UPDATED INCLUSION AND EXCLUSION CRITERIA FOR IV TPA ADMINISTRATION ACUTE STROKE TREATMENT: AN UPDATE GOALS OF TALK

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1 ACUTE STROKE TREATMENT: AN UPDATE James M. Gebel MD MS FAHA Medical Director Akron General Medical Center Cerebrovascular Center GOALS OF TALK Review changes to IV tpa administration as per new 2013 AHA clinical practice guidelines Discuss current core measure challenges and public reporting of stroke core measures Discuss new core measures for both ischemic and hemorrhagic stroke required for comprehensive stroke center certification Review stroke research at AGMC Review new, government- sponsored stroke care paradigm UPDATED INCLUSION AND EXCLUSION CRITERIA FOR IV TPA ADMINISTRATION

2 UPDATES ON IV TPA USE The FDA has now officially DISapproved IV tpa for use in the 3 to 4.5 hour time window AHA and other clinical practice guidelines continue to recommend it despite this Written informed consent should now be obtained and documented prior to any administration of IV tpa beyond 3 hours UPDATES ON IV TPA USE INCLUSION CRITERIA (unchanged) Diagnosis of ischemic stroke causing measurable neurological deficit Note: no absolute minimum NIHSS score Onset of symptoms <3 hours before beginning treatment Aged 18 years UPDATES ON IV TPA USE: HARD EXCLUSION CRITERIA Significant head trauma or prior stroke in previous 3 months Symptoms suggest subarachnoid hemorrhage Arterial puncture at noncompressible site in previous 7 days History of previous intracranial hemorrhage Intracranial neoplasm, arteriovenous malformation, or aneurysm

3 UPDATES ON IV TPA USE: HARD EXCLUSION CRITERIA Acute bleeding diathesis, including but not limited to: Platelet count < /mm3 Heparin received within 48 hours, resulting in abnormally elevated aptt>upper limit of normal Current use of anticoagulant with INR >1.7 or PT >15 seconds Current use of direct thrombin inhibitors or direct factor Xa inhibitors with elevated sensitive laboratory tests (such as aptt, INR, platelet count, and ECT; TT; or appropriate factor Xa activity assays IV TPA UPDATED EXCLUSION CRITERIA: NEW ORAL ANTICOAGULANTS Use of dabigatran (Pradaxa) within the past 48 hours is a contraindication to IV tpa unless you get a normal TT Use of Rivaroxiban (Xarelto) within the past 48 hours is a contraindication unless you can get a normal anti- factor Xa level done in time Use of apixaban (Eliquis) within the past 48 hours is a contraindication unless you can get a normal anti- factor Xa level done in time UPDATES ON IV TPA USE: HARD EXCLUSION CRITERIA Recent intracranial or intraspinal surgery Elevated blood pressure (systolic >185 mm Hg or diastolic >110 mm Hg) Active internal bleeding Blood glucose concentration <50 mg/dl CT demonstrates multilobar infarction (hypodensity >1/3 cerebral hemisphere)

4 UPDATES ON IV TPA USE: RELATIVE EXCLUSION CRITERIA Only minor or rapidly improving stroke symptoms (clearing spontaneously) New evidence suggests that up to one third of such patients experience a delayed deterioration Especially if CTA shows a large vessel occlusion Pregnancy Seizure at onset with postictal residual neurological impairments May now give IV TPA if you are convinced residual deficits are not likely explained by the seizure UPDATES ON IV TPA USE: RELATIVE EXCLUSION CRITERIA Major surgery or serious trauma within previous 14 days Call the surgeon to discuss the circumstances if feasible Recent gastrointestinal or urinary tract hemorrhage (within 21 days) Recent acute myocardial infarction (within previous 3 months) Call cardiology and see what risks of pericardial/ myocardial bleeding may be (STEMI vs NSTEMI etc.) RELATIVE EXCLUSION CRITERIA WITH IV TPA USE Must carefully document your reasoning process and obtain informed consent whenever feasible if proceeding despite one or more relative exclusion criteria Good judgment is the intention behind making some of these relative rather than dogmatically absolute Mild dysarthria very disabling for a professional singer or auctioneer

5 IV TPA RADIOLOGICAL EXCLUSION CRITERIA UPDATE CT: early ischemic changes including sulcal effacement, such as gray- white junction blurring are NOT a contraindication to IV TPA They are associated with a worse outcome independent of IV tpa treatment but do not negate the net therapeutic gain of IV TPA use Obtaining additional imaging including MRI/ MRA or CTA should not delay IV TPA administration UPDATES ON IV TPA USE: LAB REQUIREMENT CHANGES LABS: only a blood glucose result is now mandatory prior to IV TPA initiation Obtaining or waiting for additional labs should NOT delay initiation of IV TPA Still need an aptt if patient has had heparin use within 48hrs Still need PT INR for warfarin pts treated within 3 hours (any warfarin use is contraindication beyond 3 hrs even with normal PT INR) LESS THAN 3 HOURS VERSUS 3 TO 4.5 HOUR EXCLUSION CRITERIA: THE DIFFERENCES EXCLUSION <3 HOURS 3 TO 4.5 HRS. Time to treatment Within 3 hours 3 to 4.5 hours Age No age limit Age>80 PT INR for pts on warfarin >1.7 Any PT INR value NIH score No upper limit NIH>25 Prior stroke and diabetes Stroke within past 90 days Any prior h/o both stroke and diabetes

6 PITFALLS IN IV TPA USE: HISTORY HISTORY: accurate onset time is critical witnessed onset how did patient or witnesses know time? Time elapsed (if any) between symptom onset and last seen normal TV shows, phone conversations PITFALLS IN IV TPA USE: HISTORY unwitnessed onset last known to be normal phone conversations neighbors, coworkers awakening with stroke inpatient stroke nurses notes ancillary staff, family PITFALLS IN IV TPA USE: RAPIDLY IMPROVING DEFICITS The technical language in the exclusion criterion is rapidly resolving deficits Most frequently given and controversial reason for not giving IV tpa No longer an absolute exclusion criterion Requires physician judgment and documentation For non-disabling minor strokes (NIHSS<4) a clinical trial is needed

7 PITFALLS IN IV TPA USE: RAPIDLY IMPROVING DEFICITS Consider a patient who presents with abrupt onset of expressive aphasia, left gaze preference, right homonymous hemianopsia and right hemiplegia NIHSS= 1a---0; 1b---2; 1c---0; 2---2; 3---2; 4---2; 5---4; 6---4; 7---0; 8---0; 9---3; ; ; TOTAL = 20 What if patient improves to an NIHSS of 10 in 15 minutes time? PITFALLS IN IV TPA USE: RAPIDLY IMPROVING DEFICITS PATIENT #1 1a--- 0; 1b--- 1; 1c ; ; ; ; ; Total = 10 PATIENT #2 1a--- 0; 1b--- 2; 1c ; ; ; ; ; Total = 10 PITFALLS IN IV TPA USE: RAPIDLY IMPROVING DEFICITS SPECIFIC ITEMS IMPROVING SHOWN IN GREEN PATIENT #1 1a--- 0; 1b--- 1; 1c ; ; ; ; ; ; Total = 10 PATIENT #2 1a--- 0; 1b--- 2; 1c ; ; ; ; ; Total = 10

8 PITFALLS IN IV TPA USE: CEREBELLAR STROKES The NIHSS is relatively insensitive to neurological deficits caused by cerebellar strokes (dysmetria, ataxia, nystagmus, dysarthria) IRR for item 7 literally no better than chance Often very difficult to distinguish by history or examination from BPPV, labyrinthitis, EtOH or benzodiazepine intoxication Paying close attention to speech and walking the patient may sometimes help differentiate from mimics Recovery from cerebellar stroke usually very good Common source of (unsuccessful) stroke litigation PITFALLS IN IV TPA USE: MINOR NEUROLOGICAL DEFICITS Remains a highly controversial area PRISMS trial to investigate IV tpa in these patients General rule is need at least 4 points on NIHSS No longer an absolute exclusion criterion Isolated dense homonymous hemianopsia and isolated severe aphasia are two exceptions Truly isolated severe aphasia should score points on item 1b &/or 1c as well CTA done acutely may help identify those at risk for deterioration (especially if cortical deficit present) PITFALLS IN IV TPA USE: ANTIPLATELET MEDICATIONS Combined use of aspirin and Plavix (Clopidogrel) is not a contraindication to IV tpa use but does probably raise the risk of bleeding as compared to aspirin alone Combined use of aspirin + prasugrel (Effiant) raises the risk of bleeding even more than ASA + Plavix (Clopidogrel) in stroke patients and should probably be avoided in most patients

9 PITFALLS IN IV TPA USE: BLEEDING AFTER IV TPA Stop infusion if bleeding or suspected bleeding identified Check STAT CBC [with platelets], fibrinogen levels, head CT (in ICH suspected) 12 U platelet transfusion Check fibrinogen q 4 hrs until 24 hrs post- TPA if fibrinogen less than 100, infuse cryoprecipitate 6 bags and repeat fibrinogen level again STAT until greater than 100 (6 bags raises fibrinogen by appx in a 70kg person) PITFALLS IN IV TPA USE: ANGIOEDEMA DURING/AFTER TPA INFUSION Typically occurs near the end of the IV TPA infusion Bradykinin pathway mediated Patients on ACE inhibitors at increased risk (perhaps as high as 1:500 to 1:1000) Stop infusion, administer SQ epinephrine, racemic epinephrine aerosol, IV steroids [typically methylprednisolone], and antihistamine [typically diphenhydramine] Self- limited Avoid intubation if feasible and safe to do so RECANALIZATION RATES VERSUS OUTCOME IN IA THERAPY Nogueira. AJNR Am J Neuroradiol 30: May 2009 AJNR Am J Neuroradiol 30: May 2009

10 THE 50% BARRIER In clinical trials of neurointerventional therapy, good clinical outcomes fail to exceed 50% despite improving recanalization rates Is this a physiological barrier rather than a technical barrier HYPOTHESIS: Do slightly less than or equal to 50% of acute large vessel occlusion ischemci stroke patients have a robust enough collaterals blood supply to sustain the ischemic brain tissue until revascularization is achieved? Duration and Degree of CBF CBF ml / 100g / min Normal neuronal function Abnormal neuronal function Reversible injury Infarction: Irreversible injury 1 Time (hrs) 2 Duration and Degree of CBF 25 Normal neuron CBF ml / 100g / min Reversible injury Irreversible injury Time (hrs) 2

11 Percentage of Patients The Capillary Index Score CIS A Marker of Residual Viable Tissue in the Ischemic Area A New Method for Better Patient s Selection in Acute Ischemic Stroke Al Ali f et al. J NeuroIntervent Surg 2013;5: doi: neurintsurg DIFFERENTIATING ISCHEMIC BUT VIABLE FROM NON-VIABLE BRAIN TISSUE The capillary blush is the hallmark of normal cerebral tissue on Diagnostic Cerebral Angiogram (DCA) The extent of normal capillary blush on DCA gives an accurate and instant depiction of the percentage of viable (salvageable) tissue in the ischemic area territory = The Capillary Index Score (CIS) % %0 14.2% 85.7% Capillary Index Score % mrs % % F CIS represent the highest possible % of m RS 0-2

12 All CIS F CIS P CIS No of Patients (42%) 15 Average age Time form ictus to recanalization NIHSS ASPECTS Recanalization (TIMI 2 OR 3) Good outcome mrs 0-2 of treated patients 72% 69% 91% 53% 27% 23% 55% 0% PERCENTAGE OF PATIENTS WITH FAVORABLE CIS 46% 45% 44% BMC IMS I, II 43% 42% 41% 40% BMC IMS I, II 70% 60% 55% 62% 47% 50% 40% 30% 20% P CIS 0,1 10% 0% 7% 10% F CIS 2,3 F CIS 2,3 BMC IMS I, II IMS III P CIS 0,1

13 0% 14% 13% 13% 12% 10% 8% 6% TICI 0,1 TICI 2,3 4% 2% BMC IMS I, II IMS III 90% 86% 90% 80% 70% 64% 60% 50% 40% 30% 20% 10% 0% 29% TICI 2,3 TICI 0,1 TICI 2,3 BMC IMS I, II mrs 0-2 IMS III mrs 0-2 TICI 0,1 100% 80% 60% CIS = 0 with any revascularization CIS = 3 with TICI 3 40% 20% 0% BMC IMS I, II IMS III CIS = 3 with TICI 3 CIS = 0 with any revascularization

14 NIHSS 8 NEHCT Abnormal No IA treatment Normal Abnormal CT: - Bleed -1/3 MCA hypodensity -ASPECT 5 CTA Note Time from ictus is NOT considered in this algorithm NO LVO: No IA treatment CIS LVO -NEHCT: Non enhanced head CT -LVO: Large vascular occlusion CIS =0 No IA treatment CIS =1 Perhaps? CIS (1,2,3) Treat OUTCOMES BASED ON CIS SELECTION BMC IMS I,II IMS III Actual % of m RS % 32% 32% If We chose CIS % 41% 36% If We Chose f CIS (CIS 2-3) 55% 62% 46% CONCLUSION The 50% Barrier: you are born with robust collaterals or not Time available to rescue the ischemic area varies from patient to patient, depending on the available collaterals (residual CBF) hence the relying on arbitrary time cutoff or rushing to intervention prior to obtaining reliable information on tissue viability is NOT likely to ever be a successful strategy in a clinical trial

15 ICBF (cc / 100 gms / min) Time to Permanent Damage y = 6.3ln(x) + 3 R² = Time (in hrs of MCA occlusion)

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