New 'pipeline' device offers new option for difficult-to-treat aneurysms

December 3, 2012

A new technology called the Pipeline embolization device (PED) shows encouraging results in patients with certain types of difficult-to-treat brain aneurysms, reports the December issue of Neurosurgery, official journal of the Congress of Neurological Surgeons.

Data collected since the PED was approved for marketing show generally good results in "real world" clinical practice. However, the report raises concerns about fatal bleeding and other serious complications, especially for aneurysms in one specific location. The lead author of the study was Dr. Peter Kan of University at Buffalo, N.Y.

Pipeline Device Shows Promising Results…

The researchers evaluated "early postmarket" results—that is, after approval by the U.S. (FDA)—using the PED at seven surgical centers. The PED is designed for use in treating certain types of aneurysms that can't be blocked off by surgery or other treatments, such as "wide-necked" or giant aneurysms.

An is a weakened spot in a blood . If the aneurysm enlarges or ruptures (breaks), it can cause a stroke or life-threatening bleeding in the brain. The study reflects the increased emphasis on collecting postmarketing data on newly approved to see if the results in initial are comparable to those in research trials. The PED received FDA approval for use in treating specific types of brain aneurysms in 2011.

The study included 62 PED procedures performed to treat aneurysms in 56 patients. The patients' average age was 59 years. More than 40 percent of the aneurysms were discovered incidentally, before they caused any symptoms or bleeding.

On average, it took two PEDs to treat each aneurysm. Some patients needed additional procedures related to problems deploying the PEDs. In one-fourth of aneurysms, additional "coil" treatments were used in addition to PEDs to help block off the aneurysm.

Three-month follow-up data were available for 19 patients. In 68 percent, the aneurysm was completely blocked off. Two patients had some narrowing within the Pipeline device—this was successfully treated with an additional angioplasty procedure.

…But Also Some Serious Complications

However, the data also showed substantial risks, including an 8.5 percent rate of major complications or death. Six patients had clots leading to strokes or transient ischemic attacks ("mini strokes") after the PED procedure. Most of these patients had vertebrobasilar aneurysms—located in an area at the base of the brain where three major arteries meet.

In addition, four patients suffered bleeding, which developed up to two months after the PED procedure. Bleeding was fatal in all four cases.

Unlike surgery or other treatments for brain aneurysms, the PED does not achieve immediate occlusion. Rather, the "Pipeline" redirects blood flow away from the aneurysm and through the parent vessel. Over time, new blood vessel tissue grows across the neck of the aneurysm, blocking it off permanently.

This initial "real world" experience with the PED shows results similar to those achieved in clinical trials leading to . Although treatment may take months to complete, the aneurysm is eventually completely occluded in most patients. Thus the PED offers an effective new option for with aneurysms that would previously have been difficult or impossible to treat.

The postmarketing data also show a significant risk of serious complications, including potentially fatal bleeding. Pending further study, Dr. Kan and colleagues caution against "off-label" use of the PED to treat aneurysms in the vertebrobasilar region. They conclude, "Long-term data are needed to establish long-term efficacy and to understand the delayed complications of this new technology."

Explore further: New device offers revolutionary treatment for difficult-to-Treat brain aneurysms

Related Stories

New device offers revolutionary treatment for difficult-to-Treat brain aneurysms

June 8, 2011
Physicians at Rush University Medical Center are offering a new and effective treatment to patients suffering from complex brain aneurysms. The recently FDA-approved technology called the Pipeline Embolization Device (PED ...

FDA approval of brain aneurysm device gives Jefferson neurosurgeons another life-saving tool

April 18, 2011
The recent U.S. Food and Drug Administration (FDA) approval of a brain aneurysm device has opened the door for neurosurgeons at Jefferson Hospital for Neuroscience (JHN) to offer advanced treatment to patients suffering from ...

The Medical Minute: Pipes in the brain as treatment for aneurysms

December 9, 2011
Brain aneurysms are balloon-like out-pouchings that can develop off of brain arteries. Like balloons, these out-pouchings can burst causing a devastating type of stroke as blood leaks in and around the brain. Many years ago ...

Minimally invasive surgery works well for abdominal aortic aneurysms, Mayo finds

September 6, 2012
A minimally invasive procedure known as endovascular repair used for abdominal aortic aneurysms has a low rate of complications, even in high-risk patients such as those with kidney, heart or lung problems, a Mayo Clinic ...

Recommended for you

World's first child hand transplant a 'success'

July 19, 2017
The first child in the world to undergo a double hand transplant is now able to write, feed and dress himself, doctors said Tuesday, declaring the ground-breaking operation a success after 18 months.

Knee surgery—have we been doing it wrong?

July 18, 2017
A team of University at Buffalo medical doctors have published a study that challenges a surgical practice used for decades during arthroscopic knee surgery.

New tools help surgeons find liver tumors, not nick blood vessels

July 17, 2017
The liver is a particularly squishy, slippery organ, prone to shifting both deadly tumors and life-preserving blood vessels by inches between the time they're discovered on a CT scan and when the patient is lying on an operating ...

Researchers discover indicator of lung transplant rejection

July 13, 2017
Research by scientists at Dignity Health St. Joseph's Hospital and Medical Center's Norton Thoracic Institute was published in the July 12, 2017 issue of Science Translational Medicine titled "Zbtb7a induction in alveolar ...

New device could make closing surgical incisions a cinch

July 7, 2017
Like many surgeons, Dr. Jason Spector is often faced with the challenge of securely closing the abdominal wall without injuring the intestines. If the process goes awry, there can be serious consequences for patients, including ...

Success with first 20 patients undergoing minimally invasive pancreatic transplant surgery

June 29, 2017
Surgeons at Johns Hopkins Medicine report that their first series of a minimally invasive procedure to treat chronic pancreas disease, known as severe pancreatitis, resulted in shorter hospital stays, less need for opioids ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.