Safety and efficacy of the Pipeline Flex embolization device with Shield Technology for the acute treatment of ruptured internal carotid artery pseudoaneurysms: a multi-institution case series.

OBJECTIVE: Ruptured blister, dissecting, and iatrogenic pseudoaneurysms are rare pathologies that pose significant challenges from a treatment standpoint. Endovascular treatment via flow diversion represents an increasingly popular option; however, drawbacks include the requirement for dual antiplatelet therapy and the potential for thromboembolic complications, particularly acute complications in the ruptured setting. The Pipeline Flex embolization device with Shield Technology (PED-Shield) offers reduced material thrombogenicity, which may aid in the treatment of ruptured internal carotid artery pseudoaneurysms. METHODS: The authors conducted a multi-institution, retrospective case series to determine the safety and efficacy of PED-Shield for the treatment of ruptured blister, dissecting, and iatrogenic pseudoaneurysms of the internal carotid artery. Clinical, radiographic, treatment, and outcomes data were collected. RESULTS: Thirty-three patients were included in the final analysis. Seventeen underwent placement of a single device, and 16 underwent placement of two devices. No thromboembolic complications occurred. Four patients were maintained on aspirin alone, and all others were treated with long-term dual antiplatelet therapy. Among patients with 3-month follow-up, 93.8% had a modified Rankin Scale score of 0-2. Complete occlusion at follow-up was observed in 82.6% of patients. CONCLUSIONS: PED-Shield represents a new option for the treatment of ruptured blister, dissecting, and iatrogenic pseudoaneurysms of the internal carotid artery. The reduced material thrombogenicity appeared to improve the safety of the PED-Shield device, as this series demonstrated no thromboembolic complications even among patients treated with only single antiplatelet therapy. The efficacy of PED-Shield reported in this series, particularly with placement of two devices, demonstrates its potential as a first-line treatment option for these pathologies.

Patient-Tailored Stenting versus Endarterectomy for the Treatment of Asymptomatic Carotid Artery Stenosis.

Carotid artery stenosis is a major cause of acute ischemic strokes in adults. Given the consequences and sequelae of an acute ischemic stroke, intervention while patients are still asymptomatic is a key opportunity for stroke prevention. Although carotid endarterectomy has been the gold standard of treatment for carotid stenosis for many years, recent advances in carotid stenting technology, practitioner experience, and dual antiplatelet therapy have expanded the use for treatments other than endarterectomy. Review of the current literature has demonstrated that endarterectomy and carotid artery stenting produce overall similar results for the treatment of asymptomatic carotid stenosis, but certain factors may help guide physicians and patients in choosing one treatment over the other. Age 70 years and older, renal disease, poor medication compliance, and unstable plaque features all portend better outcomes from endarterectomy, whereas age under 70 years, high cervical location of disease, cardiac disease, and reliable medication compliance favor stenting. The decision to pursue endarterectomy versus stenting is therefore complex, and although large studies have demonstrated similar outcomes, the approach to treatment of asymptomatic carotid stenosis must be optimized for each individual patient to achieve the best possible outcome.

Poor Results of Flow Diversion as Salvage Treatment for Intracranial Aneurysm Rerupture After Surgical Clip Reconstruction.

Rebleeding episodes after a ruptured intracranial aneurysm has been secured are considered a significant source of patient morbidity and mortality. Theoretically, acute treatment with a flow-diversion device may offer a reasonable treatment option to prevent future bleeding and to remodel the diseased vessel segment. The authors identified two patients who underwent emergent treatment with the placement of a Pipeline Embolization Device (PED) in the setting of an acute rebleeding of a ruptured intracranial aneurysm previously treated with clip reconstruction. The first patient was a 50-year-old woman who underwent clip reconstruction for a broad-based right anterior choroidal artery aneurysm measuring approximately 2×8 mm. Clip reconstruction was achieved with a single fenestrated clip. On day 14, the patient experienced a rebleeding episode. She underwent emergent treatment with a single PED but experienced another rebleeding and died. The second patient was a 53-year-old woman who presented with a ruptured dorsal variant blister aneurysm, which was treated with clip reconstruction. On day 22, she experienced a rebleeding episode and underwent emergent treatment using two PEDs in a duplicative fashion. After the procedure, she experienced another acute rebleeding episode and died. The treatment of reruptured intracranial aneurysms in a salvage fashion with emergent placement of PEDs in two patients resulted in good technical placement of the device covering the neck of the aneurysm, yet both patients experienced additional rebleeding and did not survive. Future generations of flow diverters may have more appropriate properties that would allow their use as salvage treatment in the setting of acutely ruptured aneurysms.

Moderate Sedation for Pipeline Embolization of Posterior Circulation Disease: Technical Note from a Single Center.

OBJECTIVE: Flow diversion has been an important addition to endovascular neurosurgery, but its use in the posterior circulation remains controversial. Our goal is to describe the safety and efficacy of moderate sedation during flow diversion for posterior circulation lesions (aneurysms or dissecting pseudoaneurysms). METHODS: The authors retrospectively reviewed the medical records of all patients who underwent placement of a Pipeline embolization device for a posterior circulation lesion using moderate sedation at a single institution from August 2012 through November 2017. Clinical data and outcomes were evaluated. RESULTS: Fifteen consecutive patients were identified: 8 female, 7 male (mean age 52.2 ± 16.3 years, range 15-81). Eleven lesions were located in the vertebral artery, 1 in the posterior inferior cerebellar artery, 2 in the posterior cerebral artery, and 1 in the basilar artery. All patients underwent flow diversion with Pipeline embolization devices. One patient experienced an acute occlusion of the basilar artery during the procedure that required revascularization. Mean fluoroscopy time was 35.6 ± 16.5 minutes (range 15.5-75). Mean follow-up time was 12.7 ± 8.8 months (range 3-36). No patient had new neurologic deficits in the perioperative or postoperative period. Conversion to general anesthesia was not required in any case. CONCLUSIONS: Moderate sedation is safe and feasible in patients undergoing flow diversion for posterior circulation lesions. In addition, its use may allow for more rapid identification of procedural complications, facilitating emergent treatment and decreasing procedure-related morbidity.

An institutional approach to maintenance of excellent outcomes for carotid endarterectomy in a setting with moderate-to-low procedure volume.

BACKGROUND: Institutions and surgeons with high procedure volumes have been reported to have lower morbidity and mortality rates for patients undergoing carotid endarterectomy. Demonstrating comparable results is essential for centers with moderate or low volume. If comparable results cannot be demonstrated, a low- to moderate-volume center should not perform the procedure. STUDY DESIGN: A prospective study of a program to achieve and sustain excellent outcomes after carotid endarterectomy was conducted at a single institution with low-to-moderate volumes. Results of this effort from January 1997 through December 2005 are reported. Key features of our approach include institutional control over which and how many surgeons can perform carotid endarterectomy. Surgeons must be experienced carotid surgeons and consistently perform more than 12 procedures annually and be continuously monitored. Surgical outcomes were independently audited through a mandated institutional carotid endarterectomy data registry. Surgeons with poor outcomes are barred from doing carotid endarterectomies; and annually updated outcomes data are posted on the Internet. RESULTS: This approach was used for 555 carotid endarterectomies in 503 patients. Our outcomes-with total death and disabling stroke rate of 1.6%-compare favorably with, and are not statistically different from, published benchmarks, despite volumes at our institution ranging from 44 to 81 patients annually and the participation of 8 surgeons during the study period. CONCLUSIONS: Surgeons should perform carotid endarterectomies only if excellent outcomes can be demonstrated. We conclude that by using an approach like ours, even institutions with moderate-to-low carotid endarterectomy volumes can achieve excellent outcomes. We propose that all institutions should assume responsibility for ensuring excellent carotid endarterectomy outcomes using a comprehensive outcomes-based approach with independent auditing similar to that presented here.