Presentazione sul tema: "IV CONVENTION UTIC LOMBARDE 8-9 Aprile 2011"— Transcript della presentazione:
1 IV CONVENTION UTIC LOMBARDE 8-9 Aprile 2011 Gestione del rischio emorragico nella chirurgia non cardiaca maggioreMaria Rosa ConteOspedale Mauriziano -Torino1
2 Age (years) Number of procedures(in thousands) % change Guidelines for pre-operative cardiac risk assessment and perioperative cardiac management in non-cardiac surgery The Task Force for Preoperative Cardiac Risk Assessment and Perioperative Cardiac Management in Non-cardiac Surgery of the European Society of Cardiology (ESC) and endorsed by the European Society of Anaesthesiology (ESA)Change in numbers of discharges for surgical procedures by age for the time periods 1994/95 and 2004/05 as reported from the 2005 US National Hospital Discharge Survey (non-federal short-stayhospitals)Age (years) Number of procedures(in thousands) % change1994/ /0518–45–65–75 and over18 and over4317 þ24.1þ10.7
3 Impact of the ageing population Within the next 20 years, the acceleration in ageing of the populationwill have a major impact on perioperative patient management.It is estimated that elderly people require surgery four times more often than the rest of the population.Although exact data regarding the number of patients undergoing surgeryin Europe are lacking, it is estimated that this number will increase by 25% by 2020, and for the same time period the elderly population will increase by .50%.The total number of surgical procedures will increase even faster because of the rising frequency of interventions with age.
4 Incidence of surgery within 1 year after coronary stenting 10-8-6-4-2-0-Noncardiac8.6%NoncardiacNoncardiac2.0%minorCardiac (20%)+ NoncardiacNoncardiac5.0%4.4%4.4%major3.8%AustrianVicenzi MNBJA 2006ClevelandAnwaruddin SJACC Intv 2009New ZealandTo ACYCirc CV Intv 2009ScottishCruden NCirc CV Int 2010EVENTREGISTRYBerger PBJACC Intv 20104
5 In patients with stable CAD, Probability of surgery higher than probability of D+MICNR-OD 1 studyEvents per year (%)1083 pts with stable CADfollowed for months,pre-PCI eraIncidence of surgery first yearafter stent (%)10-8-6-4-2-0-10-8-6-4-2-0-8.65.04.43.81.51.0CardiovasculardeathMyocardialInfarctionAustrianN=2000ClevelandN=12,794ScottishN=1,953New ZealandBrunelli C. Eur Heart J 1989Vicenzi MN. BJA 2006; Anwaruddin S. JACC Intv 2009Cruden N. Circ CV Int 2010; To ACY. Circ CV Interv 20095
8 Circ Cardiovasc Intervent. 2009;2:213-221. 11150 patients (age, years;30% women) who underwent PCI from 1996 to 2001 (New Zealand), 5-year follow-up: 26% of the population underwent at least 1 noncardiac surgical procedure(23% orthopedic, 20% abdominal, 12% urologic, 10% vascular, 35% others)Circ Cardiovasc Intervent. 2009;2:
10 The main clinical predictors of noncardiac surgery were advanced age, previous noncardiac surgery, osteoarthritis, and peripheral vascular disease.Noncardiac surgery is required frequently after PCI, whereas bleeding is less common. Before implanting a drug- eluting or bare-metal stent, individual patient risk stratification by the interventional cardiologist should include assessment of whether there is an increased likelihood of needing noncardiac surgery or developing bleeding.
12 Perioperative death and ischemic cardiac events occurred more frequently when surgery was in patients revascularized after an acute coronary syndrome (65% versus 32% - elective indication - ; P=0.037).(acute coronary syndrome [triangles] vs stable coronary artery disease [diamonds])Patients undergoing noncardiac surgery after recent coronary stent implantation are at increased risk of perioperative myocardial ischemia, myocardial infarction, and death, particularly after an acute coronary syndrome. For at least 2 years after percutaneous coronary intervention, cardiac outcomes after noncardiac surgery are similar for both drug-eluting and bare-metal stents.
13 Time course and incidence of ST after a NSTEACS Does not differ between BMS and DESDefinite/Probable ST: DES Only (N=5743)Definite/Probable ST: BMS Only (N=6461)2.31%2.41%2.52.522% of Subjects1.51.51Clopidogrel-treated patientsClopidogrel-treated patients10.50.550100150200250300350400450DAYS50100150200250300350400450DAYSWiviott SD. Lancet 2008;371:13531313
15 Circ Cardiovasc Interv. 2010;3:236-242.) Scottish Coronary Revascularisation RegisterFrom April 2003 and March 2007,1953 post-PCI patients underwent noncardiac surgery. Of these, 570 (29%) were treated with at least 1 drug-eluting stent and 1383 (71%) with bare-metal stents only.Circ Cardiovasc Interv. 2010;3: )
17 Timing of noncardiac surgery in cardiac-stable/ asymptomatic patients with prior PCI2009 ESC Guidelines on perioperative evaluation for noncardiac surgery17
18 Guidelines for pre-operative cardiacmanagement in non-c Recommendations on timing of non-cardiac surgery incardiac-stable/asymptomatic patients with prior revascularizationRecommendations Class LevelIt is recommended that patients withprevious CABG in the last 5 years be sent I Cfor non-cardiac surgery without furtherdelayIt is recommended that non-cardiac surgerybe performed in patients with recent bare I Bmetal stent implantation after a minimum 6weeks and optimally 3 months followingthe interventionbe performed in patients with recent I Bdrug-eluting stent implantation nosooner than 12 months following theinterventionConsideration should be given to postponingnon-cardiac surgery in patients with recent II a Bballoon angioplasty until at least 2 weeksfollowing the intervention
21 Occurrence of early and late angiographically- documented stent thrombosis in theRotterdam andBern registries0.6% per year30D3yIndependent predictorsHR 95%CIACS at presentationDiabetesDaemen J, Lancet 2007;369:66721
22 Predictors of stent thrombosis the dutch registry: 437 out of 21,009 pts (2.1%)Van Werkum JW. JACC 2009;53:139922
23 Clopidogrel discontinuation and incidence of stent thrombosis after PCI in the ISAR studiesCumulative incidence of stent thrombosis in patients who continued (black) and those who discontinued clopidogrel (red).Patients switched from one group to the otheras soon as they stopped taking clopidogrel.Schulz S. Eur Heart J 2009;30:27142323
24 Clinical outcome of stent thrombosis At 30-day and 180-day follow-up Airoldi F. Circulation 2007;116:745-5424
25 NCS after percutaneous coronary intervention Stent Thrombosis riskTiming dell’impianto StentSCA o coronaropatia stabileTipo di STENTDiabeteLunghezza dello StentBiforcazioni / lesioni ostiali…BLEEDING RISKFemale sexDiabetes, Chronic renal impairmentbleeding……SURGICAL RISKCh aortica e vascolare maggioreBLEEDING SURGICAL RISKintracranialspinalExtraocularTURP
26 con necessità di anestesia retro bulbare RISCHIO EMORRAGICOCHIRURGIA OCULARERISCHIO EMORRAGICOCatarattaTrabeculectomiaGlaucomaBassoChirurgia complessa su retinaChirurgia complessa su palpebraChirurgia complessa su ghiandole lacrimaliChirurgia complessa a livello orbitariocon necessità di anestesia retro bulbareIntermedioAltoIckx et al. Can J Anesth 2006; 53: 6; S113-22Thachil J. et al. British Journal of Surgery 2008; 95: 1437–1448.
27 RISCHIO EMORRAGICO PROCEDURE UROLOGICHE Cistoscopia Litotrissia BassoLitotrissiaBiopsia prostaticaBiopsia renaleIntermedioAltoIckx et al. Can J Anesth 2006; 53: 6; S113-22Thachil J. et al. British Journal of Surgery 2008; 95: 1437–1448.
28 Recommendation/statement on surgical risk estimate Recommendation/statement Class LevelLaparoscopic procedures demonstrate a cardiacstress similar to open procedures and it is I Arecommended that patients be screened priorto intervention accordingly
29 PROCEDURE ENDOSCOPICHE GASTROINTESTINALI (GI) RISCHIO EMORRAGICOPROCEDURE ENDOSCOPICHE GASTROINTESTINALI (GI)RISCHIO EMORRAGICOdel tratto gastrointestinale superioredel tratto gastrointestinale inferioreERCP senza sfinterectomiaInserzione di stent biliare senza sfinterectomiaEndosonografia senza incannulazioneEnteroscopia “push” dell’intestino tenueCapsula endoscopicacon o senza biopsiaBasso<1%PolipectomiaCoagulazione laserSfinterectomia endoscopicaDilatazione pneumaticaStenting esofageoPosizionamento di PEGTrattamento di variciERCP con sfinterectomiaResezione della mucosa o dissezione sub mucosa per via endoscopicaEndoscopia ad ultrasuoni con ago aspiratoAlto≥1%Ickx et al. Can J Anesth 2006; 53: 6; S113-22Thachil J. et al. British Journal of Surgery 2008; 95: 1437–1448.Kwok A. et al. Am J Gastroenterol online pubblication, 11 August 2009; doi: /ajg
31 British Journal of Anaesthesia 105 (S1): i3–i15 (2010) Relative contributions of key hazards associated with major adverse cardiovascular events in patients with coronary stents. These form the framework for clinical decision-making.British Journal of Anaesthesia 105 (S1): i3–i15 (2010)
32 Noncardiac surgery after stent implantation: Antiplatelet therapy and risk of bleedingVan Kuijk P. Am J Cardiol 2009;104:122932
37 Clopidogrel was discontinued 5 days before surgery, and hospital admission was planned for the day after the last clopidogrel intake (4 days before surgery), when i.v. tirofiban infusion was started according to the schedule approved for patients with ACS: that is, 0.4 mg kg21 min21 over 30 min, followed by 0.1 mg kg21 min21.15 The tirofiban dose was reduced by 50% if creatinine clearance was ,30 ml min21. The infusion was stopped 4 h before surgery (8 h in the case of creatinine clearance ,30 ml min21), resumed at the same schedule (including the 30 min bolus) 2 h after the end of surgery, and continued for up to 6 h after the resumption of clopidogrel, unless oral administration could be resumed on the same day as surgery. After surgery, clopidogrel was reintroduced using a loading dose of 300 mg (four tablets) as soon as the patient could resume oral administration, and then continued at a once daily dose of 75 mg. Aspirin (75–100 mg once a day) was ideally to be continued throughout the perioperative periodResults: There were no cases of death, myocardial infarction, stent thrombosis, or surgical re-exploration due to bleeding during the index admission, with a risk estimate of 0–11.6% (one-tail 97.5% CI). There was one case of thrombolysis in myocardial infarction (TIMI) major and one of TIMI minor bleeding in the postoperative phase; another four patients were transfused without meeting the TIMI criteria for major or minor bleeding.Br J Anaesth 2010; 104: 285–91
38 Phase 2 protocol (Simon’s two stage design) for urgent surgery early after DESInclusion criteriaExclusion criteriaPatients within 6-12 monthsof DES implantation12 months in the case of high-risk of ST:stent implantation due to an ACSdiabetesrenal insufficiencysevere LV dysfunctionDES in LMCA, proximal LAD, bifurcation· Allergy to tirofiban – eptifibatide· Thrombocytopenia <· Stroke < 30 days or prior ICH· Intracranial disease· Uncontrolled hypertension· Unable to sign consent form+high-risk for surgical bleeding,“so that the surgeonwould not operate on clopidogrel”surgeryStopPlavixStartbridgeStopbridgeResumeBridge**ResumePlavix mg***Aspirin continued throughoutLow-dose LMWH for DVT preventionTDay h* h follow-up until discharge*8h in pts with eGFR <30 ml/min**if oral adminnot possible*** as soon asoral admin possiblePrimary EP: the composite ofDeath, MI, stent thrombosis, haemostatic reoperationSavonitto S. Br J Anaesth 2010;104:285-9138
39 For urgent surgery early after DES: current status Phase 2 bridge studyFor urgent surgery early after DES: current statusPATIENTS ENROLLED 56cardiac 19urinary tract 7gastrointestinal 18mixed surgery 12PRIMARY ENDPOINT* 0 (97.5% C.I. 6.4%)BLEEDING** EVENTS major 2minortransfSEVERE§ THROMBOCITOPENIA 1Urgent surgery after DES.. Savonitto De Servi* The composite of death+MI+stent thrombosis+haemostatic reoperation**Bleeding according to TIMI criteria: major means Hb decrease >5 g/dL,minor means Hb decrease >3 but <5 g/dL, after correction for transfusion(1 g ofHb for each U transfused); § platelet count <20,000.39
40 Early surgery after stent implantation: Anesthesiologist warning
43 CONCLUSIONI Icon l’ aumentare dell’eta’ un crescente numero di pazienti va incontro ad interventi di chirurgia non cardiacaal momento dell’impianto di uno Stent (che richiede una DAPT da un minimo di 1 mese ad un massimo di mesi ) devono essere considerati con attenzione il rischio emorragico ed le patologie associatela trombosi di Stent è un evento drammatico con elevata mortalità ed è principalmente determinato dalla interruzione prematura della DAPTNei pazienti portatori di Stent coronarici l’intervento chirurgico dovrebbe essere differito a 3 mesi in caso di BMS e 12 mesi in caso di DES
44 In caso di intervento non differibile ad elevato rischio emorragico in pazienti con elevato rischio trombotico la bridge strategy con agenti antipiastrinici ev a breve durata d’azione si e’ dimostrata efficace nella prevenzione della ST senza aumentare significativamentel e emorragie.l’impiego di tale strategia e’ tuttavia ancora controverso e non indicato dalle linee guida con livello elevato di evidenzaNei pazienti con eccessivo sanguinamento peri-operatorio sono indicati trasfusioni di piastrine e agenti pro emostaticiNuovi farmaci quali il Ticagrelor ( breve emivita ) potrebbero in futuro costituire un alternativa all’impiego degli inibitori del II b- III a ( piccole molecole ).
45 Ticagrelor vs clopidogrel: time course of IPA by 20 M/L ADP Gurbel P. Circulation 2009, published online Nov 19
46 Reversibility of platelet inhibition Oral drugaspirinclopidogrelprasugrelticagrelorReversibilityirreversiblereversibleTime to surgery5-7 days3 days?i.v. drugabciximabtirofibaneptifibatideReversibilityirreversiblereversibleTime to surgery3-5 days4 hours(8 hours if CrCl <30 ml)46
50 GESTIONE ANTIAGGREGANTI IN PROCEDURE ENDOSCOPICHE GI Kwok A. et al. Am J Gastroenterol online pubblication, 11 August 2009; doi: /ajg
51 Response to clopidogrel 300 mg Healthy volunteer crossover study IPA (20 M ADP) at 24 hours1008060Inhibition of platelet aggregation (%)4020N=64–20Response to clopidogrel 300 mgResponse to prasugrel60 mgBrandt J et al. AHJ 2006
52 325 patients with stable CVD taking ASA 325 mg >7days Prevalence of ASA Resistance325 patients with stable CVD taking ASA 325 mg >7daysASA-R: mean aggregation ≥70% with µM 10 ADP & ≥20% with 0.5 mg/ml AAGum PA et al. Am J Cardiol 2001;88:
53 La sospensione degli Antiaggreganti Sospensione ASA in 50 La sospensione degli Antiaggreganti Sospensione ASA in coronaropaticiAumentato Rischio TromboticoBiondi-Zoccai GGL, et al. Eur Heart J :
57 Conclusions on DAPT and surgical risk For surgical and endoscopic procedures at HR of bleeding, DAPT represents a serious issue.Withdrawal of DAPT + post-surgical haemostatic activation + malignancy increase severalfold the risk of ST and death, THE POST-OPERATIVE FASE BEING THE MORE DANGEROUS.Based on the results of our ongoing experience, we propose that a “bridge strategy” using short-acting i.v. antiplatelet agents confers protection against perioperative CV events that goes beyond the prevention of ST, without increasing the risk of surgical bleeding.Among the new P2Y12 antagonist, the reversible blocker ticagrelor might reduce by 1-2 days the duration of pre- operative withdrawal, but it’s use in the early post-op days should be studied, and sofar it hasn’t been shown to reduce bleeding compared to clopidogrel.The concept of “platelet anaesthesia” should be further explored57
58 Early surgery after stent implantation: Step 2: risk stratification for stent thrombosis58
61 Pazienti con STENT coronarici che devono essere sottoposti a chirurgia non cardiacaTutti gli stent coronarici richiedono un periodo di DAPT post- impianto: 4 settimane i BMS, 6-12 mesi i DES. Ciò al fine di prevenire la trombosi di stent (morte-infarto nel 50-70% dei casi)La terapia antiaggregante aumenta il rischio emorragico in chirurgia generale, laparoscopica, e durante procedure endoscopicheLa sospensione della terapia antiaggregante prima che sia finito il periodo di vulnerabilità espone al rischio di trombosi di stent, aumentato dall’ effetto pro-trombotico della chirurgiasurgery, either elective or urgent, poses a largely unsolved problem for patients on dual antiplatelet therapy and their treating physicians.Schulz S. Eur Heart J 2009;30:271461