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Percutaneous Treatment Strategies of Valvular Heart Disease

Dr.Nagula PraveenFinal Yr DM PG

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Introduction Concept of treating diseased heart valves began after the coronary

angioplasty.

Initially the stenotic valves (pulmonic, aortic, mitral) by balloon

valvuloplasty.

No much change with regards to basic techniques and equipment

required over the last two decades --- balloon valvuloplasty.

The revolution(Paradigm shift) was with regards to percutaneous

repairs of mitral regurgitation (MR), aortic valve replacement, left

atrial appendage(LAA) closure for which previously only surgery was

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1.PBMV 2.Mitral valve repair – Mitraclip, annuloplasty ring 3.Transcatheter Mitral Valve Implantation (TMVI) 4.Para Valvular Mitral Leak (PVML) 5.Balloon aortic valvuloplasty 6.Transcatheter Aortic Valve Implantation(TAVI) 7.PBPV 8.Transcatheter Pulmonary Valve Implantation 9.Tricuspid valve repair 10.Tricuspid valve replacement 11.Left atrial appendage closure

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Mitral valve apparatus

Anatomic or functional abnormalities of any structure in mitral valve apparatus lead to MR.

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15-65 mm coronary sinus length

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Approach to a patient with Mitral Regurgitation with regards to management.

Symptoms – onset ,progression Etiology Risk factors/comorbidities – age ,hypertension,diabetes,CKD. Surgical Risk score – ATS,EuroSCORE ECG Chest X ray Echo evaluation - LA size, Mitral valve apparatus,quantifying

MR,commissural level,LV EDD,LVESD,LVEF. Favorable valve anatomy for repair. Stabilization of patients symptoms.

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Carpentier’s classification

J Thorac Cardiovasc Surg. 1983 Sep;86(3):323-37. Cardiac valve surgery--the "French correction".Carpentier A.

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Risk of unsuccessful repair (Primary MR)

Presence of a large central regurgitant jet. Severe annular dilatation (D>50mm) Involvement of greater than or equal to three scallops especially

AML Extensive calcifications Lack of valve tissue in rheumatic disease IE with large perforation

David TE,J Thorac Cardiovasc Surg 2005:130(5):1245-9.

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Preoperative echocardiographic predictors of recurrent MR

Coaptation distance >10 mm Systolic tenting area > 2.5 cm2 Posterior leaflet angle > 45 Distal anterior mitral leaflet angle >25 End systolic interpapillary muscle distance >20 mm Posterior papillary – fibrosa distance >40 mm Systolic sphericity index >0.7 Severe LV enlargement (LVEDD >65 mm,LVESD >51mm).

Am J Cardiol.2010:106(3):395-401.

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Guidelines for management of Mitral Regurgitation

ACC/AHA 2014 guidelines for management of valvular heart disease.

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Ideal patient for Mitral valve repair

Impossible to precisely define the subgroups of patients who will benefit from repair.(<2000 pts).

Personalized medicine Pathology of MR to be known Symptomatic severe MR and Not candidates for surgical correction Preference of a less invasive approach without need of a CP

bypass. Comorbidities confering a high surgical risk. Life expectancy more than 1 yr. Surgical risk – assess

estimated mortality.MorbidityRisk of compromising quality of lie.

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Basis for percutaneous mitral valve repair

Best studied approach is the edge to edge repair Based on the surgical repair championed by Dr.Alfieri. Coronary sinus proximity to the mitral annulus – conformational

change – decreases MR. LV reshaping – subvalvular pathology tackled – better than all in

causing reduction in septal –lateral diameter. Direct annuloplasty – annulus repair directly

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Goal

To restore normal leaflet function but not necessarily normal valve anatomy.

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Modalities of mitral valve repair (MVRe)

Isolated leaflet repair

Edge to edge leaflet repair – Mitraclip

Indirect annuloplasty via coronary sinus

Cardiac chamber remodelling

Transventricular (retrograde) direct annuloplasty.

Others

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Alfieri Edge to Edge stitch repair

1998,Milan,Italy. Initially developed for anterior leaflet prolapse. Posterior and bileaflet prolapse. Free edge of anterior and posterior leaflets are sewn together in an

attempt to increase leaflet contact and coaptation and reduce regurgitation.

Prevents systolic anterior motion of AML following traditional MVRe techniques.

Double orifice mitral valve does not cause stenosis,even when combined with an annuloplasty ring.

Maisano F,Eur J Cardiothorac Surg 13:240-245.1998.

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Results

January 1991 to Septmeber 1997. 432 patients 121 patients –edge to edge correction Anterior prolapse in 61% patients Double orifice repair(60%) others paracommissural repair. Low in hospital mortality(1.6%) Survival (92%) at 6 years. Freedom from reoperation 95%. >80% in NYHA I/II

Maisano F,Eur J Cardiothorac Surg 13:240-245.1998.

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Mitral Clip Best studied of the options for percutaneous MVRe. 24F steerable delivery guide catheter Trans septal approach to place a v shaped clip (Mitraclip) on the

mitral leaflets – double orifice repair. Under TEE guidance. Device – guiding catheter – LA – arms of clip opened, clip aligned to

long axis of the heart. Arms of clip – perpendicular to the line of coaptation of the valve

leaflets. Clip advance to LV – retracted during systole to grasp the middle

scallops of the anterior and posterior valve lealfets in the gripper arms.

After confirmation – clip is locked into position. Process can be repeated until satisfactory. Fibrosis and scarring in the bridging segment.

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Mitraclip apparatus

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Methods: Anatomic Eligibility TEE evidence of FMR:

Absence of Degenerative valve disease Presence of leaflet “tethering”

Not exceeding 10mm

Sufficient leaflet tissue available for mechanical coaptation > 2mm “vertical” leaflet tissue available Protocol anatomic exclusions

Coaptation depth >11mm Coaptation length < 2mm

Absence of severe LV dysfunction Excluding LVID-s > 55mm or EF <25% Ischemic or non-ischemic etiology

<2mm

>11mm

Exclusions

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EVEREST I trialEndovascular Valve Edge to Edge REpair STudy I Year 2005

Type of study Phase I ,Prospective,multicenter safety and feasibility trial

No .of patients 27

Inclusion criteria Moderate to severe MR,primary MR(93%),Ischemic MR(7%)

Exclusion criteria Rheumatic disease, severeMAC, severeLV systolic dysfunction, severe LV cavity dilation.

Primary end point Acute safety at 30 days(freedom from death,cardiac tamponade,stroke,clip detachment,septicemia,cardiac surgery for failed clip).

MACE events 15% (3 clip detachments) ,1 stroke (<34.4% required on basis of comparison with surgical data).

Successful depolyment 24 patients (89%)

Partial clip detachment 3 patients

30 day follow up 6 patients had ≥3+ MR

At 6 months follow up 13 patients (48%) MR ≤ 2+

2 years Mild MR,positive LV remodelling noticed.

JACC 46:2134-2140,2005.

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EVEREST cohort follow up

Patients 79% primary MR,21% functional MR

Acute procedural success (APS) 79 patients(74%)

Priamry end point(MR < 2+,freedom from surgery,death)

66% patients

At discharge MR 77% < 2+MR

At 6 months follow up 50 of 76 patients (66%) < 2 + MR

Mitral valve surgery 32 patients (23 had clip placement)

For clip detachment 10 patients

For >2+MR 9 patients

MV replcement 4 patients

Surgical repair is feasible for upto 18 months

JACC 54(8):686-694,2009.

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EVEREST trial IIRandomized Controlled trial,prospective,multicentered 2:1 randomization

Mitraclip with standard cardiac surgery

No. 279 patients(184 Mitraclip,85 surgery)

Severe MR (73% degenerative,27% functional)

Priamry end point MACE – death,stroke,MI,reoperation,transfusion

Secondary end point Noinferiority compared to surgery

Study group 178 underwent treatment

APS 137 (77%)

At 30 days 1 end point – 9.6%(study group),(57% controls)(more transfusions)

At 12 months Echo – positive LV remodelling ( LVEDD),81% <2+MR,

Symptoms – NYHA I or II – 97.6% vs 87.9%

Cross over 21%

No events in 136 patients who underwent Mitraclip placement

Importance in functional MR also

Mitraclip is noninferior to surgery 72.4% vs 87.8%

Feldman et al, ACC/AHA 2010

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EVEREST high risk group cohort

Registry 78 patients vs 36 controls

Patients Symptomatic moderate to severe MR

Surgical risk >12%

Mean age >77 yrs

Previous cardiac surgery >50% in both groups

Successful treatment 96%

Improvement in MR 78% had atleast 1 grade improvement

One month mortality 7.7%(8.3% control group)

One year survival 76.4% vs 55.3% p=0.037

At one yr 74% < 2+MR

Annual rate of hospitalization for CHF Decreased by 45%

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REALISM trialReal World Expanded Multicenter Study of the Mitraclip System Continued access registry High risk patients and no high risk patients

ClinicalTrials.gov Identifier:NCT01931956First received: August 27, 2013Last updated: March 5, 2014Last verified: March 2014

Ted Feldmann

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June 2012. Safety and efficacy in HF patients with functional MR,at high surgical

risk. As of December 22, 2014, the total enrollment is 159 randomized of

an expected 420 (+42 roll-ins); there are 71 of 83 activated sites, with a projected date of completion in quarter one or two of 2017 (personal correspondence with Abbott Vascular, February 2015).

Primary end point Single leaflet device attachment

Device embolization

Endocarditis requiring surgery

MS requiring surgery

LVAD implantation,Heart TRx

Hospital readmission

Secondary end points Composite of all cause death,stroke,MI,MR severity,6 min walk test

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RESHAPE HF

Abbott Vascular Safety and efficacy of MitraClip in patients with HF and severe

cardiomyopathy. Not yet started enrolling patients, and the projected completion date

will be determined after the first patient is enrolled.

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Current status of Mitraclip

FDA approved 2013

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Indirect annuloplasty via coronary sinus.

Annuloplasty,integral part of MVRe in the majority of the surgical approachs – improves mitral valve leaflet coaptation,reduces MR.

Reduction in mitral annulus diameter of ≥25%. Coronary Sinus (CS) covers about 50% mitral annulus perimeter

80% posterior inter trigonal distance. Anatomic proximity of the CS to the mitral annulus for modulating

annular size and shape. (VARIABLE) LCx crosses between the myocardium and the CS in nearly 50% -

arterial compromise. Cardiac CT, angiography,echocardiography – important for

relationship. Success depends on long term safety of instrumenting the CS.

Percutaneous Transvenous Mitral Annuloplasty system (PTMA)

Viacor,Wilmington,MA

Decrease the septal –lateral mitral annular diameter.

Composite nitinol and stainless steel construct coated with teflon and

plastic – lengths ranging from 35 mm to 85 mm.

Rigid distal element

Flexible push rod to facilitate delivery.

Straight shape of the distal portion of the device causes a

conformational change in mitral annulus.

ProcedureAccess Right internal jugular vein

Balloon tipped catheter is advanced to the ostium of the coronary sinus.

Inflation of the balloon

Coronary venogram obtained Anterior interventricular branch of the great cardiac vein

Engaging of great cardiac vein by hydrophilic wire

9F delivery catheter advanced upto the ostium of the anterior interventricular branch

Annuloplasty device is introduced into the lumen of the delivery catheter and advance to the distal portion of the guiding catheter at the ostium of the vein (anterior IVbranch)

Optimal size based on the length of the distal straight segment

Combination of rods can be used

Advantage – can be revised – number and stiffness of rods

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Trial evidence Human feasibility studies Results of first 27 patients,Moderate or severe functional MR General anaesthesia. A diagnostic PTMA device placed for determining efficacy and safety. If benefit to treatment noticed – changes to permanent implant device. Diagnostic procedure was done in 19 patients Successful in decreasing the MR by atleast one grade in 13 patients (48%). Successful change to permanent implant device in 9 patients (33%). Device fracture – one patient Crossover to surgical annuloplasty – 3 patients Follow up – reduction in septal lateral dimension – modest Procedural MACE – 1pericardial effusion,1 device fracture,1 circumflex

impingement Long term efficacy need to be determined.

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PTOLEMY trial

Percutaneous TransvenOus Mitral AnnuloplastY The PTOLEMY I trial evaluated the feasibility and safety of the

PTMA device in 27 symptomatic patients with moderate-severe functional mitral regurgitation. The device was successfully implanted in only 9 patients. In these patients, there was a reduction in the degree of mitral regurgitation and a reduction in the mitral annulus septal–lateral dimension (Sack et al., 2009).

PTOLEMY II trial since 2014

CARILLON Mitral Contour SystemCardiac Dimensions

Fixed length double anchor device Positioned in coronary sinus. Tension applied to anchors of the device results in tissue plication and

reduces the mitral annular diameter and MR. 9F catheter,Internal Jugular vein Nitinol annuloplasty device Distal anchor of the device is deployed b passive expansion,locked into

the fully expanded position by use of delivery catheter. Tension is placed on the delivery system bringing the proximal anchor

toward the coronary sinus ostium. Optimal reduction in annular dimension(≈25%),reduced MR on real

time echocardiography. Adjustment can be done again if needed.

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AMADEUS trialDevice CARILLON XE device

No. 48 patients

Etiology Functional MR,LV systolic dysfunction

Successful implantation 30 patients

6 month follow up

Decrease in mitral annular diameter 4.2 to 3.78 cm,10%

MR reduction 23%

NYHA class 2.9 to 1.8

Quality of life score improved

6 minute walk test 307- 403 meters

18 patients

5 Coronary sinus related complications(n=3)Fluoroscopic equipment failure(n=2)

13 Retrieval of device after implantation (inadequate reduction in MR or coronary compromise.

complications 6 patients within 30 days of procedure

One multiorgan failure,3 MI,3 coronary dissection /perforation

Siminiak  T.; Effectiveness and safety of percutaneous coronary sinus-based mitral valve repair in patients with dilated cardiomyopathy (from the AMADEUS trial). Am J Cardiol. 104 2009:565-570

Present status

CE approval in Europe.

TITAN trial

No. 53 patients

country 8 centers in Europe

6 months interim report 68% successful implantation

15% transient coronary impingement

MACE rate 1.9%

6 month follow up Reduction in MR was 35%.

1 grade reduction in NYHA class

100 meter improvement in 6 min walk distance

Eur J Heart Fail, 14 (2012), pp. 931–938

MONARC (originally VIKING system)Edwards LifesciencesInc., Irvine,CA.

VIKING - Distal self expanding anchor,a spring like bridge segment and a proximal self expanding anchor.

Bridge segment – shape memory properties. Shortening of the device at the room temperature. MONARC – delayed release system of nitinol and biodegradable

spacers –slowly dissolve over 3-6 weeks. Shortening intended to induce a conformational change in the

coronary sinus,extending to the mitral annulus,further reducing any postprocedural MR.

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Procedure Access Internal Jugular vein

Cannulation of the coronary sinus with hydrophilic wire and advanced into the distal great cardiac vein.

Measurement catheter for the proper device size.

9F delivery catheter

Left coronary injections – verify proper device positioning,distal anchor is released by retracting the outer restraining sheath.

Distal anchor of the device is intended to be on the inner curve of the coronary sinus

Slack is removed from the bridging element by placing tension on the delivery catheter

Proximal anchor is released just within the edge of the coronary sinus by further retraction of the outer restraining sheath of the delivery catheter.

Device cannot be recaptured after the anchor has been deployed.

EVOLUTION trial

Multicenter feasibility and safety study

Europe and Canada

Interim 2 year follow up of 72 patients

Inclusion criteria 2+ to 4+ functional MR

Exclusion criteria Severe LVSD(<25%),organic mitral valve disease,severe MAC,coronary sinus pacing leads.

Device implantation 59 patients (82%)

Venous tortuoisity or unfavorable size 13 patients

Safety from secondary end point 83% (6 months),81% @ 1 yr,72%@ 2 yrs.

NYHA class improvement 2.7 to 2.0(p=0.002)

At 2 yrs MR improvement was significant

Device is moderately effective

Cardiac chamber remodelling devices

Functional MR caused by dilated cardiomyopathy and ischemic MR caused by geometric alterations affect not only the mitral annulus but also the LA and the LV and their relationships to the annulus.

These alterations in paravalvular geometry are not addressed by typical ring annuloplasty.

Two rings have been engineered with this consideration in mind. 1.Coapsys iCoapsys 2.Percutaneous Septal Sinus Shortening system(PS3)

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COAPSYS and iCOAPSYS PS3 System

Myocor ,Maple Grove,MN Ample Medical Inc,Foster city,CA.

Surgical placement of pericardial implants pumps off pump.

Trans atrial bridge

Epicardial surface of the heart Uses the coronary sinus and a septal closure device to place a cord across the atrium,create tension on the annulus, remodel the mitral annulus and LA.

Tethering subvalvular cord that crosses the ventricle internally.

Septal lateral annular cinching – traction between the interatrial septum and the coronary sinus at the level of the P2 mitral segment.

Cord is cinched to decrease the mitral annulus diameter and eliminate MR.

Adv – 1.ability to treat functional MR off pump2.Allow the combination of off pump bypass and MVRe.

3.Preserves normal valve dynamics

4.Addresses mitral annulus as well as the subvalvular space and abnormal left ventricular geometry.

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Trial evidenceCOAPSYS

1. Clinical feasibility trial – successful implantation in 34 patients with functional MR at the time of bypass surgery.

One year follow up – 11 patients - decrease in MR (2.9 to 1.1),jet area 7.4cm2 -3.0 cm2 and NYHA class improvement(2.5-1.2) at 12 months.

2.RESTORE MV – randomized trial

CAD and ischemic MR

CABG+MVRe vs CABG+COAPSYS

19 patients received the implant

Reduction in MR is significant (P=0.0001)

165 patients have been randomized 77 pts with MVRe and 87 with COAPSYS

Funding issues – terminated prematurely

Results have not yet been published

iCOAPSYS pericardial access sheath.

VIVID trial – prematurely discontinued because of funding issues.

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Trial Evidence

PERCUTANEOUS SEPTAL SINUS SHORTENING SYSTEM(PS3)

Palacios and colleagues

2 patients with functional MR

Mitral annular reduction was significant

No further testing because of financial constraints

Reduction of mitral annular diameter comparable withthat of surgical annuloplasty and greater than that of other percutaneous approaches

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Trans ventricular (Retrograde)Direct Annuloplasty

Exciting area of development. Ability to apply repair directly to the annulus,where the pathological

mechanism of MR is frequently located. Eliminated the anatomic uncertainity about the LCx artery,and the

proximity of the coronary sinus to the mitral annulus Addresses the pathological mechanisms of functional MR. 1.Mitralign Direct Annuloplasty System 2.GDS AccuCinch Annuloplasty System

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Mitralign Direct Annuloplasty System Based on the concept of direct suture annuloplasty. Three metal anchors connected by standard suture materials. Anchors are placed in the mitral annulus and suture cinched to

perform the annuloplasty. Retrograde ventricular access Unique translation catheter with a two pronged “bi dent” design

for device delivery. Magnetic guiding catheter placed in the coronary sinus Anchors placed from the ventricular side by imaging techniques. Positioned below the valve at the level of each posterior leaflet

scallop – deployed – connected by suture material. Plicating the annulus by cinching the suture. In clinical testing

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GDS Accucinch Annuloplasty System

Same as the previous First in human study was initiated in the Europe Implantation was successful in several patients.

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Other Annuloplasty devices

Application of subablative RF energy to remodel the mitral annulus

QUANTUMCOR Transventricular annulus remodelling – scarring and shrinkage of

the mitral annulus after application of RF energy directly to the annulus.

Surgical and transcatheter use. Malleable tip ,seven electrodes to deliver RF energy. Pulse generator – modulated by temperature sensors in the

electrodes –regulate the amount,duration of energy delivery. Specific locations can be applied. No human data available.

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Dynaplasty ring

Micardia Adjustable annuloplasty ring Early phases of development Not yet been used in humans. Implanted surgically during conventional repair procedures. Ring responds to the electrical stimulation by RF wires placed

directly against the ring in the activation zones. Ring changes configuration – favorable shape. Reshaped intraoperatively or subsequently via transseptal approach if

MR recurs.

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28 mm through 36 mm

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Transcatheter Mitral Valve Implantation

Has not yet been applied clinically. Radial force cannot be applied in the mitral position. CardiAQ valve Technologies and EndoValve

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CardiAQ valve

Self expanding nitinol frame 3 leaflets of bovine pericardial tissue. Does not use radial force for fixation to the annulus. Two sets of anchors grasping the mitral leaflets from LA and LV side

- used for fixation. Foreshortening of the frame creates a clamping action that anchors

the valve above and below the annulus. Chordae and papillary muscles to be preserved. Can be repositioned. Percutaneously through the femoral vein Transeptal access to LA (antegrade),transapical approach

(retrograde)

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Tiara ValveNeovasc Inc,British Columbia,Canada

Self expanding bioprosthesis

Cross linked bovine pericardial tissue leaflets mounted inside a metal alloy frame.

Atrial portion – specifically fits the saddle shaped annulus

D shape – natural shape of the mitral orifice and prevent impingement of the LVOT.

Ventricular shape – covered skirt to prevent PVL

3 anchoring structures – 2 anterior – fibrous trigones at both sides of AML

1 posterior – behind PML

Retrograde dislodgement during systole is prevented by this mechanism

Can be retreivable and repositionable before deployment

Transapically

32F delivery catheterNo need of rapid pacing

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Trial evidencePreclinical Development

Safety and feasiblity of the Tiara valve has been successful.

Acute and chronic animal models and human cadavaers.

Acute cases 29/36 successfully implanted

None of the valve migrated or embolized after implantation

No LVOT obstruction

No coronary artery obstruction

No transvalvular gradient

High rate of PVL in chronic models – one size only available.

White fibrotic connective tissue along the atrial and ventricular struts.

Intact leaflets at follow up without tears or perforations

HUMAN CADAVERIC MODEL – appropriate geometric positioning with full circumferential coverage of the atrial aspect of the mitral annulus and good apposition and location of the ventricular anchoring system

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Tendyne valve Medtronic TMV FORTIS Valve Cardiovalve

Device Trileaflet pericardial valve

Trileaflet pericardial valve

Bovine pericardial tissue

frame Nitinol self expanding stent

Large atrial inflowShort outflow ventricular portion

Cloth covered self expanding frame

Descendant of the Lutter valve

retreivable Fully retreivable Fully retreivable

delivery transapically TransatriallyTransseptal

Transapically Transfemoral route

Secured via a tether(neochordae) near the LV apex - sits on epicardium

2 step processA.Polyester skirtB.Implantation of valve

Animal studies successful successful

First in Human French HospitalParaguay

--- St.Thomas Hospital,London

Year 2013 March 6,2014

Approval Status

TENDYNE VALVE

MEDTRONIC TMV

FORTIS VALVE

CARDIOVALVE

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High life Medical TMV

Endovalve Gorman TMV Mitrassist

access Transfemoral Transatrial access

Foldable nitinol structure

Nitinol framework

Neither repair nor replacement

Locking component in LV through femoral approach

Transapical approach

Single nitinol wire –woven to complex 3D

Valve implant placed on top of the native MV

Stent valve deployed via transatrial access

Valve sparing deviceSpecially designed grippers

Arms insinuate themselves around leaflets – exposure to LVSP

Nitinol frame with pericardium.Asymmetrical bileaflet design

Groove in stent valve shape should engage with locking component

No risk of LVOT obstruction

Left thoracotomyAtriotomy30F delivery system

Conform to the native MV anatomic shape,Preserve function

Anchoring and sealing in the annular region

Permaseal technologySutureless wound closure

18 F catheter

Preclinical Animal studies successful

successful successful

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Percutaneous Repair of Paravalvular leaks

All are being used off label Device Shape of device Device deployment

Amplatzer device (AGA Medical,MN,USA)

Septal occluder Round Antegrade or retrograde

Muscular VSD occluder Round Anterograde or retrograde

Duct occluder Round Only antegrade

Vascular plugs Round Either antegrade or retrograde

Amplatzer vascular plug III (AVP III) occluder

oval Either antegrade or retrograde

Vascular coils Round Either antegrade or retrograde

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TEE is mandatory – identify,characterize,number,shape of PVLs. Paravalvular MR may be missed on TTE because of artifacts and

reverberations caused by MV prosthesis. Leaks have irregular shape. Color doppler flow jet outside of the sweing ring of the

implanted valve. Severity –MR jet width at its origin is measured. Vitarelli and colleague

3D TEE useful in management. Rocking valve,PVML >30% of valve circumference,active

endocarditis,intracardiac thrombus - C/I

Mild 1-2 mm

3-6 mm moderate

>6 mm severe PVL

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Antegrade approach Retrograde approach Transapical access

Femoral veinIJV

Severe PVML PVML along IAS

IJV- leak close to IAS Femoral artery Ruiz and colleagues

PVML End hole diagnostic JR or JL Guide wire and support catheter

Hydrophilic 0.035 in wire JR or MP

Stiffer exchange wire replaces above once crossed

Hydrophilic wire

Delivery sheath into LV LA disc is deployed first

Proximal device is opened in the LV

LV disc is deployed later

Device pulled back to the ventricular side

Risk of injury to chordae,papillary muscles

LA disc deployed

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Complications of PVML closure

complication Etiology Treatment/prevention

Pericardial effusion /tamponade

TS puncture,guidewire or catheter perforation of LA/LV

Pericardial drainageSurgery if needed.

Air embolism Large sheaths – allow air into circulation

Aspiration,flushing of catheterKeep at level below the heart – insertion or removal

Thrombus formation Foreign material - thrombus ACT 250 -300msec

Failure to cross the leak with delivery sheath

Severe friction Hydrophilic wires

Difficulty to probe the lesions Steerable sheath

Persistent ASD

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Recurrence rates and mortality assosciated with each reoperation for paravalvular leakReoperation Recurrence rate Mortality

1st 8 13

2nd 20 15

3rd 42 37

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Future

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Conclusions

Percutaneous mitral valve repair is an exciting new field with many devices at early stages of preclinical and clinical evaluation.

Can be used as a preventive technology – alter the course of disease.

Nothing to lose standards – surgery can be done. Collegial interaction between the specialities of

cardiology,cardiothoracic surgery and imaging is needed.

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Take Home Message

Percutaneous MVRe and TMVR have been proved to be feasible procedures in patients at high surgical risk.

Percutaneous MVRe – the future of management of MR. TMVR – valve in valve and valve in ring procedure. Part of preventive approach. First in Man studies of these approaches are impressive.

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Thank you