Qi et al.

European Journal of Medical Research (2024) 29:85 European Journal

https://doi.org/10.1186/s40001-023-01070-1
of Medical Research

RESEARCH Open Access

Mean compression ratio of a self‑expandable

valve is associated with the need for pacemaker
implantation after transcatheter aortic valve
replacement
Yiming Qi1†, Yuefan Ding2†, Wenzhi Pan1†, Xiaochun Zhang1, Xiaolei Lin2, Shasha Chen1, Lei Zhang1,
Daxin Zhou1* and Junbo Ge1

Abstract
Background The risk and timing of permanent pacemaker implantation (PPMI) after transcatheter aortic valve
replacement (TAVR) is still hard to predict. We aimed to analyze the relationship between the compression ratio
of a self-expandable valve (SEV) and the need for PPMI after TAVR.
Methods A total of 106 patients who were implanted with the VitaFlow transcatheter aortic valve system
and for whom complete imaging information was available were included in this retrospective cohort study. Eight
lines perpendicular to the long axis of the SEV were drawn (the top and bottom of the SEV and the intersection
of each row of wires) for measurement purposes. The compression ratio was calculated as 1 − (in vivo meridian/in vitro
meridian) and compared between patients undergoing and those not undergoing PPMI after adjusting for implanta-
tion depth. Multivariable logistic regression and Cox proportional hazards models were used to assess factors associ-
ated with the risk and timing of the need for PPMI.
Results Fifteen (14.2%) patients underwent PPMI after TAVR. Patients with a higher mean compression ratio (20%,
odds ratio [OR] = 214.82; p < 0.001) and prior right bundle branch block (OR = 51.77; p = 0.015) had a higher risk
of the need for PPMI after TAVR. These two factors were also associated with the timing of PPMI, according to the Cox
proportional hazards model.
Conclusions The compression ratio of the SEV was positively associated with the risk of PPMI after TAVR,
and the association was most significant in the annular and supravalvular planes. The compression ratio may
also affect the time to PPMI.
Keywords TAVR, Self-expandable valve, Pacemaker implantation, Compression level, Mechanical stress

Background
†
Yiming Qi, Yuefan Ding, and Wenzhi Pan contributed equally to this work Transcatheter aortic valve replacement (TAVR) is a safe
*Correspondence: and effective treatment for patients with severe aortic
Daxin Zhou stenosis with even low surgical risks [1, 2]. The necessity
zhou.daxin@zs-hospital.sh.cn
1 of permanent pacemaker implantation (PPMI) caused by
Department of Cardiology, Zhongshan Hospital, Shanghai Institute
of Cardiovascular Diseases, National Clinical Research Center conduction block remains a common complication after
for Interventional Medicine, Fudan University, Shanghai, China TAVR, which increases mortality among these patients
2
School of Data Science, Fudan University, Shanghai, China
[3]. The anatomical characteristics of the conduction

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Qi et al. European Journal of Medical Research (2024) 29:85 Page 2 of 8

pathway associated with the mechanical stress of the secondary endpoint was time to PPMI, defined as the
prosthesis are believed to be one of the main mechanisms number of days between TAVR and PPMI, censoring data
of the necessity for PPMI after TAVR [4]. The prediction for patients without PPMI. The need for PPMI was evalu-
of stress distribution in the tissue around the prosthesis is ated by a consensus committee consisting of experienced
reportedly beneficial in predicting the risk of the need for cardiac electrophysiology specialists and interventional
PPMI [5, 6]. The incidence of delayed PPMI has increased cardiologists.
in recent years, which may be due to early-discharge
practice and the resulting sustained stress of the self- Image processing
expandable valve (SEV) [7]. We selected angiographic images of the aortic root after
An SEV, made of memory alloy, returns to its origi- valve implantation; the projection angles were deter-
nal size at human body temperature, and the pressure mined according to the position of the coronary artery
it exerts on the surrounding tissue is proportional to and the shape of the sinus. The projection angles were
the degree of prosthesis compression [8]. Therefore, we divided into four categories, with the following order of
thought the compression level of the SEV may associ- priority: the view in which the left and right coronary
ated with the risk of conduction block after TAVR, which sinuses overlap, that in which the right and non-coronary
may be used to evaluate the risk and timing of PPMI. In sinuses overlap, that in which the non-coronary sinus is
this study, we measured the SEV compression ratio with in the middle, and that in which the right coronary sinus
the aim of determining its correlation with the need for is in the middle (Fig. 1). The annulus plane was defined as
PPMI after TAVR. the lowest position of sinus angiography in the selected
projection angle. After calibrating the length according
Methods to the pigtail catheter, eight lines were drawn perpen-
Study population dicular to the long axis of the SEV (the top and bottom
This retrospective cohort study was approved by the of the SEV and the intersection of each row of wires) for
Ethics Committee of Zhongshan Hospital, Fudan Uni- measurement purposes (Fig. 2). We compared the meas-
versity (No. B2020-039), and written informed consent ured meridian with the in vitro measured meridian of the
was obtained from all the participants for participation stent (data not shown owing to commercial confidenti-
in this study and publication of their data. A total of 381 ality), and we calculated the compression ratio as 1 − (in
patients with aortic stenosis were treated with TAVR at vivo meridian/in vitro meridian). The line closest to the
Zhongshan Hospital (a tertiary teaching hospital affili- annulus plane was defined as position 0; those below the
ated with Fudan University) in Shanghai, China from annulus plane as positions − 1, − 2, and − 3; and those
June 2015 to September 2021. We excluded patients with above the annulus plane as positions 1, 2, 3, and so on
previous PPMI, TAVR, or surgical aortic valve replace- (Fig. 2). The mean compression ratio was calculated using
ment; those who underwent valve-in-valve TAVR during the positions most relevant to PPMI.
the procedure; those transferred for surgical operation
owing to complications; and those who died of any cause. Statistical analysis
Ultimately, 106 patients who were implanted with the Continuous variables were described using the mean and
VitaFlow transcatheter aortic valve system (Microport standard deviation, whereas categorical variables were
CardioFlow Medtech Corporation, Shanghai, China) and described using the frequency and proportion per cate-
for whom complete imaging information was available gory. Patient characteristics were compared using a two-
were included in this analysis. sample t-test for continuous variables and a Chi-square
or Fisher’s exact test for categorical variables. Univariate
Data acquisition, pre‑processing, and endpoint definition logistic regression was performed for each position in
Baseline characteristics, medical history, pre-procedural which compression was measured, the maximum com-
electrocardiograms, procedural characteristics, pre-pro- pression value, and the mean compression value for posi-
cedural transesophageal/transthoracic echocardiograms, tions 1 to 4. Forward variable selection was performed,
laboratory results, and intraoperative X-ray images were and a multivariable logistic regression model was used
acquired for each patient. Percent oversizing of the pros- to determine the association between the factors and the
thetic valve was calculated as the ratio of the nominal risk of the necessity of PPMI. Time-to-event analysis was
valve perimeter to the measured aortic annulus perimeter performed using a multivariate Cox proportional hazards
via computed tomography images. The primary endpoint model to identify potential factors influencing the time
was PPMI within 60 days of TAVR owing to complete to PPMI among patients who underwent TAVR. All sta-
heart block (CHB), high-degree atrioventricular block tistical analyses were performed using R, version 4.1.2 (R
(HAVB), sinus arrest, or symptomatic bradycardia. The Foundation for Statistical Computing, Vienna, Austria).
Qi et al. European Journal of Medical Research (2024) 29:85 Page 3 of 8

Fig. 1 The projection angles were divided into four categories according to the position of the coronary artery and the shape of the sinus. Top
left: the left and right coronary sinuses overlap; top right: the right and non-coronary sinuses overlap; bottom left: the non-coronary sinus is in the
middle; bottom right: the right coronary sinus is in the middle

Fig. 2 Eight lines perpendicular to the long axis of the self-expandable valve (SEV) drawn (middle) for measurement purposes; these were drawn
at the top and bottom of the SEV and at the intersection of each row of wires (left). The line closest to the annulus plane was defined as position 0;
those below the annulus plane were positions − 1, − 2, and − 3; and those above the annulus plane were positions 1, 2, 3, and so on
Qi et al. European Journal of Medical Research (2024) 29:85 Page 4 of 8

Daxin Zhou had full access to all the data in the study and Identification of risk factors
takes responsibility for its integrity and the data analysis. Candidate risk factors were selected based on their uni-
variate associations with the need for PPMI as well
as their clinical significance. The multivariable logis-
Results tic regression models for the prediction of the need for
Patient characteristics PPMI are presented in Table 2. The mean compression
A total of 106 patients treated with TAVR were included, ratio (20%, odds ratio [OR] = 214.82; p < 0.001) and prior
of whom 15 (14.2%) underwent PPMI. The major rea- right bundle branch block (RBBB; OR = 51.77; p < 0.001)
sons for PPMI were CHB (11/15, 73%) and HAVB (4/15, were independent risk factors for the need for PPMI.
27%). Twelve patients underwent PPMI within 7 days of Although atrial fibrillation (OR = 5.08; p = 0.054) and a
TAVR, while 2 and 1 PPMIs were conducted between history of smoking (OR = 6.29; p = 0.095) did not achieve
8 and 30 days and beyond 30 days, respectively. Patient statistical significance in the model, these should not be
characteristics are summarized in Table 1. Compared to discounted as potential risk factors, given the relatively
those not requiring PPMI, patients requiring PPMI had small sample of this study. Patients were divided into
a similar disease history and a higher mean compression
ratio (21.4% vs. 8.4%; p < 0.001).

Image measurement
The projection angle in which the left and right coronary
sinuses overlapped was selected in 67 cases (63.2%), that
in which the right and non-coronary sinuses overlapped
was selected in 22 cases (20.8%), that in which the non-
coronary sinus was in the middle was selected in 15 cases
(14.2%), and that in which the right coronary sinus was in
the middle was selected in 2 cases (1.9%). Comparisons
of the compression ratios of each position of the SEV are
illustrated in Fig. 3; it was highest in patients with a PPMI
in positions − 1 to 5. Therefore, the mean compression Fig. 3 Comparison of the compression ratio at each position
ratio was calculated using positions 0 to 4. of the self-expandable valve

Table 1 Patient characteristics

Non-PPMI (n = 91) PPMI (n = 15) Total (n = 106) p value

Age 75.39 (6.98) 78.8 (6.59) 75.88 (7.00) 0.081

Female 38 (41.8%) 2 (13.3%) 40 (37.7%) 0.012
CAD 73 (80.2%) 13 (86.7%) 86 (81.1%) 0.527
Hypertension 47 (51.6%) 6 (40%) 53 (50%) 0.420
Smoker 10 (11%) 3 (20%) 13 (12.3%) 0.432
History of stroke 2 (2.2%) 1 (6.7%) 3 (2.8%) 0.523
History of syncope 9 (9.9%) 3 (20%) 12 (11.3%) 0.377
Atrial fibrillation 17 (18.7%) 7 (46.7%) 24 (22.6%) 0.061
Prior RBBB 4 (4.4%) 2 (13.3%) 6 (5.7%) 0.353
BAV 48 (52.7%) 11 (73.3%) 59 (55.7%) 0.137
AVA 0.695 (0.202) 0.775 (0.338) 0.706 (0.226) 0.386
Oversize rate − 0.008 (0.078) 0.009 (0.049) − 0.005 (0.074) 0.276
Pre-dilatation 89 (97.8%) 14 (93.3%) 103 (97.2%) 0.899
Post-dilatation 28 (30.8%) 5 (33.3%) 33 (31.1%) 1.000
Mean compression 0.084 (0.082) 0.214 (0.066) 0.103 (0.092) < 0.001
Values are mean ± SD or frequency (%)
AVA aortic valve area, BAV bicuspid aortic valve, CAD coronary artery disease, PPMI permanent pacemaker implantation, RBBB right bundle branch block
P values are obtained by two-sample t-test
Qi et al. European Journal of Medical Research (2024) 29:85 Page 5 of 8

Table 2 Multivariate logistic regression models for risk factors of Table 3 Cox proportional hazards model for the time to PPMI
PPMI
Covariances Hazard ratio (95% CI) p value
Odds ratio (95% CI) p value
Mean compression (20%) 53.41 (11.2, 254.7) < 0.001***
Mean compression (20%) 214.82 (20.53, 5803.48) < 0.001*** Prior RBBB 39.44 (5.73, 271.5) < 0.001***
Prior RBBB 51.77 (2.26, 1632.21) 0.015* Smoker 7.24 (1.65, 31.73) 0.009**
Atrial fibrillation 5.08 (1.01, 29.67) 0.054# Atrial fibrillation 3.46 (1.13, 10.57) 0.030*
Smoker 6.29 (0.71, 62.17) 0.095# Abbreviations as in Table 1
Abbreviations as in Table 1 Signif. codes: 0 ‘***’ 0.001 ‘**’ 0.01 ‘*’ 0.05 ‘#’ 0.1 ‘†’ 1
Signif. codes: 0 ‘***’ 0.001 ‘**’ 0.01 ‘*’ 0.05 ‘#’ 0.1 ‘†’ 1

Fig. 4 The permanent pacemaker implantation rates among low

Fig. 5 Kaplan–Meier curves of the low, moderate, and high mean
(≤ 0.09220), moderate (> 0.09220 and ≤ 0.15899), and high (> 0.15899)
compression ratio groups, indicating that patients with a higher
mean compression ratio groups after transcatheter aortic valve
mean compression ratio are likely to undergo permanent pacemaker
replacement
implantation sooner than patients with a lower mean compression
ratio (p < 0.001)

three groups according to quantiles of mean compression

ratio: low (mean compression ratio ≤ 0.09220), moderate Discussion
(0.09220 < mean compression ratio ≤ 0.15899), and high The need for PPMI due to conduction block remains a
(mean compression ratio > 0.15899). The PPMI rates in major complication after TAVR. Mechanical compression
these three groups are displayed in Fig. 4. of the surrounding tissue by the prosthesis, especially the
vulnerable area near the junction of the right and non-
coronary sinus, where the conduction bundle crosses [5,
Time‑to‑PPMI analysis 6], is considered to be one of the main mechanisms of the
Time to PPMI and the censoring status (whether the need for PPMI after TAVR [7]. The rise in the incidence
patient underwent PPMI within 60 days of TAVR) were of delayed PPMI in recent years [7] raises new questions
treated as the outcomes in the Cox proportional haz- regarding the assessment of the need for PPMI and the
ards model, and predictors that potentially influence choice of post-discharge monitoring modalities.
patients’ time to PPMI are provided in Table 3. In brief, To the best of our knowledge, the pressure distribu-
patients with a higher mean compression ratio (hazard tion of the device landing zone is mainly simulated and
ratio [HR] = 53.41; p < 0.001), prior RBBB (HR = 39.44; predicted via preoperative finite element analysis [9],
p < 0.001), history of smoking (HR = 7.24; p = 0.009), and and there is no evaluation method for the actual pressure
atrial fibrillation (HR = 3.46; p = 0.030) had a shorter after implantation. In a previous study, the vast majority
time from TAVR to PPMI after adjusting for other fac- of implanted valve frames suffered from some degree of
tors in the model. Kaplan–Meier curves of the three compression [10]. In vitro experiments on valve stents
compression level groups (Fig. 5) revealed that patients made of memory alloys demonstrated that, under a con-
with a higher mean compression ratio were more likely stant temperature, the radial support force is propor-
to require PPMI sooner than patients with a lower mean tional to the degree of valve compression [8].
compression ratio (p < 0.001).
Qi et al. European Journal of Medical Research (2024) 29:85 Page 6 of 8

Therefore, we used postoperative fluoroscopic images angiographic images are normally obtained in the left and
of the SEV to measure and calculate the compression right coronary sinus overlap position after implantation,
ratio in different positions of the valve frame. As the that is, the non-coronary sinus is located at the lowest
implantation depth of the prosthesis was not the same position, and the view is relatively close to the vulnerable
in different patients, and implantation depth affects the area. Therefore, we prioritized this projection angle in
need for PPMI [11, 12], we compared the SEV compres- our study. Our results showed that the SEV compression
sion ratios at the same location relative to the annulus. ratio measured at the left and right coronary sinus over-
We discovered significant differences in positions − 1 to 5 lap position or the right and non-coronary sinus over-
between patients undergoing PPMI and those not under- lap position was related to the need for PPMI. However,
going PPMI, with higher rates of compression associated owing to the limitations of sample size and imaging data,
with higher rates of PPMI. Positions − 1 to 5 are equiva- it remains unclear which projection angle is most suitable
lent to the middle and lower parts of the valve frame and for the prediction of the need for PPMI.
are mostly located near the annulus plane and supraval- Other independent risk factors for the need for PPMI
vular structures. This is the main anchoring area of the in our multivariable analysis were prior RBBB and atrial
SEV, and the position experiencing the greatest force fibrillation. RBBB has been reported as a risk factor for
[13]. We selected positions 0 to 4 (those with the largest the need for PPMI in many previous studies [11, 12, 14,
differences between the groups) to calculate the average 15]. The high incidence of new-onset left bundle branch
compression ratio for multivariable analysis. The results block after TAVR may explain why prior RBBB is strongly
suggested that the mean compression ratio differed sig- associated with CHB or HAVB [3]. A previous study
nificantly between the PPMI and non-PPMI groups; revealed that atrial fibrillation is associated with the need
hence, it is an independent risk factor for PPMI. When for PPMI owing to an underlying conduction disease pre-
we further divided patients into three groups according disposing to both atrial fibrillation and conduction block
to the mean compression ratio, we discovered that the [16].
compression ratio affected the time to PPMI; a larger Many studies suggest that the oversize rate is related
compression ratio was associated with earlier PPMI. to the need for PPMI [17, 18], but our results were not
Therefore, we believe that measurement of the compres- in agreement (− 0.8% ± 7.8% vs. 0.9% ± 4.9%, p = 0.420).
sion ratio in the lower part of the SEV after TAVR may be This may be owing to the low oversize rate in our study,
used to evaluate the risk of the need for PPMI and may be as downsized prostheses were often selected after bal-
predictive of the late need for PPMI. Owing to the lim- loon pre-dilation because of the large proportion of
ited sample size, we could not accurately determine the bicuspid valves (~ 56% of the total cases in our study) and
range of compression ratios that indicate that a patient is relatively heavy calcification. Although the mean over-
prone to require late PPMI. size rate was close to zero, the compression ratio differed
As implantation depth is a risk factor for the need of between groups, suggesting that the compression ratio
PPMI [11, 12], the compression ratios at especially posi- may be a more accurate indicator of the need for PPMI
tions − 2 and − 3 should differ between patients under- than the oversize rate. For patients with the same annu-
going and those not undergoing PPMI. However, this lus and SEV size, the compression ratio of the prosthesis
was not the case, possibly because there was no signifi- typically differs owing to different degrees of valve leaf
cant difference in the implantation depth between the calcification, adhesion, and fusion.
two groups (3.666 ± 2.873 mm vs. 3.664 ± 3.623 mm, Owing to the differences in metals and shapes used for
p = 0.998). The vast majority of SEVs were implanted at a different SEVs, comparison of different SEVs is challeng-
depth of no more than 7.5 mm; position − 2 was approxi- ing. Therefore, we only included patients implanted with
mately equivalent to a depth 7.6–12.5 mm, and position the same type of SEV, which is one of the reasons for the
− 3 was approximately equivalent to a depth of 12.5 mm small sample. Thus, one should be cautious when apply-
or more. Our results suggest that the compression ratio ing the results of this study directly to patients implanted
may be a more sensitive indicator of the need for PPMI with other types of SEVs; however, the measurement
than implantation depth when the implantation is not method used in this study and its relationship with the
deep. need for PPMI should be applicable to all SEVs.
The vulnerable area of the conduction tract is located
in the interventricular septal region at the junction of the Study limitations
right and non-coronary sinuses [7]. Therefore, the com- First, the sample was relatively small; however, this is, to
pression ratio of the valve frame at the right and non-cor- our knowledge, the first report of intraoperative fluoro-
onary sinus overlap position may most accurately reflect scopic image-measured compression ratios being sig-
the force exerted in the vulnerable position. However, nificantly correlated with the need for PPMI after TAVR.
Qi et al. European Journal of Medical Research (2024) 29:85 Page 7 of 8

Studies with larger samples are needed to confirm this Consent for publication
Not applicable.
conclusion and clarify the dose–effect relationship. Sec-
ond, owing to the retrospective nature of this study, Competing interests
projection angles with aortic root angiography after The authors declare that they have no competing interests.
implantation were limited, and we were not able to deter-
mine the best projection angle for measurement of the Received: 5 February 2023 Accepted: 15 February 2023
compression ratio. Third, owing to the small sample, we
could not separately analyze the bicuspid and tricuspid
valves, which may result in differences in the location
of maximum compression. We are collecting relevant References
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