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2. Is the Evidence Catching UpWith Reality? A. Yes B. No C. Both3/13/2012 3 3. Acceptance with Pros & ConsMore Judicioususe & Innovations MultipledeficienciesExplosiveuse in RealWorld Excellent results in ResearchSettings New Idea3/13/2012 4 4. The evolution of TAVI Henning Anderson(1992) first transcatheterimplantation of aortic valve in animal model Philipp Bonhoeffer(2000) first transcatheterimplantation of pulmonary valve in animalmodel Alain Cribier on April 16,2002 firstsuccessful in human TAVI3/13/20125 5. Surgical AVR For > 40 years Surgical AVR The Gold standard for symptomaticAS Relieves symptoms, prolongs life but not for everyone 32% of symptomatic patients with severe AS were denied surgery. Reasons high-risk features of the population including oldage, presence of serious co-morbidities.Iung B: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J2003;24:123143.3/13/20126 6. Unmet clinical needs These medically managed patients had a dismalprognosis (1-, 5-, and 10-year survival was60%, 32%, and 18%, respectively) Morbidity and mortality of valve replacementsurgery remains significant in several subgroups. Surgical mortality increases by 33% in low-volume centers3/13/2012 7 7. 3/13/2012 8 8. TAVI simple but convincingconcept It has generated enthusiasm as A technique easily adopted by interventionalcardiologists A large unmet clinical need.3/13/20129 9. The opposite course While SAVR, in analogy to most other medicalprocedures (i.e. PCI), slowly progressed from lowto higher risk patient populations, The evolution of TAVI took the oppositecourse, with early candidates being high risksurgical patients with relevant co-morbiditiesjudged to be inoperable.3/13/201210 10. After the first in-human use in 2002, few caseseries were published by leaders In 2007 the technique got approval in Europe Since then multiple registries have cropped up These reflect the real world status of TAVI3/13/201211 11. 3/13/2012 12 12. 1. The reproducible safety and efcacy2. Data of unfavourable patient populations3. Increased condence in the technique4. Also established a novel, valuable treatment option 3/13/2012 13 13. Experience of two latest registries Eltchaninoff et al. (France) and Zahn et al. (Germany) publish the results of twomoderate to large-scale national registries on TAVI in Europe. Have almost similar enrolment period starting in early 2009 Industry independent Report data on both commercially available devices The Edwards Sapien balloon-expandable prosthesis (23 and 26 mm prosthesis with 2224 Fdelivery sheath) and The Medtronic CoreValve self-expanding device (26 and 29 mm prosthesis with 18 F deliverysheath), Include all presently established access options Mainly octogenarians with a high prevalence of CAD , PVD previous cardiacsurgery and stroke in every 10th patientEuropean Heart Journal(2011) 32, 133-1373/13/201214 14. Both studies corroborate the results of previousreports in a real-world within their respectivecountries, Demonstrating1. Technical success rate of 9899%,2. Similar 30-day mortality of 12%, and3. An incidence of stroke of 34%.3/13/2012 15 15. What can we learn from these studies? TAVI is associated with a high technicalsuccess rate using both devices inappropriately selected patients, and conversionto open surgery is exceedingly rare. But the involvement of cardiac surgeonsinvaluable.3/13/2012 16 16. The 30-day mortality of 12% in both registries remainshigh1. May compare favourably with expected mortality2. More than 80% of all reported deaths in these seriesoccurred during the rst week and3. Were largely related to severe vascular complications.4. The smaller introducer and delivery systems3/13/2012 17 17. As both registries included a considerable numberof sites with no previous TAVI experience It is likely that results will improve further inexperienced centres. The importance of the learning curve in reducingmortality has been clearly shown3/13/2012 18 18. Thirty-day mortality as a function of learning curve:Vancouver experience. John Webb, ; Circulation 2009;119; 3009-30163/13/2012 19 19. The need for pacemaker implantation in 1239% of patients isnotable. The anatomic proximity of the AV node and His bundle to thevalvular apparatus Balloon- and device-mediated injury and inammation. Device-specic differences A higher incidence with the Medtronic CoreValve prosthesis. Precautionary measures will help reduce the incidence rate3/13/2012 20 20. Notwithstanding, the threshold for pacemakerimplantation varies widely according to clinicalpractice, as exemplied by a pacemaker rate of 5% in the French and 21% in theGerman registry following implantation of the EdwardsSapien prosthesis, Which shows the need for widely accepted and uniformcriteria on pacemaker indications after TAVI procedures3/13/2012 21 21. The haemodynamic short-term proles of both prostheses areexcellent and similar to surgically implanted valves in terms of Transvalvular gradient Effective orice area, Symptomatic improvement and improved left ventricular function. Conversely, TAVI remains associated with more frequentparavalvular regurgitation as compared with SAVR whose long-termsequelae require careful study.3/13/2012 22 22. Significant AR after TAVI is common and isassociated with increased in-hospital mortality. Long-termfollow-up is critical to further define the impact of residualAR on clinical outcome. Until these data becomeavailable, every effort should be made to prevent and treatthis complication.Mohamed Abdel-Wahab et al;European Heart Journal; Published Online First 12 March 20113/13/201223 23. TAVI is a catheterization laboratory-basedtechnique With more than two-thirds of proceduresperformed in this environment in the Frenchregistry.3/13/2012 24 24. A favorable cost-effectiveness ratio3/13/2012 25 25. TAVI is a highly versatile technique, can be doneusing various access routes -1. Transfemoral,2. Transapical, and3. Trans-subclavian site,allows for a broad clinical applicability in the majority ofpatients.3/13/201226 26. 3/13/2012 27 27. Both devices play a complementary role Currently accommodate a valve annulus ranging from 19 to27 mm Largely independent of the take-off of the coronary arteries A wider range of device sizes will allow the indications tobe extended to even smaller and larger aortic annuli in thenear future.3/13/2012 28 28. Limitations of Registries The two devices as well as the access routes have been usedaccording to the discretion of the operator. Report only short-term clinical outcome data at 1 month, which areimportant to dene device safety, but are clearly insufficient todelineate the efficacy prole of this technology. In addition, the data become outdated with the advent of new deviceiterations.3/13/2012 29 29. The newest generation Edwards SAPIEN XT prosthesis has a lowerprole (NovaFlex delivery system) and is delivered through 18/19 Fsheaths. The next iteration of the Medtronic CoreValve device uses theAccutrak feature for improved stability upon device placement. Finally, the lack of data monitoring, independent eventadjudication, differences in event reporting as well as inconsistentoutcome denitions provide additional sources of relevant bias3/13/201230 30. VARC Valve Academic Research Consortium3/13/2012 J Am Coll Cardiol 2011;57:25369 31 31. Randomized controlled Trials 3/13/201232 32. PARTNER Trial Cohort B First RCT A total of 358, aortic stenosis candidatesconsidered inoperable 21 centersNEJM october 21, 2010 vol. 363 no. 173/13/2012 33 33. 3/13/2012 34 34. In standard therapy group 83.8 % of patientsunderwent BAV in addition to maximalmedical management.3/13/201235 35. 3/13/2012 36 36. 3/13/2012 37 37. 3/13/2012 38 38. 3/13/2012 39 39. 3/13/2012 40 40. 3/13/2012 41 41. 3/13/2012 42 42. 3/13/2012 43 43. 3/13/2012 44 44. 3/13/2012 45 45. 3/13/2012 46 46. 3/13/2012 47 47. AV areas over time3/13/201248 48. Paravalvular Regurgitation with TAVI3/13/2012 49 49. Implications of PARTNER I(Cohort B) Standard medical therapy(including BAV) did not alterthe natural history Transfemoral TAVI was superior In the firstyear, NNT = 5 Significant reduction in symptoms in TAVI group More neurologic events, major vascularcomplications, and major bleeding events in the TAVIgroup3/13/201250 50. Hemodynamic performance of the bioprosthetic valve wasexcellent, no evidence of deterioration in the first year. Frequent occurrence of paravalvular regurgitation, whichwas -1.Usually mild,2.Remained stable during 1-year follow-up period, and3.Rarely required further treatment for worsening symptoms.3/13/2012 51 51. PARTNER II (Cohort A) 25 centers 699 high-risk patients with severe aortic stenosisbut considered operable were randomizedNEJM, June 9, 2011 vol. 364 no. 233/13/201252 52. 3/13/2012 53 53. ResultsAt 30 days At 1 year TAVI SAVR P-TAVI SAVR P- VALUE VALUE All 3.4% 6.5%0.07 24.2%26.8% 0.44CauseMortality Major 3.8% 2.1%0.20 5.1%2.4% 0.07 Stroke Major 11%3.2% 0.001 - - -VascularComplic ations 3/13/2012 54 54. Adverse events that were more frequent after surgicalreplacement included Major bleeding (9.3% vs. 19.5%, P