Table 2.
Procedure-related complications and outcomes of aneurysms treated with the pipeline embolization device
| Reference | Number of IAs | Technical problems | Symptomatic procedure-related complications | Mortality | Number of complete IA occlusion/number assessed | In-construct stenosis/migration | Recanalization after initial occlusion | Functional/symptomatic outcomes |
|---|---|---|---|---|---|---|---|---|
| McAuliffe et al. [15] | 57 | 1 poor deployment | 4 TIAs; 3 transient worsening of mass effect; 1 retroperitoneal hematoma | 0 | 48/56 at 6 mos | 2 stenosis 2 migration | 0 | NA |
| McAuliffe and Wenderoth [14] | 11 | 1 poor deployment | 2 IA ruptures; 1 cerebellar ICH | 2 | 8/9 at 6 mos | 1 stenosis 1 migration | Not mentioned | NA |
| Nelson et al. [16] | 31 | 1 failed deployment | 1 ICA rupture; 1 ischemic infarction | 0 | 28/30 at 6 mos | 1 stenosis | Not mentioned | NA |
| Lubicz et al. [13] | 27 | 9 “minor technical issues” | 1 ICH; 1 SAH (not IA related); 1 retroperitoneal hematoma | 0 | 21/25 at 4–6 mos | 3 stenosis | Not mentioned | All survivors had mRS = 0 |
| De Barros Faria et al. [18] | 23 | 5 “technical issues” | 1 ischemic stroke; 1 retroperitoneal hematoma | 0 | 16/23 at 6 mos | 2 stenosis | 0 | 74 % GOS 4 or 5 |
| Fischer et al. [19] | 101 | 1 failed deployment | 1 IA rupture; 2 ischemic infarctions; 3 ICHs | 2 | 47/90 at 3; 36/49 at 10 mos | 0 | 0 | NA |
| Food and Drug Administrationa [12] | 107 | 1 device failure | 2 ICHs; 3 ischemia infarctions; 1 unknown fatal event | 3 | 78/106 at 6 mos | 1 stenosis | 2 at 12 mos | 6 of 100 assessed worsened; others unchanged or improved |
| Szikora et al. [17] | 19 | 2 failed deployment | 2 ischemic infarctions; 1 embolic occlusion of retinal artery; 1 SAH | 1 | 17/18 at 6 mos | 1 stenosis | Not mentioned | 7 unchanged; 6 of 6 mass effects improved, 5 of 10 headaches improved |
| Lylyk et al. [9] | 63 | 2 failed deployment | 3 worsening of pre-existing cranial nerve palsies due to mass effect; 5 femoral hematomas; 1 contrast allergy | 0 | 62/63 at 12 mos | 7 stenosis | 0 | 54 of 56 assessed were unchanged; 2 improved |
| Food and Drug Administration [20] | 8 | 0 | 1 fatal ICH, 1 femoral pseudoaneurysm, 2 retroperitoneal hematomas | 1 | 5/6 at 6 mos | 0 | Not mentioned | NA |
| Total | 447 | 23 | 3 IA ruptures; 14 ischemic events; 11 non-IA-related intracranial hemorrhagic events; 6 worsening of mass effects; 1 unknown nature; 11 puncture-site hematoma | 9 | 319/385 | 21 | 2 | – |
Ant anterior, EVT endovascular treatment, IA intracranial aneurysm, ICH intracerebral hemorrhage, mos months, NA data not available, PITA pipeline for the intracranial treatment of aneurysms, Post posterior, SAH subarachnoid hemorrhage, TIA transient ischemic attack
aOne IA was excluded from the final analysis of the study