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Atrial fibrillation (AF) is a commonly encountered chronic and progressive heart rhythm disorder, characterized by exacerbations and remissions. Contemporary clinical practice guidelines recommend a trial of antiarrhythmic drugs (AADs) as the initial therapy for sinus rhythm maintenance; however, these medications have modest efficacy and are associated with significant adverse effects. Recently, several trials have demonstrated that an initial treatment strategy of cryoballoon catheter ablation significantly improves arrhythmia outcomes (e.g. freedom atrial tachyarrhythmia and reduction in arrhythmia burden), produces clinically meaningful improvements in patient-reported outcomes (e.g. symptoms and quality of life), and significantly reduces subsequent healthcare resource utilization (e.g. hospitalization), without increasing the risk of serious or any adverse events. These findings are relevant to patients, providers, and healthcare systems, helping inform the decision regarding the initial choice of rhythm-control therapy in patients with treatment-naïve AF.

BACKGROUND: Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line CBA on quality of life (QoL) and symptoms has not been well characterized. METHODS: Patients aged 18 to 75 with symptomatic paroxysmal AF naïve to rhythm control therapy were randomized (1:1) to CBA (Arctic Front Advance, Medtronic) or AAD (Class I or III). Symptoms and QoL were assessed at baseline, 1, 3, 6, 9, and 12 months using the EHRA classification and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and SF-36v2 questionnaires. Symptomatic palpitations were evaluated via patient diary. RESULTS: Overall, 107 patients were randomized to CBA and 111 to AAD; crossovers occurred in 9%. Larger improvements in the AFEQT summary, subscale and treatment satisfaction scores were observed at 12 months with CBA vs AAD (all P

Although cryoballoon ablation of atrial fibrillation (AF) has been traditionally guided by pulmonary vein (PV) occlusion, there is evidence and growing interest in performing segmental, non-occlusive cryoballoon ablation to target not only large/common PVs, but extra-PV structures such as the left atrial (LA) roof and posterior wall in conjunction with PV isolation. To date, a number of studies have demonstrated improved clinical efficacy associated with non-occlusive cryoballoon ablation of the LA roof and posterior wall in addition to PV isolation, particularly in patients with persistent AF. Not only the cryoballoon can be utilized for targeting extra-PV structures through segmental, non-occlusive ablation, but the large size and durability of cryolesions coupled with the enhanced stability afforded through cryoadhesion render the cryoballoon an effective tool for such an approach. This manuscript reviews the rationale and the practical approach to segmental, non-occlusive cryoballoon ablation of large/common PV antra and the LA roof and posterior wall.

Atrial fibrillation (AF), the most common sustained arrhythmia observed in clinical practice, is a chronic and progressive disorder characterized by exacerbations and remissions. Guidelines recommend antiarrhythmic drugs as the initial therapy for the maintenance of sinus rhythm; however, antiarrhythmic drugs have modest efficacy to maintain sinus rhythm and can be associated with significant adverse effects. An initial treatment strategy of cryoballoon catheter ablation in patients with treatment-naive AF has been shown to significantly improve arrhythmia outcomes (freedom from any, or symptomatic atrial tachyarrhythmia), produce clinically meaningful improvements in patient-reported outcomes (symptoms and quality of life), and significantly reduce subsequent health care resource use (hospitalization), and it does not increase the risk of serious or any adverse events compared with initial antiarrhythmic drug therapy. These findings are relevant to inform patients, providers, and health care systems regarding the initial choice of rhythm-control therapy in patients with treatment-naive AF.

Heart failure with reduced ejection fraction (LV-EF < 35%) is diagnosed in app. 11,000,000 patients worldwide. For the treatment of these patients, guideline directed medical therapy has proven to reduce mortality and rehospitalization regardless of the disease’s etiology. It is implemented to treat clinical symptoms by improving the left ventricular ejection fraction. Patients with a transient risk of ventricular tachycardia and sudden cardiac death can be protected by a defibrillator vest. The defibrillator vest is capable to detect and terminate ventricular arrhythmias during Guideline Directed Medical Therapy (GDMT). It is based on the recommendations of the European society of cardiology for 3 months. Afterwards, the WCD wear time could be prolonged, or, in case of persistent low ejection fraction (LV-EF ≤ 35%), an implantable cardioverter defibrillator (ICD) should be implanted, as shown in the WEARIT-II-registry. Our goal was to evaluate the effects of GDMT on LV-recovery and reduction of ICD implantations under protection with a defibrillator vest—depending on the uptitration of GDMT. Methods: 339 consecutive patients between August 2017 and September 2020 with newly diagnosed cardiomyopathy and an EF ≤ 35% were analyzed retrospectively by chart review. All patients were protected by a wearable cardioverter defibrillator (WCD). GDMT as recommended by the ESC started at discharge from hospital. The left ventricular ejection fraction (LV-EF) was determined by transthoracic echocardiography at week 4, 8 and at week 12 (in case of prolonged WCD wear time). Uptitration was performed after 4 and 8 weeks during patient visits. We focused on baseline medication as per GDMT and the dosage increase at week 4, 8 and 12. The aim was the uptitration to the maximum dosage tolerated by the patient. We also compared the LV-EF improvement in the group with and without uptitration of medication dosage. Results: The patient age was, on average, 63.2 years (SD ± 11.9 years). A total of 129 pts (38%) had ICM, 196 (58%) had NICM (incl 66 pts (19%) with DCM and 51 pts (15%) with Myocarditis, 79 pts (24%) with unknown origin) and 14 pts (4%) had other entities (e.g., Tachycardiomyopathy). In total, 21 pts (6%) had an LV-EF of less than 16%, 130 pts (38%) between 16–25% and 183 pts (54%) between 26–35%. GDMT started at discharge from the hospital included treatment with beta blocker for 327 pts (96.5%), ACE-inhibitors/Angiotensin/ARNI for 283 pts (83.5%) and Mineralcorticoid receptor antagonists (MRA) for 334 pts (88.4%). Uptitration was performed in all groups at a rate of 82.3%, 91.1% and 81.0% after 4 weeks and 64.7%, 50.3% and 66.3% after 8 weeks, respectively. After 4 weeks, 25 pts (7.4%) and, after 8 weeks, 171 pts (50.4%) had an EF increase of 5% or more (mean 14.2%). After 4 weeks, 81 patients had an LV-EF more than 35%. A total of 169 pts had a wear time of 12 weeks and an improvement of LVEF of more than 35%. Interestingly, in our study we did not find a significant difference in LV-EF improvement between the group with no uptitration and the group with uptitration. Conclusions: Guideline-directed medical therapy under protection with a WCD from ventricular arrhythmia can reduce the need for implantation of an ICD and can lead to an improvement of ejection fraction. Interestingly, the LV-EF improvement depends on the GDMT at discharge. Current guidelines recommend an initiation of all therapy columns of GDMT (sacubitril/valsartan, ACE-inhibitor/AT1-blocker, mineralcorticoidreceptorblocker, beta blocker) at once and further uptitration to the maximal dosage (ESC Guidelines 2021). A further uptitration of all drugs of GDMT should lead to improvement of LV-EF and consequently to a reduction in ICD implantations.

AimsCryoballoon (CB)-based pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). The most frequent complication during CB-based PVI is right-sided phrenic nerve injury (PNI) which is leading to premature abortion of the freeze cycle. Here, we analysed reconnection rates after CB-based PVI and PNI in a large-scale population during repeat procedures.Methods and resultsIn the YETI registry, a total of 17 356 patients underwent CB-based PVI in 33 centres, and 731 (4.2%) patients experienced PNI. A total of 111/731 (15.2%) patients received a repeat procedure for treatment of recurrent AF. In 94/111 (84.7%) patients data on repeat procedures were available. A total of 89/94 (94.7%) index pulmonary veins (PVs) have been isolated during the initial PVI. During repeat procedures, 22 (24.7%) of initially isolated index PVs showed reconnection. The use of a double stop technique did non influence the PV reconnection rate (P = 0.464). The time to PNI was 140.5 ± 45.1 s in patients with persistent PVI and 133.5 ± 53.8 s in patients with reconnection (P = 0.559). No differences were noted between the two populations in terms of CB temperature at the time of PNI (P = 0.362). The only parameter associated with isolation durability was CB temperature after 30 s of freezing. The PV reconnection did not influence the time to AF recurrence.ConclusionIn patients with cryoballon application abortion due to PNI, a high rate of persistent PVI rate was found at repeat procedures. Our data may help to identify the optimal dosing protocol in CB-based PVI procedures.Clinical Trial Registrationhttps://clinicaltrials.gov/ct2/show/NCT03645577?term=YETI&cntry=DE&draw=2&rank=1 ClinicalTrials.gov Identifier: NCT03645577.

Guideline-directed medical therapy (GDMT) is crucial in reducing mortality in patients with heart failure with heart rate lowering by a beta blocker (BB) being an important therapeutic concept. We aimed to assess the usefulness of a wearable cardioverter/defibrillator (WCD) to provide detailed information about heart rate for managing patients with reduced left ventricular ejection fraction (LVEF) and symptoms of heart failure and to correlate mortality with the mean heart rate. A total of 4509 consecutive patients (mean age: 59 + 13 years, 88% male) were analyzed retrospectively. All patients had reduced LVEF and were prescribed a WCD for protection from sudden cardiac death (SCD) during GDMT uptitration awaiting LVEF recovery. The device continuously measured nighttime and daytime HR at the beginning and end of WCD use. Patients who died during wear time had significantly higher HRs compared with survivors: daytime beginning of use (BOU), 80 ± 15 bpm vs. 76 ± 13, p < 0.01; nighttime BOU, 76 ± 14 vs. 69 ± 13, p < 0.0001; daytime end of use (EOU), 84 ± 20 vs. 73 ± 13, p < 0.0001; nighttime EOU, 80 ± 20 vs. 65 ± 12, p < 0.0001). In conclusion, HR monitoring with a WCD yields important prognostic information and may assist in optimal usage of BB in patients with low LVEF.

Supplemental Digital Content is available in the text., Background: Cryoballoon-based pulmonary vein isolation (PVI) has emerged as an effective treatment for atrial fibrillation. The most frequent complication during cryoballoon-based PVI is phrenic nerve injury (PNI). However, data on PNI are scarce. Methods: The YETI registry is a retrospective, multicenter, and multinational registry evaluating the incidence, characteristics, prognostic factors for PNI recovery and follow-up data of patients with PNI during cryoballoon-based PVI. Experienced electrophysiological centers were invited to participate. All patients with PNI during CB2 or third (CB3) and fourth-generation cryoballoon (CB4)-based PVI were eligible. Results: A total of 17 356 patients underwent cryoballoon-based PVI in 33 centers from 10 countries. A total of 731 (4.2%) patients experienced PNI. The mean time to PNI was 127.7±50.4 seconds, and the mean temperature at the time of PNI was −49±8°C. At the end of the procedure, PNI recovered in 394/731 patients (53.9%). Recovery of PNI at 12 months of follow-up was found in 97.0% of patients (682/703, with 28 patients lost to follow-up). A total of 16/703 (2.3%) reported symptomatic PNI. Only 0.06% of the overall population showed symptomatic and permanent PNI. Prognostic factors improving PNI recovery are immediate stop at PNI by double-stop technique and utilization of a bonus-freeze protocol. Age, cryoballoon temperature at PNI, and compound motor action potential amplitude loss >30% were identified as factors decreasing PNI recovery. Based on these parameters, a score was calculated. The YETI score has a numerical value that will directly represent the probability of a specific patient of recovering from PNI within 12 months. Conclusions: The incidence of PNI during cryoballoon-based PVI was 4.2%. Overall 97% of PNI recovered within 12 months. Symptomatic and permanent PNI is exceedingly rare in patients after cryoballoon-based PVI. The YETI score estimates the prognosis after iatrogenic cryoballoon-derived PNI. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03645577. Graphic Abstract: A graphic abstract is available for this article.

It is unknown whether left atrial (LA) roof ablation combined with pulmonary vein isolation (PVI) using a second-generation cryoballoon provides additional benefit beyond that of PVI alone in patients with persistent atrial fibrillation (AF). The aim of this study was to compare arrhythmia recurrence rates after PVI alone versus PVI plus LA roof ablation. In this observational study, we analyzed 399 symptomatic patients with persistent AF treated with cryoballoon ablation. After univariate and multivariate analyses of the entire cohort, propensity score matching resulted in two groups of 86 patients each: (1) PVI plus LA roof ablation (PVI-plus group) and (2) PVI alone (PVI-only group). The primary endpoint was the first documented > 30-s arrhythmia recurrence after a 3-month blanking period. PVI was successful in all patients. A bidirectional conduction block across the LA roof was verified in 91.9% of patients in the PVI-plus group. During a median mid-term follow-up of 33 months, 21 patients (24.4%) in the PVI-plus group and 37 patients (43.0%) in the PVI-only group (P = 0.01) reached the primary endpoint. Multivariate analysis revealed AF history > 2 years (hazard ratio [HR] = 2.04, P 21 cm2 (HR = 2.36, P

Introduction There are no data concerning clinical outcome and left atrial (LA) function after LA roof ablation using a second-generation cryoballoon (CB) for treatment of persistent atrial fibrillation (AF). Here, we report the first follow-up results after pulmonary vein isolation (PVI) plus LA roof ablation with the CB technique in patients with symptomatic persistent AF. Methods and results We enrolled 107 consecutive patients who underwent CB ablation at our institution with the aim of PVI and bidirectional conduction block across the LA roof. Clinical success was defined as freedom from >30-s recurrence of AF, atrial flutter, or atrial tachycardia after a 3-month blanking period. Follow-up data were collected during outpatient clinic visits. LA volume, LA emptying fraction, and LA expansion index (parameters of LA function) were evaluated by echocardiography before and 3 months after ablation. PVI was achieved in all patients, and bidirectional conduction block was verified in 91.6%. Median follow-up duration was 31 (interquartile range 11/44) months. PVI plus LA roof ablation was sufficient to restore and maintain sinus rhythm in 72.9% ( n = 78) of patients. The overall complication rate was 1.8%. LA volumes decreased significantly after ablation ( P P = 0.25) and LA expansion index ( P = 0.32) were preserved within the 3-month follow-up. Conclusions LA roof ablation combined with PVI using the CB technique is a safe and effective adjuvant treatment with a promising midterm outcome and preserved LA function 3 months after ablation.

Aims To evaluate the effectiveness and safety of cryoballoon ablation (CBA) compared with radiofrequency ablation (RFA) for symptomatic paroxysmal or drug-refractory persistent atrial fibrillation (AF). Methods and results Prospective cluster cohort study in experienced CBA and RFA centres. Primary endpoint was ‘atrial arrhythmia recurrence’, secondary endpoints were as follows: procedural results, safety, and clinical course. A total of 4189 patients were included: CBA 2329 (55.6%) and RFA 1860 (44.4%). Cryoballoon ablation population was younger, with fewer comorbidities. Procedure time was longer in the RFA group (P = 0.01). Radiation exposure was 2487 (CBA) and 1792 cGycm2 (RFA) (P Conclusions The primary endpoint did not differ between CBA and RFA. Cryoballoon ablation was completed rapidly; the radiation exposure was greater. Rehospitalization due to re-ablations and adverse events during follow-up were observed significantly less frequently after CBA than after RFA. Subgroup analysis suggested a lower risk of recurrence after CBA in paroxysmal AF. Trial Registration ClinicalTrials.gov (NCT01360008), https://clinicaltrials.gov/ct2/show/NCT01360008.

Introduction Stroke is one of the most feared complications during catheter ablation of atrial fibrillation (AF). While symptomatic thromboembolic events are rare, magnetic resonance imaging (MRI) may identify asymptomatic (ie, silent) cerebral lesions (SCLs) following pulmonary vein isolation (PVI) procedures. Methods and Results The REDUCE‐TE Pilot was a prospective multicenter, single‐arm observational study investigating the incidence of SCL in patients with symptomatic paroxysmal AF undergoing PVI with a novel gold‐tip, externally irrigated ablation catheter. After ablation, cerebral diffusion‐weighted MRI and a postablation follow‐up were performed at 1 to 3 days after the ablation procedure. A neurocognitive test was done before and after ablation. The primary study endpoint was the occurrence of one or more new SCLs. Secondary study endpoints included neurocognitive status, procedural success rate, and periprocedural complications including symptomatic thromboembolic events. A total of 104 patients were enrolled (69% male, mean age: 61.5 ± 9.7 years, mean CHA2DS 2‐VASc score: 1.7 ± 1.2). Postprocedural MRI examination was performed in 97 patients, and in nine of them (9.3%; 95% CI: 4.3‐16.9%) a total of 11 SCLs were detected. Univariate analyses did not reveal any significant predictor for new SCLs. Nonsignificant trends were observed for low activated clotting time during ablation and for international normalized ratio value outside the range of 2 to 3 at ablation. There was no evidence of significant deterioration of neurocognitive function after PVI. In four patients, a pericardial tamponade was noted but all patients fully recovered during follow‐up. Conclusions Ablation of AF using a novel gold‐tip, externally irrigated ablation catheter, resulted in SCLs in approximately one out of 10 patients without a measurable effect on neurocognitive function.

Ventrikulare Extrasystolen (VES) sind ein haufiger, oft zufalliger und meist harmloser Befund. Bei sehr haufigem Auftreten mit Beschwerden oder Verschlechterung der linksventrikularen Funktion besteht eine Behandlungsindikation. Idiopathische ventrikulare Tachykardien (VT) finden sich uberwiegend bei Patienten mit strukturell gesundem Herz. Diese VES/VT haben meist einen fokalen Ursprung. Der wahrscheinlichste Mechanismus sind verzogerte Nachdepolarisationen. Die Lokalisation des Ursprungortes basiert auf der Erstellung eines Aktivierungsmaps mit oder ohne Kombination eines Pacemappings. Die charakteristischen anatomischen Ursprungsstellen idiopathischer VES/VT sind die Ausflussbahnen des rechten und linken Ventrikels einschlieslich der Aortenwurzel. Weitere typische Lokalisationen sind der Trikuspidal- oder Mitralklappenring, Papillarmuskeln und Purkinje-Fasern. Die Katheterablation ist bei symptomatischen, monomorphen VES/VT eine Alternative zu antiarrhythmischer Medikation. Die Erfolgsrate ist hoch, wobei das Mapping und die Ablation oftmals eine Herausforderung darstellen konnen. Dieser Artikel ist der funfte Teil einer Serie zur gezielten Fort- und Weiterbildung im Bereich „Spezielle Rhythmologie – Invasive Elektrophysiologie“. Er beschreibt pathophysiologische Grundlagen, Formen sowie typische Befunde, die bei einer elektrophysiologischen Untersuchung erhoben werden konnen.

Atrial fibrillation (AF), the most common sustained arrhythmia observed in clinical practice, is a chronic and progressive disorder characterized by exacerbations and remissions. Guidelines recommend antiarrhythmic drugs as the initial therapy for the maintenance of sinus rhythm; however, antiarrhythmic drugs have modest efficacy to maintain sinus rhythm and can be associated with significant adverse effects. An initial treatment strategy of cryoballoon catheter ablation in patients with treatment-naïve AF has been shown to significantly improve arrhythmia outcomes (freedom from any, or symptomatic atrial tachyarrhythmia), produce clinically meaningful improvements in patient-reported outcomes (symptoms and quality of life), and significantly reduce subsequent health care resource use (hospitalization), and it does not increase the risk of serious or any adverse events compared with initial antiarrhythmic drug therapy. These findings are relevant to inform patients, providers, and health care systems regarding the initial choice of rhythm-control therapy in patients with treatment-naïve AF.

Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Medtronic OnBehalf The Cryo-FIRST Investigators Background Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial arrhythmia recurrence; however, the impact of first-line CBA specifically on atrial fibrillation (AF) recurrence and quality of life (QoL) has not been well characterized. Purpose To compare AF recurrence and QoL following first-line CBA vs. AAD therapy in patients with paroxysmal AF within the CryoFIRST trial (NCT01803438). Methods Patients with recurrent symptomatic paroxysmal AF who had not been administered class I or III AAD therapy for >48 hours were enrolled at 18 sites in 9 countries. Patients were randomized (1:1) to CBA or AAD treatment (Class I or III). Subjects were followed by 7-day Holter at 1, 3, 6, 9, and 12 months. Time-to-first AF recurrence outside of a 90-day blanking period was estimated by Kaplan-Meier analysis. QoL was evaluated using the Atrial Fibrillation Effect on Quality of Life (AFEQT) and 36-Item Short Form Health Survey (SF-36) v2 questionnaires. Results Of the 218 randomized subjects, 187 (86%) completed the 12-month follow-up. By intention-to-treat (ITT) analysis, freedom from AF after blanking was achieved in 86.6% in the CBA and 74.5% in the AAD group (p = 0.023). There was no difference in the time-to-first serious adverse event between groups. In total, 84.3% of patients in the CBA vs. 75.0% of patients in the AAD arm had a clinically important improvement (≥5 points) in the AFEQT summary score. The adjusted mean difference in the AFEQT summary score at 12 months was 9.9 points higher in the CBA group (95% CI: 5.5-14.2; P Conclusion CBA is superior to AAD for preventing AF recurrence and improving AF-specific QoL in patients with paroxysmal AF. AFEQT Scores at Baseline and 12 MonthsAFEQT Score, Mean ± Standard DeviationCBAAADAdjusted Mean Difference at 12 Months (CBA vs. AAD)p-valueBaseline12 MonthsBaseline12 MonthsDaily Activities65.3 ± 25.887.8 ± 17.161.0 ± 27.976.6 ± 25.48.9 (3.2-14.6)0.002Symptoms59.9 ± 24.888.8 ± 15.658.4 ± 25.280.9 ± 22.27.1 (1.5-12.7)0.014Treatment Concern59.9 ± 23.189.8 ± 14.060.4 ± 24.577.7 ± 22.212.7 (7.9-17.5)

Introduction: The Cryo-FIRST study (NCT01803438) demonstrated that pulmonary vein isolation (PVI) with cryoballoon catheter ablation (CA) is superior to antiarrhythmic drug (AAD) therapy as a first line treatment for the prevention of atrial arrhythmia recurrence in patients with paroxysmal atrial fibrillation (PAF). Earlier CA may also be beneficial for improving quality of life (QoL). Hypothesis: We hypothesized that PVI with cyroballoon CA is superior to AAD therapy for improving QoL in treatment naïve patients with PAF. Methods: Patients with symptomatic PAF free of heart disease who had not been administered AAD therapy for >48 hours were enrolled at 18 sites in 9 countries. Patients were randomized (1:1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD therapy (Class IC or III). Subjects were followed at 1, 3, 6, 9, and 12 months. QoL was evaluated using the Atrial Fibrillation Effect on Quality of Life (AFEQT) and SF-36 v2 questionnaires. Health domains and component scores from the SF-36 were transformed to norm-based T scores. Mean adjusted differences between arms were compared at each follow-up. Results: Of the 218 patients randomized (age 52±13 years, 68% male) 86% completed the 12-month follow-up. Crossovers occurred in 9% of subjects (N=20, CA-to-AAD: N=1, AAD-to-CA: N=19). There were no group differences in baseline AFEQT or SF-36 scores. The mean AFEQT summary score was more favorable in the CA vs. AAD group at 12 months (88.9 vs. 78.1 points, respectively). The adjusted difference was 9.9 points (95%CI: 5.5-14.2; P < .0001, Figure). A significant adjusted mean difference favoring CA was observed for the SF-36 physical component score at months 3 (1.8 points, p=0.031) and 9 (2.0 points, p=0.018). No other differences were observed in the physical or mental component scores between groups. Conclusions: Cryoballoon CA was superior to AAD therapy for improving AF-specific QoL in treatment naïve patients with symptomatic PAF.

Introduction: Early catheter ablation (CA) may increase procedure efficacy and reduce the risk of atrial fibrillation (AF) disease progression. Cryo-FIRST (NCT01803438) evaluated whether pulmonary vein isolation (PVI) with cryoballoon CA is superior to antiarrhythmic drug (AAD) therapy as a first-line treatment for the prevention of atrial arrhythmia recurrence (AAR) in patients with paroxysmal AF (PAF). Methods: Patients with symptomatic PAF, free of heart disease and not administered an AAD for >48 hours were enrolled at 18 sites in 9 countries, randomized (1:1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD therapy (Class IC or III). Using a 90-day blanking period, subjects were followed at 1, 3, 6, 9, and 12 months by 7-day Holter monitoring. Primary endpoint failure was defined as AAR lasting >30 s. Safety was evaluated by comparing the incidence of serious adverse events (SAEs). Palpitations were monitored by a patient diary. Results: Of the 218 randomized subjects (age 52±13 years, 68% male), 187 (86%) completed the 12-month follow-up. Crossovers occurred in 20 subjects (9%; 1 subject from CA-to-AAD and 19 from AAD-to-CA). By intention-to-treat analysis, freedom from AAR after blanking was achieved in 82.2% of subjects in the cryoballoon CA arm and 67.6% of subjects in the AAD arm (HR=0.48, 95% CI: 0.26-0.86; P =0.013). There were no group differences in the time-to-first SAEs (HR=0.76, 95% CI: 0.46-1.26; P =0.28), and there was no death, atrio-esophageal fistula, pericardial tamponade, or stroke reported during the study. Also, there was no phrenic nerve injury present at the time of hospital discharge. The incidence rate of symptomatic palpitations after the 3 month follow-up was lower in the cryoballoon CA (4.61 days/year) compared to the AAD arm (15.18 days/year; IRR=0.30, 95% CI: 0.16-0.58; P Conclusions: Cryoballoon CA was superior to AAD for the prevention of AAR in treatment naïve patients with PAF, and CA was associated with less frequent symptom recurrence. Moreover, CA had a safety profile comparable to AAD therapy. These results suggest cryoballoon CA is an effective first-line treatment for patients with symptomatic PAF.

Background By consensus statements, catheter ablation is a recommended treatment for patients with symptomatic drug-refractory paroxysmal atrial fibrillation (AF), as patients try to alleviate the burdensome AF symptoms that reduce the Quality of Life (QoL). Yet, first-line treatment of symptomatic patients via catheter ablation prior to initiation of antiarrhythmic drugs (AADs) is only a reasonable alternative (Class IIa). Clearly, more clinical data is necessary that compares catheter ablation to AAD therapy in treatment naïve patients. Purpose The Cryo-FIRST trial was designed to compare AAD treatment against pulmonary vein isolation (PVI) while using a cryoballoon catheter (Arctic Front Advance; Medtronic, Inc.). This current data analysis examines the QoL endpoints when comparing AADs to cryoballoon ablation in patients with symptomatic treatment naïve paroxysmal AF. Methods This randomized multicenter trial enrolled 220 patients from 18 sites in 9 countries (Europe, Australia, and Latin America) in a prospective open-blinded endpoint study design. Patients had not been administered a class I or III AAD for longer than 48 hours for inclusion into the study. Subjects were randomized (1:1) into a cohort that was administered AAD therapy or a cohort that received PVI via cryoablation. The prespecified QoL endpoint at 12 months was measured using the Atrial Fibrillation Effect on Quality of Life (AFEQT) scores, and QoL recordings were taken at baseline, 1, 3, 6, 9, and 12 months following the index treatment. Results Of the 218 patients randomized (age 52±13 years, 68% male) 86% completed the 12-month follow-up. Crossovers occurred in 9% of subjects (N=20), including: 1 subject in the cryoablation arm and 19 subjects in the AAD arm. At 12 months, 86.5% of the patients in the cryoablation arm and 70.4% of the patients in the AAD arm where without symptoms (EHRA score 1). The mean AFEQT summary score was more favorable in the catheter ablation group compared to the drug therapy group at 12 months (88.9 vs. 78.1 points, respectively). The adjusted difference was 9.9 points (95% CI: 5.5–14.2; P Conclusions Cryoballoon ablation resulted in a significant improvement in QoL at 12 months compared to AAD therapy in treatment naïve patients with first-line symptomatic paroxysmal AF. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic International Trading Sàrl

Background It is well known that prevalence of atrial fibrillation correlates with age, however the data on ablation of atrial fibrillation in elderly patients is poor. Aim of this study was analysis of outcome and prediction of recurrence after cryo-balloon ablation (CBA) in elderly patients based on available data in our registry. Methods The history of AF was assessed at admission. Additionally, all patients received echocardiographic examination and blood test. After a single trans-septal access and PV angiography PVI was performed using a 28-mm CBA. Mapping of PV signals before, during, and after each cryo application was performed with a 3F lasso catheter. The procedural endpoint after PVI was defined as complete elimination of all fragmented signals at the PV antrum with verification of entrance and exit block. Primary endpoint was first documented recurrence of AF, atrial tachycardia or atrial flutter (>30 sec.). All patients received a follow-up every 3 month within 1st year, once yearly thereafter and in case of symptoms. Seven days Holter ECG was recorded by every follow up. Results A total of 44 (39%) of enrolled patients were male, 48 (43%) suffered non- paroxysmal AF(nPAF), 93 (82%) had hypertension, CAD was diagnosed by 27 (24%), 28 (25%) had DM (Hb1AC > 6), Stroke/TIA was observed in 11 (10%). Median Age in elderly was 76 (75-78) y, BMI 25.77 (23.51-28.69), time since 1st diagnosis 40 (6-50) month, LA area index 11.36 (9.77-13.20), TAPSE 23 (19-26), GFR 74 (66-83) mL/min, LVEF 60 (57-62). A total of 44 patients (39%) reached endpoint within follow up of 20 (12-38) months. Univariate association with outcome was found by follows parameter: Time from 1st diagnosis > 3 y (HR = 3.22 (1.66-6.27), p=.001); LA area index (HR = 1.17 (1.03-1.32), p=.013); DM (HR = 1.89 (1.02-3.55), p=.042); nPAF (HR = 1.90 (1.04-3.47), p=.036). After multivariate analysis only time from 1st diagnosis > 3 y, (HR= 3.17 (1.62-6.16), p=.001 and nPAF (HR = 1.84 (1.01-3.36)), p=.048 were revealed to be predictive. The area under probability score calculated for these predictors was .731 (.638-8.25), p=.001. Follows complications were observed: 2 (2%) - pericard tamponades, 4 (4%) phrenicus nerve injury. Conclusion. PVI with cryo-balloon is effective for elderly patients providing freedom of arrhythmic events in 61% of patients. Longer history of AF over 3 years since 1st diagnosis was main predictor for post ablation recurrence. In elderly patients with shorter history of AF efficiency and safety of CBA is comparable with general population.

Background Radiofrequency current (RFC) catheter ablation for patients with paroxysmal atrial fibrillation (AF) has been shown to be safe and effective in first-line therapy. Recent data demonstrates that RFC ablation provides better clinical outcomes compared to antiarrhythmic drug (AAD) in the treatment of early AF disease. Furthermore, studies comparing RFC and cryoballoon have established comparable efficacy and safety of pulmonary vein isolation (PVI) for patients with symptomatic paroxysmal AF. Objectives The Cryo-FIRST trial was designed to compare AAD treatment against cryoballoon PVI as a first-line therapy in treatment naive patients with AF. Efficacy and safety will be compared between the two cohorts and amongst subgroups. Methods The primary hypothesis is that cryoablation is superior to AAD therapy. To test this hypothesis, patients will be randomized in a 1:1 design. Using a 90-day blanking period, primary efficacy endpoint failure is defined as (at least) one episode of atrial arrhythmia with a duration >30 sec (documented by 7-day Holter or 12-lead ECG). Secondary endpoints (Quality-of-Life, rehospitalization, arrhythmia recurrence rate, healthcare utilization, and left atrial function) and adverse events will also be evaluated. Study enrollment will include 218 patients in up to 16 centers. Conclusions This study will be a multi-national randomized controlled trial comparing cryoablation against AAD as a first-line treatment in patients with paroxysmal AF. The results may help guide the selection of patients for early AF disease therapy via cryoballoon ablation.

Robotic (RNS) or magnetic navigation systems (MNS) are available for remotely performed catheter ablation for atrial fibrillation (AF). The present study compares remotely assisted catheter navigation (RAN) to standard manual navigation (SMN) and both systems amongst each other. The analysis is based on a sub-cohort enrolled by five hospitals from the multicenter German ablation Registry. Out of 2442 patients receiving catheter ablation of AF, 267 (age 61.4 ± 10.4, 69.7% male) were treated using RAN (RNS n = 187, 7.7% vs. MNS n = 80, 3.3%). Fluoroscopy time [RNS median 17 (IQR 12–25) min vs. MNS 22 (16–32) min; p

CardioInsight™ ist ein nichtinvasives elektrokardiographisches Mappingsystem, mit dem durch eine einzigartige Technologie elektrische epikardiale Potenziale bestimmt und lokalisiert werden konnen. Mittels einer EKG-Weste mit 252 Elektroden, die am Torso des Patienten befestigt werden, und einer CT-Untersuchung ohne Kontrastmittel konnen epikardiale Potenziale detektiert werden. Mithilfe eines Rekonstruktions-Algorithmus werden Aktivierungs- und Phasenmaps erstellt, die eine bessere Kenntnis der Lokalisierung und Mechanismen der Rhythmusstorungen einschlieslich Vorhofflimmern ohne Anwendung eines endokardialen Katheters erlauben. Das System eignet sich aufgrund seiner Prazision nachweislich fur den klinischen Einsatz in der Lokalisationsdiagnostik akzessorischer Leitungsbahnen, vorzeitiger ventrikularer Kontraktionen („premature ventricular contractions“, PVC), atrialer Tachykardien und Vorhofflimmern. Die Schlag-zu-Schlag-Analyse erlaubt auch die Detektion und damit eine Therapie von Arrhythmien, die nur paroxysmal auftreten, wie z. B. supraventrikulare Extrasystolen, Episoden von Vorhofflimmern oder VES. Ein weiterer Vorteil ist die gleichzeitige Darstellung verschiedener Herzkammern, wie z. B. linker und rechter Vorhof. Jedoch liegen bislang noch keine multizentrischen, prospektiv randomisierten Daten vor. Sollte das nichtinvasive Mapping zukunftig MRT-fahig und mit einem invasiven Mappingsystem kompatibel sein, so dass eine Katheterdarstellung auch wahrend einer invasiven elektrophysiologischen Untersuchung moglich ist, ware nach Ansicht der Autoren eine neue Dimension in der Mappingtechnologie und Ablationsstrategie von Arrhythmien erreicht.

Objectives This study provides an update and comparison to a 2010 nationwide survey on cardiac electrophysiology (EP), types and numbers of interventional electrophysiological procedures, and training opportunities in 2015. Background In 2010, German cardiology centers performing interventional EP were identified and contacted to provide a survey on cardiac EP. Methods German cardiology centers performing interventional EP in 2015 were identified from quality reports and contacted to repeat the 2010 questionnaire. Results A majority of 131 centers (57%) responded. EP (ablation procedures and device therapy) was mainly part of a cardiology department (89%) and only independent (with its own budget) in 11%. The proportion of female physicians in EP training increased from 26% in 2010 to 38% in 2015. In total, 49,356 catheter ablations (i.e., 81% of reported ablations in 2015) were performed by the responding centers, resulting in a 44% increase compared with 2010 (the median number increased from 180 to 297 per center). Atrial fibrillation (AF) was the most common arrhythmia interventionally treated (47%). At 66% of the centers, (at least) 2 physicians were present during most catheter ablations. A minimum of 50 (75) AF ablations were performed at 80% (70%) of the centers. Pulmonary vein isolation with radiofrequency point-by-point ablation (62%) and cryoablation (33%) were the preferred ablation strategies. About one-third of centers reported surgical AF ablations, with 11 centers (8%) performing stand-alone surgical AF ablations. Only one-third of the responding 131 centers fulfilled all requirements for training center accreditation. Conclusions Comparing 2010 with 2015, an increasing number of EP centers and procedures in Germany are registered. In 2015, almost every second ablation was for therapy for AF. Thus, an increasing demand for catheter ablation is likely, but training opportunities are still limited, and most centers do not fulfil recommended requirements for ablation centers.

Introduction Data on long-term outcomes of cryoballoon (CB) ablation for treatment of persistent atrial fibrillation (AF) are sparse. Here, we report the first 3-year follow-up results and predictors of success for catheter ablation using the second-generation CB in patients with persistent AF. Methods and results For this prospective observational study, we enrolled 101 patients ablated with the second-generation CB at our institution. The endpoint was the first documented recurrence (> 30 seconds) of AF, atrial flutter, or atrial tachycardia after a 3-month blanking period. Follow-up data were collected during outpatient clinic visits and included Holter-ECG recordings. The impact of several variables on recurrence was evaluated by means of univariate and multivariate analyses and Cox proportional hazards regression models. After a median follow-up of 37 (31 of 42) months, recurrence was documented in 30 patients (29.7%). The median procedure and fluoroscopy times were 120 (102 of 147) and 20 (16 of 27) minutes, respectively. Phrenic nerve palsy occurred in 2.0% of the patients. Among the 30 patients who experienced recurrence, 16 underwent repeat ablation in radiofrequency technique. Cox regression analysis showed that left atrial area > 21 cm2 and AF history duration > 2 years independently predicted recurrence. Conclusions Sinus rhythm was maintained in a substantial proportion of patients even 3 years after CB ablation. Patients with a nonenlarged left atrium and short AF history had the best outcome.

Background Second-generation cryoballoon (CB2) based pulmonary vein isolation (PVI) has emerged as a safe and effective treatment option for symptomatic atrial fibrillation (AF). Although published complication rates of CB2 based-PVI are relatively low and several safety algorithms have been implemented in the protocols the most frequent complication is right-sided phrenic nerve injury (PNI). The reported incidence of PNI varies from 2–5% of patients. However data on PNI characteristics as well as follow-up is sparse. Purpose We aimed to evaluate the incidence, characteristics and outcome of PNI during after CB2 based-PVI in a large patients population. Methods and results From July 2012 to November 2018 a total of 13693 patients received CB2 or CB3 (third-generation) based-PVI in 23 EP centers (Germany: 12, China: 1, Turkey: 3, Japan: 3, USA: 1, Austria: 1, Poland: 1, Swizerland: 1). A total of 596 (4.4%) of patients experienced PNI during treatment of the right superior (84%) right inferior (15%) right middle (0.3%) (and left superior (0.3%) pulmonary veins. The mean time to PNI was 127±51 seconds and the mean temperature at the time of PNI was −49±7 °C. The target PV was isolated at time of PNI in 84% of cases. The applications were interrupted using double-stop technique in (71%). In 212/306 (52%) a CMAP was utilized. At the end of the procedure PNI persistent in 45% of patients. Fluoroscopic or sonographic evaluation of PNI was performed 1–3 days after the procedure and revealed persistent PNI in 35% of patients. Dyspnea before discharge was reported in 18% of patients with persistent PNI. Patients follow up at 1–3, and 6–12 months included fluoroscopy and a visit in an outpatient clinic. After 1–3 months 18% of patients showed persistent PNI including 13% of patients complaining of dyspnea. After 6–12 months of follow-up including fluoroscopic evaluation PNI was persistent in 1.8% of patients while dyspnea was reported by 1.7% patients. Only 0.08% of the overall population of 13693 patients showed permanent and symptomatic PNI. Conclusion The incidence of PNI during CB2-based PVI is low. About 55% of PNI recovered until the end of the procedure. Most of PNI recovered within 12 months. Symptomatic permanent PNI is very rare in patients after CB2/CB3-based PVI.

Premature ventricular contractions (PVC) are a common, often incidental and mostly benign finding. Treatment is indicated in frequent and symptomatic PVC or in cases of worsening of left ventricular function. Idiopathic ventricular tachycardia (VT) is mostly found in patients with a structurally healthy heart. These PVC/VT usually have a focal origin. The most likely mechanism is delayed post-depolarization. Localization of the origin is based on the creation of an activation map with or without combination of pace mapping. Idiopathic PVC/VT are most frequently located on the outflow tracts of the right and left ventricles, including the aortic root. Other typical locations include the annulus of the tricuspid or mitral valve, papillary muscles and Purkinje fibers. Catheter ablation is an alternative to antiarrhythmic medication in symptomatic monomorphic PVC/VT. The success rate is good whereby mapping and ablation can often represent a challenge. This article is the fifth part of a series dedicated to specific advanced training in the field of special rhythmology and invasive electrophysiology. It describes the pathophysiological principles, types and typical findings that can be obtained during an electrophysiological investigation.

Aims There is no objective, early indicator of occlusion quality, and efficacy of cryoballoon pulmonary vein isolation. As previous experience suggests that the initial cooling rate correlates with these parameters, we investigated the slope of the initial temperature drop as an objective measure. Methods and results A systematic evaluation of 523 cryoapplications in 105 patients using a serial ROC-AUC analysis was performed. We found the slope of a linear regression of the temperature–time function to be a good predictor (PPV 0.9, specificity 0.72, sensitivity 0.71, and ROC-AUC 0.75) of acute isolation. It also correlated with nadir temperatures ( P < 0.001, adjusted R 2= 0.43), predicted very low nadir temperatures, and varied according to visual occlusion grades (ANOVA P < 0.001). Conclusions About 25 s after freeze initiation, the temperature–time slope predicts important key characteristics of a cryoablation, such as nadir temperature. The slope is the only reported predictor to actually precede acute isolation and thus to support decisions about pull-down manoeuvres or aborting a cryoablation early on. It is also predictive of very low nadir temperatures and phrenic nerve palsy and thus may add to patient safety.

Background Although radiofrequency (RF) ablation has long been the standard of care for atrial fibrillation (AF) ablation, cryoballoon technology has emerged as a feasible approach with promising results. Prospective multicenter registry data referring to both ablation technologies in AF ablation are lacking so far. Objective The purpose of this study was to report data from the German ablation registry with respect to efficacy and safety in pulmonary vein ablation with different energy sources for paroxysmal AF after 1-year follow-up. Methods A total of 2306 patients with symptomatic paroxysmal AF from the German ablation registry were included in this analysis. The cohort was divided into two groups according to the ablation energy source used: cryoballoon and RF ablation. MACCE was defined as a combination of death, myocardial infarction, or stroke. Results AF recurrence rate after a single ablation procedure at 1 year follow-up was not significantly different between the two groups (45.8% after cryoablation and 45.4% after RF ablation, P = .87). Also, the rate of patients without AF recurrence and free of antiarrhythmic drug at 12-month follow-up was similar (cryoablation 44.2% and RF 41.4%, P = .25). MACCE occurred with an incidence of 0.7% within 500 days after cryoablation and 1.4% after RF ablation ( P = .30). Persistent phrenic nerve palsy was more common after cryoablation compared to RF ablation (1.1% vs 0.3%, P Conclusion AF recurrence rate at 1-year follow-up was similar in RF ablation compared to cryoablation, whereas the spectrum and relevance of complications were significantly different between the two ablation methods. This finding might influence the choice of ablation method offered to the individual paroxysmal AF patient.

Lesion formation is a critical determinant of technical and clinical success of pulmonary vein isolation. Different catheter designs aim to enhance tissue contact during ablation to enable optimized lesion formation. We analyzed procedural characteristics and predictors of clinical success in patients ablated with three different contemporary ablation catheters. Two hundred sixty-eight sequentially included patients receiving pulmonary vein isolation (PVI) with conventional (n = 122), contact-force (n = 96) and flexible-tip (n = 60) catheters were followed for a median of 14.1 months with 7d-Holter-monitoring and TTE at 3, 6, 12, and 24 months. Baseline characteristics and follow-up times were homogeneous across all groups. Multivariable Cox proportional hazard regression for arrhythmia recurrence demonstrated a favorable hazard ratio for contact-force and flexible-tip catheters vs. conventional open irrigation catheters. Procedure time and fluoroscopy time were shorter for contact-force and flexible-tip catheters versus conventional catheters, but equal between. Linear lesions were applied in 58 % of contact-force and 66 % of flexible-tip cases, and CFAEs were targeted in 26 % of either. Our non-randomized prospectively collected data do not show a difference in observed procedure characteristics and in clinical outcome for flexible-tip versus contact-force catheter designs, while both display improved performance against conventional open irrigated-tip catheters. Linear lesions and CFAEs ablation were not associated with improved arrhythmia-free survival.

Vorhofflattern ist die haufigste atriale Makro-Reentry-Tachykardie. Die altersabhangige Inzidenz von Vorhofflattern verschiedener Atiologie steigt von 5/100.000 (< 50 Jahre) bis zu etwa 600/100.000 bei uber 80-Jahrigen.

CardioInsight™ is a noninvasive three-dimensional mapping system technology which offers a unique method for arrhythmia characterization and localization. With a 252-lead ECG vest on the patient's torso and a noncontrast CT scan, epicardial potentials are detected and by means of reconstruction algorithms activation and phase maps are created, offering a deeper understanding of localization and mechanisms of arrhythmias including atrial fibrillation without the need for an endocardial catheter.The system has proven to be accurate and applicable in the clinical setting of accessory pathways, premature ventricular contractions (PVC), atrial tachycardias and atrial fibrillation. Beat-to-beat analysis offers detection and thus a therapeutic approach for arrhythmias which occur only paroxysmally such as supraventricular extrasystoles, atrial bursts or PVCs. Another advantage is the simultaneous display of various heart chambers such as the left and right atrium. However, major multicenter prospective randomized data are still lacking.If in the future noninvasive mapping could be achieved with MRI and if the technology was compatible with invasive mapping systems so that catheter positioning and noninvasive maps can be merged, the authors believe that this would represent a new dimension of mapping technology and ablation strategy of arrhythmias.

INTRODUCTION We analyzed the procedural experience and clinical outcome after pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (AF) gained over 5 years using the second-generation cryoballoon (CB-Adv). METHODS AND RESULTS For this retrospective study, we enrolled 281 patients undergoing PVI at our institution between 2012 and 2016. The analyzed period was divided into 5 calendar years. Follow-up data, including Holter electrocardiography recordings, were collected during outpatient clinic visits. The impact of several variables on outcome was evaluated by means of univariate and multivariate analyses and Cox proportional hazards regression models. The median procedure and fluoroscopy times over the years were 90 (72 of 114) and 15 (11 of 21) minutes, respectively. A continuous decline in complication rates and fluoroscopy and procedure times was observed in each subsequent year. During mid-term follow-up (33 [25 of 48] months), 178 (63.3%) patients were AF, atrial flutter, or atrial tachycardia free. Multivariate analysis revealed left atrial area (hazard ratio [HR] = 1.05; P

The AV nodal reentrant tachycardia (AVNRT) is one of the most common arrhythmias encountered in clinical practice. It is characterized by a constant heart rate and an on/off phenomenon. The clinical symptoms may include palpitations, anxiety, polyuria, and dyspnea. Typically, tachycardia may be disrupted by vagal maneuvers in many patients. First-line treatment of symptomatic AVNRT is radiofrequency ablation. The present article deals with the characteristics, differential diagnosis and treatment of AVNRT in the EP lab. It is the second part of a series of manuscripts which may facilitate further education in the specific field of electrophysiology.

Rapid Mapping and Ablation Using a Novel PlatformIntroduction A noninvasive 3D mapping technique (ECVUE™, CardioInsight Inc., Cleveland) maps the origin and mechanisms of various arrhythmias without catheterizing the heart. Methods Thirty-three patients (3 centers, mean 45.0 ± 14.6 years,) with symptomatic premature ventricular complexes (24 PVCs), focal atrial tachycardias (2 ATs), and manifest accessory pathways (7 WPW syndromes) were prospectively explored using 3D, noninvasive bedside electrocardiomapping. The location of origin of the focal arrhythmia was first determined using noninvasive mapping. Subsequently, a stimulus artifact was delivered at this site to confirm and evaluate the precise location of the mapped focal origin. The procedural parameters and clinical efficacy were studied. Results Ablation was successful in 32/33 (97%) patients (PVCs: 13 right, 10 left, 1 septal; WPW: 3 left, 3 right; ATs: 2 left) without complications. The time from catheterization to permanent arrhythmia elimination/termination, RF duration, skin-to-skin procedural duration, and fluoroscopic exposure were median 16, 3.98, 71, and 11.9 minutes (for n = 29), respectively. At mean 24.7 ± 3.7 months of follow-up, 31 patients remain arrhythmia-free after a single procedure. One patient (right WPW syndrome) required repeat ablation 1 month later. One patient had recurrence of PVCs and is now deceased. The cumulative radiation (CT scan and fluoroscopy) exposure was median 7.57 mSv. Conclusion ECVUETM is a noninvasive tool allowing rapid preprocedural localization of focal arrhythmia and enables the electrophysiologist with highly specific information to direct RF delivery at the source of the arrhythmia with minimal intracardiac mapping.

Aims In this observational study, we examine the significance of the left atrial (LA) surface area and compare the clinical usage of the Arctic Front Advance (CBA) versus Arctic Front (CB) cryoballoon with the intent to investigate the impact of each in terms of long-term freedom from atrial fibrillation (AF) for patients with nonvalvular AF. Methods Pulmonary vein isolation (PVI) was performed while using a cryoballoon ablation catheter in conjunction with an intraluminal circular diagnostic mapping catheter, Achieve. The consecutive patients ablated with CBA were matched with patients previously ablated with CB, using propensity score matching. The primary endpoint of this observational single-center retrospective study was the first observation of electrocardiogram-documented recurrence of atrial arrhythmias lasting >30 seconds. Results The patient demographic data were similar in the CBA- and CB-group (N = 188 patients each group). In all patients in the CBA-group and in 95% of the patients in the CB group, acute procedural PVI of all veins was achieved with the single usage of a 28-mm cryoballoon. The one-year freedom from atrial arrhythmias was significantly better in the CBA- versus the CB-group of patients, 90% versus 64%, respectively. During 15-month clinical follow-up in CBA group, patients with LA area above 23 cm2 were more likely to experience recurrence of AF (23%) than patients with LA area below 23 cm2 (7%). Conclusions Comparing one-year outcomes, the CBA is superior to the CB with regards to maintenance of normal sinus rhythm. When using the CBA catheter, an enlarged LA is associated with a higher recurrence of arrhythmia.

Background: Relation between pre-procedural selection of patients and the success rate after a single cryoballoon ablation (CAB) procedure is unknown. Methods: CAB was performed in 378 (65% male, median age 58 years, 85% paroxysmal atrial fibrillation [AF]) consecutive patients with symptomatic and drug refractory AF. The combined ALARMEc (Atrial fibrillation type, Left Atrium size, Renal insufficiency, Metabolic syndrome, cardiomyopathy) risk score was calculated for each individual patient. The end-point of the study was the first AF, atrial flutter or atrial tachycardia recurrence after the 3-month blanking period in the 1-year follow-up since the index procedure, in the absence of anti-arrhythmic (class I and III) therapy. Results: Single and multi-catheter approach was used in 79% and 21% of patients, respec­tively. The acute success rate with single and multi-catheter approach was 79% and 99%, respectively. The overall 1-year success rate after a single CAB procedure was 70%. The 1-year outcome was: 83%, 70%, 60%, 40% and 29% in patients with ALARMEc risk score: 0, 1, 2, 3 and 5, respectively. Total rate of complications was 11%, including transient phrenic nerve palsy in 9.5% of cases. Conclusions: Multi-catheter approach was needed in 21% of patients to achieve acute pulmo­nary vein isolation. Patients with low (≤ 1) ALARMEc risk score, preferably young individuals with sole paroxysmal AF (ALARMEc = 0), are best candidates for CBA procedure. Performing CBA in patients with higher (> 2) ALARMEc risk score should be avoided. Phrenic nerve palsy was a transient complication.

This study provides an update and comparison to a 2010 nationwide survey on cardiac electrophysiology (EP), types and numbers of interventional electrophysiological procedures, and training opportunities in 2015.In 2010, German cardiology centers performing interventional EP were identified and contacted to provide a survey on cardiac EP.German cardiology centers performing interventional EP in 2015 were identified from quality reports and contacted to repeat the 2010 questionnaire.A majority of 131 centers (57%) responded. EP (ablation procedures and device therapy) was mainly part of a cardiology department (89%) and only independent (with its own budget) in 11%. The proportion of female physicians in EP training increased from 26% in 2010 to 38% in 2015. In total, 49,356 catheter ablations (i.e., 81% of reported ablations in 2015) were performed by the responding centers, resulting in a 44% increase compared with 2010 (the median number increased from 180 to 297 per center). Atrial fibrillation (AF) was the most common arrhythmia interventionally treated (47%). At 66% of the centers, (at least) 2 physicians were present during most catheter ablations. A minimum of 50 (75) AF ablations were performed at 80% (70%) of the centers. Pulmonary vein isolation with radiofrequency point-by-point ablation (62%) and cryoablation (33%) were the preferred ablation strategies. About one-third of centers reported surgical AF ablations, with 11 centers (8%) performing stand-alone surgical AF ablations. Only one-third of the responding 131 centers fulfilled all requirements for training center accreditation.Comparing 2010 with 2015, an increasing number of EP centers and procedures in Germany are registered. In 2015, almost every second ablation was for therapy for AF. Thus, an increasing demand for catheter ablation is likely, but training opportunities are still limited, and most centers do not fulfil recommended requirements for ablation centers.

Sequence variants in the ion channel genes KCNH2 and SCN5A may cause the cardiac disorder long QT syndrome (LQTS). This disorder is associated with incomplete penetrance and variable expression in KCNH2- or SCN5A-mutation carriers. Common genetic variants, if associated with a mutation, may affect the severity of this cardiac disorder. This study identified rare mutations in the cardiac ion channel genes KCNH2 and SCN5A in a SCD case, as well as in a LQTS-affected family with a history of SCD. Moreover, common variants were found to occur together within the same genes. These findings support the concept that common single-nucleotide polymorphisms (SNPs) in genes encoding cardiac ion channels can directly modulate the functional effect of mutations and therefore enhance or weaken the risk of cardiac events.

Introduction Antiarrhythmic drug (AAD) therapy of patients with atrial fibrillation (AF) has limitations. We investigated the 2-year outcome and pre-procedural predictors of recurrence for first-line catheter ablation using the second-generation cryoballoon (CB-Adv) in a large cohort of patients with symptomatic AF. Methods and results For this prospective observational study, we enrolled 457 patients with symptomatic AF (278 paroxysmal, 179 persistent) who had no history of AAD use and who underwent pulmonary vein isolation (PVI) with the CB-Adv at our institution. Follow-up data, including Holter-ECGs, were collected during outpatient clinic visits. The impact of several variables on outcome was evaluated in univariate and multivariate analyses and Cox proportional hazards regression models. Median follow-up duration was 28 (interquartile range 15/42) months. PVI was sufficient in restoring and maintaining sinus rhythm in 79.2% ( n =362) of patients. The median procedure and fluoroscopy times were 90 (72/120) and 16 (12/21) min, respectively. Phrenic nerve injury occurred in 16 (3.5%) patients, persisting until hospital discharge in 6 (1.3%) patients; phrenic nerve function recovered in all patients during follow-up. Seven patients developed groin hematomas (1.5%). Cox regression analysis showed that left atrial area >21cm 2 independently predicted recurrence. Conclusion This is the first demonstration that PVI with CB-Adv is safe and effective as a first-line treatment of symptomatic AF. Sinus rhythm persisted in 79.2% of patients even 2years after ablation. The success rate was lower in patients with enlarged left atria.

Aims Predictors of atrial arrhythmia recurrence have not been described in a long-term follow-up study of patients undergoing pulmonary vein isolation (PVI) using the cryoballoon technique. We aimed to evaluate the efficacy of a second-generation cryoballoon and identify pre-procedural predictors of 3-year outcome after PVI. Methods and results For this observational cohort study, we enrolled 440 patients ablated at our institution with a second-generation cryoballoon. The endpoint was the first documented recurrence (>30 s) of atrial fibrillation (AF), atrial flutter, or atrial tachycardia after a 3-month blanking period. The impact of several pre-existing variables on clinical outcome was evaluated by univariate and multivariate analyses using the Cox proportional hazards regression model. The PLAAF (persistent AF, left atrial area, abnormal PV anatomy, AF history, female gender) score was defined to predict outcome. After a median follow-up of 36 months (interquartile range 25/75-27/42), the endpoint was achieved in 95 of 440 (21.6%) patients. Cox regression analysis showed that persistent AF, left atrial (LA) area, abnormal PV anatomy, AF history, and female gender independently predicted recurrence. The calculated optimal cut-offs for LA area and AF history were 21 cm2 and 3 years, respectively. Patients with a PLAAF score of 0 showed the best outcome, with an arrhythmia-free survival of 86.7%. Conclusion PVI using the cryoballoon technique shows acceptable long-term results depending on predictors described by the new PLAAF score, which may facilitate patient selection for PVI.

The aim of this observational study was to compare the postprocedural incidence of bleeding and thromboembolic complications associated with novel oral anticoagulants (NOACs) with that of interrupted and continuous phenprocoumon after pulmonary vein isolation (PVI) using a purse-string suture (PSS) closure of the puncture site.Consecutive patients who had undergone PVI via cryoballoon ablation were divided into the following groups: (1) interrupted phenprocoumon with heparin bridging (n=101), (2) continuous phenprocoumon targeting an internationally normalized ratio2 (n=70), and (3) NOACs without bridging that were restarted 2-4h after the procedure (n=185). Protamine was not administered after venous closure with PSS at the end of the procedure. The total complication rate was significantly lower in group 3 than in groups 1 and 2 (1.62% vs. 6.93% vs. 7.14%, p=0.04). The hospital costs were lower and the hospital stay length was significantly shorter (4484±3742 vs. 6082±4044 Euro vs. 4908±2925, p=0.03; 1.94±1.67 vs. 2.70±1.80 vs. 2.19±1.30days, p0.01). No thromboembolic event occurred. Vascular complications were the most common complications noted (80%). The occurrence of any complication led to a significantly longer hospital stay (5 vs. 2days, p0.01) and higher costs (10,052±6241 Euro vs. 4747±3447, p0.01). The vascular complication rate after PSS was independent of intraprocedural heparin dosage and activated clotting time.NOACs have a lower complication rate and appear to be safer in this setting than phenprocoumon. The hospital costs and hospital stay length after PVI was significantly reduced in patients treated with NOACs compared with phenprocoumon.