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BACKGROUND: Limited data on the real-world safety and efficacy of leadless pacemakers (LPMs) post-transvenous lead extraction (TLE) are available. OBJECTIVE: The purpose of this study was to assess the long-term safety and effectiveness of LPMs following TLE in comparison with LPMs de novo implantation. METHODS: Consecutive patients who underwent LPM implantation in 12 European centers joining the International LEAdless PacemakEr Registry were enrolled. The primary end point was the comparison of LPM-related complication rate at implantation and during follow-up (FU) between groups. Differences in electrical performance were deemed secondary outcomes. RESULTS: Of the 1179 patients enrolled, 15.6% underwent a previous TLE. During a median FU of 33 (interquartile range 24-47) months, LPM-related major complications and all-cause mortality did not differ between groups (TLE group: 1.6% and 5.4% vs de novo group: 2.2% and 7.8%; P = .785 and P = .288, respectively). Pacing threshold (PT) was higher in the TLE group at implantation and during FU, with very high PT (>2 V@0.24 ms) patients being more represented than in the de novo implantation group (5.4% vs 1.6 %; P = .004). When the LPM was deployed at a different right ventricular (RV) location than the one where the previous transvenous RV lead was extracted, a lower proportion of high PT (>1-2 V@0.24 ms) patients at implantation, 1-month FU, and 12-month FU (5.9% vs 18.2%, P = .012; 3.4% vs 12.9%, P = .026; and 4.3% vs 14.5%, P = .037, respectively) was found. CONCLUSION: LPMs showed a satisfactory safety and efficacy profile after TLE. Better electrical parameters were obtained when LPMs were implanted at a different RV location than the one where the previous transvenous RV lead was extracted.

Arrhythmogenic cardiomyopathy (ACM) is a genetic disorder characterized by ventricular arrhythmias, contractile dysfunctions and fibro-adipose replacement of myocardium. Cardiac mesenchymal stromal cells (CMSCs) participate in disease pathogenesis by differentiating towards adipocytes and myofibroblasts. Some altered pathways in ACM are known, but many are yet to be discovered. We aimed to enrich the understanding of ACM pathogenesis by comparing epigenetic and gene expression profiles of ACM-CMSCs with healthy control (HC)-CMSCs. Methylome analysis identified 74 differentially methylated nucleotides, most of them located on the mitochondrial genome. Transcriptome analysis revealed 327 genes that were more expressed and 202 genes that were less expressed in ACM- vs. HC-CMSCs. Among these, genes implicated in mitochondrial respiration and in epithelial-to-mesenchymal transition were more expressed, and cell cycle genes were less expressed in ACM- vs. HC-CMSCs. Through enrichment and gene network analyses, we identified differentially regulated pathways, some of which never associated with ACM, including mitochondrial functioning and chromatin organization, both in line with methylome results. Functional validations confirmed that ACM-CMSCs exhibited higher amounts of active mitochondria and ROS production, a lower proliferation rate and a more pronounced epicardial-to-mesenchymal transition compared to the controls. In conclusion, ACM-CMSC-omics revealed some additional altered molecular pathways, relevant in disease pathogenesis, which may constitute novel targets for specific therapies.

Cryoballoon ablation is a recognized and widespread method for pulmonary vein isolation. For many years the impossibility of using it to create additional lines was considered a drawback of this approach. However, recently, the technique was adapted to allow the creation of rooflines, and potentially also inferior lines. In this article, we present the first reported case of a patient submitted to pulmonary vein isolation plus posterior wall isolation using the novel Boston POLAR X™ cryoballoon exclusively. To confirm the quality of the lesions, the patient underwent pre and postablation high-density mapping.

Background Ventricular tachycardia (VT) is a life-threatening condition, which usually implies the need of an implantable cardioverter defibrillator in combination with antiarrhythmic drugs and catheter ablation. Stereotactic body radiotherapy (SBRT) represents a common form of therapy in oncology, which has emerged as a well-tolerated and promising alternative option for the treatment of refractory VT in patients with structural heart disease. Objective In the STRA-MI-VT trial, we will investigate as primary endpoints safety and efficacy of SBRT for the treatment of recurrent VT in patients not eligible for catheter ablation. Secondary aim will be to evaluate SBRT effects on global mortality, changes in heart function, and in the quality of life during follow-up. Methods This is a spontaneous, prospective, experimental (phase Ib/II), open-label study (NCT04066517); 15 patients with structural heart disease and intractable VT will be enrolled within a 2-year period. Advanced multimodal cardiac imaging preceding chest CT-simulation will serve to elaborate the treatment plan on different linear accelerators with target and organs-at-risk definition. SBRT will consist in a single radioablation session of 25 Gy. Follow-up will last up to 12 months. Conclusions We test the hypothesis that SBRT reduces the VT burden in a safe and effective way, leading to an improvement in quality of life and survival. If the results will be favorable, radioablation will turn into a potential alternative option for selected patients with an indication to VT ablation, based on the opportunity to treat ventricular arrhythmogenic substrates in a convenient and less-invasive manner.

Background The combined left atrial appendage closure (LAAC) and cryoenergy pulmonary vein isolation (PVI) procedure has been proven safe and effective in managing stroke in patients with nonvalvular atrial fibrillation (AF), although most data refer to procedures performed using radiofrequency as the main energy source. Objective The purpose of this study was to evaluate long-term follow-up of patients with AF undergoing concomitant LAAC and cryoenergy PVI. Methods Patients undergoing LAAC and cryoballoon PVI at our institution were enrolled. At 3, 6, and 24 months from the index procedure, we determined the atrial arrhythmia recurrence rate, the extent of LAAC, and the rate of cerebrovascular/bleeding events. Results Forty-nine patients (mean age 69 ± 8 years; 32/49 (67%) men; CHA2DS2-VASc score 2.8 ± 1.2; HAS-BLED score 3 ± 1) with a guideline-recommended LAAC indication were included. Acute PVI and complete LAAC were achieved in 100% of patients. All patients completed at least 24 months of follow-up. At 8 weeks and 6 months, complete or satisfactory ( Conclusion Concomitant cryoballoon ablation and LAAC procedures appear safe and effective at long-term follow-up, with high antithrombotic drug withdrawal rates at 24 months.

BACKGROUND The novel fourth-generation cryoballoon (CB4) potentially allows for enhanced catheter maneuverability and more frequent capture of pulmonary vein (PV) potentials which can be used to monitor real-time PV isolation (PVI). The aim of our study is to compare the acute procedural endpoints between the CB4 and second-generation cryoballoon (CB2). METHODS A single-center retrospective chart review was used to examine 50 consecutive patients with drug-refractory atrial fibrillation undergoing CB4-based PVI. Procedural data and acute success of these patients were compared to 50 propensity-matched controls who underwent cryoballoon ablation procedure using CB2. RESULTS Procedures performed with the CB4 showed significant shorter fluoroscopy time (14.8 ± 5.5 vs 18.0 ± 6.5 minutes, P = .04), shorter procedure time (58.3 ± 15.7 vs 65.3 ± 21 minutes, P = .13), and shorter total ablation time (10.8 ± 1.5 vs 13.8 ± 1.9 minutes, P = .42). The real-time PVI visualization rate was 33.3% in the CB2 group and 74.7% in the CB4 group (P

Background A new intracardiac leadless pacemaker (ILP) has been developed to ensure atrioventricular (AV) synchrony (AVS) during ventricular pacing (VP). Recent studies have shown the feasibility and safety of accelerometer-based atrial sensing and an improvement in AVS among patients with atrioventricular block implanted with the Micra AV ILP (Medtronic Inc., Minneapolis, MN, USA). However, no data exists about the benefits of a VDD ILP in patients wearing a still working VVI Nanostim ILP (St Jude Medical, St Paul, MN, USA). We describe the feasibility of the procedure and the absence of device-related adverse events in the short-term follow-up. Case summary We present the case of a 72-year-old man implanted with a VVI ILP (Nanostim, St Jude Medical, St Paul, MN, USA) on May 2014, who has developed symptomatic high percentage of VVI asynchronous pacing and was treated with an upgrade to synchronous AV pacemaker (PM) ILP—Micra AV (Medtronic Inc., Minneapolis, MN, USA), which has improved symptoms and functional class. Discussion Intracardiac leadless pacemakers represent the best current option for patients requiring PM implantation who are at high risk of infection and bleeding. Our case shows that the new AVS ILP is a good alternative to VVI ILP in patients with sinus rhythm and a strong need for VP.

PURPOSE A new cryoballoon (CB) technology (POLARx™; Boston Scientific) for pulmonary vein (PV) isolation in patients with atrial fibrillation (AF) has recently been introduced. The aim of this study was to evaluate procedural and biophysical parameters resulting in acute PV isolation when using this new CB. METHODS We assessed the first 69 consecutive patients indicated for AF ablation who underwent PV isolation by means of a novel CB system. Procedural metrics were prospectively recorded. RESULTS A total of 274 PVs were targeted in 69 patients. PV isolation was achieved in all patients by means of cryoablation alone. The median time to isolation (TTI) was 44 [31-68] s (median temperature at TTI = - 49 [- 53 to - 41] °C). The median duration of CB ablation was 180 [180 to 240] s. The median nadir temperature was - 56.0 [- 61 to - 52] °C, and the median thaw time to 0 °C was 18 [15-21] s. The median grade of PV occlusion was 4 [3 to 4]. On the basis of ROC analysis, we defined the following cut-off values for acute PV isolation: - 56 °C for nadir temperature (sensitivity = 73.3%, specificity = 64.6%, AUC = 0.716; positive predictive value = 88.1%), 30 s for TTT (60.2%, 53.3%, 0.578; 79.7%), thaw time > 17 s (65.3%, 70.0%, 0.709; 86.9%), and grade of PV occlusion = 4 (79.4%, 66.7%, 0.738; 88.5%). No major procedure-related adverse events were observed at 30-day post-procedure. CONCLUSIONS The new POLARx™ CB appears to be effective and safe. A nadir temperature of - 56 °C, a thaw time to 0 °C ≥ 17 s, and complete PV occlusion were the best predictors of acute PV isolation. CLINICAL TRIAL REGISTRATION Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/Identifier : NCT03793998. Registration date: January 4, 2019.

Funding Acknowledgements Type of funding sources: None. Background Complete electrical pulmonary vein isolation (PVI) by cryo-balloon approach is a well-established ablation strategy of atrial fibrillation (AF). Recently, a new cryoablation system (POLARx) with unique features has been made available for clinical use. To date, no data exist on procedural characteristics of this system in a multicentric clinical practice. Purpose We aimed to characterize the initial experience of this technology in the Italian clinical practice. Methods Consecutive patients (pts) undergoing AF ablation from the CHARISMA registry at 5 Italian centres were included. Protocol-directed cryoablation was delivered for 180 sec or 240 sec according to operator’s preference for isolation achieved in ≤60 sec, or 240 sec if isolation occurred >60 sec or when time to isolation (TTI) was not available. The ablation endpoint was PV isolation as assessed by entrance and exit block. Results Two-hundred sixty-two cryoapplications from 49 pts (194 PVs) were analyzed. PVI was achieved with cryoablation only in all pts. The mean number of freeze applications per pt was 5.3 ± 1.5 (1.3 ± 0.6 for LIPV, LSPV and RSPV, 1.6 ± 1.3 for RIPV), with 143 (73.7%) PVs treated in a single-shot fashion (38, 19.6% with 2 shots; 13, 6.7% with more than 2 shots). Sixteen (33%) pts were treated with a single freeze to each of the PVs. The mean nadir temperature was -55.5 ± 6.9 °C and was colder than -50°C in 83% of the PVs. TTI information was evaluable in 120 (46%) cryoapplications with a median TTI of 47 [32-75] sec (median temperature at TTI = -49 [-53 to -42] °C). The mean time to target -40 °C (TTT) was 30.1 ± 6.9 sec with a TTT < 60 sec achieved in 99.2% of the cryoapplications; the mean thaw time to 0 °C was 18.6 ± 5.8 sec (thaw time >15 sec in 70.3% of the cryoapplications). The mean PV occlusion grade (rank 1-4) was 3.6 ± 0.6 (grade 2 in 5.2% of the cases, grade 3 in 25.6% and grade 4 in 69.2%). No complications were observed at 30 days post-procedure. Conclusion In this first multicentric experience in a clinical practice setting, the novel cryo-balloon system proved to be safe and effective and resulted in a high proportion of successful single-freeze isolation. Cooling parameters seem to be slightly different from reference cryo-balloon technology.

Introduction: Catheter ablation is superior to drugs regarding atrial fibrillation (AF) recurrence, symptoms improvement, and mortality reduction in heart failure. POLARx™ is a novel cryoballoon, with technical improvements seeking to improve outcomes. So far, its clinical evidence is restricted to a case report. Methods: To compare the POLARx™ cryoballoon procedural safety and efficacy to the already established Arctic Front Advance PRO™ (AFAP) in a single-center cohort study, consecutive patients undergoing AF cryoablation with the POLARx™ were enrolled. Data were prospectively gathered. POLARx™ patients were compared to a historical cohort of patients submitted to AF cryoablation with the AFAP. Results: Seventy patients were analyzed, 20 in POLARx™, and 50 in the AFAP group. They all underwent first-time pulmonary vein isolation, 77% were male, 94% had paroxysmal AF, median age was 62.5 years, median CHA2DS2-VASc 1, left-atrium size 34ml/m², and 65% were receiving anticoagulation. The primary end-point, all pulmonary veins isolation, was 100% in both groups. The complication rate was similar (0% POLARx™ vs. 5.7% AFAP, p=0.39). The median total procedural time was longer in the POLARx™ group (90min vs. 60min, p

Background Current arrhythmogenic right ventricular cardiomyopathy (ARVC) diagnostic criteria are mostly based on ventricle function and dimension. Previous studies have reported a significant overlap between ARVC and chronic myocarditis, at non-invasive assessment. Purpose Tto compare biopsy-proven ARVC and myocarditis patients, in order to identify clinical, imaging and invasive electroanatomic voltage mapping (EVM) differences between the two groups. Methods Patients with borderline diagnosis of ARVC or suspected myocarditis underwent compete assessment with cardiac magnetic resonance (CMR). All patients underwent endomyocardial biopsy (EMB) with targeted tissue sampling guided by EVM. All patients with an histological diagnosis of myocarditis or ARVC were included. Results 83 patients were included, divided into 35 (42.2%) ARVC and 48 (57.8%) myocarditis. Among ARVC patients, 25 (71.4%) had right dominant ARVC, 5 (14.3%) left dominant patter and 5 (14.3%) bi-ventricular involvement. Nine patients (23.1%) with suspected clinic diagnosis of ARVC before EMB, received and histological diagnosis of myocarditis. Two (5.7%) patients with suspected myocarditis were proven to have ARVC. When comparing patients with ARVC and patients with myocarditis, univariate analysis showed that age, sex, family history, arrhythmic disorders at presentation and ECG abnormalities were similar between the two groups (P>0.05 for all the variables). There was also no significant difference with regards to bi-ventricular function and dimension at CMR evaluation. More patients with myocarditis resulted positive at late gadolinium enhancement (LGE) evaluation, although non-significantly (P=0.082). Oedema was more frequently present in patients with myocarditis (P=0.01), while adipose tissue infiltration and segmental wall motion abnormalities were more often observed in patients with ARVC (P=0.002 and P Conclusion(s) A significant number of patients who received a clinical diagnosis of Myocarditis or ARVC according to current guidelines, were subsequently reclassified after histological analysis. Patients with ARVC and myocarditis were not distinguishable on the basis of clinical features and ventricular function and dimensions. Conversely, tissue analysis with CMR demonstrated how patient with ARVC had less oedema, more adipose tissue infiltration and had more extensive scar at EVM evaluation. Funding Acknowledgement Type of funding source: None

Background The number of master athletes is increasing and treatment of AF is mandatory for sports continuation. However, few data exist about the effectiveness of catheter ablation (CA) in athletes and the feasibility of resuming vigorous exercise afterwards. Objectives Aim of our study was to analyze the efficacy and safety of AF CA in athletes and to evaluate the feasibility of resuming vigorous exercise. Methods We report a retrospective registry of athletes referred to our center for AF CA in the last five years. All athletes were previously declared non-eligible to competitive sport because of recurrences of AF or evidence of persistent asymptomatic AF. CA was performed as per practice and recurrences were defined as recrudescence of symptoms and/or any documentation of AF lasting more than 30 sec. At the end of the follow-up all pts were asked about resuming sport. Results We ablated 40 athletes (38 males, 95%) with a mean age of 48±13 years. Mean left atrium volume was 36±11 ml/m2 and mean ejection fraction was 61±5%. Distribution between AF characteristics was: 31 (78%) paroxysmal AF, 8 (20%) early-persistent AF, 1 (2%) long-persistent AF. After a median follow-up of 787 days, 62,5% of athletes were free from recurrences after one CA procedure and mostly without antiarrhythmic drugs (87%). 7 athletes underwent a redo procedure and all of them were then free of recurrences with an overall freedom from recurrences of 84%. No major complication was observed. Athletes practicing endurance sports showed a negative trend in terms of recurrences (p = ns). Most (72%) of the athletes resumed vigorous exercise after at least 3 months from the CA as per Italian sport protocols. Conclusions CA is safe and efficient in treating AF also in athletes. Resuming high intensity sports is often possible after 3 months from CA. Funding Acknowledgement Type of funding source: None

During the past years, endomyocardial biopsy (EMB) has gradually spread into clinical practice. However, the role of EMB in the diagnosis and treatment of cardiovascular diseases remains a controversial issue, especially in the setting of unexplained ventricular arrhythmias. Areas covered: This review describes the methodology of EMB guided by combined use of three-dimensional electroanatomical mapping systems and intracardiac echo and summarizes the classical, fluoroscopy-guided EMB technique. Finally, the personal experience acquired with the 'electrophysiologist-made' integration methodology has been reported. Expert commentary: Since EMB has been considered in the setting of arrhythmogenic cardiomyopathy, myocarditis, cardiac sarcoidosis, drug toxicity, and/or other diseases causing malignant ventricular arrhythmias, the electrophysiologists have started to perform firsthand biopsy. The electrophysiologists introduced the use of electroanatomical mapping systems and intracardiac echo. This new methodology improved significantly biopsy diagnostic yield and allowed to reduce complications.

Background:Electroanatomic voltage mapping (EVM) is a promising modality for guiding endomyocardial biopsies (EMBs). However, few data support its feasibility and safety. We now report the largest cohort of patients undergoing EVM-guided EMBs to show its diagnostic yield and to compare it with a cardiac magnetic resonance (CMR)–guided approach.Methods:We included 162 consecutive patients undergoing EMB at our institution from 2010 to 2019. EMB was performed in pathological areas identified at EVM and CMR. CMR and EVM sensitivity and specificity regarding the identification of pathological substrates of myocardium were evaluated according to EMB results.Results:Preoperative CMR showed late gadolinium enhancement in 70% of the patients, whereas EVM identified areas of low voltage in 61%. Right (73%), left (19%), or both ventricles (8%) underwent sampling. EVM proved to have sensitivity similar to CMR (74% versus 77%), with specificity being 70% and 47%, respectively. In 12 patients with EMB-proven cardiomyopathy, EVM identified pathological areas that had been undetected at CMR evaluation. Sensitivity of pooled EVM and CMR was as high as 95%. EMB analysis allowed us to reach a new diagnosis, different from the suspected clinical diagnosis, in 39% of patients. The complications rate was low, mostly related to vascular access, with no patients requiring urgent management.Conclusions:EVM proved to be a promising tool for targeted EMB because of its sensitivity and specificity for identification of myocardial pathological substrates. EVM was demonstrated to have accuracy similar to CMR. EVM and CMR together conferred a positive predictive value of 89% on EMB.

Background The diagnosis of concealed cardiomyopathies in patients with ventricular arrhythmias (VAs) is one of the major challenging issues faced by physicians. Purpose We aimed at reporting the cardiomyopathic substrate in patients with recurrent arrhythmias of ventricular origin. Methods Consecutive patients with unexplained VAs underwent a complete diagnostic work-out, including endomyocardial biopsy (EMB). Results Ninety-seven patients were enrolled (76.3% male, age 39.7±13.3 yrs). The presenting arrhythmic manifestation was aborted cardiac arrest in 30 (30.9%) patients, sustained ventricular tachycardia (VT) in 9 (9.3%), nonsustained VT in 15 (15.5%) and frequent premature ventricular complexes in 43 (44.3%). Overall, 350 biopsies were collected (3.6/patient). The incidence of procedure-related complications was 5.1% (n=5): 4 major complications (1 rupture of a tricuspid chorda tendinea w/o hemodynamic impairment, 1 dissection of right external iliac artery treated with stent, 1 thrombotic occlusion of left superficial femoral artery which required surgical treatment, 1 TIA) and 1 minor complication (groin hematoma) occurred. The final diagnosis was arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C) (n=41; 42.3%), followed by myocarditis (n=20; 20.6%), dilated cardiomyopathy (n=6; 6.2%), cardiac sarcoidosis (n=6; 6.2%), and myocarditis in ARVD/C (n=5; 5.1%). Among the 25 patients whose final diagnosis was consistent with myocarditis, an acute stage of the disease was documented in 7 (7.2%), while a chronic myocarditis in 18 (18.5%). Additionally, according to medical history and diagnostic workout, in 2 of the 6 patients the dilated cardiomyopathy had a likely post-inflammatory etiology. Absence of myocardial abnormalities was documented in 15 (15.5%) patients: this group included 1 case of methadone-induced torsade de pointes. The remaining 4 (4.1%) patients were diagnosed with a cardiac hypertrophy (n=2, 2.1%, secondary to exercise or Fabry disease), a dilated mitochondrial cardiomyopathy (n=1, 1.0%), a dilated cardiomyopathy in Emery-Dreifuss muscular dystrophy (n=1; 1.0%). Conclusion In our series, approximately 45% of patients with unexplained VAs had a final diagnosis of ARVD/C.

Introduction Patients with myocarditis may fulfill the cardiac magnetic resonance (CMR) criteria set forth by the 2010 Task Force for arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C), thereby increasing the risk of misdiagnosis. Purpose We sought to evaluate the role of CMR and endomyocardial biopsy (EMB) in the differential diagnosis between myocarditis and ARVD/C. Methods Consecutive patients presenting with ventricular arrhythmias, underwent a complete diagnostic work-out, which included CMR and EMB. The final diagnosis served as the gold standard to assess the diagnostic accuracy of CMR and EMB. Results Overall, 74 consecutive patients presenting with VAs underwent a complete diagnostic workout at our institution. The cohort was 70.3% male, with a mean age of 38.9±12.1 years. A final diagnosis of ARVD/C was made in 30 (40.5%) patients, whereas 19 (25.7%) had a diagnosis of myocarditis. The McNemar's test showed significant differences in the diagnostic performance of EMB and cardiac MRI (p=0.003 for ARVD/C, p=0.04 for myocarditis). At receiver operating characteristic (ROC) analyses, the area under the curve (AUC) to discriminate between controls and ARVD/C patients was 0.711 (95% CI: 0.59–0.83) for MRI and 0.944 (95% CI: 0.88–1.00) for biopsy (p Diagnostic performance of CMR and EMB Conclusion Even though CMR has good diagnostic performances as single technique, a complete diagnostic work-out including EMB may frequently reduce the risk of misdiagnoses.

Aims Pulmonary veins (PVs) isolation is the cornerstone of atrial fibrillation (AF) ablation and can be achieved either by conventional radiofrequency ablation or by cryoenergy. Left atrial appendage (LAA) closure has been proposed as alternative treatment to vitamin K antagonists (VKA). We aimed to evaluate the feasibility of combining cryoballoon (CB) ablation and LAA occlusion in patients with AF and a high thromboembolic risk or contraindication to antithrombotic therapy. Methods and results Thirty-five patients (28 males, 74 ± 2 years) underwent CB ablation. Left atrial appendage occlusion was carried out by using two occluder devices (Amplatz Cardiac Plug, ACP, St. Jude Medical, MN, USA, in 25 patients; Watchman, Boston Scientific, MA, USA, in 10 patients). Thirty patients (86%) had previous stroke/TIA episodes, 6 patients (17%) had major bleeding while on VKA therapy, and 7 patients (20%) had inherited bleeding disorders. Over the follow-up (24 ± 12 months), atrial arrhythmias recurred in 10 (28%) patients. Thirty patients (86%) had complete sealing; 5 patients (14%) showed a residual flow (

Key Clinical Message Transvenous extraction of Riata lead could be a challenging procedure due to insulation failure and conductor cables’ externalization through the eroded outer insulation. In this case, a complete lead extraction was achieved through a combined LASER and femoral approach because of the massive conductors’ externalization.

Cryoballoon ablation was developed as a new treatment for pulmonary vein (PV) isolation and has demonstrated high procedural success and comforting long-term clinical outcome. However, some improvements are necessary for real-time visualization of PV signals that appeared important to increase the efficacy and reduce ineffective cryoapplications. We report, for the first time, a cryoablation procedure using the fourth-generation cryoballoon, describing betterment in vein signal recording and acute procedural success.

Previous studies indicate force time integral (FTI) as a radiofrequency (RF) lesion quality marker, while not considering power supply. Tacticath™ Quartz catheter provides Lesion index (LSI), a lesion quality marker derived by contact force (CF), power supply, and RF time combined. Our aim is to assess LSI and FTI correlation and a LSI-related cutoff of atrial fibrillation (AF) recurrences 12 months after pulmonary vein isolation (PVI). We retrospectively enrolled 37 patients who underwent RF ablation using Tacticath™ Quartz catheter. AF recurrence rate was evaluated 3, 6, and 12 months after PVI procedure. AF recurrence was detected in 32% of patients. FTI mean value was significantly lower in left superior pulmonary vein (LSPV: 256 ± 86 gs vs 329 ± 117 gs, p = 0.05) and right inferior pulmonary vein (RIPV: 253 ± 128 gs vs 394 ± 123 gs p = 0.006) in patients with AF recurrences; no significant differences were found in right superior pulmonary vein (RSPV) and left inferior pulmonary vein (LIPV). LSI instead was significantly higher for all veins in patients without AF recurrences: LSPV (5.2 ± 0.7 vs 4.6 ± 0.8, p = 0.03), LIPV (5.0 ± 0.8 vs 4.5 ± 0.6, p = 0.04), RSPV (5.5 ± 0.6 vs 5.1 ± 0.6, p = 0.05), and RIPV (5.5 ± 0.7 vs 4.7 ± 0.8, p = 0.006). Receiver operator characteristic curve suggests 5.3 as LSI overall cutoff value predicting freedom from disease at 1-year follow-up. Our preliminary data suggest that a LSI mean value higher than 5.3 can be considered a good predictor of AF freedom at 1-year follow-up.

Background Only a few studies have systematically evaluated fluoroscopy data of electrophysiological and device implantation procedures. Aims of this study were to quantify ionizing radiation exposure for electrophysiological/device implantation procedures in a large series of patients and to analyze the x‐ray exposure trend over years and radiation exposure in patients undergoing atrial fibrillation ablation considering different technical aspects. Methods and Results We performed a retrospective analysis of all electrophysiological/device implantation procedures performed during the past 7 years in a modern, large‐volume laboratory. We reported complete fluoroscopy data on 8150 electrophysiological/device implantation procedures (6095 electrophysiological and 2055 device implantation procedures); for each type of procedure, effective dose and lifetime attributable risk of cancer incidence and mortality were calculated. Over the 7‐year period, we observed a significant trend reduction in fluoroscopy time, dose area product, and effective dose for all electrophysiological procedures ( P P P P = 0.74) for radiofrequency catheter ablation in comparison with cryoablation, though cryoablation was still associated with higher dose area product and effective dose values ( P Conclusions Electrophysiological procedures involve a nonnegligible x‐ray use, leading to an increased risk of malignancy. Awareness of radiation‐related risk, together with technological advances, can successfully optimize fluoroscopy use.

Background— Endomyocardial biopsy (EMB) has a low sensitivity. Electroanatomic voltage mapping (EVM) is effective in guiding EMB thanks to its ability in identifying and locating low-voltage regions. The analysis of unipolar EVM can correlate with epicardial pathological involvement. We evaluated the unipolar EVM in EMB areas to determine whether it can increase EMB sensitivity in diagnosing epicardial diseases. Methods and Results— We performed endocardial bipolar EVM-guided EMBs in 29 patients and we analyzed unipolar EVM at withdrawal sites. Eighty myocardial samples were collected (mean, 2.8±0.9; median, 3 fragments per patient) and 60 were suitable for histological analysis. Ten specimens (17%) were collected from an area with discordant normal bipolar/low-voltage unipolar EVM and they were diagnostic or suggestive for arrhythmogenic right ventricular dysplasia/cardiomyopathy in 6 patients, for myocarditis and sarcoidosis in 1 patient each. Six samples (10%) were collected from an area with discordant low-voltage bipolar/normal unipolar EVM and they showed nonspecific features. The sensitivity of unipolar EVMs for a diagnostic biopsy finding EMB was significantly higher compared with bipolar EVMs analyzed according to samples ( P P =0.008). The specificity of unipolar EMB was better than bipolar EMB when analyzed for all samples ( P =0.0014) but the difference did not reach statistical significance when analyzed by patient ( P =0.083). The diagnostic yield was 63.3% for the bipolar and 83.3% for the unipolar EVM. Conclusions— These findings suggest that use of a combined bipolar/unipolar map may be able to improve the diagnostic yield of endomyocardial ventricular biopsy.

Background Advanced techniques of electroanatomical mapping efficiently guide ventricular tachycardia (VT) ablation strategies; in this context, the adjunctive value of combining activation mapping (AMap) to improve accuracy has not been elucidated. Objective To investigate whether conventional AMap further contributes to the identification of critical sites of VT reentry and whether this translates into a more effective ablation outcome in a cohort of patients undergoing VT ablation. Methods We prospectively enrolled 126 patients (mean age 65.3 ± 10.5 years; left ventricular ejection fraction 33.3% ± 7.2%) with ischemic (n = 89) or idiopathic (n = 37) dilated cardiomyopathy undergoing endocardial (n = 105) or endo-epicardial (n = 21) electroanatomical mapping and ablation. A substrate-guided strategy targeting surrogate markers of reentry was accomplished in all patients, but the feasibility and efficacy of AMap was preliminarily assessed for all induced VTs focusing on early VT suppression obtained during radiofrequency delivery. VT-free survival was assessed by ICD interrogation. Results AMap successfully guided ablation in 62 of 104 (59.6%) patients with inducible VT(s). At 1 year, 6 of 126 (4.8%) patients died; VT recurred in 28 of 126 (22.2%) patients. No significant difference in VT recurrence rate was observed between patients in whom AMap proved effective versus those in whom substrate-guided ablation was not corroborated by AMap (16 of 62 [25.8%] vs 12 of 64 [18.8%]; log-rank test, P = .3). Conclusions Our findings support the efficacy of a substrate-guided strategy targeting specific markers of arrhythmogenicity identified during sinus rhythm. AMap proves highly efficient acutely but does not improve overall VT-free survival, suggesting that in patients with advanced cardiac disease, life-threatening arrhythmias can be successfully treated by ablation in sinus rhythm, thus limiting procedural risks.

In the present study, we aimed to test the value of CAAP-AF score for prediction of atrial fibrillation (AF) recurrence at follow-up in a group of our patients treated by balloon cryoablation. A total of 283 symptomatic drug-refractory AF patients [261 (92%) with paroxysmal AF] who underwent pulmonary vein isolation (PVI) with second-generation cryoballoon between April 2012 and October 2016 were included. The CAAP-AF score was calculated for every patient. A total of 283 patients [68 female (20%), mean age 59.8 ± 11.4 years] were included in the present analysis. Eighty-nine patients (31%) had hypertension and 13 (4%) had coronary artery disease. The mean left atrial diameter and left ventricular ejection fraction were 40.6 ± 7.0 mm and 60.0 ± 9.1%, respectively. The mean CHA2DS2-VASc score was 1.2 ± 1.1, and mean number of prior failed antiarrhythmic drugs was 1.4 ± 0.8. At 18 ± 6 months follow-up, 25 patients (8.87%) developed AF recurrence. The recurrence rate was as follows: 3.17% (score 0–3), 8.47% (score 4), 16.28% (score 5), 6.67% (score 6), 23.08% (score 7), and 36.36% (score ≥8). The recurrence rate was 4.86% at a score

Background: To evaluate the changes in autonomic neural control mechanisms before malignant ventricular arrhythmias, we measured heart rate variability (HRV) and heart rate turbulence (HRT) in patients with ventricular tachycardia or fibrillation (Group I; n=6), non sustained ventricular tachycardia (Group II; n=32), frequent premature ventricular beats (Group III; n=26) and with ICD implantation (Group IV; n=11). Methods: Time domain parameters of HRV and turbulence onset (TO) and slope (TS) were calculated on 24 hour Holter recordings. Normal values were: SDNN > 70 msec for HRV, TO 2.5 msec/RR-I for HRT. Results: Whereas SDNN was within normal range and similar in all study groups, HRT parameters were significantly different in patients who experienced VT/VF during Holter recording. Abnormal TO and/or TS were present in 100% of Group I patients and only in about 50% of Group II and IV. On the contrary, normal HRT parameters were present in 40-70% of Group II, III and IV patients and none of Group I. Conclusions: These data suggest that HRT analysis is more suitable than HRV to detect those transient alterations in autonomic control mechanisms that are likely to play a major trigger role in the genesis of malignant cardiac arrhythmias. (Heart International 2007; 3: 51-7)

Resumen Introduccion y objetivos La incidencia real de las elevaciones de la troponina I cardiaca tras la cirugia toracica y su correlacion con otros parametros clinicos no esta plenamente definida. El objetivo de este estudio fue evaluar la frecuencia de las elevaciones postoperatorias de la troponina I cardiaca despues de cirugia pulmonar o pleural por sospecha de cancer e investigar las correlaciones con los perfiles clinicos basales, con la proteina C reactiva y los parametros perioperatorios. Metodos Se registro a 50 pacientes consecutivos y se midieron los siguientes parametros en cada paciente: variables clinicas basales y concentracion de la proteina C reactiva, concentracion de troponina I cardiaca en los dias 1, 3 y 5 del postoperatorio, electrocardiograma, presion arterial, y frecuencia cardiaca diarias desde el dia de la operacion hasta el dia 5 del postoperatorio. Resultados Se produjeron elevaciones postoperatorias de la troponina I cardiaca en el 20% de los pacientes y estas estaban significativamente asociadas con los antecedentes de coronariopatia o mas de 2 factores de riesgo coronario (el 80 frente al 32,5%; p = 0,011), los antecedentes de tratamiento antiagregante plaquetario cronico (el 50 frente al 17,5%; p = 0,046), la neumonectomia comparada con los procedimientos menos invasivos (el 40 frente al 10%; p = 0,041), la pericardiotomia (el 30 frente al 2,5%; p = 0,022) y las modificaciones transitorias del segmento ST en el electrocardiograma perioperatorio (el 60 frente al 20%; p = 0,02). No se observo correlacion significativa entre las elevaciones de la troponina I cardiaca y la proteina C reactiva basal. Conclusiones Las elevaciones de la troponina I cardiaca despues de la cirugia toracica son frecuentes y estan asociadas con marcadores clinicos de coronariopatia, procedimientos quirurgicos extensos y cambios isquemicos en el electrocardiograma perioperatorio.

Introduction and objectives. The exact incidence of cardiac troponin-I elevation after thoracic surgery and its correlation with other clinical parameters has not been fully described. The aims of this study were to determine the frequency of postoperative cardiac troponin-I elevation following lung or pleural surgery for suspected cancer, and to investigate correlations with baseline clinical characteristics, the C-reactive protein level, and perioperative parameters. Methods. Fifty consecutive patients were enrolled in the study. In each patient, the following parameters were measured: clinical characteristics and C-reactive protein level at baseline, cardiac troponin-I level on postoperative days 1, 3 and 5, and blood pressure, heart rate and ECG parameters every day from the day of the operation until postoperative day 5. Results. The cardiac troponin-I level was elevated postoperatively in 20% of patients. There were significant associations with either a history of coronary artery disease or the presence of more than two coronary risk factors (80% vs. 32.5%; P=.011), a history of chronic antiplatelet therapy (50% vs. 17.5%; P=.046), pneumonectomy compared with less invasive procedures (40% vs. 10%; P=.041), pericardiotomy (30% vs. 2.5%; P=.022), and transient ST-segment alterations on perioperative ECGs (60% vs. 20%; P=.02). No significant correlation was found between cardiac troponin-I elevation and the baseline C-reactive protein level. Conclusions. Cardiac troponin-I elevation occurs frequently after thoracic surgery and it is associated with clinical markers of coronary artery disease, extensive surgical procedures, and ischemic changes observed on perioperative ECGs.

Contact with cardiac tissue is an important determinant of lesion efficacy during atrial fibrillation (AF) ablation. The Sensei X™ robotic navigation system (RNS) (Hansen Medical, Mountain View, CA, USA) has been validated for contact force (CF) sensing expressed in grams (g). The Thermocool® SmartTouch™ catheter enables the measurement of catheter tip CF and direction inside the heart. We aimed to investigate the catheter CF with and without RNS during pulmonary vein isolation (PVI) procedures.Eighty patients with symptomatic AF (56 males, age 63 ± 18) were enrolled in this study. Fifty-seven patients had paroxysmal AF and 23 early persistent AF. All procedures were performed with the Thermocool® SmartTouch™ ablation catheter. Forty patients were randomized to perform PVI with the Sensei X™ RNS (group 1), while in the other 40 patients (group 2), PVI was performed without the RNS.AF ablation was performed successfully in all patients without complications, while contact force was kept in the established 10-40 g range. A significantly higher CF was documented on the PVs in group 1 compared to group 2. The 1-year freedom from AF recurrence was higher in group 1 compared to group 2 (90 vs. 65 %, p = 0.04). Moreover, a significant reduction of fluoroscopy time was noted in the RNS group (13 ± 10 vs. 20 ± 10 min, respectively, p = 0.05).The Sensei X™ RNS permits a significantly higher CF during transcatheter AF ablation with a low rate of AF recurrence at clinical follow-up.

Chagas disease patients often present premature ventricular complexes (PVCs), depression of left ventricular ejection fraction (LVEF) and autonomic dysfunction, which is generally evaluated by heart rate variability (HRV) analysis. As frequent PVCs may complicate HRV computation, we measured heart rate turbulence (HRT) and evaluated the correlation between ejection fraction and HRT or HRV in Chagas disease.We studied 30 patients (47+/-11 years, 20 men) with Chagas cardiomyopathy and left ventricular dilatation who underwent clinical evaluation, ejection fraction (EF: 45+/-14%) determination and 24-h Holter monitoring (median PVC=1781). In all patients, the standard deviation of normal RR intervals (SDNN), the square root of the mean square differences of successive RR intervals (RMSSD) and values of turbulence onset (TO) and turbulence slope (TS) were calculated.HRT indices were independent of mean RR interval and presented high correlation with EF: TO (-0.11+/-0.01%, r=-0.60, P0.001) and TS (5.8+/-3.7 ms/RR-interval, r=0.73, P0.001). Of HRV parameters, only SDNN, corrected for mean RR interval, showed a weak but not significant correlation with EF (r=0.41). The comparison of HRT/EF and HRV/EF correlation coefficients, indicated the presence of a significant difference (P=0.017).HRT indices appear to correlate better with EF than SDNN in Chagas disease. Thus, an analysis based on heart rate transient adaptation seems to perform better than HRV in detecting the autonomic alterations that parallel left ventricular dysfunction in Chagas disease patients. The high number of PVCs observed in these patients further support the use of HRT methodology.

Previous studies reported the usefulness of an irrigated circular radiofrequency ablation catheter (nMARQ(TM), Biosense Webster) for pulmonary vein isolation (PVI). We evaluated the role of intracardiac echocardiography (ICE) to optimize the manipulation of nMARQ(TM) catheter.Thirty-seven patients (pts), (mean age 55 ± 12 years; 28 males) were enrolled to perform PVI. All pts underwent PVI with the nMARQ(TM) catheter. In 20 pts (group 1), we utilized ICE to guide nMARQ(TM) catheter positioning at the PV ostia; in the other 17 pts (group 2), nMARQ(TM) catheter was positioned at the PV ostia guided by fluoroscopy and TissueConnect(TM) technology.Radiofrequency (RF) applications were significantly lower in group 1 compared to group 2 [left PVs: 6 (range 3 to 12) in group 1 and 12 (range 5 to 16) in group 2 (p0.001); right PVs: 7 (range 4 to 14) in group 1 and 10 (range 5 to 16) in group 2 (p = 0.04)]; similarly regarding the time of RF delivery [left PVs: 318 ± 194 s in group 1 vs. 542 ± 104 s in group 2 (p0.001); right PVs: 410 ± 270 s in group 1 vs. 550 ± 156 s in group 2 (p = 0.05)]. Fluoroscopy time (23 ± 9 min vs. 28 ± 5 min; p = 0.05), procedural time (83 ± 23 min vs. 160 ± 42 min; p0.001), and radiation dose (109 ± 20 Gy/cm(2) vs. 127 ± 29 Gy/cm(2); p = 0.04) were significantly lower in group 1 compared to group 2.ICE might be a useful tool to guide nMARQ(TM) catheter position in the left atrium during atrial fibrillation (AF) ablation procedures.

The cornerstone of the new imaging technologies to treat complex arrhythmias is the electroanatomic (EAM) mapping. It is based on tissue characterization and in particular on determination of low potential region and dense scar definition. Recently, the identification of fractionated isolated late potentials increased the specificity of the information derived from EAM. In addition, non-invasive tools and their integration with EAM, such as cardiac magnetic resonance imaging and computed tomography scanning, have been shown to be helpful to characterize the arrhythmic substrate and to guide the mapping and the ablation. Finally, intracardiac echocardiography, known to be useful for several practical uses in the setting of electrophysiological procedures, it has been also demonstrated to provide important informations about the anatomical substrate and may have potential to identify areas of scarred myocardium.