TAVR 2016 Requirements for the Cath Lab TAVR

TAVR 2016 - Requirements for the Cath Lab TAVR 2019 - Management Research Vs Commercial Petros Okubagzi, MD MCRN Washington, DC

Petros Okubagzi, MD I have no relevant financial relationships

TAVI Implants per Annum 2018 Grover, F. L. et al. J Am Coll Cardiol. 2017; 69(10): 1215– 30. Registry data

TAVI Implants Locations All the red dots started TAVR in 2015. . and they are expanding Grover, F. L. et al. J Am Coll Cardiol. 2017; 69(10): 1215– 30. Registry data

TAVR revenue • Koncept analytics Registry

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SAPIEN 3 Transcatheter Aortic Valve Replacement Compared with Surgery in Intermediate-Risk Patients: A Propensity Score Analysis Was a study a year ago Vinod H. Thourani, MD on behalf of The PARTNER Trial Investigators ACC 2016 | Chicago | April 3, 2016

Was a study a year ago Ron Waksman on Behalf of the Low Risk TAVR team ACC 2016 | Chicago | April 3, 2016

Screening Process • • • Review of History Echocardiogram CT- Heart Structure and Iliofemoral Frailty Assessment Surgeon Review Patient review

Clinical History STS score: 4. 31% Relevant history: XX y/o male with severe AS and progressive dyspnea. Ht = 175 cm, Wt = 84 kg, BMI = 27. 4, BSA = 2. 0 m 2 PMHx: Hypertension Hyperlipidemia Spinal stensois s/p surgical repair Criteria Score Cutoff 6 ≤ 4/6 Grip Strength 34 < 30 kg 15 -Foot Walk 8. 0 > 6 sec Albumin 3. 4 < 3. 5 g/dl TOTAL 2 Activities of Daily Living

Echocardiogram Echo Variable (TTE) Measure Trileaflet valve Yes Peak Velocity 3. 45 m/sec Mean Gradient 28 mm. Hg Calculated AVA 0. 95 cm 2 Calculated AVA index 0. 48 cm 2/m 2 Severity of AR None Severity of MR None Ejection Fraction 60 % TTE/TEE annulus diameter RV Pressures Comment NA mm. Hg Research requires EF>20 AVA<1 MG>40

CT Analysis (2/14/2017) Aortic Root by CT Measure Sinus of Valsalva Diameter 36. 9(L)x 35. 1(R)x 36. 7(N)m m Sinotubular Junction Diameter 30. 4 x 32. 6 mm Sinus Height 21. 9(L)x 24. 6(R)x 26. 1(N)m m Left Coronary Height 11. 6 mm Right Coronary Height 21. 3 mm

Access (2/14/2017) Right Left CIA 8. 0 mm 9. 1 mm EIA 7. 1 mm 7. 0 mm CFA 7. 2 mm 8. 1 mm Research requires larger vessel sizes

Heart team

Access

Transcaval Access

Commercially available valves

Second Generation@ MWHC Lotus Valve- Boston Scientific Portico valve- St. Jude/ Abbott Jena valve

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Transcaval Access Commercial Edwards Sapien S 3 Medtronic Evolut Research Portico Jena Valve Lotus