Intravenous thrombolysis: the Modena experience

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Leonora Patrizia Marchetti
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1 Intravenous thrombolysis: the Modena experience Dr. Andrea Zini, MD Stroke Unit Neurology Clinic Dept. of Neuroscience Nuovo Ospedale Civile S.Agostino-Estense AUSL Modena

2 History Modena Neurology Clinic has always admitted stroke patients Modena Stroke Unit opened in Modena Hospital-based Stroke registry started in : participation to AbESTII trial (Abciximab <6 h): stopped 2005: participation to SITS-MOST study. Authorization to IVT. 27-dec-2005: the Dept. of Neuroscience was transferred from Policlinico di Modena to Nuovo Ospedale Civile di Baggiovara (Azienda USL).

h): stopped 2005: participation to SITS-MOST study. Authorization to IVT. 27-dec-2005: the Dept.

3 Nuovo Ospedale Civile Sant Agostino-Estense

4 Nuovo Ospedale Civile Sant Agostino-Estense New Dept. of Neuroscience University of Modena and Reggio Emilia Stroke Unit: 6 monitored bed plus 8 beds inside neurology ward (Organised stroke care based on intensity of care) RIS-PACS (connecting all 8 Modena hospitals) Neuroradiologist on duty h24/h24 since 2006 Local acute stroke management protocol since 2006 Interventional neuroradiology since 2008

inside neurology ward (Organised stroke care based on intensity of care) RIS-PACS (connecting all 8

5 Nuovo Ospedale Civile Sant Agostino-Estense Vascular neurologists are dedicated in Stroke Unit but integrated in the neurology ward. All neurologists perform i.v. thrombolysis. Neurologist on duty h24/h24 Case manager for acute stroke in ER is the neurologist Multisciplinary staff: dedicated neurologists, nurses, physiatrist, physiotherapists and speech therapist. Continuing stroke education program

Neurologist on duty h24/h24 Case manager for acute stroke in ER is the neurologist Multisciplinary

6 Emilia-Romagna

7 Lowlands 86,000 SP Metropolitan area 459,000 Baggiovara HUB Baggiovara Hospital 5 Spoke Hospitals without stroke care 2 Spoke Hospitals (Carpi and Pavullo) with stroke care Mountain area 59, ,286 residents

without stroke care 2 Spoke Hospitals (Carpi and

8 Early recanalization and reperfusion 90 mins NNT=4 to 5 90 min - 3 h NNT= h NNT=14 mrs, modified Rankin Scale Pazients treated to be independent at 3 months (mrs 0-1) (Lees et al. Lancet 2010;375: )

5 h NNT=14 mrs, modified Rankin Scale Pazients

10 To reduce DNT: 1. Pre-notification by the EMS personnel, optimally directly to stroke neurologist. 2. EMS will insert an IV line with a large-bore needle and collect laboratory exams during the transport. 3. Empty the CT room prior to patient s arrival 4. Neuroradiology staff members, ER staff and stroke neurologist are alarmed during the transport and waiting for the patient in the ER at the estimated arrival time. 5. Use a stretcher scale to weigh the patient in ER 6. Use a neuroimaging protocol 7. Deliver thrombolysis directly in CT room. 8. Continuing monitoring process indicators and improving quality of care

Neuroradiology staff members, ER staff and stroke neurologist are alarmed during the transport and waiting for the patient in the ER at the estimated

11 Modena Experience IVT and EVT :753 Totale 983 :230

14 Ischemic stroke: % IVT Year 2013 PROVINCE N. CASI t-pa N. % PIACENZA ,4% OSPEDALE FIDENZA 11 AOSPU OSPEDALI RIUNITI - PR 43 PARMA ,2% REGGIO EMILIA ,1% MODENA ,9% AVEN ,3% OSPEDALE MAGGIORE 46 AOSPU S.ORSOLA-MALPIGHI - BO 37 OSPEDALE IMOLA 8 BOLOGNA ,6% FERRARA ,7% AVEC ,9% RAVENNA ,0% FORLI' ,7% CESENA ,8% RIMINI ,0% USL ROMAGNA ,2% TOTALE ,8%

MODENA 1.248 149 11,9% AVEN 3.451 357 10,3% OSPEDALE MAGGIORE 46 AOSPU S.

15 Ischemic Stroke: 30 days mortality in Emilia Romagna region, year 2013

16 Equity of access to IVT

(min) Onset-door time 61.2 Door-needle time 66.0 Onset needle time 127.

17 Modena Telestroke Project Started in 2013: 1st year: 7 telestroke, 0 telethrombolysis 2nd year: 16 telestroke, 4 telethrombolysis Telestroke Timing (min) Onset-door time 61.2 Door-needle time 66.0 Onset needle time Mountain area near Pavullo Hospital (admitted about 80 ischemic strokes per year) about residents

18 Advanced Neuroimaging CBF MTT WAKE-UP STROKE CBV

19 3-months mrs on-label vs. time window off-label IVT pts

24 3-months mortality IVT <4.5h (years ) Mortalità % IC Modena 8.7% Italy 10.5% SITS-ISTR 12.9%

25 3-months mrs 0-2 IVT <4.5h years Modena Italy SITS

26 Time logistics/time delay (median) IVT <4.5h Median Onset to Door time Door to Needle time Onset to Needle time minutes reduction in DNT in 2 years (-16%)

27 IVT

28 Participation to RCT Trial Years Recruitment ABeSTT II (2004) 5 IST-3 ( ) 40 TESPI ( ) 18 Synthesis Expansion ( ) 51 DIAS-4 ( ) 10 BASICS (2012-ongoing) 3 ULTRAS (2014- ongoing) 0 SWIFT PRIME EC approval 0

29 Abstract to the World Stroke Conference Seiffge DJ et al., for the Novel oral anticoagulants in stroke patients (NOACISP) study group

30 Bleeding risk after iv rtpa

31 Early fibrinogen degradation coagulopathy after iv rtpa

34 Fibrinogenemia (mg/dl) Andamento fibrinogenemia nelle 24 h post-trombolisi Fibrinogenemia media basale Fibrinogenemia media a 2h Fibrinogenemia media a 6h Fibrinogenemia media a 12h Fibrinogenemia media a 24h Popolazione totale 339,8 mg/dl 254,5 mg/dl (-21.6%) 254,8 mg/dl (-21,20%) 257,5 mg/dl (-20%) 278,7 mg/dl (-12,8%) Gruppo fibrinogeno basso 362 mg/dl 225,3 mg/dl (-33,5%) 222,8 mg/dl (-33,9%) 225,6 mg/dl (-32,6%) 241,7 mg/dl (-27,6%) Gruppo fibrinogeno normale 319,3 mg/dl 281,7 mg/dl (-10,5%) 284,7 mg/dl (-9,3%) 287,3 mg/dl (-8,2%) 313,2 mg/dl (+0,9%) Popolazione totale Gruppo fibrinogeno basso Gruppo fibrinogeno normale Tempo (ore)

35 Tromboelastrogramma (ROTEM ) ROtation TromboElastoMetry Fibrinolysis Coag Factors Inhibitors Heparin Platelets Leucocytes Red cells

36 Fattori, cellule, Fibrinogeno Piastrine Piastrine Fibrinogeno F XIII Leucociti Eritrociti Enzimi della fibrinolisi Inibitori della fibrinolisi

37 Ictus ischemico e trombolisi Aprotinina: processo fibrinolitico

38 Ictus ischemico e trombolisi Al momento abbiamo osservato 3 SCENARI: IPOFIBRINOGENEMIA IPERFIBRINOLISI NORMALE

39 Thanks to all doctors, nurses, and paramedics Neurosonologis t Vascolar Surgeon Nurse Neurologist Physiatrist Physiotherapist and speech therapist Neurosurgeon Patient Cardiologist Relatives Neuroradiologist Emergency Room Emergency Medical Services

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