2012/13 NHS STANDARD CONTRACT FOR ACUTE, AMBULANCE, COMMUNITY AND MENTAL HEALTH AND LEARNING DISABILITY SERVICES (MULTILATERAL)

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1 A9d 2012/13 NHS STANDARD CONTRACT FOR ACUTE, AMBULANCE, COMMUNITY AND MENTAL HEALTH AND LEARNING DISABILITY SERVICES (MULTILATERAL) SECTION B PART 1 - SERVICE SPECIFICATIONS Service Specificatin N. A9d Service Primary percutaneus crnary interventin (PPCI) Cmmissiner Lead Simn Griffith Prvider Lead Perid 12 mnths Date f Review Octber Ppulatin Needs 1.1 Natinal/lcal cntext and evidence base Percutaneus crnary interventin (PCI), r crnary angiplasty, is a prcedure carried ut under lcal anaesthetic in which narrwings (stenses) f the crnary arteries are dilated with a balln catheter and are then treated with a stent (a tubular metal ally device) which is implanted int the artery. The stent prvides a permanent internal scaffld t maintain patency f the artery. In patients with a specific frm f heart attack knwn as ST segment elevatin mycardial infarctin (r STEMI); the artery supplying the relevant area f heart muscle is usually cmpletely blcked by a cmbinatin f atherma and bld clt. Primary angiplasty (PPCI) is the use f the PCI technique t relieve the blckage as the main r first treatment fr patients suffering a heart attack. The alternative treatment fr patients experiencing an ST Segment Elevatin Mycardial Infarctin (STEMI) is fibrinlysis: this invlves the intravenus administratin a clt busting drug which is injected as sn as pssible after a heart attack t disslve the blckage in the artery. Fibrinlysis, hwever has a number f disadvantages; arund 30% f STEMI patients will have a cntraindicatin t fibrinlytic drugs and the drugs are successful in re-pening the

2 blcked vessel in nly arund 60-70% f cases. Even if the vessel is successfully re-pened, the rate f re-cclusin, causing a further heart attack, is high. Fr all f the abve reasns, primary percutaneus crnary interventin (PPCI) is the preferred reperfusin treatment fr patients presenting with ST segment elevatin mycardial infarctin (STEMI). During the third quarter f 2008, just 46% f thse STEMI patients in England wh received reperfusin treatment were being treated by PPCI while the remaining 54% were treated with thrmblysis. Fllwing the publicatin f the NIAP reprt in 2008 (see belw), there was a crdinated rll-ut f PPCI services in England. The use f primary angiplasty cntinued t increase between 2008 and By the secnd quarter f 2011, 94% f STEMI patients in England were being treated with PPCI. The rate f primary PCI reached 287 pmp in This treatment ptin was prvided 24/7 by 52 f the 97 NHS PCI centres (Natinal Audit f Percutaneus Crnary Interventin 2011 Annual Reprt). Evidence Base fr PPCI Percutaneus crnary interventin (PCI) had been used by individual centres fr the treatment f acute ST-elevatin mycardial infarctin (STEMI) fr many years, but it was nt until the DANAMI-2 and PRAGUE-1 & 2 trials (and the ensuing meta-analysis by Keeley et al) that primary PCI (PPCI) became mre widely acknwledged as the preferred methd f reperfusin (1-4). Trial evidence had demnstrated the benefits f PPCI ver fibrinlysis, but in the UK the infrastructural and rganisatinal changes required fr implementatin were unclear, and the cst-effectiveness and sustainability f a 24/7 PPCI reperfusin strategy had nt been tested. In additin, any prpsed change was t be made against the backgrund f a previusly successful in-hspital fibrinlysis strategy. In December 2006, the Department f Health published the reprt Mending Hearts and Brains clinical cases fr change. The reprt advcated a PPCI service, running 24 hurs a day, 7 days a week basis as a first treatment fr heart attacks. It als stated that by bypassing lcal hspitals t deliver PPCI in centres f excellence fr heart attack victims culd save an estimated 500 lives, and may prevent arund 1,00 further heart attacks and arund 250 strkes. Treatment f a Heart Attack Natinal Guidance Final Reprt f the Natinal Infarct Angiplasty Prject (NIAP) In 2008 the Department f Health guidance Treatment f Heart Attack reprted the utcmes f the Natinal Infarct Angiplasty Prject (NIAP) were reprted. Analysis f the evidence shwed that: PPCI reduces mrtality and imprves lnger-term utcme cmpared with fibrinlysis when delivered within a similar timeframe. 2

3 In-hspital mrtality fr patients underging PPCI was 5.2% and 7.1% fr thse given fibrinlysis. At 18 mnths mrtality rates were 9.9% fr patients wh had received PPCI and 14.8% fr thse wh had been given fibrinlysis. Patients wh were admitted directly t the catheter labratry bypassing accident and emergency departments had the lwest mrtality. Mre patients are ptentially suitable fr PPCI than fibrinlysis and PPCI is assciated with fewer strkes and recurrent heart attacks during the hspital admissin. The greatest delay in prviding effective treatment is ften the time taken fr patients t recgnise that they have a prblem and call fr help. Vlume and Outcme Relatinships fr PCI and PPCI Fr PCI in general, there is evidence suggesting imprved utcmes fr patients being treated in higher vlume PCI centres, particularly thse that perfrm at least 400 prcedures per annum (pa). This frms part f the recmmendatins f the Jint Wrking Grup n PCI f BCIS and the British Cardivascular Sciety (5). In 2010, 25% f PCI units were perfrming 400 r less cases pa, althugh sme f these were new units undertaking a gradually increasing vlume f wrk Primary PCI fr STEMI is a much higher risk prcedure than PCI fr stable patients r fr nn-stemi acute patients. PPCI patients have a much higher rate than stable PCI patients f requiring a secnd visit t the cath lab fr repeat prcedure (after stent thrmbsis), intra-artic balln pump insertin etc. Primary PCI is a service, therefre, which must be prvided 24 hurs a day, 7 days a week, 365 days a year with cntingencies t deal with brken cath lab, staff illness etc. When PPCI services were being develped acrss England, mst cardiac netwrks designed their service in such a way that all STEMI patients were taken t a 24/7 PPCI centre. A minrity f services were set up with smaller lcal hspitals prviding a limited hurs service (typically Mn - Fri 9-5 r 8-8) with the ut f hurs presenters being taken t the nearest 24/7 centre. The issue was whether the pssibly better utcmes f the larger PPCI centre are ffset by the pssibility f shrter call-t-balln times had the patients been taken t a lcal hspital that invlved a shrter travelling time. This issue is unreslved althugh the Eurpean Sciety f Cardilgy guidelines are specific n this pint nly hspitals with an established interventinal cardilgy prgramme (24 h/7 days) shuld use primary PCI as a rutine treatment ptin fr patients presenting with the symptms and signs f STEMI (5). The Eurpean Sciety f Cardilgy has advcated ne 24/7 PPCI centre fr every 600,000 t 1 millin f the ppulatin based n a PPCI rate f 600 per millin. In the UK, the rate f PPCI is lwer than in east Eurpean cuntries and is currently arund per millin. 3

4 The clear cnsensus view f the Clinical Reference Grup was that PPCI patients shuld nly be treated in 24/7 centres nly in keeping with ESC guidelines and that high vlume centres, where all members f the cath lab and ward teams were familiar with the presentatins and cmplicatins assciated with STEMI patients, were likely t achieve better utcmes. Fr a 24/7 centre t treat 300 PPCI patients wuld require a catchment ppulatin f arund 1 millin. Sme centres (Lndn, Manchester, Liverpl, Newcastle, and Leeds) will have much larger catchment ppulatins. The views f the CRG culd be summarised as fllws: PPCI patients shuld be treated in 24/7 PCI centres. PPCI centres are likely t be treating 300 r mre PPCI patients per annum, with an abslute minimum f 100 PPCI patients per annum as per BCIS guidance. A PPCI centre shuld have 2 r mre cardiac catheter labratries. It is recgnised that there may be exceptins t the guidance n bth chice f reperfusin strategy (PPCI vs fibrinlysis) and numbers in the mre remte areas f England where the cmmissiners will have t balance the arguments in favur f transfer t a large vlume PPCI centre against the inherent delay in receiving treatment. Mst peple nw believe that utcmes with PPCI are better than with lysis fr mst patients with a Call-t-balln time f 150 minutes r less. Allwing minutes fr initial assessment f the patient, and a dr-t-balln time f minutes fr an expected patient, this allws a travel time t the PPCI centre f minutes. A travel time t a PPCI centre exceeding minutes prbably applies t n mre than 5% f the ppulatin f England. References 1. Andersen HR, Nielsen TT, Rasmussen K, Thuesen L, Kelbaek H, Thayssen P, Abilgaard U, Pedersen F, Madsen JK, Grande P, Villadsen AB, Krusell LR, Haghfelt T, Lmhlt P, Husted SE, Vighlt E, Kjaergard HK, Mrtensen LS fr the DANAMI 2 Investigatrs. A cmparisn f crnary angiplasty with fibrinlytic therapy in acute mycardial infarctin. NEJM. 2003;349: Widimsky P, Grch L, Zelizk M, Aschermann M, Bednar F, Suryapranata H. Multicentre randmized trial cmparing transprt t primary angiplasty vs immediate thrmblysis vs cmbined strategy fr patients with acute mycardial infarctin presenting t a cmmunity hspital withut a catheterizatin labratry. Eur Heart J. 2000;21: Widimsky P, Budesinsky T, Vrac D, Grch L, Zelizk M, Aschermann M, Branny M, St asek J, Frmanek P, n behalf f the PRAGUE Study Grup Investigatrs. Lng-distance transprt fr primary angiplasty vs immediate thrmblysis in acute mycardial infarctin. Final results f the randmized natinal multicentre trial PRAGUE-2. Eur Heart J. 2003;24:

5 4. Keeley EC, Bura JA, Grines CL. Primary angiplasty versus intravenus thrmblytic therapy fr acute mycardial infarctin: a quantitative review f 23 randmised trials. Lancet. 2003:361: Management f acute mycardial infarctin in patients presenting with persistent ST-segment elevatin:the Task Frce n the management f ST-segment elevatin Eurpean Heart Jurnal (2008) 29, Scpe 2.1 Aims and bjectives f service Aims The aim f the service is t ensure, where pssible, whle ppulatin cverage t allw patients experiencing ST Segment Elevatin Mycardial Infarctin (STEMI) t be treated by timely PPCI in a Heart Attack Centre (HAC). Access t Primary PCI services will be prvided 24 hurs per day, and 7 days per week. HACs will versee effective discharge planning including ensuring that apprpriate rehabilitatin arrangements are in place. Objectives The service will deliver the aim f prviding timely Primary PCI services, 24 hurs per day, and 7 days per week by: Wrking clsely with Ambulance services and nn-ppci hspital A&E departments t ensure timely and accurate diagnsis. Prviding high quality practive treatment and care. Prviding high quality audit data t ensure that excellent clinical utcmes are maintained. Ensuring that systems are in place t mnitr the timeliness f the whle patient pathway (call t balln time etc). 5

6 2.2 Service descriptin/care pathway Natinal and internatinal guidelines recmmend that in the emergency treatment f patients with STEMI, angiplasty treatment shuld be perfrmed within 90 minutes f arrival f the patient at the angiplasty site, termed dr t balln (DTB) time, and within 150 minutes f a patient s call fr help, termed call t balln (CTB) time. The pathway includes thse patients wh self-present t hspital, thse wh are taken by ambulance t hspital fr assessment, and thse wh are already in hspital at the time f their heart attack whether the first hspital is the PPCI centre r a nn-ppci hspital. Inclusin criteria Symptms cmpatible with an acute MI within the last 12 hurs AND with the fllwing ECG criteria: ST segment elevatin >1mm r mre in cntiguus limb leads r >2mm in cntiguus chest leads LBBB believed t be new in the cntext f acute cardiac sunding chest pain Patients resuscitated frm cardiac arrest with ECG criteria as abve. Nte: Patients with LBBB believed t be pre-existing and apprpriate histry fr MI shuld be discussed with the PPCI service, The inclusin criteria are evidence based t maximise patient benefit; in exceptinal circumstances, if the senir n-site clinician cnsiders a patient des nt meet the standard inclusin criteria, but might still benefit frm PPCI, they shuld discuss the case with the n-call interventinist via the HAC. Patient Assessment Ambulance Assessment In line with lcal ambulance service prtcl Upn arrival at scene the paramedic will establish the clinical histry whilst ensuring ABCs. 6

7 Once it is established that the patient is suspected f having cardiac related chest pain, the patient will be placed n xygen if required t maintain the SpO2 > 94%, then will receive 300 mg f aspirin and GTN and will be transferred t the ambulance at the earliest pprtunity. Once n bard the ambulance the paramedic shuld acquire a 12 lead ECG and determine if a STEMI is evident (defined as elevatin f 1 mm r mre in at least 2 standard limb leads r 2mm r mre in at least 2 adjacent chest leads, nt including V1). If n STEMI is evident, the patient must be transprted t their nearest hspital immediately with apprpriate treatment being prvided en-rute. If a STEMI is evident and if PPCI is available at the present time, then the paramedic must prceed t cmplete the PPCI assessment checklist t establish if the patient meets the inclusin criteria. NOTE: Different PPCI centres and different PPCI centres have different prtcls fr patient referral. Sme ambulance centres send the patient s ECG by telemetry t the PPCI centre; the PPCI centre then reviews the ECG and decides whether r nt t accept the patient fr PPCI. In ther services, there is n ECG telemetry and the patient is accepted n the basis f the interpretatin f the ECG by the paramedic wh has assessed the patient. Bth systems are acceptable. If the patient des nt meet the inclusin criteria then they must be transprted t their nearest hspital immediately fr further assessment. If the patient fully meets the inclusin criteria and has given cnsent in principle t being transprted t a HAC fr the prcedure then the paramedic shuld infrm the HAC that a patient requiring Primary PCI is being transprted t the HAC, giving the patient s name, sex, age and brief f the patient s cnditin and an ETA. The patient must then be transprted t the HAC immediately using visual and auditry warning devices. Attempt at canulatin can be made whilst en-rute and when it is safe t d s, preferably aviding the right wrist and frearm. Whilst en-rute t the HAC the paramedic must cmplete bservatins and administer pain relief. 7

8 In-hspital Assessment STEMI patients presenting at any f lcal hspitals will have access t the 24/7 PPCI based at the HAC. In additin, patients wh have nt fully met the ambulance inclusin criteria and have subsequently been taken t their lcal hspital may then be cnsidered as suitable candidates fllwing further clinical assessment and/r discussin f their individual case with a specialist clinician at the lcal HAC. If the referring hspital identifies the need t discuss the clinical r ECG evidence with the n-call cardilgy cnsultant at the HAC then this will be carried ut with a minimum f delay. Shuld discussin be required regarding an individual case with the n call cardilgist, then the patient s ECG can be faxed t CCU. Once the patient has been assessed as being a suitable candidate t receive PPCI they will then be rapidly transferred t the HAC via ambulance. Patient Preference When a patient is cnsidered suitable fr PPCI the final determinatin in the selectin f this treatment strategy must always be that f patient preference. In btaining the agreement t transfer, it is imprtant that the patient understands the benefits and risks assciated with the treatment they are likely t be ffered at the HAC. This agreement shuld be sught befre transfer t the HAC. If a patient meets the clinical inclusin criteria but des nt cnsent t transfer, then the patient shuld be transprted t their nearest hspital A&E immediately fr further assessment/treatment. They may require fibrinlysis r may cnsent t the prcedure nce they arrive at their lcal hspital. Arranging Ambulance Transfer frm Lcal Hspital t HAC The lcal hspital clinician must arrange an emergency ambulance transfer t the HAC by telephning the cntrl centre. The lcal hspital clinician must then activate the lcal HAC Primary PCI Plicy by telephning the dedicated number. This shuld be dne after requesting an emergency ambulance, t ensure the transfer is as quick as pssible. This prcess will ensure the HAC are infrmed f the patient s imminent arrival, thus activating the internal prtcls that will ensure the PPCI team and the catheter lab are ready t receive the patient. This will include calling in the PPCI team if ut f hurs. The lcal hspital clinician must then ensure that a Hspital PPCI Transfer Checklist is cmpleted and placed within the patient s ntes, ready fr transferring with the patient t the HAC. Patient/Family Infrmatin It is imprtant that the patient and their family/carer/next f kin are kept fully infrmed f their cnditin, the treatment ptins available t them and the risks and benefits assciated with thse treatment ptins. Once cnsent t transfer t the HAC has 8

9 been btained, the patient and/r their family member/carer/next f kin may be handed a Primary PCI Infrmatin Sheet. This infrmatin sheet briefly describes the prcedure they are likely t have at the HAC and gives details f hw t get t the HAC, where they shuld park and what t d/expect when they arrive. Handver Upn arrival at the HAC the ambulance will be met at the cath lab entrance by the Cardiac Specialist Nurse/r a CCU nurse; the paramedic crew and patient will then be escrted t the area f Catheter Lab, where handver will take place. If the crew have a relative accmpanying the patient the relative shuld be directed t the designated waiting area n CCU. Paramedics will then cmplete all relevant dcumentatin including the Patient Reprt Frm (PRF). Cpies f all dcuments and riginal ECGs shuld be handed t the nursing team at the HAC. Cnsent t Prcedure Cnsent fr the prcedure is usually taken, ensuring the clinician wh delivers the explanatin f treatment als explains the risks/benefits and pssible cmplicatins, and any alternative treatment available. They must be either medically qualified r trained in btaining cnsent and deemed cmpetent by the cardilgy cnsultants. If the patient is unable t cmprehend the prcedure (uncnscius patient etc.), then the clinician can cmplete a Frm 4 cnsent stating that he/she believes the prcedure is in the patient s best interests. False Psitive Activatins Sme patients will be referred as pssible r prbable STEMI but will then be cnsidered by the cardilgy team nt t be a STEMI presentatin and nt t require diagnstic angigraphy r PPCI. If the diagnsis is clear-cut (e.g. pericarditis, NSTEMI), then the patient shuld be managed in the usual way. This may invlve admissin t the cardilgy ward, admissin t a medical ward r transfer t the patient s lcal hspital. If the diagnsis is nt clear and an A&E assessment is required t determine diagnsis, then the Cath Lab Team (CSN r Cardilgy Registrar) must speak t the Nurse in Charge f A&E t refer the patient. This may be a referral t the A and E f the PPCI centre if the patient is lcal r a transfer, usually in the ambulance which has brught the patient, t the A and E f the hspital clsest t the patient s hme. The registrar and CSN must stay with the patient until safe transfer has been rganised and delivered. False psitive referrals will be audited and fed back t the relevant management teams and persnnel. 9

10 False Negatives If patients are taken t their lcal A&E by ambulance, and are then cnsidered t have a first ECG fulfilling the criteria fr PPCI, the patient will be referred fr PPCI and the infrmatin fed back t the relevant management teams and persnnel. In-Patient Stay Fllwing the prcedure all patients will be transferred frm the catheter labratry t the Crnary Care Unit fr a perid f mnitring. Different PPCI centres will have different arrangements with the nn-ppci hspitals within their netwrk. In sme netwrks, the patient will remain in the PPCI centre until discharge hurs after the prcedure. In ther netwrks, patients wh are stable may be transferred t their lcal hspital 6-24 hurs after the prcedure. Discharge planning will take place frm the time f arrival, utilising the PPCI inpatient pathway. Discharge The majrity f patients will be discharged hme hrs after PPCI. The extent f CK r Trpnin rise will nt determine length f stay. Sme units may rutinely repatriate patients at 6-24 hurs t their lcal hspital. A Medical Discharge Pack will be cmpleted. Patients with the fllwing cmplicatins may require a lnger inpatient stay. This will be guided by the duty Cnsultant r the Cnsultant respnsible fr the patient s care. Cardigenic shck Hyptensin. Pr left ventricular functin. Persistent r recurrent pst reperfusin rhythm disturbance. Prlnged slw flw r n reflw. Awaiting further angiplasty r surgical pinin. Cncmitant significant cardiac disease such as severe artic stensis. Access site cmplicatins. Sepsis. Adverse drug reactin r drug intlerance. Renal impairment fr bservatin f cntrast induced nephrpathy. Newly diagnsed diabetes mellitus. Other significant c-mrbidity. Inadequate scial circumstances. 10

11 Patients suitable fr transfer t their lcal hspital will be identified as sn as pssible, and ntice given t the lcal hspital f the anticipated date f discharge. Lcal hspitals shuld cmmit t cmplete transfer as early as pssible in rder t free up beds in the PPCI centre fr subsequent referrals. Referral f patients t the lcal hspital will be made by the PPCI centre t the relevant persnnel as per lcal hspital arrangement. The patient will be prvided with a discharge pack indicating diagnsis, preprcedure ECG, the prcedure undertaken (cath lab reprt), management plan, rehab infrmatin, ut-patient fllw up, medicatins and cntact numbers fr discussin in case f prblems r cncerns directly related t the admissin. The GP will receive a discharge summary, including medicines and medicine infrmatin sheet fr drug titratin The discharge summary will clearly indicate whether r nt the patient has had a cnfirmed MI and whether r nt a pre-discharge ECHO was undertaken, as this will impact n the fllw up care prvided. The nurse respnsible fr the patient s discharge hme will fax a discharge summary t the lcal cardiac rehabilitatin team and cardilgy unit requesting apprpriate fllw-up frm rehabilitatin services and the cardilgy department, accrding t lcal prtcl. The respnsible nurse will g thrugh the discharge pack with the patient predischarge. Medicatin & Discharge Advice Patients will receive therapy in accrdance with NICE guidelines (May 2007) prir t discharge unless cntraindicated. Aspirin (indefinite) Aspirin 75mg daily fr life Fr patients with a histry f dyspepsia r aspirin induced peptic ulceratin cnsider using an H2 antagnist (Ranatidine) r a PPI (meprazle) Secnd anti-platelet drug fr 12 mnths. Lcal prtcls shuld determine whether this is: Clpidgrel 75 mg nce daily Prasugrel 10 mg nce daily (5 mg if age > 75) Ticagrelr 90 mg bd Beta blcker Bisprll mg daily r atenll mg daily If prescribed fr LV dysfunctin, bisprll 1.25mg titrated up t 10mg if tlerated. ACE inhibitr r angitensin II receptr blcker 11

12 Ramipril; dse 2.5mg nce daily, up titrating as tlerated t 10mg nce daily, aiming t keep systlic BP between 120/140 mmhg. D nt rutinely give angitensin II receptr blckers unless the patient is intlerant r allergic t ACE-Inhibitrs. Patients will need t have their renal functin and ptassium checked 1-2 weeks fllwing cmmencement and at each dse increment. Statins and lipid lwering drugs Simvastatin 40mg nce daily, reduce t 20mg if nt tlerated. LFT at baseline will be nted in discharge letter and shuld be checked at 6 weeks with repeat chlesterl Check serum creatine kinase in patients wh develp muscle symptms. This shuld nt be checked rutinely in asymptmatic patients. Antihypertensives Target bld pressure shuld be 140/90mmHg r lwer Fr diabetic patients target bld pressure shuld be 130/80mmHg. Only after titrating the dse f ACEI and beta blcker t the maximum tlerated shuld an additinal anti-hypertensive be cnsidered. Amldipine may be a suitable agent in this situatin. Sublingual nitrates All patients n discharge will be issued with sublingual glyceryl trinitrate. All patients will be instructed as t the apprpriate use. Cardiac Rehabilitatin Phase 1 Cardiac Rehabilitatin Rehabilitatin arrangements will be initiated prir t discharge. Phase 1 rehabilitatin will be carried ut during the HAC inpatient stay. This will be undertaken by the HDU ward nurse/cardiac rehab nurse. All patients will receive heart manual/leaflet cvering basic infrmatin i.e. GTN/chest pain guidance, driving, sexual guidance, risk factr mdificatin etc. A patient held recrd will be started at this pint. This will include the risk factr analysis, cardiac diagnsis, prcedures undertaken, chlesterl results, bld pressure recrds, drugs etc. This will facilitate transitin t their lcal DGH rehabilitatin prgramme The patients may receive an educatinal DVD r vide t take hme and return by pst. British Heart Fundatin bklets will be given as necessary. The patient will be made aware f cntact numbers fr advice as needed. 12

13 The nurse respnsible fr discharge will fax the rehabilitatin referral and supprting patient infrmatin t the designated number fr lcal rehab fllw up t ensure that the patient has nging arrangements fr rehabilitatin. Phase 1 Cntinued, Phase II and III Cardiac Rehabilitatin This will ccur in the patients lcality. Fr cntinuity the patient held recrd shuld be passed nt the next rehabilitatin team by the patient. This will be cmpleted as rehabilitatin prgresses and will remain in the patient s pssessin. Fllw Up All patients will have a clear fllw-up plan at the time f discharge. Upn discharge patients will be referred t the lcal district general hspital fr medical review and t the lcal cardiac rehabilitatin service fr cardiac rehabilitatin. An intrductin t phase 1 rehabilitatin will take place at the HAC pre-discharge A discharge pack will be prvided t the patient and the referring hspital. Data will be cllected and exprted t NICOR (Natinal Institute fr Cardivascular Outcmes Research) via the BCIS and MINAP databases n the last day f each mnth, n mre than ne mnth in arrears. This dataset is linked t the ONS which will prvide mrtality infrmatin. 2.3 Ppulatin cvered The service utlined in this specificatin is fr patients rdinarily resident in England*; r therwise the cmmissining respnsibility f the NHS in England (as defined in Wh Pays?: Establishing the respnsible cmmissiner and ther Department f Health guidance relating t patients entitled t NHS care r exempt frm charges). *Nte: fr the purpses f cmmissining health services, this EXCLUDES patients wh, whilst resident in England, are registered with a GP Practice in Wales, but INCLUDES patients resident in Wales wh are registered with a GP Practice in England. The intentin is t ensure clse t 100% ppulatin cverage acrss England fr adult patients experiencing an ST Segment Elevatin Mycardial Infarctin (STEMI) t receive access t primary PCI. 13

14 2.4 Any acceptance and exclusin criteria Acceptance criteria The service will accept referrals fr patients wh meet ne f the fllwing criteria: Symptms cmpatible with a STEMI <12hrs duratin frm maximum chest pain and any f the fllwing ECG criteria: ST segment elevatin >1mm in 2 cntiguus limb leads r >2mm in 2 cntiguus chest leads. LBBB r paced rhythm if the clinical picture is acute mycardial infarctin. Patients resuscitated frm cardiac arrest with ECG criteria as abve. Excluded patients: Evidence f significant, active bleeding Paced ECG r Left Bundle Branch Blck (LBBB) n ECG in a clinical picture nt suggestive f acute mycardial infarctin Cardiac arrest patients whse ECG des nt shw criteria fr STEMI. 2.5 Interdependencies with ther services The majrity f PPCI patients will arrive at PPCI Centres fllwing assessment by paramedics. It is therefre essential that rbust cmmunicatin is in place with the Ambulance Service and that regular jint service review is undertaken. Since fllwup care will generally be prvided within the patient s lcal area, it is als essential that rbust discharge prtcls are in place and that regular dialgue is had with district hspitals via existing clinical and managerial Cardiac Netwrk facilitated grups. C-lcated services Access t cardiac ITU r general ITU shall be available fr thse patients wh are uncnscius r wh require ventilatr supprt Interdependent services Access t cardiac surgery, nt necessarily n-site, shall be available fr the small number f patients wh have severe and diffuse crnary disease and wh are stable enugh t be cnsidered fr cardiac surgical referral. This will als apply t patients wh have a mechanical cmplicatin f STEMI (acute VSD, acute mitral regurgitatin, partial LV rupture). 14

15 Related services Rehabilitatin services (see abve). Expected numbers This is an emergency service in which the prviders have n ability t cntrl the number f referrals. The expected number f referrals is patients per millin per annum. 3. Applicable Service Standards CORE STANDARDS Institutinal facilities PPCI centres shuld perate 24 hurs a day, 7 days a week, 365 days a year as per ESC guidance. A centre perfrming PPCI requires at least tw cardiac catheterisatin labratries. PPCI centres shuld have cntingencies (r Business Cntinuity Plans) t deal with rare ccasins when the service has t be temprarily withdrawn (adverse weather, majr pwer failure etc.) Full resuscitatin facilities including a defibrillatr, intra-artic balln cunterpulsatin, and an anaesthetic backup must be readily available in any catheterisatin labratry undertaking PPCI. Bichemistry, haematlgical, and bld transfusin labratries shuld be immediately accessible. A dedicated multidisciplinary team cmprising catheterizatin labratry and recvery nurses, radigraphers, and technicians will be in place. PPCI centres need apprpriate supprt frm ther clinical disciplines, particularly anaesthetic and intensive care services. 15

16 Institutinal vlumes PPCI centres shuld perfrm an abslute minimum f 100 PPCI patients per annum as per BCIS guidance. Individual peratr vlumes Current guidelines suggest that a minimum f 75 PCI prcedures per peratr per year is required t maintain cmpetence as an independent peratr that is, ne wh can decide n PCI as apprpriate management, plan the strategy, and perfrm the PCI. RECOMMENDED STANDARDS Institutinal Vlumes In practice, mst PPCI centre will treat 300 r mre patients per annum. 3.1 Applicable natinal standards e.g. NICE, Ryal Cllege Department f Health (2008) Treatment f Heart Attack Final reprt f the Natinal Infarct Angiplasty Reprt (NIAP) Department f Health (2000) Natinal Service Framewrk fr Crnary Heart Disease Department f Health (2006) Mending Hearts and Brains - Clinical case fr change: Reprt by Prfessr Rger Byle, Natinal Directr fr Heart Disease and Strke Ryal Cllege f Physicians (2009) Mycardial Ischaemia Natinal Audit Prgramme (MINAP) Hw the NHS Manages Heart Attacks: Eighth Public Reprt 2009, Prepared n behalf f the MINAP Steering Grup June 2009 Natinal Institute fr Health and Clinical Excellence. MI: Secndary Preventin; secndary preventin in primary and secndary care fr patients fllwing a mycardial infarctin. Quick Reference Guide (May 2007) 2007 Natinal rll-ut f Primary PCI fr patients with ST segment elevatin mycardial infarctin: An interim reprt Gateway Reference: Hw the NHS Cares fr Patients with Heart Attack (MINAP 10 TH Public Reprt) 16

17 4. Key Service Outcmes Key utcmes The service is based n an accepted internatinal and natinal evidence base The service will be sustainable and value fr mney Equity f access t the service acrss c England Delivers n the recmmendatins f Evidence t Excellence Key service utcmes fr a PPCI service are: All patients experiencing a STEMI wh fulfil the clinical inclusin criteria will be transprted straight t a Heart Attack Centre (HAC) t receive a PPCI, (even if it is nt their lcal /clsest hspital) fr treatment nce the diagnsis f STEMI is cnfirmed/suspected. The % f patients achieving a Call-t-balln time f 150 minutes r less shuld be audited and will be 75% r greater. T maximise the prprtin f patients wh achieve the call t balln time target f 150 minutes, it is essential that patients are diagnsed crrectly by Ambulance services and taken straight t a HAC, aviding A&E and nn-ppci hspitals. The % f direct referrals frm the ambulance service will be audited. Dr-t-balln times will be audited. These will vary depending n the rute f admissin but will be less than 45 minutes fr daytime presenters and fr thse patients abut whm there has been advance warning (direct ambulance referrals and inter-hspital transfers). Fibrinlysis will be available fr the small number f patients wh decline PPCI r wh cannt have PPCI within an apprpriate time-frame fr whatever reasn. If these patients fail t reperfuse with thrmblysis, then they will be referred fr rescue PCI. Even if thrmblysis is successful, patients will still be cnsidered fr angigraphy and pssible PCI, preferably within 24 hurs. All PPCI centres will submit their prcedural and utcme data n-line t the BCIS database. The data will then be analysed at NICOR (Natinal Institute fr Clinical Outcmes Research). Analysis f submitted data will give PPCI centres infrmatin n their prcesses (Call-t-balln time, dr-t-balln time etc.), their utcmes (mrtality etc.) and whether any patient grups are underrepresented in their treated ppulatin (e.g. patients ver the age f 80). 17

18 The Clinical Reference Grup (CRG) strngly recmmends that NHS CB shuld establish frmal cntract arrangements with NICOR t prvide prcedural and utcme data, by named centre, fr all centres perfrming PPCI. 18