INTRODUCTION: A variable proportion of non-responders to cardiac resynchronization therapy (CRT) warrants the search for new approaches to optimize the position of the left ventricular (LV) lead and the CRT device programming. CineECG is a novel ECG modality proposed for the spatial visualization and quantification of myocardial depolarization and repolarization sequences. OBJECTIVE: The present study aimed to evaluate CineECG-derived parameters in different pacing modes and to test their associations with acute hemodynamic responses in CRT patients. METHODS AND RESULTS: CineECG was used to construct the average electrical path within the cardiac anatomy from the 12-lead ECG. CineECG and LV dP/dt max were tested in 15 patients with nonischemic dilated cardiomyopathy and left bundle branch block (QRS: 170 ± 17 ms; LVEF: 26 ± 5.5%) under pacing protocols with different LV lead localizations. The CineECG-derived path directions were computed for the QRS and ST-T intervals for the anteroposterior (Xh), interventricular (Yh), and apicobasal (Zh) axes. In a multivariate linear regression analysis with adjustment for the pacing protocol type, the ST-T path direction Yh was independently associated with the increase in dP/dt max during CRT, [regression coefficient 639.4 (95% confidence interval: 187.9-1090.9), p = 0.006]. In ROC curve analysis, the ST-T path direction Yh was associated with the achievement of a 10% increase in dP/dt max (AUC: 0.779, p = 0.002) with the optimal cut-off > 0.084 (left-to-right direction) with sensitivity 0.67 and specificity 0.92. CONCLUSION: The acute hemodynamic response in CRT patients was associated with specific CineECG repolarization sequence parameters, warranting their further testing as potential predictors of clinical outcomes.
- MeSH
- Action Potentials MeSH
- Bundle-Branch Block * physiopathology therapy diagnosis MeSH
- Time Factors MeSH
- Cardiomyopathy, Dilated physiopathology therapy diagnosis MeSH
- Electrocardiography * MeSH
- Ventricular Function, Left * MeSH
- Hemodynamics * MeSH
- Middle Aged MeSH
- Humans MeSH
- Predictive Value of Tests * MeSH
- Cardiac Resynchronization Therapy Devices MeSH
- Aged MeSH
- Heart Rate MeSH
- Cardiac Resynchronization Therapy * MeSH
- Heart Failure physiopathology therapy diagnosis MeSH
- Stroke Volume MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
BACKGROUND: Aveir DR (Abbott, Abbott Park, IL) is a dual-chamber leadless pacemaker (LP) system with distinct atrial and ventricular LPs (ALP, VLP) that communicate wirelessly to deliver atrioventricular synchronous pacing. Success rates of these implant-to-implant (i2i) transmissions have not been systematically evaluated. OBJECTIVE: This study aims to evaluate chronic i2i success rates in a clinical setting. METHODS: Patients meeting standard dual-chamber pacing indications were enrolled and implanted with dual-chamber LP systems as part of a prospective international clinical trial (Aveir DR i2i Study). The percent of successful i2i transmissions from ALP-to-VLP (A-to-V) and VLP-to-ALP (V-to-A) were interrogated from LPs in de novo patients using the device programmer at implant, discharge, and at 1, 3, and 6 months postimplant (1M, 3M, 6M). RESULTS: A total of 399 patients completed device implant and i2i diagnostic interrogation (62% male; age 69 years; 65% sinus node dysfunction, 32% atrioventricular [AV] block). Median A-to-V and V-to-A i2i success rates exceeded 90% of beats at all time-points from implant to 6M. The minority of patients with A-to-V or V-to-A i2i success in <70% of beats at implant (A-to-V: 19% of patients, V-to-A: 31% of patients) showed roughly 40% improvement by 1M, with this minority dropping to roughly 5% of patients by 6M. Improvement in i2i communication success may be attributed to reprogramming of i2i setting levels, natural changes in dominant posture, and device stabilization. CONCLUSION: Wireless implant-to-implant communication in the new dual-chamber leadless pacemaker system demonstrated successful transmissions in >90% of beats throughout the 6-month evaluation period. Communication success improved significantly over time postimplant for specific subgroups. CLINICAL TRIAL REGISTRATION: Aveir DR i2i Study, ClinicalTrials.gov ID NCT05252702.
- MeSH
- Wireless Technology MeSH
- Equipment Design * MeSH
- Cardiac Pacing, Artificial methods MeSH
- Pacemaker, Artificial * MeSH
- Middle Aged MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Prospective Studies MeSH
- Aged MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
Pole indikací k zavedení kardiostimulátoru pacientovi se stále vylepšuje stejně jako ošetřovatelská péče o pacienta. Protože je celý výkon nyní prakticky rutinní záležitostí kardiologů, celý proces od příjmu pacienta do zdravotnického zařízení až po jeho propuštění se výrazně urychlil. Pacient bez přítomných komplikací nebývá hospitalizován více než 3 dny a celkem se u pacienta vystřídají až tři ošetřovatelské týmy. Pacient prochází předoperační přípravou, perioperační péčí a pooperační péčí. Celý proces obsahuje dílčí kroky, které na sebe navazují, a právě celé toto spektrum výkonů činí tento zákrok velmi rychlým a pacient tak odchází stabilizován, edukován a připraven do života s implantovaným kardiostimulátorem. Tento příspěvek mapuje roli ošetřovatelského týmu a cestu pacienta. Cílem je poukázat na velké množství zásadních úkonů, bez kterých se péče neobejde a které jsou zároveň nutné ke snížení výskytu komplikací. Výsledky studie jsou rozděleny do čtyř zásadních oblastí, které poskytují vhled do celé problematiky, vč. jednotlivých úkonů dispenzarizační péče a edukace pacienta.
The field of indications for implanting a cardiac pacemaker in a patient is constantly improving, as is the patient’s nursing care. Since the entire procedure is now practically routine for cardiologists, the entire process from the patient’s admission to the medical facility to discharge has been significantly accelerated. A patient without complications is usually hospitalized for less than 3 days, and a total of up to three nursing teams take turns for the patient. The patient undergoes pre-operative preparation, peri-operative care, and post-operative care. The entire process includes sub-steps that follow each other, and it is this entire spectrum of procedures that makes this procedure very fast, and the patient leaves stabilized, educated, and ready for life with an implanted pacemaker. This post maps the role of the nursing team and the patient journey. The aim is to point out many essential actions without which care cannot be done and which are also necessary to reduce complications. The results of the study are divided into four fundamental areas that provide insight into the entire issue, including individual actions as well as dispensary care and patient education.
AIMS: A dual-chamber leadless pacemaker (LP) system that employs distinct atrial and ventricular LP devices (ALP, VLP) has been introduced to clinical practice. Proprietary, low-energy, implant-to-implant (i2i) communication at each beat enables the devices to maintain synchronous atrioventricular sensing and pacing. We evaluated device longevities and contributing factors, such as i2i communication. METHODS AND RESULTS: Patients meeting dual-chamber pacing indications received the dual-chamber LP system as part of a prospective, multi-centre, international clinical trial (Aveir DR i2i Study, NCT05252702). Programming and diagnostics were interrogated from all de novo, non-revised, dual-chamber programmed devices at 12 months post-implant. This analysis included 302 patients (65% male; age 70 ± 13 years; weight 80 ± 19 kg; intrinsic heart rate 55 ± 7 bpm; 58% sinus node dysfunction, 27% atrioventricular block). At 12 months, devices were programmed to dual-chamber pacing (DDD(R) or DDI(R)) at a median 60 bpm rate, median 1.25 V pulse amplitude in ALP and 1.5 V in VLP, median 0.4 ms pulse width, and median i2i signal setting level 5 out of 7. Median ALP and VLP remaining battery longevities at 12 months were 4.3 and 9.1 years, with median total ALP and VLP longevities of 5.3 and 9.9 years. Base rate, pulse amplitude, pacing percentage, event rate, impedance, and i2i setting level all exhibited significant correlations with ALP and VLP longevities (P < 0.001). Programming i2i setting levels below 7 produced the greatest longevity savings. CONCLUSION: The first dual-chamber LP demonstrated adequate projected battery longevity after 12 months of use. Patient-specific device programming considerations, unique to leadless devices, may extend longevity.
- MeSH
- Atrioventricular Block therapy diagnosis physiopathology MeSH
- Time Factors MeSH
- Equipment Design MeSH
- Cardiac Pacing, Artificial * methods MeSH
- Pacemaker, Artificial * MeSH
- Middle Aged MeSH
- Humans MeSH
- Prospective Studies MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Arrhythmias, Cardiac * therapy diagnosis physiopathology MeSH
- Heart Rate MeSH
- Treatment Outcome MeSH
- Electric Power Supplies * MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial MeSH
- Multicenter Study MeSH
Up to one-third of patients referred for transcatheter tricuspid valve intervention (TTVI) have a transvalvular pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) lead in place. Both the electrophysiology and interventional cardiology communities have been alerted to the complexity of decision-making in this situation due to potential interactions between the leads and the TTVI material, including the risk of jailing or damage to the leads. This document, commissioned by the European Heart Rhythm Association and the European Association of Percutaneous Cardiovascular Interventions of the ESC, reviews the scientific evidence to inform Heart Team discussions on the management of patients with a PPM or ICD who are scheduled for or have undergone TTVI.
- MeSH
- Heart Valve Prosthesis Implantation * adverse effects standards methods instrumentation MeSH
- Defibrillators, Implantable * standards MeSH
- Pacemaker, Artificial * standards MeSH
- Consensus MeSH
- Humans MeSH
- Risk Factors MeSH
- Cardiac Catheterization * adverse effects standards instrumentation MeSH
- Tricuspid Valve * surgery physiopathology MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Practice Guideline MeSH
BACKGROUND: A dual-chamber leadless pacemaker can provide bradycardia therapy to most patients with pacemaker indications without the complications associated with a lead or pulse generator. We sought to confirm whether previously reported 3-month safety and performance outcomes were sustained through 12 months by determining whether 12-month complication-free and performance success rates exceeded their prespecified performance goals. METHODS: Patients were enrolled in the prospective, single-group Aveir DR i2i Study if they had a standard indication for dual-chamber pacing. Enrolled patients were implanted with an Aveir DR dual-chamber leadless pacemaker system, which comprised 2 communicating leadless pacemakers (1 in the right atrium and 1 in the right ventricle). The primary safety outcome evaluated whether freedom from serious device- or procedure-related events through 365 days exceeded the predetermined performance goal of 76.5%. The primary performance outcome determined whether the composite of atrial capture threshold (≤3.0 V at 0.4 ms) and sensing amplitude (P-wave ≥1.0 mV) at the 12-month visit exceeded the predetermined performance goal of 80.0%. RESULTS: Sites attempted implantation in 300 subjects, where 63.3% had sinus-node dysfunction and 33.3% had atrioventricular block as their primary pacing indication. The primary safety end point was achieved, with a Kaplan-Meier 12-month complication-free rate of 88.6% (95% CI, 84.5-91.8; P<0.001). The primary performance end point was achieved in 92.8% of patients (95% CI, 89.7-95.8; P<0.001). CONCLUSIONS: Both primary safety and performance end points were met after 1 year, demonstrating consistency with previously reported 3-month outcomes of a dual-chamber leadless pacemaker. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05252702.
- MeSH
- Atrioventricular Block * therapy physiopathology MeSH
- Bradycardia * therapy physiopathology diagnosis MeSH
- Time Factors MeSH
- Equipment Design MeSH
- Cardiac Pacing, Artificial * adverse effects methods MeSH
- Pacemaker, Artificial * MeSH
- Middle Aged MeSH
- Humans MeSH
- Prospective Studies MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Heart Rate * MeSH
- Sick Sinus Syndrome * therapy physiopathology diagnosis MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
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. The retrieval success rate was evaluated for all attempted retrievals. Site-reported complications associated with LP retrievals were quantified, with the severity and relationship adjudicated by an independent clinical events committee. RESULTS: There were 1,423 successful LP implants and 234 chronic LP retrieval attempts in 233 subjects. The overall retrieval success rate was 87.6% (205 of 234 attempts). The most common reason for failed retrieval (86.2%, 25 of 29 attempts) was inability to access the LP docking button. The mean time from implantation to attempted retrieval was 3.2 years (range 0.2-9.0 years) and did not significantly influence the retrieval success (P = 0.71). The clinical events committee adjudicated 11 complications in 9 subjects as being retrieval related (3.9%, 9 of 233 subjects). CONCLUSIONS: The safety and efficacy of chronic LP retrieval of an active helix-fixation device was demonstrated in an international clinical trial setting, with implant durations up to 9 years.
- MeSH
- Equipment Design MeSH
- Adult MeSH
- Pacemaker, Artificial * MeSH
- Middle Aged MeSH
- Humans MeSH
- Device Removal * methods MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
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. Herein, the experience gained from a decade of leadless pacing is reviewed. We cover the safety and efficacy of single-chamber LPs, including comparisons with transvenous pacemakers and various models, and the initial clinical results of the first dual-chamber LP system. Furthermore, evidence and considerations regarding the optimal replacement strategy will be covered. Finally, we discuss future device developments that may broaden indications, such as LPs communicating with subcutaneous implantable cardiac defibrillators and energy-harvesting LPs.
- MeSH
- Equipment Design * MeSH
- Cardiac Pacing, Artificial * methods trends MeSH
- Pacemaker, Artificial * trends MeSH
- Humans MeSH
- Arrhythmias, Cardiac therapy MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
- MeSH
- Bundle-Branch Block * therapy MeSH
- Cardiac Pacing, Artificial * methods MeSH
- Pacemaker, Artificial MeSH
- Quality of Health Care MeSH
- Humans MeSH
- Health Care Reform MeSH
- Check Tag
- Humans MeSH
- Publication type
- Newspaper Article MeSH
