1. Which Patients Should Be Targeted for MitraClip Procedures?
Ted Feldman, M.D., MSCAI FACC FESC
Evanston Hospital
The MitraClip Workshop - Supported by an educational grant from Abbott (12:00 PM – 5:10 PM)
CRT 2017
Track: CRT Valve & Structural
The MitraClip Workshop (NON-CME)
Session: Setting The Stage - Part II (1:15 PM – 3:45 PM)
Saturday, February 18, 2017
1:15 PM – 1:25 PM
Room: Blue Pre-Function Room
Which Patients Should Be Targeted for MitraClip Procedures?
Your role: Presenter
Setting The Stage - Part II
1:15 PM - 3:45 PM
1:15 PM
Session ModeratorsModerator: Ted Feldman, MD, MSCAI
Moderator: Scott Lim, MD
Which Patients Should Be Targeted for MitraClip Procedures?Presenter: Ted Feldman, MD, MSCAI
1:25 PM
Echo-Imaging Criteria for MitraClip ProceduresPresenter: Zuyue Wang, MD
1:35 PM
Evaluating and Avoiding Mitral Stenosis Post-ClipSpeaker: Vivek Rajagopal, MD
1:45 PM
CTA Imaging of the Mitral Valve: What Is Needed for Today's InterventionsPresenter: Carlos E. Ruiz, MD, PhD, MSCAI
1:55 PM
What Are the Limitations of the MitraClip? Predictors of Success and ComplicationsPresenter: Ted Feldman, MD, MSCAI
2:05 PM
Treatment of Post-Surgical MR with MitraClipSpeaker: Scott Lim, MD
2:15 PM
What To Do With Single Leaflet Clip Detachment?Presenter: Samir R. Kapadia, MD, FSCAI
2:25 PM
How Much Is Too Much Gradient in MitraClip Repair?Presenter: Michael J. Rinaldi, MD
2:35 PM
Recorded CasePresenter: Brijeshwar S. Maini, MD
2:50 PM
Tea Break
3:05 PM
When to Use More Than One Clip and When to StopPresenter: Samir R. Kapadia, MD, FSCAI
3:15 PM
Transseptal Tips for MitraClip Implantation: How to Ensure Success and SafetyPresenter: Zoltan G. Turi, MD, MSCAI
3:25 PM
Management of MitraClip Single Leaflet DetachmentPresenter: Michael J. Rinaldi, MD
3:35 PM
Unusual Mitral Clip ComplicationPresenter: Itsik Ben-Dor, MD
CRT
Cardiovascular Research Technologies
Washington D.C.
February 18-21st, 2017

2. Ted Feldman MD, MSCAI FACC FESC
Disclosure Information The following relationships exist: Grant support: Abbott, BSC, Cardiokinetics, Corvia, Edwards, WL Gore
Consultant: Abbott, BSC, Edwards, WL Gore
Stock Options: Mitralign
Off label use of products and investigational devices will be discussed in this presentation

3. MitraClip Patient Selection
Guidelines
Critical data review
Broad community consensus
MR etiology
FMR outcomes remain incompletely defined
Leaflet morphology
Relative and absolute limits of the technology
Patient characteristics
Comorbidities may overwhelm treatment effects

4. Recommendations for Chronic Primary MR
Nishimura, RA et al AHA/ACC Valvular Heart Disease Guideline

5. Interventional Cardiology of the German Society for Cardiology Arbeitsgemeinschaft Interventionelle Kardiologie (AGIK)

6. Interventional Cardiology of the German Society for Cardiology Percutaneous interventional mitral regurgitation treatment using the Mitra-Clip system
Clin Res Cardiol Accepted: 21 August 2013

7. Interventional Cardiology of the German Society for Cardiology Percutaneous interventional mitral regurgitation treatment using the Mitra-Clip system
Clin Res Cardiol Accepted: 21 August 2013

10. The role of isolated mitral valve surgery in patients with severe functional mitral regurgitation and severe LV systolic dysfunction (LVEF , 30%) who cannot be revascularized or have non-ischaemic cardiomyopathy is questionable
in most patients conventional medical and device therapy are preferred.
In selected cases, repair may be considered in order to avoid or postpone transplantation.
The decision should be based on comprehensive evaluation within the ‘heart team’.
In patients with HF with moderate-severe, secondary mitral regurgitation who are judged inoperable or at high surgical risk, percutaneous mitral valve intervention may be considered
to improve symptoms and quality of life
no RCT evidence of improvement has been published, only registry studies
504. D’ascenzo F, Moretti C, Marra WG, Montefusco A, Omede P, Taha S, Castagno D, Gaemperli O, Taramasso M, Frea S, Pidello S, Rudolph V, Franzen O, Braun D, Giannini C, Ince H, Perl L, Zoccai G, Marra S, D’Amico M, Maisano F, Rinaldi M, Gaita F. Meta-analysis of the usefulness of mitraclip in patients with functional mi- tral regurgitation. Am J Cardiol 2015;116:325 – 331.
505. Nickenig G, Estevez-Loureiro R, Franzen O, Tamburino C, Vanderheyden M, Lu ̈scher TF, Moat N, Price S, Dall’Ara G, Winter R, Corti R, Grasso C, Snow TM, Jeger R, Blankenberg S, Settergren M, Tiroch K, Balzer J,Petronio AS, Bu ̈ttner H-J, Ettori F, Sievert H, Fiorino MG, Claeys M, Ussia GP, Baumgartner H, Scandura S, Alamgir F, Keshavarzi F, Colombo A, Maisano F, Ebelt H, Aruta P, Lubos E, Plicht B, Schueler R, Pighi M, Di Mario C, Transcatheter Valve Treatment Sentinel Registry Investigators of the EURObservational Re- search Programme of the European Society of Cardiology. Percutaneous mitral valve edge-to-edge repair: in-hospital results and 1-year follow-up of 628 patients of the 2011–2012 pilot European Sentinel Registry. J Am Coll Cardiol 2014;64: 875 – 884.
506. Puls M, Lubos E, Boekstegers P, von Bardeleben RS, Ouarrak T, Butter C, Zuern CS, Bekeredjian R, Sievert H, Nickenig G, Eggebrecht H, Senges J, Schillinger W. One-year outcomes and predictors of mortality after MitraClip therapy in contemporary clinical practice: results from the German transcatheter mitral valve interventions registry. Eur Heart J 2016;37:703–12.

11. Negative Predictors coaptation length <2.7 mm
coaptation depth >6.3 mm
distance between papillary muscles >32 mm
thickening and calcification of the subvalvular apparatus
cleft
effective regurgitant orifice area (EROA)
mitral valve orifice area (MVOA) <4cm2
mean transmitral pressure gradient (TMPG)
TAPSE <15mm
TR>2+
EF<25%
PASP
RV function
Ischemic etiology
NTPro BNP >10000
NYHA Class 4
CKD, Diabetes, Age >80

12. COAPT Expanded Enrollment Feb 14th, 2017 83 active sites
<
Expanded enrollment
n=610
Subject:
FW: COAPT-Enrollment Report (04 Jan 2016)
Top ten sites have enrolled n=141 (43.5%)
27 sites enrolled 0-3 cases
28 sites enrolled 4-9 cases
0-12 sites
1-15
2-11
3-11
4-7
5-6
6-3
7-4
8-3
9-1
________________________________
From: Tish O'Mara
Sent: Monday, January 04, :35 PM
To: Tish O'Mara
Cc: 'Gregg Stone QXA79874-PMF; QXA79874-ClinMon; Nicole Kilburn; 'Morey, Vicky'; Elek, Candace L; Tish O'Mara
Subject: COAPT-Enrollment Report (04 Jan 2016)
Greetings COAPT Investigators and Research Coordinators,
Happy New Year! Please find attached the most recent enrollment report. As of today, 324 patients are randomized and 47 patients are roll-ins (total 371 registered). Currently, eighty three (83) sites are activated and approved to enroll. (106 patients to be randomized in order to complete enrollment.)
Jan 4, 2016
Tish O’Mara
Sr. Project Manager, Medical Device & Diagnostics
CardioVascular Therapies
Office Phone:
Mobile Phone:
Global Headquarters: 1700 Perimeter Park Drive, Morrisville, NC 27560
1st COAPT patient randomized on Dec 27, 2012

13. Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary MR (MITRA-FR)
MitraClip vs optimal therapy alone
Estimated Enrollment: 288 at 22 sites- 290 enrolled as of Jan 2017
Primary Outcome Measures: All-cause mortality and unplanned hospitalizations for heart failure 1 year 
Inclusion Criteria
Age > 18 years old
Severe secondary mitral regurgitation confirmed by the Echocardiography Core Laboratory Characterized by a regurgitation volume > 30 mL/beat or a regurgitant orifice area > 20 mm2
New York heart Association Class≥ II.
Left ventricular ejection fraction between 15% and 40%
Minimum of 1 hospitalization for heart failure within 12 months preceding randomization
Assessed by the investigator to be on optimal standard of care therapy for heart failure
Assessed by the heart team to be not eligible to a mitral surgery intervention
Professeur Jean-François OBADIA
Chef de Service Hôpital Louis Pradel – CHU LYON
Chirurgie Cardio-Vasculaire et Transplantation Cardiaque
28 Avenue du Doyen Lépine
69677 BRON cedex
Secrétariat
Mobile
Finished !!! The goal was 288 and since some patients were screened when the last randomisation was done, We have also enrolled the last ones. As a consequence the total number will be around I will send you the News letter next week with all the last details.Primary endpoint January 2018Results presentation probably ESC august 2018
Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation (MITRA-FR)NCT Primary Outcome Measures: All-cause mortality and unplanned hospitalizations for heart failure [ Time Frame: 1 year ]Inclusion Criteria: Age > 18 years old Severe secondary mitral regurgitation confirmed by the Echocardiography Core Laboratory Characterized by a regurgitation volume > 30 mL/beat or a regurgitant orifice area > 20 mm2 New York heart Association Class≥ II. Left ventricular ejection fraction between 15% and 40% Minimum of 1 hospitalization for heart failure within 12 months preceding randomization Assessed by the investigator to be on optimal standard of care therapy for heart failure Assessed by the heart team to be not eligible to a mitral surgery interventionExclusion Criteria: Primary mitral regurgitation Myocardial infarction or coronary bypass grafting surgery within 3 months prior to randomization Cardiac resynchronization therapy within 3 months prior to randomization Cardioversion within 3 months prior to randomization Need for any cardiovascular surgery (including registration on cardiac transplant list) Coronary angioplasty within 1 month prior to randomization History of mitral valve repair Active infection requiring current antibiotic therapy Terminal renal insufficiency (renal replacement therapy) Severe hepatic insufficiency Evidence of stroke within 3 months prior to randomization Concurrent medical condition with a life expectancy of less than 12 months Uncontrolled hypertension Known hypersensitivity to nitinol Currently participating in another trial Pregnant womenContact: JEAN FRANCOIS OBADIA, MD ext +33 Contact: Nathan MEWTON, MD ext +33
Profs. Obadia and Vahanian
NCT

14. COAPT Inclusion
Symptomatic functional MR ≥3+ due to ischemic or non- ischemic cardiomyopathy
HF specialist investigator judges subject has been adequately treated, including CAD, LV dysfunction, MR and heart failure e.g., with CRT, revascularization, and/or GDMT
one hospitalization for heart failure in the 12 months and/or a corrected BNP 300 pg/ml or corrected NT-proBNP pg/ml
NYHA Functional Class II, III or ambulatory IV.
Local Site Heart Team concurs that surgery will not be offered
LVEF is 20% and 50%
LVESD ≤70 mm assessed by TTE
The primary regurgitant jet is non-commissural.
If a secondary jet exists, it must be considered clinically insignificant.
CK-MB obtained within prior 14 days < local laboratory ULN
Transseptal and femoral access is feasible

15. COAPT Exclusions-1
COPD requiring continuous home oxygen or chronic oral steroid use.
Untreated clinically significant CAD requiring revascularization.
CABG, PCI , CRT or TAVR within 30 days
Tricuspid valve disease requiring surgery.
Aortic valve disease requiring surgery or transcatheter intervention
Cerebrovascular accident, carotid surgery or stenting within 30 days
Severe symptomatic carotid stenosis > 70% by ultrasound
ACC/AHA Stage D heart failure.
Presence of any of the following:
PASP > 70 mm Hg
other structural heart disease
Hemodynamic instability requiring inotropic support or mechanical heart assistance
Physical evidence of right-sided failure with TTE evidence of moderate or severe RV dysfunction

16. COAPT Exclusions-2 Mitral valve orifice area < 4.0 cm2
Leaflet anatomy which may preclude MitraClip implantation
Insufficient mobile leaflet available for grasping with the MitraClip device
Evidence of calcification in the grasping area
Presence of a significant cleft in the grasping area
Lack of both primary and secondary chordal support in the grasping area
Leaflet mobility length < 1 cm
Need for any emergent or urgent surgery or planned cardiac surgery < 1 year
Life expectancy < 12 months due to non-cardiac conditions.
Modified Rankin Scale ≥4 disability.
Status 1 heart transplant or prior orthotopic heart transplantation.
Prior mitral valve leaflet surgery or prosthetic mitral valve, or any prior transcatheter mitral valve procedure.
Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated).
Active infections requiring current antibiotic therapy.
TEE is contraindicated or high risk.

17. CARDIOBAND
Edwards PASCAL Repair System

18. What can be asserted without evidence can also be dismissed without evidence.
― Christopher Hitchens