HTA

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HTA Regione

• Trans-catheter aortic valve implantation (TAVI)
• Andrea Finzi Ettore Beghi

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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

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PREVALENZA DELLA STENOSI AORTICA NELLA
POPOLAZIONE GENERALE
Lindroos et al, J Am Coll Cardiol 1993
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S.Ao. IERI e OGGI
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Pts non surgically treated year 2005
Age 72.5

Bach et al Unoperated aortic stenosis. Circ
Cardiovasc Qual Outcomes, 2009
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40 se terapia medica ottimizzata ?
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Thomas et al. SOURCE registry of transcatherer
AVI Circulation 2011
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Tamburino et al Circulation 2011 123 299-308
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26.8
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Mortalità in base al trattamento
Fonte Ist Monzino, Milano
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Euroscore e tipo di trattamento in pazienti con
stenosi aortica
Fonte Ist Monzino, Milano
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Comorbilità in pazienti con stenosi aortica e
tipo di terapia
Fonte Ist Monzino, Milano
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MAIN CAUSES FOR INELIGIBILITY IN TAVI TRIALS
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• 2012 EXPERT CONSENSUS Inclusion Criteria
• Patient has calcific aortic valve stenosis with
  echocardiographically derived criteria mean
  gradient gt40 mm Hg or jet velocity gt4.0 m/s and
  an initial AVA of lt0.8 cm2 or indexed EOA lt0.5
  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.

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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 lt20 8. Severe pulmonary
hypertension and RV dysfunction 9.
Echocardiographic evidence of intracardiac mass,
thrombus
13. Renal insufficiency (creatinine gt3.0 mg/dL)
and/or end-stage renal disease requiring chronic
dialysis at the time of screening 14. Estimated
life expectancy lt12 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 (gt5
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
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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 loutcome a medio termine che
  dipende da altre variabili.
• La valutazione di molte variabili funzionali
  non cardiache è spesso indeterminata (frialty.)

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PARTNER EU 18mo trial
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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
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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 scompenso è spesso il risultato di diversi
  fattori e la sua stadiazione è ostacolata da
  patologie extracardiache, prime le polmonari
• Langina è difficilmente valutabile per anamnesi
  non precisa, ecg cronicamente alterato,
  impossibilità ad eseguire test provocativi.

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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

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Cè anziano e anziano.
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Male sex BMI Cardiovascular Elderly mobility
score Motor and process skills in daily life
Pjipers et al Postgrad J Med J, 2009
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Lombardia 10 mln Veneto 5 mln
Emilia Romagna 4,5 mln
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DOCUMENTO DI INDIRIZZO PER LIMPIANTO
CLINICAMENTE APPROPRIATO DELLE PROTESI VALVOLARI
AORTICHE PER VIA PERCUTANEA-TRANSAPICALE 2009
Stima del fabbisogno regionale
In Emilia-Romagna, nellultimo triennio sono
stati mediamente operati di sostituzione
valvolare aortica circa 600 pazienti lanno (562
nel 2005, 640 nel 2006, 579 nel 2007) e sono
stati mediamente ricoverati perpatologia aortica,
circa 1300 pazienti lanno (1235 nel 2005, 1325
nel 2006, 1392 nel 2007). Applicando alla
popolazione dellEmilia-Romagna la proporzione di
pazienti inoperabili riportata dallEuroHeart
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 lanno. Tenendo conto
dellapprossimazione nel calcolo effettuato,
riteniamo plausibile una stima del fabbisogno
regionale variabile tra 50-70 interventi anno.
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Casistica TAVI (DRG)

• Lombardia Veneto
  Italia
• 2009 366 156 1142
• 2010 542
• Nello stesso periodo (2009-2010)
• In Lombardia 2142 controlli(non TAVI)

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Casi sottoposti a TAVI presso lIstituto Monzino
in un triennio
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EVENTI CEREBROVASCOLARI E MORTE IN PAZIENTI CON
VALVULOPATIE CARDIACHE
Petty et al, Stroke 2000
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EVENTI CEREBROVASCOLARI ATTESI ED OSSERVATI DOPO
RISCONTRO DI VALVULOPATIA CARDIACA
Petty et al, Stroke, 2000
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Petty et al, Stroke 2000
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FIBRILLAZIONE ATRIALE E RISCHIO DI M.
CEREBROVASCOLARE
Petty et al, Strok 2000
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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
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Petty et al, Stroke 2000
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VALVULOPATIA CARDIACA E M. CBV. Analisi
Multivariata - I
Petty et al, Stroke 2000
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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
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Calcific Aortic Valve Spontaneous Embolic Stroke
Author, year Population Results
Boon et al, 1996 815 pts with aortic valve calcification 562 controls No difference in stroke incidence
Cosmi et al, 2002 1610 pts with aortic sclerosis 92 pts with aortic stenosis No differences
Kizer et al, 2005 2723 healthy individuals No increased incidence of stroke
Khetarpal et al, J Neurol Sci 2009
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RISK OF STROKE AFTER TAVIA meta-analysis of
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 81.51.8-years-old and had a mean
  logistic EuroSCORE of 24.775.60.
• Procedural stroke (lt24 h) occurred in 1.51.4.
  The overall 30-day stroke/TIA was 3.31.8,
  mostly major strokes (2.91.8).

Eggebrecht et al, Eurointerv 2012
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RISK OF STROKE AFTER TAVI - II

• During the first year after TAVI, stroke/TIA
  increased up to 5.23.4.
• Differences in stroke rates were associated with
  different approaches and valve prostheses used
  with lowest stroke rates after transapical TAVI
  (2.71.4).
• Average 30-day mortality was more than 3.5-fold
  higher in patients with compared to those without
  stroke.

Eggebrecht et al, Eurointerv 2012
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RISK OF STROKE AFTER TAVI - III

• Conclusions TAVI was associated with average
  30-day stroke/TIA rate of 3.31.8 (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
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TAVI (n3512) vs TAVR (n5024)
End-point SAVR TAVR
30-day mortality 9 8.5
1-year mortality 18.4 22.8
2-year mortality 23.3 26.5
30-day stroke 2.4 2.6
New pacemaker 5.9 12.1
Need for dialysis 2.4 4.3
Jilaihawi et al, 2012
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