PERCUTANEOUS MITRAL VALVE REPAIR

1. PERCUTANEOUS MITRAL VALVE
INTERVENTIONS (REPAIR)
AJAY PRATAP SINGH
DEPARTMENT OF CARDIOLOGY
DR. RAM MANOHAR LOHIA HOSPITAL, NEW DELHI

2. • Interest in the mitral valve has increased over the past few years
with the development of new technologies that allow intervention in
patients previously deemed too ill for treatment
• In addition, MVRe can be achieved through minimally invasive
approaches. This desire for less invasive approaches coupled with
the fact that a significant proportion of patients—especially elderly
persons or those with significant comorbidities or severe left
ventricular (LV) dysfunction, are not referred for surgery, has driven
the field of percutaneous MVRe.

4.  Severe MR has a annual mortality rate of at least 5%
 As many as 49% of with MR are at high-risk for surgery ( not
amenable to surgery) and managed conservatively with
medical management.
(J Am Coll Cardiol 2008;52:319-26)

5. CLASSIFICATION OF MR

7. • A classification of percutaneous MVRe technologies on the basis of
functional anatomy is proposed that groups the devices into those
targeting
– The leaflets
• percutaneous leaflet coaptation,
• percutaneous leaflet plication,
• percutaneous leaflet ablation,
– The annulus
• indirect: coronary sinus approach or an asymmetrical
approach;
• direct: true percutaneous or a hybrid approach,
– The chordae
• percutaneous chordal implantation,
– The LV
• percutaneous LV remodeling.

11. Percutaneous Leaflet Plication
(Edge-to-Edge Leaflet Repair)
• Based on the surgical Alfieri technique
Brings anterior and posterior leaflet together with a
suture
“Double orifice” MV.
• Most suitable for degenerative MR,

12. Alfieri technique

15. MAJOR TRIALS ON MITRA CLIP

20. Percutaneous repair was less effective at reducing mitral
regurgitation than surgery before hospital discharge, at 12 and
24 months the rates of reduction in mitral regurgitation were
similar, and percutaneous treatment was associated with
increased safety, improved left ventricular dimensions, and
clinical improvements in NYHA class and quality of life.

21. 4-Year Results EVEREST II
J Am Coll Cardiol. 2013;62(4):317 28. doi:10.1016/j.jacc.2013.04.030

23. 452 Patients
307 Randomized
152 Patients 152 Patients
145 not eligible
3 consent Issues
109 Patients 137 Patients
Intention To Treat
Per-protocol Analysis
15 Exclusions43 Exclusions
Mitraclip Control
Follow-up > 99%

25. Conclusion :
Among patients with severe secondary mitral regurgitation, the rate of
death or unplanned hospitalization for heart failure at 1 year did not
differ significantly between patients who underwent percutaneous
mitral-valve repair in addition to receiving medical therapy and those
who received medical therapy alone.

27. The benefits were consistent across numerous subgroups, including :
• Ischemic and nonischemic cardiomyopathy
• Those who were and were not at high risk for surgery-related complications or death
• Benefits were independent of the mitral regurgitation grade and left ventricular volume and
function at baseline.

29. CONCLUSION :
• Among patients with HF and moderate-to-severe or severe
secondary MR who remained symptomatic despite the use of
maximal doses of GDMT,
• Transcatheter mitral-valve repair resulted in a lower rate of
hospitalization for heart failure and lower all-cause mortality
within 24 months of follow-up than medical therapy alone.
• rate of freedom from device-related complications exceeded a
prespecified safety threshold.

30. • The stricter criteria for enrollment in COAPT resulted in a slower rate of
enrollment in the trial, which required 8 years to complete.
• Enrollment in MITRA-FR did not have any medication requirements, but it
was a pragmatic trial studying the types of patients who are currently
referred for MitraClip.
• Patients in COAPT had more severe mitral regurgitation with a mean
effective orifice area of 41 mm2 compared with 31 mm2 in MITRA-FR,
but these patients also had smaller left ventricular end-diastolic volumes
(101 mL/m2 in COAPT versus 135 mL/m2 in MITRA-FR), suggesting that
their disease may not have been as severe.

31. Leaflet (coaptation)Space Occupier: Percu-Pro
device
• Positioned across the MV orifice to provide a surface against which
the leaflets can coapt as in degenerative or functional MR
• Limitations-thrombus on the device
-residual MR
-iatrogenic MS

32. Leaflet Ablation
• Principle- Radiofrequency energy (fibrosis)
• Target degenerative MR
• Device. The Thermocool irrigation ablation electrode
• Access- femoral artery (retrograde )
• Limitation-Leaflet perforation,
-Damage to adjacent cardiac structures

33. Annuloplasty—Indirect
• Mimics surgical annuloplasty rings
• Alternative for
• - Excessive surgical-risk
• -No concomitant cardiac sx
-Refused mitra clip(30%)

35. CS Approach (CS Reshaping)
• Aim “pushing” the posterior annulus anteriorly
• Reducing the septal-lateral (anterior-posterior)
dimension of the MA.

36. The Monarc device
• Distal anchor- at
transition of anterior
interventricular vein
and GCV
• Proximal anchor-
ostial CS
• Spring like bridge

37. Monarc device
• Phase 1 trial (Evolution trial)
• Functional MR
• Success - 82% (59 of 72 patients)
• Failures (18%) - tortuous anatomy or inappropriate CS dimensions
• 3 MI- coronary artery compression
• Event-free survival was 81%, 72%, and 64% at 1 year and 2 and 3
years, respectively.
(JACC Cardiovasc Interv 2011;4:115–22 )
Further evaluation -suspended

38. Carillon device

39. The Viacor PTMA device
• Plastic CS catheter
• Up to three nitinol rods
• Provide incremental cinching/ pushing of the posterior
annulus.
• PTMA investigations suspended due (circumflex artery
occlusion and fatal CS perforation).
(EuroIntervention 2011;7:148–50 )

41. Limitations of CS Approach …
• significant variable relation of the CS to MA
• CS devices likely shrink the MA only indirectly by traction on
the LA wall.
• diagonal or ramus crossed between the CS and MA in 16% ,
whereas 64% -80% for the LCX (Circulation
2007;115:1426 –32.).

43. Annuloplasty—Direct:
Percutaneous Energy-Mediated
Cinching Approach
• Principle. Heat energy is applied to the MA
• Transatrial (transseptal) route- QuantumCor
• High intensity focused ultrasound circumferentially-recor
device
• Limitation- damage to surrounding structures (leaflets, myo-
cardium, coronary sinus, circumflex artery, aortic valve) and
thrombus formation

44. QuantumCor system (QuantumCor; Lake Forest, California,
United States) consists of a circular probe with thermal
electrodes, which induce scarring and annular shortening
following radiofrequency ablation of different points of the
mitral annulus

45. Annuloplasty—Direct:
Hybrid Approach
• Principle. An annuloplasty ring is implanted surgically
• subsequently adjusted via transseptal access if MR recurs or
worsens
• Pre clinical developement

47. Chordal Implantation
• Principle. Synthetic chords or sutures
- transapical or transseptal
- anchored myocardium with leaflet
• Mainly for degenerative MR.
• Devices.
• Transapically - MitraFlex and NeoChord
transapical-transseptal - Babic device
• Limitations.
residual leaflet prolapse(chords to long)
leaflet restriction (chords too short)
residual MR ,
thrombus formation

49. The TRACER (Mitral TransApical NeoChordal Echo-Guided Repair-CE Mark Study for the
Harpoon Medical Device

50. LV Remodeling
• Principle. To reduce the anterior–posterior dimension of the LV.
• mainly for functional MR
• The percutaneous iCoapsys technology-
- pads on either side of the LV
-cord passing through the LV cavity (to apply tension to the MA
and basal LV wall)
• The Mardil-BACE device requires a mini-thoracotomy , implanted
on a beating heart. silicone band is placed around the
atrioventricular groove with built-in inflatable chambers placed on
the MA

51. The percutaneous iCoapsys technique is based on the Coapsys surgical system
(Edwards Lifesciences; Irvine, California, United States) and involves implanting 2
epicardial pads on both sides of the LV, joined by a flexible polyethylene cord that
crosses the ventricular chamber and applies tension to the mitral annulus and LV basal
wall.
Indirectly, the septal-lateral distance is reduced and the papillary muscles are drawn
closer to the leaflets. This is adequate for functional ischemic MR or MR secondary to
cardiomyopathy. Surgical data have shown acute MR reduction and positive LV
remodeling.
Although transpericardial access via the subxiphoid approach was feasible in
animals,in humans development has been halted.

52. A silicon band is inflated around the atrioventricular notch; inflation can be
adjusted after the procedure by means of a subcutaneous connection
The device was implanted in 11 patients undergoing coronary bypass and a mean
2.5-grade MR reduction was achieved. Although clinical evidence of LV
remodeling techniques for MR treatment have shown promising results, more
data are needed to draw conclusions about its safety and efficacy

53. PERCUTANEOUS TREATMENT OF
MITRAL VALVE REPLACEMENT

54. • MV apparatus hamper the development of a percutaneous MV
prosthesis:
– The asymmetry of the mitral annulus and absence of a single
valvular plane.
– The constant movement of the mitral annulus and the basal
part of the LV hampers stable anchoring of the prosthesis.
– The fact that the MV is large and is close to the aortic valve
and LV outflow tract.
– Paravalvular leaks in the mitral position are less well-tolerated
than elsewhere due to the high gradients through the valves

55. • Lutter prosthesis- implanted transapically in numerous porcine
models.
• Tiara - transapical self-expandable
• Endovalve-Herrmann- from LA via right mini-thoracotomy on
beating heart.
• CardioValve- delivered off-pump through the LA

61. SUMMARY
• Currently, there are many developments in the field of mitral
valve disease that offer promise in improving our understanding
and management of these patients.
• Application of novel imaging methods is providing us greater
insights into mitral valve remodeling with disease and how these
could contribute to possible mechanisms for failure with valve
interventions.
• As the experience will grow, there will be improvement in both
the design of the devices and the competence of the operators.
The success of the procedure will also improve.