Right ventricular and tricuspid valve function in patients chronically implanted with leadless pacemakers (original) (raw)
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Journal of Innovations in Cardiac Rhythm Management
The contribution of endocardial cardiac device leads to severe tricuspid regurgitation (TR) has become increasingly recognized. Current strategies for treating cardiac device lead-related TR have limitations. We present a case of a pacemaker-dependent patient with severe TR as a complication of multiple cardiac device leads who underwent laser lead extraction, which was followed by implantation of a dual-chamber pacemaker with a coronary sinus lead for left ventricular pacing and a leadless transcatheter pacemaker for backup right ventricular (RV) pacing. This report represents one of the first cases of a leadless pacemaker implanted for RV backup pacing, highlighting the possibility of future biventricular pacing therapy (with a leadless pacemaker in VVT mode) without endocardial leads crossing the tricuspid valve.
Cureus
Background: Pacing-induced cardiomyopathy (PICM) is a clinical syndrome that is characterized by a drop in the left ventricular ejection fraction (LVEF) due to chronic high-burden right ventricular (RV) pacing. It has been postulated that leadless pacemakers (LPs) cause decreased risk of PICM compared to transvenous pacemakers (TVPs), but the exact risk reduction is unknown. Methods: We performed a single-center retrospective analysis of adults who received an LP or TVP between January 1, 2014, and April 1, 2022, and had echocardiograms before and after the pacemaker implant. This study's outcomes were the RV pacing percentage, change in EF, the need for cardiac resynchronization therapy (CRT) upgrade, and follow-up duration. A Wilcoxon rank-sum test calculated the change in EF. RV time, defined as the duration from pacemaker placement to the follow-up echocardiogram in months multiplied by the RV pacing percentage, served as a surrogate for how long the RV was paced. Results: A total of 614 patients were screened, and 198 patients were included in the study, where 72 received LP and 126 received TVP. The median follow-up was 480 days. The average of the reported RV percentage pacing was 63.43% for LP and 71.30% for TVP (p=0.14). The incidence of PICM and CRT upgrade was 44% and 9.7% in the LP group and 37% and 9.5% in the TVP group (p=0.3 and p>0.9), respectively. After accounting for age, sex, LP versus TVP, atrioventricular nodal ablation, RV pacing percentage, and follow-up duration, univariate analysis showed that RV time was significantly different between the two types of pacemakers (13.54 ± 14.21 months (LP) versus 9.26 ± 13.95 months (TVP), p=0.009). The difference in RV time between patients who underwent CRT upgrade and those who did not was statistically insignificant (12.11 ± 14.47 months (no CRT) versus 9.19 ± 12.00 months (CRT), p=0.5). Conclusions: This analysis demonstrated that the incidence of PICM was high in both groups (44% (LP) versus 37% (TVP)), despite significantly more RV time in patients with LP. There was no difference in CRT upgrade between LP and TVP.
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.
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 ...
Journal of Cardiovascular Electrophysiology, 2020
Background: Leadless pacemakers preclude the need for permanent leads to pace endocardium. However, it is yet to be determined whether a leadless pacemaker of a similar design to those manufactured for the right ventricle (RV) fits within the left ventricle (LV) without interfering with intracardiac structures. Methods: Cardiac computed tomography scans were obtained from 30 patients indicated for cardiac resynchronisation therapy upgrade. The mitral valve annulus, chordae tendineae, papillary muscles, and LV endocardial wall were marked in the end-diastolic frame. Intracardiac structures motions were tracked through the cardiac cycle. Two pacemaker designs similar to commercially manufactured leadless systems (Abbott's Nanostim LCP and Medtronic's Micra TPS) as well as theoretical designs with calculated optimal dimensions were evaluated. Pacemakers were virtually placed across the LV endocardial surface and collisions between them and intracardiac structures were detected throughout the cycle. Results: Probability maps of LV intracardiac structures collisions on a 16 segment AHA model indicated possible placement for the Nanostim LCP, Micra TPS, and theoretical designs. Thresholding these maps at 20% chance of collision revealed only about 36% of the endocardial surface remained collision free with the deployment of Micra TPS design. The same threshold left no collision free surface in the case of the Nanostim LCP. To reach at least half of the LV endocardium, the volume of Micra TPS, which is the smaller design, needed to be decreased by 41%. Conclusion: Due to presence of intracardiac structures, placement of leadless pacemakers with dimensions similar to commercially manufactured RV systems would be limited to apical regions.
Complications of leadless vs conventional (lead) artificial pacemakers – a retrospective review
Journal of Community Hospital Internal Medicine Perspectives, 2020
Background: Leadless pacemakers (LPM) are introduced in cardiovascular market with a goal to avoid lead-and pocket-associated complications due to conventional artificial pacemakers (CPM). The comparison of LPM and CPM complications is not well studied at a case by case level. Methods: Comprehensive literature was searched on multiple databases performed from inception to December 2019 and revealed 204 cases that received LPM with a comparison of CPM. The data of complications were extracted, screened by independent authors and analyzed using IBM SPSS Statistics for Windows, Version 22.0 (Armonk, NY: IBM Corp.). Results: The complications of CPM were high in comparison to LPM in terms of electrode dislodgement (56% vs 7% of cases, p-value < .0001), pocket site infection rate (16% vs 3.4%, p-value = 0.02), and a lead fracture rate (8% vs 0%, p-value = 0.04). LPMs had a statistically non-significant two-times high risk of pericardial effusion (8%) compared to CPMs (4%) with a p-value = 0.8. Conclusion: LPMs appear to have a better safety profile than CPMs. There was a low pocket site and lead-related infections in LPM as compared to CPM. However, LPM can have twice the risk of pericardial effusion than CPMs, but this was not statistically significant.