Percutaneous Approach to Aortic Valve Repair

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Percutaneous Approach to Aortic Valve Repair

• William W. ONeill, M.D.
• Executive Dean Clinical Affairs
• Miller School of Medicine
• University of Miami

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CAD Circa 1950
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Coronary Heart DiseaseDeaths in the U.S. 1973 -
1998"A Shift to the Right"
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Source wwwBBHQ.com
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ACC/AHA 2006 Practice Guidelines JACC
200648598-675
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At least 30-40 Of Cardiologists AS Patients Go
Untreated
Severe Symptomatic Aortic StenosisPercent of
Cardiology Patients Treated
No AVR
AVR
Under-treatment especially prevalent among
patients managed by Primary Care physicians
Update May 2008

• Bouma B J et al. To operate or not on elderly
  patients with aortic stenosis the decision and
  its consequences. Heart 199982143-148
• Iung B et al. A prospective survey of patients
  with valvular heart disease in Europe The Euro
  Heart Survey on Valvular Heart Disease. European
  Heart Journal2003241231-1243 (includes both
  Aortic Stenosis and Mitral Regurgitation
  patients)
• Pellikka, Sarano et al. Outcome of 622 Adults
  with Asymptomatic, Hemodynamically Significant
  Aortic Stenosis During Prolonged Follow-Up.
  Circulation 2005
• Charlson E et al. Decision-making and outcomes
  in severe symptomatic aortic stenosis. J Heart
  Valve Dis200615312-321

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The Problem Is Urgent Treatment Options and
Timing Matter
Aortic stenosis is life-threatening and
progresses rapidly

• Survival after onset
• of symptoms is 50
• at two years and
• 20 at five years.1
• Surgical intervention
• for severe AS should
• be performed promptly
• once even minor
• symptoms occur.2

Update May 2008
Sources 1 S.J. Lester et al., The Natural
History and Rate of Progression of Aortic
Stenosis, Chest 1998 2 C.M. Otto, Valve
Disease Timing of Aortic Valve Surgery, Heart
2000 Chart Ross J Jr, Braunwald E. Aortic
stenosis. Circulation. 196838 (Suppl 1)61-7.
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Natural History of Candidates for Balloon Aortic
Valvuloplasty, OKeefe et alMayo Clinic
Proceedings 62986-991, 1987
50 Patients, mean age 77 yrs., operation declined
in 28 and deferrred in 22
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Predictors of Long Term Survival After
Percutaneous Aortic Valvuloplasty Report of the
Mansfield Scientific Balloon Aortic Valvuloplasty
Registry ONeill et al. JACC Vol.17, No.1, Jan
1991193-8
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Hemodynamic ComparisonBAV vs. AVR
One year post-operation. Jin et al. Ann Thor
Surg. 2001 May 71(5 Suppl)S311-4
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Bittl et al. NEJM 19963351290
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Clinical Trial Update
Edwards SAPIENTM Transcatheter Heart Valve1 Its
What You Leave Behind That Matters
Update May 2008
1. CAUTION Investigational device. Limited by
United States law to investigational use.
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PROCEDURAL RESULTS
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Edwards SAPIEN Transcatheter Delivery
Systems
Transfemoral
Transapical
Pulmonic
Update SEPT 2008
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CC Mark
-
Edwards-Sapien
ReValving? System CoreValve

• Single layer porcine pericardium
• Tri-leaflet configuration
• Nitinol frame self-expandable - Inflow 26 and 29
  mm 20 to 27 mm annulus
• Delivery system 18F / 12F (OD)

• Bovine pericardium
• Tri-leaflet configuration
• Mounted on a 14 mm long x 23 mm or 26 mm diameter
  highly resistant stainless steel balloon
  expandable stent
• Delivery system 24F - 26F (ID)

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1/9/2009 1121 AM
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1/9/2009 1121 AM
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The PARTNER IDE Trial
Co-principal InvestigatorsMartin B. Leon, MD
Interventional CardiologyCraig Smith, MD,
Cardiac SurgeonColumbia University
Population High Risk/Non-Operable Symptomatic,
Critical Calcific Aortic Stenosis
Two Trials Individually Powered Cohorts(Cohorts
A B)
Update SEPT 2008
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n 1975
n 456
n 723
n 121
n 253
n 95
n 172
n 106
n 25
n 24
CAUTION Investigational device. Limited by
Federal (USA) law to Investigational use
only. This product has not been approved
for marketing in the United States, and is
not available for sale in the United States.
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Edwards Lifesciences RetroFlex II Transfemoral
Delivery Kit
Update SEPT 2008