ABSTRACT
PURPOSE: The Pipeline Embolization Device (PED) is a routine first-line treatment option for intracranial aneurysms (IAs). The Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is an updated version of the PED which has been modified to include a surface phosphorylcholine biocompatible polymer. Its early technical success and safety have been reported previously. Here, we assessed the long-term safety and efficacy of the Pipeline Shield for the treatment of IAs. MATERIALS AND METHODS: The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study was a prospective, single-arm, multicenter study for the treatment of unruptured IAs using the Pipeline Shield. The primary endpoint was a major stroke in the territory supplied by the treated artery or neurologic death at 1-year post-procedure. Angiographic outcomes were also assessed by an independent radiology laboratory at 6 months and 1 year. RESULTS: Fifty patients (mean age, 53 years; 82% female) with 50 unruptured IAs were treated. Mean aneurysm diameter was 8.82±6.15 mm. Of the target aneurysms, 38/50 (76%) were small (<10 mm), 11/50 (22%) were large (≥10 and<25 mm), and 1/50 (2%) was giant (≥25 mm). Forty-seven (94%) were located in the internal carotid artery and three (6%) in the vertebral artery. At 1-year post-procedure, no major strokes or neurologic deaths were reported, and complete occlusion was achieved in 27/33 (81.8%). There were no instances of aneurysm recurrence or retreatment. CONCLUSIONS: Our 1-year follow-up concerning angiographic and safety outcomes corroborate previous evidence that the Pipeline Shield is a safe and effective treatment for IAs. TRIAL REGISTRATION NUMBER: NCT02390037.
Subject(s)
Cerebral Angiography/trends , Embolization, Therapeutic/instrumentation , Embolization, Therapeutic/trends , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/therapy , Adult , Aged , Blood Vessel Prosthesis/adverse effects , Blood Vessel Prosthesis/trends , Cerebral Angiography/adverse effects , Embolization, Therapeutic/adverse effects , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies , Recurrence , Retreatment/trends , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND AND PURPOSE: The Pipeline Embolization Device (PED) has become a routine first-line option for treatment of intracranial aneurysms (IAs). We assessed the early safety and technical success of a new version of PED, Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield), which has the same design and configuration but has been modified to include a surface synthetic biocompatible polymer. MATERIALS AND METHODS: The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study is a prospective, single-arm, multicenter study for the treatment of unruptured IAs using Pipeline Shield. The primary study endpoints included the occurrence of major stroke in the territory supplied by the treated artery or neurologic death at 1â year post-procedure. Secondary endpoints included the rate of Pipeline Shield-related or procedure-related serious or non-serious adverse events. Analyses were conducted to evaluate early safety findings in the 30-day post-procedure period as well as technical procedural success outcomes. RESULTS: Fifty patients with 50 unruptured target IAs were enrolled. Mean aneurysm diameter was 8.82±6.15â mm. Thirty-eight aneurysms (76%) were small (<10â mm). Device deployment was technically successful with 98% of devices. Complete wall apposition was achieved immediately post-procedure in 48 cases (96%). No major strokes or neurologic deaths were reported in the 30-day post-procedure period. CONCLUSIONS: The results of this first experience with the new Pipeline Flex corroborate the early safety of the device. Mid-term and long-term follow-up examinations will provide data on safety outcomes at the 6-month and 1-year follow-up periods. CLINICAL TRIAL REGISTRATION: NCT02390037.
Subject(s)
Embolization, Therapeutic/methods , Intracranial Aneurysm/diagnosis , Intracranial Aneurysm/therapy , Perioperative Care/methods , Stents , Adult , Aged , Embolization, Therapeutic/trends , Female , Follow-Up Studies , Humans , Male , Middle Aged , Perioperative Care/trends , Prospective Studies , Treatment OutcomeABSTRACT
In this study we aimed to evaluate the efficiency of percutaneous endovascular aortic aneurysm repair (p-EVAR). Anatomically selected patients treated with a single 10Fr Perclose Prostar XL vascular closure device (VCD) were examined. Primary success rate and common femoral artery (CFA) open conversion (OC) requirement per sheath size used were recorded. A literature review on p-EVAR results was also performed. One-hundred patients were enrolled. Successful p-EVAR was achieved in 183 of the 196 CFA access sites (93.4%), and was specifically 85.9% and 98.3% for sheaths ≥20Fr and ≤18Fr respectively. There were 13 periprocedural complications (bleeding = 10, arterial dissection and thrombosis = 1, pseudoaneurysm = 2) all leading to OC. Use of ≥20Fr sheaths had significantly higher OC rate (P < .05). Reconstruction was achieved with primary repair (N = 11) and patch angioplasty (N = 2). Mean hospital stay was 1.8 days. The literature review (vascular closure of 2921 CFA access sites) revealed an overall technical success rate of 92.3%. Device related- were more common than patient related-OCs (P < .05). p-EVAR procedures are safe and feasible. Sheath size is a significant predictor of OC rate and more OCs might be expected with very large (≥20Fr) sheath sizes.
