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Breakthrough treatments

A new option in treating aneurysms

D. KOJO HAMILTON, M.D.
Stanley L. Barnwell, M.D., Ph.D., Medical Director, Interventional Neuroradiology

For more than two decades, OHSU Brain Institute and the Dotter Interventional Institute at OHSU have worked to improve endovascular treatments by utilizing new devices and techniques, including minimally invasive procedures such as the stent coil retriever and similar devices.

Recent clinical trials at OHSU have shown that patients with previously inoperable aneurysms may have a new treatment option: the Federal Drug Administration-approved Pipeline™ Embolization Device (PED).

About the Pipeline™ Embolization Device
The PED is a braided, platinum and nickel-cobalt chromium alloy, wire mesh cylindrical implanted device <30mm. The PED differs from a stent in that it diverts flow away from the aneurysm in order to create stasis within the aneurysm. It is designed to slow blood flow into an aneurysm, inducing thrombosis in regions without demand. PED insertion is performed with the use of a catheter placed inside the blood vessel, compared to an open surgical procedure with the use of clips to block the aneurysm.

The PED is intended to treat adults with large or giant, wide-necked brain aneurysms of the internal carotid from the petrous to the superior hypophyseal segments. PED is a viable alternative to coil embolization, which is only appropriate in aneurysms with narrow necks, may require multiple coils and has a relatively high recurrence rate. Multiple PEDs may be telescoped to increase length or coverage ratio.

Contraindications
The PED shoul not be used in patients with an active infection, in patients for whom the use of antiplatelet blood thinners, such as aspirin and clopidogrel is contraindicated or in patients who have not received adequate antiplatelet therapy prior to PED placement. Medication and follow-up therapy includes:

  • Aspirin 325 mg load day before and 6 months post, then 81 mg daily
  • Plavix 600 mg load day before, then 75 mg daily X 5 months and stop
  • Plavix resistant: Ticagrelor (reduce ASA to 81 mg)
  • Angiogram at six months

Clinical trials and procedure data
In previous clinical trials of which OHSU was a part, a 31-patient study showed 93 percent occlusion at 6 months, and 100 percent occlusion at 1 year; a 104-patient study showed 81.8 percent occlusion at 6 months and 85.7 percent at 1 year.

At OHSU, 55 aneurysms were treated in 43 patients; six aneurysms required treatment with multiple PED and five patients had more than one aneurysm treated with separate devices. Sixteen of 24 aneurysms achieved immediate stasis. To date, 24 aneurysms from 18 procedures at OHSU have been reviewed at a 6-month follow-up: four major complications occurred (two deaths, by intracranial hemorrhage and ischemic stroke, respectively, one intracranial hemorrhage and one small ischemic stroke). Mortality and morbidity rates are 4.9 percent per patient and 4.3 percent per procedure, with permanent disability in 2.4 percent of patients and 2.2 percent of procedures.

OHSU’s leadership in pipeline embolization
Since the FDA approved the Pipeline™ Embolization Device approximately a year ago, Stanley Barnwell, M.D., Ph.D., and team have treated more than 50 patients, the most cases on the west coast, and Dr. Barnwell is involved in Pipeline Embolization education, which includes a didactic training course and physician proctorship. Aside from the OHSU Brain Institute team, no other physician in Oregon is FDA-certified to use the Pipeline device.

Multiple treatment options
Coil embolization is one of many aneurysm treatment options available at OHSU Brain Institute. Our multidisciplinary team of neurointerventional radiologists and neurosurgeons work together to determine the best treatment option for your patient.

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