Echo Essentials for TAVI Steven A. Goldstein, MD Director, Noninvasive Cardiology Washington Hospital Center Sunday, February 27, 2011

financial relationships DISCLOSURE I have N O relevant financial relationships

Severe Aortic Stenosis One of the most lethal of all cardiovascular diseases

Percutaneous/Transapical AVR Team Approach Interventional cardiologist Imaging cardiologist Vascular surgeons Cardiac surgeons Anesthesiologists

TEE in Cath Lab: Set-up O Nurse Operator Monitors Tech Echo- 2 SUCTION Nurse Echo- Operator cardiographer Monitors Tech

Percutaneous AV Replacement Role of Pre-Procedure Echo Determine severity of aortic stenosis Assess aortic valve morphology Estimate annular size Distance from valve to L-main orifice Discovery of severe aortic atheroma (may mandate transapical approach)

Percutaneous AV Replacement Role of On-Line TEE Reassess annular diameter  critical for sizing Monitor deployment of valve Assess severity and location of AR Assess leaflet motion of the deployed valve Measure gradients (transgastric views) Detect new regional WMAs Detection of complications (verify correct positioning)  co-axial alignment (detect impingement on coronaries)

Measurement of aortic annulus 1.8 cm Measurement of aortic annulus

Measurement of aortic annulus 1.8 cm Measurement of aortic annulus

Percutaneous AV Replacement Role of On-Line TEE Reassess annular diameter  critical for sizing Monitor deployment of valve Assess severity and location of AR Assess leaflet motion of the deployed valve Measure gradients (transgastric views) Detect new regional WMAs Detection of complications (verify correct positioning)  co-axial alignment (detect impingement on coronaries)

Percutaneous AV Replacement Complications Vascular complications Stroke Dislodgement of aortic atheroma Thrombus formation of catheters, wires, etc Valve migration Myocardial ischemia from coronary obstruction Damage to mitral valve AV block

Percutaneous AV Replacement Role of On-Line TEE Additional Miscellaneous Issues Sigmoid septum MV structure, function, calcification LV apical thrombus Occurrence of thrombi on catheters Wire not through mitral apparatus

Case 1 Case 1

95 year-old man  mentally clear 2 years ago  bowling and yard work Since then, progressive effort angina and dyspnea “Burning” and pressure with exertion Now NYHA class III-IV

Vmax = 4.3 m/s  peak instantaneous gradient = 74 mm Hg

23 mm balloon 25 mm balloon 22

LAD flow velocity pre transcatheter AV replacement 51 cm/sec  LAD flow velocity pre transcatheter AV replacement

LAD flow velocity post transcatheter AV replacement 63 cm/sec  LAD flow velocity post transcatheter AV replacement

Pre Post

This 95 year-old man has returned to bowling !

LA LV Coaxial Not coaxial

LA LV distal proximal

Case 2 Case 7

Percutaneous Aortic Valve Replacement b. c. AV placed to avoid impingement on coronary ostia or to impeded motion of anterior mitral leaflet Prosthesis deployed by inflating the delivery balloon Balloon is deflated and rapidly withdrwan

Make sure wire does not interfere with mitral apparatus

Case 3 Case 7

Transapical approach - wire not thru mitral apparatus

Balloon valvuloplasty

Pre-deployment - valve in good position

Deployment of valve

Valve deployed - good position

Case 4 Case 7

Valve deployed - slightly “aortic” (too high)

Case 5 Case 7

Wire passing through mitral apparatus

Wire passing through mitral apparatus

Wire withdrawn and re-inserted  now “safe”

Potential problem Now OK

Case 6 Case 7

Mobile thrombus in descending thoracic aorta

Mobile thrombus in aortic arch

Case 7 Case 7

SK - 67 year old lawyer Severe aortic stenosis Symptomatic  dyspnea and angina Successful transcatheter deployment Post-procedure  R-hemiparesis of #26 Edwards-Sapien prosthetic aortic valve

The End

Different Shapes of Stent Deployment Zegdi (Paris) J Am Coll Cardiol 2008; 51:579-84

Sharp Calcific Excrescenses Crossing the Stent Frame Protrude Inside the Aortic Lumen Zegdi (Paris) J Am Coll Cardiol 2008; 51:579-84

Influence of Size or Shape of the Orifice On the Valved Stent Deployment Zegdi (Paris) J Am Coll Cardiol 2008; 51:579-84

Leaflet Distortion in the Presence of Annular Calcification Close to One Commissure of the Deployed Valved Stent Zegdi (Paris) J Am Coll Cardiol 2008; 51:579-84

Valve Distortion Secondary to the Valved Stent Deployment Inside a Triangular Orifice Zegdi (Paris) J Am Coll Cardiol 2008; 51:579-84

Stent Shapes after Deployment According to Aortic Valve Pathology Tricuspid (n = 19) Bicuspid (n = 19) Circular n (%) Elliptic n (%) Triangular n (%) 13 2 4 (68) (11) (21) 2 11 1 (14) (79) (7) Zegdi (Paris) J Am Coll Cardiol 2008; 51:579-84

Backup Slides

Symptomatic Aortic Stenosis AVR Must Be Performed 100 80 Valve Replacement 60 Survival (%) 40 No surgery 20 Chi2 = 23.5 P<0.001 P<0.05 P<0.001 1 2 3 4 5 Years Schwartz Circulation 1982;66:1105-10

Based on estimated population growth projection Incidence of Aortic Stenosis for Population > 65 Based on estimated population growth projection data from US census 2.00 1.80 1.60 1.40 1.20 Population (x106) 1.00 0.80 0.60 0.40 0.20 0.00 2000 2010 2020 2030 2040 2050 Year US Census Bureau. US Interim Projections by Age, Sex, Race, and Hispanic Origin. In 2004.

Aortic Valve Replacement Increasing need over next 10 years Aging population Increase of world population Under-diagnosed in upcoming countries (China, India)

Transcatheter Percutaneous Aortic Valve Replacement A driving force for catheter-based therapies for valvular heart disease since mid-1980s Alain Cribier Rouen, France Pioneered the development of Cribier-Edwards heart valve Performed the first PTAVR in 2002

Percutaneous Aortic Valves CoreValve Edwards-Sapien Direct Flow Lotus Paniagua Enable Perceval Jena CoreValve, Inc Edwards Life Sciences Direct Flow Medical, Inc Sadra Medical Endoluminal Technology Research ATS Sorin Group Jena Valve technology

Placement of AoRTic TraNscathetER Valves Trial PARTNER Trial

Severe AS - symptomatic PARTNER - Algorithm Severe AS - symptomatic High Risk Patient Operable High Risk Non-operable Percutaneous AVR Percutaneous AVR Surgery High Risk Medical Therapy

Percutaneous Aortic Valve Indications Severe AS from degenerative disease Symptomatic Aortic valve area <0.8 cm2 and Surgical mortality > 20% Vmax >4.0 m/s or mean gradient > 40 mm Hg

Edwards SAPIEN™ THV using the RetroFlex 3™ Transfemoral Delivery System Procedural Steps Balloon Valvuloplasty Aortic Arch Navigation Native valve crossing Valve deployment Final assesment

Edwards SAPIEN™ THV using the Ascendra™ Transapical Delivery System Direct access the apex Balloon valvuloplasty Native valve crossing Valve deployment Final assesment Procedure steps

Valve before deployment

Valve after deployment

Transcatheter AV Replacement Rapidly Emerging Field Improving technology Improved patient selection Growing procedural experience

Transcatheter AV Replacement Progress with Successive Device Generations - Core Valve 1st (25-F) 2nd (21-F) 3rd (18-F) Procedure success rate Periprocedural mortality Periprocedural stroke rate 70% 10% 71% 8% 91% 0% <5% Grube Circulation Cardiovasc Intervent 2008;1;167-75

RetroFlex RetroFlex II Next-Generation Transfemoral Valve Delivery System RetroFlex RetroFlex II RetroFlex II Offers: Greatly improved native valve crossability Smoother tracking Improved handle functionality Fewer system components Continued advancement of the THV Program 80

Conclusions Marked hemodynamic and clinical improvement Careful selection and screening essential TEE  important role during procedure Procedural success rate ≈ 90% At present, only short-term results improvement (closely linked to experience)

New

Case 57

DR - 85 year-old woman Longstanding aortic stenosis Felt not to be surgical candidate due to multiple Entered PARTNER Trial and randomized to Transapical due to small femoral arteries medical problems and small size receive transcatheter prosthetic aortic valve

Valve positioned properly

Valve deployed properly

Coronary flow pre-procedure 42 cm/sec Coronary flow pre-procedure

68 cm/sec

Case 8 Case 7

History 85 year-old man with aortic stenosis, mild CAD, and PVD complained of shortness of breath with minimal exertion.

LVOTD=2.0cm Ao Valve Area = 0.8cm2 V2=4.1m/s V1=1.1m/s

After deployment of 23mm Edwards-Sapien aortic valve

Reason……

Patient’s blood pressure decreased from 170/69 to 93/32mmHg

Decision was made to place 2nd valve inside the 1st valve.

Deployment of 2nd valve inside the 1st valve

After valve deployment  trace aortic regurgitation

“If at first you don’t succeed, try and try again.” Confucius said…… “If at first you don’t succeed, try and try again.”

ECHO

Transcatheter AV Repalcement Edwards-Sapien Valve Successful deployment 30-day mortality Major adverse cardiac event rate 87% 7.4% 16.7% Tops, Kapadia, Tuzcu, Vahanian, Alfieri, Webb, Bax Current Problems in Cardiology 2008;33A:415-57

Aortic Valve Replacement Percutaneous Approach General anesthesia or awake patients Avoids surgery Steep learning curve Still experimental

Edwards-Sapien Valve Balloon expandable Stainless steel stent Fabric sealing cuff Bovine pericardial leaflets Two sizes: 23 mm 26 mm New height

CoreValve Prosthesis Self expanding Nitinol alloy stent Porcine pericardial leaflets Pericardial sealing cuff 50 mm long Waist in the middle part Two sizes: 26 mm 29 mm