ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing
Cardiac pacing with implantable electronic cardiac devices and transvenous leads has been introduced since 1960 and is considered a safe, effective and low-risk therapy. The most common indications for permanent cardiac pacing are sinus node dysfunction and atrioventricular blocks. In Europe, pacemaker implants exceed 1000 per million inhabitants. The aim of this therapy is not only to improve patients survival but also their quality of life, which is an essential aspect in assessing patients clinical status and prognosis. Nowadays, five types of cardiac pacing are recognised in clinical practice: - Endocardial right chambers pacing: the device is implanted in the subcutaneous subclavian area and it is connected to transvenous leads implanted in the right cardiac chambers, which detect intrinsic electrical activity and stimulate when needed; - Epicardial pacing: this procedure is often performed in conjunction with cardiac surgery; - Cardiac resynchronisation therapy (CRT): it delivers biventricular or left ventricular pacing in order to correct interventricular electromechanical dyssynchrony and to improve cardiac output; - Conduction system pacing: it stimulates the His bundle or the left bundle branch area downstream of the conduction block, in order to restore a physiological electromechanical activation. - Leadless pacing: via a percutaneous approach through a large-calibre vein, leadless device is placed inside the right ventricle. These pacing modalities have different possibilities to restore a normal cardiac electromechanical activation, resulting in different degrees of mechanical efficiency in terms of systolic output and diastolic pressures, with consequent effects on improvement/onset of heart failure and cardiopulmonary performance of our patients. Right ventricular pacing induces a dyssynchronous cardiac activation pattern that can lead to left systolic dysfunction and a consequent increased risk of death related to the development of heart failure. These observations led to the study of alternative cardiac pacing modalities since the 1990s, in order to improve the clinical outcome of patients with symptomatic bradyarrhythmias. The study of pathological ventricular activation due to left bundle-branch block represents the pathophysiological premise of cardiac resynchronisation in patients with systolic dysfunctional heart failure, and constitutes the developmental model for physiological pacing. CRT improves mortality and quality of life in patients with heart failure and reduced left ventricular ejection fraction. Typically left ventricular pacing is achieved by placing a catheter in the posterolateral area through a venous branch of the coronary sinus. Unfortunately, despite several years of experience in this field, clinical non-response to this therapy is observed in between 20% and 40% of patients, mostly due to the inability to reach the appropriate pacing site because of anatomical difficulties/absence of veins in the target area. Recently, conduction system pacing (CSP) has rapidly emerged as an alternative pacing modality to both right ventricular pacing (RVP) and CRT, in order to achieve a more physiological pacing. His bundle pacing (HBP) is considered the physiological pacing "par excellence", but the results in literature show rather frequent technical difficulties due to high pacing thresholds, inadequate ventricular signal amplitude for the detection of intrinsic cardiac activity, low success rate and risk of progression of conduction system pathology in patients with infranodal conduction defects. Left bundle area pacing has more recently emerged as a viable alternative to achieve physiological pacing with haemodynamic parameters similar to those of HBP, but with lower and stable pacing thresholds, ventricular signal amplitude adequate for the detection of intrinsic cardiac activity and high success rate. Several experiences with different pacing systems have been published, mainly single-centre studies with small sample sizes and different definitions of conduction system pacing success. In non-randomised comparative studies, and thus with methodological limitations, clinical superiority over conventional right ventricular pacing, and a substantial efficacy equivalent to CRT in patients with left bundle-branch block, has been shown, creating the preconditions for widespread use of the CSP. Considering, therefore, the widespread use of the latter technique and the high rate of implants that can potentially benefit from physiological pacing, evaluating safety, feasibility, timing and benefits becomes more crucial than ever. Therefore, the goal of this observational study is to evaluate the clinical characteristics of patients undergoing permanent cardiac pacing and to compare procedural efficacy and safety of different implantation approaches in the clinical practice of the participating centres. The contribution of non-fluoroscopic anatomical and electrophysiological reconstruction systems to device implantation procedures will also be evaluated. The investigators will collect clinical and procedural data from patients with an indication for permanent cardiac pacing who have consecutively undergone an implantable electronic device implant procedure at the Electrophysiology Laboratories of the participating centres over a period of 120 months from the time of approval with a follow-up of an equal 120 months. Patients will be classified according to the type of stimulation: 1. Right chambers endocardial pacing; 2. Cardiac resynchronisation therapy; 3. Conduction system pacing: 1. His bundle pacing 2. Left bundle branch area pacing. In addition, the efficacy and safety at 30 days, and the efficacy and safety at 6 and 12 months of the various pacing modalities, will be evaluated. The investigators defined efficacy at 30 days the presence of stable electrical parameters - or, if unstable, not requiring early re-intervention, the absence of cardiovascular hospitalizations and the absence of cardiovascular death. The investigators defined safety at 30 days the absence of procedural complications, such as haematoma requiring re-intervention or with haemoglobin loss >2gr/dl, pneumothorax, pericardial effusion requiring drainage, lead dislocation, cardiac implantable electronic device (CIED) infection or a re-intervention for any cause. Equally, the investigators defined efficacy at 6-12 months the presence of stable electrical parameters - or, if unstable, not requiring re-intervention, the absence of cardiovascular hospitalizations, the absence of cardiovascular death, the occurrence of heart failure, the occurrence or worsening of atrial or ventricular tachyarrhythmias. Therefore, the investigators defined safety at 6-12 months the proper functioning of the device, the absence of infection and the absence of re-intervention for any cause.
Phase
N/ASpan
626 weeksSponsor
University Hospital of FerraraFidenza
Recruiting
Slew Rate As a Predictor for Optimal Lead Fixation
During the implantation of transvenous pacemakers and implantable cardiac defibrillators, the placement of active fixation leads requires the measurement of standard electrical parameters (sensing, impedance, and capture threshold) to identify the optimal pacing site before helix deployment into the cardiac muscle. Selecting the optimal site at the time of implantation is crucial to ensure long-term lead performance and to prevente potential device malfunctions secondary to threshold elevation or sensing reduction. Two additional electrical parameters-slew rate and the current of injury-may aid in selecting the optimal pacing site. However, these parameters have been poorly studied in the literature and exhibit significant differences. While the slew rate is easily measurable, as it is automatically determined by the pacing system analyzer (PSA), the current of injury requires non-standardized, complex, operator-dependent, and time-consuming manual measurements. Additionally, the slew rate can be assessed before helix deployment, whereas the current of injury can only be measured after helix fixation. While the current of injury generally indicates adequate helix fixation, at least in the acute setting, the significance of slew rate in predicting long-term lead stability remains uncertain. The study hypothesis is that the slew rate significantly correlates with sensed electrical activity at 12 months post-implantation and may therefore serve as a predictor of optimal long-term lead fixation and performance. This is a prospective, observational, single-arm, investigator-initiated, multicenter, non-profit cohort study. Four Italian centers are participating: Ospedale di Fidenza, Arcispedale Santa Maria Nuova di Reggio Emilia, Ospedale Civile di Piacenza, and Azienda Ospedaliero-Universitaria di Ferrara. Patients undergoing pacemaker or ICD implantation with active-fixation atrial or ventricular leads, either for pacing or defibrillation, will be enrolled. The lead fixation site (right ventricular apex or septum) and pacing modality (traditional right ventricular pacing or conduction system pacing) will be determined at the physician's discretion. Electrical parameters at implantation-including slew rate, current of injury, sensing, impedance, and capture threshold-will be measured in all participating centers using the same pacing system analyzer (PSA) model (Medtronic, Model 2290). Slew rate, sensing, impedance, and capture threshold will be assessed before and after helix deployment, as well as after lead fixation. The current of injury is defined as an increase in ST-segment elevation of at least 5 mV for ventricular leads and 1 mV for atrial leads compared to baseline in the intracardiac electrogram (EGM). All characteristics of the current of injury-including total intracardiac EGM duration, maximum ST elevation, and maximum ST elevation 80 msec after the first EGM deflection-will be assessed immediately after helix deployment, as the current of injury is a dynamic and time-dependent electrical phenomenon. Following implantation-after device connection and prior to discharge-and throughout the follow-up period, electrical parameters (sensing, impedance, and capture threshold) will be assessed using the device programmer provided by the manufacturer of the implanted device. Follow-up visits are scheduled at 1 and 12 months post-implantation and may be conducted either as in-person ambulatory visits or via remote monitoring, according to the standard clinical practice of each center. During these visits, lead dislodgement and any significant variations in electrical parameters will also be assessed. The total follow-up duration is 12 months from implantation.
Phase
N/ASpan
211 weeksSponsor
Paolo Pastori, MDFidenza
Recruiting
Oxygen-ozone Therapy Plus Antibiotic Therapy in the Treatment of Infections Secondary to Implant of Orthopaedic Devices
This will be an open-label, multicentre, randomized, parallel group study. The study plan will include a screening visit (Visit 1, Day -7/-3) in which patients will be screened on the basis of inclusion/exclusion criteria and clinically evaluated. At the end of the 3-7 days of run-in (Visit 2, Baseline visit, Day 0), patient still eligible will be randomised to one of the two following treatment groups: 1. Oxygen-ozone therapy SIOOT plus antibiotic therapy 2. Antibiotic therapy Patients in both groups will receive oral antibiotic therapy, which will be prescribed at discretion of the Investigator, based on the results of the colture of the swab collected in the target lesion at the screening visit (and later, if needed) and the associated antibiogram. Follow-up visits will be performed after 7 days (Visit 3, Day 7), 14 days (Visit 4, Day 14), 28 days (Visit 5, Day 28) and 42 days (Visit 6, End of study, Day 42) from the start of treatment. A visit window of ± 2 days for the date of Visits 3-5 and of ± 3 days for the date of Visits 6 will be allowed. Patients prematurely discontinued from the study will perform an 'Early termination visit', in which procedures schedule for Visit 6 (End of study, Day 42) will be performed. In case of premature study discontinuation, the Investigator will duly record the reason for premature withdrawal in the appropriate section of the case report form (eCRF). Visit 6, or the 'Early termination Visit' will represent the conclusion of patient's participation in the investigation.
Phase
N/ASpan
106 weeksSponsor
Società Scientifica Internazionale di Ossigeno Ozono TerapiaFidenza
Recruiting