Update on Percutaneous Therapies for Structural Heart Disease. William Thomas MD Director of Structural Heart Program Tucson Medical Center

Transcription

1 Update on Percutaneous Therapies for Structural Heart Disease William Thomas MD Director of Structural Heart Program Tucson Medical Center

2 NCVH Tucson Disclosure of Financial Interest Research: Stock : Consulting / Lecuture series- None None Edwards Lifesciences

3 Cross Boss

4 Stingray

5 Retrograde crossing

6 CTO techniques: A stretch of the old PCI

7 Structural Heart Inteventions!

8 Percutaneous valve replacement: TAVR / TMVR

9 Paravalvular leak closures

10 Structural Heart Dz Interventions TAVR TMVR TPVR ASD VSD PDA ASA-Alcohol Septal Ablations PVL- Para-valvular leak closures LAA closure

11 What is TAVR? For patients who are either at high risk or too sick for open-heart surgery, TAVR may be an alternative This less invasive procedure allows the aortic valve to be replaced with a new valve while the heart is still beating 11

12 The Problem: Aortic Stenosis Gross specimen of minimally diseased aortic valve (left) and severely stenotic aortic valve (right) Images courtesy of Renu Virmani MD at the CVPath Institute 12

13 Aortic Stenosis Is Life Threatening and Progresses Rapidly 7 Survival after onset of symptoms is 50% at 2 years 1 Surgical intervention for severe aortic stenosis should be performed promptly once even minor symptoms occur 1 13

14 In the Era of Evidence Based-Medicine: What is the absolute Benefit? Absolute % difference in Mortality From Randomized Trials

15 So What are the Tx options for severe Aortic Stenosis. SAVR TAVR BAV Med tx 15

16 Survival, % Aortic Valve Replacement Greatly Improves Survival Patient Survival Years AVR, No no Symptoms Sx AVR, Symptoms Sx No AVR, No no Symptoms Sx No AVR, Symptoms Sx Study data demonstrate that early and late outcomes were similarly good in both symptomatic and asymptomatic patients It is important to note that among asymptomatic patients with SAS, omission of surgical treatment was the most important risk factor for late mortality 16

17 Addressing a Serious Unmet Need Studies show at least 40% of SAS patients are not treated with an AVR

18 All-Cause Mortality, % Standard Therapies are Inadequate Treatments for Severe Aortic Stenosis Patients The PARTNER Trial 50.7% Control Group (Med Rx and BAV) 68.0% 20 0 Numbers at Risk Control Group Months As seen previously, survival after onset of symptoms in patients with aortic stenosis is 50% at 2 years 1 The PARTNER Trial showed that in inoperable patients with severe aortic stenosis who did not receive a valve replacement, 50% died within 1 year Despite the frequent utilization of BAV, standard therapy did not do much to alter the dismal course of disease for inoperable patients with severe aortic stenosis 18

19 Edwards SAPIEN Transcatheter Heart Valve The Edwards SAPIEN transcatheter heart valve is indicated for patients with severe symptomatic calcified native aortic valve stenosis who have been examined by a Heart Team including an experienced cardiac surgeon and cardiologist and found to be either inoperable or at high risk for surgical aortic valve replacement.

20 Definitive Results Through Rigorous Design THE PARTNER TRIAL COHORT B 20

21 Definitive Results Through Rigorous Design THE PARTNER TRIAL COHORT B 22

22 Edwards SAPIEN THV Improved Survival THE PARTNER TRIAL COHORT B 23

23 Edwards SAPIEN THV Reduced Symptoms THE PARTNER TRIAL COHORT B 24

24 All-Cause Mortality (%) All-Cause Mortality (ITT) Crossover Patients Censored at Crossover Standard Rx (n = 179) TAVR (n = 179) 80.9% 87.5% 93.6% 68.0% 71.8% 50.8% 64.1% 53.9% 43.0% 30.7% HR [95% CI] = 0.50 [0.39, 0.65] p (log rank) < Months * In an age and gender matched US population without comorbidities, the mortality at 5 years is 40.5%.

25 Rehospitalization (%) Repeat Hospitalization (ITT) Standard Rx (n = 179) TAVR (n = 179) 83.0% 87.3% 72.5% 75.7% 53.9% 43.1% 46.3% 47.6% 34.9% 27.0% HR [95% CI] = 0.40 [0.29, 0.55] p (log rank) < Months

26 Study Design & Inclusion Criteria THE PARTNER TRIAL COHORT A 27

27 All-Cause Mortality ITT Population THE PARTNER TRIAL COHORT A 28

28 NYHA Class ITT Population THE PARTNER TRIAL COHORT A 29

29 Second Generation TAVR valves

30 TAVR: Extreme Risk study of the Core Valve U.S. Pivotal trial 4:57pm FDA grants earlier than expected approval for medtronic s CoreValve

31 Choice Trial: ACC 2014 RCT- 241 high surgical risk pts- Randomized 1:1 Sapien vs CoreValve 30day mortility = 4.1% and 4.3% 30 day MACCE = 6.6% and 3.4% (p=0.38) Device success = 96% vs 77% 3-4+ AI in: 4% Sapien and 18% CoreValve (p=0.001) Need for new PPM= 17% (Sapien) vs 38% (CoreValve)

32 33 Clinical Outcomes Improve as Therapy Evolves Low Stroke Rates Patient selection, procedural techniques, device evolution RetroFlex Delivery System RetroFlex 3 Delivery System NovaFlex+ Delivery System Improved Vascular Access Alternative access, lower profile devices 22F 16F RetroFlex 3 Introducer Sheath esheath Increased Treatment Range Advanced imaging, larger size devices 23 mm SAPIEN XT 26 mm SAPIEN XT 29 mm SAPIEN XT

33 Partners II Trial Design Trial Design Trial Design A prospective randomized, multicenter trial with A prospective randomized, multi-center trial with two population cohorts: 1) patients who are designated two population cohorts: 1) patients who are designated to have intermediate risk for surgical aortic valve to have intermediate risk for surgical aortic valve replacement (operable replacement (operable Cohort A) and 2) patients who are not suitable for aortic valve surgery (inoperable (inoperable Cohort B). Cohort A 1364 subjects randomized 1:1 Cohort B 500 subjects randomized 1:1- Sapien vs Sapien XT

34 PARTNER II Mortality Cohort B HR [95% CI] = 0.93 [0.66, 1.33] p (log rank) = % 22.5%

35 Clinical Gains From PARTNER II Clinical Gains From PARTNER II Decreased Anesthesia Time (p=0.02) Decreased Vascular Complications (p=0.03) Decreased Multiple Valve Implants (p=0.06) Decreased Aborted Procedures (p=0.06) Decreased Need For IABP (p=0.06)

36 PARTNER II- Inoperables What Did Not Change Mortality: Sapien XT 3.5% Sapien 5.1% Stroke: Sapien XT 3.2% Sapien 3.0% Paravalvular Leak Similar at 1 year

37 Future Challenges to Be Addressed by Next Generation TAVR Technology Low Profile Systems Retrievable and Repositionable Reduction of Paravalvular Leak Ability to Deliver Through Alternative Access Reduce Conduction System Disturbances Integrate with Embolic Protection Systems Keep The Surgeon Engaged!

38 Procedural Complications

39 Procedural Complications Death Vascular injury Peravalvular regurgitation 1-2% (2-4+) Atrioventricular block % Stroke 0-9% Myocardial infarction- emboli/lm occlusion Aortic rupture Device Malposition/ Embolization Acute Renal failure

40 PVL

41 42 Low Frame Height Designed to Respect the Cardiac Anatomy and Minimize the Risk of Conduction System Interference Edwards SAPIEN XT transcatheter heart valve Carpentier-Edwards PERIMOUNT Magna Ease surgical heart valve 23 mm 21 mm 14 mm 14 mm

42 Sapien 3

43 Mitral Valve Interventions for MR Edge to Edge & MitraClip Concepts Facilitates proper leaflet coaptation Degenerative - Anchor flail and prolapsed leaflets Functional - Coapt tethered leaflets to reduce time and force required to close valve Reduces LV volume overload by reducing MR Creates tissue bridge May limit dilatation of annulus Septal-lateral (A-P) dimension Supports durability of repair Restrains LV wall Limits LV dilatation

44 Two types of MR: Degenerative and Functional

45 Everest II: 4yr data PerQ Surgery Composite efficacy 39.8% 53.4% Death 17.4% 17.8% Surgery/reop 24.8% 5.5% P= or 4+ MR 21.7% 24.7%

46 Source: Schillinger, W. ACCESS-EUROPE Phase I: A Post Market Study of the MitraClip System for the Treatment of Significant Mitral Regurgitation in Europe: Analysis of Outcomes at 1 Year. ESC 2012; August 25-29, 2012; Munich, Germany.

47

48

49 MitraClip Clip Delivery System INDICATION FOR USE The MitraClip Clip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation. CONTRAINDICATIONS The MitraClip Clip Delivery System is contraindicated in DMR patients with the following conditions: Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen Active endocarditis of the mitral valve Rheumatic mitral valve disease Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus

50 TMVR: on the horizon-?3-5yrs?

51 Para-Valvular Leaks 1-5% clinically significant leaks with both Surgical Also occur in TAVR/TMVR Increase risk with reoperation Associated with: CHF Hemolytic anemia Endocarditis

52 PerQ Closure of PVL

53 Use of 3-D echo to close PVL s

54 Amplatzer plugs

55 PerQ closure of PVL s Success rate 70-90% pending on anatomy TEE- 2D and or 3D essential Clinical improvement common Still off lable and restricted to poor surgical candidates Avoid in unstable prosthetic valve Avoid if additional surgeries needed-? CABG Avoid in endocarditis

56