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Published on: July 18, 2014
Risk factors associated with clinically relevant pericardial effusion after primary cardiac implantable electronic
Yangzhi Zhou1, Saranda Haxha1,2, Andrim Halili1,2
1Department of Cardiology, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.
Insights
Clinically relevant pericardial effusion after cardiac implantable electronic device (CIED) implantation is rare but associated with specific patient and procedure factors. Identifying these risks can improve patient safety during CIED procedures.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Research
Background:
- Pericardial effusion is a known complication of cardiac implantable electronic device (CIED) implantation, potentially leading to cardiac tamponade.
- Limited data exists on risk factors for clinically relevant procedural pericardial effusion following CIED procedures.
Purpose of the Study:
- To identify patient- and procedure-related risk factors associated with clinically relevant procedural pericardial effusion after CIED implantation.
Main Methods:
- Nationwide observational cohort study using data from the Danish Pacemaker Register (2000-2018) on 55,121 patients.
- Clinically relevant procedural pericardial effusion defined as occurring within 90 days of primary CIED procedure.
- Multivariable logistic regression analysis was used to assess risk factors.
Main Results:
- 115 patients (0.21%) were diagnosed with clinically relevant procedural pericardial effusion, requiring pericardiocentesis in 80.9%.
- Risk factors included female sex, heart failure, prior cardiac surgery, CRT-device implantation, tertiary care centers, high procedural volume, atrioventricular block indication, and number of leads implanted.
- Increased odds ratios were observed for female sex (1.49), heart failure (1.54), previous cardiac surgery (1.63), CRT-device (2.05), tertiary centers (1.8), high procedural volume (1.85), AV block (2.37), two leads (2.39), and three leads (4.77).
Conclusions:
- Clinically relevant procedural pericardial effusion is a rare complication post-CIED implantation in Denmark.
- This study identified significant patient and procedural risk factors, aiding in risk stratification and prevention strategies.
Introduction:
Pericardial effusion, a known complication to implantation of cardiac implantable electronic devices (CIED), may cause life-threatening cardiac tamponade. Limited knowledge is available about risk factors for clinically relevant procedural pericardial effusion. The aim is to identify the patient- and procedure-related risk factors associated with clinically relevant procedural pericardial effusion.
Method:
A nationwide observational cohort study based on data on 55 121 patients from the Danish Pacemaker Register between 2000 and 2018. We defined a clinically relevant procedural pericardial effusion related to the implantation if it occurred within 90 days after the primary CIED-procedure. Prespecified risk factors were analysed by multivariable logistic regression models to estimate the association with pericardial effusion.
Results:
There were 115 (0.21%) patients diagnosed with clinically relevant procedural pericardial effusion, with a median age of 75 years and 38.3% were females. Of these, 80.9% lead to a subsequent pericardiocentesis procedure. In adjusted logistic regression analysis, an increased risk of clinically relevant pericardial effusion was associated with female sex (OR:1.49 [95%CI: 1.03-2.16]), heart failure (OR:1.54 [95%CI: 1.06-2.23]), previous cardiac surgery (OR:1.63 [95%CI: 1.05-2.55]), CRT-device (OR:2.05 [95%CI: 1.23-3.41]), tertiary-centres (OR:1.8 [95%CI: 1.18-2.73]), increased procedural volume per year (>1000) (OR:1.85 [95%CI: 1.03-3.30]), indication of device-implantation (atrioventricular block) (OR:2.37 [95CI: 1.45-3.87]), and increasing number of leads implanted (two leads (OR:2.39 [95%CI: 1.43-4.00]), three leads (OR:4.77 [95%CI: 2.50-9.10])).
Conclusion:
Clinically relevant procedural pericardial effusion is a rare complication after CIED-implantation in Denmark. This study reveals important patient- and procedure-related risk factors associated with clinically relevant procedural pericardial effusion.
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