Interventional Diagnosis And Treatment of Valvular Heart Disease

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1 Interventional Diagnosis And Treatment of Valvular Heart Disease Peter S. Fail, MD, FACC, FACP, FSCAI Director of the Cardiac Catheterization Laboratories And Interventional Research Co-Director of the Structural Heart Program Cardiovascular Institute of the South Terrebonne General Medical Center Houma, LA

2 Peter S. Fail, MD FACC, FACC, FSCAI Disclosure Statement of Financial Interest Grant Research Support Stock Abbott Vascular Medtronic CardioKinetix Boston Scientific Covina Direct Flow Medical (Steering Committee ) CardioSolutions Off label use of products and investigational devices will be discussed in this presentation

3 Structural Heart Arena Over the past 10 years the area of structural heart has virtually exploded Many of the areas that have been the exclusive domain of Cardiovascular surgery are now being evaluated treated by the Heart Team Many newer devices and ideas are being put forth each day Only time will tell which treatment strategy will survive

4 Aortic Stenosis

5 Incidence and Prevalence Aortic stenosis is the most common acquired valvular disorder found in developed countries Affects approximately 5 out of every 10,000 people in the United States Mild to severe AS present in up to 9% of adults over age 65 years The prevalence of calcific aortic stenosis increases with age and is expected to double in the next 20 years* Freeman RV, Otto CM. Spectrum of Calcific Aortic Valve Disease: Pathogenesis, Disease Progression, and Treatment Strategies. Circulation 2005;111: *Nkomo VT, et al. Lancet 2006;368:

6 % Survival Symptomatic Patients with Severe AS Require Urgent Attention Valvular Aortic Stenosis In Adults (Average Course) Latent Period Increasing Obstruction Myocardial Overload Onset Severe Symptoms - Angina -Syncope -CHF Age in Years Ross J Jr, Braunwald E. Aortic stenosis. Circulation 1968;38 (Suppl 1) C.M. Otto. Valve Disease: Timing of Aortic Valve Surgery. Heart 2000 Surgical intervention should be performed promptly even once minor symptoms occur.

7 Assessing Futility Is Not Frailty Alone Co-Morbidities STS - Euroscore Charlson Score Two or more medical conditions Frailty Impairment in multiple systems that leads to a decline in homeostatic reserve and resiliency Disability: ADL IADLs Difficulty or dependency in daily living

8 CoreValve US Extreme Risk Baseline Co-Morbidities Co-Morbidity Assessment N=471 Any Chronic Lung Disease (STS Criteria), % 58.8 Moderate, % 15.3 Severe*, % 24.0 Home Oxygen, % 30.4 FEV cc, % 23.1 Diffusion Capacity < 50%, % 22.3 Charlson Co-Morbidity Score**, % 5.3 ± 2.3 Moderate (3, 4), % 32.9 Frailty Severe Characteristic (> 5), % N= Anemia With Prior Transfusion, % 22.9 BMI < 21 kg/m 2, % 7.6 Albumin < 3.3 g/dl, % 18.5 Unplanned Weight Loss > 10 pounds, % 16.9 *STS Criteria: Severe = FEV1 < 50% predicted and/or RA po 2 < 60 or pco 2 > 50 BAD LUNGS Charlson Score: = 1 MI, CHF, PVD, CVD, Dementia, chronic lung disease, connective tissue disease, ulcer disease, mild liver disease, DM; =2 BAD hemiplegia, BODY mod-severe kidney disease, diabetes with end organ damage, leukemia, lymphoma; = 3 moderate or severe liver disease; = 6 metastatic solid tumor, AIDS BAD EVERYTHING ELSE Falls in Past 6 Months, % Meter Gait Speed > 6 secs, % 84.2 Grip Strength < Threshold, % 67.6 **Charlson Score: = 1 MI, CHF, PVD, CVD, dementia, chronic lung disease, connective tissue disease, ulcer, mild liver disease, DM; = 2 hemiplegia, modsevere kidney disease, diabetes with end organ damage, leukemia, lymphoma; = 3 moderate or severe liver disease; = 6 metastatic solid tumor, AIDS Extreme Risk Study Iliofemoral Pivotal

9 Where it all started April 16th, 2002 Alain Cribier April 16 th 2002 Implanted the worlds first Percutaneous Aortic Valve

10 Approved Devices CoreValve Aortic Annulus Range 1 CT mm Sapien XT Aortic Annulus Range 2 TEE CT mm mm 1. Medtronic CoreValve System Instructions for Use. M053136T001 Rev. 1C. 06/ Edwards SAPIEN XT Transcatheter Heart Valve with the NovaFlex+ Delivery System Instructions for Use D. 06/2014.

11 Current Generation of Approved Stent Valves S3

12 All-Cause Mortality NOTE: The charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to clinical study outcomes and need to be considered in making any assessments across different studies.

13 Major Stroke NOTE: The charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to clinical study outcomes and need to be considered in making any assessments across different studies.

14 Aortic Valve Area NOTE: The charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to clinical study outcomes and need to be considered in making any assessments across different studies.

15 Mean Gradient NOTE: The charts are not intended to be a comparison of the two devices as there is no head-to-head clinical study, but rather are intended to illustrate the clinical results of two similar trials. Multiple factors contribute to clinical study outcomes and need to be considered in making any assessments across different studies.

16 84 yo F STS 11, FEV1 38% predicted (0.790 L) Critical AS (AVA 0.5cm2, 64mmHg Gradient) Severe PVD densely calcified Iliacs

17 So Many Options that are on the Horizon

18 Repositionable Mechanical Expansion No Metal Components

19 Newer indications Valve -in- Valve Aortic Insufficiency

20 Lower Risk Patients Reported at the ACC 2016 Vinod Thourani, MD PARTNERS 2A Mortality (7.4% for TAVR versus 13.0% for surgery, P<0.001 for superiority) Stroke (4.6% versus 8.2%, P=0.004 for superiority). Moderate or severe aortic regurgitation, favored surgery (1.2% versus 1.5% for TAVR, P= for superiority). Medtronic SURTavi (intermediate risk) Completed enrollment Data will be available 2017 ACC??? Both companies are engaged in Low Risk Trail

21 Mitral Regurgitation

22 Bulging Mechanisms Mitral Regurgitation Degenerative Functional Redundant / Broken Chordea Sick Valve Papillary muscle traction Sick Heart Increased tethering Flail or Degenerative Leaflets Decreased closing force MR MR Annular dilatation

23 Re-operation rate vs. MR reoccurrence Degenerative Valve Disease N Surgical Technique Reoperation rate % at latest follow-up (y) % MR 3+ at latest follow-up (Y) Author Gillinov, et al. Ann Thor Surg, Carpentier* 5% (5 y) 9% (1.5 y) Tanaka, et al. Am J Cardiol, Carpentier* 5.3 (3.7 y) 7% (3.5 y) Flameng, et al. Circulation, Carpentier* 5.8 (7 y) 29% (7 y) * Standard repair with annuloplasty in vast majority

24 Durability of Ischemic Mitral Valve Repair? 78 patients with IMR treated with Mitral Valve Repair Long follow-up 94% success rate in obtaining long-term ECHO Results at mean of 28 months: Recurrent MR (2+) in 37% of patients Severe MR (3 to 4+) in 20% of patients Serri et al. JTCVS 131: , 2006

25 Original Article Two-Year Outcomes of Surgical Treatment of Severe Ischemic Mitral Regurgitation Daniel Goldstein, M.D., Alan J. Moskowitz, M.D., Annetine C. Gelijns, Ph.D., Gorav Ailawadi, M.D., Michael K. Parides, Ph.D., Louis P. Perrault, M.D., Judy W. Hung, M.D., Pierre Voisine, M.D., Francois Dagenais, M.D., A. Marc Gillinov, M.D., Vinod Thourani, M.D., Michael Argenziano, M.D., James S. Gammie, M.D., Michael Mack, M.D., Philippe Demers, M.D., Pavan Atluri, M.D., Eric A. Rose, M.D., Karen O Sullivan, M.P.H., Deborah L. Williams, B.S.N., M.P.H., Emilia Bagiella, Ph.D., Robert E. Michler, M.D., Richard D. Weisel, M.D., Marissa A. Miller, D.V.M., Nancy L. Geller, Ph.D., Wendy C. Taddei-Peters, Ph.D., Peter K. Smith, M.D., Ellen Moquete, R.N., Jessica R. Overbey, M.S., Irving L. Kron, M.D., Patrick T. O Gara, M.D., Michael A. Acker, M.D., for the CTSN N Engl J Med Volume 374(4): January 28, 2016

26 OUTCOMES AT 2 YEARS Outcome Repair Replacement p Value LVESVI ml/m ml/m2 Mortality 19% 23% 0.42 Moderate/Severe MR 59% 3.8% < SAE with Heart Failure 24% 15% 0.05 Cardiac Readmits 48% 32% 0.01 LVESVI ml/m cc/m Ejection Fraction 43% 38%

27 Functional MR vs Organic Valve Disease ~ 1,100,000 patients/yr with US 1 85% with dilated Cardiomyopathy = 950,000/yr 65% with MR = ~620,000 with FMR in US 40% with more then mild MR = ~380,000/yr VERSUS 38,000 discharges with Mitral Valve Disease/yr 2 48,000 discharges with Aortic Valve Disease/yr 2 <50,000 Aortic or Mitral Surgeries (2005) 3 1 Roger JAMA 2004;292:344 2 AHA Heart Disease and Stroke 2008 update 3 Barnett J Thoracic Cardiovasc Surg 2009

28

29 2 Different etiologies of MR

30 PRE CLIP POST CLIP

31

32 FDA MitraClip Approval October 24 th, 2013 The MitraClip is approved for treatment of patients with primary (degenerative) MR who are at prohibitive risk for mitral valve surgery and are likely to benefit from MR reduction

33 Kaplan-Meier Freedom From Mortality EVEREST II RCT MitraClip (N=178) 93.7% 92.3% 1 year Surgery (N=80) 81.2% 79.0% 5 years Baseline 6 Months 12 Months 18 Months 2 Years 3 Years 4 Years 5 Years MitraClip # At Risk Surgery # At Risk

34 Kaplan-Meier Freedom From MV Surgery in MitraClip Group or Re-operation in Surgery Group Surgery (N=80) MitraClip (N=178) 78.9% 97.4% 1 year 74.3% 92.5% 5 years Baseline 6 Months 12 Months 18 Months 2 Years 3 Years 4 Years 5 Years MitraClip # At Risk Surgery # At Risk EVEREST II RCT Deaths are censored

35 Kaplan-Meier Freedom From MV Surgery in MitraClip Group or Re-operation in Surgery Group Surgery MitraClip 97.1% 98.7% 1 year 91.4% 93.7% 5 years 6-Month Landmark Analysis EVEREST II RCT

36 Transcatheter MV Repair: Device Landscape 2016 Edge-to-edge MitraClip* MitraFlex Direct annuloplasty and basal ventriculoplasty Mitralign Bident* GDS Accucinch* Valtech Cardioband* Quantum Cor (RF) Micardia encor *In patients Coronary sinus annuloplasty Cardiac Dimensions Carillon* Cerclage annuloplasty MV replacement CardiAQ* Neovasc * Edwards Fortis* Micro Interventional Valtech Cardiovalve ValveXchange Lutter Valve Medtronic Tendyne* MitrAssist MValve Other approaches MitraSpacer* St. Jude leaflet plication* Cardiac Implant perc ring NeoChord* Babic chords Valtech Vchordal Middle Peak Medical Mardil BACE Mitralis Millipede

37 Mitral Annuloplasty Systems Under current development Cardiac Dimensions Carillon Indirect annuloplasty Coronary sinus cinching Mitralign TAMR GDS Accucinch Valtech Cardioband - Trans-aortic - LV implant of 1-3 annular pairs of pledgets - Basal ventriculoplasty - LV implant of anchors - Trans-septal - LA implant of a posterior annulus band (screw fixation)

38 Transcatheter MV Replacement Devices with Human Implants CardiAQ 2 chronic implants Edwards Fortis 5 chronic implants Neovasc Tiara 2 chronic implants Tendyne 2 acute implants before surgery

39 Transcatheter MV Replacement Edwards Fortis Neovasc Tiara CardiAQ Tendyne Micro Interventional Valtech Cardiovalve ValveXchange Lutter Valve Medtronic MitrAssist MValve Challenges

40 Off Label 74 yo female with critical Mitral Stenosis Cosgrove ring for MR 10 years ago Prohibitive surgical risk

41 TAVR vs. TMVR Annulus Size and Calcifications Leaflet Calcification Annulus Size, Shape, excursion, Leaflet Size, Thickness, Tenting Sub-valvular Apparatus Circumflex Coronary Artery LV Size, Geometry, Function Risk of SAM and Out Flow obstruction Dynamic Environment

42 Conclusion Valvular Heart Disease Intervention has exploded over the past Decade. Multiple devices and procedures continues to be available Alternative indications are currently being explored TAVR has been the driving force in the structural heart world, but mitral will separate the men from the boys Next 10 years will be incredibly exciting

43 Interventional Diagnosis And Treatment of Valvular Heart Disease Peter S. Fail, MD, FACC, FACP, FSCAI Director of the Cardiac Catheterization Laboratories And Interventional Research Co-Director of the Structural Heart Program Cardiovascular Institute of the South Terrebonne General Medical Center Houma, LA

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