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International Journal of Cardiovascular Sciences. 2016;29(2):110-117
ORIGINAL MANUSCRIPT
Prosthesis-Patient Mismatch in Individuals Undergoing Aortic
Valve Replacement
Ramsés Miotto, Marcos Venicio Garcia Joaquim
Instituto de Cardiologia de Santa Catarina – São José, SC – Brazil
Abstract
Background: Prosthesis-patient mismatch (PPM) in patients undergoing aortic valve replacement surgery is the
subject of many research studies and is associated with worse prognosis in the long term.
Objectives: To evaluate the incidence of PPM after aortic valve replacement surgery and characterize the clinical
profile of patients undergoing this surgery.
Methods: Cross-sectional observational retrospective study of 53 patients hospitalized for surgical treatment of
severe aortic valve stenosis from January 2014 to June 2015. Three models of bioprosthesis and a metal prosthesis
model were used. Indexed effective orifice area (iEOA) was calculated by dividing the effective orifice area provided
by the prosthesis manufacturer by the body surface area of the recipient patient. The presence of PPM was defined
when iEOA <0.90 cm²/m².
Results: The average age of patients was 65,8±9,9. Male sex prevailed. Overall mortality rate was 11.3%. PPM
occurred in 32.0% of patients, mostly of which were moderate degree. The prosthesis Biocor showed 70.5% of PPM
while the Braile prosthesis showed no case. There was no difference in the reduction of transvalvular aortic gradients
in the postoperative period between the groups with and without PPM.
Conclusions: The patients profile is similar to that described in the literature, the incidence of PPM is high, varying
greatly between the prosthesis models. There was no difference in the reduction of postoperative gradients between
the groups with or without PPM.
Keywords: Aortic valve stenosis; Heart valve prosthesis implantation; Prosthesis fitting; Prosthesis failure
Introduction
Aortic stenosis is the most common acquired valvular
heart disease and its relevance, in terms of public health,
rises progressively with population aging, considering
that 2-4% of people older than 70 are affected by the
disease.1-5 The valve replacement surgery is the treatment
of choice for aortic stenosis, considering the significant
change of the natural evolution as clearly demonstrated
by the studies of Schwarz et al.6 and Pellikka et al.7
Since the definition of prosthesis-patient mismatch (PPM)
by Rahimtoola in 1978, this topic has been the subject of
many research studies due to its influence on the
prognosis of patients.8 Prosthesis-patient mismatch is
considered when the relationship between the effective
orifice area of ​​the valve prosthesis and the body surface
area of the patient is reduced compared to the healthy
native valve. Particularly, patients undergoing valve
replacement surgery through aortic stenosis have a
higher incidence of PPM compared to patients with aortic
regurgitation, which can be explained by the degeneration
and calcification of the aortic annulus and consequent
narrowing present in aortic stenosis; aortic regurgitation
is usually associated with the enlargement of the aortic
annulus.
Corresponding author: Ramsés Miotto
Rua Adolfo Donato da Silva, s/n – Praia Comprida – 88103-901 – São José, SC – Brazil
E-mail: [email protected]
DOI: 10.5935/2359-4802.20160018
Manuscript received on March 1, 2016; approved on April 12, 2016; revised on April 28, 2016.
Int J Cardiovasc Sci. 2016;29(2):110-117
Original Manuscript
ABBREVIATIONS AND
ACRONYMS
•ECC — endogenous
creatinine clearance
•ICSC – Instituto de
Cardiologia de Santa
Catarina
•IEOA — indexed effective
orifice area
•MTG — mean transvalvular
gradient
•PG — peak gradient
•PPM — prosthesis-patient
mismatch
Miotto and Joaquim
Prosthesis-Patient Mismatch in Valve Replacement
PPM in classified into three
levels of severity: mild, when
the indexed effective orifice
area is <0.90 cm²/m² and
≥0,85 cm²/m²; moderate, when
<0.85 cm² and ≥0,65 cm²/m²; and
severe, when <0.65 cm²/m².8-11
Prosthesis-patient mismatch is
associated with less regression
of symptoms and left ventricular
hypertrophy, maintenance
of elevated transvalvular
gradients, decreased durability
of prostheses and increased
mortality in the long term.10,12-16
This study aims to assess the incidence of PPM after aortic
valve replacement surgery and characterize the clinical
profile of patients undergoing this surgery.
The prostheses used and evaluated in this study were:
the bioprosthesis Carpentier-Edwards Perimount model
2900 manufactured by Edwards Lifesciences (Irvine,
California, USA); the bioprosthesis Biocor model B30
and the mechanical prosthesis model AJ-501 both
manufactured by St Jude Medical (Saint Paul, Minnesota,
USA) and the Braile bioprosthesis manufactured by
Braile Biomédica (São José do Rio Preto, São Paulo,
Brazil). The effective orifice area values taken from the
manufacturers’ technical specifications obtained from
in vitro tests conducted by the manufacturers (Chart 1)
were used.
Chart 1
Effective orifice area in cm² of valve prostheses
Prosthesis
Size
19
21
23
25
27
29
Carpentier (cm²)
1.3
1.5
1.8
2.0
2.1
2.2
Methods
St Jude Biocor (cm²)
NA
1.2
1.4
1.7
2.1
NA
Cross-sectional observational retrospective study of
53 patients hospitalized at Instituto de Cardiologia de
Santa Catarina (ICSC) for surgical treatment of severe
aortic valve stenosis from January 2014 to June 2015.
St Jude Standard (cm²) 1.16 1.51 2.03 2.59 3.08 NA
Braile (cm²)
1.3
1.6
1.9
2.4
2.6
3.1
NA = non-available
This study has been approved by the Research
Ethics Committee of the institution under no. CAAE
45315515.2.0000.0113. Because this is a retrospective
study, Informed Consent Form was not required.
The institution’s Statistical Services database was used
to find all patients undergoing aortic valve replacement
in the period cited and 93 individuals were identified.
The study included patients older than 18, with severe
stenosis of the native aortic valve who underwent aortic
valve replacement (with or without coronary artery
bypass grafting associated).
Patients with other moderate or severe valve disease
associated, with moderate or severe double valve lesion,
patients with prosthetic valve and those undergoing
valve re-replacement were excluded.
At the end, there was a sample of 53 patients whose data
were collected through the electronic medical records
system Micromed and the database of the institution’s
Echocardiography Service.
For data collection, performed by one of the authors, a
handwritten sheet establishing criteria and routine to
evaluate the medical records was used. Echocardiography
tests were performed during hospitalization for
cardiologists specializing in echocardiography using the
device Vivid E9 with the M5S transducer manufactured
by GE (Waukesha, Wisconsin, USA).
Ejection fraction was obtained by the biplane method;
aortic valve area was obtained by the continuity equation
method and the peak and mean gradients were obtained
by continuous-wave left parasternal, apical or
supraclavicular window Doppler.
Body surface area was calculated by the Du Bois17 formula
and the indexed effective orifice area was obtained by
dividing the effective orifice area of the prosthesis by the
body surface area retrospectively from the anthropometric
measurements stated on the patient records. Such
measure did not influence the surgeons’ prosthesis
choices.
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Prosthesis-Patient Mismatch in Valve Replacement
For the endogenous creatinine clearance (ECC), we used
the CKD-EPI18 formula, which considers the serum
creatinine, age, sex and ethnicity.
Patients using antihypertensive medication were
considered hypertensive; diabetics were considered to
be those using oral hypoglycemic medication and/or
insulin; dyslipidemia was considered when there was
documentation through preoperative laboratory tests
and/or use of lipid-lowering medication.
The presence of coronary artery disease was determined
in case of prior coronary event or previous coronary
procedure or coronary angiography, demonstrating
stenosis greater than 50%. To define chronic obstructive
pulmonary disease, spirometry results were used when
available and/or use of bronchodilators and inhaled
corticosteroids. Peripheral occlusive vascular disease was
defined when there was history of ischemic vascular
event, bypass surgery, previous angioplasty or
amputation.
To estimate operative risk, EuroSCORE II was
calculated retrospectively from patient records data
through the electronic calculator available at
www.euroscore.org/calc.html.
For the electrocardiographic diagnosis of left
ventricular hypertrophy, at least one of the following
criteria was considered: Sokolow-Lyon, Sokolow-LyonRappaport; Lewis; Cornell, Gubner-Ungerleider and
Romhilt-Estes.19,20
Data for categorical variables were described by absolute
count and percentage and analyzed using Fisher’s exact
test or chi-square test.
Data related to continuous variables were expressed as
mean and standard deviation. Intra- and intergroup
comparison of continuous variables was performed
using paired and/or unpaired t-test; p<0.05 was
considered significant. Data were analyzed using
Microsoft Excel®.
Results
The general characteristics of the group are shown in Table
1. The sample was predominantly male and mean age of
65.8±9.9 years. Most had clinical manifestations of dyspnea
(NYHA functional class II and III) and angina pectoris.
The predominant subtype of aortic stenosis in these
patients was degenerative involvement with calcification.
Int J Cardiovasc Sci. 2016;29(2):110-117
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Table 1
General characteristics of the study sample (n=53)
Variables
Age in years (mean±SD)
Male gender (%)
Values
65.8 ± 9.9
62.3
Comorbidities (%)
Hypertension
56.6
Diabetes
30.2
Dyslipidemia
39.6
CAD
41.5
PVOD
5.7
COPD
11.3
ECC < 60 mL/min
26.4
Clinical conditions (%)
Dyspnea
83.0
Chest pain
60.4
Syncope
14.0
LVH on ECG
82.0
Functional Class (NYHA) (%)
Class I
9.6
Class II
30.8
Class III
44.2
Class ignored
15.4
Anthropometry (mean±SD)
Body surface area (m²)
1.8 ± 0.2
Weight (kg)
71.0 ± 14.0
Height (cm)
154.0 ± 32.1
Valve disease etiology (%)
Three-valve calcified
75.4
Bicuspid valve
20.8
Rheumatic disease
3.8
EuroSCORE II rating (mean±SD)
2.1 ± 1.6
Isolated valve replacement (n, %)
38/53 – 71.7
Valve replacement combined with MR (n,%)
15/53 – 28.3
Minutes under CPB (mean±SD)
Minutes in aortic clamping (mean±SD)
98.8 ± 40.9
75 ± 28.9
CAD – coronary artery disease; PVOD – peripheral occlusive vascular
disease; COPD – chronic obstructive pulmonary disease; ECC –
endogenous creatinine clearance; LVH – left ventricular hypertrophy;
ECG – electrocardiogram; NYHA – New York Heart Association;
CABG – coronary artery bypass grafting; CPB – cardiopulmonary
bypass; SD – standard deviation
Int J Cardiovasc Sci. 2016;29(2):110-117
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Miotto and Joaquim
Prosthesis-Patient Mismatch in Valve Replacement
On average, patients had left ventricular hypertrophy,
preserved ejection fraction and high transvalvular
gradients, as it can be seen on the preoperative
echocardiography on Table 2.
Table 2
Preoperative echocardiographic characteristics of the
study sample
Aortic valve area (cm²)
0.7 ± 0.2
Table 4 presents postoperative echocardiography data of
the patients evaluated: none of them presented prosthesis
dysfunction or severe paravalvular failure; there was mild
paravalvular failure in 15.6% and moderate in 2.2% of
patients. Peak and mean transvalvar aortic gradients were
31.5±11.3 mmHg and 17.2±7.5 mmHg, respectively.
Table 4
Postoperative echocardiographic characteristics of the
study sample
Ejection fraction (%)
57.0 ± 18.9
IVS thickness (mm)
14.3 ± 2.7
Prosthesis dysfunction (%)
0.0
LVPW thickness (mm)
13.5 ± 2.4
Mild paravalvular failure (%)
15.6
Peak transvalvular gradient (mmHg)
86.7 ± 26.0
Mean transvalvular gradient (mmHg)
56.1 ± 19.2
Moderate paravalvular failure (%)
2.2
Severe paravalvular failure (%)
0.0
Values expressed as mean±standard deviation.
IVS – interventricular septum; LVPW – left ventricular posterior
wall
Chart 1 specifies the effective orifice areas of the
prosthesis according to the manufacturer and the
nominal size, obtained from material published by the
industry (values obtained by in vitro tests).
Table 3 presents hospitalization time and hospital
mortality data. The hospitalized patients studied waited
28.4±12.6 days on average to undergo surgery, amounting
to an average hospital stay of 45.1±20.2 days. In-hospital
mortality was 20.0% for those who underwent combined
surgery and 7.9% for those who underwent isolated valve
replacement.
Table 3
Hospitalization of the study sample
Pre-op hospitalization days (mean±SD)
28.4 ± 12.6
Hospitalization days in the ICU
postoperatively (mean±SD)
8.1 ± 15.6
Post-op days in the ward (mean±SD)
16.7 ± 17.1
Total hospital stay (mean±SD)
45.1 ± 20.2
Overall hospital mortality (n,%)
6/53 – 11.3
Hospital mortality in combined surgery (n,%)
3/15 – 20.0
Hospital mortality in isolated valve
replacement (n,%)
3/38 – 7.9
Pre-op – preoperative; Post-op – post-operative; SD – standard
deviation
Peak transvalvular gradient (mmHg)
(mean±SD)
31.5 ± 11.3
Mean transvalvar gradient (mmHg)
(mean±SD)
17.2 ± 7.5
There was no statistically significant difference in the
reduction of the postoperative transvalvular gradient among
the patients who did or did not present PPM (Table 5).
A total of 17 (32.0%) patients presented PPM, of which 3
(5.6%) presented mild PPM, 13 (24.5%) presented
moderate PPM and 1 (1.8%), severe PPM.
Analyzing by prosthesis, 10 (18.8%) patients had Braile
bioprosthesis implanted; 17 (32.0%) received the
prosthesis St Jude Biocor, 8 (15.0%) received Carpentier
and 18 (34.0%) patients received the metal prosthesis St.
Jude Standard. All 53 patients had a statistically significant
reduction in peak (PG) and mean (MG) transvalvular
gradient compared to the preoperative value (Figure 1).
No patient receiving the Braile prosthesis presented PPM.
The following presented PPM: for the Biocor prosthesis
12 (70.5%) of the 17 patients; for the Carpentier prosthesis,
3 (37.5%) of the 8 patients; and 2 (11.1%) of the 18 patients
who received the metal St. Jude Standard prosthesis.
Between Biocor and Carpentier, there was no statistically
significant difference in the incidence of PPM. There
was a significant difference between Biocor and the
metal St. Jude prosthesis (p=0.005) and between Biocor
and Braille (p=0.0001).
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Table 5
Comparison of reduction of gradients between the groups studied
Patients with PPM (n=17)
Patients without PPM (n=36)
p value
Pre-op peak grad
89.4 ± 24.9
85.4 ± 26.7
ns
Pre-op mean grad
57.6 ± 18.9
55.4 ± 19.5
ns
Post-op peak grad
34.3 ± 10.2
30.3 ± 11.7
ns
Post-op mean grad
17.1 ± 5.6
17.2 ± 8.1
ns
Pre- and post-operative mean peak gradients expressed in mmHg
Grad – gradient; Pre-op – preoperative; Mean grad – mean gradient; Post-op – post-operative; ns – non-significant; PPM – prosthesis-patient
mismatch
Figure 1
Distribution of cases of PPM and pre- and postoperative gradients by prosthesis.
PPM – prosthesis-patient mismatch; PG – peak gradient; MG – mean gradient; Pre-op – preoperative period; post-op – postoperative
period.
Discussion
The profile of the patients in this study is very similar to
that found by other authors,11,14,21-26 but the study sample
showed higher percentage of patients with diabetes and
chronic kidney disease. The larger number of patients
with renal failure may be related to different definition
criteria adopted: while in most studies the creatinine
value was used, in this study, the endogenous creatinine
clearance was used.
All patients had a significant reduction of transvalvular
gradients in relation to the preoperative period, however,
there was no difference between patients with or
without PPM. Mean postoperative PG values around
31.5±11.3 mmHg were found. Flameng et al.14 found a
significant difference in postoperative PG among
patients with or without PPM, with mean values of
29.0±11.2 mmHg and 22.9±9.3 mmHg, respectively.
The study of Hanayama et al. 25 found an average
postoperative PG of 23.9±9.8 mmHg and an average MG
of 13.6±6.5 mmHg, and showed a significant difference
with a lower postoperative MG among patients without
PPM.25 These contradictory results, found in this study,
are probably due to the small sample size and the absence
Int J Cardiovasc Sci. 2016;29(2):110-117
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Miotto and Joaquim
Prosthesis-Patient Mismatch in Valve Replacement
of data on the medical records for postoperative
echocardiography.
is much higher than our findings. Both authors used vitro
data for the calculations.
The general hospital mortality found in this study was
11.3%; however, for patients undergoing isolated aortic
valve replacement, it was 7.9% — lower than in another
study conducted in Brazil in 2011, with patients
undergoing isolated aortic valve replacement21 and
similar to the overall mortality of 7.2% obtained by
Dayan et al.22 Howell et al.23 published a study in
which they obtained mortality of 3.8% in a sample of
944 patients undergoing isolated aortic valve
replacement,23 which may be even lower according to
other authors.24,25,27
Other authors have used in vivo measurements to
calculate the iEOA, including Blais et al.11 who found
36.0% of moderate PPM and 2.0% severe PPM.
Bleiziffer et al.30 found 33.4% of moderate PPM and 6.3%
of severe PPM. Flameng et al.14 identified 46.0% of
moderate PPM and 4.0% of severe PPM. Yap et al.31
described 6.6% of severe PPM and Dayan et al.22 reported
62.8% of moderate PPM and 1.8% of severe PPM.
Several studies have shown that aortic valve replacement
surgery associated with coronary artery bypass grafting
increases mortality. In this study, 20% hospital mortality
was found for combined surgery, which can be
considered high, compared to the findings in the
literature, ranging from 5.0 to 8.2%.23,27,28
There is conflicting information about the best iEOA
calculation methodology. Pibarot et al.9 affirmed that the
measurements from in vitro tests are similar to in vivo
findings, suggesting that, for the evaluation of metal
prostheses, in vitro measurements should be used, while
others suggest that in vitro values ​​are overestimated
and which should be based on in vivo tests from
echocardiography.29,30
For the Braile prosthesis, no reference on in vivo
hemodynamic performance was found, and in vitro data
were used for all prostheses. Interestingly, none of the
patients who received the Braile prosthesis presented
PPM and the postoperative gradients tended to be
smaller, but without statistical significance. Even
considering that the EOA supplied by the manufacturers
are overestimated, still, for the Biocor, the metal prosthesis
St. Jude and Carpentier-Edwards Perimount 2900, there
is a high prevalence of PPM, with worse performance
found in the Biocor prosthesis. Similarly, this PPM
proportion may be underestimated for the same reason.
In this study, 32.0% patients with PPM were identified.
Only one (1.88%) patient had severe PPM. Kaminishi
et al.24 obtained a total of 8.5% of patients with PPM,
however, in their study, they used only mechanical
prostheses, stentless models and Carpentier, known to
have better hemodynamic profile. 24 Howell et al. 23
concluded that 8.6% of patients had severe PPM, which
There is a difference in the incidence of PPM in studies
with in vivo data compared to those with in vitro data
for the definition of PPM, which reinforces the argument
that in vitro test values ​​are overestimated.
Although the study sample is based on in vitro data, it
was very similar to studies using in vivo data, which
showed that the problem of PPM is very common,
although severe cases are a minority.
The problem of PPM is very common in the literature, as
well as in the ICSC, where the prevalence is similar to that
of major studies. This clinical situation has important
prognostic implications and there should be efforts to
minimize it, using surgeries to increase the aortic annulus
and implant prostheses with a better hemodynamic profile.
Some of the medical records searched included no data
on the control echocardiography conducted before
hospital discharge or during follow-up, which may have
affected the calculation of postoperative gradients.
However, this did not invalidate the research.
The iEOA were calculated based on the technical
specifications of the manufacturer of each prosthesis and
no patient was submitted to control echocardiography
to calculate iEOA using the continuity equation. In
anyway, one should try to avoid the PPM by calculating
the preoperative prosthesis size based on the specifications
disclosed by the suppliers, although they can be obtained
using non-standard methodologies and suffer commercial
industry bias.32
Conclusions
The general characteristics of patients undergoing
surgery are similar to those of other published studies.
The incidence of PPM is high, but there are sharp
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Prosthesis-Patient Mismatch in Valve Replacement
differences between the prosthesis models. Regarding
the gradients, there was no significant difference between
patients with or without PPM.
Potential Conflicts of Interest
This study has no relevant conflicts of interest.
Int J Cardiovasc Sci. 2016;29(2):110-117
Original Manuscript
Sources of Funding
This study had no external funding sources.
Academic Association
This manuscript is part of the Final Term Paper of Ramsés
Miotto for the Medical Residency Program in Cardiology at
Instituto de Cardiologia de Santa Catarina.
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