Gaetano Senatore

Long-Term Outcome of Right and Left Atrial Radiofrequency Ablation in Patients with Persistent Atrial Fibrillation

Objectives: To investigate the clinical outcome of right and left atrial radiofrequency ablation after the first 12 months in patients with drug‐refractory persistent atrial fibrillation (AF), and to identify predictors of long‐term success.

Twelve-year follow-up of catheter ablation for atrial fibrillation: A prospective, multicenter, randomized study

BACKGROUND Randomized and controlled studies have reported the effect of catheter ablation (CA) for atrial fibrillation (AF) over a follow-up of 12-24 months. OBJECTIVE We report on the effect of CA plus antiarrhythmic drugs in comparison with antiarrhythmic drugs alone on the maintenance of sinus rhythm over 12-year follow-up. METHODS We extended the follow-up duration of the 137 patients who were enrolled in the Catheter Ablation for the Cure of Atrial Fibrillation Study between February 1, 2002, and June 30, 2003, and randomized to antiarrhythmic drugs (control group) or antiarrhythmic drugs plus CA (ablation group). The primary end point was time to first symptomatic or asymptomatic recurrence of atrial arrhythmia lasting >30 seconds during follow-up. RESULTS During follow-up, 19 of 68 (27.9%; 95% confidence interval [CI] 18.7%-39.6%) ablation group patients and 3 of 69 (4.3%; 95% CI 1.49%-12.0%) control group patients did not experience any relapse of atrial tachyarrhythmia (P < .001). The Kaplan-Meier analysis performed to determine the probability of survival free from atrial arrhythmias showed a statistical difference in favor of the ablation group (log-rank, P < .001). The effect of CA was consistent in both patients with paroxysmal AF and those with persistent AF. In the multivariate Cox regression analysis, belonging to the control group (hazard ratio 2.95; 95% CI 1.896-4.726; P < .001) and longer time since first AF episode (hazard ratio 1.004; 95% CI 1.002-1.084; P = .041) were predictors of atrial tachyarrhythmia recurrence. CONCLUSION In patients with paroxysmal and persistent AF, CA significantly increased time to first recurrence of atrial arrhythmias during 12-year follow-up.

Documentation of pulmonary vein isolation improves long term efficacy of persistent atrial fibrillation catheter ablation

BACKGROUND The aim of this study was to investigate the efficacy of catheter ablation in the treatment of persistent atrial fibrillation (AF) and the predictors of arrhythmia recurrence. METHODS Absence of atrial tachyarrhythmia (AT) recurrence during a mid-term follow-up was correlated with several clinical and procedural characteristics in a population of 82 patients aged 20-70 years who had experienced at least one documented relapse of persistent AF during a single trial of antiarrhythmic drug therapy. Electrophysiological success of ablation was declared when all identified PVs were isolated (confirmation of entry and exit block). Patients were followed for a maximum of 24 months after the blanking period with outpatient visits, ECG recordings, 24-hour Holter monitoring, and weekly transtelephonic monitoring for 30s. RESULTS Electrophysiological success was documented in 38/82 (46.3%) patients. During a mean follow-up of 24.7 ± 4.2 months, 69/82 (84.1%) patients presented at least one episode of AT after the 2 month blanking period. According to univariate and multivariate logistic regression analyses, only an electrophysiologically successful ablation significantly correlated with the absence of documented AT relapse (OR 5.32, 95% CL 1.02-27.72; p=.0472). CONCLUSIONS Mid-term outcome of a single procedure of catheter ablation without the adjunction of antiarrhythmic drug therapy is poor in patients with persistent AF. Documented PV isolation is useful to increase the success rate of circumferential PV ablation even in persistent AF patients.

High prevalence of cooled tip use as compared with 8-mm tip in a multicenter Italian registry on atrial fibrillation ablation: focus on procedural safety.

Background Whether cooling catheters should be preferred for atrial fibrillation (AF) ablation is not yet clear. Methods From April 2005 to October 2006, 991 (74% men) consecutive patients who underwent AF ablation were prospectively enrolled in 10 Italian centers. For the present subanalysis, patients were ranked in the two study groups on the basis of the catheter system chosen: 8-mm tip was used in 86 patients (9% conventional group) and open-irrigated tip in 905 patients (91% cooled group). Results The registry clinical data of both groups showed marked heterogeneity due to the fact that the higher number of patients of the cooled group had longer AF history (4.9 ± 4.1 versus 1.2 ± 1.8 years; P = 0.0001), permanent/persistent AF (41.2 versus 27.9%; P = 0.01), and larger left atrium (LA) size (44.1 ± 6.2 versus 33.4 ± 10.5 mm; P ≤ 0.00001). Moreover, they underwent a longer procedure (207.2 ± 70.8 versus 85.2 ± 58 min; P = 0.00001), with longer fluoroscopy time (36.5 ± 20.1 versus 15.6 ± 12 min; P ≤ 0.0000), and LA roof ablation lines were more frequently added (29.6 versus 3.5%; P < 0.0001). Data were confirmed in the multivariate analysis, in which a longer procedure [odds ratio (OR) 1.018; 95% CI 1.009–1.027; P = 0.0001], added linear lesions (OR 16.847; 95% CI 4.288–66.190; P = 0.0001), and a longer AF history (OR 1.311; 95% CI 1.063–1.616; P = 0.01) continued to characterize the cooled group. Even though the lack of homogeneity of the groups could not render any reliable comparison about safety, we report that the rate of cumulative complications (4.7 versus 3.8%; P = NS), cerebral thromboembolism (0 versus 0.4%; P = NS), pulmonary vein (PV) stenosis (0 versus 0.5%; P = NS), pericardial effusions or tamponade (1.2 versus 1.5%; P = NS), and groin complications (4.7 versus 2.0%, P = NS) was low and similar in both the groups. Conclusion In the present subanalysis, both the systems showed a similar safety procedural profile, though the lack of homogeneity observed in the two study groups could render any straight conclusion as mere speculation. The longer availability and the consequent higher use of open-irrigated catheters technology for LA ablation in Europe could explain the large preference given to the latter system in the present registry.

Dynamic and Dual‐Site Atrial Pacing in the Prevention of Atrial Fibrillation: The STimolazione Atrial DInamica Multisito (STADIM) Study

Objectives: The impact of new algorithms to consistently pace the atrium on the prevention of atrial fibrillation (AF) remains unclear. Our randomized, crossover study compared the efficacy of single‐ and dual‐site atrial pacing, with versus without dynamic atrial overdrive pacing in preventing AF.

Access to magnetic resonance imaging of patients with magnetic resonance-conditional pacemaker and implantable cardioverter-defibrillator systems: results from the Really ProMRI study

Aims The Really ProMRI study evaluates magnetic resonance imaging (MRI) access for patients with cardiac implantable electronic devices (CIEDs) as well as the performance of magnetic resonance (MR)-conditional leads when undergoing MRI. Methods and results Patients either with an MR-conditional pacemaker or implantable defibrillator (ICD) system or with at least a component (device or one or more leads) from an MR-conditional system, were asked to fill in a questionnaire when they were referred to a MR scan. The rate of prescription, denial, or execution of MR examinations was evaluated in a 1-year follow-up visit. In total, 555 patients [median age (interquartile range) 72.2 (62.2-78.6); 72% male] were enrolled, 49% (270) with a pacemaker, 51% (285) with an ICD system. Five-hundred and ten patients completed the follow-up period. A total of 37 MRI referrals were reported in 35 patients, with a consequent event rate of 7.0/100 patient-years (CI, 4.9-9.7). Fourteen were denied, while 23 [66%; (CI, 48-81%)] were performed. The number of patients with MR referrals was not statistically different between pacemaker and ICD groups (21 vs. 14; P = 0.178). The rate of scans performed was higher in the pacemaker subjects (19/23 vs. 4/14, P = 0.003), while it was similar between patients with or without a complete MR-conditional system (19/30 vs. 4/7, P = 0.606). Conclusion In this study, we reported a 7.0/100 patient-years event rate of MR prescriptions in CIED patients. Many examinations were denied, despite MR-conditional systems, especially in ICD patients. Regulatory and cultural changes are needed to allow wider access to MR imaging in CIED patients with MR-conditional systems.

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.

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.

Center experience does not influence long-term outcome and peri-procedural complications after cryoballoon ablation of paroxysmal atrial fibrillation: Data on 860 patients from the real-world multicenter observational project

BACKGROUND The aim of this research was to evaluate whether the procedural data, the incidence of complications, and the long-term freedom from atrial fibrillation (AF) recurrences are influenced by center experience in a paroxysmal AF (PAF) population performing a first-time pulmonary vein isolation (PVI) by cryoballoon ablation (CBA). METHODS A total of 860 patients underwent PVI by CBA. Center experience groups were predefined according to the quartiles of the distribution regarding the amount of performed procedures: 3.1%, 10.6%, 22.7% and 63.6% of patients were respectively followed in each group from 1st (less experienced) to 4th (more experienced) quartile of experience. RESULTS In the entire population, median procedure and fluoroscopy time were 105 and 25 min, respectively. The median procedure time significantly decreased from 130 to 90 min (P < 0.001) as the centers experience increased. In 47 (5.5%) patients, a peri-procedural complication occurred. As the experience of centers increased, the acute intraprocedural PVI success rate increased (from 94.3% to 98.9%, P = 0.007), whereas there was a tendency towards a decreased incidence of peri-procedure complications (from 7.4% to 4.6%, P = 0.998). The mean 1-year freedom from AF recurrence probability was 78.3%, and the 18-month mean was 68.9% with no difference among the groups with different levels of experience. CONCLUSION CBA is a safe and effective treatment for patients with PAF. Peri-procedural complications and procedural times were low in all the analyzed sub-groups, showing a decreasing trend in function of center expertise. The long-term freedom from AF recurrence was not influenced by the level of experience. (clinicaltrials.gov: NCT01007474).

Combining Watchman left atrial appendage closure and catheter ablation for atrial fibrillation: multicentre registry results of feasibility and safety during implant and 30 days follow-up

Abstract Aims Long-term results from catheter ablation therapy for atrial fibrillation (AF) remain uncertain and clinical practice guidelines recommend continuation of long-term oral anticoagulation in patients with a high stroke risk. Left atrial appendage closure (LAAC) with Watchman has emerged as an alternative to long-term anticoagulation for patients accepting of the procedural risks. We report on the initial results of combining catheter ablation procedures for AF and LAAC in a multicentre registry. Methods and results Data were pooled from two prospective, real-world Watchman LAAC registries running in parallel in Europe/Middle-East/Russia (EWOLUTION) and Asia/Australia (WASP) between 2013 and 2015. Of the 1140 patients, 139 subjects at 10 centres underwent a concomitant AF ablation and LAAC procedure. The mean CHA2DS2-VASc score was 3.4 ± 1.4 and HAS-BLED score 1.5 ± 0.9. Successful Watchman implantation was achieved in 100% of patients. The overall 30-day serious adverse event (SAE) rate was 8.7%, with the device and/or procedure-related SAE rate of 1.4%. One pericardial effusion required percutaneous drainage, but there were no strokes, device embolization, or deaths at 30 days. The 30-day bleeding SAE rate was 2.9% with 55% of patients prescribed NOAC and 38% taking warfarin post-procedure. Conclusion The outcomes from these international, multicentre registries support the feasibility and safety of performing combined procedures of ablation and Watchman LAAC for patients with non-valvular AF and high stroke risk. Further data are needed on long-term outcomes for the hybrid technique on all-cause stroke and mortality.

Optimization of coronary sinus lead placement targeted to the longest right-to-left delay in patients undergoing cardiac resynchronization therapy: The Optimal Pacing SITE 2 (OPSITE 2) acute study and protocol

Left ventricular (LV) lead positioning at the site of delayed electrical activation is associated with better response to cardiac resynchronization therapy (CRT). We hypothesized that a long electrical conduction delay between right ventricular (RV) and coronary sinus (CS) leads during RV pacing (RLD index) is correlated with a better clinical outcome