Transcatheter Valve Replacement: Current State in 2017
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1 Transcatheter Valve Replacement: Current State in 2017 Marc A. Sintek MD Assistant Professor of Medicine Interventional Cardiology Cardiovascular Division Washington University in St. Louis Missouri ACP 2017 CME Meeting Updates in Internal Medicine September 17, 2017 Disclosures: Consultant Volcano Corporation
2 Overview A Standard TAVR Case Evidence review and update for TAVR Evaluating Patients for TAVR Future of TAVR and unique TAVR populations Mitral valve therapies Complex TAVR Case
3 Case XX
4 The Evidence for TAVR The original data (PARTNERS) Intermediate Risk Patients Durability and Safety updates CoreValve Evolute R Sapien S3
5 Brief history of TAVR Alain Cribier: First human transcatheter valve replacement (2002) Slide Courtesy Edwards Life Sciences
6 Slide Courtesy Edwards Life Sciences Brief history of TAVR
7 Brief history of TAVR PARTNERS Cohort B (Inoperable) PARTNERS Cohort A (High Risk) NEJM 2010; 363: NEJM 2011;364:
8 Brief history of TAVR CoreValve Extreme Risk Trial (Inoperable) CoreValve Pivotal Trial (High Surgical Risk) JACC 2014; 63: NEJM 2014;370:
9 Brief history of TAVR Low mortality and stroke rates Patient selection, procedural techniques, device evolution RetroFlex 3 delivery system NovaFlex+ delivery system Edwards Commander delivery system Improved vascular access Lower profile devices expands treatment possibilities 22F 16F 14F RetroFlex 3 introducer sheath Edwards esheath introducer set Edwards esheath introducer set* Increased treatment range Larger and smaller valves SAPIEN valve 23 mm and 26 mm SAPIEN XT valve 23 mm, 26 mm, 29 mm SAPIEN 3 valve 20 mm, 23 mm, 26 mm, 29 mm *Only used with 20 mm,23 mm,26 mm valve sizes Slide Courtesy Edwards Life Sciences
10 Slide Courtesy Edwards Life Sciences Brief history of TAVR
11 PARTNER II NEJM 2016; 374: patients with STS score between 4-8%. PCI/CABG allowed Sapein XT valve
12 PARTNER II 236 patients (11%) were transthoracic TAVR. NEJM 2016; 374:
13 PARTNER II LEAK is BAD NEJM 2016; 374:
14 The PARTNER IIA and S3i Trial Study Design Intermediate-Risk Symptomatic Severe Aortic Stenosis Intermediate-Risk Assessment by Heart Team PII S3i n = 1078 PIIA n = 2032 ASSESSMENT: Optimal Valve Delivery Access Yes ASSESSMENT: Transfemoral Access No Transfemoral (TF) Transapical / Transaortic (TA / TAo) Transfemoral (TF) Transapical / Transaortic (TA / TAo) 1:1 Randomization 1:1 Randomization TF TAVR SAPIEN 3 TA / TAo TAVR SAPIEN 3 TF TAVR SAPIEN XT VS. Surgical AVR TA /TAo TAVR SAPIEN XT VS. Surgical AVR
15 All-Cause Mortality (%) PARTNER II S3i 40 Surgery (PIIA) TAVR with SAPIEN 3 Valve % 4.0% 1.1% 1.1% Months from Procedure Number at Risk: Surgery SAPIEN 3 TAVR % 7.4% *The PARTNER II trial intermediate-risk cohort unadjusted clinical event rates. Slide Courtesy Edwards Life Sciences
16 PARTNER II S3i Leak 100% 3.8% 0.5% 1.5% 0.3% 80% 60% Severe Moderate 40% Mild None / Trace 20% Number of Echos: Surgery SAPIEN 3 TAVR 0% PARTNER II S3i Trial SAPIEN 3 Valve PARTNER IIA Trial Surgery PARTNER II S3i Trial SAPIEN 3 Valve 30 Days 1 Year PARTNER IIA Trial Surgery Slide Courtesy Edwards Life Sciences
17 SURTAVI 1746 patients STS score 3-15% but heart team agreed intermediate risk (mean STS score was 4%). Corevavle 84% (Evolute R 16%). NEJM 2017; 376:
18 SURTAVI SURTAVI 30 day Outcomes TAVR SAVR Significant All cause death 2.2% 1.7% No Any Stroke 3.4% 5.6% No Pacemaker 25.9% 6.6% Yes Vascular Complication 6.0% 1.1% Yes NEJM 2017; 376:
19 JACC Imaging : PARTNER I- 5 year
20 TVT Registry JACC : ,998 implants from % had STS <8% (intermediate)
21 JACC : TVT Registry
22 JACC : TVT Registry
23 The TAVR Evaluation Understanding risk and STS score TAVR diagnostic testing Cohort C The heart team
24 The TAVR Evaluation 1. Does the patient have Severe AS? 2. Is the patient having symptoms of severe aortic stenosis? 3. What is the best treatment?
25 The TAVR Evaluation
26 The TAVR Evaluation RISK LEVEL STS Risk of Mortality Low <3% Intermediate 4-8%* High >8% Extreme >15%
27 The TAVR Evaluation Consultation with 1 cardiologist and 2 cardiac surgeons Echocardiogram Coronary angiogram Pulmonary function testing Carotid Dopplers TAVR protocol CT (gated CT with 1mm slices of the heart, chest, abdomen and pelvis) Fraility Evaluation
28 The CT is King
29 JACC Invent : Cohort C
30 JACC Invent : Cohort C
31 The Heart Team Concept RISK ANATOMY
32 The Unique TAVR Valve in Valve Pulmonic valve
33 Valve in Valve Common Surgical Valves Valve Failure JACC :
34 Valve in Valve Global ViV registry 202 patients 93% Success rate Circulation. 2012; Online.
35 JACC : Valve in Valve
36 Valve in Mitral CASE
37 Pulmonic Valve Replacement CASE
38 Future of TAVR Low Risk Trial PARTNER 3 (Corevalve low Risk) currently enrolling. Bicuspid Valve disease. PCI/TAVR versus AVR/CABG. Moderate AS in setting of LV dysfunction (TAVR-UNLOAD).
39 Transcatheter Mitral Valve Therapies Mitral Clip New valve replacement technologies New valve repair technologies Carpentier Classification of mitral regurgitation
40 Mitraclip FDA approved for treatment of degenerative mitral valve disease in those at high surgical risk High risk: >6% mirtal valve repair or >8% for replacement COAPT trial: treatment of functional MR in patients with LV dysfunction Continued Access COAPT registry
41 Mitraclip CASE
42 TMVR Mitral valve position Valve sealing Obstruction of the LV outflow tract Delivery system Anchoring and retention Complex mitral valve anatomy JACC :
43 TMVR Tendyne Intrepid JACC :
44 JACC : TMVR
45 JACC :1-13. ANCORA/ACCUCINCH
46 Case XX
47 Conclusion Transcatheter aortic valve replacement has been transformative for the care of patients with Severe AS. Refinements in technology has improved care. Mitral Valve disease is the new frontier in structural heart disease.
48 Questions Marc A. Sintek MD Assistant Professor of Medicine Interventional Cardiology Cardiovascular Division Washington University in St. Louis
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