PERCEVAL S. Giovanni Troise MD CARDIAC SURGERY UNIT. SORIN GROUP 2011 ANALYST AND INVESTOR MEETING Milano - March 21st G.

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1 PERCEVAL S INITIAL EXPERIENCE REPORT Giovanni Troise MD CARDIAC SURGERY UNIT CARDIOVASCULAR DEPARTMENT SORIN GROUP 2011 ANALYST AND INVESTOR MEETING Milano - March 21st 2011

2 AORTIC STENOSIS IS A TYPICAL DISEASE OF ELDERLY GENERALLY DUE TO A DEGENERATIVE CALCIFICATION OF THE AORTIC VALVE

3 EPIDEMIOLOGY LIFE EXPECTANCY (years) Men Population > 80 years = 5% A woman who was born in 2007 has a life expectancy of 103 years and a man 97 years

4 LIFE EXPECTANCY IN OLDER PEOPLE Years still to live Men Women Age INCREASING Healthy Average CARE EXPECTANCY Frail Based on NCMS Life Tables of the United States 1997, Adapted from Walter LC and Covinsky KE. JAMA 2001:285;

5 % SORIN GROUP 2011 ANALYST AND INVESTOR MEETING - MILANO MARCH 21st CARDIAC SURGERY IN PATIENTS 80 YEARS Poliambulanza Foundation 16% 14% 13,90 14,10% 12% 10% 9,10 10,60 9,80 11,90 8% 6% 756 7,56 6,08 6,20 4% 2% 2,13 3,30 3,23 0% years

6 AORTIC VALVE DISEASE IN ELDERLY 21-26% of adults over 65 ys (48% over 85 ys) are affected with - fibrotic thickening of aortic cusps - calcification of aortic cusps 4% over 85 ys have a significant Aortic Stenosis Stewart BF et Al., J Am Coll Cardiol 1997;29: Lindroos M et Al., J Am Coll Cardiol 1993 ;21:

7 TREATMENT OF SEVERE AORTIC STENOSIS AORTIC VALVE REPLACEMENT

8 OPTIONS CONVENTIONAL SURGERY Long history (started 50 years ago) Long follow-up Large literature Very good early and late results TAVI (Trans Aortic Valve Implantation) ti Recently introduced d in clinical i l practice For patients with contraindication to surgery

9 Aortic Stenosis Effects of aortic valve replacements on survival A) Schwarz F, et al. Circulation. 1982;66: B) Horstkotte D, Loogen F. Eur Heart J. 1988;9(suppl E):57 64.

10 Patients with severe symptoms require urgent care Chart: Ross J Jr, Braunwald E. Aortic stenosis. Circulation 1968;38 (Suppl 1):61-7 Surgical intervention should be performed promptly once even minor symptoms occur C.M. Otto. Valve Disease: Timing of Aortic Valve Surgery. Heart 2000

11 TAVI Complications European Registry Thomas M et al. Circulation. 2010;122:62-69

12 Isolated AVR (Poliambulanza): Gen 2002 Sept 2008) 342 patients Hospital mortality 1.69 % (4 pts) Euroscore log < pts. Mortality 0.97 % Euroscore log > pts. Mortality 2.85 % 10,2% 89,8%

13 CASE 1 Female, 85 y, Kg 45, NYHA III, Previous heart failure Geriatric multidimensional assessment: FRAIL COMORBIDITIES HCV + Low level albumin Moderate renal dysfunction ECHOCARDIOGRAPHIC DATA EF 65% AVA 0.7 cm2 ΔP max 90 mmhg ΔP mean 58 mmhg Anulus 19 mm STJ 21 mm SEVERE AORTIC STENOSIS LOG. EUROSCORE (surgical risk): HIGH Previous evaluation for TAVI procedure (percutaneous approach)

14 CASE 2 Female, 77 y, Kg 100, NYHA III, Recent heart failure COMORBIDITIES Severe bilateral coxartrosis Severe obesity Severe deficit of physical activity ECHOCARDIOGRAPHIC DATA EF 73% AVA 0.8 cm2 ΔP max 67 mmhg ΔP mean 42 mmhg Anulus 19 mm STJ 21 mm SEVERE AORTIC STENOSIS LOG. EUROSCORE (surgical risk): 7.0 HIGH Previous evaluation for TAVI procedure (percutaneous approach)

15 CASE 3 Female, 85 y, Kg 87, NYHA III, Previous heart failure (2) COMORBIDITIES Hepatic cirrhosis (Child A) Colon angiodysplasia Coronary disease (previous PCI) Diabetes Renal dysfunction ECHOCARDIOGRAPHIC DATA EF 68% AVA 0.8 cm2 ΔP max 78 mmhg ΔP mean 45 mmhg Anulus 20 mm STJ 22 mm SEVERE AORTIC STENOSIS LOG. EUROSCORE (surgical risk): 8.27 HIGH Previous evaluation for TAVI procedure (percutaneous approach)

16 SUMMARY OF OUR INITIAL CLINICAL EXPERIENCE Easy and fast preparation of the valve kit on the bench Easy and fast surgical implantation of the valve Very short clamp and ECC time Good performance of the implanted valve at the intra-operatory t trans-esophageal ECHO Normal and smooth post-operative p course.

17 BENEFITS FOR CENTERS AND PATIENTS Product/Procedure Benefits for the Benefits for the features hospital patients Reproducible and Quicker training i Results are more easy curves guaranteed (standardization of fthe procedure) Matches surgery Native diseased gold standards valve is removed Effective and safe Less traumatic Lower surgery procedural risk Suitable for minimally invasive Improvement of the outcomes Access to higher risk patients

18 The future of AVR is bright with Sutureless Valves Perceval is a more effective procedural option than TAVI for operable high risk patients Mnimally invasive AVR can become a routine approach Sutureless valve could potentially ti replace the traditional prosthetic valve IT IS THE VALVE I VE BEEN WAITING FOR A LONG TIME

19 CARDIAC SURGERY UNIT Director: Giovanni Troise MD Medical Staff: Federico Brunelli MD Marco Cirillo MD Margherita Dalla Tomba MD Antonio Messina MD Zen Mhagna MD Emmanuel Villa MD