scope of problem and landscape of...
TRANSCRIPT
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MITRAL REGURGITATION: SCOPE OF PROBLEM AND
LANDSCAPE OF TMVR
Ailin Barseghian El-Farra, MD, FACCAssistant Professor, Interventional Cardiology
University of California, IrvineDepartment of Cardiology
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Prevalence of Mitral Regurgitation Increases with Age
Nkomo VT, et al. Burden of valvular heart disease: a population-based study. The Lancet 2006 368, 1005-1011.
Moderate to Severe MR
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MR – Survival and HF hospitalizations
• Patients with MR have:
– 2-fold shorter survival
– 2-fold more heart failure hospitalizations
Prakash R, Horsfall M, Markwick A, et al. Prognostic impact of moderate or severe mitral regurgitation (MR) irrespective of concomitant comorbidities: a retrospective matched cohort study. BMJ Open. 2014;4(7):e004984. Published 2014 Jul 17.
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ANATOMY OF THE MITRAL VALVE
Nyman CB, et al. J Am Soc Echocardiogr 2018;31:434-53.
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PRIMARY vs SECONDARY MITRAL REGURGITATION
Zoghbi WA, et al. J Am Soc Echocardiogr 2017;30(4):303-371.
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NORMAL, PROLAPSE, FLAIL LEAFLET COAPTATION
Nyman CB, et al. J Am Soc Echocardiogr, 2018;31(4):434-53.
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PROLAPSED LEAFLET
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FLAIL LEAFLET
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PRIMARY or “Degenerative”
MITRAL REGURGITATION
Zoghbi WA, et al. J Am Soc Echocardiogr, 2018;30(4):303-371.Fuster V, Walsh RA, Harrington RA: Hurst’s The Heart, 13 th Edition: www.accessmedicine.com. Copyright The McGraw-Hill Companies, Inc.
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SECONDARY or “FUNCTIONAL” MITRAL REGURGITATION
Capoulade R, et al. J Thorac Dis 2017;9(Suppl 7):S640-S660.
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Stages of Progression of VHDSTAGE DEFINITION DESCRIPTION
A At Risk Patients with risk factors for development of VHD
B Progressive Patients with progressive VHD (mild-to-moderate severity and asymptomatic).
C Asymptomatic Severe Asymptomatic patients who have the criteria for severe VHD:
• C1 Asymptomatic patients with severe VHD in whom the left or right ventricle remains compensated
• C2 Asymptomatic patients with severe VHD, with decompensation of the left or right ventricle
D Symptomatic Severe Patients who have developed symptoms as a result of VHD
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SCOPE OF MITRAL REGURGITATION
• We are operating after the onset of left ventricular dysfunction
• We need lower risk, effective and durable interventions
• Still need to determine the patients that will benefit
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EVEREST II Randomized Clinical Trial
Feldman T, et al. NEJM 2011;364:1395-406
DEVICE GROUPPercutaneous mitral valve
repair (MitraClip)N=184
CONTROL GROUPSurgical repair or
replacementN=95
279 patients enrolled in 37 sitesSevere MR (3+ or 4+)
73% degenerative MR, 27% functional MRRandomized 2:1
Echo and Clinical Follow up - 5 years
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EVEREST II Randomized Clinical Trial
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EVEREST II Randomized Clinical Trial
Primary End Point at 1 and 5 years: Freedom from death, MV surgery, or 3-4+ MRDegenerative Mitral Regurgitation, Functional Mitral Regurgitation
Feldman T, et al. NEJM 2011;364:1395-406Feldman T, et al. JACC 2015;66:2844-54
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Secondary or Functional MR Due to Left Ventricular Dilation
Asgar AW, et al. J Am Coll Cardiol2015;65:1231-48
ISCHEMIC Cardiomyopathy
IDIOPATHIC DILATED Cardiomyopathy
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Top Advances in 20191. Edge-to-Edge Mitral Valve Repair Trials
• MitraClip
– MitraFR
– COAPT
• PASCAL
– CLASP Study
2. Transcatheter Mitral Valve Replacement (TMVR)
• SAPIEN 3 MViV
Khan f, et al. Front. Cardiovasc. Med., 18 September 2019
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MITRA-FR Trial
304 patients with SMR due to LV dysfunction, EF 15-40%, NYHA II-IVa, hospitalization for HF within the previous 12 months, not surgical candidates
Randomized 1:137 French centers
MitraClip + Medical TherapyN=152
Medical Therapy aloneN=152
Primary Endpoint: Freedom from death or HF hospitalization through 12 months
Obadia JF, et al. N Engl J Med. 2018;379:2297-306
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MITRA-FR Trial
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COAPT Trial
610 patients with heart failure and moderate-to-severe (3+) or severe (4+) secondary MR who remained symptomatic despite
maximally-tolerated goal-directed medical therapyRandomized 1:1
MitraClip + Medical TherapyN=305
Medical TherapyN=305
Primary Endpoint: All HF hospitalizations through 24 months
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COAPT Trial
Primary Effectiveness Endpoint: All hospitalizations for HF within 24 months
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NNT to prevent 1 death
1. Packer M, et a l NEJM 19962. SOLVD Investigators. NEJM 1991;325:294-3023. Swedberg K, et a l. Lancet 2010;376:19884. Zannad F, et al. NEJM 2011;364:11-215. McMurray JJV, et a l . NEJM 2014;371:993-10046. Stone GW, et al. NEJM 2018;379-2307-18
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Landscape following COAPT trial
• Optimism with MV therapies
• Heart failure specialists are now more actively involved
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COMMERCIALLY AVAILABLE TMVR DEVICES
MitraClip• Primary (Degenerative) MR
• Prohibitive surgical risk
• 10/24/2013
• Secondary (Functional) MR
• All surgical risk
• 3/14/2019
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TREATMENT OPTIONS: MITRAL REPAIR VS REPLACEMENT
Courtesy of E Grube
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Courtesy of E Grube
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ALFIERI STICH
Alfieri O. (2015) The Genesis of the Edge-to-Edge Technique. In: Alfieri O., De Bonis M., La Canna G. (eds) Edge-to-Edge Mitral Repair. Springer, Cham
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MitraClip
Delgado V, et al. Eur Heart J Suppl 2010;12:E10-E23.
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• Standard therapy for select patients
• Excellent safety
• Comparable efficacy
• Durability up to 4 years
PERCUTANEOUS THERAPY FOR MR
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The 4th Generation MitraClipMitraClip G4
• WIDER CLIP ARMS
• 4 CLIP SIZES– BETTER COAPTATION
• CONTROLLED GRASPING
• CONTINUOUS LEFT ATRIAL PRESSURE MONITORING
• MORE PRECISE AND PREDICTABLE STEERING
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REPAIR-MR
• RANDOMIZED CLINICAL TRIAL
• INTERMEDIATE SURGICAL RISK
• MITRAL VALVE SURGICAL REPAIR VS MITRACLIP
• INCLUSION: AGE >75, OR >65 WITH RISK
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TREATMENT OPTIONS: MITRAL REPAIR VS REPLACEMENT
Courtesy of E Grube
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Andersen Stent-Valve 1989The valve was constructed of a handmade wire frame to which was sewn a porcine valve.
Transcatheter aortic valve implantation: The evolution of prostheses, delivery systems and approaches - Scientific Figure on ResearchGate. Available from: https://www.researchgate.net/figure/The-Andersen-valve-The-valve-was-constructed-of-a-handmade-wire-frame-to-which-was-sewn_fig9_224809453 [accessed 21 Jan, 2020]
https://healthcare-in-europe.com/en/news/tavi-s-unsung-hero.html
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First In Man - Alain Cribier
Cribier, Alain. (2017). The development of transcatheter aortic valve replacement (TAVR). Global Cardiology Science and Practice. 2016.
APRIL 16, 2002
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COMMERCIALLY AVAILABLE TMVR DEVICES
MitraClip• Primary (Degenerative) MR
• Prohibitive surgical risk
• 10/24/2013
• Secondary (Functional) MR
• All surgical risk
• 3/14/2019
SAPIEN 3:• Mitral Valve-In-Valve
• High or greater surgical risk
• 6/5/2017
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Guerrero M, et al. Transseptal transcatheter mitral valve‐in‐valve: A step by step guide from preprocedural planning to postprocedural care. CCI May 2017;92:E185-E196.
MITRAL VALVE-IN-VALVE OPTION
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All-Cause Mortality According to TMVR
Yoon SH, EHJ 2018;40:441
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TRANSCATHETER MITRAL VALVE REPLACEMENT
Courtesy of E Grube
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TMVR
• Devices in Randomized Controlled Trials in US
1. Tendyne (Abbott)
– SUMMIT
2. Intrepid (Medtronic)
– APOLLO
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MITRAL REGURGITATION IN THE US
• Most PRIMARY MR patients are better served with surgical repair
• Most SECONDARY MR patients are best treated with optimal or guideline-directed medical therapy.
• Interventional population is unknown
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THANK YOU