Rivaroxabananddabigatraninpatientsundergoing 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

Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation.

BACKGROUND: Current guidelines recommend pulmonary-vein isolation by means of catheter ablation as treatment for drug-refractory paroxysmal atrial fibrillation. Radiofrequency ablation is the most common method, and cryoballoon ablation is the second most frequently used technology. METHODS: We conducted a multicenter, randomized trial to determine whether cryoballoon ablation was noninferior to radiofrequency ablation in symptomatic patients with drug-refractory paroxysmal atrial fibrillation. The primary efficacy end point in a time-to-event analysis was the first documented clinical failure (recurrence of atrial fibrillation, occurrence of atrial flutter or atrial tachycardia, use of antiarrhythmic drugs, or repeat ablation) following a 90-day period after the index ablation. The noninferiority margin was prespecified as a hazard ratio of 1.43. The primary safety end point was a composite of death, cerebrovascular events, or serious treatment-related adverse events. RESULTS: A total of 762 patients underwent randomization (378 assigned to cryoballoon ablation and 384 assigned to radiofrequency ablation). The mean duration of follow-up was 1.5 years. The primary efficacy end point occurred in 138 patients in the cryoballoon group and in 143 in the radiofrequency group (1-year Kaplan-Meier event rate estimates, 34.6% and 35.9%, respectively; hazard ratio, 0.96; 95% confidence interval [CI], 0.76 to 1.22; P<0.001 for noninferiority). The primary safety end point occurred in 40 patients in the cryoballoon group and in 51 patients in the radiofrequency group (1-year Kaplan-Meier event rate estimates, 10.2% and 12.8%, respectively; hazard ratio, 0.78; 95% CI, 0.52 to 1.18; P=0.24). CONCLUSIONS: In this randomized trial, cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation, and there was no significant difference between the two methods with regard to overall safety. (Funded by Medtronic; FIRE AND ICE ClinicalTrials.gov number, NCT01490814.)

Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial.

AIMS: The primary safety and efficacy endpoints of the randomized FIRE AND ICE trial have recently demonstrated non-inferiority of cryoballoon vs. radiofrequency current (RFC) catheter ablation in patients with drug-refractory symptomatic paroxysmal atrial fibrillation (AF). The aim of the current study was to assess outcome parameters that are important for the daily clinical management of patients using key secondary analyses. Specifically, reinterventions, rehospitalizations, and quality-of-life were examined in this randomized trial of cryoballoon vs. RFC catheter ablation. METHODS AND RESULTS: Patients (374 subjects in the cryoballoon group and 376 subjects in the RFC group) were evaluated in the modified intention-to-treat cohort. After the index ablation, log-rank testing over 1000 days of follow-up demonstrated that there were statistically significant differences in favour of cryoballoon ablation with respect to repeat ablations (11.8% cryoballoon vs. 17.6% RFC; P = 0.03), direct-current cardioversions (3.2% cryoballoon vs. 6.4% RFC; P = 0.04), all-cause rehospitalizations (32.6% cryoballoon vs. 41.5% RFC; P = 0.01), and cardiovascular rehospitalizations (23.8% cryoballoon vs. 35.9% RFC; P < 0.01). There were no statistical differences between groups in the quality-of-life surveys (both mental and physical) as measured by the Short Form-12 health survey and the EuroQol five-dimension questionnaire. There was an improvement in both mental and physical quality-of-life in all patients that began at 6 months after the index ablation and was maintained throughout the 30 months of follow-up. CONCLUSION: Patients treated with cryoballoon as opposed to RFC ablation had significantly fewer repeat ablations, direct-current cardioversions, all-cause rehospitalizations, and cardiovascular rehospitalizations during follow-up. Both patient groups improved in quality-of-life scores after AF ablatio

Amplified sinus-P-wave analysis predicts outcomes of cryoballoon ablation in patients with persistent and long-standing persistent atrial fibrillation: A multicentre study

IntroductionOutcomes of catheter ablation for non-paroxysmal atrial fibrillation (AF) remain suboptimal. Non-invasive stratification of patients based on the presence of atrial cardiomyopathy (ACM) could allow to identify the best responders to pulmonary vein isolation (PVI).MethodsObservational multicentre retrospective study in patients undergoing cryoballoon-PVI for non-paroxysmal AF. The duration of amplified P-wave (APW) was measured from a digitally recorded 12-lead electrocardiogram during the procedure. If patients were in AF, direct-current cardioversion was performed to allow APW measurement in sinus rhythm. An APW cut-off of 150 ms was used to identify patients with significant ACM. We assessed freedom from arrhythmia recurrence at long-term follow-up in patients with APW ≥ 150 ms vs. APW &lt; 150 ms.ResultsWe included 295 patients (mean age 62.3 ± 10.6), of whom 193 (65.4%) suffered from persistent AF and the remaining 102 (34.6%) from long-standing persistent AF. One-hundred-forty-two patients (50.2%) experienced arrhythmia recurrence during a mean follow-up of 793 ± 604 days. Patients with APW ≥ 150 ms had a significantly higher recurrence rate post ablation compared to those with APW &lt; 150 ms (57.0% vs. 41.6%; log-rank p &lt; 0.001). On a multivariable Cox-regression analysis, APW≥150 ms was the only independent predictor of arrhythmia recurrence post ablation (HR 2.03 CI95% 1.28–3.21; p = 0.002).ConclusionAPW duration predicts arrhythmia recurrence post cryoballoon-PVI in persistent and long-standing persistent AF. An APW cut-off of 150 ms allows to identify patients with significant ACM who have worse outcomes post PVI. Analysis of APW represents an easy, non-invasive and highly reproducible diagnostic tool which allows to identify patients who are the most likely to benefit from PVI-only approach

Feasibility and safety of same-day home discharge after radiofrequency catheter ablation

Interventional cardiology in a day-case setting might reduce logistic constraints on hospital resources. However, in contrast with coronary angioplasty, few data support the feasibility and safety of radiofrequency catheter ablation (RCA). The aim of this prospective, multicenter cohort study was to evaluate the feasibility and safety of RCA in 1,342 patients (814 men; mean age 57 +/- 17 years) considered eligible for ambulatory RCA, according to specific set of criteria, for common atrial flutter (n = 632), atrioventricular nodal reentrant tachycardia (n = 436), accessory pathways (n = 202), and atrial tachycardia (n = 72). Patients suitable for early discharge (4 to 6 hours after uncomplicated RCA) were scheduled for 1-month follow-up. Predictive factors for delayed complications were studied by multivariate analysis. Of the 1,342 enrolled patients, 1,270 (94.6%) were discharged the same day and followed for 1 month; no deaths occurred, and the readmission rate was 0.79% (95% confidence interval 0.30% to 1.27%). Six patients had significant puncture complications, 2 presented with symptomatic delayed pulmonary embolism, and 2 had new onset of poorly tolerated atrial flutter. None of these complications was life threatening. Multivariate analysis did not identify any significant independent predictors for delayed complications. In conclusion, these data suggest that same-day discharge after uncomplicated RCA for routine supraventricular arrhythmias is safe and may be applicable in clinical practice. This approach is known to be associated with significant patient satisfaction and cost savings and can be considered a first-line option in most patients who undergo routine ablation procedures

Impact of transcatheter aortic valve implantations on temporal trends of pacemaker implantations among French octogenarians: A Nation-Wide Cohort Study over the period 2008-2018

International audienceBackground: The indications for permanent pacemaker implantation (PPMI) are strongly associated with age, with the highest rates for octogenarians (> 80 years old). Over the last decade, impact of aging on temporal trends in PPMI rates among octogenarians is questionable. In the 2010’s, transcatheter aortic valve implantation (TAVI) has emerged for inoperable or high-risk patients, mainly octogenarians, with an exponential increase over years. PPMI is a common short-term complication after TAVI procedure. Many studies have explored these post-TAVI PPMI in terms of incidence, timing and outcomes of PPMI following TAVI, but there are no data on the impact of TAVI on PPMI temporal trend at a nationwide scale.Purpose:To evaluate whether PPMI in octogenarians have increased during the last decade, independently from age and sex, on a nationwide scale. Eventually, to estimate the potential contribution of TAVI in PPMI increase in this setting. Methods:Our study was based on octogenarians from the Echantillon Généraliste de Bénéficiaires, the 1/97 random sample of the French nationwide health insurance claims database. Between 2008 and 2018, we identified de novo PPMI and TAVI with medical procedures codes in the French Common Classification of Medical Procedures (CCAM). Annual incidence rates of PPMI were evaluated between 2008 and 2012 (preTAVI-period). The number of observed PPMI cases, O, in the period 2013-2018 (TAVI-period) was compared with the expected number of PPMI cases, E, calculated by using 2008-2012 incidence rates with age and sex standardization. We then computed the standardized incidence ratio (SIR) of the observed number of PPMI to the expected number of PPMI (O/E), with 95% confidence intervals (CIs). Thereafter, we evaluated the contribution of post-TAVI PPMI in the number of excess cases of PPMI (O-E) for the period 2013-2018. Results:The population of octogenarians increased from 23,822 in 2008 to 33,752 in 2018. In 2008, 130 PPMI were observed (546/100,000 inhabitants) reaching 228 PPMI (676/100,000) in 2018 with a marked increase in rates from the year 2012. During the period 2013-2018, for all octogenarians, 1242 cases of PPMI were observed, compared with 1171.3 expected cases of PPMI, corresponding to a significant SIR=1.06 (95%CI: 1.01-1.12). For the subpopulation of octogenarians without TAVI, no excess risk was observed with a SIR=1.01 (95%CI: 0.95 – 1.06). Among the excess cases of PPMI observed in 2013-2018 in all octogenarians, 72% were post-TAVI PPMI.Conclusion:Based on our study, the number of observed PPMI in octogenarians in period 2013-2018 is 6% higher than the number we would expect. Nearly three-quarter of these excess cases are attributable to TAVI complication

Impact of transcatheter aortic valve implantations on temporal trends of pacemaker implantations among French octogenarians: A Nation-Wide Cohort Study over the period 2008-2018

International audienceBackground: The indications for permanent pacemaker implantation (PPMI) are strongly associated with age, with the highest rates for octogenarians (> 80 years old). Over the last decade, impact of aging on temporal trends in PPMI rates among octogenarians is questionable. In the 2010’s, transcatheter aortic valve implantation (TAVI) has emerged for inoperable or high-risk patients, mainly octogenarians, with an exponential increase over years. PPMI is a common short-term complication after TAVI procedure. Many studies have explored these post-TAVI PPMI in terms of incidence, timing and outcomes of PPMI following TAVI, but there are no data on the impact of TAVI on PPMI temporal trend at a nationwide scale.Purpose:To evaluate whether PPMI in octogenarians have increased during the last decade, independently from age and sex, on a nationwide scale. Eventually, to estimate the potential contribution of TAVI in PPMI increase in this setting. Methods:Our study was based on octogenarians from the Echantillon Généraliste de Bénéficiaires, the 1/97 random sample of the French nationwide health insurance claims database. Between 2008 and 2018, we identified de novo PPMI and TAVI with medical procedures codes in the French Common Classification of Medical Procedures (CCAM). Annual incidence rates of PPMI were evaluated between 2008 and 2012 (preTAVI-period). The number of observed PPMI cases, O, in the period 2013-2018 (TAVI-period) was compared with the expected number of PPMI cases, E, calculated by using 2008-2012 incidence rates with age and sex standardization. We then computed the standardized incidence ratio (SIR) of the observed number of PPMI to the expected number of PPMI (O/E), with 95% confidence intervals (CIs). Thereafter, we evaluated the contribution of post-TAVI PPMI in the number of excess cases of PPMI (O-E) for the period 2013-2018. Results:The population of octogenarians increased from 23,822 in 2008 to 33,752 in 2018. In 2008, 130 PPMI were observed (546/100,000 inhabitants) reaching 228 PPMI (676/100,000) in 2018 with a marked increase in rates from the year 2012. During the period 2013-2018, for all octogenarians, 1242 cases of PPMI were observed, compared with 1171.3 expected cases of PPMI, corresponding to a significant SIR=1.06 (95%CI: 1.01-1.12). For the subpopulation of octogenarians without TAVI, no excess risk was observed with a SIR=1.01 (95%CI: 0.95 – 1.06). Among the excess cases of PPMI observed in 2013-2018 in all octogenarians, 72% were post-TAVI PPMI.Conclusion:Based on our study, the number of observed PPMI in octogenarians in period 2013-2018 is 6% higher than the number we would expect. Nearly three-quarter of these excess cases are attributable to TAVI complication