Search

Dupilumab is a biologic, acting on IL-4 and IL-13 pathways. Dupilumab has a pediatric indication for treating severe asthma and atopic dermatitis. We report a pediatric case concerning paucisymptomatic, transient, and self-resolving hyperthyroidism. The updated literature includes the case of an adult patient who reported with hyperthyroidism, which was transient and self-resolving. Despite that these cases were transient and self-resolving, we would suggest that thyroid function assessment could be included in the follow-up of patients treated with Dupilumab. Dupilumab discontinuation is not required pending endocrinological assessment, mainly if there is an optimal clinical response to the biologic.

Aims: Sudden cardiac death (SCD) causes high mortality and substantial societal burdens for healthcare systems (HSs). The risk of SCD is significantly increased in patients with reduced left ventricular ejection fraction after myocardial infarction (MI). Current guidelines recommend re-evaluation of cardioverter-defibrillator implantation 40 days post-MI, earliest. Medical therapy alone does not provide sufficient protection against SCD, especially in the first month post-MI, and needs time. Consequently, there is a gap in care of high-risk patients upon hospital discharge. The wearable cardioverter defibrillator (WCD) is a proven safe, effective therapy, which temporarily protects from SCD. Little information on WCD cost-effectiveness exists. We conducted this research to demonstrate the medical need of the device in the post-MI setting defining WCD cost-effectiveness. Methods & results: Based on a randomized clinical trials (RCTs) and Italian and international data, we developed a Markov-model comparing costs, patient survival, and quality-of-life, and calculated the Incremental Cost-Effectiveness Ratio (ICER) of a WCD vs. current standard of care in post-MI patients. The rather conservative base case analysis – based on the RCT intention-to-treat results - produced an ICER of €47,709 per Quality Adjusted Life Year (QALY) gained, which is far lower than the accepted threshold of €60,000 in the Italian National HS. The ICER per Life Year (LY) gained was €38,276. Conclusion: WCD utilization in post-MI patients is clinically beneficial and cost-effective. While improving guideline directed patient care, the WCD can also contribute to a more efficient use of resources in the Italian HS, and potentially other HSs as well.

Purpose Highly localized impedance (LI) measurements during atrial fibrillation (AF) ablation have emerged as a viable real-time indicator of tissue characteristics and the consequent durability of the lesions created. We investigated the impact of catheter-tissue contact force (CF) on LI behavior during pulmonary vein isolation (PVI). Methods Forty-five consecutive patients of the CHARISMA registry undergoing de novo AF radiofrequency (RF) catheter ablation with a novel open-irrigated-tip catheter endowed with CF and LI measurement capabilities (Stablepoint™ catheter, Boston Scientific) were included. Results A total of 2895 point-by-point RF applications were analyzed (RF delivery time (DT) = 8.7±4s, CF = 13 ±±8 g, LI drop = 23 ±±7 Ω). All PVs were successfully isolated in an overall procedure time of 118 ±±34 min (fluoroscopy time = 13 ±±8 min). The magnitude of LI drop weakly correlated with CF (r = 0.13, 95% confidence interval (CI): 0.09 to 0.16, p < 0.0001), whereas both CF and LI drop inversely correlated with DT (r = −0.26, 95%CI: −0.29 to −0.22, p < 0.0001 for CF; r = −0.36, 95%CI: −0.39 to −0.33, p < 0.0001 for LI). For each 10 g of CF, LI drop markedly increased from 22.4 ± 7 Ω to 24.0 ± 8 Ω at 5 to 25 g CF intervals (5–14 g of CF vs 15–24 g of CF, p < 0.0001), whereas it showed smooth transition over 25 g (24.8 ± 7Ω at ≥ 25 g CF intervals, p = 0.0606 vs 15–24 g of CF). No major complications occurred during the procedures or within 30 days. Conclusions CF significantly affects LI drop and probable consequent lesion formation during RF PVI. The benefit of higher contact (> 25 g) between the catheter and the tissue appears to have less impact on LI drop. Trial registration Catheter Ablation of Arrhythmias With High Density Mapping System in the Real World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998

BACKGROUND Highly localized impedance (LI) measurements during atrial fibrillation (AF) ablation have recently emerged as a viable real-time indicator of tissue characteristics and durability of the lesions created. We report the outcomes of acute and long-term clinical evaluation of the new DirectSense algorithm in AF ablation. METHODS Consecutive patients undergoing AF ablation were included in the CHARISMA registry. RF delivery was guided by the DirectSense algorithm, which records the magnitude and time-course of the impedance drop. The ablation endpoint was pulmonary vein isolation (PVI), as assessed by the entrance and exit block. RESULTS 3556 point-by-point first-pass RF applications of >10 s duration were analyzed in 153 patients (mean age=59 ± 10 years, 70% men, 61% paroxysmal AF, 39% persistent AF). The mean baseline LI was 105 ± 15 Ω before ablation and 92 ± 12 Ω after ablation (p

ContextData on pubertal timing in Silver Russell syndrome (SRS) are limited.Design and methodsRetrospective observational study including twenty-three SRS patients [11p15 loss of methylation, (11p15 LOM, n=10) and maternal uniparental disomy of chromosome 7 (mUPD7, n=13)] and 21 small for gestational age (SGA). Clinical (thelarche in females; testis volume ≥ 4 ml in males; pubarche), BMI SD trend from the age of 5 to 9 years to the time of puberty, biochemical parameters of puberty onset [Luteinizing hormone (LH), 17-β-estradiol, testosterone], and bone age progression were evaluatedResultsPubertal onset and pubarche occurred significantly earlier in children with SRS than in SGA (p 0.03 and p 0.001, respectively) and clinical signs of puberty onset occurred earlier in mUPD7 than in 11p15LOM group (p 0.003). Five SRS children experienced central precocious puberty and LH, 17-β-estradiol, testosterone were detected earlier in SRS than in SGA (p 0.01; p 0.0001). Bone age delay in SRS children was followed by rapid advancement; the delta between bone age and chronological age in SRS group became significantly higher than in SGA group at the age of 9-11 years (p 0.007). 11p15LOM patients were underweight at the age of 5 years and showed a progressive normalization of BMI that was significantly higher than in mUPD7 (p 0.04) and SGA groups (p 0.03) at puberty onset.ConclusionTiming of puberty is affected in SRS and occurred earlier in mUPD7 compared to 11p15LOM. The impact of early puberty on adult height and metabolic status deserves long-term evaluation.

Introduction Radiofrequency transcatheter ablation (RFCA) for atrial fibrillation (AF) in patients with hypertrophic cardiomyopathy (HCM) has been proven feasible. However, the long-term results of RFCA and its impact on clinical course of HCM are unknown. The aim of this study was to analyse clinical outcomes and long-term efficacy of RFCA in a multicentre cohort of patients with HCM and concomitant AF. Methods Patients with HCM and AF consecutively undergoing RFCA were included. Ablation failure was defined as recurrence of AF, atrial tachycardia or flutter lasting more than 3 minutes and occurring after the blanking period. Results Overall, 116 patients with symptomatic AF refractory to antiarrhythmic drugs were included. Over a median follow-up of 6.0 years (IQR 3.0-8.9 years) recurrence rate after a single RFCA was 32.3 per 100 patient/years with 26% of patients free from AF relapses at six years follow-up. Among patients experiencing AF recurrence, 51 (66%) underwent at least one redo-procedure. The overall recurrence rate considering redo-procedures was 12.6 per 100 patients/years with 53% of patients free from AF relapses at six years. At last follow-up, with an average of 1.6 procedures, 67 (61%) patients were in sinus rhythm (SR). Patients remaining in SR showed better functional status compared with those experiencing arrhythmic recurrences (NYHA class 1.6±0.1 vs. 2.0±0.1, p=0.009). Conclusions RFCA of AF in HCM patients is an effective and safe strategy favoring long-term SR maintenance, reduction of atrial arrhythmic events and improved functional status. However, most patients need repeat procedures and continuation of antiarrhythmic drugs. This article is protected by copyright. All rights reserved.

Aims Ablation index (AI) is a marker of lesion quality during catheter ablation that incorporates contact force, time, and power in a weighted formula. This index was originally developed for pulmonary vein isolation as well as other left atrial procedures. The aim of our study is to evaluate the feasibility and efficacy of the AI for the ablation of the cavotricuspid isthmus (CTI) in patients presenting with typical atrial flutter (AFL). Methods and results This prospective multicentre non-randomized study enrolled 412 consecutive patients with typical AFL undergoing AI-guided cavotricuspid isthmus ablation. The procedure was performed targeting an AI of 500 and an inter-lesion distance measurement of ≤6 mm. The primary endpoints were CTI ‘first-pass’ block and persistent block after a 20-min waiting time. Secondary endpoints included procedural and radiofrequency duration and fluoroscopic time. A total of 412 consecutive patients were enrolled in 31 centres (mean age 64.9 ± 9.8; 72.1% males and 27.7% with structural heart disease). The CTI bidirectional ‘first-pass’ block was reached in 355 patients (88.3%), whereas CTI block at the end of the waiting time was achieved in 405 patients (98.3%). Mean procedural, radiofrequency, and fluoroscopic time were 56.5 ± 28.1, 7.8 ± 4.8, and 1.9 ± 4.8 min, respectively. There were no major procedural complications. There was no significant inter-operator variability in the ability to achieve any of the primary endpoints. Conclusion AI-guided ablation with an inter-lesion distance ≤6 mm represents an effective, safe, and highly reproducible strategy to achieve bidirectional block in the treatment of typical AFL.

Subfertility and infertility are common problems among couples of reproductive age, and they increasingly require the use of assisted reproductive techniques (ART). Understandably, doubts about the safety of such methods are increasing among future parents. The purpose of this review is to analyse the real impact of ART, such as in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI), on the health of the unborn baby; in particular, this work is focussed on the problems related to the neuro-psycho-motor area. Twenty-four studies were reviewed and outcomes investigated were: risk of the onset of neurodevelopmental diseases, worsening of school cognitive performance and risk of developing infantile cerebral palsy (CP) or neurological sequelae. For the first two outcomes, we did not find a correlation with ART; nevertheless, the results of the included studies about risk of CP are discordant and influenced by various confounding factors, such as pre-term birth and multiple pregnancies.IMPACT STATEMENTWhat is already known on this subject? Assisted reproductive techniques (ART) are the main answer for achieving pregnancy in infertile couples. However, a wide number of studies have tried to focus on possible different outcomes in terms of maternal and foetal/new-born health. Regarding this scenario, a peculiar importance is given to diseases affecting the neuro-psycho-motor area of the new-born. Since this group of detrimental pathologies could heavily affect the new-born’s quality of life and require costly social facilities, different studies have tried to focus on possible outcomes after ART.What do the results of this study add? This manuscript provides a review of the literature regarding ART procedures and neuro-psycho-motor implication. A review is strongly required due to the importance of collecting evidence from studies with different methodologies.What are the implications of these findings for clinical practice and/or further research? This manuscript provides evidence about the need for wider and more congruent studies regarding neurodevelopment disorders in new-borns after ART procedures. Data are prone to suggest a slight correlation, but several confounding factors can heavily hamper the possibility to draw a firm conclusion about the topic. What is already known on this subject? Assisted reproductive techniques (ART) are the main answer for achieving pregnancy in infertile couples. However, a wide number of studies have tried to focus on possible different outcomes in terms of maternal and foetal/new-born health. Regarding this scenario, a peculiar importance is given to diseases affecting the neuro-psycho-motor area of the new-born. Since this group of detrimental pathologies could heavily affect the new-born’s quality of life and require costly social facilities, different studies have tried to focus on possible outcomes after ART. What do the results of this study add? This manuscript provides a review of the literature regarding ART procedures and neuro-psycho-motor implication. A review is strongly required due to the importance of collecting evidence from studies with different methodologies. What are the implications of these findings for clinical practice and/or further research? This manuscript provides evidence about the need for wider and more congruent studies regarding neurodevelopment disorders in new-borns after ART procedures. Data are prone to suggest a slight correlation, but several confounding factors can heavily hamper the possibility to draw a firm conclusion about the topic.

Cell-free fetal DNA (cffDNA) analysis is a non-invasive prenatal diagnostic test with a fundamental role for the screening of chromosomic or monogenic pathologies of the fetus. Its administration is performed by fetal DNA detection in the mother’s blood from the fourth week of gestation. Given the great interest regarding its validation as a diagnostic tool, the authors have set out to undertake a critical appraisal based on a wide-ranging narrative review of 45 total studies centered around such techniques. Both chromosomopathies and monogenic diseases were taken into account and systematically discussed and elucidated. Not surprisingly, cell-free fetal DNA analysis for screening purposes is already rather well-established. At the same time, considerable interest in its diagnostic value has emerged from this literature review, which recommends the elaboration of appropriate validation studies, as well as a broad discourse, involving all stakeholders, to address the legal and ethical complexities that such techniques entail.

Aims Whereas pulmonary vein isolation (PVI) is the universally agreed target in catheter ablation of paroxysmal atrial fibrillation (AF), an ideal ablation set in persistent AF remains questioned. Aim of this study is to conduct a network meta-analysis (NMA) of randomized clinical trials (RCTs) comparing different ablation strategies in persistent AF patients. Methods and results Network meta-analysis was performed in a frequentist framework with the different ablation strategies constituting the competitive arms of interest. Primary efficacy endpoint was recurrences of atrial tachyarrhythmia (AF, atrial flutter, and/or organized atrial tachycardia). Secondary endpoints included major peri-procedural complications, procedure, and fluoroscopy duration. PubMED/MEDLINE and EMBASE databases were searched through June 2020. 2548 records were screened and 57 full-text articles assessed. Eventually 24 RCTs were included, encompassing 3245 patients (median follow-up 15 months, IQR 12–18). Compared to PVI alone, PVI plus linear lesions in the left atrium and elimination of extra-PV sources was the only strategy associated with a reduced risk of arrhythmia recurrence (RR 0.49, 95%CI 0.27–0.88). Most treatment arms were associated with longer procedural time compared with PVI; however, major peri-procedural complications and fluoroscopy time did not differ. Conclusion A comprehensive strategy including PVI, linear lesions in the left atrium, and elimination of extra-PV sources (constrained by a heterogeneous definition across studies) was associated with reduced risk of recurrent atrial tachyarrhythmias compared to PVI alone. All investigated treatment arms yielded similar safety profiles. Further research should rely on enhanced substrate-based approach definitions to solve one of the most evident knowledge gaps in interventional electrophysiology.

Aims Radiation use in medicine has significantly increased over the last decade, and cardiologists are among the specialists most responsible for X-ray exposure. The present study investigates a broad range of aspects, from specific European Union directives to general practical principles, related to radiation management among a national cohort of cardiologists. Methods and results A voluntary 31-question survey was run on the Italian Arrhythmology and Pacing Society (AIAC) website. From June 2019 to January 2020, 125 cardiologists, routinely performing interventional electrophysiology, participated in the survey. Eighty-seven (70.2%) participants are aware of the recent European Directive (Euratom 2013/59), although only 35 (28.2%) declare to have read the document in detail. Ninety-six (77.4%) participants register the dose delivered to the patient in each procedure, in 66.1% of the cases both as fluoroscopy time and dose area product. Years of exposition (P = 0.009) and working in centers performing pediatric procedures (P = 0.021) related to greater degree of X-ray equipment optimization. The majority of participants (72, 58.1%) did not recently attend radioprotection courses. The latter is related to increased awareness of techniques to reduce radiation exposure (96% vs. 81%, P = 0.022), registration of the delivered dose in each procedure (92% vs. 67%, P = 0.009), and X-ray equipment optimization (50% vs. 36%, P = 0.006). Conclusion Italian interventional cardiologists show an acceptable level of radiation awareness and knowledge of updated European directives. However, there is clear space for improvement. Comparison to other health professionals, both at national and international levels, is needed to pursue proper X-ray management and protect public health.

Funding Acknowledgements Type of funding sources: None. Background Limited data exist on factors associated with radiation exposure during ablation procedures when a high definition mapping technology is used. Purpose To report factors associated with radiation exposure and data on feasibility and safety of a minimal fluoroscopic approach using the Rhythmia mapping system in supraventricular tachycardia (SVT) ablation procedures. Methods Consecutive patients indicated for arrhythmia ablation were enrolled in the CHARISMA study at 12 centers. We included in this analysis consecutive right-side procedures performed through a minimal fluoroscopy approach with the Rhythmia mapping system were analyzed. A 3D geometry of chambers of interest was reconstructed on the basis of the electroanatomic information taken from the mapping system. Fluoroscopy was used only if deemed necessary. The effective dose (ED) was calculated using accepted formula. For our purpose high dose exposure was defined as an ED greater than the median value of ED of the population exposed to radiation. Results This analysis included 325 patients (mean age = 56 ± 17 years, 57% male) undergoing SVT procedures (152 AVNRT, 116 AFL, 41 AP and 16 AT). During the study, 27481 seconds of fluoroscopy was used (84.6 ± 224 seconds per procedure), resulting in a mean equivalent ED of 1.1 ± 3.7 mSv per patient. The mean reconstructed RA volume was 99 ± 54 ml in a mean mapping time of 12.2 ± 7 min. The mean number of radiofrequency ablations (RFC) to terminate each arrhythmia was 9.4 ± 9 (mean RFC delivery time equal to 6.7 ± 6 min). 192 procedures (59.1%) were completed without any use of fluoroscopy; during the remaining 133 procedures (39.9%), 206.6 ± 313.4 seconds of fluoroscopy was used (median ED = 1.2 mSv). In a minority of the cases (n = 25, 7.7%) the fluoroscopy time was higher than 5 minutes (median ED = 6.5 mSv), whereas radiologic exposure time greater than 1 minute occurred in ninety cases (27.7%, median ED = 2.1 mSv). On multivariate logistic analysis adjusted for baseline confounders the RFC application time (OR = 1.0014, 95%CI: 1.0007 to 1.0022; p = 0.0001) was independently associated to an ED greater than 1.2 mSv, whereas female gender had an inverse association (0.54, 0.29 to 0.98; p = 0.0435). Acute success was reached in 97.8% of the cases. During a mean of 290.7 ± 169.6 days follow-up, no major adverse events related to the procedure were reported. Overall, the recurrence rate of the primary arrhythmia during follow-up was 2.5%. Conclusions In our experience, arrhythmias ablation through minimal fluoroscopy approach with the use of a novel ablation technology is safe, feasible, and effective in common right atrial arrhythmias. High-dose exposure occurred in a very limited number of cases, without any reduction of the safety and acute and long-term effectiveness profile.

Funding Acknowledgements Type of funding sources: None. Background Ventricular tachycardia (VT) ablation techniques in ischemic cardiomyopathy have evolved during the recent years. However, the long-term success rate remains disappointing. A technique based on channel identification and ablation through a novel automated algorithm may limit the extent of ablation needed and possibly lead to higher successful rate. Purpose To report preliminary data on feasibility and safety of a channel identification approach and to characterize late potentials (LPs) features using an ultra-high density mapping system with a novel analysis tool in ischemic VT procedures. Methods Consecutive patients (pts) indicated for ischemic VT ablation were enrolled in the CHARISMA study. A complete map of the left ventricle was performed prior and after ablation through the Rhythmia mapping system. For our purpose channels were defined as any signal activity bounded by anatomic and functional barriers and characterized through a novel map analysis tool (Lumipoint-LM-) that automatically identifies fragmented late potentials (LPs) and continuous activation was used on the whole ventricular substrate. Procedural endpoint was the elimination of all identified conducting channels (CCs) by ablation at the CC entrance and exit followed by abolition of any residual LPs inside the CC. The ablation endpoint was noninducibility. Results A total of 18 channels were identified through LM from 14 pts: 71.4% of the pts had 1 CC, 28.6% had 2 CCs. In the majority of the cases LPs where identified only inside CCs (57.1%), whereas in 6 cases (42.9%) LPs were present both inside and outside. The mean conduction time inside CCs was 50.3 ± 30ms, the mean CC length was 32.6 ± 17mm and the conduction velocity was 0.8 ± 0.5 mm/ms. LPs covered a mean area of 7.0 ± 5mm2 (ratio between LPs area and CCs’ area = 52.4 ± 33.7%). At voltage map analysis 1 CC was present in 78.6% of the cases (2 CCs in 21.4%). LPs were identified only inside CCs in 42.9% of the cases, both inside and outside in 50% and only outside in 7.1%. Healthy tissue (voltage level≥0.5mV) was prevalent (61.2 ± 13.8%), followed by intermediate voltage areas (0.5-0.05mV; 37.5 ± 13.7%) and very low voltage areas ( Conclusions In our preliminary experience, a new channel identification approach through the advanced Lumipoint algorithm seems to be safe, feasible and effective at least in the acute setting of ischemic VT ablation.

Funding Acknowledgements Type of funding sources: None. BACKGROUND The Wearable Cardioverter Defibrillators (WCD) has been used extensively in Italy since 2015, following long years of experience in other countries. This technology provides temporary protection from Sudden Cardiac Death (SCD) for patients with an evolving risk profile that may not yet be eligible for an Implantable Cardioverter Defibrillator (ICD). Collecting national data on use of the device can help build a picture that will enable an understanding on how to use the WCD appropriately in the future. PURPOSE Our purpose has been to investigate WCD usage on a nationwide level. This is in terms of target population, average wear time, patient compliance, diagnosed and treated arrhythmic events and patient outcome once they stopped wearing the device. METHODS WEAR-ITA is a nationwide, multi-centre retrospective observational project. Patient data was retrospectively collected from the Italian hospitals that agreed to take part in the data collection for all patients fitted with a WCD between April 2015 to May 2018. All data refers to the range from the first day of wear until the end of use. RESULTS We collected data for 411 patients from 15 (75%) Italian regions. WCD use among the different regions was heterogeneous with a median of 0.5 (0.2-1.2) WCD wore/105 inhabitants. The mean age of the population was 55(±14) and the majority of patients were male (79%). Main WCD indication was non-ischemic cardiomyopathy with reduced ejection fraction (51%), ischemic etiology with severe systolic dysfunction (31%), uncertain or unidentified diagnosis (10%) that then revealed to be predominantly channelopathies or myocarditis and after ICD extraction (8%). Patients wore the WCD for a median of 59 (33-90) days and the median daily weartime was 23 (22,7-23,8) hours. In 15 patients (4%), the WCD recorded non sustained ventricular tachycardia (VT), 10 patients (2%) had hemodynamically well-tolerated sustained VT not needing a shock. 8 patients (2%) received effective appropriate shocks. Time to episodes were respectively 61 (14-61) days for non-sustained VT and 28 (19-70) days for VT/VF. 2 patients (0.5%) received inappropriate shocks for sinus tachycardia and atrial fibrillation (AF) respectively. WCD recorded new onset of supra ventricular tachycardia episodes in 12 patients (3%) and of atrial fibrillation (AF) in 7 patients (2%). 7 patients (2%) died while wearing WCD; none of them from SCD. At the end of the WCD use, 195 patients (47%) did not receive an ICD while 209 patients (51%)were implanted. CONCLUSIONS WCD is an effective therapy for the treatment of SCD with a very low complication rates. The indication and penetration in Italy is quite heterogeneous. The patient’s compliance is high over time. The incidence of appropriate shock is not negligible; only half of patients, who wore WCD, received an ICD. There is however still a requirement to conduct further randomized trials to understand which patients could most benefit from the use of WCD. Abstract Figure. Wereable Cardioverter Defibrillator

Funding Acknowledgements Type of funding sources: None. Background An early and comprehensive rhythm-control therapy emerges as a need to treat AF in an effective way and to improve the ablation outcomes, in terms of arrhythmia-free survival. Purpose We aimed to investigate the importance of timing of ablation in preventing AF recurrences. Methods 153 consecutive patients (pts) undergoing AF ablation from the CHARISMA registry at 8 Italian centres were included. Ablations were guided by a novel radiofrequency ablation catheter with local impedance (LI)-sensing capability through a dedicated algorithm (DirectSense, Boston Scientific). Pts were grouped as early treated (ET) if the procedure was performed within 1 year after the first AF episode and as delayed treated (DT) if admitted for ablation after more than 1 year. The ablation endpoint was PVI as assessed by entrance and exit block. Post-ablation follow-up was scheduled at 3, 6 and 12 months. AF and atrial tachycardia (AT) recurrences were considered as long-term endpoint. Results Of the 153 pts enrolled (69.9% male, 59 ± 10 years, 61.4% paroxysmal AF, 38.6% persistent AF), 123 (80.4%) met Class I indications, 23 (15%) Class IIa indications and 7 (4.6%) Class IIb indications according to current ESC AF guidelines. The mean time to ablation procedure from the first AF episode was 1034 ± 1483 days. Eighty pts (52.3%) were included in ET group, whereas 73 pts (47.7%) in DT group. No differences were found between AF type in terms of ablation strategy (53.3% of the cases -52 out 94- were classified as ET for paroxysmal AF vs 47.5% of the cases -28 out 59- were ET for persistent AF, p = 0.4346). At the end of the procedures, all PVs had been successfully isolated in all study pts. During a mean follow-up of 366 ± 130 days, 18 pts (11.8%) suffered an AF/AT recurrence after the 90-day blanking period. Recurrences occurred mostly in the DT group compared to the ET one (13 out 73 -17.8%- vs 5 out 80 -6.3%-, p = 0.042) and the time to AT/AF recurrence was longer in the ET group (HR = 0.2876, 95%CI: 0.1029 to 0.8038; p = 0.0181). On multivariate logistic analysis adjusted for baseline confounders, only hypertension (HR = 4.66, 95%CI: 1.5 to 14.48, p = 0.0081) was independently associated with recurrences. An early rhythm-control therapy was associated with a low risk of recurrences beyond the hypertension risk factor, ranging from 2% (no hypertension and an ET ablation therapy) to 30.3% (with hypertension and a DT procedure) (Figure 1). Conclusion A LI-guided ablation strategy for PVI proved to be safe and effective and resulted in a very high recurrence-free rate. An early rhythm-control therapy in the absence of common risk factors was associated with the lowest rate of recurrences. Abstract Figure. AT/AF Recurrence

Background: Subcutaneous implantable cardioverter defibrillator (S-ICD) is a well-established therapy for sudden death prevention. Considering the painful nature of the procedure anaesthesia may be required for analgo-sedation. Hypnosis is emerging as a promising therapeutic strategy for pain control. Few data are available regarding the use of hypnosis as adjunctive technique for pain control during S-ICD implantation. Methods: Thirty consecutive patients referred to our centre for S-ICD implantation were prospectively and alternatively allocated with 1:1 ratio in two groups: A) Standard analgo-sedation approach (Hypnosis non responder patients) B) Standard analgo-sedation approach with the addition of hypnotic communication (Hypnosis responder patients). Peri-procedural pain perception and anxiety, perceived procedural length, type and dosage of administered analgesic drugs have been measured using validate scores and compared. Results: Hypnotic communication was offered to 15 patients of which was successful in 11 patients (73%). There were no statistical differences between the two study groups according to baseline characteristics. Hypnosis communication resulted in significant pain perception reduction (Group A 6,9 ± 1,6 Vs Group B 1,1 ± 0,9, p value

We report the case of a 13-year-old patient, female, born in Northern Italy, who presented with an acute episode of aphasia, lasting about 15 min, accompanied by left arm dysesthesia. The state of consciousness remained preserved throughout the episode. After a first clinical evaluation at second-level hospital, the patient was sent to our institute for further investigations. Brain MRI performed at admission showed no noteworthy structural alterations. Electroencephalogram was not significant, as was the echocardiographic examination. ECG was normal, except for a corrected-QT at the upper limits of the normal range for age and gender. The neurological examination was substantially normal for the entire duration of the hospital stay. The symptomatology initially described has never reappeared. Blood tests were substantially negative, in particular thrombophilic screening excluded hereditary-familial thrombophilic diseases. Color doppler ultrasound of the supra-aortic trunks, splanchnic vessels and lower limbs were also normal. Only positivity to SARS-CoV-2 serology is reported. In the recent clinical history there were no symptoms attributable to symptomatic coronavirus infection.

Background Transcatheter ablation is the most effective treatment for patients with symptomatic or high-risk accessory pathways (AP). At present, no clear recommendations have been issued on the optimal approach for left sided AP ablation. We performed this meta-analysis to compare the safety and efficacy of transaortic retrograde versus transseptal approach for left sided AP ablation. Methods and results MEDLINE/PubMed and Cochrane database were searched for pertinent articles from 1990 until 2016. Following inclusion/exclusion criteria application, 29 studies were selected including 2030 patients (1013 retrograde, 1017 transseptal) from 28 observational single Centre studies and one randomized trial. Patients approached by transseptal puncture presented a significantly higher acute success (98% vs. 94%, p = 0.040). The incidence of late recurrences ( p = 0.381) and complications ( p = 0.301) did not differ among the two groups, but the pattern of complications differed: vascular complications were more frequent with transaortic retrograde approach, while cardiac tamponade was the main transseptal complication. No difference was noted in terms of procedural duration and fluoroscopy time ( p = 0.230 and p = 0.980, respectively). Meta-regression analysis showed no relation between year of publication and acute success ( p = 0.325) or incidence of complications ( p = 0.795); additionally, no direct relation was found between age and acute success ( p = 0.256) or complications ( p = 0.863). Conclusions Left sided AP transcatheter ablation is effective in around 95% of the cases, with a very limited incidence of complications. Transseptal access provides higher acute success in achieving AP ablation; late recurrences are rare but observed similarly following both approaches. Retrograde approach is affected by a relatively high incidence of vascular complications.

Aim: This study aims to describe prevalence and clinical significance of latent Brugada syndrome (BrS) in a young population with atrial fibrillation (AF). Methods: Between September 2015 and November 2017, among 111 AF patients below 45 years of age, those without pre-existing pathologies and/or known risk factors were selected for the study. Based on baseline 12-lead−24-h Holter electrocardiogram (ECG), previous class 1C antiarrhythmic drug therapy, or ajmaline testing, patients were stratified as latent type 1 BrS or not. Results: Within the 78 enrolled patients, 13 (16.7%; group 1) revealed a type 1 BrS ECG pattern, while 65 (83.3%; group 2) did not. Mean age was 37 ± 8 vs. 35 ± 7 (p = 0.42), and males were 7 (54%) vs. 54 (83%) (p = 0.02) in the two groups, respectively. Family history of BrS was significantly more common within group 1 patients (2, 15% vs. 0; p = 0.03), and 4 (31%) patients experienced syncope in group 1 vs. 5 (8%) in group 2 (p = 0.02). After a mean follow-up of 42 ± 18 months from the index AF event, more than 80% of the patients, in both study groups, were in sinus rhythm. Conclusion: In young patients with AF without pre-existing pathologies and/or known risk factors, latent BrS should be suspected. Syncope and a family history of BrS emerge as easily identifiable factors related to BrS. Long-term sinus rhythm maintenance appears satisfactory, either in the presence or not of BrS.

Background Electrophysiological studies and ablation procedures expose both physicians and patients to a large amount of radiation. Most of 3-D mapping systems provide improved tracking of catheters, possibly allowing relevant reductions in radiation exposure. No data exists on the ability of the Rhythmia mapping system to minimize fluoroscopy time and dose. Purpose To report preliminary data on feasibility and safety of a minimal fluoroscopic approach using the Rhythmia mapping system in supraventricular tachycardia (SVT) procedures. Methods Consecutive patients indicated for arrhythmia ablation were enrolled in the CHARISMA study at 12 centers. For our purpose consecutive right-side procedures performed through a minimal fluoroscopy approach with the Rhythmia mapping system were analyzed. A 3D geometry of chambers of interest was reconstructed on the basis of the electroanatomic information taken from the mapping system. Fluoroscopy was used only if deemed necessary. Results This analysis included 266 patients (mean age = 57±17 years, 57% male) undergoing SVT procedures (120 AVNRT, 91 AFL, 32 AP, 11 AT and 12 other right atrial procedures). In all cases, diagnostic EP and ablation catheters were positioned using a low fluoroscopic electroanatomic guided approach. The mean fluoroscopy time needed for each procedure was 55±128 s. The median reconstructed RA volume was 92 [63–131] ml in a median mapping time of 11 [7–17] min. The median number of radiofrequency ablations to terminate each arrhythmia was 6 [3–12] (total RF delivery time of 291 [180–505] s). Sixty-five percent of the procedures (n=174) were completed with less than 10 s of fluoroscopy. Low fluoroscopy approach with less than 10 s (minimal fluoroscopy approach) was most frequently obtained in case of AVNRT (91, 76%) compared to other arrhythmias' ablation (83, 57%, p=0.001) Achievement of a minimal fluoroscopic approach was not affected by operator's experience (65% vs 66%, p=1.00, respectively within physician with more or less of 10 years of active practice), whereas it was affected by presence of a fellow in training during the procedure (72% without fellow vs 26% with fellow, p Conclusions In our preliminary experience, arrhythmias' ablation through minimal fluoroscopy approach with the use of a novel ablation technology seems to be safe, feasible, and effective in common right atrial arrhythmias. Use of fluoroscopy can be dramatically reduced in most cases, without any reduction of the safety and acute effectiveness profile. Funding Acknowledgement Type of funding source: None

Funding Acknowledgements NO FUNDING Background Electrophysiological studies and ablation procedures expose both physicians and patients to a significant amount of radiation. Nowadays, most of 3-D mapping systems allow for improved tracking of catheters with possible reduction in radiation exposure. No data exists on the ability to minimize fluoroscopy time and dose while using the Rhythmia mapping system. Purpose To report preliminary data on feasibility and safety of a low fluoroscopic approach using the Rhythmia mapping system in SVT procedures. Methods The CHARISMA study is a non-randomized, multicenter, prospective study in which consecutive patients indicated for arrhythmia were enrolled. For our purpose consecutive right-side procedures performed through a low fluoroscopy approach with the Rhythmia mapping system were analyzed. The mapping system was used to create the 3D geometry of chambers of interest and anatomic reference points and to visualize the catheters from the beginning to the end of the procedure. Fluoroscopy was used only if deemed necessary. Results 204 unselected consecutive cases of SVT from 11 centers were included in the study (mean age = 55 ± 18 years, 53% male, 85 AVNRT, 75 AFL, 28 AP, 9 AT and 7 other right atrial procedures). In all the cases, diagnostic EP and ablation catheters were positioned using only the low fluoroscopic guided mapping approach. During the study, a total of 7157 s of fluoroscopy was needed in 204 patients (51 ± 137 s per procedure). One hundred fourty-one procedures (69%) were completed with less than 10 seconds of fluoroscopy, whereas in 169 (83%) of the cases the fluoroscopy time was lower than 60 seconds. Low fluoroscopy approach with less than 10 seconds was less frequently obtained in case of AFL (46, 61.3%) compared to AVNRT ablation (65, 76.5%, p = 0.041) whereas no differences were found comparing with AP (21, 75%, p = 0.248). The median reconstructed RA volume was 94[65-133] ml in a median mapping time of 11 [6-16] min. The median number of radiofrequency ablations to terminate each arrhythmia was 5 [3-12] (total RF delivery time of 293 [180-505] sec). A 100% rate of acute success was observed in our case series. No complications occurred. Conclusions In our preliminary experience, arrhythmias ablation through low fluoroscopy approach and the use of a novel ablation technology seems to be safe, feasible, and effective in common right atrial arrhythmias. Use of fluoroscopy can be nearly avoided in most cases, without any reduction of the safety and effectiveness profile.

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.

INTRODUCTION Atrial fibrillation ablation has historically been guided by fluoroscopy, with the related enhanced risk deriving from radiation. Fluoroscopy exposure may be confined to guide the transseptal puncture. Small sample size study presented a new methodology to perform a totally fluoroless atrial fibrillation ablation in the case of a patent foramen ovale (PFO). We evaluated this methodology in a large sample size of patients and a multicentre experience. METHODS AND RESULTS Two hundred and fifty paroxysmal atrial fibrillation patients referred for first atrial fibrillation ablation with a CARTO3 electroanatomic mapping system were enrolled. In 58 out of 250 patients, a PFO allowed crossing of the interatrial septum, and a completely fluoroless ablation was performed applying the new method (Group A). In the remaining patients, a standard transseptal puncture was performed (Group B). Pulmonary vein isolation was achieved in all patients with comparable procedural and clinical outcomes at short- and long-term follow-up. CONCLUSION The presence of a PFO may allow a completely fluoroless well tolerated and effective atrial fibrillation ablation. Probing the fossa ovalis looking for the PFO during the procedure is desirable, as it is not time-consuming and can potentially be done in every patient undergoing atrial fibrillation ablation.

Background Ablation technique targeting high-amplitude signals (maximum voltage guided - MVG -) on the cavotricuspid isthmus (CTI) has emerged as viable alternative option compared to standard anatomical approach (ST) for the creation of bidirectional conduction block (BDB) across the isthmus but limited data are available to date. Purpose To evaluate the effectiveness of acute and long-term outcome of CTI ablation through MVG technique for AFL compared to standard linear (SL) lesion ablation. Methods Atrial Flutter Ablation in a Real World Population (LEONARDO) is a prospective, multicenter cohort study aimed at providing an estimate of acute to long-term outcome in a large population of patients (pts) indicated for AFL ablation. Recurrence of AFL were retrieved at 12-month follow-up. Complete BDB was defined by agreement with the presence of widely split double potentials (DP) along the ablation line and assessment of the atrial activation sequence (AAS). For MVG technique the ablation catheter was positioned at the site of maximum local electrogram voltage. Results Two-hundred fifteen consecutive pts were included (mean age 68 years, 73% male). A median of 4 [2–6] ablation lesions were required. Median follow up was 359 [192–443] days. Complete BDB was achieved in 175 (81.4%) pts (9 pts had DP only criterion, 30 pts had AAS only criterion whereas in 1 pt we failed to reach a BDB). In the 106 pts with complete data at 1-year follow-up, 10 (9.4%) had a recurrence of AFL. 171 pts (79%) underwent a SL ablation whereas 44 pts (21%) were treated by MVG approach. The median number of lesions/pt was significantly lower in the group of pts targeted with MVG compared to the SL approach (3 [2–4] vs 4 [2–8], p Conclusion Ablation of a targeted site through MGV approach seems to be safe and effective as standard anatomical ablation technique. This strategy may avoid unnecessary ablation of the entire anatomic isthmus. Acknowledgement/Funding None

Background Arial fibrillation (AF) ablation outcome is still operator dependent. Ablation Index (AI) is a new lesion quality marker that has demonstrated to allow acute durable pulmonary vein (PV) isolation followed by a high single-procedure arrhythmia-free survival. Aim This prospective, multi-centre study was designed to evaluate the reproducibility of 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 380–500). Radiofrequency energy was delivered targeting interlesion distance ≤ 6 mm. Results At 12 months’ follow-up a high rate of freedom from AF recurrences was observed in patients with both paroxysmal and persistent AF (91% vs. 83.3%, P = 0.039). There was no difference in the rate of atrial arrhythmias 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 = 0.083). At 12 months’ follow-up, the rate of atrial arrhythmias recurrence was also similar between patients treated with a ST catheter (8%) and STSF catheter (12.1%, P = 0.2), between patients treated with an AI settings of 330–450 (10.9%) and an AI of 380–500 (10.3%, P = 0.64), and among the several operators (P = 0.84 and P = 0.75 respectively in patients with paroxysmal and persistent AF) ( Fig. 1 ). Conclusions An ablation protocol respecting strict criteria for contiguity and quality lesion resulted in high rate of one-year freedom from AF recurrence, both in patients with paroxysmal and persistent AF, irrespective of the ablation catheters, AI settings, and operator.

Atrial fibrillation (AF) catheter ablation is increasingly proposed for patients suffering from AF and concomitant heart failure (HF). However, the optimal ablation strategy remains controversial. We performed this study to assess the prevalence of pulmonary vein (PV) or linear lesion reconnection in HF patients undergoing repeated procedures.At seven high-volume centres, 165 patients with HF underwent a repeat procedure after a first AF ablation including PV isolation alone (47 patients, group A) or PV isolation plus left atrial lines (118 patients, group B). Group A patients presented more often paroxysmal AF (p0.001), less enlarged left atrium (p0.001) and less left ventricular systolic dysfunction (p=0.031) compared to Group B, that more commonly had atypical atrial flutter (p0.001). Forty-one (87%) patients in Group A and 69 (58%) in Group B presented at least one reconnected PV (p0.001). Sixty-one (52%) patients in Group B presented at least one reconnected atrial line (left isthmus or roof). Patients without any reconnected PV (n=54, 33%) more frequently experienced persistent AF (p0.001), had longer AF duration (p=0.047) and larger left atrial volume (p0.001). Twenty-five patients (15%) with no PV and/or line reconnection did not significantly differ, concerning baseline characteristics, compared to those with at least one reconnected ablation site.As in the general AF population undergoing catheter ablation, PV reconnection is frequent in patients with HF and symptomatic recurrence. However, one third of patients presented arrhythmic recurrences even in the absence of PV reconnection, highlighting the importance of the underlying atrial substrate.

Introduction Pulmonary vein (PV) isolation is the cornerstone of catheter ablation in patients with atrial fibrillation (AF). Surround flow and contact force (CF) measurement capabilities might enhance procedure efficacy and safety. We report on the safety and midterm efficacy of a novel ablation catheter for PV isolation in patients with AF. Methods and results Two hundred thirty-three consecutive patients (57 ± 11 years, 76% males, 51% with structural heart disease), referred for paroxysmal (157) or persistent (76) AF, underwent PV isolation by a surround flow catheter with CF measurement capability in four centers. Ablation was guided by electroanatomic mapping allowing radiofrequency (RF) energy delivery in the antral region aiming at PV isolation. Mean overall procedure time was 100 ± 42 minutes with a mean fluoroscopy time of 6 ± 5 minutes. Mean ablation time was 31±15 minutes; 99% of the targeted veins were isolated. The mean CF value during ablation was 13 ± 4 g. Intraprocedural early (30 minutes) PV reconnection occurred in 12% PVs, and all PVs were effectively reisolated. One pericardial effusion and five groin hematomas were reported. During a mean follow-up of 12 ± 6 months, 30 (12.9%) (10% paroxysmal AF vs. 18% persistent AF, P = 0.07) patients had an atrial arrhythmias recurrence. Conclusions In this multicenter registry, RF ablation using a new surround flow catheter, with CF sensor, resulted as feasible, achieving a high rate of isolated PVs. Procedural and fluoroscopy times and success rates were comparable with other techniques with a low complication rate.

Objectives This study sought to evaluate the incidence and clinical effect of coronary chronic total occlusions (CTOs) in patients with ischemic cardiomyopathy receiving an implantable cardioverter-defibrillator (ICD) for secondary prevention of sudden cardiac death (SCD). Background CTOs are common in patients with ischemic cardiomyopathy, which is the major cause of SCD. However, the impact of CTO in SCD survivors receiving an ICD is unknown. Methods A total of 425 patients who had survived an episode of ventricular arrhythmias and underwent ICD implantation for secondary prevention in 8 centers were included. Coronary angiogram, CTO angiographic characteristics, and ventricular arrhythmia pattern were centrally analyzed. Primary and secondary endpoints were appropriate ICD therapies and mortality during a median follow-up of 4.1 years, according to the presence of CTO in the baseline angiogram. Results Appropriate ICD therapies were higher in patients with CTO (51.7% vs. 36.3%; p = 0.001 at 4 years). Left ventricular ejection fraction (LVEF) (p = 0.015) and CTO (p = 0.001) were independent predictors of appropriate ICD therapy. Ventricular arrhythmia onset was associated to a shorter coupling interval and lower prematurity index in CTO patients. Defibrillator therapies were independently associated with worse LVEF (p = 0.046) and renal dysfunction (p = 0.023) among patients with CTO, and a tendency was observed in patients with better collateral flow (p = 0.093). Patients with poorer renal function (p = 0.029), LVEF (p = 0.041), and CTO (p = 0.033) experienced higher mortality rate. Conclusions Among ICD recipients for secondary prevention of SCD, coronary CTO conferred a higher risk of VA recurrence and mortality in long-term follow-up. Angiographic and VA patterns could provide insights into the mechanisms of SCD and may have implications for the use of interventions designed to limit ICD shocks in this high-risk population.

Aim of this study is to evaluate the impact of antiarrhythmic drugs (AADs) administration for at least one month before ECV on the acute and long term success rate of the procedure.1313 consecutive persistent AF patients were enrolled in 3 different centers (Turin, Asti and Avellino): 692 patients received AADs before and after ECV (group A), 621 patients were treated only after the procedure, at discharge (group B). Primary end point was the restoration and maintenance of sinus rhythm acutely and at a long-term follow up.Acute ECV success was higher in group A compared with group B (99% vs. 88%, p=0.0001) and a fewer number of shock attempts were administered (1.15±0.42 vs. 1.27±0.53 p0.0001). Moreover group A maintained SR more often than group B at one month (99% vs. 89%, log-rank p0.0001), at one year (55% vs. 48% log-rank p=0.01) and at the end of follow up (mean 2.7±2.1years, 45% vs. 29%, log-rank p0.0001). At multivariate analysis AADs premedication was the strongest independent predictor of acute and long-term ECV success (respectively p0.0001 OR 10.71 CI 5.10-22.50 and p=0.004, OR 1.50 CI 1.14-1.97). At sensitivity analysis no differences were found between ADDs in terms of acute success improvement (p=0.605), number of shock attempts (p=0.853) and long term SR maintenance (log-rank p=0.480).AADs administration for at least 4weeks before the ECV in persistent AF increases significantly the acute success rate and this result was maintained over a long-term follow-up.

Aims Atrial fibrillation (AF) transcatheter ablation is a safe and effective procedure. However, outcome over 10 years of follow-up has never been reported. The aim of this study is to assess outcome, describe predictors of recurrences, and report on quality of life (QoL) the decade after an AF ablation. Methods and results Patients referred for AF ablation in a single high volume centre from June 2004 to June 2006 were enrolled and followed in a prospective fashion by yearly clinical assessment and Holter monitoring. Among 255 patients (42.7% paroxysmal AF, 77% males, after a follow-up of 125 ± 7 months), 132 (52%) were arrhythmia-free including (58, 32% after a single procedure) while 27 (10%) progressed to permanent AF. At multivariate analysis, a greater left atrium antero-posterior diameter (HR 1.05 95% CI 1.02-1.09, P = 0.02) related to arrhythmic recurrences, while no increase in blood pressure (HR 0.06 95% CI 0.02-0.20, P = 0.01), BMI (HR 0.06 95% CI 0.02-0.09, P

Background This meta-analysis aims to assess the impact of a voltage-guided substrate modification by targeting low-voltage area (LVA) in addition to pulmonary vein isolation (PVI) in patients undergoing catheter ablation for atrial fibrillation (AF). Methods MEDLINE/PubMed, Cochrane Library, and references reporting AF ablation and “voltage* OR substrate* OR fibrosis OR fibrotic area*” were screened and studies included if matching inclusion and exclusion criteria. Results Six studies were included. Patients enrolled were 885 (517 in the study group and 368 in the control group). Median age was 60 years; 92% had nonparoxysmal AF. At a mean follow-up of 17 months, 70% of patients in the study group vs. 43% in the control group were free from AF/atrial tachycardia (AT) recurrences (odds ratio [OR] = 3.41, 95% confidence interval [CI] 2.22–5.24). LVA ablation in addition to PVI was more effective than PVI alone and PVI + conventional wide empirical ablation (70% vs. 43%, OR = 3.41, 95% CI 2.22–5.24), without increasing the adverse event rate (2.5% vs. 6%, OR = 0.43, 95% CI 0.15–1.26). Compared to PVI + conventional wide empirical ablation, LVA ablation reduced the occurrence of postablation AT (14% vs. 46%, OR = 0.16, 95% CI 0.07–0.37), procedure time (176 min vs. 220 min, OR = 0.36, 95% CI 0.24–0.56), fluoroscopy time (25 min vs. 31 min, OR = 0.22, 95% CI 0.12–0.39), and radiofrequency time (55 min vs. 90 min, OR = 0.49, 95% CI 0.27–0.90). Conclusions A voltage-guided substrate modification by targeting LVA in addition to PVI is more effective, safer, and holds a lower proarrhythmic potential than conventional ablation approaches. Further randomized studies are necessary to confirm these findings.

Catheter ablation of the slow pathway is the most effective treatment for atrioventricular nodal reentrant tachycardia (AVNRT). Cryoenergy, compared to radiofrequency, relates to lower heart block risk but higher incidence of AVNRT recurrences. The aims of this study are to confirm the safety and efficacy of AVNRT cryoablation and to identify predictors of long-term recurrences. Among 241 patients undergoing AVNRT cryoablation, 239 (99.2%) experienced acute effective cryoablation of the slow pathway, and no procedure-related complications were reported. After a follow-up of 44.9 ± 31.7 months, 28 (11.7%) patients presented AVNRT recurrences. A shorter preablation (p = 0.05) and postablation anterograde Wenckebach cycle length (p

Introduction: Hypnosis is a therapeutic strategy for pain control. We aimed at investigating the use of this technique in a large population undergoing atrial fibrillation (AF) ablation. Methods: 70 consecutive AF patients referred for transcatheter ablation, underwent hypnotic communication for periprocedural analgesia (Group A), were compared with 70 patients undergoing conventional analgesia (Group B). Procedural data, anxiety, perceived pain, perceived procedural duration and the dosages of administered analgesic drugs were compared using validated score scales. Results: Hypnotic communication (Group A) resulted in a significant procedural-related anxiety reduction (Pre procedural 4.7 ± 2.9 Vs Intra Procedural 0.8 ± 1.2, P

Background Atrial fibrillation (AF) ablation outcome is still operator dependent. Ablation Index (AI) is a new lesion quality marker that has demonstrated to allow acute durable pulmonary vein (PV) isolation followed by a high single-procedure arrhythmia-free survival. Purpose This prospective, multi-center study was designed to evaluate the inter-operator reproducibility of acute PV isolation guided by the AI. Methods A total of 490 consecutive patients with paroxysmal (80.4%) and persistent (19.6%) 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 sourrounding flow (SF) catheter) and the AI setting (330 at posterior wall and 450 at anterior wall or 380 at posterior wall and 500 at anterior wall). Radiofrequency energy was delivered to produce a wide area circumferential ablation around the proximal part of each PV's ostium or around ipsilateral PVs. In all patient radiofrequency was delivered targeting interlesion distance ≤ 6 mm. Results Procedure (ST330 129 ± 44 min, ST380 144 ± 44 min, SF330 120 ± 72 min, SF380 125 ± 73 min, P Conclusions Ablation protocol respecting strict criteria for contiguity and quality lesion results in high and comparable rate of acute PV isolation among operator with different skill performing ablation with different procedure and fluoroscopy times.

Over the years, the number of total hip replacements has been steadily increasing. Despite the improvement in surgical results, the number of claims for malpractice is higher. The primary endpoint of this work is to provide an analysis of litigation after hip replacement, to outline what are the instigating causes and costs. The secondary endpoint is to propose a possible preventive strategy for an improved care and a reduction in legal proceedings. The data of this study were collected from medical and legal files and from professional liability insurance of our institution from January 2005 to December 2016. Out of a total of 4770 THA, 40 claims were received. Peripheral nerve injuries represent the first cause of litigation (37%), followed by infectious complications, leg length discrepancy, metallosis, dislocations of the implant and a case of deep vein thrombosis. From the analysis of the past trial judgment, complications such as nerve lesions and infections are almost always recognized, as a medical error, with a high percentage of claims settled. This study shows the necessity of preventive strategies to reduce the higher number of claims for malpractice in total hip arthroplasty. Some complications such as nerve injuries and infection are frequently considered directly dependent on physician’s errors. Litigations can be reduced providing evidence of a diligent execution of the surgical procedure and of a proper postoperative management: the correct compilation of a specific informed consent and adequate doctor–patient communication.

BACKGROUND Radiofrequency and cryoballoon pulmonary vein isolation are common approaches for paroxysmal atrial fibrillation treatment, showing similar results in recent multicenter studies, including heterogeneous tools and protocols. The aim of this study is to compare prospectively in a single, high-volume center the outcome of paroxysmal atrial fibrillation ablation performed specifically by second-generation cryoballoon or contact force radiofrequency ablation. METHODS Consecutive patients scheduled for paroxysmal atrial fibrillation transcatheter ablation have been included and prospectively followed up. Aiming to reduce potential bias deriving from baseline characteristics, a propensity score matching analysis has been performed to analyze safety and efficacy outcomes. RESULTS Out of consecutive patients undergoing atrial fibrillation transcatheter ablation between January 2015 and December 2016, 46 patients approached by cryoablation were matched 1 : 1 by propensity score to a similar population treated by last-generation radiofrequency ablation. Freedom from atrial fibrillation after 12 months (76 vs. 78%, P = 0.804) and incidence of complications (4 vs. 6%, P = 0.168) did not differ between the two groups. Radiological exposure was higher for the cryoballoon group (11 vs. 4 min, P

Background Fluoroscopic catheter ablation of cardiac arrhythmias in pediatric patients exposes the patients to the potential risk of radiation considering the sensitivity of this population and its longer life expectancy. We evaluated the feasibility, safety, and efficacy of accessory pathway (AP) ablation guided by CARTO3 electroanatomic mapping (EAM) system with both cryoenergy and radiofrequency (RF) energy in order to avoid x-ray exposure in pediatric patients. Methods We included 44 patients (mean age: 13.1 ± 3.3 years); nine of 44 presented concealed AP. An electrophysiological study with a three-dimensional EAM reconstruction was performed in every patient with a venous transfemoral direct right atrium approach or an arterial transfemoral retrograde approach to reach the mitral annulus. In two patients with left-sided AP, the ablation was performed via a patent foramen ovale. Results A total of 47 APs were present, left sided in 45% (21/47) of cases (15 lateral, one anterior, three posteroseptal, and two posterolateral) and right sided in 55% (26/47; one anterior, three anterolateral, one posterolateral, three lateral, five para-Hisian, 12 posteroseptal, and one anteroseptal). Ablation without the use of fluoroscopy was successfully performed in every patient (33 with RF and in 11 with cryoenergy). No complication occurred. At a mean follow-up of 16.0 ± 11.7 months, we observed seven recurrences, three of them successfully re-ablated without fluoroscopy. In one case cryoablation of a para-Hisian AP was ineffective in the long term. Conclusions Three-dimensional EAM allowed a safe and effective fluoroless AP ablation procedure in a pediatric population both with RF and cryoenergy.

Brain magnetic resonance imaging (MRI) has identified a high incidence of cerebral ischemia in asymptomatic patients after atrial fibrillation (AF) ablation (silent). Detection of cerebral ischemic events on MRI is based on acute hyperintense lesions on diffusion-weighted imaging. In the literature, the incidence is related to specifications of MRI and depends on the definition applied. In comparative studies, silent cerebral events (SCE, diffusion-weighted MRI [DWI] positive only) appear to be approximately 3 times more common compared to using a definition of silent cerebral lesions (SCL; without fluid attenuated inverse recovery sequence [FLAIR] positivity). Whereas the FLAIR sequence may turn positive within days after the ischemic event, SCE definition is highly sensitive for early phases of ischemic brain damage. SCE/SCL appear to represent cerebral ischemic infarcts and determine the "embolic fingerprint" of a specific ablation technology and strategy used. The optimum time point for detecting SCE is early after AF ablation (24-72 hours), whereas detection of SCL can only be performed within the first 2-7 days (due to delay of FLAIR positivity). Different technology-, procedure-, and patient-related parameters have been identified to play a role in the multifactorial genesis of SCE/SCL. In recent years, evidence has been gathered that there may be differences of SCE/SCL rates depending upon the ablation technology used, but small patient numbers and a large number of potential confounders hamper all studies. As major findings of recent studies, mode of periprocedural and intraprocedural anticoagulation has been identified as a major predictor for incidences of SCE/SCL. Whereas procedural characteristics related to higher SCE/SCL-rates may be modified, unchangeable patient-related factors should be taken into account for future individualized risk assessment. Novel ablation devices introduced into the market should be tested for their potential embolic fingerprint and refinements of ablation procedures to reduce their embolic potential should be prompted. The knowledge of "best practice" in terms of low SCE/SCL rates has prompted changes in work-flow, which have been implemented into ablation procedures using novel ablation devices. So far, no study has linked SCE/SCL to neuropsychological decline and the low number of AF-ablation-associated events needs to be weighted against the multitude of preexisting asymptomatic MRI-detected brain lesions related to the course of AF itself. Future studies are needed to evaluate if more white matter hyperintensities due to AF may be prevented by AF ablation (producing only a small number of SCE/SCL).

PVI with nMARQ™ Background Simultaneous multipolar ablation catheters have been proposed to simplify pulmonary vein isolation (PVI) in paroxysmal atrial fibrillation (AF). Recently, a new multipolar irrigated radiofrequency (RF) ablation catheter (nMARQ™, Biosense Webster Inc., Diamond Bar, CA, USA) combining both 3-dimensional electroanatomic mapping and multipolar open-irrigated ablation capability has been developed. Aim of our study was to assess feasibility, acute and short-term success and safety of PVI by the use of this new technology with particular regard to the incidence of postablation silent cerebral ischemia (SCI). Methods and Results Twenty-five patients (76% males; age 57 ± 13 years) with paroxysmal AF underwent PVI using the nMARQ™ catheter. PVI, confirmed by Lasso catheter mapping, was achieved in 100 out of 102 pulmonary veins (98%) identified, and final PVI was obtained in 24 out of 25 (96%) patients. The overall concordance between Lasso and nMARQ™ signals in demonstrating PVI was 78%. No major procedural complications occurred and no patient suffered SCI, on the basis of cerebral magnetic resonance imaging performed before and after the procedure. Following a 6-month follow-up, 17/25 (68%) patients remained free from AF without antiarrhythmic drugs. Conclusions In our preliminary experience, PVI with nMARQ™ catheter appears to be feasible and safe, without incidence of SCI. Long-term clinical efficacy has to be evaluated in further studies.