&

Cardiac Rehabilitation After TAVI A

Systematic Review and Meta-
Analysis
Asena Oz*, Ioannis Tsoumas,
Konstantinos Lampropoulos, Theodoros Xanthos,
Nikos Karpettas, and Dimitrios Papadopoulos
From the European University Cyprus, School of medicine, Nicosia, Cyprus.

Abstract: Despite the increasing popularity of Trans-

catheter aortic valve implantation (TAVI) in patients
with high surgical risk, there is no current guideline for
the management of patients following the intervention.
This systematic review and meta-analysis aims to summa-
rize and analyse all clinical data and evidence regarding
the effectiveness and outcomes of CR following TAVI.
The first meta-analysis measured the walked distance in
the Six-Minute Walk Test (6MWT) and the second meta-
analysis included studies that showed the Barthel Index
(BI) before and after CR. The mean distance walked
prior to CR was 235.88 § 69.36 m increased to 292.12 §
54.92 m after rehabilitation, signifying a moderate clini-
cally relevant effect size (0.593 (0.42, 0.76); P=0.00). The
mean BI score before CR was 76.6 § 11.5 which
increased to 89.8 § 5.5 after the programme and simi-
larly demonstrated a significant standardized mean
improvement (0.75 (0.57, 0.93); I= 0.00). Exercise-based
CR in patients with aortic stenosis treated with TAVI
demonstrated a significant improvement in exercise toler-
ance and functional independence shown by the 6MWT
and BI. (Curr Probl Cardiol 2023;48:101531.)

Conflict of interest: No conflict of interest to disclose.

Funding: None.
*Corresponding Author: Asena Oz, European University Cyprus, School of Medicine, 6, Diogenous Str, 2404
Engomi, Nicosia, P.O. Box: 22006, 1516 Nicosia, Cyprus E-mail: ao161573@students.euc.ac.cy

Curr Probl Cardiol 2023;48:101531

0146-2806/$ see front matter
https://doi.org/10.1016/j.cpcardiol.2022.101531

Curr Probl Cardiol, March 2023 1

Introduction

&
A
ortic stenosis (AS) is caused by progressive calcification of the
valve and is the leading cause of left ventricular outflow tract
obstruction.
In total, the prevalence in developed countries is between 2%-7% of
patients over 65 years, whereas the incidence increases with age. Once
symptoms occur in severe AS, the prognosis is very poor without treat-
ment, with a 5-year mortality rate of 50%.1

Theoretical background
Surgical aortic valve replacement (sAVR) remains the gold standard
procedure for patients with severe symptomatic aortic valve stenosis.
However, many of the affected patients are of advanced age and have a
high level of frailty, increasing the risk for surgery and complications.
For these patients transcatheter aortic valve implantation (TAVI) is a
good therapeutic alternative since the only other option would be conser-
vative medical treatment. Since its discovery in 2002, TAVI has revolu-
tionized clinical outcomes in inoperable symptomatic aortic stenosis
patients and has demonstrated in the PARTNER study to be superior to
conservative medical treatment.2
With an ageing population and the burden of severe increasing aortic
stenosis the number of patients obtaining TAVI will thereby increase
simultaneously.

Definition of review purpose and research question

Despite the increasing popularity of TAVI and its advantages in the
elderly population,3 literature portraying the results of cardiac rehabilita-
tion (CR) after TAVI is still very limited and there is no current guideline
for the management of patients after the procedure, many of whom have
more comorbidities and frailty than surgical patients. Even though the
benefits of CR after surgical valve replacement are well known,4,5 a
recent Danish survey showed that a TAVI procedure was associated with
a lower probability of both participation and referral to a cardiac rehabili-
tation programme.6
The question arises if especially TAVI patients, given their increased
age, comorbidities and frailty do benefit even more from exercise-based
CR than other patients.
This systematic review and meta-analysis aims to summarize and ana-
lyze all clinical data and evidence regarding the effectiveness and

2 Curr Probl Cardiol, March 2023

outcomes of CR following TAVI, to answer the following research ques-
tion: What are the effects of exercise-based CR in TAVI patients and
how does exercise-based CR benefit TAVI patients.

Methods

Study design
A systematic review and meta-analysis of studies evaluating the effects
of CR in patients with AS after TAVI was conducted, whereby measure-
ments before and after TAVI were compared in regard to physical toler-
ance and functional independence.
Two separate meta-analysis were conducted, the first one evaluating
the physical function before and after CR using the 6-Meter-Walk test
(6MWT) and the second one evaluating the functional independence of
patients before and after CR which was assessed with the Barthel Index
(BI).

Search strategy
The search was conducted on a single database, which was chosen to
be PubMed, from November 2021 to March 2022. There was no restric-
tion on the year of publication as the application of TAVI is still a very
new procedure.
Relevant studies were identified using the following MeSH terms: aor-
tic valve stenosis, transcatheter aortic valve implantation, TAVI, aortic
valve replacement and cardiac rehabilitation. The literature of the
included studies and the recognized related papers were searched manu-
ally and evaluated thereafter.

Inclusion and exclusion criteria

All studies that assessed the effects of cardiac rehabilitation in aortic
stenosis patients after TAVI including comparisons made with a control
group or no control group were considered eligible. Since there is only a
limited amount of studies there was no limitation set regarding sample
size, whereas the study design was limited to observational studies and
randomized controlled studies, which were mostly small pilot studies,
excluding systematic reviews and editorials.
Key criteria for selecting appropriate studies included the presence of
specific measurements and baseline characteristics of patients before and

Curr Probl Cardiol, March 2023 3

after CR in order to measure the effects and outcomes regarding func-
tional capacity and quality of life.
Furthermore, there was no differentiation made between inpatient and
residential CR and both types were included.

Final selection of studies

The results of each search were exported to an Excel sheet and a title
screen followed by an abstract screen was conducted. Most of the studies
were already excluded during the initial screening since many were devi-
ating from the topic. Studies were considered eligible if they included: 1)
a TAVI procedure as an intervention, 2) patients were adults (>18 years),
3) who received an exercise-based CR, 4) compared to a control group
receiving no CR or a surgical group receiving CR or no group at all, and
5) demonstrated these outcomes by the use of certain measurements
including effects on physical functioning, mortality, health-related qual-
ity of life, adverse effects, mental alterations.
The full text of all interesting and potentially eligible papers was
downloaded and screened according to the pre-established inclusion and
exclusion criteria.

Data extraction and quality assessment of studies

The data extraction was focused on 1) sample size, 2) country of origin
and 3) patient characteristics including age, BMI, gender, LVEF%, Euro-
SCORE and comorbidities. Regarding the CR program details were
extracted describing the type of exercise, frequency per week, and meas-
urements taken to evaluate functional capacity, exercise tolerance
(6MWT), effects on functional independence (BI) as well as health-
related quality of life (EuroQol visual analogue scale and HADS). The
extracted data on all studies were summarized in an excel worksheet.
For the quantitative synthesis data was extracted and a search of pat-
terns was made to compare the utilized measurements. To measure each
category, it was decided to focus on the 6MWT to assess physical func-
tion since it was included in all of the chosen studies (n = 7) and the BI
for patient autonomy, as it was the second most frequently used scale
(n = 5).
The methodological quality of studies was assessed using the PEDro
scale. The complete scoring system can be seen in appendix 1.

4 Curr Probl Cardiol, March 2023

Statistical analysis
The meta-analysis included papers that provided descriptions of the
walked distance in the 6MWT before and after a CR (Fig 1) to assess the
effect size of CR after the TAVI intervention. A second meta-analysis
was conducted including studies that showed the BI before and after a
CR (Fig 2).
The standardized mean difference (SMD) was used before and after
CR (so-called standardized mean improvement) as the treatment effect
estimate in both analyses, with a 95% confidence interval (CI).
A moderate, clinically relevant effect size was defined as one with an
SMD greater than 0.5.
To examine the heterogeneity of the studies included, the statistical I2
was determined. Heterogeneity was defined as an I2 score greater than or
equal to 50%.
To check for publication bias, the effect estimate was plotted by the
inverse of its standard error for each trial. To detect probable publication
bias, the symmetry of such “funnel plots” was analyzed. The statistical
analyses and funnel and forest plots were created using IBM SPSS Statis-
tic Version 28.0.1.1.

Results

Study selection
From the utilized databank, the systematic search yielded 192 referen-
ces. After eliminating duplicates and conducting preliminary screening
(reading titles and abstracts), 32 studies were selected as potentially rele-
vant. Eight clinical studies were chosen for qualitative analysis based on
the study criteria, all of which were published in English. Of the chosen
eight studies, the data of seven were sufficient for the first meta-analysis
regarding the 6MWT, and five had sufficient data for the second meta-
analysis comparing the BI before and after CR.

Description of included studies

Table 1 lists the details of the patient characteristics that were
included. It was noticeable that patients having TAVI were often older
(81.3 § 2.8 years), with a normal BMI (25.28 § 1.5 kg/m2), less often
male (43.5 § 11.3 %), a high EuroSCORE (20.6 § 1.5 %) and a border-
line LVEF (56 § 1.3 %).

Curr Probl Cardiol, March 2023 5

6
Curr Probl Cardiol, March 2023

FIG 1. . Forest plot 6-Minute-Walk Test.

Curr Probl Cardiol, March 2023

FIG2. . Forest Plot Barthel Index.

7
8

TABLE 1. Characteristics of studies included in meta-analysis mean § SD

Study (y) Location Type of study Sample Age BMI Gender LVEF (%) NHYA class Euro-SCOrE (%)
size (kg/m2) male (>III)
(CR after (%)
TAVI)
1. Yu et al. China Retrospective 90 74.7§8.1 23.3§4.2 54 (60%) 25 (28%)
(2021) analysis
2. Zanetti et al. Italy Prospective, 60 83.5 § 5.0 25.2 § 4.5 28 (46%) 22 § 13
(2014) observational
3. Eichler et al. Germany Prospective, 136 80.6 § 5.0 27.7 § 4.2 65 (47.8%) 56.1 § 9.7 51 (37.5%)
(2017) observational
4. Tarro Genta Italy Prospective, 65 82 § 6 24 § 4 20 (33%) 55.3 § 9 21.4 § 10.7
(2017) observational
5. Tarro Genta Italy Prospective, 95 82.7 § 4.9 24.8 § 4.8 33 (34%) 55.8 § 8.94 19.7 § 11.03
et al. (2019) observational
6. Russo et al. Italy Prospective, 78 83.7 § 3.6 24.7 § 3.7 24 (31.7%) 55.9 § 11.3
(2014) observational
7. Pressler et al. Germany RCT 13 81 § 7 26.9 § 3.1 7 (54%) 58 § 8 2 (15%)
(2016)
Curr Probl Cardiol, March 2023
 Half of the studies do not compare the TAVI group to another control
group,7,11,13 whereas two,8,10 compare the results to a sAVR group post-
rehabilitation, one compares two TAVI groups comparing the survivors
vsno survivors9 and another one compares a TAVI group receiving eight
weeks of endurance and strength training to a usual care group which is
not clearly defined.12 Furthermore, two of the studies were conducted in
an inpatient CR program,7,11 whereas the rest was carried out in a resi-
dential program allowing the patients to stay in a more comfortable
home-like setting.8-10,12,13

Cardiac rehabilitation description

Cardiac rehabilitation attempts to aid recovery, improve physical and
mental performance, and avoid cardiovascular disease development.
It involves components of health education, guidance on cardiovascu-
lar risk reduction, physical activity, and stress management, as well as
diagnostic and treatment approaches.
In the studies that were included, all except one13 have illustrated
detailed information about the CR program that was utilized.
The usual duration was 3 weeks in most studies with a frequency of
5-6 times per week with typically 1-2 30 minute sessions, starting as soon
as possible after the intervention. The physical exercises consisted of
mostly individualized training such as ergometer endurance training
(cycling or treadmill), (Nordic) walking, as well as additional strength
and resistance training and callisthenic exercise.

Quality assessment
The PEDro scale that was used to evaluate the chosen studies varied
from 4-6 points, having an average score in total (4.8 § 0.69). Only one
study received the highest points which was by Pressler et al.12 and was
the only study that randomly allocated the two groups to either an eight-
week program or usual care, the remaining groups had either 5
points10,11,13 or 4 points.7,8

Safety and complications

Regarding safety, the analyzed data shows that regardless of the train-
ing modality and intensity of the rehabilitation program it was safe
and no complications were demonstrated that were associated with the
program itself.

Curr Probl Cardiol, March 2023 9

 In one study by Zanetti et al.7 the most frequent complication during
the in-hospital CR was heart failure (n = 7). In total, almost one-third of
patients had significant complications interfering with the recovery pro-
cess and hospital length. Nevertheless, the majority experienced no com-
plications and there were no dropouts noted, except for one patient who
suffered from a pelvis fracture, all patients completed a final 6MWT,
whereas at admission 6 patients were unable to perform the test.
Since the majority of the TAVI patients are very frail, much older and
have an increased number of comorbidities compared to other patients
participating in CR, some complications are to be expected, which have
not been linked to the CR program itself.

Effects of CR on physical function

The six-minute walk test (6MWT) is a straightforward exam that
assesses a patient’s functional capacity objectively. Given the risks
of acute cardiac events associated with the gold standard maximal exer-
cise testing for measuring functional capacity, this short walk test is
particularly useful due to its lower probability of adverse events and
complications.
The data for the 6MWT was accessible for all studies included in the
quantitative synthesis, which described 446 patients before CR and 456
after. The mean distance walked prior to rehabilitation was 235.88 §
69.36 m, which increased to 292.12 § 54.92 m after rehabilitation (Fig
1). In the pooled analysis CR following TAVI was linked to a significant
standardized mean improvement (0.593 (0.42, 0.76); P = 0.00) signifying
a moderate clinically relevant effect size.14 Additionally, there was no
evidence of heterogeneity in the included studies (I2 = 32%).

Effects of CR on functional independence

The Barthel Index (BI) is an ordinal scale that is used to assess daily
living performance and functional independence in the areas of personal
care and mobility.
The data for the BI scoring was demonstrated in 5 studies,7-10,13 which
reported in total 377 TAVI patients before and after CR.
The mean score before CR was 76.6 § 11.5, which increased to a mean
score of 89.8 § 5.5 after the CR program (Fig 2). In the pooled analysis, a
significant standardized mean improvement post CR has been demon-
strated (0.75 (0.57, 0.93); P = 0.00), indicating a medium effect size.14

10 Curr Probl Cardiol, March 2023

 In addition, the I2 test demonstrated a very low heterogeneity, compa-
rable to the one measured in the 6MWT (I2= 33%)

Discussion
As far as we know, this systematic review and meta-analysis is the first
one investigating the effects of CR while comparing only the outcomes
before and after CR in TAVI patients, without comparing them to another
group of patients receiving a different intervention. It was decided to do
so since the purpose was to solely focus on TAVI patients and assess how
much they truly benefit from this program.
Another important factor to be considered is that TAVI patients are
considerably older with more comorbidities and disabilities than surgical
patients and have due to that nature a significantly lower physical out-
come when compared to much fitter and younger groups, demonstrated in
the study by Ribeiro et al.15
In the systematic review and meta-analysis by Anayo et al.16 a dis-
tinct limitation and improvement for future studies was, to separate
TAVI and sAVR groups and analyze each of them individually since
they both represent different procedures such as the use of general
anaesthesia and thoracotomy in sAVR while TAVI only utilizes local
anaesthesia and a percutaneous approach. Therefore, different
responses might be expected regarding exercise-based CR, not only
due to different patient characteristics but also due to a significant
difference in the procedure.

Effects of CR on physical function

In all included studies exercise capacity and physical function were
assessed using the 6MWT given its simple use and availability.
Overall the data demonstrated similar results regarding exercise capac-
ity. Given the increased age and risk scores (Table 1), there was a signifi-
cant increase in distance walked from 235.88 § 69.36 to 292.12 §
54.92 m and an increased total standardized mean improvement (0.593
(0.42, 0.76); P = 0.00), showing a significant improvement in the effect
size (Fig 1).
In two studies10,12 physical function was additionally assessed by the
Cardiopulmonary Exercise Test (CPET). Both studies reported fewer
patients who were able to perform the CPET and an overall low func-
tional capacity which was explained partly by the disease and comorbid-
ities and partly by the increased age.

Curr Probl Cardiol, March 2023 11

 In a study by Tarro Genta et al.17 it was also mentioned that only very
few patients could take part in a CPET, even fewer patients than the ones
participating in the 6MWT.
A small number of patients were also not able to perform the 6MWT at
admission to CR, in the study by Zanetti et al.,7 since baseline patient
characteristics were recorded to be very frail. Nevertheless, at the end of
the program, all patients were able to complete the 6MWT even the ones
who were not able to participate at admission.
An improvement of mean distance during the 6MWT was also demon-
strated in the study by V€ oller et al.18 which compared TAVI to sAVR
patients where both groups showed an improvement of more than 50 m
after CR. Once again TAVI patients compared to sAVR had an overall
lower physical function and shorter mean distance, due to differences in
patient characteristics, underlining the question if those two different
groups should be compared to each other.
Other studies have also found evidence to explain the difference in the
distance walked during the 6MWT, which is inversely associated with
age, comorbidities and gender.19,20
In the systematic review and meta-analysis by Ribeiro et al.22 compar-
ing TAVI and sAVR patients after CR, similar results to our study regard-
ing TAVI patients after CR were found, showing a significant 6MWT
standardized mean improvement (0.69 (0.47, 0.91); P < 0.001).

Effects on functional independence

Similar to the results in the exercise tolerance, from the five included
studies7-10,13 all patients have increased their function in autonomy and
mobility measured by the BI. Whereas a higher score indicates a greater
ability of independence the mean score increased from 76.6 § 11.5
before CR to 89.8 § 5.5 after CR, showing an overall significant
improvement (0.75 (0.57, 0.93); P = 0.00). Similar results have been
found in the study by Ribeiro et al.15 with a significant BI standardized
mean improvement (0.80 (0.29, 1.30); P = 0.002) demonstrating a large
clinically relevant effect size. Overall the use of the BI index was limited
in the studies, and different modalities and questionnaires were used,
which makes a comparison of outcomes more difficult.
In the study by Kleczynski et al.21 the Katz index of Independence of
Activities in Daily Living (KI of ADL, 6 points - not frail, <6 points -
frail) was used to assess patient autonomy. The overall increase was from
4.7 § 1.2 at baseline to 5.0 § 0.8 at discharge and was even sustained at
the follow up after 6 months.

12 Curr Probl Cardiol, March 2023

 The two studies11,12 excluded from the meta-analysis, that did not
utilize the BI used the Short Form 12 (SF-12) questionnaire instead.
Both reported very similar results and measured an overall positive
improvement.
Overall it is clear that CR not only benefits the physical health and
function of the patients but also significantly improves functional inde-
pendence which is still observed during the follow-up.21 There is still a
lot of variation concerning the measurement and deciding on a universal
tool to measure autonomy and quality of life may be of benefit to facili-
tate the comparison and effect outcomes.

Long term effects and follow up

Regarding long-term effects and follow up the study by Zanetti et al.7
is the only one which assessed the same measurement after 6-12 months
(T1) and 18-24 months (T2). Of the 12 deaths that occurred during the
follow-up only 3 deaths were related to cardiovascular causes. Regarding
the results, performance was consistent among patients who were able to
complete the 6MWT however, the number of patients that were able to
perform the test decreased over time. A small number of patients’ func-
tional status deteriorated as well, primarily due to orthopedic issues. This
could have played a role in the considerable decline in the quality of life
reported at T2.
Similar results have been observed in the study by Kleczynski
et al.21 that assessed follow up data after 1 year of discharge follow-
ing a CR program after TAVI. Even though inpatient CR was strongly
associated with improved clinical performance as well as the quality
of life in all patients, the outcomes were reduced after 1 year of
follow-up.
This might raise the question of whether a different and more long-
term approach for CR should be established.
A multidisciplinary approach with regard to the well-being of non-car-
diac organs and systems, such as the musculoskeletal system, may be
additionally effective in achieving a successful CR with long-term bene-
fits, since the majority of patients might present with a variety of comor-
bidities.
Additionally, highlighted in the follow-up study by Pressler et al.12 in
multimorbid TAVI patients it was rather difficult to sustain short-term
exercises over a longer period, and once the program was completed
many patients did not meet the requirements of daily exercising at home.

Curr Probl Cardiol, March 2023 13

TABLE 2. Summary of exercises and main findings

Study (y) Type of exercise Frequency Main findings Follow up

1. Yu et al. (Residential CR) 6MWT Δ73.90m
(2021) BI Δ 6.50
2. Zanetti et al. Bed and sitting 6/week 6MWT Δ65.00m T1 (6-12 mo)
(2014) exercise Total duration BI Δ 11.00 T2(18-24 mo)
Callisthenics 3 weeks
exercise (Inpatient CR)
Ambulatory
training
Cycle
ergometer/
treadmill
3. Eichler et al. Bicycle exercise Endurance 6MWT Δ56.20m
(2017) (Nordic) training 5/ Max. exercise
walking week capacity Δ
Strength Average bicycle 8.1W
training session 30min
Total duration
3 weeks
(Inpatient CR)
4. Tarro Genta Aerobic 6/week 6MWT Δ78.00m
et. al (2017) incremental Total duration BI Δ 18.00
exercise 2/ 3 weeks
daily (cycling or (Residential)
treadmill)
5. Tarro Genta Aerobic 6/week 6MWT Δ62.70m 3 years
et al. (2019) incremental Total duration BI Δ 21.30 non-survivors
exercise 2/ 3 weeks vs survivors
daily (cycling or (Residential
treadmill) CR)
6. Russo et al. Low/medium 3 sets of 6MWT Δ31.90m
(2014) intensity exercise 6/ BI Δ 9.40
exercise week
Respiratory Total duration
workout 2 weeks
Aerobic (Residential
sessions CR)
Callisthenic
exercise
7. Pressler et al. Cycle ergometer 2/w (1st w), 3/w 6MWT Δ26.00m
(2016) Resistance (following 6
training started weeks)
in w 2 (Inpatient CR)
Abbreviations: Mo,months;Y,years

Therefore, it is crucial to identify common barriers in the future for TAVI

patients to facilitate and motivate them for regular exercises even after
the completion of the program.

14 Curr Probl Cardiol, March 2023

 Future investigation is needed however by offering continuous home-
based or institutional-based cardiac rehabilitation programs which might
increase adherence and advantages for the long-term well-being of
patients.22

Limitations
One of the most important limitations was the limited evidence base,
the majority of the studies were observational cohort studies and only one
study was a pilot RCT.12 Most studies included a rather small sample
size and reporting bias might propose a risk of bias and therefore might
impact the results of this systematic review and meta-analysis.
Moreover, some studies compared the outcomes of TAVI to sAVR
patients after CR. Whereby it is necessary for future studies in order to
compare intervention effectiveness, to have two similar groups (two
TAVI) and randomize them either to a training program or no program.
This might be challenging due to ethical reasons and thereby denying one
group potentially effective training to improve their physical function
and quality of life.
In addition, the scale used for the quality assessment of the studies
(PEDro scale) was developed to assess randomized control studies,
explaining the reason why the majority of the assessed studies received a
lower average score.

Conclusion
In conclusion, CR is a complex program with the purpose to increase
patients’ health and quality of life as well as lowering risk factors to pre-
vent future disease and complications. It plays an important role in facili-
tating and improving recovery after intervention especially in an older
population.
The results from this study demonstrate that exercise-based CR in
patients with aortic stenosis treated with TAVI improves exercise toler-
ance as well as functional independence demonstrated by the measured
6-MWT and BI.
Furthermore, it is proven to be safe even in advanced age, as the major-
ity of the complications were not due to cardiac causes and were not
related to the training programme.
Nevertheless, future studies are needed to shape an improved program
including long-term benefits and follow-ups to sustain a longer benefit.
(Table 2)

Curr Probl Cardiol, March 2023 15

Supplementary materials
Supplementary material associated with this article can be found, in
the online version, at doi:10.1016/j.cpcardiol.2022.101531.

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