[Lead extraction in cardiac implantable electronic devices]. / Sondenextraktionen bei implantierbaren kardialen Devices.

Lead extraction due to infection or lead dysfunction has become more important in recent years. Patients with high risk of severe and life-threatening complications should only undergo surgery in experienced centers where appropriate personnel and equipment are available. In this review, different techniques and methods to safely and successfully perform transvenous lead extraction are summarized.

Electrophysiology lab efficiency comparison between cryoballoon and point-by-point radiofrequency ablation: a German sub-analysis of the FREEZE Cohort study.

BACKGROUND: Pulmonary vein isolation (PVI) is recommended to treat paroxysmal and persistent atrial fibrillation (AF). This analysis aimed to assess the hospital efficiency of single-shot cryoballoon ablation (CBA) and point-by-point radiofrequency ablation (RFA). METHODS: The discrete event simulation used PVI procedure times from the FREEZE Cohort study to establish the electrophysiology (EP) lab occupancy time. 1000 EP lab days were simulated according to an illustrative German hospital, including 3 PVI cases per day using CBA at one site and RFA at the other. RESULTS: The analysis included 1560 CBA patients and 1344 RFA patients from the FREEZE Cohort. Some baseline patients' characteristics were different between groups (age, AF type, and some concomitant diseases), without being statistically associated to ablation procedure time. Mean procedure time was 122.2 ± 39.4 min for CBA and 160.3 ± 53.5 min for RFA (p < 0.0001). RFA was associated with a more than five-fold increase of cumulative overtime compared to CBA over the simulated period (1285 h with RFA and 253 h with CBA). 70.7% of RFA lab days included overtime versus 25.7% for CBA. CBA was associated with more days with an additional hour at the end of the EP lab shift compared to RFA (47.8% vs 11.5% days with one hour left, respectively). CONCLUSION: CBA is faster and more predictable than point-by-point RFA, and enables improvements in EP lab efficiency, including: fewer cumulative overtime hours, more days where overtime is avoided and more days with remaining time for the staff or for any EP lab usage. Clinical trial registration NCT01360008 (first registration 25/05/2011).

Novel cryoballoon ablation system for pulmonary vein isolation: multicenter assessment of efficacy and safety-ANTARCTICA study.

AIMS: Pulmonary vein isolation (PVI) either by balloon devices or radiofrequency forms the cornerstone of invasive atrial fibrillation (AF) treatment. Although equally effective cryoballoon (CB)-based PVI offers shorter procedure duration and a better safety profile. Beside the worldwide established Arctic Front Advance system, a novel CB device, POLARx, was recently introduced. This CB incorporates unique features, which may translate into improved efficacy and safety. However, multicentre assessment of periprocedural efficacy and safety is lacking up to date. METHODS AND RESULTS: A total of 317 patients with paroxysmal or persistent AF were included and underwent POLARx CB-based PVI in 6 centres from Germany and Italy. Acute efficacy and safety were assessed in this prospective multicenter observational study. In 317 patients [mean age: 64 ± 12 years, 209 of 317 (66%) paroxysmal AF], a total of 1256 pulmonary veins (PVs) were identified and 1252 (99,7%) PVs were successfully isolated utilizing mainly the short tip POLARx CB (82%). The mean minimal CB temperature was -57.9 ± 7°C. Real-time PVI was registered in 72% of PVs. The rate of serious adverse events was 6.0% which was significantly reduced after a learning curve of 25 cases (9.3% vs. 3.0%, P = 0.018). The rate of recurrence-free survival after mean follow-up of 226 ± 115 days including a 90-day blanking period was 86.1%. CONCLUSION: In this large multicentre assessment, the novel POLARx CB shows a promising efficacy and safety profile after a short learning curve.

Stand-alone Focal Impulse and Rotor Modulation (FIRM) ablation versus second-generation cryoballoon pulmonary vein isolation for paroxysmal atrial fibrillation.

INTRODUCTION: Focal Impulse and Rotor Modulation (FIRM) guided catheter ablation aiming at stable rotors has been investigated as a treatment option in patients with atrial fibrillation (AF). The objective of this study was to compare the safety and efficacy of FIRM-guided ablation with second-generation cryoballoon pulmonary vein isolation (CB2-PVI) in paroxysmal AF. METHODS: Consecutive patients (n = 22, mean age 60 ± 11 years, 59.1% of males) who were treated with a stand-alone FIRM-guided ablation were included in this retrospective single-center study. Procedural data and arrhythmia-free survival at 12 months were compared with n = 86 consecutive patients (mean age 62 ± 13 years, 62.4% of males) who received de-novo CB2-PVI. RESULTS: Median procedure duration was significantly longer in the FIRM group than in the CB2-PVI group (152 [IQR 120-176] minutes vs. 122 [110-145] minutes; p = .031). One patient (1.2%) in the CB2-PVI group and five patients (22.7%) in the FIRM group had vascular access complications. Atrial tachyarrhythmias recurred in 15 patients in the FIRM group and 11 in the CB2-PVI group. Kaplan-Meier estimation of single-procedure arrhythmia-free survival at 12 months was 25% (95% confidence interval [CI] 6%-44%) in the FIRM group and 87% (95% CI 78%-96%) in the CB2-PVI group (p < .001). Repeat ablations were performed in 14/20 (70.0%) patients in the FIRM group and in 12/85 (14.1%) in the CB2-PVI group (p < .001). CONCLUSION: De novo ablation of AF using FIRM-guided AF ablation results in shorter arrhythmia-free survival after 12 months compared to CB2-PVI and a need for repeat ablation in the majority of patients to achieve stable sinus rhythm.

[Practical guide for safe and efficient cryoballoon ablation for atrial fibrillation : Practical procedure, tips and tricks]. / Leitfaden zur sicheren und effizienten Kryoballon-Vorhofflimmerablation : Praktisches Vorgehen, Tipps und Tricks.

In the current guidelines on treatment of atrial fibrillation, cryoballoon-based catheter ablation of atrial fibrillation is recommended in addition to radiofrequency ablation and has become established as a standard procedure in the clinical routine of many centers for index pulmonary vein isolation. A safe, simplified and often durable pulmonary vein isolation can be achieved by a systematic approach. This review article provides a practical guide for all steps of cryoballoon-based pulmonary vein isolation, including preprocedural preparation and postinterventional follow-up. Both cryoballoon systems currently available on the market are considered.

Stroke and left atrial thrombi after cryoballoon ablation of atrial fibrillation: incidence and predictors. Results from a long-term follow-up.

Stroke after catheter ablation (CA) of atrial fibrillation (AF) is a potential complication with long term consequences. Aim of this study was to determine incidence and potential predictors of stroke and left atrial appendage (LAA) thrombi after AF ablation with cryo-energy. Two hundred nine consecutive patients with symptomatic drug refractory AF (65% male; 61 ± 11 yo, 69% paroxysmal AF, mean CHA2DS2-VASc score 2 ± 1.4) were enrolled between October 2012 until December 2015. Long term follow-up was performed with outpatient clinic visits at 6-month intervals. Incidence of stroke after CA was 1.4% (3/209 pts) at long term follow-up. Two out of 3 pts experienced stroke during the first 3 month after CA and one after 36 months. At long term follow-up LAA thrombi were found in two patients (1%) that were on therapeutic oral anticoagulation. Recurrence of AF was found in 4 out of 5 pts with stroke or LAA thrombi. Patients with stroke or LAA thrombi did not differed from those without in term of age, gender, CV risk factors, LA size and AF type. They differed only for EHRA score (2.4 vs 1.3, p = 0.01) before CA. At multivariate analysis after correction for age, gender, LA size, LVEF and AF type, only EHRA score (ß 1.92, 95% C.I. 1.3-35 p = 0.02), was an independent predictor of stroke/LAA thrombi. Incidence of stroke after cryoablation is low, with a relative higher prevalence during the first 3 months after CA. Prospective, multicenter long-term registries are needed for a better stroke risk stratification.

Incidence of Significant Delayed Esophageal Temperature Drop After Cryoballoon-Based Pulmonary Vein Isolation.

BACKGROUND: The second-generation cryoballoon (CB2) has demonstrated superior clinical outcome. Potential procedural complications include esophageal thermal lesions due to excessive esophageal temperature (ET). Safety cut-offs for the ET have previously been published. A safety margin was incorporated due to a delayed esophageal temperature decline even after termination of the CB2 freeze cycle. The extent of these delayed temperature drops requires further systematic evaluation. METHODS AND RESULTS: The study enrolled 29 patients with paroxysmal or shortstanding persistent AF who underwent CB2-based PVI. Freeze cycle duration was 240 seconds. No bonus freeze was applied after successful PVI. The intraluminal ET was continuously measured via a transorally inserted probe (SensiTherm, St. Jude Medical, Inc.). The CB2 temperature and ET were recorded throughout the procedure using a camera setup. The mean number of freeze cycles per patient was 4.3 ± 2. A total of 147 cryoenergy applications were analyzed. A delayed decline in ET of >0.5 °C was recorded following termination of 23.1% of freeze cycles. The maximum drop in delayed ET was 6.4 °C. Excessive esophageal cooling during the freeze cycle exceeding 8.5 °C/min may result in ET ≤10 °C. CONCLUSIONS: Following termination of cryoenergy delivery, the ET may decline an additional 6.4 °C. Proposed ET safety cut-offs during CB2-based PVI need to account for a significant ET drop that may occur even after termination of the individual freeze cycle.

Ablation of atrial fibrillation in patients ≥75 years: long-term clinical outcome and safety.

AIMS: The prevalence of atrial fibrillation (AF) increases with age. Catheter ablation is an established treatment option for patients with symptomatic AF. We sought to determine the safety and long-term clinical efficacy of AF ablation in patients ≥75 years. METHODS AND RESULTS: Patients ≥75 years with symptomatic, drug-refractory AF were included in the study. Circumferential pulmonary vein isolation (PVI) was performed in all patients, extended to ablation of complex fractionated atrial electrograms, and/or linear lesions in PVI non-responders. Retrospective follow-up (FU) was based on routine outpatient clinic visits and regular telephone interviews. A total of 94 patients (54 male, age 78 ± 2 years, and left atrium diameter 46 ± 6 mm) with drug-refractory AF [55/94 (59%) paroxysmal AF (PAF), 29/94 (31%) persistent AF, and 10/94 (11%) long-standing persistent AF] underwent ablation. Follow-up was obtained in 93/94 (99%) patients. Following a single procedure, 35/93 (38%) patients were in stable sinus rhythm (SR; 46% PAF, 31% persistent AF, and 10% long-standing persistent AF) after a mean FU of 37 ± 20 months. After a mean of 1.5 ± 0.6 procedures, 55/93 (59%) patients were ultimately in stable SR (76% PAF, 41% persistent AF, and 20% long-standing persistent AF). In a total of 137 procedures, 8 major (5.8%) and 26 minor (19%) complications occurred. CONCLUSIONS: Catheter ablation in patients ≥75 years is associated with a favourable clinical long-term outcome in patients with PAF, while results are less promising in persistent or long-standing persistent patients. The safety profile of AF ablation in patients ≥75 years is comparable with patients of younger age.

Asymptomatic brain lesions following laserballoon-based pulmonary vein isolation.

AIMS: Laserballoon-based pulmonary vein isolation (PVI) for the treatment of atrial fibrillation (AF) has proven safe and effective. Silent brain lesions after AF ablation detected on magnetic resonance imaging (MRI) have been described for several technologies, but its incidence following laserballoon PVI is unknown. The current study sought to assess the incidence of new asymptomatic brain lesions in patients undergoing laserballoon-based PVI. METHODS AND RESULTS: Patients referred for PVI underwent pre- and post-procedural MRI of the brain. A total of 86 patients were enroled into the study (laserballoon group: 44 patients, 15 female, age 63 ± 9 years, left atrial (LA) diameter 43 ± 5 mm; cryoballoon group: 20 patients, 6 female, age 61 ± 9 years, LA diameter 41 ± 4 mm; and irrigated radiofrequency (RF) group: 22 patients, 11 female, age 64 ± 8 years, LA diameter 43 ± 6 mm). There was no statistically significant difference between the groups with regard to new asymptomatic brain lesions detected on post-procedural MRI: 5 of 44 (11.4%) patients in the laserballoon group, 1 of 20 (5.0%) patients in the cryoballoon group, and 4 of 22 (18.2%) patients in the irrigated RF group, respectively. In the laserballoon group, one additional patient with a new cerebral lesion experienced transient diplopia. In a multivariate regression model the only risk factor for asymptomatic new lesions was the CHA2DS2VASc score. CONCLUSION: Following laserballoon-based PVI, new asymptomatic brain lesions were detected in 11.4% of patients. A higher CHA2DS2VASc score, but not the ablation technology utilized, was the only associated risk factor.

Luminal esophageal temperature rise and esophageal lesion formation following remote-controlled magnetic pulmonary vein isolation.

BACKGROUND: Remote magnetic pulmonary vein isolation (PVI) demonstrates comparable success rate to manual ablation, but thermal effects on esophageal tissue remain undefined. OBJECTIVE: The purpose of this study was to evaluate the potential thermal effects on esophageal tissue during remote magnetic wide-area circumferential pulmonary vein isolation (CPVI). METHODS: Twenty-five patients (23 men, age 57 ± 10 years) in the magnetic navigation system (MNS) group and 25 control subjects (15 men, age 61 ± 12 years) with drug-refractory paroxysmal or persistent atrial fibrillation underwent CPVI. A magnetic 3.5-mm irrigated-tip catheter (NaviStar ThermoCool RMT, Biosense Webster) and a nonmagnetic 3.5-mm irrigated-tip catheter (NaviStar ThermoCool, Biosense Webster) were used in the MNS and control group, respectively. A temperature probe (SensiTherm, St. Jude Medical), containing 3 thermocouples was placed in close proximity to the ablation site monitoring luminal esophageal temperature (LET). LET changes did not guide therapy. Postprocedural esophagogastroduodenoscopy (EGD) was performed in all patients. RESULTS: Successful CPVI was achieved in all patients. No esophageal lesions, minimal lesions, or ulcerations were found in 16 of 25 (64%), 7 of 25 (28%), and 2 of 25 (8%) in the MNS group and in 14 of 25 (56%), 10 of 25 (40%), and 1 of 25 (4%) patients in the control group, respectively. No atrioesophageal fistula occurred. Mean maximum LET in the magnetic group was 43.7°C ± 3.7°C compared to 45.4°C ± 3.5°C in the manual control group (P = .09). CONCLUSION: Remote magnetic PVI is associated with significant rise in LET and development of thermal esophageal lesions. In the MNS group, higher LET recordings were more likely to cause esophageal injury, whereas this association was not seen in the manual group despite a tendency toward higher mean maximum LET recordings.

Catheter ablation for ventricular tachycardia after failed endocardial ablation: epicardial substrate or inappropriate endocardial ablation?

BACKGROUND: The substrate of myocardial ventricular tachycardia (VT) may involve the subepicardial myocardium. OBJECTIVE: The purpose of this study was to assess the incidence of epicardial substrates in patients with a previously failed endocardial ablation attempt for VT as well as the safety and effectiveness of epicardial ablation. METHODS: Using an electroanatomic mapping system, endocardial and epicardial maps were acquired. Irrigated radiofrequency current ablations of all inducible VTs were performed. RESULTS: Between 2005 and 2009, 59 patients with or without structural heart disease underwent epicardial VT ablation. Pericardial access failed in 3 (5%) of these patients. Of the remaining 56 patients, an epicardial substrate was found in 41 (73%). Overall, acute success was achieved in 46 (78%) of 59 patients, with complete VT abolition in 27 (46%) and partial abolition in 19 (32%). Successful outcomes were the result of endocardial ablation only in 14 (24%) patients, epicardial ablation in 21 (36%), and endocardial/epicardial in 11 (19%). Ablation failed to prevent reinduction in 8 (13%) patients, and VTs were noninducible prior to ablation in 5 (8%). Two periprocedural deaths occurred, one after right ventricular perforation and one due to electromechanical dissociation. Hepatic bleeding occurred in two patients. Recurrence of any VT occurred in 27 (47%) of 57 surviving patients during median follow-up of 362 days (q1-q3; 180-468 days). Repeat epicardial mapping was not feasible due to adhesions in 3 (25%) of 12 patients. CONCLUSION: In patients with a previously failed endocardial VT ablation, epicardial mapping reveals a VT substrate in nearly three fourths of all patients, and epicardial ablation is required for successful VT abolition in more than half of patients. However, life-threatening complications may occur. Repeat epicardial access was not possible in 25% due to local pericardial adhesions.

Unexpected high incidence of esophageal injury following pulmonary vein isolation using robotic navigation.

INTRODUCTION: Robotic navigation (RN) is a novel technology for pulmonary vein isolation (PVI). We investigated the incidence of thermal esophageal injury using RN with commonly used power settings in comparison to manual PVI procedures. methods: Thirty-nine patients underwent circumferential PVI using a 3.5-mm irrigated-tip-catheter. In the manual (n = 25) and the RN(1) group (n = 4) power was limited to 30 W (17 mL/min flow, maximal temperature 43 degrees C, max. 30 sec/spot) at the posterior left atrial (LA) wall. In RN-based procedures, ablation was performed with a contact force of 10-40 g. The operator was blinded to the esophageal temperature (T(eso)). In the RN(2) group ablation power along the posterior LA wall was reduced to 20 W and ablation terminated at T(eso) of 41 degrees C. Endoscopy was carried out 2 days post-ablation. RESULTS: PVI was achieved in all patients. In the manual group no esophageal lesions, minimal lesions, or ulcerations were found in 15 of 25 (60%), 7 of 25 (28%), and 3 of 25 (12%) patients, respectively. All patients in the RN(1) group had an ulceration and one developed esophageal perforation. A covered stent was placed 14 days post-PVI and removed at day 81. In the RN(2) group, only a single minimal lesion was found. CONCLUSIONS: A high incidence of thermal esophageal injury including a perforation was noted following robotic PVI using 30 W along the posterior LA wall. During RN-based PVI procedures esophageal temperature monitoring is advocated. Reduction of ablation power to 20 W and termination of energy delivery at T(eso) of 41 degrees C significantly reduced the risk of esophageal injury.

Remote robotic navigation and electroanatomical mapping for ablation of atrial fibrillation: considerations for navigation and impact on procedural outcome.

BACKGROUND: Radiofrequency current ablation of atrial fibrillation (AF) requires high technical skills to achieve optimal catheter stability and is associated with an individually high x-ray exposure to both the patient and the operator. To facilitate catheter navigation and to reduce the operator's x-ray burden, remote navigation (RN) systems have been developed. Considerations for navigation of a novel remote robotic navigation system in pulmonary vein isolation (PVI) procedures are reported. METHODS AND RESULTS: In 65 patients with drug-refractory AF (43 paroxysmal, 22 persistent), complete circumferential PVI was performed using RN in conjunction with different electroanatomic mapping systems. Acute complete PVI using exclusively RN was achieved in 95%. The procedure time was 195+/-40 minutes. The operator's x-ray exposure time was reduced by 6+/-4 minutes (35%) using RN. In 7 of 14 patients with persistent AF, conversion to sinus rhythm was achieved by radiofrequency current ablation. During a median follow-up period of 239 days (range, 184 to 314 days), 47 of 65 patients (73%) remained free of any documented atrial tachyarrhythmia recurrences after a single procedure. The relative proportion of patients remaining free of AF was 76% and 68% for paroxysmal and persistent AF, respectively. CONCLUSIONS: PVI using the novel RN system can be performed safely and effectively. One third of the operator's fluoroscopy exposure time might be saved using RN. However, the questions of whether the overall fluoroscopy exposure is reduced by RN and whether RN improves PVI procedures needs to be assessed during a comparative trial between man and machine.

Remote navigation systems in electrophysiology.

Today, atrial fibrillation (AF) is the dominant indication for catheter ablation in big electrophysiologists (EP) centres. AF ablation strategies are complex and technically challenging. Therefore, it would be desirable that technical innovations pursue the goal to improve catheter stability to increase the procedural success and most importantly to increase safety by helping to avoid serious complications. The most promising technical innovation aiming at the aforementioned goals is remote catheter navigation and ablation. To date, two different systems, the NIOBE magnetic navigation system (MNS, Stereotaxis, USA) and the Sensei robotic navigation system (RNS, Hansen Medical, USA), are commercially available. The following review will introduce the basic principles of the systems, will give an insight into the merits and demerits of remote navigation, and will further focus on the initial clinical experience at our centre with focus on pulmonary vein isolation (PVI) procedures.