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Lead dwell time10 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.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.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.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.

Atrial fibrillation (AF) is an uncommon arrhythmia in young adults without structural heart disease, and cryoballoon pulmonary vein isolation (CB-PVI) is an important therapeutic strategy for rhythm control in patients with drug-refractory AF. The aim of this analysis was to evaluate efficacy and safety of CB-PVI in a large cohort of young patients in comparison with middle-aged adults in a real-world setting.From 2012 to 2020, a total of 3033 patients with AF underwent CB-PVI and were followed prospectively in the framework of the 1STOP Clinical Service project, involving 34 Italian centers. Out of 3033 total 1STOP project subjects, a subgroup of 1318 patients were defined which included a YOUNG group (age ≤ 45 years; n = 368) and a MIDDLE-AGED group (age 60-65 years; n = 950).The acute success rate of PVI did not differ between the two cohorts (99.9 ± 1.3% vs. 99.8 ± 3.2%, p = 0.415). There was no difference in procedural characteristics, and periprocedural complication rates were similar among the two cohort (1.9% vs. 2.3%, p = 0.646). The 12-month freedom from AF recurrence was 88.9% (95% confidence interval [CI]: 84.7-92.0) in the YOUNG cohort and 85.6% (95% CI: 82.9-88.0) in the MIDDLE-AGED group. At 36-month follow-up, freedom from AF recurrence was 72.4% (65.5%-78.2%) and 71.8% (67.7%-75.6%), respectively with no significant difference among groups (p = 0.550).CB-PVI had similar efficacy and safety in YOUNG and MIDDLE-AGED patients. Younger age did not affect acute procedural results, complication rate, or AF recurrence after a single procedure.

BACKGROUND Recent studies have shown that Evolution RL bidirectional rotational mechanical sheath (Cook Medical,USA) is an effective and safe technique for transvenous lead extraction (TLE). We reported our experience with the bidirectional rotational mechanical tools using a multidisciplinary approach highlighting the value of a joint cardiac surgeon and electrophysiologist collaboration. METHODS The study population comprised 84 patients (77%male;mean age 65±18 years) undergoing TLE.After multidisciplinary evaluation, a combined procedure was considered. RESULTS The main indication for TLE was infection in 54 cases (64%).Overall,152 leads were extracted with a mean implant duration of 94±63 months (range 12-421).Complete procedural success rate, clinical success rate, and lead removal with clinical success rate were 91.6 % (77/84),97.6% (82/84), and 98.6%(150/152), respectively.Eighteen combined procedure were performed in 12 patients (14%), such as "hybrid approach" (n = 2) or TLE concomitant to:1) transcatheter aspiration procedure for large vegetation (n = 8); 2) left ventricular assistance device implantation as bridge to cardiac transplantation (n = 1); 3) permanent pacing with epicardial leads (n = 6); 4) tricuspid valve replacement (n = 1).One major complication (1.2%) and 11 (13%) minor complications were encountered.No injury to the superior vena cava occurred and no procedure-related deaths were reported. During a mean time follow-up of 21±18 months, 17 patients (20%) died.They were more often diabetics (P = 0.02), and they underwent TLE more often for infection (P = 0.004). CONCLUSIONS Our results support the finding that excellent outcomes can be achieved in performing TLE of chronically implanted leads by using the Evolution RL bidirectional rotational mechanical sheath and a multidisciplinary team approach involving both electrophysiologist and cardiac surgeon as first line operators. This article is protected by copyright. All rights reserved.

AngioVac system (AngioDynamics) has already proved to be a useful tool in the treatment of thrombotic and endocarditic formations concerning the venous district. Herein, the AngioVac aspiration system combined with the bidirectional rotational Evolution mechanical sheath lead extraction was used for an effective and safety cardiac-device-related-infective-endocarditis removal in a grown-up congenital heart disease patient through a totally peripheral approach.

BACKGROUND Axillary vein access (AVA) using fluoroscopic landmarks is an effective and safe approach for cardiac implantable electronic devices (CIEDs) implantation. However, it may result in a higher radiation exposure. Ultrasound-guided axillary access (USAA) is an effective alternative technique to conventional subclavian access for CIEDs implantation. Studies comparing USAA and AVA using fluoroscopic landmarks are lacking. The purpose of this study was to compare the safety, efficacy, and radiation exposure data of the USAA approach with the AVA using fluoroscopic landmarks. METHODS The study population included 95 consecutive patients (61% male, median age 78 years [71-85 years]) referred for CIEDs implantation using AVA with fluoroscopic landmark (n = 46) or USAA (n = 49). Baseline characteristics and radiation exposure data (Air-Kerma [mGy], DAP [Gy-cm2 ], fluoroscopy time [seconds], and X-rays emission time [seconds]) were compared according to the technique used for the AVA. RESULTS Axillary vein was successfully accessed in 45 of 49 (92%) patients using ultrasound and in 42 of 46 (91%) patients using fluoroscopic landmarks (P = 1.00). Air-Kerma, DAP, fluoroscopy time, and X-rays emission time were shorter for USAA group compared with AVA using fluoroscopic landmarks (11 mGy [8-20] vs 37 mGy [24-81], P

A 52‐year‐old male with no history of familiar sudden death arrived at our Emergency Department after syncope with loss of consciousness occurred during high fever. The thoracic high‐resolution computed tomography demonstrated bilateral multiple ground‐glass opacities. The nose‐pharyngeal swab resulted positive for SARS‐CoV‐2. The 12‐lead ECG presented a “coved‐type” aspect in leads V1 and V2 at the fourth intercostal space and a first degree atrio‐ventricular block. As soon as the temperature went down, the 12‐lead ECG resumed a normal aspect, maintaining a long PR interval.

BACKGROUND Multipoint pacing (MPP) may improve clinical outcomes in patients with cardiac resynchronization therapy defibrillators (CRT-D), but its impact on battery longevity in a real-world population has not been investigated in large trials. OBJECTIVE Compare projected battery longevity in CRT-D patients with and without MPP during long-term follow-up. METHODS The Italian registry on multipoint left ventricular pacing (IRON-MPP) is a prospective, multicenter registry of patients implanted with MPP-capable CRT-D devices. Projected battery longevity during follow-up was compared for patients with MPP (MPP ON) vs single-site (MPP OFF) left ventricular pacing at CRT-D implantation. A sub-analysis excluded crossover patients with MPP activation or deactivation occurring after implantation. A second sub-analysis excluded patients with a right or left ventricular pacing amplitude >2.5 V. RESULTS Out of 237 CRT-D patients (71 ± 9 years, 81% male) followed for 1.9 ± 0.8 years, 102 (43%) had MPP ON at implantation. Programmed atrial and ventricular outputs and percentage of pacing were similar between groups. MPP was associated with a 0.44 years reduction in projected battery longevity (P = .03) during long-term follow-up. Results were similar for the first and second sub-analyses, with a 0.57 years (P

Permanent His bundle pacing (HBP) has rapidly been adapted into clinical practice in recent years as a physiologic pacing. The 3830 (Medtronic Inc, MN, USA) pacing lead commonly used for HBP is lumenless, and there are limited reports available on extraction of this lead. No data exists on transvenous lead extraction (TLE) of very old HBP lead. Concerns remain about injury to the conduction system during extraction and the lack of lumen for placing a locking stylet for TLE when powered sheaths are required. We reported a unique case of TLE of very old HBP lead (14 years and 3 months) and other two leads, such as passive atrial and passive right ventricular apex backup.

Background The effectiveness of implantable cardioverter-defibrillator (ICD) in the elderly is uncertain, given their competing risk of nonarrhythmic death. Guidelines state that an ICD should be implanted if the expectation of survival is at least 1 year. However, survival is not easy to predict in elderly patients with severe cardiac disease. Aim To assess 12-month survival after ICD implantation in patients aged ≥75 years, to identify predictors of 12-month mortality, and to evaluate the incidence of ICD therapy during follow-up. Methods We retrospectively analyzed all clinical, instrumental, and survival data of patients ≥75 years old who received an ICD in our center from 2000 to 2013. Results We included 127 patients (mean age 78 years). ICD was implanted for primary prevention in 61%. The 12-month survival rate was 87.4%. At both univariate and multivariate analyses, left ventricular ejection fraction (EF) ≤ 25%, and moderate to severe impaired renal function (IRF) independently predicted 12-month mortality that was as high as 45.5% in patients with both risk factors. During a median follow-up of 38 months, 30 patients (23.6%) received ≥1 appropriate ICD interventions, but only 3.1% of shocks occurred during the first year, and none in the subgroup of patients with EF ≤ 25% and IRF. Conclusion Twelve-month survival in elderly patients after ICD implantation is good and the indication for ICD should not be based on age alone. However, the subgroup with EF ≤ 25% and IRF showed a high 12-month nonarrhythmic mortality and did not benefit from ICD implantation.

Background The traditional technique for subcutaneous implantable cardioverter defibrillator (S-ICD) implantation, which involves three incisions and a subcutaneous pocket, is associated with possible complications, including inappropriate interventions. The aim of this prospective multicenter study was to evaluate the efficacy and safety of an alternative intermuscular two-incision technique for S-ICD implantation. Methods The study population included 36 consecutive patients (75% male, mean age 44 ± 12 years [range 20–69]) who underwent S-ICD implantation using the intermuscular two-incision technique. This technique avoids the superior parasternal incision for the lead placement and consists of creating an intermuscular pocket between the anterior surface of the serratus anterior and the posterior surface of the latissimus dorsi muscles instead of a subcutaneous pocket. Results All patients were successfully implanted in the absence of any procedure-related complications with a successful 65-J standard polarity defibrillation threshold testing, except in one, who received a second successful shock after pocket revision. During a mean follow-up of 10 months (range 3–30), no complications requiring surgical revision were observed. At device interrogation, stable sensing without interferences was observed in all patients. Two patients (5.5%) experienced appropriate and successful shock on ventricular fibrillation and in four patients (11%), a total of seven nonsustained self-terminated ventricular tachycardias were correctly detected. No inappropriate interventions were observed. Conclusions Our experience suggests that the two-incision intermuscular technique is a safe and efficacious alternative to the current technique for S-ICD implantation that may help reducing complications including inappropriate interventions and offer a better cosmetic outcome, especially in thin individuals.

BACKGROUND: Atrial fibrillation (AF) ablation outcome is still operator dependent. Ablation Index (AI) is a new lesion quality marker that has been demonstrated to allow acute durable pulmonary vein (PV) isolation followed by a high single-procedure arrhythmia-free survival. This prospective, multicenter study was designed to evaluate the reproducibility of acute PV isolation guided by the AI. METHODS: A total of 490 consecutive patients with paroxysmal (80.4%) and persistent AF underwent first time PV encircling and were divided in four study groups according to operator preference in choosing the ablation catheter (a contact force [ST] or contact force surround flow [STSF] catheter) and the AI setting (330 at posterior and 450 at anterior wall or 380 at posterior and 500 at anterior wall). Radiofrequency was delivered targeting interlesion distance ≤6 mm. RESULTS: The rate of first-pass PV isolation (ST330 90 ± 16%, ST380 87 ± 19%, STSF330 90 ± 17%, STSF380 91 ± 15%, P = .585) was similar among the four study groups, whereas procedure (ST330 129 ± 44 minutes, ST380 144 ± 44 minutes, STSF330 120 ± 72 minutes, STSF380 125 ± 73 minutes, P < .001) and fluoroscopy time (ST330 542 ± 285 seconds, ST380 540 ± 416 seconds, STSF330 257 ± 356 seconds, STSF380 379 ± 454 seconds, P

Laboratorio di Elettrofisiologia Dipartimento di Cardiologia Ospedale Civile di Mirano, Mirano, Italy;†Az. Ospedaliera S. Maria della Misericordia, Udine, Italy; ‡Azienda Ospedaliera Sacro Cuore Don Calabria, Negrar,Italy; §Ospedale Mater Salutis di Legnago, Legnago, Italy; ¶Ospedale Santa Maria del Carmine, Rovereto, Italy

Background Cardiac perforation of the right ventricle (RV) is a rare but potentially life-threatening complication of both pacemaker (PM) and implantable cardioverter defibrillator (ICD) implant. Appropriate management is still uncertain. We assessed the incidence of subacute (24 hours–1 month) or delayed (>1 month) cardiac perforation by RV lead and the results of percutaneous lead extraction. Method The study population included all patients diagnosed with subacute or delayed RV-lead perforation during the period 2007–2013. The incidence of perforation according to device type and fixation mechanism was calculated. The outcome of the percutaneous approach, consisting of lead extraction by simple traction, was assessed. Results Cardiac perforation was diagnosed in 14 (eight females, mean age 71 [range 47–83] years) patients out of 3,815 who received an RV-lead implant (0.4%). The overall incidence of RV-lead perforation was similar between ICD (0.3%) and PM (0.4%) implants (P = 1.0) and between active (0.5%) and passive (0.3%) fixation leads (P = 0.3). All perforating leads were originally placed at the RV apex. Five patients were asymptomatic, but all presented altered lead electrical parameters. Surgical removal of the lead was performed in one patient while in the remaining the leads were successfully extracted by direct manual traction in the absence of any complications. In all patients, new active fixation leads were positioned in the RV septum and the follow-up (42 ± 27 months) was uneventful. Conclusions RV perforation is a rare complication of both PM and ICD implants, regardless of the lead fixation mechanism. In most patients, percutaneous lead extraction is a safe and effective management approach.

Rhythm-Symptom Correlation in Patients on Continuous Monitoring Introduction Correlation between symptoms and atrial fibrillation (AF) episodes after catheter ablation may have clinical relevance, especially for anticoagulation usage. The aim of our project was to analyze the relationship between symptoms and AF recurrences in unselected patients following AF catheter ablation during long-term follow-up. Methods and Results One hundred and forty-three consecutive patients (mean age 59 ± 9 years, 85% male) were implanted with a continuous cardiac monitor (RevealXT, Medtronic Inc., Minneapolis, MN, USA) following first pulmonary vein ablation procedure. Device data were downloaded every 3 months and correlated to patients’ symptom diary. AF was paroxysmal in 55% and persistent in 45%. At a mean follow-up of 14 ± 6 months, 98/143 (69%) patients had at least one AF recurrence. Among these, 53 (54%) reported AF-related symptoms while 45 (46%) were totally asymptomatic. Conversely, 13 (29%) out of 45 patients without AF recurrences reported symptoms. Globally, a significant reduction of symptoms (from 82% at baseline to 44% at last follow-up; P

Safety of Catheter Ablation for Atrial Fibrillation Introduction Despite catheter ablation (CA) becoming an accepted treatment option for symptomatic, drug-resistant atrial fibrillation (AF), safety of this procedure continues to be cause for concern. Aim of the present multicenter registry was to assess the incidence of early CA complications and detect their predictors in a contemporary, unselected AF population Methods and Results From January 1, 2011 to December 31, 2011, data from 2,323 consecutive patients who underwent CA (median age 60 [52–67]; 72.3% male) for AF in 29 Italian centers were collected. All major complications occurring to the patient from admission to 30th postprocedural day were recorded. No procedure-related death was observed. Major complications occurred in 94 patients (4.0%): 50 patients (2.2%) suffered vascular access complications; 12 patients (0.5%) developed cardiac tamponade; 14 patients (0.6%) presented with pericarditis; 5 patients (0.2%) had transient ischemic attack; 4 patients had stroke; 3 patients (0.1%) had phrenic nerve paralysis; 3 patients (0.1%) had hemothorax. Other isolated but serious adverse events were documented in 3 patients (0.1%). Female gender (OR 2.643; 95% CI 1.686–4.143; P < 0.0001) and longer procedural duration (OR 2.195; 95% CI 1.388–3.473; P < 0.001) independently predicted a higher risk of complications. Conclusion Major complications occurred in 4.0% of the CA procedures for AF, with vascular access complications being the most frequent events.

Implantable cardiac monitors (ICMs) continuously monitor the patient's electrocardiogram and perform real-time analysis of the heart rhythm, for up to 36 months. The current clinical use of ICMs involves the evaluation of transitory symptoms of possible arrhythmic origin, such as unexplained syncope and palpitations. Moreover, ICMs can also be used for the evaluation of difficult cases of epilepsy and unexplained falls, though current indications for their application in these sectors are less clearly defined. Finally, the ability of new-generation ICMs to automatically record arrhythmic episodes suggests that these devices could also be used to study asymptomatic arrhythmias, and thus could be proposed for the long-term evaluation of the total (symptomatic and asymptomatic) arrhythmic burden in patients at risk of arrhythmic events. In particular, ICMs may have an emerging role in the management of patients with atrial fibrillation and in those at risk of ventricular arrhythmias. (PACE 2012; 35:1169–1178)

Background and Objectives: The reliability of active-fixation atrial leads has been compared with that of passive-fixation leads; comparisons have also been made between straight and J-shaped screw-in lead systems. However, few data are available on procedural and short-term safety. This retrospective study compared the procedural safety of non-pre-shaped screw-in leads with that of passive- and active-fixation J-shaped leads. Patients and Methods: From January 2004 to January 2010, 1,464 patients underwent new pacemaker/implantable cardioverter-defibrillator implantation. Of these, 915 (study population) received a passive- or active-fixation pre-J-shaped lead, or a straight screw-in atrial lead; the remaining 549 patients, who received only a ventricular lead, were excluded. The three study groups were: Group S-FIX (165 patients, 18%), receiving a straight screw-in atrial lead (postshaped in the right appendage); Group J-PASS (690 patients, 75.4%), receiving a passive-fixation J-shaped atrial lead; and Group J-FIX (60 patients, 6.6%), receiving an active-fixation screw-in J-shaped atrial lead. Procedural and short-term complication rates were analyzed up to 3 months postimplantation. Results: One complication occurred in each group (S-FIX 0.6% vs J-PASS 0.1% vs J-FIX 1.6%, P = 0.3, 0.1, and 0.4, respectively, for each comparison). The rate of atrial lead dislodgement was higher in Group J-PASS than in S-FIX but not J-FIX (Group S-FIX 0 vs Group J-PASS 16 vs Group J-FIX 1 dislodgements; P = 0.04 and 0.7, respectively). Conclusion: Straight screw-in atrial leads, “J-post shaped” in the right appendage, offer better stability than passive-fixation J-shaped leads and display a similarly acceptable safety profile compared with both the J-shaped systems. (PACE 2011; 34:325–330)

Background: The role of pulmonary veins (PV) isolation in patients with persistent atrial fibrillation (AF) is still debated. The aim of this study was to evaluate the adjunctive role of PV isolation in patients with persistent AF who underwent circumferential PV ablation (anatomical approach). Methods: We treated 97 consecutive patients presenting with drug-refractory persistent AF by an anatomical approach (group A, n = 36, mean age = 60 ± 8 years, 29 males) or an integrated approach (group B, n = 61, mean age 59 ± 10 years, 48 males). In all patients, radiofrequency (RF) ablation was performed by means of a nonfluoroscopic navigation system, in order to anatomically create circumferential lines around the PV. In group B, the persistence of PV potentials was ascertained with a multipolar circular catheter. If PV potentials persisted, RF energy targeting the electrophysiological breakthroughs was delivered to disconnect the PV. Past a 2-month period of observation, success was defined as absence of any atrial tachyarrhythmia recurrence lasting >30 seconds. Results: Total procedure duration (220 ± 62 minutes vs 140 ± 43 minutes, P < 0.001), fluoroscopy time (35 ± 15 minutes vs 17 ± 9 minutes, P < 0.001), and RF delivery time (48 ± 22 minutes vs 27 ± 9 minutes, P < 0.001) were significantly longer in group B than in group A. One cardiac perforation occurred in group A. After 15 ± 9.1 months, 21 patients in group A (58%) and 34 patients in group B (56%) were free of atrial tachyarrhythmia recurrence (P = 0.9). Conclusions: In patients with persistent AF, who underwent an anatomical approach, electrophysiological confirmation of PV disconnection significantly increased the fluoroscopy and procedural times, without effect on the long-term outcomes.

Objective: Radiofrequency (RF) ablation at the ostia of the pulmonary veins (PVs) to cure atrial fibrillation (AF) is often followed by early AF recurrence. The aims of this study were to determine the rate of early atrial tachyarrhythmia as recurrence after circumferential anatomical PV ablation; to evaluate whether the early recurrence of atrial tachyarrhythmias correlates with the long-term outcome of ablation; and to identify the predictors of early atrial tachyarrhythmias relapse. Methods: We studied 143 consecutive patients who underwent circumferential anatomical PV ablation. We defined early atrial tachyarrhythmias relapse as the recurrence of atrial tachyarrhythmias during the first 3 months after RF ablation. Results: After a mean follow-up of 18.7 ± 7.2 months, 102/143 patients (71%) were deemed responders to ablation. Atrial tachyarrhythmias relapsed during the first 3 months of follow-up in 65/143 (46%) patients. Patients without early atrial tachyarrhythmias relapse had a higher probability of long-term clinical success than patients with early atrial tachyarrhythmias relapse (95% vs 43%, P < 0.0001). However, patients who relapsed within the first month had 45.5% probability of long-term clinical success. On multivariate analysis, the presence of structural heart disease and the lack of a successful anatomical ablation of all targeted PV were significantly and independently correlated with early atrial tachyarrhythmias relapse. Conclusion: A delayed cure may be expected in almost 50% of patients in whom atrial tachyarrhythmias relapses within the first month after circumferential anatomical PV ablation. The presence of structural heart disease and the lack of a successful anatomical ablation of all targeted PV predict early atrial tachyarrhythmias recurrence.

This case describes a young woman with a manifest left inferoparaseptal accessory pathway and previous history of surgical repair of a defect of the ventricular inlet septum in whom a transient complete AV block occurred during radiofrequency ablation performed from the coronary sinus. The presence of a preexisting surgery related AV block unmasked by anomalous pathway ablation is the more reliable explanation for this case.