Transcatheter Valve Therapies Update

Transcription

1 Providence Heart and Vascular Institute Transcatheter Valve Therapies Update Where In The Is All This Going??? Robert Hodson MD Medical Director, Providence Valve Center October 24, 2015 DISCLOSURES Providence Medical Group Investigator Edwards Life Sciences Abbott Vascular Boston Scientific Speaker/Proctor Edwards Life Sciences General Approach-Simplified New Onset Heart Failure Symptoms Need a diagnosis, echocardiogram Newly Discovered Murmur Need a diagnosis, echocardiogram Echocardiogram - Moderate or Severe Valve disease LV, RV dysfunction LV, RV chamber enlargement Follow Up Plan Diagnosis (accurate label) Assume this is not going away Assume all heart failure will need on going treatment 1

2 Mitral Regurgitation COAPT Trial MitraClip COAPT 2

3 EVEREST II N Engl J Med 2011;364: When You Say MR??? Primary Structurally Abnormal Valve Degenerative Myxomatous, Inflammatory, Calcific Secondary Structurally Normal Valve Functional (Ischemic and Non-ischemic) Primary Myocardial Disease Tethering, Leaflet Retraction Mitral Regurgitation COAPT Trial Inclusion Criteria Symptomatic Secondary (Functional) MR High Risk Surgical Candidate Central Jet (A2-P2) EF >20% < 50% Optimal CHF Treatment Clinical Outcomes Assessment of the MitraClipPercutaneousTherapy 3

4 Summary MitraClip Trials J Am CollCardiolIntv. 2014;7(8): doi: /j.jcin

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6 MitraClip Summary Surgery is better procedure MitraClip is safer procedure MitraClipis good enough for many Technology is being refined Valve anatomy matters Medical management matters Both primary and secondary respond TRICUSPID VALVE DISEASE Stay Tuned Aortic Stenosis Gross specimen of minimally diseased aortic valve (left) and severely stenotic aortic valve (right) 6

7 Aortic Stenosis Symptom Triad Angina Dyspnea Syncope All associated with exertion Echo is Gold Standard PFV > 4.0 m/s Mean grad > 40 mmhg AVA < 1.0 cm2 Reduced valve motion Aortic Stenosis is LifeThreatening Survival after onset of symptoms is 50% at twoyears and 20%at five years 1 Surgical intervention [for severe AS] should be performed promptly once even minor symptoms occur 2 1 S.J. Lester et al., The Natural History and Rate of Progression of Aortic Stenosis, Chest C.M. Otto, Valve Disease: Timing of Aortic Valve Surgery, Heart 200 Chart: Ross J Jr, Braunwald E. Aortic Stenosis. Circulation. 1968;38(Suppl 1):61-7. Sobering Perspective 35 5-Year Survival 8 Survival, % Breast Cancer 4 Lung Cancer Colorectal Cancer Prostate Cancer Ovarian Cancer 5 year survival of breast cancer, lung cancer, prostate cancer, ovarian cancer and severe inoperable aortic stenosis 3 Severe Inoperable AS* *Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu, MD, Cleveland Clinic 7

8 Addressing a Serious Unmet Need Studies show at least 40% of SAS patients are not treated with an AVR 9-15 Aortic Valve Replacement Greatly Improves Survival Survival, % Years AVR, no Sx AVR, Sx No AVR, no Sx No AVR, Sx Prevalence of Aortic Stenosis Aortic stenosis is estimated to be prevalent in up to 7% of the population over the age of 65 1 It is more likely to affect men than women; 80% of adults with symptomatic aortic stenosis are male Million People in US Over the Age of 65 2 Percentage Diagnosed with Aortic Stenosis 7% 24 8

9 Boomer Stats ( ) In 2011 started turning 65 at a rate of 10,000/day By 2015, those age 50+ will represent 45% of the U.S. population By 2030, the 65+ population will reach about 71.5 million In 2050, the 65+ population is projected to be 88.5 million Transcatheter Aortic Valve TAVI/TAVR First in man case 2002 (Alain Cribier) Rapid growth throughout the world for the treatment of severe AS in patients who are at high surgical risk (> 50,000) Additional > 25% of cases in Germany Placement of AoRTic TraNscathetERValve Trial (PARTNER Trial) PARTNER II 9

10 10/19/2015 Program Overview First in Oregon First TAVR in Oregon (Commercial TF) First PARTNER II Enrolled in Oregon (TF) February 1st, 2012 April 5th, 2012 First Oregon Transapical TAVR (PARTNER II) First Oregon Transaortic TAVR (PARTNER II) January 16th, 2013 First Oregon Valve In Valve (PARTNER II) August 21st, 2012 February 7th, th in Nation, PARTNER II Enrollment September th TAVR Case - November 13th, 2013 First Sapien 3 in Oregon (3rd generation valve) First MitraClip Case in Oregon December 4th, 2013 February 19th, th TAVR Case January 7th, 2015 First Conscious Sedation Case in Oregon February 4th, 2015 Tool Box Sapien 3 10

11 REPRISE III 11

12 Trans-apical Approach 12

13 Transapical video Trans-aortic Approach 13

14 PVC Access Experience: (1y to Q4 2014) 12% 6% 4% Access 78% TF TA TAO TC 14

15 PVC TAVR Outcomes: 1 Year Survival (n=102 through 4/2015) 17 Dead;17% One Year n= Alive; 83% Alive Dead 15

16 Where Is All This Going? Sapien 3 Lotus On The Horizon Intermediate Risk TAVR Low Risk TAVR,? Ultra Low Risk TAVR >90% Transfemoral, Percutaneous Standard Cath Lab Procedure Discharge < 24 hours Mitral and Tricuspid Valve Valve in Valve (bioprosthetics) Valve in Ring Mitral and Tricuspid Valve Replacement Edge to Edge technology to become standard Tricuspid Clip (edge to edge) Infrequent Surgical Sternotomy Requirement Surgical Training and Experience Access >90% Percutaneous Transfemoral Smaller Sheath Sizes Repositional, Removable, No PVL <10% Alternative Access Avoid Chest Incisions Subclavian Cutdown Carotid Cutdown Iliac Conduit 16

17 Minimalist Approach Minimalist Approach Conscious Sedation Local Anesthesia Only Standby Echo CathLab No OR Standby No Primed Pump Out Patient Procedure Treatment Groups Lower Risk Groups Lowest Risk Groups? Intermediate Risk 4-8% Mortality Low Risk <4% Mortality Asymptomatic Disease No Routine Surgical AVR TAVR will become lower risk procedure Indications for Surgery Heavy LVOT Calcification Para-valvular leak (PVL) Risk of annular rupture Root/coronary Anatomy Complex CAD Multi-valvular Disease 17

18 Providence Valve Center Multidisciplinary Team Interventional Cardiology Hodson, Korngold, Cannan Cardiac Surgery Swanson, Kirker, Ott Cardiac Imaging Walsh, Wilson Zinck, Morozova CV Anesthesia Kelly, Holmes Midlevel Lisa Bauer, Stuart Sharp Nurse Coordinator Marla Craft Administrative Support Renee Swanson, Lynn Sprague PROVIDENCE VALVE CENTER Dedication June 1, 2011 Providence Valve Center The Integrated Team Approach Patient Screening Valve Clinic Imaging Multidisciplinary Valve Conference Treatment Cognitive decline/ dementia Deconditioning Malnutrition Depression CVA, PVD, CHF, COPD Lack of social support Incontinence TAVR patient with aortic stenosis Constipation Alcohol dependence Osteoarthritis +/- joint replacement Living alone Courtesy C. Galte NP(F), MSN St. Paul s Hospital Renal insufficiency Balance problems/ immobility Polypharmacy Inappropriate housing Chronic benzodiazepine use 18

19 Thank You 19