Heart Team for Left Appendage Occlusion without the Use of Antithrombotic Therapy: The Epicardial Perspective.

BACKGROUND: Left atrial appendage occlusion is an increasingly proposed treatment for patients with atrial fibrillation and poor tolerance to anticoagulants. All endovascular devices require antithrombotic therapy. Anatomical and clinical variables predisposing to device-related thrombosis, as well as post-procedural peri-device leaks, could mandate the continuation or reintroduction of aggressive antithrombotic treatment. Because of the absence of foreign material inside the heart, epicardial appendage closure possibly does not necessitate antithrombotic therapy, but data of large series are missing. METHODS: Multidisciplinary team evaluation for standalone totally thoracoscopic epicardial appendage closure was done in 180 consecutive patients with atrial fibrillation and poor tolerance to antithrombotic therapy. One hundred and fifty-two patients consented (male 66.1%, mean age 76.1 ± 7.4, CHA2DS2VASc mean 5.3 ± 1.6, HASBLED mean 3.8 ± 1.1). Indications were cerebral hemorrhage (48%), gastro-intestinal bleeding (33.3%), and other bleeding (20.7%). No antithrombotic therapy was prescribed from the day of surgery to the latest follow up. RESULTS: Procedural success was 98.7%. At a mean follow up of 38.2 ± 18.8 months, cardioembolic and bleeding events were 1.3% and 0.6%, respectively. Among patients with a history of blood transfusions (41.1%), none needed further transfusions or treatment post procedure. CONCLUSION: Epicardial appendage occlusion without any antithrombotic therapy appears to be safe and effective. This strategy could be advised when minimization of bleeding risk concomitant to stroke prevention is needed.

First-line therapy: insights from a real-world analysis of cryoablation in patients with atrial fibrillation.

AIMS: Pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) is mainly reserved for patients with drug-refractory or drug-intolerant symptomatic atrial fibrillation. We evaluated a large cohort of patients treated in a real-world setting and examined the safety and efficacy profile of CBA when applied as a first-line treatment for atrial fibrillation. METHODS: In total, 249 patients (23% women; 56 ±â€Š13 years; mean left atrial diameter 41 ±â€Š7 mm; 73.5% paroxysmal atrial fibrillation; and 26.5% persistent atrial fibrillation) underwent an index PVI by CBA. Data were collected prospectively in the framework of the 1STOP ClinicalService project, involving 26 Italian cardiology centers. RESULTS: Median procedure and fluoroscopy times were 90.0 and 21.0 min, respectively. Acute procedural success was 99.8%. Acute/periprocedural complications were observed in seven patients (2.8%), including: four transient diaphragmatic paralyses, one pericardial effusion (not requiring any intervention), one transient ischemic attack, and one minor vascular complication. The Kaplan--Meier freedom from atrial fibrillation recurrence was 86.3% at 12 months and 76% at 24 months. Seventeen patients (6.8%) had a repeat catheter ablation procedure during the follow-up period. At last follow-up, 10% of patients were on an anticoagulation therapy, whereas 6.8% were on an antiarrhythmic drug. CONCLUSION: In our multicenter real-world experience, PVI by CBA in a first-line atrial fibrillation patient population was well tolerated, effective, and promising. CBA with a PVI strategy can be used to treat patients with paroxysmal and persistent atrial fibrillation with good acute procedural success, short procedure times, and acceptable safety. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov (NCT01007474).

Integration of activation maps of epicardial veins in computational cardiac electrophysiology.

In this work we address the issue of validating the monodomain equation used in combination with the Bueno-Orovio ionic model for the prediction of the activation times in cardiac electro-physiology of the left ventricle. To this aim, we consider four patients who suffered from Left Bundle Branch Block (LBBB). We use activation maps performed at the septum as input data for the model and maps at the epicardial veins for the validation. In particular, a first set (half) of the latter are used to estimate the conductivities of the patient and a second set (the remaining half) to compute the errors of the numerical simulations. We find an excellent agreement between measures and numerical results. Our validated computational tool could be used to accurately predict activation times at the epicardial veins with a short mapping, i.e. by using only a part (the most proximal) of the standard acquisition points, thus reducing the invasive procedure and exposure to radiation.

Cryoballoon or radiofrequency ablation? Alternating technique for repeat procedures in patients with atrial fibrillation.

BACKGROUND: Which technique is better for repeat ablation in patients with atrial fibrillation (AF) remains unclear. The aim of the study was to compare long-term efficacy of repeat ablation using the alternative technique for the first redo ablation procedure: (a) cryoballoon (CB) re-ablation after a failed index pulmonary vein isolation (PVI) with radiofrequency (RF) ablation, RF-then-CB group or (b) RF repeat ablation following a failed CB ablation, CB-then-RF group. METHODS: Within the 1STOP Italian Project, consecutive patients undergoing repeat ablation with a different technique from the index procedure were included. RESULTS: We studied 474 patients, 349 in RF-then-CB and 125 in CB-then-RF group. Less women (21% vs 30%; P = .041), more persistent AF (33% vs 22%; P = .015), longer duration of AF (60 vs 31 months; P < .001), and more hypertension (50% vs 36%; P = .007) were observed in the RF-then-CB cohort as compared with the CB-then-RF group. The number of reconnected PVs was 3.7 ± 0.7 and 1.4 + 1.3 in RF-then-CB and CB-then-RF group, respectively (P < .001). During the follow-up, significantly less AF recurrence occurred in the CB-then-RF group (22% vs 8%, HR = 0.46; 95% CI: 0.24-0.92; P = .025). Cohort designation was the only independent predictor of AF recurrence. CONCLUSION: Alternation of energy source for repeat ablation was safe and effective, regardless the energy used first. However, patients initially treated with CB PVI undergoing repeat ablation with RF current had less AF recurrence at long-term follow-up as compared with those originally treated by RF ablation receiving a CB repeat ablation.

Cryoablation for paroxysmal and persistent AF in patients with structural heart disease and preserved ejection fraction: Clinical outcomes from 1STOP, a multicenter observational project.

BACKGROUND: Pulmonary vein isolation (PVI) is an accepted strategy for paroxysmal atrial fibrillation (PAF) and persistent AF (PerAF) ablation. Limited data are available on outcomes of cryoballoon (CB) PVI in patients with structural heart disease (SHD). The purpose is to assess the clinical efficacy of a single CB-PVI procedure in patients with PAF or PerAF who also have SHD. METHODS: From April 2012, 460 AF patients with concomitant SHD underwent CB-PVI and were followed prospectively in the framework of the 1STOP ClinicalService® project. Data on procedural outcomes and long-term freedom from AF recurrence were evaluated. Out of 460 subjects, 282 patients (61%) had PAF and 178 (39%) PerAF. RESULTS: SHD patients were predominantly male (80.9%), old (62.8±8.9 years), with preserved functional capacity (New York Heart Association class >1: 39.4%), high cardioembolic risk (CHA2DS2VASc score ≥2: 69.3%), and conserved left ventricular ejection fraction (56.5±8% LVEF). Both subjects with PAF and PerAF had similar baseline clinical characteristics except for left atrial diameter (43.8±7 vs. 45.7±7mm) and area (22.9±5.2 vs. 25.1±4.4cm2), respectively. Procedure time and fluoroscopic time as well as the rate of procedural complications were not different between subjects with PAF and PerAF. After a mean follow-up of 12 months, antiarrhythmic drug therapy had dropped from 71.7% before ablation to 33.6% post-ablation (p<0.001) and the freedom from symptomatic AF recurrence was 78% for PAF and 77% for PerAF (p=0.793). Furthermore, atrial arrhythmia recurrence rate was not related to SHD. CONCLUSIONS: In a large multicenter, real-world cohort, CB-PVI was used to treat patients with PAF and PerAF who also had SHD. The arrhythmia recurrence after a single procedure was not related to either the degree of cardiac structural remodeling or the type of AF, and the rate of AF recurrence was lower than previously reported in patients with SHD in other cohort series using focal radiofrequency catheter ablation. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov (NCT01007474).

Use of impedance-based catheter tip-to-tissue contact assessment (electroanatomic coupling index, ECI) in typical right atrial flutter ablation.

PURPOSE: The electrical coupling index (ECI) (Abbott, USA) is a marker of tissue contact and ablation depth developed particularly for atrial fibrillation treatment. We sought to evaluate if these measures can be also a marker of lesion efficacy during cavotricuspid isthmus (CTI) ablation for typical right atrial flutter. METHODS: We assessed the ECI values in patients undergoing typical right atrial flutter point-by-point ablation guided by the Ensite Velocity Contact™ (St. Jude Medical, now Abbott St. Paul, MN, USA) electroanatomic mapping system. ECI values were collected before, during (at the plateau), and after radiofrequency (RF) delivery. The physician was blinded to ECI and judged ablation efficacy according to standard parameters (impedance drop, local potential reduction, and/or split in two separate potentials). Patients were followed up at 3 and 12 months. RESULTS: Fifteen consecutive patients (11 males, mean age 69.2 ± 10.6 years) with a history of typical right atrial flutter were included in this study. A total of 158 RF applications were assessed (mean 10.5 ± 6.6 per patient, range 6-28). The absolute and percentage ECI variations (pre-/post-ablation) were significantly greater when applications were effective (p < 0.001). A 12% drop in the ECI after ablation was identified by the ROC curve as the best cutoff value to discriminate between effective and ineffective ablation (sensitivity 94%, specificity 100%). Acute success was achieved in all patients with no complications and no recurrences during follow-up. CONCLUSION: The ECI appeared a reliable index to guide CTI ablation. A 12% drop of ECI during radiofrequency energy delivery was highly accurate in identifying effective lesion.

Management of patients with cardiac implantable electronic devices (CIED) undergoing radiotherapy: A consensus document from Associazione Italiana Aritmologia e Cardiostimolazione (AIAC), Associazione Italiana Radioterapia Oncologica (AIRO), Associazione Italiana Fisica Medica (AIFM).

The management of patients with a cardiac implanted electronic device (CIED) receiving radiotherapy (RT) is challenging and requires a structured multidisciplinary approach. A consensus document is presented as a result of a multidisciplinary working group involving cardiac electrophysiologists, radiation oncologists and physicists in order to stratify the risk of patients with CIED requiring RT and approaching RT sessions appropriately. When high radiation doses and beam energy higher than 6MV are used, CIED malfunctions can occur during treatment. In our document, we reviewed the different types of RT and CIED behavior in the presence of ionizing radiations and electromagnetic interferences, from the cardiologist's, radiation oncologist's and medical physicist's point of view. We also reviewed in vitro and in vivo literature data and other national published guidelines on this issue so far. On the basis of literature data and consensus of experts, a detailed approach based on risk stratification and appropriate management of RT patients with CIEDs is suggested, with important implications for clinical practice.

Coronary sinus activation patterns in patients with and without left bundle branch block undergoing electroanatomic mapping system-guided cardiac resynchronization therapy device implantation.

BACKGROUND: Implantation of the left ventricular (LV) lead in segments with delayed electrical activation may improve response to cardiac resynchronization therapy (CRT). OBJECTIVE: The purpose of this study was to evaluate the amount and regional distribution of LV electrical delay (LVED) in patients with or without left bundle branch block (LBBB). METHODS: We enrolled 60 patients who underwent electroanatomic mapping system-guided CRT device implantation. Activation mapping of the coronary sinus (CS) branches was performed using an insulated guidewire. LVED was defined as the interval between the beginning of the QRS complex on the surface electrocardiogram (ECG) and the local electrogram and expressed in milliseconds or as percentage of the total QRS duration (LVED%). RESULTS: Forty-three patients showed a LBBB and 17 a non-LBBB electrocardiographic pattern. A total of 148 CS branches (mean 2.5 per patient; range 2-4 per patient) were mapped. Patients with LBBB showed higher maximum LVED (135 ms [108-150 ms] vs 100 ms [103-110 ms]; P < .001) and LVED% (86% [79%-89%] vs 72% [54%-80%]; P < .001) than did patients without LBBB. The maximum LVED was recorded in mid-basal anterolateral or inferolateral LV segments (traditional CRT targets), significantly more often in patients with LBBB than in patients without LBBB (85% vs 59%; P = .02). The number of CS branches showing LVED >50% of the total QRS duration, >75% of the total QRS duration, and >85 ms was significantly higher in patients with LBBB than in patients without LBBB. CONCLUSION: Patients without LBBB showed lower LVED and more heterogeneous electrical activation of the CS than did patients with LBBB. This finding may contribute to a lower rate of response to CRT of patients without LBBB and suggests the use of activation mapping to guide LV lead placement.

Pulmonary Vein Isolation with the Cryoballoon Technique: Feasibility, Procedural Outcomes, and Adoption in the Real World: Data from One Shot Technologies TO Pulmonary Vein Isolation (1STOP) Project.

BACKGROUND: Catheter ablation (CA) is recommended for patients with drug refractory symptomatic atrial fibrillation (AF). "One Shot" catheters have been introduced to simplify CA and cryoballoon ablation (CBA) is spreading rapidly. Few real-world data are available on standard clinical practice, mainly from single-center experience. We aimed to evaluate clinical settings, demographics, and acute procedural outcomes in a large cohort of patients treated with CBA. METHODS: A total of 903 patients (73% male, mean age 59 ± 11) underwent pulmonary vein CBA. Correlations between the patient's inclusion time and clinical characteristics, procedure duration, acute success rate, and intraprocedural complications were evaluated. RESULTS: Seventy-seven percent of patients were affected by paroxysmal AF and 23% by persistent AF. Overall, acute success rate was 97.9% and periprocedural complications were observed in 35 (3.9%) patients, 13 (1.4%) of which were classified as major complications. With respect to the patient's inclusion time analysis, an increase in treatment of persistent AF was observed, a significant decrease in CBA times (procedure, ablation, and fluoroscopy: 136.0 ± 46.5 minutes, 28.8 ± 19.6 minutes, and 34.3 ± 15.4 minutes, respectively) was observed, with comparable acute success rate and intraprocedural complications over time. The rate of major complications was extremely low (1.4%); no death, atrioesophageal fistula, stroke, or other major periinterventional or late complications occurred. CONCLUSION: This series represents the largest experience of CBA in the treatment of AF that also describes the adoption curve of this relatively recent technology. CBA showed an excellent safety profile when performed in a large real-world clinical setting, with satisfactory acute success rate and, on average, short procedural times. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov (NCT01007474).

Spontaneous and adenosine-induced pulmonary vein reconnection after cryoballoon ablation with the second-generation device.

INTRODUCTION: Longer observational time and adenosine challenge have proven to be able to detect pulmonary vein (PV) reconnections. The aim of this study was to assess incidence of spontaneous and adenosine-induced PV reconnection after ablation with second-generation cryoballoon (CB-Adv). METHODS AND RESULTS: Fifty consecutive patients (76% male, mean age 60.5 ± 11.9 years) having undergone PV isolation (PVI) using the CB-Adv were enrolled. After isolation, reconnections were evaluated using the Achieve catheter over 30 minutes observation and adenosine administration during isoproterenol infusion (adenosine challenge). Among 200 PVs, isolation was achieved in 190 (95%) during the first application. Lower nadir temperature and longer rewarming time were associated with successful PVI (P = 0.02 and 0.04). Spontaneous (4 veins) and adenosine-induced (4 veins) PV reconnections occurred in the 4% of initially isolated veins (8 veins) in 6 patients (12%). At receiver-operator curve analysis, nadir temperature <-51 °C and rewarming time >28 seconds identified absence of reconnections (sensitivity 100% and 87%, area under the curve 0.75 and 0.72). Patients with right-sided early branching frequently experienced reconnections (P < 0.01). After a mean follow-up of 7.0 ± 1.7 months, 86% of patients were free from atrial fibrillation. None of those with PV reconnections experienced recurrences. CONCLUSIONS: The incidence of spontaneous and adenosine-induced PV reconnection following ablation with the novel CB-Adv is very low occurring in 4% of initially isolated veins. Nadir temperature <-51 °C and rewarming time >28 seconds identified absence of acute reconnections, thus avoiding prolonged waiting time and adenosine challenge in such cases.