MitraClip - Fonds de dotation ACTIONRepair, Replacement, LVAD, Transplantation) Patient Selection...

MitraClip

Alec Vahanian, Dominique Himbert ,Eric Brochet

Bichat Hospital, Paris

General comments

Mitral Valve Apparatus

Subvalvular apparatus

Leaflets

Commissures

Papillary

muscles

Annulus

Complex interaction

2008-Hugo Vanermen 2008-Hugo Vanermen

Principles of a reconstructive valve operation

• Preserve or restore full leaflet motion

• Create a large surface of coaptation

• Remodel and stabilise the entire annulus

« The duty of any valvular surgeon today is no longer to

correct a mitral valve regurgitation, but to correct a mitral

valve regurgitation for the rest of the patient’s life »

A .Carpentier

Surgery in Mitral Regurgitation

In expert centres, in patients with primary MR, the repair

rate is >90% and >90% of patients are alive and free

from reoperation after 10-15 years.

Surgery for secondary MR remains a challenge. Most

studies failed to demonstrate improved long-term clinical

outcome following surgical correction.

Rationale for Percutaneous

Valve Interventions

VHD is frequent and carries a poor prognosis

Patients are often elderly with several comorbidities

Surgery is « the gold standard » but may be high-risk

or even contraindicated

In practice, many patients are denied surgery

The natural evolution of a surgical into a

percutaneous procedure

Open Video assisted Robotic Percutaneous

Sternotomy

Skin incisions

CPB

X X

X

Direct vision Video assisted Echo-guided

(Maisano. J Am Coll Cardiol 2011;58: 2174–82)

years

14121086420

Fre

edom

fro

m r

eopera

tion a

nd M

R3-4

+

1,0

,9

,8

,7

,6

,5

,4

,3

,2

,1

0,0

At 12.5 years: 39±7%

Pts at risk:

51 42 39 30 20 13 1

Edge-to-edge without annuloplasty

Freedom from reoperation and MR 3+ or more

(Courtesy O.Alfieri))

General comments

The MitraClip procedure

www.escardio.org/guidelines

Treatment of Valve

disease

SURGEONS CARDIOLOGISTS

Imaging specialists (Echo, CT, MRI)

Anesthesiologists

The « Heart Team »

Other

specialists:HF,EP,

Geriatricians……

http://www.escardio.org/guidelines


Essential questions in the evaluation of a patient for valvular intervention

● Is valvular heart disease severe?

● Does the patient have symptoms?

● Are symptoms related to valvular disease?

● What are patient life expectancy and expected quality of life?

● Do the expected benefits of intervention (versus spontaneous

outcome) outweigh its risks?

● What are the patient's wishes?

● Are local resources optimal for planned intervention?

European Heart Journal 2012 - doi:10.1093/eurheartj/ehs109 &

European Journal of Cardio-Thoracic Surgery 2012 -

doi:10.1093/ejcts/ezs455).


PMVR Surgery (Repair, Replacement, LVAD,

Transplantation)

Patient Selection for Percutaneous

Valve Intervention

Medical Rx

« Futility > Utility » Because of cardiac and

extra cardiac factors

The « Heart Team »

MitraClip Therapy

Selection of patients

TTE TEE 3D TEE

Comprehensive and systematic assessment

using multiple echo modalities - Quality of recordings

- Key echocardiographic views in each echo modality

- Optimal visualization of MR origin and valve pathology

Specific measurements

Flail gap Flail width

(Feldman T et al

JACC 2009;54:

686-94)

•

Secondary MR

(Feldman T et al JACC 2009;

54 :686-94)

Coaptation length Coaptation depth

(Boekstegers et al. Clin Res Cardiol (2014) 103:85–96)

Optimal Valve morphology

Central pathology in segment 2

No leaflet calcification

Mitral valve opening area >4cm2

Mobile length of the posterior leaflet ≥10mm

Coaption depth <11mm

Normal leaflet strength and mobility

Flail-width <15mm Flail-gap <10mm

(Boekstegers et al. Clin Res Cardiol (2014) 103:85–96)

Unsuitable valve morphology

Perforated mitral valve leaflet or cleft

Severe calcification in the grip-zone

Haemodynamically significant mitral stenosis (valve opening area

<3cm2, MPG ≥5mmHg)

Mobile length of the posterior leaflet <7mm

Rheumatic leaflet thickening and restriction in systole and diastole

(Carpentier IIIA)

Barlow’s syndrome with multisegment flail leaflets

TS Puncture for Mitraclip

S. Y. Ho et al. Eur J of Echocardiography (2011)

SUP (SVC)

INF (IVC)

ANT (Ao)

POST (PV)

HIGH (PV)

LOW (AV Valve plane)

2

Bicaval SAX

4ch

Spatial orientation

Short-axis view at the

base (for anterior -

posterior orientation)

Bicaval view (for inferior.superior orientation)

Midesophageal 4-

chamber view (for

assessing height

above the valve

plane).

Silvestry et al JASE 2007

TS Puncture for MitraClip

Introduction of the Steerable Guide

Catheter into the LA

(Wunderlich NC, Siegel R. Eur Heart J Cardiovasc Imaging 2013;14:935-949)

Advancement of the Clip Delivery

System into the LA


Steering and positioning of the

MitraClip above the mitral valve


Advancement of the MitraClip into

the Left ventricle


Grasping of the leaflets

(Wunderlich NC, Siegel R. J Eur Heart J Cardiovasc Imaging 2013;14:935-949)

Assessment of results


Advanced techniques for

Degenerative MR

Implantation of 2 or more clips

Grasping during asystole (Adenosine infusion)

Grasping during rapid pacing

Volume control (ventilation manoeuvres)

Use of two delivery systems

Importance of the learning Curve

The learning curve: Procedure time reduction: 180min to 55min

Acute procedural success from 80% to 92%

*

Optimising the Initial Results

(Lim DS. JACC 2014;64;182-92)

General comments


Results

(Feldman T, N Engl J Med 2011;364:1395 – 1406)

MitraClip indication

(Feldman T, N Engl J Med 2011;364:1395 – 1406)

(Feldman ACC 2014)

Temporal Changes in MitraClip

indication

Safety of MitraClip in the real world

Overall (n = 628) (%)

Death 2.9

Tamponade 1.1

Stroke 0.2

Severe bleeding 1.1

Transfusion 10.1

Vascular complication requiring intervention

0.7

New-onset atrial fibrillation 11.7

Acute procedural success 95.4

Clip embolization 0.7

Inability to reduce MR 3.5

Implant ≥2 clips 37.5

Procedure duration, min 138.3 ± 67.9

Median hospital stay (IQR), d 5 (3–7)

(Nickenig G et al. J Am Coll Cardiol 64;2014:875-884)


MR Grade


NYHA Functional class

(Kar ACC 2014)

Propensity-matched analysis of survival

of MitraClip vs Controls

(IN-HF registry 32 centres from ANMCO database) Heart

failure patients with MR>3+

MitraClip treated patients

Medically treated patients

(Source: CERGAS Dr Tarricone)

Need for Rehospitalization

Source: CERGAS (Dr Tarricone)

Treated patients: 232 patients enrolled in 2 centres (Milano, Catania).

Untreated patients were extracted from the in-hf database from ANMCO.

Propensity-matched cohorts of MitraClip vs Control heart failure patients with FMR>3+

Primary/secondary MR: Freedom from

heart failure rehospitalization

(Rudolph V et al. Eur J Heart Fail 2013;15:796-807)

Timing of Intervention is Key

(Neuss M et al. Eur J Heart Fail 2013;15:786-795)

The influence of

Severe tricuspid regurgitation

(Ohno Y et al. Eur Heart J Cardiovasc Imaging 2014;15:1246-1255)


ESC/ EACTS Guidelines for the

Management of Valvular Heart Disease

« The percutaneous MitraClip procedure may be considered in symptomatic patients with severe primary or secondary MR despite optimal medical therapy, who fulfil the echo criteria of eligibility, are judged inoperable or at high risk for surgery by a heart team, and who have a life expectancy greater than one year »

(Recommendation class IIb, level of Evidence C)

European Heart Journal 2012 - doi:10.1093/eurheartj/ehs109 &

European Journal of Cardio-Thoracic Surgery 2012 -

doi:10.1093/ejcts/ezs455).


ACC/AHA Recommendations for

chronic primary MR

Recommendations COR LOE

Transcatheter mitral valve repair may be considered for severely symptomatic patients with chronic severe primary MR who have a reasonable life expectancy but a prohibitive surgical risk because of severe comorbidities

IIb

B

(Nishimura et al. J Am Coll Cardiol 2014 In Press. DOI:

10.1016/j.jacc.2014.02.537)

Global experience > 20000 patients worlwide

General comments


Results

How to move forward

annuloplasty replacement

Cardioband Implant

(Maisano. JACC Cardiovasc Interv. 2014;7:1326 -1328)

Combination of

Techniques

Transcatheter Mitral Valve Implantation

EndoValve CardiAQ( n=3)

Neovasc – Tiara( n=3) Lutter Valve (n=2) Fortis (n=12)

Medtronic

HF patients with Severe MR and Low EF

Edge-to-Edge Medical therapy

Symptoms despite Optimal Medical Management

(including Revascularisation and/or CRT)

The Trials we need

COAPT, and Mitra-FR are ongoing .RESHAPE will

restart

> 300 Pts included

Mitral VARC will be published in 2015

HiRiDe

High Risk Degenerative Mitral

Regurgitation

Objective: To evaluate safety and efficacy of MitraClip® vs. surgery in

high-risk but operable patients with DMR

Elderly (>65yo) and with significant comorbidities

STS 3-10%

NYHA ≥ III

Study size: n=294

Follow up: up to 12 months

Endpoints:

Safety: Major Adverse Event Composite (MAE) including all-cause death,

prolonged ventilation (>48h), renal failure, stroke and need for non-elective

cardiovascular or thoracic surgery in order to show superiority of MitraClip to

surgery

Efficacy: In order to show non-inferiority to surgery, it will be a composite of

all-cause death, NYHA Functional Class and HF Hospitalization.

A dedicated “Heart Team” is key at all steps of the new transcatheter

procedures.

Pre-procedural evaluation relies on a comprehensive evaluation of cardiac

and extra-cardiac conditions combining clinical assessment, multimodality

imaging, and other investigations if needed.

The current results of the Edge-to-Edge technique, in > 19000 patients,

suggest that in selected high-risk patients:

- Safety is good

- “It gives life to years and may add years of life”

- The results are stable up to 5 years

In the future improvement may be expected from:

• Better evaluation including long-term follow-up and RCT to evaluate the

effect on mortality and refine the indications

• Combination of techniques

Conclusions

(Treede. J Thorac Cardiovasc Surg 2012;143:78-84)

The Future of the Treatment of

Mitral Regurgitation

• Comparison of MitraClip therapy vs optimal medical

management in patients with severe secondary mitral

regurgitation after 12 months:

• All-cause mortality

• Hopsitalisation for heart failure

Primary objective

• Death

All cause @ 30d, 6m,12m, 24m

Cardiovascular death @ 30d, 6m,12m, 24m

• Survival without major cardiovascular event @ 30d,

6m,12m, 24m

• Safety of MitraClip @30d, 6m,12m

• Medicoeconomic study @12m

• QOL, biomarkers, LV remodelling @ 6-12m

Secondary objectives

• Open, Multicentric, comparative, randomized

study

• Patients with severe secondary MR with CI to

surgery

• MitraClip vs optimal medical management

• Total duration of the study: 4 years

Start: December 2013

Patient enrollment: 24m

Follow-up: 24m

Protocol

• Severe secondary MR (Carpentier type III)

• Severity assessed by TTE/TEE

• NYHA class >= II

• LVEF 15-40%

• >= 1 heart failure hospitalisation <12m

• Optimal medical management

• Contraindication to mitral valve surgery decided by the Heart team

• Confirmation of inclusion echo criteria by Echo CoreLab

Inclusion criteria

• Absence of CI to surgery

• Primary MR

• MI or CABG< =3m

• CRT<= 3m

• Other surgery planned

• PCI<= 1m

• Previous mitral valve repair

• Active Infection

• Dialysis for renal failure

• Severe hepatic insufficiency

• Stroke<=3m

• Life expectancy<=1year

• Uncontrolled HTN

• Allergy to Nitinol

Exclusion criteria

MitraClip - Fonds de dotation ACTIONRepair, Replacement, LVAD, Transplantation) Patient Selection...

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