Purpose: Reflex syncope is a burdensome disease with considerable repercussions on the quality of life. Tilt training is a therapeutic option, but evidence on this topic is scarce and outdated. Hyperventilation is oftentimes associated with reflex syncope.
View Article and Find Full Text PDFJ Cardiovasc Electrophysiol
December 2024
Background: The leadless Micra AV pacemaker is designed to provide atrioventricular (AV) synchronous tracking by detecting atrial contraction. Detection of the mechanical atrial signals can become challenging at a fast sinus rate.
Objective: The purpose of the study was to evaluate the AV synchronous performance during exercise in outpatients implanted with a Micra AV pacemaker.
Aims: In cardiac device implantation, having both surgical skills and ability to manipulate catheter/lead/wire is crucial. Few cardiologists, however, receive formal surgical training prior to implanting. Skills are mostly acquired directly on-the-job and surgical technique varies across institutions; suboptimal approaches may increase complications.
View Article and Find Full Text PDFBackground: Advances in leadless pacemaker technology have enabled accelerometer-based atrioventricular (AV) synchronous pacing by sensing atrial mechanical contraction.
Objective: The purpose of this study was to report the performance of the Micra AV leadless pacemaker from the worldwide Micra AV post-approval registry (PAR) through 12 months.
Methods: The Micra AV PAR is a prospective, single-arm, observational registry designed to assess the safety and effectiveness of Micra AV in a real-world setting.
Background And Aims: Prior reports have demonstrated a favourable safety and efficacy profile of the Micra leadless pacemaker over mid-term follow-up; however, long-term outcomes in real-world clinical practice remain unknown. Updated performance of the Micra VR leadless pacemaker through five years from the worldwide post-approval registry (PAR) was assessed.
Methods: All Micra PAR patients undergoing implant attempts were included.
Background: Leadless pacemakers (PMs) were recently introduced to overcome lead-related complications. They showed high safety and efficacy profiles. Prospective studies assessing long-term safety on cardiac structures are still missing.
View Article and Find Full Text PDFEur Heart J Cardiovasc Imaging
February 2024
Aims: Left bundle branch pacing (LBBP) has been shown to better maintain electrical synchrony compared with right ventricular pacing (RVP), but little is known about its impact on mechanical synchrony. This study investigates whether LBBP better preserves left ventricular (LV) mechanical synchronicity and function compared with RVP.
Methods And Results: Sixty patients with pacing indication for bradycardia were included: LBBP (n = 31) and RVP (n = 29).
Importance: In cardiac device implant training, there is no common system to objectively assess trainees' ability to perform tasks at predetermined performance levels before in vivo practice; therefore, patients are potentially exposed to risks related to operators' early learning curve.
Objective: To assess the effect on implant performance quality of novel metrics-based simulation training to proficiency (proficiency-based progression [PBP]) vs traditional simulation-based training (SBT).
Design, Setting, And Participants: In this prospective randomized trial, conducted between March 8, 2022 and November 24, 2022, novice implanters were randomized (blinded) 1:1 to participate in an SBT curriculum (procedural knowledge e-learning and in-person simulation training) at an international skills training center, with proficiency demonstration requirements at each training stage for advancing (PBP approach) or without the requirements.
Background: Leadless pacemakers have been developed to avoid some of the complications that are associated transvenous pacemakers. Pericardial effusion is a rare complication of leadless pacemaker implantation, which may result from perforation of the delivery catheter. In this study, we describe preclinical perforation performance of an updated Micra delivery catheter.
View Article and Find Full Text PDFAims: Diagnosis of Long QT syndrome (LQTS) is based on prolongation of the QT interval corrected for heart rate (QTc) on surface ECG and genotyping. However, up to 25% of genotype positive patients have a normal QTc interval. We recently showed that individualized QT interval (QTi) derived from 24 h holter data and defined as the QT value at the intersection of an RR interval of 1,000 ms with the linear regression line fitted through QT-RR data points of each individual patient was superior over QTc to predict mutation status in LQTS families.
View Article and Find Full Text PDFBackground: While prior Micra trials demonstrated a high implant success rate and favorable safety and efficacy results, changes in implant populations and safety over time is not well studied. The objective of this analysis was to report the performance of Micra in European and Middle Eastern patients and compare to the Micra Investigational Device Exemption (IDE) and Micra Post Approval Registry (PAR) studies.
Methods: The prospective, single-arm Micra Acute Performance European and Middle Eastern (MAP EMEA) registry was designed to further study the performance of Micra in patients from EMEA.
Introduction: Micra atrioventricular (AV) provides leadless atrioventricular synchronous pacing by sensing atrial contraction (A4 signal). Real-world operation and reliability of AV synchrony (AVS) assessment using device data have not been described. The purposes of this study were to (1) assess the correlation between AVS and atrial mechanical sensed-ventricular pacing (AM-VP) percentages in patients with permanent high-degree AV block and (2) report on the real-world effectiveness of Micra AV.
View Article and Find Full Text PDFAim: To provide a detailed description of the workflow at our telecardiology centre and to analyse the workload of real-world remote monitoring with the aim to assess the feasibility to outsource this service.
Methods: analysis was conducted on the telecardiology service provided at the University Hospitals of Leuven by extracting patient demographic data, general time usage and detailed information about the type of remote contacts. 10,869 contacts in 948 patients have been included.
Aims: There is limited information on what clinical factors are associated with the development of pericardial effusion after leadless pacemaker implantation. We sought to determine predictors of and to develop a risk score for pericardial effusion in patients undergoing Micra leadless pacemaker implantation attempt.
Methods And Results: Patients (n = 2817) undergoing implant attempt from the Micra global trials were analysed.
Background: Early results from the Micra investigational trial and Micra Post-Approval Registry (PAR) demonstrated excellent safety and device performance; however, outcomes based on anticoagulation (AC) status at implant have not been evaluated.
Objective: The purpose of this study was to report implant characteristics, perforation rate, and vascular-related events based on perioperative oral AC strategy in patients undergoing Micra implant.
Methods: We compared procedure characteristics, major complications, and vascular events, including pericardial effusion, stratified by any adverse event (including major complications, minor complications, and observations) or major complication only according to AC status in the Micra PAR.
Pacing Clin Electrophysiol
October 2021
Background: Cryoballoon ablation (CRYO) for pulmonary vein isolation (PVI) in atrial fibrillation (AF) has become an established treatment option as alternative for radiofrequency catheter ablation (RFCA). As symptom relief is still the main indication for PVI, quality of life (QoL) is a key outcome parameter. This review summarizes the evidence about the evolution of QoL after CRYO.
View Article and Find Full Text PDFEur Heart J Cardiovasc Imaging
September 2021
Aims: Mitral valve prolapse (MVP) causes left ventricular (LV) remodelling even in the absence of significant mitral regurgitation. To evaluate whether apical insertion of the papillary muscle (PM) influences the pattern and severity of MVP-related LV remodelling.
Methods And Results: All MVP patients who underwent CMR at our institution between December 2008 and December 2019 were included, thoroughly reviewed and grouped according to apical/non-apical PM insertion.
Introduction: MARVEL 2 assessed the efficacy of mechanical atrial sensing by a ventricular leadless pacemaker, enabling a VDD pacing mode. The behavior of the enhanced MARVEL 2 algorithm during variable atrio-ventricular conduction (AVC) and/or arrhythmias has not been characterized and is the focus of this study.
Methods: Of the 75 patients enrolled in the MARVEL 2 study, 73 had a rhythm assessment and were included in the analysis.
Background: The feasibility and outcomes of concomitant atrioventricular node ablation (AVNA) and leadless pacemaker implant are not well studied. We report outcomes in patients undergoing Micra implant with concomitant AVNA.
Methods: Patients undergoing AVNA at the time of Micra implant from the Micra Transcatheter Pacing (IDE) Study, Continued Access (CA) study, and Post-Approval Registry (PAR) were included in the analysis and compared to Micra patients without AVNA.
Objectives: This study sought to formulate a predictive model for describing the long-term electrical performance of Micra (Medtronic, Mounds View, Minnesota).
Background: The Micra leadless pacemaker is an alternative ventricular pacing option that avoids the pitfalls of transvenous leads. However, well-defined metrics to predict the long-term electrical performance of the device are lacking.