Intra-Aortic Balloon Perforations (Update)
Hazard Update [Health Devices May 1997;26(5):217-9]
In Health Devices
18(12), December 1989, ECRI published a Hazard
Report addressing perforations of intra-aortic balloons (IABs). Although rare, balloon
perforations are a recognized complication of intra-aortic balloon pump (IABP) therapy,
and we continue to receive reports of perforations involving all brands of IABs.
Therefore, we are updating the original Hazard Report to review the causes and possible
serious consequences of IAB perforations, along with methods to minimize their incidence.
Causes of Balloon Perforations
For safe and effective operation, an IAB must be inflated and deflated quickly and must be
insertable through as narrow an arterial sheath as possible. To this end, the balloon membrane of
an IAB is only a few thousandths of an inch thick, making it susceptible to abrasion and
Balloon perforations have several causes. Some patients (especially the
elderly) have tortuous vessels lined with calcified atherosclerotic plaque. In our
experience, IAB perforations can usually be traced to insertion of an IAB through these
vessels and to repeated contact between the IAB and the calcified plaque as the balloon is
inflated and deflated. These actions can cause abrasion and eventual perforation of the
balloon's thin membrane. Other sources of perforation include manufacturing defects and
abrasions and punctures that arise during handling.
Problems Stemming from Balloon Perforations
An IAB perforation can lead to the following problems, either of which can
cause serious injury to the patient:
- The IAB can become trapped within the aorta or
femoral artery. This can occur when enough blood (i.e., several cubic
centimeters) enters the balloon through a perforation to form a hard clot
inside the balloon sufficiently large to prevent the balloon's removal.
- Helium gas can leak into the bloodstream through a perforation in the
balloon, possibly causing a gas embolus. However, this is very uncommon
since 1.) most perforations in an IAB are minute and 2.) during inflation,
the pressure gradient across the balloon membrane is too low to overcome the
large surface tension at the balloon/blood interface. Instead, blood is more
likely to enter the IAB; this happens during deflation, when the pressure
gradient is greater and in the opposite direction.
Minimizing Perforations and Managing Their Complications
Two ways to minimize the incidence of IAB
perforations are to 1) use the correct size balloon and 2) position it
properly. Although IABs are now available in a variety of volumes (e.g., 30, 40,
50 cc), the standard 40 cc IAB is still generally used for all adult patients,
regardless of their size. However, studies(1,2,3) show that
using smaller IABs in shorter patients may reduce the incidence of IAB perforations.
Choosing an IAB to match the size of the patient helps ensure that the
balloon can be properly placed—that is, that the tip of the IAB can be positioned
below the subclavian artery while the proximal portion of the balloon membrane remains in
the descending thoracic aorta and out of the abdominal aorta. This is important, since the
abdominal aorta generally has more calcified plaque than does the descending thoracic
aorta. Proper positioning of the IAB is crucial and should be verified radiographically or
Careful review of the instructions for balloon insertion and
contraindications for use will also keep balloon perforations to a minimum.
Even when perforations do occur, careful observation by clinicians and
immediate investigation of gas leak alarms from an IABP typically prevent serious injury
to the patient. For example, if blood is seen in the extension tubing or in the balloon
catheter, clinicians are instructed to discontinue pumping and remove the balloon
- Choose the balloon size that best matches the size
of the patient (e.g., use smaller balloons for shorter patients).
- Verify proper positioning of the IAB within the
aorta radiographically or fluoroscopically.
- While the IABP is in use, instruct staff to inspect
the entire length of the IAB catheter and extension tubing for the presence
of blood at least every two hours. If blood is seen in the catheter or
tubing, the appropriate clinical staff should take action to safely
discontinue operation and remove the balloon immediately.
- Investigate gas leak alarms from an IABP
- Consider the perforation of any balloon to be a
warning that the patient's vasculature may cause perforations or abrasions
in subsequent balloons. Therefore, if a balloon is perforated during use and
an alternative therapeutic modality is unavailable or ineffective, increase
the IAB catheter and extension tubing inspection frequency to every half
hour for the next balloon that is inserted.
- Have clinicians review balloon insertion instructions before each use to
verify that no changes have been made in the recommended procedure.
- Cohen M, Patel JJ, Dohad S, et al. Pilot prospective evaluation of
counterpulsation with different intra-aortic balloon volumes on cardiac
performance in humans. Cathet Cardiovasc Diagn
- Cox PM, Kellett M, Goran SF, et al. Plaque abrasion and intra-aortic
balloon leak. Chest 1995
- Wolvek S. The hostile environment of the aging human aorta and the
smaller patient--their implications for the intra-aortic balloon.
Perfusion 1994 Mar;9(2):87-94.
- Catheters, Intra-Aortic Balloon [10-725]
- Circulatory Assist Units, Intra-Aortic Balloon [10-846]
Cause of Device-Related Incident
Device factor: Device failure
User errors: Inappropriate reliance on an automated feature; Incorrect clinical use
Support system failures: Failure to train
and/or credential; Use of inappropriate devices
Mechanism of Injury or Death
Embolism (gaseous); Failure to deliver therapy