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HTA – Regione

HTA – Regione. Trans-catheter aortic valve implantation (TAVI) Andrea Finzi & Ettore Beghi. Argomenti di Discussione. Risultati della sperimentazione INDICAZIONI AL TRATTAMENTO DELLA SAo INDICAZIONI ALLA TAVI VS CHIRURGIA Mortalità a 30 giorni

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HTA – Regione

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  1. HTA – Regione Trans-catheteraortic valve implantation (TAVI) Andrea Finzi & Ettore Beghi

  2. Argomenti di Discussione Risultati della sperimentazione INDICAZIONI AL TRATTAMENTO DELLA SAo INDICAZIONI ALLA TAVI VS CHIRURGIA Mortalità a 30 giorni Mortalità a lungo termine (1 anno, etc.) Mortalità attesa nei soggetti per cui la TAVI è indicata Complicanze lievi Complicanze gravi (stroke, etc.) Costi

  3. PREVALENZA DELLA STENOSI AORTICA NELLA POPOLAZIONE GENERALE Lindroos et al, J Am Coll Cardiol 1993

  4. S.Ao.: IERI e OGGI

  5. Pts non surgically treated year 2005 Age 72.5 Bach et al: Unoperated aortic stenosis. Circ Cardiovasc Qual Outcomes, 2009

  6. 40 % se terapia medica ottimizzata ?

  7. Thomas et al. SOURCE registry of transcatherer AVI Circulation 2011

  8. Tamburino et al Circulation 2011; 123: 299-308

  9. 26.8

  10. Mortalità in base al trattamento Fonte: Ist Monzino, Milano

  11. Euroscore e tipo di trattamento in pazienti con stenosi aortica Fonte: Ist Monzino, Milano

  12. Comorbilità in pazienti con stenosi aortica e tipo di terapia Fonte: Ist Monzino, Milano

  13. MAIN CAUSES FOR INELIGIBILITY IN TAVI TRIALS

  14. 2012 EXPERT CONSENSUS Inclusion Criteria • Patient has calcific aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mm Hg or jet velocity >4.0 m/s and an initial AVA of <0.8 cm2 or indexed EOA <0.5 cm2/m2. Qualifying AVA baseline measurement must be within 45 days of the date of the procedure. • 2. A cardiac interventionalist and 2 experienced cardiothoracic surgeons agree that medical factors either precludeoperation or are high risk for surgical AVR, based on a conclusion that the probability of death or serious,irreversible morbidity exceeds the probability of meaningful improvement. The surgeons' consult notes shall specify the medical or anatomic factors leading to that conclusion and include a printout of the calculation ofthe STS score to additionally identify the risks in the patient. At least 1 of the cardiac surgeon assessors must have physically evaluated the patient. • 3. Patient is deemed to be symptomatic from his/her aortic valve stenosis, as differentiated from symptoms related to comorbid conditions, and as demonstrated by NYHA functional class II or greater.

  15. 2012 EXPERT CONSENSUS Exclusion Criteria (candidates will be excluded if any of the following conditions are present) 6. Hypertrophic cardiomyopathy with or without obstruction 7. Severe left ventricular dysfunction with LVEF <20% 8. Severe pulmonary hypertension and RV dysfunction 9. Echocardiographic evidence of intracardiac mass, thrombus 13. Renal insufficiency (creatinine >3.0 mg/dL) and/or end-stage renal disease requiring chronic dialysis at the time of screening 14. Estimated life expectancy <12 months (365 days) due to noncardiac comorbid conditions 15. Severe incapacitating dementia 16. Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminaldiameter 5 cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma [especially if thick (>5 mm), protruding or ulcerated] or narrowing (especially with calcification and surface irregularities) of theabdominal or thoracic aorta, severe “unfolding” and tortuosity of the thoracic aorta 17. Severe mitral regurgitation

  16. INDICAZIONE ALLA TAVI CRITERI DI INCLUSIONE NEL MONDO REALE • La classe NYHA presuppone uno standard non applicabile alla popolazione anziana e subisce interferenze da patologie extracardiache. • Euroscore e STS contengono variabili utili a definire il rischio operatorio in sé ma non sono idonei a prevedere l’outcome a medio termine che dipende da altre variabili. • La valutazione di molte variabili funzionali non cardiache è spesso indeterminata (frialty….)

  17. PARTNER EU 18mo trial

  18. About 53% of the patients enrolled in the study are in NYHA class I or II About 7 % are in NYHA Class III or V About 38 % are dead (there is no NYHA Class for death) 2 % are lost to followup At one year follow-up, 60 pts of the 118 (2 lost to follow-up) improved at least one NYHA class – this equates to 51% of all patients, not 81% as reported. The remaining 58 pts. saw no improvement or got worse, with 46 being dead by year end J. Pokorney, Cardious, weblog

  19. INDICAZIONE ALLA TAVI NELLA POPOLAZIONE GERIATRICA DIVERSA INTERPRETAZIONE DELLA SINTOMATOLOGIA • La sincope è fenomeno comune in tutta la popolazione geriatrica per cause neurologiche, aritmiche ed emodinamiche non correlate alla SAo • Lo scompensoè spesso il risultato di diversi fattori e la sua stadiazione è ostacolata da patologie extracardiache, prime le polmonari • L’angina è difficilmente valutabile per anamnesi non precisa, ecg cronicamente alterato, impossibilità ad eseguire test provocativi.

  20. DETERMINANTI DI PROCEDURA INAPPROPRIATA • Indicazione in pazienti con terapia medica non ottimizzata per sintomi apparentemente “indice” • Indicazione dopo evento occasionale che evidenzia impropriamente la SAo come “la causa di tutti i mali” • “Overconfidence” che estende le indicazioni a pazienti ancora non a rischio specifico imminente , nei quali,invece, sono in crescita determinanti di morte molto più efficienti

  21. C’è anziano e anziano….

  22. Male sex BMI Cardiovascular Elderly mobility score Motor and process skills in daily life Pjipers et al Postgrad J Med J, 2009

  23. Lombardia 10 mln Veneto 5 mln Emilia Romagna 4,5 mln

  24. DOCUMENTO DI INDIRIZZO PER L’IMPIANTO CLINICAMENTE APPROPRIATO DELLE PROTESI VALVOLARI AORTICHE PER VIA PERCUTANEA-TRANSAPICALE 2009 Stima del fabbisogno regionale In Emilia-Romagna, nell’ultimo triennio sono stati mediamente operati di sostituzione valvolare aortica circa 600 pazienti l’anno (562 nel 2005, 640 nel 2006, 579 nel 2007) e sono stati mediamente ricoverati perpatologia aortica, circa 1300 pazienti l’anno (1235 nel 2005, 1325 nel 2006, 1392 nel 2007). Applicando alla popolazione dell’Emilia-Romagna la proporzione di pazienti inoperabili riportata dall’EuroHeart Survey (31,8%) e la percentuale di eleggibili al trattamento innovativo stimata dagli esperti francesi (12%) si ottiene un numero medio di circa 50 interventi l’anno. Tenendo conto dell’approssimazione nel calcolo effettuato, riteniamo plausibile una stima del fabbisogno regionale variabile tra 50-70 interventi ’anno.

  25. Casistica TAVI (DRG) Lombardia Veneto Italia • 2009 = 366 156 1142 • 2010 = 542 Nello stesso periodo (2009-2010) In Lombardia 2142 “controlli”(non TAVI)

  26. Casi sottoposti a TAVI presso l’Istituto Monzino in un triennio

  27. EVENTI CEREBROVASCOLARI E MORTE IN PAZIENTI CON VALVULOPATIE CARDIACHE Petty et al, Stroke 2000

  28. EVENTI CEREBROVASCOLARI ATTESI ED OSSERVATI DOPO RISCONTRO DI VALVULOPATIA CARDIACA Petty et al, Stroke, 2000

  29. Petty et al, Stroke 2000

  30. FIBRILLAZIONE ATRIALE E RISCHIO DI M. CEREBROVASCOLARE Petty et al, Strok 2000

  31. TRATTAMENTI E MALATTIE CEREBROVASCOLARI • 12/740 patients (16.7%) ha valve repair or replacement • Valve repair or replacement was not a determinant of survival free of CBV events (RR 1.64; 95% CI 0.95-2.84) • 3/6 intracerebral hemorrhages and 14/68 ischemic strokes occurred in patients treated with warfarin Petty et al, Stroke 2000

  32. Petty et al, Stroke 2000

  33. VALVULOPATIA CARDIACA E M. CBV. Analisi Multivariata - I Petty et al, Stroke 2000

  34. VALVULOPATIA CARDIACA E M. CBV. Analisi Multivariata - II • After adjustment for the independent determinants of death, the type and severity of valve disease were not improtant determinants of survival • Valve repair or replacement was not a determinant of survival (RR 1.01; 95% CI 0.72-1.41) Petty et al, Stroke 2000

  35. Calcific Aortic Valve & Spontaneous Embolic Stroke Khetarpal et al, J Neurol Sci 2009

  36. RISK OF STROKE AFTER TAVIA meta-analysisof 10,037 cases • Source: Fifty-three studies with 10,037 patients undergoing TAVI for native aortic valve stenosis published between 01/2004 and 11/2011. • Patients were 81.5±1.8-years-old and had a mean logistic EuroSCORE of 24.77±5.60%. • Procedural stroke (<24 h) occurred in 1.5±1.4%. The overall 30-day stroke/TIA was 3.3±1.8%, mostly major strokes (2.9±1.8%). Eggebrecht et al, Eurointerv 2012

  37. RISK OF STROKE AFTER TAVI - II • During the first year after TAVI, stroke/TIA increased up to 5.2±3.4%. • Differences in stroke rates were associated with different approaches and valve prostheses used with lowest stroke rates after transapical TAVI (2.7±1.4%). • Average 30-day mortality was more than 3.5-fold higher in patients with compared to those without stroke. Eggebrecht et al, Eurointerv 2012

  38. RISK OF STROKE AFTER TAVI - III • Conclusions: TAVI was associated with average 30-day stroke/TIA rate of 3.3±1.8% (range 0-6%). Most of these strokes were major strokes and were associated with increased mortality within in the first 30 days. Eggebrecht et al, Eurointerv 2012

  39. TAVI (n=3512) vs TAVR (n=5024) Jilaihawi et al, 2012

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