http://dx.doi.org/10.7775/rac.v91.i1.20596
ORIGINAL ARTICLE
Presence of Moderate or Severe
Regurgitation after Transcatheter Aortic Valve Implant with the Cusp Overlap
Strategy
Presencia de regurgitagión moderada o grave luego del
implante percutáneo de la válvula aórtica con la estrategia de “Cusp Overlap”
Carlos Fava1, Gustavo Lev1, Andrés Rodríguez, Franco Andreoli, Silvina Gómez, Oscar
Mendiz1
1 Instituto de
Cardiología y Cirugía Cardiovascular, Hospital Universitario Fundación Favaloro
Address for reprints: Oscar A Mendiz - Av. Belgrano 1746 - (1093) Ciudad Autónoma de Buenos Aires,
Argentina - E-mail: omendiz@ffavaloro.org
This work received the 2022 Isaac Berconsky Award
ABSTRACT
Background: The aim of this study is to whether higher transcatheter aortic valve
implantation (TAVI) with self-expandable valves using the right and left cusp
overlap strategy (Cusp Overlap, COVL) is associated with a lower incidence of
moderate or severe paravalvular regurgitation (PVR), compared with the
conventional strategy (CON).
Methods: A total of 206 consecutive patients undergoing TAVI with
self-expandable valves between August 2019 and May2022 were analyzed. The CON
technique was used in the first 101 patients (49%) and COVL was used in 105
(51%).
The primary
endpoint (PEP) was the presence of moderate or severe paravalvular
regurgitation at 30 days.
Results: There were no clinical differences between the groups in terms of mean
age, sex or comorbidities, except for a trend towards more patients with
diabetes and previous percutaneous coronary intervention in the COVL group.
The STS score was
greater in the COVL group (6.9 ± 2.2 vs. 5.8 ± 2.4 in the CON group; p = 0.01).
There was no
difference in the PEP at 30 days with 2% incidence of moderate PVR in the CON
group and 0.9% in the COVL group, and none of them presented severe PVR. There
were no differences in mortality, myocardial infarction, coronary artery
obstruction, stroke, major bleeding or vascular complications. The need for
permanent pacemaker was lower with the COVL strategy (6.7% vs. 17.8%, p = 0.01)
and a new left bundle branch block occurred in 5.7% vs. 12.9% (p = 0.07).
Conclusions: In this single-center series, the strategy of high transcatheter aortic
valve implantation using the COVL strategy showed no difference in the presence
of moderate or severe regurgitation compared with the conventional strategy,
with no differences in complications, and was associated with a lower need for
definitive pacemaker and with a trend towards lower incidence of left bundle
branch block at 30 days.
Key words: Aortic Valve Insufficiency - Self Expandable Metallic Stents -
Transcatheter Aortic Valve Replacement
RESUMEN
Introducción: Analizar si la estrategia del implante
alto usando superposición de las cúspides derechas e izquierdas (Cusp Overlap,
COVL) en el implante percutáneo de la válvula aórtica (TAVI) se relaciona con
menor incidencia de regurgitación paravalvular (RPV) moderada o grave,
comparada con la estrategia convencional (CON).
Material y métodos: Se analizaron 206 pacientes consecutivos
que recibieron TAVI con válvulas autoexpandidles entre agosto de 2019 y mayo de
2022. Se utilizó una estrategia CON en 101 pacientes (49%) y COVL en 105 (51%).
El Punto Final Primario (PFP) fue la
presencia de regurgitación paravalvular moderada y grave a 30 días.
Resultados: No hubo diferencia clínica entre los
grupos en cuanto a la edad media, sexo ni comorbilidades; excepto una tendencia
a más diabetes y angioplastia coronaria previa en el grupo COVL El STS score
fue mayor en el grupo de COVL (6,9 ± 2,2 vs. 5,8 ± 2,4 en CON, p = 0,01).
A 30 días no hubo diferencia en el PFP
(RPV moderada en 2% en CON, y 0,9% en COVL; ninguno presentó RPV grave).
Tampoco hubo diferencia en mortalidad, infarto, oclusión coronaria, accidente
cerebrovascular, sangrado mayor y complicación vascular. La necesidad de
marcapasos definitivo fue menor con la estrategia de COVL (6,7% vs. 17,8%, p =
0,01) y un nuevo bloqueo de rama izquierda ocurrió en 5,7% vs. 12,9% (p =
0,07).
Conclusiones: En esta serie de un solo centro, la
estrategia del implante alto de la válvula aórtica percutánea usando la técnica
de COVL no demostró diferencia en la presencia de regurgitaciones moderadas o
graves comparada con la estrategia convencional, sin presentar diferencia en
las complicaciones, y se asoció a una menor necesidad de marcapasos definitivo
y a una tendencia de menos bloqueos de rama izquierda a 30 días.
Palabras clave: Insuficiencia de la Válvula Aórtica -
Stents Metálicos Autoexpandibles - Reemplazo de la Válvula Aórtica Transcatéter
Received: 09/28/2022
Accepted: 12/14/2022
INTRODUCTION
Transcatheter aortic valve
implantation (TAVI) has shown its benefit in high-risk or inoperable patients, (1,2) those at intermediate risk (3,4) and also in
low-risk patients. (5,6)
According to different analyses, the
presence of mild paravalvular regurgitation (PVR) occurs in 20% to 40% of the
cases, (7) while moderate or severe PVR in
about 3% to 12% (2) and has been associated with higher
mortality rates. (8,9) Although the
incidence of PVR has decreased with the learning curve of the operators and the
new devices, it represents a complication that should be avoided or managed
during the procedure.
Another issue with self-expandable
valves is the need for implantation of a permanent pacemaker (PPM), with an
incidence of about 17%-30% in large, randomized studies. (2-6)
To overcome these limitations, higher
implant of percutaneous aortic valves using a view where the right and left
cusps are overlapped (Cusp-overlap, COVL) is a technique developed to reduce
contact with the membranous septum and conduction system and thereby reduce the
need for PPM. (10)
This strategy has demonstrated a
significant decrease in the need for PPM in some observational series, (11-13) but the
impact on the incidence of perivalvular leaks leading to moderate or severe regurgitation
has not been clearly evaluated.
METHODS
We analyzed 206 consecutive patients
undergoing TAVI with self-expandable valves between August 2019 and May 2022.
The conventional technique (CON) was used in the first 101 patients (49%) and
the COVL strategy in the subsequent 105 (51%).
Patients with previous surgical
bioprosthetic valves, prior PPM, bicuspid aortic valve or pure or predominant
aortic regurgitation as indication of TAVI or implant of a balloon-expandable
valve were excluded from the study.
The primary endpoint (PEP) was the
presence of moderate or severe PVR at 30 days, defined according to the
criteria of the VARC-3. (14) The incidence of the following
events was also analyzed: all-cause mortality, acute myocardial infarction
(MI), acute coronary artery obstruction due to TAVI, stroke, major bleeding (as
defined by VARC), vascular complication, emergency cardiac surgery, reintervention,
need for PPM implantation, and new-onset left bundle branch block (LBBB)
persistent at 30 days.
Implant success (IS) was defined as
adequate valve implant with a residual gradient <10 mm Hg at the end of the
procedure in the absence of severe regurgitation, and clinical success (CS) as
IS in the absence of death, acute MI, stroke, reintervention or urgent valve
surgery.
All the patients were evaluated by
the hospital “Valve Heart Team”, with Doppler-echocardiography, coronary
angiography with aortography, and a multi-slice contrast-enhanced computed
tomography angiography with 3D reconstruction of the aortic valve, thoracic aorta,
abdominal aorta, and subclavian, iliac and femoral arteries. An electrocardiogram
(ECG) was recorded before TAVI, at 24 hours and at 30 days. Color Doppler-echocardiography
was performed before TAVI, immediately after and at 30 days.
Anesthesia with conscious sedation
was used, except for those in whom a percutaneous femoral access was not used
and thus required general anesthesia. All patients received dual antiplatelet
therapy with aspirin and clopidogrel; in those patients receiving oral anticoagulants
for any other reason, only clopidogrel was indicated.
Anticoagulation with heparin 100 U/Kg
was used during the procedure, with values controlled during its course.
In patients receiving implants with
the CON strategy, the valve was positioned and implanted using the coplanar
3-cusp projection according to the computed tomography angiography and usually
corrected by the left anterior oblique slightly cranial angiographic
projection. The implantation was performed having as target an implant depth of
approximately 2-4 mm below the aortic annulus under high stimulation frequency
(120 bpm) with temporary pacing, at the operator’s discretion.
In those undergoing the COVL
strategy, the computed tomography angiography was previously analyzed in
detail, identifying the projection where there was right and left cusp overlap,
in opposition to the non-coronary cusp, and this was chosen as the projection
for the implantation. In case of difficulties or differences, corrections were
made according to the previous angiography.
When this was not feasible,
positioning was performed using two pigtail or Amplatz AL2 catheters placed in
the right and left sinuses, and then the angiographic projection showing cusp
overlap was sought.
Usually, the COVL projection coincides
with a caudally oriented right oblique projection.
The target was implantation
approximately 2-3 mm below the aortic annulus with respect to the non-coronary
sinus.
At the time of the final deployment,
overstimulation with temporary pacemaker at 120 beats per minute was used to
achieve system stability.
Both pre-dilation with a balloon
diameter lower than that of the aortic annulus and post-dilation were performed
according to the operator´s criterion.
All the patients were followed-up at
30 days with a face-to-face visit and analysis of PVR by Dopper-echocardiography
performed 30 days after the implant.
Ethical considerations
The study was conducted following the
recommendations of the Declaration of Helsinki and the International Conference
of Good Clinical Practice. All patients signed an informed consent form before
participating in the study. Their identity was preserved for the moment of the
analysis.
Statistical analysis
Continuous variables are presented as
mean and standard deviation and categorical variables as absolute value and
percentage. The Student’s t test was used to compare continuous variables and
the chi-square test or Fisher's exact test was used for categorical variables.
A p value < 0.05 was considered statistically significant.
RESULTS
The clinical characteristics of the
populations were similar; age was 79.8 ± 7.9 years vs. 80.4 ± 6.9 years in the
CON strategy vs. COVL strategy, and 48.5% were male vs. 55%. There was no
difference in the prevalence of hypertension, previous MI, history of coronary
artery surgery, percutaneous coronary intervention (PCI) before TAVI, chronic
obstructive pulmonary disease (COPD), renal function, and dialysis. Diabetes
and PCI were slightly more common in the COVL group (20.8% vs. 32.3%, p = 0.06,
and 31.7% vs. 44.8% p = 0.05, respectively).
The STS risk score was greater in the
COVL group (5.8 ± 2.4 vs. 6.9 ± 2.2, p = 0.01).
There were no differences in the
baseline ECG in terms of previous conduction disorders as atrioventricular (AV)
block, right bundle branch block (RBBB), LBBB, or atrial fibrillation.
There was also no difference in left
ventricular ejection fraction, mean trans-aortic gradient or aortic valve area.
Femoral access was used in all the p
except for 2 p. in the COVL group who underwent subclavian access. Predilation
was greater in this group (87.6% vs. 57.4%, p<0.001) with no differences in
the use of post-dilation. There was no difference in the use of percutaneous
closure, which was done with any of the following devices: PROSTAR XL® (ABBOTT
Vascular, Santa Clara, California) and Proglide® (ABBOTT Vascular, Santa Clara,
California). (Table 1).
Table 1.
Characteristics
of the population
|
|
CON (101
p.) |
COVL (105
p.) |
P value |
|
Age, years, (mean ± SD) |
79.8±7.9 |
80.4±6.9 |
0.41 |
|
Men |
49 (48.5) |
58 (55.2) |
0.33 |
|
Hypertension |
90 (89.1) |
98 (93.3) |
0.20 |
|
Diabetes |
21 (20.8) |
34 (32.3) |
0.06 |
|
Previous MI |
23 (22.7) |
18 (17.1) |
0.31 |
|
Previous CABGS |
19 (18.8) |
16 (15.2) |
0.42 |
|
Previous PCI |
32 (31.7) |
47 (44.5) |
0.05 |
|
PCI before TAVI |
22 (21.8) |
30 (28.6) |
0.18 |
|
COPD |
19 (18.8) |
13 (12.4) |
0.22 |
|
Stroke |
5 (4.9) |
4 (3.8) |
0.68 |
|
eGFR |
60.1±19.3 |
61.8±20.1 |
0.44 |
|
Dialysis |
3 (3) |
4(3.8) |
0.73 |
|
Mortality according to STS
score |
5.8±2.4 |
6.7±2.2 |
0.01 |
|
Atrial fibrillation |
16 (15.8) |
25 (23.8) |
0.43 |
|
AV block |
6 (5.9) |
7 (6.7) |
0.83 |
|
RBBB |
10 (9.9) |
9 (8.6) |
0.73 |
|
LBBB |
10 (9.9) |
15 (14.3) |
0.33 |
|
LVEF (%) |
52.7±13.4 |
53.1±12.6 |
0.45 |
|
AVA |
0.71±0.15 |
0.73±0.9 |
0.43 |
|
Mean gradient (mm Hg) |
40.8±10.7 |
41.3±10.2 |
0.35 |
|
Femoral access |
101 (100) |
103
(98.1) |
0.16 |
|
Subclavian access |
- |
2 (1.9) |
0.16 |
|
Pre-dilation |
58 (57.4) |
92 (87.6) |
<0.001 |
|
Post-dilation |
25 (24.5) |
36 (34.3) |
0.92 |
|
Pop-Up |
- |
- |
|
|
Percutaneous closure |
100 (99) |
103 (98.1) |
0.58 |
AV: atrioventricular. AVA: aortic valve area. CABG: coronary artery bypass grafting. CON: conventional COPD:
chronic obstructive pulmonary disease. COVL: Cusp overlap. eGFR:
estimated glomerular filtration rate LBBB: left bundle branch block. LVEF: left
ventricular ejection fraction. MI: myocardial infarction. p.: patients. PCI:
percutaneous coronary intervention. RBBB: right bundle branch block. SD:
standard deviation. STS: Society of Thoracic Surgeons. TAVI: transcatheter
aortic valve implantation. Categorical variables are presented as n(%) and continuous variables as mean ± SD.
Self-expanding valves were implanted
in all the patients. (Table
2)
Table 2.
Prosthetic
valves implanted
|
|
CON n
(%) |
COVL n
(%) |
|
Evolut-Evolut R®/PRO® |
101
(100%) |
79 (74.5) |
|
Accurate Neo® |
- |
15 (14.3) |
|
PORTICO® |
- |
11 (11.2) |
CON: conventional; COVL:
Cusp overlap
There was no difference in the PEP at
30 days between both strategies (Figure 1), with 2% incidence of moderate PVR
in the CON group and 0.9% in the COVL group, and there were no cases of severe
PVR. There was no difference in mortality, acute MI, coronary obstruction,
stroke, cardiac surgery, reoperation, vascular complication or major bleeding.
CON: conventional. COVL: Cusp overlap. Mod: moderate.
PVR: paravalvular regurgitation. S: severe
Fig. 1. Primary end point
The COVL strategy resulted in a
significant reduction in conduction disorders after implantation, with a lower
need for PPM (6.7% vs. 17.8%; p = 0.01) and a trend towards less development of
new LBBB (5.7% vs. 12.9%; p = 0.07). Of the patients requiring PPM, 6 were
≥ 80 years and only one patient presented normal sinus rhythm. One
patient had previous atrial fibrillation, one presented first degree AV block,
another had LBBB, and one had trifascicular block. (Table 3) (Figure 2)
Table 3. Outcomes at 30 days
|
|
CON (101
p.) n
(%) |
COVL (105
p.) n
(%) |
|
|
Implant success |
101 (100) |
105 (100) |
- |
|
Clinical success |
5 (4.9) |
5 (4.8) |
0.94 |
|
Moderate PVR |
2 (2) |
1 (0.95) |
0.53 |
|
Severe PVR |
- |
- |
- |
|
Death |
5 (4.9) |
3 (2.8) |
0.43 |
|
Infarction |
- |
1 (0.95) |
1 |
|
Coronary obstruction |
- |
1 (0.95) |
1 |
|
Stroke |
- |
1 (0.95) |
1 |
|
Major bleeding |
2 (2) |
1 (0.95) |
0.53 |
|
Vascular complication |
2 (2) |
4 (3.8) |
0.43 |
|
PPM |
18 (17.8) |
7 (6.7%) |
0.01 |
|
New-onset LBBB |
13 (12.9) |
6 (5.7) |
0.07 |
|
Cardiac surgery |
- |
- |
- |
|
Reintervention |
- |
- |
- |
CON: conventional. COVL: Cusp overlap. LBBB: left
bundle branch block. p.: patients. PPM: permanent pacemaker. PVR: paravalvular regurgitation
CON: conventional. COVL: Cusp overlap. LBBB: left
bundle branch block. PPM: permanent pacemaker.
Fig. 2. Permanent pacemaker and new onset left bundle branch block.
DISCUSSION
In our series, TAVI with the COVL
technique was not significantly associated with a difference in the presence
of PVR compared with the conventional strategy, but there was less need for PPM
and lower incidence of LBBB, with no differences in mortality, acute MI,
stroke, coronary obstruction, major vascular complications and major bleeding,
cardiac surgery or reintervention.
Of the 7 p. in our series requiring
PPM, 6 were ≥ 80 years and 5 presented a significant conduction disorder.
The presence of PVR has been related
to valvular calcification with a generally asymmetrical pattern with dominating
non-coronary leaflet and sinus calcification in most p. (15) Different
studies have analyzed the presence of calcium and its quantity in the implant
site (16,17) and demonstrated that asymmetry in
calcification is related to PVR. (18) Some authors analyzed the presence
of calcium in the left ventricular outflow tract which could be a risk factor
for PVR. However, we must also consider that calcification of the annulus may
contribute to annular rupture, especially in balloon-expandable valves in case
of aggressive pre-dilation or post-dilation and need for a second valve. (19-21)
Total device landing zone calcium
volume could predict the degree of PVR: none with 389 mm3, mild with
371 mm3, moderate with 690 mm3 and severe PVR with 777 mm3.
We should also analyze asymmetry in the CT scan as it is a predictor of PVR. (22)
The risk of moderate or severe PVR is
lower in women; this seems to be related to a smaller diameter annulus that
facilitates perivalvular sealing. (23)
The presence of moderate to severe
regurgitation was more common at the beginning of the experience and with the
first-generation devices. The learning curve of the operators,
which has improved the implants, and the new devices with a perivalvular
"skirt" at the base to improve sealing, have led to a significant
reduction of this phenomenon.
Although the use of the COVL
technique seems to help in the same sense (in fact, in our series PVR decreased
by 50%), a greater number of patients would be needed to obtain considerable
higher differences than those of our experience.
The presence of moderate or severe
PVR is often associated with low functional class dyspnea or even hemolysis.
One of the treatments proposed to avoid surgery is closure of PVR with plugs
under transesophageal Doppler echocardiography. Although this strategy is not
easy to perform and is not frequently used, it has demonstrated favorable
outcome in some publications with a low rate of complications. (25)
An important meta-analysis evaluated
the outcome of patients with PVR at 4 years. Those with moderate to severe PVR
had higher mortality than those with mild or minimal PVR. But when first-generation
valves were compared with second-generation valves, the incidence of PVR was
significantly lower with second-generation valves. Mild PVR had higher 4-year
mortality rate than minimal PVR. For this reason, it is currently necessary to
be extremely accurate at the time of implantation, choosing the most suitable
device and performing post-dilations if necessary to leave the minimal
regurgitation possible; ideally, absolutely no regurgitation.
Our group started several years ago
with the implantation of self-expandable valves with the COVL strategy. In our
publications, we demonstrated a significant decrease in the need for PPM after
implantation and a trend towards lower LBBB without increasing the incidence of
complications or valve embolization. In our publications, implants were performed
with different self-expanding valves in the COVL group. (11,12)
We believe that this strategy offers
benefits, and although we did not observe a significant difference in the incidence
and severity of PVR that would have an impact on survival, the reduction in
conduction disorders after implantation justifies its implementation, since
conduction disorders also have an impact on survival and on hospital and
long-term costs. (26,27)
Study limitations
The lack of randomization and the
fact that this analysis was performed in a single center are the limitations of
this study. In order to try to avoid the influence of the learning curve, a
historical series of the last 101 patients treated with the CON strategy was
compared with the first 105 patients treated with the higher transcatheter
aortic valve implantation strategy.
CONCLUSIONS
In this single-center series, the
strategy of high transcatheter aortic valve implantation showed no difference
in the presence of moderate or severe PVR compared with the conventional
strategy with no differences in complications and was associated with a lower
need for definitive pacemaker and a trend towards lower incidence of LBBB at 30
days.
Conflicts of interest
Oscar A. Mendiz is proctor in Latin
America for Evolut, Accurate and Edwards Valves.
(See authors conflicts of interest
forms in the website/ Supplementary material)
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