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, chordae tendinae, 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 dilated cardiomyopathy.

The Alfieri technique

In the early 1990s, Alfieri pioneered a novel approach to mitral repair. By simply placing a suture at the centralfree edges of the anterior and posterior mitral leaflets, he was able to reduce the severity of MR in patients with mitral prolapse involving the midsegment of the orifice. A double, or bow-tie, orifice is constructed by the fixation of the anterior and posterior leaflets with such a stitch, which reduces the leaflet mobility, forces leaflet approximation, and decreases regurgitant flow while maintaining 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 and effective. The procedure, is performed in the cardiac catheterisation laboratory under general anaesthesia with TOE and fluoroscopic guidance. A 24F(8 mm diameter) steerable guide catheter containing a delivery system and clip is introducing into the femoral vein and then into the left atrium via transseptal 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 the leaflets. The clip is passed across the mitral valve into the left ventricle, then retracted to grasp both mitral leaflets. Finally, clip is closed to bring the leaflets together. Intraprocedural transoesophageal echocardiography is a key component of the procedure to guide clip Placement and evaluate the result. If suboptimal results are achieved in the initial attempt, the clip can be reopened, the leaflets released, the clip repositioned, and the mitral leaflets regrasped at a different location. Theoretical adverse event include leaflet tearing, clip embolism, partial clip detachment, complications from vascular access, cardiac tamponade ,atrial septal defect, and scar formation around clips, causing mitral stenosis.

Endovascular Valve Edge-to-Edge REpair 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 > 2mm Key Exclusions EF < 25% or LVESD > 55 mm Renal insufficiency Endocarditis, rheumatic heart disease

<2mm

>11mm

Studies
Enrollment Population n

EVEREST I Feasibility (completed)

Registry patients

55

Roll-in EVEREST II Randomized n=279 Randomized Clip

60 187 92

Randomized Surgery

EVEREST,

cont

In EVEREST II, 279 patients with significant mitral regurgitation (3+ to 4+) were randomized 2:1 to the MitraClip procedure(184 patients) or to surgical repair (95 patients). The trial was conducted at 37 centers and included patients with both functional mitral regurgitation (27%) and degenerative mitral regurgitation (73%) Primary effectiveness endpoint: Freedom from death, surgery for mitral valve dysfunction, and >2+ mitral regurgitation at 12 months Primary safety endpoint: Death, myocardial infarction, reoperation for failed surgical repair/replacement, nonelective cardiovascular surgery for adverse events, stroke, renal failure, deep wound infection, ventilation for more than 48 hours, gastrointestinal complication requiring surgery, new-onset atrial fibrillatin, sepsis, and transfusion of 2 U blood.

EVEREST,

cont

Secondary Endpoints Quality of life NYHA functional class Major adverse events at 30 days occurred in 9.6% of the clip group versus 57% of the control group (p < 0.0001 for superiority). This outcome was driven by increased need for blood transfusion in the control group. Clinical success rate at 12 months was 72% versus 88% (p = 0.0012 for noninferiority), respectively. In the per-protocol group, 82% achieved 2+ or less mitral regurgitation versus 97% in the control group. New York Heart Association (NYHA) class I or II at follow-up was 98% in the clip group versus 88% in the control group. The pattern of benefit was similar for the different components of the efficacy end point. While reductions in mitral-regurgitation grade were greater in the surgery group,

Results EVEREST I + roll-in phase of EVEREST II

One or more Clips implanted in 90% of cases

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 two groups. After 1 year, 52% of the patients treated with the clip had mitral regurgitation of 2+ severity or worse, compared with 16% of patients in the surgical control group. Interpretation:Among patients with severe mitral regurgitation, repair with a percutaneous mitral valve clip was feasible. This therapy demonstrated improved safety at 30 days compared with surgery. The mitral valve clip was 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 the great cardiac vein and thus encircle approximately two thirds to three-quarters of the circumference of the mitral annulus. 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 technical features: distal fixation in great cardiac vein and proximal fixation in the coronary sinus and a bridge between these two fixating elements. The MONARC percutaneous transvenous annuloplasty device consists of a stent-like anchor placed in the great cardiac 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 withdrawn allowing the self-expanding nitinol alloy anchors to expand, providing fixation . Tensioning the device before deployment of the proximal anchor allows for acute shortening of the coronary sinus. In addition, the nitinol bridge segment is constructed like a spring with biodegradable spacers. Over a few weeks the spacers dissolve and the bridge shortens, the anchors are drawn together and the coronary sinus shortens further. Thus, there is both an acute and delayed effect. Preliminary results from the EVOLUTION study in 60 patients show high feasibility (90%) and good safety profiles as almost 80% of the patients experienced no complications within 90 days. Preliminary efficacy data suggest a reduction in the degree of regurgitation .

Coronary Sinus annuloplasty, cont..

The similar CARILLON Mitral Contour System has shown benefit 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 annuloplasty and subsequent PTOLEMY trial found a reduction of MR by at least 1 grade. Draining into the right atrium the coronary sinus and great cardiac vein typically lie on the atrial side of the mitral annulus rather than immediately in the plane of the annulus. Moreover, the anatomic relationship of the sinus to the mitral annulus is highly variable. An additional concern is that branches of the circumflex artery travel under the great cardiac vein in more than one half of the patients. Clinical experience has confirmed that coronary artery compression, ischemia and infarction may occur and consequently pre procedural screening using noninvasive imaging may be required.

Coronary sinus annuloplasty de vices

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

Co p y rig h t 2 0 0 9 American Heart Asso c ia tio n

A, CARILLON XE. B, MONARC. C, Percutaneous transvenous mitral annuloplasty device.

Schematic representation of a coronary annuloplasty procedure wi th the MONARC device

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

Copyright 2009 American Heart Assoc ia tion

Direct Annuloplasty
When the mitral annulus dilates, it is primarily the less fibrous posterior portion of the annulus that is involved. Direct modification of the mitral annulus using a radiofrequency 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 to access the left ventricular attachment of the posterior leaflet. In both the Mitralign Percutaneous Annuloplasty System and the Accucinch system several anchors are implanted in the subannular ventricular myocardium that corresponds to the mitral valve annulus. Linking sutures can be tensioned like a belt shortening the posterior annulus.

Direct annular plication concept

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

Copyright 2009 American Heart Assoc ia tion

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 a sophisticated positioning system, 2 fixation pads are placed 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 is reduced, the anteroposterior dimension of the mitral annulus also reduces, hopefully resulting in improved leaflet coaptation, reduced chordal tethering, and improved 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 out only in specialist units by a multidisciplinary team including an interventional cardiologist with expertise in echocardiography and a cardiac surgeon, anaesthesiologist and with arrangements for access to emergency cardiac surgery. Definite place for this technology in a subset of patients with MR and suitable anatomy. All potential candidates should be evaluated by a multidisciplinary team. Patient selection is paramount.