Publications by authors named "Maria-Grazia Bongiorni"

Article Synopsis
  • A new dual chamber leadless pacemaker system utilizes a temperature-based sensor to monitor heart rate response during exercise, focusing on its effectiveness in both the right ventricle and right atrium.
  • An exercise test was conducted 6 weeks post-implant on eligible subjects to evaluate the pacing response of the ventricular and atrial devices, measuring if the rate increased proportionately with metabolic workload.
  • Results showed that both the ventricular and atrial devices had mean rate-response slopes (0.93 and 0.91, respectively) within the acceptable range, indicating that the temperature-based sensor effectively adjusts pacing to meet increased metabolic demands.
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Background: Atrial fibrillation (AF) results in electrical and structural remodeling of the atria, which extent is known to be associated with a higher AF recurrence rate after catheter ablation (CA). Recently, a novel echocardiographic parameter derived from tissue Doppler imaging (TDI) [PA-TDI] has been introduced to assess the total atrial activation time, as a noninvasive surrogate of fibrosis and remodeling. The aim of the study is to investigate the role of PA-TDI interval as a predictor of AF ablation efficacy.

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Article Synopsis
  • * This system uses two leadless devices that communicate with each other instead of traditional wires, which makes it unique in its design.
  • * The paper provides an overview of the dual-chamber pacemaker implantation process, highlighting important steps to ensure safe and efficient procedures.
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Background: A dual-chamber leadless pacemaker system has been designed for atrioventricular synchronous pacing using wireless, beat-to-beat, implant-to-implant (i2i) communication between distinct atrial and ventricular leadless pacemakers. The atrioventricular synchrony achieved across various ambulatory scenarios has yet to be systematically evaluated.

Methods: A prospective, single-arm, unblinded, multicenter, international clinical trial of the leadless pacemaker system was conducted in patients with a conventional dual-chamber pacing indication enrolled from February 2022 to March 2023.

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Background: The subcutaneous implantable cardioverter-defibrillator (ICD) is associated with fewer lead-related complications than a transvenous ICD; however, the subcutaneous ICD cannot provide bradycardia and antitachycardia pacing. Whether a modular pacing-defibrillator system comprising a leadless pacemaker in wireless communication with a subcutaneous ICD to provide antitachycardia and bradycardia pacing is safe remains unknown.

Methods: We conducted a multinational, single-group study that enrolled patients at risk for sudden death from ventricular arrhythmias and followed them for 6 months after implantation of a modular pacemaker-defibrillator system.

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Background: The first dual-chamber leadless pacemaker (DC-LP) system consists of 2 separate atrial and ventricular devices that communicate to maintain synchronous atrioventricular pacing and sensing. The initial safety and efficacy were previously reported.

Objective: The purpose of this study was to evaluate the chronic electrical performance of the DC-LP system.

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Background: Epicardial access is often crucial for successful ventricular tachycardia (VT) ablation, but it is often burdened by significant procedural risk. Intentional coronary vein exit and intrapericardial CO insufflation (EpiCO) can facilitate subxiphoid pericardial access.

Objective: This prospective study aimed to assess procedural feasibility, safety, and impact of the introduction of intrapericardial CO insufflation for epicardial access in a referral center for VT ablation.

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Introduction: Mitral valve prolapse (MVP) is a common clinical condition in the general population. A subgroup of patients with MVP may experience ventricular arrhythmias and sudden cardiac death ("arrhythmic mitral valve prolapse" [AMVP]) but how to stratify arrhythmic risk is still unclear. Our meta-analysis aims to identify predictive factors for arrhythmic risk in patients with MVP.

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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.

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Background: The prognosis for heart failure (HF) patients remains poor, with a high mortality rate, and a marked reduction in quality of life (QOL) and functional status. This study aims to explore the ongoing needs of HF management and the epidemiology of patients followed by Italian HF clinics, with a specific focus on cardiac contractility modulation (CCM).

Research Design And Methods: Data from patients admitted to 14 HF outpatients clinics over 4 weeks were collected and compared to the results of a survey open to physicians involved in HF management operating in Italian centers.

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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).

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Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has demonstrated safety and efficacy for the treatment of malignant ventricular arrhythmias. However, a limitation of the S-ICD lies in the inability to either pace-terminate ventricular tachycardia or provide prolonged bradycardia pacing support.

Objective: The rationale and design of a prospective, single-arm, multinational trial of an intercommunicative leadless pacing system integrated with the S-ICD will be presented.

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This review illustrates the pathophysiological aspects and available scientific evidence on molecular mechanisms about cardiac contractility modulation (CCM) therapy. The main advances in understanding the effect of this electrical therapy at cellular level in the heart are critically discussed in light of the data from clinical trials supporting the use of CCM therapy in patients with heart failure across a wide range of left ventricular ejection fraction values. This electrical therapy triggers a physiological cellular response leading to an improvement of cardiac performance and reverse ventricular remodeling, with no increase in oxygen consumption.

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(1) Background: Infections are among the most frequent and life-threatening complications of cardiovascular implantable electronic device (CIED) implantation. The aim of this study is to compare the outcome and safety of a single-procedure device extraction and contralateral implantation versus the standard-of-care (SoC) two-stage replacement for infected CIEDs. (2) Methods: We retrospectively included 66 patients with CIED infections who were treated at two Italian hospitals.

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Article Synopsis
  • A dual-chamber leadless pacemaker system, involving devices placed in both the right atrium and right ventricle, aims to improve treatment options for patients needing pacemakers without the conventional wiring.
  • In a study of 300 patients, the new system demonstrated high safety, with 90.3% of participants avoiding serious complications within 90 days, which surpassed the target benchmark.
  • The effectiveness of the pacemaker was also confirmed, as 90.2% of patients achieved satisfactory atrial capture and sensing performance, indicating it can reliably support necessary heart functions.
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Introduction: Transcatheter atrial fibrillation (AF) ablation is still carried out with continuous invasive radial arterial blood pressure (IBP) monitoring in many centers. Continuous noninvasive blood pressure (CNBP) measurement using the volume-clamp method is a noninvasive alternative method used in ICU. No data on CNBP reliability are available in the electrophysiology lab during AF ablation, where rhythm variations are common.

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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.

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Article Synopsis
  • * A total of 2,669 patients were followed for about 39 months, revealing that L-PM patients had lower device-related complications overall (0.5% vs. 1.9% at 12 months).
  • * While early complication rates were similar for both types, L-PM had significantly fewer late complications, indicating it could be a safer option for patients.
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Daptomycin pharmacokinetics may not depend on renal function only and it significantly differs between healthy volunteers and severely ill patients. Herein, we propose a population pharmacokinetics model based on 424 plasma daptomycin concentrations collected from 156 patients affected by severe Gram-positive infections during a routine therapeutic drug monitoring protocol. Model building and validation were performed using NONMEM 7.

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Leadless, intracardiac pacemakers are a major innovation in the management of bradyarrhythmia. Both safety and feasibility of leadless pacing have been assessed in acute settings and mid-term follow-up showing a significant reduction of pacing-related complications as compared with standard transvenous pacemakers. There are many advantages of the leadless approach including a reduction of infection risk and malfunction due to the absence of transvenous leads and the pacemaker pocket.

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A 63-year-old man with hypertension and 3-vessel coronary artery disease previously treated with coronary artery bypass graft was admitted to our emergency room complaining of chest pain. He had undergone pacemaker implant 5 months before due to paroxysmal advanced atrioventricular block. Electrocardiography and troponin testing were unremarkable.

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Introduction: Low-voltage activity beyond pulmonary veins (PVs) may contribute to the failure of ablation of atrial fibrillation (AF) in the long term. We aimed to assess the presence of gaps (PVG) and residual potential (residual antral potential [RAP]) within the antral scar by means of an ultra-high-density mapping (UHDM) system.

Methods: We studied consecutive patients from the CHARISMA registry who were undergoing AF ablation and had complete characterization of residual PV antral activity.

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Background: Transvenous lead extraction (TLE) remains a high-risk procedure.

Objective: The purpose of this study was to develop a machine learning (ML)-based risk stratification system to predict the risk of major adverse events (MAEs) after TLE. A MAE was defined as procedure-related major complication and procedure-related death.

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