Quando è realmente utile la chiusura percutanea dell auricola sinistra?

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1 Quando è realmente utile la chiusura percutanea dell auricola sinistra? Gennaro Santoro, Firenze Fondazione CNR-Regione Toascana G.Monasterio per la Ricerca Medica e la Sanità Pubbica santorogenn@gmail.com

2 DISCLOSURE INFORMATION NESSUN CONFLITTO DI INTERESSE Gennaro Santoro Firenze negli ultimi due anni non ho avuto rapporti di finanziamento con soggetti portatori di interessi commerciali in campo sanitario

3 Profilassi dello stroke cardioembolico in FA (non valvolare) Le opzioni terapeutiche Terapia farmacologica Terapia meccanica percutanea Terapia meccanica chirurgica

4 ACC/AHA 2014: CHA 2 DS 2 -VASc 2 ECS 2012: CHA 2 DS 2 -VASc 1 * CCS 2012: CHADS2 1 con lone FA * Eccetto donne NOAC/Warfarin Rischio di sanguinamento HAS-BLED 3 JACC CJC 2012;28: EHJ 2012;33:

5 TAO a lungo termine Sanguiname nti Compliance Efficacia TAO efficace se TTR > 70%

6 Prevalence of irreversible contraindication* to OAC in general AF population depending on age and gender * SPAF III study: Major bleeding previous 6 months, frequent falls, inability to comply to treatment, excessive alcohol consumption, (uncontrolled hypertension, daily use of NSAIDs) 40% 34% 35% 30% 20% 14% > 75 years years 10% 7% 0% Women Men Sudlow M et al. The Lancet 1998

7 Prevalenza della TAO in Registri Italiani Contemporanei % CARD 55.5 Totale 64.2 CARD MED MMG 42.7 Post dimissione 38 Database HSD PREFER in AF 3 (N=1888) ATA AF 9 FA non valvolare (N=7148) ISAF 12 (N=6036) ARNO 14 (N=2605) OSMED 15 FA ad alto rischio di ictus (N=9204) Di Pasquale G et al. G Ital Cardiol 2014

8 Age-related trends in AF Unmet need >89 Age, years Wolf PA, Arch Intern Med 1987; 147: White RH, Am J Med 1999; 106:165-71

9 Profilassi dello stroke cardioembolico in FA (non valvolare) Le opzioni terapeutiche Terapia farmacologica Terapia meccanica percutanea Terapia meccanica chirurgica

10 PERCHÉ CHIUDERE L AURICOLA SINISTRA?

11 90% of clots form in the LAA dell auricola sinistra Razionale per l occlusione Ann Thorac Surg 1996; 61:

12 COME CHIUDERE L AURICOLA SINISTRA?

13 Approccio endocardico Le modalità di chiusura dell auricola sinistra Approccio epicardico Atritech-4 generation device AGA -ACP device Occlutech Coherex Custom Medical Devices (Sideris Patch) Gore AtriCure Epitek Medtronic SentreHeart

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17 Monitoraggio della Procedura Posizione del device Concovità lieve del disco Spazio fra disco e lobo Lieve tenting posteriore del lobo Assenza di flusso in auuricola sinistra

18 RISULTATI CLINICI DELLA CHIUSURA PERCUTANEA

19 Studi osservazionali

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21 PROTECT AF Clinical Trial Design Prospective, randomized study of WATCHMAN LAA Device vs. Long-term Warfarin Therapy 2:1 allocation ratio device to control Non-inferiority comparison 800 Patients enrolled from Feb 2005 to Jun randomized 59 Enrolling Centers (U.S. & Europe) Follow-up Requirements TEE follow-up at 45 days, 6 months and 1 year Clinical follow-up biannually up to 5 years Regular INR monitoring while taking warfarin Enrollment continues in Continued Access Registry

22 PROTECT AF Trial Endpoints Primary Efficacy Endpoint All stroke: ischemic or hemorrhagic deficit with symptoms persisting more than 24 hours or symptoms less than 24 hours confirmed by CT or MRI Cardiovascular and unexplained death: includes sudden death, MI, CVA, cardiac arrhythmia and heart failure Systemic embolization Primary Safety Endpoint Device embolization requiring retrieval Pericardial effusion requiring intervention Cranial bleeds and gastrointestinal bleeds Any bleed that requires 2uPRBC NB: Primary effectiveness endpoint contains safety events

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24 Lancet 2009

25 Event-free probability 1,0 Intent-to-Treat: Hemorrhagic Stroke Device Control Posterior probabilities Events Total Rate Events Total Rate RR Non- Superiority Cohort (no.) pt-yr (95% CI) (no.) pt-yr (95% CI) (95% CI) inferiority pt-yr (0.0, 0.9) (0.5, 3.9) (0.00, 0.80) > pt-yr (0.0, 0.6) (0.7, 3.7) (0.00, 0.45) WATCHMAN Randomization allocation (2 device:1 control) 0,9 0,8 900 patient-year analysis Control ITT cohort: Superiority criteria met 0, Days

26 PROTECT AF Procedural Complications 12,3% Pericardial effusion requiring drainage 4,8% - reduction 50% > 3 cases- none disabiling Periprocedure ischemic stroke 1,1% - air or thromboemboli Device removal -embolization or sepsis n=4 Thrombus on device in 3,7% -clopidogrel x 6 months Learning curve effect substantial

27 PROTECT AF & CAP Registry: Safety events Reddy et al Circulation 2011

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29 PROTECT-AF follow up

30 PROTECT AF: efficacia al follow-up

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33 WATCHMAN PREVAIL 3 CO-PRIMARY ENDPOINTS Primary Efficacy Endpoint All stroke: ischemic or hemorrhagic deficit with symptoms persisting more than 24 hours or symptoms less than 24 hours confirmed by CT or MRI Cardiovascular and unexplained death: includes sudden death, MI, CVA, cardiac arrhythmia and heart failure Systemic embolization Late ischemic Efficacy Endpoint Ischemic stroke or SE excluding the first 7 days after randomization Early safety primary endpoint All cause of death Ischemic stroke SE Device/procedure related events between randomization and within 7 days of the procedure

34 PRIMARY PRIMO EFFICACY END END-POINT Statistical noninferiority was not achieved

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36 SECONDO END POINT LATE ISCHEMIC EFFICACY END-POINT Statistical noninferiority was achieved

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42 OAC CONTRAINDICATION 1) hemorrhagic/bleeding tendencies defined as active peptic ulcer disease or history of overt bleeding of the gastrointestinal, genitourinary, or respiratory tract; central nervous system hemorrhage, cerebral aneurysms, dissection of the aorta, pericarditis/pericardial effusions or bacterial endocarditis; 2) blood dyscrasias; 3) unsupervised patients with senility and/or high fall risk 4) other documented reason (including hypersensitivity to warfarin). INCLUSION CRITERIA Age > 18 years, Nonvalvular AF (paroxysmal, persistent, or permanent) CHADS2 score 1 Contraindication for even shortterm oral anticoagulation therapy, and eligibility for 6 months of treatment with a thienopyridine antiplatelet agent (clopidogrel or ticlopidine) and lifelong aspirin. EXCLUSION CRITERIA Left ventricular ejection fraction < 30% Intracardiac thrombus/dense spontaneous contrast by transesophageal echocardiography A patent forman ovale with atrial septal aneurysm Complex atheroma with mobile plaque in the ascending aorta/aortic arch, significant mitral stenosis, or an existing pericardial effusion > 3 mm

43 ASAP risultati

44 ACP

45 Risultati con ACP Successo procedurale: 97,6% Stroke periprocedurale: 0,38% Embolizzazione del device: 0,67% Versamento pericardico (trattato): 1,25% Complicanze periprocedurali: 2,8% Stroke al follow-up: 0,62% Meier B et al, Europace 2014

46 EuroIntervention 2014, in press

47 Results Stroke rate reduction Bleeding rate reduction 10% 8,6% p < 0,01 6% 5,4% - 35% 5% - 82% Expected stroke rate based on CHADS 3% 3,5% Expected bleeding risk based on HAS- BLED 0% 1,5% Observed stroke rate in the study (median=3) 0% Observed major bleeding rate in the study (median=3)

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51 INDICAZIONI ALLA CHIUSURA PERCUTANEA

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54 Documento di posizione sui requisiti di processo diagnostico ed interventistico riferiti al trattamento della chiusura dell auricola sinistra in pazienti affetti da fibrillazione atriale non valvolare Società Italiana di Cardiologia Invasiva GISE. Indicazioni proposte alla chiusura percutanea dell auricola sinistra In pazienti con alto rischio di tromboembolismo (CHA2DS2VaSc >=2) Controindicazione all anticoagulazione o alto rischio emorragico (HAS-BLED >=3) Pazienti anziani con FA e DES Recidiva di stroke in corso di TAO ben condotta

55 Indicazioni NICE 2010 ESC 2012 GISE/AIAC 2014 Contraindication to OAC Increased bleeding risk FDA Watchman EHRA/EAPCI 2014 As alternative to oral anticoagulation

56 Cardiochirurgia NICE 2010 Cardiac surgery on-site EHRA/EAPCI 2014 Cardiac surgery center at 60 min (operating room) GISE/AIAC 2014 Cardiac surgery on-site

57 Neurologist Clinical Cardiologist Echo Team Interventional Cardiologist Electrophysiologist Cardiac Surgeon Thank you for your attention!