) by means of biventricular pacing (BiVP) is well established as a treatment for patients with heart failure (HF). Post-extrasystolic potentiation, (PESP) which involves a transient increase in myocardial contractility following a ventricular extrasystole, can be achieved using extrasystolic stimulation (ESS). On this basis, ESS has been proposed as a therapeutic. We assessed acute haemodynamic effects of ESS in the context of BiVP., Methods and Results: Patients (n = 15, left ventricular ejection fraction < 40%, QRS ≥ 125 ms) with HF, received BiVP in combination with right ventricular (RV) ESS (single stimulus or pulse train). Left ventricular (LV) and peripheral arterial pressures were recorded and dP/dt was monitored. Addition of RV ESS to BiVP pacing led to a 21% increase in maximum (max) dP/dt (P < 0.001) and an 8.5 mm Hg increase in a systolic arterial pressure (P < 0.001). The modest fall in end-diastolic pressure (3.3 mmHg, P < 0.001) observed during ESS and BiVP was prevented by maintaining baseline sinus rate. Varying ESS modes or pacing outputs was not associated with differences in haemodynamic parameters., Conclusions: Biventricular pacing in combination with ESS, with maintenance of sinus rate, improves myocardial contractility in patients undergoing CRT.

Atrial fibrillation and chronic heart failure are two major and even growing cardiovascular conditions that often coexist. Cardiac resynchronization therapy is an important, device-based, non-pharmacological approach in a selected group of chronic heart failure patients that has been shown to improve left ventricular function and to reduce both morbidity and mortality in large randomized trials. The latest European and American guidelines have considered atrial fibrillation patients with heart failure eligible for cardiac resynchronization therapy. This review summarizes current literature concerning the following topics: prognostic relevance of atrial fibrillation in heart failure, effects of cardiac resynchronization therapy in atrial fibrillation, relevance and strategies of rhythm and rate control in this group of patients. Authors explain how atrial fibrillation may interfere with the delivery of adequate cardiac resynchronization therapy, how to reduce the burden of atrial tachyarrhythmias, and finally present a brief overview.

Purpose: In patients with paroxysmal atrial fibrillation (PAF) little information is available about left atrial (LA)function, and there is less information about LA appendage (LAA) function, and about their relations., Methods and Results: 46 patients were selected for catheter ablation (CA) because of nonvalvular PAF.Transthoracic, tissue Doppler and transoesophageal echocardiography was performed before CA. LA volumes and volume index (LAVI) were calculated. LA function was assessed by LA filling fraction (LAFF), LA emptying fraction (LAEF), systolic fraction of pulmonary venous flow (PVSF) and late diastolic velocities of mitral annulus(Aa,, A5at) LAA function was assessed by peak LAA emptying flow velocity (PLAAEFV). Diastolic dysfunction(DD) was also assessed. Dilated LAVI in 32, LA dysfunction in 20, DD with elevated LV filling pressure in 19 patients was found. Aa,at and Aa,p correlated with LAFF (r:0.53; p<0.001 and r:0.43; p<0.05), LAEF (r:0.51;p<0.001 and r:0.63; p<0.001), PVSF (r:0.49; p<0.001 and r:0.46; p<0.005) and PLAAEFV (r:0.58; p<0.001 and r:0.45; p<0.01)., Conclusions: In PAF patients Aa velocity is useful to assess LA function and correlates positively with other TTE derived LA functional parameters and LAA function by TEE derived PLAAEFV.

Unlabelled: Left atrial tachycardia is the most common arrhythmia developing after pulmonary vein (PV) isolation in patients with atrial fibrillation., Aim: To compare the clinical effectiveness of class Ic propafenone and class III D,L sotalol in antiarrhythmic treatment of post-ablation left atrial tachycardias., Methods and Results: A total of 75 consecutive patients with an age of 55.4 +/- 7.14 (mean +/- SD) years underwent real electrical isolation of the pulmonary veins. Beside electroanatomical guidance, a circular mapping catheter was used to achieve total electrical disconnection of the pulmonary veins from left atrium at the antrum level. After procedure, the antiarrhythmic drug therapy was continued with the tendency to taper down during follow up visits. These were scheduled 1 and later 3 monthly after PV isolation. After the first 3 months follow-up period, left atrial tachycardia occurred in 21 patients (31.3 %). 11 of them were on propafenone therapy, 6 were on sotalol therapy and 4 patients with left atrial tachycardia received amiodarone. In the first and third group, after developing left atrial tachycardia, the 1C class drug or amiodarone was changed to III D,L sotalol. In the second group, after developing left atrial tachycardia, the III D,L sotalol was changed to 1C class drug. 9 months later, in III D,L sotalol treated group of left atrial tachycardia patients (15), the drug was considered effective in 12 patients., Conclusion: In prevention of left atrial tachycardia occurred after PV isolation, sotalol is not more effective than 1C class propafenone. Otherwise, III D,L sotalol seems to be effective in anti-arrhythmic treatment of developed post-ablation in late left atrial tachycardias.

Atrial fibrillation is the most frequent arrhythmia with increasing prevalence. Given a limited success rate of drug therapy for atrial fibrillation, interventional treatment options have been developed during the last years. Catheter ablation of atrial fibrillation (until recently the mostly used energy source was radiofrequency energy) has been established as an important therapeutic alternative. Depending on interpersonal (both on patient and operator side) and technical variabilities using radiofrequency energy potentially life-threatening complications such as pulmonary vein stenosis or atrio-esophageal fistulas may occur. Cryoenergy is a novel energy source for transcatheter ablation eliminating the arrhythmia substrate by freezing. The cornerstone of catheter ablation for atrial fibrillation is electrical isolation of the pulmonary veins. During cryoballoon ablation the targeted pulmonary vein transiently occluded by the inflated balloon catheter and using this method a circumferential lesion is created. The success rate of cryoballoon ablation is comparable with the radiofrequency ablation with increased safety. We performed the first cryoballoon ablations for patients with paroxysmal atrial fibrillation in Hungary. On this occasion we review the potential advantages of this technique which may serve as basis for its widespread use in the future.

Coronary sinus lead placement for transvenous left ventricular pacing in cardiac resynchronization has significant failure rate at implant and significant dislocation rate during follow-up. Alternative methods are necessary for these patients. We aim to describe a fundamentally new approach using transapical implantation of an active fixation endocardial pacing lead. This technique is based on direct puncture of the left ventricular apex using standard Seldinger technique. The tip of the lead is positioned with intracavitary navigation under fluoroscopy. This method offers various advantages, because it is minimally invasive, provides endocardial pacing and does not involve the mitral valve.

Unlabelled: Implantable cardioverter-defibrillator implantation is an important adjunct in the management of these patients, although cardiac device endocarditis is an infrequent, but potentially lethal infectious complication. Cure of cardiac device endocarditis is achievable in the large majority of patients treated with an aggressive approach of combined antimicrobial treatment and complete cardiac device removal. Re-implantation of the device requires additional caution, but still associated with increased risk for recurrences., Aim: The aim of this case presentation is to demonstrate the feasibility of permanent subcutaneous defibrillation system in a patient with recurrent endocarditis., Method: In our case a 37-year-old patient--operated several times due to Fallot tetralogy, with permanent pacemaker and later implantable cardioverter defibrillator, requiring several replacements--was treated with recurrent device endocarditis. After device explantation and long-term standard antibiotic treatment, in order to decrease further risk for the development of recurrent endocarditis, we implanted a defibrillation system with an individually designed subcutaneous lead configuration., Conclusion: This case report suggests that individually tailored defibrillator lead configuration is a feasible option for patients until a fully automatic effective subcutaneous system will be available.

The role of sympathetic activation in the genesis of life threatening ventricular arrhythmia is abundantly documented. The protective effect of sympathetic activation at the time of destabilizing ventricular tachycardia is less well known. Recently, muscle sympathetic nerve activity was recorded at our cardiac electrophysiology laboratory in a 62-year-old man who suffered from severe left ventricular failure. In order to elucidate the complex relationship between arrhythmias and autonomic nervous activity, his muscle sympathetic nerve activity recording depicting response to pulseless ventricular tachycardia is hereby presented.

A case of a patient with narrow QRS tachycardia and without structural heart disease is presented. The electrophysiologic study revealed an atrial tachycardia in the presence of dual atrioventricular (AV) nodal physiology and AV block at suprahisian level, the latter two leading to an unusual Wenckebach periodicity. The entire septal area was mapped as was the coronary sinus (CS) os and the earliest atrial activation was found at the apex of Koch's triangle in close vicinity to the His bundle (HB). Cryomapping at that point reproducibly terminated the tachycardia without impairing AV conduction. Cryoablation rendered the tachycardia non-inducible. Discontinuous AV conduction persisted but AV nodal reentrant tachycardia (AVNRT) was not inducible. Six months later the patient is arrhythmia-free.

Introduction: Recently catheter ablation has been accepted as standard therapy for symptomatic supraventricular tachycardia in children. Nature of childhood and the variability of congenital heart diseases and congenital heart surgery distinguishes pediatric catheter ablation from the adult practice., Objectives: The aim of the present study was to summarize a single-center experience of the first 30 consecutive patients regarding the electrophysiological studies and catheter ablations, moreover to report on the national adoption of these interventions for pediatric patients in Hungary., Methods: Between April 1996 and September 2004 catheter ablation was offered for 30 children as treatment of their supraventricular tachycardia because of failure of pharmacological therapy or parents preference., Results: The mean age of the patients was 13.7 years (2.3-18.0 years) and the mean weight was 52.0 kg (12.0-81 kg). Electrophysiology study revealed 33 arrhythmogenic substrates in 30 patients, 30 of those 33 were congenital while 3 were acquired. Catheter ablation was attempted in 27 patients with acute success in 24 cases (89%). Recurrence was observed in 2 patients and the redo ablation was effective in both, although a second recurrence occurred later in one of them. There were no major complications, but two minor ones (pseudoaneurysm of arteria femoralis, transient ventricular ectopy) occurred., Conclusions: Catheter ablation is safe and effective in children with congenital heart disease. Our results are comparable with the international data.

The term atrial flutter was introduced 90 years ago for an arrhythmia with a unique electrocardiographic pattern. The development of endocardial mapping techniques in the last decade allowed the detailed characterization of the tachycardia circuit and the identification of the cavotricuspid isthmus as its critical part. This review stresses the position of atrial flutter in the new classification of atrial tachycardias and focuses on its unique electrophysiological characteristics and different variants described in humans. Transcatheter radiofrequency ablation across the cavotricuspid isthmus constitutes a feasible and safe therapy, which prevents flutter recurrences during the long-term follow-up. This paper describes the different techniques that validate bidirectional isthmus block, which is an important endpoint for successful ablation.

Circulatory consequences of cardiac arrhythmias are not always evident. Proper interpretation of the clinical symptoms in certain cases requires assessment of the patients' other hemodynamic characteristics. The authors present the case of a patient with left ventricular hypertrophy, who developed severe circulatory failure at the time of artrioventricular dyssynchrony in association with junctional rhythm. Analogy between the circulatory consequences of the junctional rhythm and ventricular pacing was documented by hemodynamic measurements. The patient was subsequently treated by implanting an atrioventricular pacemaker.