Critical assessment of complications associated with use of the Pipeline Embolization Device.

BACKGROUND

The Pipeline Embolization Device (PED) has become an important tool in the treatment of complex cerebrovascular pathology since it was approved by the Food and Drug Administration in April 2011.

OBJECTIVE

To determine the overall complication rate (permanent and transient) associated with the use of this new device from a single institution.

METHODS

We retrospectively examined a prospectively maintained database of our patients treated with the PED since its availability to the current time. 126 patients (24 men, 102 women; age range 14-83 years, mean 59.8 years) were treated for a total of 137 intracranial aneurysms, one cervical internal carotid artery dissection, one cervical vertebral artery dissection, and one carotid-cavernous fistula with a total of 217 PEDs (1.72 PED/patient).

RESULTS

A total of 40 complications were experienced by 33 patients in our cohort. Four complications (4/126, 3.2%) in four patients were permanent, resulting in three deaths and one permanent disability. The other 36 complications (28.6%) occurred in 29 patients, all of whom went on to recover completely. The total complication rate associated with the use of the PED was 31.7% (40/126).

CONCLUSIONS

Despite a low rate of permanent complications associated with the PED in this series, the total complication rate was high. This finding supports the conclusion that this device should be reserved for the most challenging aneurysms. Patients should be advised of this higher rate of transient periprocedural complications.

TRIAL REGISTRATION NUMBER

IRB#:14BN027 Q7.