Transcatheter therapeutic options for treatment of Mitral Regurgitation

1. Transcatheter Therapy for Mitral
Regurgitation
Clinical Challenges and Potential Solutions
Dr G.Raghu Kishore

2. • INTRODUCTION
• MITRAL VALVE ANATOMY
• MITRAL REGURGITATION AND THERAPEUTIC OPTIONS
• MITRA CLIP-PROCEDURE
• EVIDENCE
• OTHER PERCUTANEOUS MITRAL REPAIR PROCEDURES
• CLOSURE OF THE MITRAL PARAVALVULAR LEAK

3. INTRODUCTION
• Mitral regurgitation (MR) is one of the most common heart valve disorders
• If left untreated it leads to progressive LV dysfunction, heart failure, and
death.
• Surgical repair or replacement is the established treatment for
degenerative MR.
• patients with associated comorbidities or LV dysfunction put them at very
high surgical risk.
• Need exists for less invasive, safer options for selected patients

4. Mitral valve anatomy
• The MV comprises two leaflets, annular
attachment at the atrioventricular junction,
tendinous chords and the papillary muscles
(PMs).
• Mural leaflet has three scallops (segments) along
the elongated free edge
• Carpentier’s nomenclature describes the most
lateral segment as P1, which lies adjacent to the
anterolateral commisure, P2 is central and most
medial is P3 segment, which lies adjacent to the
posteromedial commissure.

5. • Normal mitral valve function depends on perfect function and complex
interaction between various structures
• The broader concept of “mitral valve complex” allows a better
characterization of both normal and abnormal valvular function.
Mitral Valve Morphology
Mitral annulus
Mitral valve
Mitral valve
complex
Mitral leaflets
Chordae tendineae Sub valvular
apparatus
Papillary muscles
Left Ventricular wall
Left atrium

6. 5

7. Carpentier Classification of MR

8. Etiology of MR
• The anatomic aetiologies of MR include degenerative or functional
• Degenerative MR -- leaflets or chordae are structurally altered (fibroelastic
deficiency, leaflet prolapse and flail, or Barlow’s disease).
• Functional MR --is a direct consequence of underlying myocardial disease
affecting the valvular apparatus and is observed in patients with ischaemic
or dilated cardiomyopathy

9. Etiology

10. Echocardiographic assessment

11. Echocardiographic assessment

12. Mitral Valve Morphology - TEE
SCALLOP ANALYSIS BY TEE •Mid-esophageal 4C View
•A3 and A1
•Commisural View
•P3-A2-P1
•Two Chamber View
•P3-A1
•Long Axis View
•A2
•Transgastric Views (Short)
•Posteromedial commissure
•Anterolateral commissure
•Transgastric Views (Long)
•Chordae Tendinae
•Papillary Muscle

13. Echocardiographic assessment

14. Stages of Chronic Primary MR

15. Stages of Chronic Secondary MR

16. AHA/ACC guidelines for the management of MR

18. 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.

19. 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 > 55mm)
Am J Cardiol.2010:106(3):395-401.

22. SEVERE SYMPTOMATIC MR - PATIENTS WHO ARE DENIED SURGERY
EURO HEART SURVEY on valvular heart disease – Mirabel et al. EHJ

23. SEVERE PRIMARY MR : INDICATIONS FOR SURGERY

24. SEVERE SECONDARY MR – INDICATIONS FOR SURGERY

25. Ideal patient for Percutaneous Mitral valve repair
• Impossible to precisely define the subgroups of patients who will benefit
from repair
• 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 conferring a high surgical risk.
• Life expectancy more than 1 yr.

26. 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

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

28. Percutaneous procedures for treatmet of MR

29. Percutaneous devices for treatmet of MR

30. Double Orifice Repair - Published Surgical Results
 Introduced by Alfieri for degenerative and functional MR
 >1000 repairs reported >10 yrs follow up
 Equivalent to standard surgical repair for short and long term outcomes
 No creation of stenosis of the orifice
 Overall freedom from re-operation 90% @ 5yr

31. The transition from surgical repair to transcatheter repair

33. HISTORY AND DEVELOPMENT OF MITRAL CLIP
• The development of the MitraClip dates back to 1998, when interventional
cardiologist Frederick St. Goar started experimenting with percutaneous
techniques for MVR.
• The feasibility of percutaneous MVR with the MitraClip device was first
demonstrated in a animal model.
• The first human implant of a MitraClip was performed in June 2003 by Dr. Jose
Condado in Caracas Venezuela in a 48-year-old woman with severe MR due to a
bileaflet flail.
• The procedure was performed without complications and after successful clip
deployment her MR decreased to <2+.

34. Clinical experience from first in man to commercial use
• The Mitraclip has been used in humans with success, due to the very promising animal
experience.
• Main drivers for success of the therapy have been the precise and stable delivery system, the
solid and reliable tissue approximation, the good visualization of the device, and its
repositionability and retrievability.
• The main strength is feasibility of the procedure under beating heart conditions, guided by
the regurgitant jet position.
• Main disadvantage is the limited applicability, according to strict anatomical features.
• Applied to a wide spectrum of degenerative and functional MR pathologies.

35. • However, considerable uncertainty still remains about indications and ideally suitable
patient populations for percutaneous MVR.
• Current patient selection criteria are based on the Endovascular Valve Edge-to-Edge
Repair Study (EVEREST) programme and include clinical patient characteristics and
anatomical features of the mitral valve.
• The main anatomical selection criterion appears to be the ability to properly grasp
both leaflets
• Treating MR at the medial or lateral commissures is feasible, but requires exceptional
care as the ability to manoeuvre the device is limited and the risk of entanglement in
the commissural chordae is high and TEE may be necessary to resolve relevant
morphological features.
• MitraClip treatment does not preclude the later use of other device-based therapies
that are often applied in patients with heart failure

36. Mitraclip for DMR
• In experienced centers, DMR is treated with
surgical repair at low risk, long term
durability of repair is achieved in the
majority of patients
– 50% of Euro Heart Survey patients were not
referred to surgery (Mirabel EHJ 2007)
– Age and comorbidity increase the risk of surgery
(STS database, 2010)
– Surgery is not associated with improved QoL in
most elderly patients (Maisano et al EJCTS 2009)

37. Mitraclip for FMR
• Surgical treatment of FMR is associated with
– High hospital mortality
– High recurrence rate
– Long hospital stay
– Unproven survival benefit
• Mitraclip for FMR
– Procedure more simple than for DMR
– Improvement of symptoms at low risk
– Failure does not modify the surgical option

38. The MitraClip
• The MitraClip device consists of a percutaneously delivered MRI-compatible
cobalt-chromium implant with two arms and two grippers which are used to grasp
the opposing edges of the mitral leaflets .
• The two arms have a span of approximately 2 cm when opened in the grasping
position.
• On the inner portion of the clip are U- shaped “grippers,”
• It is designed to hold up to 8 mm of leaflet height ( vertically ) and 4 mm of width.
• Leaflet tissue is secured between the arms and each side of the gripper, and the
clip is then closed and locked to effect and maintain coaptation of the two leaflets

40. MitraClip System

41. Clip Delivery System (CDS):
Consists of 3 main parts:
 Delivery Catheter
 Steerable Sleeve
 MitraClip Device
* The Delivery Catheter and Steerable Sleeve plant the device

42. Steerable Guide Catheter (SGC):
 Contains a handle made up of knobs and levers, which control the system,
and is attached to a dilator.
 Positions the CDS into the appropriate location.

43. Guide (+) Knob
(+) curves guide (-) straightens guide

44. MitraClip anatomical patient selection considerations
• Moderate to severe MR
(Grade 3 or more out of 4 grades)
• Pathology in A2-P2 area
• Coaptation length > 2 mm
(depending on leaflet mobility)
• Coaptation depth < 11 mm
• Flail gap < 10 mm
• Flail width < 15 mm
• Mitral valve orifice area > 4cm2
(depending on leaflet mobility)
• Mobile leaflet length > 1 cm
Recommended criteria1
1. The current patient considerations are based on EVEREST II and
commercial European experience to date. The MitraClip Patient
Selection Coniderations document has been endorsed by Expert
Opinion (Crossroads institute).

45. MitraClip anatomical patient selection considerations

46. Mitra clip procedure
• The procedure is generally performed under general anaesthesia with fluoroscopic
and TEE guidance and haemodynamic monitoring with a Swan-Ganz catheter in
the pulmonary artery.
• The device is delivered via transfemoral venous route.
• After transseptal puncture, the transseptal sheath is exchanged by a steerable 24-F
guide catheter (which tapers to 22-F at the interatrial septum) through which the
clip delivery system is advanced into the left atrium.
• Thereafter, the MitraClip device is manoeuvered under TEE guidance, aligned with
the origin of the regurgitant jet, and pushed below the level of the mitral leaflets
into the LV

48. Transseptal puncture

49. Introduction of the Steerable GuideCatheter (SGC) into the LA

50. Advancement of the Clip Delivery System(CDS) into the LA

51. Steering and positioning of the MitraClip above the mitral valve

52. Advancing the MitraClip into the left ventricle

53. Grasping of the leaflets and assessment of proper leaflet insertion

54. Assessment of result and MitraClip release

57. • The initial evaluation of the MitraClip result is usually done at the time of the procedure under
general anaesthesia.
• Due to the newly created double MV orifice, quantitative Doppler evaluation is problematic.
• The area of colour jets is larger with multiple jets, which commonly occur after a MitraClip is
implanted.
• Relevant MR reduction leads to an elimination of pulmonary vein flow reversal and reduced or
even normalized LA pressures.
• The PISA method is not validated for multiple MR jets which appear frequently after MitraClip
implantation.
• The summation of two-dimensionally measured venae contracta is not reliable in the
presence of multiple jets.

58. Defining Success of Transcatheter MV Repair
• Successful deployment of one or more clips that is/are attached to both
leaflets.
• ≤2+ MR (it should be at least <2+ MR (less is better).
• Mean transmitral gradient <5 (relationship between post procedure
stenosis and outcome is not fully known)

59. Post Clip Hemodynamics
LA Pressure Pre-Clip
V waves to 60 mmHg
LA Pressure Post-Clip
V waves abolished

60. Comparison of mitral valve area using different methods
% change in MVA nearly identical with each method

61. SAFETY
• Serious life-threatening or fatal complications related to the MitraClip procedure are
exceedingly rare.
• Rates of major clinical complications such as stroke, MI,AKI and septicemia are below 5%.
• Urgent surgery for persistent or aggravated MR varies across different reports (0–8%).
• Among minor complications, the most common was access site bleeding or groin
hematoma.
• Clip-related complications are rare5%) but potentially deleterious.
• Complications from transseptal puncture may include pericardial tamponade
• Clip-related chordal rupture may result from inadvertent tangling of the device in the
subvalvular apparatus and may result in acute MR.

62. Procedural Adverse Events
• Single leaflet device attachment……... 1.3%
• Device embolization…………………….. 0.2%
• Other………………………………………. 0.6%
• Major bleeding....………………………... 3.7%
• Cardiac perforation……..………………. 0.9%
• Stroke……………….…………………….. 0.6%
• Cardiac surgery………………...……….. 0.06%
• ASD Closure………………………………1.6%

63. CONTRAINDICATIONS
The MitraClip Clip Delivery System is contraindicated in DMR patients
with the following conditions:
– Patients who cannot tolerate procedural anticoagulation or post
procedural anti-platelet regimen.
– Active endocarditis of the mitral valve
– Rheumatic mitral valve disease
– Evidence of intracardiac, IVC or femoral venous thrombus
In FMR patients
- with EF < 25%
- with ESD > 55 mm

64. Data
• EVEREST I: Feasibility study (n=55)
• EVEREST II: Randomized trial (n=279)
• REALISM: Registry
• ACCESS Europe: Registry
• TRAMI: Registry
• GRASP: Registry
• COAPT: Ongoing randomized study to study safety and efficacy
• RESHAPE-HF: Randomized study, clip vs. medical therapy

65. EVEREST I -Endovascular Valve Edge to edge REpair pair STudy
JACC 46:2134-2140,2005

68. EVEREST-II Trial

70. COMPARATIVE EFFECTIVENESS THROUGH 5 YEARS.
 Freedom from death, surgery for MV dysfunction, and +++ and ++++ MR occurred
at 5 years in 44.2% of patients receiving percutaneous repair and in 64.3% of
those receiving surgery (p 0.01).
 At 5 years, freedom from death and surgery for MV dysfunction was 60.6% with
the device versus 73.3% in the surgery group (p 0.03)
 No significant difference IN MORTALITY between surgery and percutaneous repair
at 5 years (20.8% vs. 26.8%; p 0.36) .

71. COMPARATIVE EFFECTIVENESS THROUGH 5 YEARS.
• Surgery or reoperation (27.9% vs. 8.9%; p 0.003) and +++ or ++++ MR (12.3% vs.
1.8%; p 0.02) was more frequent with percutaneous repair.
• Beyond 6 months through 5 years, there was no difference in the rate of freedom
from surgery for MV dysfunction (77.7% with percutaneous repair vs 76.2% with
surgery; p 0.77).
• Survivors in both groups demonstrated significant reduction in MR from baseline to
12 months (p < 0.001 ) and from baseline to 5 years (p < 0.001), demonstrating the
durability of MV repair with both the surgical and the percutaneous approaches.

72. Primary Effectiveness MR Reduction

73. NYHA Functional Class LV Volumes

75. For patients who survived to 5 years and had pertinent data reported at each time point, comparisons are seen for (A)
echocardiographic severity of MR in 101 and 40 patients in the device and surgery arms, respectively, and (B) NYHA
functional class in 105 and 40 patients in the device and surgery arms, respectively.

76. Hospitalizations for Heart Failure

77. COMPARATIVE EFFECTIVENESS THROUGH 5 YEARS.
• Surgery proved to be more effective at 12 months because fewer patients
had +++ or ++++ MR after surgery than after percutaneous repair (0% vs.
17.9%; p 0.004). This difference remained at 5-year follow-up (2.5% vs.
18.8%; p = 0.01).
• Despite increased MR reduction with surgery, NYHA functional class III/IV
symptoms were more frequent at 12 months with surgery compared with
percutaneous repair (7.5% vs. 1.0%; p = 0.03)

78. Surgery is superior in
• Surgery Performed better than percutaneous repair in younger patients
(interaction p = 0.005)
• Similar to what was seen at 1 year, surgery was superior to percutaneous
repair in patients with degenerative MR at 5 years (interaction p = 0.02)

79. PREDICTORS OF 5-YEAR MORTALITY.
• Largely of established clinical risk factors and comorbid conditions
including older age; diabetes; hypertension;
• moderate-to-severe renal disease;
• COPD; established CAD, PAD , or CVA;
• low LVEF;
• atrial fibrillation
• Prior MI
• Prior cardiac surgery
• Functional MR etiology and higher NYHA functional class portended
worse 5-year survival.

80. CONCLUSIONS
• The final 5-year results of the EVEREST II trial supported the superiority of surgery in
reducing MR but clearly supported the long-term safety of the MitraClip and the durability
of MR reduction after percutaneous repair.
• Beyond 1 year, worsening MR and surgery for MV dysfunction occurred rarely after either
surgery or percutaneous repair.
• Similarly, improvements in heart failure symptoms and in LV dimensions remained stable
through 5-year follow-up, mitigating the concerns of residual MR after device placement
• Finally, despite reduction of MR with either percutaneous repair or surgery, functional MR
has increased risk of long-term mortality.
• Whether reduction of MR in such patients prolongs survival remains to be determined within
the ongoing COAPT trial

83. Worldwide Experience Using the MitraClip

84. Ongoing studies
• The MITRA-FR study: Design and rationale of a randomised study of
percutaneous mitral valve repair compared with optimal medical
management alone for severe secondary mitral regurgitation
• MATTERHORN Study: A Multicenter, Randomized, Controlled Study to
Assess Mitral vAlve reconsTrucTion for advancEd Insufficiency of
Functional or iscHemic ORigiN

85. Present status of MitraClip
• In the United States, MitraClip received FDA approval in October 2013 for
patients with primary (degenerative) MR who are deemed prohibitive risk
for surgery by a multidisciplinary heart team.
• Recent ACC/ AHA guidelines recommend (class IIb, level of evidence B)
consideration of transcatheter repair for severely symptomatic patients
with chronic severe primary MR, reasonable life expectancy, and
prohibitive surgical risk attributable to severe comorbidities.

90. Other percutaneous therapeutic options
• Coronary sinus angioplasty
• Direct Mitral Annuloplasty
• Hybrid Ring Annuloplasty
• Percutaneous Chordal Implantation
• Ventricular Remodelling Devices
• Percutaneous Mitral Valve Replacement

91. Coronary Sinus Annuloplasty
• Annuloplasty, integral part of MVR 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.

92. Coronary Sinus Devices: potential anatomical issues associated
with efficacy / safety
• Anatomical relations with the
mitral annulus
 only posterior
 Atrialization
• Relation with the Cx artery
– Potential risk of AMI
• PREDICTABILITY OF RESULT

93. MONARC (Edwards
Lifesciences LLC)
Two-anchor design with
chronic reshaping (6weeks)
by a foreshortening bridge
EVOLUTION trial
(69 pts enrolled)
CARILLON
(Cardiac
Dimensions Inc)
Acute reshaping device
acting in P2P3,
repositionable, retrievable
AMADEUS trial
(43 pts enrolled )
PTMA
(Viacor Inc)
Tri-lumen catheter,
reshapable, possibility of
multiple long term
adjustment
PTOLEMY
(24 pts enrolled)
Devices in clinical trials

94. The MONARC percutaneous transvenous annuloplasty device
(Edwards Lifesciences)
• 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 CS
ostium.
• 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 selfexpanding nitinol alloy
anchors to expand, providing fixation

95. The MONARC percutaneous transvenous annuloplasty device
(Edwards Lifesciences)
• Tensioning the device before
deployment of the proximal anchor
allows for acute shortening of the CS
• 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

97. CARILLON Mitral Contour System (Cardiac Dimensions, Inc,
Kirkland, Wash)
 CARILLON Mitral Contour System uses 2 self-
expanding nitinol anchors connected by a wire
 The distal coronary sinus anchor is deployed,
manual tension is applied to the connecting wire,
and then the proximal anchor is deployed
 As shortening of the coronary sinus is immediate,
the effect on MR and the potential for coronary
compression can be readily assessed by
echocardiography and angiography.
 Optimal reduction in annular dimension (≈25%),
reduced MR on real-time echocardiography.
 If necessary, the amount of tension can be
adjusted or the device can be retrieved before final
release

99. 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
The Viacor (Viacor, Inc., Wilmington, Massachusetts) PTMA
rods (top left), access to the coronary sinus (bottom left),
introduction of the rods (top right), and after full
implantation of the rods (bottom right) in the coronary sinus.

100. 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 MR. The
device was successfully implanted in
only 9 patients. In these patients, there
was a reduction in the degree of MR
and a reduction in the mitral annulus
septal–lateral dimension (Sack et al.,
2009).
 PTOLEMY II trial since 2014

101. Direct Annuloplasty Approaches

102. Direct Annuloplasty
• Direct modification of the mitral annulus is the most obvious means of
reproducing the effects of surgical annuloplasty.
• Annuloplasty rings that can be introduced through a catheter are one possible
approach
• However, reliable methods of positioning and fixation have proved problematic.
• Direct modification of the mitral annulus using a radiofrequency catheter to heat
and shrink annular collagen has been proposed (QuantumCor Inc, Lake Forest,
Calif)

103. 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 CS
• 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.

104. GDS Accucinch Annuloplasty System
 Same as the previous
 First in human study was initiated in the Europe
 Implantation was successful in several patients.

105. Other Annuloplasty Rings

106. 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.

108. Edwards Cardioband Mitral Repair System

109. Data on annular approaches
• Feasibility data in humans have been demonstrated for several of the annular approaches.
• In a study of 30 patients with secondary MR, Cardioband was successfully implanted with no
procedural deaths; implantation reduced the annular septolateral dimension from 3.7±0.5
cm to 2.5±0.4 cm (P<0.001), and the residual MR was 2+ or better in 86.3% of patients at 6
months of follow-up
• In the TITAN study (Transcatheter Implantation of Carillon Mitral Annuloplasty Device), the
Carillon device was associated with reduction in mitral ERO area (0.23±0.07 cm2 to 0.12±0.08
cm2; P<0.0001) and regurgitant volume in follow-up at 12 months (34±10 mL to 17±12 mL;
P<0.0001).
• In a separate study of 71 patients undergoing treatment with Mitralign, device success was
70.4% and was associated with MR reduction occurring in 50% of patients, beneficial LV
remodeling (reduction of EDD [0.20±0.4 mm]), and symptom improvement.

110. 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)

111. Percutaneous Septal Shortening System (PS3, Ample Medical Inc,
Foster City, Calif)
• Percutaneous Septal Shortening System (PS3)
uses transvenous access to the RA to allow
placement of an anchor in the coronary sinus
adjacent to the mitral P2 scallop
• However, an atrial TSP allows implantation of the
second anchor in the IAS
• A magnetic catheter system facilitates placement
of a wire connecting these 2 anchors.
• Tensioning this wire reduces the diameter of the
mitral annulus.
• bovine studies and temporary human implants
have demonstrated a reduction in AP annulus
diameter and MR severity

112. Predictors of MitraClipFailure

113. Trial Evidence

114. Ven-Touch System
• The Ven-Touch system consists of a bladder that
is inserted via a left thoracotomy off-pump and
positioned over the posterior-septal lateral
aspects of the LV.
• The bladder is inflated to reduce the dimensions
of the left ventricle and mitral annulus, thereby
improving leaflet coaptation.
• An exterior port connected to the bladder is
available for future adjustments.
• The VenTouch system was first implanted in
humans in 2014 and remains under
investigation.

115. Chordal Repair
MitraFlex™
• MitraFlex™ is a mitral valve repair system
designed for direct thorascopic approach
through the apex of a beating heart.
The MitraFlex™ system performs the following
functions on a beating heart:
• Stabilization and centering of the mitral valve
leaflets
• Automatic capturing and connection of the
approximate midpoint of the leaflets.
• Implantation of an artificial cordae tendonae that
controls the movement of the valve leaflets and
reduces the annulus thereby reducing or
eliminating mitral valve regurgitation The MitraFlex device sheath (TransCardiac Therapeutics, Atlanta, Georgia) (top
left), clip for leaflet plication (top middle), and artificial chord implantation (top
right); the NeoChord device (Neochord, Inc., Minnetonka, Minnesota) implanted
from a transapical approach (middle); the Babic device (bottom).

116. Percutaneous Mitral Valve Replacement (PMVR)
• Transcatheter implantation of a valved stent within a degenerated surgical mitral
bioprosthesis has been accomplished, at least to some degree demonstrating the
feasibility of this approach
• However, implantation of a valved stent within a native mitral valve is problematic due
to the saddle shape of the native annulus, chordal structures, limited fluoroscopic
landmarks, and the need to avoid obstruction to the left ventricular outflow tract.
• Nevertheless, a number of groups have pursued this goal, generally combining a self-
expanding valved stent with percutaneous transseptal, direct left atrial, or transapical
access to the mitral valve.
• Clinical trials are ongoing.

118. CT pre-procedural data showing several different measurements used to screen patients for
TMVR on the basis of anatomic criteria. (A) Mitral annulus measurements showing septal-
to-lateral distance (dotted line) and intercommisural distance (solid line). (B) Distance
between papillary muscles heads. (C) Projected distance from papillary muscle head to the
mitral annulus plane (solid line), projected distance betweenpapillary muscle head and the
center of the mitral annulus (dashed line), and distance between papillary muscle head and
LV wall(dotted line). (D) Posterior leaflet length at the P2 level. (E) Aortomitral angulation.
(F) LA height (solid line) and short-axisdiameter (dotted line).

119. TMVR Technologies – Clinical evolution

120. 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)

121. Tendyne Valve
• The Tendyne valve is a self-expanding, nitinol
prosthesis with a double-frame design that
contains a trileaflet porcine pericardial valve
and has an effective orifice area of >3.2 cm2.
• The cuff of the outer frame extends above the
plane of the annulus to abut the anterioratrial
wall and aortic-mitral continuity.
• delivered via a 34 Fr transapical sheath, is
uniquely anchored with a tether connected to
an epicardial pad and is retrievable and
repositionable after full deployment .
• In the Tendyne global feasibilitystudy (n=30),
successful implantation occurred in 93.3% of
patients without deaths, strokes, or MI

122. Intrepid-Medtronic
• The Medtronic Intrepid valve is a self-expanding,
nitinol prosthesis with bovine pericardial leaflets,
with several unique design characteristics.
• The nitinol frame has a symmetrical outer fixation
ring and an inner circular stent that houses a 27-
mm valve with an effective orifice area of 2.4
cm2.
• The outer fixation ring contains variable degrees
of stiffness, which facilitates anchoring through a
champagne cork-like effect
• The circular inner stent houses a 27-mm valve
across the 3 outer stent sizes . There is no need
for rotational alignment or to search for leaflets.
• Trans apical access only.

123. NEOVASC- TIARA
• The Tiara valve is a self-expanding trileaflet
valve made of bovine pericardium and a nitinol
frame.
• The valve is designed to fit the D-shaped mitral
annulus.
• The atrial portion helps to seat the prosthesis
into the atrial portion of the mitral annulus and
has a full atrial skirt.
• The ventricular anchors (2 anterior and 1
posterior) fix the valve onto the fibrous trigon
and the posterior part of the annulus.
• Trans apical approach

124. TMVR – Valves under preclinical evolution

125. Percutaneous repair of the paravalvular leak

126. Percutaneous repair of the paravalvular leak
• 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.
Mild 1-2 mm
3-6 mm moderate
>6 mm severe PVL
• 3D TEE useful in management.
• Contraindications - Rocking valve, PVML >30% of valve
circumference,active endocarditis, intracardiac thrombus -

127. Conclusions
• MitraClip therapy is FDA approved for symptomatic patients with severe MR of
primary (or mixed) etiology who are poor surgical candidates (ACC/AHA IIb).
• For patients with symptomatic secondary MR MitraClip is available through the
COAPT randomized trial.
• Newer devices have potential but are a long way off.
• TMVR may be the future but given the safety profile of MitraClip there may be a
roll for both technologies

128. THANK YOU