Polyglycolic acid sheet with fibrin glue potentiates the effect of a fibrin-based haemostat in cardiac surger

Hirofumi Kasahara

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RESEARCH ARTICLE Open Access
Polyglycolic acid sheet with fibrin glue potentiates
the effect of a fibrin-based haemostat in cardiac
surgery
Hirofumi Kasahara
* and Ichiro Hayashi
Abstract
Background: Hemorrhage from the left ventricle can be critical and sutureless repair using a fibrin-based haemostat
(TachoComb) is one effective option. When active hemorrhage is not controlled by the haemostat, we have
used a polyglycolic acid (PGA) sheet and fibrin glue in addition. Here we investigated whether the PGA sheet
and fibrin glue combined with TachoComb had stronger adhesive properties than TachoComb alone in two
experimental models.
Methods: Experiment 1. An airtight circuit that included rab b i ts k i nw i t hh o l e sc o v e r e db ye a c ht y p eo fs e a l a n t
was gradually pressurized and the burst pressure was recorded automatically (n =10). Experiment 2. A suture
loop was attached to a porcine heart by each sealant, and the peel-off pressure was measured (n =12).
Results: The PGA sheet and fibrin glue combined with TachoComb showed significantly higher adhesive
strength than TachoComb alone in both experiments (p <0.05).
Conclusions: Adding a PGA sheet and fibrin glue increased the adhesive strength of TachoComb in two
experimental models, suggesting that this method might be effective for achieving haemostasis in difficult
clinical situations.
Keywords: Polyglycolic acid sheet, TachoComb, Hemorrhage, Left ventricle
Background
Active hemorrhage from a ventricle is potentially cata-
strophic. Critical left ventricular (LV) wall injury can be
caused by myocardial infarction, catheter intervention,
cardiac surgery, or trauma. Recent changing trends in
the population at risk have resulted in an increasing
number of high-risk patients undergoing coronary inter-
vention and cardiac surgery, leading to a potential in-
crease in the risk of such complications. Sutureless
repair methods have been reported for ventricular injury,
especially using TachoComb (TC) or TachoSil, which are
biodegradable collagen patches with a fibrinogen/throm-
bin-based coating. In severe cases, such as active bleed-
ing from the left ventricle or LV free wall rupture, we
have applied a polyglycolic acid (PGA) mesh sheet with
fibrin glue in addition to TC in order to achieve stronger
adhesion, and we have the clinical impression that this
method is often effective even in dire situations.
Polyglycolic acid is gradually degraded by hydrolysis
and slowly loses strength in vivo, and it is currently used
to make absorbable surgical sutures. Polyglycolic acid
mesh sheet is a soft nonwoven fabric known for its flexi-
bility, elasticity, and low cost, which is available in the
EU countries and Japan for clinical use as an absorbable
reinforcing material. Since PGA itself is not adhesive, fi-
brin glue is usually combined with PGA sheets for surgi-
cal use. There have been many reports about the use of
PGA sheets with fibrin glue for the treatment of lung in-
jury or pulmonary artery damage in the field of thoracic
surgery [1,2]. However, there have been no reports con-
cerning PGA sheets as a haemostatic material for cardiac
surgery to our knowledge.
* Correspondence: kasa7777@gmail.com
Department of Cardiovascular Surgery, National Hospital Organization
Saitama Hospital, 2-1 Suwa, Wako 351-0102, Japan
© 2014 Kasahara and Hayashi; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the
Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use,
distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public
Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this
article, unless otherwise stated.
Kasahara and Hayashi Journal of Cardiothoracic Surgery 2014, 9:121
http://www.cardiothoracicsurgery.org/content/9/1/121Methods
The polyglycolic acid sheet used in this study (Neoveil,
Gunze, Kyoto, Japan) was a 0.15 mm thick biodegradable
synthetic nonwoven fabric that is absorbed about
15 weeks after implantation. In order to evaluate the
usefulness of combining a PGA sheet and fibrin glue
(Bolheal, Kaketsuken, Kumamoto, Japan) with TC (Nycomed
P h a r m a ,L i n z ,A u s t r i a ) ,w ec o n d u c t e dt h ef o l l o w i n g2
experiments to assess adhesive force.
Experiment 1: An airtight circuit was made with a digital
pressure gauge (PG-208-102GH, Copal Electronics
Co., Tokyo, Japan), a plastic syringe, and a pressure
hardened plastic tank with an opening at the top [2]
(Figure 1A). A sheet of skin from a Japanese white rabbit
with 5 holes 2 mm diameter in a 10 mm square created by
a template and a metal puncher was attached to the top of
the tank. The holes in the skin sheet were covered by TC
with (n =5)/without a PGA sheet and fibrin glue (n =5),
as follows. Either a 15 mm square of TC was compressed
manually over a hole with moist gauze for 3 minutes by a
technician, or else a 30 mm square PGA sheet was placed
over the center of the TC sheet, attached with 0.5 ml of fi-
brin glue, and stabilized for 3 minutes. Fibrin glue was ap-
plied by spraying from the nozzle of the spray applicator,
w h i c hm i x e dt h et w oc o m p o n e n t so ft h eg l u e( f i b r i n o g e n
and thrombin solutions). Then the pressure of the airtight
circuit was gradually increased using a syringe pump at a
rate of 2 mmHg per second approximately, and the max-
imum pressure at the rupture point (the onset of air leak-
age) was recorded automatically to assess the adhesive
strength of each sealant. The rabbit skin sheet was ex-
changed for a new one with every measurement.
Experiment 2: Adhesive strength was evaluated using
porcine hearts. Six frozen porcine hearts were defrosted
and allowed to reach room temperature. A loop was
made from a 1–0 surgical silk suture and was fixed to
the pericardium by using a 15 mm square TC sheet with
(n =6)/without a 30 mm square PGA sheet and fibrin
glue (n =6), as in experiment 1 (Figure 1B). After
stabilization by manual pressure, the suture loop was
gradually elevated at a constant speed with a digital
gauge (AE-1, Aikoh Engineering Co., Osaka, Japan), and
the peel-off pressure (which was the maximum pressure
at which the suture remained on pericardium) was re-
corded automatically. One porcine heart was used once
for each group. The pericardium along the border of the
left anterior descending artery, which was not rich in
fatty tissue and not markedly curved (Figure 1B), was se-
lected for attachment of the suture and the same site
was not used again.
Statistical analysis
Data are presented as the mean ± SD. All data were con-
firmed with respect to the normality of distribution
using the Shapiro-Wilk test. Differences were assessed
by using the paired t-test and unpaired t-test, as appro-
priate, with P <0.05 being considered statistically signifi-
cant. The SPSS 19 statistical software package (SPSS
Inc., Chicago, IL) was used for data analysis.
Results
All procedures were conducted in a laboratory with a
stable room temperature and humidity. In each experi-
ment, the pressure or strain was increased gradually
until the end-point was reached.
Experiment 1: The PGA sheet and fibrin glue combined
with a TC sheet showed a significantly higher burst pres-
sure (178.2±51.1 mmHg) when resisting the internal pres-
sure of the airtight circuit compared with a TC sheet alone
(111.6±45 mmHg) (p =0.03 unpaired t-test) (Figure 2).
Experiment 2: The PGA sheet and fibrin glue combined
with a TC sheet showed significantly stronger adhesion to
porcine pericardium (335.2±51.7 mmHg) compared with
a TC sheet alone (140.2±28.8 mmHg) (p =0.0004 paired
t-test) (Figure 3).
Discussion
Haemostasis is compromised after cardiopulmonary by-
pass with full heparinization in patients undergoing car-
diovascular surgery [3]. An increased blood transfusion
volume due to bleeding during surgery or reexploration
to control persistent hemorrhage is associated with a
worse postoperative course and a higher mortality rate
[4]. In particular, LV wall injury or LV rupture is a ser-
ious situation. For example, in the case of LV rupture as-
sociated with myocardial infarction or cardiac surgery,
A  B 
Figure 1 Experimental design. A: Experiment 1; An airtight circuit
is formed from a pressure gauge, a plastic syringe, and a pressure-
hardened plastic tank covered by rabbit skin with 5 holes. The holes
are covered with TachoComb sheets (arrow). B: Experiment 2; A silk
suture loop was placed on the pericardium and fixed with a TachoComb
sheet plus a PGA sheet and fibrin glue (arrows). After stabilization, tension
was gradually applied to the loop with a digital gauge.
Kasahara and Hayashi Journal of Cardiothoracic Surgery 2014, 9:121 Page 2 of 4
http://www.cardiothoracicsurgery.org/content/9/1/121compromised tissue can often extend beyond the peri-
cardial rupture site. This means that surgical repair is
often difficult, and suturing can sometimes make the
situation worse by enlarging the ventricular injury. In
addition, if prolonged cardiopulmonary bypass and aor-
tic cross-clamping are required to control bleeding,
there is potentially a significant risk of myocardial ische-
mia in these compromised patients and haemostasis can
be further impaired [5]. Therefore, we believe that
sutureless repair under off-pump conditions is an
attractive method for achieving haemostasis, while pre-
serving coagulation and avoiding further myocardial
injury.
Many authors have reported that TC (or Tachosil) is
an effective alternative for controlling hemorrhage. In a
case of oozing cardiac rupture, complete hemostasis
could be achieved by using TC [6]. The present study
showed that TC alone might be adequate for patching
the myocardium, since the burst pressure was 111.6 ±
45 mmHg, and the peel-off pressure was 140.2 ±
28.8 mmHg. Even when LV rupture is not of the oozing
type, a layer of TC with overlapping fascia was reported
to be effective [5,7]. However, we feel that this might still
not be strong enough in some cases. The surface of the
left ventricle is round and uneven. Moreover the twisting
contraction of the ventricular myocardium interferes
with attachment of TC, making it difficult to achieve
strong adhesion at sites of active hemorrhage. Tacho-
Comb sheets can be detached by the pressure of active
bleeding. Even if most of a sheet remains attached to the
ventricular pericardium, incomplete hemostasis due to a
small gap between the sheet and pericardium caused by
high-pressure bleeding is often a problem in our clinical
experience. Although adding a layer of TC may be one
option, it is still sometimes difficult to achieve complete
haemostasis due to the limited size of TC sheets (95 ×
48 mm at maximum), which means that one sheet may
not have wide enough margins to be attached firmly to
the ventricular surface and suppress active bleeding. The
combined TC method also has a higher cost. Greater ad-
hesive strength or extremely rapid curing of the sealant
is probably necessary. Our method of using a PGA sheet
and fibrin glue for reinforcement of TC can augment the
adhesive strength, as demonstrated in the present study.
The PGA sheet is flexible, inexpensive and larger (150 ×
150 mm) than a TC sheet, and has already been reported
to be an effective haemostatic agent for lung surgery. This
was the first study in which PGA sheets were applied for
cardiac surgery to our knowledge. The results of the
present study suggest that the PGA sheet may compensate
for the weaknesses of sutureless repair using TC alone.
The adhesive strength achieved with the combination of
TC and PGA sheets was enough to resist the LV pressure
or systolic blood pressure in the present study (335.2±
51.7 mmHg ≒ 446.9±68.9 hPa), although it is probably
impossible to achieve such high adhesive strength at a site
of active bleeding with LV contraction in a critical situ-
ation. We think that the key to achieving haemostasis with
TC is whether adequate compression is applied until fibrin
spreads between the epicardium and the sheet and then
polymerises to attach the sheet stably [8]. Adding a PGA
sheet with fibrin glue augments sealing by TC alone due
to covering a larger area, and PGA probably conforms
during ventricular contraction without loss of flexibility.
0
50
100
150
200
250
TC TC+PGA
I
n
n
e
r
 
p
r
e
s
s
u
r
e
 
(
m
m
H
g
)
(n = 5)( n = 5)
Figure 2 Results of experiment 1. *Statistically significant
difference (p <0.05), TC =A TachoComb sheet alone, TC+PGA = A
PGA sheet with fibrin glue and a TachoComb sheet.
0 
100 
200 
300 
400 
500 
TC TC+PGA 
P
u
l
l
 
p
r
e
s
s
u
r
e
 
(
m
m
H
g
)
 
(n = 6)  (n = 6) 
Figure 3 Results of experiment 2. *Statistically significant
difference (p <0.05), TC =A TachoComb sheet alone, TC+PGA = A
PGA sheet with fibrin glue and a TachoComb sheet.
Kasahara and Hayashi Journal of Cardiothoracic Surgery 2014, 9:121 Page 3 of 4
http://www.cardiothoracicsurgery.org/content/9/1/121Both the PGA sheet and fibrin glue are biodegradable, so
strength will decline in the chronic phase. Although there
is thus a potential risk of pseudoaneurysm in the chronic
phase after LV rapture, as well as the risk of pathogen
transmission, to address catastrophic situations such as LV
rupture and serious bleeding from other sites during car-
diovascular surgery, this method might be a useful option.
Conclusion
The present study demonstrated that adding a PGA sheet
with fibrin glue to a TC sheet achieves stronger attach-
ment than a TC sheet alone in two experimental models.
Although further investigation is required, this method
might be effective for haemostasis in cardiac surgery.
Abbreviations
PGA: Polyglycolic acid; LV: Left ventricular; TC: TachoComb.
Competing interests
The authors declare that they have no competing interests.
Authors’ contributions
HK has made all design of this study, interpretation of data, and drafting the
manuscript. IH has made all design of this study, and given final approval of
this study. Both authors read and approved the final manuscript.
Received: 15 November 2013 Accepted: 27 June 2014
Published: 8 July 2014
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doi:10.1186/1749-8090-9-121
Cite this article as: Kasahara and Hayashi: Polyglycolic acid sheet with
fibrin glue potentiates the effect of a fibrin-based haemostat in cardiac
surgery. Journal of Cardiothoracic Surgery 2014 9:121.
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