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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3590_Библиотеки_им_академика_М_И_Перельмана
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150 3—MITRAL VALVE INTERVENTIONS
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TABLE 14.1 n Component of the Wilkins Score for Risk Stratification of Patients Considered for
Mitral Balloon Valvuloplasty
Grade Leaflet Mobility
1 Highly mobile with only leaflet tips restricted
2 Leaflet midportions and base portions have normal mobility
3 Valve continues to move forward in diastole, mainly from the base
4 No or minimal forward movement of the leaflets in diastole
1 Leaflets near normal in thickness (4-5 mm)
2 Middle of the leaflets normal, considerable thickening of margins (5-8 mm)
3 Thickening extending through the entire leaflets (5-8 mm)
4 Considerable thickening of all leaflet tissue (.8-10 mm)
1 A single area of increased brightness on echocardiogram
2 Scattered areas of brightness confined to leaflet margins
3 Brightness extending into the midportions of the leaflets
4 Extensive brightness throughout much of the leaflet tissue
1 Minimal thickening just below the mitral leaflets
2 Thickening of chordal structures extending to one of the chordal lengths
3 Thickening extended to distal third of the chords
4 Extensive thickening and shortening of all chordal structures extending to the papillary muscles
Leaflet Thickening
Leaflet Calcifications
Subvalvular Thickening
TABLE 14.2 n Lung and Cormier Score for Risk Stratification of Patients Considered for Mitral
Balloon Valvuloplasty
Echocardiographic Group Mitral Valve Anatomy Suitability for PBMV
Group 1 Pliable, noncalcified anterior mitral leaflet and
mild subvalvular disease (thin chordae 10
mm long)
Group 2 Pliable, noncalcified anterior mitral leaflet and
severe subvalvular disease (thickened chordae ,10 mm long)
Group 3 Calcification of mitral valve of any extent, as as-
sessed by fluoroscopy, whatever the state of
the subvalvular apparatus
PBMV, Percutaneous balloon mitral valvuloplasty.
1
6
2
Contraindications to PBMV
The presence of greater-than-moderate MR is considered an absolute contraindication to
PBMV. Relative contraindications include a Wilkins score .10, left atrial or left atrial
appendage thrombus, severe or bicommissural calcification, absence of bicommissural
fusion, severe mitral annular calcification, international normalized ratio (INR) .1.5 or
bleeding diathesis, and other significant coronary or valvular pathology requiring surgery.
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PBMV With the Inoue Balloon
The patient preparation is similar to all other procedures in the catheterization laboratory.
We do not recommend general anesthesia unless in rare conditions in which the patient
is not cooperative or for airway protection. Anecdotally, in pregnant patients in whom
the operator aims to use minimal fluoroscopy, general anesthesia may be considered
for transseptal puncture and navigating the balloon across the MV under the guidance of
TEE. Intracoronary cardiac imaging (ICE) is an alternative that does not require general
anesthesia.
We use intravenous short-acting beta-blockers to treat patients with AF and rapid ventricular
rate, aiming to reduce the heart rate to ,100 and ideally ,80 beats per minute. Patients with a
history of AF should also have a TEE within a week before the procedure to demonstrate the
presence or absence of left atrial or left atrial appendage thrombus. If the patient is taking anticoagulation, it should be held per standard protocol. In the case of warfarin, the INR should be
less than 2 before the procedure.
The retrograde (transarterial) approach to the MV through the aortic valve has fallen out of
favor due to the significant challenges. The transseptal approach is currently the standard method
for PBMV. Historically, PBMV was first performed with the double-balloon technique through
a transseptal approach. In 1984, Dr. Inoue introduced the single modified balloon technique,
which is currently utilized in the majority of PBMV procedures.
Transseptal Puncture for PBMV: We obtain percutaneous access in the right femoral vein
with a 12F sheath. We also insert a 5F sheath in the radial and femoral artery and advance a
pigtail catheter into the aortic root via this sheath. We use an 8.5F Mullins transseptal introducer sheath and Brockenbrough-1 needle (Medtronic, Minneapolis, MN) to perform the
transseptal puncture. In patients with MS, atrial enlargement and inferior displacement of the
fossa ovalis are common. Imaging-guided transseptal puncture (with TEE or ICE), albeit not
mandatory, increases the safety of the procedure and affords the ability to puncture the fossa
ovalis in the specific desired location. Ideally a mid-mid or mid-posterior location on the
superior/inferior and anterior/posterior axes of the fossa ovalis is preferable for PBMV. If cost
of TEE or ICE is a concern, transseptal puncture can be performed under fluoroscopy and the
rest of the procedure can be carried out using transthoracic echocardiography (TTE) guidance
alone.
Also, in challenging anatomies, levo-phase right atrial angiography can delineate the landmarks necessary to perform the transseptal puncture. Patients with severe MS almost always
have an enlarged left atrium (LA) that is visible on the posterior-anterior (PA) view on the
chest x-ray—the so-called “double-shadow” sign. This double shadow can also be observed on
the PA projection with fluoroscopy. By placing a pigtail in the noncoronary cusp of the aortic
root (the most posterior cusp of the aortic valve), the operator can identify this point as a surrogate for the anterior tricuspid leaflet. This point is at the proximity of the nadir of the pigtail
in the PA view.
The Inoue Balloon Components: Because the Inoue balloon is the most utilized balloon system
for PBMV, we will elaborate on its components and operating mechanisms. We will subsequently
address other systems that can be used for PBMV.
The Inoue balloon kit has seven components (Fig. 14.2): (1) the balloon-stretching tube, which
is a silver-colored, long, metal hypo-tube that is used to elongate and slenderize the balloon system
by passing it through the inner tube; (2) a calibrated syringe used for inflation of the balloon; (3) a
14F dilator used to dilate the subcutaneous tissue at the femoral venous puncture site and the fossa
ovalis; (4) a 0.025-inch stainless steel spring guidewire; (5) a steering stylet that is introduced
through the inner tube after the balloon is in the LA to help guide it across the MV; (6) the balloon
7
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Fig. 14.2 Anatomy of the Inoue balloon. (From Lapp H, Krakau I. The Cardiac Catheter Book: Diagnostic
and Interventional Techniques. © 2014 Georg Thieme Verlag KG Stuttgart.)
catheter itself, which has a W connector from which arise a vent tube, an inner tube (gold color),
and a main stopcock for balloon inflation; and (7) a caliper, which is used to confirm that the
graduations on the syringe used to inflate the balloon result in the desired inflation diameters. The
main balloon is connected to an inner tube that can be stretched by the hypo-tube. The stretcher
(silver color) hypo-tube and the inner tube (gold color) can be locked together. The silver stretcher
only moves in or out simultaneous with the gold hypo-tube. If one inadvertently pushes the gold
inner tube to stretch the balloon, it may kink the balloon and it may not be stretched again. Therefore stretching of the balloon should always be via the silver hypo-tube, and ideally it should always
be over the wire.
Inoue Balloon Sizing and Inflation Protocol: The Inoue balloon comes in three sizes for the
PBMV in adult patients: 26, 28, and 30 mm. The height of the patient is the most important
determinant for reference size of the balloon. The inflation size is dependent on anatomic and
physiologic features of the valve. Patients with mild to moderate MR may still undergo
PBMV, but careful and gradual dilation of the Inoue balloon is needed. Table 14.3 summa-
rizes the Inoue balloon reference sizing, balloon sizing, inflation protocol, and termination
protocol.
Entering the LA With the Inoue Balloon: After successful transseptal puncture, the spring
0.0250 wire is placed in the LA. The transseptal sheath is removed, and the 14F dilator is advanced to dilate the interatrial septum. After that, the dilator is removed and the balloon is advanced into the LA over the spring wire. The silver hypo-tube will lock with the gold inner tube,
and both move forward as one assembly to stretch the balloon. After approximately half the balloon has entered into the LA, the silver tube is withdrawn and the system is guided over the
spring wire to the LA (Fig. 14.3). After the balloon is completely inside the LA, the gold inner
tube is also pulled back, and the balloon will be guided further over the wire until it reaches the
medial commissure of the mitral annulus.
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Table 14.3 n Balloon Size Selection, Inflation, and Termination Protocols for PBMV Using the Inoue
Balloon
Reference Size Measurement
Method 1: Height (cm / 10) 110 (rounded up to the nearest zero)
Example: (178 cm/10) 1 10 5 27.8 n 28 mm
Method 2: Height 180 cm n 30 mm; 160–180 n 28 mm; ,160 cm n 26 mm RS balloon
Balloon Size Selection
Downgrade balloon size to one size smaller than RS if:
n
Elderly patient
n
Thickened leaflets
n
Calcified commissures
n
MR .11
Inflation Protocol
Start 2 mm below the RS in low-risk patients, 4 mm in high-risk patients (elderly, calcified commissures,
pregnant women, MR .11)
Increase by 1-mm increments, 0.5-mm in high-risk patients
Termination Protocol
Stop the procedure when:
n
MVA .1.5 cm2 or MVA .1 cm2/m
n
50% increase in the MVA
n
50% fall in mean gradient or fall in mean gradient from .10 mmHg to ,5 mmHg
n
11 increase in MR
n
Complete opening of at least one commissure
MR, Mitral regurgitation; MVA, mitral valve area; PBMV, percutaneous balloon mitral valvuloplasty;
RS, reference size.
2
Fig. 14.3 Introduction of the Inoue balloon into the left atrium. (From Lapp H, Krakau I. The Cardiac
Catheter Book: Diagnostic and Interventional Techniques. © 2014 Georg Thieme Verlag KG Stuttgart.)
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Fig. 14.4 Crossing the mitral annulus with the Inoue balloon. (A and B) Standard technique. Note the
counterclockwise rotation and withdrawal of the steering stylet to cross the annulus. (C) Modified technique
for small or large annuli.
Crossing the Mitral Valve Annulus to the Left Ventricle: After the balloon is positioned close
to the medial commissure, the spring wire is removed from the LA, and the inner tube is carefully
aspirated to prevent air embolism. The steering stylet is then advanced through the gold inner
tube, which will shape the Inoue balloon similar to an inverted U at the posterior-inferior free
wall of the LA (Fig. 14.4). A gentle back and counterclockwise rotation on the balloon along with
a rapid withdrawal of the stylet for 4 to 5 cm usually moves the balloon forward through the MV.
To ensure cord-free passage of the balloon, we inflate the distal third of the balloon just inside
the MV and advance it back and forth to ensure it is not tangled in the mitral apparatus.
Echocardiography can also aid in confirming the balloon tract through the MV. When TTE is
utilized, the apical two- or four-chamber view can demonstrate the presence or absence of entanglement of the balloon in the subvalvular apparatus. If the balloon buckles against the LV wall
or cannot move freely at any time, no inflation should be performed to avoid any damage to the
subvalvular apparatus.
Inflation of the Inoue Balloon: Balloon inflation can now be started with the calibrated syringe.
The distal portion of the balloon inflates first, followed by the most proximal portion of the balloon. The middle 4-mm segment of the balloon inflates to the nominal size, as previously chosen
by the operator (Fig. 14.5).
Techniques to Cross the Inoue Balloon in Challenging Patients: Despite optimal transseptal
puncture and balloon maneuvering techniques, difficulties may arise in passing the balloon across
the mitral annulus. A number of techniques can be applied in these challenging situations:
1. Reverse Loop Technique: This technique is useful in patients with very large LAs, in
whom the balloon may not reach the mitral annulus with the standard technique. With
this method, the operator removes the steering stylet by at least 6 to 7 cm to soften the
terminal end of the balloon. Clockwise rotation of the stylet with a forward push will then
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Fig. 14.5 The inflation of the Inoue balloon in three stages. The transesophageal echo (Asterisks); The
waist of the balloon at the level of the mitral valve annulus (Arrows). (Reprinted with permission from Wunderlich NC, Beigel R, Siegel RJ. Management of mitral stenosis using 2D and 3D echo-Doppler imaging.
JACC Cardiovasc Imaging. 2013;6[11]:1191-1205).
Fig. 14.6 Reverse loop technique. Note the clockwise rotation of the steering stylet and further withdrawal
of the stylet to soften the distal segment of the Inoue balloon. (From Lapp H, Krakau I. The Cardiac Catheter
Book: Diagnostic and Interventional Techniques. © 2014 Georg Thieme Verlag KG Stuttgart.)
force the balloon against the posterior and caudal surface of the LA, and a loop develops
(Fig. 14.6). At this point, the stylet should be kept tight in place and the balloon should
be pushed forward across the mitral annulus. Once the balloon is across the MV, the rest
of the procedure is similar to the standard approach. The main advantage of this technique
is that it requires no additional cost of equipment.
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2. Venous-Arterial Rail: Another approach is to form a venous-arterial (VA) rail for increased
support. This technique is useful in difficult-to-cross cases but also in patients with a fixed
left atrial appendage thrombus, as it avoids the risk of entry of the tip of the Inoue balloon
to the appendage ostium. Several techniques can be used to establish a VA rail. We cross
the mitral annulus antegrade with a 300-cm, 0.0350, stiff-angled Glidewire (Terumo,
Tokyo, Japan) through a balloon wedge catheter to prevent subvalvular entanglement. We
then push the wire across the aortic valve into the aortic arch, where it is snared from the
arterial side. Once the VA rail is established, the Inoue balloon can be railed over the wire
across the MV and inflated as per the standard approach.
PBMV With Other Balloon Systems
Conventional aortic valvuloplasty balloon systems are generally not ideal for PBMV for two
reasons: (1) these balloons are generally not large enough to treat the large mitral annulus; and
(2) single unmodified cylinder-shaped balloons do not allow effective commissural splitting because they do not exert maximal force laterally towards the fused commissures (Fig. 14.7). Hence,
the Inoue balloon remains the most commonly used balloon in PBMV due to its established
safety and effectiveness. However, the Inoue balloon is expensive and might not be available in
parts of the world where rheumatic MS is prevalent. Alternative techniques have therefore been
used, including PBMV with double conventional valvuloplasty balloon (kissing technique) and
PBMV with a single modified balloon valvuloplasty catheter.
DOUBLE-BALLOON TECHNIQUE
This technique utilizes a single transseptal puncture to introduce two conventional valvuloplasty
balloons across the mitral annulus. After transseptal puncture, the septum is dilated with a 14 to
18F dilator or with a 6- to 8-mm peripheral balloon to facilitate the passage of the two valvuloplasty balloons. The MV should be crossed with an inflated balloon wedge catheter to prevent
chordal entanglement. A precurved wire is then advanced into the left ventricular apex to serve as
a platform to deliver the valvuloplasty balloon (anchoring wire). The transseptal sheath is advanced
into the left ventricle, and a second precurved wire is then inserted into the ventricle side by side
to the first wire. Two valvuloplasty balloons (15 to 20 mm) are then guided over the wires, positioned across the MV, and simultaneously inflated. A modified single-puncture double-balloon
8-10
Fig. 14.7 An illustration of the difference between single- and double-balloon techniques in treating
commissural fusion. (A) Single balloon. (B) Double balloon. (From Lapp H, Krakau I. The Cardiac Catheter
Book: Diagnostic and Interventional Techniques. © 2014 Georg Thieme Verlag KG Stuttgart.)
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Fig. 14.8 A modified double-balloon, single-wire technique aided by the Multi-Track system. (A) Infla-
tion of the first balloon. (B) Inflation of the second balloon. Note the waist in the middle of both balloons.
(C) Both balloons fully inflated with attenuation of the waist. White arrow in (A) refers to the Multi-Track.
(Reprinted with permission from Sadaka MA, Elsharkawy EM, Elsharkawy MA. The impact of commissural
morphology on clinical outcome in patients undergoing percutaneous balloon mitral valvuloplasty. Egypt
Heart J. 2012;64:233-240.)
method utilizing the Multi-Track system (Numed, Hopkinton, NY ) can be employed (Fig. 14.8).
11
Although the double-balloon technique has been shown to be safe and effective, it is rarely used
in current practice due to its complexity and associated potential complications.
SINGLE MODIFIED BALLOON TECHNIQUE
The JOMVIA balloon (Numed, Hopkinton, NY ) is a modified version of the commonly used
Nucleus balloon. The JOMVIA balloon is low profile (9 to 11F), expands to a fixed diameter, and
has two radio-opaque markers corresponding with a 40-mm working length. This balloon is currently only marketed in India and has demonstrated similar safety and efficacy compared with the
Inoue Balloon.
9,10
Outcomes of PBMV
Acute Success and Complications: Procedural success in experienced centers exceeds 98%.
plications of PBMV can be related to vascular access, transseptal puncture, and the valvuloplasty
itself. Albeit uncommon, the feared complications of the valvuloplasty itself include cardiac tamponade, severe MR, and death. Severe MR is usually due to nonsplit of the commissures (because
of the high burden of calcium) that leads to increased pressure on the leaflet and leaflet tearing.
However, worsening MR can also result from rupture of mitral chord(s) or using the wrong-size
balloon. The incidence of severe MR after PBMV ranges between 1% and 10% in the largest
reported series.
septal defect, which is reported in 5% to 20% of patients.
12–14
Another potential complication after PBMV is persistent iatrogenic atrial
15
The impact of a left-to-right shunt
2,12
Com-
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associated with a persistent atrial septal defect is related to the degree of shunting, the right
ventricular function, and the pulmonary arterial pressure. Hence, we recommend routine right
heart catheterization before and after the valvuloplasty.
Long-Term Results: The best results of PBMV are observed in young patients who have fa-
vorable anatomic MV features.
16
In these patients, the rates of event-free survival and freedom
from symptoms exceed 90% at 5 years and are comparable to those of open-heart commissurot-
16
omy.
However, in a series examining long-term outcomes in mixed populations with variable
valve anatomy and in older patients, event-free survival rates at 5 years ranged from 55% to 70%.
Restenosis requiring reintervention is uncommon (5% to 10%) at 5 years, but increases significantly after 10 years. In a study of 912 patients who had good immediate results with PBMV,
38% of them needed reintervention (surgery of repeat valvuloplasty) during a median follow-up
of 12 years.
17
Predictors of worse long-term outcomes include age, 13 MR post-PBMV,
Wilkins score .8, prior surgical commissurotomy, NYHA functional class IV, 12 MR
pre-PBMV, and higher post-PBMV pulmonary artery pressure.
14
Conclusion and Take-Home Messages
l
PBMV has replaced surgical commissurotomy as a first-line treatment option in selected
patients with severe rheumatic MS.
l
Success of PBMV relies on a comprehensive assessment of the patient’s risk profile and MV
anatomy, as well as familiarity with the indications, potential complications, and techniques
of PBMV.
l
The Inoue single-balloon valvuloplasty technique is most commonly used and has been
shown to be safe and effective with durable results.
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