European experience with a first totally leadless cardiac resynchronization therapy pacemaker system (original) (raw)
Related papers
State of the art of leadless pacing
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 2015
Despite undisputable benefits, conventional pacemaker therapy is associated with specific complications related to the subcutaneous device and the transvenous leads. Recently, two miniaturized leadless pacemakers, Nanostim™ (St. Jude Medical) and Micra™ (Medtronic), which can be completely implanted inside the right ventricle using steerable delivery systems, entered clinical application. The WiCS™-cardiac resynchronisation therapy (CRT) system (wireless cardiac stimulation for CRT, EBR Systems) delivers leadless left ventricular endocardial stimulation for cardiac resynchronization. In addition to obvious cosmetic benefits, leadless pacing systems may have the potential to overcome some complications of conventional pacing. However, acute and long-term complications still remains to be determined, as well as the feasibility of device explantation years after device placement.
JACC: Clinical Electrophysiology, 2019
OBJECTIVES This study sought to assess immediate and short-term performance of the Medtronic Attain Stability Quadripolar 4798 lead (Medtronic, Dublin, Ireland). BACKGROUND Cardiac resynchronization therapy (CRT) is an established treatment for appropriately selected patients with left ventricular (LV) systolic dysfunction. The most common reason for failure to implant a lead is the lack of a suitable epicardial vein, due either to an absent vessel in the target site, an unacceptably high threshold, lead instability, phrenic nerve stimulation, or a combination of reasons. In August 2017, a novel quadripolar active fixation LV lead (Medtronic) was released. This paper reports the initial clinical experience with lead implantation and specifically immediate and short-term pacing parameters across 3 United Kingdom centers. METHODS Consecutive patients eligible for CRT were deemed suitable for this lead. Immediate and short-term lead performance data regarding LV threshold, impedance, and displacement rates were collected at standard pacing checks (1 day, 5 weeks, 3 months, and 9 months post-implantation). RESULTS CRT using this lead was attempted in 82 cases and was successful in 81 cases (98.
Frontiers in Physiology
Leadless left bundle branch area pacing (LBBAP) represents the merger of two rapidly progressing areas in the field of cardiac resynchronisation therapy (CRT). It combines the attractive concepts of pacing the native conduction system to allow more physiological activation of the myocardium than conventional biventricular pacing, with the potential added benefits of avoiding long-term complications associated with transvenous leads via leadless left ventricular endocardial pacing. This perspective article will first review the evidence for the efficacy of leadless pacing in CRT. We then summarise the procedural steps and pilot data for leadless LBBAP, followed by a discussion of the safety and efficacy of this novel technique. Finally, we will examine how further mechanistic evidence may shed light to which patients may benefit most from leadless LBBAP, and how improvements in current experience and technology could promote widespread uptake and expand current clinical indications.
Journal of the American College of Cardiology, 2017
A total of 30% to 40% of patients with congestive heart failure eligible for cardiac resynchronization therapy (CRT) either do not respond to conventional CRT or remain untreated due to an inability or impediment to coronary sinus (CS) lead implantation. The WiSE-CRT system (EBR Systems, Sunnyvale, California) was developed to address this at-risk patient population by performing biventricular pacing via a wireless left ventricular (LV) endocardial pacing electrode. The SELECT-LV (Safety and Performance of Electrodes implanted in the Left Ventricle) study is a prospective multicenter non-randomized trial assessing the safety and performance of the WiSE-CRT system. A total of 35 patients indicated for CRT who had "failed" conventional CRT underwent implantation of an LV endocardial pacing electrode and a subcutaneous pulse generator. System performance, clinical efficacy, and safety events were assessed out to 6 months post-implant. The procedure was successful in 97.1% (n ...
Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study
European heart journal, 2015
Permanent cardiac pacing is the only effective treatment for symptomatic bradycardia, but complications associated with conventional transvenous pacing systems are commonly related to the pacing lead and pocket. We describe the early performance of a novel self-contained miniaturized pacemaker. Patients having Class I or II indication for VVI pacing underwent implantation of a Micra transcatheter pacing system, from the femoral vein and fixated in the right ventricle using four protractible nitinol tines. Prespecified objectives were >85% freedom from unanticipated serious adverse device events (safety) and <2 V 3-month mean pacing capture threshold at 0.24 ms pulse width (efficacy). Patients were implanted (n = 140) from 23 centres in 11 countries (61% male, age 77.0 ± 10.2 years) for atrioventricular block (66%) or sinus node dysfunction (29%) indications. During mean follow-up of 1.9 ± 1.8 months, the safety endpoint was met with no unanticipated serious adverse device even...
EP Europace, 2020
To study the proportion of leadless pacemaker (LL-PM) implants and the factors influencing the choice of LL-PM vs. transvenous pacemaker (TV-PM) across tertiary centres in Europe with routine availability of the LL-PM. A European Heart Rhythm Association (EHRA) prospective snapshot survey using electronically distributed questionnaire sent to participating centres. Participating tertiary cardiac pacing centres prospectively included consecutive patients implanted between November 2018 and January 2019. Questions covered standards of care and policies used for patient management, focusing particularly on the reasons for choosing LL-PM vs. TV-PM. Overall, 21 centres from four countries (France, Netherlands, Spain, and Italy) participated, with eventual data from 798 patients (n = 472, 59% male). With 69 implants, LL-PM represented only 9% of all implants and 36% of the single-chamber pacing group; double-chamber transvenous pacemakers were implanted in 528 patients and biventricular (...