Thursday, January 13, 2011

COmprehensive Mitral Valve Apparatus Reconstruction.

COMVAR is a surgical procedure that is developed to preserve the mitral valve.
COMVAR can treat mitral valve diseases, e.g., mitral insufficiency, mitral stenosis, and combined
mitral steno-insufficiency.
COMVAR is an acronym of COmprehensive Mitral Valve Apparatus Reconstruction.


The goal of COMVAR is to reconstruct the patient's native mitral valve apparatus anatomically and physiologically, instead of resection and replacement.

Depending on the patient's pathologic conditions, all or some of the above surgical steps are performed.
Mitral valve repair has been done commonly in the cardiac surgery. Nevertheless, COMVAR procedure provides the
uniform standardized modality in treating various types of mitral valve diseases, preserving the native mitral valve
structure as much as possible, because it restores not only mitral annulus, but also reconstructs the mitral leaflets. COMVAR procedure using the Mitra-Lift® series and COMVAR templates can be applied to the following cases.
1) Isolated mitral regurgitation
Isolated mitral regurgitation is a good indication and prolapsed leaflet regardless its location
(anterior or posterior, or both).
2) Isolated mitral stenosis
Isolated mitral stenosis even with annular calcifications can be managed by COMVAR technique together with
meticulous decalcification procedures.
3) Combined mitral regurgitation and stenosis
Regardless of its causative and initiating disease, once the mitral annulus, valve leaflet, or chorda is involved
pathologically, all of them are supposed to be diseased as time passes. Diseases such as mitral regurgitation,
stenosis, and combined steno-insufficiency belong to this category. COMVAR technique can be successfully
applied to these indications.
4) Prosthetic valve failure at the aortic position
Conditions with present artificial heart valve can be indicated for COMVAR, if the patient's mitral annulus has
been preserved.



COMVAR procedure is composed of 4 surgical steps.
1. Restoration of mitral annulus (lifting annuloplasty)
2. Reconstruction of chordae (chordoplasty)
3. Reconstruction of mitral valve leaflets (leaflet extension)
4. Restoration of mitral commissure (commissuroplasty)




ntraoperative sequence of COMVAR procedure
1. Left atriotomy (trans-atrial or trans-septal)
2. Submitral apparatus correction (chordoplasty) 
3. Mitral commissurotomy in mitral stenosis (commissuroplasty) 
4. Mitral leaflet extension (posterior and/or anterior)
5. Anterior annulus diameter measurement and determination
6. Posterior lifting annuloplasty
7. Removal of the product
Established techniques for cardiopulmonary bypass are used in the usual manner.
The followings are the specific procedures in the COMVAR procedure.
COMVAR (Comprehensive Mitral Valve Apparatus Reconstruction) procedure is performed in the
following order;

To expose the mitral valve and chordae, left atriotomy by either trans-atrial or trans-septal approach is possible.
1.Left atriotomy
Left atriotomy can be performed by either trans-atrial or trans-septal approach to expose the mitral valve structures adequately.
However, in case of small left atrium or combined tricuspid pathology, trans-septal approach allows much better exposure of mitral structures.
2.Submitral apparatus correction (chordoplasty)
When the chorda is torn by either endocarditis or degenerative reasons causing mitral insufficiency, neo-chordae
reconstruction can be done by conventional way using PTFE sutures.
3.Mitral commissurotomy (commissuroplasty) 
In case of mitral stenosis, commissurotomy can be perfomed anteriorly as well as posteriorly as needed.
Fused commissures can be divided until to reach the mitral annulus (Fig.1).
4. Mitral leaflet extension
-To be updated-
5. Anterior annulus diameter measurement and determination
To determine the length of mitral posterior lifting annuloplasty strip (Mitra-Lift®), anterior annulus diameter
should be measured from trigone to trigone using Mitral Sizers.
6. Posterior lifting annuloplasty
Lifting annuloplasty is a key procedure in MR, increasing the physiologic coaptation surface in systolic phase and elevates downward displaced LV free wall.
Specially designed structure of Mitra-Lift® strip is placed at the LA wall along the posterior annulus (Fig. 4).
7. Removal of the Product
After operation, the implanted device can be monitored and evaluated by Transesophageal Echocardiography or
Magnetic Resonance Imaging.If the implants are found to be wrongly located, or displaced after operation,
implants should be removed through the previous route and re-implanted or replaced with other new implant.
When endocarditis occurs in the annulus of mitral valve before neo-intima is created by the endothelialization process, implanted products are easy to be removed. Simply cut the knot of sutures on the strip and
take them out. However, when endocarditis occurs after endothelialization is completed, neo-intima has to be surgically opened to remove the encapsulated strip. The other processes are same.

Advantage of COMVAR
Technically Easy and SafeIn comparison with the conventional prosthetic mitral valve replacement technique,
this standardized COMVAR technique helps surgeon operate in comfort.
Minimizes Functional Impairment of mitral valve apparatusCOMVAR can preserve the function of mitral valve apparatus without prosthetic mitral valve replacement.
Obviates Anticoagulation
Anticoagulant is unnecessary; no danger of blood clots.
Excellent ApplicabilityCOMVAR is applicable to all kinds of Mitral Valve diseases including severely calcified or thickened Mitral stenosis.
Preserves Hemodynamics
COMVAR ensures the normal function of cardiac valve and whereby it leads to ideal blood pressure and blood flow.
COMVAR can also gurantee the sufficiency of mitral orifice.
Improves Quality of LifeQuick recovery from surgical operation and low rate of recurrence ensure active and energetic life.
Tissue Compatibility: reduces the threat of endocarditisAs COMVAR® Set is made of Dacron in form of flexible strips, it can endure repetitive contraction and relaxation of mitral annulus and does not give any stress on the tissues.

Procedure of CARVAR





Indications of CARVAR?
Aortic valve repair has been considered as the challenging area in the cardiac surgery.
But CARVAR procedure provides the uniform standard modality in treating various types of
aortic root and valve diseases, preserving the native aortic root and valve structure
as much as possible, because it restores not only aortic root cage, but also reconstructs
the aortic leaflets.CARVAR procedure using the Rootcon® and
Leafcon® series can be applied to the following cases
1) Isolated aortic valve disease
Isolated aortic regurgitation is a good indication and aortic stenosis can also be indicated, even though severe
calcification and leaflet distortion are present.
- Aortic Valve Insufficiency
- Aortic Valve Stenosis
- Annulo-Aortic Ectasia (including Marfan Syndrome)
2) Combined aortic root and valve disease 
Regardless of its causative and initiating disease, once the aortic root or valve is involved pathologically, both
aortic root and valve are supposed to be all diseased as time passes. Diseases such as aortic aneurysm,
annuloaortic ectasia, aortic dissection belong to this category.
CARVAR technique also can be successfully applied to these cases.
- Aortic Aneurysm (ascending aorta, descending aorta)
- Aortic Dissection
- Infective Endocarditis
3) Prosthetic valve failure at the aortic position
Conditions with present artificial heart valve can be indicated for CARVAR,
if the patient's aortic root has been preserved.
- Other aortic valve diseases


CARVAR procedure is largely composed of 3 surgical steps.
1. retention of appropriate aortic annulus size
2. restoration of appropriate sinotubular junction size
3. reconstruction of aortic valve leaflets 

Depending on the patient's pathologic condition, all or some of the above surgical steps are performed.

For example, in most cases for aortic regurgitation, step 1 is not needed.
But in most cases for aortic stenosis or aortic valve leaflet prolapsed, step 2 and 3 should be performed.
In most cases for aortic dissection and ascending aortic aneurysm,
step 2 and ascending aorta replacement are enough to do.

1. Peri-root dissection

The aortic root should be first dissected and freely mobilized with complete resection of fatty tissue attatched to
the aortic root and its neighboring structures before aortotomy. If the coronary arteris are "high take -off" type,
sub-coronary dissection is recommended.
2. Aortotomy
If the ascending aorta is hugely dilated like in the annuloaortic ectasia, ascending aortic aneurysm and aortic
dissection, the ascending aorta is transected. But if the ascending aorta is not dilated or slightly to moderately
dilated, the ascending aorta is incisied partially and anteriorly.
The level of aortotomy is usually 7~10㎜ above the sinotubular junction. If the coronary arteries take off high,
then the level of aortotomy is 7~10㎜ above the origin of coronary arteries.
3. Annulus diameter measurement
The annulus diameter is measured with the Annulus Sizer 011 series.
The aortic annulus is composed of fibrous annulus and muscular annulus. First, measure the length of muscular
annulus. When the muscular annulus is measured, measure the circumferential length from the commissure
between noncoronary leaflet and right coronary leaflet to the mid-point of left coronary leaflet (Fig. 4).
Next, measure the opposite fibrous annulus in the similar manner and compare it with the length of muscular
annulus. Then, make the length of muscular annulus as a reference because the ratio of the length of fibrous
versus muscular part is approximately 1:1 in the normal condition (Fig. 5). 
If the muscular annulus is dilated and ejection fraction (EF) is less than 30%, it may be attributed to
a kind of cardiomyopathy. Consider a cardiac transplantation instead of CARVAR procedure.)


4. STJ diameter measurement and determination of ideal STJ diameter.
The STJ diameter is measured with the Sciencity STJ Sizer 012 series. There can be two situations:
(1) aortic leaflets look like normal and
(2) aortic leaflets are deteriorated like in the calcified aortic stenosis.
When the aortic leaflets look like normal, 3 leaflets are pulled together by a single stitch (Frater's stitch) that is
passed through the 3 nodules of Aranti (center of leaflet margin), and measure the leaflet surface (Fig. 6).
If STJ diameter is measured in the aortic aneurysm and dissection, the level of STJ is determined just above
the level of commissures. When the aortic leaflets are deteriorated, cut them to open the commissural fusion
and remove the calcifed mass sufficient enough to mobilize the leaflets and then measure the STJ diameter in the
manner that sizer can be passed without resistance (Fig. 7).
Select the one as large as possible of these diameters, considering that the ratio of Annulus/STJ diameter is
normally within the range 1.0 ~1.2.


5. Annulus reduction (Annuloplasty)
If the fibrous annulus is not dilated, this procedure is not needed (Table 1).
But if the annulus part is dilated larger than muscular part by 2㎜ more, reduce it to the length of muscular
annulus. Also in all Marfan patients (annuloaortic ectasia), the fibrous annulus have to be always reduced.
The same numbered strip as the length of muscular annulus measured is selected.
For example, if the length of muscular annulus is measured 30㎜, then select the Rootcon® Annulus In 30 strip.
After peeling off the lid of the package, remove the strip with its holder and separate the strip from the holder.
Six 4-0 polypropylene double-armed sutures are evenly placed on the Rootcon® Annulus In 30 strip and then
passed through the aortic annulus wall and come out of the aortic root, so that 2 suture in left coronary leaflet
and 4 suture in noncoronary leaflet are approximately placed. Then, select the +6 numbered Annulus Out strip,
that is, 36 and call for Annulus Out strip 36 and remove the strip with its holder from package and place
the above sutures in order sequence on the Annulus Out strip 36. After separating the Annulus Out 36 strip from
its holder, pull out all 6 sutures and push down the Annulus Out 36 strip and make alignment with the Annulus In
30 strip and tie tightly (Fig. 8).
6. Aortic leaflet reconstruction
If aortic valve leaflets are normal, skip this step (Table 1). But when the aortic valve leaflets are distorted and
diseased, resect the aortic leaflets. Often the subaortic membrane over the muscular annulus can be present in
severe aortic stenosis. Then resect it at the same time.
When the aortic leaflets are resected, decide the resection type or range among the following 3 methods,
depending on the scope of the disease involvement.
1) Complete resection down to the annulus
2) Partial resection to 2~3㎜ away from the annulus
3) Leaflet extension without resection of diseased leaflet
Resect all 3 leaflets, rather than leaving 1 or 2 leaflets. New leaflets are reconstructed with bovine or
glutaraldehyde-fixed autologous pericardium.
It is very convenient to use the template (Leafcon®) for designing the pericardial patch. When template is used,
select the same numbered template as the number of STJ diameter measured and the same type of template as
the resection type performed. There are provided 3 types of template in concordance with resection type,
C-Leafcon®, P-Leafcon®, and E-Leafcon® for each size (Fig. 9).
For example, if the diameter of STJ was determined as 28㎜ and leaflets were partially resected,
select the #28 P-type template(P-Leafcon® 28) among 3 types of template.
Then place the bovine or glutaraldehyde-fixed autologous pericardium between the plates of selected template
and cut the pericardium along the margin of the template with the scissors.
(See the User’s manual of Leafcon® Set) Attach the cut pericardial cusp to the remnant of the aortic leaflet with
continuous 5-0 polypropylene sutures (Fig. 10).
7. Commissure reduction (Commissuroplasty)
After new leaflets are reconstructed, commissuroplasty is added in the following manner in order to compress or
reduce a commissural gap and subcommissural triangle. Three 4-0 pledget-reinforced mattress sutures are placed
through the adjacent edges of the newly reconstructed pericardial leaflets at each commissural level.
These sutures can be externalized outside the aorta and secured (Fig. 11).
8. STJ reduction
STJ reduction should be always carried out in CARVAR procedure. But only when the aortic stenosis without STJ
dilatation (STJ diameter <24㎜) is corrected, STJ reduction is done enoughly with the outer strip (STJ Out)
without inner ring (STJ In) (Table 1). Otherwise, both of inner and outer ring or strip are together used. The size
selection of STJ inner ring (STJ In) is automatically determined by the diameter of STJ measured. When the size
of STJ outer ring or strip is selected, it is determined as the +6 numbered STJ outer ring in the usual cases but if
the aortic root is huge-dilated or involved by dissection, select the +8 numbered STJ outer ring (STJ Out) or
open STJ outer strip (STJ Out Strip 40). Also, when the aorta is partially incised, it is convenient to use the open
STJ Out Strip 40. For example, if the diameter of STJ is measured 28㎜, select the same numbered STJ In 28.
Then, select +6 ~ +8 numbered STJ Out Ring, that is STJ Out Ring 34 or 36. Normally STJ ring or strip is located
5mm above the ostia of coronary artery. But if the coronary artery is highly taken off just like in the huge aortic
aneurysm, STJ reduction should be performed in the sub-coronary position.
When STJ is reduced, there can be 2 types of situations:
(1) complete transection of ascending aorta and
(2) anterior partial incision of ascending aorta. When the asceding aorta is completely transected,
inner ring is inserted with three 4-0 double-armed orientaional mattress sutures which pass through the aortic wall
from the inner ring. (There are 3 equidistant vertical marks for alignment with commissures
and another 3 mid-way marks between them on the ring) Next, another three 4-0 mattress mid-way sutures are
placed between the orientational sutures. Additional two 4-0 mattress sutures are placed mid-way between each
orientational and mid-way sutures. These sutures in due order are passed through the outer ring or strip and
tied (Fig. 12 and 13). When the ascending aorta is anteriorly and partially incised, outer strip is first placed behind
the dissected aortic root and 3 orientational sutures are first placed from the inner ring through the aortic wall to
the outer strip and tied. Again, 3 mid-way mattress sutures encompassing the inner ring, aortic wall and outer
strip are placed mid-way between the orientational sutures and tied. In the regular order, 12 additional sutures
are placed between them in the same manner and tied (Fig. 14) 
9. New leaflets coaptation sutures
5-0 polypropylene sutures are passed over and over the adjacent pericardial new leaflets near
the each commissural region and externalized outside the aorta and tied to make the new commissures (Fig. 15).
10. Removal of the product 
Evaluation on the implanted device after operation can be achieved by Transesophageal Echocardiography or Multi-Channel CT or Magnetic Resonance Imaging.If the implants are wrongly located, or if the implant is displaced after operation, implants can be removed through the previous route and reimplanted or replaced with other new implant. When endocarditis occurs in the aortic root before neo-intima is created by endothelialization process, implanted ring and/or strip are easy to be removed. Simply cut the knot of sutures on the ring/strip and take them out. However, when endocarditis occurs after endothelialization is completed, neo-intima has to be surgically opened to remove the encapsulated ring/strip. The other processes are same.



Advantage of CARVAR
Technically Easy and Safe In comparison with the conventional prosthetic aortic valve replacement technique, this standardized
CARVAR technique helps surgeon operate in comfort.
Minimizes Functional Impairment of Aortic RootCARVAR Set (Rootcon® series and Leafcon® series) can preserve the function of Aortic Root without prosthetic aortic valve replacement.
Obviates Anticoagulation
Anticoagulant is unnecessary; no danger of blood clots.
Preserves Hemodynamics (Reduces Progression of Aortic Valve Regurgitation)CARVAR Set (Rootcon® series and Leafcon® series) ensures the normal function of cardiac valve and whereby it leads to ideal blood pressure and blood flow.
Improves Quality of Life
Quick recovery from surgical operation and low rate of recurrence ensure active and energetic life.
Tissue Compatibility: reduces the threat of endocarditisAs CARVAR Set (Rootcon® series and Leafcon® series) is made of Dacron in form of flexible bands and strips, it can endure repetitive contraction and relaxation of aorta and does not give any stress on the tissues.