1. www.fundacionfavaloro.org Percutaneous Aortic Valve Replacement without Predilatation for Symptomatic Severe Aortic Stenosis in High-Risk Patients Lev G, Valdivieso L, Fava C, Caponi G, Hidalgo G, Mendiz O. Favaloro Foundation University Hospital. Buenos Aires. Argentina.

2. www.fundacionfavaloro.org CoreValve Primario Background Since the beginning of percutaneous Aortic valve replacement was considered that the previous balloon valvuloplasty was essential to facilitate optimal implant and expansion.

3. www.fundacionfavaloro.org CoreValve Primario Background The procedure has a certain risk of stroke and valvuloplasty may have an important responsibility. The rapid pacing for valvuloplasty can have deleterious effect mainly the pts with ventricular dysfunction.

4. www.fundacionfavaloro.org Primary Aortic Valve Replacement AIM To assess the in-hospital and follow-up results of the primary (without predilatation) percutaneous aortic valve replacement with the selfexpandable Nitinol CoreValve device (Medtronic®), in patients with symptomatic aortic valve severe stenosis and high surgery risk.

5. www.fundacionfavaloro.org Between march 2009 and december 2011, 57 consecutive patients (ptes) with symtomatic severe aortic valve stenosis were treated with CoreValve device. 48 ptes (84%) with primary elective implantation. Primary Aortic Valve Replacement Materials and Methods

6. www.fundacionfavaloro.org Primary Aortic Valve Replacement Material and Methods Characteristicn=48 ptes Age (years) 79±8 Males (%) 30 (63)

7. www.fundacionfavaloro.org Primary Aortic Valve Replacement Material and Methods Variablen=48 ptes Personal history AMI (%)10 (21) CABG (%)9 (19) PTCA (%)13 (27) Chronic renal failure (%)6 (13) Severe COPD (%)8 (17) E.F.< 40% (%)4 (8) Stroke (%)5 (10) Logistic Euroscore20±15

8. www.fundacionfavaloro.org Primary Aortic Valve Replacement Material and Methods Complementary Studies Variablen=48 ptes ECG Sinusal rythm (%)43 (90) Sinusal rythm+1º AVB (%)1 (2) Sinusal rhythm + RBBB (%)1 (2) Atrial fibrilation(%)2 (4) Pacemaker rythm (%)1 (2) Echo-Doppler Mitral insufficiency grade 3-4 (%)4 (8) Aortic valve ring (mm)22±3 Severe grade aortic valve calcification (%)30 (63)

9. www.fundacionfavaloro.org CoreValve´s primary implantation was succesfully achieved in 48 ptes: –Predilatation was requiered in 1 patient because of extremely asymetric valve expansion. –Postdilatation was necessary in 15 ptes (31%). Primary Aortic Valve Replacement Results

10. www.fundacionfavaloro.org Variablen=48 Procedure succeed (%)46 (96) MACE (%)2 (4) Death (%)2 (4) Cardiac failure(%)15 (31) Minor Stroke(%)1 (2) Right ventricle perforation treated with pericardiocentesis (%)3 (6) Acute renal failure (%)2 (4) Permanent pacemaker (%)13 (27) AV Complete block (%)10 (21) Left bundle branck block (%)17 (35) Final moderate aortic valve insuficiency(%)20 (42) Final mild aortic valve insuficiency(%)27 (56) Primary Aortic Valve Replacement 30 days Results

11. www.fundacionfavaloro.org Primary Aortic Valve Replacement Follow-up Results Variablen=46 Follow-up period (2-35 months)12±11 Death of any cause (%)5 (11) AMI(%)1(2) Minor Stroke (%)1 (2) Permanent pacemaker (%)1 (2) Asymtomatics (%)39 (85) Echo-Dopplern=41 Well-function valve(%)41 (100) Mild aortic valve insufficiency (%)30 (73) Moderate aortic valve insufficiency (%)11 (27)

12. www.fundacionfavaloro.org The percutaneous aortic valve replacement without predilatation with the self expandable Nitinol device was safe and efective with low Stroke incidence. Primary Aortic Valve Replacement Conclusión