ORIGINAL ARTICLE
Impact of a Heart Team in patients with aortic
stenosis who are candidates for transcatheter aortic valve replacement
Impacto de un
Heart Team en pacientes con estenosis aórtica candidatos a reemplazo percutáneo
Marcelo
S. Trivi1, María F. Castro2,
Romina Trossero1, Fernando A. Cura3,
Fernando F. Piccinini4, Alfonsina Candiello3,
Pablo O. Lamelas3, Ruth P. Henquin5,
Fernando O. Botto5, Ricardo R. Ronderos2
1 Cardiovascular Medicine Services,
Instituto Cardiovascular de Buenos Aires (ICBA)
2 Imaging, Instituto Cardiovascular de
Buenos Aires (ICBA)
3 Cardiovascular Intervention, Instituto
Cardiovascular de Buenos Aires (ICBA)
4 Cardiovascular Surgery, Instituto
Cardiovascular de Buenos Aires (ICBA)
5 Research, Instituto Cardiovascular de
Buenos Aires (ICBA)
Address for reprints: Dr. Marcelo Trivi. E-mail:
mstrivi@icba.com.ar.
Blanco Encalada 1543. City of Buenos Aires (Zip Code 1428), Argentina
Rev Argent Cardiol
2023;91:246-251.
http://dx.doi.org/10.7775/rac.v91.i4.20649
SEE RELATED ARTICLE: Rev Argent Cardiol
2023:91:237-238. http://dx.doi.org/10.7775/rac.v91.i4.20645
ABSTRACT
As transcatheter aortic valve implantation (TAVI) for
aortic stenosis (AS) became widespread, the need for a Heart Team (HT) arose to
choose the best treatment. There are few reports regarding its usefulness.
Objectives: To analyze treatment outcomes in patients with AS evaluated
by a HT for 10 years.
Methods: Consecutive enrollment of all patients with AS who were candidates for
TAVI between January 2012 and July 2021 to choose the best treatment, including
surgical aortic valve replacement (SAVR) and conservative medical management
(CMM).
Results: Out of 841 patients, 455 were assigned to TAVI (53%), 213 to SAVR
(24%), and 183 to CMM (23%). The percentage assigned to TAVI has increased from
48% to 62% over time (p<0.05). Patients who underwent TAVI versus those who
underwent SAVR were older (86 ± 7 vs. 83 ± 7 years), had a higher EUROSCORE II
(6.2, 95% CI 5.7-6.6 vs. 5.6; 95% CI 4.4-6.5) and were frailer (1.62 ± 1 vs.
0.91 ± 1), in all cases p<0.01. Actuarial survival (95% CI) at 1 and 2 years
was 88% (84-91%) and 82% (77-86%) for TAVI, 83% (76-88%) and 78% (70-84%) for
SAVR, and 70% (60-87%) and 59% (48-68%) for CMM, respectively (p<0.001).
Conclusions: For the first 10 years after a Heart Team was
established for AS decision-making, approximately half of the patients were assigned
to TAVI, and the rest were equally assigned in halves to either surgery or
observation. Survival for patients who received interventions was similar at 2
years and higher than in those who did not.
Keywords: Aortic stenosis - Transcatheter aortic valve implantation - Prosthetic
heart valves.
RESUMEN
La difusión del
reemplazo valvular aórtico percutáneo (TAVI) en la estenosis aórtica (EAo)
generó la creación de un Heart Team (HT), para elegir el mejor tratamiento.
Existen pocos reportes sobre su utilidad.
Objetivos:
analizar los resultados del tratamiento de los pacientes con EAo evaluados por
un HT durante 10 años
Material
y métodos: Inclusión consecutiva de todos los
pacientes con EAo candidatos a TAVI entre enero del 2012 y julio del 2021 para seleccionar
el mejor tratamiento, incluyendo además Cirugía de Reemplazo Valvular Aórtico
(CRVA) y Tratamiento Médico Conservador (TMC).
Resultados:
De 841 pacientes, se asignaron a: TAVI 455 (53%), CRVA 213 (24%) y TMC 183
(23%). El porcentaje asignado a TAVI aumentó con el tiempo de 48 a 62%
(p<0,05). Los pacientes que fueron a TAVI, con respecto a los enviados a
CRVA eran mayores (86±7 vs 83±7 años), con mayor EUROSCORE II (6,2, IC95%
5,7-6,6 vs 5,6, IC95% 4,4-6,5) y más frágiles (1,62±1 vs 0,91±1), en todos los
casos p<0,01. La sobrevida actuarial (IC 95%) a 1 y a 2 años fue, para TAVI
88% (84-91%) y 82% (77-86%), para CRVA 83% (76-88%) y 78% (70-84%) y para TMC
70% (60-87%) y 59% (48-68%) respectivamente (p<0,001).
Conclusiones:
Durante los primeros 10 años de establecido un Heart Team para la toma de
decisiones en EAo, se asignaron a TAVI aproximadamente la mitad y el resto se
asignó por mitades a cirugía u observación. La sobrevida de los pacientes
intervenidos fue similar a 2 años y mayor que la de los no intervenidos.
Palabras
clave: Estenosis aórtica - Reemplazo de la
Válvula Aórtica Transcatéter - Prótesis valvulares cardíacas
Received: 20/03/2023
Accepted: 18/07/2023
INTRODUCTION
Degenerative aortic stenosis (AS) is a disease with an
incidence and prevalence that increase at the same
rate as life expectancy in the population. (1) In fact, the degenerative etiology has become the
most common, replacing rheumatic heart valve disease. (2)
As the population over 80 years old has been
increasing, the problem of how to treat degenerative AS in the elderly has
increased as well.
Typically considered to be an end-of-life disease and
usually associated with other heart and non-cardiovascular (CV) diseases, the
emergence and popularization of transcatheter aortic valve implantation (TAVI)
has put the focus on a new therapeutic option for these patients, previously
left to the natural progression of the disease. (3)
As in many other cases, appearance of a new treatment
led to reconsider the usefulness and selection of candidates for traditional
treatment i.e., surgical aortic valve replacement (SAVR). The need to select patients for one treatment
or the other derived in multidisciplinary team discussions about the best
treatment for different conditions. Thus, a Heart Team (HT) or a Valve Team for
AS was created (with no equivalent term in Spanish).
HT discussion about the choice of treatment for
degenerative AS was quickly incorporated by clinical practice guidelines, (4,5) though with little evidence due to the lack of large
and controlled studies that might show its usefulness. However, the need to
discuss the best treatment for these complex patients immediately led to its
implementation, and it soon became unavoidable and required when planning a
TAVI. (6)
Our site has had a Heart Team for 10 years, so we felt
the need to analyze its results and compare the characteristics of the patients
assigned to each treatment.
METHODS
Design: A retrospective and single site study with
consecutive enrollment of all patients with severe AS evaluated by the HT from
January 2012 to July 2021. HT referral criteria were the following: 1) cases
already selected for TAVI, and 2) uncertain cases when choosing between TAVI,
SAVR and conservative medical management (CMM) as the best strategy. TAVI was
recommended for symptomatic patients with known severe AS and variables
warranting indication, such as increased surgical risk, old age, frailty, and
suitability for the procedure, while SAVR was advised in patients with a lower
surgical risk, unsuitable for TAVI, or requiring another intervention. Patients
who failed to meet intervention criteria, patients for whom invasive treatment
was considered futile, patients with a life expectancy of less than 1 year, or
patients who refused to receive the procedure continued with CMM.
Severe AS was defined as a valve area 1 cm2
(or 0.6 cm2/m2), based on the definition
of the ESC (European Society of Cardiology) guidelines on valvular heart
disease. (4) When in doubt, especially in cases of low-flow,
low-gradient AS, the Agatston aortic valve calcium score by computed tomography
(CT) was used, where a score over 2000 in men and 1300 in women was considered
as severe. (5) All patients under intervention were evaluated by
catheter coronary angiography, and a vast majority were
also assessed using multi-layer contrast CT.
Members of the HT: The HT was composed of, at least,
one cardiovascular surgeon, one interventional cardiologist, one CV imaging
specialist, and one clinical cardiologist specialized in valve disease. The HT
held weekly meetings (online during the pandemic). In case of disagreement,
agreement was reached via a new discussion. The number of evaluated patients,
recommended management, and interventions were annually compared over 10 years.
Patients under intervention were followed up via personal, telephone or e-mail
contact.
Frailty score: The degree of frailty was measured
using Fried 1-5 scale assessing mobility, autonomy, handgrip response, etc. (7). A patient with a score 2 was considered frail
according to median values.
Statistical analysis
Quantitative variables were reported as mean ±
standard deviation (SD) or median and interquartile range (IQR) based on
distribution and were compared using the Kruskal Wallis multiple comparisons
test; categorical variables were reported as percentages and compared using the
multiple chi-square test. A p value <0.05 was considered to be statistically
significant. The STATA 13 statistical package was used.
Ethical considerations
The protocol was sent to the PRIISA platform and
approved by the institutional Ethics Committee.
RESULTS
Of 841 evaluated patients, 455 (54%) were assigned to
TAVI, of which 385 (85% of those assigned) received treatment; 213 (25%) were
assigned to SAVR, of which 183 (86% of those assigned) underwent surgery and
173 (22%) received CMM (Figure 1).
Fig.
1. Heart Team assignment and actual treatment received.
CMM: conservative medical management; SAVR: surgical
aortic valve replacement; TAVI: transcatheter aortic valve implantation.
The number of patients evaluated by the HT increased
every year, with a marked reduction associated with the COVID-19 pandemic (see Figure 2). The proportion of patients under TAVI also
increased from 48% in the first half of the assessed patients to 65% in the
most recent half (p <0.05).
Fig. 2.
Number of patients evaluated by the HT and recommended management. The
proportion assigned to TAVI increased significantly over the years. The decrease
in 2020 is related to the COVID-19 pandemic.
CMM: conservative medical management; SAVR: surgical
aortic valve replacement; TAVI: transcatheter aortic valve implantation.
The baseline characteristics of the patients assigned
to every treatment are summarized in Table 1: the mean age was 85 ± 5 years, 46% were female, the
aortic valve area determined by ultrasound was 0.67 ± 0.2 cm2, the
left ventricular ejection fraction (LVEF) was 55 ± 13%, 53% had coronary artery
disease, and 46% had comorbidities. Patients assigned to TAVI were older than
those assigned to SAVR, had a smaller valve area, had a higher EuroSCORE II,
and were frailer. Those assigned to CMM were similar to those who underwent
TAVI, except for the larger valve area. Actuarial survival (95% CI) at 1 and 2
years was 88% (84-91%) and 82% (77-86%) for TAVI, 83% (76-88%) and 78% (70-84%)
for SAVR, and 70% (60-87%) and 59% (48-68%) for CMM, respectively, (p
<0.001, Figure 3).
Table
1. Comparison of patients assigned to TAVI, SAVR and CMM
by the HT
|
|
Total: 841 |
TAVI: 455 |
SAVR: 213 |
CMM: 173 |
P |
|
Age (years), mean + SD |
85 ± 5 |
87 ± 6 |
83 ± 8 |
86 ± 8 |
<0.001* |
|
Male sex (%) |
54 |
54 |
61 |
57 |
<0.05 ** |
|
Valve area, cm2, median (IQR) |
0.67 (0.5-0.8) |
0.65 (0.5-0.8) |
0.69 (0.6-0.9) |
0.70 (0.5-0.8) |
<0.05*** |
|
LVEF (%), mean + SD |
55 ± 13 |
55 ± 11 |
55 ± 12 |
54 ± 12 |
NS |
|
Comorbidities (%) |
46 |
46 |
44 |
49 |
NS |
|
Coronary artery disease (%) |
53 |
55 |
57 |
44 |
NS |
|
EuroSCORE II, median (IQR) |
6.0 (4.2-7.0) |
6.1 (3.8-7.8) |
5.6 (2.6-6.2) |
6.1 (3.8-6.4) |
<0.05* |
|
Frailty score, mean ± SD |
1.49 ± 1 |
1.62 ± 1 |
0.91 ± 1 |
1.74 ± 1 |
<0.05* |
*SAVR vs. TAVI and CMM; **CMM vs. SAVR and TAVI;
***TAVI vs. SAVR and CMM CMM: conservative medical management
IQR: interquartile range
LVEF: left ventricular ejection fraction SAVR:
surgical aortic valve replacement SD: standard deviation
TAVI:
transcatheter aortic valve implantation
Fig. 3. Actuarial survival for patients under TAVI (transcatheter aortic
valve implantation), SAVR (surgical aortic valve replacement) or CMM
(conservative medical management) as recommended by the HT.
CMM: conservative medical management; SAVR: surgical
aortic valve replacement; TAVI: transcatheter aortic valve implantation
The independent predictors of actuarial mortality are
detailed in Table 2.
Table
2. Independent predictors of actuarial
mortality.
|
|
RR |
95% CI |
p |
|
Age |
1.04 |
1.01–1.06 |
0.002 |
|
LVEF |
0.98 |
0.97–0.99 |
0.015 |
|
Renal failure |
1.58 |
1.16–2.17 |
0.004 |
|
Diabetes |
1.52 |
1.07–2.15 |
0.018 |
|
CMM |
1.99 |
1.41–2.81 |
0.001 |
CMM: conservative medical management; LVEF: left
ventricular ejection fraction; RR: relative risk
DISCUSSION
The emergence of a new therapeutic option like TAVI in
patients with severe AS –which to a large extent supplements the treatment of
patients with high surgical risk– also requires a multidisciplinary approach in
the cardiovascular team in charge of these patients.
Thus, there emerged the need to discuss the most
appropriate management for each case by interventionists, surgeons, imaging
specialists, valve disease specialists, etc. (8)
Though recommendations by the scientific societies are
unanimous and often required by procedure funders, the lack of publications on
the results of the Heart Team (HT) is remarkable both nationally and globally. (9-12).
Therefore, the objective of this study was to analyze
the results of treatment in patients with AS evaluated by the HT over the first
10 years of its creation.
Notably, during this period some changes occurred both
in the prostheses and in the implantation techniques,
and experience was gained in terms of diagnosis, patient selection, and
therapy. (13) In addition, the acceptance of a new therapeutic
approach allowed us to evaluate more patients with no prior intervention. In
fact, the annual analysis showed sustained increase in evaluated patients, as
well as a larger number of TAVIs, with an average of half the patients under
assessment, and there was a significant decrease associated with the COVID-19
pandemic, which reflects the side effect suffered by this population with
severe cardiovascular conditions. (14)
About half of the patients were assigned to TAVI (this
percentage increased to 60% in the last few years due to the increased
acceptance of the procedure), and the rest were equally assigned to surgery or
conservative management. These percentages are remarkably similar to those
recently presented by the HT from the Italian group of Burzotta et al., for
patients with valvular heart disease, with 77% experiencing AS. (15)
Evaluated patients were mostly in their eighties, had
severe AS (reconfirmed by the HT, a major task of this team), were mostly
asymptomatic, had comorbidities and an estimated surgical risk that was at
least intermediate, and an EuroSCORE II around 6, on
average. The LVEF was near the lower limit of normal, and at least half of the
patients had coronary artery disease.
Patients selected for TAVI were comparable to those
selected for SAVR, except for a higher estimated surgical risk in the former,
who were older and frailer. Actuarial survival at 1 and 2 years (88% and 82%
with TAVI, 83% and 78% with SAVR, p = NS) seems to be reasonable with both
strategies and suggests an adequate choice of treatment in a setting where
access to transcatheter valve implantations is limited by high costs.
Focus should be made on the group under CMM: this is a
heterogenous group ranging from a subgroup with less severe valve disease and
absence of symptoms i.e., with no intervention indicated at the time of
assessment, to a subgroup with no intervention required due to the lack of
severe comorbidities, futility or end stage, also including patients who refuse
to have the intervention, thus making a comparison difficult.
As observed virtually in every set, patients without
intervention show significantly poorer survival (70% and 59% at 1 and 2 years),
which supports intervention in candidates. In fact, CMM was the main mortality
predictor in a multivariate analysis (see Table 2), with a relative risk near
2: patients under (non-interventional) medical management had twice the
mortality rate of those under intervention (either with TAVI or surgery) during
the follow-up, beyond other risk predictors.
Notably, patients evaluated by the HT were not all patients
with AS but those considered for TAVI. Patients with an indication of
conventional surgery or patients for whom no intervention was considered were
not evaluated. This is the most common strategy at present and seems to be the
future in terms of the HT. (16)
Our study showed 12% mortality at 1 year for TAVI, 17%
for SAVR, and 30% for CMM. The Portuguese group from Catia Costa et al. (10) published a similar study of 473 patients evaluated
by their HT over 8 years: mortality after a year was 16% for TAVI, 11% for
surgery, and 20% for medical management. For the Spanish group from Diego
Iglesias et al. (11), mortality at 1 year was 20% for TAVI and 18% for
surgery. In addition, this study analyzed the prognostic value of the HT
decision in the long term and found that such decision was an independent
predictor of long-term mortality. The
results from our study can also be compared to those from large studies, such
as PARTNER and SURTAVI. (17,18) In our setting, the only publication referring to the
usefulness of the HT for AS is the work by Garmendia et al. on new
hospitalization predictors. (19)
Limitations
As cited above, our study has a selection bias, as it
includes only patients considered to be candidates for TAVI. (20,21) Another limitation is the retrospective nature of
data collection, the involvement of only one site (making it difficult to generalize
findings), and major financial restrictions in terms of percutaneous valves
availability in our setting, especially in the first half of the decade under
analysis.
CONCLUSIONS
Ten years after creation of the Heart Team to select
patients with AS who are candidates for TAVI, about half of them have been
assigned to TAVI, while the rest were divided in two to undergo either surgery
or observation. Patients under intervention seem to follow the selection
pattern suggested by the team. Survival in patients under intervention seems to
be similar up to 2 years with TAVI or SAVR, and is reasonable for both
strategies, which suggests an adequate choice of treatment. Worse progression
in patients under no intervention supports an invasive strategy in those who
are candidates for intervention.
Conflicts of interest
None declared.
(See authors’ conflict of interests
forms on the web).
Financing
None.
https://creativecommons.org/licenses/by-nc-sa/4.0/
©Revista Argentina de Cardiología
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