Search

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.

In December 2019, the world started to face a new pandemic situation, the severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2). Although coronavirus disease (COVID-19) clinical manifestations are mainly respiratory, major cardiac complications are being reported. Cardiac manifestations etiology seems to be multifactorial, comprising direct viral myocardial damage, hypoxia, hypotension, enhanced inflammatory status, ACE2-receptors downregulation, drug toxicity, endogenous catecholamine adrenergic status, among others. Studies evaluating patients with COVID-19 presenting cardiac injury markers show that it is associated with poorer outcomes, and arrhythmic events are not uncommon. Besides, drugs currently used to treat the COVID-19 are known to prolong the QT interval and can have a proarrhythmic propensity. This review focus on COVID-19 cardiac and arrhythmic manifestations and, in parallel, makes an appraisal of other virus epidemics as SARS-CoV, Middle East respiratory syndrome coronavirus, and H1N1 influenza.

Background We sought to evaluate the additional value of left atrial appendage (LAA) 3D printing derived from computed tomography (CCT) in determining the size for LAA occlusion (LAAO) devices as compared to standard measurement by using occurrence of LAA leak as endpoint. Methods We evaluated 6 patients with LAA leak (cases) and 14 matched patients without LAA leak (controls) after LAAO. For each group, a patient-specific 3D printed model of LAA was manufactured using CT pre-operative images. The size recommended by the 3D printed model was compared with the size of the implanted device. Results Compared to the 3D printed model, 55% of the devices were underestimated, the two sizing approaches agreed in 35% of the patients, while the 3D printed model overestimated the size in 10% of patients. The prevalence of LAA leak was significantly higher in the subset of patients with underestimation of prosthesis implanted with the standard approach as compared to the other patients (p = 0.019). Conclusion 3D printing of the LAA may provide additional value to standard practice for LAAO device prosthesis sizing with the potential impact to reduce LAA leak.

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

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.

Background: Percutaneous left atrial appendage closure (LAAC) requires accurate pre- and intraprocedural measurements, and multimodality imaging is an essential tool for guiding the procedure. Two-dimensional (2D TOE) and three-dimensional (3D TOE) transoesophageal echocardiography, cardiac computed tomography (CCT), and conventional cardiac angiography (CCA) are commonly used to evaluate left atrial appendage (LAA) size. However, standardized approaches in measurement methods by different imaging modalities are lacking. The aims of the study were to evaluate the LAA dimension and morphology in patients undergoing LAAC and to compare data obtained by different imaging modalities: 2D and 3D TOE, CCT, and CCA. Methods: A total of 200 patients (mean age 70 ± 8 years, 128 males) were examined by different imaging techniques (161 2D TOE, 103 3D TOE, 98 CCT, and 200 CCA). Patients underwent preoperative CCT and intraoperative 2D and 3D TOE and CCA. Results: A significant correlation was found among all measurements obtained by different modalities. In particular, 3D TOE and CCT measurements were highly correlated with an excellent agreement for the landing zone (LZ) dimensions (LZ diameter: r = 0.87; LAA depth: r = 0.91, p < 0.001). Conclusions: Head-to-head comparison among imaging techniques (2D and 3D TOE, CCT, and CCA) showed a good correlation among LZ diameter measurements obtained by different imaging modalities, which is a parameter of paramount importance for the choice of the LAAC device size. LZ diameters and area by 3D TOE had the best correlation with CCT.

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 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

The outcome of radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF) has improved thanks to left atrium (LA) anatomy reconstruction by cardiac computed tomography (CCT). A new model-based iterative reconstruction algorithm (MBIR) provides image noise reduction achieving effective radiation dose (ED) close to chest X-ray exposure. Aim of this study was comparing RFCA procedural characteristics, AF recurrence and radiation exposure between patients in whom RFCA was guided by CCT image integration with MBIR versus a CCT standard protocol.Three-hundred consecutive patients with drug-refractory AF were studied with CCT using MBIR (Group 1; N:150) or CCT with standard protocol (Group 2; N:150) for LA evaluation and treated by image integration-supported RFCA. Image noise, signal to noise ratio (SNR), contrast to noise ratio (CNR), RFCA procedural characteristics, rate of AF recurrence and radiation exposure were compared.Group 1 showed higher SNR (25.9±7.1 vs. 16.2±4.8, p0.001) and CNR (23.3±7.1 vs. 12.2±4.2, p0.001) and lower image noise (22.3±5.2 vs. 32.6±8.1 HU, p0.001), fluoroscopy time (21±12 vs. 29±15min, p0.01) and procedural duration (135±89 vs. 172±55, p0.001). Group 1 showed a 94% reduction of ED as compared to Group 2 (CCT-ED related: 0.41±0.04 vs. 6.17±4.11mSv, p0.001; cumulative CCT+RFCA-ED related: 21.9±17.9 vs. 36.0±24.1mSv, p0.001) with similar rate of AF recurrence (25% vs. 29%, p=0.437).CCT with MBIR allows accurate reconstruction of LA anatomy in AF patients undergoing RFCA with a sub-millisievert ED and comparable success rate of RFCA as compared to a standard CCT scan protocol.

Background Percutaneous endo-myocardial biopsy (EMB) is an invasive diagnostic test used to reach or confirm a diagnosis when structural or substrate anomalies are suspected, such as in cardiomyopathies or myocarditis evaluation. In recent years, cardiac magnetic resonance imaging (MRI) and endo-cavitary electro-anatomical mapping (EAM) have been used to localize the most significant myocardial area to sample, therefore increasing EMB overall effectiveness and reliability. Purpose To describe and characterize safety, feasibility and anatomical findings of a large cohort of patients (pts) undergoing diagnostic EMB and to assess its impact on the treatment decision making algorithm. Methods A cohort of all pts undergoing a percutaneous EMB at our Institution from January 2014 to January 2019 was analyzed. All EMB procedures were guided by a pre-procedural cardiac MRI radiological alteration analysis and an endo-cavitary EAM. Intra-cardiac echography (ICE) was used in all procedures, to directly visualize the sample area and to evaluate in real time post-EBM complications. Demographics, clinical data, MRI data, pathological EMB features, and peri-procedural data were systematically retrieved. Results One-hundred and eleven pts were enrolled (78% male, 47±4 y.o., 33% athletes). EMB indication was abnormal MRI findings in 94 (85%), pathological EMB voltages in 10 (9%) and clinical suspect and patient history in 7 (6%) pts. EMB sample area was determined by both MRI and EAM pathological area analysis in 92 (83%) pts, while by EAM alone in 19 (17%) pts (n=6 pathological unipolar EAM; n=13 bipolar and unipolar pathological EAM). The sample site was the right ventricle in 89 (80%), the left ventricle in 20 (18%), and both in 3 (2%) pts. In 103 (93%) pts a concomitant electrophysiological induction study was performed (40% positive for sustained ventricular arrhythmias) and 35 (32%) pts underwent a trans-catheter ablation (TCA) (n=8 epicardial TCA; n=2 endo-epicardial TCA; n=25 endocardial ATC). Only 2 (2%) peri-procedural adverse events were witnessed, specifically femoral pseudo-aneurysms, requiring surgical repair. EMB analysis allowed to confirm 58 (52%) pre-procedural diagnosis and to reach 32 (29%) new diagnosis, while resulting inconclusive or non-specific in the diagnostic process only in 21 (19%) cases [Figure1]. A total of 33 (30%) intra-cardiac devices (ICDs) were implanted contextually in the cohort, of which 9 (8%) solely upon EMB indication; in 4 (4%) other patients, biopsy represented a strong decisional factor in the multi-modality decision process for abstaining from ICD implant. Dashed lines: diagnosis changed upon EMB Conclusion MRI and EAM guided EMBs allowed to finely define a large cohort of patients by representing a disease defining parameter in over 80% of the enrolled pts while and a decision shifting parameter in ICD implant algorithm in a high % of pts.

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.

Background Myocarditis represents a common but often under-diagnosed disease, with a wide range of clinical presentations; diagnosis is often presumptive and a clear etiology leading to a specific therapeutic approach is usually not identified. Purpose To describe and assess disease etiology in a cohort of myocarditis patients (pts) with arrhythmic presentation undergoing an invasive diagnostic work-up. Methods All pts with myocarditis presenting with ventricular arrhythmias undergoing an electro-anatomical mapping (EAM) guided endo-myocardial biopsy (EMB) at our institution were enrolled. All enrolled pts also underwent cardiac magnetic resonance imaging (MRI) and an electrophysiological study (EPS). Demographics, arrhythmic presentation, MRI data, arrhythmic inducibility at EPS, EAM and EMB biopsy data were retrieved and analyzed. Molecular biology testing for cardio-tropic virus genome as well as leukocyte immunohistochemical typization were routinely performed on all EMB samples. Results Twenty-six pts were enrolled (85% male, 39±6 y.o.). Clinical presentation was an organized ventricular arrhythmia in 16 (62%) pts (n=3 non-sustained ventricular arrhythmia; n=9 sustained ventricular arrhythmia; n=4 ventricular fibrillation) while frequent (>10.000) premature ventricular complexes (PVCs) in the remaining 10 (38%) pts. MRI showed a late gadolinium enhancement (LGE) pattern consistent with myocarditis in all pts (35% left LGE; 65% right LGE). At the EPS, 10 (38%) pts showed inducibility for SVTs and underwent an intra-cardiac defibrillator (ICD) implant, while 4 (16%) more were implanted for secondary arrhythmic prevention. EAM was performed in 18 (70%), 6 (22%) and 2 (8%) pts in the right, left and in both ventricle respectively; in all cases, abnormal myocardial voltages were retrieved in the area showing LGE at MRI. Extensive myocardial scarring was detected in 7 (27%) pts. All EMB were performed without peri-procedural complications; inflammatory infiltrate and substrate alteration consistent with myocarditis were retrieved in 100% of the bioptic samples. Viral genome was identified in 13 (50%) samples (n=5 Human Herpes Virus 6; n=2 Parvovirus B 19; n=3 Adenovirus; n=1 Ebstein Barr Virus; n=1 Cytomegalovirus; n=1 Rhinovirus) and specific human immunoglobulin treatment was undergone by a single pt; eosinophilic infiltration was found in 2 (8%) patients; lymphocite invasion and auto-antibodies consistent with auto-immune myocarditis were detected in 2 (8%) patients and appropriate immunosuppressive therapy was started, while a myocardial band contraction pattern typical of toxic myocarditis was found in a single (4%) patient [Figure 1]. Different Myocarditis Etiology Rates Conclusion In our myocarditis cohort, EMB confirmed viruses to represented the first myocarditis etiological agent. Despite an invasive work-out, 31% of the cohort etiology still remains unclear.

Background Arrhythmogenic cardiomyopathy (ACM) is a genetically inherited cardiomyopathy characterized by myocardial fibro-fatty replacement. A pathogenetic role of viral myocardial infections in ACM natural history has been proposed over the years, although no definitive conclusion has been reached yet. Purpose To describe viral genome presence into a cohort of ACM biopsy proven patients (pts) and its impact on clinical features and outcome. Methods A cohort of all ACM pts undergoing an invasive third level evaluation at our institution was enrolled. All pts underwent a cardiac magnetic resonance (MR), an invasive electrophysiological study (EPS) with endo-cavitary electro-anatomical mapping (EAM), and a EAM guided endo-myocardial biopsy (EMB). Viral genome research through molecular biology techniques was performed on all biopsied samples. According to arrhythmic risk evaluation, a trans-catheter ablation (TCA) and/or an internal cardioverter device (ICD) implant was performed. Clinical arrhythmic presentation, MR data, arrhythmia inducibility at EPS, EAM and EMB characteristic, and arrhythmic events at a 12-month follow up visit were retrieved in all pts and compared between the viral genome positive (v+ACM) and negative group (v-ACM). Results Forty-five pts were enrolled in our study (48±13 years; 66% male); the EMB samples of 7 (15%) pts presented a lymphocytic infiltrate and tested positive for viral genome (n=3 B19 Parvovirus; n=2 for Citomegalovirus; n=2 for Ebstein-Bar Virus) [Figure1]. At arrhythmic presentation, complex ventricular arrhythmias (NSVT, SVT and FV) were more frequent in the v+ACM group (86% vs 50%; p=0.039). Both left and right ventricular ejection fraction at MR resulted more depressed in the v+ACM group (44±7 vs 52±2 and 47±2 vs 52±2; p=0.047 and p=0.041). Complex ventricular arrhythmia inducibility at EPS was more frequent in v+ACM (72% vs 34%; p=0.032), while no differences in pathological potentials rate and extension at unipolar and bipolar EAM were found. TCA was performed in 55% and 57% and an ICD was implanted in 29% and 42% in the v+ACM and v-ACM group respectively. No differences in 12-months arrhythmic event rates (39% vs 42%) between the two groups were described. EBM at different magnifications/stains Conclusion In our cohort a viral infection super-imposed to the fibrofatty infiltration was found in 15% of the patients. ACM pts testing positive for viral genome at the EMB had a more severe arrhythmic disease presentation, a more impaired heart function, and a higher rate of complex ventricular arrhythmias at disease presentation, but seemed to respond as well as viral genome negative ACM to ablative and pharmacological treatment

Background Arrhythmogenic Cardio-Myopathy (ACM) is characterized by epi-endocardial fibro-fatty replacement. Depending on the most affected ventricle, right dominant (RDACM) or left dominant (LDACM) phenotypes can be defined. RDACM voltage mapping characteristics have already been described, with late potentials strongly correlating with arrhythmia recurrence risk; LDACM voltage features have not been described yet. Purpose To analyze voltage map characteristics in LDACM patients (pts) and compare them with RDACM; to assess if there is any correlation between late potentials and recurrence rate in LDACM as well. Methods We retrospectively enrolled all consecutive ACM patients treated c/o our center and diagnosed according to the 2010 Task Force Criteria. Procedural and follow up data were collected. Patient were sorted by ventricular involvement lateralization. Recurrence rates were evaluated and linearly regressed for the presence of late potentials. Results 89 ACM patients were enrolled (67 RDACM, 22 LDACM; 76% males, 69±4 y.o.) in our study. All patients underwent endocardial voltage mapping; procedurally, 43 (48%) pts underwent catheter ablation, while 46 (52%) were managed conservatively with anti-arrhythmic drugs. Bipolar pathological potentials were found in 43 (64%) and 13 (59%), unipolar pathological potentials in 45 (67%) and 14 (63%), while late potentials in 19 (31%) and 8 (36%) in the RDACM and LDACM group respectively [p = 0.66, p=0.63, and p=0.33]. The average follow-up was 18 months [14–48]; 15 (22%) in the RDACM and 9 (40%) in LDACM arrhythmic recurrences were respectively encountered; recurrences in both groups were regressed for the presence of late potentials. Results were as follows: the presence of late potentials correlated with recurrences with an 4,3 [1.15–16.1; p=0.03] OR and with an 11 [0.4–85; p=0.022] OR in the RDACM and LDACM group respectively. Conclusion Pathologically low unipolar, bipolar and late potentials can be found in comparable % both in RDACM and LDACM; like in RDACM, late potentials represent an important risk factor for arrhythmic recurrence in LDACM as well.

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.

OBJECTIVES: The aim of this study was to compare patient and procedural characteristics, clinical events, and left atrial appendage (LAA) occlusion rates among implantation procedures guided either by intracardiac echocardiography (ICE) or by transesophageal echocardiography (TEE) in the Amulet Observational Study.BACKGROUND: TEE is standard for intraprocedural imaging during LAA occlusion. ICE is an alternative enabling local rather than general anesthesia.METHODS: The Amulet Observational Study is a prospective, multicenter, post-market study of the Amulet device in patients with atrial fibrillation at risk for thromboembolism from the LAA. Procedures were guided by ICE in the left atrium or TEE. A clinical events committee adjudicated serious adverse events. LAA closure was assessed by a core laboratory 1 to 3 months post-implantation.RESULTS: Nine hundred fifty-five procedures were TEE guided and 130 (12%) were ICE guided. Local anesthesia was used in 93% of ICE-guided cases. Implantation success was >99% in both groups (p = 1.00). The procedure was longer (40 ± 31 min vs. 33 ± 21 min; p = 0.01) and contrast use higher (145 ± 157 ml vs. 98 ± 76 ml; p < 0.01) for ICE cases. LAA closure rate was 100% using ICE and 98% using TEE. Vascular access serious adverse events occurred in 0.8% of ICE patients and 1.5% of TEE patients (p = 0.52). Pericardial effusions or tamponade was observed at rates of 2.5% per year and 1.7% per year in ICE and TEE patients, respectively (p = 0.57). Rates of ischemic stroke (4.1% per year vs. 2.6% per year; p = 0.37) and major bleeding (8.2% per year vs. 10.6% per year; p = 0.44) did not differ significantly between ICE and TEE patients.CONCLUSIONS: Amulet LAA occlusion procedures guided by ICE and TEE resulted in comparable clinical event and LAA closure rates, without differences in procedural or vascular complications despite longer procedures and more contrast use.

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 (

Emerging Directions and Future Trends Introduction Percutaneous left atrial appendage (LAA) occlusion has emerged as an alternative therapeutic approach to medical therapy for stroke prevention in patients with atrial fibrillation. 3D printing is a novel technology able to create a patient specific model of any given anatomical portion of the heart. Results Herein we report the first 2 cases of LAA occlusion procedure with 2 different systems, the Wave Crest device (Coherex Medical, Inc., USA) and the Amplatzer Amulet device (St. Jude Medical, St. Paul, MN, USA), in which a 3D printed LAA model (Care Tronik, Prato, Italy) was used in a rehearse phase. Both patients had history of paroxysmal AF and previous transient ischemic attack (TIA) occurred during oral anticoagulation with correct INR. In the first patient the occlusive device was positioned within the LAA after a rehearse occlusion using the 3D printed LAA plus a 27 mm Coherex Wavecrest device, demonstrating a good compression and sealing, particularly considering a proximal lobe of the appendage. In the second patient an attempt with the 27 mm Amulet device delivered within the 3D printed LAA, based on angiography and transesophageal echocardiographic (TEE), revealed insufficient covering of the proximal part of LAA vestibule; the device was released only after a second test with the 31 mm Amulet demonstrating a good sealing. Conclusion These 2 cases demonstrated that 3D model could help in finding the correct position within LAA, sizing the device and guiding the choice of the closure device despite the measurements provided by angiography and TEE.

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.

Since the introduction of catheter ablation as a mainstream treatment for atrial fibrillation (AF), several technical improvements have been put forward. In this contest, Ablation Index (AI) is an accurate ablation quality marker by incorporating power, delivery time, contact force (CF), and catheter stability in a weighted formula. The aim of our study is to evaluate the efficacy of AI-guided AF ablation over 24 month follow-up. We evaluated 72 consecutive patients with drug-refractory paroxysmal (66.7%) and early-persistent AF (33.3%) undergoing AI-guided ablation, compared to 72 propensity-matched control patients who underwent CF-guided procedure. All procedures were performed by three skilled operators. Data concerning procedural characteristics and long-term freedom from AF recurrence were analyzed. At 24-month follow-up, Kaplan-Meier curves of AF recurrence were significantly lower in AI group than in CF group (15.5% vs. 30.6%; p 0.042). These findings were confirmed in a sub analysis regardless of the continued use of antiarrhythmic drugs in the follow-up (42.2% in AI-guided group and 66.7% in CF-guided group, p 0.004). At 24-month follow-up, a positive trend in the decrease of arrhythmia recurrences was observed in AI-guided ablation for all operators. AI-guided ablation results more effective than CF-guided ablation as demonstrated by a lower incidence of AF recurrences regardless of the use of antiarrhythmic drugs in the follow-up. Each operator seems to improve the long-term success using an AI-guided ablation, thus showing both the efficacy and the reproducibility of this approach.

This study sought to determine whether cardiac magnetic resonance (CMR) may identify structural heart disease (SHD) in patients with ventricular arrhythmia who had echocardiography ruled out pathological findings.Approximately one-half of sudden cardiac deaths are attributable to malignant VA. Echocardiography is commonly used to identify SHD that is the most frequent substrate of VA.A single-center prospective study was conducted in consecutive patients with significant VA, categorized as1,000 but 10,000 ventricular ectopic beats [VEBs]/24 h; ≥10,000 VEBs/24 h; nonsustained ventricular tachycardia, sustained ventricular tachycardia, or a history of resuscitated cardiac arrest, and no pathological findings at echocardiography, requiring a clinically indicated CMR. Primary endpoint was CMR detection of SHD. Secondary endpoints were a composite of CMR detection of SHD and abnormal findings not specific for a definite SHD diagnosis.A total of 946 patients were enrolled (mean 41 ± 16 years of age; 64% men). CMR studies were used to diagnose SHD in 241 patients (25.5%) and abnormal findings not specific for a definite SHD diagnosis in 187 patients (19.7%). Myocarditis (n = 91) was the more frequent disease, followed by arrhythmogenic cardiomyopathy (n = 55), dilated cardiomyopathy (n = 39), ischemic heart disease (n = 22), hypertrophic cardiomyopathy (n = 13), congenital cardiac disease (n = 10), left ventricle noncompaction (n = 5), and pericarditis (n = 5). The strongest univariate and multivariate predictors of SHD on CMR images were chest pain (odds ratios [OR]: 2.52 and 2.38, respectively) and sustained ventricular tachycardia (ORs: 2.67 and 2.23, respectively).SHD was able to be identified on CMR imaging in a sizable number of patients with significant VA and completely normal echocardiography. Chest pain and sustained ventricular tachycardia were the strongest predictors of positive CMR imaging results.

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.

Introduction. Cryoballoon (CB) ablation has emerged as a novel treatment for pulmonary vein isolation (PVI) for patients with paroxysmal atrial fibrillation (PAF). The second-generation Arctic Front Advance (ADV) was redesigned with technical modifications aiming at procedural and outcome improvements. We aimed to compare the efficacy of the two different technologies over a long-term follow-up.Methods. A total of 120 patients with PAF were enrolled. Sixty patients underwent PVI using the first-generation CB and 60 patients with the ADV catheter. All patients were evaluated over a follow-up period of 2 years.Results. There were no significant differences between the two groups of patients. Procedures performed with the first-generation CB showed longer fluoroscopy time (36.3±16.8versus14.2±13.5 min, resp.;p=0.00016) and longer procedure times as well (153.1±32versus102±24.8 min, resp.;p=0.019). The overall long-term success was significantly different between the two groups (68.3 versus 86.7%, resp.;p=0.017). No differences were found in the lesion areas of left and right PV between the two groups (resp.,p=0.61and0.57). There were no significant differences in procedural-related complications.Conclusion. The ADV catheter compared to the first-generation balloon allows obtaining a significantly higher success rate after a single PVI procedure during the long-term follow-up. Fluoroscopy and procedural times were significantly shortened using the ADV catheter.

It is unclear whether isolation of the left atrial posterior wall (LAPW) offers additional benefits over pulmonary vein antrum isolation (PVAI) alone in patients with persistent atrial fibrillation (AF).We sought to determine the impact of PVAI and LAPW isolation (PVAI+LAPW) versus PVAI alone on the outcome of ablation of persistent AF.During the first procedure, PVAI was performed in 20 patients (group 1), whereas in 32 patients (group 2), PVAI was extended to the left atrial (LA) septum and coronary sinus (CS), and isolation of the LAPW was targeted (ePVAI+LAPW). Isolation of the superior vena cava was achieved in both groups. All patients, regardless of arrhythmia recurrence, underwent a second procedure 3 months after the first procedure. In patients with reconnection of pulmonary veins or LAPW, reisolation was performed, and a third procedure was performed 3 months later to verify isolation. Patients entered follow-up only after PVAI (group 1) or PVAI+LAPW (group 2) isolation was proven.At the 1-, 2-, and 3-year follow-up examinations, the rates of freedom from atrial tachyarrhythmia without use of an antiarrhythmic drug were 20%, 15%, and 10% in group 1 and 65%, 50%, and 40% in group 2, respectively (log-rank P.001). The median recurrence-free survival time was 8.5 months (interquartile range 6.5-11.0) in group 1 and 28.0 months (interquartile range 8.5-32.0) in group 2.Proven isolation of the LAPW provides additional benefits over PVAI alone in the treatment of persistent AF and improves procedural outcome at follow-up. However, the ablation strategy of ePVAI+LAPW is still associated with a significant high incidence of very late recurrence of atrial tachyarrhythmia."Outcome of Atrial Fibrillation Ablation After Permanent Pulmonary Vein Antrum Isolation With or Without Proven Left Atrial Posterior Wall Isolation" (LIBERATION). ClinicalTrials.gov Identifier: NCT01660100.

The goal of this study was to evaluate the impact of hypertension on the outcome of atrial fibrillation (AF) ablation.Hypertension is a well-known independent risk factor for incident AF.A total of 531 consecutive patients undergoing AF ablation were enrolled in this study and divided into 3 groups: patients with uncontrolled hypertension despite medical treatment (group I, n = 160), patients with controlled hypertension (group II, n = 192), and patients without hypertension (group III, n = 179). Pulmonary vein (PV) antrum and posterior wall isolation was always performed, and non-PV triggers were identified during isoproterenol infusion. All patients underwent extensive follow-up.Three groups differed in terms of left atrial (LA) size, non-PV triggers, and moderate/severe LA scar. Non-PV triggers were present in 94 (58.8%), 64 (33.3%), and 50 (27.9%) patients in groups I, II, and III, respectively (p 0.001). After 19 ± 7.7 months of follow-up, 65 (40.6%), 54 (28.1%), and 46 (25.7%) patients in groups I, II, and III had recurrences (log-rank test, p = 0.003). Among patients in group I who underwent additional non-PV trigger ablation, freedom from AF/atrial tachycardia was 69.8%, which was similar to groups II and III procedural success (log-rank p = 0.7). After adjusting for confounders, uncontrolled hypertension (group I) (hazard ratio [HR]: 1.52, p = 0.045), non-PV triggers (HR: 1.85, p 0.001), and nonparoxysmal AF (HR: 1.64, p = 0.002) demonstrated significant association with arrhythmia recurrence.Controlled hypertension does not affect the AF ablation outcome when compared with patients without hypertension. By contrast, uncontrolled hypertension confers higher AF recurrence risk and requires more extensive ablation.

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 Pulmonary vein isolation (PVI) is a cornerstone ablation strategy in the management of patients with atrial fibrillation (AF). Consensus guidelines and statements recommend PVI during the index catheter ablation procedure in patients with paroxysmal and persistent AF. Objective The objective of this analysis was to evaluate patients with persistent and long-standing persistent AF who were treated with the cryoballoon ablation catheter by PVI technique. Methods Consecutive patients with drug-refractory symptomatic persistent and long-standing persistent AF who underwent cryoballoon catheter ablation by a PVI-only procedure were prospectively included in this single-arm multicenter evaluation. Data on procedural characteristics, safety, and long-term freedom from AF recurrence were analyzed. Results Four hundred eighty-six subjects (mean age 60.8 ± 9.3 years; 389 (80%) men; 434 (89.3%) with persistent AF; 52 (10.7%) with long-standing persistent AF; left atrial diameter 44.6 ± 6.2 mm) underwent cryoballoon ablation in 35 Italian centers. The mean procedure time (skin-to-skin) was 109.9 ± 52.9 minutes, and the mean fluoroscopy time was 29.6 ± 14.5 minutes. Periprocedural complications were observed in 21 subjects (4.3%), and the acute PVI success rate was 97.6% across all patients. Using a 90-day blanking period, the single procedure Kaplan-Meier estimates of AF event–free survival were 63.9% at 12 months and 51.5% at 18 months. Conclusion In this multicenter evaluation of cryoballoon ablation, the PVI procedure was safe, effective, and efficient with regard to the treatment of patients with persistent and long-standing persistent AF. The reasonable mid-term success rates agree with current clinical studies that establish PVI as a cornerstone index ablation strategy.

Electrophysiology procedures are traditionally performed under fluoroscopic guidance. Nowadays a growing interest in the radiation risk associated to these procedures has been cultivated, since radiation exposure has non-negligible stochastic and deterministic effects on health. A correlation between radiation exposure and lifetime malignancy effect is difficult to establish and the threshold of a completely safe exposure dose is unknown. Thus, electrophisiologists have become aware of the use of fluoroscopy and they have tried to use all the complementary imaging technologies available in order to reduce the radiological exposure. This review is aimed at evaluating the radiation exposure risk, both for the patients and the operators. We describe electroanatomical mapping systems and technologies, which allow the reduction of radiation exposure. We review the main literature based on different catheter ablation procedures with the use of the abovementioned technologies, specifically focusing on feasibility, safety, and radiation exposure. Finally, we highlight the necessity of increasing the radiological risk awareness among operators and cardiological scientific societies.

Aims The aim of this study was to investigate the feasibility, safety and efficacy of percutaneous closure for prevention of thromboembolic events in patients with atrial fibrillation (AF) and left atrial appendage (LAA) thrombus. Methods and results The study included consecutive patients with AF and LAA thrombus who underwent transcatheter occlusion in eight high-volume centres. Clinical and transoesophageal echocardiography (TEE) follow-up was carried out as per each centre's protocol. Twenty-eight patients were included. The location of the LAA thrombus was distal in 100% of cases. Technical and procedural success was achieved in all patients. A cerebral protection device was used in six cases. There were no periprocedural adverse events. Follow-up was complete in all patients (total 32 patient-years). No death or thromboembolic events were reported. There was one major bleeding during follow-up. Among the 23 patients undergoing TEE, device thrombosis was present in one patient. No significant peri-device leaks were observed. Conclusions In this multicentre study, percutaneous closure in selected patients with distal LAA thrombus appears to be feasible and safe, and is associated with high procedural success and a favourable outcome for the prevention of AF-related thromboembolism. Special implant techniques avoiding mechanical mobilisation of the thrombotic mass and the liberal use of cerebral embolic protection devices are recommended.

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

Contact with cardiac tissue is a determinant of lesion efficacy during atrial fibrillation (AF) ablation. The Sensei®X Robotic Catheter System (Hansen Medical, CA) has been validated for contact force sensing. The electrical coupling index (ECI) from the EnSite Contact™ system (St. Jude Medical, MN) has been validated as an indicator of tissue contact. We aimed at analyzing ECI behavior during radiofrequency (RF) pulses maintaining a stable contact through the robotic navigation contact system. In 15 patients (age, 59 ± 12) undergoing AF ablation, pulmonary vein (PV) isolation was guided by the Sensei®X System, employing the Contact™ catheter. During the procedure, we assessed ECI changes associated with adequate contact based on the IntelliSense® force-sensing technology (Hansen Medical, CA. Baseline contact (27 ± 8 g/cm2) ECI value was 99 ± 13, whereas ECI values in a noncontact site (0 g/cm2) and in a light contact site (1–10 g/cm2) were respectively 66 ± 12 and 77 ± 10 (p

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.

Background Epicardial ablation is often necessary for the treatment of complex arrhythmias refractory to endocardial ablation. Conventional needle access to the pericardial space is considered quite challenging, and it is often associated with several potential complications, particularly inadvertent right ventricular puncture. The novel EpiAccess needle tip is embedded with a pressure sensor able to report the pressure waveform in real time when used with the EpiAccess System. Objective We prospectively evaluated the feasibility and safety of the EpiAccess System by EpiEP, Inc., with a novel epicardial access needle in a multicenter study. Methods Twenty-five patients with a clinical need for epicardial access were enrolled. The EpiAccess needle and EpiAccess System were used for epicardial access in each case. Successful epicardial access, defined as the ability to introduce a guidewire into the epicardial space, was assessed via the device and confirmed with fluoroscopy. Significant pericardial bleeding was defined as >80 mL of blood by using peer review article definitions. Results Patients were men (76%) with a mean age of 62 years (range 28-84 years). Epicardial access for ventricular tachycardia ablation was indicated in 80% of the patients. Successful epicardial access was obtained in all cases, with pressure monitoring guiding pericardial wire access in all cases. One delayed pericardial effusion occurred. Conclusion Epicardial access with the novel EpiAccess needle and System with real-time pressure monitoring is feasible and safe. The pressure monitoring capability identifies successfully the epicardial space, facilitating access and potentially minimizing complications. This has relevant clinical implications.

Transesophageal echocardiography (TEE) is the standard imaging technique to guide device implantation for left atrial appendage (LAA) closure. Unfortunately, TEE was contraindicated in this patient due to the high risk of variceal hemorrhage. Critical information about the exact anatomic characteristics of the LAA can be obtained using intracardiac echocardiography (ICE). However, standard right-side views do not allow a complete visualization of the LAA: in particular, a reliable left circumflex coronary artery short axis view, relevant for device positioning, is not always achievable. Transseptal views of the LAA with ICE might be used in planning an appropriate intervention strategy for patients who are not suitable for TEE imaging.

Transesophageal echocardiography (TEE) is standard for intra-procedural imaging in transcatheter left atrial appendage occlusion (LAAO). Intracardiac echocardiography (ICE) is an alternative that enables local rather than general anesthesia. We compared patient and procedural characteristics

In patients with severe cardiomyopathy, recurrent episodes of nontolerated ventricular tachycardia (VT) or electrical storm (ES) frequently cause acute heart failure and cardiac death; the suppression of the arrhythmia is therefore lifesaving, but feasibility of catheter ablation (CA) is precluded by the adverse hemodynamic conditions together with the characteristics of the arrhythmia that interdicts efficacious mapping. The use of the percutaneous cardiopulmonary support (CPS) for circulatory assistance may allow patient's stabilization and enhance efficacy and safety of CA in this emergency setting.19 patients (19 males; mean age 61 +/- 6 years; chronic ischemic cardiomyopathy, eleven patients; primary dilated cardiomyopathy, six patients; arrhythmogenic right ventricular dysplasia/ cardiomyopathy, two patients) with recurrent nontolerated VT episodes undergoing CPS-assisted CA were retrospectively evaluated. Twelve patients had acute hemodynamic failure refractory to inotropic agents and ventilatory assistance, seven patients had undergone a failing nonconventional CA procedure. 14 patients presented with ES, and in twelve the procedure was undertaken under emergency conditions within 24 h from admission. Patients were ventilated under general anesthesia and assisted by a multidisciplinary team. The CPS system consisted in a Medtronic Bio-Medicus centrifugal pump and in a Maxima Plus oxygenator, a 15-F arterial cannula, and a 17-F venous cannula.Flows between 2 and 3 l/min were activated after induction of 56/62 forms of nontolerated VT, achieving hemodynamic stabilization in all patients. CA was mainly guided by conventional activation mapping and was effective in abolishing 45/56 supported VTs; in 10/19 patients all clinical VTs were suppressed by CA. Mean procedural time was 4 h and 20 min. Complete stabilization was achieved in 13 patients (68%) without VT recurrence during a 7-day in-hospital monitoring. A significant clinical improvement was observed in two patients (11%); one patient (5%) with persistent VT episodes acutely died after heart transplant. At a mean follow-up of 42 months (range 15-60 months), 5/18 patients (28%) were free from VT recurrence, 7/18 (39%) had a clear clinical improvement with reduced implantable cardioverter defibrillator interventions. 5/14 patients (36%) had ES recurrence; among them, three died because of acute heart failure. No serious CPS-related complications were observed.The CPS warrants acceptable hemodynamic stabilization and efficacious mapping in high-risk patients undergoing CA for unstable VT in the emergency setting. Safety and efficacy of this technique translate into significant clinical improvement in the majority of patients. Even if only relatively invasive, CPS should be reserved to patients with ES or intractable arrhythmia causing acute heart failure; moreover, the need for an experienced team of multidisciplinary operators implies that its use is restricted to selected high-competency institutions.

Image Integration for Catheter Ablation of Atrial Fibrillation. Background: Several studies have provided details of left atrial anatomy by means of the image integration techniques, particularly focusing on the atypical patterns of the pulmonary veins. Objective: To compare, in a prospective, randomized fashion, the conventional method of pulmonary vein disconnection and the image integration-guided approach. Methods: Two hundred and ninety consecutive patients (290 patients, mean age 55 ± 11 years) with drug-refractory paroxysmal or persistent atrial fibrillation were enrolled in the study and were divided into two treatment groups: group 1 (145 patients) undergoing an imaging integration-guided (CartoMerge TM) ablation; group 2 (145 patients) treated by a conventional radiofrequency catheter ablation procedure. The arrhythmia was refractory to at least two antiarrhythmic drugs (IC, amiodarone). Results: Electrical disconnection of all identified pulmonary veins was obtained in all patients of both groups. Bidirectional block of the cavotricuspid isthmus was achieved in 34 group 1 patients and in 40 group 2 patients. Left mitral isthmus ablation was attempted in 52 group 1 patients and in 56 group 2 patients. At a mean follow-up of 14 ± 12 months, the atrial fibrillation-free survival rate was significantly higher in group 1 patients compared with group 2 patients (88% vs 69%, P = 0.017). The analysis for the subset of patients with previously ineffective ablation (98 patients: 52 group 1 patients and 46 group 2 patients) showed a significantly lower recurrence rate in group 1 versus group 2 (19% vs 48%, P < 0.01). Conclusions: Our data indicate a superior efficacy of the image-integration guided catheter ablation of atrial fibrillation over the long term. (J Cardiovasc Electrophysiol, Vol. 20, pp. 258-265, March 2009)

Electrical disconnection of pulmonary veins (PV) is regarded as the cornerstone to treat atrial fibrillation (AF) by means of transcatheter ablation [1–4]. This target can be achieved by conventional point-to-point radiofrequency current delivery with an irrigated tip electrode catheter or, more recently, by using cryoenergy through a specific balloon designed platform. Furthermore, AF is probably the most challenging arrhythmia to treat in the general population, due to the unsatisfactory efficacy provided by drug treatment in the long term and the high risk of thromboembolic event [5–8]. It is reported that the overall annual risk of stroke is 5 % in patients suffering from AF and, increasing up to 15 % in very high-risk patients [9]. The left atrial appendage (LAA) is undoubtedly the main source of thrombus formation in patients with non-valvular AF, as autopsies and echocardiography studies have revealed [10]. According to international guidelines, anticoagulation treatment needs to be prescribed to patients with CHA2DS2-VASc score ≥1 to prevent embolic events [11]. In clinical practice, the administration of vitamin K antagonists (VKA) or novel oral anticoagulants (NOACs) can carry some critical disadvantages, such as profuse and frequent bleeding, noncompliance, difficulty keeping in a therapeutic range and frequent interactions with some dietary components and medications [12–14]. All these reasons can lead to undertreatment of patients, especially elderly patients who have high propensity to major hemorrhage [15, 16] associated with thromboembolic risk.

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.