Transcatheter Ablation of Atrial Fibrillation in Patients With Hypertrophic Cardiomyopathy: A Multicenter Propensity Score-Based Analysis.

Background: The prognostic impact of catheter ablation (CA) of atrial fibrillation (AF) in hypertrophic cardiomyopathy (HCM) patients has not yet been satisfactorily elucidated. Objectives: The aim of the study was to assess the impact of CA of AF on clinical outcomes in a large cohort of HCM patients. Methods: In this retrospective multicenter study, 555 HCM patients with AF were enrolled, 140 undergoing CA and 415 receiving medical therapy. 1:1 propensity score matching led to the inclusion of 226 patients (113 medical group, 113 intervention group) in the final analysis. The primary outcome was a composite of all-cause mortality, heart transplant and acute heart failure exacerbations. Secondary outcomes included AF recurrence and transition to permanent AF. Additionally, an inverse probability weighted (IPW) model was examined. Results: At propensity score matching analysis, after a median follow-up of 58.1 months, the primary endpoint occurred in 29 (25.7%) patients in intervention group vs 42 (37.2%) in medical group (P = 0.9). Thromboembolic strokes and major arrhythmic events in intervention vs medical group were 9.7% vs 7.1% (P = 0.144) and 4.4 vs 8.0% (P = 0.779), respectively. Fewer patients in intervention vs medical group experienced AF recurrences (63.7% vs 84.1%, P = 0.001) and transition to permanent AF pattern (20.4% vs 33.6%, P = 0.026). IPW analysis showed consistent results. Severe complications related to CA were uncommon (0.7%). Conclusions: After 5 years of follow-up, CA did not improve major adverse cardiac outcomes in a large cohort of patients with HCM and AF. Nevertheless, CA seems to facilitate the maintenance of sinus rhythm and slow the progression to permanent AF, without significant safety concerns.

Long-Term Outcomes of Transvenous Lead Extraction: A Comparison in Patients with or without Infection from the Italian Region with the Oldest Population.

BACKGROUND: The gold standard for the treatment of cardiac implantable electronic devices (CIEDs)-related infection and lead malfunction is transvenous lead extraction (TLE). To date, the risk of mortality directly related to TLE procedures is relatively low, but data on post-procedural and long-term mortality are limited, even more in the aging population. METHODS: Consecutive patients with CIEDs who underwent TLE were retrospectively studied. The primary outcome was the endpoint of death, considering independent predictors of long-term clinical outcomes in the TLE aging population comparing patients with and without infection. RESULTS: One hundred nineteen patients (male 77%; median age 76 years) were included in the analysis. Eighty-two patients (69%) documented infection, and thirty-seven (31%) were extracted for a different reason. Infected patients were older (80 vs. 68 years, p-value > 0.001) with more implanted catheters (p-value < 0.001). At the last follow-up (FU) available (median FU 4.1 years), mortality reached 37% of the patient population, showing a statistically significant difference between infected versus non-infected groups. At univariable analysis, age at TLE, atrial fibrillation, and anemia remained significant correlates of mortality; at multivariable analysis, only patients with anemia and atrial fibrillation have a 2.3-fold (HR 2.34; CI 1.16-4.75) and a 2.5-fold (HR 2.46; CI 1.33-4.54) increased rate of death, respectively. CONCLUSION: Our long-term data showed that aging patients who underwent TLE for CIED-related infection exhibit a high mortality risk during a long-term follow-up, potentially leading to a rapid and effective procedural approach in this patient population.

Syncope in hypertrophic cardiomyopathy (part I): An updated systematic review and meta-analysis.

AIMS: To describe the proportion of patients with syncope among those affected by hypertrophic cardiomyopathy (HCM) and the relevance of syncope as risk factor for sudden cardiac death and life-threatening arrhythmic events. METHOD AND RESULTS: Systematic review of original articles that assessed syncope in HCM patients. Literature search of PubMed including all English publications from 1973 to 2021.We found 57 articles for a total of 21.791 patients; of these, 14 studies reported on arrhythmic events in the follow-up. Syncope was reported in 15.8% (3.452 of 21.791) patients. It was considered unexplained in 91% of cases. Life-threatening arrhythmic events occurred in 3.6% of non-syncopal patients and in 7.7% of syncopal patients during a mean follow-up of 5.6 years. A relative risk of 1.99 (95%CI 1.39 to 2.86) was estimated for syncope patients by the random effect model using Haldane continuity correction for 0 events. CONCLUSIONS: In the current practice, the cause of syncope remained unexplained in most patients affected by HCM. The management of patients seems mainly driven by risk stratification rather than identification of the aetiology of syncope. There is a need of precise instructions how to apply the recommendations of current guidelines to this disease, which tests are indicated and how to interpret their findings. The protocol was registered in Prospero (ID: 275963).

Sport practice in hypertrophic cardiomyopathy: running to stand still?

During the last decades, the practice of sport and hypertrophic cardiomyopathy (HCM) were considered as incompatible, since evidence was not sufficient to gauge the risk associated to repeat and/or vigorous exercise across the spectrum of HCM. Additionally, it was acknowledged thatrisk stratification tools developed for HCM were not derived from athlete cohorts. Recent epidemiological studies focused on HCM both in the general population and in athletes, however, have de-emphasized the contribution of this condition to the risk of sport-associated sudden death, supporting the possibility of allowing the practice of some sports, even at professional level, for certain low-risk HCM categories. We hereby analyze the complex interaction of vigorous and continuative exercise with HCM, revising the available evidence for sports eligibility in HCM, the challenges and limitations of shared decision-making, as well as the potential harms and benefits of a highly personalised exercise schedule in subjects diagnosed with this complex disease.

Adjunctive hypnotic communication for analgosedation in subcutaneous implantable cardioverter defibrillator implantation. A prospective single center pilot study.

BACKGROUND: Subcutaneous implantable cardioverter defibrillator (S-ICD) is a well-established therapy for sudden death prevention. Considering the painful nature of the procedure anaesthesia may be required for analgo-sedation. Hypnosis is emerging as a promising therapeutic strategy for pain control. Few data are available regarding the use of hypnosis as adjunctive technique for pain control during S-ICD implantation. METHODS: Thirty consecutive patients referred to our centre for S-ICD implantation were prospectively and alternatively allocated with 1:1 ratio in two groups: A) Standard analgo-sedation approach (Hypnosis non responder patients) B) Standard analgo-sedation approach with the addition of hypnotic communication (Hypnosis responder patients). Peri-procedural pain perception and anxiety, perceived procedural length, type and dosage of administered analgesic drugs have been measured using validate scores and compared. RESULTS: Hypnotic communication was offered to 15 patients of which was successful in 11 patients (73%). There were no statistical differences between the two study groups according to baseline characteristics. Hypnosis communication resulted in significant pain perception reduction (Group A 6,9 ± 1,6 Vs Group B 1,1 ± 0,9, p value < 0,01), peri-procedural anxiety (Group A 3,5 ± 1,6 Vs Group B 1,9 ± 0,5, p value < 0,01) and reduced perceived procedural length (Group A 58,7 ± 13,4 min Vs Group B 44,7 ± 5,5 min, p value < 0,01). Fentanyl dosage was significantly lower in Group B patients. CONCLUSIONS: Our results demonstrated a significant reduction of perceived pain, anxiety, procedural time and use of analgesic drugs in hypnosis responder patients. These results reinforce the beneficial effects of the hypnotic technique in patients undergoing S-ICD implantation.

Transcatheter ablation for atrial fibrillation in patients with hypertrophic cardiomyopathy: Long-term results and clinical outcomes.

INTRODUCTION: Radiofrequency transcatheter ablation (RFCA) for atrial fibrillation (AF) in patients with hypertrophic cardiomyopathy (HCM) has been proven feasible. However, the long-term results of RFCA and its impact on clinical course of HCM are unknown. The aim of this study was to analyse clinical outcomes and long-term efficacy of RFCA in a multicentre cohort of patients with HCM and concomitant AF. METHODS: Patients with HCM and AF consecutively undergoing RFCA were included. Ablation failure was defined as recurrence of AF, atrial tachycardia, or flutter lasting more than 3 min and occurring after the blanking period. RESULTS: Overall, 116 patients with symptomatic AF refractory to antiarrhythmic drugs were included. Over a median follow-up of 6.0 years (interquartile range: 3.0-8.9 years) recurrence rate after a single RFCA was 32.3 per 100 patient/years with 26% of patients free from AF relapses at 6-year follow-up. Among patients experiencing AF recurrence, 51 (66%) underwent at least one redo-procedure. The overall recurrence rate considering redo-procedures was 12.6 per 100 patients/years with 53% of patients free from AF relapses at 6 years. At last follow-up, with an average of 1.6 procedures, 67 (61%) patients were in sinus rhythm (SR). Patients remaining in SR showed better functional status compared with those experiencing arrhythmic recurrences (NYHA Class 1.6 ± 0.1 vs. 2.0 ± 0.1, p = .009). CONCLUSIONS: RFCA of AF in HCM patients is an effective and safe strategy favoring long-term SR maintenance, reduction of atrial arrhythmic events, and improved functional status. However, most patients need repeat procedures and continuation of antiarrhythmic drugs.

Zero-fluoroscopy atrial fibrillation ablation in the presence of a patent foramen ovale: a multicentre experience.

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

Very long-term outcome following transcatheter ablation of atrial fibrillation. Are results maintained after 10 years of follow up?

Aims: Atrial fibrillation (AF) transcatheter ablation is a safe and effective procedure. However, outcome over 10 years of follow-up has never been reported. The aim of this study is to assess outcome, describe predictors of recurrences, and report on quality of life (QoL) the decade after an AF ablation. Methods and results: Patients referred for AF ablation in a single high volume centre from June 2004 to June 2006 were enrolled and followed in a prospective fashion by yearly clinical assessment and Holter monitoring. Among 255 patients (42.7% paroxysmal AF, 77% males, after a follow-up of 125 ± 7 months), 132 (52%) were arrhythmia-free including (58, 32% after a single procedure) while 27 (10%) progressed to permanent AF. At multivariate analysis, a greater left atrium antero-posterior diameter (HR 1.05 95% CI 1.02-1.09, P = 0.02) related to arrhythmic recurrences, while no increase in blood pressure (HR 0.06 95% CI 0.02-0.20, P = 0.01), BMI (HR 0.06 95% CI 0.02-0.09, P < 0.001), and fasting glucose (HR 0.58 95% CI 0.36-0.92, P = 0.02) during follow-up were protective for arrhythmic recurrences. Overall QoL improved significantly, significantly related to the absence of recurrences, arrhythmic burden reduction and blood pressure, and BMI control (P < 0.001). Conclusion: The outcome of AF ablation over more than 10 years is characterized by a low incidence of progression towards permanent AF. Greater LA anteroposterior diameter related to arrhythmic recurrences, while blood pressure, BMI, and fasting blood glucose control emerged as predictors of sinus rhythm maintenance. Eventually, QoL improved significantly over the follow-up.

Safety and efficacy of pulmonary vein isolation using a surround flow catheter with contact force measurement capabilities: A multicenter registry.

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

Cooling dynamics: a new predictor of long-term efficacy of atrioventricular nodal reentrant tachycardia cryoablation.

PURPOSE: Catheter ablation of the slow pathway is the most effective treatment for atrioventricular nodal reentrant tachycardia (AVNRT). Cryoenergy, compared to radiofrequency, relates to lower heart block risk but higher incidence of AVNRT recurrences. The aims of this study are to confirm the safety and efficacy of AVNRT cryoablation and to identify predictors of long-term recurrences. METHODS: Among 241 patients undergoing AVNRT cryoablation, 239 (99.2%) experienced acute effective cryoablation of the slow pathway, and no procedure-related complications were reported. RESULTS: After a follow-up of 44.9 ± 31.7 months, 28 (11.7%) patients presented AVNRT recurrences. A shorter preablation (p = 0.05) and postablation anterograde Wenckebach cycle length (p < 0.01), a shorter postablation atrioventricular node refractory period (p = 0.04), and persistence of the crossover sign (p = 0.03) were associated with higher incidence of long-term recurrences. Considering cooling dynamics, a longer time to reach temperature ≤-70 °C (p = 0.03) and a higher minimal temperature during ablation (p = 0.04) were related to recurrences. Patients without residual markers of dual AV node physiology (AH jump, single atrial echo beat, crossover) reported a lower recurrence rate (p = 0.05) compared to those without. At multivariate analysis, a longer time to -70 °C was the strongest independent predictor of long-term recurrence (OR 1.75, 95% CI 1.01-3.03, p = 0.04). CONCLUSIONS: AVNRT cryoablation is safe and effective. Long-term recurrence rate was 11.7%. An ablation approach directed to the complete elimination of dual AV node physiology, along with assessment of the tissue's cooling dynamics, holds the potential to improve long-term AVNRT cryoablation efficacy.

Zero-Fluoroscopy Ablation of Accessory Pathways in Children and Adolescents: CARTO3 Electroanatomic Mapping Combined with RF and Cryoenergy.

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

Pulmonary vein isolation with a new multipolar irrigated radiofrequency ablation catheter (nMARQ™): feasibility, acute and short-term efficacy, safety, and impact on postablation silent cerebral ischemia.

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

Very long-term results of electroanatomic-guided radiofrequency ablation of atrial arrhythmias in patients with surgically corrected atrial septal defect.

AIMS: Atrial tachycardias are common after repair of atrial septal defect (ASD). Although ablation has shown promising results in the short and mid-term follow-up, little data regarding the very long-term success exist. Our aim was to assess very long-term follow-up in patients who have undergone electroanatomic-guided radiofrequency (RF) ablation of late-onset atrial arrhythmias after ASD surgery. METHODS AND RESULTS: Forty-six consecutive patients with surgically repaired ASD were referred for atrial tachycardia ablation. Electrophysiological (EP) study and ablation procedure with the aid of an electroanatomic mapping (EAM) system were performed. Mean age was 49 ± 13 years (females 61%). The presenting arrhythmias were typical atrial flutter (48%), atypical atrial flutter (35%), and atrial tachycardia (17%). In 41% of patients, atrial fibrillation was also present. The EP study showed a right atrial macroreentrant circuit in all the patients. In 12 of 46 (26%), the circuit was localized in the cavo-tricuspid isthmus, whereas in the remaining 34 patients (74%) was atriotomy-dependent. Acute success was 100%. Clinical arrhythmia recurred in 24% of the patients. Nine patients underwent a second and two a third ablation procedure, reaching an overall efficacy of 87% (40 of 46) at a mean follow-up of 7.3 ± 3.8 years since the last procedure. With antiarrhythmic drugs the success rate increased to 96% (44 of 46). No complications occurred. CONCLUSION: In patients with surgically corrected ASD, EAM-guided RF ablation of late-onset macroreentrant atrial arrhythmias demonstrated a high success rate in a very long-term follow-up. Therefore, RF ablation could be considered early in the management of late-onset macroreentrant atrial tachycardias.

Single center experience of fluoroless AVNRT ablation guided by electroanatomic reconstruction in children and adolescents.

BACKGROUND: Anatomical considerations and risks related to x-ray exposure make atrioventricular nodal reentrant tachycardia (AVNRT) ablation in pediatric patients a concerning procedure. We aimed to evaluate the feasibility, safety, and efficacy of performing fluoroless slow-pathway cryoablation guided by the electroanatomic (EA) mapping in children and adolescents. METHODS: Twenty-one consecutive patients (mean age 13.5 ± 2.4 years) symptomatic for AVNRT were prospectively enrolled to right atrium EA mapping and electrophysiological study prior to cryoablation. Cryoablation was guided by slow-pathway potential and performed using a 4-mm-tip catheter. RESULTS: Sustained slow-fast AVNRT was inducible in all the patients with a dual AV nodal physiology in 95%. Acute success was achieved in 100% of the patients with a median of two cryo-applications. Fluoroless ablation was feasible in 19 patients, while in two subjects 50 seconds and 45 seconds of x-ray were needed due to difficult progression of the catheters along the venous system. After a mean follow-up of 25 months, AVNRT recurred in five patients. All the recurrences were successfully treated with a second procedure. In three patients, a fluoroless cryoablation with a 6-mm-tip catheter was successfully performed, while in the remaining two patients, a single pulse of 60 seconds of radiofrequency energy was applied under fluoroscopic monitoring. No complications occurred. CONCLUSIONS: Combination of EA mapping systems and cryoablation may allow to perform fluoroless slow-pathway ablation for AVNRT in children and adolescents in the majority of patients. Fluoroless slow-pathway cryoablation showed a high efficacy and safety comparable to conventional fluoroscopy guided procedures.

Relationship of ECG findings to phenotypic expression in patients with hypertrophic cardiomyopathy: a cardiac magnetic resonance study.

BACKGROUND: The 12-lead electrocardiogram (ECG) is considered an essential screening tool for hypertrophic cardiomyopathy (HCM). A vast array of ECG abnormalities has been described in HCM, although their relationship to left ventricle (LV) morphology and degree of hypertrophy appears elusive. Aim of this study was to assess the relationship of ECG patterns with the HCM phenotype assessed according to the novel opportunities offered by cardiac magnetic imaging (CMR). METHODS: CMR and 12-lead ECG were performed in 257 HCM patients. Severity of ECG abnormalities was defined by the sum of 9 criteria: abnormal cardiac rhythm, QRS duration ≥ 100 ms, Romhilt-Estes score ≥ 5, fascicular block (LAHB) and/or bundle-branch block (LBBB or RBBB), ST-T abnormalities, ST-T segment elevation ≥ 0.2 mV, prolonged QTc interval, pathological Q waves, absence of normal Q wave. Four ECG groups were identified: normal (0 criteria); mildly abnormal (1-3 criteria); moderately abnormal (4-6 criteria); markedly abnormal (7-9 criteria). RESULTS: There was a direct relationship between severity of ECG abnormalities and HCM phenotype. LV mass index was normal in most patients with normal ECG and progressively increased with each class of ECG score, from 70.9 ± 18.6g/m(2) in patients with normal ECG to 107.1 ± 55.1g/m(2) among those with markedly abnormal ECG (p=<0.0001). Likewise, the prevalence and extent of late gadolinium enhancement (LGE) increased significantly with the ECG score, from 37% in patients with normal ECG to 93% in patients with markedly abnormal ECG (overall p=0.0012). A normal ECG had a negative predictive accuracy of 96% for markedly increased LV mass (>91 g/m(2) for men and >69 g/m(2) for women), and of 100% for maximum LV thickness ≥ 30 mm. CONCLUSIONS: In a large HCM cohort, the number and severity of ECG abnormalities were directly related to phenotypic expression as revealed by CMR. Although false negative ECG findings remain a challenge in population screenings for HCM, a normal ECG proved effective in ruling out severe LV hypertrophy, suggesting potential implications for long-term follow-up of HCM patients and family members. A simple score for quantification of ECG abnormalities in HCM patients is proposed.

Impact of ablation catheter irrigation design on silent cerebral embolism after radiofrequency catheter ablation of atrial fibrillation: results from a pilot study.

INTRODUCTION: Silent cerebral lesions (SCL) are a sensitive tool to evaluate thromboembolic risk of catheter ablation. Recent data showed the possibility to reduce thrombus formation when the electrode-tissue interface cooling is optimized by a homogeneous flushing of saline along the entire surface of the distal electrode through a larger number of irrigation holes. The study aim is to compare procedural parameters and safety of pulmonary vein isolation (PVI) performed by using open-irrigated catheters with different irrigation design. METHODS AND RESULTS: Eighty patients (74% males; age 57 ± 12 years) with paroxysmal AF randomly underwent PVI performed with a new irrigation design catheter (group A, 40 patients) versus a standard irrigated catheter (group B, 40 patients). A cerebral magnetic resonance imaging (MRI) was performed before and after the procedure. Postprocedural brain MRI unveiled SCL in 2 patients in group A and in 3 in group B (5% vs 7.5%, P = 0.500). Intraprocedural ACT was the only independent factor associated with the occurrence of SCL (OR = 0.996; 95% CI 0.994-0.998, P < 0.001). Among procedural parameters, we observed a reduction of irrigation saline volume of 662 mL in group A versus group B (P < 0.001). CONCLUSION: PVI performed with a new irrigated catheter did not reduce significantly the SCL risk when compared to a standard irrigated catheter. Intraprocedural ACT reduces the SCL risk of 0.4% for each point of ACT increase. For ACT > 320 seconds no SCL occurred. Finally, compared to a standard irrigated catheter, PVI performed with a new irrigation design catheter reduces significantly saline volume infusion.