PERCUTANEOUS TREATMENT STRATEGIES OF VALVULAR HEART DISEASE

Percutaneous Treatment
Strategies of
Valvular Heart Disease
Dr.Nagula Praveen
Final Yr DM PG
8/5/2015

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
the choice.
8/5/2015
2

 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
8/5/2015 3

Mitral valve apparatus
 Anatomic or functional abnormalities of any structure in mitral
valve apparatus lead to MR.
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4

15-65 mm coronary
sinus length
8/5/2015 7

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.
8/5/2015 9

Carpentier’s
classification
8/5/2015 12
J Thorac Cardiovasc Surg. 1983 Sep;86(3):323-
37. Cardiac valve surgery--the "French
correction".Carpentier A.

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
148/5/2015 David TE,J Thorac Cardiovasc Surg 2005:130(5):1245-9.

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).
158/5/2015 Am J Cardiol.2010:106(3):395-401.

Guidelines for management of Mitral
Regurgitation
 ACC/AHA 2014 guidelines for management of valvular heart
disease.
8/5/2015 16

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.
8/5/2015 22
Surgical risk – assess
estimated mortality.
Morbidity
Risk of compromising quality of lie.

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
8/5/2015 23

Goal
To restore normal leaflet function but not necessarily
normal valve anatomy.
8/5/2015 24

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
8/5/2015 25

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.
8/5/2015 26Maisano F,Eur J Cardiothorac Surg 13:240-245.1998.

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
8/5/2015 27
Maisano F,Eur J Cardiothorac Surg 13:240-245.1998.

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. 28

Mitraclip apparatus
8/5/2015 29

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
8/5/2015 33

EVEREST I trial
Endovascular 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.
8/5/2015 34

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.
8/5/2015 35

EVEREST trial II
Randomized 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
8/5/2015 36

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%
8/5/2015 37

REALISM trial
Real World Expanded Multicenter Study of
the Mitraclip System
 Continued access registry
 High risk patients and no high risk patients
8/5/2015 38
ClinicalTrials.gov Identifier:NCT01931956
First received: August 27, 2013
Last updated: March 5, 2014
Last verified: March 2014
Ted Feldmann

 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).
398/5/2015
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

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.
408/5/2015

Current status of Mitraclip
 FDA approved
 2013
8/5/2015 41

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.
8/5/2015 43

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.
8/5/2015 44

Procedure
Access 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
8/5/2015 45

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.8/5/2015 48

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
8/5/2015 49

CARILLON Mitral Contour System
Cardiac 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.
8/5/2015 50

AMADEUS trial
Device 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 /perforation8/5/2015 52
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
8/5/2015 53
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.
8/5/2015 54

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.8/5/2015 56

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
8/5/2015 57

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)
8/5/2015 58

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 pump
2.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.8/5/2015 59

Trial evidence
COAPSYS
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.
8/5/2015 62

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
8/5/2015 63

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
8/5/2015 64

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
8/5/2015 65

GDS Accucinch Annuloplasty System
 Same as the previous
 First in human study was initiated in the Europe
 Implantation was successful in several patients.
8/5/2015 67

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.
8/5/2015 69

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.
8/5/2015 70

 28 mm through 36 mm

8/5/2015 71

Transcatheter Mitral Valve Implantation
 Has not yet been applied clinically.
 Radial force cannot be applied in the mitral position.
 CardiAQ valve Technologies and EndoValve
8/5/2015 83

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)
8/5/2015 85

Tiara Valve
Neovasc 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 catheter
No need of rapid pacing8/5/2015 87

Trial evidence
Preclinical 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 system8/5/2015 91

Tendyne valve Medtronic TMV FORTIS Valve Cardiovalve
Device Trileaflet
pericardial valve
Trileaflet
pericardial valve
Bovine pericardial
tissue
frame Nitinol self
expanding stent
Large atrial inflow
Short outflow
ventricular portion
Cloth covered self
expanding frame
Descendant of the
Lutter valve
retreivable Fully retreivable Fully retreivable
delivery transapically Transatrially
Transseptal
Transapically Transfemoral
route
Secured via a
tether(neochordae)
near the LV apex -
sits on epicardium
2 step process
A.Polyester
skirt
B.Implantation
of valve
Animal studies successful successful
First in Human French Hospital
Paraguay
--- St.Thomas
Hospital,London
Year 2013 March 6,2014
Approval Status
TENDYNE VALVE
MEDTRONIC TMV
FORTIS VALVE
CARDIOVALVE
8/5/2015 92

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
device
Specially
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 thoracotomy
Atriotomy
30F delivery
system
Conform to the
native MV
anatomic shape,
Preserve function
Anchoring and sealing
in the annular region
Permaseal
technology
Sutureless wound
closure
18 F catheter
Preclinical Animal studies
successful
successful successful
8/5/2015 94

Percutaneous Repair of Paravalvular leaks
 All are being used off labelDevice 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
retrograde8/5/2015 95

 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
8/5/2015 97

Antegrade approach Retrograde approach Transapical access
Femoral vein
IJV
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
8/5/2015 98

Complications of PVML closure
complication Etiology Treatment/prevention
Pericardial effusion
/tamponade
TS puncture,guidewire or
catheter perforation of LA/LV
Pericardial drainage
Surgery if needed.
Air embolism Large sheaths – allow air into
circulation
Aspiration,flushing of catheter
Keep 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 ASD8/5/2015 100

Recurrence rates and mortality assosciated
with each reoperation for paravalvular leak
Reoperation Recurrence rate Mortality
1st 8 13
2nd 20 15
3rd 42 37
8/5/2015 101

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.
8/5/2015 103

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.
8/5/2015 104

PERCUTANEOUS TREATMENT STRATEGIES OF VALVULAR HEART DISEASE

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