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Original Article
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Wanchai Wongkornrat, M.D., Kornkan Mahasawas, M.D., Punnarerk Thongcharoen, M.D., Thaworn
Subtaweesin, M.D.
Department of Cardiothoracic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, ailand.
Long Term Outcomes and Durability of Bioprosthetic
Valve for Valve Replacement at Siriraj Hospital
ABSTRACT
Objective: Bioprosthesis has been used in cardiac valve replacement for a long time. However, structural valve
deterioration is still a major cause of failure. ere are several risk factors for valve deterioration. is study evaluates
the risk factors of valve deterioration in the long term (10 years) at Siriraj Hospital.
Materials and Methods: We retrospectively reviewed the medical records of 249 patients who underwent mitral
or aortic valve replacement between January 2006 and December 2012 using various tissue valves, comprising
Carpentier–Edwards porcine, Carpentier–Edwards Perimount bovine pericardial, Carpentier–Edwards Perimount
Magna bovine pericardial, and St Jude Trifecta bovine pericardial types. e information from each patient was
entered into a database at the time of the operation and followed up regularly, with a mean follow-up of 10 years.
Results: Aer 10 years follow-up time, the incidence of valve deterioration events were 1.2% and 8.43% in the rst
ve and ten years, respectively. e overall death rate during follow-up was 2.41%. ere were three statistically
signicant risk factors (p < 0.05) of valve deterioration: gender (female) (p = 0.042), age ≤ 60 years old (p = 0.010)
and St Jude Trifecta bovine pericardial valve (p = 0.004).
Conclusion: In the surgical populations who underwent valve replacement at Siriraj Hospital with tissue valves,
we found an acceptable long-term durability of the tissue valve. e risk factors of valve deterioration were female
gender, age ≤ 60 years old, and St Jude Trifecta bovine pericardial valve.
Keywords: Tissue valve; bioprosthesis valve; structural valve deterioration (Siriraj Med J 2022; 74: 211-216)
Corresponding author: aworn Subtaweesin
E-mail: subtaweesin@gmail.com
Received 3 November 2021 Revised 30 December 2021 Accepted 8 January 2022
ORCID ID: https://orcid.org/0000-0003-4497-6171
http://dx.doi.org/10.33192/Smj.2022.26
All material is licensed under terms of
the Creative Commons Attribution 4.0
International (CC-BY-NC-ND 4.0)
license unless otherwise stated.
INTRODUCTION
ere are two types of prosthetic heart valves: the
mechanical heart valve and the bioprosthetic tissue
valve. The mechanical valve is recommended for
young patients because of its durability, but the patient
is required to take anticoagulants for life to prevent
thromboembolism events; whereas the tissue valve is less
durable than the mechanical valve, but the patient is not
required to take anticoagulants for life; thus leading to a
lower risk of bleeding events associated with the use of
anticoagulants.
In 1966, Dr. Alain Carpentier invented the stented
porcine valve and used glutaraldehyde solution as the
chemical preservative for porcine valves by creating collagen
cross-links. is preservation protected the denaturation
of tissue leaets and made the tissue immunologically
inactive.
1
Since 1980s, tissue valves have been improved
through the use of low-pressure xation to maintain a
normal leaet morphology. Anti-calcication and anti-
mineralization treatment methodologies were developed
to obtain longer durable leaets.
2
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Porcine and pericardial tissue valves have been
used for cardiac valve replacement surgery for 20 years
at Siriraj Hospital. However, it is known that these may
suer structural valve deterioration over time, which is
the major cause of tissue valve failure worldwide. Data
collected from 1970 to 2000 revealed that 30% - 40%
of tissue valves at the mitral or aortic position require
replacement within 15 years following implantation
because of structural valve deterioration.
3
ere are several
risk factors for structural valve deterioration, such as a
younger patient, renal insuciency, hyperparathyroidism,
hypertension, tissue valve at the mitral position, and an
older generation of tissue valve.
Calcication is accelerated in younger patients,
renal insuciency, or hyperparathyroidism patients.
Systemic hypertension damages tissue valves at the mitral
and aortic positions due to the increased systolic and
diastolic closing pressure. Older generations of tissue
valves are less durable than the newer generation of
tissue valves. Pericardial valves are more durable than
porcine valves.
4,5
e primary objective of this study was durability of
tissue valve and secondary objective was the risk factors
of long-term (10-year) structural valve deterioration in
patients at Siriraj Hospital, which are essential to have
a better understanding of in order to support selection
of the proper tissue valve types for patients in terms of
the position and timing of tissue valve replacement.
MATERIALS AND METHODS
is research was approved by the Ethical Committee
on Research Involving Human Subjects, Faculty of Medicine
Siriraj Hospital, Mahidol University on March 24, 2021.
We retrospectively reviewed the medical records
of 249 patients who underwent mitral or aortic valve
replacement since January 2006 to December 2012 using
the Carpentier–Edwards porcine (porcine) (24 cases),
Carpentier–Edwards Perimount bovine pericardial (PM)
(165 cases), Carpentier–Edwards Perimount Magna
bovine pericardial (PM magna) (57 cases), and St Jude
Trifecta bovine pericardial (trifecta) (3 cases) tissue
valves types and who survived the operation. e types
of tissue valve were selected by the individual surgeon’s
preference and the valves available at that time. e case
of structural valve deterioration was dened by clinical
presentation, echocardiographic nding results and
reoperation event.
Statistical analysis
e baseline demographic continuous data were
presented as number or percentage, mean and standard
deviation were carried out as normal distribution.
Categorical data was presented as percentage or ratio/
In inferential statistic, 95%CI was used. In case of time
to deterioration in univariate analysis, deterioration was
obtained from Kaplan-Meier survival curves and log-rank
test for compared each group. For multivariate analysis
using Cox (Proportional Hazards) regression analysis
was performed aer adjusted controlling confounding
factors with p-value < 0.2 from univariate analysis using
backward elimination for variable selection. e statistical
signicance was accepted if the p-value was < 0.05.
Table 1 summarizes the preoperative clinical
characteristics of all the patients. The male gender
represented 48.2% of cases and the female gender 51.8%.
e mean age was 69.2 years old (range 15–98 years old),
with 203 patients (81.5%) being more than 60 years old.
Overall, 148 patients underwent aortic valve replacement
(AVR) (59.4%), 84 patients underwent mitral valve
replacement (MVR) (33.7%), and 17 patients underwent
double valve replacement (DVR) (6.8%).
Also, 79 patients (31.7%) with signicant coronary
artery disease who received preoperative angiography
underwent concomitant coronary artery bypass gra
surgery were included in this study. e data obtained
from all the patients were entered into a database at
the time of the operation and then those patients were
followed up regularly.
TABLE 1. Preoperative clinical characteristics.
Variables (n=249) Number (%) or Mean ± SD
Gender; Male 120 (48.2%)
Female 129 (51.8%)
Age (years) 69.2 ± 11.4
≤60years 46(18.5%)
>60years 203(81.5%)
Follow-up time (years) 10.0 (4.0-15.0)
Diagnosis
Regurgitation 153(61.4%)
Stenosis 79(31.7%)
Mixed 17(6.8%)
Operation
AVR 148 (59.4%)
MVR 84(33.7%)
DVR 17(6.8%)
Type of tissue valve
PM 165(66.3%)
PMmagna 57(22.9%)
Porcine 24(9.6%)
Trifecta 3(1.2%)
Concomitant CABG 79(31.7%)
Wongkornrat et al.
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RESULTS
Aer 10 years (range 4-15 years) follow-up time,
the incident of structural valve deterioration events was
1.2% (95%CI: 0.25-3.47) and 8.43% (95%CI: 5.27-12.56)
in the rst ve and ten years, respectively (Fig 1). e
overall death rate during follow-up was 2.41% (95%CI:
0.97-5.66). A summary of the incidence of structural
valve deterioration is shown in Table 2.
According to Table 3, there were three statistically
signicant risk factors (p < 0.05) of structural valve
deterioration, i.e., female gender, age ≤ 60 years old,
and St Jude Trifecta bovine pericardial valve. e risk
of structural valve deterioration was 2.75 times (95%Cl:
1.04 to 7.28 times) higher signicant (p = 0.042) in
females compared to males, and the risk of structural
valve deterioration is 3.33 times (95%Cl: 1.34 to 8.29
times) more signicant (p = 0.010) in the adult group
(age ≤ 60 years old) compared with the elderly group
(age > 60 years old). e St Jude Trifecta valve was also
found to be a signicant risk factor of structural valve
deterioration (p = 0.004)
DISCUSSION
The expanding use of tissue valves for valve
replacement has been supported by evidence of their
long term durability and freedom from structural valve
deterioration. In this present study at Siriraj Hospital,
we followed 249 cases of tissue valve replacement in
the aortic and mitral valve positions. During the early
years of our experience, the main reasons for using a
tissue valve were patients having a contraindication
to taking anticoagulants, elderly patients, and women
of reproductive age. Nowadays, patient preference has
become one of the most important factors for choosing the
proper valve. In our series, the freedom from structural
valve deterioration at 10 years was 91.57% (Fig 1). ere
were three statistically signicant risk factors (p < 0.05)
of structural valve deterioration identied in our study:
female gender, age ≤ 60 years old and St Jude Trifecta
bovine pericardial valve (Table 3, Fig 2, Fig 3).
Fig 1. Freedom from structural valve deterioration for all tissue valves.
TABLE 2. Incidence of structural valve deterioration.
Variables (n=249) Number of Deterioration Incident of Deterioration (95%CI)
Deterioration
at5years 3 1.20%(0.25-3.47)
at10years 21 8.43%(5.27-12.56)
Died during follow-up 6 2.41%(0.97-5.66)
e risk of structural valve deterioration in the
mitral position has been considered to be higher than in
the aortic position because the systolic closing pressure
at the mitral position is higher than the diastolic closing
pressure at the aortic position. In an Edinburgh study
6
,
aer 15 year tissue valve follow-up, a reoperation rate of
29% due to structural valve deterioration was observed
in the AVR group and 44% in the MVR group. In our
series, aer 10 year tissue valve follow-up, we found
a rate of structural valve deterioration of 6.8% in the
AVR group and 10.7% in the MVR group. However,
the statistical dierence was insignicant (p = 0.183).
Regarding gender, as far as we know there has been no
report about the eects of gender associated with structural
valve deterioration aer tissue valve replacement, but we
found a structural valve deterioration rate of 11.6% in
females and 5.0% in males. e risk of structural valve
deterioration was 2.75 times (95%Cl: 1.04-7.28) more
signicant (p = 0.042) in female compared to male. e
suggested reason behind this result might be the use of a
smaller valve in female patients, which carries a higher
risk of structural valve deterioration.
4
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TABLE 3. Risk factors of structural valve deterioration.
Variable Number (%) or Mean ± SD Log-rank Multivariate Cox
Non- Deterioration test Adjusted HR regression
deterioration (n=21) (p-value) (95%Cl) (p-value)
(n=228)
Gender
Male(n=120) 114(95.0) 6(5.0) 0.069 1
Female(n=129) 114(88.4) 15(11.6) 2.75(1.04-7.28) 0.042*
Age (year) 69.8±10.7 63.05±15.7
Adultgroup;age≤60year(n=46) 38(82.6) 8(17.4) 0.021 3.33(1.34-8.29) 0.010*
Elderlygroup;age>60year(n=203) 190(93.6) 13(6.4) 1
Diagnosis
Regurgitation(n=153) 137(89.5) 16(10.5) 0.930
Stenosis(n=79) 75(94.9) 4(5.1)
Mixed(n=17) 16(94.1) 1(5.9)
Operation
AVR(n=148) 138(93.2) 10(6.8) 0.183
MVR(n=84) 75(89.3) 9(10.7)
DVR(n=17) 15(88.2) 2(11.8)
Type
PM(n=165) 153(92.7) 12(7.3) 0.052 1
PMmagna(n=57) 53(93.0) 4(7.0) 1.53(0.47-5.00) 0.479
Porcine(n=24) 20(83.3) 4(16.7) 2.22(0.70-7.01) 0.173
Trifecta(n=3) 2(66.7) 1(33.3) 23.71(2.69-209.09) 0.004*
CABG
yes(n=79) 75(94.9) 4(5.1) 0.176
no(n=170) 153(90.0) 17(10.0)
Fig 2. Freedom from structural valve deterioration for male and female patients.
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Fig 3. Freedom from structural valve deterioration for adult and elderly patients.
Elderly patients have been shown to be the most
powerful determinants of tissue valve longevity.
7
Rizzoli
et al.
3
reported the actual freedom from structural valve
deterioration in patients younger than 65 years old was
less than that seen in older patients (84.5% vs. 95%).
Similarly, we found the rate of structural valve deterioration
was 17.4% in the adult group (age ≤ 60 years old) and
6.4% in the elderly group (age > 60 years old). e risk
of structural valve deterioration was 3.33 times (95%Cl:
1.34-8.29) more signicant (p = 0.010) in the adult group
(age ≤ 60 years old) compared to the elderly group (age
> 60 years old).
e newer generations of tissue valves are more
durable than older generations of tissue valves. Likewise,
pericardial valves are more durable than porcine valves.
5
Bourguignon et al.
8,9
reported the long-term outcomes
of patients tted with a Carpentier–Edwards Perimount
valve in the aortic or mitral position. ey found that
the expected valve durability was 19.7 years in the aortic
position and 14.2 years in the mitral position.
In our series, aer 10 year tissue valve follow-up,
we found structural valve deterioration in 7.3% of cases
in the Perimount group, 7.0% in the Perimount Magna
group, 16.7% in the porcine group, and 33.3% in the
Trifecta group. However, the statistical dierence was
insignicant for the Carpentier–Edwards porcine compared
to the Carpentier-Edwards Perimount bovine pericardial
type (p = 0.173, 95%Cl: 0.70-7.01). Conversely, the St
Jude Trifecta bovine pericardial type was found to be a
signicant risk factor of structural valve deterioration
(p = 0.004, 95%Cl: 2.69-209.09), but it should be noted
that the total number of cases in the Trifecta group was
very small (n = 3) compared to in the other groups. So,
we cloud not conclude that they were more likely to
deteriorate than other types.
When reoperation is required, reoperative AVR or
MVR can be done safely. e recent mortality outcomes
were 5%-7% in reoperative AVR or reoperative MVR.
10,11
Besides, in the future, valve in valve transcatheter aortic
valve replacement (TAVR) and transcatheter mitral
valve replacement (TMVR) may be the second optional
treatments for patients who develop structural tissue
valve deterioration. In our series, there were 7 cases who
underwent reoperative AVR or reoperative MVR without
mortality and 2 cases who underwent TAVR without
mortality, while 12 structural valve deterioration cases
were still waiting for their denitive treatment soon.
CONCLUSION
In surgical populations that underwent valve
replacement at Siriraj Hospital with tissue valves, we
found an acceptable long-term durability of the new tissue
valve. e risk factors of structural valve deterioration
were the female gender and age ≤ 60 years. e freedom
from reoperation was not signicantly dierent in terms
of the valve position. However, we need to further re-
evaluate the data in the next 5-10 years to obtain longer
term results.
ACKNOWLEDGMENTS
The authors thank Miss Nachasa Khongchu of
Research Department, Faculty of Medicine Siriraj
Hospital, Mahidol University, Bangkok, ailand for
her professional statistical analysis.
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Wongkornrat et al.
