FDA Cautions About Risks of Coiling for Brain Aneurysms

Did gluing fall by the wayside? Be careful out there.
I guess this is why gluing is not done:
FDA issues warning about Covidien brain device that has killed nine - Onyx glue
Maybe this instead:

Startup tests mesh+microsponges as alternative brain aneurysm treatment

But don't listen to me I have no medical training. 

FDA Cautions About Risks of Coiling for Brain Aneurysms

Procedural risks, patient selection should be considered

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• by Nicole Lou,

Reporter, MedPage Today/CRTonline.org May 09, 2018

WASHINGTON -- After reports of periprocedural stroke and death with the use of neurovascular stents for stent-assisted coiling (SAC), the FDA issued a safety alert with recommendations for safe use of these devices in the treatment of unruptured brain aneurysms.

Reports received of periprocedural stroke and death may have been related to procedural risks or poor patient selection, the FDA determined.

"Neurovascular stents for SAC provide important options for the treatment of wide-neck brain aneurysms, and their technology continues to evolve. However, these procedures are not without risks, and careful patient selection and proper device use are critical to ensure that the benefits to the patient outweigh the risk of treatment. Many patients with unruptured brain aneurysms can be managed conservatively with routine monitoring and follow-up depending on their individual risk factors for aneurysm rupture," wrote the FDA's William Maisel, MD, MPH, in the letter to healthcare providers.

In smaller brain aneurysms or in patients with reduced life expectancy, the risks of endovascular coiling may outweigh their benefits, the agency noted. Operators should also be aware that neurovascular stents are only approved for certain brain aneurysms, and that they should avoid use of these devices in patients who cannot take systemic anticoagulant or antiplatelet drugs.

Hydrogel Beats Standard Platinum for Coiling Aneurysms

Just in case you need factual data to question your doctor about your aneurysm. It joins the other options for handling aneurysms, coiling, surgery, mesh, and glue   being the others.
http://www.medpagetoday.com/MeetingCoverage/ISC/63401?

European study shows lower rate of composite adverse events with second-generation coil

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• by Kristina Fiore
  Associate Editor, MedPage Today February 24, 2017

HOUSTON -- Treating medium-sized intracranial aneurysms with second-generation hydrogel coils diminished adverse outcomes compared with standard platinum coils, researchers reported here.
In the GREAT trial, a smaller proportion of patients hit the composite adverse event endpoint at 18 months if they were treated with hydrogel coils (19.9% versus 28.7%), Christian Taschner, MD, PhD, of University Hospital Freiburg in Germany, and colleagues reported during a press briefing at the International Stroke Conference.
Physicians traditionally used clips to treat intracranial aneurysm, placed via neurosurgery. That began to change after the ISAT trial showed that using platinum coils, delivered via endovascular therapy, to fill the aneurysm was superior to clipping, Taschner explained.
Still, rates of aneurysm recurrence with the new procedure could be improved, he said, leading to the development of second-generation coils that are filled with a hydrogel. When the gel comes into contact with liquid, its volume increases, boosting the packing density of the coiled aneurysm.
For their study, Taschner and colleagues randomized 513 intracranial aneurysm patients from 22 centers in France and Germany to treatment with either hydrogel coils (MicroVention's HydroSoft or HydroFrame) or standard platinum coils, from October 2009 to January 2014.
The primary endpoint was the composite of four outcomes: major aneurysm recurrence at 18 months, retreatment for major recurrences within 18 months, morbidity that prevented angiographic follow-up, and death.
Overall, they achieved the technical outcome of greater coil volume with the hydrogel versus platinum coils (0.041 cm³ versus 0.038 cm³), as well as a higher mean packing density (39% versus 31%) which was 8 percentage points higher (P=0.0001).
Taschner said this translated to a significant difference in terms of the primary outcome at 18 months, with a significant 8.4% reduction in the proportion of patients having those adverse events if treated with hydrogel coils (95% CI 0.5%-16.2%, P=0.036).
When looking at individual outcomes, he noted that there were higher rates of major recurrence and retreatment for those in the standard coil group, while there were no differences between groups in terms of disability or mortality:

• Major recurrence: 12% versus 18%
• Retreatment: 3% versus 6%
• Modified Rankin Score of 3-5: 1% versus 0
• Modified Rankin Score of 6: 3% versus 4%

Taschner concluded that second-generation hydrogel coils reduced adverse events for patients with medium-sized intracranial aneurysms.
First- and second-generation hydrogel coil devices are available in Europe, but are not as commonly used in the U.S., said Mark Alberts, MD, of Hartford Healthcare in Connecticut, who was not involved in the study.
"In the U.S., most patients get the classic coil or the clip," he said during a press briefing. "But this could potentially be an advance."
Alberts referred to presentations from the meeting that highlighted the use of stent diverters to prevent blood from flowing into the occluded aneurysm, in order to let the aneurysm heal better: "Both hydrogel coils and stent diverters are new and advanced technologies that we're hopeful about."

The study was supported by MicroVention of Tustin, Calif.
Taschner disclosed financial relationships with MicroVention, Stryker Neurovascular, Avandis, Neuravi, and Covidien.

• Primary Source

  International Stroke Conference

  Source Reference: Taschner C, et al "Second generation hydrogel-coated coils for the endovascular treatment of intracranial aneurysms: A randomized controlled trial" ISC Meeting 2017; Abstract LB8.

Incidence of delayed ipsilateral intraparenchymal hemorrhage after stent-assisted coiling of intracranial aneurysms in a high-volume single center

You'll have to be awake and cognitive enough to ask your doctor if they are monitoring you for a hemorrhage after they coil an aneurysm. It has already been noted that strokes in hospitals have worse treatment and outcomes.  Be careful out there. 

Incidence of delayed ipsilateral intraparenchymal hemorrhage after stent-assisted coiling of intracranial aneurysms in a high-volume single center

Kayan Y, Almandoz J, Fease J, Tran K, Milner A, Scholz J; Neuroradiology (Nov 2015)

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INTRODUCTION Delayed ipsilateral intraparenchymal hemorrhage (IPH) has been reported following technically successful treatment of intracranial aneurysms using flow-diverting stents in up to 8.5 % of patients. We report a similar, though less frequent phenomenon in the setting of stent-assisted coil embolization.
METHODS Institutional review board approval was obtained. A retrospective analysis of a prospective neurointerventional procedure registry was performed to review all IPHs that occurred in aneurysm patients within 90 days of endovascular treatment performed between November 2002 and November 2014 at one institution. Age, sex, hypertension, dual antiplatelet therapy, and technical details of the procedure were recorded.
RESULTS A total of 1697 patients underwent endovascular treatment of an intracranial aneurysm without a flow diverter at our institution during the study period. Among these, 138 patients underwent stent-assisted coiling (8.1 %). Of these, three patients (2.2 %) suffered a delayed IPH within the vascular territory distal to the treated lesion (one woman, median age 60 years).
CONCLUSIONS Recently described in the setting of flow diversion, delayed ipsilateral IPH is not limited to flow-diverting stents. Though less frequent, a potential for this complication may exist following any intracranial stenting procedure, possibly related to hemorrhagic conversion of microembolic phenomena in the setting of dual antiplatelet or anticoagulation therapy.

Aneurysms Commonly Recur After EVT

I don't know what this means  but if you were treated with coiling you should followup with your doctor.
http://www.medpagetoday.com/Cardiology/PCI/52034?

The durability of endovascular coiling versus neurosurgical clipping of ruptured cerebral aneurysms: 18 year follow-up of the UK cohort of the International Subarachnoid Aneurysm Trial (ISAT)

Has gluing never gotten to widespread use?
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2960975-2/fulltext

Dr Andrew J Molyneux FRCR a , Jacqueline Birks MSc b, Alison Clarke BA a, Mary Sneade BA a, Richard S C Kerr FRCS c

Summary

Background

Previous analyses of the International Subarachnoid Aneurysm Trial (ISAT) cohort have reported on the risks of recurrent subarachnoid haemorrhage and death or dependency for a minimum of 5 years and up to a maximum of 14 years after treatment of a ruptured intracranial aneurysm with either neurosurgical clipping or endovascular coiling. At 1 year there was a 7% absolute and a 24% relative risk reduction of death and dependency in the coiling group compared with the clipping group, but the medium-term results showed the increased need for re-treatment of the target aneurysm in the patients given coiling. We report the long-term follow-up of patients in this UK cohort.

Methods

In ISAT, patients were randomly allocated to either neurosurgical clipping or endovascular coiling after a subarachnoid haemorrhage, assuming treatment equipoise, between Sept 12, 1994, and May 1, 2002. We followed up 1644 patients in 22 UK neurosurgical centres for death and clinical outcomes for 10·0—18·5 years. We assessed dependency as self-reported modified Rankin scale score obtained through yearly questionnaires. Data for recurrent aneurysms and rebleeding events were collected from questionnaires and from hospital and general practitioner records. The Office for National Statistics supplied data on deaths. This study is registered, number ISRCTN49866681.

Findings

At 10 years, 674 (83%) of 809 patients allocated endovascular coiling and 657 (79%) of 835 patients allocated neurosurgical clipping were alive (odds ratio [OR] 1·35, 95% CI 1·06—1·73). Of 1003 individuals who returned a questionnaire at 10 years, 435 (82%) patients treated with endovascular coiling and 370 (78%) patients treated with neurosurgical clipping were independent (modified Rankin scale score 0—2; OR 1·25; 95% CI 0·92—1·71). Patients in the endovascular treatment group were more likely to be alive and independent at 10 years than were patients in the neurosurgery group (OR 1·34, 95% CI 1·07—1·67). 33 patients had a recurrent subarachnoid haemorrhage more than 1 year after their initial haemorrhage (17 from the target aneurysm).

Interpretation

Although rates of increased dependency alone did not differ between groups, the probability of death or dependency was significantly greater in the neurosurgical group than in the endovascular group. Rebleeding was more likely after endovascular coiling than after neurosurgical clipping, but the risk was small and the probability of disability-free survival was significantly greater in the endovascular group than in the neurosurgical group at 10 years.

Wall Shear Stress Distribution of Small Aneurysms Prone to Rupture: A Case-Control Study

Your doctor should be able to look at your other aneurysms and determine the best course of action to prevent them rupturing; clipping, coiling, gluing.
http://www.docguide.com/wall-shear-stress-distribution-small-aneurysms-prone-rupture-case-control-study?hash=7e422beb&eid=36167&alrhash=3c9ebc-5aeefe0d7ed0a73e6788dca4998df39c

Bouillot P, Narata A, Schaller K, Lovblad K, Ouared R; Stroke (Nov 2013)

Tags:

• Vascular Disorders

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BACKGROUND AND PURPOSE Subarachnoid hemorrhage after intracranial aneurysm rupture remains a serious condition. We performed a case-control study to evaluate the use of computed hemodynamics to detect cerebral aneurysms prone to rupture.
METHODS Four patients with incidental aneurysms that ultimately ruptured (cases) were studied after initially being included in a prospective database including their 3-dimensional imaging before rupture. Ruptures were located in different arterial segments: M1 segment of the middle cerebral artery; basilar tip; posterior inferior cerebellar artery; and anterior communicating artery. For each case, 5 controls matched by location and size were randomly selected. An empirical cumulative distribution function of aneurysm wall shear stress percentiles was evaluated for every case and used to define a critical prone-to-rupture range. Univariate logistic regression analysis was then used to assess the individual risk of rupture.
RESULTS A cumulative wall shear stress distribution characterizing a hemodynamic prone-to-rupture range for small-sized aneurysms was identified and fitted independent of the location. Sensitivity and specificity of the preliminary tests were 90% and 93%, respectively.
CONCLUSIONS The wall shear stress cumulative probability function may be a potential predictor of small-sized aneurysm rupture.

Northwestern study compares endovascular brain aneurysm repair devices

To do this properly they should also be comparing glueing the aneurysm.
http://medicalxpress.com/news/2012-04-northwestern-endovascular-brain-aneurysm-devices.html

Aneurysms can be a very serious health threat, according to Bernard R. Bendok, MD, a neurosurgeon at Northwestern Memorial Hospital, who is the principal investigator for the new generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT). "When an aneurysm needs treatment, it is important to perform the safest, most effective and most durable treatment. This clinical research trial, called HEAT, will help us determine whether bare platinum coils, which have been used for years, or the newer gel-coated coils are more effective long-term," said Bendok, who is also an associate professor of neurological surgery and radiology at Northwestern University Feinberg School of Medicine.

Coiling involves inserting a catheter into an artery and threading it through the body using live x-rays as a guide to the site of the aneurysm. Coils are passed through the catheter and released into the aneurysm filling it to block blood from entering. Blood clots then form around the coil preventing the vessels from rupturing or leaking and destroying the aneurysm.

"Coils are not always able to fill the aneurysm completely, which leaves dead space in the aneurysm. This space has been associated with a higher rate of aneurysm recurrence," explained Bendok. "The new coils are made with platinum and a hydrogel that expands over time to eliminate the space between the coils, potentially limiting the need for future treatment."

HEAT is an international randomized study that seeks to determine how the gel packed coils measure up to the standard option in preventing future aneurysm recurrence. Northwestern is the lead site for the trial. Patients may be eligible for the trial if they are between the ages of 18 and 75 years with aneurysms 3 to 14mm in size, amenable to coiling. An estimated 30 sites around the world are expected to join the trial which has an enrollment goal of 600 participants.

On average aneurysms impact about one percent of the adult population. Understanding symptoms and risk factors can be potentially lifesaving. Small aneurysms may not be associated with symptoms, but a larger, growing aneurysm may cause pressure on tissues and nerves, leading to symptoms including headache, pain above and behind the eye, a dilated pupil, double vision, and weakness, numbness or paralysis on one side of face or body.

"In many cases, brain aneurysms remain silent until there's a major problem," said Bendok. "Most are not found until they rupture or are found incidentally on brain images taken to assess another condition. The number one sign to look for is a sudden and extremely severe headache. If this occurs, one should seek immediate medical attention."

Other indicators that a person may have a ruptured aneurysm include double vision, nausea, vomiting, stroke-like symptoms, stiff neck, loss of consciousness and in some cases, seizure and changes in memory. Risk factors include hypertension, alcohol and drug abuse, and smoking. Aneurysms can be influenced by genetic factors and family history may be an indication for screening. People with certain hereditary diseases including connective tissue disorders or polycystic kidney disease can have a higher occurrence. Other associations include arteriovenous malformation (AVM) and blockage of certain blood vessels in the brain. Women are more likely than men to have brain aneurysms. It's estimated about 10 in every 100,000 people will experience a ruptured aneurysm each year.

"Brain aneurysm rupture can be very devastating," said H. Hunt Batjer, MD, chairman of the department of neurological surgery at Northwestern Memorial and Michael J. Marchese Professor of neurological surgery at the Feinberg School. "It's important to know what to look for and who might be at increased risk for aneurysm disease. While current treatments are effective, trials like HEAT have the potential to advance the art and science of brain aneurysm treatment and lead to even better treatment options in the future."

More information: To learn more about the HEAT trial, visit http://clinicaltri … /NCT01407952