Early Clinical Outcomes and Advantages of a Novel-Size Adjustable Second-Generation Cryoballoon: A Proof-of-Concept Study.

(1) Background/Objective Balloon-guided catheter ablation (CA) has emerged as an alternative option for atrial fibrillation (AF) management. The recent introduction of a novel-size adjustable second-generation cryoballoon (CB) system offers innovations, but clinical outcomes remain unexplored. This study aims to assess the acute performance of the POLARx FIT™ CB system in AFCA. (2) Methods: Consecutive patients undergoing AF ablation with the POLARx FIT™ CB system in our center were included. The primary outcome was the rate of 31 mm balloon-size utilization, with secondary outcomes including acute pulmonary vein isolation (PVI) rate, periprocedural complications, and in-hospital AF recurrences. (3) Results: Twenty-four patients with a mean age of 59.5 years, predominantly male (87.5%), and exhibiting paroxysmal AF (91.7%) were enrolled. Procedural characteristics demonstrated a high acute success rate (100% PV isolation) with a favorable safety profile. Notably, the 31 mm CB configuration was utilized in 51% of applications, showcasing its adaptability in challenging anatomies. No major complications occurred, with two patients experiencing in-hospital self-limiting AF recurrences. (4) Conclusions: This study represents the first comprehensive assessment of the POLARx FIT™ CB system in AF ablation. While acknowledging the study's limitations, this novel CB emerges as a promising tool, warranting further exploration in larger studies with extended follow-up periods.

Pulsed field ablation technology for pulmonary vein and left atrial posterior wall isolation in patients with persistent atrial fibrillation.

INTRODUCTION: Limited data exist on pulsed-field ablation (PFA) in patients with persistent atrial fibrillation (PeAF) undergoing left atrial posterior wall isolation (LAPWI). METHODS: The Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA) prospective registry included consecutive patients referred for PeAF catheter ablation at 9 Italian centers, treated with the FARAPULSETM-PFA system. The primary efficacy and safety study endpoints were the acute LAPWI rate, freedom from arrhythmic recurrences and the incidence of major periprocedural complications. Patients undergoing pulmonary vein isolation (PVI) alone, PWI + LAPWI and redo procedures were compared. RESULTS: Among 249 patients, 21.7% had long-standing PeAF, 79.5% were male; mean age was 63 ± 9 years. LAPWI was performed in 57.6% of cases, with 15.3% being redo procedures. Median skin-to-skin times (PVI-only 68 [60-90] vs. PVI + LAPWI 70 [59-88] mins) did not differ between groups. 45.8% LAPWI cases were approached with a 3D-mapping system, and 37.3% with intracardiac echocardiography. LAPWI was achieved in all patients by means of PFA alone, in 88.8% cases at first pass. LAPWI was validated either by an Ultrahigh-density mapping system or by recording electrical activity + pacing maneuvers. No major complications occurred, while 2.4% minor complications were detected. During a median follow-up of 273 [191-379] days, 41 patients (16.5%) experienced an arrhythmic recurrence after the 90-day blanking period, with a mean time to recurrence of 223 ± 100 days and no differences among ablation strategies. CONCLUSION: LAPWI with PFA demonstrates feasibility, rapidity, and safety in real-world practice, offering a viable alternative for PeAF patients. LAPWI is achievable even with a fluoroscopy-only method and does not significantly extend overall procedural times.

Pulmonary vein isolation by means of a novel cryoballoon technology in paroxysmal atrial fibrillation patients: 1-year outcome from a large Italian multicenter clinical registry.

INTRODUCTION: Recently, a new cryoballoon (CB) technology (POLARx; Boston Scientific) has come onto the market. Preliminary data have shown that its acute safety and efficacy are similar to those of the first-generation CB. The aim of this study was to assess the medium-term outcome of pulmonary vein isolation (PVI) with the POLARxTM CB in a large multicenter registry. METHODS: We prospectively collected data on 125 consecutive patients with paroxysmal atrial fibrillation (AF) who underwent PVI by means of a novel CB system. Two cases of transient phrenic nerve palsy occurred, with full recovery in the 48h post procedure; no major procedure-related adverse events were reported. During the 90-day blanking period, 4 (3.2%) patients experienced an early recurrence. After the blanking period, over a mean follow-up of 411 ± 62 days, 19 patients (15.2%) suffered an AF/atrial tachycardia (AT) recurrence. The 1-year freedom from AF/AT recurrence was 86.4% (n = 17): 10 (8%) patients had an AF recurrence, 6 (4.8%) had an AT occurrence and 1 (0.8%) suffered both events. Patients with AF/AT recurrences had both a shorter deflation time and total deflation time. Moreover, CB ablations with measured TTI < 90 s and TTI < 60 s were more frequent in patients without AF/AT recurrence (88.5% and 77.4%, respectively) than in those who experienced at least one AF/AT recurrence (67.5% and 55.0%, p = .001 and p = .005, respectively). CONCLUSION: The novel POLARx cryo-balloon system is safe and effective for PV isolation, displaying a 1-year freedom from atrial arrhythmia recurrence of 86.4%, which is in line to that reported with AFA-Pro CB or RF ablation. 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.

Pulsed-field ablation of pulmonary vein and left atrial posterior wall combined with left atrial appendage occlusion as single procedure.

Pulmonary vein isolation and left atrial posterior wall ablation using the Farapulse system, followed by left atrial appendage occlusion, have been achieved as single combined procedure to treat long-standing persistent atrial fibrillation in a patient at high hemorrhagic risk.

Peri-procedural and mid-term follow-up age-related differences in leadless pacemaker implantation: Insights from a multicenter European registry.

BACKGROUND: Age-related differences on leadless pacemaker (LP) are poorly described. Aim of this study was to compare clinical indications, periprocedural and mid-term device-associated outcomes in a large real-world cohort of LP patients, stratified by age at implantation. METHODS: Two cohorts of younger and older patients (≤50 and > 50 years old) were retrieved from the iLEAPER registry. The primary outcome was to compare the underlying indication why a LP was preferred over a transvenous PM across the two cohorts. Rates of peri-procedural and mid-term follow-up major complications as well as LP electrical performance were deemed secondary outcomes. RESULTS: 1154 patients were enrolled, with younger patients representing 6.2% of the entire cohort. Infective and vascular concerns were the most frequent characteristics that led to a LP implantation in the older cohort (45.8% vs 67.7%, p < 0.001; 4.2% vs 16.4%, p = 0.006), while patient preference was the leading cause to choose a LP in the younger (47.2% vs 5.6%, p < 0.001). Median overall procedural (52 [40-70] vs 50 [40-65] mins) and fluoroscopy time were similar in both groups. 4.3% of patients experienced periprocedural complications, without differences among groups. Threshold values were higher in the younger, both at discharge and at last follow-up (0.63 [0.5-0.9] vs 0.5 [0.38-0-7] V, p = 0.004). CONCLUSION: When considering LP indications, patient preference was more common in younger, while infective and vascular concerns were more frequent in the older cohort. Rates of device-related complications did not differ significantly. Younger patients tended to have a slightly higher pacing threshold at mid-term follow-up.

A case of myopericarditis recurrence after third dose of BNT162b2 vaccine against SARS-CoV-2 in a young subject: link or causality?

The rate of post-vaccine myocarditis is being studied from the beginning of the massive vaccination campaign against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although a direct cause-effect relationship has been described, in most cases, the vaccine pathophysiological role is doubtful. Moreover, it is not quite as clear as having had a previous myocarditis could be a risk factor for a post-vaccine disease relapse. A 27-year-old man presented to the emergency department for palpitations and pericardial chest pain radiated to the upper left limb, on the 4th day after the third dose of BNT162b2 vaccine. He experienced a previous myocarditis 3 years before, with full recovery and no other comorbidities. Electrocardiogram showed normal atrioventricular conduction, incomplete right bundle branch block, and diffuse ST-segment elevation. A cardiac echo showed lateral wall hypokinesis with preserved ejection fraction. Troponin-T was elevated (160 ng/L), chest X-ray was normal, and the SARS-CoV-2 molecular buffer was negative. High-dose anti-inflammatory therapy with ibuprofen and colchicine was started; in the 3rd day high-sensitivity Troponin I reached a peak of 23000 ng/L. No heart failure or arrhythmias were observed. A cardiac magnetic resonance was performed showing normal biventricular systolic function and abnormal tissue characterization suggestive for acute non-ischaemic myocardial injury (increased native T1 and T2 values, increased signal intensity at T2-weighted images and late gadolinium enhancement, all findings with matched subepicardial distribution) at the level of mid to apical septal, anterior, and anterolateral walls. A left ventricular electroanatomic voltage mapping was negative (both unipolar and bipolar), while the endomyocardial biopsy showed a picture consistent with active myocarditis. The patient was discharged in good clinical condition, on bisoprolol 1.25 mg, ramipril 2.5 mg, ibuprofen 600 mg three times a day, colchicine 0.5 mg twice a day. We presented the case of a young man with history of previous myocarditis, admitted with a non-complicated acute myopericarditis relapse occurred 4 days after SARS-CoV-2 vaccination (3rd dose). Despite the observed very low incidence of cardiac complications following BNT162b2 administration, and the lack of a clear proof of a direct cause-effect relationship, we think that in our patient this link can be more than likely. In the probable need for additional SARS-CoV-2 vaccine doses in the next future, studies addressing the risk-benefit balance of this subset of patient are warranted. We described a multidisciplinary management of a case of myocarditis recurrence after the third dose of SARS-CoV-2 BNT162b2 vaccine.

Key characteristics for effective acute pulmonary vein isolation when using a novel cryoballoon technology: insights from the CHARISMA registry.

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.

Leadless Pacemaker Implantation in the Emergency Bradyarrhythmia Setting: Results from a Multicenter European Registry.

Background. Data on leadless pacemaker (LPM) implantation in an emergency setting are currently lacking. Objective. We aimed to investigate the feasibility of LPM implantation for emergency bradyarrhythmia, in patients referred for urgent PM implantation, in a large, multicenter, real-world cohort of LPM recipients. Methods. Two cohorts of LPM patients, stratified according to the LPM implantation scenario (patients admitted from the emergency department (ED+) vs. elective patients (ED−)) were retrieved from the iLEAPER registry. The primary outcome of the study was a comparison of the peri-procedural complications between the groups. The rates of peri-procedural characteristics (overall procedural and fluoroscopic duration) were deemed secondary outcomes. Results. A total of 1154 patients were enrolled in this project, with patients implanted due to an urgent bradyarrhythmia (ED+) representing 6.2% of the entire cohort. Slow atrial fibrillation and complete + advanced atrioventricular blocks were more frequent in the ED+ cohort (76.3% for ED+ vs. 49.7% for ED−, p = 0.025; 37.5% vs. 27.3%, p = 0.027, respectively). The overall procedural times were longer in the ED+ cohort (60 (45−80) mins vs. 50 (40−65) mins, p < 0.001), showing higher rates of temporary pacing (94.4% for ED+ vs. 28.9% for ED−, p < 0.001). Emergency LPM implantation was not correlated with an increase in the rate of major complications compared to the control group (6.9% ED+ vs. 4.2% ED−, p = 0.244). Conclusion. LPM implantation is a feasible procedure for the treatment of severe bradyarrhythmia in an urgent setting. Urgent LPM implantation was not correlated with an increase in the rate of major complications compared to the control group, but it was associated with longer procedural times.

A new leadless pacemaker with atrioventricular synchronous pacing replacing a still working VVI leadless pacemaker: a case report.

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

Long-Term Outcomes of Near-Zero Radiation Ablation of Paroxysmal Supraventricular Tachycardia: A Comparison With Fluoroscopy-Guided Approach.

OBJECTIVES: This study aimed to assess the long-term outcomes of minimally fluoroscopic approach (MFA) compared with conventional fluoroscopic ablation (ConvA) in terms of recurrences of arrhythmia and long-term complications. BACKGROUND: Catheter ablation (CA) of supraventricular tachycardia (SVT) with an MFA, under the guidance of electroanatomic mapping (EAM) systems, results in a significant reduction in exposure to ionizing radiations without impairing acute procedural success and complication rate. However, data regarding long-term outcomes of MFA compared with ConvA are lacking. METHODS: This is a retrospective observational study. All patients undergoing MFA CA of SVT (atrioventricular nodal re-entrant tachycardia and atrioventricular re-entrant tachycardia) between 2010 and 2015 were enrolled and were compared with matched subjects (1 MFA: 2 ConvA) undergoing ConvA during the same period. The 2 co-primary outcomes were recurrence of arrhythmias and long-term complications. RESULTS: A total of 618 patients (mean age 38 ± 15 years, 60% female) were enrolled. MFA included 206 patients, whereas 412 were treated with ConvA. Acute success (99% vs. 97%; p = 0.10) and acute complications (2.4% vs. 5.3%; p = 0.14) were similar in the 2 groups. During a median follow-up of 4.4 years, 5.9% of patients experienced recurrence of arrhythmias. At multivariate analysis, ConvA (hazard ratio [HR]: 3.03) and procedural success (HR: 0.10) were independently associated with recurrence of arrhythmias. Late complications (i.e., advance atrioventricular block and need for pacemaker implantation) occurred more frequently in ConvA (3.4% vs. 0.5%; p = 0.03) compared with MFA. CONCLUSIONS: CA guided by EAM systems with MFA provided better long-term results and reduced risk of complications compared with ConvA.

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).

Cryoballoon atrial fibrillation ablation: Single-center safety and efficacy data using a novel cryoballoon technology compared to a historical balloon platform.

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 with 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 CHA2 DS2 -VASc 1, left-atrium size 34 ml/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 = .39). The median total procedural time was longer in the POLARx™ group (90 min vs. 60 min, p < .001), but the overall time-to-isolation (TTI; 44.8 s vs. 39 s, p = .253) and ablation time (15 min vs. 13.7 min, p = .122) was similar between POLARx™ and AFAP groups, respectively. Despite equal TTI, the POLARx™ had a lower minimal temperature reached (-57°C vs -47°C, p < .001). CONCLUSION: The novel POLARx™ cryoballoon had similar efficacy and safety compared with the AFAP. It was also associated with longer procedural times, similar TTI, and lower minimum temperature reached.

High-density mapping validation of antral pulmonary vein isolation and posterior wall isolation created with a new cryoballoon ablation system: The first reported case.

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.

Expert opinion on continuous rhythm monitoring of patients with atrial fibrillation for candidates or patients who have already undergone ablation.

BACKGROUND: Continuous monitoring by implantable loop recorder (ILR) can provide information relevant to rhythm control and oral anticoagulation (OAC) after atrial fibrillation (AF) ablation, but there is little agreement on patients' selection and appropriate management strategy. METHODS: An expert panel (EP) made up of eight Italian electrophysiologists with expertise in AF ablation, gathered to define an algorithm to guide continuous rhythm monitoring in AF patients who have undergone ablation. The process included a review of the current literature and two EP face-to-face meetings. Between the two meetings, an on-line survey was sent to 50 Italian electrophysiologists practicing AF ablation. Agreement level was considered reached when ≥70% of respondents agreed or were neutral. RESULTS: Two algorithms were developed to define patients for whom the ILR would be suggested support for (OAC) therapy discontinuation and rhythm management after AF ablation. Thirty-three out of 50 physicians responded to on-line survey (66% response rate). Together with EP members the responders accounted for electrophysiology centers performing about 50% of total yearly Italian AF ablation procedures. Agreement level was reached at the first survey round on all the questions, so the algorithms were not further modified and re-tested. CONCLUSIONS: EP developed two algorithms for ECG monitoring to guide OAC therapy discontinuation and rhythm management after AF ablation. These suggestions, validated by wide feedback and consensus of physicians performing AF ablations, might support the decision on the choice and the use of ECG monitoring techniques, based on specific patient characteristics.

Acute outcome after a single cryoballoon ablation: Comparison between Arctic Front Advance and Arctic Front Advance PRO.

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 < .001). CB4 was correlated to significant increase of acute real-time recordings with regard to all the single PV (left superior PV: 58% vs 84%, P = .02; left inferior PV: 26% vs 71%, P = .001; right superior PV 29% vs 61%, P = .01; and right inferior PV 19% vs 58%, P = .002). CONCLUSION: The CB4 was more often able to capture real-time recordings of PV potentials and the subsequent acute PV isolation.

Cryoballoon pulmonary vein ablation and left atrial appendage closure combined procedure: A long-term follow-up analysis.

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 (<5 mm leak) LAAC rates were achieved in 40 (82%) and 9 (18%) and in 42 (86%) and 7 (14%) of patients, respectively. The overall freedom from atrial arrhythmia rate at 24 months was 29 (60%), and 45 (92%) of patients were off antithrombotic drugs. The observed annualized stroke and bleeding rates were 1% and 2%, respectively, a 71% and 60% risk reduction in comparison to event rates predicted from CHA2DS2-VASc and HAS-BLED scores. 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.

Lesion index: a novel guide in the path of successful pulmonary vein isolation.

PURPOSE: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Cryoablation of atrial fibrillation with the fourth-generation balloon: The first reported case.

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.

X-Ray Exposure in Cardiac Electrophysiology: A Retrospective Analysis in 8150 Patients Over 7 Years of Activity in a Modern, Large-Volume Laboratory.

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<0.001) and a not statistically significant trend reduction for device implantation procedures. Analyzing 2416 atrial fibrillation ablations, we observed a significant variability of fluoroscopy time, dose area product and effective dose among 7 different experienced operators (P<0.0001) and a significant reduction of fluoroscopy use over time (P<0.0001) for all of them. Considering atrial fibrillation ablation techniques, fluoroscopy time was not different (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<0.001). 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.