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Open Access A Meta-analysis of Major Complications between Traditional Pacemakers and Leadless Pacemakers

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Objectives: We aim to compare the major complications between leadless pacemakers and traditional pacemakers.

Background: Leadless pacemakers, which are increasingly used in clinical practice, have several advantages compared with traditional pacemakers in avoiding pocket- and lead-related complications. However, the clinical effect of leadless pacemakers remains controversial.

Methods: PubMed, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), the CNKI database, and the Wanfang database were searched from July 2013 to December 2019. Studies comparing leadless pacemakers and traditional pacemakers were included. The primary end point was major complications. The secondary end points were cardiac perforation/pericardial effusion, device revision or extraction, loss of device function, and death.

Results: Six studies fulfilled the inclusion criteria. Only four of the six studies reported data on major complications. Leadless pacemakers were associated with a lower incidence of major complications (risk ratio 0.33, 95% confidence interval 0.25‐0.44, P<0.00001, I 2=49%). We extracted data on cardiac perforation/pericardial effusion, device revision or extraction, loss of device function, and death from six studies. Our meta-analysis showed that leadless pacemakers have a higher risk of cardiac perforation or pericardial effusion (risk ratio 4.28, 95% confidence interval 1.66‐11.08, P=0.003, I 2=0%). No statistically significant differences were found for mortality, device revision or extraction, and loss of device function.

Conclusion: Compared with traditional pacemakers, leadless pacemakers have a significantly decreased risk of major complications, but have a higher risk of cardiac perforation or pericardial effusion.

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Keywords: Leadless pacemaker; complication; meta-analysis; traditional pacemaker; treatment effect

Document Type: Research Article

Affiliations: Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing 400010, China

Publication date: February 1, 2021

This article was made available online on November 9, 2020 as a Fast Track article with title: "A Meta-analysis of Major Complications between Traditional Pacemakers and Leadless Pacemakers".

More about this publication?
  • Cardiovascular Innovations and Applications (CVIA) publishes focused articles and original clinical research that explore novel developments in cardiovascular disease, effective control and rehabilitation in cardiovascular disease, and promote cardiovascular innovations and applications for the betterment of public health globally. The journal publishes basic research that has clinical applicability in order to promote timely communication of the latest insights relating to coronary artery disease, heart failure, hypertension, cardiac arrhythmia, prevention of cardiovascular disease with a heavy emphasis on risk factor modification. Cardiovascular Innovations and Applications is the official journal of the Great Wall International Congress of Cardiology (GW-ICC). It aims to continue the work of the GW-ICC by providing a global scientific communication platform for cardiologists that bridges East and West.

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