Yunshan Cao1, Vikas Singh2, Aqian Wang3, Liyan Zhang4, Tingting He4, Hongling Su3, Rong Wei3, Yichao Duan5, Kaiyu Jiang4, Wenyu Wu5, Yan Huang3, Sammy Elmariah6, Guanming Qi7, Xin Su4, Yan Zhang8, Min Zhang9. 1. Department of Cardiology, Gansu Provincial Hospital, No. 204, Donggang West Road, Chengguan District, Lanzhou, Gansu 730000, China. 2. Division of Cardiovascular Medicine, University of Louisville School of Medicine, Louisville, KY, USA. 3. Department of Cardiology, Gansu Provincial Hospital, Lanzhou, China. 4. Clinical Medicine School, Gansu University of Chinese Medicine, Lanzhou, China. 5. School of Clinical Medicine, Ningxia Medical University, Ningxia, China. 6. Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School Boston, MA, USA. 7. Pulmonary and Critical Care Division, Tufts Medical Center, Boston, MA, USA. 8. Tianjin Key Laboratory of Retinal Functions and Diseases, Tianjin International Joint Research and Development Center of Ophthalmology and Vision Science, Eye Institute and School of Optometry, Tianjin Medical University Eye Hospital, No. 251, Fukang Road, Nankai District, Tianjin, China. 9. Department of Pathology, Gansu Provincial Hospital, No.204, Donggang West Road, Chengguan District, Lanzhou, Gansu 730000, China.
Abstract
BACKGROUND: Right ventricular function (RVF) is an independent predictor of prognosis for patients undergoing aortic valve replacement: transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). The effect of transfemoral aortic valve replacement (TF-TAVR) on RVF is uncertain. We aimed to perform a meta-analysis of the effect of TF-TAVR on RVF in patients with aortic stenosis (AS) and compare the effect of TF-TAVR with SAVR. METHODS: We searched relevant studies from PubMed, Embase, Cochrane Library databases, and Web of Science. Furthermore, two reviewers (Wang AQ and Cao YS) extracted all relevant data, which were then double checked by another two reviewers (Zhang M and Qi GM). We used the forest plot to present results. Tricuspid annular plane systolic excursion (TAPSE) was the primary outcome. RESULTS: This meta-analysis included 11 studies. There were 353 patients who underwent TF-TAVR, and 358 patients who were subjected to SAVR. There was no significant difference in TAPSE at 1 week and 6 months as well as right ventricular ejection fraction (RVEF) at <2 weeks and 6 months after TF-TAVR. For the SAVR group, TAPSE at 1 week and 3 months as well as fractional area change (FAC) at 3 months post procedure were significantly aggravated, while RVEF did not change significantly. Moreover, TAPSE post-TF-TAVR was significantly improved as compared with post-SAVR. The △TAPSE, the difference between TAPSE post-procedure and TAPSE prior to procedure, was also significantly better in the TF-TAVR group than in the SAVR group. CONCLUSION: RVF was maintained post TF-TAVR. For SAVR, discrepancy in the measured parameters exists, as reduced TAPSE indicates compromised longitudinal RVF, while insignificant changes in RVEF implicate maintained RVF post procedure. Collectively, our study suggests that the baseline RV dysfunction and the effect of TF-TAVR versus SAVR on longitudinal RVF may influence the selection of aortic valve intervention.
BACKGROUND: Right ventricular function (RVF) is an independent predictor of prognosis for patients undergoing aortic valve replacement: transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). The effect of transfemoral aortic valve replacement (TF-TAVR) on RVF is uncertain. We aimed to perform a meta-analysis of the effect of TF-TAVR on RVF in patients with aortic stenosis (AS) and compare the effect of TF-TAVR with SAVR. METHODS: We searched relevant studies from PubMed, Embase, Cochrane Library databases, and Web of Science. Furthermore, two reviewers (Wang AQ and Cao YS) extracted all relevant data, which were then double checked by another two reviewers (Zhang M and Qi GM). We used the forest plot to present results. Tricuspid annular plane systolic excursion (TAPSE) was the primary outcome. RESULTS: This meta-analysis included 11 studies. There were 353 patients who underwent TF-TAVR, and 358 patients who were subjected to SAVR. There was no significant difference in TAPSE at 1 week and 6 months as well as right ventricular ejection fraction (RVEF) at <2 weeks and 6 months after TF-TAVR. For the SAVR group, TAPSE at 1 week and 3 months as well as fractional area change (FAC) at 3 months post procedure were significantly aggravated, while RVEF did not change significantly. Moreover, TAPSE post-TF-TAVR was significantly improved as compared with post-SAVR. The △TAPSE, the difference between TAPSE post-procedure and TAPSE prior to procedure, was also significantly better in the TF-TAVR group than in the SAVR group. CONCLUSION: RVF was maintained post TF-TAVR. For SAVR, discrepancy in the measured parameters exists, as reduced TAPSE indicates compromised longitudinal RVF, while insignificant changes in RVEF implicate maintained RVF post procedure. Collectively, our study suggests that the baseline RV dysfunction and the effect of TF-TAVR versus SAVR on longitudinal RVF may influence the selection of aortic valve intervention.
Aortic stenosis (AS) is the most prevalent acquired valvular disorder, affecting up
to 4% of the elderly population and associating with significant morbidity and
mortality.[1-3] Surgical aortic
valve replacement (SAVR) has been the conventional treatment of choice for patients
with severe AS. Over the past decade, transcatheter aortic valve replacement (TAVR)
has emerged as an effective alternative for patients at intermediate, high, or
prohibitive risk of ongoing SAVR.[4-6] TAVR is extensively performed
worldwide and reduced rates of mortality and re-hospitalization in operable patients
when compared with optimal medical treatment.[4] In patients with severe AS and reduced left ventricular ejection fraction
(LVEF), TAVR attains better recovery of EF than SAVR.[7]Right ventricular dysfunction is a well-recognized adverse prognostic factor in
patients with SAVR.[8] In addition, right ventricular function (RVF) may further deteriorate after SAVR.[9] The influence of RVF on TAVR and the effect of TAVR on RVF are currently
uncertain. This is partly due to the complex geometry of right ventricle and the
lack of a widely accepted and generally applicable index for measurement of RVF.[10] Furthermore, RV size and function are not routinely measured or reported with
outcomes of TAVR.[11] Of all the possible access sites, transfemoral transcatheter aortic valve
replacement (TF-TAVR) accounts for 96% of the TAVR cases.[12] A recent meta-analysis showed that TAPSE remained unchanged following the
TF-TAVR, but reduced significantly after the transapical TAVR (TA-TAVR) at the time
of hospital discharge.[13] The purpose of the current meta-analysis is to evaluate the effect of TF-TAVR
as opposed to SAVR on RVF in patients with severe AS.
Methods
Data sources and search strategy
We searched the PubMed, Embase, the Web of Science and the Cochrane library for
relevant articles published prior to February 14, 2020. The search strategy
contained a mix of MeSH and free text terms for key concepts related to
transcatheter aortic valve implantation, surgical aortic valve replacement, and
RVF in patients with aortic valve stenosis. Searches were limited to the trials
of human subjects, with no language restriction. The detailed search strategy is
shown in the electronic database search hedges in Appendix 1.
Study selection and eligibility criteria
Two investigators (Wang AQ and Cao YS) independently searched and critically
selected the articles to ensure eligibility. We utilized the following criteria:
(a) the procedure was performed in the patients diagnosed as AS (defined as the
aortic valve area <1 cm2 or the indexed aortic valve area
<0.06 cm2/m2), and only human studies were
included; (b) intervention was TF-TAVR and/or SAVR; (c) the outcome was RVF as
assessed by echocardiography, cardiac magnetic resonance imaging, or
radionuclide angiocardiography. The measurements of RVF included tricuspid
annular plane systolic excursion (TAPSE), right ventricular ejection fraction
(RVEF), and fractional area change (FAC). The primary outcome was TAPSE, the
secondary outcomes included RVEF and FAC. Studies were excluded if they met one
of the following criteria: (a) duplicate publication, (b) case reports and
animal studies, (c) correspondence and letter, (d) published as abstracts
without specific data, (e) articles that did not match inclusion criteria, or
(f) papers unrelated to the topic. There were no restrictions on follow-up
period.
Data extraction and management
All selected articles were assessed by two reviewers (Wang AQ and Cao YS) for
relevance and eligibility by scrutinizing titles and abstracts. Full texts were
reviewed and data extracted in the relevant studies assessing RVF after aortic
valve replacement. Methodological disagreements were resolved by a third
reviewer (Zhang M). The patients’ characteristics included the traits that may
influence the outcome of procedure, such as age, sex, Society of Thoracic
Surgeons Predicted Risk of Mortality, coronary artery bypass grafting, chronic
obstructive pulmonary disease, and so forth.
Quality assessment
Two authors (Zhang LY and He TT) independently assessed the risk of bias of
randomized controlled trials using the Cochrane Risk-of-Bias tool,[14] which assesses the sequence generation, allocation concealment, masking,
and incomplete outcome data. The risk of bias in cohort and case–control studies
was assessed using the Newcastle–Ottawa scale, which evaluates sample
representativeness and size, representativeness of the cases as compared with
control group, comparability between pre- and post-procedure as well as
post-TF-TAVR and post-SAVR, ascertainment of AVR, and thoroughness of
descriptive statistics reporting. The studies were judged as high risk of bias
when assessment score was lower than three points, and as low risk of bias when
the score was higher than three points. Another co-author (Wang AQ) resolved
disagreements.
Statistical analysis and data synthesis
Meta-analysis was performed using RevMan 5.3 according to the Cochrane
Handbook. The forest plot, the standard way to illustrate results
of individual studies and meta-analysis, was used to present the results in our
analyses. We used means, standard deviations (SDs), and p
values to present outcomes.We used funnel plots to assess the publication bias. A funnel plot is a scatter
plot of the effect estimates from individual studies against a measure of each
study’s size. For the effect estimate, the accuracy increases with the sample
size. In addition, effect estimates of the small sample distribute at the bottom
of the figure with a wide range; in contrast, the range of the big sample is
narrow. A symmetrical distribution of the studies’ effect estimates in the
funnel plot would suggest the absence of publication bias.For the studies that were included in this meta-analysis but did not report SDs
in the texts, we calculated the SDs after determining the correlation
coefficient from a similar study. The correlation coefficient in the
experimental group was calculated according to the following formula[15]:(CorrE = the correlation coefficient in the experimental group,
E = experiment)We then calculated SDE,final using the following formula[15]:The heterogeneity was assessed using Chi-square test
(p < 0.10) and the I2 value.
When the study demonstrated heterogeneity using
I2 >50%, we selected the random-effects model.
Otherwise, we chose the fixed-effects model. The vertical dashed line on the
forest plot represents an invalid line. The size of each box is proportional to
the weight of the trial result. Diamonds represent the 95% confidence interval
for the pooled estimates of the effect. The dashed vertical line through the
middle of the diamond is the mean estimate of the meta-analysis and provides a
reference line for an individual study.
Results
Study selection
We initially found 1537 articles by systematic literature search. After removing
duplicates (316), there were 1221 studies to be screened for title and abstract.
After irrelevant studies, case reports, animal studies, response to letter,
meeting abstracts, reviews and meta-analyses were removed, 87 articles were
evaluated in full-text. Irrelevant, correspondence only, abstracts without
relevant data, articles that did not meet inclusion criteria or papers unrelated
to the topic were then excluded. Finally, 11 studies met the inclusion criteria
and were included in this meta-analysis (Figure 1).[12,16-25]
Figure 1.
Flow diagram of literature search and study selection.
Flow diagram of literature search and study selection.The search for the meta-analysis was performed on February 14, 2020. Study
descriptions and patient characteristics are summarized in Tables 1 and 2 as well as Supplemental Tables 1 and 2 online. The studies were published
from 1990 to 2016. The age of all the patients who underwent TF-TAVR or SAVR
ranged from 61 to 88 years old. There were 353 patients who underwent TF-TAVR;
358 patients underwent SAVR. All patient characteristics were collected.
Table 1.
Characteristics of transfemoral transcatheter aortic valve replacement
studies.
Study
n
Patient selection
Age, years
Male
Pre-AVA, cm2
Euro SCORE
STS score
STS mortality
NYHA
I
II
III
IV
Quick et al.[16]
74
Severe and symptomatic AS
80.5 ± 4.9
27
<1
21.2 ± 10.4
8.6 ± 4.9
NR
35
39
Ayhan et al.[17]
50[a]
Severe calcified AS
78.1 ± 8.5
21
0.62 ± 0.17
22.2 ± 15.4
6.8 ± 5.0
NR
0
2
31
17
Okada et al.[18]
13
Severe AS
82.4 ± 4.3
6
NR
NR
NR
NR
NR
NR
NR
NR
Crouch et al.[19]
26
Severe AS
84.6 ± 5.6
17
NR
NR
7.7 ± 3.9
NR
2.5 ± 0.8
Keyl et al.[20]
20
AS
83.0 ± 6.0
7
NR
11.9 ± 5.8
11.4 ± 9.4
NR
NR
NR
NR
NR
Musa et al.[21]
56[b]
Severe trileaflet degenerative AS
80.4 ± 6.6
32
0.60 ± 0.2
NR
NR
5.54 ± 3.41
NR
NR
NR
NR
Gronlykke et al.[12]
114[c]
Isolated severe AS
79.0 ± 5.1
64
NR
8.2 ± 4.1
3.0 ± 1.7
NR
5
54
53
2
Data presented as mean ± standard deviation, or number.
Included two patients who underwent trans-subclavian artery
transcatheter aortic valve replacement (TAVR).
Included four patients who underwent trans-subclavian artery
TAVR.
Included three patients who underwent trans-subclavian artery TAVR,
one patient who underwent trans-carotid artery TAVR and one patient
who underwent direct trans-aortic TAVR.
AS, aortic stenosis; NR, not reported; NYHA, New York Heart
Association; pre-AVA, pre-operation aortic valve area; STS, Society
of Thoracic Surgery
Table 2.
Characteristics of surgical aortic valve replacement studies.
Study
n
Patient selection
Age, years
Male
Pre-AVR, cm2
Euro SCORE
STS score
STS mortality
NYHA
I
II
III
IV
Harpole and Jones[24]
11
AS
62 ± 15
NR
0.7 ± 0.2
NR
NR
NR
NR
NR
7
Sandstede et al.[25]
14
AS
64 ± 10
12
0.7 ± 0.2
NR
NR
NR
NR
NR
NR
NR
Zhao et al.[22]
30
Symptomatic, severe AS
62 ± 11
19
NR
4.0 ± 2.1
NR
NR
1
17
12
0
Kempny et al.[23]
22
Symptomatic, severe AS
71 ± 12
8
0.73 ± 0.24
7.2 ± 4.7
NR
NR
1
4
17
0
Quick et al.[16]
63
Symptomatic, severe AS
73.8 ± 8.1
22
NR
6.5 ± 3.7
2.2 ± 1.8
NR
40
23
Okada et al.[18]
15
Severe AS
79.6 ± 5.9
9
NR
NR
NR
NR
NR
NR
NR
NR
Crouch et al.[19]
21
Severe AS
79.6 ± 4.0
8
NR
NR
5.9 ± 3.4
NR
2.7 ± 0.6
Gronlykke et al.[12]
106
Isolated severe AS
78.4 ± 4.7
58
NR
8.7 ± 4.1
3.2 ± 1.7
NR
3
57
42
4
Keyl et al.[20]
20
AS
77 ± 4
9
NR
7.0 ± 3.3
10.7 ± 4.1
NR
NR
NR
NR
NR
Musa et al.[21]
56
Severe trileaflet degenerative AS
72.8 ± 7.2
38
0.82 ± 0.4
NR
NR
2.13 ± 0.73
NR
NR
NR
NR
Data presented as mean ± standard deviation, or number.
AS, aortic stenosis; NR, not reported; NYHA, New York Heart
Association; pre-AVA, pre-operation aortic valve area; STS, Society
of Thoracic Surgery
Characteristics of transfemoral transcatheter aortic valve replacement
studies.Data presented as mean ± standard deviation, or number.Included two patients who underwent trans-subclavian artery
transcatheter aortic valve replacement (TAVR).Included four patients who underwent trans-subclavian artery
TAVR.Included three patients who underwent trans-subclavian artery TAVR,
one patient who underwent trans-carotid artery TAVR and one patient
who underwent direct trans-aortic TAVR.AS, aortic stenosis; NR, not reported; NYHA, New York Heart
Association; pre-AVA, pre-operation aortic valve area; STS, Society
of Thoracic SurgeryCharacteristics of surgical aortic valve replacement studies.Data presented as mean ± standard deviation, or number.AS, aortic stenosis; NR, not reported; NYHA, New York Heart
Association; pre-AVA, pre-operation aortic valve area; STS, Society
of Thoracic SurgeryThe outcomes of RVF in the selected studies are shown in Tables 3 and 4. All trials’ follow-up time included
pre-procedure and post-procedure, and quantitative data were presented as
mean ± SD. The longest follow-up time was 6 months after procedure.
Echocardiogram was the most common method to measure RVF whereas three studies
used cardiac magnetic resonance imaging and one used radionuclide
angiocardiography.
Table 3.
Right ventricular function of pre- and post-transfemoral transcatheter
aortic valve replacement.
Study
Measure method
n
TAPSE (mm)
RVEF (%)
FAC (%)
Pre-
Post-
Pre-
Post-
Pre-
Post-
<2 ws
3–6 ms
<2 ws
3–6 ms
<2 ws
3–6 ms
Quick et al.[16]
Echo
74
21.7 ± 5.0
22.1 ± 4.9(<8 ds)
NR
NR
NR
NR
NR
NR
NR
Ayhan et al.[17]
Echo
50[a]
16.8 ± 0.3
17.9 ± 0.3(24 h)
18.7 ± 0.2(6 ms) (n = 47)
51.6 ± 10.1
53.7 ± 9.8(24 h)
57.8 ± 10.2(6 ms) (n = 47)
45.3 ± 7.6
50.1 ± 9.3(24 h)
54.2 ± 8.7(6 ms) (n = 47)
Okada et al.[18]
Echo
13
18 ± 5
19 ± 5(1 w[#])
NR
NR
NR
NR
35 ± 10
42 ± 10(1 w[#])
NR
Crouch et al.[19]
Echo/CMR
26
NR
NR
NR
61 ± 11
54 ± 13(<2 ws)
NR
NR
NR
NR
Keyl et al.[20]
3D echo
20
24 ± 5
24 ± 7(5–7 ds)
NR
54 ± 7
56 ± 8(5–7 ds)
NR
NR
NR
NR
Musa et al.[21]
CMR
56[b]
19 ± 6
NR
19 ± 7(6 ms)
52 ± 10
NR
52 ± 10(6 ms)
NR
NR
NR
Gronlykke et al.[12]
Echo
114[c]
24 ± 5.1(n = 107)
NR
24 ± 4.9(3 ms) (n = 107)
NR
NR
NR
45 ± 9(n = 97)
NR
45 ± 10(3 ms) (n = 86)
Data presented as mean ± standard deviation.
Median.
Included two patients who underwent trans-subclavian artery
transcatheter aortic valve replacement (TAVR).
Included four patients who underwent trans-subclavian artery
TAVR.
Included three patients who underwent trans-subclavian artery TAVR,
one patient who underwent trans-carotid artery TAVR and one patient
who underwent direct trans-aortic TAVR.
ds, days; FAC, fractional area change; ms, months; NR, not reported;
RVEF, right ventricular ejection fraction; CMR, cardiac magnetic
resonance imaging; TAPSE, tricuspid annular plane systolic
excursion; ws, weeks
Table 4.
Right ventricular function of pre- and post-surgical aortic valve
replacement.
Study
Measure method
n
TAPSE (mm)
RVEF (%)
FAC (%)
Pre-
Post-
Pre-
Post-
Pre-
Post-
<2 ws
3–6 ms
<2 ws
3–6 ms
<2 ws
3–6 ms
Harpole and Jones[24]
Radionuclide
11
NR
NR
NR
54 ± 13
64 ± 6(18–24 h)
58 ± 8(3.5 ms)
NR
NR
NR
Sandstede et al.[25]
MR
14
NR
NR
NR
66 ± 10
NR
62 ± 10(3 ms)
NR
NR
NR
Zhao et al.[22]
Echo
30
21.6 ± 5.0
9.2 ± 3.2(1 w)
NR
NR
NR
NR
NR
NR
NR
Kempny et al.[23]
Echo
22
24.1 ± 5.0
NR
15.9 ± 4.1(100 ds)
NR
NR
NR
47.0 ± 7.0
NR
39.8 ± 10.7(100 ds)
Quick et al.[16]
Echo
63
23.7 ± 4.0
15.6 ± 2.9(<8 ds)
NR
NR
NR
NR
NR
NR
NR
Okada et al.[18]
Echo
15
18 ± 5
11 ± 7(1 w[#])
NR
NR
NR
NR
38 ± 12
–1 ± 5[*]
(1 w[#])
NR
Crouch et al.[19]
Echo/CMR
21
NR
NR
NR
59 ± 8
58 ± 8(<2 ws)
NR
NR
NR
NR
Keyl et al.[20]
3D echo
20
26 ± 4
13 ± 2(5–7 ds)
NR
55 ± 7
55 ± 6(5–7 ds)
NR
NR
NR
NR
Musa et al.[21]
CMR
56
22 ± 5
NR
14 ± 3(6 ms)
58 ± 8
NR
53 ± 9(6 ms)
NR
NR
NR
Gronlykke et al.[12]
Echo
106
24 ± 5.2(n = 99)
NR
16 ± 4.2(3 ms) (n = 91)
NR
NR
NR
44 ± 11(n = 91)
NR
39 ± 10(3 ms) (n = 72)
Data presented as mean ± standard deviation.
Mean change.
Median.
CMR, cardiac magnetic resonance imaging; ds, days; FAC, fractional
area change; ms, months; NR, not reported; RVEF, right ventricular
ejection fraction; TAPSE, tricuspid annular plane systolic
excursion; ws, weeks
Right ventricular function of pre- and post-transfemoral transcatheter
aortic valve replacement.Data presented as mean ± standard deviation.Median.Included two patients who underwent trans-subclavian artery
transcatheter aortic valve replacement (TAVR).Included four patients who underwent trans-subclavian artery
TAVR.Included three patients who underwent trans-subclavian artery TAVR,
one patient who underwent trans-carotid artery TAVR and one patient
who underwent direct trans-aortic TAVR.ds, days; FAC, fractional area change; ms, months; NR, not reported;
RVEF, right ventricular ejection fraction; CMR, cardiac magnetic
resonance imaging; TAPSE, tricuspid annular plane systolic
excursion; ws, weeksRight ventricular function of pre- and post-surgical aortic valve
replacement.Data presented as mean ± standard deviation.Mean change.Median.CMR, cardiac magnetic resonance imaging; ds, days; FAC, fractional
area change; ms, months; NR, not reported; RVEF, right ventricular
ejection fraction; TAPSE, tricuspid annular plane systolic
excursion; ws, weeksThe quality of the included studies was assessed by the Cochrane Risk-of-Bias
tool and shown in Supplemental Figure 1. Two trials[12,18] did not report allocation
concealment, and it was unclear how the random sequence was generated and
whether there were incomplete outcome data. The Newcastle–Ottawa score
components for eight cohort studies are shown in Supplemental Table 3. Eight studies[16,17,19-24] were of high quality. All
cohort studies[16,17,19-24] did not report the
representativeness of the exposed cohort. Only two studies[17,21] followed
up long enough (⩾6 months) to observe the outcomes. The Newcastle–Ottawa score
components for case–control study are listed in Supplemental Table 4. The study was of high quality,[25] but it did not report the representativeness of the cases, selection of
controls, and ascertainment of AVR.
Meta-analysis of RVF in patients with AS after TF-TAVR
The primary outcome
As compared with the TAPSE level pre-procedure, there were not significant
differences in TAPSE at 1 week (including <8 days, 5–7 days, and 1 week;
Figure 2) and
6 months (Figure 3)
post TF-TAVR.
Figure 2.
Fixed-effects meta-analysis of TF-TAVR post-procedure
versus pre-procedure for the primary outcome of
TAPSE at 1 week (including 5–7 days, 1 week and <8 days)
follow-up.
Fixed-effects meta-analysis of TF-TAVR post-procedure
versus pre-procedure for the primary outcome of
TAPSE at 1 week (including 5–7 days, 1 week and <8 days)
follow-up.CI, confidence interval; IV, inverse variance; SD, standard
deviation; TAPSE, tricuspid annular plane systolic excursion;
TF-TAVR, transfemoral transcatheter aortic valve replacementRandom-effects meta-analysis of TF-TAVR post-procedure
versus pre-procedure for the primary outcome of
TAPSE at 6 month follow-up.CI, confidence interval; IV, inverse variance; SD, standard
deviation; TAPSE, tricuspid annular plane systolic excursion;
TF-TAVR, transfemoral transcatheter aortic valve replacement
The secondary outcome
The RVEF at <2 weeks (including 5–7 days and <2 weeks; Figure 4) and 6 months
(Figure 5) post
TF-TAVR were not significantly different from those at the baseline,
respectively.
Figure 4.
Random-effects meta-analysis of TF-TAVR post-procedure
versus pre-procedure for the secondary outcome
of RVEF at <2 week (including 5–7 days and <2 weeks)
follow-up.
CI, confidence interval; IV, inverse variance; RVEF, right
ventricular ejection fraction; SD, standard deviation; TF-TAVR,
transfemoral transcatheter aortic valve replacement
Figure 5.
Random-effects meta-analysis of TF-TAVR post-procedure
versus pre-procedure for the secondary outcome
of RVEF at 6 month follow-up.
CI, confidence interval; IV, inverse variance; RVEF, right
ventricular ejection fraction; SD, standard deviation; TF-TAVR,
transfemoral transcatheter aortic valve replacement
Random-effects meta-analysis of TF-TAVR post-procedure
versus pre-procedure for the secondary outcome
of RVEF at <2 week (including 5–7 days and <2 weeks)
follow-up.CI, confidence interval; IV, inverse variance; RVEF, right
ventricular ejection fraction; SD, standard deviation; TF-TAVR,
transfemoral transcatheter aortic valve replacementRandom-effects meta-analysis of TF-TAVR post-procedure
versus pre-procedure for the secondary outcome
of RVEF at 6 month follow-up.CI, confidence interval; IV, inverse variance; RVEF, right
ventricular ejection fraction; SD, standard deviation; TF-TAVR,
transfemoral transcatheter aortic valve replacement
Meta-analysis of RVF in patients with AS after SAVR
Compared with baseline, there was significant deterioration in TAPSE at
1 week (including <8 days, 5–7 days, and 1 week; Figure 6) and 3 months (including
100 days and 3 months; Figure 7) after SAVR.
Figure 6.
Random-effects meta-analysis of SAVR post-procedure
versus pre-procedure for the primary outcome of
TAPSE at 1 week (including 5–7 days, 1 week and <8 days)
follow-up.
CI, confidence interval; IV, inverse variance; SAVR, surgical aortic
valve replacement; SD, standard deviation; TAPSE, tricuspid annular
plane systolic excursion
Figure 7.
Fixed-effects meta-analysis of SAVR post-procedure
versus pre-procedure for the primary outcome of
TAPSE at 3 month (including 100 days and 3 months) follow-up.
CI, confidence interval; IV, inverse variance; SAVR, surgical aortic
valve replacement; SD, standard deviation; TAPSE, tricuspid annular
plane systolic excursion
Random-effects meta-analysis of SAVR post-procedure
versus pre-procedure for the primary outcome of
TAPSE at 1 week (including 5–7 days, 1 week and <8 days)
follow-up.CI, confidence interval; IV, inverse variance; SAVR, surgical aortic
valve replacement; SD, standard deviation; TAPSE, tricuspid annular
plane systolic excursionFixed-effects meta-analysis of SAVR post-procedure
versus pre-procedure for the primary outcome of
TAPSE at 3 month (including 100 days and 3 months) follow-up.CI, confidence interval; IV, inverse variance; SAVR, surgical aortic
valve replacement; SD, standard deviation; TAPSE, tricuspid annular
plane systolic excursionThe RVEF at <2 weeks (including 5–7 days and <2 weeks; Figure 8) and 3 months
(including 3.5 months and 3 months; Figure 9) post SAVR did not
significantly differ from the baseline levels, respectively; however, the
FAC was significantly worse at 3 months (including 100 days and 3 months)
post SAVR than that before SAVR (Figure 10).
Figure 8.
Fixed-effects meta-analysis of SAVR post-procedure
versus pre-procedure for the secondary outcome
of RVEF at <2 week (including 5–7 days and <2 weeks)
follow-up.
CI, confidence interval; IV, inverse variance; RVEF, right
ventricular ejection fraction; SAVR, surgical aortic valve
replacement; SD, standard deviation
Figure 9.
Fixed-effects meta-analysis of SAVR post-procedure
versus pre-procedure for the secondary outcome
of RVEF at 3 month (including 3.5 months and 3 months)
follow-up.
CI, confidence interval; IV, inverse variance; RVEF, right
ventricular ejection fraction; SAVR, surgical aortic valve
replacement; SD, standard deviation
Figure 10.
Fixed-effects meta-analysis of SAVR post-procedure
versus pre-procedure for the secondary outcome
of FAC at 3 month follow-up.
CI, confidence interval; FAC, fractional area change; IV, inverse
variance; SAVR, surgical aortic valve replacement; SD, standard
deviation
Fixed-effects meta-analysis of SAVR post-procedure
versus pre-procedure for the secondary outcome
of RVEF at <2 week (including 5–7 days and <2 weeks)
follow-up.CI, confidence interval; IV, inverse variance; RVEF, right
ventricular ejection fraction; SAVR, surgical aortic valve
replacement; SD, standard deviationFixed-effects meta-analysis of SAVR post-procedure
versus pre-procedure for the secondary outcome
of RVEF at 3 month (including 3.5 months and 3 months)
follow-up.CI, confidence interval; IV, inverse variance; RVEF, right
ventricular ejection fraction; SAVR, surgical aortic valve
replacement; SD, standard deviationFixed-effects meta-analysis of SAVR post-procedure
versus pre-procedure for the secondary outcome
of FAC at 3 month follow-up.CI, confidence interval; FAC, fractional area change; IV, inverse
variance; SAVR, surgical aortic valve replacement; SD, standard
deviation
Meta-analysis of RVF in patients with AS after TF-TAVR
versus SAVR
TAPSE post-TF-TAVR was significantly better than TAPSE post-SAVR at 1 week and
3–6 month follow-ups (Supplemental Figures 2 and 3). Furthermore, △TAPSE, the
difference of TAPSE between post- and pre-procedure, was significantly improved
in TF-TAVR group in comparison with SAVR group at 1 week and 3–6 months
following procedure (Figures
11 and 12).
Figure 11.
Random-effects meta-analysis of TF-TAVR versus SAVR for
the primary outcome of △TAPSE at 1 week (including <8 days, 5–7 days
and 1 week) follow-up.
Random-effects meta-analysis of TF-TAVR versus SAVR for
the primary outcome of △TAPSE at 1 week (including <8 days, 5–7 days
and 1 week) follow-up.△, post–pre; CI, confidence interval; IV, inverse variance; SAVR,
surgical aortic valve replacement; SD, standard deviation; TAPSE,
tricuspid annular plane systolic excursion; TF-TAVR,
transfemoral-transcatheter aortic valve replacementFixed-effects meta-analysis of TF-TAVR versus SAVR for
the primary outcome of △TAPSE at 3–6 month follow-up.△, post-pre; CI, confidence interval; IV, inverse variance; SAVR,
surgical aortic valve replacement; SD, standard deviation; TAPSE,
tricuspid annular plane systolic excursion; TF-TAVR,
transfemoral-transcatheter aortic valve replacement
Discussion
This is the first meta-analysis evaluating the effect of TF-TAVR on RVF evaluated by
a variety of parameters and comparing it with that of SAVR. Our main findings are:
longitudinal RVF, indicated by TAPSE, is not adversely affected at 1 week and
6 months post TF-TAVR as compared with the baseline level. Moreover, RVEF
(<2 weeks and 6 months) did not exhibit significant deterioration post TF-TAVR,
either. On the other hand, TAPSE at 1 week and 3 months post SAVR and FAC at
3 months post SAVR were significantly aggravated, but RVEF did not show significant
deterioration. Furthermore, both post-procedure TAPSE and △TAPSE were significantly
improved in TF-TAVR group as compared with those in SAVR group.RV dysfunction has been reported in one out of four patients with severe
AS.[26,27] RV dysfunction
at baseline has been associated with an elevated risk of cardiovascular mortality
after SAVR.[28] Several explanations have been proposed for this association. Thoracotomy and
pericardiotomy impact RV myocardial blood flow and may further result in RV failure.[29] Alternatively, the negative impact of cardiopulmonary bypass on inflammatory
and coagulation cascades following SAVR may cause exacerbation in the RVF.[30,31] Other
potential contributing factors may include loss of cardioprotection and
atrioventricular synchrony, air embolism of right coronary, and increased pulmonary
artery pressure as a result of impaired pulmonary perfusion.[8] On the other hand, the studies evaluating the effect of RV dysfunction at
baseline on the patients undergoing TAVR have yielded conflicting results. Studies
including sub-analysis of the PARTNER trial showed no influence of baseline RV
dysfunction on outcomes of TAVR; whereas others have observed up to 2-fold increase
in post-TAVR mortality in patients with baseline RV dysfunction.[32-34] Therefore, the effect of
baseline RV dysfunction on TF-TAVR outcomes remains controversial.A recent meta-analysis has shown that TAPSE remains unchanged post TAVR while it
decreases by 12 months after SAVR; however, the inclusion of cases that have
undergone alternative access TAVR may influence the results and no comparison was
made specifically between the TF-TAVR and SAVR in that study.[13] In the present study, despite more comorbidities were presented in the
TF-TAVR group than in the SAVR group,[35] TF-TAVR was superior to SAVR in regard to maintaining TAPSE level. This is
similar to the findings reported by Quick et al. in a small
observational study,[16] in which marked deterioration of TAPSE after SAVR (23.7 +/– 4 mm
versus 15.6 +/– 2.9 mm, p < 0.001) and
TA-TAVR (21.1 +/– 4.7 mm versus 19.1 +/– 4.7 mm,
p = 0.02) was observed. TAPSE remained unchanged in the TF-TAVR
group (21.7 +/– 5 mm versus 22.1 +/– 4.9 mm, p = 0.38).[16] Likewise, in 27 pairs of TAVR (TA-TAVR and TF-TAVR) and SAVR patients matched
by gender, age, and LV function, Forsberg and colleagues demonstrated that TF-TAVR
was associated with better longitudinal RVF than TA-TAVR; whereas SAVR was
associated with worse longitudinal RVF than TAVR.[36] In addition, a sub-analysis from the randomized CoreValve US high-risk Clinic
Study showed that RV systolic function was significantly compromised in the patients
subjected to SAVR (p < 0.001) and was inferior to that in the
patients subjected to TAVR at discharge and 1 month post procedure. However, RVF was
not significantly different between the treatment groups at 6-month
(p = 0.83) or 1-year (p = 0.14) follow-up.[37] Studies have indicated that the reduction in the TAPSE following SAVR was
presumably due to conformational rather than functional changes in the RV after
cardiac surgery, and such a reduction in most cases occurred shortly after weaning
from cardiopulmonary bypass.[38] However, the present study showed that both the TAPSE, representing
longitudinal RVF, and the FAC, reflecting the whole RVF, were significantly
exacerbated as long as 3 months following SAVR, implicating the possible functional
impairments elicited by the surgical procedure. Admittedly, one should also note
that RVEF did not show statistically significant aggravation following SAVR. This
could be due to the compensated latitudinal RVF in the face of reduced longitudinal
RVF, as reflected by the diminished TAPSE post SAVR. Therefore, further study might
be needed to evaluate the RVEF using cardiac magnetic resonance imaging or 3D
echocardiography. Taken together, these results indicate that TF-TAVR might avoid
the acute insults to the RV likely caused by conformational changes, cardioplegia,
and cardiopulmonary bypass that are entailed in SAVR.[16,38,39]
Limitations
The heterogeneity among trials was significant, which was related to the type of
study. Some studies were not randomized control trials and the sample size was
small.[16,20,22] We chose random effects based solely on
I2 more than 50, which may increase the risk of
Type 2 error due to lack of power. Secondly, there are discrepancies in
follow-up time periods and outcomes among the selected studies.
Conclusion
TAPSE and RVEF were maintained post TF-TAVR; whereas TAPSE and FAC were significantly
deteriorated post SAVR, while RVEF did not exhibit significant deterioration. In
addition, post-TAPSE and △TAPSE are significantly improved in TF-TAVR group as
compared with those in SAVR group. These results implicate that RVF is maintained
post TF-TAVR and at least longitudinal RVF is compromised post SAVR. Therefore,
baseline RV dysfunction should be considered when selecting TF-TAVR or SAVR, and
TF-TAVR could be a preferred option in patients with RV dysfunction.Click here for additional data file.Supplemental material, Supplemental_table_1_clean for Meta-analysis of right
ventricular function in patients with aortic stenosis after transfemoral aortic
valve replacement or surgical aortic valve replacement by Yunshan Cao, Vikas
Singh, Aqian Wang, Liyan Zhang, Tingting He, Hongling Su, Rong Wei, Yichao Duan,
Kaiyu Jiang, Wenyu Wu, Yan Huang, Sammy Elmariah, Guanming Qi, Xin Su, Yan Zhang
and Min Zhang in Therapeutic Advances in Chronic DiseaseClick here for additional data file.Supplemental material, Supplemental_table_2_clean for Meta-analysis of right
ventricular function in patients with aortic stenosis after transfemoral aortic
valve replacement or surgical aortic valve replacement by Yunshan Cao, Vikas
Singh, Aqian Wang, Liyan Zhang, Tingting He, Hongling Su, Rong Wei, Yichao Duan,
Kaiyu Jiang, Wenyu Wu, Yan Huang, Sammy Elmariah, Guanming Qi, Xin Su, Yan Zhang
and Min Zhang in Therapeutic Advances in Chronic DiseaseClick here for additional data file.Supplemental material, Supplemental_table_3_clean for Meta-analysis of right
ventricular function in patients with aortic stenosis after transfemoral aortic
valve replacement or surgical aortic valve replacement by Yunshan Cao, Vikas
Singh, Aqian Wang, Liyan Zhang, Tingting He, Hongling Su, Rong Wei, Yichao Duan,
Kaiyu Jiang, Wenyu Wu, Yan Huang, Sammy Elmariah, Guanming Qi, Xin Su, Yan Zhang
and Min Zhang in Therapeutic Advances in Chronic DiseaseClick here for additional data file.Supplemental material, Supplemental_table_4_clean for Meta-analysis of right
ventricular function in patients with aortic stenosis after transfemoral aortic
valve replacement or surgical aortic valve replacement by Yunshan Cao, Vikas
Singh, Aqian Wang, Liyan Zhang, Tingting He, Hongling Su, Rong Wei, Yichao Duan,
Kaiyu Jiang, Wenyu Wu, Yan Huang, Sammy Elmariah, Guanming Qi, Xin Su, Yan Zhang
and Min Zhang in Therapeutic Advances in Chronic Disease
Authors: Aleksander Kempny; Gerhard-Paul Diller; Gerrit Kaleschke; Stefan Orwat; Angela Funke; Renate Schmidt; Gregor Kerckhoff; Farshad Ghezelbash; Andreas Rukosujew; Holger Reinecke; Hans H Scheld; Helmut Baumgartner Journal: Heart Date: 2012-06-11 Impact factor: 5.994
Authors: M A Clavel; J G Webb; J Rodés-Cabau; J B Masson; E Dumont; R De Larochellière; D Doyle; S Bergeron; H Baumgartner; I G Burwash; J G Dumesnil; G Mundigler; R Moss; A Kempny; R Bagur; J Bergler-Klein; R Gurvitch; P Mathieu; P Pibarot Journal: Circulation Date: 2010-10-25 Impact factor: 29.690
Authors: Lars Grønlykke; Nikolaj Ihlemann; Anh Thuc Ngo; Hans Gustav Hørsted Thyregod; Jesper Kjaergaard; André Korshin; Finn Gustafsson; Christian Hassager; Jens Christian Nilsson; Lars Søndergaard; Hanne Berg Ravn Journal: Interact Cardiovasc Thorac Surg Date: 2017-02-01
Authors: Tarique Al Musa; Akhlaque Uddin; Timothy A Fairbairn; Laura E Dobson; Christopher D Steadman; Ananth Kidambi; David P Ripley; Peter P Swoboda; Adam K McDiarmid; Bara Erhayiem; Pankaj Garg; Daniel J Blackman; Sven Plein; Gerald P McCann; John P Greenwood Journal: Int J Cardiol Date: 2016-08-07 Impact factor: 4.164