Intravenous thrombolysis: the Modena experience Dr. Andrea Zini, MD Stroke Unit Neurology Clinic Dept. of Neuroscience Nuovo Ospedale Civile S.Agostino-Estense AUSL Modena
History Modena Neurology Clinic has always admitted stroke patients Modena Stroke Unit opened in 2000. Modena Hospital-based Stroke registry started in 2002 2004: 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).
Nuovo Ospedale Civile Sant Agostino-Estense
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
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
Emilia-Romagna
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 59,000 688,286 residents
Early recanalization and reperfusion 90 mins NNT=4 to 5 90 min - 3 h NNT=9 3-4.5 h NNT=14 mrs, modified Rankin Scale Pazients treated to be independent at 3 months (mrs 0-1) (Lees et al. Lancet 2010;375:1695-1703.)
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
Modena Experience IVT and EVT :753 Totale 983 :230
Ischemic stroke: % IVT Year 2013 PROVINCE N. CASI t-pa N. % PIACENZA 528 60 11,4% OSPEDALE FIDENZA 11 AOSPU OSPEDALI RIUNITI - PR 43 PARMA 747 54 7,2% REGGIO EMILIA 928 94 10,1% MODENA 1.248 149 11,9% AVEN 3.451 357 10,3% OSPEDALE MAGGIORE 46 AOSPU S.ORSOLA-MALPIGHI - BO 37 OSPEDALE IMOLA 8 BOLOGNA 1.631 91 5,6% FERRARA 744 50 6,7% AVEC 2.375 141 5,9% RAVENNA 526 16 3,0% FORLI' 277 24 8,7% CESENA 376 18 4,8% RIMINI 436 26 6,0% USL ROMAGNA 1.615 84 5,2% TOTALE 7.441 582 7,8%
Ischemic Stroke: 30 days mortality in Emilia Romagna region, year 2013
Equity of access to IVT 2010 2009 2008 2007 2006 2005 2012 2011 2005-2012
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 127.2 Mountain area near Pavullo Hospital (admitted about 80 ischemic strokes per year) about 20.000 residents
Advanced Neuroimaging CBF MTT WAKE-UP STROKE CBV
3-months mrs on-label vs. time window off-label IVT pts
3-months mortality IVT <4.5h (years 2005-2013) Mortalità % IC Modena 8.7% 6.6 11.5 Italy 10.5% 10 11.1 SITS-ISTR 12.9% 12.6 13.2
3-months mrs 0-2 IVT <4.5h years 2005-2013 Modena Italy SITS
Time logistics/time delay (median) IVT <4.5h Median 2012 2013 2014 Onset to Door time 65 75 83 Door to Needle time 78 68 65 Onset to Needle time 153 145 145 13 minutes reduction in DNT in 2 years (-16%)
IVT
Participation to RCT Trial Years Recruitment ABeSTT II (2004) 5 IST-3 (2008-2011) 40 TESPI (2008-2011) 18 Synthesis Expansion (2008-2012) 51 DIAS-4 (2012-2014) 10 BASICS (2012-ongoing) 3 ULTRAS (2014- ongoing) 0 SWIFT PRIME EC approval 0
Abstract to the World Stroke Conference Seiffge DJ et al., for the Novel oral anticoagulants in stroke patients (NOACISP) study group
Bleeding risk after iv rtpa
Early fibrinogen degradation coagulopathy after iv rtpa
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%) 375 350 325 Popolazione totale 300 275 250 Gruppo fibrinogeno basso Gruppo fibrinogeno normale 225 200 0 2 6 12 24 Tempo (ore)
Tromboelastrogramma (ROTEM ) ROtation TromboElastoMetry Fibrinolysis Coag Factors Inhibitors Heparin Platelets Leucocytes Red cells
Fattori, cellule, Fibrinogeno Piastrine Piastrine Fibrinogeno F XIII Leucociti Eritrociti Enzimi della fibrinolisi Inibitori della fibrinolisi
Ictus ischemico e trombolisi Aprotinina: processo fibrinolitico
Ictus ischemico e trombolisi Al momento abbiamo osservato 3 SCENARI: 23 1 - IPOFIBRINOGENEMIA IPERFIBRINOLISI NORMALE
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