Publications by authors named "Reinoud Knops"
Background: The growing use of leadless pacemaker (LP) technology requires safe and effective solutions for retrieving and removing these devices over the long term.
Objectives: This study sought to evaluate retrieval and removal of an active helix-fixation LP studied in worldwide regulatory clinical trials.
Methods: Subjects enrolled in the LEADLESS II phase 1 investigational device exemption, LEADLESS Observational, or LEADLESS Japan trials with an attempted LP retrieval at least 6 weeks postimplantation were included.
Uncomplicated Extravascular Implantable Cardioverter-Defibrillator Extraction After 4 Years Dwell Time: A Case Report.
J Cardiovasc Electrophysiol
December 2024
The extravascular implantable cardioverter-defibrillator (EV-ICD) was developed to overcome complications associated with transvenous leads while being able to deliver anti-tachycardia pacing (ATP). The lead is implanted in the substernal space, which makes extraction a cautious procedure. We present a case of a 51-year-old women with a successful EV-ICD extraction after a lead dwell time of 4 years, which is the longest reported.
View Article and Find Full Text PDFInappropriate Therapy and Shock Rates Between the Subcutaneous and Transvenous Implantable Cardiac Defibrillator: A Secondary Analysis of the PRAETORIAN Trial.
Circ Arrhythm Electrophysiol
December 2024
Article Synopsis
- Inappropriate therapy (IAT) is a significant issue associated with implantable cardiac defibrillator (ICD) therapy, particularly highlighted in early subcutaneous ICD (S-ICD) studies which showed high rates of inappropriate shocks (IAS).
- The PRAETORIAN trial, an international study with 849 patients, found no major differences in IAT and IAS rates between S-ICD and transvenous ICD (TV-ICD) groups, as both groups had similar cumulative incidences.
- Key predictors for IAT varied between the two groups, with TV-ICD patients experiencing IAT mainly from supraventricular tachycardias, while S-ICD patients faced issues from cardiac oversensing
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.
Article Synopsis
- The S-ICD was created to eliminate lead-related issues found in the TV-ICD, as it is an external device that sits under the skin rather than using leads inside the body.
- This analysis comes from the PRAETORIAN trial, where patients were randomly assigned to either S-ICD or TV-ICD and assessed for quality of life through various questionnaires at different stages.
- Results showed no significant differences in physical and mental well-being between the groups, but patients who experienced a shock recently reported lower social functioning and emotional health compared to those who did not.
Leadless pacemakers (LPs) are self-contained pacemakers implanted inside the heart, providing a clinical strategy of pacing without pacemaker leads or a subcutaneous pocket. From an experimental therapy first used clinically in 2012, a decade later this technology is an established treatment option. Because of technologic advances and growing evidence, LPs are increasingly being used.
View Article and Find Full Text PDFArticle Synopsis
- - The Aveir DR system is a new type of dual-chamber leadless pacemaker that features separate atrial and ventricular components capable of communicating wirelessly for synchronized heart pacing.
- - A study involving 399 patients showed that the success rates of implant-to-implant (i2i) communication between the atrial and ventricular pacemakers exceeded 90% at all tested intervals over six months.
- - Improvements in communication success were noted, particularly for patients with initial lower success rates, suggesting benefits from reprogramming and device stabilization over time.
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.
Article Synopsis
- The study evaluates the long-term performance and safety of the extravascular implantable cardioverter-defibrillator (EV ICD) after initial findings showed its effectiveness for 6 months.
- A total of 316 patients were enrolled, with a successful implant in 299 cases, experiencing various arrhythmic events that were effectively treated using antitachycardia pacing (ATP) and shocks.
- The results indicated high success rates for both ATP (77.1%) and shock therapy (100%), with low rates of complications and inappropriate shocks over the three-year study period.
Aims: Wearable health technologies are increasingly popular. Yet, wearable monitoring only works when devices are worn as intended, and adherence reporting lacks standardization. In this study, we aimed to explore the long-term adherence to a wrist-worn activity tracker in the prospective SafeHeart study and identify patient characteristics associated with adherence.
View Article and Find Full Text PDFArticle Synopsis
- - This study investigates the relationship between physical activity and the need for implantable cardioverter defibrillator (ICD) therapy in patients with an ICD by analyzing their movement and sleep data collected via wrist accelerometers over 28 days.
- - Among 253 participants, higher inactive durations and specific walking cadences were linked to an increased risk of needing ICD therapy, with a U-shaped relationship observed for inactivity and a linear relationship for cadence and sleep duration.
- - The findings suggest that monitoring daily movement and sleep patterns could help predict the risk of ventricular arrhythmia, highlighting the need for larger studies to further explore the use of these digital biomarkers in clinical risk assessment.
We aimed to identify and characterise behavioural profiles in patients at high risk of SCD, by using deep representation learning of day-to-day behavioural recordings. We present a pipeline that employed unsupervised clustering on low-dimensional representations of behavioural time-series data learned by a convolutional residual variational neural network (ResNet-VAE). Data from the prospective, observational SafeHeart study conducted at two large tertiary university centers in the Netherlands and Denmark were used.
View Article and Find Full Text PDFSudden cardiac death (SCD) remains a pressing health issue, affecting hundreds of thousands each year globally. The heterogeneity among people who suffer a SCD, ranging from individuals with severe heart failure to seemingly healthy individuals, poses a significant challenge for effective risk assessment. Conventional risk stratification, which primarily relies on left ventricular ejection fraction, has resulted in only modest efficacy of implantable cardioverter-defibrillators for SCD prevention.
View Article and Find Full Text PDFIntroduction: Conventional implantable cardioverter-defibrillators (ICDs) and pacemakers carry a risk of pocket- and lead-related complications in particular. To avoid these complications, extravascular devices (EVDs) have been developed, such as the subcutaneous ICD (S-ICD) and leadless pacemaker (LP). However, data on patient or centre characteristics related to the actual adoption of EVDs are lacking.
View Article and Find Full Text PDFBackground: The PRAETORIAN score was developed as an alternative for defibrillation testing after subcutaneous implantable cardioverter-defibrillator implantation to assess 3 aspects of implant position on a bidirectional chest radiograph. The score is validated on a standard standing chest radiograph with arms elevated in the lateral view.
Objective: We aimed to evaluate the effect of different anatomic positions on the PRAETORIAN score.
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.
Article Synopsis
- The study examines the effectiveness of an implantable cardioverter-defibrillator (ICD) for preventing sudden cardiac death in patients with non-ischaemic cardiomyopathy, which is a topic of debate.
- Researchers developed a deep learning model (DEEP RISK) that combines data from cardiac MRI, ECG, and clinical information to predict the risk of dangerous heart rhythms.
- The multimodal DEEP RISK model demonstrated high accuracy in predicting malignant ventricular arrhythmias, with an AUROC of 0.84, outperforming models that used single data types like MRI or ECG alone.
The subcutaneous implantable cardioverter-defibrillator (S-ICD) has emerged as a feasible alternative to the transvenous ICD in the treatment of ventricular tachyarrhythmias in patients without indications for pacing or cardiac resynchronization therapy. Since its introduction, numerous innovations have been made and clinical experience has been gained, leading to its adoption in current practice and preference in certain populations. Moreover, emerging technologies like the extravascular ICD and the combination of the S-ICD with the leadless pacemaker offer new possibilities for the future.
View Article and Find Full Text PDFBackground: 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.
Background: Remote monitoring devices for atrial fibrillation are known to positively contribute to the diagnostic process and therapy compliance. However, automatic algorithms within devices show varying sensitivity and specificity, so manual double-checking of electrocardiographic (ECG) recordings remains necessary.
Objective: The purpose of this study was to investigate the validity of the KardiaMobile algorithm within the Dutch telemonitoring program (HartWacht).
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.
Background: Recent studies suggest that participation in recreational and even competitive sports is generally safe for patients with implantable cardioverter-defibrillators (ICDs). However, these studies included only patients with implanted transvenous ICD (TV-ICD). Nowadays, subcutaneous ICD (S-ICD) is a safe and effective alternative and is increasingly implanted in younger ICD candidates.
View Article and Find Full Text PDFBackground: The PRAETORIAN score estimates the risk of failure of subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy by using generator and lead positioning on bidirectional chest radiographs. The PRospective randomized compArative trial of subcutanEous implanTable cardiOverter-defibrillatoR ImplANtation with and without DeFibrillation Testing (PRAETORIAN-DFT) investigates whether PRAETORIAN score calculation is noninferior to defibrillation testing (DFT) with regard to first shock efficacy in spontaneous events.
Objective: This prespecified subanalysis assessed the predictive value of the PRAETORIAN score for defibrillation success in induced ventricular arrhythmias.
Objective: Data and guidelines are lacking, so implantable cardioverter-defibrillators (ICDs) are often deactivated during labour to prevent inappropriate shocks. This study aimed to ascertain the safety of an activated ICD during labour.
Design: An observational study was performed.