BMV Balloon, PTMC Balloon, Accura Inoue, Gold- silver

1. BMV BALLOONS
Dr. RohitWalse

2. SCOPE OF DISCUSSION
• History
• Techniques
• Balloon anatomy
• Inoue and Accura balloon
• Balloon sizing
• JOMIVA balloon
• Multitrack system
• NUCLEUS balloon
• Data comparing results of various balloons

3. HISTORY
• Concept of mitral commissurotomy - Brunton in 1902.
• 1920 – 1st successful CMC done
• Development of CPB in 1960s, open surgical mitral commissurotomy
• Kanji Inoue –1976.
Lock et al, 1985 -
cylindrical polyethylene
balloon

4. HISTORY
1997- Cribier - metallic valvulotome
1986 - Al-Zaibag-DBT
Simplified DBT- Multi-Track
system Philip Bonhoeffer

5. TECHNIQUES OF BMV
Balloon
commissurotomy
1. Dumb-bell shaped (non-over the wire
balloons)
a. Inoue balloon
b. Accura balloon
2. Cylindrical balloons (over the wire)
a. Double balloon (two wire, two
balloons)
b. Multitrack system (single wire, two
balloons)
c. Nucleus/JOMIVA balloon (single
balloon over the wire)
Metallic (blade)
commissurotomy

6. INOUE BALLOON
• Vent – vent out the air in the balloon during preparation of the balloon
prior to the procedure.
• Two small holes on the outer latex layer intended to prevent deflation
failure of the balloon.
• Security thread - prevents the detachment of the balloon during the
procedure.
• Central lumen of the balloon is formed proximally by the “gold metal
tube” which extends 2 cm into the balloon shaft even at the non-
streched (fully pulled back) position
• Gold metal tube merges with a stiff polythene tube which extends
through the entire length of the shaft and the balloon till its tip.

7. PROXIMAL PART

8. SHAFT OF BALLOON

11. INOUE BALLOON PMV SYSTEM
• Polyvinyl chloride catheter with a balloon
• Balloon- 2 latex layers with a polyester micromesh in between
• Catheter is 12 F with a length of 70 cm; the length of balloon is 2.5
cm (un-stretched).
• Two proximally positioned stopcocks accomplish balloon inflation
and catheter venting
• Stainless steel stylet and guidewire are employed to track the
catheter inside the heart and blood vessels.

13. ACCURA BALLOON
• Manufactured from polyvinyl chloride with a balloon attached to the
distal end
• Balloon has also 3 layers, 2 Latex layers and 1 micromesh layer.The
micromesh layer is sandwiched between the two latex layers.The
length of balloon is 2.5 cm (un-stretched).
• 12 French 80 cm tapered medical grade polymer tube called dilator is
a provided to enlarge the interatrial septal puncture.

17. PRESSUREVOLUME
RELATIONSHIP
• Single balloon mitral valvotomy catheters are compliant balloons
and are volume driven
• Balloon is precalibrated so that inflation with volumes labelled on the
inflation syringe result in corresponding inflated diameters of the
balloon.
• Low-pressure zone - the first two-thirds of its range of inflation and
balloon pressure at this point is approximately 2 to 3 atm
• Balloon is inflated to its last couple of millimeters of diameter with
increasing inflation volumes, the balloon pressure rises towards 4
atm.

18. • At similar inflated diameters, smaller balloons will be able to
generate more lateral pressure.
• Higher lateral pressure may be helpful in dilating thick fibrotic valves,
but may lead to valve tear and mitral regurgitation.
• Accura balloon can deliver more stable and higher pressures when
the balloon is inflated within the stated diameter range.
• Proportion of low pressure zone available for balloon dilatation is
more with the Inoue balloon.
PRESSUREVOLUME
RELATIONSHIP

19. PressureVolume loop
ACCURA INOUE

20. BALLOON SIZING
Based on height :
 Hung’s formula;
Patient height (in cm) /10 +10 = Reference size (in mm)
Based on pathological condition of valve
Non-calcified valve - nominal balloon size at least that of the RS (an
RS-matched catheter) is used
Pre-existing MR, subvalvular disease, and calcified valve, a balloon
catheter one size smaller than RS is selected.
Based on age and physical activity :
Sedentary life style or aged patients, the valve need not be dilated to
a size required by active younger patients.

21. ADVANTAGES OF SINGLE
BALLOON
• Short cycle of positioning-inflation-deflation (5 seconds). Procedure time is
only 25-50% of double balloon
• LV perforation is also rare as the balloon is engaged into the mitral valve and
has a smaller size.
• Does not necessitate a guide wire into the LV.
• Minimal hemodynamic disturbance due to rapidity of the procedure.
Maximum occlusion time of 2 to 4 seconds only.
• Its strong rubber-nylon micromesh texture resists rupture which is rarely
reported. It can stand a pressure of 6 Kg/cm²(only 2 kg/cm² is needed for
commissural splitting, i.e. wide margin of safety).
• Less potential for severe MR due to stepwise nature of dilatation and proper
positioning across the valve.

22. DOUBLE BALLOON
• Larger polyethylene balloons (up to 30 mm in diameter) -> largeASD.
• Mullin’s sheath left atrium through which an end-hole balloon
tipped catheter can be floated across the mitral valve, avoiding the
chordae tendineae. It is then turned in the left ventricular apex using
a curved tipped guide wire and advanced out the aortic valve
• Long guidewire (260 cm) is then introduced through this catheter
from the femoral vein across the atrial septum and the mitral and
aortic valves, terminating in the descending aorta.

23. • 2 guidewires through the same Mullin’s sheath
• Two polyethylene balloons are then introduced, one over each
guidewire, and simultaneously inflated to dilate the stenotic valve
DOUBLE BALLOON

25. DOUBLE BALLOON
• BALLOON SIZING:
• Reid et al - combined diameter of the two balloons were
approximately equal to the mitral valve annulus
measured by 2D echo. It decreases the potential of
rupture of mitral annulus by over-dilatation.
• Chen et al. - ratio of (sum of balloon diameters)/(mitral
annulus diameter) of 1 to 1.1.

26. PROS AND CONS OF DOUBLE
BALLOON
• PROS
• Stenotic mitral valve orifice is oval and not circular, double balloon self-
orient and exert maximal force laterally towards the fused commissures
• DBT provides a higher final MVA and higher absolute increase of the
MVA than the IBT.
• CONS
• DBT is a more technically challenging
• Difficulty in obtaining stable position across mitral valve
• Incidence of persistent ASD, severe MR, large ventricular apex
perforation are higher

27. JOMIVA BALLOON
• Joseph et al - simple over-the-wire mitral valvuloplasty balloon catheter
(JOMIVA)
• It is cylindrical, expands to a fixed size, has two radiopaque markers - thin
thermoplastic polymer that gives these larger diameter balloons a low crossing
profile.
• Catheter shaft (9 Fr for smaller balloons, 11 Fr for larger balloons)
• J-tip of a 0.035 inch valvuloplasty guidewire is then positioned at the LV apex
• Septum is then dilated with 14 French septal dilator
• Jomiva balloon is then introduced through a 50 cm long, 12 to 14 Fr valved LA
sheath
• Commissurotomy is performed after withdrawing the sheath into the IVC to
allow a more transverse and stable lie of the balloon and the guidewire across the
mitral valve
• Other approaches – right IJV and right radial artery
• Results are comparable with Inoue balloon technique

31. MULTI-TRACK SYSTEM
• 5 components; two balloon catheters, a Multi-Track angiographic
catheter, a guidewire and a septal dilator.
• Guidewire - two separate wires welded at the distal end to form a single
wire and allows loading two balloon catheters on the same wire.
• Multi-Track balloon has a 10 cm nylon plastic shaft and a Multi-Track tip
of only 1 cm at the tip [(14, 16, 18 or 20 mm in diameter) × 5 cm in
length].
• Sum of the diameters of the two balloons is chosen to be 90 to 100 % of
the measured mitral annulus
• It is a refinement of DBT, as it uses a monorail system, but requiring only
one guidewire thus easing the procedure compared to the standard DBT.

33. Bonhoeffer et al reported the results of 153 patients from 16 centers
across all continents
Only 4 pts had a significant increase in MR, two needed surgery.
Remaining two pts, there was a progressive clinical improvement.
Hemopericardium occurred in 4 occasions, twice due to trans-septal
puncture and twice due to wire perforation of the left ventricular apex.
Advantage of the system is the ability to simultaneously measure the
pressure in LA and LV.

35. NUCLEUS BALLOON
• Used when difficulty in positioning the balloon across the valve.
• NUCLEUS and the new NUCLEUS-X™ balloon valvuloplasty catheter
• Coaxial shaft design- enhanced column strength and pushability
• Flexible distal tip- optimum steerability
• Initial inflation will hold balloon in the desired position, further inflation
expands the center of the balloon to effect satisfactory dilatation.
• Platinum marker bands facilitate reliable positioning of the balloon and
for clear identification under fluoroscopy.
• Simpler than DBT and much cheaper than Inoue balloon technique and
claimed to be useful in moderately calcified valves

36. • In a comparative study of 15 patients each using the Double balloon
technique and Nucleus balloon technique, the Nucleus balloon group
performed better.

37. COMPLICATIONS
• BALLOON RUPTURE :
• Abnormal or unusual balloon inflation is usually caused by a mesh
breakage.
• The mesh regulates maximum diameter and inner pressure of the balloon.
• Due to presence of this mesh, the Inoue balloon is reported to have less
incidence of tear and rupture compared to usual polythene balloons.
• Mesh breakage can be caused by overinflation of the balloon or rapid
increase of inner pressure.
• While preparing balloon prior to PMV
• 1) Do not exceed the maximum recommended inflation volume marked on
the syringe provided with the balloon catheter.
• 2) Inject dilute contrast slowly to inflate the balloon during test inflations
to avoid rapid stretching of the mesh layer.

38. • Occurs when balloon catheters are re-used.
• A deformity in the Inoue balloon catheter was noted 1.6 % (4/264 pts)
procedures and actual rupture of the deformed balloon occured in 0.4 % in a
series reported by Ho et al.
• All deformities were found at the distal portion of the Inoue balloon in this
series.
• Two problems can occur subsequent to rupture of the balloon –
• 1) Latex material or the wire mesh can get detached and embolize in the
arterial system.
• 2)If the contrast mix contains air , which occurs during preparing, it can
embolize and produce air embolism.
COMPLICATIONS

39. CATHETER CARDIOVASCULAR INTERVENTIONS

41. CCI
GB Pant hospital

43. • N-100 (Inoue-49; M commi-51)
• Both procedures gave similar procedural success and had similar complication
rates.
• PMMC produced larger MVA immediate post-procedure compared to IBT. But
at three months, the difference disappeared.
2002, AHJ

44. • Age <20 yrs
• N- 66 (33-Inoue, 33-M Commi)
• Similar procedural success & complications
• Similar restenosis rates on follow up
• Metallic commissurotomy- cost effective

45. • Total- 816 (Inoue-329;Accura-487) [1997-2003]
• Immediate procedural success- 93.9% Inoue;Accura-
91.6% (p-NS)
• Complicatios- 6.6% Inoue; 5.6% Accura (p-NS)
• Restenosis rates- Inoue-0.9%; 1.6% Accura (p-NS)@1 yr
• Accura –Cost efective
2012

46. • THANKYOU