Deans' stroke musings: More Bad News for Embolic Protection Devices Randomized trial shows little benefit for filtration or suction

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Thursday, August 17, 2017

More Bad News for Embolic Protection Devices Randomized trial shows little benefit for filtration or suction

If you need this, you will have lots of questions for your doctor to answer.
https://www.medpagetoday.com/Cardiology/Strokes/67168?

by Nicole Lou, Contributing Writer, MedPage Today August 09, 2017
This article is a collaboration between MedPage Today® and:

Cerebral embolic protection devices do nothing to cut down on ischemic strokes after surgical aortic valve replacement (SAVR), a randomized trial suggested.
Freedom from clinical or radiographic central nervous system (CNS) infarction stood at 32.0% at the 7-day mark after surgery with suction-based extraction using CardioGard, versus 33.3% for protection-less control (P=0.84), reported Annetine C. Gelijns, PhD, of New York's Icahn School of Medicine at Mount Sinai, and collaborators of the Cardiothoracic Surgical Trials Network, online in the Journal of the American Medical Association.
The Embol-X system for intra-aortic filtration also failed to deliver significant protection, with infarct freedom rate of 25.6% versus 32.4% for control (P=0.22).
Patients also gained no clinical advantage with respect to combined mortality, clinical ischemic stroke, and acute kidney injury within 30 days of surgery, no matter if they got a suction device (21.4% versus 24.2% for control) or a filter protector (33.3% versus 23.7%),
Preliminary results from the study were previously reported at this year's American College of Cardiology meeting.
No differences in the individual endpoints of mortality or clinical stroke were observed between device groups and control. Nor was there a benefit relative to control for quality of life at 90 days.
"Despite the fact that debris was captured in most patients who received a cerebral embolic protection device, rates of clinical and radiographic infarction were not reduced," Gelijns' group concluded.
"However, the infarct volume pattern suggested a possible differential effect of devices compared with the control intervention, with larger volume infarcts more numerous in patients in the control group. This observation may be important because the risk of clinically evident stroke increases with infarct volume," they suggested, even as study groups shared similar numbers of MRI lesions and total lesion volume.
One benefit for embolic protection was identified, though: a reduction in delirium risk at day 7 when suction was employed during surgery (6.3% versus 15.3% for control, P=0.03).
"This difference may be related to the fact that, in addition to particulate matter, the suction-based device also extracts gaseous microemboli, which have been shown to affect neuropsychological functioning early during the postoperative phase among patients undergoing cardiac surgery," they suggested.
Embol-X, on the other hand, not only failed to reduce delirium but was also associated with more 90-day acute kidney injury (3.8% versus 1.1% for control, P=0.02) and cardiac arrhythmias (15.3% versus 8.1%, P=0.004).
For this study, patients were randomized to a suction-based extractor (n=118), an intra-aortic filtration device (n=133), or standard aortic cannula/control (n=132) at the time of surgery, which was more likely than not to be isolated SAVR (58%) or concomitant SAVR and coronary artery bypass grafting (41%). North American centers performed all surgeries from 2015 to 2016.
Radiographic lesions -- identified using diffusion-weighted 1.5- or 3.0-T MRI scanners -- made up the bulk of CNS infarcts found. "The significance of the many small and clinically silent lesions identified by diffusion-weighted MRI cannot be established," Gelijns and colleagues admitted.
Another caveat: performing scans at 7 days could overestimate infarct burden by capturing lesions unrelated to intraoperative factors -- but also could underestimate it, if smaller lesions disappeared by then. Furthermore, the authors said, they stopped randomization prematurely due to low conditional power for the primary endpoint.

Gelijns disclosed no conflicts of interest.
Co-authors reported relationships with Edwards LifeSciences, Abbott Vascular, Medtronic, and Claret Medical.