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Background: Existing data on the impact of sex differences on transvenous lead extraction (TLE) outcomes in cardiac device patients are limited., Objective: The purpose of this study was to evaluate the safety and efficacy of mechanical TLE in female patients., Methods: A retrospective evaluation was performed on 3051 TLE patients (group 1: female; group 2: male) from a single tertiary referral center. All individuals received treatment using single sheath mechanical dilation and various venous approaches as required., Results: Our analysis included 3051 patients (group 1: 750; group 2: 2301), with a total of 5515 leads handled with removal. Female patients were younger, had a higher left ventricular ejection fraction, and lower prevalences of coronary artery disease and diabetes mellitus. Infection was more common in male patients, whereas lead malfunction or abandonment were more frequent in female patients. Radiologic success was lower in female patients (95.8% vs 97.5%; P = .003), but there was no significant difference in clinical success between groups (97.2% vs 97.5%; P = .872). However, major complications (1.33% vs 0.60%; P <.001) and procedural mortality (0.4% vs 0.1%; P <.001) were higher in females compared to male patients. After multivariate analysis, female sex emerged as the only predictor of major complications, including deaths (odds ratio 3.96; 95% confidence interval 1.39-11.24)., Conclusion: TLE using unpowered simple mechanical sheaths in female patients is safe and effective, but is associated with lower radiologic success and higher complication rates and mortality than in males. This finding underscores the importance of recognizing sex differences in TLE outcomes., (© 2023 Heart Rhythm Society. Published by Elsevier Inc.)

High-power short-duration (HPSD) ablation is an increasingly used ablation strategy for pulmonary vein isolation (PVI) procedures, but Lesion Index (LSI)-guided HPSD radiofrequency (RF) applications have not been described in this clinical setting. We evaluated the procedural efficiency and safety of an LSI-guided HPSD strategy for atrial fibrillation (AF) ablation. Paroxysmal and persistent AF patients scheduled for AF ablation were prospectively enrolled and divided into two groups, according to the ablation power used (≥45 W for the LSI-HP Group and ≤40 W for the LSI-LP group). All patients underwent only PVI LSI-guided ablation (5.5 to 6 anteriorly; 5 to 5.5 superiorly, 4.5 to 5 posteriorly) with a point-by-point strategy and an inter-lesion distance <6 mm. Forty-six patients with AF (25 in the LSI-HP Group vs 21 in the LSI-LP Group)-59% paroxysmal, 78% male, with low-intermediate CHA 2 DS 2 -Vasc scores (2 [1-3]), a preserved ejection fraction (65 ± 6%) and a mean left atrial index volume of 39 ± 13 mL/m 2 were prospectively enrolled. Baseline clinical characteristics were comparable between groups. PVI was successful in all patients. The RF time (29 (23-37) vs. 49 (41-53) min, p < 0.001), total procedure time (131 (126-145) vs. 155 (139-203) min, p = 0.007) and fluoroscopy time (12 (10-18) vs. 21 (16-26) min, p = 0.001) were significantly lower in the LSI-HP Group. No complications or steam pops were seen in either group. LSI-HP AF ablation significantly improved procedural efficiency-reducing ablation time, total procedural duration, and fluoroscopy use, while maintaining a comparable safety profile to lower-power procedures.

Aims: Permanent pacemaker implantation (PPM-I) remains nowadays the most important drawback of transcatheter aortic valve replacement (TAVR) procedure and the optimal strategy of delayed conduction disturbances (CDs) in these patients is unclear. The study aimed to validate an ambulatory electrocardiogram (ECG) monitoring through a 30 s spot ambulatory digital mobile ECG (AeECG), by using KardiaMobile-6L device in a 30-day period after TAVR procedure., Methods and Results: Between March 2021 and February 2022, we consecutively enrolled all patients undergoing TAVR procedure, except pacemaker (PM) carriers. At discharge, all patients were provided of a KardiaMobile-6L device and a spot digital ECG (eECG) recording 1 month schedule. Clinical and follow-up data were collected, and eECG schedule compliance and recording quality were explored. Among 151 patients without pre-existing PM, 23 were excluded for pre-discharge PPM-I, 18 failed the KardiaMobile-6L training phase, and 10 refused the device. Delayed CDs with a Class I/IIa indication for PPM-I occurred in eight patients (median 6 days). Delayed PPM-I vs. non-delayed PPM-I patients were more likely to have longer PR and QRS intervals at discharge. PR interval at discharge was the only independent predictor for delayed PPM-I at multivariate analysis. The overall eECG schedule compliance was 96.5%. None clinical adverse events CDs related were documented using this new AeECG monitoring modality., Conclusion: A strategy of 30 s spot AeECG is safe and efficacious in delayed CDs monitoring after TAVR procedure with a very high eECG schedule level of compliance., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: An early, comprehensive rhythm-control therapy is needed in order to treat atrial fibrillation (AF) effectively and to improve ablation outcomes., Methods: A total of 153 consecutive patients from the CHARISMA registry undergoing AF ablation at eight centers were included. Patients with de novo PVI were classified as having undergone early treatment (ET) if the procedure was performed within 6 months after the first AF episode, and as having undergone delayed treatment (DT) if ablation was performed over 6 months after the first AF episode., Results: One-hundred fifty-three patients were enrolled (69.9% male, 59 ± 10 years, 61.4% paroxysmal AF, 38.6% persistent AF). The time from the first AF episode to the ablation procedure was 1034 ± 1483 days. The ET group comprised 36 patients (25.3%), the DT group 60 (39.2%) and Redo cases were 57 (37.3%). During a mean follow-up of 366 ± 130 days, 18 patients (11.8%) suffered an AF/AT recurrence. More DT patients than ET patients suffered recurrences (15.7% vs. 2.2%, p = 0.0452) and the time to AT/AF recurrence was shorter in the group of patients who received an ablation treatment after 6 months (HR = 6.19, 95% CI: 1.7 to 21.9; p = 0.0474). On multivariate Cox analysis, only hypertension (HR = 4.86, 95% CI: 1.6 to 14.98, p = 0.0062) was independently associated with recurrences. Beyond the hypertension risk factor, ET was associated with a low risk of recurrence; recurrence rate ranged from 0% (ET patients without hypertension) to 25.0% (DT patients with hypertension)., Conclusions: An early rhythm-control ablation therapy in the absence of common risk factors was associated with the lowest rate of recurrences., (© 2021 Wiley Periodicals LLC.)

This critical review illustrates the pathophysiological aspects and available scientific evidence about cardiac contractility modulation therapy. A useful algorithm dealing with the essential decisional knots to consider for device implantation in patients with heart failure in NYHA class >II and ejection fraction ≤45% is presented. The present review paves the way for the development of an Italian registry aiming at analyzing the characteristics of implanted patients based on a multiparametric approach, including cardiac biomarkers, to identify clinical profiles and predictors of response to therapy. The "Answers and Questions" section provides useful insights into pathophysiology, technical specifications, clinically relevant scenarios and future perspectives.

Purpose: The aim of the study was to compare the long-term clinical and electrical performance of Micra leadless pacemaker with transvenous single-chamber pacemaker (TV-VVI PM) in a high-volume centre for transvenous lead extraction (TLE)., Methods: One-hundred patients (group 1) undergoing Micra implant were matched with 100 patients undergoing TV-VVI PM implant (group 2) by age, sex, left ventricular systolic ejection fraction and previous TLE., Results: The implant procedure was successful in all patients. In group 1, the procedure duration was lower than in group 2 (43.86 ± 22.38 vs 58.38 ± 17.85 min, p < 0.001), while the fluoroscopy time was longer (12.25 ± 6.84 vs 5.32 ± 4.42 min, p < 0.001). There was no difference about the rate of septal implant at the right ventricle (76% vs 86%, p = 0.10). Patients were followed-up for a median of 12 months. No acute and chronic procedure-related complication was observed in group 1, while we reported acute complications in seven patients (7%, p = 0.02) and long-term complications in three patients (3%, p = 0.24), needing for a system revision in 6 cases (6%, p = 0.038), in group 2. One systemic infection occurred in TV-VVI PM group. Electrical measurements were stable during follow-up in both groups, with a longer estimated battery life in group 1 (mean delivered energy at threshold at discharge: 0.14 ± 0.21 vs 0.26 ± 0.22 μJ, p < 0.001)., Conclusion: Micra pacemaker implant is a safe and effective procedure, with a lower rate of acute complications and system revisions compared with TV-VVI PM, even in a real-life setting including patients who underwent TLE., (© 2020. Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Highly localized impedance (LI) measurements during atrial fibrillation (AF) ablation have recently emerged as a viable real-time indicator of tissue characteristics and durability of the lesions created. We report the outcomes of acute and long-term clinical evaluation of the new DirectSense algorithm in AF ablation., Methods: Consecutive patients undergoing AF ablation were included in the CHARISMA registry. RF delivery was guided by the DirectSense algorithm, which records the magnitude and time-course of the impedance drop. The ablation endpoint was pulmonary vein isolation (PVI), as assessed by the entrance and exit block., Results: 3556 point-by-point first-pass RF applications of >10 s duration were analyzed in 153 patients (mean age=59 ± 10 years, 70% men, 61% paroxysmal AF, 39% persistent AF). The mean baseline LI was 105 ± 15 Ω before ablation and 92 ± 12 Ω after ablation (p < .0001). Both absolute drops in LI and the time to LI drop (LI drop/τ) were greater at successful ablation sites (n = 3122, 88%) than at ineffective ablation sites (n = 434, 12%) (14 ± 8 Ω vs 6 ± 4 Ω, p < .0001 for LI; 0.73 [0.41-1.25] Ω/s vs. 0.35[0.22-0.59 Ω/s, p < .0001 for LI drop/τ). No major complications occurred during or after the procedures. All PVs had been successfully isolated. During a mean follow-up of 366 ± 130 days, 18 patients (11.8%) suffered an AF/atrial tachycardia recurrence after the 90-day blanking period., Conclusion: The magnitude and time-course of the LI drop during RF delivery were associated with effective lesion formation. This ablation strategy for PVI guided by LI technology proved safe and effective and resulted in a very low rate of AF recurrence over 1-year follow-up., (© 2021 Wiley Periodicals LLC.)

Purpose: Early detection of cardiac arrhythmias is a major opportunity for mobile health, as wearable devices nowadays available can detect single-lead electrocardiogram (ECG). The study aims to validate the in-ear region as a new anatomical site for ECG signal detection and looks towards designing innovative ECG wearable devices., Methods: We performed ECG using KardiaMobile device (AliveCor®) on 35 healthy volunteers. First, ECG was detected by standard modality using both hands. Then, ECG was detected using the left in-ear region instead of the right hand. All the recorded ECGs were analyzed by the device and by two cardiologists in blind testing., Results: We successfully collected 70 ECGs performed on 35 volunteers (male 54%, age 39.1 ± 10.7 years; BMI 22.9 ± 2.89 kg/m 2 ) with no differences observed by KardiaMobile in ECG reports detected in the two different modalities. All the ECGs were reported as normal by the device and the two cardiologists. Moreover, linear regression analysis showed good correlation between the amplitude (mV) of P (r = 0.76; r 2  = 0.57; p < 0.0001) and QRS waves (r = 0.81; r 2  = 0.65; p < 0.0001), the intervals (ms) of PR (r = 0.91; r 2  = 0.83; p < 0.0001; LOA - 0.60-0.41; CC = 0.91), QRS (r = 0.78; r 2  = 0.61; p < 0.0001; LOA - 0.49-0.43; CC = 0.78), QT (r = 0.85; r 2  = 0.71; p < 0.0001; LOA - 1.31-1.20; CC = 0.85), and heart rate (r = 0.94; r 2  = 0.89; p < 0.0001; LOA - 7.82-7.76; CC = 0.94) detected in two different modalities., Conclusion: The in-ear region is a reliable novel anatomical site for ECG signal detection in normal healthy subjects. Further studies are needed to validate this new ECG detection modality also in case of cardiac arrhythmias and to support the development of new wearable devices.

Rates of cardiac pacemaker implantation rise with age, and, meanwhile, elderly patient may be at great risk of complications, as pneumothorax, lead perforation, or pocket dehiscence. The use of leadless pacemaker could overcome peri- and post-procedural complications related to the presence of transvenous leads and pocket. The study aims to investigate feasibility and outcomes of Micra Transcatheter Pacing System (M-TPS) implantation in elderly, which represents a challenge for conventional cardiac pacing. Between May 2014 and July 2019, 109 patients (88 males, mean age 77.71±9.68 years) underwent M-TPS implantation at our Center, targeting a non-apical site of delivery when feasible. Study population was divided into two groups according to age (group 1 <79 years vs group 2 group 2 ≥80 years). The outcome evaluation included electrical performance at hospital discharge, and during follow-up. In 46/109 cases (34 males, 73.91%) M-TPS was implanted in patients older than 80 years. There were no statistically significant differences between groups for demographics characteristics, except for age. The procedure was performed via the right femoral access in 102/109 cases and was successful in all cases, with no device-related events. No differences were observed between groups in procedure duration, single device delivery, electrical performance at implant and at 12 month F-U. MTP-S implant is an effective and safe procedure in elderly patients, with similar electrical performance and outcome compared with younger patients at mid-term follow-up.

Aims: Optimal management of redundant or malfunctioning leads is controversial. We aimed to assess safety and efficacy of mechanical transvenous lead extraction (TLE) in patients with abandoned leads., Methods and Results: Consecutive TLE procedures performed in our centre from January 2009 to December 2017 were considered. We evaluated the safety and efficacy of mechanical TLE in patients with abandoned (Group 1) compared to non-abandoned (Group 2) leads. We analysed 1210 consecutive patients that required transvenous removal of 2343 leads. Group 1 accounted for 250 patients (21%) with a total of 617 abandoned leads (26%). Group 2 comprised 960 patients (79%) with 1726 leads (74%). The total number of leads (3.0 vs. 2.0), dwelling time of the oldest lead (108.00 months vs. 60.00 months) and infectious indications for TLE were higher in Group 1. Clinical success was achieved in 1168 patients (96.5%) with a lower rate in Group 1 (90.4% vs. 98.1%; P < 0.001). Major complications occurred in only 9 patients (0.7%), without significant differences among the two groups. The presence of one or more abandoned leads [odds ratio (OR) 3.47; 95% confidence interval (CI) 1.07-11.19; P = 0.037] and dwelling time of the oldest lead (OR 1.01 for a month; 95% CI 1.01-1.02; P < 0.001) were associated with a higher risk of clinical failure., Conclusion: Transvenous mechanical lead extraction is a safe procedure also in high-risk settings, as patients with abandoned leads. Success rate resulted a bit lower, especially in the presence of abandoned leads with long implantation time., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Background: Managing elderly patients with infection or malfunction deriving from a cardiac implantable electronic device (CIED) may be challenging. The aim of this study was to evaluate safety and efficacy of mechanical transvenous lead extraction (TLE) in elderly patients., Methods: Patients who had undergone TLE in single tertiary referral center were divided in two groups (group 1: ≥ 80 years; group 2: < 80 years) and their acute and chronic outcomes were compared. All patients were treated with manual traction or mechanical dilatation., Results: Our analysis included 1316 patients (group 1: 202; group 2: 1114 patients), with a total of 2513 leads extracted. Group 1 presented more comorbidities, more pacemakers than implantable cardioverter-defibrillators, whereas the dwelling time of the oldest lead and the number of leads were similar, irrespective of patient's age. In group 1, the radiological success rate for lead was higher (99.0% vs 95.9%; P < .001) and the fluoroscopy time lower (13.0 vs 15.0 min; P = .04) than in group 2. Clinical success was reached in 1273 patients (96.7%), without significant differences between groups (group 1: 98.0% vs group 2: 96.4%; P = .36). Major complications occurred in 10 patients (0.7%) without significative differences between patients with more or less than 80 years (group 1: 1.5% vs group 2: 0.6%; P = .24) and with no procedure-related deaths in elderly group., Conclusions: Mechanical TLE in elderly patients is a safe and effective procedure. In the over-80s, a comparable incidence of major complications with younger patients was observed, with at least a similar efficacy of the procedure., (© 2020 Wiley Periodicals, Inc.)

Introduction: Increasing device implantations, patient comorbidities, and longer life expectancy contribute to an increased need for lead extraction. Even if transvenous lead extraction (TLE) is a highly successful procedure, some serious procedural complications are reported. In order to identify those patients who are at higher risk, risk stratification scores were proposed. Areas covered: The major obstacles to lead extractions are represented by the body's response to the foreign implanted material and by the following development of fibrotic reaction between the lead and the vascular system. Several clinical factors and device features are associated with major complications and worse outcomes. Although different multiparametric scores predicting the safety and the efficacy of TLE procedures were reported, none of these scores were prospective evaluated. Expert commentary: A correct risk stratification is needed in order to refer complex patients to centers with proven experience and avoid futile procedures. Furthermore, the identification of high-risk patients allows to perform the extraction procedure in the operating room instead of electrophysiology lab. Albeit some risk scores able to predict adverse event in cardiac lead extraction were described, there are still several limitations to their use and reproducibility.