Aims
Background:
The number of patients with cardiac implantable electronic devices (CIEDs) is rising. These individuals are often older, comorbid, and on antiplatelet or anticoagulant therapy, placing them at greater risk of iron deficiency anaemia and gastrointestinal bleeding. Despite two decades of video capsule endoscopy (VCE) use, uncertainty about its safety in CIED carriers persists due to long-standing concerns over electromagnetic interference, limiting access to this valuable diagnostic tool. This study seeks to clarify and reconcile the long-standing disconnect between industry-driven recommendations and the clinical evidence base by synthesising, updating, and critically examining the totality of available data.
Aim:
To assess the safety and diagnostic performance of VCE, among patients with CIEDs being investigated for gastrointestinal bleeding.
Methods
A systematic review was conducted using EMBASE, MEDLINE, and PubMed. A random-effects meta-analysis of proportions, using the Freeman–Tukey double arcsine transformation (FTDT), assessed the following: adverse cardiac events, signal interference, and diagnostic yield
Results
From 275 publications, 18 studies involving 443 patients were included. Transient CIEDs malfunction occurred in 0.9% of cases (4/443), with no clinically significant adverse events. The pooled estimate for cardiac malfunction was 0% (95% CI: 0–1%) for Implantable cardioverter–defibrillators (ICDs) and left ventricular assist devices (LVADs), and 0% (95% CI: 0–6%; I² = 63%) for pacemakers (PM). Signal interference affecting video quality was reported in only 1.8% of patients (8/443), with a pooled rate of 0% (95% CI: 0–2%; I² = 0%). LVADs had a slightly higher interference rate of 1% (95% CI: 0–6%; I² = 25%). The pooled diagnostic yield was 69% (95% CI 58–80; I² = 55.5%), a finding that aligns closely with previously published estimates and reinforces the consistency of results across device types.
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Table 2. Characteristics and Summary Findings of the 18 Included Studies |
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|
Type of device |
Total number of cardiac devices (n) |
VCE brand |
Image transmission inference |
Cardiac malfunction rate |
|
Overall |
443 |
Given Imaging, M2A, MiroCam, Olympus EndoCapsule |
1.8% (8/443) |
0.9% (4/443) |
|
PPM |
172 |
Given Imaging, M2A, MiroCam, Olympus EndoCapsule |
1.7% (3/172) |
2.3% (4/172) |
|
ICD |
79 |
Given Imaging, M2A, MiroCam, Olympus EndoCapsule |
0% |
0% |
|
LVAD |
144 |
Given Imaging, M2A |
4.9% (7/144) |
0% |
|
Other |
48 |
Given Imaging, M2A |
0% |
0% |
Conclusions
This meta-analysis demonstrates that VCE can safely be performed in patients with CIEDs, presenting with anaemia or gastrointestinal bleeding. Adverse events and signal interference were rare, with no major adverse events and no significant compromise in diagnostic yield. These findings support review of existing guidelines to improve outcomes for patients with CIEDs, a population at increased risk of gastrointestinal bleeding.