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Patient enrollment DIAS-4 vs. Endovascular Therapy
What does the cath lab offer?
MERCI® Retrieval System
Mechanical Thrombectomy: The MERCI Trial
• 151 pts with intracranial occlusions treated <8 hr from symptom onset (no control group)
• Recanalization in 48%; SICH in 8%
• Improved patient outcomes with recanalization
– 46% vs 10% without disability at 90 days
Smith WS et al. Stroke. 2005;36:1432
FDA Approval of MERCI Retriever:August 2004
Indications for Use:
“The Merci Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for treatment with intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment."
Food and Drug Administration website. Available at http://www.fda.gov/cdrh/pdf3/k033736.pdf. Accessed Jan 24, 2008
L5
Multi MERCI
Slide courtesy of WS Smith.
Improved Recanalization
48.2
57.3 60.3
69.5
0102030405060708090
100
%
DeviceRecanalization
FinalRecanalization
MERCI
Multi MERCI L5
Mechanical Thrombectomy: PENUMBRA®
Penumbra System: Registration Trial
• 125 patients• NIHSS 17.6• Recanalization (TIMI 2-3) 82%• SICH 11.2%• Nondisabled (mRS 0-2) outcome 90
d 25%• Death 90 d 33%
SOLITAIRE With the Intention For Thrombectomy (SWIFT) Study :
Mechanical Recanalization: Misperceptions about Terminology: regulatory
Two mechanical thrombectomy devices have been approved for use in stroke
patients by the FDA
Misperceptions in brain ischemia: technology, terminology, tissue and time
True or False?
“The term "FDA approval" is never appropriate to describe a device that is legally marketed under a 510(k). The correct term is "cleared for marketing" or "cleared by FDA". Neurothrombectomy devices currently on the market in the US have been cleared via the 510(k) pathway.”
Natalie Getzoff, MD, Medical OfficerNeurodiagnostic and Neurotherapeutic Devices BranchDivision of Ophthalmic, Neurological, and ENT DevicesFood and Drug Administration
Mechanical Recanalization: Misperceptions
Our job to figure out which patients benefit from these devices
How well are we doing?
Misperceptions in brain ischemia: technology, terminology, tissue and time
Case series:“My recanalization rate
is bigger than yours”
Mechanical Recanalization: Misperceptions about Terminology: recanalization
Misperceptions in brain ischemia: technology, terminology, tissue and time
Thomas TomsickDepartment of Radiology University Hospital Cincinnati, Ohio
confusing and misleading
•
Mechanical Recanalization: Misperceptions about Technology: recanalization
Complete success
Partial success
No success
Misperceptions in brain ischemia: technology, terminology, tissue and time
no recanalization
recanalization
Endovascular Therapy: Clinical Trials
MR Rescue
IMS 3
DEFUSE 2
MRIbaseline
Intra-arterial therapy
MRIpost-procedure
(reperfusion)
MRIday 5
(infarct volume)
Favorable clinical response:
• NIHSS score of 0-1 at day 30 or improvement of NIHSS score by ≥ 8 points between baseline and day 30
DEFUSE 2 Protocol
66 yo, MCA M1 occlusion
Recanalization of ant temporal branch of MCA
Recanalization; 20% reperfusion = TIMI 2, TICI 2A
74 yo, R MCA occlusion at 9 hrs (witnessed), NIHSS 12
Early f/u DWI/PWI at 11 hrs; NIHSS 6cath lab merci (10 hrs) and 3 mg IA tPA (10.5 hrs)
Baseline DWI; NIH 12 5-day FLAIR; NIH 37 ccm 10 ccm
79 yo female, left hemiplegia
Angiogram pre and post Penumbra device (7 hrs)
DWI at Day 3
DWI / PWI 10 hrs after cath labDWI / PWI 10 hrs after cath lab
CTP at 6 hrs (prior to cath lab)
Patient enrollment DIAS-4 vs. Endovascular Therapy
Must avoid biased enrollment in DIAS (M1s cath lab, M2s DIAS; high NIH vs. low; investigator impression of prognosis)
Various non-biased strategies possible
Communication/consensus with IA team on a site-specific plan