Table 2

Clinical outcomes (intention-to-treat analysis unless otherwise described)

OutcomeUnruptured cohort (n=108)Major or minor
Periprocedural
 Adverse events (no neurological sequelae)Difficulty deploying PEDV: 6 (5.6%)
Groin hematoma: 4 (3.7%)
Failure to deploy PEDV*: 3 (2.8%)
Transient thrombus: 2 (1.9%)
Extracranial ICA dissection: 1 (0.9%)		16 Minor
 Neurological adverse eventsIschemic stroke: 7 (6.5%)
Cranial neuropathy: 2 (1.9%)
Intraparenchymal hemorrhage: 1 (0.9%)
Death†: 1 (0.9%)		2 Major & 5 Minor
2 Major
1 Major
1 Major
        Total complications
        (ITT analysis)		Minor: 21 (19.6%)
Major: 6 (5.6%)
        Total complications
        (per-protocol basis‡)		Minor: 21 (20.2%)
Major: 5 (4.8%)
        Total complications
        (per-protocol basis and additionally including those with failed PEDV deployment§)		Minor: 21 (19.6%)
Major: 5 (4.7%)
Postprocedural
 Adverse events (no neurological sequelae)N/A
 Neurological adverse eventsIschemic stroke: 3 (2.8%)
Cranial neuropathy: 1 (0.9%)
Parent artery occlusion¶: 1 (0.9%)
Aneurysm growth with mass effect: 1 (0.9%)		3 Minor
1 Major
1 Major
1 Major
        Total complications
        (ITT analysis)		Minor: 3 (2.8%)
Major: 3 (2.8%)
        Total complications
        (per-protocol basis‡)		Minor: 3 (2.9%)
Major: 3 (2.9%)
        Total complications
        (per-protocol basis and additionally including those with failed PEDV deployment§)		Minor: 3 (2.8%)
Major: 3 (2.8%)
Ruptured cohort (n=22)
Peri-procedural
 Adverse events (no neurological sequelae)Groin hematoma: 1 (4.5%)
Extracranial ICA dissection: 1 (4.5%)
Difficulty deploying PEDV: 1 (4.5%)		3 Minor
 Neurological adverse eventsDeath**: 5 (22.7%)
Ischemic stroke**: 4 (18.2%)
Second subarachnoid hemorrhage††: 1 (4.5%)		5 Major
3 Major & 1 Minor
1 Major
        Total complications
        (ITT analysis)		Minor: 4 (18.2%)
Major: 9 (40.9%)
        Total complications
        (per-protocol basis‡‡)		Minor: 4 (23.5%)
Major: 4 (23.5%)
Post-procedural
 Adverse events (no neurological sequelae)N/A
 Neurological adverse eventsN/A

  • Peri-procedural, occurring <30 days after embolization. Post-procedural, occurring ≥30 days after embolization.

  • "Major” adverse event: a persistent clinical deficit at 7 days following the event. “Minor” adverse event: events that resolved within 7 days with no clinical sequelae.

  • *Unclear why two PEDVs failed to deploy, but appeared to be entirely technical. There was in-stent stenosis from a previous stenting which may have contributed to failure to deploy PEDV in the third case. For the two purely technical failures, both cases were cancelled with one patient undergoing subsequent parent vessel occlusion and one patient undergoing subsequent p64 (Phenox, Bochum, Germany) flow diversion. In the third case where there was in-stent stenosis, the patient underwent coiling during the same session.

  • †Adjudication concluded death inevitable without PEDV implantation.

  • ‡Denominator n=104.

  • §Denominator n=107. Includes three patients requiring alternative treatment.

  • ¶No neurological clinical features but included as neurological adverse event according to IntrePED methodology.10

  • **Adjudication concluded death more likely to be attributable to presenting subarachnoid hemorrhage than PEDV implantation; data were less clear for ischemic stroke.

  • ††Patient had ruptured ICA para-ophthalmic aneurysm. Pre-operative intravenous tirofiban with infusion. Underwent PEDV deployment, adjunctive coiling and balloon angioplasty. Loaded with aspirin and clopidogrel. Re-rupture with immediate hydrocephalus in recovery. Given two pools of platelets and underwent extraventricular drain insertion. Subsequently underwent ventriculo-peritoneal shunt insertion. Complete occlusion of aneurysm at follow up.

  • ‡‡Denominator n=17.

  • ICA, internal carotid artery; ITT, intention-to-treat ; N/A, not applicable; PEDV, Pipeline Vantage Embolization Device.