Leadless pacing using the transcatheter pacing system (Micra TPS) in the real world: initial Swiss experience from the Romandie region (original) (raw)
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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 (...
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...
Europace
Aims Since their introduction in 1958, traditional cardiac pacemakers have undergone considerable upgrades over the years, but they continue to have a complication rate of ∼3.8%–12.4%. There are no randomized controlled trials comparing outcomes of leadless pacemakers (LPM) with single-chamber transvenous pacemakers (TV-VVI). The aim is to assess the differences in the procedural complications and in-hospital outcomes between LPM and TV-VVI implants. Methods and results We queried the national inpatient database from 2016 to 2019 to include adult patients undergoing LPM and TV-VVI. Admissions for leadless and single-lead transvenous pacemakers were identified by their appropriate ICD-10 codes. Complications were identified using ICD-10 codes that mostly represent initial encounter. The difference in outcomes was assessed using multivariable logistic regression and 1:1 propensity score matching between the two cohorts. Thirty-five thousand four hundred thirty expanded samples of admi...
Heart rhythm, 2018
Leadless cardiac pacemakers (LCPs) aim to mitigate lead- and pocket-related complications seen with transvenous pacemakers (TVPs). The purpose of this study was to compare complications between the LCP cohort from the LEADLESS Pacemaker IDE Study (Leadless II) trial and a propensity score-matched real-world TVP cohort. The multicenter LEADLESS II trial evaluated the safety and efficacy of the Nanostim LCP (Abbott, Abbott Park, IL) using structured follow-up, with serious adverse device effects independently adjudicated. TVP data were obtained from Truven Health MarketScan claims databases for patients implanted with single-chamber TVPs between April 1, 2010 and March 31, 2014 and more than 1 year of preimplant enrollment data. Comorbidities and complications were identified via International Classification of Diseases, Ninth Revision and Current Procedural Terminology codes. Short-term (≤1 months) and mid-term (>1-18 months) complications were compared between the LCP cohort and ...
Kardiologia Polska, 2021
Permanent cardiac pacing is a recognized method of treatment of patients with sick sinus syndrome and/or atrioventricular conduction disturbances. Implantation of a traditional pacing system with transvenous leads is associated with a risk of complications, such as pneumothorax perforation of cardiac wall or cardiac device-related infection. An alternative method that may be used for permanent cardiac pacing is represented by the leadless pacemaker, implanted directly into the target cardiac chamber. Such devices have been implanted in Poland since 2016, but the number of procedures is limited due to the lack of clear reimbursement rules. The expert panel appointed by the National Consultant in Cardiology and the Executive Board of the Heart Rhythm Section of the Polish Cardiac Society presents a statement on the use of a leadless pacemaker in Polish conditions. The statement present streatment method and results of clinical studies that confirm its safety and efficacy, indications and contraindications for its use, and precise requirements to be fulfilled by the implanting centers.
Heart rhythm, 2017
Device repositioning during Micra leadless pacemaker implantation may be required to achieve optimal pacing thresholds. To describe the natural history of acute elevated Micra versus traditional transvenous lead thresholds METHODS: Micra study VVI patients with threshold data (at 0.24 msec) at implant (n=711) were compared with Capture study patients with de novo transvenous leads at 0.4 msec (n=538). In both cohorts, high thresholds were defined as >1.0V and very-high as >1.5V. Change in pacing threshold (0-6 months) with high (1.0 to ≤1.5V) or very high thresholds (>1.5V) were compared using the Wilcoxon signed rank test. Among 711 Micra patients, 83 (11.7%) had an implant threshold >1.0 V at 0.24 msec. Among 538 Capture patients, 50 (9.3%) had an implant threshold of >1.0 V at 0.40 msec. There were no significant differences in patient characteristics between those with and without an implant threshold >1.0 V, with the exception of LVEF in the Capture cohort (lo...
Safety and Efficacy of Leadless Pacemakers: A Systematic Review and Meta‐Analysis
Journal of the American Heart Association, 2021
Background Leadless pacemaker is a novel technology, and evidence supporting its use is uncertain. We performed a systematic review and meta‐analysis to examine the safety and efficacy of leadless pacemakers implanted in the right ventricle. Methods and Results We searched PubMed and Embase for studies published before June 6, 2020. The primary safety outcome was major complications, whereas the primary efficacy end point was acceptable pacing capture threshold (≤2 V). Pooled estimates were calculated using the Freedman‐Tukey double arcsine transformation. Of 1281 records screened, we identified 36 observational studies of Nanostim and Micra leadless pacemakers, with most (69.4%) reporting outcomes for the Micra. For Micra, the pooled incidence of complications at 90 days (n=1608) was 0.46% (95% CI, 0.08%–1.05%) and at 1 year (n=3194) was 1.77% (95% CI, 0.76%–3.07%). In 5 studies with up to 1‐year follow‐up, Micra was associated with 51% lower odds of complications compared with tra...
Percutaneous Implantation of an Entirely Intracardiac Leadless Pacemaker
New England Journal of Medicine, 2015
BACKGROUND Cardiac pacemakers are limited by device-related complications, notably infection and problems related to pacemaker leads. We studied a miniaturized, fully self-contained leadless pacemaker that is nonsurgically implanted in the right ventricle with the use of a catheter. METHODS In this multicenter study, we implanted an active-fixation leadless cardiac pacemaker in patients who required permanent single-chamber ventricular pacing. The primary efficacy end point was both an acceptable pacing threshold (≤2.0 V at 0.4 msec) and an acceptable sensing amplitude (R wave ≥5.0 mV, or a value equal to or greater than the value at implantation) through 6 months. The primary safety end point was freedom from device-related serious adverse events through 6 months. In this ongoing study, the prespecified analysis of the primary end points was performed on data from the first 300 patients who completed 6 months of follow-up (primary cohort). The rates of the efficacy end point and safety end point were compared with performance goals (based on historical data) of 85% and 86%, respectively. Additional outcomes were assessed in all 526 patients who were enrolled as of June 2015 (the total cohort). RESULTS The leadless pacemaker was successfully implanted in 504 of the 526 patients in the total cohort (95.8%). The intention-to-treat primary efficacy end point was met in 270 of the 300 patients in the primary cohort (90.0%; 95% confidence interval [CI], 86.0 to 93.2, P = 0.007), and the primary safety end point was met in 280 of the 300 patients (93.3%; 95% CI, 89.9 to 95.9; P<0.001). At 6 months, device-related serious adverse events were observed in 6.7% of the patients; events included device dislodgement with percutaneous retrieval (in 1.7%), cardiac perforation (in 1.3%), and pacing-threshold elevation requiring percutaneous retrieval and device replacement (in 1.3%). CONCLUSIONS The leadless cardiac pacemaker met prespecified pacing and sensing requirements in the large majority of patients. Device-related serious adverse events occurred in approximately 1 in 15 patients. (Funded by St. Jude Medical; LEADLESS II ClinicalTrials .gov number, NCT02030418.