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

DISCLOSURE I have N O relevant financial relationships DISCLOSURE I have N O relevant financial relationships

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

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

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

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

1. 8 cm Measurement of aortic annulus 1. 8 cm Measurement of aortic annulus

1. 8 cm 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 Percutaneous AV Replacement Role of On-Line TEE • Reassess annular diameter critical for sizing • Monitor deployment of valve (verify correct positioning) co-axial alignment (detect impingement on coronaries) • Assess severity and location of AR • Assess leaflet motion of the deployed valve • Measure gradients (transgastric views) • Detect new regional WMAs • Detection of complications

Percutaneous AV Replacement Complications • Vascular complications • Stroke • Dislodgement of aortic atheroma 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 • 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, 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 Vmax = 4. 3 m/s peak instantaneous gradient = 74 mm Hg

23 mm balloon 25 mm balloon 23 mm balloon 25 mm balloon

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

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

Pre Post Pre Post

This 95 year-old man has returned to bowling ! This 95 year-old man has returned to bowling !

LA LV Coaxial No tc oa xia l LA LV Coaxial No tc oa xia l

LA LV proximal distal LA LV proximal distal

Case 2 Case 7 Case 2 Case 7

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

Make sure wire does not interfere with mitral apparatus Make sure wire does not interfere with mitral apparatus

Case 3 Case 7 Case 3 Case 7

Transapical approach - wire not thru mitral apparatus Transapical approach - wire not thru mitral apparatus

Balloon valvuloplasty Balloon valvuloplasty

Pre-deployment - valve in good position Pre-deployment - valve in good position

Deployment of valve Deployment of valve

Valve deployed - good position Valve deployed - good position

Case 4 Case 7 Case 4 Case 7

Valve deployed - slightly “aortic” (too high) Valve deployed - slightly “aortic” (too high)

Case 5 Case 7 Case 5 Case 7

Wire passing through mitral apparatus Wire passing through mitral apparatus

Wire passing through mitral apparatus Wire passing through mitral apparatus

Wire withdrawn and re-inserted now “safe” Wire withdrawn and re-inserted now “safe”

Potential problem Now OK Potential problem Now OK

Case 6 Case 7 Case 6 Case 7

Mobile thrombus in descending thoracic aorta Mobile thrombus in descending thoracic aorta

Mobile thrombus in aortic arch Mobile thrombus in aortic arch

Case 7 Case 7

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

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

Symptomatic Aortic Stenosis AVR Must Be Performed 100 Survival (%) 80 Valve Replacement 60 Symptomatic Aortic Stenosis AVR Must Be Performed 100 Survival (%) 80 Valve Replacement 60 40 No surgery 20 P<0. 05 0 0 1 P<0. 001 2 3 Years Schwartz Circulation 1982; 66: 1105 -10 Chi 2 = 23. 5 P<0. 001 4 5

Incidence of Aortic Stenosis for Population > 65 Population (x 106) Based on estimated Incidence of Aortic Stenosis for Population > 65 Population (x 106) Based on estimated population growth projection data from US census 2. 00 1. 80 1. 60 1. 40 1. 20 1. 00 0. 80 0. 60 0. 40 0. 20 0. 00 2010 2020 2030 2040 Year US Census Bureau. US Interim Projections by Age, Sex, Race, and Hispanic Origin. In 2004. 2050

Aortic Valve Replacement • Increasing need over next 10 years - Aging population - 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 Transcatheter Percutaneous Aortic Valve Replacement A driving force for catheter-based therapies for valvular heart disease since mid-1980 s Pioneered the development of Cribier-Edwards heart valve Performed the first PTAVR in 2002 Alain Cribier Rouen, France

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

Placement of Ao. RTic Tra. Nscathet. ER Valves Trial PARTNER Trial Placement of Ao. RTic Tra. Nscathet. ER Valves Trial PARTNER Trial

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

Percutaneous Aortic Valve Indications • Severe AS from degenerative disease • Symptomatic • Aortic Percutaneous Aortic Valve Indications • Severe AS from degenerative disease • Symptomatic • Aortic valve area <0. 8 cm 2 and Vmax >4. 0 m/s or mean gradient > 40 mm Hg • Surgical mortality > 20%

Edwards SAPIEN™ THV using the Retro. Flex 3™ Transfemoral Delivery System Procedural Steps Balloon Edwards SAPIEN™ THV using the Retro. Flex 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 Edwards SAPIEN™ THV using the Ascendra™ Transapical Delivery System Direct access the apex Balloon valvuloplasty Native valve crossing Valve deployment Procedure steps Final assesment

Valve before deployment Valve before deployment

Valve after deployment Valve after deployment

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

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

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

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

Case 57 Case 57

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

Valve positioned properly Valve positioned properly

Valve deployed properly Valve deployed properly

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

68 cm/sec 68 cm/sec

Case 8 Case 7 Case 8 Case 7

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

LVOTD=2. 0 cm Ao Valve Area = 0. 8 cm 2 V 2=4. 1 LVOTD=2. 0 cm Ao Valve Area = 0. 8 cm 2 V 2=4. 1 m/s V 1=1. 1 m/s

After deployment of 23 mm Edwards-Sapien aortic valve After deployment of 23 mm Edwards-Sapien aortic valve

Reason…… Reason……

Patient’s blood pressure decreased from 170/69 to 93/32 mm. Hg Patient’s blood pressure decreased from 170/69 to 93/32 mm. Hg

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

Deployment of 2 nd valve inside the 1 st valve Deployment of 2 nd valve inside the 1 st valve

After valve deployment trace aortic regurgitation After valve deployment trace aortic regurgitation

Confucius said…… “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 ECHO

Transcatheter AV Repalcement Edwards-Sapien Valve Successful deployment 87% 30 -day mortality 7. 4% Major Transcatheter AV Repalcement Edwards-Sapien Valve Successful deployment 87% 30 -day mortality 7. 4% Major adverse cardiac event rate Tops, Kapadia, Tuzcu, Vahanian, Alfieri, Webb, Bax Current Problems in Cardiology 2008; 33 A: 415 -57 16. 7%

Aortic Valve Replacement Percutaneous Approach • General anesthesia or awake patients • Avoids surgery 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 Edwards-Sapien Valve Balloon expandable Stainless steel stent Fabric sealing cuff Bovine pericardial leaflets Two sizes: New height 23 mm 26 mm

Core. Valve Prosthesis Self expanding Nitinol alloy stent Porcine pericardial leaflets Pericardial sealing cuff Core. Valve 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