Edwards Transcatheter AVR: Have the Outcomes Changed after CE Approval?

Transcription

1 Edwards Transcatheter AVR: Have the Outcomes Changed after CE Approval? Update from PARTNER EU and SOURCE Registries T. Lefèvre

2 Disclosure Statement Cardiologist Interventional cardiologist 1 st PABV in st PAVI in 2006 Modest fees from Edwards (Proctoring)

3 Prevalence of Aortic Stenosis % > 65 years > 85 years

4 Aortic Stenosis Background 100 Latency period Survival (%) Symptoms 20 Death Age (years) Ross and Brauwald, Circulation 1968

5 Aortic Stenosis Background > 30% of Symptomatic Patients Will not Have Surgery 100 No Surgery Surgery Bouma 1999 Iung 2004 Pellikka 2005 Bach Charlson 2006 Spokane Vannan 1. Bouma et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart 1999; 82: Iung et al. A prospective survey of patients with valvular heart disease in Europe. European Heart Journal 2003; 24: Pellikka et al. Outcome of 622 Adults with Asymptomatic, Hemodynamically Significant Aortic Stenosis During Prolonged Follow-Up. 4. Circulation Charlson et al. Decision-making and outcomes in severe symptomatic aortic stenosis. J Heart Valve Dis 2006; 15:

6 Compassionate use for the 1st case Cardiogenic shock, surgery denied 16th of April 2002

7 Cribier Edwards Percutaneous Valve

8 Surgeon Anesthesiologist Intensive care Interventional Cardiologist Patient With Symptomatic Aortic Stenosis Clinical Cardiologist GP, Geriatrist Image Specialist (Echo, CT, MRI)

9 Balloon Dilatation Classical Surgery PAVI Patient With Symptomatic Aortic Stenosis Medical Treatment

10 THV Treats a High Risk Patient Population # Patients Surgery PAVI Risk

11 Edwards SAPIEN THV Clinical Research Program > 2500 Patients treated with Edwards Valve First in Man Feasibility Randomized Control Post Market Procedural success in humans Demonstrate reasonable safety & effectiveness Effectiveness vs. control (AVR & medical therapy) Evaluate transition to commercial use Procedural success & clinical outcomes RECAST REVIVE REVIVE I REVIVAL I REVIVE II REVIVAL II IDE TRAVERCE PARTNER EU PARTNER IDE SOURCE

12 PARTNER EU Study Overview Prospective, multicenter, non-randomized, observational trial of the Edwards SAPIEN transcatheter heart valve (THV) in high risk patients who require treatment of severe senile degenerative aortic stenosis using either a transfemoral or transapical delivery approach.

13 PARTNER EU Complete data at 6 months adjudicated by independent comitee (CERC) will be presented at Paris Course meeting in May Complete data at 12 months will be presented at ESC meeting in September 2009.

14 PARTNER EU Edwards SAPIEN THV 9 Balloon expandable stainless steel bioprosthesis 9 Radial strength for concentric shape that create uniform stress on leaflets and limits contact with frame 9 Skirt height optimized for maximum landing zone and reduced paravalvular leak 9 Treated Bovine pericardial valve ThermaFix anti-calcification process 9 23 and 26 mm 9 Transfemoral or transapical approach leaflets with

15 PARTNER EU - Study Design Primary Safety Endpoints Survival at 30 days and 6 months Secondary Efficacy Endpoints Hemodynamic valve performance and functional improvement

16 PARTNER EU - Main Inclusion Criteria Logistic EuroSCORE > 20% and/or STS score 10% If EuroSCORE < 20%, surgeon and cardiologist combined determine that significant co-morbidities are not captured in scores Mean gradient > 40 mmhg /or jet velocity > 4.0 m/s, or initial AVA < 0.8 cm 2 within 30 days of procedure NHYA class > II or class I with LV dysfunction Porcelain aorta Chest deformities or irradiation that preclude open chest procedures

17 PARTNER EU - Main Exclusion Criteria Recent MI (< 14 days) Invasive cardiac procedure, other than BAV, < 30 days Unprotected LM disease > 70% Hemodynamic instability, cardiogenic shock, emergency surgery Primary hypertrophic obstructive cardiomyopathy Native aortic annulus size < 16mm or > 25mm Chronic Dialysis Active infection or endocarditis Life expectancy < 12 months due to non-cardiac co-morbidities Thoracic aortic aneurysm Neurological event or dysfunction < 6 weeks, senile dementia

18 Vienna Paris London Ess en Mas s y Aals t R ouen Frankfurt R otterdam n PARTNER EU 9 Participating Centers in 6 Countries Transapical Transfemoral

19 PARTNER EU Baseline Demographics Transfemoral n=60 Transapical n=71 p-value Age, yrs 82.5 ± ± 5.7 NS Female Gender, % NS NYHA class 2.9 ± ± 0.6 NS Logistic EuroSCORE 24.7 ± ± 14.8 p = STS Risk Assessment 10.9 ± ± 7.0 NS Aortic Valve Area, cm² 0.8 ± ± 0.4 NS Mean Gradient, mmhg 49.7 ± ± 17.8 NS Ejection Fraction, % 53.5 ± ±13.5 NS Intent to Treat

20 PARTNER EU Comorbidities Transfemoral n=60 Transapical n=71 p-value Systemic hypertension 71% 77% NS Coronary artery disease 48% 65% NS Pulmonary disease 50% 34% NS Diabetes mellitus 33% 27% NS Chronic renal disease 31% 41% NS Peripheral vascular disease 14% 44% Congestive heart failure 28% 21% NS Myocardial infarction 17% 20% NS Carotid disease 9% 31% Prior CABG 21% 39% Prior Stroke 7% 10% NS Prior pacemaker 5% 20% Intent to Treat

21 PARTNER EU TA - Procedure Outcomes Patients Planned n = 71 Patients Implanted n = 67 Implant aborted n = 4 Increased CRP (n = 1) Septal hypertrophy (n = 1) Annulus too large (n =1) Ventricular bleeding, conversion (n = 1) 95.5% Successful Implants* n = 64 Implant failures n = 3 23 mm SAPIEN valve N=21 26 mm SAPIEN valve N=43 Ventricular embolization (n = 1) Annular dissection (n=1) Valve in valve for AR (n=1) *Implant success = Successful device delivery and deployment resulting in an AVA>0.9cm² with AI <2+

22 PARTNER EU TA - Survival Probability (event free) M surv: Time (months) Data Extracted: 15AUG2008 Per protocol, n= 67

23 PARTNER EU TA - Survival 80 Probability (event free) Euroscore predicted 1 month mortality Leipzig Euroscore 31 % Traverse Euroscore 27% Partner Euroscore 34% Time (months) Data Extracted: 15AUG2008

24 PARTNER EU TA - Complications Complication Procedural Total at 6 months Non Hierarchical Ranking Myocardial Infarction, % Stroke, % 5.6 Renal Failure with Dialysis, % 4.2 Arrhythmias requiring intervention, % New Pacemaker, % 2.8 Cardiogenic Shock, % Congestive Heart Failure, % 12.7 Vascular Events, % 7.0 Respiratory Complication, % 9.9 Major Bleeding Event, % Multiple Organ Failure, % 5.6 Sepsis, % 4.2 Per protocol, n= 67

25 PARTNER EU TA - Cause of Death Causes Procedural Total at 6 months Myocardial Infarction, % 2.8 Stroke, % 1.4 Multiple Organ Failure, % 5.6 Cardiac Arrhythmia, % 2.8 Cardiac Failure, % Respiratory Complications, % 7.0 Sepsis, % 2.8 Major Bleeding Event, % Annular Rupture, % 1.4 Sudden Death, % 1.4 Other, % 2.8 Per protocol, n= 67

26 PARTNER EU TA NYHA Class at 6 Mo 4 Death N = 26 NYHA IV N = NYHA IV N = 0 NYHA III N = 44 3 NYHA III N = 3 NYHA II N = NYHA II N = 11 NYHA I N = 2 1 NYHA I N = 13

27 PARTNER EU TF - Procedure Outcomes 96.3% Patients Planned n = 60 Patients Implanted n = 54 Successful Implants* n = 52 Implant aborted n = 6 Vascular access (n = 3) Unsucessfull BAV (n=2) Endocarditis (n=1) Implant failures n = 2 23 mm SAPIEN valve N=25 26 mm SAPIEN valve N=27 Ventricular embolization (n = 1) Aortic embolization (n=1) *Implant success = Successful device delivery and deployment resulting in an AVA>0.9cm² with AI <2+

28 Percent Successful Implant % irevive/recast Vancouver REVIVAL II REVIVE II PARTNER EU TF

29 PARTNER EU TF - Survival Probabilty of daeth (%) Euroscore predicted 1 month mortality Freedom from death at 6M = 90% N at risk: 54 N at risk: Time (months) Data Extracted: 01SEP2008

30 PARTNER EU TF - Survival 1 Freedom from Death 0,9 0,8 0,7 0,6 0,5 0,4 0,3 0,2 0,1 0 Partner Revival Canada Revive Months Post Procedure

31 PARTNER EU TF - Complications Complication Intraprocedural Total Myocardial Infarction, % Stroke, % Renal Failure (Dialysis), % New Pacemaker, % Cardiogenic Shock, % Congestive Heart Failure, % Vascular Events, % Valve Embolization, % Non Hierachical Ranking

32 PARTNER EU TF - Cause of Death Causes Procedural Total at 6 months Myocardial Infarction (%) Sepsis (%) Multiple Organ Failure (%) Cardiac Arrhythmia (%) Unknown (%) 0 1.7

33 PARTNER EU TF - EOA EOA (cm²) Baseline Visit Discharge 30 Day 3 Month 6 Month Data Extracted: 01SEP2008

34 PARTNER EU TF NYHA Class at 6 Mo Death N = 4 NYHA IV N = NYHA IV 2 NYHA III N = 30 NYHA III N = 2 NYHA II N = NYHA II N = 13 NYHA I N = 1 1 NYHA I N = 20

35 SOURCE Registry The Source Registry describes the outcomes in a consecutive group of patients treated in European centres during the first year of commercialisation of the Edwards Sapien Valve. 2 cases with a proctor 85% of cases performed without a proctor

36 SOURCE Registry November 2007 January Centers in 12 countries: Austria, Belgium, Denmark, France, Germany, Greece, Italy, The Netherlands, Spain, Sweden, Switzerland, United Kingdom First 592 consecutive Pts with 100% data available 1 month Outcome of the total cohort (n=1119) will be presented at PCR 2009.

37 SOURCE Registry TF TA Patients, n Age, years Euroscore, % Device Success,% Vascular complication, % Renal failure, % Pace maker, % CBVA, % day survival, %

38 Conclusions Percutaneous Aortic Valve Implantation adresses an important clinical need in high risk patients with severe AS. Although this technique is still in its infancy, the preliminary outcomes of PARTNER EU show very encouraging results.

39 Conclusions TA and TF patient populations cannot be directly compared due to different patient profiles. The different results observed with the TA approach are mainly related to the poor baseline characteristics observed in this no-option group and also underline the role of the learning phase inherent to an hybrid technique.

40 Conclusions Careful attention should be paid to the access site when selecting TF patients and performing the procedure. Shared learning and in-depth training shortens the learning curve and continues to demonstrate improved outcomes as observed in the SOURCE Registry.

41 Thank you for your attention! Hybrid Room, Massy May 2008