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Updated: May 3, 2026
Insertion, Maintenance, and Removal of the Percutaneous Dual Lumen Cannula Right Ventricular Assist Device
Published on: July 20, 2022
Increased risk of cardiovascular perforation during ECMO with a bicaval, wire-reinforced cannula
Sidney M Johnson1, Nathan Itoga2, Gwendolyn M Garnett3
1Department of Pediatric Surgery, Kapiolani Medical Center, University of Hawaii, John A. Burns School of Medicine, Honolulu, HI, USA.
Insights
Cardiac perforation during ECMO is a serious risk. This study found the dual lumen bicaval cannula design is associated with higher perforation rates compared to other designs.
Area of Science:
- Cardiovascular Medicine
- Medical Devices
- Patient Safety
Background:
- Cardiac or major vascular perforation is a rare but serious complication of Extracorporeal Membrane Oxygenation (ECMO).
- Understanding risk factors is crucial for improving patient outcomes during ECMO therapy.
Purpose of the Study:
- To investigate the relationship between specific ECMO cannula designs and the incidence of cardiac or major vascular perforation.
- To determine if certain cannula types are associated with a higher risk of perforation.
Main Methods:
- Utilized the Extracorporeal Life Support Organization (ELSO) registry to determine historical rates of hemorrhagic pericardial tamponade.
- Surveyed ELSO centers regarding cannula-related perforations and brands used between January 2008 and March 2012.
- Reviewed the FDA's MAUDE database for adverse events linked to ECMO cannulas.
Main Results:
- The historical rate of hemorrhagic pericardial tamponade in the ELSO registry was 0.53%.
- A survey revealed a 0.74% perforation rate across responding centers, with significantly higher incidence (3.6%) for wire-reinforced bicaval cannulas versus atrial cannulas (0.1%).
- FDA MAUDE database review identified 19 adverse events for bicaval cannulas, 16 involving hemorrhagic pericardial effusions or tamponade.
Conclusions:
- The dual lumen bicaval cannula design is associated with a notably higher rate of cardiac perforation.
- This increased risk may stem from the inherent design of the bicaval cannula or the required inferior vena cava positioning.
Purpose:
Cardiac or major vascular perforation is a rare but serious risk of ECMO. We sought to determine if perforation rates are related to cannula design.
Methods:
We utilized three methods to evaluate perforation on ECMO. 1. The ELSO registry was queried to establish the historical rate of hemorrhagic pericardial tamponade. 2. ELSO centers were surveyed regarding cannula related perforation events and brands of cannulas used over a four year time period (January 2008-March 2012). 3. The FDA's MAUDE database was reviewed looking for adverse events related to ECMO cannulas.
Results:
The historical rate of hemorrhagic pericardial tamponade in the ELSO registry was 0.53% (~1985-2010, ELSO registry). In the survey there were eleven reports of cannula-related perforation, 0.74% (11/1482 p-value=0.29) at 7 different ELSO centers with 23 ELSO centers responding (17% response rate). The incidence of perforation was much higher for the wire-reinforced bicaval design 3.6% (10/279) as compared to catheters designed for the atrial position, 0.1% (1/1203, p-value<0.0001). Review of the FDA's MAUDE database revealed 19 adverse events related to the bicaval cannula design, 16 of which were hemorrhagic pericardial effusions or tamponade.
Conclusion:
These findings suggest a relatively high rate of cardiac perforation associated with the dual lumen bicaval cannula. This may be related to inherent differences in cannula design or the IVC positioning required by the design.
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