On Monday, Brown underwent a different procedure to prevent a second aneurysm from causing harm. But instead of an incision across her head, she has a tiny incision on her groin.

Brown was the first patient in the country to receive a new FDA-approved alternative surgical procedure.

Brown first discovered she had aneurysms when she started getting headaches in 2009.

Her primary care physician recommended she go see Dr. Adam Arthur at Semmes-Murphey where a scan of her brain revealed she had an aneurysm about the size of a pen hole on each side of her brain.

Determined too small to operate, Brown was seen every six months to a year to make sure there were no changes.

“Back in December of 2015, something shifted. I don’t know what, but they started growing,” Brown said.

The aneurysm on the right side of her brain grew to the size of a small fruit, and the first surgery was scheduled.

After Brown was put under anesthesia, Arthur, who is also the chief of neurosurgery at Methodist University Hospital, pinned her head to keep it still and cut an incision from behind her ear up to her hairline.

“She’s a beautiful woman and I didn’t want to do anything to her face,” he said.

He then cut a muscle near her temple and removed a piece of her skull, so he could go into her brain and insert a titanium clip to pinch the opening of the aneurysm. Arthur then put the skull back in and sewed her muscle and skin back together.

“I don’t want to criticize the work that was done on her because it’s my work and I’m proud of it, and she’s still a fully-functional person. She didn’t have a stroke, but for a patient,” Arthur said, “the difference between having that done, versus a little hole in her groin, you’re done, you go home the next day — if we can fix the aneurysm on the other side of her head without putting her through that, she prefers that.”

Brown was in the hospital for a week after the first surgery and in recovery for seven to eight months, undergoing both occupational and physical therapy. She had to go on short-term disability from her job as a human resources clerk at Memphis Light, Gas and Water Division, where she has worked for 13 years.

After the second procedure Monday, Brown, a born and raised Memphian who lives in South Memphis, was scheduled to go home within 72 hours.

“The time is nothing compared to three years ago,” she said.

After her first surgery, Arthur continued to monitor the aneurysm on the left side of Brown’s brain, while also working with Sequent Medical, a California-based medical device company, on a less invasive option.

Arthur had met two Sequent principals in 2011 after he gave a presentation at a medical conference in Europe.

They were Tom Wilder, president and CEO of Sequent Medical Inc., and Dr. Bill Patterson, who developed the Woven EndoBridge (WEB), an intravascular therapy for aneurysms.

They asked if he’d be the principal investigator on the clinical trial for WEB.

“No one had ever asked me to run an international trial at multiple, different centers,” Arthur said.

Arthur accepted and began what would be a more than five-year effort to perform the first FDA-approved surgery on Brown. The WEB has been available in Europe since 2010.

Methodist University Hospital was the first among the 27 clinical sites to enroll a patient, and Arthur was the first doctor to perform the surgery in August 2014. Those who enrolled in the clinical trial had a minimum year of follow up to make sure their aneurysms were fixed.

In September 2018, Arthur and Sequent Medical executives presented their findings to an FDA panel in Washington, D.C., who voted for the device’s approval.

When Brown was considering the WEB device for her second surgery, Arthur described the procedure and showed her a small woven metal basket that would fill her aneurysm and prevent it from rupturing.

The WEB is designed to treat aneurysms that occur at bifurcations or terminuses, where the artery splits into two other arteries and an aneurysm grows off the top.

“The arteries are God’s or nature’s own way of getting things to everywhere in your body, so you hop on the freeway and get to anywhere you need to go,” Arthur said.

Using a catheter inserted through either the groin or wrist, Arthur guides the WEB, a small sphere made out of woven metal fibers, to the aneurysm and blocks the blood flow to prevent a rupture that could cause a stroke.

“The results of the trial, which we’re getting ready to publish, are really good — 150 patients, an outstanding safety record and a very good effectiveness record,” Arthur said. “It’s ironic we did the first trial at (Methodist) University Hospital and the first commercial case right here at University Hospital in Memphis.”

The risk, like with the traditional method, is the potential for the aneurysm to rupture during the procedure, or for one of the arteries to be unintentionally blocked, resulting in stroke.

“That’s the risk with anything you do. If you’re sticking things in people’s brains you can screw it up,” Arthur said. “I speak from personal experience.”

More than 40 doctors from around the country are in Memphis watching the first procedures through a live-stream at the Medical Education & Research Institute (MERI) across the street, so they can learn how to perform the procedure.

The second set of cases will be performed beginning Thursday in New York and expand to other cities thereafter. There are about 100 surgeries scheduled in the next month.

Five doctors in the Methodist Le Bonheur Healthcare system are trained and available to perform the WEB procedure.

“I put my trust in God and then Dr. Arthur,” Brown said. “When I first got here (Monday) morning, I kept thinking about three years ago for some reason. I wasn’t fearful, but I kept thinking about how he wouldn’t have to go into my skull the way he did. I’m so grateful.”

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May 3, 2012 — Patients diagnosed with aneurysmal subarachnoid hemorrhage (aSAH) in hospitals that manage fewer than 10 cases per year should be considered for immediate transfer to a hospital that treats at least 35 cases a year, according to updated guidelines on management of aSAH from the American Heart Association/American Stroke Association (AHA/ASA).

Research has shown that 30-day death rates are significantly higher in low-volume facilities (39% in hospitals treating fewer than 10 patients compared with 27% in hospitals treating more than 35 patients each year), the AHA/ASA notes in a statement.

The new guideline, published online May 3 in Stroke, updates guidelines issued in 2009 and reported by Medscape Medical News at that time.

Rapidly Developing Field

“These guidelines are released every 2 to 3 years; nothing prompted them, they were a planned update,” E. Sander Connolly Jr, MD, chair of the statement writing group, noted in an email to Medscape Medical News.

“The biggest take home message is that the field is changing fast. There are lots of new guidelines; staying on top of these is critical to patient care,” added Dr. Connolly, vice-chairman of neurological surgery at Columbia University in New York City and the co-director of the neurosciences intensive care unit at New York-Presbyterian Hospital.

The writing group notes that the new update, “which is based on a mere 42 months of publications,” contains 21 new recommendations (outlined in Table 4 in the paper), 5 of which are Class I recommendations. There are also 9 changes in prior recommendations. In total, there are now 22 Class I recommendations (outlined in Table 3).

Although it’s not completely clear why outcomes are better at high-volume centers, “patients admitted to high-volume facilities have increased access to experienced cerebrovascular surgeons and endovascular specialists, as well as multidisciplinary neuro-intensive care services, such as EEG [electroencephalography] monitoring to rule out non-convulsive status seizures,” Dr. Connolly noted in a statement.

Larry B. Goldstein, MD, professor of medicine (neurology) and director of the Duke Stroke Center in Durham, North Carolina, told Medscape Medical News that transfer to high-volume centers when possible “makes sense [as] there is an association between center volume and outcomes, and has been seen for some other conditions.”

He noted, however, that “decisions regarding transfer of unstable patients with recent SAH is a bit more complicated, and would likely need to be determined regionally and depending on individual patient issues.”

In these patients, “a multidisciplinary approach afforded in larger centers might also contribute to better outcomes. Studies have shown better outcomes for patients with hemorrhagic strokes cared for in Primary Stroke Centers, even though the focus of these centers is on non-hemorrhagic strokes. This may reflect institutional commitment to stroke care in general, and better care organization.”

aSAH is responsible for about 5% of all strokes and affects more than 30,000 Americans each year, most of them aged 40 to 60 years. Prevention recommendations still center on controlling hypertension and avoiding cigarette smoking and excessive alcohol use.

The 5 new class I (level B) recommendations are as follows:

• After any aneurysm repair, immediate cerebrovascular imaging is generally recommended to identify remnants or recurrence of the aneurysm that may require treatment.
• Digital subtraction angiography with 3-dimensional rotational angiography is indicated for detection of aneurysm in patients with aSAH (except when the aneurysm was previously diagnosed by noninvasive angiography) and for planning treatment (to determine whether an aneurysm is amenable to coiling or to expedite microsurgery).
• Between the time of aSAH symptom onset and aneurysm obliteration, blood pressure should be controlled with a titratable agent to balance the risk for stroke, hypertension-related rebleeding, and maintenance of cerebral perfusion pressure.
• In the absence of a “compelling” contraindication, patients who undergo coiling or clipping of a ruptured aneurysm should have delayed follow-up vascular imaging (timing and modality to be individualized), and re-treatment, by repeat coiling or clipping, should be strongly considered if there is a clinically significant (eg, growing) remnant.
• Heparin-induced thrombocytopenia and deep venous thrombosis are both infrequent but not uncommon occurrences after aSAH. Early identification and targeted treatment are recommended, but further research is needed to identify the ideal screening paradigms.

The 9 revised recommendations are as follows:

• For patients with an unfavorable delay in obliteration of aneurysm, a significant risk for rebleeding, and no compelling medical contraindications, short-term ( < 72 hours) therapy with tranexamic acid or aminocaproic acid is reasonable to reduce the risk for early aneurysm rebleeding. (Class IIa, Level B)
• Experienced cardiovascular surgeons and endovascular specialists should determine a multidisciplinary treatment approach based on characteristics of the patient and the aneurysm. (Class I, Level C)
• For patients with ruptured aneurysms judged to be technically amenable to both endovascular coiling and neurosurgical clipping, endovascular coiling should be considered. (Class I, Level B)
• Low-volume hospitals should consider early transfer of patients with aSAH to high-volume centers. (Class I, Level B)
• Maintaining euvolemia and normal circulating blood volume is recommended to prevent disseminated intravascular coagulation (DCI). (Revised, Class I, Level B)
• Induction of hypertension is recommended for patients with DCI unless blood pressure is elevated at baseline or cardiac status precludes it. (Class I, Level B)
• Cerebral angioplasty and/or selective intra-arterial vasodilator therapy is “reasonable” in patients with symptomatic cerebral vasospasm, particularly those who are not rapidly responding to hypertensive therapy. (Class IIa, Level B)
• aSAH-associated acute symptomatic hydrocephalus should be managed by cerebrospinal fluid diversion (external ventricular drainage or lumbar drainage, depending on the clinical scenario). (Class I, Level B)
• aSAH-associated chronic symptomatic hydrocephalus should be treated with permanent cerebrospinal fluid diversion. (Class I, Level B)

In this “fast-developing field,” frequent revision of these guidelines is “clearly needed [and] the data presented here only begin to scratch the surface of the burgeoning knowledge,” the writing group concludes. “Those faced with managing these patients will thus do well to use these guidelines as merely a starting point for doing everything possible to improve the outcomes of patients with aSAH.”

Dr. Connolly has disclosed no relevant financial relationships. A complete list of disclosures for members of the guideline writing group is published with the original article. Dr. Goldstein has disclosed no relevant financial relationships.