2. ” سبحانك لا علم لنا إلا ما علمتنا إنك أنت العليم الحكيم “

3. Aortic valve Stenosis

4. Natural History of Aortic Stenosis 740 pts with severe AS AVA < 0.8 cm 2 451 had non surgical treatment Mean age: 75+13yrs LVEF < 40%: 33% CHF: 42% Ann Thorac Surg 2006; 82: 2111-5

5. Operative Mortality for AVR AVR in octogenarians  Op mortality 13% if AVR  Op mortality 24% if AVR + CABG  Morbidity 60%  Survival 85%, 80%, 73% (1,3,5 yrs ) Eur J Cardio Thorac Surg 2007;31:600-606. Eur J Cardio Thorac Surg 2007;31: 1099-1105. Euro J Cardiothorac Surg 2006; 30: 722-727

6. AVR High risk for surgery Complications 30-40% do not undergo Sx Advanced age LV dysfunction Multiple co-morbidities Pt. preference Physician assessment 30-40% do not undergo Sx Advanced age LV dysfunction Multiple co-morbidities Pt. preference Physician assessment “Symptomatic Severe Aortic Stenosis” ~ 3% mortality ~2% Stroke ~11% prolonged ventilation Organ failure Thromboembolic Complications Bleeding Prosthetic valve Dysfunction ~ 3% mortality ~2% Stroke ~11% prolonged ventilation Organ failure Thromboembolic Complications Bleeding Prosthetic valve Dysfunction J. Am. Coll. Cardiol. 2012;59;1200-1254 Operative Mortality for AVR

8. Indications of TAVI A Symptomatic severe calcific Aortic Stenosis [trileaflet] who have aortic and vascular anatomy suitable for TAVR and a predicted survival >12 months, and who have a prohibitive surgical risk as defined by an estimated 50% or greater risk of mortality or irreversible morbidity at 30 days or other factors such as frailty, prior radiation therapy, porcelain aorta, and severe hepatic or pulmonary disease. TAVR is a reasonable alternative to surgical AVR in patients at high surgical risk (PARTNER Trial Criteria: STS >8) J. Am. Coll. Cardiol. 2012;59;1200-1254 Dr. Nithin P G

9. Patient selection in clinical trials Logistic EuroSCORE >20% or STS Score > 10. J. Am. Coll. Cardiol. 2012;59;1200-1254 Dr. Nithin P G Indications of TAVI

10. J. Am. Coll. Cardiol. 2012;59;1200-1254 Dr. Nithin P G Contrindications of TAVI

11. hotuolon Oritorla 1. Potioot has caioilic oortlc vnhro stonoois with oohooardiopaptticaly dorivod mum: moan padioot >40 mm I-lg or jot velocity >4.0 rrq/s anion Initial AVA of <0.8 cm’ or lndomod GOA <05 om’/nu’. Qualifying AVA blooiino nuoostnomontmirsthovoitlikilfadaysoitrtodutoolthoprooodtlo. 2. A cardiac lntorvonflonalist and 2 ozporioncod cardiothoraoic surpom apoo that modioal factors ollhor prooludo operation or on high rbk for wrflcal AVR. baud on 0 oonoiuoion that tho probobllky of mm or aoriom. lrrovonibio morbidity oxooods tho probability oi rmaninflul improuomont. Tho upon’ oonouit nous still spoclfy tho modical or anatomic factors looting to that conclusion and hcludo a printout of tho calculation oi‘ tho S1'SooorotoaMitlonaliy idontllytho rlsialn the potlont.Atioosl ioflhooardlacwrgoon aoosoorsmusthovo physically woiuotod tho potiool. 3. Patient ls doomod to in symptomatic from his/hor aortic volvo stonods. as dlloronthtod from symptoms roiatoo to oomorblrl conditions. and no dornonotramod by NYHA functional also ll or punter.

12. hotuolon Oritorla 1. Potioot has caioilic oortlc vnhro stonoois with oohooardiopaptticaly dorivod mum: moan padioot >40 mm I-lg or jot velocity >4.0 rrq/s anion Initial AVA of <0.8 cm’ or lndomod GOA <05 om’/nu’. Qualifying AVA blooiino nuoostnomontmirsthovoitlikilfadaysoitrtodutoolthoprooodtlo. 2. A cardiac lntorvonflonalist and 2 ozporioncod cardiothoraoic surpom apoo that modioal factors ollhor prooludo operation or on high rbk for wrflcal AVR. baud on 0 oonoiuoion that tho probobllky of mm or aoriom. lrrovonibio morbidity oxooods tho probability oi rmaninflul improuomont. Tho upon’ oonouit nous still spoclfy tho modical or anatomic factors looting to that conclusion and hcludo a printout of tho calculation oi‘ tho S1'SooorotoaMitlonaliy idontllytho rlsialn the potlont.Atioosl ioflhooardlacwrgoon aoosoorsmusthovo physically woiuotod tho potiool. 3. Patient ls doomod to in symptomatic from his/hor aortic volvo stonods. as dlloronthtod from symptoms roiatoo to oomorblrl conditions. and no dornonotramod by NYHA functional also ll or punter.

14. Procedure & Hardware LA + Conscious sedation/ GA, hemodynamic stability [ SBP~120 mm Hg / MAP >75 mm Hg] Vascular access Sites Transfemoral Transapical Left ant. thoracotomy More direct, shorter catheter Septal hypertrophy Ascendra2, Sapien valve Transaortic Upper partial sternotomy Mini-sternotomy 2/3 RICS Aorta 5 cm above valve Less painful, familiar approach Manipulation of ascending aorta Subclavian Percutaneou s or Cut- down technique J. Am. Coll. Cardiol. 2012;59;1200-1254 Modified from www.edwards.comwww.edwards.com Dr. Nithin P G

17. Procedure & Hardware ‘Sapien’ device Balloon deployment Transapical deployment also Leaflets in open mode, more chance for AR ‘CoreValve’ device Partially repositionable Larger annular size Higher chance for CHB ‘Sapien XT’ device Lesser calcification [reduction of 98% calcium binding sites] Shorter stent size More radial strength grater durability More closed form, less chance for AR www.edwards.com www.medtronic.com Dr. Nithin P G

18. The demonstration movie

20. Conclusions T-AVR is a revolutionary new option for patients with severe AS. Choosing the patient that will definitely improve after T-AVR requires thoughtful screening. Patient selection is a complex decision, best achieved by an experienced Cardiac Team.

22. We still have a lot to learn