Original Article

Trifecta versus Perimount Magna Ease
aortic valves: Failure mechanisms

Asian Cardiovascular & Thoracic Annals
2022, Vol. 30(7) 797–806© The Author(s) 2022
Article reuse guidelines:
sagepub.com/journals-permissions
DOI: 10.1177/02184923221100994
journals.sagepub.com/home/aan

Ryo Suzuki , Toshiro Ito, Masato Suzuki, Shunsuke Ohori,
Ryo Takayanagi and Shiro Miura

Abstract
Background: There are increasing reports of early externally mounted pericardial Trifecta bioprosthesis failure. We
compared the hemodynamic performance of Trifecta and Carpentier–Edwards Perimount Magna Ease valves to determine the failure mechanism.
Methods: We retrospectively included 270 consecutive patients (age: 73.4 ± 8.2 years; 57.5% male; mean follow-up: 48.0
± 20.3 months) who underwent aortic valve replacement from 2014 to 2021 at a single center and compared the Trifecta(N = 137) and Carpentier–Edwards Perimount Magna Ease valve (N = 133) patients.
Results: The prosthetic valve major aortic regurgitation incidence was higher for the Trifecta than that for the
Carpentier–Edwards Perimount Magna Ease valve (6.3% vs. 0%, P < 0.009). Among the Trifecta failures, 33% developed
structural valve deterioration, but all requiring redo aortic valve replacement developed major prosthetic valve aortic
regurgitation. Freedom at 5 years from redo aortic valve replacement due to structural valve deterioration was signiﬁcantly lower for Trifecta (89.4% vs. 100%, P = 0.003). The reoperation hazards were determined for Trifecta (vs.
Carpentier–Edwards Perimount Magna Ease): 11.6 (1.47–90.9; P = 0.02), prosthetic valve aortic regurgitation: 2.38
(1.70–3.32; P < 0.01), structural valve deterioration: 20.82 (4.08–106.2; P < 0.01), 5-year mean transprosthetic pressure
gradient: 1.14 per 1-point increase (1.03–1.24; P = 0.007), and urgent surgery: 10.1 (2.59–39.0; P = 0.001). The Cox
regression analysis identiﬁed that prosthetic valve aortic regurgitation solely contributed to redo aortic valve replacement(hazard ratio: 2.38; conﬁdence intervals: 1.70–3.32).
Conclusions: Signiﬁcantly, more early failures occurred with the Trifecta valve than the Carpentier–Edwards Perimount
Magna Ease valve but the Trifecta showed reasonable mean transprosthetic pressure gradient over time. Prosthetic valve
aortic regurgitation and calciﬁc structural valve deterioration synergistically contributed to Trifecta valve failure
alternatively.
Keywords
Trifecta, Magna ease, reoperation, aortic valve replacement, structural valve deterioration, aortic prosthetic valve
regurgitation

Introduction
Aortic bioprostheses are the most common prostheses used
for aortic valve replacement (AVR) in the current era
because they have the advantage of avoiding anticoagulation in a predominantly older adult population because
bleeding complications due to anticoagulation cannot be
neglected. However, their drawback is greater susceptibility
to structural valve deterioration (SVD) over time.1 The
unique Trifecta design with valve leaﬂets manufactured
from a single bovine pericardial sheet externally mounted
onto a ﬂexible titanium stent enables a superior effective
oriﬁce area over internally mounted bioprostheses, especiallyfor smaller valve sizes.2,3 In addition, the Trifecta valve
eliminated alignment stitches on the top of the leaﬂets,
which is thought to be a plausible cause of early valve
failure in externally mounted bioprostheses.4 One study

Department of Cardiovascular Surgery, Hokkaido Ohno Memorial
Hospital, Hokkaido, Japan
Corresponding author:
Ryo Suzuki, Department of Cardiovascular Surgery, Hokkaido Ohno
Memorial Hospital, 2-1-16-1 Miyanosawa, Nishi-ku, Sapporo 063-0052,
Japan.
Email: ryosuzuki0722@yahoo.co.jp

798
reported favorable midterm 6-year outcomes of 710 Trifecta
valve patients implanted between 2007 and 2009. The rateof freedom from reoperation due to SVD was 97%.5
However, there have been an increasing number ofreports regarding early Trifecta valve failure,6,7 whichraises concerns about its durability. The Trifecta bioprosthesis appears to be associated with a greater rate of
SVD and a higher need for repeat AVR for SVD thanthose of some other bioprostheses.8 This study compared
the hemodynamic performance of Trifecta valves withthat of new or old-generation internally mounted valves
to determine the mechanism of failure.

Materials and methods
Study design
We retrospectively reviewed consecutive patients who underwent AVR between 2014 and 2021 at a single center. Of thesepatients, the Trifecta valve (St Jude Medical Inc., St Paul, MN,
USA), Carpentier–Edwards Perimount Magna Ease (CEP)
valve (Edwards Lifesciences, Inc., Irvine, CA, USA) werecompared preoperatively and postoperatively.

Data selection
We participated in the national database registry, Japan
Cardiovascular Surgery Database and had the right to use
our own data out of the database.

EthicsThe local ethics committee granted the permission for theuse of patients’ clinical data for the present observational
retrospective study (EC/IRB ﬁle number: 2022-3).

Inclusion criteria
Urgent cases, redo operations, AVR concomitant with othercardiac operations, and all causes of aortic valve disease
were included. Patients who received an initial aortic mechanical valve and underwent redo AVR with either Trifecta or
CEP within the observational period were included in the
study, regardless of the date of the mechanical valve implant.

Exclusion criteria
AVR cases using mechanical prostheses were excluded.
Patients who underwent initial AVR with either Trifecta
or CEP valve >10 years prior to the observation period
and had redo AVR within the observation period were
not considered as valve-failure events and were not enrolled
in the present study.
The choice of valve was at the discretion of the surgeon.
We gradually switched over to the Trifecta™ Valve with

Asian Cardiovascular & Thoracic Annals 30(7)Glide™ Technology (Trifecta GT) in October 2016.
Before this, ﬁrst-generation Trifecta valves were used.
Regarding operative techniques, median sternotomy was performed, and everting mattress sutures with pledgets wereplaced at the supra-annular position to secure the valves. We
checked the operative gradient with transesophageal echocardiography (TEE) when coming off the cardiopulmonary
bypass. With that, we were left with almost no or trivial transvalvular or paravalvular leakage (PVL) in the operating room.
What if there was signiﬁcant leakage found by TEE, weusually employed a second pump run to ﬁx the leakage.
Within the Trifecta group, patients receiving redo AVR
werecompared
with
non-redo
AVR
patients.
Echocardiography was performed in the short-term within 1month of post-implant and periodically thereafter for 5
years. Five-year echocardiography was deﬁned as either
right before the reintervention or at the end of the follow-up
period of 5 years. Univariate and multivariate analyses were
performed to investigate the factors associated with redo
AVR among the patients in the Trifecta and CEP groups.

Deﬁnition of SVD
SVD is an acquired intrinsic bioprosthetic valve abnormality characterized by deterioration of the leaﬂets, resulting inthickening, calciﬁcation, and tearing of the prosthetic valve
materials with eventual associated hemodynamic dysfunction, manifested as stenosis or regurgitation.9 Our deﬁnitionof SVD was based on the universal deﬁnitions proposed byRodriguez–Gabella et al.,10 which were modiﬁed to reﬂect
the availability of our retrospective data. Accordingly, SVD
was deﬁned as an increase in the mean transprosthetic pressure gradient (mTPG) by >20 mmHg with a concomitantdecrease in the effective oriﬁce area by >0.6 cm2 duringfollow-up.10 The cases showing a high mTPG from initial
echocardiography postoperatively were considered not tohave SVD but as having a patient prosthesis mismatch(PPM). Hence, SVD occurs over a certain period, while
PPM occurs immediately post-implant in patients who
receive an inappropriately sized valve, given the bodysurface area (BSA) of particular patients. Clinical valve
abnormalities that did not result from deterioration of thevalve tissue were not included in the deﬁnition of SVD.
These include PPM, device malposition, PVL, and prosthetic valve endocarditis (PVE).9 In general, SVD encompasses calciﬁc SVD and prosthetic aortic regurgitation(AR) due to tearing of the prosthetic valve. However, forthe purpose of distinguishing the mode of failure precisely,
we modiﬁed the deﬁnition so that prosthetic AR was
excluded from SVD.

Statistical analysis
SPSS version 22.0 (IBM Japan, Ltd, Tokyo, Japan) wasused for data analysis. Continuous variables wereSuzuki et al.
summarized as the mean ± standard deviation. The
Shapiro–Wilk test was used to assess normality.
Categorical data are expressed as frequencies and percentages. A paired t-test was used to compare the pressure gradients of a particular valve over time. An unpaired t-test wasused to compare two independent groups when the dependent variables were normally distributed. If they were notnormally distributed, a Mann–Whitney U-test was performed to compare two independent groups when thedependent variables were either ordinal or continuous.
Fisher’s exact test was used to compare categorical variables between the valve groups. The univariate and multivariate analyses were conducted for redo AVR among thepatients in the Trifecta and CEP groups. To avoid bias, acomparison between the two groups was performed todetermine whether there were any differences in the variables. Variables that were signiﬁcantly different in thiscomparison were then subjected to univariate analysis.
For the Cox regression analysis, variables with a P-valueof <0.05 in the univariate analysis were entered into theﬁnal multivariate analysis. The forward stepwise selection
was performed for the multivariate analysis. The results
are presented as hazard ratios (HRs) with corresponding
95% conﬁdence intervals (CIs). Freedom from reoperation
was compared by performing Kaplan–Meier survival analysis and log-rank tests. A two-tailed P-value of <0.05
was considered to be indicative of statistical signiﬁcance.

Results
A total of 270 consecutive patients (Trifecta valve (N =137) and CEP valve (N = 133)) admitted to our institution
between 2014 and 2021 were reviewed. Fifteen patients,
who underwent initial AVR with CEP valve >10 years
ago prior to the observation period and had redo AVR
within the observation period, were not enrolled in the
study. In total, 11.6% (16/137) and 18.8% (25/133) of thepatients in the Trifecta and CEP groups, respectively,
were aged 65 years or younger. No patients in the CEPgroup underwent redo AVR except one case complicatedby PVE. Nine patients in the Trifecta group underwent
redo AVR (6.5%, 9/134), including one who underwent
transcatheter AVR (TAVR). Of these, three patients werecomplicated by PVE and PVL, which was a consequenceof the endocarditis process. Therefore, six patients in the
Trifecta group developed prosthesis failure due to the new
onset of severe prosthetic AR because of a cusp tear,which required redo AVR (4.47%). Among these six
patients, only one received the Trifecta GT; the remaining
ﬁve patients received a ﬁrst-generation Trifecta valve at
the initial AVR. Three patients in their 60s received surgicalredo AVR, two patients in their 70s had anatomical issues
that prevented them from receiving TAVR, and they
instead received surgical redo AVR, and one patient intheir 70s underwent valve-in-valve TAVR. This AR

799
disorder was characterized by a partial cusp tear alongwith the stent post, as shown in Figure 1. Cusp tears
included 3 of the right coronary cusp (RCC) tears, 1 of noncoronary cusp (NCC) tear, 1 each of RCC and NCC stent
post-tear, and 1 of left coronary cusp tear. Two patients in
the Trifecta group developed pannus formation on the prosthesis, which was conﬁrmed by the last echocardiographythat exhibited a low pressure gradient (6 and 11 mmHg).
The average duration from initial AVR with a Trifecta
valve to redo AVR was 46.8 months. The preoperative
characteristics, operative data, and outcomes of the twogroups are summarized in Table 1. Heart failure symptoms
based on the New York Heart Association classiﬁcation
were worse in the Trifecta group than in the CEP group,
but the difference was not signiﬁcant. The mTPG at 1
month was lower in the Trifecta than the CEP group (7.7
± 3.1 vs. 9.3 ± 2.8 mmHg; P < 0.05), but the 5-year
results were similar. There were no signiﬁcant differencesin total operating time, pump time, or concomitant procedures between the groups. Thirty-day mortality was
similar among the groups (3.6 vs. 3.0, 0%). Other
comorbidities were similar among the groups, except for
prolonged ventilation (5.8% vs. 0.8, 0% P < 0.05). The incidence of SVD was greater in the Trifecta group, although
the difference was not statistically signiﬁcant (Trifecta vs.
CEP: 3.9% (5/127) versus 0.9% (1/112)). The rate of prosthetic valve AR was signiﬁcantly greater in the Trifecta
group than in the CEP group (6.3% vs. 0% for major AR
P < 0.009).

Redo AVR patients versus non-redo AVR patients
within the Trifecta group
Results from a comparative analysis are presented inTable 2. All six patients who underwent redo AVR werecomplicated by major prosthetic valve AR (>III). None ofthe patients in the non-redo AVR group developed major
prosthetic valve AR. Of the six patients, two were complicated by calciﬁc SVD (33%). The 5-year mTPG was higher
in the early failure group than in the non-redo AVR group(16.6 ± 9.0 vs. 9.6 ± 4.5 mmHg P = 0.001), although the
1-month mTPGs were similar between the groups (7.8 ±3.6 vs. 7.7 ± 3.1 mmHg). The incidence of SVD was signiﬁcantly higher in the redo AVR group than in the
non-redo AVR group (2/6, 33.3%; 3/119, 2.5%; P = 0.018).

Longitudinal hemodynamics of prostheses measured
by echocardiography
The mTPG measured by echocardiography was followed
over time (Table 3). The follow-up period was 5 years.
The follow-up rate was 89% (122/137) for the Trifecta
group and 89.4% (119/133) for the CEP group. The
mTPG was greater for the CEP group than for the Trifecta

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Asian Cardiovascular & Thoracic Annals 30(7)Figure 1. Representative photographs of explanted Trifecta valves. Arrows indicate a tear around the commissure post.

group at 1-month post-implant (9.3 ± 3.1 vs. 8.0 ± 3.3 mmHg,
P = 0.011). The 5-year mTPGs were similar between thegroups. There was a gradual increase in the gradient for the
Trifecta valve over time, but the absolute difference wassmall (8.0 ± 3.3 to 10.0 ± 5.1 mmHg; P < 0.05).

Freedom from redo AVR
The average observation period was 41.2 ± 20.3 for the
Trifecta group and 53.8 ± 19.1 months for the CEP group.
The estimated freedom from redo AVR overall at 60
months was 87.4% ± 4.4% in the Trifecta group and99.2% ± 0.8% in the CEP group as shown by the Kaplan–
Meier curve in Figure 2A. The freedom from redo AVR
at 5 years due to SVD, excluding PVE patients, was
89.4% ± 4.3% in the Trifecta group and 100% in the CEPgroup (Figure 2B) (log-rank test; P = 0.003).

Cox regression analysis for redo AVR
Univariate analysis revealed that the Trifecta valve (HR:11.62; CI: 1.47–90.9; P = 0.02), prosthetic valve AR (HR2.38; CI: 1.70–3.32; P < 0.01), 5-year mTPG (HR: 1.14
per 1-point increase; CI: 1.03–1.24; P < 0.01), SVD (HR20.8; CI: 4.08–106; P < 0.01) and urgent surgery (HR: 10;
CI: 2.6–39; P < 0.01) contributed to redo AVR (Table 4).
However, multivariate analysis identiﬁed prosthetic valve
AR as the sole strong contributor to redo AVR (HR:2.38; CI: 1.70–3.32; P < 0.05).

Discussion
The 5-year rate of redo AVR due to SVD was 4% for the
Trifecta valve, which was close to the 4%–6% rates previously reported.7 Among the six Trifecta failure cases requiring reintervention in our study, only one received Trifecta
GT; the remaining ﬁve patients received a ﬁrst-generation
Trifecta valve at the initial AVR. It has been reported thatthe rate of reintervention in patients who received the ﬁrst-

generation Trifecta valve is more than double that of those
who received the Trifecta GT at the initial AVR, at 1.86%
and 0.56%, respectively.11 Early failure of the ﬁrstgeneration Trifecta valve prompted improvement in thedesign of Trifecta GT, including new anticalciﬁcation technology and the Glide Technology for ease of implantationand minimal distortion during implantation. Despite thesechanges, they reported the early failure of Trifecta GTwith cusp tear.12 Furthermore, Trifecta GT valves were naturally implanted at later dates; therefore, their lower reintervention rate may reﬂect the shorter duration of observation.
If standardized for time, the true-reintervention rate may
differ.11 When patients required reintervention for a
failing Trifecta valve, we provided a redo surgical AVRor valve-in-valve TAVR option. The 10-year durability of
the TAVR valve in tissue valve is now being guaranteed
but not for 15 years. Therefore, for patients younger than
70 years, we usually offer surgical redo AVR over the
TAVR option given their life expectancy; patients receiving
valve-in-valve TAVR following a failing Trifecta valve
may require a third surgery. For patients older than 70
years, we offer both options. If the patient has any anatomical issues that would prevent them from receiving the
TAVR, we offer the surgical redo AVR option. The
5-year rate of redo AVR for the CEP group was 0%.
Kaplan–Meier curve analysis gave similar ﬁndings for theestimated freedom from redo AVR due to SVD at 5
years. Other studies have found that the Trifecta valve
failed signiﬁcantly earlier than the CEP valve due to SVD
over 5–7 years.1,13 In general, externally mounted pericardial bioprostheses such as Trifecta valve show superior
hemodynamics, but they are known to cause leaﬂet tears,
leading to early valve failure.14 In vitro experiments comparing internally and externally mounted tissue valves identiﬁed the reason for the failure of an externally mounted
prosthesis as leaﬂet tears around the commissure posts
after 400 billion cycles of mechanical wear tests.15 A
single pericardial leaﬂet wrapped around stent frames
repeatedly experienced leaﬂet to stent contact, which

Suzuki et al.

801

Table 1. Comparison of baseline characteristics, operative data, and postoperative outcomes between the Trifecta and Perimount
Magna Ease valves.

Age (years)
Sex
Male
FemaleBSA
BMI
Preoperative creatinine
Diabetes melliltus
Dyslipidemia
Heart failure (NYHA)
No, I, II
III, IV
Preoperative shock
History of coronary artery disease
Arrhythmia
Hemodialysis
Hypertension
Chronic lung disease
Cerebrovascular disease
Ejection fraction (%)
Aortic valve area
Aortic stenosis or regurgitation
Pure aortic stenosis
ASR
Total operation time (h)Cardiopulmonary bypass time
Aortic cross-clamp time
Aortic prosthesis size
Urgent or emergent
Concomitant procedure
Aorta
CABG
Prosthetic valve AR
No
TrivialI
II
III
IV
1-Month mTPG
5-Year mTPG
SVD
30-Day mortality
StrokeRenal failure
Atrial ﬁbrillation
Prolonged ventilation

Trifecta
N = 137 (%)

CEP
N = 133 (%)

P-value

74.3 ± 8.9

73.1 ± 8.3

0.230
0.714

a
b

76 (55.5)
61 (44.5)
1.6 ± 0.2
24.1 ± 4.3
1.4 ± 1.9
37 (27.0)
78 (56.9)

70 (52.6)
63 (47.4)
1.6 ± 0.2
23.5 ± 3.6
1.4 ± 1.7
30 (22.6)
75 (56.4)

0.325
0.234
0.912
0.403
>0.999
0.056

a
a
a
b
b
b

116 (84.7)
21 (15.3)
2 (1.5)46 (33.6)
39 (28.5)
8 (5.8)126 (92.0)
8 (5.8)20 (14.6)
64.1 ± 12.6
0.82 ± 0.26

123 (92.5)
10 (7.5)
0 (0.0)46 (34.6)
36 (27.1)
12 (9.0)115 (86.5)
10 (7.6)
24 (18.0)
65.3 ± 12.4
0.85 ± 0.25

0.498
0.898
0.892
0.359
0.171
0.270
0.511
0.433
0.320
0.183

b
b
b
b
b
c
b
a
a
b

46 (33.6)
91 (66.4)
6.3 ± 2.6
3.5 ± 1.7
2.4 ± 1.0
21.0 [21.0–25.0]
7 (5.1)34 (25.6)
99 (74.4)
6.3 ± 2.4
3.2 ± 1.3
2.2 ± 0.9
23.0 [21–23]
3 (2.3)20 (14.6)
36 (26.3)

15 (11.3)
35 (26.3)

0.975
0.115
0.104
0.123
0.335
0.625
0.471
>0.999
0.009

a
a
a
c
b
b
b
b
c

96 (75.6)
16 (12.6)
5 (3.9)2 (1.6)
1 (0.8)7 (5.5)7.7 ± 3.1
10.0 ± 5.1
5 (3.9)5 (3.6)6 (4.4)6 (4.4)63 (46.0)
8 (5.8)98 (87.5)
14 (12.5)
0 (0.0)0 (0.0)0 (0.0)0 (0.0)9.3 ± 2.8
9.0 ± 3.5
1 (0.9)4 (3.0)2 (1.5)2 (1.5)52 (39.1)
1 (0.8)

0.000
0.179
0.218
>0.999
0.282
0.282
0.270
0.036

a
a
b
b
b
b
b
b

Data are expressed as the mean ± SD or n (%). Boldface indicates statistical signiﬁcance (P < 0.05). BSA: body surface area; BMI: body mass index; CABG:
coronary artery bypass grafting; ASR: aortic stenosis and regurgitation; mTPG: mean transprosthetic valvular pressure gradient; SVD: structural valve
deterioration; CEP: Carpentier–Edwards Perimount Magna Ease.
a
Unpaired t-test (P-value).
b
Fisher’s exact test (P-value).
cMann–Whitney U-test (P-value).

802

Asian Cardiovascular & Thoracic Annals 30(7)Table 2. Comparison between the early failure and non-failure patients within the Trifecta group.

Age (years)
Sex
Male
FemaleBSA
BMI
Preoperative creatinine
Diabetes mellitus
Dyslipidemia
Heart failure (NYHA)
No, I, II
III, IV
Preoperative shock
History of coronary artery disease
Arrhythmia
Hemodialysis
Hypertension
Chronic lung disease
Cerebrovascular disease
Ejection fraction (%)
Total operation time
Cardiopulmonary bypass time
Aortic cross-clamp time
Aortic prosthesis size
Urgent or emergent
Concomitant procedure
Aorta
CABG
Prosthetic valve AR
No
TrivialI
II
III
IV
1-Month mTPG
5-Year mTPG
SVD
30-Day mortality
StrokeRenal failure
Atrial ﬁbrillation
Prolonged ventilation

No failure

Redo AVR

N = 128 (%)

N = 6 (%)

P-value

74.6 ± 8.5

69.5 ± 4.0

0.146
0.691

a
b

70 (54.7)
58 (45.3)
1.6 ± 0.2
24.2 ± 4.3
1.4 ± 2.0
36 (28.1)
71 (55.5)

4 (66.7)
2 (33.3)
1.6 ± 0.1
20.6 ± 2.6
0.9 ± 0.2
0 (0.0)4 (66.7)

0.562
0.044
0.555
0.191
0.694
>0.999

a
a
a
b
b
b

109 (85.2)
19 (14.8)
2 (1.6)44 (34.4)
36 (28.1)
8 (6.3)117 (91.4)
7 (5.5)18 (14.1)
64.3 ± 12.7
6.1 ± 2.4
3.4 ± 1.6
2.4 ± 1.0
23.0
4 (3.1)

5 (83.3)
1 (16.7)
0 (0.0)1 (16.7)
2 (33.3)
0 (0.0)6 (100.0)
0 (0.0)1 (16.7)
60.0 ± 13.3
6.0 ± 2.5
4.5 ± 0.8
2.5 ± 0.6
23.0
3 (50.0)>0.9990.663>0.999>0.999>0.9990.638>0.999
0.418
0.941
0.113
0.808
0.922
0.002
0.083
0.594
0.191
0.000

b
b
b
b
b
c
b
a
a
a
a
c
b
b
b
b
c

0.974
0.001
0.018
>0.999>0.999>0.9990.419>0.999

a
a
b
b
b
b
b
b

21.0–25.0

19 (14.8)
36 (28.1)

0 (0.0)0 (0.0)94 (80.3)
16 (13.7)
5 (4.3)2 (1.7)0 (0.0)0 (0.0)7.7 ± 3.1
9.6 ± 4.5
3 (2.5)4 (3.1)6 (4.7)5 (3.9)59 (46.1)
8 (6.3)0 (0.0)0 (0.0)0 (0.0)0 (0.0)1 (16.7)
5 (83.3)
7.8 ± 3.6
16.6 ± 9.0
2 (33.3)
0 (0.0)0 (0.0)0 (0.0)4 (66.7)
0 (0.0)18.5–25.5

Data are expressed as the mean ± SD or n (%). Boldface indicates statistical signiﬁcance (P < 0.05). BSA: body surface area; BMI: body mass index; CABG:
coronary artery bypass grafting; ASR: aortic stenosis and regurgitation; mTPG: mean transprosthetic valvular pressure gradient; SVD: structural valve
deterioration; AVR: aortic valve replacement; AR: aortic regurgitation.
aUnpaired t-test (P-value).
b
Fisher’s exact test (P-value).
cMann–Whitney U-test (P-value).

seemed to cause tissue abrasion and ultimately tears or holes in
the leaﬂet at commissure posts of the Trifecta valve. In clinicalsettings, there have been reports of early Trifecta valve failurescaused by cusp tears which lead to prosthetic valve AR.4,16,17

On the other hand, Yongue et al.3 reported that the main modeof Trifecta valve failure was calciﬁc SVD rather than prosthetic valve AR. Consequently, the mode that contributes tothe valve failure remains unknown.

Suzuki et al.

803

Low transprosthetic valvular gradient and relatively
low rate of SVD in Trifecta valve
We observed that the 5-year mTPG was higher in the redo
AVR than in the non-redo AVR patients within the Trifecta
group (Table 2). However, the 5-year mTPG was low andsimilar between the Trifecta and CEP valve groups(Table 3). Good hemodynamic performance and durabilityof the Trifecta valve in relatively old patients with small
BSA in which very low mean gradients at discharge thatwere maintained through 7 years of follow-up have beenreported in the past.8 Biancari et al.13 and Fukuhara et al.6
reported that they implanted an average of 22.7–23 mm
Trifecta valves in patients with BSAs of 1.9–2.0, whereas
we implanted an average of 23 mm Trifecta valves in
Asian patients with a BSA of 1.6 ± 0.2. As a result, low

Table 3. Mean transprosthetic gradient trends after implant overtime.

N
Trifecta
CEP
P-value(TF vs.
CEP)

122
119

1 Month
(mmHg)

5-Year(mmHg)

8.0 ± 3.3
9.3 ± 3.1
0.011

10.0 ± 5.1
9.1 ± 3.5
b 0.236

P-Value(withingroup)
0.001
0.606

a
a

mTPG was maintained for over 5 years. The reason forthis was that we used the ultrasonic surgical aspirator forthe aortic annulus debridement, which enabled us to placea larger valve.18 For bioprostheses, it is crucial to expose
to a low-pressure environment from the durability
standpoint.
Similarly, the incidence of SVD was higher in the redo
AVR patients than in the non-redo AVR patients within
the Trifecta group; however, the comparison between the
Trifecta and CEP valve groups did not show a signiﬁcantdifference, suggesting that the mTPG and incidence of
SVD were relatively low in all cohorts of our study.
Many original articles with a high volume of Trifecta
cases revealed that most of the failed Trifecta valves werecomplicated by SVD or high mTPG at 5–7 years, postoperatively (Table 5). One study reported that the averageincrease in mTPG between the initial echocardiography
after the ﬁrst AVR and reintervention was 31 ±17 mmHg, which is considered to be SVD, suggestingthat all Trifecta failure cases requiring redo AVR were complicated by calciﬁc SVD.7 However, in our study, the rate of
SVD in the failed Trifecta patients was only 33% and theirmTPG remained low over time, although it was increased
from 7.8 ± 3.6 before discharge to 16.6 ± 9 mmHg on thelast echocardiographic assessment.

b

TF: Trifecta; CEP: Carpentier–Edwards Perimount Magna Ease.
a
Unpaired t-test (P-value).
b
Fisher’s exact test (P-value).
cMann–Whitney U-test (P-value).

High rate of prosthetic valve Ar in Trifecta valve
patients
On the other hand, the rate of major prosthetic valve AR(greater than III) was consistently greater in the Trifecta
group than in the CEP group in all comparisons either

Figure 2. Kaplan–Meier 5-year freedom from reoperation for the Trifecta and Perimount Magna Ease valves. (A) All reoperation
cohorts; (B) reoperation due to structural valve deterioration (SVD).

804

Asian Cardiovascular & Thoracic Annals 30(7)Table 4. Cox regression analysis for redo AVR.
Univariate analysis

Age (per 1 year)
Valve type Trifecta (vs. CEP)
BMI (per 1)
BSA (per 0.1)
Preoperative creatinine (per 1)
Aortic valve area (per 0.1)
Ejection fraction (%) (per 1)
Aortic prosthesis size (per 1)
1-Month mTPG (per 1)
5-Year mTPG (per 1)
Prosthetic valve AR
SVD
Heart failure (NYHA) (per 1)
Urgent or emergent

Multivariate analysis

HR

95% CI

P-value

HR

0.955
11.62
0.901
1.026
0.886
1.377
0.989
0.976
0.856
1.135
2.378
20.8151.735
10.0640.897–1.016
1.47–90.9
0.753–1.078
0.738–1.426
0.466–1.685
0.965–1.966
0.946–1.033
0.741–1.285
0.652–1.125
1.034–1.244
1.702–3.324
4.079–106.2
0.971–3.102
2.596–39.03

0.147
0.020
0.255
0.879
0.713
0.078
0.610
0.863
0.265
0.007
0.000
0.000
0.063
0.001

－
n.e.
－
－
－
－
－
－
－
－
2.378
n.e.
－
n.e.

95% CI

P-value

1.702–3.324

0.000

CEP: Carpentier–Edwards Perimount Magna Ease; BSA: body surface area; BMI: body mass index; HR: hazard ratio; 95% CI: conﬁdence interval; n.e.: notentered; mTPG mean transprosthetic valvular pressure gradient; SVD: structural valve deterioration; AVR: aortic valve replacement; AR: aortic regurgitation.
Boldface indicates statistical signiﬁcance (P < 0.05).

Table 5. Original articles with high-volume Trifecta valve patients.
5- To 7-year mean pressure gradientamong failed valves

Observation period andcase number

Rate of prosthesis failure due to AR
component in SVD

Kattach andcolleagues1
Biancarni andcolleagues13
Fukuhara et al.6

35 ± 21mmHg

17/24 (71%)

Yongue andcolleagues3
Stubeda andcolleagues19
Kaneyuki andcolleagues7

17 mmHg

5 Years TF (n = 836)
CEP (n = 1031)
7 Years TF (n = 851)
CEP (n = 1365)
7 Years TF (n = 508)
Others (n = 550)
5 Years TF (n = 2298)
CEP (n = 2298)
6 Years TF (n = 453)
CEP (n = 711)
6 Years TF (n = 107)

Authors

76 (max) mmHg
N/A

N/A
42 ± 17 mmHg

7/13 (53.8%)
12/22 (54.5%)
AR% in TF vs. CEP overall (21% vs.
11%)
5/10 (50%)
4/7 (57%)

CEP: Carpentier–Edwards Perimount Magna Ease; TF: Trifecta; SVD: structural valve deterioration.

within the Trifecta groups or among the groups (Tables 1
and 2). Therefore, univariate analysis revealed that prosthetic valve AR and 5-year mTPG and SVD contributed
to redo AVR; however, Cox regression analysis showedthat prosthetic valve AR was the sole strong contributor
to redo AVR. Fukuhara et al.6 reported that there was no
prosthetic valve AR in the failed CEP valves, whereas theprosthetic AR component was involved in >50% of failed
Trifecta cases, which led to repeat AVR within 7 years. It
may be premature to conclude that prosthetic valve AR isthe sole contributor to redo AVR as the incidence of SVD
occurs around 7 years generally for any kind of bioprosthesis.9 Given our follow-up duration, further follow-up isrequired to elucidate the cause of failure. It is worth

mentioning that the important features of Trifecta valve
failure are different from others as patients tend todevelop cardiogenic shock due to the acute onset of wideopen AR. Therefore, the requirement of an emergency
surgery was commonly seen, and consequently, the outcomes were worse.1 Univariate analysis identiﬁed emergent
surgery as a factor associated with redo AVR for Trifecta
valve in our study (Table 4).

Prosthetic valve Ar and calciﬁc SVD synergisticallycontributed to the Trifecta valve failure
A fair number of original articles with high-volume Trifecta
patients have revealed the presence of a 5- to 7-year highSuzuki et al.
prosthetic gradients on echocardiography and prosthetic
valve AR (Table 5). The only report from the Cleveland
Clinic3 afﬁrmed that the main mode of Trifecta valve
failure was calciﬁc SVD rather than prosthetic valve AR
due to cusp tear within 5 years post-implant. However,
the incidence of prosthetic valve AR in Trifecta patientswas twice as much as that of CEP cases overall in theirstudy.3 Thus, we believe that some AR component contributed to the SVD. The majority of those original articles
showed that most of the failed Trifecta valves exhibitedhigh mTPG at 5–7 years post-implant and the prosthetic
AR component was involved in >50% of failed Trifecta
patients, which led to the repeat AVR within 5–7 years(Table 5). In addition to other bioprostheses, some percentage of Trifecta valves usually develop SVD around 7 years
after implant.6 However, prosthetic valve AR occurs relatively early up to 3–5 years after implant in Trifecta
patients.3,16,17 Therefore, there was some time delay
between those two events. Given this delay, we speculated
that SVD had started with prosthetic valve AR, which was
exacerbated by calciﬁc SVD later with the development of
leaﬂet thickening that can affect leaﬂet coaptation. As aresult, prosthetic valve AR and calciﬁc SVD synergisticallycontributed to early Trifecta valve failure in phases.

Limitations
This was basically a retrospective, observational study withlimited statistical power to elucidate the mechanisms of
how and why Trifecta valve failed earlier than the
Perimount valve. A future follow-up study with alarge-scale protocol is needed for clariﬁcation. Although
we included all patients receiving either a Trifecta valve
or Perimount valve between 2014 and 2021, only 10%–20% were aged 65 years or younger. In general, SVD
occurs earlier in the process post-implant for young
patients.20 Therefore, if we had a greater fraction ofyoung patients receiving bioprosthesis in our study population, SVD would have occurred earlier and there would
have been less time delay between the prosthetic valve
AR and calciﬁc SVD events. However, it was clear thatthose two factors contributed to Trifecta valve failuresynergistically.

Conclusion
The Trifecta valve failed signiﬁcantly earlier than the CEP
valve, although its hemodynamic performance showed areasonable transprosthetic pressure gradient over time.
Prosthetic valve AR and calciﬁc SVD synergistically contributed to early Trifecta valve failure alternatively.
Acknowledgement
Author thank the statistical support provided by Yosuke Sasaki.

805
Declaration of conﬂicting interests
The authors declared no potential conﬂicts of interest with respect
to the research, authorship, and/or publication of this article.

Funding
The authors received no ﬁnancial support for the research, authorship, and/or publication of this article.

Ethical approval
The local ethics committee granted permission for the use ofpatients’ clinical data for the present observational retrospective
study (EC/IRB ﬁle number: 2022-3).

Informed consent
All patients provided signed informed consent to allow clinicaland administrative data storage and utilization for scientiﬁc
purposes.

ORCID iD
Ryo Suzuki

https://orcid.org/0000-0003-4682-7233

References
1. Kattach H, Shah BN, Harden S, et al. Premature structural
failure of trifecta bioprosthesis in midterm follow-up: a singlecenter study. Ann Thorac Surg 2021; 112(5): 1424–1431.
2. Kalra A, Rehman H, Ramchandani M, et al. Early trifecta
valve failure: report of a cluster of cases from a tertiary carereferral center. J Thorac Cardiovasc Surg 2017; 154: 1235–
1240.
3. Yongue C, Lopez DC, Soltesz EG, et al. Durability and performance of 2298 trifecta aortic valve prostheses: apropensity-matched analysis. Ann Thorac Surg 2021; 2021:
1198–1205.
4. Eichinger S, Badreldin AMA and Eichinger WB. Early
degeneration caused by cusp tear of ﬁrst-generation trifecta
bioprosthesis. Ann Thorac Surg 2018; 106: e297–e298.
5. Goldman S, Cheung A, Bavaria JE, et al. Midterm, multicenter clinical and haemodynamic results for the Trifecta aortic
pericardial valve. J Thorac Cardiovasc Surg 2017; 153:
561–569.e2.
6. Fukuhara S, Shiomi S, Yang B, et al. Early structural valve
degeneration of trifecta bioprosthesis. Ann Thorac Surg
2020; 109: 720–727.
7. Kaneyuki D, Nakajima H, Asakura T, et al. Early ﬁrstgeneration trifecta valve failure: a case series and a reviewof the literature. Ann Thorac Surg 2020; 109: 86–92.
8. Mortelé A, Dereu A, Bové T, et al. Mid-term clinical andhaemodynamic results after aortic valve replacement with
the Trifecta bioprosthesis. Interact Cardiovasc Thorac Surg
2021: ivab205.
9. Dvir D, Bourguignon T, Otto CM, et al. Standardized deﬁnition of structural valve degeneration for surgical and806transcatheter bioprosthetic aortic valves. Circulation 2018;
137: 388–399.
10. Rodriguez-Gabella T, Voisine P, Puri R, et al. Aortic bioprosthetic valve durability incidence, mechanisms, predictors, andmanagement of surgical and transcatheter valve degeneration.
JACC 2017; 70: 1013–1028.
11. Fard A, Mahmood Z, Nair S, et al. Analysis of incidence andreasons for re-intervention after aortic valve replacement
using the Trifecta aortic bioprosthesis. Curr Probl Cardiol
2022; 101125.
12. Tchouta L, Liesman D, Kim K, et al. Early failure of the
Trifecta GT bioprostheses. JTCVS Tech 2020; 4: 106–108.
13. Biancari F, Valtola A, Juvonen T, et al. Trifecta versus perimount magna ease aortic valve prostheses. Ann Thorac Surg
2020; 110: 879–888.
14. Schoen FJ, Fernandez J, Gonzalez-Lavin L, et al. Causes offailure and pathologic ﬁndings in surgically removed
Ionescu-Shiley standard bovine pericardial heart valve bioprostheses: emphasis on progressive structural deterioration.
Circulation 1987; 76: 618–627.

Asian Cardiovascular & Thoracic Annals 30(7)15. Vriesendorp MD, de Lind van Wijngaarden RAF, Rao V,
et al. An in vitro comparison of internally versus externallymounted leaﬂets in surgical aortic bioprostheses. Interact
Cardiovasc Thorac Surg 2020; 30: 417–423.
16. Schaeffer T, Berdajs D and Reuthebuch O. Early surgicalaortic bioprosthesis failure caused by cusp tear: a word ofcaution. Clin Case Rep 2021; 9: 286–290.
17. Hamamoto M, Kobayashi T, Ozawa M, et al. Pure cusp tear oftrifecta bioprosthesis 2 years after aortic valve replacement.
Ann Thorac Cardiovasc Surg 2017; 23: 157–160.
18. Kellner HJ, Pracki P, Hildebrandt A, et al. Aortic valve
debridement by ultrasonic surgical aspirator in degenerative,
aortic valve stenosis: follow-up with Doppler echocardiography. Eur J Cardio-Thorac Surg 1996; 10: 498–504.
19. Stubeda H, Aliter H, Gainer R, et al. Six-year follow-up of aortic
valve reoperation rates: Carpentier-Edwards Perimount versus St
Jude Medical Trifecta. J Card Surg 2020; 35: 3347–3353.
20. Percy ED, Harloff M, Hirji S, et al. Subclinical structural
valve degeneration in young patients with bioprosthetic
aortic valves. Ann Thorac Surg 2021; 111: 1486–1493.