Dataset Information

Efficacy and safety of leadless pacemaker: A systematic review, pooled analysis and meta-analysis.

ABSTRACT:

Background

Leadless pacemakers have been designed as an alternative to transvenous systems which avoid some of the complications associated with transvenous devices. We aim to perform a systematic review of the literature to report the safety and efficacy findings of leadless pacemakers.

Methods

We searched MEDLINE and EMBASE to identify studies reporting the safety, efficacy and outcomes of patients implanted with a leadless pacemaker. The pooled rate of adverse events was determined and random-effects meta-analysis was performed to compare rates of adverse outcomes for leadless compared to transvenous pacemakers.

Results

A total of 18 studies were included with 2496 patients implanted with a leadless pacemaker and success rates range between 95.5 and 100%. The device or procedure related death rate was 0.3% while any complication and pericardial tamponade occurred in 3.1% and 1.4% of patients, respectively. Other complications such as pericardial effusion, device dislodgement, device revision, device malfunction, access site complications and infection occurred in less than 1% of patients. Meta-analysis of four studies suggests that there was no difference in hematoma (RR 0.67 95%CI 0.21-2.18, 3 studies), pericardial effusion (RR 0.59 95%CI 0.15-2.25, 3 studies), device dislocation (RR 0.33 95%CI 0.06-1.74, 3 studies), any complication (RR 0.44 95%CI 0.17-1.09, 4 studies) and death (RR 0.45 95%CI 0.15-1.35, 2 studies) comparing patients who received leadless and transvenous pacemakers.

Conclusion

Leadless pacemakers are safe and effective for patients who have an indication for single chamber ventricular pacing and the findings appear to be comparable to transvenous pacemakers.

SUBMITTER: Darlington D

PROVIDER: S-EPMC8981159 | biostudies-literature | 2022 Mar-Apr

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of leadless pacemaker: A systematic review, pooled analysis and meta-analysis.

Darlington Daniel D Brown Philip P Carvalho Vanessa V Bourne Hayley H Mayer Joseph J Jones Nathan N Walker Vincent V Siddiqui Shoaib S Patwala Ashish A Kwok Chun Shing CS

Indian pacing and electrophysiology journal 20211216 2

<h4>Background</h4>Leadless pacemakers have been designed as an alternative to transvenous systems which avoid some of the complications associated with transvenous devices. We aim to perform a systematic review of the literature to report the safety and efficacy findings of leadless pacemakers.<h4>Methods</h4>We searched MEDLINE and EMBASE to identify studies reporting the safety, efficacy and outcomes of patients implanted with a leadless pacemaker. The pooled rate of adverse events was determ ...[more]

PMID: 34922032

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Project description:BackgroundThe Micra leadless pacemaker (MLP) has been demonstrated to be safe and effective as a substitute for conventional transvenous ventricular pacemakers (TVP). However, its application in the general population is still restricted. The aim of this retrospective study was to assess the safety and efficacy of MLP.MethodsClinical data and device parameters were gathered on every patient receiving MLP implantation between 1 January 2019 and 31 December 2023, in the First Affiliated Hospital of Soochow University. The efficacy of MLP on the primary composite endpoint, atrioventricular (AV) synchrony, hospitalization, and post-implantation quality of life was assessed. Safety outcomes included implantation procedural characteristics, acute and chronic complications, and stability of pacing parameters. Meanwhile, we compared pacing parameters, AV synchrony, and improvement of life quality between patients who had been implanted with the MicraTM VR (Medtronic Micra™ MC1VR01) and Micra™ AV (Medtronic Micra™ MC1AVR1). Multivariate linear regression models were used to unearth potential predictors of echocardiography or electrocardiogram (ECG) parameters on pacing parameters.ResultsA total of 94 patients were included, and implantation was successful in all of the cases. A single patient experienced effusion hours after the implantation, indicating a low rate of both acute and chronic complications. In patients with complete AV block (AVB), Micra AV increased AV synchrony from 23.2%±6.3% to 80.8%±5.7%. After 28 days of implantation, the patients' Minnesota Living with Heart Failure Questionnaire (MLHFQ) score decreased from 27.1±18.6 to 20.0±17.6, and none of them required hospital readmission. Left ventricular end-diastolic diameter (LVEDD, 50.0±6.7 cm), left ventricular end-systolic diameter (LVESD, 32.6±3.9 cm), and ECG R wave in lead V5 (RV5, 1.3±0.6 mV) can be employed for the prediction of pacemaker threshold [0.50 (0.38-0.67) mV], sensing voltage (10.1±4.7 mV), and impedance (785.9±226.4 Ohm) correspondingly.ConclusionsDespite being a small, single-center, retrospective study, our study provided data for assessing the safety and efficacy of MLP. Clinicians and patients can make well-informed therapy decisions by being aware of its benefits and forecasting pacing parameters.

Project description:Vancomycin and teicoplanin are the glycopeptides currently in use for the treatment of infections caused by invasive beta-lactam-resistant gram-positive organisms. We conducted a systematic review and meta-analysis of randomized controlled trials that have compared vancomycin and teicoplanin administered systemically for the treatment of suspected or proven infections. A comprehensive search of trials without year, language, or publication status restrictions was performed. The primary outcome was all-cause mortality. Two reviewers independently extracted the data. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled by using the fixed-effect model (RRs of >1 favor vancomycin). Twenty-four trials were included. All-cause mortality was similar overall (RR, 0.95; 95% CI, 0.74 to 1.21), and there was no significant heterogeneity. In trials that used adequate allocation concealment, the results favored teicoplanin (RR, 0.82; 95% CI, 0.63 to 1.06), while in trials with unknown methods or inadequate concealment, the results favored vancomycin (RR, 3.61; 95% CI, 1.27 to 10.30). The latter trials might have recruited more severely ill patients. No other variable affected the RRs for mortality, including the assessment of glycopeptides administered empirically or for proven infections, neutropenia, the participant's age, and drug dosing. There were no significant differences between teicoplanin and vancomycin with regard to clinical failure (RR, 0.92; 95% CI, 0.81 to 1.05), microbiological failure (RR, 1.24; 95% CI, 0.93 to 1.65), and other efficacy outcomes. Lower RRs (in favor of teicoplanin) for clinical failure were observed with a lower risk of bias and when treatment was initiated for infections caused by gram-positive organisms rather than empirically. Total adverse events (RR, 0.61; 95% CI, 0.50 to 0.74), nephrotoxicity (RR, 0.44; 95% CI, 0.32 to 0.61), and red man syndrome were significantly less frequent with teicoplanin. Teicoplanin is not inferior to vancomycin with regard to efficacy and is associated with a lower adverse event rate than vancomycin.

Dataset Information

Efficacy and safety of leadless pacemaker: A systematic review, pooled analysis and meta-analysis.

Background

Methods

Results

Conclusion

Publications

Efficacy and safety of leadless pacemaker: A systematic review, pooled analysis and meta-analysis.

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