percutaneous mitral valve repair nicvd

7/27/2019 PERCUTANEOUS MITRAL VALVE REPAIR nicvd

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PERCUTANEOUS MITRAL

VALVE REPAIR

Presenter

DR.KAZI AZAJUL FERDOUSH

D-CARD STUDENT.

NICVD

Moderator DR. M G AZAM

ASSISTANT PROFESSOR.

CARDIOLOGY DEPARTMENT. NICVD



INTRODUCTION

• Mitral regurgitation (MR) arises commonly from the

failure of mitral leaflet coaptation during ventricular systole.

• The mitral valve is a complex structure consisting of anterior (aortic) and posterior (mural) leaflets, chordaetendinae, papillary muscles and the mitral annulus.

• Common causes include:Rheumatic heart disease

Myxomatous or degenerative valve disease,

Ischaemic heart disease, or

„Functional‟ MR due to mitral annular and left

ventricular dilatation as seen in patients with dilatedcardiomyopathy.



The Alfieri technique

• In the early 1990s, Alfieri pioneered a novel approach tomitral repair.

• By simply placing a suture at the centralfree edges of theanterior and posterior mitral leaflets, he was able to

reduce the severity of MR in patients with mitral prolapseinvolving the midsegment of the orifice.

• A double, or “bow-tie,” orifice is constructed by thefixation of the anterior and posterior leaflets with such astitch, which reduces the leaflet mobility, forces leafletapproximation, and decreases regurgitant flow whilemaintaining normal LV contractile dynamics.



Percutaneous Mitral Repair Approaches

Coronary sinus annuloplasty

• Edwards Monarc • Cardiac Dimensions Carillon

• Viacor Shape Changing Rods

• St. Jude Annulus Reshaping

Direct annuloplasty

• Mitralign Suture-Based Plication• Guided Delivery Anchor -Cinch Plication

• QuantumCor RF Annulus Remodeling

• MiCardia variable size ring

Leaflet repair

• EValve Mitraclip • Edwards Mobius stitch

Chamber + annular remodeling

• Myocor iCoapsys

• Ample PS3



Percutaneous mitral valve leaflet repair

• Two percutaneous leaflet repair procedures have been

evaluated to date.• The Mobius device used a transeptal suction catheter to

grasp the mitral leaflets and deploy percutaneous sutures.The procedure was complex and is not currently being

pursued.• The Mitraclip device has proven relatively safe andeffective.

• The procedure, is performed in the cardiac catheterisationlaboratory under general anaesthesia with TOE and

fluoroscopic guidance.• A 24F(8 mm diameter) steerable guide catheter

containing a delivery system and clip is introducing intothe femoral vein and then into the left atrium viatransseptal access.



Percutaneous mitral valve leaflet repair, cont….

• The two arms of the clip are opened and rotated so that

they are perpendicular to the axis of coaptation of theleaflets.

• The clip is passed across the mitral valve into the leftventricle, then retracted to grasp both mitral leaflets.

• Finally, clip is closed to bring the leaflets together.

• Intraprocedural transoesophageal echocardiography is akey component of the procedure to guide clip Placementand evaluate the result.

• If suboptimal results are achieved in the initial attempt, theclip can be reopened, the leaflets released, the clip

repositioned, and the mitral leaflets regrasped at a differentlocation.

• Theoretical adverse event include leaflet tearing, clipembolism, partial clip detachment, complications fromvascular access, cardiac tamponade ,atrial septal defect,

and scar formation around clips, causing mitral stenosis.



Endovascular Valve Edge-to-EdgeREpair STudy (EVEREST)

Patient Population • Moderate to severe (3+) or severe (4+) MR• Symptomatic • Asymptomatic with LVEF < 60% or LVESD > 40mm

• Candidate for mitral valve surgery• Sufficient leaflet tissue available for mechanical coaptation

Anatomic considerations

– Flail gap <10mm

– Flail width <15mm

– Mitral Area > 4.0cm

– Coaptation length > 2mmKey Exclusions

– EF < 25% or LVESD > 55 mm – Renal insufficiency – Endocarditis, rheumatic heart disease

<2mm

>11mm



Enrollment Population n

EVEREST IFeasibility (completed)

Registry patients 55

EVEREST II

Randomized n=279

Roll-inRandomized Clip

RandomizedSurgery

60

187

92

Studies



EVEREST, cont…

• In EVEREST II, 279 patients with significant mitral

regurgitation (3+ to 4+) were randomized 2:1 to theMitraClip procedure(184 patients) or to surgical repair (95 patients).

• The trial was conducted at 37 centers and includedpatients with both functional mitral regurgitation (27%)

and degenerative mitral regurgitation (73%)• Primary effectiveness endpoint: Freedom from death,surgery for mitral valve dysfunction, and >2+ mitralregurgitation at 12 months

• Primary safety endpoint: Death, myocardial infarction, re-

operation for failed surgical repair/replacement,nonelective cardiovascular surgery for adverse events,stroke, renal failure, deep wound infection, ventilation for more than 48 hours, gastrointestinal complicationrequiring surgery, new-onset atrial fibrillatin, sepsis, andtransfusion of ≥2 U blood.



EVEREST, cont…

• Secondary Endpoints

Quality of lifeNYHA functional class

• Major adverse events at 30 days occurred in 9.6% of theclip group versus 57% of the control group (p < 0.0001 for superiority). This outcome was driven by increased needfor blood transfusion in the control group. Clinical successrate at 12 months was 72% versus 88% (p = 0.0012 for noninferiority), respectively.

• In the per-protocol group, 82% achieved 2+ or less mitralregurgitation versus 97% in the control group. New York

Heart Association (NYHA) class I or II at follow-up was98% in the clip group versus 88% in the control group.

• The pattern of benefit was similar for the differentcomponents of the efficacy end point. While reductions inmitral-regurgitation grade were greater in the surgery

group,



One or more Clips implanted in 90% of cases

Results

EVEREST I + roll-in phase of EVEREST II



Reverse LV remodelling

• LV Dysfunction Population (EF <55% or LVIDs > 4.5cm)



EVEREST, cont…

• Improvements in left ventricular volume, left ventricular

dimension, and NYHA class were similar between the twogroups.

• After 1 year, 52% of the patients treated with the clip hadmitral regurgitation of 2+ severity or worse, compared with16% of patients in the surgical control group.

• Interpretation: Among patients with severe mitralregurgitation, repair with a percutaneous mitral valve clipwas feasible. This therapy demonstrated improved safetyat 30 days compared with surgery. The mitral valve clipwas also noninferior for effectiveness at 12 months.



Coronary Sinus annuloplasty

• As the coronary sinus is parallel to the mitral annulus, a

device may be passed via the coronary sinus toward thegreat cardiac vein and thus encircle approximately twothirds to three-quarters of the circumference of the mitralannulus.

• Tension placed on the coronary sinus results in a decrease

in the mitral annular circumference.• More than ten devices have been designed and three are

currently being studied. They share common technicalfeatures: distal fixation in great cardiac vein and proximalfixation in the coronary sinus and a bridge between thesetwo fixating elements.

• The MONARC percutaneous transvenous annuloplastydevice consists of a stent-like anchor placed in the greatcardiac vein, a connecting bridge, and a second anchor located proximally at the coronary sinus ostium.



Coronary Sinus annuloplasty, cont..

• The compressed device can be introduced from the jugular vein using a long sheath. Once positioned within

the cardiac venous system, the sheath is withdrawnallowing the self-expanding nitinol alloy anchors toexpand, providing fixation .

• Tensioning the device before deployment of the proximalanchor allows for acute shortening of the coronary sinus.

In addition, the nitinol bridge segment is constructed likea spring with biodegradable spacers. Over a few weeksthe spacers dissolve and the bridge shortens, theanchors are drawn together and the coronary sinusshortens further. Thus, there is both an acute anddelayed effect.

• Preliminary results from the EVOLUTION study in 60patients show high feasibility (90%) and good safetyprofiles as almost 80% of the patients experienced nocomplications within 90 days. Preliminary efficacy datasuggest a reduction in the degree of regurgitation .



Coronary Sinus annuloplasty, cont..

• The similar CARILLON Mitral Contour System has shownbenefit with an acute reduction in MR by a mean of 1

grade.• The Percutaneous transvenous mitral annuloplasty device

represents a third approach to coronary sinus annuloplastyand subsequent PTOLEMY trial found a reduction of MRby at least 1 grade.

• Draining into the right atrium the coronary sinus and greatcardiac vein typically lie on the atrial side of the mitralannulus rather than immediately in the plane of theannulus. Moreover, the anatomic relationship of the sinusto the mitral annulus is highly variable.

• An additional concern is that branches of the circumflexartery travel under the great cardiac vein in more than onehalf of the patients. Clinical experience has confirmed thatcoronary artery compression, ischemia and infarction mayoccur and consequently pre procedural screening usingnoninvasive imaging may be required.



A, CARILLON XE. B, MONARC.

C, Percutaneous transvenous mitral annuloplasty device.

Copyrigh t ©200 9 A merican H eart Association

Masson, J.-B. et al. Circ Cardiovasc Intervent 2009;2:140-146

Coronary sinus annuloplasty devices


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Schematic representation of a coronary annuloplasty procedure with the MONARC device



Direct Annuloplasty

• When the mitral annulus dilates, it is primarily the lessfibrous posterior portion of the annulus that is involved.

• Direct modification of the mitral annulus using aradiofrequency catheter to heat and shrink annular collagen has been proposed.

• Current percutaneous approaches use a catheter

advanced from the femoral artery into the left ventricle toaccess the left ventricular attachment of the posterior leaflet.

• In both the Mitralign Percutaneous Annuloplasty Systemand the Accucinch system several anchors are implantedin the subannular ventricular myocardium that correspondsto the mitral valve annulus. Linking sutures can betensioned like a belt shortening the posterior annulus.


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Direct annular plication concept



Ventricular Remodeling

• The iCoapsys device is designed to produce a reduction

in MR by remodeling the left ventricle .• This percutaneous device is implanted using a

subxiphoid pericardial access sheath. Using asophisticated positioning system, 2 fixation pads areplaced on the surface of the left ventricle, 1 anterior and

1 posterior.• Left ventricular puncture allows a cable to connect the 2

pads. Tensioning the cable draws the 2 pads together.

• As the anteroposterior diameter of the left ventricle isreduced, the anteroposterior dimension of the mitral

annulus also reduces, hopefully resulting in improvedleaflet coaptation, reduced chordal tethering, andimproved left ventricular function.



Conclusions

• Preliminary results of percutaneous mitral valve repair demonstrate that it is safe and feasible.

• Patient selection and treatment should be carried outonly in specialist units by a multidisciplinary teamincluding an interventional cardiologist with expertise inechocardiography and a cardiac surgeon,anaesthesiologist and with arrangements for access toemergency cardiac surgery.

• Definite place for this technology in a subset of patientswith MR and suitable anatomy.

• All potential candidates should be evaluated by amultidisciplinary team.

• Patient selection is paramount.

percutaneous mitral valve repair nicvd

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