Preventing atrial fibrillation by combined right isthmus ablation and cryoballoon pulmonary vein isolation in patients with typical atrial flutter: PAF-CRIOBLAF study.

BACKGROUND: Although less common, typical atrial flutter shares similar pathophysiological roots with atrial fibrillation. Following successful cavo-tricuspid isthmus ablation using radiofrequency, many patients, however, develop atrial fibrillation in the mid-to-long-term. This study sought to assess whether pulmonary vein isolation conducted at the same time as cavo-tricuspid isthmus ablation would significantly modify the atrial fibrillation burden upon follow-up in patients suffering from typical atrial flutter. METHODS: This was a multicenter randomized controlled study involving typical atrial flutter patients with history of non-predominant atrial fibrillation (1 atrial fibrillation episode only, in 67% of population) who were scheduled for cavo-tricuspid isthmus radiofrequency ablation. Patients were randomly assigned to either undergo cavo-tricuspid isthmus ablation alone or cavo-tricuspid isthmus plus pulmonary vein isolation (CTI+). Pulmonary vein isolation was performed using cryoballoon technology. An outpatient consultation with ECG and 1-week Holter monitoring was performed at 3, 6 months, 1 year, and 2 years postprocedure. The primary endpoint was atrial fibrillation recurrences lasting more than 30 s at 2 years postablation. RESULTS: Of the patients enrolled, 36 were included in each group. At 2-year follow-up, the atrial fibrillation recurrence rate was significantly higher in the CTI vs CTI+group (25/36, 69% vs. 12/36, 33% respectively; P < .001), with similar typical atrial flutter recurrence rates. There were no differences in undesirable events, except for transient phrenic nerve palsy reported from three CTI+patients (8.3%). CONCLUSION: Pulmonary vein isolation using cryoballoon technology was proven to significantly reduce the atrial fibrillation incidence at 2 years postcavo-tricuspid isthmus ablation.

Cryoablation for persistent and longstanding persistent atrial fibrillation: results from a multicentre European registry.

AIMS: Although cryoballoon pulmonary vein isolation is a well-established treatment for paroxysmal atrial fibrillation (AF), it's role in persistent AF is unclear. We examined procedural success and long-term outcomes of cryoablation in persistent and longstanding persistent AF. METHODS AND RESULTS: International multicentre registry from three UK and eight European centres. Consecutive patients undergoing cryoablation for persistent AF included. Procedural data, complications, and follow-up were prospectively recorded. Patients were followed-up at 3, 6, and 12 months with an electrocardiogram with open access to arrhythmia nurses thereafter. Ambulatory monitoring was dictated by symptoms. Success was defined as freedom from AF or atrial tachycardia lasting >30 s off antiarrhythmic drugs (AADs). Six hundred and nine consecutive cryoablation procedures. Mean procedure and fluoroscopy times were 95 ± 65 and 13 ± 10 min. Single procedure success rates were 368/602 (61%) off AADs over a median of 2.4 (1.0-4.0) years. Arrhythmia-free survival off AADs was 64% and 57% for persistent and longstanding persistent AF at 24 months of follow-up (P = 0.02). Rate of repeat ablations was 20% in persistent and 32% in longstanding persistent AF (P = 0.006). Cox regression analyses showed a significant association between duration of AF and left atrial diameter and arrhythmia recurrence [hazard ratio (HR) 1.05, P-value 0.01 and HR 1.02, P-value 0.004]. CONCLUSION: Cryoablation for persistent AF is safe, fast and has good outcomes at long-term follow-up. Cryoablation is reasonable as a first line option for these patients. Short procedure times may help increase capacity of cardiac units to meet the rising demand for AF ablation. Randomised control trials are needed to compare outcomes with different techniques.

How is Contact Force implemented in routine clinical practice? Results from a French National and Monaco Survey.

BACKGROUND: Combination of elementary parameters (force, time, power, impedance drop) has been proposed to optimize radiofrequency (RF) delivery. They have been partially validated in clinical studies. AIMS: The aim of this study was to assess contact-force (CF) implementation into clinical practice. METHODS: A 36-question electronic form was sent to 105 electrophysiologists (EP) including some general questions concerning the practice of catheter atrial fibrillation ablation and items concerning the parameters used for CF-guided ablation. RESULTS: Answers from 98 EP were collected (93% response rate). The CF-catheters used were Smart Touch, Biosense (52%), Tacticath, Saint-Jude Medical (12%), or both (27%) and no CF (9%). The power applied on the left atrial (LA) anterior (LAAW) and posterior (LAPW) wall was, respectively, 26-34 W (for 73% of the EP) and below 25 W (88% of the EP). Forty percent of the Visitag® users mostly used the nominal parameters. Seventy-five percent of the users did not use automatic display of the impedance drop. For the Tacticath users, 57% used a target value of 400 gs on the LAAW and 300 to 400 gs on the LAPW. Lesion Size Index was exceptionally used. CONCLUSIONS: The parameters used for CF-guided ablation are widely variable among the different operators. Further prospective studies are needed to validate the targets for automatic annotation of the RF applications.

Results from a multicentre comparison of cryoballoon vs. radiofrequency ablation for paroxysmal atrial fibrillation: is cryoablation more reproducible?

AIM: Cryoballoon ablation (Cryoballoon) has emerged as a new alternative for the treatment of symptomatic drug-refractory atrial fibrillation (AF). Whether the results of Cryoballoon are more reproducible than those of radiofrequency (RF) ablation remains to be proved. METHODS AND RESULTS: A total of 860 consecutive patients undergoing a first ablation procedure for paroxysmal AF (467 treated with RF and 393 treated with Cryoballoon) were selected from a prospective multicentre survey of AF ablation (FrenchAF). Radiofrequency and Cryoballoon were compared regarding mid-term efficacy and safety. During a median follow-up of 14 months (interquartile range 8-23), patients treated with Cryoballoon displayed similar rates of freedom from atrial arrhythmia relapse in centres performing this technique (68-80% at 18 months). However, in centres performing RF, a greater heterogeneity in procedural results was observed (46-79% were free from atrial arrhythmia relapse at 18 months). On multivariate analysis, Cryoballoon (HR = 0.47, 95% CI 0.35-0.65, P < 0.001) and annual AF ablation caseload (HR = 0.87 per every 100 AF ablation procedures per year; 95% CI 0.80-0.96, P = 0.003) were independent predictors of procedural success. However, on sensitivity analysis, according to the ablation method, annual AF ablation caseload predicted only sinus rhythm maintenance in the subgroup of patients treated with RF. Analysis of interoperator results with Cryoballoon and RF confirmed lower reproducibility of RF, but suggested that besides caseload, other operator-related factors may play a role. CONCLUSION: Cryoballoon seems to be less operator-dependent and more reproducible than RF in the setting of paroxysmal AF ablation.

Outcomes after cryoballoon or radiofrequency ablation for persistent atrial fibrillation: a multicentric propensity-score matched study.

PURPOSE: Recent data show no benefit of additional ablation beyond pulmonary vein isolation (PVI) in persistent atrial fibrillation (AF). Evidence suggests that radiofrequency energy (RF) and cryoballoon (CRYO) have comparable efficacy for PVI. We aimed to assess the outcomes after a single catheter ablation procedure, comparing PVI using CRYO vs. RF ablation for PVI plus additional ablation in a cohort of patients with persistent AF. METHODS: In this prospective multicenter propensity score-matched comparison, 59 consecutive patients undergoing CRYO ablation of persistent AF were matched to 59 patients treated with RF from November 2010 to June 2012. RESULTS: During a mean follow-up of 15.6 ± 11.5 months, 43.2 % of patients presented atrial arrhythmia relapse after a blanking period of 3 months, which was comparable between the two groups (40.7 % in CRYO vs. 45.8 % in RF, Log rank P = 0.14; HR = 0.67, 95 %CI 0.38-1.16, P = 0.15), despite the fact that 52.5 % of RF patients add additional complex fractionated atrial electrogram ablation, as well as left atrial linear ablation in over two-thirds (roof line in 67.8 % and mitral isthmus in 32.2 %). On multivariate Cox regression, only AF duration in years (HR = 1.10, 95 %CI 1.01-1.10, P = 0.04) was a predictor of relapse. Patients undergoing RF ablation presented a numerically, but non-significantly, lower complication rate (6.8 vs 10.2 %, P = 0.51). CONCLUSION: In our multicenter experience, freedom from atrial arrhythmias was comparable among matched patients treated with CRYO and RF, despite non-significant trends in favor of RF in terms of complications, at the cost of longer procedure times.

Non-physiological increase of AV conduction time in sinus disease patients programmed in AAIR-based pacing mode.

PURPOSE: The EVOCAV(DS) trial aimed to quantify the paradoxal atrioventricular (AV) conduction time lengthening in sinus node (SD) patients (pts) paced in AAIR-based pacing mode. METHODS: SD pts, implanted with dual-chamber pacemaker programmed in AAIR-based pacing mode, were randomized in two arms for a 1-month period: the low atrial pacing (LAP; basic rate at 60 bpm, dual sensor with minimal slope) and the high atrial pacing (HAP; basic rate at 70 bpm, dual sensor with optimized slope, overdrive pacing) arm. At 1 month, crossover was performed for an additional 1-month period. AV conduction time, AV block occurrence and AV conduction time adaptation during exercise were ascertained from device memories at each follow-up. RESULTS: Seventy-nine pts participated to the analysis (75 ± 8 years; 32 male; PR = 184 ± 38 ms; bundle branch block n = 12; AF history n = 36; antiarrhythmic treatment n = 53; beta-blockers n = 27; class III/Ic n = 18; both n = 8). The mean AV conduction time was significantly greater during the HAP (275 ± 51 ms) vs. LAP (263 ± 49 ms) period (p < 0.0001). Class III/Ic drugs were the only predictors of this abnormal behaviour. Degree II/III AV blocks occurred in 49 % of pts in the HAP vs. 19 % in the LAP period (p < 0.0001). Fifty-two patients (66 %) presented a lengthening of AV conduction time during exercise. CONCLUSION: AAIR-based pacing in SD pts may induce a significant lengthening of pts' AV conduction time, including frequent abnormal adaptation of AV conduction time during exercise.

Identification of a strong genetic background for progressive cardiac conduction defect by epidemiological approach.

INTRODUCTION: Progressive cardiac conduction defect (PCCD) is a frequent disease attributed to degeneration and fibrosis of the His bundle. Over the past years, gene defects have been identified demonstrating that PCCD could be a genetic disease. The aim of this study was to show a familial aggregation for PCCD using a genetic epidemiological approach to improve in fine genetic knowledge of the transmission of the disease. METHODS AND RESULTS: Using the French social security number, the authors have been able to determine the city of birth of the 6667 patients implanted with a pacemaker (PM) for PCCD between 1995 and 2005 in the western part of France. The authors then mapped the frequency of PM implantations for PCCD. A large heterogeneity of the frequency of the disease has been observed, with a frequency of 0.21% in the major city (Nantes) ranging up to 2.28% in specific parishes. Familial studies performed in the parishes with the highest frequency of the disease allowed the authors to identify five large families with PCCD. Clinical investigations demonstrated phenotype heterogeneity between families. Three patterns have been differentiated. CONCLUSIONS: This study demonstrates a disparate geographical repartition of the frequency of PM implantation in the area of the authors at least in part related to a hereditary factor. The identification of five large families affected by PCCD using epidemiological approach underlines the existence of a major genetic background in PCCD.

A randomized study of defibrillator lead implantations in the right ventricular mid-septum versus the apex: the SEPTAL study.

INTRODUCTION: The study was designed to evaluate the feasibility and performance of right ventricular (RV) mid-septal versus apical implantable defibrillator (ICD) lead placement. METHODS AND RESULTS: SEPTAL is a randomized, noninferiority trial, which randomly assigned patients to implantation of ICD leads in the RV mid-septum versus apex, with a primary objective of comparing the implant success rate of implant at each site, based on strict electrical predefined criteria. We also compared the (1) pacing lead characteristics, (2) rates of appropriate and inappropriate ICD therapies, and (3) all-cause mortality between the 2 sites at 1 year. The trial enrolled 215 patients (mean age = 59.7 ± 12.4 years, mean LVEF = 34.0 ± 14.2%, 84.2% men), of whom 148 (68.8%) presented with ischemic heart disease. The ICD indication was primary prevention in 117 patients (54.4%). The lead was successfully implanted in 96/107 patients (89.7%) assigned to the RV mid-septum, and in 99/108 (91.7%) assigned to the apex (ns). The 1-year rate of lead-related adverse events was similar in both groups. A total of 8 first inappropriate ICD therapies (7.9%) were delivered in the RV mid-septal group, versus 8 (7.8%) in the apical group (ns), while first appropriate therapies were delivered to 22 (21.4%) and 24 patients (23.8%), respectively (ns). All-cause mortality was 7.9% in the RV mid-septal versus 2.9% in the RV apical group (ns). CONCLUSION: This study confirmed the technical feasibility and noninferior performance of ICD leads implanted in the RV mid-septum versus the apex.

The use of telescoping guide catheters for coronary sinus cannulation and sub-selecting tributaries in left ventricular lead placement.

INTRODUCTION: Failure to enter the coronary sinus (CS) with a guiding catheter and entering its tributaries remains challenging in left ventricle (LV) pacing lead implants for cardiac resynchronization therapy (CRT). A dual telescoping catheter system (8F outer/6F inner) is designed to provide the ability to adjust the catheter curve size, shape and/or reach to the patients' anatomy avoiding the need for catheter change. METHODS: Five different designs for CS cannulation were randomly tested in 64 patients scheduled for CRT device implant. RESULTS: In 33 consecutive patients three adaptable telescoping guiding catheter systems were tested per patient, the adaptable catheters had higher overall cannulation success rates (68, 63 and 62%) compared to the fixed shape catheter (46%) and an greater cannulation success rate when the CS location was not known (70, 53 and 72% vs 33% for the fixed shape). In a second group of 31 CRT patients the two telescoping catheters had similar high levels of success (71-80%), with or without using the inner catheter. CONCLUSIONS: The telescopic system is adaptable to a wide range of anatomical variations in patients and can result in a higher CS cannulation success rate due to its adjustability in the RA in search for the CS ostium. On top of this the inner catheter allows for sub-selecting the CS tributaries.

Optimal stimulation of the left ventricle.

Cardiac resynchronization therapy has been proposed to alleviate heart failure symptoms refractory to classic drug treatment. Potential benefits hinge on a number of key components, including judicious selection of patients likely to respond to the therapy and appropriate placement of the leads, particularly the lead responsible for left ventricular pacing. Evidence of ventricular asynchrony is an individual prerequisite for consideration of cardiac resynchronization therapy. Ventricular asynchrony can be diagnosed by recording a QRS duration >150 msec or during echocardiography, with the goal of investigating the mechanical aspect of asynchrony. The optimal left ventricular pacing site can be defined by the latest segmental contraction, which is mainly the mid-lateral wall. The first-choice technique to initiate left ventricular pacing consists of a transvenous approach via the coronary sinus tributaries. In practice, the final left ventricular pacing location also depends on highly variant coronary sinus anatomy, acceptable electrical parameters, and lead stability. Procedure-related complications, which consist mainly of coronary sinus perforation and phrenic nerve stimulation, remain low (<1%) and should decrease further with the use of new features specific to the procedure.