Artificial intelligence software standardizes electrogram-based ablation outcome for persistent atrial fibrillation.

INTRODUCTION: Multiple groups have reported on the usefulness of ablating in atrial regions exhibiting abnormal electrograms during atrial fibrillation (AF). Still, previous studies have suggested that ablation outcomes are highly operator- and center-dependent. This study sought to evaluate a novel machine learning software algorithm named VX1 (Volta Medical), trained to adjudicate multipolar electrogram dispersion. METHODS: This study was a prospective, multicentric, nonrandomized study conducted to assess the feasibility of generating VX1 dispersion maps. In 85 patients, 8 centers, and 17 operators, we compared the acute and long-term outcomes after ablation in regions exhibiting dispersion between primary and satellite centers. We also compared outcomes to a control group in which dispersion-guided ablation was performed visually by trained operators. RESULTS: The study population included 29% of long-standing persistent AF. AF termination occurred in 92% and 83% of the patients in primary and satellite centers, respectively, p = 0.31. The average rate of freedom from documented AF, with or without antiarrhythmic drugs (AADs), was 86% after a single procedure, and 89% after an average of 1.3 procedures per patient (p = 0.4). The rate of freedom from any documented atrial arrhythmia, with or without AADs, was 54% and 73% after a single or an average of 1.3 procedures per patient, respectively (p < 0.001). No statistically significant differences between outcomes of the primary versus satellite centers were observed for one (p = 0.8) or multiple procedures (p = 0.4), or between outcomes of the entire study population versus the control group (p > 0.2). Interestingly, intraprocedural AF termination and type of recurrent arrhythmia (i.e., AF vs. AT) appear to be predictors of the subsequent clinical course. CONCLUSION: VX1, an expertise-based artificial intelligence software solution, allowed for robust center-to-center standardization of acute and long-term ablation outcomes after electrogram-based ablation.

Reproducibility of pulmonary vein isolation guided by the ablation index: 1-year outcome of the AIR registry.

BACKGROUND: Ablation index (AI) is a new lesion quality marker that has been demonstrated to allow a high single-procedure arrhythmia-free survival in single-center studies. This prospective, multi-center study was designed to evaluate the reproducibility of pulmonary vein (PV) isolation guided by the AI. METHODS: A total of 490 consecutive patients with paroxysmal (80.4%) and persistent AF underwent first time PV isolation and were divided in four study groups according to operator's preference in choosing the ablation catheter (a contact force (ST) or contact force surround flow (STSF) catheter) and the AI setting (330-450 or 380-500 at anterior wall or posterior wall, respectively). RESULTS: At 12 months a high rate of freedom from AF recurrences was observed in patients with both paroxysmal and persistent AF (91% vs 83.3%; P = .039). There was no difference in the rate of AF recurrence among the four study groups (4.5% in group ST330-450, 12.2% in group ST 380-500, 14.9% in group STSF330-450, 9.4% in group STSF380-500; P = .083). Recurrence was also similar between patients treated with a ST (8%) or STSF catheter (12.1%; P = .2), and within patients targeting an AI settings of 330 to 450 (10.9%) or 380 to 500 (10.3%; P = .64). In patients with paroxysmal AF, there was no difference (P = .12) in the 1-year freedom from AF recurrence among 14 operators that performed ≥10 ablation procedure. CONCLUSIONS: An ablation protocol respecting strict criteria for contiguity and quality lesion resulted in high rate of 1-year freedom from AF recurrence, irrespective of the ablation catheters, AI settings, and operator.

Reproducibility of acute pulmonary vein isolation guided by the ablation index.

BACKGROUND: Atrial fibrillation (AF) ablation outcome is still operator dependent. Ablation Index (AI) is a new lesion quality marker that has been demonstrated to allow acute durable pulmonary vein (PV) isolation followed by a high single-procedure arrhythmia-free survival. This prospective, multicenter study was designed to evaluate the reproducibility of acute PV isolation guided by the AI. METHODS: A total of 490 consecutive patients with paroxysmal (80.4%) and persistent AF underwent first time PV encircling and were divided in four study groups according to operator preference in choosing the ablation catheter (a contact force [ST] or contact force surround flow [STSF] catheter) and the AI setting (330 at posterior and 450 at anterior wall or 380 at posterior and 500 at anterior wall). Radiofrequency was delivered targeting interlesion distance ≤6 mm. RESULTS: The rate of first-pass PV isolation (ST330 90 ± 16%, ST380 87 ± 19%, STSF330 90 ± 17%, STSF380 91 ± 15%, P = .585) was similar among the four study groups, whereas procedure (ST330 129 ± 44 minutes, ST380 144 ± 44 minutes, STSF330 120 ± 72 minutes, STSF380 125 ± 73 minutes, P < .001) and fluoroscopy time (ST330 542 ± 285 seconds, ST380 540 ± 416 seconds, STSF330 257 ± 356 seconds, STSF380 379 ± 454 seconds, P < 0.001) significantly differed. The difference in the rate of first-pass isolation was not statistical different (P = .06) among the 12 operators that performed at least 15 procedures. CONCLUSIONS: An ablation protocol respecting strict criteria for contiguity and quality lesion results in high and comparable rate of acute PV isolation among operator performing ablation with different catheters, AI settings, procedure, and fluoroscopy times.

Left atrial appendage closure in very elderly patients in the French National Registry.

OBJECTIVE: Left atrial appendage closure (LAAC) is recommended to decrease the stroke risk in patients with atrial fibrillation and contraindications to anticoagulation. However, age-stratified data are scarce. The aim of this study was to provide information on the safety and efficacy of LAAC, with emphasis on the oldest patients. METHODS: A nationwide, prospective, multicentre, observational registry was established by 53 French cardiology centres in 2018-2021. The composite primary endpoint included ischaemic stroke, systemic embolism, and unexplained or cardiovascular death. Separate analyses were done in the groups <80 years and ≥80 years. RESULTS: Among the 1053 patients included, median age was 79.7 (73.6-84.3) years; 512 patients (48.6%) were aged ≥80 years. Procedure-related serious adverse events were non-significantly more common in octogenarians (7.0% vs 4.4% in patients aged <80 years, respectively; p=0.07). Despite a higher mean CHA2DS2-VASc score in octogenarians, the rate of thromboembolic events during the study was similar in both groups (3.0 vs 3.1/100 patient-years; p=0.85). By contrast, all-cause mortality was significantly higher in octogenarians (15.3 vs 10.1/100 patient-years, p<0.015), due to a higher rate of non-cardiovascular deaths (8.2 vs 4.9/100 patient-years, p=0.034). The rate of the primary endpoint was 8.1/100 patient-years overall with no statistically significant difference between age groups (9.4 and 7.0/100 patient-years; p=0.19). CONCLUSION: Despite a higher mean CHA2DS2-VASc score in octogenarians, the rate of thromboembolic events after LAAC in this age group was similar to that in patients aged <80 years. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT03434015).

Contact-force local impedance algorithm to guide effective pulmonary vein isolation in AF patients: 1-year outcome from an international multicenter clinical setting.

BACKGROUND: The combination of highly localized impedance (LI) and contact force (CF) may improve tissue characterization and lesion prediction during radiofrequency (RF) pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). OBJECTIVE: We report the outcomes of our acute and long-term clinical evaluation of CF-LI-guided PVI in consecutive AF ablation cases from an international multicenter clinical setting. METHODS: Three hundred twenty-four consecutive patients from 20 European centers undergoing RF catheter ablation with the Stablepoint™ catheter were enrolled in the CHARISMA registry. Of these, 275 had a minimum follow-up of 1 year and were included in the primary analysis. RESULTS: The mean procedure duration was 115 ± 47 min, and the mean fluoroscopy time was 9.9 ± 6 min. At the end of the procedures, all PVs had been successfully isolated in all study patients. Minor complications were reported in 12 patients (4.4%). At 1 year, 36 (13.1%) patients had had an AF recurrence, and freedom from antiarrhythmic drugs and AF recurrence was achieved in 228 (82.9%) patients. The recurrence rate was higher in patients with persistent AF (21/116, 18.1%) than in those with paroxysmal AF (15/159, 9.4%; p = 0.0459). On multivariate logistic analysis adjusted for baseline confounders, only time > 6 months from first diagnosis of AF to ablation (HR = 2.93, 95%CI 1.03 to 8.36, p = 0.0459) was independently associated with recurrences. CONCLUSION: An ablation strategy for PVI guided by CF-LI technology proved safe and effective and resulted in a low recurrence rate of AF over 1-year follow-up, irrespective of the underlying AF type. CLINICAL TRIAL REGISTRATION: Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice. (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998.

Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study.

Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.

Insight into contact force local impedance technology for predicting effective pulmonary vein isolation.

Background: Highly localized impedance (LI) measurements during atrial fibrillation (AF) ablation have the potential to act as a reliable predictor of the durability of the lesions created. Objective: We aimed to collect data on the procedural parameters affecting LI-guided ablation in a large multicenter registry. Methods: A total of 212 consecutive patients enrolled in the CHARISMA registry and undergoing their first pulmonary vein (PV) isolation for paroxysmal and persistent AF were included. Results: In all, 13,891 radiofrequency (RF) applications of ≥3 s duration were assessed. The first-pass PV isolation rate was 93.3%. A total of 80 PV gaps were detected. At successful ablation spots, baseline LI and absolute LI drop were larger than at PV gap spots (161.4 ± 19â€…Ω vs. 153.0 ± 13 Ω, p < 0.0001 for baseline LI; 22.1 ± 9â€…Ω vs. 14.4 ± 5 Ω, p < 0.0001 for LI drop). On the basis of Receiver operating characteristic curve analysis, the ideal LI drop, which predicted successful ablation, was >21â€…Ω at anterior sites and >18â€…Ω at posterior sites. There was a non-linear association between the magnitude of LI drop and contact-force (CF) (r = 0.14, 95% CI: 0.13-0.16, p < 0.0001) whereas both CF and LI drop were inversely related with delivery time (DT) (-0.22, -0.23 to -0.20, p < 0.0001 for CF; -0.27, -0.29 to -0.26, p < 0.0001 for LI drop). Conclusion: An LI drop >21â€…Ω at anterior sites and >18â€…Ω at posterior sites predicts successful ablation. A higher CF was associated with an increased likelihood of ideal LI drop. The combination of good CF and adequate LI drop allows a significant reduction in RF DT. Clinical trial registration: http://clinicaltrials.gov/, identifier: NCT03793998.

Recurrences of Atrial Fibrillation Despite Durable Pulmonary Vein Isolation: The PARTY-PVI Study.

BACKGROUND: Recurrences of atrial fibrillation (AF) after pulmonary vein isolation (PVI) are mainly due to pulmonary vein reconnection. However, a growing number of patients have AF recurrences despite durable PVI. The optimal ablative strategy for these patients is unknown. We analyzed the impact of current ablation strategies in a large multicenter study. METHODS: Patients undergoing a redo ablation for AF and presenting durable PVI were included. The freedom from atrial arrhythmia after pulmonary vein-based, linear-based, electrogram-based, and trigger-based ablation strategies were compared. RESULTS: Between 2010 and 2020, 367 patients (67% men, 63±10 years, 44% paroxysmal) underwent a redo ablation for AF recurrences despite durable PVI at 39 centers. After durable PVI was confirmed, linear-based ablation was performed in 219 (60%) patients, electrogram-based ablation in 168 (45%) patients, trigger-based ablation in 101 (27%) patients, and pulmonary vein-based ablation in 56 (15%) patients. Seven patients (2%) did not undergo any additional ablation during the redo procedure. After 22±19 months of follow-up, 122 (33%) and 159 (43%) patients had a recurrence of atrial arrhythmia at 12 and 24 months, respectively. No significant difference in arrhythmia-free survival was observed between the different ablation strategies. Left atrial dilatation was the only independent factor associated with arrhythmia-free survival (HR, 1.59 [95% CI, 1.13-2.23]; P=0.006). CONCLUSIONS: In patients with recurrent AF despite durable PVI, no ablation strategy used alone or in combination during the redo procedure appears to be superior in improving arrhythmia-free survival. Left atrial size is a significant predictor of ablation outcome in this population.

Temporary transvenous VDD pacing as a bridge to permanent pacemaker implantation in patients with sepsis and haemodynamically significant atrioventricular block.

AIMS: Permanent pacemaker (PM) implantation is temporarily contraindicated in patients (pts) with sepsis. In patients with symptomatic atrioventricular (AV) block and infection, prolonged VVI pacing is therefore usually ensured by a ventricular pacing lead (PL) connected to an external PM generator. In patients with normal sinus function and heart failure, the VVI mode can exacerbate haemodynamic dysfunction. A single AV PL can be attractive to achieve physiological pacing. This study was designed to assess the efficacy and safety of temporary VDD pacing as a bridge to permanent PM implantation in patients with complete AV block until control of infection. METHODS AND RESULTS: This study included eight patients with complete AV block and sepsis with negative blood culture. Due to the presence of congestive heart failure, a single bipolar AV PL connected to an external VDD PM generator. At VDD implantation, P-wave amplitude was 1.9 ± 1.6 mV and R-wave was 11.3 ± 5.2 mV. The ventricular pacing threshold was 0.53 ± 0.1 V for a 0.5 ms pulse. Antibiotic therapy was instituted in all patients. A permanent VDD or DDD PM was implanted after 8 ± 2.5 days of temporary VDD pacing. At permanent PM implantation, the mean brain natriuretic peptide level had decreased and sepsis was controlled in all patients. No recurrence of sepsis was observed with a mean follow-up of 15.8 ± 5.3 months. CONCLUSION: Temporary VDD pacing is a safe and effective method to achieve prolonged AV physiological pacing in patients with AV block until infection has been controlled.

Left atrial appendage closure for thrombus trapping: the international, multicentre TRAPEUR registry.

BACKGROUND: Although the presence of a thrombus contraindicates left atrial appendage closure procedure (LAAC), a previous study reported the feasibility of the thrombus trapping procedure (TTP) technique to overcome this limitation. AIMS: This study aimed to analyse the short-term outcomes in a series of patients who underwent LAAC using the TTP (TTP-LAAC). METHODS: This retrospective series included patients who underwent TTP-LAAC between January 2018 and May 2020 in 13 European centres. Device choice, pre-interventional work-up and post-discharge antithrombotic therapy regimens were left to the discretion of the operators. The primary endpoint was the 30-day occurrence of stroke, systemic embolism or cardiovascular death. RESULTS: During the study period, a total of 1,918 patients underwent LAAC. A thrombus was identified in 71 cases but completely disappeared in 24 patients before procedure. TTP-LAAC was finally performed in 53 cases (3%). Thrombi were identified ahead of the actual day of implantation in 47 patients (87%) and were mostly limited in size (50 cases with extension <50% of the LAA surface). The Amplatzer Amulet and WATCHMAN FLX occluders were implanted in 44 and 9 patients, respectively. A single deployment approach was applied in 70% and a cerebral embolic protection system was used in 9% of the patients. The overall success rate was 100%. Small pericardial effusion without tamponade was observed in 6% of the cases. Patients were discharged with 72% under antiplatelet therapy and 10% under short-term oral anticoagulation. The primary endpoint occurred in one patient. CONCLUSIONS: TTP-LAAC might be used in a minority of LAAC procedures but appears to be feasible and safe in the short-term, in select cases.

Definition of success criteria for ablation of typical right atrial flutter with a single-catheter approach: A pilot study.

BACKGROUND: The success rate of cavotricuspid isthmus ablation to treat right common flutter is high (up to 95%), but needs bidirectional block confirmation, requiring two or three catheters. AIM: To describe a new pacing technique using a single catheter to ablate and confirm cavotricuspid isthmus block with differential PR interval measurements. METHODS: We included 61 patients from five centres, who were referred for cavotricuspid isthmus ablation. All patients had cavotricuspid isthmus ablation, and the cavotricuspid isthmus block was confirmed by differential pacing using two or three catheters. The new method consisted of measuring the PR interval on the surface electrocardiogram using pacing from the tip of the ablation catheter on the lateral side (lateral delay) and the septal side (coronary sinus ostium) of the cavotricuspid isthmus line (difference=delta PR interval), before and after cavotricuspid isthmus ablation. We analysed the value of the delta PR interval in predicting bidirectional cavotricuspid isthmus block as confirmed by standard methods. RESULTS: Among our patient population (mean age 63±12 years), 39 patients were ablated during sinus rhythm, and 22 during common flutter. Cavotricuspid isthmus block was achieved in all patients but one. Lateral delay and delta PR interval increased significantly after validation of cavotricuspid isthmus block (257±42 vs. 318±50ms and 32±23 vs. 96±22ms, respectively; P<0.0001). A delta PR interval cut-off of ≥70ms had 100% sensitivity and specificity to predict bidirectional cavotricuspid isthmus block. CONCLUSIONS: A single-catheter ablation approach to performing cavotricuspid isthmus line based on surface electrocardiogram PR interval measurement is feasible. After ablation, cavotricuspid isthmus block was systematically obtained when the delta PR interval was>70ms.

Reduced Rivaroxaban Dose Versus Dual Antiplatelet Therapy After Left Atrial Appendage Closure: ADRIFT a Randomized Pilot Study.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) exposes to the risk of device thrombosis in patients with atrial fibrillation who frequently have a contraindication to full anticoagulation. Thereby, dual antiplatelet therapy (DAPT) is usually preferred. No randomized study has evaluated nonvitamin K antagonist oral anticoagulant after LAAC, and we decided to evaluate the efficacy and safety of reduced doses of rivaroxaban after LAAC. METHODS: ADRIFT (Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban in Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure) is a multicenter, phase IIb study, which randomized 105 patients after successful LAAC to either rivaroxaban 10 mg (R10, n=37), rivaroxaban 15 mg (R15, n=35), or DAPT with aspirin 75 mg and clopidogrel 75 mg (n=33). The primary end point was thrombin generation (prothrombin fragments 1+2) measured 2 to 4 hours after drug intake, 10 days after treatment initiation. Thrombin-antithrombin complex, D-dimers, rivaroxaban concentrations were also measured at 10 days and 3 months. Clinical end points were evaluated at 3-month follow-up. RESULTS: The primary end point was reduced with R10 (179 pmol/L [interquartile range (IQR), 129-273], P<0.0001) and R15 (163 pmol/L [IQR, 112-231], P<0.0001) as compared with DAPT (322 pmol/L [IQR, 218-528]). We observed no significant reduction of the primary end point between R10 and R15 while rivaroxaban concentrations increased significantly from 184 ng/mL (IQR, 127-290) with R10 to 274 ng/mL (IQR, 192-377) with R15, P<0.0001. Thrombin-antithrombin complex and D-dimers were numerically lower with both rivaroxaban doses than with DAPT. These findings were all confirmed at 3 months. The clinical end points were not different between groups. A device thrombosis was noted in 2 patients assigned to DAPT. CONCLUSIONS: Thrombin generation measured after LAAC was lower in patients treated by reduced rivaroxaban doses than DAPT, supporting an alternative to the antithrombotic regimens currently used after LAAC and deserves further evaluation in larger studies. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03273322.

Rates and predictors of appropriate implantable cardioverter-defibrillator therapy delivery: results from the EVADEF cohort study.

BACKGROUND: The implantable cardioverter defibrillator (ICD) is the therapy of choice in patients at risk for sudden cardiac death in both primary and secondary prevention indication. There are no recent data concerning the delivery rate and etiology of appropriate ICD therapies in routine medical care. METHODS: The EVADEF study was a French multicenter, prospective, observational cohort study of ICD patients with a 2-year follow-up. Every 6 months we recorded patients' survival status and evaluated appropriate ICD therapies-antitachycardia pacing or shocks. Causes of ICD activation were also recorded from among ventricular tachycardia (VT), fast VT and ventricular fibrillation (VF). RESULTS: From 2001 to 2003, 2296 unselected patients were implanted and followed until 2005. During a mean follow-up of 20.5 months, 274 deaths occurred. In 2009 patients with cardiopathy, 22 patients per 100 person-years had at least one appropriate therapy. Twenty-four and 11 patients per 100 person-years had at least one therapy in secondary and primary prevention, respectively. Age >65 years, left ventricular ejection fraction <30% and secondary prevention were independently associated with appropriate therapy. Besides, 5 patients per 100 person-years had at least 1 episode of life-threatening arrhythmia (fast VT or VF). Left ventricular ejection fraction <30% and secondary prevention were independently associated with life-threatening arrhythmia. In 287 patients without cardiopathy, the rate of appropriate therapy was twice as less, whereas the rate of life-threatening arrhythmia was similar. CONCLUSION: Over a 24-month follow-up, the rate of appropriate therapy was substantial while few patients had life-threatening arrhythmia. Appropriate therapies and life-threatening arrhythmia were more frequent in patients with secondary prevention indication.

Relationship between New York Heart Association class change and ventricular tachyarrhythmia occurrence in patients treated with cardiac resynchronization plus defibrillator.

AIMS: In patients with advanced heart failure (HF) and prolonged QRS interval, cardiac resynchronization therapy (CRT) reduces symptoms and risk of death. The added benefit of an implantable cardioverter defibrillator (ICD) remains questionable in some patients. METHODS AND RESULTS: In 332 HF patients treated with CRT-D (CRT with ICD) [65 +/- 10 years, 86% men, 23% New York Heart Association (NYHA) class II, 65% class III, and 11% class IV, 70% primary prevention, 55% ischaemic cardiomyopathy, left ventricular ejection fraction 25 +/- 7.5%, and QRS width 167 +/- 32 ms], we evaluated the relationship between functional status change, death at 6-month follow-up (FU), and the occurrence of ventricular tachyarrhythmia/ventricular fibrillation (VT/VF). A total of 68 patients (20.5%) experienced 1266 spontaneous episodes of VT/VF during FU. There was no difference in baseline characteristics between patients with or without VT/VF, except for ICD indication (primary or secondary prevention). Improvement in NYHA class was significantly associated with a decreased occurrence of VT/VF (P = 0.004). Sixteen patients who died had significantly more often VT/VF than the survivors (50 vs. 19%, P = 0.007). CONCLUSION: Within the initial 6-month post-CRT therapy, 20% of patients received an appropriate ICD therapy. Patients improving on NYHA class (responders to CRT) have less VT/VF episodes than non-responders. Discriminant criteria for CRT response are awaited to optimize the choice of the device (CRT alone, defibrillator alone, or CRT-D).

[Treatment of atrial fibrillation in heart failure]. / Traiter la fibrillation atriale dans l'insuffisance cardiaque.

Treatment of patients with both atrial fibrillation and heart failure remains uneasy. In theory maintenance of sinus rhythm is desirable but the only pharmacological intervention able to do it safely is amiodarone. A trial of strategy randomisation, restoration of sinus rhythm or slowing of atrial fibrillation, has been done in patients with both atrial fibrillation and heart failure. This trial, named AF-CHF has shown neutral results, the 2 strategies, rhythm control or simple rate control were similar in terms of mortality. Dronedarone is an innovative drug bringing new possibilities in the treatment of atrial fibrillation but it is contra-indicated in case of severe heart failure. Another possible approach is that of non pharmacological techniques. Sinus rhythm maintenance may be obtained by pulmonary vein isolation. The other possibility is the ablation of atrio-ventricular node with implantation of a pacemaker, technique which is reserved to selected patients.

Percutaneous Left Atrial Appendage Closure Is a Reasonable Option for Patients With Atrial Fibrillation at High Risk for Cerebrovascular Events.

BACKGROUND: Percutaneous left atrial appendage (LAA) closure is an emerging option for patients with atrial fibrillation at high risk for cerebrovascular events. The multicenter FLAAC registry (French Nationwide Observational LAA Closure Registry) was established to assess LAA closure outcomes in everyday practice. METHODS AND RESULTS: Four hundred thirty-six patients referred from April 2013 to September 2015 to 33 French interventional cardiology centers for percutaneous LAA closure were included prospectively in the FLAAC registry. Mean age was 75.4±0.4 years. The stroke risk was high (mean CHA2DS2-VASc score, 4.5±0.1) and most patients had experienced clinically significant bleeding (HAS-BLED score, 3.1±0.05). The device used was Amplatzer LAA occluder in 58% and the Watchman device in 42% of the patients. The procedural success rate was 98.4%. Median postprocedure follow-up was 12.0 (11.8-12.0) months and a single patient was lost to follow-up. During the periprocedural and subsequent follow-up period, procedure-related severe adverse events occurred in 21 (4.9%) and 10 (2.3%) patients, respectively. One-year cumulative incidences of ischemic stroke and cerebral hemorrhage were 2.9% (1.6-5.0) and 1.5% (0.7-3.2), respectively. Overall, 1-year mortality was 9.3% (6.9-12.5) with 7 of the 39 deaths related or possibly related to the device or procedure. CONCLUSIONS: This nationwide prospective registry shows that, in the French population, LAA closure is mainly used in patients with high comorbidity rates and a poor prognosis. LAA closure in such patients seems reasonable to decrease the stroke rate. The overall health status of these patients should be taken into account during the preprocedural evaluation process. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02252861.

Device-Related Thrombosis After Percutaneous Left Atrial Appendage Occlusion for Atrial Fibrillation.

BACKGROUND: Transcatheter left atrial appendage (LAA) occlusion is an alternative strategy for stroke prevention in patients with atrial fibrillation (AF). OBJECTIVES: This study sought to determine the incidence, predictors, and prognosis of thrombus formation on devices in patients with AF who were treated with LAA closure. METHODS: The study retrospectively analyzed data from patients treated with 2 LAA closure devices seen in 8 centers in France from February 2012 to January 2017. RESULTS: A total of 469 consecutive patients with AF underwent LAA closure (272 Watchman devices [Atritech, Boston Scientific, Natick, Massachusetts] and 197 Amplatzer devices [St. Jude Medical, Minneapolis, Minnesota]). Mean follow-up was 13 ± 13 months, during which 339 (72.3%) patients underwent LAA imaging at least once. There were 98 major adverse events (26 thrombi on devices, 19 ischemic strokes, 2 transient ischemic attacks, 18 major hemorrhages, 33 deaths) recorded in 89 patients. The incidence of device-related thrombus in patients with LAA imaging was 7.2% per year. Older age (hazard ratio [HR]: 1.07 per 1-year increase; 95% confidence interval [CI]: 1.01 to 1.14; p = 0.02) and history of stroke (HR: 3.68; 95% CI: 1.17 to 11.62; p = 0.03) were predictors of thrombus formation on the devices, whereas dual antiplatelet therapy (HR: 0.10; 95% CI: 0.01 to 0.76; p = 0.03) and oral anticoagulation at discharge (HR: 0.26; 95% CI: 0.09 to 0.77; p = 0.02) were protective factors. Thrombus on the device (HR: 4.39; 95% CI: 1.05 to 18.43; p = 0.04) and vascular disease (HR: 5.03; 95% CI: 1.39 to 18.23; p = 0.01) were independent predictors of ischemic strokes and transient ischemic attacks during follow-up. CONCLUSIONS: Thrombus formation on the device is not uncommon in patients with AF who are treated by LAA closure. Such events are strongly associated with a higher risk of ischemic stroke during follow-up. (REgistry on Real-Life EXperience With Left Atrial Appendage Occlusion [RELEXAO]; NCT03279406).

A 5-year clinical follow-up after duty-cycled phased RF ablation of paroxysmal atrial fibrillation.

PURPOSE: Catheter radiofrequency ablation (RFA) is an effective treatment for symptomatic paroxysmal atrial fibrillation (AF). It has been demonstrated that the multielectrode pulmonary vein ablation catheter (PVAC) has favourable outcomes at 6-12 months post-ablation, but there are only few studies with a long-term follow-up. METHODS: We retrospectively reviewed 77 consecutive PVAC procedures in our centre, from November 2007 to December 2012. RFA was attempted in patients with symptomatic paroxysmal AF (mean age 58.7 ± 9.8 years, 50 men (64.9 %). The ablation strategy consisted of circumferential pulmonary vein isolation (CPVI) with the PVAC system. A questionnaire was used over the follow-up period to assess the efficacy of AF ablation. Success was defined as freedom from AF/atrial flutter or atrial arrhythmia for a period ranging from 3 to 12 months or more. RESULTS: Seventy-seven patients were included with paroxysmal AF. The mean duration of the procedure was 99.6 ± 26 min and fluoroscopy time 19.4 ± 6.8 min. Time of RFA was 22.4 ± 5.8 min. Acute complication rate was 10.4 % (the most frequent was vascular injury for 6 patients 7.8 %, 1 patient presented sepsis (1.3 %), 1 patient presented transient ischemic stroke). After a single procedure at a mean FU of 55 ± 11 months, 54/77 (70.1 %) patients were free of symptomatic AF. CONCLUSIONS: These long-term results suggest that PVAC is an efficient system for CPVI of symptomatic paroxysmal AF.