Patient Transfer. Mark de Belder The James Cook University Hospital Middlesbrough

Transcription

1 Patient Transfer Mark de Belder The James Cook University Hospital Middlesbrough

2 Current Management Strategies for ACS ACS No ST Elevation ST ST Elevation Elevation Early Invasive Early Conservative Fibrinolysis Fibrinolysis Fibrinolysis PRIMARY Primary Primary PCI PCI

3 Guidelines for the management of non-stemi Acute Coronary Syndromes Coping with ACS angiography Rapid turnover of patients required (pressure on ambulance services) Organisation of diagnostic and revascularisation services Cath lab spaces required every day in interventional centres Referral to a specific cath lab slot rather than a specific Consultant Increased use of Cath? Proceed slots (for elective work as well) Referring hospitals need to take some patients back after revascularisation (?swaps) Weekend working? Elective work may have to slow pending an increase in the infrastructure for angiography Clinical networks with appropriate support from commissioners

4 Patient Transfer in the setting of STEMI

5 Meta-analysis of 23 randomised trials 7739 patients: 4-6 week data Keeley EC, Boura JA, Grines CL The Lancet 2003;361: % 12% 10% P= P= P< P= P< % 6% PCI Lysis 4% 2% 0% Death Exc.Shock Non-fatal MI CVA Combined

6 Meta-analysis of 8 randomised trials Streptokinase trials patients Keeley EC, Boura JA, Grines CL The Lancet 2003;361: % 16% 14% 12% 10% 8% 6% 4% 2% 0% 0.53 ( ) 0.11 ( ) 0.32 ( ) 0.40 ( ) Death Non-fatal MI CVA Combined PCI Lysis

7 Meta-analysis of 15 randomised trials Fibrin-specific trials patients Keeley EC, Boura JA, Grines CL The Lancet 2003;361: % 12% 10% 0.80 ( ) 0.42 ( ( ) 0.57 ( ) 8% 6% PCI Lysis 4% 2% 0% Death Non-fatal MI CVA Combined

8 Meta-analysis of 5 randomised trials Transfer for PCI vs On-Site Lysis 2909 patients: 4-6 week data Keeley EC, Boura JA, Grines CL The Lancet 2003;361: % 14% 12% 10% 8% 6% 4% 2% 0% P=0.057 P< P=0.049 P< Death Non-fatal MI CVA Combined PCI Lysis

9 Mortality by time to presentation 14% 12% 10% 8% 6% 4% PCI Lysis 2% 0% <2 hrs 2-4hrs >4hrs Ziljstra EHJ 2002;23:556

10 30-day mortality by time from enrollment to first balloon inflation 16% 14% 12% 10% 8% 6% 4% 2% 0% <60mins 61-75mins 76-90mins >91mins No PTCA PCI Berger P et al, Circ 1999;100:14-20 (GUSTO-IIb)

11 Door-to-Balloon times in Primary PCI outside of trials N=27,080 Cannon CP, Gibson CM, et al. JAMA P=NS P=NS P=0.01 P= P= >180 N=2,230 N=5734 N=6616 N=4461 N=2627 N=5412 Corrected for age, anterior MI location & gender

12 134 (33%) unscheduled Urgent PCI 295 (70%) unscheduled PCI within 30 days 16 (4%) unscheduled urgent PCI 60 (14%) unscheduled PCI within 30 days CAPTIM Comparison of Angioplasty and Prehospital Thrombolysis in Acute Myocardial Infarction Bonnefoy E et al, The Lancet 2002;360: A trial of prehospital fibrinolysis plus selected PCI 840 randomised 419 pre-hospital alteplase 421 primary PCI 5 primary PCI 14 no lysis 16 had no angiography 41 no PCI 400 pre-hospital alteplase 364 primary PCI

13 CAPTIM Comparison of Angioplasty and Prehospital Thrombolysis in Acute Myocardial Infarction Bonnefoy E et al, The Lancet 2002;360: Physician-manned mobile emergency-care units (Service d Aide Medicale d Urgence SAMU) Planned for 1200 patients Trial terminated early due to lack of funding 30 day Composite Pre-hospital lysis n=419 Primary PCI n=421 P value 34 (8.2%) 26 (6.2%) 0.29 Death 16 (3.8%) 20 (4.8%) 0.61 Reinfarction 15 (3.7%) 7 (1.7%) 0.13 Death & recurrent ischaemia 57 (13.5%) 41 (9.8%) 0.06 Disabling Stroke 4 (1%)

14 Pre-hospital lysis - ER-TIMI19 Morrow DA et al, JACC 2002;40: pts (65 cath d) vs 650 in-hospital lysis pts EMS Arrival EMS Arrival Pre-hosp rpa 13% >70% STres ED Arrival 4.7% death 3.3% remi % ICH In-hospital lysis 90mins post-lysis 49% >70% STres 65 (21%) cath d 56 (18%) PCI 33% >70% STres mins 90mins post-lysis 48% >70% STres mins

15 Why so little primary PCI in UK? Lack of evidence? Belief in pre-hospital lysis? Insufficient PCI centres? Too few cardiologists? (Interventional) cardiologists have too many other things to do? Reluctance to take on nocturnal work? Competing demands for finances (statins, ACE-I, DES, ICDs etc)? Lack of organisation?

16 Transferring patients for Primary PCI Zijlstra F et al, Heart 1997;78:333-6 The Weezenlanden Hospital, Zwolle Local patients Transferred Symptom-onset to admission Local admission to WZL admission WZL door-to-balloon time N=416 N= (69) mins 90 (60) mins - 70 (27) mins 67 (28) mins 39 (31) mins Total ischaemia time 196 (74) mins 200 (62) mins Transfer patients (104) 10 in shock (1 died) 1 ventilated prior to transfer 1 intubated during transfer 1 VT lignocaine 2 VF defibrillated 2 required IV fluids

17 Helicopter vs Ambulance transfer for Primary PCI Straumann E et al, Heart 1999;82:415-9 Triemli Hospital, Zurich Distance (km) Journey time (mins) Total transfer time (mins) Ambulance N=54 Helicopter N=14 Total N=68 Sig 8 (5-68) 42 (24-122) 9 (5-122) (15-126) 37 (7-60) 50 (18-110) 63 (40-115) 55 (18-115) patients died in shock prior to transfer 0 patients transferred died 8 patients were ventilated during transfer 0 defibrillation during transfer (15 resuscitated prior to transfer)

18 AIR PAMI 138 patients: 30 day data (trial stopped for poor recruitment) Grines CL et al, JACC 2002;39: % 30% 25% P=0.46 P=1.0 P=0.11 P=0.33 P= % 15% 10% PCI Lysis 5% 0% Death Non-fatal remi CVA MACE Ischaemia 79% ambulance transfer 26±28 miles; 21% Helicopter 57±50 miles 0 patients needed resuscitation during transfer, 0 patients died ER to treatment times 174±80 for transfer vs 63±39 mins for local lysis

19 22 referring hospitals 5 PCI centres DANAMI-2 Serving two thirds of the Danish population (5.4million) Plan for 1100 patients at referring hospitals and 800 patients at invasive centres Average distance 35 miles (56km) Up to 95 miles (153km) Halted by Safety & Efficacy Committee after 1129 patients enrolled because of clear efficacy in PCI patients

20 Anderson HR et al, ACC 2002; Oral Presentation DANAMI-2 Trial design ST-elevation MI < 12 hours Randomization (total planned 1900 pts) * Referral Hospital: Planned 1100 pts at 24 sites * Angioplasty Center: Planned 800 pts at 5 sites Fibrinolysis Accelerated tpa (max. 100 mg) Stent Acute transfer for 1 PTCA + stent Primary Endpoint: Death, Reinfarction, or Disabling Stroke through 30 days

21 1 PCI Lysis DANAMI-2 - Time from Symptom Onset to Admission and Time from Door to Rx Hospital Referral Symptom to Hosp. Door to t-pa Invasive Symptom to Hosp. Door to t-pa Average Door to Balloon (jncludestransfer) < 120 minutes Referral Invasive Symptom to Hosp. Symptom to Hosp. admit to transfer transfer Door to PCI Door to PCI (Balloon) minutes ACC 2002; Oral presentation

22 DANAMI-2 Transfer problems AF in 2.5% VT in 0.2% VF 1.4% 2/3 heart block in 2.3% 0 intubations 0 deaths

23 % of Patients DANAMI-2: 30 day Primary Endpoint All Patients p = Accel. t-pa (n=782) PCI (n=790) p = p < p = Combined* Death Reinfarction Disabling Stroke *Primary Endpoint: Death, Reinfarction, or Stroke ACC 2002; Oral presentation

24 % of Patients DANAMI-2: 30 day Primary Endpoint* Referral vs. Invasive Hospitals p= p=0.002 Accel. t-pa PCI p= All patients (n=1572) Referral hospitals (n=1129) *Primary Endpoint: Death or Reinfarction or Stroke Invasive Centers (n=443) ACC 2002; Oral presentation

25 DANAMI 2: Time to treatment 30 day results 20% 18% 16% 14% 12% 10% 8% 6% 4% 2% 0% <1.5hrs hrs 2.5-4hrs >4-12hrs Combined end-point - All significant PCI tpa

26 DANAMI 2: Results by age group 30 day results 30% 25% 20% 15% 10% PCI tpa 5% 0% <55yrs Combined end-point - All significant

27 PRAGUE T'lysis 429 Transport Time to treatment 245 minutes 425 transported 2 died and 3 VF in transit 1.2% complications 4 stayed Early Shock T'lysis 3 died Time to treatment 277 minutes (+32 minutes) Widimsky P et al, ESC 2002

28 PRAGUE 2: 30 day mortality 16% 14% 12% 10% 8% 6% 4% 2% 0% P=0.12 P=NS P<0.02 Death 0-3hrs 3-12hrs PCI SK Widimsky P et al, ESC 2002 Trial stopped early because of reluctance to enrol patients >3 hours

29 Shock patients Hochman JS et al, NEJM 1999;341: Revascularisation patients n=152 Medical Therapy patients n=150 Transfer patients 55.3% 55.3% Thrombolysis 49.3% 63.3% IABP 86.2% 86% PCI 54.6% 14% CABG 37.5% 11.3% PCI or CABG 86.8% 25.3%

30 Ambulance transfer

31 Strategy for centres with door-to-balloon times >120 mins? Send anyway for primary PCI? Make do with best lysis strategy? As above and select out patients for rescue? Conventional lysis and send for rescue on arrival if required? Half-dose lysis ± GP IIb/IIIa inhibitor and send?

32 Facilitated PCI Studies such as PACT, SPEED, TIMI-14 and GUSTO V suggest that combination pharmacotherapy may improve effects of fibrinolysis, and pharmacotherapy combined with a PCI strategy may improve results of PCI FINESSE and ASSENT IV ongoing High risk patients who cannot be treated with early PCI

33 Current Process for Infarct Angioplasty MI Ambulance Centre

34 MI Centres MI Ambulance Centre

35 Lysis 1 PCI DANAMI-2 - Time from Symptom Onset to Admission and Time from Door to Rx Potential impact of MI centres Hospital Referral Symptom to Hosp. Door to t-pa Invasive Symptom to Hosp. Door to t-pa Could reduce time by mins Referral Invasive Symptom to Hosp. Symptom to Hosp. transfer Door to PCI Door to PCI (Balloon) minutes Paradox: referral patients might get more rapid reperfusion!

36 MI Centres MI Ambulance Centre Ambulance Centre As per C-PORT MI

37 Emergency Ambulance Service Hartlepool 3 Stockton 3 Carlton How 1 Redcar 3 Middlesbrough 3 Coulby Newham 1/2 Blue light trained 1

38 Government policy Is there one? Get the best out of the old treatments before looking at new ones Pilot studies of pre-hospital lysis But data already available from Scotland, N. Ireland, France, Holland, Germany, Belgium, USA and Israel! A better approach? Get the best out of the old treatments and look at new ones Look at studies of pre-hospital lysis and allow (ie fund) introduction (?via NICE) Look at studies of primary PCI and allow (ie fund) introduction (?via NICE)

39 Conclusions If clinical investigators can organise trials, then governments, commissioners and clinical cardiologists should be able to organise an infarct angioplasty service

40 Feasible Conclusions Patient transfer in AMI Cardiovascular events are uncommon Need paramedics, ALS trained nurses or doctors Appropriately equipped ambulances Continuous ECG monitoring Defibrillation Mechanical ventilation Thrombolytic agents IV fluids Resuscitation drugs Ability to transfer IABP Need new law to oblige rapid ambulance response to AMI transfer requests (<8 minute response time)

41 Conclusions Primary PCI vs Fibrinolysis If hospital fibrinolysis is local strategy, change to primary PCI, at least for all patients presenting >3 (?>2) hours after symptom onset If pre-hospital fibrinolysis is local strategy, need appropriate numbers of appropriately equipped and staffed ambulances Such a strategy requires a PCI strategy Contraindication to lysis Early shock High risk rescues Re-infarction If such ambulance crews exist, then use them for transfer for primary PCI (as the PCI team exists anyway)!

42 Conclusions For PCI centres (on-site surgery) with 4 or more interventionists primary PCI should be preferred treatment for STEMI??offer fibrin-specific lysis to patients presenting in first 3 hours at night) For PCI centres with off-site surgery - Local arrangements needed for surgical candidates.

43 Conclusions For centres that cannot offer PCI but transfer possible within 3 hours - transfer patients to local PCI centre for primary PCI??offer fibrin-specific lysis to patients presenting in first 3 hours but respond to ongoing problems). For centres that cannot offer PCI, when transfer within 3 hours not possible - use fibrinolysis but consider protocol for immediate transfer of patients to PCI centre (?all-comers or selective). Role of facilitated PCI to be determined

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45 DANAMI 2: 30 day results 25% P< % 15% 10% remi No remi 5% 0% Death

46 DANAMI day data (6months-4 years) End-point Fibrinolysis PCI P value NNT Combined - All patients 24.2% 17.8% Combined - Referral hospitals 23.3% 16.9% Mortality - All patients 16% 13.4% Mortality - Referral hospitals 15.3% 11.9% Anderson HR et al, XIVth World Congress of Cardiology 2002

47 Is simple primary PCI still going to be best? Vermeer et al, Heart 1999;82: % 14% 12% 10% 8% 6% 4% 2% 0% In-hospital mortality Conservative Rescue Primary PCI