Regional variations in patient selection and procedural characteristics for cryoballoon ablation of atrial fibrillation in the cryo global registry.

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.

Cryoballoon ablation of atrial fibrillation in octogenarians: one year outcomes from the cryo global registry.

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 CHA2DS2-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%, HRadj: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.

Upgrade of right ventricular pacing to cardiac resynchronization therapy in heart failure: a randomized trial.

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.

Case series of catheter-based arrhythmia ablation in 13 pregnant women.

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.

[Prognostic significance of variant left common pulmonary vein after transcatheter pulmonary vein isolation]. / A variáns bal oldali közös tüdovéna prognosztikus jelentosége transzkatéteres tüdovéna-izolációt követoen.

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.

Impact of first-line cryoablation for atrial fibrillation on healthcare utilization, arrhythmia disease burden and efficacy outcomes: real-world evidence from the Cryo Global Registry.

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%, HRunadj 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 (HRadj 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.

Evaluation of Isolation Area, Myocardial Injury and Left Atrial Function Following High-Power Short-Duration Radiofrequency or Second-Generation Cryoballoon Ablation for Atrial Fibrillation.

This randomized study aims to compare the left atrial (LA) lesion size, function, and tissue damage following pulmonary vein isolation (PVI) by high-power short-duration (HPSD) radiofrequency (RF) and second-generation cryoballoon (CB2) ablation. We enrolled 40 patients with paroxysmal atrial fibrillation who underwent PVI by HPSD RF (n = 21) or CB2 (n = 19). Every patient underwent LA CT angiography and transthoracic echocardiography (TTE) to assess the LA anatomy and function. Biomarker levels (hs-cTnT, hs-CRP, LDH) were compared pre- and post-procedurally. Pre- and post-ablation high-density mapping (HDM) was performed. The isolation area was defined under 0.2 mV bipolar voltage (low voltage area, LVA). We calculated the post-PVI LVA/LA surface ratio using LA CT-HDM merge images. At 3-month follow-up, TTE was performed to assess the changes in LA function. Post-ablation hs-cTnT level was significantly higher in the RF group (RF: 1249 ± 469 ng/L, CB2: 995 ± 280 ng/L, p = 0.024). Post-PVI hs-CRP (RF: 9.53 ± 10.30 mg/L, CB2: 12.36 ± 5.76 mg/L, p = 0.034) and LDH levels (RF: 349.9 ± 65.6 U/L, CB2: 451.6 ± 91.3 U/L, p < 0.001) were significantly higher following CB2 ablation. Post-PVI LVA/LA surface ratios were 8.37 ± 6.42% in the RF group and 13.58 ± 8.92% in the CB2 group (p = 0.022). LA function did not change significantly after the PVI procedure. Our data indicate that second-generation cryoballoon ablation produces a significantly larger LA lesion size compared to "point-by-point" HPSD radiofrequency. Both techniques preserve LA function. The myocardial component of tissue loss appears to be higher using HPSD radiofrequency ablation, with less collateral damage.

Baseline clinical characteristics of heart failure patients with reduced ejection fraction enrolled in the BUDAPEST-CRT Upgrade trial.

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 (>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.

Cryoballoon Ablation for the Treatment of Atrial Fibrillation in Patients With Concomitant Heart Failure and Either Reduced or Preserved Left Ventricular Ejection Fraction: Results From the Cryo AF Global Registry.

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.

Safety and efficacy of cryoballoon ablation for the treatment of paroxysmal and persistent AF in a real-world global setting: Results from the Cryo AF Global Registry.

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.

Safety of cryoballoon ablation for the treatment of atrial fibrillation: First European results from the cryo AF Global Registry.

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.

Inadequate, inappropriate sinus-node tachycardia: an old cardiac arrhythmia in a new perspective (II.): Our experiences with the pharmacological treatment / Inadekvát, aránytalan sinuscsomó-tachycardia: egy régi szívritmuszavar új megvilágításban (II.).

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 foként palpitációs panaszok jellemzik. Célkituzés: Az aránytalan sinuscsomó-tachycardiás betegeink gyógyszeres kezelésével szerzett tapasztalataink ismertetése. Módszerek: 2008 és 2018 között 104 beteget (92 no, 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 elott és után (bizoprolol: 2 × 5 mg/nap; ivabradin: 2 × 5 mg/nap). Az életminoség változását a European Heart Rhythm Association (EHRA) tüneti skálája szerint állapítottuk meg. Eredmények: Mindkét gyógyszer jelentosen csökkentette a nyugalmi sinusfrekvenciát (kontroll: 102 ± 10/min; bizoprolol: 78 ± 6/min; ivabradin: 74 ± 8/min, mindketto: p<0,0001). A gyógyszeres kezelés nélküli, 24 órás Holter-monitoros EKG-felvételek során mért szívfrekvenciák (minimum-maximum [átlag] sinusfrekvencia/min) a kontrollértékekrol (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 elott (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 jelentosen mérséklodtek. Az azonos dózisban adott két gyógyszer szívfrekvencia-csökkento hatásai között számottevo különbséget nem tapasztaltunk. Az életminoséget tükrözo 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. Számottevo 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 számottevo 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.

[Inadequate, inappropriate sinus-node tachycardia. An old cardiac arrhythmia in a new perspective]. / Inadekvát, aránytalan sinuscsomó-tachycardia. Egy régi szívritmuszavar új megvilágításban.

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.

Prospective evaluation of iatrogenic atrial septal defect after cryoballoon or radiofrequency catheter ablation of atrial fibrillation-"EVITA" study.

PURPOSE: Iatrogenic atrial septal defect (IASD) after catheter ablation (CA) for atrial fibrillation (AF) due to transseptal puncture (TSP) can occur. The aim of this prospective study was to describe the incidence of IASD and to detect any cerebrovascular accident (CVA) after radiofrequency (RF) and cryoballoon (CB) CA. METHODS: Between July 2014 and September 2016, 94 patients (pts) (RF; 48, CB; 46, 30 (31.9%) women, mean age = 60 ± 9.7 years) with paroxysmal AF were enrolled who underwent CA procedure for the first time. During RF ablation a single (n = 30, 62.5%) or double (n = 18, 37.5%) TSP was performed. Transoesophageal echocardiography before the procedure and at the 3-month and 12-month follow-up (FU) was accomplished. During the FU period, we evaluated the occurrence of any postprocedural CVA. RESULTS: At the 3-month FU, IASD was detected in 17/94 (18.1%) pts; in 9/48 (18.8%) pts in the RF while in 8/46 (17.4%) pts in the CB group (p = 0.866), all of them with left-to-right shunt. In the RF group, 6/30 (20%) pts with a single TSP while 3/18 (16.7%) pts in the double TSP group had IASD (p = 0.780). 14/17 (82.4%) IASDs showed high spontaneous closure rate at the 12-month FU. None of the pts died or suffered from CVA. CONCLUSION: Persistent IASD can occur rather frequently following AF CA. No significant difference was observed between the RF and CB techniques concerning the presence of IASD at 3-month. IASDs showed a high spontaneous closure rate. No cerebral thromboembolic event was observed in the 12-month FU period.

Long-term cerebral thromboembolic complications of transapical endocardial resynchronization therapy.

PURPOSE: Cardiac resynchronization therapy (CRT) is an established therapeutic option in selected heart failure patients (pts). However, the transvenous left ventricular (LV) lead implantation remains ineffectual in a considerable number of pts. Transapical LV (TALV) lead implantation is an alternative minimally invasive, surgical, endocardial implantation technique. The aim of the present prospective study is to determine the long-term outcome, including the cerebral thromboembolic complications, of pts who underwent TALV lead placement. METHODS: Twenty-six CRT candidates (19 men (78 %); mean age 61 ± 10 years) with a previously failed transvenous approach underwent TALV lead placement as a last resort therapy. The following data was collected: mortality rate, reoperation rate, and cerebrovascular event rate. Patients underwent a cerebral CT scan to determine any possible cerebrovascular event related to the presence of the TALV lead. RESULTS: Eleven out of 26 (47 %) patients survived after a median follow-up of 40 ± 24.5 months. Major acute ischemic stroke occurred in two cases, while in one case transient ischemic stroke was observed. Cerebral CT scan examination performed in asymptomatic patients revealed chronic ischemic lesions with minimal extension in two patients. Reoperation occurred in one case due to TALV lead fracture. CONCLUSIONS: This is the first study reporting the long-term outcome, mortality, and thromboembolic event rate exclusively after TALV lead implantation. Patients who underwent TALV lead implantation have a comparable long-term mortality rate to conventional CRT, although a major ischemic cerebrovascular event after TALV lead implantation is worrisome and has an impact on the outcome.

Polymorphisms in the GNAS Gene as Predictors of Ventricular Tachyarrhythmias and Sudden Cardiac Death: Results From the DISCOVERY Trial and Oregon Sudden Unexpected Death Study.

BACKGROUND: Population-based studies suggest that genetic factors contribute to sudden cardiac death (SCD). METHODS AND RESULTS: In the first part of the present study (Diagnostic Data Influence on Disease Management and Relation of Genetic Polymorphisms to Ventricular Tachy-arrhythmia in ICD Patients [DISCOVERY] trial) Cox regression was done to determine if 7 single-nucleotide polymorphisms (SNPs) in 3 genes coding G-protein subunits (GNB3, GNAQ, GNAS) were associated with ventricular tachyarrhythmia (VT) in 1145 patients receiving an implantable cardioverter-defibrillator (ICD). In the second part of the study, SNPs significantly associated with VT were further investigated in 1335 subjects from the Oregon SUDS, a community-based study analyzing causes of SCD. In the DISCOVERY trial, genotypes of 2 SNPs in the GNAS gene were nominally significant in the prospective screening and significantly associated with VT when viewed as recessive traits in post hoc analyses (TT vs CC/CT in c.393C>T: HR 1.42 [CI 1.11-1.80], P=0.005; TT vs CC/CT in c.2273C>T: HR 1.57 [CI 1.18-2.09], P=0.002). TT genotype in either SNP was associated with a HR of 1.58 (CI 1.26-1.99) (P=0.0001). In the Oregon SUDS cohort significant evidence for association with SCD was observed for GNAS c.393C>T under the additive (P=0.039, OR=1.21 [CI 1.05-1.45]) and recessive (P=0.01, OR=1.52 [CI 1.10-2.13]) genetic models. CONCLUSIONS: GNAS harbors 2 SNPs that were associated with an increased risk for VT in ICD patients, of which 1 was successfully replicated in a community-based population of SCD cases. To the best of our knowledge, this is the first example of a gene variant identified by ICD VT monitoring as a surrogate parameter for SCD and also confirmed in the general population. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00478933.

Two-Year Follow-Up after Contact Force Sensing Radiofrequency Catheter and Second-Generation Cryoballoon Ablation for Paroxysmal Atrial Fibrillation: A Comparative Single Centre Study.

Background. There are little comparative data on catheter ablation of paroxysmal atrial fibrillation (AF) using the contact force radiofrequency (CF-RF) catheter versus the second-generation cryoballoon (CB2). Methods and results. This is a single center, retrospective, nonrandomized study of 98 patients with symptomatic, drug-refractory paroxysmal AF who underwent their first PVI ablation using either the CB2 (n = 40) or CF-RF (n = 58). The mean age was 60 years with 63% men, a mean LA size of 42 mm. The procedure duration (74 ± 17 versus 120 ± 49 minutes p < 0.05) was shorter for CB2 group; the fluoroscopy time (14 ± 17 versus 16 ± 5 minutes, p = 0.45) was similar. Complete PVI was achieved in 96% of patients with RF-CF and 98% with CB2. Phrenic nerve palsies (2 transient and 1 persistent) occurred exclusively in the CB2 group and 1 severe, nonlethal complication (pericardial tamponade) occurred in the CF-RF group. At 24-month follow-up, the success rate, defined as freedom from AF/atrial tachycardia (AT) after a single procedure without antiarrhythmic drug, was comparable in CF-RF group and CB2 group (65.5% versus 67%, resp., log rank p = 0.54). Conclusion. Both the CB2 and the RF-CF ablation appeared safe; the success rate at 2 years was comparable between both technologies.

[Catheter ablation for paroxysmal atrial fibrillation: new generation cryoballoon or contact force sensing radiofrequency ablation?]. / A paroxysmalis pitvarfibrilláció kezelésének transzkatéteres ablatiós technikái: új generációs krioballon vagy kontaktero-méréssel kombinált rádiófrekvenciás ablatio?

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.

Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE).

BACKGROUND: Defibrillation testing by induction and termination of ventricular fibrillation is widely done at the time of implantation of implantable cardioverter defibrillators (ICDs). We aimed to compare the efficacy and safety of ICD implantation without defibrillation testing versus the standard of ICD implantation with defibrillation testing. METHODS: In this single-blind, randomised, multicentre, non-inferiority trial (Shockless IMPLant Evaluation [SIMPLE]), we recruited patients aged older than 18 years receiving their first ICD for standard indications at 85 hospitals in 18 countries worldwide. Exclusion criteria included pregnancy, awaiting transplantation, particpation in another randomised trial, unavailability for follow-up, or if it was expected that the ICD would have to be implanted on the right-hand side of the chest. Patients undergoing initial implantation of a Boston Scientific ICD were randomly assigned (1:1) using a computer-generated sequence to have either defibrillation testing (testing group) or not (no-testing group). We used random block sizes to conceal treatment allocation from the patients, and randomisation was stratified by clinical centre. Our primary efficacy analysis tested the intention-to-treat population for non-inferiority of no-testing versus testing by use of a composite outcome of arrhythmic death or failed appropriate shock (ie, a shock that did not terminate a spontaneous episode of ventricular tachycardia or fibrillation). The non-inferiority margin was a hazard ratio (HR) of 1·5 calculated from a proportional hazards model with no-testing versus testing as the only covariate; if the upper bound of the 95% CI was less than 1·5, we concluded that ICD insertion without testing was non-inferior to ICD with testing. We examined safety with two, 30 day, adverse event outcome clusters. The trial is registered with ClinicalTrials.gov, number NCT00800384. FINDINGS: Between Jan 13, 2009, and April 4, 2011, of 2500 eligible patients, 1253 were randomly assigned to defibrillation testing and 1247 to no-testing, and followed up for a mean of 3·1 years (SD 1·0). The primary outcome of arrhythmic death or failed appropriate shock occurred in fewer patients (90 [7% per year]) in the no-testing group than patients who did receive it (104 [8% per year]; HR 0·86, 95% CI 0·65-1·14; pnon-inferiority <0·0001). The first safety composite outcome occurred in 69 (5·6%) of 1236 patients with no-testing and in 81 (6·5%) of 1242 patients with defibrillation testing, p=0·33. The second, pre-specified safety composite outcome, which included only events most likely to be directly caused by testing, occurred in 3·2% of patients with no-testing and in 4·5% with defibrillation testing, p=0·08. Heart failure needing intravenous treatment with inotropes or diuretics was the most common adverse event (in 20 [2%] of 1236 patients in the no-testing group vs 28 [2%] of 1242 patients in the testing group, p=0·25). INTERPRETATION: Routine defibrillation testing at the time of ICD implantation is generally well tolerated, but does not improve shock efficacy or reduce arrhythmic death. FUNDING: Boston Scientific and the Heart and Stroke Foundation (Ontario Provincial office).

[Percutaneous left atrial appendage closure after resolution of left atrial appendage thrombi with dabigatran]. / Percutan bal pitvari fülcsezárás dabigatrannal való fülcsethrombus feloldását követoen.

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.