Transvenous pacing in pediatric patients with bipolar lumenless lead: Ten-year clinical experience.

INTRODUCTION: A number of challenges can affect long-term performance of endocardial implanted systems in pediatric patients. Select Secure™ lead offers potential advantages for this population. This analysis aims to evaluate long-term performance of this lead in children, with and without congenital heart disease. METHODS: A retrospective analysis of all patients younger than 16years, implanted with at least one Select Secure™ lead at our institution, was performed. Clinical patient characteristics, electrical lead parameters, implant related complications, occurrence of surgical revisions and other complications were analyzed. RESULTS: From 2006 to 2016, 40 pediatric patients (26 males; age: 10.3±4.6years) underwent a cardiac device implantation with at least one Select Secure™ lead. Axillary vein access was chosen in 77.5% of the procedures. The intra-atrial loop of the leads was successfully created and the generator was placed in a sub-pectoral pocket in all patients. A total of 57 Select Secure™ leads were implanted: 23 in the right atrium and 34 in the right ventricle. PM/ICDs implantation was uneventful in all 40 patients. One lead, dislodged the day after implantation, was successfully extracted and replaced in the same day. Adequate pacing parameters were achieved during a follow-up of 6±2.9years (range 0.9-10.8years). CONCLUSIONS: In a pediatric population, the Select Secure™ lead used in the axillary vein, the creation of an intra-atrial loop and the placement of the generator in a sub-pectoral pocket ensured a safe implantation of pacemaker or ICD and an effective stimulation at medium-term follow-up.

Effects of simulated altitude (normobaric hypoxia) on cardiorespiratory parameters and circulating endothelial precursors in healthy subjects.

BACKGROUND: Circulating Endothelial Precursors (PB-EPCs) are involved in the maintenance of the endothelial compartment being promptly mobilized after injuries of the vascular endothelium, but the effects of a brief normobaric hypoxia on PB-EPCs in healthy subjects are scarcely studied. METHODS: Clinical and molecular parameters were investigated in healthy subjects (n = 8) in basal conditions (T0) and after 1 h of normobaric hypoxia (T1), with Inspiratory Fraction of Oxygen set at 11.2% simulating 4850 mt of altitude. Blood samples were obtained at T0 and T1, as well as 7 days after hypoxia (T2). RESULTS: In all studied subjects we observed a prompt and significant increase in PB-EPCs, with a return to basal value at T2. The induction of hypoxia was confirmed by Alveolar Oxygen Partial Pressure (PAO2) and Spot Oxygen Saturation decreases. Heart rate increased, but arterial pressure and respiratory response were unaffected. The change in PB-EPCs percent from T0 to T1 was inversely related to PAO2 at T1. Rapid (T1) increases in serum levels of hepatocyte growth factor and erythropoietin, as well as in cellular PB-EPCs-expression of Hypoxia Inducible Factor-1alpha were observed. CONCLUSION: In conclusion, the endothelial compartment seems quite responsive to standardized brief hypoxia, possibly important for PB-EPCs activation and recruitment.

External closed-circuit cooling system for management of patients after device implantation: A feasibility study.

BACKGROUND: In the first 24h after pacemaker or implantable cardioverter/defibrillator (ICD) implantation or replacement, the occurrence of hematoma and pain in the surgically treated region is not infrequent and may result in re-intervention and/or more severe complications, such as infections. Currently, the post-implant phase management is very empiric. The aim of this study was to test the clinical applicability and usefulness of an external close-circuit cooling system for the management of the early post-implant period in patients with high risk of hematoma due to anticoagulant and/or antiplatelet therapy. METHODS: We studied 135 patients (78M; 71±11years) with high risk of hematoma occurrence after pace-maker (63 patients) or ICD (72 patients) implantation or replacement. Immediately after the intervention, a closed-circuit cooling system (CAREPACE™ system, Zamar, Italy) was externally applied on the pre-pectoral region to each patient and maintained for 24h. The system has a compressive pad and a refrigerating circuit in which non-toxic glycolic fluid is pumped. The fluid temperature was set and kept at 5°C for the whole period. RESULTS: The compressive and cooling effect of the system was well tolerated by all the patients at the temperature set. Four patients complained of noise due to machine operation, but in none the treatment was interrupted. The average length of hospital stay was 2.8±0.4days. No clinically significant hematoma was observed at discharge and after one month follow-up visit. CONCLUSIONS: This new system can be used for the management of the early phase after device implantation or replacement and appears clinically useful and well tolerated. Further studies on a larger scale are needed to test the potential reduction of post-intervention complications and the cost-effectiveness of this device.

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.

Manufacturer change and risk of system-related complications after implantable cardioverter defibrillator replacement: physicians' survey and data from the Detect Long-term Complications After Implantable Cardioverter Defibrillator Replacement Registry.

AIMS: Some barriers seem to exist in changing implantable cardioverter defibrillator (ICD) manufacturer at the time of device replacement. We sought to understand the obstacles to changing ICD manufacturer within the cohort of patients enrolled in the Detect Long-term Complications After ICD Replacement Registry. METHODS: We analyzed 784 consecutive ICD/cardiac resynchronization therapy defibrillator (CRT-D) device replacements within a 1.5-year time-frame in 36 Italian centers to evaluate potential factors associated with changing manufacturers and system-related complications. RESULTS: Manufacturer change occurred in 191 patients (24%): 72/211 single-chamber ICDs (34%), 52/210 dual-chamber ICDs (25%) and 67/363 CRT-D (18%, P < 0.0001 vs. single-chamber). Replacement-only procedures were associated with a lower rate of manufacturer change than upgrading procedures (23 vs. 32%, P = 0.02). In the single-chamber/dual-chamber cohort, the only variables associated with manufacturer change were the number of available manufacturers (OR = 1.9; P < 0.0001) and an upgrade procedure (OR = 1.7; P = 0.035), whereas the center volume was associated with maintenance of the same manufacturer (OR = 0.5; P = 0.0172). In the CRT-D group, the number of available manufacturers [OR = 2.9; P < 0.0001, service life below the median value (OR = 2.5; P = 0.0026)], and physiological design (OR = 8.4; P = 0.0048) were associated with manufacturer change. At 6-month follow-up, 17 patients (2.2%) experienced a system complication that was lead-related in all cases; upgrade procedure was the only predictor (hazard ratio = 6.7) of complications. CONCLUSION: At the time of ICD replacement, a manufacturer change occurred in 24% of patients and it was less likely in CRT-D devices, which are equipped with more specific technology and less frequently require the addition of features. System-related complications are strongly associated to upgrade procedures rather than to manufacturer change.

Intermuscular pocket for subcutaneous implantable cardioverter defibrillator: Single-center experience.

The subcutaneous implantable cardioverter defibrillator (S-ICD) is a novel device now accepted in clinical practice for treating ventricular arrhythmias. In 14 consecutive patients, S-ICD devices were placed in the virtual space between the anterior surface of the serratus anterior muscle and the posterior surface of the latissimus dorsi muscle. During a mean follow up of 9 months, no dislocations, infections, hematoma formations, or skin erosions were observed. Intermuscular implantation of the S-ICD could be a reliable, safe, and appealing alternative to the standard subcutaneous placement.