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Catheter ablation (CA) technology development reflects the need to improve the effectiveness of atrial fibrillation (AF) treatment. Recently, the DiamondTemp Ablation (DTA) RF generator software was updated with a more responsive power ramp.DIAMOND FASTR-AF was a prospective, single-arm, multicenter trial. This study sought to characterize the performance of the updated DTA system for the treatment of patients with drug-refractory paroxysmal and persistent AF (PAF and PsAF). The primary effectiveness endpoint was freedom from atrial arrhythmia recurrence following a 90-day blanking period through 12 months, and the primary safety endpoint was a composite of serious adverse events.In total, 60 subjects (34 PAF and 26 PsAF) underwent CA at three centers. Patients were 71.7% male, (age 63.9 ± 10.2 years, with an AF diagnosis duration 3.1 ± 3.9 years and left atrial size 4.4 ± 0.8 cm). Pulmonary vein isolation-only ablation strategy was performed in 34 (56.7%) subjects. The procedural characteristics show a procedure time 90.8 ± 31.6 min, total RF time 14.7 ± 7.7 min, ablation duration 10.7 ± 3.6 s, and fluid infusion 284.7 ± 111.5 ml. The serious adverse event rate was 8.3% (5/60), 3 pulmonary edema and 2 extended hospitalizations. Freedom from atrial arrhythmia recurrence was achieved in 67.6% of subjects by 12 months.The updated DTA system demonstrated long-term safety and effectiveness through 12 months of post-ablation follow-up for patients with atrial fibrillation. Additionally, procedures were demonstrated to be highly efficient with short procedure times and low levels of fluid infusion.Sponsored by Medtronic, Inc.; FASTR-AF ClinicalTrials.gov; NCT03626649.

Pulmonary vein isolation (PVI) is effective at treating 50% of unselected patients with persistent atrial fibrillation (AF). Alternatively, PVI combined with a new ablation strategy entitled the Marshall-PLAN ensures a 78% 1-year sinus rhythm (SR) maintenance rate in the same population. However, a substantial subset of patients could undergo the Marshall-PLAN unnecessarily. It is therefore essential to identify those patients who can be treated with PVI alone versus those who may truly benefit from the Marshall-PLAN before ablation is performed. In this context, we hypothesized that electrical cardioversion (EC) could help to select the most appropriate strategy for each patient.In this multicentre, prospective, randomized study, patients with AF recurrence within 4 weeks after EC will be randomized 1:1 to PVI alone or the Marshall-PLAN. Conversely, patients in whom SR is maintained for ≥4 weeks after EC will be treated with PVI only and included in a prospective registry. The primary endpoint will be the 1-year SR maintenance rate after a single ablation procedure.The Marshall-PLAN might be necessary in patients with an advanced degree of persistent AF (i.e., where SR is not maintained for ≥4 uninterrupted weeks after EC). Conversely, in patients with mild or moderate persistent AF (i.e., where SR is maintained for ≥4 weeks after EC), PVI alone might be a sufficient ablation strategy. The PACIFIC trial is the first study designed to assess whether rhythm monitoring after EC could help to identify patients who should undergo adjunctive ablation strategies beyond PVI.

ObjectivePulmonary vein isolation (PVI) guided by a standardised CLOSE (contiguous optimised lesions) protocol has been shown to increase clinical success after catheter ablation for paroxysmal atrial fibrillation (PAF). This study analysed healthcare utilisation and quality of life (QOL) outcomes from a large multicentre prospective study, measured association between QOL and atrial fibrillation (AF) burden and identified factors associated with lack of QOL improvement.MethodsCLOSE-guided ablation was performed in 329 consecutive patients (age 61.4 years, 60.8% male) with drug-refractory PAF in 17 European centres. QOL was measured at baseline and 12 months post-ablation via Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT) and EuroQoL EQ-5D-5L questionnaires. All-cause and cardiovascular hospitalisations and cardioversions over 12 months pre-ablation and post-ablation were recorded. Rhythm monitoring included weekly and symptom-driven trans-telephonic monitoring, plus ECG and Holter monitoring at 3, 6 and 12 months. AF burden was defined as the percentage of postblanking tracings with an atrial tachyarrhythmia ≥30 s. Continuous measures across multiple time points were analysed using paired t-tests, and associations between various continuous measures were analysed using independent sample t-tests. Each statistical test used two-sided p values with a significance level of 0.05.ResultsBoth QOL instruments showed significant 12-month improvements across all domains: AFEQT score increased 25.1–37.5 points and 33.3%–50.8% fewer patients reporting any problem across EuroQoL EQ-5D-5L domains. Overall, AFEQT improvement was highly associated with AF burden (p=0.009 for 2DS2-VASc scores at baseline, and higher AF burden following PVI.ConclusionsQOL improved and healthcare utilisation decreased significantly after ablation with a standardised CLOSE protocol. QOL improvement was significantly associated with impairment at baseline and AF burden after ablation.Trial registration numberNCT03062046.

DIAMOND-AF (DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation) was a prospective, multicenter, noninferiority, randomized trial that compared the safety and effectiveness of the DTA system versus those of a force-sensing RF ablation system (control) for the treatment of patients with drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (AF).Irrigated radiofrequency (RF) ablation catheters lose tissue temperature acuity, which is vital in assessing lesion formation. DiamondTemp Ablation (DTA) was designed to re-establish accurate tissue temperature measurements during ablation.A total of 482 patients with paroxysmal AF were randomized (239 DTA, 243 control) to undergo pulmonary vein isolation and were followed up at 23 sites. Patients were screened for disease progression, cardiac characteristics, and prior interventions. Primary endpoints were effectiveness (freedom from atrial arrhythmia recurrence) and safety (composite of procedure- and device-related serious adverse events).The primary safety event rate was 3.3% in the DTA group versus 6.6% in the control group (p 0.001 vs. 6.5% noninferiority margin). Primary effectiveness was met in 79.1% of DTA subjects and 75.7% of control subjects (p 0.001 vs. -12.5% noninferiority margin). Secondary endpoint analysis found that off-drug effectiveness favored DTA compared with the control (142 [59.4%] vs. 120 [49.4%], respectively; p = 0.03). Total RF time and individual RF ablation duration were significantly shorter with less saline infused through the DTA catheter (p 0.001). Both arms saw clinically meaningful improvements in quality of life at 12 months.Safety and efficacy of the DTA system proved noninferior to force-sensing RF ablation in a paroxysmal AF population. Efficiencies were observed using DTA with shorter total RF times, individual RF ablation durations, and less saline infusion. (DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation; NCT03334630).

Background: Fifty-watt radiofrequency applications have proven to be safe and efficient for pulmonary vein isolation (PVI). However, as PV reconnection still occurs and ablation catheter instability significantly contributes to suboptimal lesion formation, a new ablation catheter capable of delivering 90 W for 4 seconds only has been developed with the aim of improving PVI outcomes. In this setting, we sought to determine whether 90 W applications create transmural lesions without collateral damage experimentally and whether they can safely improve PVI procedures clinically compared with 50 W settings. Methods: Experimentally, individual lesions were created in vivo in the right atrium of 6 swine with 90 W-4 seconds applications using the SmartTouch-SF catheter in a power-controlled mode (3 animals) or the QDOT-MICRO catheter in a temperature-controlled mode (3 animals). Clinically, PVI was performed in a homogenous population of 150 consecutive paroxysmal atrial fibrillation patients using CARTO and the QDOT-MICRO catheter in a temperature-controlled mode (75 patients 50 W-ablation index-guided and 75 patients 90 W-4 seconds). Results: Mostly, (94.9%) experimental lesions were transmural in the thin-walled right atrium of swine. However, collateral damage was observed with both catheters in 17.9% of lesions. Clinically, 90 W procedures had a lower first-pass PVI rate (49% versus 81%, P −4 ) and a higher acute PV reconnection rate (21% versus 5%, P =0.004) than 50 W procedures, whereas total procedural duration (62 versus 66 minutes, P =0.09), 1-year sinus rhythm maintenance (88% versus 90%, P =0.6) and safety (1 tamponade per group) were similar in both groups. Conclusions: Experimentally, using the QDOT-MICRO catheter, 90 W-4 seconds lesions are mostly transmural in the thin-walled right atrium of swine (median depth 1.87 mm) with a moderate lesion diameter of 6.62 mm but retain the potential for collateral damage. Clinically, 90 W-4 seconds applications are associated with a lower first-pass PVI rate and a higher acute PV reconnection rate than 50 W applications but similar safety outcomes and effectiveness at 1 year.

International audience; Background: Women with congenital heart disease at high risk for sudden cardiac death have been poorly studied thus far.Objectives: The aim of this study was to assess sex-related differences in patients with tetralogy of Fallot (TOF) and implantable cardioverter-defibrillators (ICDs).Methods: Data were analyzed from the DAI-T4F (French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator) cohort study, which has prospectively enrolled all patients with TOF with ICDs in France since 2010. Clinical events were centrally adjudicated by a blinded committee.Results: A total of 165 patients (mean age 42.2 ± 13.3 years) were enrolled from 40 centers, including 49 women (29.7%). Among the 9,692 patients with TOF recorded in the national database, the proportion of women with ICDs was estimated to be 1.1% (95% CI: 0.8%-1.5%) vs 2.2% (95% CI: 1.8%-2.6%) in men (P < 0.001). The clinical profiles of patients at implantation, including the number of risk factors for ventricular arrhythmias, were similar between women and men. During a median follow-up period of 6.8 years (IQR: 2.5-11.4 years), 78 patients (47.3%) received at least 1 appropriate ICD therapy, without significant difference in annual incidences between women (12.1%) and men (9.9%) (HR: 1.22; 95% CI: 0.76-1.97; P = 0.40). The risk for overall ICD-related complications was similar in women and men (HR: 1.33; 95% CI: 0.81-2.19; P = 0.30), with 24 women (49.0%) experiencing at least 1 complication.Conclusions: Our findings suggest that women with TOF at high risk for sudden cardiac death have similar benefit/risk balance from ICD therapy compared with men. Whether ICD therapy is equally offered to at-risk women vs men warrants further evaluation in TOF as well as in other congenital heart disease populations. (French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator [DAI-T4F]; NCT03837574)

Background: Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart disease, and sudden cardiac death represents an important mode of death in these patients. Data evaluating the implantable cardioverter defibrillator (ICD) in this patient population remain scarce. Methods: A Nationwide French Registry including all patients with tetralogy of Fallot with an ICD was initiated in 2010 by the French Institute of Health and Medical Research. The primary time to event end point was the time from ICD implantation to first appropriate ICD therapy. Secondary outcomes included ICD-related complications, heart transplantation, and death. Clinical events were centrally adjudicated by a blinded committee. Results: A total of 165 patients (mean age, 42.2±13.3 years, 70.1% males) were included from 40 centers, including 104 (63.0%) in secondary prevention. During a median (interquartile range) follow-up of 6.8 (2.5–11.4) years, 78 (47.3%) patients received at least 1 appropriate ICD therapy. The annual incidence of the primary outcome was 10.5% (7.1% and 12.5% in primary and secondary prevention, respectively; P =0.03). Overall, 71 (43.0%) patients presented with at least 1 ICD complication, including inappropriate shocks in 42 (25.5%) patients and lead dysfunction in 36 (21.8%) patients. Among 61 (37.0%) patients in primary prevention, the annual rate of appropriate ICD therapies was 4.1%, 5.3%, 9.5%, and 13.3% in patients with, respectively, 0, 1, 2, or ≥3 guidelines-recommended risk factors. QRS fragmentation was the only independent predictor of appropriate ICD therapies (hazard ratio, 3.47 [95% CI, 1.19–10.11]), and its integration in a model with current criteria increased the 5-year time-dependent area under the curve from 0.68 to 0.81 ( P =0.006). Patients with congestive heart failure or reduced left ventricular ejection fraction had a higher risk of nonarrhythmic death or heart transplantation (hazard ratio, 11.01 [95% CI, 2.96–40.95]). Conclusions: Patients with tetralogy of Fallot and an ICD experience high rates of appropriate therapies, including those implanted in primary prevention. The considerable long-term burden of ICD-related complications, however, underlines the need for careful candidate selection. A combination of easy-to-use criteria including QRS fragmentation might improve risk stratification. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03837574.

Background Electroanatomic mapping is usually required in order to obtain a precise diagnosis and guide the ablation of atrial tachycardias (ATs) after ablation for atrial fibrillation (AF). However, epicardial connections may limit the interpretation of the endocardial activation sequence as well as the efficacy of endocardial radiofrequency ablation. Case summary A 53-year-old man with history of AF ablation 2 years ago was admitted for ablation of a recurrent AT (cycle length 275 ms). Ultra-high-density mapping with the Rhythmia™ system revealed a challenging activation map with two focal points of early activation in the left atrium. The use of an advanced mapping software allowed the rapid reanalysis and reannotation of the activation map and suggested epicardial involvement of the Marshall bundle (MB). Subsequent ethanol infusion in the vein of Marshall (VOM) immediately terminated the tachycardia. Six months post-ablation, the patient had no recurrence of arrhythmias. Discussion This case highlights the role of novel diagnostic and treatment methods in the management of a post-AF ablation AT. By developments in cardiac mapping systems, the rapid editing of a high-density activation map and clarification of the arrhythmia origin can be facilitated overcoming the limitations of conventional techniques. Moreover, ethanol infusion in the VOM was shown to be an effective alternative method in the management of MB-related tachycardias.

Type-2 diabetes mellitus (DM) is associated with an increased risk of atrial fibrillation (AF). It is unclear whether DM is a risk factor for arrhythmia recurrence following catheter ablation of AF. We performed a nonrandomised, observational study in 7 high-volume European centres. A total of 2,504 patients who underwent catheter ablation of AF were included, and procedural outcomes were compared among patients with or without DM. Patients with DM (234) accounted for 9.3% of the sample, and were significantly older, had a higher BMI and suffered more frequently from persistent AF. Arrhythmia relapses at 12 months after AF ablation occurred more frequently in the DM group (32.0% vs 25.3%, p = 0.031). After adjusting for type of AF (i.e., paroxysmal vs persistent), during a median follow-up of 17 ± 16 months, atrial arrhythmia free-survival was lower in the diabetics with persistent AF (log-rank p = 0.003), and comparable for paroxysmal AF (log-rank p = 0.554). These results were confirmed in a propensity-matched analysis, and DM was also an independent predictor of AF recurrence on the multivariate analysis (hazard ratio 1.39; 95% confidence interval 95%1.07 to 1.88; p = 0.016). There was no significant difference in the rate of periprocedural complications among DM and non-DM patients (3.8% vs 6.3%, p = 0.128). Efficacy and safety of cryoballoon ablation were comparable to radiofrequency ablation in both DM and no-DM groups. In conclusion, catheter ablation of AF appears to be safe in patients with DM. However, DM is associated with higher rate of atrial arrhythmia relapse, particularly for patients with persistent AF.

Background 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. Funding Acknowledgement Type of funding sources: None.

Background The assessment of noninvasive markers of left atrial (LA) low-voltage substrate (LVS) enables the identification of atrial fibrillation (AF) patients at risk for arrhythmia recurrence after pulmonary vein isolation (PVI). Methods In this prospective multicenter study, 292 consecutive AF patients (72% male, 62 +/- 11 years, 65% persistent AF) underwent high-density LA voltage mapping in sinus rhythm. LA-LVS (

INTRODUCTION: Catheter ablation of atrial fibrillation (AF) has been recently shown to have an impact on the outcome of patients with heart failure and reduced LV ejection fraction (LVEF). We aimed to assess patients with reduced LVEF referred to catheter ablation of AF, and the efficacy and safety of this procedure compared with healthier patients. METHODS: 2083 consecutive procedures of catheter ablation of AF in six centers were divided into two groups on the basis of LVEF (≤ vs >35%) and comparisons were performed regarding procedural safety and efficacy. RESULTS: Only 51 (2.4%) of patients had low LVEF. Complication rate was comparable: 8.0% vs 6.9% (P = .760). Low LVEF patients are more frequently in persistent AF at the time of the procedure, have a higher degree of left atrial dilation, and higher CHA2 DS2 VASc score. The rate of atrial arrhythmia relapse post-blanking period in the first 12 months was higher in the low LVEF group: 58.0% vs 37.6% (P

ObjectivesThe association between obesity and atrial fibrillation (AF) is well-established. We aimed to evaluate the impact of index body mass index (BMI) on AF recurrence at 12 months following catheter ablation using propensity-weighted analysis. In addition, periprocedural complications and fluoroscopy details were examined to assess overall safety in relationship to increasing BMI ranges.MethodsBaseline, periprocedural and follow-up data were collected on consecutive patients scheduled for AF ablation. There were no specific exclusion criteria. Patients were categorised according to baseline BMI in order to assess the outcomes for each category.ResultsAmong 3333 patients, 728 (21.8%) were classified as normal (BMI 2), 1537 (46.1%) as overweight (BMI 25.5–29.0 kg/m2) and 1068 (32.0%) as obese (BMI ≥30.0 kg/m2). Procedural duration and radiation dose were higher for overweight and obese patients compared with those with a normal BMI (p=0.002 and p2led to a 1.2-fold increased likelihood of experiencing recurrent AF at 12-months follow-up as compared with overweight patients (HR 1.223; 95% CI 1.047 to 1.429; p=0.011), while no significant correlation was found between overweight and normal BMI groups (HR 0.954; 95% CI 0.798 to 1.140; p=0.605) and obese versus normal BMI (HR 1.16; 95% CI 0.965 to 1.412; p=0.112).ConclusionsPatients with a baseline BMI ≥30 kg/m2have a higher recurrence rate of AF following catheter ablation and therefore lifestyle modification to target obesity preprocedure should be considered in these patients.

Aims Despite advances in interventional treatment strategies, atrial fibrillation (AF) remains associated with significant morbidity and mortality. Fibrotic atrial myopathy (FAM) is a main factor for adverse outcomes of AF-ablation, but complex to diagnose using current methods. We aimed to derive a scoring system based entirely on easily available clinical parameters to predict FAM and ablation-success in everyday care. Methods In this multicenter, prospective study, a new risk stratification model termed AF-SCORE was derived in 220 patients undergoing high-density left-atrial(LA) voltage-mapping to quantify FAM. AF-SCORE was validated for FAM in an external mapping-validation cohort (n = 220) and for success following pulmonary vein isolation (PVI)-only (without adjunctive left- or right atrial ablations) in an external outcome-validation cohort (n = 518). Results FAM was rare in patients p p p p Conclusions Age, sex and AF-phenotype are the main determinants for the development of FAM. A low AF-SCORE ≤ 2 is found in paroxysmal AF-patients of any age and younger patients with persistent AF irrespective of sex, and associated with favorable outcomes of PVI-only. Freedom from arrhythmia remains unsatisfactory with AF-SCORE ≥ 3 as found in older patients, particularly females, with persistent AF, and future studies investigating adjunctive atrial ablations to PVI-only should focus on these groups of patients. Graphical abstract

BACKGROUND The STAR AF II (Substrate and Trigger Ablation for Reduction of Atrial Fibrillation 2) was a multicenter, randomized trial which randomized patients to pulmonary vein isolation (PVI) alone, PVI plus complex fractionated electrograms (CFE), or PVI plus linear ablation (roof line and mitral line). The study failed to show any additional benefit of additional substrate ablation (CFE or lines) in addition to PVI. However, complete block of linear ablations or total elimination of CFE was not achieved in all patients in the adjuvant ablation arms and this could explain why these additive ablation strategies did not improve outcome. We sought to determine whether completeness of adjuvant linear or CFE ablation affected the outcome of these additive ablation strategies when combined with PVI. METHODS AND RESULTS In STAR AF II, 549 patients were randomized 1:4:4 to PVI alone, PVI plus lines, and PVI plus CFE. In this substudy, outcomes of patients with complete linear block and without complete linear block in the PVI + lines group and outcomes for patients with all CFE regions successfully ablated and without all of them ablated in the PVI + CFE are analysed. Of the 243 patients in the PVI plus lines group who received both mitral and roof lines, bidirectional block across both lines was achieved in 179 (74%) but was not achieved in 65 (26%). At 18 months follow-up, AF recurrence occurred in 107 of 179 patients (59.8%) with complete block conduction block across lines and in 40 of 64 patients (62.5%) without complete block (p=0.89) (Figure 1). Even after 2 procedures, AF recurred in 51.9% of patients with complete linear block and 46% of patients without complete block (p=0.09). Of the 207 patients in the PVI plus CFE group who actually underwent CFE ablation, 188 (91%) had elimination of all CFE sites while all CFE were not eliminated in 19 (9%). At 18 months follow-up, AF recurrence occurred in 117 of 188 patients (62.2%) with all the CFE ablated and in 11 of 19 patients (57.9%) without all CFE ablated (p=0.47) (Figure 1). After 2 procedures, AF recurrence occurred in 56.7% of patients with all CFE ablated and 68.0% of patients without all CFE ablated (p=0.29). CONCLUSION PVI combined with both linear and CFE ablation did not result in less AF recurrence compared to PVI alone even after more than one procedure regardless of how well empiric linear or CFE ablation is performed.

Aims To evaluate the safety and effectiveness of pulmonary vein isolation in paroxysmal atrial fibrillation (PAF) using a standardized workflow aiming to enclose the veins with contiguous and optimized radiofrequency lesions. Methods and results This multicentre, prospective, non-randomized study was conducted at 17 European sites. Pulmonary vein isolation was guided by VISITAG SURPOINT (VS target ≥550 on the anterior wall; ≥400 on the posterior wall) and intertag distance (≤6 mm). Atrial arrhythmia recurrence was stringently monitored with weekly and symptom-driven transtelephonic monitoring on top of standard-of-care monitoring (24-h Holter and 12-lead electrocardiogram at 3, 6, and 12 months follow-up). Three hundred and forty participants with drug refractory PAF were enrolled. Acute effectiveness (first-pass isolation proof to a 30-min wait period and adenosine challenge) was 82.4% [95% confidence interval (CI) 77.4–86.7%]. At 12-month follow-up, the rate of freedom from any documented atrial arrhythmia was 78.3% (95% CI 73.8–82.8%), while freedom from atrial arrhythmia by standard-of-care monitoring was 89.4% (95% CI 78.8–87.0%). Freedom fromrepeat ablations by the Kaplan–Meier analysis was 90.4% during 12 months of follow-up. Of the 34 patients with repeat ablations, 14 (41.2%) demonstrated full isolation of all pulmonary vein circles. Primary adverse event (PAE) rate was 3.6% (95% CI 1.9–6.3%). Conclusions The VISTAX trial demonstrated that a standardized PAF ablation workflow aiming for contiguous lesions leads to low rates of PAEs, high acute first-pass isolation rates, and 12-month freedom from arrhythmias approaching 80%. Further research is needed to improve the reproducibility of the outcomes across a wider range of centres. Clinical trial registration: ClinicalTrials.gov, number NCT03062046, https://clinicaltrials.gov/ct2/show/NCT03062046.

Sergio Conti, Chen-yang Jiang, Timothy R. Betts, Jian Chen, Isabel Deisenhofer, Roberto Mantovan ... et al.

BACKGROUND AND PURPOSE: Saline-irrigated radiofrequency ablation (RFA) for atrial fibrillation (AF) is limited by the absence of reliable thermal feedback limiting the utility of temperature monitoring for power titration. The DiamondTemp (DT) ablation catheter was designed to allow efficient temperature-controlled irrigated ablation. We sought to assess the 1-year clinical safety and efficacy of the DT catheter in treating drug-refractory paroxysmal AF. METHODS: The TRAC-AF trial (NCT02821351) is a prospective, multi-center (n = 4), single-arm study which enrolled patients with symptomatic, drug-refractory, paroxysmal AF. Using the DT catheter, point-by-point ablation was performed around all pulmonary veins (PVs) to achieve PV isolation (PVI). Ablation was performed in a temperature-controlled mode (60 °C, max 50 W). Acute and chronic efficacy and safety was evaluated. RESULTS: Seventy-one patients (age 69.9 ± 11.0 years; 60.6% male) were ablated using the DT catheter. The mean fluoroscopy and RF ablationtimes were 9.3 ± 6.1 min and 20.6 ± 8.9 min, respectively. Acute isolation of all PVs was achieved in 100% of patients, and freedom from AF after 1 year was 70.6%. There were no steam pops, char, or coagulum on the catheter tip after ablation. There were few serious procedure/device-related adverse events including a single case of cardiac tamponade (1.4%) and transient ischemic attack (1.4). CONCLUSION: This first in man series demonstrates that temperature-controlled irrigated RFA with the DT catheter is efficient, safe, and effective in the treatment of paroxysmal AF. Randomized controlled trials are ongoing and will evaluate better the role of this catheter in relation to standard RFA. TRIAL REGISTRATION: Registered on the site ClinicalTrials.gov January 2016 with identifier: NCT02821351.

Aims: Saline-irrigated radiofrequency ablation (RFA) for atrial fibrillation (AF) is limited by the absence of reliable thermal feedback limiting the utility of temperature monitoring for power titration. The DiamondTemp (DT) ablation catheter allow efficient temperature-controlled irrigated ablation. We sought to assess the 1-year clinical safety and efficacy of the DT catheter in treating drug-refractory paroxysmal AF. Methods and results: The TRAC-AF trial (NCT02821351) is a prospective, multi-center (n=4), single-arm study that enrolled patients with symptomatic, drug-refractory paroxysmal AF. Using the DT catheter, point-by-point ablation was performed around all pulmonary veins (PVs) to achieve PV isolation (PVI). Ablation was performed in a temperature-control mode (60oC, max 50 W) until the split-tip EGM amplitude decreased by ≤75%. The primary efficacy endpoints included acute procedural success and freedom from AF at 12 months. A total of 62 patients (age 60.3 ± 11.4 years; 60% male) were evaluated after AF ablation using the DT catheter. The mean fluoroscopy and RF ablation times were 9.4±6.4 min and 19.8±8.6 min, respectively. Acute isolation of all PVs was achieved in 100% of patients. There were no steam pops and there were not seen any char or caugulum on the catheter tip after ablation. There were very few serious procedure/device-related adverse events including a single case of cardiac tamponade (1.6%). At 1 year, the freedom from AF was 74.2%. Conclusion: This first in man series demonstrates that temperature-controlled irrigated RFA with the DT catheter is efficient, safe, and effective in the treatment of paroxysmal AF.

Background/Introduction The ‘CLOSE’ protocol, incorporating standardized ablation index (AI) targets in conjunction with defined inter-tag distance (ITD) has been shown to improve the acute and long-term success of pulmonary vein isolation (PVI) when treating paroxysmal atrial fibrillation (PAF). The reproducibility and learning curve for this protocol has not been studied. Purpose To assess the acute and long-term efficacy of CLOSE PVI across multiple operators (n = 37) in the 17-centre European study ‘VISTAX’. Methods 329 patients with PAF (61.8% male, 61.3 ± 10.1 years) underwent PVI according to the CLOSE protocol, with target AI values for each lesion of ≥400 on the posterior wall and ≥550 on the anterior wall, and target ITD of ≤6mm. Each 3-dimensional electroanatomic map was evaluated at a core lab where adherence to each of these criteria was assessed. 281/329 patients (85.1%) fulfilled all standardized workflow requirements and were adjudicated as having their PVI per-protocol (PP). First pass PVI and acute effectiveness (adenosine-proof first pass PVI at 30-minute challenge) were recorded. Clinical effectiveness was assessed as freedom from atrial arrhythmia recurrence through 12 months recorded via transtelephonic monitoring (weekly and symptomatically), in addition to holter and electrocardiogram monitoring during 3,6,12 month follow up visits. Learning curve analysis was evaluated on all investigators. Results First pass PVI rates were similar in the overall (86%) and PP cohorts (85%), as was acute effectiveness (82% in both cohorts). Freedom from atrial arrhythmia at 12 months too was identical for both cohorts (79%). Total procedure time and total ablation time decreased by an average 8 minutes and 10 minutes respectively after the first procedure and then showed further steady decreases over the number of ablations performed by the investigator (Figure). The procedural efficiencies and clinical success were reproducible across different centers. No significant deviations were found from individual sites. Conclusion The standardized CLOSE workflow is reproducible across centres, and is ‘forgiving’ without impacting on high efficacy of almost 80%. The learning curve is short, suggesting that the excellent clinical results can be replicated widely and easily. Abstract Figure. Learning Curves- Procedure & Ablation

Background/Introduction The use of a standardized ‘CLOSE’ ablation workflow for pulmonary vein isolation (PVI), with defined inter-tag distance (ITD) with targeted ablation index (AI) values, has been shown in single centre reports to result in good outcomes. The effect of this approach on patients’ quality of life (QoL) has not been studied. Purpose To evaluate the effects of paroxysmal atrial fibrillation (PAF) ablation by the CLOSE workflow on QoL and symptomatic AF reduction in the multicenter VISTAX study. Methods 329 patients with PAF (61.5% male, 61.3 ± 10.1 year) were treated at 17 European centres by point-by-point radiofrequency ablation using the CLOSE protocol to achieve PVI. An ITD ≤6mm and AI values of ≥400 on the posterior wall and ≥550 on the anterior wall were targeted. The AI value on the posterior wall was lowered as per investigator discretion in case of safety concerns. Patients were monitored for atrial arrhythmia recurrences via weekly and symptom-activated transtelephonic monitoring (TTM), for 12 months post procedure. Patients completed an Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire at their baseline and 12-month follow up visits. Results Majority (83.3% [274/329]) of patients experienced freedom from symptomatic atrial recurrence through 12 months. Of the 70 documented recurrences, 34 (49%) were documented by trans-telephonic monitoring only. All domains captured on the AFEQT questionnaire showed improvement with the overall score improving by 25.7, which exceeded the threshold of clinically meaningful improvement (±5) (Table). Patient reported most improvements in PAF control and symptoms relieved. The overall AFEQT score improvement was seen both in patients with or without documented atrial arrhythmia recurrence, with improvement by 21.5 and 26.8, respectively. Conclusion PAF ablation using a standardized CLOSE workflow resulted in consistent improvements in QoL. The improved QoL was observed regardless of atrial arrhythmia recurrence likely reflecting the low residual arrhythmia burden in patients with documented recurrence identified only on TTM. AFEQT Scores Through 12 Months AFEQT Domain Baseline 12 Months Change from Baseline* Daily Activities 59.2 85.3 26.0 Treatment Concerns 62.2 88.1 26.0 Controlling PAF 50.2 87.8 37.5 Symptoms 63.7 89.0 25.1 Symptoms Relieved 52.0 88.4 36.3 Overall AFEQT Score 61.3 87.2 25.7 *only includes patients who completed both baseline and 12 month AFEQT questionnaire

Background Advancements in electrophysiology 3-D mapping systems facilitate the broadening scope of electrophysiology study and catheter ablation to treat complex arrhythmias. While electroanatomical mapping systems have default settings available for a variety of mapping parameters, significant operator customization driven by arrhythmia type and experience can occur. However, multicenter comprehensive reporting of customized mapping settings is lacking. Methods In this prospective, multicenter observational registry, subjects with cardiac arrhythmias underwent electrophysiology study and ablation procedure using the EnSite Precision™ electroanatomical mapping system per standard of care, and associated automated mapping thresholds and procedural characteristics were observed. Results Cardiac mapping and ablation was performed in 503 patients (64.4% male, 59.6 ± 13.2 years) for a variety of indications including atrial fibrillation (N = 277), atrial flutter (N = 67), other supraventricular tachycardias (N = 96), and ventricular tachycardia (N = 56). Automated electroanatomical mapping was used to generate 88.2% of all maps, and arrhythmia-specific adjustments of mapping thresholds were utilized to collect electrophysiologically relevant data. The most commonly used thresholds for mapping in AF were Distance (average 2.7 ± 3.5 mm) and Signal-to-Noise Ratio (5.2 ± 1.1), while mapping in VT commonly used Score (88.5 ± 6.5%) and Distance (0.6 ± 0.5 mm). Automated mapping collected and utilized 8.8 times more data than manual mapping without increasing mapping time. Conclusions This registry revealed arrhythmia-specific automated mapping settings used to generate electroanatomical maps of multiple cardiac rhythms with higher point density than manual mapping without increasing mapping time. Commonly used mapping threshold settings could serve as an important reference for new automated electroanatomical mapping users or those expanding their usage to new indications and arrhythmias.

Controversy exists about the impact of acute atrial fibrillation (AF) termination and prolongation of atrial fibrillation cycle length (AFCL) during ablation on long-term procedural outcome.The purpose of this study was to analyze the influence of AF termination and AFCL prolongation on freedom from AF in patients from the STAR AF II (Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial-Part II) trial.Acute changes in AFCL and AF termination were collected during the index procedure of the STAR AF II trial and compared to recurrence of AF at 18 months. Recurrence was assessed by ECG, Holter (3, 6, 9, 12, 18 months), and weekly transtelephonic ECG monitoring for 18 months.AF terminated in 8% of the pulmonary vein isolation (PVI) arm, 45% in the PVI+complex electrogram arm, and 22% of the PVI+linear ablation arm (P.001), but freedom from AF did not differ among the 3 groups (P = .15). Freedom from AF was significantly higher in patients who presented to the laboratory in sinus rhythm (SR) compared to those without AF termination (63% vs 44%, P = .007). Patients with AF termination had an intermediate outcome (53%) that was not significantly different from those in SR (P = .84) or those who did not terminate (P = .08). AF termination was a univariable predictor of success (P = .007), but by multivariable analysis, presence of early SR was the strongest predictor of success (hazard ratio 0.67, P = .004). Prolongation of AFCL was not predictive of 18-month freedom from AF.Acute AF termination and prolongation in AFCL did not consistently predict 18-month freedom from AF. Presence of SR before or early during the ablation was the strongest predictor of better outcome.

Background 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). Objective 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. Methods 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. Results 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). Conclusion 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.

Aims Non-invasive electrocardiogram (ECG) mapping allows the activation of the entire atrial epicardium to be recorded simultaneously, potentially identifying mechanisms critical for atrial fibrillation (AF) persistence. We sought to evaluate the utility of ECG mapping as a practical tool prior to ablation of persistent AF (PsAF) in centres with no practical experience of the system. Methods and results A total of 118 patients with continuous AF duration

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 2 , pre‐obese 25–30 kg/m 2 , obesity 30–35 kg/m 2 , and morbid obesity ≥35 kg/m 2 ) 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% P BMI was an independent predictor of relapse (hazard ratio=1.01 per kg/m 2 ; 95% CI 1.01–1.02; P =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.

Background: The FIRE AND ICE trial assessed efficacy and safety of pulmonary vein (PV) isolation using cryoballoon versus radiofrequency current (RFC) ablation in patients with drug refractory, symptomatic, paroxysmal atrial fibrillation (AF). The purpose of the current study was to assess index lesion durability as well as reablation strategy and outcomes in trial patients undergoing a reablation procedure. Methods: Patients with reablation procedures during FIRE AND ICE were retrospectively consented and enrolled at 13 trial centers. The first reablation for each patient was included in the analysis. Documented arrhythmias before reablation, number and location of reconnected PVs, lesions created during reablations, procedural characteristics, and acute as well as long-term outcomes were assessed. Results: Eighty-nine (36 cryoballoon and 53 RFC) patients were included in this study. Paroxysmal atrial fibrillation was the predominant recurrent arrhythmia (69%) before reablation. Reablations occurred at a median of 173 and 182 days ( P =0.54) in the cryoballoon and RFC cohorts, respectively. The number of reconnected PVs was significantly higher in the RFC than the cryoballoon group (2.1±1.4 versus 1.4±1.1; P =0.010), which was driven by significantly more reconnected left superior PVs and markedly more reconnected right superior PVs. The number of (predominantly RFC) lesions applied during reablation was significantly greater in patients originally treated with RFC (3.3±1.3 versus 2.5±1.5; P =0.015) with no difference in overall acute success ( P =0.70). After reablation, no differences in procedure-related rehospitalization or antiarrhythmic drug utilization were observed between cohorts. Conclusions: At reablation, patients originally treated with the cryoballoon had significantly fewer reconnected PVs, which may reflect RFC catheter instability in certain left atrial regions, and thus required fewer lesions for reablation success. Repeat ablations were predominantly performed with RFC and resulted in similar acute success, duration of hospitalization, and antiarrhythmic drug prescription between the study cohorts. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03314753.

In 2012, the year the FIRE AND ICE Trial was initiated, the European Society of Cardiology and the Heart Rhythm Society consensus statements recognized RFC as the dominant energy source for AF catheter ablation and discussed PVI as a promising treatment approach.14, 15 In response to the FIRE AND ICE Trial and many other trials, the consensus documents were updated to recognize PVI as a safe and effective strategy for the treatment of AF with either of the 2 leading catheter ablation modalities, cryoballoon or RFC ablation.16, 17 Evaluation of the comprehensive end points, in addition to the primary end point that demonstrated noninferiority between the treatment modalities, may have contributed to the acceptance and adoption of cryoballoon ablation. Indeed, secondary end points of the trial were critical in identifying clinically important differences between the 2 treatment cohorts. Thoughtful design and rigorous assessment of secondary outcomes of future clinical trials may be essential to defining the patient‐specific impact of new catheter ablation technologies for the treatment of AF.

IMPORTANCE: Catheter ablation is effective in reducing atrial fibrillation (AF), but the association of ablation for AF with quality of life is unclear. OBJECTIVE: To evaluate whether the procedural outcome of ablation for AF is associated with quality of life (QOL) measures. DESIGN, SETTING, AND PARTICIPANTS: This was a prespecified secondary analysis of the Substrate and Trigger Ablation for Reduction of Atrial Fibrillation–Part II (STAR AF II) prospective randomized clinical trial, which compared 3 strategies for ablation of persistent AF. This analysis included 549 of the 589 patients enrolled in the trial who underwent ablation. Enrollment occurred at 35 centers in Europe, Canada, Australia, China, and Korea from November 2010 to July 2012. Data for the current study were analyzed on December 11, 2019. INTERVENTIONS: Patients underwent AF ablation with 1 of 3 ablation strategies: (1) pulmonary vein isolation (PVI), (2) PVI plus complex fractionated electrograms, or (3) PVI plus linear lesions. MAIN OUTCOMES AND MEASURES: Quality of life was assessed at baseline and at 6, 12, and 18 months after ablation for AF using the 36-Item Short Form Health Survey and the EuroQol Health-Related Quality of Life 5-Dimension 3-Level questionnaire. Scores were also converted to a physical health component score (PCS) and a mental health component score (MCS). Individual AF burden was calculated by the total time with AF from Holter monitors and the percentage of transtelephonic monitor recordings showing AF. RESULTS: Among the 549 patients included in this secondary analysis, QOL was assessed in 466 (85%) at baseline and at 6, 12, and 18 months after ablation for AF. The mean (SD) age of the study population was 60 (9) years; 434 (79%) individuals were men, and 417 (76%) had continuous AF for 6 months or more before ablation. The AF burden significantly decreased from a mean (SD) of 82% (36%) before ablation to 6.6% (23%) after ablation (P

International audience; 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.

Objectives This study sought to characterize the clinical characteristics, atrial substrate, and prognosis in a subgroup of patients with persistent atrial fibrillation (AF) from the onset (PsAFonset). Background Patients with AF frequently progress from trigger-driven paroxysmal arrhythmias to substrate-dependent persistent arrhythmias. Methods Patients referred for persistent AF (PsAF) ablation were enrolled from 3 centers. Consecutive patients with PsAFonset (n = 129) were compared with patients with PsAF that progressed from paroxysmal AF (n = 231). In addition, 90 patients (30 patients with PsAFonset and 60 control subjects) were studied with noninvasive mapping to characterize the AF drivers. The degree of fractionation and endocardial voltages were assessed invasively. Results Patients with PsAFonset were younger (p = 0.047) and more obese (p Conclusions Patients with PsAFonset represent a distinct subgroup defined by specific demographics, underlying diffuse biatrial substrate disease, and worse clinical outcome. The findings highlight the importance of defining criteria for early detection of atrial substrate disease.

International audience; 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.

International audience; Background Post-procedural recovery following sub-cutaneous ICD (S-ICD) implantation is feared to be more painful and to require more prolonged hospital admission. The purpose of this study was to compare peri-procedural and short clinical outcomes of the S-ICD vs. the Transvenous ICD (TV-ICD). Methods We conducted a single-center cross-sectional study including all consecutive patients who underwent S-ICD implantation by the same operator since January 2016 and a gender and age-matched control group with all single chamber TV-ICD implanted patients over a contemporary time period. Results Thirty-one patients (sex ratio 1/5; mean age 58.7 ± 13.2 years) with S-ICD were compared to 31 matched TV-ICD patients. Duration of the implant procedure was significantly longer for the S-ICD (58.0 ± 24.4 min vs 41.7 ± 20.8 min TV-ICD, p < 0.01). Mean fluoroscopy time for the TV-ICD was 3.5 ± 3.6 min vs 0.1 ± 0.01 min for all S-ICD patients (p < 0.01). Requirement of on-demand analgesia administration, and duration of hospitalization (1.5 days for both groups; p = NS) were similar in the two groups. No peri-procedural events were reported, and after a mean follow-up of 6 months, the only complication was a pocket infection requiring reintervention in the TV-ICD group. Conclusions The S-ICD appears to be as effective and safe as the conventional single chamber TV-ICD. Duration of hospital admission and need of on-demand analgesia are also comparable for S-ICD patients. © 2017 Elsevier Ireland Ltd

Background: Data on predictors of long-term clinical outcomes after catheter ablation of atrial fibrillation (AF) are limited. We sought to assess the association of baseline covariates with clinical outcomes in the 750 patients with drug-refractory paroxysmal AF enrolled in FIRE AND ICE. Methods: In a 2-part analysis, univariate and multivariable Cox regression models were first used to identify baseline patient characteristics predictive of catheter ablation efficacy determined by the clinical end points of (1) atrial arrhythmia recurrence (primary efficacy failure), (2) cardiovascular rehospitalization, and (3) repeat ablation. Propensity score stratification methods were then used to account for differences in baseline characteristics between sexes. RESULTS: Female sex (hazard ratio [HR], 1.37; 95% confidence interval [CI], 1.08–1.73; P =0.010) and prior direct current cardioversion (HR, 1.40; 95% CI, 1.07–1.82; P =0.013) were independently associated with atrial arrhythmia recurrence. Female sex (HR, 1.36; 95% CI, 1.02–1.80; P =0.035) and hypertension (HR, 1.48; 95% CI, 1.09–2.00; P =0.013) independently predicted cardiovascular rehospitalization. A longer history of AF (HR, 1.03; 95% CI, 1.00–1.06; P =0.039) increased the rate of repeat ablation. Women continued to have higher rates of primary efficacy failure and cardiovascular rehospitalization after propensity score adjustment, with adjusted HRs of 1.51 (95% CI, 1.16–2.18; P P Conclusions: After catheter ablation of paroxysmal AF, female sex was associated with an almost 40% increase in the risks of primary efficacy failure and cardiovascular rehospitalization. Primary efficacy failure was also adversely impacted by a history of direct current cardioversion, whereas hypertension had a negative impact on cardiovascular rehospitalization. History of AF was the only predictor of repeat ablation. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01490814.