Meta-analysis

Short- and Long-term Clinical Outcomes of Balloon-expandable Versus Self-expanding Valves in Patients Undergoing Transcatheter Aortic Valve Replacement: A Meta-analysis

Register or Login to View PDF Permissions
Permissions× For commercial reprint enquiries please contact Springer Healthcare: ReprintsWarehouse@springernature.com.

For permissions and non-commercial reprint enquiries, please visit Copyright.com to start a request.

For author reprints, please email rob.barclay@radcliffe-group.com.
Information image

  • Views: 1388

  • Likes: 0

  • Downloads: 38

  • Read time: 18m
Average (ratings)
No ratings
Your rating

Abstract

Background: Distinct clinical differences exist between balloon-expandable valves (BEVs) and self-expanding valves (SEVs) used in transcatheter aortic valve replacement (TAVR) for aortic stenosis. However, randomised data on comparative outcomes are limited. The aim of this metaanalysis was to analyse the differences in short- and longer-term clinical outcomes between the two valve designs. Methods: A comprehensive literature search for all studies up to and including April 2020 on the clinical outcomes of BEVs versus SEVs was performed. Study outcomes were divided into short term (in-hospital or 30 days), intermediate term (1 year) and long term (3 years). The primary outcome was all-cause mortality. Secondary endpoints were stroke or transient ischaemic attack (TIA), life-threatening or major bleeding, at least moderate paravalvular leak (PVL), permanent pacemaker (PPM) implantation, aortic valve area (AVA) and aortic valve mean pressure gradient (AV MPG). Results: A total of 41 studies (BEV, n=23,892; SEV, n=22,055) were included. At in-hospital/30 days, all-cause mortality favoured BEV (OR 0.85; 95% CI [0.75–0.96]). BEV had lower rates of PVL (OR 0.42; 95% CI [0.35–0.51]) and PPM (OR 0.56; 95% CI [0.44–0.72]), but smaller AVA (mean −0.09 cm2 ; 95% CI [−0.17, 0.00]) and higher AV MPG (mean 2.54 mmHg; 95% CI [1.84–3.23]). There were no significant differences in the incidence of stroke/TIA or bleeding between the two valve designs. At 1 year a lower PPM implantation rate (OR 0.44; 95% CI [0.37–0.52]), fewer PVLs (OR 0.26; 95% CI [0.09–0.77]), smaller AVA (mean −0.23 cm2 ; 95% CI [−0.35, −0.10]) and higher AV MPG (mean 6.05 mmHg; 95% CI [1.74–10.36]) were observed with BEV. No significant differences were observed in mortality, stroke/TIA or bleeding. There was no significant difference in mortality at 3 years between the two valve designs. Conclusion: In the short–intermediate term, SEVs had better valve haemodynamics but had higher PVL and PPM implantation rates than BEVs. However, there were no differences in intermediate–long-term mortality, stroke or TIA, or bleeding complications. A better understanding of these differences will enable TAVR operators to tailor their valve choice based on individual patient profile.

Keywords

Transcatheter aortic valve replacement, aortic valve stenosis, self-expandable valve, balloon-expandable valve,

Disclosure:KWH has received speaker fees from Edwards LifeSciences, Medtronic and Abbott. JY has received a speaker’s honorarium from Biosensors, Boston Scientific, Edwards LifeSciences, Johnson & Johnson, Kaneka, Medtronic and Terumo; JY is on the editorial board of Journal of Asian Pacific Society of Cardiology; this did not influence peer review. All other authors have no conflicts of interest to declare.

Received:

Accepted:

Published online:

DOI:https://doi.org/10.15420/japsc.2022.33

Data Availability Statement:

Data sharing is not applicable because no new data were created or analysed in this study.

Acknowledgements:JJW and EG contributed equally

Correspondence Details:Jonathan Yap, Department of Cardiology, National Heart Centre Singapore, 5 Hospital Drive, Singapore 169609. E: jonyap@yahoo.com.

Open Access:

This work is open access under the CC-BY-NC 4.0 License which allows users to copy, redistribute and make derivative works for non-commercial purposes, provided the original work is cited correctly.

With continued advances in valve design and accumulated operator experience there has been improved clinical outcomes in the field of transcatheter aortic valve replacement (TAVR), with a resulting extension of TAVR as a treatment option beyond the high-risk patient to the low-risk subset of patients.1

There exist distinct technical and clinical differences between the various types of TAVR valves, which are inherent to the differences in valve design and deployment. Balloon-expandable valves (BEVs) typically adopt an intra-annular position, have a shorter frame length, and exert a higher radial force during deployment, whereas self-expanding valves (SEVs) are repositionable, may adopt an intra-annular or supra-annular position, have a longer frame length, and exert a smaller but sustained radial force beyond their nominal diameter.2 These factors may translate into potential differences in valve haemodynamics, paravalvular leak (PVL) and conduction disturbances, which may have important implications for valve durability, functional capacity, rehospitalisations and quality of life.3–5 Data on mortality between valve types are also limited and conflicting.6,7 With the inclusion of the low-risk subset of patients who may be younger with more remaining years of life, there exists a greater need to understand the possible differences in outcomes between BEV and SEV to guide valve selection for the individual patient.8 To date, several meta-analyses have compared outcomes of the different transcatheter heart valve types, but the vast majority are lacking long-term data beyond 1 year.

In this updated meta-analysis, we aim to evaluate differences in short- and longer-term clinical outcomes between BEV and SEV.

Methods

Literature Search

This meta-analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.9 We performed an electronic search of the MEDLINE database up to and including April 2020 using the keywords ‘transcatheter aortic valve replacement’, ‘transcatheter aortic valve implantation’, ‘aortic stenosis’, ‘balloon expandable’, ‘self-expanding’ and ‘self-expandable’. Permutations of the search terms were explored until no further new or relevant articles were generated. The reference lists of all review articles were searched for potentially relevant studies. Only studies published in English were included. The process of searching and reviewing was performed by two independent evaluators (EG, YSK) and discrepancies were discussed to achieve a consensus.

Selection Criteria

Studies were included in the meta-analysis if they fulfilled the following criteria: reported on the outcomes of BEV versus SEV; study design structured as a prospective or retrospective observation study or randomised controlled trial; minimum study duration of 30 days; and study population ≥50 subjects. Studies were excluded based on at least one of the following: study population <50 subjects; a focus on non-native aortic valve stenosis (e.g. valve-in-valve TAVR); and a focus on transapical TAVR.

Definitions

Study outcomes were divided based on time period into short term (in-hospital or 30 days), intermediate term (1 year) and long term (3 years). Data at other intervals (e.g. 2 years and 5 years) were not included due to the small number of studies. The primary outcome was all-cause mortality. Secondary endpoints included stroke or transient ischaemic attack (TIA), life-threatening or major bleeding, at least moderate PVL, permanent pacemaker (PPM) implantation, aortic valve area (AVA) and aortic valve mean pressure gradient (AV MPG).

Data Extraction

Studies were first screened at the title and abstract level. Studies matching the inclusion criteria were analysed at the full-text level. Two authors (EG, YSK) extracted the data independently, including type of study, number of cases, baseline characteristics (including age, gender, Society of Thoracic Surgeons (STS) score, EuroSCORE II, and type of access), duration of follow-up, and definition of outcomes. The BEVs consisted of the SAPIEN/SAPIEN 3/SAPIEN XT series. The SEVs consisted of the CoreValve/Evolut R/Evolut PRO series, the ACURATE/ACURATE Neo series and Portico.

Statistical Analysis

Meta-analysis using a random-effects model was performed to determine the pooled effect estimates. The estimators of difference were expressed as weighted mean difference with 95% CIs for continuous outcomes and ORs for dichotomous outcomes (i.e. stroke or TIA, mortality, and bleeding). When the mean was not reported, we estimated the mean using the median, and the standard deviation using the interquartile range with an assumption of normal distribution. Assessment of bias was completed on all included studies using funnel plots to visually display evidence of small-study effects. Heterogeneity was assessed using a homogeneity test based on the χ2 test. The I2 statistic was used to assess the impact of heterogeneity on the results.10 I2 values <25% represented low, values of 25–50% represented medium, and values >50% represented high heterogeneity. Two-tailed p<0.05 was considered statistically significant. All statistical analysis were performed using R version 4.1.1 (R Foundation) using the metafor package.11

Figure 1: Flow Diagram of the Study Selection Process.

Article image
Download

Results

We identified a total of 41 studies comprising a pooled population of 46,000 patients of whom 23,892 (51.9%) had BEV implantation and 22,055 (47.9%) had SEV implantation (Figure 1). Valve type was unknown for 53 patients (0.1%). All BEVs were from the SAPIEN/SAPIEN 3/SAPIEN XT series. Of the SEVs, 19,920 (90.3%) were from the CoreValve/Evolut R/Evolut PRO series, 1,882 (8.5%) were from the ACURATE/ACURATE neo series, and 253 (1.1%) were Portico. Patients with Lotus valves were excluded from our analysis (n=18) because this valve has been withdrawn by the manufacturer.12 The baseline characteristics, including mean age, proportion of male patients, and STS score are listed in Supplementary Table 1. There were no significant differences in age or STS score between the BEV and SEV studies.

Short-term Outcomes (30 days)

A total of 37 studies (n=45,262) were included. At 30 days, mortality was lower with BEV than SEV (OR 0.85; 95% CI [0.75–0.96]). BEV had lower rates of at least moderate PVL (OR 0.42; 95% CI [0.35–0.51]) and PPM implantation (OR 0.56; 95% CI [0.44–0.72]), but smaller AVA (mean difference −0.09 cm2; 95% CI [−0.17, 0.00]) and higher AV MPG (mean difference 2.54 mmHg; 95% CI [1.84–3.23]). There were no significant differences in stroke/TIA or life-threatening or major bleeding between the two valve designs. Heterogeneity was low for mortality (I2=8.2%), stroke/TIA (I2=1.4%) and life-threatening or major bleeding (I2=0.0%). Heterogeneity was moderate for PVL (I2=37.4%) and high for PPM implantation, AVA and transvalvular MPG (I2>80%) (Table 1, Figure 2 and Supplementary Figure 1A).

Outcomes of Balloon-expandable versus Self-expanding Valves in TAVR

Article image
Download

Figure 2: Forest Plots of Short-term (In-hospital or 30-day) Clinical Outcomes

Article image
Download

Figure 2: Cont

Article image
Download

Figure 2: Cont

Article image
Download

Figure 2: Cont

Article image
Download

Figure 2: Cont

Article image
Download

Figure 2: Cont

Article image
Download

Figure 2: Cont

Article image
Download

Intermediate-term Outcomes (1 year)

A total of 17 studies (n=30,996) were included. At 1 year the BEV design had a lower PPM implantation rate (OR 0.42; 95% CI [0.35–0.51]) and a lower rate of significant PVL (OR 0.26; 95% CI [0.09–0.77]), but a smaller AVA (mean difference −0.23 cm2; 95% CI [−0.35, −0.10]) and higher AV MPG (mean difference 6.05 mmHg; 95% CI [1.74–10.36]). There were no significant differences in mortality, stroke/TIA or life-threatening or major bleeding between the two valve designs. Heterogeneity was low for mortality (I2=9.3%), stroke/TIA (I2=0.0%), PVL (I2=0.0%) and PPM implantation (I2=0.004%). Heterogeneity was moderate for life-threatening or major bleeding (I2=52.9%) and AVA (I2=35.02%), and high for transvalvular MPG (I2=95.7%) (Table 1, Figure 3 and Supplementary Figure 1B).

Figure 3: Forest Plots of Intermediate-term (1-year) Clinical Outcomes.

Article image
Download

Long-term Outcomes (3 years)

A total of 3 studies were included (n=22,142). At 3 years there was no difference in mortality between BEV and SEV (OR 0.93; 95% CI [0.85–1.03]). There was no heterogeneity between the studies (I2=0.0%). The other outcomes were not analysed due to the small number of reporting studies (Table 1, Figure 4 and Supplementary Figure 1C).

Figure 4: Forest Plot of Long-term (3-year) Clinical Outcomes.

Article image
Download

Discussion

This is the largest meta-analysis to compare short- and long-term outcomes between BEVs and SEVs. With 41 studies and 46,000 patients included, the pertinent findings are as follows: the SEV design had better valve haemodynamics than the BEV design; in the short to intermediate term, SEVs had higher PPM implantation and significant paravalvular regurgitation rates than BEVs; there were no differences between bleeding complications and stroke or TIA between the two valve designs; and with regards to mortality, BEVs had improved short-term mortality, but these differences were not seen in the intermediate to long term.

Valve haemodynamics were better at 1 year with the SEV design. This is in part attributable to valve design, in that the supra-annular position of the CoreValve/Evolut platform provides better flow haemodynamics than the intra-annular position of the BEV.13,14

Prosthetic valves that are small for the patient’s size can impair valve haemodynamics and lead to patient–prosthesis mismatch. The persistently high afterload raises ventricular filling pressures and may offset the benefits of aortic valve replacement by impeding regression of left ventricular hypertrophy and atrial dilatation.15,16 This may potentially lead to reduced improvements in functional capacity, affect valve durability and lead to rehospitalisations.5,14,17 Unlike data from surgical aortic valve replacement, however, the issue of patient–prosthesis mismatch in transcatheter heart valves has been controversial, with more recent studies showing no impact on mortality or rehospitalisations.18,19

The rate of PVL was higher with the SEV design at 30 days and 1 year. The higher incidence of at least moderate PVL with SEVs may be attributed to several aspects of the SEV design, such as the smaller outward radial force of the nitinol frame and the greater angulation between the ascending aorta and left ventricular outflow tract.20 PVL results in reduced left ventricular mass regression and increased left ventricular end-diameter.21 A graded relationship has been found between increasing PVL and mortality, with some reports even suggesting an association between mild PVL and death, although this has been debated.21,22 However, it is important to note that there are other determinants of PVL, including aortic valve calcification, larger aortic annulus dimension and elliptical shape. With improvements in valve design including the addition of a sealing skirt, the incidence of PVL has been reduced in the latest generations of the transcatheter heart valves.23,24

PPM implantation rates were higher with SEV than BEV at 30 days and 1 year. This is similar to the findings of many other studies.2,6 The continued pressure of the SEV on the septum may result in tissue oedema and cause conduction disturbances such as left bundle branch block and complete heart block.25 The longer frame and depth of implantation are also potential contributors to the higher PPM rates seen with SEV.26 With recent improvements in implantation technique including the cusp overlap technique, there has been a reduction in PPM rates with the SEV design.27

Bleeding complications and stroke/TIA were not different between the two valve designs at 30 days and 1 year. Improvements to transcatheter heart valve designs over the years have led to progressively smaller and better delivery systems and sheaths, thus greatly reducing overall bleeding complication rates.7,28 Data on stroke are more conflicting. Several studies show a higher incidence of stroke with BEV than SEV while some show similar stroke rates.29,30 A possible explanation for the higher stroke rate with the BEV design includes rapid ventricular pacing-induced cerebral hypoperfusion during BEV deployment.31 Post-TAVR strokes and silent brain infarcts are associated with post-procedure early cognitive decline, leading to increased mortality and morbidity.32

Of note, recent meta-analyses on newer generation transcatheter heart valves have also reported no significant difference in stroke incidence between BEVs and SEVs, in part due to the reduction in post-dilatations needed to reduce PVL after the addition of sealing skirts.33 This was similar to the findings of the current meta-analysis.

Although there was an initial increase in 30-day mortality with SEVs, there were no differences in mortality at 1-year and 3-year follow-up. One meta-analysis using older generation transcatheter heart valves (SAPIEN/SAPIEN XT, CoreValve) also reported an initial increase in 30-day mortality with the SEV but not 1-year mortality.6 This was attributed to initial device failures and procedural complications such as increased residual aortic regurgitation, frequent mispositioning necessitating valve-in-valve procedures, and a higher rate of valve embolisation.6,34

With limited statistical power resulting from a study population of 241 patients, the CHOICE randomised control trial showed that although BEV had higher device success rates, there was no difference in 1-year mortality outcomes between the two valve designs.35 Subsequent meta-analyses with newer generation transcatheter heart valves reported significantly reduced 30-day and 1-year mortality rates with no significant difference between BEVs and SEVs.7,20,28 This current meta-analysis extends existing knowledge by demonstrating that there were no significant differences in long-term mortality between the BEV and SEV designs. The latest advancements in transcatheter heart valve designs as well as increasing operator experience are likely to have contributed to the reduced complications and improved long-term outcomes for patients with aortic stenosis.23,24

Limitations

Several limitations should be acknowledged when interpreting these findings. First, most of the studies included were observational in nature. The pooling of observation studies with different baseline characteristics and inclusion criteria may introduce a greater probability of bias, thus these comparisons should be interpreted with caution. However, the main outcomes reported here, namely mortality, stroke and bleeding complications, were found to have low between-study heterogeneity, and the findings were consistent with other meta-analyses comparing BEVs with SEVs. Only a few randomised controlled trials were available, and inclusion of data from future randomised controlled trials is warranted for more definitive conclusions.

Second, patients in this pooled analysis were not matched for their baseline characteristics (including valve morphology), which may have introduced confounding. Although we would have preferred to perform a meta-regression with adjustment for confounders, not all studies had reported the same baseline and procedural characteristics, making detailed patient-level adjustment technically unfeasible. Third, there are limited long-term data on the comparison of BEVs and SEVs, with only a few studies being included in the analysis. Fourth, the group of self-expandable valves is heterogeneous with potential differences in valve design. This study’s findings may not be generalisable to all SEVs. And last, comparisons made across generations of transcatheter valves may affect the generalisability of the findings. Ongoing improvements in current generations of valve types and implantation techniques will aim to address the drawbacks of the older valve generations and potentially improve outcomes, which may not be captured by this current meta-analysis.

Conclusion

In the short–intermediate term, SEVs had better valve haemodynamics but had higher rates of at least moderate PVL and PPM implantation than BEVs. Nevertheless, there were no significant differences in intermediate to long-term mortality, stroke or TIA, or bleeding complications between the two valve designs. Having a better understanding of these differences will enable TAVR operators to tailor their valve choice based on individual patient profile.

Click here to view Supplementary Material

Clinical Perspective

  • Distinct clinical differences exist between balloon-expandable valves (BEVs) and self-expanding valves (SEVs) used in transcatheter aortic valve replacement (TAVR), but long-term comparative data beyond 1 year are lacking.
  • In this meta-analysis, SEVs had better valve haemodynamics but higher paravalvular leak and pacemaker implantation rates than BEVs in the short to intermediate term.
  • In the intermediate to long term, there were no differences in mortality, stroke, or bleeding complications between the two valve designs.
  • Having a better understanding of these differences will enable TAVR operators to tailor their valve choice to individual patient profiles.

References

  1. Tamburino C, Valvo R, Criscione E, et al. The path of transcatheter aortic valve implantation: from compassionate to low-risk cases. Eur Heart J Suppl 2020;22(Suppl L):L140–5.   
    Crossref | PubMed
  2. Lee HA, Chou AH, Wu VCC, et al. Balloon-expandable versus self-expanding transcatheter aortic valve replacement for bioprosthetic dysfunction: a systematic review and meta-analysis. PLoS One 2020;15:e0233894.   
    Crossref | PubMed
  3. Li YM, Mei FY, Yao YJ, et al. Causes and predictors of readmission after transcatheter aortic valve implantation: a meta-analysis and systematic review. Herz 2021;46(Suppl 1):1–8.   
    Crossref | PubMed
  4. Kampaktsis PN, Subramayam P, Sherifi I, et al. Impact of paravalvular leak on left ventricular remodeling and global longitudinal strain 1 year after transcatheter aortic valve replacement. Future Cardiol 2021;17:337–45.   
    Crossref | PubMed
  5. Flameng W, Herregods MC, Vercalsteren M, et al. Prosthesis-patient mismatch predicts structural valve degeneration in bioprosthetic heart valves. Circulation 2010;121:2123–9.   
    Crossref | PubMed
  6. Agarwal S, Parashar A, Kumbhani DJ, et al. Comparative meta-analysis of balloon-expandable and self-expandable valves for transcatheter aortic valve replacement. Int J Cardiol 2015;197:87–97.   
    Crossref | PubMed
  7. Zhang XL, Zhang XW, Wei ZH, et al. Early and midterm outcomes of transcatheter aortic-valve replacement with balloon-expandable versus self-expanding valves: a systematic review and meta-analysis. J Cardiol 2022;80:204–10.   
    Crossref
  8. Hanzel GS, Gersh BJ. Transcatheter aortic valve replacement in low-risk, young patients: natural expansion or cause for concern? Circulation 2020;142:1317–9.   
    Crossref | PubMed
  9. Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71.   
    Crossref | PubMed
  10. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327:557–60.   
    Crossref | PubMed
  11. Viechtbauer W. Conducting meta-analyses in R with the metafor package. J Stat Softw 2010;36:1–48.   
    Crossref.
  12. Tzeng YH, Lee YT, Tsao TP, et al. Performance and short-term outcomes of three different transcatheter aortic valve replacement devices in patients with aortic stenosis: a single-center experience. J Chin Med Assoc 2019;82:827–34.   
    Crossref | PubMed
  13. Midha PA, Raghav V, Condado JF, et al. Valve type, size, and deployment location affect hemodynamics in an in vitro valve-in-valve model. JACC Cardiovasc Interv 2016;9:1618–28.   
    Crossref | PubMed
  14. Külling M, Külling J, Wyss C, et al. Effective orifice area and hemodynamic performance of the transcatheter Edwards Sapien 3 prosthesis: short-term and 1-year follow-up. Eur Heart J Cardiovasc Imaging 2018;19:23–30.   
    Crossref | PubMed
  15. Head SJ, Mokhles MM, Osnabrugge RL, et al. The impact of prosthesis-patient mismatch on long-term survival after aortic valve replacement: a systematic review and meta-analysis of 34 observational studies comprising 27 186 patients with 133 141 patient-years. Eur Heart J 2012;33:1518–29.   
    Crossref | PubMed
  16. Ewe SH, Muratori M, Delgado V, et al. Hemodynamic and clinical impact of prosthesis-patient mismatch after transcatheter aortic valve implantation. J Am Coll Cardiol 2011;58:1910–8.   
    Crossref | PubMed
  17. Mauri V, Kim WK, Abumayyaleh M, et al. Short-term outcome and hemodynamic performance of next-generation self-expanding versus balloon-expandable transcatheter aortic valves in patients with small aortic annulus: a multicenter propensity-matched comparison. Circ Cardiovasc Interv 2017;10:e005013.   
    Crossref | PubMed
  18. Tang GHL, Sengupta A, Alexis SL, et al. Outcomes of prosthesis-patient mismatch following supra-annular transcatheter aortic valve replacement: from the STS/ACC TVT registry. JACC Cardiovasc Interv 2021;14:964–76.   
    Crossref | PubMed
  19. Ternacle J, Pibarot P, Herrmann HC, et al. Prosthesis-patient mismatch after aortic valve replacement in the PARTNER 2 trial and registry. JACC Cardiovasc Interv 2021;14:1466–77.   
    Crossref | PubMed
  20. Osman M, Ghaffar YA, Saleem M, et al. Meta-analysis comparing transcatheter aortic valve implantation with balloon versus self-expandable valves. Am J Cardiol 2019;124:1252–6.   
    Crossref | PubMed
  21. Maisano F, Taramasso M, Nietlispach F. Prognostic influence of paravalvular leak following TAVI: is aortic regurgitation an active incremental risk factor or just a mere indicator? Eur Heart J 2015;36:413–5.   
    Crossref | PubMed
  22. Athappan G, Patvardhan E, Tuzcu EM, et al. Incidence, predictors, and outcomes of aortic regurgitation after transcatheter aortic valve replacement: meta-analysis and systematic review of literature. J Am Coll Cardiol 2013;61:1585–95.   
    Crossref | PubMed
  23. Kowalewski M, Gozdek M, Raffa GM, et al. Transcathether aortic valve implantation with the new repositionable self-expandable Medtronic Evolut R vs. CoreValve system: evidence on the benefit of a meta-analytical approach. J Cardiovasc Med (Hagerstown) 2019;20:226–36.   
    Crossref | PubMed
  24. Ando T, Briasoulis A, Holmes AA, et al. Sapien 3 versus Sapien XT prosthetic valves in transcatheter aortic valve implantation: A meta-analysis. Int J Cardiol 2016;220:472–8.   
    Crossref | PubMed
  25. Maier O, Piayda K, Afzal S, et al. Computed tomography derived predictors of permanent pacemaker implantation after transcatheter aortic valve replacement: a meta-analysis. Catheter Cardiovasc Interv 2021;98:e897–907.   
    Crossref | PubMed
  26. Elgendy IY, Gad MM, Mahmoud AN, et al. Meta-analysis comparing outcomes of self-expanding versus balloon-expandable valves for transcatheter aortic valve implantation. Am J Cardiol 2020;128:202–9.   
    Crossref | PubMed
  27. Mendiz OA, Noč M, Fava CM, et al. Impact of cusp-overlap view for TAVR with self-expandable valves on 30-day conduction disturbances. J Interv Cardiol 2021;2021:9991528.   
    Crossref | PubMed
  28. Li YM, Tsauo JY, Liao YB, et al. Comparison of third generation balloon-expandable Edwards Sapien 3 versus self-expandable Evolut R in transcatheter aortic valve implantation: a meta-analysis. Ann Palliat Med 2020;9:700–8.   
    Crossref | PubMed
  29. Seppelt PC, Mas-Peiro S, De Rosa R, et al. Thirty-day incidence of stroke after transfemoral transcatheter aortic valve implantation: meta-analysis and mixt-treatment comparison of self-expandable versus balloon-expandable valve prostheses. Clin Res Cardiol 2021;110:640–8.   
    Crossref | PubMed
  30. Athappan G, Gajulapalli RD, Sengodan P, et al. Influence of transcatheter aortic valve replacement strategy and valve design on stroke after transcatheter aortic valve replacement: a meta-analysis and systematic review of literature. J Am Coll Cardiol 2014;63:2101–10.   
    Crossref | PubMed
  31. Woldendorp K, Indja B, Bannon PG, et al. Silent brain infarcts and early cognitive outcomes after transcatheter aortic valve implantation: a systematic review and meta-analysis. Eur Heart J 2021;42:1004–15.   
    Crossref | PubMed
  32. Yanagisawa R, Tanaka M, Yashima F, et al. Frequency and consequences of cognitive Impairmentin patients underwent transcatheter aortic valve implantation. Am J Cardiol 2018;122:844–50.   
    Crossref | PubMed
  33. Bhushan S, Huang X, Li Y, et al. Paravalvular leak after transcatheter aortic valve implantation its incidence, diagnosis, clinical implications, prevention, management, and future perspectives: a review article. Curr Probl Cardiol 2022;47:100957.   
    Crossref | PubMed
  34. Abdel-Wahab M, Comberg T, Büttner HJ, et al. Aortic regurgitation after transcatheter aortic valve implantation with balloon- and self-expandable prostheses: a pooled analysis from a 2-center experience. JACC Cardiovasc Intv 2014;7:284–92.   
    Crossref | PubMed
  35. Abdel-Wahab M, Neumann FJ, Mehilli J, et al. 1-year outcomes after transcatheter aortic valve replacement with balloon-expandable versus self-expandable valves: results from the CHOICE randomized clinical trial. J Am Coll Cardiol 2015;66:791–800.   
    Crossref | PubMed
  36. Moat NE, Ludman P, de Belder MA, et al. Long-term outcomes after transcatheter aortic valve implantation in high-risk patients with severe aortic stenosis: the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) registry. J Am Coll Cardiol 2011;58:2130–8.   
    Crossref | PubMed
  37. Gilard M, Eltchaninoff H, Iung B, et al. Registry of transcatheter aortic-valve implantation in high-risk patients. N Engl J Med 2012;366:1705–15.   
    Crossref | PubMed
  38. Ben-Shoshan J, Konigstein M, Zahler D, et al. Comparison of the Edwards Sapien S3 versus Medtronic Evolut-R devices for transcatheter aortic valve implantation. Am J Cardiol 2017;119:302–7.   
    Crossref | PubMed
  39. Eitan A, Witt J, Stripling J, et al. Performance of the Evolut-R 34 mm versus Sapien-3 29 mm in transcatheter aortic valve replacement patients with larger annuli: early outcome results of Evolut-R 34 mm as compared with Sapien-3 29 mm in patients with annuli ≥26 mm. Catheter Cardiovasc Interv 2018;92:1374–9.   
    Crossref | PubMed
  40. Finkelstein A, Steinvil A, Rozenbaum Z, et al. Efficacy and safety of new-generation transcatheter aortic valves: insights from the Israeli transcatheter aortic valve replacement registry. Clin Res Cardiol 2019;108:430–7.   
    Crossref | PubMed
  41. Kim WK, Blumenstein J, Liebetrau C, et al. Comparison of outcomes using balloon-expandable versus self-expanding transcatheter prostheses according to the extent of aortic valve calcification. Clin Res Cardiol 2017;106:995–1004.   
    Crossref | PubMed
  42. Lanz J, Kim WK, Walther T, et al. Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial. Lancet 2019;394:1619–28.   
    Crossref | PubMed
  43. Van Belle E, Vincent F, Labreuche J, et al. Balloon-expandable versus self-expanding transcatheter aortic valve replacement: a propensity-matched comparison from the FRANCE-TAVI registry. Circulation 2020;141:243–59.   
    Crossref | PubMed
  44. Rogers T, Steinvil A, Buchanan K, et al. Contemporary transcatheter aortic valve replacement with third-generation balloon-expandable versus self-expanding devices. J Interv Cardiol 2017;30:356–61.   
    Crossref | PubMed
  45. Mosleh W, Amer MR, Joshi S, et al. Comparative outcomes of balloon-expandable S3 versus self-expanding Evolut bioprostheses for transcatheter aortic valve implantation. Am J Cardiol 2019;124:1621–9.   
    Crossref | PubMed
  46. Barth S, Reents W, Zacher M, et al. Multicentre propensity-matched comparison of transcatheter aortic valve implantation using the ACURATE TA/neo self-expanding versus the SAPIEN 3 balloon-expandable prosthesis. EuroIntervention 2019;15:884–91.   
    Crossref | PubMed
  47. Husser O, Kim WK, Pellegrini C, et al. Multicenter comparison of novel self-expanding versus balloon-expandable transcatheter heart valves. JACC Cardiovasc Interv 2017;10:2078–87.   
    Crossref | PubMed
  48. Abdel-Wahab M, Mehilli J, Frerker C, et al. Comparison of balloon-expandable vs self-expandable valves in patients undergoing transcatheter aortic valve replacement: the CHOICE randomized clinical trial. JAMA 2014;311:1503–14.   
    Crossref | PubMed
  49. Wijeysundera HC, Qiu F, Koh M, et al. Comparison of outcomes of balloon-expandable versus self-expandable transcatheter heart valves for severe aortic stenosis. Am J Cardiol 2017;119:1094–9.   
    Crossref | PubMed
  50. Moriyama N, Vento A, Laine M. Safety of next-day discharge after transfemoral transcatheter aortic valve replacement with a self-expandable versus balloon-expandable valve prosthesis. Circ Cardiovasc Interv 2019;12:e007756.   
    Crossref | PubMed
  51. Tarantini G, Purita PAM, D’Onofrio A, et al. Long-term outcomes and prosthesis performance after transcatheter aortic valve replacement: results of self-expandable and balloon-expandable transcatheter heart valves. Ann Cardiothorac Surg 2017;6:473–83.   
    Crossref | PubMed
  52. Kiramijyan S, Magalhaes MA, Koifman E, et al. Aortic regurgitation in patients undergoing transcatheter aortic valve replacement with the self-expanding CoreValve versus the balloon-expandable Sapien XT valve. Am J Cardiol 2016;117:1502–10.   
    Crossref | PubMed
  53. Covolo E, Saia F, Napodano M, et al. Comparison of balloon-expandable versus self-expandable valves for transcatheter aortic valve implantation in patients with low-gradient severe aortic stenosis and preserved left ventricular ejection fraction. Am J Cardiol 2015;115:810–5.   
    Crossref | PubMed
  54. Mas-Peiro S, Seppelt PC, Weiler H, et al. A direct comparison of self-expandable Portico versus balloon-expandable Sapien 3 devices for transcatheter aortic valve replacement: a case-matched cohort study. J Invasive Cardiol 2019;31:e199–204 
    PubMed
  55. Giannini C, Petronio AS, Mehilli J, et al. Edwards SAPIEN versus Medtronic aortic bioprosthesis in women undergoing transcatheter aortic valve implantation (from the Win-TAVI registry). Am J Cardiol 2020;125:441–8.   
    Crossref | PubMed
  56. Chang HH, Chen IM, Chen PL, et al. Comparison of balloon-expandable valves versus self-expandable valves in high-risk patients undergoing transcatheter aortic valve replacement for severe aortic stenosis. J Chin Med Assoc 2015;78:331–8.   
    Crossref | PubMed
  57. Deharo P, Bisson A, Herbert J, et al. Impact of Sapien 3 balloon-expandable versus Evolut R self-expandable transcatheter aortic valve implantation in patients with aortic stenosis: data from a nationwide analysis. Circulation 2020;141:260–8.   
    Crossref | PubMed
  58. Fischer Q, Urena M, Bouleti C, et al. Performing optimal transcatheter aortic valve implantation: the need for tailored use of transcatheter valves. Arch Cardiovasc Dis 2019;112:512–22.   
    Crossref | PubMed
  59. Ochiai T, Yoon SH, Sharma R, et al. outcomes of self-expanding vs. balloon-expandable transcatheter heart valves for the treatment of degenerated aortic surgical bioprostheses – a propensity score-matched comparison. Circ J 2018;82:2655–62.   
    Crossref | PubMed
  60. Maeno Y, Abramowitz Y, Yoon SH, et al. Transcatheter aortic valve replacement with different valve types in elliptic aortic annuli. Circ J 2017;81:1036–42.   
    Crossref | PubMed
  61. Gonska B, Seeger J, Baarts J, et al. The balloon-expandable Edwards Sapien 3 valve is superior to the self-expanding Medtronic CoreValve in patients with severe aortic stenosis undergoing transfemoral aortic valve implantation. J Cardiol 2017;69:877–82.   
    Crossref | PubMed
  62. Spargias K, Toutouzas K, Chrissoheris M, et al. The Athens TAVR registry of newer generation transfemoral aortic valves: 30-day outcomes. Hellenic J Cardiol 2013;54:18–24  
    PubMed
  63. Seiffert M, Schnabel R, Conradi L, et al. Predictors and outcomes after transcatheter aortic valve implantation using different approaches according to the valve academic research consortium definitions. Catheter Cardiovasc Interv 2013;82:640–52.   
    Crossref | PubMed
  64. Schaefer A, Linder M, Seiffert M, et al. Comparison of latest generation transfemoral self-expandable and balloon-expandable transcatheter heart valves. Interact Cardiovasc Thorac Surg 2017;25:905–11.   
    Crossref | PubMed
  65. Vollenbroich R, Wenaweser P, Macht A, et al. Long-term outcomes with balloon-expandable and self-expandable prostheses in patients undergoing transfemoral transcatheter aortic valve implantation for severe aortic stenosis. Int J Cardiol 2019;290:45–51.   
    Crossref | PubMed
  66. Abdelghani M, Mankerious N, Allali A, et al. Bioprosthetic valve performance after transcatheter aortic valve replacement with self-expanding versus balloon-expandable valves in large versus small aortic valve annuli: insights from the CHOICE trial and the CHOICE-Extend registry. JACC Cardiovasc Interv 2018;11:2507–18.   
    Crossref | PubMed
  67. Rogers T, Steinvil A, Gai J, et al. Choice of balloon-expandable versus self-expanding transcatheter aortic valve impacts hemodynamics differently according to aortic annular size. Am J Cardiol 2017;119:900–4.   
    Crossref | PubMed
  68. Del Trigo M, Dahou A, Webb JG, et al. Self-expanding portico valve versus balloon-expandable Sapien XT valve in patients with small aortic annuli: comparison of hemodynamic performance. Rev Esp Cardiol (Engl Ed) 2016;69:501–8.   
    Crossref | PubMed
  69. Enríquez-Rodríguez E, Amat-Santos IJ, Jiménez-Quevedo P, et al. Comparison of the hemodynamic performance of the balloon-expandable SAPIEN 3 versus self-expandable Evolut R transcatheter valve: a case-matched study. Rev Esp Cardiol (Engl Ed) 2018;71:735–42.   
    Crossref | PubMed
  70. Nombela-Franco L, Ruel M, Radhakrishnan S, et al. Comparison of hemodynamic performance of self-expandable CoreValve versus balloon-expandable Edwards SAPIEN aortic valves inserted by catheter for aortic stenosis. Am J Cardiol 2013;111:1026–33.   
    Crossref | PubMed
  71. Kempfert J, Meyer A, Kim WK, et al. Comparison of two valve systems for transapical aortic valve implantation: a propensity score-matched analysis. Eur J Cardiothorac Surg 2016;49:486–92.   
    Crossref | PubMed
  72. Rodés-Cabau J, Urena M, Nombela-Franco L, et al. Arrhythmic burden as determined by ambulatory continuous cardiac monitoring in patients with new-onset persistent left bundle branch block following transcatheter aortic valve replacement: the MARE study. JACC Cardiovasc Interv 2018;11:1495–505.   
    Crossref | PubMed
Previous Volume Article Next Volume Article