Original Cardiovascular

Hemodynamic Results and Mid-term Follow-up of

850 19 to 23 mm Perimount Magna Ease Valves
Amedeo Anselmi1 Vito Giovanni Ruggieri2 Réda Belhaj Soulami1 Erwan Flécher1 Thierry Langanay1
Hervé Corbineau1 Alain Leguerrier1 Jean-Philippe Verhoye1

1 Division of Thoracic and Cardiovascular Surgery, Pontchaillou Address for correspondence Amedeo Anselmi, MD, PhD, Division of
University Hospital, Rennes, France Thoracic and Cardiovascular Surgery, Pontchaillou University
2 Division of Thoracic and Cardiovascular Surgery, Robert Debré Hospital, Rennes, France (e-mail: amedeo.anselmi@alice.it).
University Hospital, Reims, France

Thorac Cardiovasc Surg

Abstract Background Aortic valve replacement (AVR) in small aortic roots remains a surgical
dilemma with a higher risk of patient-prosthesis mismatch (PPM). The Perimount
Magna Ease aortic valve (PMEAV) represents an attractive device in such cases. We
examined the early hemodynamic performance, the mid-term outcomes of the PMEAV,
and the impact of PPM on outcome and functional class.

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Methods We performed a retrospective analysis of prospectively collected in-hospital
data, and a prospective single-center follow-up of 849 patients who received a 19 to
23 mm PMEAV (2008–2014). Concomitant mitral or tricuspid replacement was the
exclusion criterion. Early hemodynamic features were prospectively collected; mid-
term follow-up was conducted according to current guidelines.
Results Size of implanted prosthesis was 19 mm in 11.5% of patients, 21 mm in
36.9%, and 23 mm in 51.5%. Operative mortality was 4.5% (3.1% for isolated AVR). The
rate of severe and moderate PPMs was significantly higher in the 19 mm group. Follow-
up was 99.9% complete (3.7
2 years). Actuarial freedom from structural valve
deterioration (SVD) at 5 years was 99.1%. At stratified Kaplan–Meier’s analysis, PPM
and age <70 years were associated with SVD. PPM was not associated with worse
Keywords functional status (New York Heart Association class) or mortality at follow-up.
► aortic valve Conclusion This series shows satisfactory clinical outcomes of the PMEAV implanted
replacement in small aortic annuli at mid-term follow-up. Although PPM may occur in smaller sizes, it
► patient-prosthesis has limited clinical impact, and it is not associated with mid-term mortality or worse
mismatch functional class. Few SVD events are evidenced; nonetheless, limited follow-up
► follow-up duration and its methodology need to be considered.

Introduction
Aortic valve replacement (AVR) in small aortic roots remains
a surgical dilemma with a higher risk of residual gradient.1 It
has been reported that residual gradient has negative impact
on patient’s survival and quality of life1–4; hence, annulus
enlargement and stentless valves have been proposed. It is
however established that both these options have minor
clinical effect on long-term outcomes,5–7 while many sur-
geons are still reluctant to use them. These patients are
particularly challenging, since average results in terms of
transvalvular gradient can be observed after transcatheter
valve-in-valve procedure, which further limits the treatment
options in case of structural valve deterioration (SVD).
Contemporary third-generation stented pericardial pros-
theses demonstrate comparable hemodynamic performance
than stentless valves.8 Moreover, supra-annular implanta-
tion provides a larger effective orifice area9 (EOA). The

received © Georg Thieme Verlag KG DOI https://doi.org/

January 30, 2018 Stuttgart · New York 10.1055/s-0038-1660517.
accepted after revision ISSN 0171-6425.
April 14, 2018
Follow-up Magna Ease Valve Anselmi et al.

Carpentier–Edwards Perimount Magna Ease aortic valve Table 1 Baseline characteristics in the population (N ¼ 849)
(PMEAV) was introduced in our institution in 2008.10,11 It
is built on a flexible cobalt–chromium alloy stent, intended Preoperative characteristics
to absorb energy and reduce leaflet stress. In addition to its Age (y) 74.1
9.1
supra-annular design, the PMEAV is characterized by lower Male gender 406 (47.8%)
profile, sleek commissure posts and a low stent base. Such
NYHA status NYHA I or II 569 (67.1%)
features are intended to enhance the ease of implant and
hemodynamic performance, particularly in patients with NYHA III or IV 279 (32.9%)
small aortic annuli. Several institutions have reported excel- LVEF (%) 61.1
10.9
lent hemodynamic results of the PMEAV among other supra- COPD 92 (10.8%)
annular bioprostheses.12–14 Nevertheless, follow-up data are
Renal insufficiency 40 (4.7%)
not available so far.
In this investigation, the primary purpose was to present Peripheral artery disease 224 (26.3%)
our single-center experience and mid-term durability (aver- Native valve Prevalent stenosis 805 (94.7%)
age follow-up: 3.7 years, 2,992.2 patient-years, up to dysfunction
Prevalent 45 (5.3%)
7.6 years) of 850 consecutive PMEAV implants for AVR in regurgitation
small aortic annuli (i.e., 19, 21, and 23 mm). As secondary Infective endocarditis 23 (2.7%)
objectives, we evaluate the postoperative hemodynamic
Logistic EuroSCORE I 8.6%
performance of the PMEAV, the rate of patient-prosthesis
mismatch (PPM), and its clinical impact in the entire cohort. Echocardiographic Mean TVG (mm Hg) 50.1
16.3
data
EOA (cm2) 0.74
0.23

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Materials and Methods Previous cardiac surgery 26 (3%)

From February 2008 to December 2014, 849 patients under-
went AVR with the PMEAV in our institution. For 2008 to
2014 period, the database contains a total of 4,547 AVRs with
a bioprosthesis (all models), 657 AVRs with a mechanical
valve, and 441 transcatheter aortic valve implantations
(TAVIs) (the TAVI program started in 2009). Our policy was
to implant the Edwards Perimount prosthesis in larger annuli
(25–29 mm) and to use the PMEAV only in smaller aortic
annuli (19–23 mm), to facilitate device implantation and
improve hemodynamics in these challenging cases. Pre-,
intra-, and early postoperative data were prospectively col-
lected, as described earlier,15 within an electronic database
at the time of patients’ discharge. The database includes all
patients undergoing cardiac surgery at our institution, and is
managed by research nurses while recurrently checked for
completeness and consistency by the surgical team. Baseline
variables as reported in ►Table 1 are defined according to the
logistic EuroSCORE I calculator. In-hospital data were
obtained and analyzed retrospectively from this prospec-
tively collected database.
The performance of mitral valve replacement or tricuspid
valve replacement at the same time of AVR was an exclusion
criterion. Any other concomitant procedure or history of
previous cardiac surgery was not an exclusion criterion.
Valve-related adverse events were defined according to
the current guidelines,16 including SVD, nonstructural valve
dysfunction (NSVD), and operated valve infective endocar-
ditis (IE). SVD was defined as dysfunction or deterioration of
the prosthesis inherent to the structure of the valve. We
differentiate between SVD (the outcome addressed in this
article) and reoperation for SVD. PPM was characterized
using the indexed EOA1,17,18 (iEOA) and defined as moderate
when the iEOA was between 0.65 and 0.85 cm2/m2 and
severe when less than 0.65 cm2/m2. According to recom-
mendations,16 SVD was defined as any intrinsic dysfunction
Abbreviations: COPD, chronic obstructive pulmonary disease; EOA,
effective orifice area; LVEF, left ventricular ejection fraction; NYHA, New
York Heart Association; TVG, transvalvular gradient.
or deterioration involving the prosthesis, exclusive of infec-
tion and thrombosis. In particular, in case of average gradient
increase by 50% with respect to discharge echocardiogra-
phy, or at least one digit increase in intraprosthetic regur-
gitation, SVD was considered.
Thromboembolic complications were defined as the
occurrence of either valve thrombosis or embolic events
(either cerebral or noncerebral). Valve-related mortality
was defined as death consequent to any adverse event
relevant to the device or to reoperation on the implanted
valve. All deaths with no established cause (including sudden
deaths) were considered as valve related.
Since all patients’ data were managed anonymously and
given that this investigation did not affect the standard
treatment protocols, patient’s informed consent for inclu-
sion was waived. Our institutional database is declared to the
CNIL online database (Commission Nationale de l’Informa-
tique et des Libertés/National Committee for Informatics and
Freedom under the number 1207754) in accordance with the
French law.
Surgical and Postoperative Protocol
In this series, all devices were implanted through median
sternotomy under mild hypothermic cardiopulmonary
bypass. Myocardial protection was achieved through cold
crystalloid cardioplegia or isothermic hyperkalemic blood
cardioplegia. Valves were implanted according to our stan-
dard protocol: supra-annular technique using interrupted,
noneverting, U-shaped stitches.
All patients were submitted to the same postoperative
protocol, including lifelong use of antiaggregant therapy,

Thoracic and Cardiovascular Surgeon


started from the first postoperative day. Administration of
anticoagulants was not implemented unless otherwise indi-
cated, and the early postoperative antithrombotic prophylaxis
was performed by subcutaneous injection of low-molecular-
weight heparin (4,000 IU/d) until mobilization of patients.
Echocardiographic examinations were performed preo-
peratively and at discharge. Corresponding data about valve
function were prospectively collected as part of our electro-
nic database. All echocardiography examinations used for
calculation of iEOA and rate of PPM were performed in-
house, and before discharge after the index operation.
Patients who died in-hospital before performance of post-
operative echocardiography were considered to have miss-
ing data with respect to echocardiography-related
end points, and therefore, excluded from the analyses. No
modifications to our standard surgical and postoperative
protocol were made during this investigation.
Follow-up
Territorial practitioners (referring cardiologists and general
practitioners) were provided with questionnaires sent
through the surface mail. Questionnaires inquired about
vital status of the patient, the occurrence of any adverse
event and the time of occurrence, as well as their functional
status (New York Heart Association [NYHA] class). In case of
incomplete or missing information, the patients themselves
or their families were contacted; local governmental autho-
rities were asked to confirm the patients’ vital status in case
of missing data. The nature of valve-related and nonvalve-
related adverse events was adjudicated by consensus.
End Points
• Operative mortality (occurring within 30 days of surgery
or later if during the same hospitalization) and early
postoperative complications (both valve related and non-
valve related)
• Hemodynamic performance and PPM rates at patient
discharge
Fig. 1 (A) Study design. (B) Overall survival curve.
Follow-up Magna Ease Valve Anselmi et al.
• Mid-term overall survival, event-free survival, SVD-free
survival and reoperation-free survival, NSVD- and IE-free
survival
• Impact of PPM on mid-term survival and functional status
(NYHA class).
Statistical Analysis
Statistical analysis was performed using the SAS software
version 9.33 (SAS Institute Inc., Cary, North Carolina,
United States). Continuous data are presented as mean

standard deviation and categorical variables as percentages.
Normality of data distribution was evaluated through the
Kolmogorov–Smirnoff’s test. Intergroup comparison was
done using the Student’s t-test (continuous variables) and
the chi-square test (categorical variables). All tests are two
tailed, and the α level was set at 0.05. Follow-up analysis was
performed using the Kaplan–Meier’s actuarial method and
the corresponding survival curves were built. Opposed
curves were compared using the log-rank statistic. Compet-
ing risks method was not used because of the small number
of events at follow-up.
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Results
The study design is given in ►Fig. 1A . During the investiga-
tion period, 849 patients received 850 PMEAV. The baseline
characteristics are summarized in ►Table 1. The average
logistic EuroSCORE I was 8.6%; patients in this cohort pre-
sented most frequently degenerative aortic stenosis (94.7%)
as indication to AVR. Interestingly, the average logistic Euro-
SCORE I was greater in patients with smaller annuli (10.45,
9.14, and 7.95% for patients implanted with 19-, 21-, and 23-
mm prostheses, respectively, p < 0.001). There were few
nonelective cases (4%). Perioperative characteristics are pre-
sented in ►Table 2.
Overall operative mortality was 4.1% (N ¼ 35), while
logistic EuroSCORE predicted 8.6%. Operative mortality
was significantly higher in case of concomitant procedure
when compared with isolated AVR (6.3 vs. 3.1%, respectively,
Thoracic and Cardiovascular Surgeon
Follow-up Magna Ease Valve Anselmi et al.

Table 2 Intraoperative characteristics in the population (N ¼ 849) 19-mm PMEAV were the most likely to present severe and
moderate mismatch (21.6 and 43.2%, respectively).
Intraoperative characteristics
Nonelective procedures 34 (4%) Follow-up Results
Implanted PMEAV 19 mm 98 (11.5%) ►Table 5 reports mid-term follow-up results. We achieved
size an almost complete follow-up (99.9%), at 3.7
2.0 years
21 mm 314 (36.9%)
(range: 0.02–7.6 years) with a total of 2,992.36 patient-years.
23 mm 438 (51.5%) Among the 814 followed-up patients, 106 late deaths (13%)
Associated CABG 198 (23.3%) were observed, occurring at an average of 2.9 years (range:
procedure 0.08–7.0 years) after surgery. Causes of late death were
Ascending aorta 27 (3.2%)
extracardiac in 6.3% of patients, cardiac nonvalvular in
Annulus enlargement 0 (0%)
2.6%, and valve related in 4.2% of cases (including 3.1% of
Mitral/tricuspid 45 (5.2%) unknown causes, 0.6% due to IE, and 0.5% due to stroke). At
valve repair
5 years, the overall survival in the entire cohort was
Other procedures 25 (2.9%) 82.7
1.7% (►Fig. 1B) and the freedom from valve-related
CPB time (min) 71.5
32.6 death reached 93.8
1.1% (►Fig. 2A).
Cross-clamp 57.1
28.6 During follow-up, nine SVD events (1.1%) occurred at an
time (min) average 4.5
2.0 years after implantation (range: 1.1–
6.7 years). Detail of SVD events is given in ►Table 5. The 5-
Abbreviations: CABG, coronary artery bypass grafting; CPB, cardiopul-
years Kaplan–Meier’s survival free from SVD was
monary bypass; PMEAV, Perimount Magna Ease aortic valve.
99.1%
0.5 (►Fig. 2B). Two patients required reintervention

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for SVD at 6.1 and 4.4 years after index surgery (one redo AVR
p ¼ 0.029). The details of early postoperative complications and one valve-in-valve procedure); one patient is currently
are listed in ►Table 3. scheduled for a valve-in-valve procedure. Two patients were
Operative mortality was related to cardiac causes in 1.6% deceased (in one case for noncardiac causes and in the other
of patients and extracardiac in 2.5%. There was no case of for prosthetic endocarditis later after occurrence of SVD).
early valve-related death. Early valve-related complications Prosthesis size was not found to be associated with SVD at
were observed in 1% of cases, namely, nine strokes (1%), of 5 years (p ¼ 0.89, Kaplan–Meier). Stratified Kaplan–Meier’s
which five were permanent (0.6%). There was no case of early analysis indicated significantly worse freedom from SVD in
IE, SVD, or NSVD. Four patients required early reintervention younger patients (<70 years at implantation, p ¼ 0.004). At
(0.5%). All reinterventions were related to cardiac failure, follow-up, no association was found between PPM and late
requiring coronary artery bypass grafting in three patients mortality in the entire cohort at 5 years (survival:
(0.3%), and leading to patient’s death in two cases (0.2%). 83.1%
2.2 in absence of PPM vs. 84.8%
2.8 in presence
►Table 4 reports hemodynamic valve performance at of moderate or severe PPM, log-rank p ¼ 0.48) (►Fig. 2C).
discharge. Average mean transvalvular gradient was The prosthesis size (19, 21, or 23 mm) was not associated
14
5.0 mm Hg and average iEOA was 0.9
0.2 cm2/m2 at with late mortality either (p ¼ 0.53, Kaplan–Meier). As
control transthoracic ecocardiography (TTE). Overall, 6.5% of expected, age at surgery older than 80 years was strongly
patients presented severe PPM and 29.6% presented moderate associated with late mortality (p < 0.001, Kaplan–Meier)
PPM at discharge. As expected, patients implanted with the (►Fig. 2D).
One NSVD event occurred in the entire cohort at 1.9 years,
the 5-year actuarial freedom from NSVD being 99.8%
0.2.
Table 3 Early postoperative outcomes in the population During follow-up, 16 late IE were observed in our cohort (2%)
(N ¼ 849) at an average 1.7 years
1.5 (range: 0.2–4.9 years), requiring
reoperation in 4 cases (0.5%) and leading to patient’s death in
Early postoperative outcomes 5 cases (0.6%); the rests were managed through medical
Operative mortality Overall 35 (4.1%) therapy alone. Thus, the 5-year actuarial freedom from IE
was 97.2%
0.7 (linearized rate: 0.53).
Isolated AVR (3.1%)
Overall, six patients required valve-related reintervention
Associated (6.3%) during the follow-up, after 2.6
2.7 years (two for SVD and
procedures
four for IE). The 5-year Kaplan–Meier survival free from
Valve related 0 (0%) reoperation for all causes was 99.2
0.4% (linearized rate:
Cardiac related 13 (1.6%) 0.17).
Operative mortality 19 mm 5.1% NYHA functional classification among surviving patients
by PMEAV size at follow-up was class I in 45.4% of cases, class II in 48.5%,
21 mm 4.1%
class III in 5.9%, and class IV in 0.2%. There was no significant
23 mm 3.9% difference in the rate of severe or moderate PPM at discharge
Abbreviations: AVR, aortic valve replacement; PMEAV, Perimount among patients who were in NYHA classes I and II at follow-
Magna Ease aortic valve. up (35.6%) versus patients who were in classes III and IV

Thoracic and Cardiovascular Surgeon

 Follow-up Magna Ease Valve Anselmi et al.

Table 4 Hemodynamics at discharge

Overall 19 mm 21 mm 23 mm
Mean transvalvular 14.3
5.0 17.9
5.5 14.1
5.0 13.7
4.7
gradient (mm Hg)
EOA (cm2) 1.5
0.21 1.2
0.19 1.5
0.2 1.8
0.22
iEOA (cm2/m2) 0.92
0.20 0.79
0.15 0.91
0.19 0.97
0.21
No PPM 476 (63.6%) 31 (35.2%) 173 (62.2%) 475 (70.9%)
Moderate PPM 224 (29.9%) 38 (43.2%) 87 (31.3%) 99 (25.9%)
Severe PPM 49 (6.5%) 19 (21.6%) 18 (6.5%) 12 (3.1%)

Abbreviations: EOA, effective orifice area; iEOA, indexed EOA; PPM, patient-prosthesis mismatch.

(41.7%) (p ¼ 0.46). Similarly, there was no significant differ-
ence in the rate of severe PPM at discharge among patients
who were in NYHA classes I and II at follow-up (6.2%) versus
those who were in classes III and IV (8.3%) (p ¼ 0.49).
Discussion
studies with an increased all-cause and cardiac mortal-
ities.1–3 It has been reported that these negative outcomes
are even more frequent in younger patients and in those with
impaired ejection fraction, regardless to PPM severity.3,4,19
Herein, PPM was defined in compliance with the Valve
Academic Research Consortium-2 (VARC-2) criteria,17 con-
cordantly with Blais et al.18 As well, other methods to

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PPM is not an uncommon issue after AVR (20–70% rate of calculate PPM exist (American Society of Echocardiography
PPM is reported after AVR).1 It has been associated by some criteria20). Although the rate of PPM in a given population

Fig. 2 (A) Freedom from valve-related death. (B) Survival free from SVD. (C) Stratified overall survival (moderate/severe PPM vs. no PPM).
(D) Stratified overall survival (age subgroups). PPM, patient-prosthesis mismatch; SVD, structural valve deterioration.

Thoracic and Cardiovascular Surgeon

Follow-up Magna Ease Valve Anselmi et al.

Table 5 Follow-up results hemodynamic performances after AVR. In addition to hemo-

dynamic performance, durability is a key requirement for
Follow-up results (mean 3.7
2.0 y [range: 0.02–7.6 y]) modern bioprostheses, given the increasing tendency to
Late mortality Overall 106 (13%) implant them in younger patients. Moreover, in the era of
Extracardiac 50 (6.2%) transcatheter therapies, such features represent a reference
of comparison with TAVI.
Cardiac related 21 (2.6%)
The PMEAV is the latest generation of the Edwards Life-
Valve Overall 34 (4.2%) sciences stented bovine pericardial prosthesis, with a supra-
related
Stroke 4 (0.5%) annular design and lower profile to improve implantability;
Infective 5 (0.6%) these features are particularly useful in small roots. More-
endocarditis over, the actual internal diameter of PMEAV represents at
Unknown 25 (3.1%) this time the largest available in these small sizes (19–
cause 23 mm) among the other stented bioprostheses. This ele-
ment can be particularly interesting in case of future trans-
Late mortality 19 mm 11.8%
by PMEAV catheter valve-in-valve procedure.
21 mm 12.3%
size One of our main findings is that the PMEAV is not immune
23 mm 13.8% from PPM in small aortic roots, as we report 6.5 and 29.9% of
Late mortality Absent 12.2% severe and moderate PPMs, respectively, in the entire cohort.
by PPM As expected, severe PPM is more prevalent in 19 and 21 mm
Moderate/ 11.4%
severe PPM devices (21.6 and 6.5%, respectively). However, PPM was not
associated with mortality at the 5-year follow-up in our

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Functional NYHA I or II 763 (93.9%)
status series of 850 device implantations. Regarding the prevalence
NYHA III or IV 50 (6.1%) of PPM in these small aortic roots, our results are consistent
SVD Overall 9 (1.1%) with literature data. Botzenhardt et al9 reported 22.2 and
Prevalent stenosis 5 (0.6%) 44.4% of severe and moderate PPMs, respectively, in 18 to
Prevalent 2 (0.2%) 20 mm annulus diameter, and 8.7 and 0% of severe and
regurgitation moderate PPMs, respectively, in 21 to 23 mm annuli using
the Perimount Magna prosthesis. They reported no signifi-
Mixed 2 (0.2%)
cant difference in the incidence of PPM among four different
Outcomes Reoperation 1 (0.1%) valve types, including the Perimount Magna, in patients with
of SVD
Transcatheter 1 (0.1%) an aortic annulus 18 to 20 mm. In a series of 270 consecutive
valve-in-valve patients implanted with the PMEAV, Wyss et al14 reported no
therapy
case of severe PPM and a 0.5 to 4.1% rate of moderate PPM.
Scheduled 1 (0.1%) These findings need to be interpreted with caution given the
valve-in-valve
little number of small bioprostheses implanted in their study
procedure
(11 PMEAV of 19 mm).
Medical treatment 4 (0.5%) Regarding the durability of PMEAV, in an in vitro study,
alone
Raghav et al23 have reported excellent durability and hydro-
Deceased 2 (0.2%) dynamic performance after 1 billion cycles, equivalent to
Abbreviations: NYHA, New York Heart Association; PMEAV, Perimount 25 years of simulated in vitro wear. Our investigation repre-
Magna Ease aortic valve; PPM, patient-prosthesis mismatch; SVD, sents the largest single-center experience published so far in
structural valve deterioration. the literature, with more than 850 implants and the longest
available follow-up (average 3.7 years, 2,992.2 patient-years,
may vary according to the calculation method employed, the up to 7.6 years). Other previous investigations have included
latter article pointed out in a direct comparison that different in the same analysis different valves of the Perimount
methods do not seem to turn into different capacity to series.24 In our population, nine SVD events (1.1%) were
associate with adverse clinical events. observed, occurring at an average 4.5
2.0 years after
These findings mandate sustained efforts to prevent PPM, implantation (5-year Kaplan–Meier survival free from SVD
or at least reduce its severity.1,2 Preventive strategies, such as ¼ 99.1%
0.5). Three of these cases required reintervention
aortic root enlargement or implantation of stentless valves, (one redo AVR and two valve-in-valve procedures), while six
suffer from contradictory data in the literature regarding cases with stable and moderate dysfunction with limited
their safety and long-term outcomes.5,16,20 In our opinion, clinical impact were medically managed. The limited num-
these strategies should only be considered in selected cases ber of SVD events herein does not allow drawing conclusions
when severe PPM cannot be otherwise avoided.21,22 about any relationship between PPM and SVD. Nevertheless,
Selection of the optimal bioprosthesis remains the cor- in the present series, we observed lower freedom from SVD
nerstone strategy in preventing PPM, especially in patients in in patients with severe/moderate PPM at discharge. Further
whom PPM can be expected before AVR. In this setting, third- studies with longer follow-up and greater number of SVD
generation bioprostheses have markedly improved the events are required. The limited average follow-up duration

Thoracic and Cardiovascular Surgeon


needs to be considered in the interpretation of SVD freedom
rates. Indeed, a significant proportion of this large popula-
tion was followed up clinically and echocardiographically
with the support of territorial cardiologists and practi-
tioners. Despite the capillarity of the health care and cardi-
ologic network of our territory, and the tendency of operated
patients to reside within the same geographical region, this
aspect may represent a limitation to our analysis.
We underline the importance of assessment of the func-
tional status in follow-up investigations after valve inter-
ventions, beyond survival and valve-related events. Herein,
PPM was associated with neither increased mid-term mor-
tality nor worse functional (NYHA) status at mid-term. This
may suggest that clinically overt consequences of PPM
(deterioration of survival or functional status), if any, might
occur only later in the follow-up (after the fifth year or in
the second decade). Therefore, patients’ life expectation and
baseline conditions/comorbidities should be considered
when evaluating additional strategies for prevention of
PPM (such as annular enlargement).
In our series, the small number of valve-related events
did not allow the performance of a multivariate analysis to
identify predictors of SVD and late mortality. The present
investigations included only 19-, 21-, and 23-mm PMEAV;
this should be considered in the interpretation of durabil-
ity findings. On the contrary, this article is focused on
issues associated with PPM and its impact on patients’
survival and functional status; the present population
(including smaller size devices only) is particularly suited
to such purpose. Accordingly, previous articles have
included small prostheses only.24,25 Our article also lacks
full hemodynamic data with confirmation of PPM at mid-
term follow-up.
Conclusion
In our series, focused on small aortic annuli, the PMEAV
showed satisfactory results in terms of hemodynamic per-
formance. Its durability seemed also satisfactory at mid-term
follow-up. Smaller sizes of the PMEAV showed to be not
immune from PPM; nonetheless, this does not display any
association with adverse clinical outcomes in the mid-term
(both mortality and deterioration of functional status).
Conflict of Interest
All authors declare no conflict of interest with respect to
the material presented in this article.
Acknowledgments
The authors would like to thank Mrs. Sylvie Marie for data
collection and Mrs. Anne Ingels for statistical analysis.
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