Sex differences in long-term outcomes following transvenous lead extraction.

INTRODUCTION: Transvenous lead extraction (TLE) is generally considered a safe procedure, albeit not without risks. While gender-based disparities have been noted in short-term outcomes following TLE, a notable gap exists in understanding the long-term consequences of this procedure. The objective of this analysis was to investigate sex differences in both acute and long-term outcomes among patients who underwent TLE at a tertiary referral center. METHODS: In this retrospective cohort study, consecutive patients who underwent TLE between January 2014 and January 2016 were enrolled. The primary outcome comprised a composite of all-cause mortality and need for repeated TLE procedures. Secondary outcomes included fluoroscopy time, lead extraction techniques, success rates, and major and minor complications. Results were compared between female and male cohorts. RESULTS: The study population comprised 191 patients (median age, 70 years), 29 (15.2%) being women and 162 men (84.8%). Study groups had similar baseline characteristics. Complete procedural success was achieved in 189 out of 191 patients (99.0%), with no significant difference observed between the two groups (p = .17). No major complications were reported in the total cohort. However, there was a significantly higher incidence of minor complications in women compared to men (17.2% vs. 2.5%, p < .01). Following a median follow-up of 6.5 years, the incidence of the primary composite outcome occurred similarly between the study groups (log-rank p = .68). CONCLUSION: Women who underwent TLE exhibited a significantly higher incidence of minor acute intra- and peri-procedural complications than men. However, no differences in long-term outcomes between genders were observed.

Sex differences among subcutaneous implantable cardioverter-defibrillator recipients: a propensity-matched, multicentre, international analysis from the i-SUSI project.

AIMS: Women have been historically underrepresented in implantable cardioverter-defibrillator (ICD) trials. No data on sex differences regarding subcutaneous ICDs (S-ICD) carriers have been described. Aim of our study was to investigate sex-related differences among unselected S-ICD recipients. METHODS AND RESULTS: Consecutive patients enrolled in the multicentre, international i-SUSI registry were analysed. Comparisons between sexes were performed using a 1:1 propensity matching adjusted analysis for age, body mass index (BMI), left ventricular function, and substrate. The primary outcome was the rate of appropriate shocks during follow-up. Inappropriate shocks and other device-related complications were deemed secondary outcomes. A total of 1698 patients were extracted from the i-SUSI registry; 399 (23.5%) were females. After propensity matching, two cohorts of 374 patients presenting similar baseline characteristics were analysed. Despite similar periprocedural characteristics and a matched BMI, women resulted at lower risk of conversion failure as per PRAETORIAN score (73.4% vs. 81.3%, P = 0.049). Over a median follow-up time of 26.5 [12.7-42.5] months, appropriate shocks were more common in the male cohort (rate/year 3.4% vs. 1.7%; log-rank P = 0.049), while no significant differences in device-related complications (rate/year: 6.3% vs. 5.8%; log-rank P = 0.595) and inappropriate shocks (rate/year: 4.3% vs. 3.1%; log-rank P = 0.375) were observed. After controlling for confounders, sex remained significantly associated with the primary outcome (aHR 1.648; CI 0.999-2.655, P = 0.048), while not resulting predictor of inappropriate shocks and device-related complications. CONCLUSION: In a propensity-matched cohort of S-ICD recipients, women are less likely to experience appropriate ICD therapy, while not showing higher risk of device-related complications. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT0473876.

Ion channel dysfunction and fibrosis in atrial fibrillation: Two sides of the same coin.

BACKGROUND: Atrial fibrillation (AF) is a common heart rhythm disorder that is associated with an increased risk of stroke and heart failure (HF). Initially, an association between AF and ion channel dysfunction was identified, classifying the pathology as a predominantly electrical disease. More recently it has been recognized that fibrosis and structural atrial remodeling play a driving role in the development of this arrhythmia also in these cases. PURPOSE: Understanding the role of fibrosis in genetic determined AF could be important to better comprise the pathophysiology of this arrhythmia and to refine its management also in nongenetic forms. In this review we analyze genetic and epigenetic mechanisms responsible for AF and their link with atrial fibrosis, then we will consider analogies with the pathophysiological mechanism in nongenetic AF, and discuss consequent therapeutic options.

Temporal association between drops in thoracic impedance and malignant ventricular arrhythmia: A longitudinal analysis of remote monitoring trends.

INTRODUCTION: Thoracic impedance (TI) drops measured by implantable cardioverter-defibrillators (ICDs) have been reported to correlate with ventricular tachycardia/fibrillation (VT/VF). The aim of our study was to assess the temporal association of decreasing TI trends with VT/VF episodes through a longitudinal analysis of daily remote monitoring data from ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds). METHODS AND RESULTS: Retrospective data from 2384 patients were randomized 1:1 into a derivation or validation cohort. The TI decrease rate was defined as the percentage of rolling weeks with a continuously decreasing TI trend. The derivation cohort was used to determine a TI decrease rate threshold for a ≥99% specificity of arrhythmia prediction. The associated risk of VT/VF episodes was estimated in the validation cohort by dividing the available follow-up into 60-day assessment intervals. Analyses were performed separately for 1354 ICD and 1030 CRT-D patients. During a median follow-up of 2.0 years, 727 patients (30.4%) experienced 3298 confirmed VT/VF episodes. In the ICD group, a TI decrease rate of >60% was associated with a higher risk of VT/VF episode in a 60-day assessment interval (stratified hazard ratio, 1.42; 95% confidence interval (CI), 1.05-1.92; p = .023). The TI decrease preceded (40.8%) or followed (59.2%) the VT/VF episodes. In the CRT-D group, no association between TI decrease and VT/VF episodes was observed (p = .84). CONCLUSION: In our longitudinal analysis, TI decrease was associated with VT/VF episodes only in ICD patients. Preventive interventions may be difficult since episodes can occur before or after TI decrease.

Leadless pacemaker implantation in dextrocardia with situs viscerum inversus: A case report and literature review.

Leadless pacemaker implantation (LPI) has fewer device complications and reduced chance of infection compared to conventional pacemakers. Dextrocardia with situs viscerum inversus (DC+SVI) is a rare condition, which seldom leads to cardiac complications. However, its presence poses a challenge to operators in cardiac procedures. LPI reports in DC patients are scarce. We report a case of LPI in a DC+SVI patient, followed by a brief but comprehensive literature review.

Permanent his bundle pacing: Description and comparison of four implantation techniques.

INTRODUCTION: Permanent His bundle pacing (HBP) is the most physiological pacing modality, and new implantation systems are now available. The aim of the present study was to describe and compare four different techniques to perform HBP. METHODS AND RESULTS: We included all consecutive patients who underwent a HBP attempt in our initial experience between June 2020 and May 2022. The success and characteristics of the procedure were compared among four implantation techniques: the Biotronik Selectra 3D sheath with Solia S60 lead (Selectra 3D), the Boston Scientific Site Selective Pacing Catheter with Ingevity lead (SSPC), the Abbott steerable stylet locator with Tendril lead (Locator), and the use of a standard stylet manually pre-shaped with a conventional pacing lead (Curved stylet). Ninety-eight patients (median age 79 years [interquartile range, 73-83], 83% men) were identified. The Selectra 3D technique was used in 43 procedures, SSPC in 26, Locator in 18 and Curved stylet in 11. The groups had similar clinical characteristics. Overall, procedural success was achieved in 91 patients (93%) with similar proportions among groups (p = .986). Fluoroscopy and procedural times were 6.0 (4.4-8.5) and 60 (45-75) min, respectively, without significant differences (p = .333 and p = .790). The rate of selective capture, the pacing threshold, and the paced QRS duration were also comparable. There was one pre-discharge HBP lead dislodgment (1%) that required implant revision. CONCLUSION: In our experience, four techniques for HBP achieved comparable results in terms of safety and effectiveness. The availability of different systems may lead to widespread use of physiological pacing.

Lead-related infective endocarditis with vegetations: Prevalence and impact of pulmonary embolism in patients undergoing transvenous lead extraction.

INTRODUCTION: The prevalence and impact of pulmonary embolism (PE) in patients with lead-related infective endocarditis undergoing transvenous lead extraction (TLE) are unknown. METHODS: Twenty-five consecutive patients with vegetations ≥10 mm at transoesophageal echocardiography were prospectively studied. Contrast-enhanced chest computed tomography (CT) was performed before (pre-TLE) and after (post-TLE) the lead extraction procedure. RESULTS: Pre-TLE CT identified 18 patients (72%) with subclinical PE. The size of vegetations in patients with PE did not differ significantly from those without (median 20.0 mm [interquartile range: 13.0-30.0] vs. 14.0 mm [6.0-18.0], p = 0.116). Complete TLE success was achieved in all patients with 3 (2-3) leads extracted per procedure. There were no postprocedure complications related to the presence of PE and no differences in terms of fluoroscopy time and need for advanced tools. In the group of positive pre-TLE CT, post-TLE scan confirmed the presence of silent PE in 14 patients (78%). There were no patients with new PE formation. Large vegetations (≥20 mm) tended to increase the risk of post-TLE subclinical PE (odds ratio 5.99 [95% confidence interval (CI): 0.93-38.6], p = 0.059). During a median 19.4 months follow-up, no re-infection of the implanted system was reported. Survival rates in patients with and without post-TLE PE were similar (hazard ratio: 1.11 [95% CI: 0.18-6.67], p = 0.909). CONCLUSION: Subclinical PE detected by CT was common in patients undergoing TLE with lead-related infective endocarditis and vegetations but was not associated with the complexity of the procedure or adverse outcomes. TLE procedure seems safe and feasible even in patients with large vegetations.

The role of preoperative venography in predicting the difficulty of a transvenous lead extraction procedure.

INTRODUCTION: We hypothesized that an accurate assessment of preoperative venography could be useful in predicting transvenous lead extraction (TLE) difficulty. METHODS AND RESULTS: A dedicated preoperative venogram was performed in consecutive patients with cardiac implantable electronic device who underwent TLE. The level of stenosis was classified as without significant stenosis, moderate, severe, and occlusion. The presence of extensive lead-venous wall adherence (≥50 mm) was also assessed. A total of 105 patients (median age: 71 years; 72% male) with a median of 2 (1-2) leads to extract were enrolled. Preoperative venography showed moderate to severe stenosis in 31 (30%), complete occlusion in 15 (14%), and extensive lead-venous wall adherence in 50 (48%) patients. Complete TLE success was achieved in 103 (98%) patients. A total of 55 (52%) were advanced extractions as they required a powered mechanical and/or laser sheath. They were more prevalent in the group with extensive lead-venous wall adherence (72% vs. 34%, p < .001), while no differences were found between patients with and without venous occlusion. In multivariate analysis, the presence of adherence was a predictor of advanced extraction (odds ratio: 2.89 [1.14-7.32], p = .025). The fluoroscopy time was also significantly longer (14.0 [8.2-18.7] vs. 5.1 [2.1-10.0] min, p < .001). The rate of complications did not differ based on the presence of venous lesions. CONCLUSION: Although procedural success and complication rates were similar, patients with extensive lead-venous wall adherence required a longer fluoroscopy time and were three times more likely to need advanced extraction tools. Conversely, the presence of total venous occlusion had no impact on the procedure complexity.

Hybrid transvenous and surgical approach for the extraction of coronary sinus leads: A case series.

BACKGROUND: Transvenous lead extraction is the standard therapy for cardiac device-related infection. In some patients, however, a hybrid surgical and transvenous approach may be necessary. METHODS AND RESULTS: We present three cases who underwent transvenous lead extraction for an infected CRT-D system. In all cases the CS lead could not be retrieved transvenously due to extensive fibrosis. The lead was successfully extracted through left minithoracotomy in two patients and midline sternotomy in one patient. CONCLUSION: In cases where the coronary sinus lead shows severe fibrosis, a transvenous approach can be used to free the proximal part of the lead, while the distal adhesions can be removed surgically through a limited thoracic incision.

Leadless pacemakers as a new alternative for pacemaker lead-related superior vena cava syndrome: A case report.

Superior vena cava (SVC) syndrome is a rare disease induced by thrombosis and consequent occlusion of SVC, negatively affecting morbidity and mortality. The incidence of SVC syndrome from central venous catheters and pacemaker or defibrillator leads is increasing. Optimal treatment of pacemaker or defibrillator-related SVC syndrome is not well defined. Lead extraction causes mechanical trauma to the vessel wall. In addition, subsequent device implantation on the contralateral side can be an added factor for venous occlusion. The use of leadless pacemakers could be an interesting option to reduce the risk of SVC restenosis after lead extraction. We report a clinical case of PM leads-related SVC syndrome referred to our centers and treated with transvenous lead extraction, leadless pacemaker implantation and subsequent percutaneous angioplasty and stenting of the SVC and left innominate vein.

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.

Transvenous lead extraction in patients with persistent left superior vena cava.

PURPOSE: Predictors of difficulty and complications of transvenous lead extraction (TLE) have been investigated in several studies; however, little is known about the venous anatomical characteristics that can have an impact on procedural outcomes. Among them, the persistent left superior vena cava (PLSVC) is a common anomaly often discovered incidentally during cardiac device implantation and could raise concerns if TLE is indicated. We report technical considerations and outcomes of TLE for two patients with leads implanted via PLSVC. METHODS AND RESULTS: Two cardiac implantable electronic device recipients with isolated PLSVC required TLE due to infective endocarditis in one case and lead failure in the other. In the first case, TLE procedure was performed in a hybrid operating room with minimally invasive video-assisted thoracoscopic monitoring due to the high procedural risk. Two active fixation 20-year-old pacing leads were removed with a relatively short fluoroscopy time. In the second case, we successfully extracted a single-coil active fixation lead without the need of a locking stylet or advanced extraction tools. There were no procedural complications or adverse events at 1-year follow-up. CONCLUSION: TLE procedures for two patients with isolated PLSVC were successfully completed with less difficulty and tools than expected based on the characteristics of the targeted leads. If indicated, TLE in the presence of a PLSVC should be considered in experienced centers.

Circadian periodicity affects the type of ventricular arrhythmias and efficacy of implantable defibrillator therapies.

INTRODUCTION: Factors influencing malignant arrhythmia onset are not fully understood. We explored the circadian periodicity of ventricular arrhythmias (VAs) in patients with implantable cardioverter and cardiac resynchronization defibrillators (ICD/CRT-D). METHODS: Time, morphology (monomorphic/polymorphic), and mode of termination (anti-tachycardia pacing [ATP] or shock) of VAs stored in a database of remote monitoring data were adjudicated. Episodes were grouped in six 4-h timeslots from 00:00 to 24:00. Circadian distributions and adjusted marginal odds ratios (ORs), with 95% confidence interval (CI), were analyzed using mixed-effect models and logit generalized estimating equations, respectively, to account for within-subject correlation of multiple episodes. RESULTS: Among 1303 VA episodes from 446 patients (63% ICD and 37% CRT-D), 120 (9%) self-extinguished, and 842 (65%) were terminated by ATP, 343 (26%) by shock. VAs clustered from 08:00 to 16:00 with 44% of episodes, as compared with 22% from 00:00 to 08:00 (p < .001) and 34% from 16:00 to 24:00 (p = .005). Episodes were more likely to be polymorphic at night with an adjusted marginal OR of 1.66 (CI, 1.15-2.40; p = .007) at 00:00-04:00 versus other timeslots. Episodes were less likely to be terminated by ATP in the 00:00-04:00 (success-to-failure ratio, 0.67; CI, 0.46-0.98; p = .039) and 08:00-12:00 (0.70; CI, 0.51-0.96; p = .02) timeslots, and most likely to be terminated by ATP between 12:00 and 16:00 (success-to-failure ratio 1.42; CI, 1.06-1.91; p = .02). CONCLUSION: VAs did not distribute uniformly over the 24 h, with a majority of episodes occurring from 08:00 to 16:00. Nocturnal episodes were more likely to be polymorphic. The efficacy of ATP depended on the time of delivery.

Atrioventricular synchronous leadless pacemaker: state of art and broadened indications.

Leadless pacemakers (LLPMs) have become a major breakthrough in the management of bradyarrhythmia as an attractive alternative to the standard transvenous pacemakers (TV-PMs). Recently, the introduction of a second-generation LLPMs (Micra AV-MC1AVR1) has expanded pacing modes to obtain atrioventricular (AV) synchronous pacing, providing an interesting alternative in the actual scenario of leadless pacing. Nevertheless, actual reports have highlighted some concerns regarding those devices. In this review, we sought to provide an overview of this technology based on its approval studies and major reports.

Characteristics and outcomes of patients hospitalized for COVID-19 and cardiac disease in Northern Italy.

AIMS: To compare demographic characteristics, clinical presentation, and outcomes of patients with and without concomitant cardiac disease, hospitalized for COVID-19 in Brescia, Lombardy, Italy. METHODS AND RESULTS: The study population includes 99 consecutive patients with COVID-19 pneumonia admitted to our hospital between 4 March and 25 March 2020. Fifty-three patients with a history of cardiac disease were compared with 46 without cardiac disease. Among cardiac patients, 40% had a history of heart failure, 36% had atrial fibrillation, and 30% had coronary artery disease. Mean age was 67 ± 12 years, and 80 (81%) patients were males. No differences were found between cardiac and non-cardiac patients except for higher values of serum creatinine, N-terminal probrain natriuretic peptide, and high sensitivity troponin T in cardiac patients. During hospitalization, 26% patients died, 15% developed thrombo-embolic events, 19% had acute respiratory distress syndrome, and 6% had septic shock. Mortality was higher in patients with cardiac disease compared with the others (36% vs. 15%, log-rank P = 0.019; relative risk 2.35; 95% confidence interval 1.08-5.09). The rate of thrombo-embolic events and septic shock during the hospitalization was also higher in cardiac patients (23% vs. 6% and 11% vs. 0%, respectively). CONCLUSIONS: Hospitalized patients with concomitant cardiac disease and COVID-19 have an extremely poor prognosis compared with subjects without a history of cardiac disease, with higher mortality, thrombo-embolic events, and septic shock rates.

Neglected lead tip erosion: An unusual case of S-ICD inappropriate shock.

A 52-year-old man experienced a subcutaneous implantable cardioverter-defibrillator (S-ICD) inappropriate shock due to electrode tip decubitus. The device, implanted two years before with a three-incision technique, was extracted, and a new electrode was implanted along the contralateral parasternal line with a two-incision technique, in a one-stage procedure. One-year follow-up was eventless. Early S-ICD electrode extraction and reimplantation during the same procedure is effective and should be considered as soon as initial signs of decubitus appear to avoid inappropriate shocks. A two-incision technique should be preferred to reduce the risk of electrode tip decubitus.

Clinical and economic impact of multipoint left ventricular pacing: A comparative analysis from the Italian registry on multipoint pacing in cardiac resynchronization therapy (IRON-MPP).

INTRODUCTION: Early evidence suggests that multipoint left ventricular pacing (MPP) may improve response to cardiac resynchronization therapy (CRT). It is unknown whether this benefit is sustained and cost-effective. We used real-world data to evaluate long-term impact of MPP-ON clinical status, heart failure hospitalizations (HFH) and costs. METHODS: The Italian registry on multipoint left ventricular pacing is a prospective, multicenter registry of patients implanted with MPP-enabled CRT devices. For this analysis, clinical and echocardiographic data were collected through 24 months and compared between patients with (MPP-ON) or without (MPP-OFF) early MPP activation at implant. The total cost of each HFH was estimated with national Italian reimbursement rates. RESULTS: The study included 190 MPP-OFF and 128 MPP-ON patients with similar baseline characteristics. At 1 and 2 years, the MPP-ON group had lower rates of HFH vs MPP-OFF (1-year hazard ratio [HR]: 0.14, P = .0014; 2-year HR: 0.38, P = .009). The finding persisted in a subgroup of patients with consistent MPP activation through follow-up (1-year HR: 0.19; P = .0061; 2-year HR: 0.39, P = .022). Total HFH per-patient costs were lower in the MPP-ON vs the MPP-OFF group at 1 year (€101 ± 50 vs €698 ± 195, P < .001) and 2 years (€366 ± 149 vs €801 ± 203, P = .038). More MPP-ON patients had ≥5% improvement in ejection fraction (76.8% vs 65.4%, P = .025) and clinical composite score (66.7% vs 47.5%, P = .01). CONCLUSIONS: In this multicenter clinical study, early MPP activation was associated with a significant reduction in cumulative HFH and related costs after 1 and 2 years of follow-up.

Predictive role of early recurrence of atrial fibrillation after cryoballoon ablation.

AIMS: The aims of this study were to determine the rate and the predictors of early recurrences of atrial fibrillation (ERAF) after cryoballoon (CB) ablation and to evaluate whether ERAF correlate with the long-term outcome. METHODS AND RESULTS: Three thousand, six hundred, and eighty-one consecutive patients (59.9 ± 10.5 years, female 26.5%, and 74.3% paroxysmal AF) were included in the analysis. Atrial fibrillation recurrence, lasting at least 30 s, was collected during and after the 3-month blanking period. Three-hundred and sixteen patients (8.6%) (Group A) had ERAF during the blanking period, and 3365 patients (Group B) had no ERAF. Persistent AF and number of tested anti-arrhythmic drugs ≥2 resulted as significant predictors of ERAF. After a mean follow-up of 16.8 ± 16.4 months, 923/3681 (25%) patients had at least one AF recurrence. The observed freedom from AF recurrence, at 24-month follow-up from procedure, was 25.7% and 64.8% in Groups A and B, respectively (P < 0.001). ERAF, persistent AF, and number of tested anti-arrhythmic drugs ≥2 resulted as significant predictors of AF. In a propensity score matching, the logistic model showed that ERAF 1 month after ablation are the best predictor of long-term AF recurrence (P = 0.042). CONCLUSION: In patients undergoing CB ablation for AF, ERAF are rare and are a strong predictor of AF recurrence in the follow-up, above all when occur >30 days after the ablation.

The MB score: a new risk stratification index to predict the need for advanced tools in lead extraction procedures.

AIMS: A validated risk stratification schema for transvenous lead extraction (TLE) could improve the management of these procedures. We aimed to derive and validate a scoring system to efficiently predict the need for advanced tools to achieve TLE success. METHODS AND RESULTS: Between November 2013 and March 2018, 1960 leads were extracted in 973 consecutive TLE procedures in two national referral sites using a stepwise approach. A procedure was defined as advanced extraction if required the use of powered sheaths and/or snares. The study population was a posteriori 1:1 randomized in derivation and validation cohorts. In the derivation cohort, presence of more than two targeted leads (odds ratio [OR] 1.76, P = 0.049), 3-year-old (OR 3.04, P = 0.001), 5-year-old (OR 3.48, P < 0.001), 10-year-old (OR 3.58, P = 0.008) oldest lead, implantable cardioverter-defibrillator (OR 3.84, P < 0.001), and passive fixation lead (OR 1.91, P = 0.032) were selected by a stepwise procedure and constituted the MB score showing a C-statistics of 0.82. In the validation group, the MB score was significantly associated with the risk of advanced extraction (OR 2.40, 95% confidence interval 2.02-2.86, P < 0.001) and showed an increase in event rate with increasing score. A low value (threshold = 1) ensured 100% sensibility and 100% negative predictive value, while a high value (threshold = 5) allowed a specificity of 92.8% and a positive predictive value of 91.9%. CONCLUSION: In this study, we developed and tested a simple point-based scoring system able to efficiently identify patients at low and high risk of needing advanced tools during TLE procedures.

Leadless pacemaker: State of the art and incoming developments to broaden indications.

Theleadless pacemaker (LLPM) therapy has been developed in recent years to overcome the transvenous lead and device pocket-related complications. The LLPMs now available are self-contained right ventricular pacemakers and are limited to single-chamber ventricular pacing modality. This literature review deals with the current status of LLPM technology and current areas of clinical applicability. The safety and efficacy outcomes published from randomized clinical trials and real world registries are analyzed and compared with historical conventional transvenous pacemaker data. Furthermore, new pacing modalities and future perspectives to broaden the clinical use and cover most of pacing indications are discussed. Due to the overall safe and effective profile in the short term and intermediate term, also in fragile patients, the LLPM use is constantly growing in daily clinical practice. Actually, it can be considered a landmark innovation, through which a new era of cardiac pacing has begun.