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Endoventricular shaper supports reproducibility of outcomes and decreased mitral regurgitation with Surgical Ventricular Restoration (SVR).
Authors: Tea Acuff, MD; Steven Boyce, MD; John Conte, MD; Marisa Di Donato, MD; and Lorenzo Menicanti, MD
STUDY DESIGN
INTRODUCTION
TR3ISVR SURGICAL VENTRICULAR
RESTORATION PROCEDURE
The TR3ISVR™ procedure helps to ensure predictable and
reproducible outcomes. To restore the ventricle to its more
anatomically correct size, shape and orientation, the
Mannequin™, (Chase Medical, Richardson, TX) an endoventricular shaping device, is inserted into the ventricle
allowing for optimization of volume, identification of the
position of the new apex, and restoration of a more normal
elliptical shape.
The correctly sized shaper is inserted into the
ventricle following incision of the akinetic or scar tissue
area of the ventricle. Sizing is determined using the BSA of
each individual patient. The basal portion of the shaper is
seated against the aortic and mitral valve annuluses and
placement of the tip of the Mannequin
clearly identifies the new apex location of
the reshaped ventricle. The Mannequin
serves as an outline for the suturing and
patch placement in forming the more
elliptically shaped ventricle.
AGGREGATE U.S. AND INTERNATIONAL RETROSPECTIVE INITIAL EXPERIENCE
NYHA Classification Pre and Post
Baseline Patient
Characteristics
M=
F=
82.5%
17.6%
80
70
60
50
40
30
20
10
0
% PRE
% POST
Mitral Regurgitation
I
Age
n = 139
< 45 =
45 - 54 =
55 - 64 =
65 - 74 =
75 - 85 =
Mean =
StDev =
I=
II =
III =
IV =
10 - 20 =
21 - 30 =
31 - 40 =
2.9%
16.5%
30.2%
33.2%
17.3%
64.1
10.3
IV
5.7%
25.7%
34.3%
34.3%
n = 70
Percent Of Total Population
NYHA Classification
I
II
III
IV
Mean =
StDev =
3
Pre
Post
5.7%
25.7%
34.3%
34.3%
25.7%
68.6%
5.7%
0%
DISCUSSION
1.24
1
0.57
Pre
n = 103
Size, Shape and Orientation are Key
Post
Degree of
Mitral Regurgitation
Mean =
Pre
Post
1.24
0.57
Mean =
StDev =
Mitral Regurgitation
Percent of Total
(n = 103)
Mean
39.1
StDev
10.3
Mean
31.5
StDev
8.4
Degree
Pre
None
I (Trivial)
II (Mild)
III (Moderate)
IV (Severe)
Post
Pre
Post
31.5
8.4
39.1
10.3
Pre
Post
21%
56%
10%
6%
7%
45%
48%
7%
0%
0%
The TR3ISVR Procedure
Progression of Heart Failure
1. Normal heart
Copyright © 2003, Chase Medical and the Chase Medical logo are registered service marks of Chase Medical.
Reshaping the Future, TR3ISVR, Mannequin, and SVR are trademarks and registered trademarks of Chase
Medical.
When surgically re-sizing the ventricle without the use of a
shaping device, the surgeon must estimate the resulting size
and final ventricular volume. Three outcomes are possible: the
resulting ventricle is too small, too large or the correct size.
Making the ventricle too small is the worst scenario, because it
will lead to immediate pulmonary hypertension (Dor,
Seminars in Thoracic and Cardiovascular Surgery, Vol. 13, #3,
Oct 2001). Making the ventricle too large leaves the patient’s
heart in a state similar to its pre-operative condition and may
fail to arrest the continuing deterioration of the patient’s condition. Though it is possible, restoring the ventricle to the optimal size without the use of a Mannequin may be dangerous.
Shaping the ventricle is even more difficult. It is a “3-D
tailoring” challenge (Jatene, JTCS, Vol. 89 #3, March 1985)
where the surgeon “imagines” to what shape the ventricle
should be restored. Use of the Mannequin device ensures that
each TR3ISVR procedure will result in an optimal elliptically
shaped ventricle.
Mitral valve apparatus misalignment causes mitral
regurgitation (Aikawa et. al., The severity of functional mitral
regurgitation depends on the shape of the mitral apparatus,
presented at AHA 1998) and reduces the ability of the mitral
valve apparatus to assist in the contraction of the ventricle.
Restoring the proper shape of the ventricle helps restore this
orientation and enables the ventricle and mitral valve to function more efficiently and reduces the amount of work required
by the papillary muscles.
CONCLUSION
Elliptical Ventricle formed with an
Endoventricular Shaping Device
NewEra2004 Cardiac Care: Innovation and Technology - January 9-11, 2004
A multi-center retrospective evaluation of pre-operative
and post-operative functional data for 153 patients who
underwent the TR3ISVR procedure with the Mannequin was
completed in September 2003. Graphical representation of
the reviewed data was prepared and reviewed at the TR3ISVR
Registry Principal Investigators Meeting held concurrent to
the 2003 Heart Failure Society of America meeting in Las
Vegas, Nevada on September 21-24, 2003.
Patient characteristics reviewed included: gender, age
and New York Heart Association (NYHA) classification.
Functional measurements were reported using degree of
mitral valve regurgitation and ejection fraction pre-and
post-operatively.
2
Mean LVEF
45
40
35
30
25
20
15
10
5
0
7.7%
46.2%
16.5%
78.5
33.6
4
0
Ejection Fraction Pre and Post
n = 91
LVESVI
n = 114
III
NYHA Classification
NYHA
n = 70
LVEF
n = 91
II
Degree of Regurg
Gender
n = 153
Mitral Regurgitation
Pre and Post
NYHA
% of Total
Clinical research has shown that the progressive degradation of physiologic function, diminished quality of life,
repeated hospitalizations and early mortality associated
with congestive heart failure (CHF) are direct consequences of a dilated spherical ventricle with limited
contractile and filling capacities.
A variety of studies have demonstrated the success
of SVR® in treatment of dilation of the post-infarcted
ventricle. However, restoration of
normal ventricular shape presented
a challenge and resulted in the
introduction of secondary mitral
regurgitation. Initial SVR procedures were performed using only a
cardiovascular patch; while the
recent introduction of an endoventricular shaping device to assist the
surgeon in restoring the ventricle to
its normal elliptical shape has
resulted in improved functional
and clinical outcomes.
Mannequin
2. Damaged left
ventricle
3. Dilated left
ventricle
Dyskinetic/Akinetic
scar
Location of Fontan
suture at transition
area
Tighten Fontan suture
for correct size and
shape
Surgical ventricular restoration using a Mannequin allows the
surgeon to restore elliptical shape, to optimally resize and to
reorient the ventricle in the ischemic heart failure patient. This
replicable process produces consistent outcomes with a
decrease in degree of mitral regurgitation. Functional
improvements have been measured using ejection fraction and
mitral regurgitation measurements in this retrospective study.
Further studies will provide additional key indicators useful in
patient selection for this procedure.