Nicolas Combes

Real-Time Contact Force Sensing for Pulmonary Vein Isolation in the Setting of Paroxysmal Atrial Fibrillation: Procedural and 1-Year Results

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.

Mortality of French participants in the Tour de France (1947–2012)

AIMS In the context of recent concerns regarding performance enhancing techniques and potential negative health effects of high-level physical activity, data on the long-term outcomes and causes of death in elite endurance cyclists are of particular interest. METHODS AND RESULTS Characteristics and vital status of all French participants in the Tour de France were collected for the 1947-2012 period. Causes of death were obtained from 1968. Overall and disease-specific mortalities were compared with the French male population using overall and specific standardized mortality ratios (SMRs) with their 95% confidence intervals (CIs). Among the 786 French cyclists who participated at least once between 1947 and 2012, 208 (26%) died by 1 September 2012. Neoplasms and cardiovascular diseases accounted for 61% of deaths. We observed a 41% lower mortality in French cyclists (SMR: 0.59, 95% CI: 0.51-0.68, P < 0.0001), which did not change over time (P = 0.70). It was observed for main mortality causes: for neoplasms (SMR: 0.56; 95% CI: 0.42-0.72, P < 0.0001) and for cardiovascular death (SMR: 0.67; 95% CI: 0.50-0.88, P = 0.004), except mortality related to external causes (SMR: 1.06, 95% CI: 0.71-1.53, P = 0.80). CONCLUSION We observed a substantially and significantly lower mortality in participants in the Tour de France, compared with the general male population. However, our results do not allow us to assess in detail the balance between positive effects of high-level sports activity and selection of healthy elite athletes, vs. any potential deleterious effects of excessive physical exercise or alleged doping.

Contact-force guided radiofrequency vs. second-generation balloon cryotherapy for pulmonary vein isolation in patients with paroxysmal atrial fibrillation—a prospective evaluation

AIMS In the setting of paroxysmal atrial fibrillation (AF), there are no available data comparing the mid-term outcome of patients undergoing pulmonary vein isolation (PVI) catheter ablation using contact-force (CF)-guided radiofrequency (RF) vs. second-generation balloon cryotherapy. METHODS AND RESULTS Prospective single-centre evaluation, carried out from March 2011 to February 2013, comparing CF radiofrequency (Thermocool(®) SmartTouch™, Biosense Webster, Inc.) (CF group) with cryoballoon ablation (Arctic Front Advance™ 28 mm cryoballoon, Medtronic, Inc.) (CB group), in regards to procedural safety and efficacy, as well as recurrence at 12 months. Overall, 150 consecutive patients were enrolled (75 in each group). The characteristics of patients of both the groups were similar (61.2 ± 9.9 years, women 25.3%, mean AF duration 4.1 ± 4.0 years, mean CHA2DS2-VASc score 1.4 ± 1.3, mean HAS-BLED 1.4 ± 0.6). Duration of the procedure was significantly lower in the CF group (110.7 ± 32.5 vs. 134.5 ± 48.3 min, P = 0.001), with a lower duration of fluoroscopy (21.5 ± 8.5 vs. 25.3 ± 9.9 min, P = 0.017) and X-ray exposure (4748 ± 2411 cGy cm² vs. 7734 ± 5361 cGy cm², P = 0.001). In contrast, no significant difference was found regarding significant procedural complication (2.7 vs. 1.3% in CF and CB groups, respectively; P = 0.56), and PVI was eventually achieved in all cases. At 12 months, AF recurrence occurred in 11 patients (14.7%) in the CB group and in 9 patients (12.0%) in the CF group (HR = 1.20 95% CI 0.50-2.90; log rank P = 0.682). CONCLUSIONS Our preliminary findings suggest that CF-guided radiofrequency and cryotherapy present very similar performances in the setting of paroxysmal AF catheter ablation.

Safety and efficacy of dabigatran versus warfarin in patients undergoing catheter ablation of atrial fibrillation: a systematic review and meta-analysis

Background 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. Objective A random effects meta-analysis was performed of controlled trials comparing dabigatran and warfarin in paroxysmal/persistent AF patients undergoing catheter ablation. Methods 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. Results 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). Conclusions 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.

Rivaroxaban and dabigatran in patients undergoing catheter ablation of atrial fibrillation

AIMS The recent availability of the novel oral anticoagulants (NOACs) may have led to a change in the anticoagulation regimens of patients referred to catheter ablation of atrial fibrillation (AF). Preliminary data exist concerning dabigatran, but information regarding the safety and efficacy of rivaroxaban in this setting is currently scarce. METHODS AND RESULTS Of the 556 consecutive eligible patients (age 61.0 ± 9.6; 74.6% men; 61.2% paroxysmal AF) undergoing AF catheter ablation in our centre (October 2012 to September 2013) and enroled in a systematic standardized 30-day follow-up period: 192 patients were under vitamin K antagonists (VKAs), 188 under rivaroxaban, and 176 under dabigatran. Peri-procedural mortality and significant systemic or pulmonary thromboembolism (efficacy outcome), as well as bleeding events (safety outcome) during the 30 days following the ablation were evaluated according to anticoagulation regimen. During a 12-month time interval, the use of the NOACs in this population rose from <10 to 70%. Overall, the rate of events was low with no significant differences regarding: thrombo-embolic events in 1.3% (VKA 2.1%; rivaroxaban 1.1%; dabigatran 0.6%; P = 0.410); major bleeding in 2.3% (VKA 4.2%; rivaroxaban 1.6%; dabigatran 1.1%; P = 0.112), and minor bleeding 1.4% (VKA 2.1%; rivaroxaban 1.6%; dabigatran 0.6%; P = 0.464). No fatal events were observed. CONCLUSION The use of the NOAC in patients undergoing catheter ablation of AF has rapidly evolved (seven-fold) over 1 year. These preliminary data suggest that rivaroxaban and dabigatran in the setting of catheter ablation of AF are efficient and safe, compared with the traditional VKA.

Incidence and prognostic significance of sustained ventricular tachycardias in heart failure patients implanted with biventricular pacemakers without a back-up defibrillator: results from the prospective, multicentre, Mona Lisa cohort study

AIMS The aim of this study was to investigate the 12-month incidence, predictive factors, and prognosis of sustained ventricular tachycardia (VT) in chronic heart failure patients implanted with biventricular pacemakers without a back-up defibrillator (CRT-P), assessed by continuous intracardiac ventricular electrograms. METHODS AND RESULTS The Mona Lisa study, a prospective, multicentre, cohort study, designed to determine the incidence of sustained VT and its prognostic impact in CRT-P recipients within the year after implant enrolled 198 patients with moderate or severe chronic heart failure, despite optimal pharmacological therapy. An independent committee reviewed the data from all arrhythmic episodes as well as causes of death according to predefined criteria. During a mean follow-up of 9.8 +/- 3.1 months after implantation, 8 patients experienced at least one episode of sustained VT [4.3%; 95% confidence interval (CI), 1.1-7.5] and 21 deaths occurred, giving a 12-month mortality rate of 11.7% (95% CI, 6.4-16.9). The presence of sustained VT was associated with a high risk of sudden cardiac death (SCD) and the lowest 12-month overall survival (P < 0.0001). CONCLUSION The incidence of sustained VT remains relatively low in the first year after CRT-P implantation, but when present appears closely associated with short-term adverse outcomes, especially SCD. This emphasizes the possible value of remote monitoring to detect high-risk patients for urgent upgrading.

Higher contact-force values associated with better mid-term outcome of paroxysmal atrial fibrillation ablation using the SmartTouch™ catheter

AIMS Real-time measurement of contact force (CF) during catheter ablation of atrial fibrillation (AF) has been recently suggested to potentially impact procedural outcome. However, the role of CF intensity on mid-term results using the SmartTouch™ catheter has not been investigated so far. METHODS AND RESULTS Pulmonary vein isolation (PVI) using the SmartTouch™ catheter was performed in 100 eligible patients (age 62 ± 8; 79% men) undergoing a first procedure of paroxysmal AF catheter ablation. Continuous CF monitoring during catheter ablation allowed calculation of mean CF per patient. Patients were dichotomized into high CF (≥22 g, upper quartile) and low CF (<22 g, remaining) and enroled in a standardized follow-up programme (after a 3-month blanking period), free from antiarrhythmic therapy, with regular evaluations including 24 h Holter recordings at 1, 3, 6, 9, 12, 18, and 24 months. Atrial fibrillation relapse was defined as any symptomatic or asymptomatic atrial arrhythmia lasting >30 s. The average CF among all procedures was 19.6 ± 3.7 g. Though complete PVI was eventually achieved in all cases in both groups, success using an exclusively anatomical approach was higher in the high CF group (92.0 vs. 72.0%; P = 0.04). During a mean follow-up of 19 ± 5 months, a lower incidence of AF relapse was observed in higher CF patients (4.0 vs. 20.0%; log rank P = 0.04). Pericardial tamponade occurred in one patient in the higher CF group. No thromboembolism or procedure-associated deaths were observed. CONCLUSION Higher values of CF overall during antral PVI appear to be associated with a higher likelihood of sinus rhythm maintenance without significantly increasing the complication rate.

Outcomes after cryoablation vs. radiofrequency in patients with paroxysmal atrial fibrillation: impact of pulmonary veins anatomy

AIMS Pulmonary vein isolation is the mainstay of treatment in catheter ablation of paroxysmal atrial fibrillation (AF). Cryoballoon ablation has been introduced more recently than radiofrequency ablation, the standard technique in most centres. Pulmonary veins frequently display anatomical variants, which may compromise the results of cryoballoon ablation. We aimed to evaluate the mid-term outcomes of cryoballoon ablation in an unselected population with paroxysmal AF from an anatomical viewpoint. METHODS AND RESULTS Consecutive patients with paroxysmal AF who underwent a first procedure of cryoballoon ablation or radiofrequency were enrolled in this single-centre study. All patients underwent systematic standardized follow-up. Comparisons between radiofrequency and cryoballoon ablation (Arctic Front™ or Arctic Front Advance™) were performed regarding safety and efficacy endpoints, according to pulmonary vein (PV) anatomical variants. A total of 687 patients were enrolled (376 radiofrequency and 311 cryoballoon ablation). Baseline characteristics and distribution of PV anatomical variants were generally similar in the groups. After a mean follow-up of 14 ± 8 months, there was no difference in the incidence of relapse (17.0% cryoballoon ablation vs. 14.1% radiofrequency, P = 0.25). We observed no interaction of PV anatomical variants on mid-term procedural success. CONCLUSION Our findings suggest that mid-term outcomes of cryoballoon ablation for paroxysmal AF ablation are similar to those of radiofrequency, regardless of PV anatomy. The presence of anatomical variants of PVs should not discourage the referral of patients with paroxysmal AF for cryoballoon ablation.

Predicting favourable outcomes in the setting of radiofrequency catheter ablation of long-standing persistent atrial fibrillation: a pilot study assessing the value of left atrial appendage peak flow velocity.

BACKGROUND Catheter ablation is an effective and potentially curative treatment in patients with atrial fibrillation (AF). AIM To test the hypothesis that left atrial appendage peak flow velocity (LAV) assessed by echocardiography can accurately predict successful catheter ablation as well as favourable outcome in the setting of long-standing persistent AF. METHODS This prospective pilot study enrolled 40 patients with long-standing persistent AF (age 60 ± 11 years; persistence of AF 4.2 ± 2 years) who underwent a first catheter ablation procedure using a standardized sequential stepwise protocol. LAV was assessed before the catheter ablation procedure along with classical factors (age, sex, left atrial area, AF cycle length, AF duration and left ventricular ejection fraction), all of which were tested using logistic regression for ability to predict restoration of sinus rhythm during catheter ablation as well as absence of recurrence during a 1-year follow-up. RESULTS Eighteen patients (45%) experienced AF termination during the procedure and 18 patients (45%) did not develop any recurrence during the first 12 months. Multivariable analysis demonstrated that high LAV (>0.3 m/s) was the only independent predictor of AF termination (odds ratio 5.91, 95% confidence interval 1.06-32.88; P=0.04) and absence of recurrence at 1 year (odds ratio 4.33, 95% confidence interval 1.05-17.81; P=0.04). CONCLUSIONS This pilot study demonstrated the feasibility and importance of LAV measurement in the setting of long-standing persistent AF to predict successful catheter ablation and favourable mid-term outcome.

Real-time assessment of pulmonary vein disconnection during cryoablation of atrial fibrillation: can it be 'achieved' in almost all cases?

AIM Real-time assessment of pulmonary vein (PV) disconnection is possible using an inner circular mapping catheter during cryoablation of atrial fibrillation (AF). However, it has been recently demonstrated that such continuous monitoring may only be possible in <50% of PVs. We hypothesized that a stepwise mapping approach, including pacing manoeuvres, could optimize monitoring of real-time PV disconnection during ablation. METHODS AND RESULTS Single-centre, prospective observational study (NCT01843465) including 34 consecutive eligible patients (128 PVs) undergoing a first procedure of cryoballoon ablation of AF using the Artic Front Advance(®) 28 mm catheter and a 20 mm diameter Achieve(®) catheter (AC) in all cases. Monitoring of real-time entrance block was possible, when AC was maintained in the standard position (distal to the tip of the Artic Front Advance(®) catheter) in 47 (36.7%) PVs. In an additional 63 cases (49.2%), such monitoring was possible after moving AC to a more proximal position and using different torqueing movements. Finally, using supplemental systematic pacing manoeuvres to test exit block, real-time assessment of PV disconnection was possible in 15 (11.7%) more PVs. Overall, real-time assessment of PV disconnection was possible in 97.7% of cases, after a mean duration of 48.6 ± 33.0 s. CONCLUSION Our results suggest that optimal use of the AC, with a systematic stepwise mapping approach, may dramatically improve the real-time monitoring of PV disconnection during AF cryoablation.