1 / 29

Percutaneous Approach to Aortic Valve Repair

Percutaneous Approach to Aortic Valve Repair. William W. O’Neill, M.D. Executive Dean Clinical Affairs Miller School of Medicine University of Miami. CAD Circa 1950. Coronary Heart Disease Deaths in the U.S. 1973 - 1998 "A Shift to the Right". Source: www:BBHQ.com. 5.

Albert_Lan
Download Presentation

Percutaneous Approach to Aortic Valve Repair

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Percutaneous Approach to Aortic Valve Repair William W. O’Neill, M.D. Executive Dean Clinical Affairs Miller School of Medicine University of Miami

  2. CAD Circa 1950

  3. Coronary Heart DiseaseDeaths in the U.S. 1973 - 1998"A Shift to the Right"

  4. Source: www:BBHQ.com

  5. 5

  6. ACC/AHA 2006 Practice Guidelines JACC 2006;48:598-675

  7. 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 1999;82:143-148 • 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 Journal2003;24:1231-1243 (*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 Dis2006;15:312-321

  8. The Problem Is Urgent Treatment Options and Timing Matter “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 Survival Percent Onset severe symptoms 100 Angina Latent Period (Increasing Obstruction, Myocardial Overload) 80 Syncope Failure 2 4 6 0 60 Avg. survivalYears 40 20 AgeYears 0 40 50 60 70 80 Aortic stenosis is life-threatening and progresses rapidly 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. 1968;38 (Suppl 1):61-7.

  9. Natural History of Candidates for Balloon Aortic Valvuloplasty, O’Keefe et al:Mayo Clinic Proceedings 62:986-991, 1987 50 Patients, mean age 77 yrs., operation declined in 28 and deferrred in 22

  10. Predictors of Long Term Survival After Percutaneous Aortic Valvuloplasty: Report of the Mansfield Scientific Balloon Aortic Valvuloplasty Registry: O’Neill et al. JACC Vol.17, No.1, Jan 1991:193-8

  11. Hemodynamic Comparison:BAV vs. AVR *One year post-operation. Jin et al. Ann Thor Surg. 2001 May; 71(5 Suppl):S311-4

  12. Bittl et al. NEJM 1996;335:1290

  13. Clinical Trial Update Edwards SAPIENTM Transcatheter Heart Valve1 It’s What You Leave Behind That Matters Update May 2008 1. CAUTION – Investigational device. Limited by United States law to investigational use.

  14. 2 1,8 Mean Gradient (mm Hg) AVA (cm²) 80 1,6 70 p = .0076 p = .0076 1,4 1.69 60 1,2 1 50 0,8 40 43 0,6 30 0,4 20 0,2 0.56 0 10 8.5 0 Pre Post Pre Post PROCEDURAL RESULTS

  15. Edwards SAPIEN® Transcatheter Delivery Systems Pulmonic Transfemoral Transapical Update SEPT 2008

  16. Lenox Hill Heart and Vascular Institute Of New York - 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)

  17. 25 1/9/2009 11:21 AM

  18. 26 1/9/2009 11:21 AM

  19. ASSESSMENT: Operability No Yes n=350 pts Cohort B n= up to 690 pts Cohort A Total n= 1040 ASSESSMENT: Transfemoral Access ASSESSMENT: Transfemoral Access No Yes No Yes Cohort A TA Powered to be Pooled with TF Cohort A TF Powered Independently 1:1 Randomization Not in Study 1:1 Randomization 1:1 Randomization Trans apical AVR Control Trans femoral Medical Management Control Trans femoral AVR Control VS VS VS Primary Endpoint: All Cause Mortality (Superiority) Primary Endpoint: All Cause Mortality(Non-inferiority) The PARTNER IDE Trial Co-principal Investigators:Martin 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

  20. 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.

  21. Edwards Lifesciences RetroFlex® II Transfemoral Delivery Kit Update SEPT 2008

More Related