Real‐Time Contact Force Sensing for Pulmonary Vein Isolation
Introduction
The additional benefit of contact force (CF) technology during pulmonary vein isolation (PVI) for paroxysmal atrial ...fibrillation (AF) to improve mid‐term clinical outcome is unclear.
Methods and Results
Eligible patients with symptomatic paroxysmal AF were enrolled in this prospective trial, comparing circular antral catheter ablation (guided by Carto 3 System, Biosense Webster) using either a new open‐irrigated CF catheter (SmartTouch Thermocool, Biosense Webster) (CF group) or a non‐CF open‐irrigated catheter (EZ Steer Thermocool, Biosense Webster) (control group). Overall, 30 patients were enrolled in each group, with a standardized 12‐month follow‐up, free of antiarrhythmic therapy. Demographic, cardiovascular and anatomic characteristics were similar in both groups. Though complete PVI was eventually achieved in all cases in both groups, success using an exclusive anatomic approach was 80.0% in CF group versus 36.7% in control group (P < 0.0001). CF use was associated with significant reductions in fluoroscopy exposure (P < 0.01) and radiofrequency time (P = 0.01). The incidence rates of AF recurrence were 10.5% (95% CI, 1.38–22.4) in the CF group, and 35.9% (95% CI, 12.4–59.4) in the control group (log rank test, P = 0.04). After adjustment on potential confounders, the use of CF catheter was found to be associated with a lower AF recurrence (OR 0.18, 95% CI 0.04–0.94, P = 0.04).
Conclusion
Our findings suggest a potential benefit of real‐time CF sensing technology, in reducing AF recurrence during the first year after PVI.
Dabigatran etexilate, a new thrombin inhibitor, has been shown to be comparable to warfarin in patients with atrial fibrillation (AF). However, there is a limited body of evidence on the efficacy and ...safety of using dabigatran among patients undergoing AF catheter ablation.
A random effects meta-analysis was performed of controlled trials comparing dabigatran and warfarin in paroxysmal/persistent AF patients undergoing catheter ablation.
Data sources included Medline, Embase, and Cochrane (from inception to April 2013). Three independent reviewers selected studies comparing warfarin to dabigatran. Descriptive and quantitative information was extracted from each selected study, regarding periprocedural all cause mortality, thromboembolic events and major bleeding, as well as modalities of periprocedural anticoagulation bridging.
After a detailed screening of 228 search results, 14 studies were identified enrolling a total of 4782 patients (1823 treated with dabigatran and 2959 with warfarin). No deaths were reported. No significant differences were found between patients treated with dabigatran and warfarin as regards thromboembolic events (0.55% dabigatran vs 0.17% warfarin; risk ratios (RR)=1.78, 95% CI 0.66 to 4.80; p=0.26) and major bleeding (1.48% dabigatran vs 1.35% warfarin; RR=1.07, 95% CI 0.51 to 2.26; p=0.86). No difference was found between the 110 mg twice daily and 150 mg twice daily dabigatran dosages concerning major bleeding (0% vs 1.62%, respectively; RR=0.19, 95% CI 0.01 to 3.18; p=0.25) and thromboembolism (0% vs 0.40%, respectively; RR=0.72, 95% CI 0.04 to 12.98; p=0.82).
In the specific setting of AF catheter ablation, this first pooled analysis suggests that patients treated with dabigatran have a similar incidence of thromboembolic events and major bleeding compared to warfarin, with low event rates overall.
Background Outcomes of catheter ablation of atrial fibrillation (AF) are variable and the predictors of success require further elucidation since the identification of correctable risk factors could ...help to optimize therapy. We aimed to assess the impact of body mass index (BMI) in the overall safety and efficacy of catheter ablation of AF, with emphasis on the use of cryoballoon ablation and novel oral anticoagulants. Methods and Results There were 2497 consecutive patients undergoing catheter ablation of AF in 7 European high volume centers were stratified according to BMI (normal weight <25 kg/m
, pre-obese 25-30 kg/m
, obesity 30-35 kg/m
, and morbid obesity ≥35 kg/m
) and comparisons of procedural outcomes evaluated. Pre-obese and obese patients presented more comorbidities (hypertension, diabetes mellitus, and sleep apnea), and had higher rates of non-paroxysmal AF ablation procedures. The rate of atrial 12-month arrhythmia relapse increased alongside with BMI (35.2%, 35.7%, 43.6%, and 48.0%
<0.001). During a median follow-up of 18.8 months (interquartile range 11-28), after adjusting for all baseline differences, BMI was an independent predictor of relapse (hazard ratio=1.01 per kg/m
; 95% CI 1.01-1.02;
=0.002), adding incremental predictive value to obstructive sleep apnea. BMI was not a predictor for any of the reported complications. Using novel oral anticoagulants and cryoballoon ablation was safe and efficacy was comparable with vitamin-K antagonists and radiofrequency ablation. Conclusions Obese patients present with a more adverse comorbidity profile, more advanced forms of AF, and have lower chances of being free from AF relapse after ablation. Use of novel oral anticoagulants and cryoballoon ablation may be an option in this patient group.
For conventional ablation of paroxysmal atrial fibrillation (AF), an ablation catheter in conjunction with a circular mapping catheter (CMC) is typically used for pulmonary vein isolation (PVI).
The ...purpose of this study was to evaluate an approach for PVI with a single contact-force (CF) ablation catheter in terms of procedural reliability, outcomes, and cost-effectiveness.
One hundred consecutive patients with paroxysmal AF were included in the study. Fifty patients (study group) underwent a CF-guided single-catheter approach, whereby PVI was demonstrated when sequential pacing at 9 equidistant points within the lesion set (carina included) failed to capture the left atrium. For confirmation, PVI was verified with a CMC. In comparison, 50 patients (control group) underwent a conventional PVI ablation guided by a CMC.
Procedure time (101 ± 17 minutes vs 107 ± 15 minutes, P = .11), ablation time (24.2 ± 7.1 minutes vs 22.6 ± 8.8 minutes, P = .37), fluoroscopy time (5.6 ± 2.2 minutes vs 8.3 ± 3.4 minutes, P = .09), and applied CF (17.8 ± 2.6 g vs 18 ± 2.8 g, P = .72) did not reach statistical difference between the study and control groups. CF-guided single-catheter ablation achieved successful PVI in 98% of the study group and a 31% reduction in cost. At 1-year follow-up, sinus rhythm maintenance rate was similar in both groups (86% vs 84%, P = .78).
In paroxysmal AF, a CF-guided single-catheter technique is an effective method for PVI, yielding substantial cost savings and clinical results similar to a conventional approach.
The prevalence of atrial fibrillation (AF) is increased in hyperthyroidism. The degree to which thyroid hormones affect the outcomes of left atrial (LA) ablation is still unclear. From September 2010 ...to September 2013, 1,095 patients who underwent LA ablation (59.7% paroxysmal AF, 32.3% persistent AF, and 8.0% LA tachycardia) had their serum thyroid-stimulating hormone (TSH) and free thyroxine (FT4 ) levels measured in the 48 hours before the procedure. Patients were followed until they presented the first AF relapse after a blanking period of 3 months. TSH and FT4 were assessed as predictors of arrhythmia relapse and were adjusted for possible confounders. During a mean follow-up of 12.5 ± 7.9 months, 28.9% of patients presented an atrial arrhythmia relapse. TSH was not a predictor of relapse. In contrast, after adjustment, FT4 (median = 11.8 ng/L and interquartile range 10.6 to 14.6 ng/L) remained a predictor of relapse with 15% increase per quartile (hazard ratio 1.15, 95% confidence interval 1.03 to 1.29, p = 0.014). In conclusion, FT4 levels influence the success rate of LA ablation procedures, even when in the normal range.
The important increase in life expectancy of adult patients with congenital heart disease (ACHD) has generated new challenges, including arrhythmias that represent one of the main late complications. ...Reentrant atrial arrhythmias are by far the main mechanism encountered, and catheter ablation has been now presented as a first-line therapy in this patient population. The number of procedures is expected to continuously increase year after year. The heterogeneity and complexity of phenotypes encountered require these cases to be performed by highly experienced operators, in specialized centers with multidisciplinary competencies. A thorough knowledge and understanding of anatomic specificities, vascular access issues, and main circuits encountered according to underlying phenotype is essential. Acute success rates have significantly improved and are now excellent, but recurrences remain a common issue, with different mechanisms or circuits frequently encountered. Observational data have suggested the interest of systematically targeting all inducible atrial arrhythmias, whether previously documented or not, and a lot of hope and research is based on the prediction of arrhythmia substrate before arrhythmia development by imaging or electroanatomic mapping to deliver a prophylactic patient tailored ablation approach. In this review, we summarize those different points in the most common or distinctive defects to offer a didactic overview of atrial flutter catheter ablation in ACHD patients.
Apart from pulmonary vein isolation (PVI), several step-by-step procedures that aim to modify left atrial substrate have been proposed for the ablation of persistent atrial fibrillation (AF), yet the ...optimal strategy remains elusive. There are cumulative data suggesting an incremental benefit of adding vein of Marshall (VOM) ethanol infusion to PVI in patients with persistent AF. We sought to evaluate the feasibility and efficacy of a novel stepwise ablation approach, incorporating a VOM alcoholization step, for persistent AF.
In this single-center study, we prospectively enrolled 66 consecutive patients with symptomatic persistent AF and failure of at least one antiarrhythmic drug (ADD). The ablation procedure consisted of (i) PVI, (ii) left atrial segmentation with VOM ethanol infusion and the deployment of linear radiofrequency lesions across the roof and the mitral isthmus and (iii) electrogram-based ablation of dispersion zones. The first two steps were performed in all patients, whereas the third step was carried out only in those still in AF at the end of the second step. Atrial tachycardias during the procedure were mapped and ablated. At the end of the procedure, cavotricuspid isthmus ablation was additionally performed in all patients. The primary endpoint was 12-month freedom from AF and atrial tachycardia after a single procedure and an initial three-month blanking period.
Total procedure time was 153 ± 38.5 min. Fluoroscopy time was 16 ± 6.5 min and the radiofrequency ablation time was 26.14 ± 0.26 min. The primary endpoint occurred in 54 patients (82%). At 12 months, 65% of patients were off any AAD. In the univariate Cox regression analysis, left ventricular ejection fraction < 40% was the only predictor of arrhythmia recurrence (HR 3.56; 95% CI, 1.04-12.19;
= 0.04). One patient developed a pericardial tamponade and another a minor groin hematoma.
A novel stepwise approach, including a step of ethanol infusion in the VOM, is feasible, safe and provides a high rate of sinus rhythm maintenance at 12 months in patients with persistent AF.
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.
Percutaneous pulmonary valve implantation (PPVI) with a SAPIEN 3 valve is effective for treating treat right ventricle outflow (RVOT) dysfunction. A modified technique was developed without ...prestenting using a protective valve delivery method. We aimed to compare the procedural results of the modified technique group (MTG) to those of patients in a conventional technique group (CTG).
We designed a matched before-after study. All consecutive PPVI with SAPIEN 3 performed in the MTG over 9 months were matched, based on the RVOT type and size, to consecutive procedures performed previously with SAPIEN 3.
A total of 54 patients were included, equally distributed in the two groups. The sizes of the SAPIEN 3 valves were 23 mm (n = 9), 26 mm (n = 9), 29 mm (n = 36). The two groups were similar regarding demographic data, RVOT type, and pre-procedure hemodynamics. PPVI was performed in a single procedure in all patients of the MTG, whereas six (22.2%) patients of the CTG group underwent prestenting as a first step and valve implantation later (
= 0.02). The procedures were successful in all cases. Stent embolization was reported in two patients (7.4%) in the CTG, which were impacted in pulmonary arteries. In one case (3.7%), in the MTG, an unstable 29 mm SAPIEN 3 valve was stabilized with two stents and additional valve-in-valve implantation. The hemodynamics results were good in all cases, without significant differences between the two groups. The procedures' durations and fluoroscopy times were significantly reduced in the MTG (48.1 versus 82.6 min,
< 0.0001; 15.2 versus 29.8 min,
= 0.0002). During follow-up, neither stent fracture nor valve dysfunction was noticed in either group.
PPVI without prestenting and with a protective delivery method of the SAPIEN 3 valve significantly reduces the procedure's complexity, the duration, and the irradiation while maintaining excellent hemodynamics results in selected cases.
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