Carátula del artículo
Clinical Impact of New-Onset Left Bundle Branch Block After
Transcatheter Aortic Valve Replacement: Data from a Single-Center Retrospective
Registry
Aleksey A. Baranov ivrach@icloud.com
Ministry of Health of Russian
Federation, Russian Federation
Aram G. Badoian
Ministry of Health of Russian
Federation, Russian Federation
Dmitrii A. Khelimskii
Ministry of Health of Russian
Federation, Russian Federation
Aryuna Yu. Tsydenova
Ministry of Health of Russian
Federation, Russian Federation
Ivan S. Peregudov
Ministry of Health of Russian
Federation, Russian Federation
Vladimir V. Beloborodov
Ministry of Health of Russian
Federation, Russian Federation
Aleksey G. Filippenko
Ministry of Health of Russian
Federation, Russian Federation
Toyche U. Khalkhozhaev
Ministry of Health of Russian
Federation, Russian Federation
Oleg V. Krestyaninov
Ministry of Health of Russian
Federation, Russian Federation
Brazilian Journal of Cardiovascular Surgery, vol. 40, no. 3, e20240187, 2025
Sociedade Brasileira de Cirurgia Cardiovascular
Received: 28 May 2024
Accepted: 09 August 2024
INTRODUCTION
Transcatheter aortic valve replacement (TAVR) is an effective alternative to surgical
aortic valve replacement for symptomatic severe aortic stenosis (AS) in patients at
high, moderate, and even low surgical risk[1-3]. Advances in
surgical proficiency and the enhancement of transcatheter valves have notably
minimized the occurrence of procedural complications. Nonetheless, a significant
challenge remains due to the high incidence of postoperative atrioventricular
conduction disorders. The emergence of periprocedural cardiac conduction disorders
during or immediately after TAVR is primarily attributed to direct mechanical damage
to the components of the cardiac conduction system located in close proximity to the
aortic valve[4]. New-onset left
bundle branch block (LBBB) is the most common type of cardiac conduction disorder
after TAVR, with incidence rates ranging from 4% to 30% for balloon-expandable and
18% to 65% for self-expanding valves[5,6]. While there is
extensive research on the occurrence and predictors of new conduction disturbances
following TAVR, the available data on the potential prognostic significance of
new-onset LBBB are limited and controversial[7,8]. Few studies have
shown competing results regarding the association between new-onset post-TAVR LBBB
and a higher increased all-cause and cardiovascular mortality, rehospitalization, as
well as a greater need for permanent pacemaker implantation (PPI)[9,10]. However, several other studies have failed to demonstrate an
association between new LBBB and mortality[11,12]. There is
currently a scarcity of data regarding the impact of new-onset LBBB on myocardial
remodeling and cardiac contractile function after TAVR. Considering the expanding
use of TAVR for younger patients, the current issue is even more important. This
study aimed to assess the effect of new-onset LBBB on long-term outcomes following
TAVR.
METHODS
This retrospective study initially included 441 patients who underwent TAVR for
severe AS at a single center from March 2015 to October 2023. Patients with
preexisting cardiac conduction abnormalities (QRS > 120 ms, LBBB, right bundle
branch block) (52 patients) and those who received a permanent pacemaker either
before or immediately after the index procedure during the same hospitalization (59
patients) were excluded from the analysis. Additionally, eight cases resulting in
hospital mortality were also excluded. Therefore, the final analysis included 322
patients. The indications for TAVR were determined by current European Society of
Cardiology/European Association for CardioThoracic Surgery guidelines for the
treatment of valvular heart disease: 1) mean aortic gradient ≥ 40 mmHg; or 2) peak
velocity ≥ 4.0 m/s[13]. Surgical
risk was assessed using the European System for Cardiac Operative Risk Evaluation
(or EuroSCORE) II and the Society of Thoracic Surgeons Predicted Risk of Mortality
(or STS-PROM)[14,15]. LBBB was diagnosed based on electrocardiogram
(ECG) findings showing wide QRS complexes >120 ms in the left-sided leads V5 and
V6, as well as a notched R wave in leads I, aVL, V5, and V6[16]. In the present study, new-onset
LBBB was considered persistent if it emerged during or following the TAVR procedure
and was recorded on the ECG upon hospital discharge or within seven days post-TAVR.
The primary endpoint was a cardiovascular death. The secondary endpoint included
all-cause mortality as well as PPI. All clinical outcomes were analyzed according to
the Valve Academic Research Consortium (or VARC-3)[17].
Statistical Analysis
All statistical tests were two-tailed, and P-values < 0.05
were considered statistically significant. Statistical analyses were performed
using R Statistical Software (version 4.3.1; R Foundation for Statistical
Computing, Vienna, Austria) and RStudio (version 2023.06.1 Build 524).
Continuous variables are presented as mean ± standard deviation when normally
distributed and as median and interquartile range - 25th and
75th percentiles for variables with non-normal distribution.
Categorical variables were presented as absolute number and percentage. For the
between-group comparison of continuous variables, the Student's
t-test was used. Non-parametric Mann-Whitney U test was
used when comparing non-normally distributed continuous variables. Between-group
comparison of categorical variables was performed using Fisher's exact test. To
determine predictors of death from cardiovascular causes, multivariate Cox
regression analysis was performed, which included all parameters that could
potentially be associated with the primary endpoint as independent variables.
Time-to-event analysis was performed using the Kaplan-Meier method, and
between-group differences were checked by log-rank test. Differences were
considered statistically significant at P ≤ 0.05. The study was
approved by the Meshalkin National Medical Research Center ethics committee (n.
06-5) and complies with the principles of the Declaration of Helsinki.
RESULTS
In the overall patient population, the incidence of new LBBB after TAVR was 20.2%.
Baseline clinical and instrumental characteristics of patients are presented in
Table 1. In patients with new LBBB, there
was a significantly smaller indexed aortic valve area (0.3 ± 0.1 mm
vs. 0.4 ± 0.1 mm, P < 0.01) and
interventricular membranous septum length (6.2 ± 1.6 mm vs. 6.9 ±
1.8 mm, P < 0.01).
Table 1
Baseline characteristics.
Procedural results are presented in Table 2.
The use of the first-generation CoreValve® prosthesis was more frequent among
patients with new LBBB compared with patients without LBBB (53.8%
vs. 36.6%, P = 0.01). Moreover, the groups
were significantly different in implantation depth (6.3 ± 2.4 mm in the new LBBB
group and 4.6 ± 2.4 mm in the no LBBB group, P < 0.01) and in
the arithmetic difference between membranous septum length and implantation depth
(0.2 [-1.6;1.3] in the new LBBB group vs. 1.8 [0.25;4.1] in the no
LBBB group, P<0.01). There were no significant differences in
preor post-dilatation between the two groups. Similarly, the frequency of procedural
failure and duration of post-TAVR hospitalization did not differ significantly.
Table 2
Procedural results.
At a mean follow-up of 2.9 ± 1.9 years, a total of 69 patients (21.4%) had died;
there were 36 cases (11.2%) of cardiovascular death. A total of 18 patients (27.7%)
with new LBBB died during the study period, 14 (21.5%) from cardiovascular causes.
There were no significant differences between new LBBB and no LBBB groups in the
incidence of death from all causes (27.7% vs. 19.8%, hazard ratio
[HR] 0.48, 95% confidence interval [CI] 0.17 - 1.37, P=0.16) (Figure 1). In contrast, patients with new LBBB
after TAVR had significantly higher rates of cardiovascular mortality (21.5%
vs. 8.6%, HR 2.31, 95% CI 1.18 - 4.53,
P=0.012) (Figure 2). In
addition, there were no significant differences between new LBBB and no LBBB groups
in the incidence of PPI during the follow-up (7.7% vs. 3.1%, HR
2.61, 95% CI 0.85 - 0.80, P=0.08) (Figure 3). All post-TAVR outcomes and HRs for adverse clinical events
are described in Table 3. Multivariate
regression analysis revealed age (odds ratio [OR] 1.26, 95% CI 1.05 - 1.51,
P = 0.01), baseline left ventricular (LV) ejection fraction
(EF) (OR 0.91, 95% CI 0.84 - 0.98, P = 0.02), and new-onset
post-TAVR LBBB (OR 7.09, 95% CI 1.16 - 43.50, P = 0.03) as
independent predictors of death from cardiovascular causes (Table 4).
Table 3
Follow-up outcomes.
Table 4
Multivariate regression analysis of predictors of death from
cardiovascular causes.
Fig. 1
Kaplan-Meier curves of the incidence of all-cause death. LBBB=left
bundle branch block.
Fig. 2
Kaplan-Meier curves of the incidence of death from cardiovascular
causes. LBBB=left bundle branch block.
Fig. 3
Kaplan-Meier curves of the incidence of permanent pacemaker
implantation. LBBB=left bundle branch block.
DISCUSSION
Our study identified several key findings: 1) the incidence of new LBBB after TAVR
was found to be 20.2%; 2) new-onset LBBB after TAVR was associated with an increased
incidence of cardiovascular death; and 3) the development of LBBB was not associated
with an increased all-cause death and the need for PPI. LBBB following TAVR is a
common complication, likely attributed to the proximity of cardiac conduction system
components to the bioprosthesis area (left half of the interventricular septum).
Damage to the left bundle branch may result from a combination of patient-related
factors (initial conduction disorders, membranous septum length, aortic root
calcification severity) and procedural variables (bioprosthesis type, implantation
depth, preor post-dilation).
The incidence of LBBB following TAVR varies between studies, with around one-quarter
of cases experiencing the first occurrence of LBBB with the use of first-generation
valves[18,19]. Specifically, the development of LBBB was most
commonly observed with CoreValve® self-expanding transcatheter valves (Medtronic
Inc., United States of America), with rates ranging from 18% to 65%, compared to
Edwards SAPIEN™/SAPIEN XT™ balloon-expandable valves (Edwards Lifesciences, United
States of America), where rates ranged from 4% to 30%[20]. Data on the occurrence of LBBB with the use of
new generation valves are limited, with reported incidences ranging from 12% to 22%
following implantation of the Edwards SAPIEN™ valve[21,22].
Similar results have been observed in studies using Portico™ self-expanding
bioprosthesis (St. Jude Medical, United States of America) and next-generation
Evolut™ R and Evolut™ R PRO valves (Medtronic Inc., United States of America) with a
reported incidence of new LBBB ranging between 18 and 28%[23,24]. Our
findings regarding the incidence of LBBB are generally consistent with the
literature and emphasize the relevance of this topic. It is noteworthy that the
differences observed in certain parameters among the comparison groups in our study
(Table 1) support the potential
relationship of LBBB with various procedural and anatomical factors, such as the
depth of implantation, the type of bioprosthesis, as well as the membranous septum
length. It is important to consider the fact that in more than a third of patients,
LBBB that developed after TAVR resolves after discharge from the hospital. Nazif et
al.[7] reported LBBB
resolved in 42.1% of patients within 30 days after TAVR.
Houthuizen et al. were the first to demonstrate the association of LBBB with
increased mortality after TAVR in 2012, and subsequent follow-up data supported
these results[23]. Nazif and Kim
et al.[7,24] reported that new-onset LBBB after TAVR increased the
incidence of adverse clinical events including all-cause mortality and
cardiovascular mortality, rehospitalization, and PPI. A comprehensive meta-analysis
involving 9,205 TAVR patients further confirmed the adverse impact of new-onset LBBB
on long-term TAVR outcomes at one, two, and three years[25]. Our results generally demonstrate similar
outcomes. In the new LBBB group, there was a higher incidence of death from
cardiovascular causes (HR 2.31, 95% CI 1.18 - 4.53, P = 0.012).
However, there were no significant differences in the incidence of death from all
causes and implantation of permanent pacemaker. The discrepancy between the results
regarding the association of LBBB with increased mortality and adverse clinical
outcomes may be related with different definitions of LBBB, characteristics of
different patient populations, and variability in follow-up time.
The underlying pathogenesis of the detrimental effects of the new-onset LBBB on the
long-term outcomes after TAVR is associated with a reduction in LV diastole time,
along with abnormal movement of the interventricular septum, leading to a decrease
in both regional contractility and global LV EF[26]. These findings have been supported by various
retrospective studies, which have demonstrated a significant decline in LV EF and a
decrease in the effectiveness of LV reverse remodeling processes in individuals with
new LBBB[7,9,24]. In the presented
study, the analysis of echocardiographic data in the long-term period was omitted
due to the lack of available data.
Thus, post-TAVR LBBB represents a significant conduction disorder, mainly due to its
high incidence and potential adverse impact on clinical outcomes. It is becoming
apparent that in addition to the improvement of transcatheter valves and methods of
implantation, optimization of the health care system is required in the context of
more thorough postoperative monitoring of this group of patients. In our view,
procedural approaches to prevent LBBB after TAVR should involve techniques such as
higher implantation of a bioprosthesis (cusp overlap), TAVR without preliminary
balloon dilatation (direct implantation), implantation of balloon-expandable valves,
and conducting invasive electrophysiological studies alongside the TAVR
procedure.
Limitations
The main limitation of the study is the retrospective design with a relatively
small sample size, based on a single-center experience. We also didn't consider
the prognostic impact of procedural factors on the development of LBBB and
didn't pay attention to cases of resolution of LBBB at different time points in
the long-term follow-up. Data on drug therapy that could potentially influence
the development of LBBB were also not available. The lack of adjustment for
multiple comparison in the multivariate regression analysis may also have
partially skewed the results.
CONCLUSION
New-onset persistent LBBB after a TAVR procedure is associated with an increased
incidence of cardiovascular mortality in the long term. However, the occurrence of
all-cause mortality and the frequency of PPI are not affected by post-TAVR LBBB.
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Notes
Notes
This study was carried out at the Meshalkin National Medical Research Center,
Ministry of Health of Russian Federation, Novosibirsk, Russian Federation.
No financial support.
Conflict of interest declaration
No conflict of interest.
Author notes
Correspondence Address: Aleksey A. Baranov https://orcid.org/0000-0002-2320-2233, Meshalkin National
Medical Research Center, Ministry of Health of Russian Federation, Department of
Endovascular Surgery, 15 Rechkunovskaya st., Novosibirsk, Russia, Zip Code:
630055, E-mail: ivrach@icloud.com
