Left atrium appendage closure: A new technique for patients at high hemorrhagic risk

Transcription

1 Left atrium appendage closure: A new technique for patients at high hemorrhagic risk Victoria Martin Yuste MD PhD ITC. Cardiology Department. Hospital Clinic. Barcelona SITE. Barcelona, Juin

2 NON VALVULAR ATRIAL FIBRILLATION It s the most frequent arrhythmia l prevalence: 5-15% in patients >80 y l Prevalence will double in the next 50 y It s the reason for >1/5 of all strokes High mortality and disability Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace.12(10):

3 NON VALVULAR ATRIAL FIBRILLATION CHA2-DS2-VASc score l 2 points: age 75 y previous stroke l 1 point: Cardiac insufficiency hypertension, diabetes mellitus, Cardiovascular disease Age y. CHA2-DS2- VASc Score n stroke (%/year) 0 1 0% % % % % % % % % % Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace.12(10):

4 NON VALVULAR ATRIAL FIBRILLATION Classic OAC disadvantages: l Non tolerance l Narrow therapeutic range l High risk for bleeding complications (gastrointestinal, intracranial) l Interactions with other medications and foods l Non compliance New OAC: higher rate of gastrointestinal bleeding Left atrial appendage (LLA) is the source of >90% thrombi Tulner LR et al. Drugs Aging. 2010;27(1): Guerrouij M et al J Thromb Thrombolysis.31(4): Connolly SJ. Et al. N Engl J Med. 2009;361(12):

5 BACKGROUND PROTECT-AF Randomized trial (2 device / 1 medical treatment) to show non inferiority. Analysis intention to treat. Primary efficacy end points: l ischemic stroke l Cardiovascular death l Hemorrhagic stroke l Systemic embolism. Primary safety end points: l Serious pericardial effusion l Device embolisation l Procedure related ischemic stroke l Hemorrhagic stroke Holmes et al. Lancet. 2009;374: :

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7 Intention to treat analysis

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9 NON VALVULAR ATRIAL FIBRILLATION HAS-BLED score l 1 point: hypertension Renal insufficiency Liver disease Previous stroke unpredictable INR levels age > 65y Need of other antithrombotic medications Alcohol abuse HAS-BLED Score n Incidence (%/ year) HAS-BLED 3: high risk of bleeding Any score Pisyers R, et al. Chest 2010 Nov;138(5):

10 NON VALVULAR ATRIAL FIBRILLATION Letter Clinical characteristic Points Letter Clinical characteristic Points C Congestive heart failure / LV disfunction H Hypertension 1 A Age 75 2 D Diabetes Mellitus 1 S Stroke/TIA/ Thromboembolism V Vascular disease 1 A Age Sex (i.e. female sex) H Hypertension 1 A Abnormal renal and liver function S Stroke 1 B Bleeding 1 L Labile INRs 1 E Elderly (e.g >65 years) 1 1 or 2 D Drugs or alcohol 1 or 2 Ruiz-Nodar et al. Circ Cardiovasc Interv Aug 1;5(4):

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12 ELIGIBLE TRIAL (Efficacy of Left atrial appendage closure after GastroIntestinal BLEeding) NCT

13 USUAL APPROACH IN GASTROINTESTINAL BLEEDING PATIENTS ON OAC STOP OAC Standard treatment Screening to establish a diagnosis l endoscopy: (esophago-gastro-duodenoscopy, colonoscopy) l wireless capsule endoscopy Possibilities: l treatment of the specific disorder and resumption of OAC l Unknown cause of bleeding. Resumption of OAC: during 12 months follow up 20% of rebleeding)

14 OBJECTIVE DESIGN To evaluate the effectiveness and safety of left atrial appendage closure (Amplatzer device) in patients with previous gastrointestinal bleeding Mutilcenter Prospective randomized study: 2 device/ 1standar therapy (OAC) to show superiority of device implantation in patients at high risk of embolism and previous gastrointestinal bleeding

15 Inclusion criteria Exclusion criteria non valvular AF > 18 y Acenocumarol (INR 2-3 ), or Dabigatran CHA2-DS2-VASC score 3 idiopathic gastrointestinal bleeding Informed consent Anatomical (size of device) Contraindication for OAC Contraindication for dual antiplatelet therapy Intracardiac thrombus Any clinical pathology at high risk of embolism

16 END POINTS PRIMARY END POINTS l All cause mortality l Stroke l Serious bleeding (VARC criteria) 1) life threatening or fatal bleeding 2) major bleeding l Device related implantation complications

17 GI BLEEDING SANGRADO DIGESTIVO + + CHA2SD2VASC? 3 3 ESTABLISHED DIAGNOSIS RESUMPTION OAC FOLLOW-UP SEGUIMIENTO EVENTOS INDICATION INDICACION REINICIAR ACO ALEATORIZADO OAC IDIOPATHIC BLEEDING NO OAC RISK OF BLEEDING 40 PACIENTS 40 PACIENTES TRATAMIENTO OAC ACO SEGUIMIENTO EVENTOS FOLLOW- UP FOLLOW-UP SEGUIMIENTO EVENTOS 80 PACIENTES PACIENTS LAA CIERRE CLOSURE, OREJUELA STOP SIN ACO OAC FOLLOW-UP SEGUIMIENTO EVENTOS

18 CLINICAL CASE 82 y old woman Hypertension Insulin-dependent Diabetes Mellitus Dyslipidemia Severe Aortic Stenosis (2007). LVEF 29%. Normal coronary angiography. Aortic valve replacement by a bioprostheses. Atrial fibrillation (digoxin and OAC) CHA2-DS2-VASc score: 6 HASBLED: 4

19 CLINICAL CASE 1 ST GASTROINTESTINAL BLEEDING 2008: Angiodysplasia: gastric, jejunum, duodenum l Rebleeding: June (INR 2.2, hematocrit 19%), red cell transfusion, Argon-Beam treatment. duodenum and jejunum angiodysplasia. July (INR 1.9, hematocrit 20%), transfusion 4 CH, Argon-Beam jejunum angiodysplasia. September (INR 2, Hematocrit 17%), transfusion, Argon-Beam duodenum. October (INR 3.3, Hematocrit 21%), transfusion, Argon-Beam gastric angiodysplasia.

20 Measurements of left atrial appendage in the cath-lab

21 IMPLANTATION (October 2011) : Measurements of left atrial appendage landing zone

22 IMPLANTATION Stiff guide wire on LLA Delivery sheath advancement

23 IMPLANTATION Device delivery

24 POSTIMPLANTATION CONTROL

25 TEE 24 H POSTIMPLANTATION

26 TEE 3 months

27 Recommendations after device implantation Discontinue oral anticoagulants AAS 100mg/24 (long term) Clopidogrel 75 mg/24 h 3 months if TEE confirms absence of thrombosis or any flow through the device Endocarditis prophylaxis (6 months) proton pump inhibitors

28 CONCLUSIONS Device implantation to close left atrial appendage has a indication IIB The randomized studies has been done mainly in low risk patients Patients at high risk can take more advantages of the technique than the low risk patients

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31 PREVAIL TRIAL

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37 STROKE

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