Διαδερμική τοποθέτηση αορτικής βαλβίδας έναντι χειρουργικής αλλαγής βαλβίδας

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1 Διαδερμική τοποθέτηση αορτικής βαλβίδας έναντι χειρουργικής αλλαγής βαλβίδας ΓΕΩΡΓΙΟΣ Δ. ΚΑΤΣΙΜΑΓΚΛΗΣ ΔΙΕΥΘΥΝΤΗΣ ΚΑΡΔΙΟΛΟΓΙΚΗΣ ΚΛΙΝΙΚΗΣ & ΑΙΜΟΔΥΝΑΜΙΚΟΥ ΕΡΓΑΣΤΗΡΙΟΥ ΝΑΥΤΙΚΟΥ ΝΟΣΟΚΟΜΕΙΟΥ ΑΘΗΝΩΝ

2 ΕΠΙΠΟΛΑΣΜΟΣ Η στένωση της αορτικής βαλβίδας αποτελεί την πιο συχνή επίκτητη ασθένεια της καρδιάς. Σύμφωνα με τις τελευταίες εκτιμήσεις, περίπου 4,6% των ενηλίκων μεγαλύτερων των 75 ετών πάσχει από στένωση αορτικής βαλβίδας. Ρευματική στένωση Εκφυλιστική στένωση Συγγενής στένωση(δίπτυχη)

3 ΣΥΜΠΤΩΜΑΤΑ-ΘΕΡΑΠΕΙΑ δύσπνοια, στηθάγχη, συγκοπτικά επεισόδια Θεραπεία εκλογής για τη σοβαρή συμπτωματική στένωση αορτής είναι η αντικατάσταση της αορτικής βαλβίδας με μεταλλικό ή βιοπροσθετικό μόσχευμα σε ανοικτή χειρουργική επέμβαση. Περίπου το 33% των ασθενών ηλικίας μεγαλύτερης των 75 ετών με σοβαρή συμπτωματική στένωση δεν υποβάλλονται σε χειρουργική αντικατάσταση της βαλβίδας, παρά το ότι αυτό αποτελεί την μόνη σωστή θεραπεία.

4 Indications for AVR(1) AVR is recommended for patients with severe high-gradient AS who have symptoms by history or on exercise testing. AVR is suggested in symptomatic patients with low-flow/lowgradient severe AS with reduced left ventricular ejection fraction with a low-dose dobutamine stress study that shows an aortic velocity 4.0 m/s (or mean pressure gradient 40 mmhg) with a valve area 1.0 cm 2 at any dobutamine dose. AVR is suggested in symptomatic patients who have lowflow/low-gradient severe AS who are normotensive and have an LVEF 50 % if clinical, hemodynamic, and anatomic data support valve obstruction as the most likely cause of symptoms.

5 Indications for AVR(2) AVR is recommended for asymptomatic patients with severe AS and LVEF <50 percent. AVR is suggested (weak recommendation) in asymptomatic patients with severe AS and decreased exercise tolerance or an exercise fall in blood pressure.

6 Cancer 5 Year Survival Rate, %

7 First in Alive 9 retrograde implantations of a balloon expandable aortic valve were performed in 7 alive closed chest pigs. Department of Cardiology, Skejby University Hospital, Aarhus, Denmark. Andersen HR, Knudsen LL, Hasenkam JM Eur Heart J May;13(5):704-8.

8 First in Man 16 April 2002 Cribier A. Circulation 2002;106:3006 8

9 Recommendations for TAVI use A. Vahanian et al, Eur Heart J Oct; 33(20):

10 Nishimura et al., Circulation, ACC/AHA Guidelines on Valvular Heart Disease

11 Clinical assessment Heart team A. Vahanian et al, Eur Heart J Oct; 33(20):

12 Clinical pre-tavi assessment EUROSCORE logistic (2011)>20 STS Score>8-10

13 Clinical pre-tavi assessment Frailty Same age and predicted risk Pre-procedural Karnofsky index (functional performance status) emerged as the only independent predictor of outcome.

14 Karnofsky index (functional performance status) 100 Normal; no complaints; no evidence of disease. 90 Able to carry on normal activity; minor signs or symptoms of disease. 80 Normal activity with effort; some signs or symptoms of disease. 70 Cares for self; unable to carry on normal activity or to do active work. 60 Requires occasional assistance, but is able to care for most of their personal needs. 50 Requires considerable assistance and frequent medical care. 40 Disabled; requires special care and assistance. 30 Severely disabled; hospital admission is indicated although death not imminent. 20 Very sick; hospital admission necessary; active supportive treatment necessary. 10 Moribund; fatal processes progressing rapidly. 0 Dead

15 1 st Generation TAVI Valves Balloon Expandable Self Expandable

16 Complications Stroke(mainly with edwards-sapien ) Permanent Pacemaker(mainly with Corevalve) Tamponade Major vascular complications Aortic regurgitation Perforation Coronary occlusion Paravalvular leakage

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18 Direct TAVI is safe and effective

19 Predictors of Major Vascular Complications Sheath to Femoral Artery Ratio (SFAR) Early center experience Femoral calcification Female gender >19Fr system A Sheath to Femoral Artery Ratio (SFAR) 1.05 is a Predictor of both VARC Major Vascular Complications and 30-Day Mortality

20 Smaller size with Medtronic CoreValve

21 Smaller size with Edwards-Sapien RetroFlex III Sapien XT NovaFlex w/ esheath Sapien XT NovaFlex w/ esheath 20mm 23mm 26mm 29mm 14F esheath 14F esheath 14F esheath 16F esheath 18Fr OD 18Fr OD 18Fr OD 20 Fr OD

22 Incidence of PM after TAVI Range % Erkapic et al., Journal of Cardiovascular Electrophysiology 2012; 23(4), Risk for Permanent Pacemaker After TAVI 41 studies with patients Edwards Sapien 6% Medtronic CoreValve 28% Siontis et al. J Am Coll Cardiol 2014;64:129 40

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24 The PARTNER 2A Trial Conclusions (1) In intermediate-risk patients with symptomatic severe aortic stenosis, results from the PARTNER 2A trial demonstrated that... TAVR using SAPIEN XT and surgery were similar (non-inferior) for the primary endpoint (all-cause mortality or disabling stroke) at 2 years. In the transfemoral subgroup (76% of patients), TAVR using SAPIEN XT significantly reduced all-cause mortality or disabling stroke vs. surgery (ITT: p = 0.05, AT: p = 0.04).

25 The PARTNER 2A Trial Conclusions (2) Other clinical outcomes: TAVR reduced AKI, severe bleeding, new AF. Surgery reduced vascular complications and PVR The SAPIEN XT valve significantly increased echo AVA compared to surgery. In the SAPIEN XT TAVR cohort, moderate or severe PVR, but not mild PVR, was associated with increased mortality at 2 years.

26 The PARTNER 2A Trial Clinical Implications The results from PARTNER 2A support the use of TAVR as an alternative to surgery in intermediate risk patients, similar to those included in this trial. In patients who are candidates for transfemoral access, TAVR may result in additional clinical advantages. Long-term durability assessments of transcatheter bioprosthetic valves are still lacking and extrapolation of these findings to low-risk patients requires further clinical trial validation.

27 FDA APPROVAL FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery (August 18, 2016) (Sapien XT and Sapien 3)

28 SURTAVI(EVOLUT-R)

29 SURTAVI-complications

30 SURTAVI-results

31 SURTAVI-results

32 SURTAVI -results TAVR was a non inferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk, with a different pattern of adverse events associated with each procedure. Surgery was associated with higher rates of acute kidney injury, atrial fibrillation, and transfusion requirements, whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation. TAVR resulted in better aortic-valve hemodynamics than surgery, and neither TAVR nor surgery showed evidence of structural valve deterioration at 24 months.

33 POTENTIAL IN LOW-RISK PATIENTS One trial (PARTNER III) will evaluate all-cause mortality, stroke, and rehospitalization at 1 year between TAVR using the SAPIEN 3 valve and SAVR in low-risk patients; the second will utilize the CoreValve Evolut R and examine all-cause mortality and disabling stroke at 2 years. Both trials will include a patient substudy using 4D CT scans looking at leaflet motion abnormalities indicative of valve thrombosis in both TAVR and SAVR.

34 PARTNER A-COST STUDY PARTNER Cohort A is the only randomized-control trial evaluating TAVR vs. SAVR in high-risk patients. The 12-Month cost-effectiveness analysis in the PARTNER Cohort A study (TAVR vs. SAVR) showed: Transfemoral (TF)-TAVR vs. SAVR: QALYs = ; Cost = - $2,210 Transapical (TA)-TAVR vs. SAVR: QALYs = ; Cost = + $9,595. Detailed cost-effective analysis has not been extensively evaluated in real world patients undergoing TAVR and SAVR. Reynolds MR, Cohen DJ JACC 2012

35 COST EFFECTIVENESS IN «REAL WORLD» registries In this analysis of real world high-risk registries, transfemoral TAVR is an economically dominant strategy compared with isolated SAVR This Markov model supports the PARTNER A CEA, though the magnitude is greater in the real world than seen in RCTs. Sensitivity analyses suggest that with significantly increased rates of major stroke (up to 8%), vascular complications or pacemaker implantation, transfemoral TAVR remains preferred.

36 COST EFFECTIVENESS IN «REAL WORLD» registries In contrast, SAVR is economically preferrable to transapical TAVR in high-risk patients. However, accounting for the learning curve demonstrated in the PARTNER A Transapical Continued Access Registry, transapical TAVR become an economically more acceptable option for high risk patients. Although avoidance of complications should improve the costeffectiveness of TAVR for inoperable and high-risk patients, reductions in the cost of uncomplicated TAVR will also be necessary to optimize the value of this rapidly evolving procedure.

37 COST- EFFECTIVENESS Under current indications, each year there are nearly 18,000 new candidates for transcatheter aortic valve implantation (TAVI) in European countries and an additional 9,200 in North America, with an estimated cost of more than $2 billion per year. TAVI leads to gains in life expectancy at an incremental cost that is acceptable by most Western standards. Current data suggest that, for patients who are eligible for transfemoral access, TAVI is economically attractive (or even economically dominant) compared with highrisk SAVR.

38 COST EFFECTIVENESS(2) For high-risk (but operable) patients with severe AS, TAVI provides no proven survival advantage and only a transient quality of life benefit compared with surgical aortic valve replacement (SAVR). Thus, for these patients, the cost-effectiveness of TAVI compared with SAVR hinges on the magnitude and duration of the quality of life benefit. However, the cost-effectiveness of TAVI for patients who are not suitable for a transfemoral approach appears to be less favourable. Cost-effectiveness of transcatheter valvular interventions: economic challenges. EuroIntervention Sep 10;9 Suppl:S48-54

39 Data from the U.S. CoreValve High Risk trial On the basis of data from the U.S. CoreValve High Risk trial, we found that TAVR in patients at high risk for complications with SAVR provides important incremental health benefits at reasonable incremental costs, and is clearly an acceptable value in the context of the U.S. health care system. With expected improvements in clinical outcomes and efficiency, TAVR with the self-expanding CoreValve is likely to provide high economic value in this patient population. Cost-Effectiveness of Transcatheter Aortic Valve Replacement With a Self- Expanding Prosthesis Versus Surgical Aortic Valve Replacement J Am Coll Cardiol Jan 5; 67(1):

40 ΣΥΜΠΕΡΑΣΜΑΤΑ(1) Η TAVI φαίνεται πως έχει την θέση της σαν 1 η επιλογή σε ασθενείς με υψηλό περιεγχειρητικό κίνδυνο. Το οικονομικό όφελος αν επιλεχθεί η διαμηριαία προσπέλαση είναι αναμφισβήτητο. Μπορεί να αποτελέσει εναλακτική λύση σε ασθενείς ενδιάμεσου περιεγχειρητικού κινδύνου. Δεν υπάρχουν στοιχεία που να ευνοούν την TAVI ως προς το οικονομικό όφελος. Η μείωση της τιμής της βαλβίδας θα βοηθούσε την ταχύτερη διείσδυση σε αυτή την ομάδα ασθενών.

41 ΣΥΜΠΕΡΑΣΜΑΤΑ(2) Πρέπει να ληφθεί υπόψιν ότι η ανθεκτικότητα και εκφύλιση των διαδερμικών βαλβίδων ακόμα ελέγχεται. Ειδικότερα για την Ελλάδα και την υφιστάμενη οικονομική κατάσταση θα πρέπει να γίνεται προσεκτική προσέγγιση από όλους τους εμπλεκομένους φορείς ποιοι τελικά θα υποβληθούν σε TAVI. Θα πρέπει να γίνεται ειδική αναφορά στην Ομάδα καρδιάς (HEART TEAM) και ότι η τελική απόφαση και εμφύτευσή της δεν αποτελεί αποκλειστικότητα μιας ειδικότητας.

42 ΣΥΜΠΕΡΑΣΜΑΤΑ(3) Όλοι εμείς καλούμαστε να προσπαθούμε να παρέχουμε πάντα τις καλύτερες, ποιοτικότερες και ασφαλέστερες παροχές υγείας στους ασθενείς μας σε ένα πολύ πιεστικά περιβάλλον. ΕΥΧΑΡΙΣΤΩ

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