Atrial fibrillation recurrences during the blanking period after catheter ablation with the laser balloon technique.

INTRODUCTION: Regardless of the catheter ablation (CA) for atrial fibrillation (AF) strategy, the role of early recurrences during the blanking period (BP) is still unclear. Our aim was to evaluate atrial tachyarrhythmias (ATAs) recurrences during the BP after CA with the laser-balloon (LB) technique. METHODS: Consecutive patients undergoing LBCA were enrolled. Primary outcome of the study was the overall crude ATA recurrence rate during the BP. ATA recurrences after the BP and in-hospital readmissions during the BP were deemed secondary outcomes. RESULTS: Two hundred and twenty-four patients underwent CA with the LB. Median age was 63.0 (55.5-69.5) years and 74.1% were males. 28.6% were persistent AF patients, and 34.8% of patients were followed up with a loop recorder. 15.6% of patients experienced at least an ATA recurrence during the BP. Male sex, chronic heart failure, persistent AF, and recurrences during the BP were found to be associated with long-term ATA recurrences. Recurrences during the BP remained associated with the outcome of interest at multivariate analysis (hazard ratio [HR] = 12.393, 95% confidence interval [95% CI] = 3.699-41.865, p < .001). An association over time was found between early and late recurrences, with 73.7%, 45.5%, and 10.8% of patients presenting with recurrences at 1-, 2-, and 3-month follow-up being free from recurrences after the BP, respectively. 8.0% of patients were readmitted during the BP: 4.5% for AF electrical cardioversion, and 1.8% for CA of other atrial arrhythmias; no redo CA was performed. CONCLUSION: After adjusting for confounders, ATA recurrences during the BP represent the most significant predictor of ATA recurrences after the BP, regardless of AF pattern.

Outcomes of transvenous lead extraction of very old leads using bidirectional rotational mechanical sheaths: Results of a multicentre study.

INTRODUCTION: Lead dwell time >10 years is a recognized predictor for transvenous lead extraction (TLE) failure and complications. Data on the efficacy and safety of TLE using the bidirectional rotational mechanical sheaths in patients with very old leads are lacking. In this multicenter study, we reported the outcomes of transvenous rotational mechanical lead extraction in patients with leads implanted for ≥10 years. METHODS: A total of 441 leads (median: 159 months [135-197]; range: 120-487) in 189 consecutive patients were removed with the Evolution RL sheaths (Cook Medical, Bloomingtom, IN, USA) and mechanical ancillary tools supporting the procedures. RESULTS: The main indication for TLE was infection in 74% of cases. Complete procedural success rate, clinical success rate, per lead were 94.8% and 98.2%, respectively. Failure of lead extraction was seen in 1.8% of leads. The additional use of a snare via the femoral approach was required in 9% of patients. Lead dwell time was the only predictor of incomplete led removal (odds ratio: 1.009; 95% confidence interval [CI]: 1.003-1.014; p = .002). Four major complication (2%) were encountered. During a mean time follow-up of 31 ± 27 months, 21 patients (11%) died. No procedure-related mortality occurred. Predictors of mortality included severe left ventricular systolic dysfunction (hazard ratio [HR]: 8.06; 95% CI: 2.99-21.73; p = .001), TLE for infection (HR: 8.0; 95% CI: 1.04-62.5; p = .045), diabetes (HR: 3.7; 95% CI: 1.48-9.5; p = .005), and previous systemic infection (HR: 3.1; 95% CI: 1.17-8.24; p = .022). Incomplete lead removal or failure lead extraction did not impact on survival during follow-up. CONCLUSION: Our findings demonstrated that the use of bidirectional rotational TLE mechanical sheaths combined with different mechanical tools and femoral approach allows reasonable success and safety in patients with very old leads at experienced specialized centers.

Long-term comparisons of atrial fibrillation ablation outcomes with a cryoballoon or laser-balloon: A propensity-matched analysis based on continuous rhythm monitoring.

OBJECTIVE: Cryoballoon (CB) and laser-balloon (LB) catheter ablation (CA) has been demonstrated to achieve durable and effective pulmonary vein isolation (PVI). Only one head-to-head comparison with an intermittent rhythm monitor strategy is currently available. The aim of this study was to compare acute and long-term outcomes of CB and LB atrial fibrillation ablation procedures, by using a continuous rhythm monitoring strategy. METHODS: This was a prospective two-arm nonrandomized propensity-matched observational trial that compared the outcomes of atrial fibrillation (AF) ablation using LB and CB techniques. To evaluate AF recurrences, an implantable cardiac monitor (ICM) was implanted before hospital discharge to detect atrial tachyarrhythmia (ATA) recurrences. RESULTS: A total of 110 propensity-matched patients undergoing AF ablation with an LB (n = 55) or with a CB system (n = 55) were enrolled (paroxysmal AF 57.3%). Procedural time (LB: 87 [73-104] vs. CB 90 [70-130] min; p = 0.264) and fluoroscopy time did not differ. No differences in ATA recurrences were observed at 12 months (LB-30.9% vs. CB-29.1% and LB-45.5% vs. CB-38.2%; log-rank 0.539). As for AF burden, the 12-month median was 0 [0-1] vs. 0 [0-3]% (p = 0.127) in the LB and CB groups, respectively. When considering only PeAF patients, the median 12-month ATA burden was 26 [18.5-40.5] vs. 29 [26-35]% (p = 0.919) for the LB and CB patients, respectively. CONCLUSION: In a propensity-matched cohort undergoing AF ablation, arrhythmia outcomes assessed by continuous rhythm monitoring did not differ between LB and CB, with an overall low ATA burden. The only predictor of recurrences was persistent AF. There was no difference in procedure or fluoroscopy time.

Second-generation laser balloon ablation for the treatment of atrial fibrillation assessed by continuous rhythm monitoring: the LIGHT-AF study.

AIMS: Balloon-based technologies have been developed to simplify catheter ablation of atrial fibrillation (AF), to improve the clinical outcome of the procedure and to achieve durable pulmonary vein isolation (PVI). The objective of this study is to evaluate the safety and efficacy of second-generation laser balloon (LB2) ablation in the treatment of AF using a continuous cardiac rhythm monitoring strategy. Atrial tachyarrhythmias (ATas) recurrences were assessed with implantable cardiac monitors (ICMs) or devices. METHODS AND RESULTS: All patients underwent LB2 ablation procedure. The primary endpoint was the first recurrence of any, >5.5 and >24 h duration ATas after the blanking period (90 days). In-hospital visits were performed at 3, 6, and 12 months. Seventy-three patients (68% male, mean age 59.8 ± 11.3) were included in the study. The average procedure, fluoroscopy, and laser ablation times were 81.5 ± 30.1, 21.5 ± 12.4, and 33.8 ± 9.7, respectively. All PVs were isolated using the LB2 with no need of touch-up using focal catheters. No major complications occurred during or after the procedures. The one-year freedom from recurrences was 66.9% (95% CI: 57.0-76.7%), 81.0% (69.5-88.5%), and 86.8% (76.1-92.9%) considering any, 5.5-h and 24-h cut-off duration, respectively. At 3, 6, and 12 months, any ATas was recorded in 22%, 32%, and 25% of patients, with a ≥5% arrhythmic burden documented in 4%, 5%, and 3%, respectively. Few patients reported AF-related symptoms (7%, 8%, and 5%). CONCLUSION: LB2 ablation is a safe and effective procedure, showing a high freedom from recurrences and low arrhythmic burden as documented by a continuous rhythm monitoring strategy.

Cryoballoon ablation for paroxysmal atrial fibrillation: mid-term outcome evaluated by ECG monitoring with an implantable loop recorder.

BACKGROUND: The success rate after cryoballoon ablation (CB-A) performed for paroxysmal atrial fibrillation (PAF) might be overestimated by traditional noninvasive monitoring techniques. The purpose of this study was to evaluate the mid-term outcome of CB-A in patients with PAF implanted with an implantable loop recorder (ILR) after the procedure. METHODS: Between January 2017 and March 2019, all patients who underwent CB-A for PAF and who were subsequently implanted with an ILR were retrospectively included. All devices were equipped with remote monitoring. All ILR-documented atrial tachycardia (AT) or AF episodes ≥ 6 min were considered as recurrence; both true and false episodes were collected. A 3-month post-procedural blanking period (BP) was applied. RESULTS: A total of 102 patients (77 men, mean age 60.6 ± 9.6 years) who underwent pulmonary vein isolation (PVI) by CB-A were included; mean time from first diagnosis of AF to PVI was 51.5 ± 46.9 months. Mean follow-up was 29.3 ± 8.1 months; at 12-month follow-up, the success rate was 65.7%, while at 2-year follow-up, freedom from AT/AF recurrences was achieved in 59.3% of the patients. In the follow-up, a total of 4987 ECG strips were analyzed; true-positive episodes were confirmed in 2026 cases (40.6%), whereas 2961 episodes (59.4%) were considered false-positive. CONCLUSION: In patients with PAF implanted with an ILR, CB-A results in freedom from any AT/AF recurrence in 65.7% of patients at 12-month follow-up and in 59.3% of patients when evaluated at 2-year. Careful adjudication of all ILR-documented AF episodes is required to avoid misdiagnosis.

First-in-man fully leadless transvenous CRT-P with a transseptal implant of WISE-CRT® system and Micra® PM.

We describe the world's first fully leadless cardiac resynchronization therapy pacing implant with transseptal approach, in a patient with pacemaker dependency, atrial fibrillation, ischemic hypokinetic cardiomyopathy, and a history of pocket infections. After lead extraction, we implanted a MicraTranscathether Pacing System® (Medtronic, Minneapolis, MN, USA) as the sole right ventricular pacemaker, and the WISECRT system (EBR Systems, Sunnyvale, CA, USA) to provide biventricular pacing. We performed the WISECRT implant procedure using the transseptal approach given the presence of a prosthetic aortic mechanical valve, achieving satisfactory periprocedural results.

Multicenter experience with the Evolution RL mechanical sheath for lead extraction using a stepwise approach: Safety, effectiveness, and outcome.

BACKGROUND: In addition to the Evolution RL sheath, tools by Cook Medical (Bloomington, IN, USA), supporting lead extraction (LE), are available. Data on their use are not reported in detail in previous studies. Moreover, data regarding outcome are lacking. The aim was to evaluate the safety and effectiveness of the Evolution sheath (Evolution RL and Evolution Shortie, Cook Medical) by using a stepwise approach with the available extraction tools and the outcome. METHODS: A total of 393 leads in 198 consecutive patients were removed with the Evolution RL sheath and ancillary tools using a stepwise approach. RESULTS: The main indication for LE was infection in 125 (63.1%) cases. The mean implant duration was 95.4 ± 59.7 months. According to our stepwise approach, the Evolution Shortie RL sheath was used in all cases and complete LE was achieved in 24 (12.2%) cases. The Evolution RL was used in 174 (87.8%) cases and the SteadySheath Evolution tissue stabilization sheath (Cook Medical) in 87 (44%) because of tenacious fibrosis anchored targeted leads. Compression coil (OneTie, Cook Medical) was used in 141 (71%) cases. Complete procedural success rate, clinical success rate, and lead removal with clinical success rate were 97%, 99%, and 99.5%, respectively. One major complication (0.5%) and 10 (5%) minor complications were encountered. During a mean time follow-up of 12 ± 9 months, 14 (7%) patients died. Predictors of mortality included impaired renal function (HR 5.7; 95% CI 1.9-17.6; P = 0.002), extraction because of infection (hazard ratio [HR] 4.0; 95% confidence interval [CI] 1-18.1; P = 0.045), and diabetes (HR 3.2; 95% CI 1.1-9.8; P = 0.036). CONCLUSIONS: Lead extraction using the Evolution RL bidirectional rotational mechanical sheath and ancillary tools in a systematic stepwise approach was effective and safe.

A comparison of 8-mm and open-irrigated gold-tip catheters for typical atrial flutter ablation: Data from a prospective multicenter registry.

BACKGROUND: Cavotricuspid isthmus (CTI) radiofrequency (RF) catheter ablation is the standard treatment for patients suffering from CTI-dependent atrial flutter (AFL). The aim of this study was to compare the use in clinical practice of 8-mm gold-tip catheter (8mmRFC) and open-irrigated gold-tip catheter (irrRFC) for RF typical AFL ablation. METHODS: Patients with typical AFL were treated with 8mmRFC or irrRFC catheters according to investigator preferences. The primary endpoint was the cumulative radiofrequency time (CRFT). Fluoroscopy time, acute and 6-month success rates were secondary endpoints. RESULTS: After excluding 3 patients with left AFL, 157 of the enrolled patients (median age 71.8 [interquartile range, 64.1-76.2], 76% men, 91% in NYHA class ≤II, 65% with no structural heart disease) were analyzed: 74 (47%) subjects were treated with the 8mmRFC and 83 (53%) with the irrRFC. The median CRFT was 3 [2-6] minutes in the 8mmRFC group and 5 [3-7] minutes in the irrRFC group (P = .183). There were no significant differences in ablation success rates, intraprocedural CTI reconnections, audible steam pops, and procedural times. In the 8mmRFC group, a significantly lower fluoroscopy time was observed as compared to the irrRFC group (8 [5-12] vs 15 [10-20] minutes, P < .001). During the follow-up period, AFL recurrences were documented in 3 patients in the 8mmRFC group and 2 in the irrRFC group (P = .655). CONCLUSIONS: The 8mmRFC and the irrRFC performed similarly in routine practice for CTI ablation in terms of cumulative RF time, acute and 6-month success rates. Fluoroscopy time was significantly lower in the 8mmRFC group.

Clinical outcomes of AF patients treated with the first and second-generation of circular mapping and ablation catheter: insights from a real world multicenter experience.

PURPOSE: Complete pulmonary vein isolation (PVI) is the best documented target for catheter ablation, and different technologies have shown comparable outcomes. The multielectrode phased-RF/duty cycled (PhRF/DC) pulmonary vein ablation catheter (PVAC) and its second generation (PVAC-GOLD) have shown promising clinical results in single and multicenter experiences. Our aim is to assess and compare the safety and efficacy in the real clinical practice among two generations of circular PhRF/DC catheters by performing PVI in patients suffering from recurrent atrial fibrillation (AF). METHODS: Eighty-four AF patients treated with PVAC and 64 with PVAC-GOLD were prospectively followed in five Italian cardiology centers in the mainframe of the 1STOP-ClinicalService project. RESULTS: Fluoroscopic and total procedure time were significantly different in the two groups. In particular, in the PVAC-GOLD group, the mean fluoroscopic time was 22.8 ± 12.7 min vs 31.6 ± 18.9 in the PVAC group (p = 0.002), and the mean total procedure duration was 117.6 ± 36.0 vs 147.4 ± 40.6, in the PVAC-GOLD group and the PVAC group, respectively (p = 0.001). Only two out of 148 patients reported a peri-procedural complication. Over 20.9 ± 12.0 months of follow-up, AF recurrence occurred in 58 patients. Kaplan-Meier freedom from AF recurrence did not differ between the two groups (64.1 ± 10% in the PVAC group vs 68.2 ± 9% in the PVAC-GOLD group at 1 year, p = ns). CONCLUSIONS: In our multicenter analysis, AF ablation using two generations of circular PhRF/DC catheters is safe and effective. No difference was observed in terms of safety and efficacy of the AF ablation between the two catheters, with the mean procedural time being shorter in the PVAC-GOLD group.