Balloon postdilation (BPD) is used to optimize valve expansion after transcatheter aortic valve implantation (TAVI). However, the clinical impact, particularly between balloon-expandable (BE) and self-expanding (SE) valves, remains unclear. We conducted a systematic search of PubMed, Embase, and Cochrane Library to compare patients undergoing TAVI with and without BPD. We pooled the risk ratios (RR) and mean differences (MD) for binary and continuous outcomes, respectively. All statistical analyses were performed using a random effects model. Sixteen observational studies comprising 15,508 patients were included, of which 3,397 (22%) underwent TAVI with BPD. BPD was associated with a significantly higher risk of in-hospital stroke (RR, 1.66; 95% CI 1.15 to 2.40; p <0.01) and 30-day mortality (RR, 1.28; 95% CI 1.05 to 1.56; p = 0.01). No significant differences were observed in terms of 30-day, 1-year, or overall stroke; pacemaker implantation; myocardial infarction; or cardiovascular or all-cause mortality. Regarding echocardiographic outcomes, BPD resulted in a larger effective orifice area (EOA) (MD 0.06; 95% CI 0.01 to 0.11; p = 0.01), with no differences in the mean transvalvular gradient and paravalvular regurgitation. In prespecified subgroup analyses, BPD was associated with an increased risk of 1-year stroke in patients receiving BE valves (RR, 1.57; 95% CI, 1.11 to 2.24; p = 0.01) and a higher 30-day mortality with SE valves (RR, 1.28; 95% CI 1.01 to 1.62; p = 0.04) compared with non-BPD. BPD is associated with an increased risk of early mortality and periprocedural stroke, albeit with a slightly larger EOA. Further randomized trials are needed to confirm our findings.
Transcatheter aortic valve implantation (TAVI) is an established therapy for symptomatic severe aortic stenosis, with current guidelines supporting its use in patients across all surgical risk categories. , Achieving optimal valve expansion is a key procedural challenge that directly affects patient outcome. In this sense, suboptimal expansion is a frequent complication that leads to poor hemodynamic performance, such as high residual gradients and significant paravalvular regurgitation (PVR). Thus, this mechanical issue has been linked to adverse 1-year clinical outcomes including mortality and stroke. ,
To address this, balloon postdilation (BPD) is the primary technique employed to correct suboptimal expansion and resolve the resulting PVR. By applying an additional radial force, the BPD aims to improve the apposition of the valve frame against the native annulus for a better seal. However, this intervention introduces a critical risk-benefit dilemma for the operator. While BPD can improve valve hemodynamics, its use carries a risk of procedural complications, including annular injury, conduction disturbances, and cerebrovascular events caused by dislodged debris, which have been reported since early TAVI experiences. ,
Recently, newer-generation valves have been introduced, such as SAPIEN 3 (Edwards Lifesciences, CA), Evolut R/PRO (Medtronic, MN), and ACURATE neo (Boston Scientific, MA) platforms. These devices feature sealing skirts and distinct mechanical properties designed to minimize PVR, potentially altering the risk-benefit calculation of BPD. , Previous meta-analyses have not fully captured the impact of these modern devices or adequately explored the differential outcomes of balloon-expandable (BE) and self-expanding (SE) valves. Therefore, this systematic review and meta-analysis aims to provide a comprehensive and contemporary assessment of BPD, focusing on its safety and efficacy, and investigating its impact across different valve types.
Material and Methods
This systematic review and meta-analysis were conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The prospective meta-analysis protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) database under protocol number CRD420251055127.
Eligibility criteria
Eligibility for inclusion in this meta-analysis was determined by the following criteria: ( ) randomized controlled trials (RCT) or cohort studies; ( ) direct comparison of TAVI with versus without BPD after valve deployment; and ( ) reporting any outcomes of interest. Studies were excluded if they ( ) were case reports, reviews, editorials, abstracts without full-text availability, or nonclinical studies; ( ) included valve-in-valve procedures; or ( ) did not provide subgroup analyses for SE and BE valves.
Search strategy and data extraction
We systematically searched PubMed, Embase, and Cochrane databases in May 2025. We applied forward snowballing to identify studies that cited the included papers. The search strategy combined keywords including “transcatheter aortic valve replacement,” “TAVR,” “postdilation,” and “BPD.” Two investigators (M. C. I. and N. A.) independently extracted data from the included studies and performed quality assessment using predefined criteria. Discrepancies were resolved by consensus or consultation with a third reviewer.
Endpoints
The outcomes of interest were stratified into clinical and echocardiographic endpoints. Endpoints were defined according to the most recent Valve Academic Research Consortium 3 (VARC-3). Given that the included studies were published over several years, some adhered to earlier VARC-2 or the original VARC criteria; in these cases, outcome data were extracted as originally reported. The primary clinical endpoints for the analysis were all-cause mortality at 30 days and 1 year. The secondary endpoints included cardiovascular mortality, cerebrovascular events (analyzed at in-hospital, 30-day, and 1-year follow-up), periprocedural myocardial infarction, and need for new permanent pacemaker implantation.
Echocardiographic outcomes were assessed based on recommendations from the American Society of Echocardiography (ASE) and the European Association of Cardiovascular Imaging (EACVI). These included the mean aortic gradient derived from continuous-wave Doppler and the effective orifice area (EOA) calculated using the continuity equation. The incidence of PVR greater than mild was a key endpoint, defined as the presence of moderate (circumferential extent of 10% to 29%) or severe (≥30%) leak, according to the integrative VARC-3 approach. ,
Statistical analysis
Risk ratios (RR) and mean differences (MD) with 95% confidence intervals (CI) were calculated for dichotomous and continuous outcomes, respectively. All pooled analyses were performed using a random-effects model, accounting for clinical, demographic, and methodological heterogeneity among studies, as per Cochrane recommendations (citation). Statistical heterogeneity was assessed using the I² statistic. prespecified subgroup analyses were conducted to evaluate the outcomes based on valve type. To assess the robustness of the pooled results and investigate potential publication bias, prespecified sensitivity analyses were planned. We conducted a leave-one-out sensitivity analysis to evaluate the influence of individual studies on the primary outcomes. Furthermore, we planned to assess publication bias for the outcome of overall stroke by visual inspection of a funnel plot for asymmetry.
Trial sequential analysis (TSA) was conducted for all reported stroke and mortality outcomes, including prespecified subgroup analyses. The analyses were planned to detect a relative risk reduction (RRR) of 20% or 30%, with a type I error risk (α) of 5% and power of 80% (type II error risk β of 20%). All statistical analyses were performed using the meta and metafor packages in R Studio (R Foundation for Statistical Computing, Vienna, Austria).
Summary of findings and certainty of evidence
Two authors (M.C.I. and I.M.E.) independently evaluated the methodological quality of included studies. The risk of bias was assessed using the Risk of Bias in nonrandomized Studies of Interventions (ROBINS-I) tool, and any disagreements were resolved by discussion and consensus. The overall certainty of evidence for each outcome was graded using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework using the GRADEpro Guideline Development Tool. Visualization of the risk of bias was performed using the Robvis tool.
Results
Study selection and baseline characteristics
A systematic literature search yielded 16 observational studies that met the inclusion criteria ( Figure 1 ). A total of 15,508 patients who underwent TAVI were included, of whom 3,397 (22%) had received BPD and 12,111 (78%) did not receive BPD. The pooled patient population was consistently elderly, with mean ages typically in the early 80s across both the BPD and non-BPD groups. The cohorts represented a high-risk population with a significant burden of cardiovascular comorbidities, and a high prevalence of hypertension and coronary artery disease was common across nearly all studies. Baseline echocardiographic parameters uniformly confirmed the diagnosis of severe aortic stenosis, characterized by high mean aortic gradients and severely reduced aortic valve areas, while the left ventricular ejection fraction was, on average, preserved. Detailed characteristics of each study are presented in Table 1 .
PRISMA flow diagram of study screening and selection.
Table 1
Baseline characteristics of included studies
| Study |
No. of
patients |
Valve type
Balloon-expandable (BE) or self-expandable (SE) |
Age (years)
mean |
Male,
(%) |
Diabetes,
(%) |
HTN
,
(%) |
CAD
,
(%) |
Prior
CABG , (%) |
Previous
Stroke, (%) |
LVEF
,
% |
Mean aortic gradient,
mm Hg |
AVA
cm 2 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BPD/No-BPD | BPD/No-BPD | BPD/No-BPD | BPD/No-BPD | BPD/No-BPD | BPD/No-BPD | BPD/No-BPD | BPD/No-BPD | BPD/No-BPD | BPD/No-BPD | BPD/No-BPD | ||
| Franco et al. | 59/152 |
SAPIEN
,
SAPIEN XT |
80/79 | 50.9/36.8 | 35.6/36.8 | 86.4/90.1 | 62.7/64.5 | 37.3/40.1 | 23.7/21.1 | 56/53 | 45/38 | 0.60/0.64 |
| Daneault et al. | 106/153 | SAPIEN | 85.4/85.8 | 67/40 | 21/31 | 78/81 | NA | 42/37 | 9/5 | 47/50.2 | 45.5/46.4 | 0.61/0.58 |
| Hahn et al. | 264/1869 | SAPIEN | 84.3/84.4 | 72.7/49.8 | 34.8/38.3 | 91.3/92.1 | 82.6/77.1 | 53.4/41.4 | 24.6/27.1 | 50.4/52.9 | 44.6/44.1 | 0.66/0.65 |
| Lasa et al. | 21/136 | SAPIEN , SAPIEN XT | 80.7/81.5 | 57.1/56.3 | 32.5/32.5 | 70/71.4 | NA | NA | NA | 51.5/51.7 | NA | 0.77/0.74 |
| Barbanti et al. | 272/1,104 | CoreValve | 80.5/81.9 | 61.8/43.9 | 26.8/29.6 | 80.8/81.4 | NA | 18.1/14.0 | 14.3/10.5 | 48/51.4 | 51.8/51.7 | 0.40/0.40 |
| Watanabe et al. | 49/421 | SAPIEN | 84/84 | 61.2/43 | 18.4/22.6 | 67.3/70.1 | 67.3/59.1 | 18.4/13.8 | 16.3/8.5 | 51.1/52.9 | 47.3/47.6 | 0.59/0.63 |
| Stundl et al. | 125/85 | CoreValve | 82.9/80.6 | 52.9/53.6 | NA | NA | 74.1/68 | 14.1/20.8 | NA | 51.8/51.1 | 46.7/39.7 | 0.67/0.74 |
| Harrison et al. | 782/2,750 | CoreValve | 83.6/83.3 | 62.5/51.7 | 36.2/38.3 | 91.8/93 | 79.8/78.5 | 35.4/34.9 | NA | 53.5/54.1 | 44.8/41.3 | NA |
| Goel et al. | 53/317 |
SAPIEN
,
SAPIEN XT |
79.9/81.1 | 77/52 | 47/40 | 92/90 | NA | 58/41 | 6/9 | 54.4/56.6 | 47.1/49.8 | 0.8/0.8 |
| Hahn et al. | 208/1,453 | SAPIEN 3 | 82.3/82.2 | 59.1/60.6 | 33.7/34.3 | 94.7./92.7 | 68.8/72.4 | NA | 18.3/17.5 | NA | NA | NA |
| Kawaguchi et al. | 121/103 | SAPIEN 3 | 84.4/84.9 | 30.6/32.1 | 24.8/14.6 | 74.4/75.7 | NA | 3.3/5.8 | 7.4/11.7 | 60.1/59.5 | 46.4/48.8 | 0.69/0.65 |
| Sammour et al. | 133/124 | SAPIEN 3 | 80 | 57 | 40.5 | 86.8 | NA | 21 | 10.1 | 68 | NA | NA |
| Nara et al. | 173/673 | SAPIEN 3 | 84/84 | 32.9/32.8 | 23.7/23.6 | NA | 24.3/35.8 | NA | 6.9/12 | 62/63 | 49/47 | 0.65/0.63 |
| Kim et al. | 521/896 |
ACURATE
neo,
ACURATE neo2 |
81.7/82 | 40.5/31.6 | NA | NA | 56.2/57.8 | NA | NA | 65/65 | 45/39 | 0.7/0.7 |
| Massoullié et al. | 104/428 |
CoreValve
,
Evolut R , and Pro |
83/82 | 53.9/50.5 | 28.9/30.6 | NA | NA | 7.7/9.3 | 9.6/7.9 | 60/59 | 55/43 | 0.64/0.74 |
| S. Sánchez et al. | 417/1418 |
CoreValve
,
Evolut R |
81/82 | 41.9/56.6 | 27.3/31.2 | 81.1/81.1 | NA | 17.0/13.9 | 16.4/14.4 | 51.6/49.8 | 53.8/51.4 | NA |
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