Search

BACKGROUND: The second-generation cryoballoon ablation (CB-A) has been proven to be safe and effective for pulmonary vein (PV) isolation. Little is known regarding the long-term outcome following CB-A ablation for paroxysmal atrial fibrillation (AF). The aim of the study was to evaluate the freedom from atrial arrhythmias during a 5-year follow-up period among consecutive patients having undergone PV isolation with the CB-A for paroxysmal AF METHODS AND RESULTS: A total of 208 consecutive patients having undergone index PV isolation using CB-A (138 males, 66%; mean age 59.0 ± 12.6 years) were included in our retrospective analysis. Follow-up was based on outpatient clinic visits including Holter electrocardiograms. Recurrence of atrial tachyarrhythmias was defined as a symptomatic or documented episode of > 30 s. At a median follow-up of 62 months, freedom from atrial arrhythmias after a single procedure was achieved in 57.2% of patients. Multivariate analysis demonstrated that obesity, left atrial diameter, and duration of symptoms before AF ablation were independent predictors of ATas recurrences. Major complications occurred in 2.4% of patients. CONCLUSIONS: The present study found a 5-year single-procedure success rate of 57.2% following CB-A ablation procedure. Obesity, higher LA dimensions, and longer duration of symptoms before ablation independently predicted the outcome.

Data indicate that the second-generation cryoballoon (Arctic Front Advance, Medtronic, Minnesota, USA) could be effective for persistent atrial fibrillation. However, electrophysiological findings and the midterm clinical outcome of repeat procedures following second-generation cryoballoon ablation are lacking. Consecutive patients with drug-resistant persistent atrial fibrillation who underwent a repeat ablation due to arrhythmia recurrence following an index procedure with second-generation cryoballoon were retrospectively included in our analysis. A total of 24 patients were included. Twenty underwent repeat procedures because of atrial fibrillation or left atrial arrhythmias and four because of typical atrial flutter. Mean time to recurrence of atrial tachyarrhythmias was 6.6 ± 3 months. Mean redo procedural time was 122 ± 23 min. At a mean follow-up of 11.8 ± 6.5 months, 15 patients (75 %) did not experience recurrence of atrial arrhythmias. Of the five patients (25 %) who had recurrence of atrial tachyarrhythmia, four presented with persistent atrial fibrillation and one with a mitral isthmus-dependent flutter. Of note is that the four patients with typical flutter were free from atrial tachycardia recurrence after the redo procedure. Two patients (9 %) underwent a third procedure. Mean time to recurrence of atrial arrhythmias from the repeat procedure was 9 ± 1 months. Our findings show that repeat ablation procedures following a second-generation cryoballoon ablation for persistent atrial fibrillation result in 75 % of freedom from any atrial tachycardia at 12 months follow-up. Of the recurrences, 63 % were due to new onset of atrial fibrillation and 37 % to organized tachycardias.

INTRODUCTION: The aim of the EuReCa ONE study was to determine the incidence, process, and outcome for out of hospital cardiac arrest (OHCA) throughout Europe.METHODS: This was an international, pr ...

BACKGROUND: The creation of a posterior box isolation of the left atrium (LAPWI) in addition to pulmonary vein isolation (PVI) with the second-generation cryoballoon (CB-A) seems to offer promising clinical outcome in patients affected by persistent atrial fibrillation (PersAF). AIM: This work aims to study the clinical outcome of an ablation strategy based on the creation of a LAPWI during repeat procedures for recurrent AF after an index CB-A procedure for PersAF. METHODS AND RESULTS: A total of 33 patients having undergone a repeat procedure consisting in redo PVI plus LAPWI for recurrent PersAF with the CB-A after an index PVI ablation were retrospective included in our study. Electrical reconnection could be documented in 18 veins (13%). The LAPW was successfully isolated solely by CB-A ablation in 30 out of 33 (91%) patients; in the remaining 3 patients, isolation of the LAPW was completed by focal tip-irrigated RF ablation. The mean number of CB-A applications required for the superior portion of theLAPW and the inferior portion of the LAPW creation were 5.4 ± 0.9 and 4 ± 0.6, respectively. After a mean follow-up of 11.8 ± 3 months, 28 patients (85%) did not experience recurrence of any atrial arrhythmias during follow-up, without the need of further ablation or class I or III AADs. CONCLUSION: Left posterior wall isolation with the CB-A is feasible and safe during repeat ablation procedures for recurrent PersAF. In our study, the 12-month freedom from any arrhythmia was 85% following this ablation strategy.

Background Early repolarization patterns (ERP) have been found to be associated with poor cardiovascular end points. We aimed to evaluate the ERP prevalence among patients with structurally normal hearts undergoing radiofrequency (RF) pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF) ablation and its association with the AF recurrence. Methods All consecutive patients who underwent RF-PVI as index procedure for paroxysmal AF in our center were evaluated. Exclusion criteria: structural heart disease, ongoing use of Class I/III antiarrhythmics, complete-bundle-branch-block. Lateral (I, aVL, V-5-V-6), inferior (II, III, aVF), or infero-lateral (both) ERP were defined in baseline ECG as horizontal/downsloping J-point elevation >= 1 mm in two consecutive leads with QRS slurring/notching. Documented episodes of AF lasting >= 30 s were considered recurrence. Results Of 701 cases, 434 patients (305 males, 58 +/- 11 years) were included for analysis. ERP observed in 67 patients (15.4%) (Infero-lateral n = 26, inferior n = 23, lateral n = 18) which were significantly younger, demonstrating longer PR-interval and lower heart rates. At a mean follow-up of 22.1 +/- 9.7 months, AF recurrences were found in 107 patients (24.6%). In middle-aged patients (>= 40-n = 206, 79% male), those with an infero-lateral ERP had higher recurrence compared with the ones without (56.3% vs. 19%; p = 0.002). Infero-lateral ERP was significantly predicting recurrence (HR 2.42, 95% CI 1.21-4.82; p = 0.01). Conclusion Early repolarization patterns was more prevalent in our AF population than in the general population. Infero-lateral ERP in baseline ECG might predict AF recurrence in the follow-up after RF-PVI in middle-aged patients.

Lessons Learned from the Hybrid Redo ProceduresIntroduction In order to increase success rates of invasive treatment of persistent atrial fibrillation, the hybrid approach was developed, combining video-assisted thoracoscopic epicardial procedure with conventional endocardial catheter ablation. Currently, there are no reports of electrophysiological findings and clinical outcomes of repeat procedures after the hybrid approach. Methods and Results Out of 64 patients who were treated by hybrid ablation for persistent atrial fibrillation (AF), 14 underwent the repeat catheter ablation and were selected for this study. All 14 patients initially presented with longstanding persistent atrial fibrillation and markedly dilated atria. The hybrid procedure was performed in a single act and the mean time to redo procedure was 346 ± 227 days. In 57% of patients indication for redo procedure was regular atrial tachycardia, and the rest presented with recurrent atrial fibrillation. In 36% of patients, recovered conduction was found along the previous ablation lesions. Only 9% of pulmonary veins were reconnected (0.36 veins per patient) and 7% of box lesions were not complete. The overall success rate at 2 years follow-up after the repeat procedure, including second repeat procedure and patients taking antiarrhythmic drugs, was 64% (57% without drugs and further ablation). One case of moderate pulmonary vein stenosis was detected as a consequence of hybrid procedure. Conclusion Hybrid atrial fibrillation ablation results in durable lesions and high rates of chronic pulmonary vein isolation even after long-term follow-up. Most of the repeat procedures after the hybrid approach are related to left atrial flutters that could be successfully treated by catheter ablation.

AIMS: Real Time Recordings (RTR) of pulmonary vein (PV) activity provide important information in the setting of the 2nd generation Cryoballoon (CB-A), as a funcion of time to isolation. Visualization of RTR with the standard inner lumen mapping catheter (ILMC) 20mm Achieve (AC) is possible in roughly 50% of PVs. A novel 25mm-Achieve Advance (AC-A) has been developed with the aim of increasing the detection of RTR. The purpose of this study is to compare the AC-A with the AC, to feasibility and improvement of RTR. METHODS: We assigned 50 patients with paroxysmal or persistent atrial fibrillation to CB-A PVI, using the AC-A as ILMC. We compared this group with 50 patients, matched for age and left atrial volume, who previously underwent the CB-A PVI using the AC. RESULTS: RTR were more frequently observed with the AC-A than with the AC (74% vs 49%; p= 0.02). RTR in the left superior PVs was similar in both groups (74% vs 72%, p= 0.8). RTR with the AC-A were equally appreciated in left or right sided, superior or inferior PVs. No significant differences were found in terms of feasibility, procedure fluoroscopy and freezing times, nadir temperatures, and acute PVI. CONCLUSIONS: CB-A PVI with the AC-A is feasible and safe in all PVs. The AC-A has proven significantly superior in visualising RTR if compared to the AC, affording RTR in 74% of PVs., Aims: Real Time Recordings (RTR) of pulmonary vein (PV) activity provide important information in the setting of the 2nd generation Cryoballoon (CB-A), as a funcion of time to isolation. Visualization of RTR with the standard inner lumen mapping catheter (ILMC) 20mm Achieve (AC) is possible in roughly 50% of PVs. A novel 25mm-Achieve Advance (AC-A) has been developed with the aim of increasing the detection of RTR. The purpose of this study is to compare the AC-A with the AC, to feasibility and improvement of RTR. Methods: We assigned 50 patients with paroxysmal or persistent atrial fibrillation to CB-A PVI, using the AC-A as ILMC. We compared this group with 50 patients, matched for age and left atrial volume, who previously underwent the CB-A PVI using the AC. Results: RTR were more frequently observed with the AC-A than with the AC (74% vs 49%; p= 0.02). RTR in the left superior PVs was similar in both groups (74% vs 72%, p= 0.8). RTR with the AC-A were equally appreciated in left or right sided, superior or inferior PVs. No significant differences were found in terms of feasibility, procedure fluoroscopy and freezing times, nadir temperatures, and acute PVI. Conclusions: CB-A PVI with the AC-A is feasible and safe in all PVs. The AC-A has proven significantly superior in visualising RTR if compared to the AC, affording RTR in 74% of PVs.

AIMS: To study the learning curve with the second-generation cryoballoon technology focusing on safety, efficacy and procedural characteristics. METHODS: We included 300 patients (men 64.6%, mean age 58.3 ± 12.4 years), 240 of whom were treated by four operators without prior experience in atrial fibrillation ablation and compared them with 60 consecutive patients treated by senior operator. To study the learning curves, we divided the study period into two trimesters and analyzed procedure duration, fluoroscopy times, complications, characteristics of the freeze-thaw cycles and midterm outcomes. RESULTS: Hands-on help from senior operators to achieve pulmonary vein isolation was needed only in the first study trimester (24.1%), most commonly to achieve right inferior pulmonary vein isolation (55.2%). The mean procedure duration shortened from 76.7 ± 17.4 to 65.1 ± 11.4 min (P

Propofol is an anesthetic drug with a very attractive pharmacokinetic profile, which makes it the induction agent of choice, especially in day-case surgery. Data on its potential proarrhythmic effects in patients with Brugada syndrome (BS) patients are still lacking. The aim of our study was to investigate whether a single dose of propofol triggered any adverse events in consecutive high-risk patients with BS.

BACKGROUND: The third-generation Cryoballoon Advance Short-tip (CB-ST) has been designed with a 40 % shortened tip length compared with the former second generation CB advance device (CB-A). Ideally, a shorter tip should permit an improved visualisation of real-time recordings in the pulmonary vein (PV) due to a more proximal positioning of the inner lumen mapping catheter. We sought to compare the incidence of visualisation of real-time recordings in patients having undergone ablation with the CB-ST with patients having received CB-A ablation. METHODS: All patients having undergone CB ablation using CB-ST technology and the last 500 consecutive patients having undergone CB-A ablation were analysed. Exclusion criteria were the presence of an intracavitary thrombus, uncontrolled heart failure, moderate or severe valvular disease, and contraindications to general anaesthesia. RESULTS: A total of 600 consecutive patients (58.1 ± 12.9 years, 64 % males) were evaluated (100 CB-ST and 500 CB-A ablations). Real-time recordings were significantly more prevalent in the CB-ST population compared with CB-A group (85.7 vs 67.2 %, p

AIMS: The third-generation Cryoballoon Advance Short-tip (CB-ST) has been designed with a 40% shortened tip length compared with the former second-generation CB Advance device. Ideally, a shorter tip should permit an improved visualization of real-time (RT) recordings in the pulmonary vein (PV) due to a more proximal positioning of the inner lumen mapping catheter. In the present study, we sought to analyse the rate of visualization of RT recordings in our first series of patients with the CB-ST device. METHODS AND RESULTS: All consecutive patients having undergone CB ablation using CB-ST technology were analysed. Exclusion criteria were the presence of an intracavitary thrombus, uncontrolled heart failure, moderate or severe valvular disease, and contraindications to general anaesthesia. A total of 60 consecutive patients (60.5 ± 11.2 years, 62% males) were evaluated. Real-time recordings were detected in 209 of 240 PVs (87.1%). Specifically, RT recordings could be visualized in 55 left superior PVs (91.7%), 51 left inferior PVs (85.0%), 53 right superior PVs (88.3%), and 50 right inferior PVs (83.3). CONCLUSION: The rate of visualization of RT recordings is significantly high during third-generation CB-ST ablation. Real-time recordings can be visualized in ∼87.1% of veins with this novel cryoballoon.

Aim The second-generation cryoballoon (CB-Adv) is effective in achieving pulmonary vein isolation (PVI) with encouraging results. In this study, we assessed the single-procedure outcome on a 1-year follow-up period in a large sample of patients having undergone PVI for drug-resistant atrial fibrillation (AF) using the CB-Adv. Methods and Results A total of 393 patients (122 female, 31%; mean age 57.7 ± 12.9 years) with drug-refractory AF undergoing PVI using the novel CB-Adv were enrolled. Follow-up was based on outpatient clinic visits including Holter electrocardiograms. Recurrence of atrial tachyarrhythmias (ATas) was defined as a symptomatic or documented episode >30 s. A total of 1572 pulmonary veins (PVs) were identified and successfully isolated with 1.2 ± 0.3 mean freezes. Mean procedure and fluoroscopy times were 87.1 ± 38.2 and 14.9 ± 6.1 min, respectively. At a mean follow-up of 12 months, freedom from ATas after a single procedure was achieved in 85.8% of patients with paroxysmal atrial fibrillation and in 61.3% of patients with persistent AF (persAF). Similar success rates were observed between bonus freeze and single freeze strategies, 82.5 and 81.8%, respectively ( P = 0.9). Multivariate analysis demonstrated that persAF ( P = 0.04) and relapses during blanking period (BP) ( P < 0.0001) were independent predictors of ATas recurrences. Conclusion Freedom from any ATa can be achieved in 81.9% of patients after a single CB-Adv procedure in a large cohort of patients. A bonus freeze does not influence the clinical outcome, and reducing the duration of the cryoapplication to 3 min offers excellent results. Persistent AF and arrhythmia recurrence during the BP are strong predictors of AF recurrence.

PURPOSE: Our aim was to analyse the temperature behaviour during second-generation cryoballoon ablation (CB-A) in patients with ongoing atrial fibrillation (AF) compared with those in sinus rhythm (SR). METHODS: Consecutive patients with drug-resistant AF who underwent pulmonary vein (PV) isolation by CB-A from April 2014 to May 2015 were analysed. The exclusion criteria were any contraindication for the procedure including the presence of an intracavitary thrombus, uncontrolled heart failure, contraindications to general anaesthesia and cardioversion to SR during the ablation procedure. RESULTS: A total amount of 323 consecutive patients having undergone PV isolation by means of CB-A (male 66 %, age 56.1 ± 13.4 years) was enrolled. During ablation in the left-sided PVs, time needed to reach -20°, -30° and -40° was significantly shorter in patients with AF than those in SR. During ablation in the right superior pulmonary vein (RSPV), time to reach -30° and -40° was also significantly longer in patients withAF; during ablation in the right inferior pulmonary vein (RIPV), although the temperature drop was faster in the AF group, times needed to reach -20°, -30° and -40° were not significantly prolonged compared with those in the SR group. Temperatures attained at 60 s, and minimal temperatures were also significantly lower in the AF group during all PV ablations except RIPV. CONCLUSIONS: The temperature drop during AF cryoablation was significantly faster and attained significantly lower freezing degrees in patients with ongoing AF during the procedure compared with those in SR. This finding resulted markedly significant during each PV isolation except for RIPV cryoablation.

An editorial written by Fritz Stertz et al. in 2002 and pubished in this journal was one of the first to highlight concerns bout the introduction of a new European Union (EU) clinical trils directive (Clinical Trials Directive 2001/20/EC) particularly for esearch in emergency settings.1 The directive sought “to simplify nd harmonize the administrative provisions governing clinical rials in the European Community, by establishing a clear, transarent procedure for conducting studies involving investigational edicinal products”. It is widely acknowledged that the Directive rought inunnecessary administrative and regulatoryburdens. The nflexibility of the Directive led to individual countries creating ocal legislation in an attempt to facilitate emergency research, hich increasedvariationbetweencountries, andaddeddelays and ncreased costs for researchers.2 A group of clinicians, ethicists and awyers (the ‘Vienna Initiative to save European Research’ (VISEAR) nvestigators) produced a consensus document to promote a unied approach to local legislation,3 although the recommendations ere never fully implemented. The EU announced its intent to revise the Clinical Trials Direcive 2001/20/EC in July 2012.4 The consultation paper draws pecific attention to research in patients without capacity statng: “Regarding clinical trials in emergency situations, Directive 001/20/EC does so far not address the specific situation where, ecause of the urgency of the situation, it is impossible to obtain ree and informed consent from the subject or the legal repreentative (‘clinical trials in emergency situations’). To address this, pecific provisions on clinical trials in emergency situations have een added in linewith existing international guidance documents n this issue.”