# Valve-in-valve transcatheter aortic valve replacement versus redo surgical aortic valve replacement in patients with degenerated aortic bioprostheses: Three-year death rates and haemodynamic performance

Grégoire Rosier, Guillaume Guimbretière, Patrice Guérin, Claire Bouquin, Stéphane Delépine, Frédéric Pinaud, Frédéric Rouleau, Thomas Sénage, Jean Christian Roussel, Jérémie Riou, et al.

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Grégoire Rosier, Guillaume Guimbretière, Patrice Guérin, Claire Bouquin, Stéphane Delépine, et al. Valve-in-valve transcatheter aortic valve replacement versus redo surgical aortic valve replacement in patients with degenerated aortic bioprostheses: Three-year death rates and haemodynamic performance. Archives of cardiovascular diseases, 2025, 118 (8-9), pp.464 - 476. 10.1016/j.acvd.2025.03.124. hal-05323498

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Clinical research

# Valve-in-valve transcatheter aortic valve replacement versus redo surgical aortic valve replacement in patients with degenerated aortic bioprosthesis: Three-year death rates and haemodynamic performance

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Grégoire Rosier<sup>a,b</sup>, Guillaume Guimbretière<sup>c</sup>, Patrice Guérin<sup>c</sup>, Claire Bouquin<sup>b</sup>, Stéphane Delépine<sup>a,b</sup>, Frédéric Pinaud<sup>a,d</sup>, Frédéric Rouleau<sup>a,b</sup>, Thomas Sénage<sup>e,f</sup>, Jean Christian Roussel<sup>c</sup>, Jérémie Riou<sup>g</sup>, Thierry Le Tourneau<sup>c</sup>, Loïc Bière<sup>a,b,*</sup>

## ARTICLE INFO

**Article history:**

Received 1st July 2024

Received in revised form 7 March 2025

Accepted 24 March 2025

Available online 24 May 2025

**Keywords:**

Degenerated bioprosthesis

Valve-in-valve transcatheter aortic valve replacement

Redo surgical aortic valve repair

Long-term haemodynamic performance

## ABSTRACT

**Background:** Management of degenerated aortic bioprosthesis through valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) or redo surgical aortic valve replacement (Re-SAVR) shows similar short-term safety and efficacy. However, long-term survival and haemodynamic performance data are limited.

**Aim:** To compare clinical characteristics, haemodynamics and outcomes at 3 years between ViV-TAVR and Re-SAVR techniques.

**Methods:** This retrospective two-centre study included 266 patients treated for isolated aortic bioprosthesis degeneration (130 Re-SAVR, 136ViV-TAVR) from 2009 to 2018, with up to 3 years of follow-up.

**Results:** The ViV-TAVR group was older (83 vs. 77 years; *P*=0.005) with higher surgical risk (Logistic EuroSCORE 22% vs. 13%; *P*=0.005). At 3 years, univariate analysis showed no significant difference in all-cause deaths (22.1% vs. 17.7%; *P*=0.37). ViV-TAVR was associated with fewer first-month complications, including major bleeding (11.0% vs. 52.3%; *P*=0.007) and acute renal failure grade 2/3 (5.1% vs. 14.6%; *P*=0.053). Inverse probability of treatment weighting analysis revealed no difference in all-cause deaths at 1 year (hazard ratio [HR] 0.78, 95% confidence interval [CI] 0.36–1.67; *P*=0.52) or between 1 and 3 years (HR 1.56, 95% CI 0.82–2.99; *P*=0.17). Composite events were similar at 1 year (HR 0.80, 95% CI 0.44–1.44; *P*=0.45) and between 1 and 3 years (HR 1.41, 95% CI 0.83–2.38; *P*=0.21). Mean gradients at 3 years were similar (16.1 ± 11.4 vs. 13.2 ± 5.3 mmHg; *P*=0.17). In patients with small bioprosthesis (true internal diameter ≤ 20 mm [*n* = 151]), death rates at 3 years were similar (21.1% vs. 20.0%; *P*=0.86), as was haemodynamic performance (mean gradient 19.2 ± 14.0 mmHg for ViV-TAVR vs. 13.7 ± 4.12 mmHg for Re-SAVR [*P* = 0.38]). Compared to balloon-expandable, self-expandable valves showed better 1-year mean gradients (16.4 ± 10.5 vs. 13.7 ± 4.12 mmHg; *P*=0.012).

**Conclusions:** ViV-TAVR and Re-SAVR had similar mortality and haemodynamic outcomes at 3 years, including in patients with small bioprosthesis where self-expandable valves yielded the best results.

© 2025 The Authors. Published by Elsevier Masson SAS. This is an open access article under the CC BY license ([http://creativecommons.org/licenses/by/4.0/](http://creativecommons.org/licenses/by/4.0/)).

<footnote><sup>a</sup> Inserm, CNRS, SFR ICAT, Équipe CarMe, MitoVasc, Angers University, 49000 Angers, France</footnote>

<footnote><sup>b</sup> Department of Cardiology, Angers University Hospital, 49000 Angers, France</footnote>

<footnote><sup>c</sup> Inserm, CNRS, Institut du Thorax, Nantes University, CHU de Nantes, 44000 Nantes, France</footnote>

<footnote><sup>d</sup> Department of Cardiac Surgery, Angers University Hospital, 49000 Angers, France</footnote>

<footnote><sup>e</sup> Oniris, 44307 Nantes, France</footnote>

<footnote><sup>f</sup> Inserm, UMR 1229 (Regenerative Medicine and Skeleton [RMeS]), Nantes University, CHU of Nantes, 44000 Nantes, France</footnote>

<footnote><sup>g</sup> Inserm U1066, UMR CNRS 6021, MINT, Angers University, 49100 Angers, France</footnote>

<footnote>* Corresponding author. Laboratoire Cardioprotection, Remodelage et Thrombose, Faculté de Médecine, Institut MitoVasc, rue Haute de Reculée, 49045 Angers cedex 1, France.</footnote>

<footnote>E-mail address: lobiere@chu-angers.fr (L. Bière).</footnote>
# 1. Abbreviations

BEV Balloon-expandable valve

CI Confidence interval

HR Hazard ratio

ID Internal diameter

IPTW Inverse probability of treatment weighting

IQR Interquartile range

Re-SAVR Redo surgical aortic valve replacement

SEV Self-expandable valve

ViV-BEV ViV-TAVR with a BEV

ViV-SEV ViV-TAVR with a SEV

ViV-TAVR Valve-in-valve transcatheter aortic valve implantation

# 2. Background

Up to 275,000 valve prostheses are implanted each year worldwide, mainly in the aortic position [1]. Aortic valve bioprostheses are now more commonly used (accounting for up to 80% of aortic valve prostheses) than mechanical prostheses; this is because American and European recommendations set an age limit of 50 and 60 years, respectively [2,3]. The use of bioprostheses is preferred over mechanical prostheses to avoid thromboembolic complications and the long-term use of anticoagulants, although this approach carries the limitation of a shorter lifespan. However, the tissues of the xenograft will degenerate into calcifications and thicken, which may result in stenosis or leaks [4]. The estimated rate of bioprosthetic degeneration is approximately 15% after 10 years, and between 33% and 63% after 20 years [5]. Additionally, certain risk factors have been identified, notably including the recipient's age, the model and the size of the device. The estimated lifetime risk of reoperation is 25% if the index surgery is performed at the age of 60 years, and up to 45% if it is performed at the age of 50 years. This implies an increasing number of patients who will require treatment in the near future [6]. In the absence of an appropriate treatment option, the patient's prognosis is significantly compromised, particularly when symptoms manifest.

Surgical management has long been the standard of care for degenerative bioprostheses. However, redo surgical aortic valve replacement (Re-SAVR) is associated with an elevated risk of death and complications, particularly in older patients [7].

Transcatheter aortic valve replacement has emerged as a safe alternative in patients with native aortic valve degeneration [8,9]. The concept of valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) appeared more than a decade ago, and involves the implantation of a new bioprosthesis in a degenerative bioprosthesis by the transcatheter route. A number of retrospective studies [10–13] and meta-analyses [14–16] have demonstrated the efficacy and safety of this procedure at 30 days and 1 year. Nevertheless, there is a paucity of studies directly comparing the two techniques in the long term, particularly with regard to haemodynamic performance. Nevertheless, concerns persist regarding elevated mean transvalvular gradients and prosthesis-patient mismatch rates with ViV-TAVR, particularly in the context of small degenerated aortic bioprostheses.

The main objective of this study was to compare the clinical characteristics, haemodynamics and outcomes at 3 years between the two techniques.

# 3. Methods

This study was a retrospective analysis of all consecutive patients who underwent either Re-SAVR or ViV-TAVR for degenerative aortic bioprosthesis between January 2009 and April 2018 in two French centres: Angers and Nantes University Hospitals. The follow-up of patient data was completed as of January 2022. The data pertaining to the patients' characteristics, the procedures themselves and the subsequent postprocedural period were collated from prospective computerized medical registries. To ascertain death rates, we used the French National Institute for Statistical and Economic Studies (INSEE) death register for follow-up.

The types of failing surgical bioprostheses were defined in accordance with the consensus published in 2017 [4]. The label size was defined as the diameter specified by the manufacturer for the aortic root. The true internal diameter (ID) of each bioprosthetic valve was determined in accordance with the methodology previously described by Bapat et al., and with the "ViV Aortic" application [17,18]. The term "small bioprosthetic valve" was used to describe those with a true ID of ≤ 20 mm, whereas a "large bioprosthetic valve" was defined as having a true ID of > 20 mm. Prosthesis-patient mismatch was defined as an indexed effective orifice area of < 0.85 cm²/m² (0.70 cm²/m² for body mass index > 30) with normal valve function, with moderate prosthesis-patient mismatch defined as an indexed effective orifice area between 0.6 and 0.85 cm²/m² (between 0.70 and 0.56 cm²/m² for a body mass index > 30). A prosthesis-patient mismatch was defined as an indexed effective orifice area of < 0.65 cm²/m² (0.70 cm²/m² for a body mass index > 30), with moderate prosthesis-patient mismatch defined as an effective orifice area between 0.65 and 0.55 cm²/m² (0.55 cm²/m² for a body mass index > 30).

The self-expandable valves (SEVs) included the CoreValve, CoreValve Evolut and Evolut R models (Medtronic, Minneapolis, MN, USA). The balloon-expandable valves (BEVs) were the SAPIEN XT and SAPIEN 3 models (Edwards Lifesciences, LLC, Irvine, CA, USA).

Assignment of patients to the Re-SAVR and ViV-TAVR groups was not based on a randomized process, but rather determined by a multidisciplinary heart team. The initial ViV-TAVR procedure was performed in 2011, and has since become a more prevalent treatment option (Fig. 1).

Patients presenting with infectious endocarditis (n = 28) and those undergoing simultaneous bypass surgery (n = 13), aortic replacement (n = 12), mitral valve replacement or ring or mitral valvuloplasty (n = 19) or myomectomy (n = 1) were excluded from the study. The analysis of haemodynamic performance excluded mechanical valves. Outcomes and complications were assessed in accordance with the Valve Academic Research Consortium 3 (VARC-3) criteria [19], and were adjudicated by two blinded physicians (G.R. and C.B.).

## 3.1. Statistical analysis

The statistical analysis was conducted in accordance with the relevant standards and guidelines. Variables are described as mean ± standard deviation if they follow a normal distribution, and as median (interquartile range) otherwise. Normality was validated graphically using Wally plots, which are based on Q-Q plots, to assess the distribution of the data. Qualitative variables are presented as numbers (proportions). Groups were compared according to standard tests: Student's t test for normally distributed
<figure><img src="image_4.png" /><figcaption>**Fig. 1.** Use of redo surgical aortic valve replacement (Re-SAVR) or valve-in-valve transcatheter aortic valve implantation (ViV-TAVR) over time.</figcaption></figure>

quantitative variables, the Mann-Whitney U test for non-normal quantitative variables and the $\chi^2$ test or Fisher's exact test for qualitative variables. These tests comparing the two groups were performed descriptively. The multiplicity induced by multiple comparisons was corrected using the Benjamini-Hochberg correction, controlling the false discovery rate at a 5% threshold.

Propensity score weighting using inverse probability weighting, based on the average treatment effect in the overlap population, was performed to balance covariates between the two groups of interest (Table A.1 and Fig. A.1) [20]. The average treatment effect in the overlap population was selected to focus on patients for whom the probability of receiving either of the two surgical approaches was similar, thereby minimizing extreme weights and allowing for a more robust comparison of the two treatments. This approach is particularly relevant, as the choice of surgical method is strongly influenced by the patient's clinical condition, with one being minimally invasive and the other more invasive. In this context, the average treatment effect in the overlap population allows for an unbiased evaluation of time to death or a major adverse cardiovascular event in a population with comparable baseline probabilities.

The variables included in the propensity score calculation were selected based on clinical relevance, and represent a comprehensive set of covariates considered important in balancing the two cohorts. No prior filtering was performed to ensure that no important clinical factors were excluded. The balance plot demonstrates that the covariates were well balanced between the groups following weighting.

Once the patient profiles were balanced between the two cohorts, a weighted Cox proportional hazards model was used to compare time to death or a major adverse cardiovascular event between the groups. The comparison of the two treatment strategies was summarized using the hazard ratio (HR), its 95% confidence interval (CI) and the associated P-value.

To test the proportional hazards assumption, we used log-log plots. These plots indicated a violation of the proportional hazards assumption, as the curves crossed at certain time points. Consequently, we applied a landmark approach, splitting the time window at 1 year as the cutoff point. This allowed us to address the non-proportionality of hazards, and to perform separate Cox

regressions for each time period, ensuring a more accurate comparison between the groups.

Finally, we used a linear mixed-effects model with the mean aortic gradient as the dependent variable to assess the trajectories over time. The model included valve type and time as fixed effects, with time modelled as both linear and quadratic to account for potential non-linear trends. A random effect was included to account for subject-specific variability. This model efficiently compares the trajectories of the aortic gradient across valve types, while minimizing multiple testing and controlling for within-subject correlation.

## 4. Results

The study population consisted of 266 patients, of whom 130 underwent re-SAVR and 136 underwent ViV-TAVR. The baseline data are presented in Table 1. The mean age of the cohort was 80 (interquartile range [IQR] 74; 84) years, with 160 patients (60.2%) being male. The ViV-TAVR cohort exhibited a higher mean age compared with the Re-SAVR group: 83 (IQR 77; 86) vs. 77 (IQR 71; 81) years ($P=0.005$). Furthermore, patients who underwent ViV-TAVR exhibited a higher prevalence of coronary artery disease (51.4% vs. 26.1%; $P=0.005$) and a trend towards more atrial arrhythmias (43.3% vs. 30.0%; $P=0.08$), along with a higher surgical risk (logistic EuroSCORE 22% [IQR 15%; 31%] vs. 13% [IQR 8%; 18%]; $P=0.005$). Furthermore, they exhibited higher rates of impaired renal function, as evidenced by lower estimated glomerular filtration rates (49 [IQR 36; 63] vs. 61 [IQR 50; 85] mL/min; $P=0.005$) and elevated serum creatinine concentrations (97 [IQR 80; 127] vs. 81 [IQR 69; 99] $\mu$mol/L; $P=0.005$). Overall, dyspnoea with a New York Heart Association functional classification of $\ge$ 3 was the predominant symptom, and a New York Heart Association score of $\ge$ 3 did not differ between the groups (69.8% vs. 57.6%; $P=0.11$). The median interval between the initial aortic valve replacement and the subsequent replacement was longer in the ViV-TAVR cohort (9.11 [IQR 7.00; 11.6] vs. 8.92 [IQR 5.34; 10.2]; $P=0.003$). The predominant mode of degeneration was stenosis (51.1%) with no significant difference between the two groups. The Re-SAVR group exhibited a higher prevalence of small prostheses (69.6% vs. 53.8%; $P=0.011$). A comprehensive list of degenerated valve types and models can be
<table><caption>**Table 1**
Baseline characteristics of the study population.</caption><thead><tr><th></th><th>All (n = 266)</th><th>Re-SAVR (n = 130)</th><th>ViV-TAVR (n = 136)</th><th>P</th><th>Adjusted P (Bonferroni)</th></tr></thead><tbody><tr><td>Angers centre</td><td>101</td><td>43 (43.0)</td><td>58 (57.4)</td><td>–</td><td></td></tr><tr><td>Nantes centre</td><td>165</td><td>87 (52.7)</td><td>78 (47.3)</td><td>–</td><td></td></tr><tr><td>Age (years)</td><td>80 (74; 84)</td><td>77 (71; 81)</td><td>83 (77; 86)</td><td>&lt;0.001</td><td>0.005</td></tr><tr><td>Male sex</td><td>160 (60.2)</td><td>71 (54.6)</td><td>89 (65.4)</td><td>0.07</td><td>0.17</td></tr><tr><td>BMI (kg/m²)</td><td>26.2 (23.4; 29.4)</td><td>26.6 (23.6; 29.8)</td><td>25.7 (23.1; 29.1)</td><td>0.022</td><td>0.08</td></tr><tr><td>Logistic EuroSCORE (%)</td><td>16 (11; 26)</td><td>13 (8; 18)</td><td>22 (15; 31)</td><td>&lt;0.001</td><td>0.005</td></tr><tr><td>Logistic EuroSCORE ≥ 20%</td><td>97 (36.5)</td><td>23 (17.7)</td><td>74 (54.4)</td><td>&lt;0.001</td><td>0.005</td></tr><tr><td>Co-morbidities</td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Hypertension</td><td>204 (76.6)</td><td>95 (73.1)</td><td>109 (80.1)</td><td>0.17</td><td>0.32</td></tr><tr><td>Dyslipidaemia</td><td>162 (60.9)</td><td>78 (60.0)</td><td>84 (61.7)</td><td>0.77</td><td>0.89</td></tr><tr><td>Diabetes</td><td>63 (23.6)</td><td>34 (26.1)</td><td>29 (21.3)</td><td>0.35</td><td>0.55</td></tr><tr><td>Smoker</td><td>70 (26.3)</td><td>35 (26.9)</td><td>35 (25.7)</td><td>0.83</td><td>0.91</td></tr><tr><td>CAD</td><td>104 (39.1)</td><td>34 (26.1)</td><td>70 (51.4)</td><td>&lt;0.001</td><td>0.005</td></tr><tr><td>Stroke/TIA</td><td>21 (7.8)</td><td>11 (8.4)</td><td>10 (7.3)</td><td>0.74</td><td>0.88</td></tr><tr><td>Peripheral vascular disease</td><td>33 (12.4)</td><td>8 (6.1)</td><td>25 (18.3)</td><td>0.002</td><td>0.0086</td></tr><tr><td>Atrial fibrillation/ flutter</td><td>98 (36.8)</td><td>39 (30.0)</td><td>59 (43.3)</td><td>0.023</td><td>0.08</td></tr><tr><td>COPD</td><td>24 (9.0)</td><td>10 (7.6)</td><td>14 (10.2)</td><td>0.46</td><td>0.60</td></tr><tr><td>Previous pacemaker</td><td>41 (15.4)</td><td>16 (12.3)</td><td>25 (18.3)</td><td>0.17</td><td>0.32</td></tr><tr><td>Laboratory tests</td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Haemoglobin (g/dL)</td><td>12.3 (11.3; 13.6)</td><td>12.75 (11.6; 13.7)</td><td>12 (11; 13.5)</td><td>0.07</td><td>0.17</td></tr><tr><td>Creatinine (µmol/L)</td><td>90 (73; 112)</td><td>81 (69; 99)</td><td>97 (80; 127)</td><td>&lt;0.001</td><td>0.005</td></tr><tr><td>eGFR (mL/min)</td><td>55 (41; 73)</td><td>61 (50; 85)</td><td>49 (36; 63)</td><td>&lt;0.001</td><td>0.005</td></tr><tr><td>Treatment</td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>Antiplatelet therapy</td><td>113 (42.4)</td><td>56 (43.1)</td><td>57 (41.9)</td><td>0.85</td><td>0.91</td></tr><tr><td>VKA/DOAC</td><td>70 (26.5)</td><td>28 (21.8)</td><td>42 (30.8)</td><td>0.10</td><td>0.21</td></tr><tr><td>Beta-blocker</td><td>120 (45.1)</td><td>55 (42.3)</td><td>65 (47.7)</td><td>0.37</td><td>0.55</td></tr><tr><td>ACE inhibitor/ARB</td><td>145 (54.5)</td><td>71 (54.6)</td><td>74 (54.4)</td><td>0.97</td><td>0.97</td></tr><tr><td>Diuretic</td><td>173 (65.0)</td><td>77 (59.2)</td><td>96 (70.5)</td><td>0.05</td><td>0.14</td></tr><tr><td>Statin</td><td>162 (60.9)</td><td>76 (58.4)</td><td>86 (63.2)</td><td>0.43</td><td>0.58</td></tr><tr><td>Symptoms</td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>NYHA ≥ 3</td><td>170 (63.9)</td><td>75 (57.6)</td><td>95 (69.8)</td><td>0.038</td><td>0.11</td></tr><tr><td>Syncope</td><td>16 (6.0)</td><td>8 (6.1)</td><td>8 (5.8)</td><td>0.93</td><td>0.96</td></tr><tr><td>Angina</td><td>40 (15.0)</td><td>23 (17.6)</td><td>17 (12.5)</td><td>0.24</td><td>0.40</td></tr><tr><td>Two previous AHFs in the year</td><td>44 (16.5)</td><td>19 (14.6)</td><td>25 (18.3)</td><td>0.41</td><td>0.58</td></tr><tr><td>Emergency procedure</td><td>24 (9.0)</td><td>9 (6.9)</td><td>15 (11.0)</td><td>0.24</td><td>0.40</td></tr><tr><td>Urgent procedure</td><td>51 (19.1)</td><td>26 (20.0)</td><td>25 (18.3)</td><td>0.74</td><td>0.88</td></tr></tbody></table>

Qualitative data are expressed as number (%); quantitative data are expressed as median (interquartile range). ACE: angiotensin-converting enzyme; AHF: acute heart failure; ARB: angiotensin II receptor blocker; BMI: body mass index; CAD: coronary artery disease; COPD: chronic obstructive pulmonary disease; DOAC: direct oral anticoagulant; eGFR: estimated glomerular filtration rate; NYHA: New York Heart Association; Re-SAVR: redo surgical aortic valve replacement; TIA: transient ischaemic attack; ViV-TAVR: valve-in-valve transcatheter aortic valve replacement; VKA: vitamin K antagonist.

found in Table A.2. The preoperative left ventricular ejection fraction did not differ between the groups (56.8 ± 12% vs. 60.1 ± 9.1%; P = 0.06). The aortic valve area (overall 0.8 [IQR 0.65; 1.10] cm²) was not statistically different between the two groups (0.85 [IQR 0.67; 1.24] cm² for ViV-TAVR vs. 0.8 [IQR 0.64; 1.00] cm² for Re-SAVR; P = 0.36) nor was the mean transprosthetic gradient (overall 42.2 ± 17.9 mmHg). The echocardiographic data are presented in Table 2.

## 4.1. Procedural characteristics and early outcomes

In the Re-SAVR group, the most frequently implanted valve was the Carpentier-Edwards Perimount (Edwards Lifesciences LLC, Irvine, USA), which was used in 56% of cases. A total of 10 (7.7%) aortic mechanical valve implantations were performed. The prostheses used in the ViV-TAVR group were predominantly SEVs (74%), and were implanted via the transfemoral route in 82.4% of patients (see Table A.3 for further details). In the ViV-TAVR cohort, 14 post-dilatations were performed, 12 of which were conducted during the index procedure. Notably, there were no instances of balloon valve fracture. Only one patient in the Re-SAVR group underwent an aortic annulus enlargement procedure. There was no statistically significant differences between the intraprocedural death rates (1.5% vs. 0.74%; P = 0.82) or the device success rates (80% vs. 78%; P = 0.82) observed in the Re-SAVR and ViV-TAVR groups. Patients in the Re-SAVR group exhibited a higher incidence of major haemorrhages (52.3% vs. 11%; P = 0.007), transfusions (56.1% vs. 8%; P = 0.007) and a trend towards a higher incidence of stage 2 or 3

acute kidney injury (14.6% vs. 5.1%; P = 0.053) compared with those in the ViV-TAVR group. A single instance of coronary occlusion was observed in each group. The median duration of hospitalization was shorter in the ViV-TAVR group than in the Re-SAVR group: 7 (IQR 5; 9) vs. 11 (IQR 9; 15) days (P = 0.007). The details are presented in Table 3.

## 4.2. Outcomes

A 3-year follow-up of all-cause deaths was completed for 266 patients (100%). At 30 days, seven patients who underwent re-SAVR (5.4%) had died, compared with three patients who underwent ViV-TAVR (2.2%). The difference between the two groups was not statistically significant (P = 0.57). Further details concerning these deaths are provided in Table 4. There was no difference at 30 days regarding the number of pacemaker implantations (13 [10.0%] vs. 10 [7.4%]; P = 0.82) and strokes (3 [3.1%] vs. 2 [2.0%]; P = 0.82).

One-year all-cause deaths (11 [8.5%] vs. 13 [9.6%]; P = 0.88 did not differ between the two groups [see Table 3]). At the 3-year mark, there was no discernible difference in all-cause deaths (23 [17.7%] vs. 30 [22.1%]; P = 0.82) or cardiovascular deaths (15 [12%] vs. 19 [14%]; P = 0.82) between the Re-SAVR and ViV-TAVR groups (see Fig. 2).

After inverse probability of treatment weighting (IPTW) analysis with the landmark method, no difference was observed in all-cause deaths at 1 year (HR 0.78, 95% CI 0.36–1.67; P = 0.52) or between 1 and 3 years (HR 1.56, 95% CI 0.82–2.99; P = 0.17) (Fig. 3).
<table><caption>**Table 2**
Echocardiographic data at baseline and follow-up for all patients.</caption><thead><tr><th></th><th>All (n = 254)</th><th>Re-SAVR (n = 121)</th><th>ViV-TAVR (n = 133)</th><th>P</th><th>Adjusted P (Bonferroni)</th></tr></thead><tbody><tr><td colspan="6"><strong>Preoperative data</strong></td></tr><tr><td>LVEF (%)</td><td>58.4 ± 10.8</td><td>60.1 ± 9.1</td><td>56.8 ± 12.0</td><td>0.011</td><td>0.06</td></tr><tr><td>LVEDD (mm)</td><td>52 (47; 59)</td><td>50 (46; 57)</td><td>54 (48; 60)</td><td>0.016</td><td>0.07</td></tr><tr><td>LVESD (mm)</td><td>34 (29; 40)</td><td>32 (27; 36)</td><td>36 (31; 44)</td><td>0.003</td><td>0.032</td></tr><tr><td>Mean aortic gradient (mmHg)</td><td>42.2 ± 17.9</td><td>45.4 ± 17.3</td><td>39.1 ± 18.0</td><td>0.007</td><td>0.06</td></tr><tr><td>Aortic valve area (cm²)</td><td>0.80 (0.65; 1.10)</td><td>0.80 (0.64; 1.00)</td><td>0.85 (0.67; 1.24)</td><td>0.22</td><td>0.36</td></tr><tr><td>Aortic valve area (cm²/m²)</td><td>0.45 (0.36; 0.64)</td><td>0.44 (0.35; 0.58)</td><td>0.47 (0.38; 0.69)</td><td>0.12</td><td>0.24</td></tr><tr><td>AR grade ≥ 3</td><td>127 (47.8)</td><td>55 (42.3)</td><td>72 (53)</td><td>0.58</td><td>0.69</td></tr><tr><td>Mitral regurgitation grade ≥ 3</td><td>16 (6.3)</td><td>6 (4.6)</td><td>10 (7.3)</td><td>0.35</td><td>0.56</td></tr><tr><td>Tricuspid regurgitation ≥ 3</td><td>15 (5.6)</td><td>4 (3.1)</td><td>11 (8.1)</td><td>0.08</td><td>0.17</td></tr><tr><td>sPAP (mmHg)</td><td>46.3 ± 14.7</td><td>44.8 ± 15.7</td><td>47.5 ± 13.7</td><td>0.98</td><td>1</td></tr><tr><td colspan="6"><strong>Postoperative data</strong></td></tr><tr><td>LVEF (%)</td><td>55.7 ± 10.1</td><td>57.6 ± 8</td><td>53.9 ± 11.4</td><td>0.002</td><td>0.032</td></tr><tr><td>Mean aortic gradient (mmHg)</td><td>14.9 ± 7.1</td><td>15.0 ± 5.9</td><td>14.8 ± 8</td><td>0.89</td><td>0.99</td></tr><tr><td>Mean aortic gradient ≥ 20 mmHg</td><td>36 (13.5)</td><td>16 (12.3)</td><td>20 (14.7)</td><td>0.57</td><td>0.69</td></tr><tr><td>Aortic valve area (cm²)</td><td>1.46 (1.20; 1.80)</td><td>1.50 (1.21; 1.63)</td><td>1.43 (1.20; 1.80)</td><td>0.90</td><td>0.99</td></tr><tr><td>Aortic valve area (cm²/m²)</td><td>0.87 (0.70; 1.05)</td><td>0.88 (0.73; 1.04)</td><td>0.85 (0.68; 1.07)</td><td>0.50</td><td>0.69</td></tr><tr><td>No PPM</td><td>90 (58.1)</td><td>36 (67.9)</td><td>54 (52.9)</td><td>0.07</td><td>0.17</td></tr><tr><td>Moderate PPM</td><td>45 (29.2)</td><td>13 (25.0)</td><td>32 (31.4)</td><td>0.37</td><td>0.56</td></tr><tr><td>Severe PPM</td><td>20 (12.9)</td><td>4 (7.5)</td><td>16 (15.7)</td><td>0.15</td><td>0.28</td></tr><tr><td>AR grade 0–1</td><td>254 (96.5)</td><td>126 (99.2)</td><td>128 (94.1)</td><td>0.023</td><td>0.08</td></tr><tr><td>AR grade 2</td><td>9 (3.4)</td><td>1 (0.7)</td><td>8 (5.8)</td><td>0.023</td><td>0.08</td></tr><tr><td colspan="6"><strong>One-year data<sup>a</sup></strong></td></tr><tr><td>LVEF (%)</td><td>59.4 ± 9.62</td><td>63.4 ± 7.98</td><td>57.3 ± 9.79</td><td>&lt;0.001</td><td>0.032</td></tr><tr><td>Mean aortic gradient (mmHg)</td><td>15.4 ± 8.91</td><td>13.9 ± 5.08</td><td>16.1 ± 10.3</td><td>0.07</td><td>0.17</td></tr><tr><td>Mean aortic gradient &gt; 20 mmHg</td><td>29 (18)</td><td>6 (11)</td><td>23 (22)</td><td>0.08</td><td>0.17</td></tr><tr><td>AR grade 0–1</td><td>157 (98)</td><td>55 (98)</td><td>102 (98)</td><td>1</td><td>1</td></tr><tr><td>AR grade 2</td><td>2 (1.2)</td><td>0 (0.0)</td><td>2 (1.9)</td><td>0.54</td><td>0.69</td></tr><tr><td>AR grade &gt; 2</td><td>1 (0.62)</td><td>1 (1.8)</td><td>0 (0.0)</td><td>0.35</td><td>0.56</td></tr><tr><td colspan="6"><strong>Three-year data<sup>b</sup></strong></td></tr><tr><td>LVEF (%)</td><td>59.7 ± 10.9</td><td>61.9 ± 9.76</td><td>57.8 ± 11.5</td><td>0.034</td><td>0.11</td></tr><tr><td>Mean aortic gradient (mmHg)</td><td>14.7 ± 9.15</td><td>13.2 ± 5.30</td><td>16.1 ± 11.4</td><td>0.07</td><td>0.17</td></tr><tr><td>Mean aortic gradient &gt; 20 mmHg</td><td>25 (20.0)</td><td>6 (10.2)</td><td>19 (28.8)</td><td>0.009</td><td>0.06</td></tr><tr><td>AR grade 0–1</td><td>123 (98.4)</td><td>59 (100.0)</td><td>64 (97.0)</td><td>0.50</td><td>0.67</td></tr><tr><td>AR grade 2</td><td>2 (1.6)</td><td>0 (0.0)</td><td>2 (3.0)</td><td>0.50</td><td>0.67</td></tr><tr><td>AR grade &gt; 2</td><td>0 (0.0)</td><td>0 (0.0)</td><td>0 (0.0)</td><td>1</td><td>1</td></tr></tbody></table>

Qualitative data are expressed as number (%); quantitative data are expressed as mean ± standard deviation, median or (interquartile range). AR: aortic regurgitation; LVEDD: left ventricular end-diastolic diameter; LVEF: left ventricular ejection fraction; LVESD: left ventricular end-systolic diameter; PPM: prosthesis-patient mismatch; Re-SAVR: redo surgical aortic valve replacement; sPAP: systolic pulmonary artery pressure; ViV-TAVR: valve-in-valve transcatheter aortic valve replacement.

<figure><img src="image_5.png" /><figcaption>**Fig. 2.** Kaplan-Meier curves in univariate analysis. A. Kaplan-Meier survival curve (all-cause death) at 3 years. B. Kaplan-Meier freedom from composite event curve (all-cause death, myocardial infarction, stroke or rehospitalization for heart failure). Re-SAVR: redo surgical aortic valve replacement; ViV-TAVR: valve-in-valve transcatheter aortic valve implantation.</figcaption></figure>

<footnote><sup>a</sup> All, n = 162; Re-SAVR, n = 57; ViV-TAVR, n = 105.</footnote>

<footnote><sup>b</sup> All, n = 125; Re-SAVR, n = 59; ViV-TAVR, n = 66.</footnote>
<table><caption>**Table 3**
Clinical outcomes.</caption><thead><tr><th></th><th>All (n=266)</th><th>Re-SAVR (n=130)</th><th>ViV-TAVR (n=136)</th><th>P</th><th>Adjusted P (Bonferroni)</th></tr></thead><tbody><tr><td colspan="6"><strong>Periprocedural/hospital outcomes</strong></td></tr><tr><td>Intraprocedural death</td><td>3 (1.1)</td><td>2 (1.5)</td><td>1 (0.74)</td><td>0.62</td><td>0.82</td></tr><tr><td>Device success</td><td>210 (78.9)</td><td>104 (80.0)</td><td>106 (77.9)</td><td>0.68</td><td>0.82</td></tr><tr><td>Intraprocedural conversion</td><td>-</td><td>-</td><td>2 (1.5)</td><td>-</td><td>-</td></tr><tr><td>Periprocedural surgical reintervention</td><td>-</td><td>7 (5.4)</td><td>-</td><td>-</td><td>-</td></tr><tr><td>Major haemorrhage</td><td>83 (31.2)</td><td>68 (52.3)</td><td>15 (11.0)</td><td>&lt;0.001</td><td>0.007</td></tr><tr><td>Loss of &gt; 3 points of haemoglobin</td><td>35 (13.1)</td><td>27 (20.7)</td><td>8 (5.8)</td><td>&lt;0.001</td><td>0.007</td></tr><tr><td>VARC-3 major vascular complication</td><td>7 (2.6)</td><td>3 (2.3)</td><td>4 (2.9)</td><td>1</td><td>1</td></tr><tr><td>VARC-3 minor vascular complication</td><td>6 (2.3)</td><td>0 (0.0)</td><td>6 (4.4)</td><td>0.03</td><td>0.15</td></tr><tr><td>Peak of creatinine (µmol/L)</td><td>96 (73; 132)</td><td>95 (70; 132)</td><td>96 (80; 130)</td><td>0.90</td><td>1</td></tr><tr><td>Acute kidney injury grade 1</td><td>29 (10.9)</td><td>15 (11.5)</td><td>14 (10.2)</td><td>0.74</td><td>0.87</td></tr><tr><td>Acute kidney injury grade 2 or 3</td><td>26 (9.7)</td><td>19 (14.6)</td><td>7 (5.1)</td><td>0.009</td><td>0.053</td></tr><tr><td>Elective dialysis</td><td>12 (4.5)</td><td>9 (6.9)</td><td>3 (2.2)</td><td>0.06</td><td>0.28</td></tr><tr><td>Coronary occlusion</td><td>2 (0.7)</td><td>1 (0.7)</td><td>1 (0.7)</td><td>0.97</td><td>1</td></tr><tr><td>Tamponade</td><td>10 (3.7)</td><td>6 (4.6)</td><td>4 (2.9)</td><td>0.47</td><td>0.82</td></tr><tr><td>Hospital length of stay (days)</td><td>9.0 (6.0; 12.0)</td><td>11.0 (9.0; 15.0)</td><td>7.0 (5.0; 9.0)</td><td>&lt;0.001</td><td>0.007</td></tr><tr><td>Return to home</td><td>111 (54.6)</td><td>28 (31.4)</td><td>83 (72.8)</td><td>&lt;0.001</td><td>0.007</td></tr><tr><td colspan="6"><strong>Thirty-day outcomes</strong></td></tr><tr><td>Thirty-day all-cause death</td><td>10 (3.8)</td><td>7 (5.4)</td><td>3 (2.2)</td><td>0.21</td><td>0.57</td></tr><tr><td>Pacemaker implantation</td><td>23 (8.6)</td><td>13 (10.0)</td><td>10 (7.4)</td><td>0.44</td><td>0.82</td></tr><tr><td>Stroke/TIA</td><td>5 (2.6)</td><td>3 (3.1)</td><td>2 (2.0)</td><td>0.68</td><td>0.82</td></tr><tr><td colspan="6"><strong>One-year outcomes</strong></td></tr><tr><td>One-year all-cause death</td><td>24 (9.0)</td><td>11 (8.5)</td><td>13 (9.6)</td><td>0.76</td><td>0.88</td></tr><tr><td>Cardiovascular death</td><td>20 (7.5)</td><td>11 (8.5)</td><td>9 (6.6)</td><td>0.57</td><td>0.82</td></tr><tr><td>Rehospitalization for heart failure</td><td>9 (4.6)</td><td>3 (3.1)</td><td>6 (6.0)</td><td>0.50</td><td>0.82</td></tr><tr><td>Stroke/TIA</td><td>9 (4.6)</td><td>3 (3.1)</td><td>6 (6.0)</td><td>0.50</td><td>0.82</td></tr><tr><td>Myocardial infarction</td><td>4 (2.0)</td><td>2 (2.1)</td><td>2 (2.0)</td><td>1</td><td>1</td></tr><tr><td>Endocarditis</td><td>4 (2.0)</td><td>1 (1.0)</td><td>3 (3.0)</td><td>0.62</td><td>0.82</td></tr><tr><td>Reintervention</td><td>1 (0.51)</td><td>1 (1.0)</td><td>0 (0.0)</td><td>0.49</td><td>0.82</td></tr><tr><td>NYHA ≥ 3</td><td>22 (8.8)</td><td>11 (8.9)</td><td>11 (8.7)</td><td>0.95</td><td>1</td></tr><tr><td colspan="6"><strong>Three-year outcomes</strong></td></tr><tr><td>Three-year all-cause death</td><td>53 (19.9)</td><td>23 (17.7)</td><td>30 (22.1)</td><td>0.37</td><td>0.82</td></tr><tr><td>Cardiovascular death</td><td>34 (12.8)</td><td>15 (11.5)</td><td>19 (14.0)</td><td>0.55</td><td>0.82</td></tr><tr><td>Rehospitalization for heart failure</td><td>20 (10.6)</td><td>8 (8.5)</td><td>12 (12.8)</td><td>0.34</td><td>0.82</td></tr><tr><td>Stroke/TIA</td><td>15 (8.2)</td><td>5 (5.4)</td><td>10 (11.0)</td><td>0.16</td><td>0.51</td></tr><tr><td>Myocardial infarction</td><td>6 (3.2)</td><td>4 (4.2)</td><td>2 (2.2)</td><td>0.68</td><td>0.82</td></tr><tr><td>Endocarditis</td><td>6 (3.2)</td><td>1 (1.1)</td><td>5 (5.4)</td><td>0.12</td><td>0.42</td></tr><tr><td>Valve thrombosis</td><td>3 (1.6)</td><td>0 (0.0)</td><td>3 (3.2)</td><td>0.12</td><td>0.42</td></tr><tr><td>Bioprosthetic valve failure</td><td>3 (1.6)</td><td>1 (1.1)</td><td>2 (2.2)</td><td>0.62</td><td>0.82</td></tr><tr><td>Reintervention</td><td>2 (1.1)</td><td>2 (2.1)</td><td>0 (0.0)</td><td>0.50</td><td>0.82</td></tr><tr><td>NYHA ≥ 3</td><td>10 (6.7)</td><td>8 (9.8)</td><td>2 (3.0)</td><td>0.19</td><td>0.55</td></tr></tbody></table>

Qualitative data are expressed as number (%); quantitative data are expressed as median (interquartile range). NYHA: New York Heart Association; Re-SAVR: redo surgical aortic valve replacement; TIA: transient ischaemic attack; VARC-3: Valve Academic Research Consortium 3; ViV-TAVR: valve-in-valve transcatheter aortic valve replacement.

<table><caption>**Table 4**
Cause of early deaths (< 30 days).</caption><thead><tr><th>Patient</th><th>Intervention</th><th>Sex</th><th>Age (years)</th><th>Logistic EuroSCORE (%)</th><th>LVEF (%)</th><th>Failed prosthesis</th><th>New prosthesis</th><th>Survival (days)</th><th>Cause of death</th></tr></thead><tbody><tr><td>#135</td><td>Re-SAVR</td><td>Female</td><td>79.7</td><td>18.3</td><td>60</td><td>Sorin Mitroflow (19 mm)</td><td>Medtronic Freestyle (21 mm)</td><td>0</td><td>RV tear</td></tr><tr><td>#227</td><td>Re-SAVR</td><td>Female</td><td>72</td><td>10.9</td><td>50</td><td>Sorin Mitroflow (21 mm)</td><td>SJM Trifecta (21 mm)</td><td>0</td><td>Unexplained death during surgery</td></tr><tr><td>#154</td><td>Re-SAVR</td><td>Male</td><td>73.5</td><td>5.8</td><td>45</td><td>Edwards Perimount</td><td>Edwards Magna Ease (27 mm)</td><td>1</td><td>Haemorrhagic shock due to iliac rupture</td></tr><tr><td>#35</td><td>Re-SAVR</td><td>Female</td><td>86.9</td><td>34</td><td>50</td><td>CryoLife O'Brien (25 mm)</td><td>Perceval (23 mm)</td><td>2</td><td>Haemopericardium, MODS</td></tr><tr><td>#233</td><td>Re-SAVR</td><td>Male</td><td>69.8</td><td>4.8</td><td>60</td><td>Edwards Perimount (23 mm)</td><td>Edwards Magna Ease (23 mm)</td><td>3</td><td>Refractory cardiogenic shock (ECMO + IABP)</td></tr><tr><td>#77</td><td>Re-SAVR</td><td>Female</td><td>83.1</td><td>36</td><td>59</td><td>Sorin Mitroflow (19 mm)</td><td>Edwards Magna Ease (19 mm)</td><td>5</td><td>RV dysfunction due to right coronary occlusion</td></tr><tr><td>#136</td><td>Re-SAVR</td><td>Female</td><td>79.1</td><td>8.4</td><td>65</td><td>Sorin Mitroflow (19 mm)</td><td>SJM mechanical valve</td><td>10</td><td>Sudden cardiac death in the service</td></tr><tr><td>#272</td><td>ViV-TAVR</td><td>Female</td><td>83.2</td><td>14.3</td><td>65</td><td>Sorin Mitroflow (21 mm)</td><td>Medtronic CoreValve (23 mm)</td><td>0</td><td>Tamponade</td></tr><tr><td>#158</td><td>ViV-TAVR</td><td>Male</td><td>85.4</td><td>22.8</td><td>70</td><td>Medtronic Freestyle (27 mm)</td><td>Medtronic CoreValve (26 mm)</td><td>3</td><td>Cardiogenic shock due to obstruction of left main coronary artery</td></tr><tr><td>#209</td><td>ViV-TAVR</td><td>Male</td><td>66.3</td><td>20.5</td><td>50</td><td>Sorin Mitroflow (23 mm)</td><td>Edwards SAPIEN (23 mm)</td><td>20</td><td>Liver dysfunction with hepatic encephalopathy</td></tr></tbody></table>

ECMO: extracorporeal membrane oxygenation; IABP: intra-aortic balloon pump; LVEF: left ventricle ejection fraction; MODS: multiple organ dysfunction syndrome; Re-SAVR: redo surgical aortic valve replacement; RV: right ventricular; SJM: St. Jude Medical; ViV-TAVR: valve-in-valve transcatheter aortic valve replacement.
<figure><img src="image_6.png" /><figcaption>**Fig. 3.** Kaplan-Meier curves in inverse probability of treatment weighting analysis. A. Kaplan-Meier curve for all-cause death, 0–1 year. B. Kaplan-Meier curve for all-cause death, 1–3 years. C. Kaplan-Meier freedom from composite event curve (all-cause death, myocardial infarction, stroke or rehospitalization for heart failure), 0–1 year. D. Kaplan-Meier freedom from composite event curve (all-cause death, myocardial infarction, stroke or rehospitalization for heart failure), 1–3 years. CI: confidence interval; HR: hazard ratio; Re-SAVR: redo surgical aortic valve replacement; ViV-TAVR: valve-in-valve transcatheter aortic valve implantation.</figcaption></figure>

The functional New York Heart Association status did not differ statistically between the two groups throughout the follow-up period (see Fig. 4 and Table 3). Two reinterventions (1.1%) were observed in the Re-SAVR group at 3 years, whereas no reinterventions were observed in the ViV-TAVR group (P = 0.82). The occurrence of composite events did not differ between the two groups at 3 years in the univariate analysis or after IPTW analysis with the landmark method at 1 year (HR 0.80, 95% CI 0.44–1.44; P = 0.45) and between 1 and 3 years (HR 1.41, 95% CI 0.83–2.38; P = 0.21) (Fig. 3).

The multivariable analysis demonstrated that systolic pulmonary artery pressure at baseline echocardiography (HR 1.248, 95% CI 1.043–1.494; P = 0.015) and serum baseline creatinine and creatine concentrations (HR 1.032, 95% CI 1.008–1.056; P = 0.006) were the only independent variables with a significant correlation with 3-year all-cause deaths.

### 4.3. Echocardiographic follow-up data

There was no difference in mean aortic gradient postoperatively (15.0 ± 5.9 vs. 14.8 ± 8 mmHg; P = 0.99) or at 1 year (13.9 ± 5.08 vs. 16.1 ± 10.3 mmHg; P = 0.17). Table 2 and Fig. 5 illustrate that, at 3 years, there was no difference in mean aortic gradients between the Re-SAVR and ViV-TAVR groups (13.2 ± 5.30 vs. 16.1 ± 11.4 mmHg; P = 0.17). In the postoperative period, there was no significant difference in the prevalence of severe prosthesis-patient mismatch

between the two groups (7.5% vs. 16%; P = 0.28). The left ventricular ejection fraction remained significantly higher in the Re-SAVR group at all time points, including the postoperative period, 1 year postoperatively and 3 years postoperatively. At the 3-year mark, the incidence of total aortic regurgitation was found to be grade 1 or below in 100% of patients in the Re-SAVR cohort and in 97% in the ViV-TAVR group (P = 0.67).

### 4.4. Small bioprosthesis

The mean true ID of small degenerated bioprosthesis was 17 (IQR 16.5; 18.5) mm in the Re-SAVR group (n = 80) and 18.5 (IQR 17.0; 19.0) mm in the ViV-TAVR group (n = 71) (P = 0.003). The all-cause death rate at 3 years was similar in the two groups. Echocardiographic data are presented in Fig. 6 and Table 5. In the ViV-TAVR group, 80% of patients received an SEV (ViV-SEV) and 20% received a BEV (ViV-BEV). At the 1-year mark, we observed a greater mean gradient in the ViV-TAVR cohort, although this difference was not evident at the 3-year interval. There was no statistically significant difference in mean gradient between the Re-SAVR and ViV-SEV groups at either 1 year (14.2 ± 3.95 vs. 19.2 ± 11.5 mmHg, respectively; P = 0.008) or 3 years (13.7 ± 4.13 vs. 19.2 ± 14.0 mmHg, respectively; P = 0.38). The gradients were observed to be greater in the ViV-BEV group compared with the Re-SAVR group at both 1 year (29.4 ± 14.7 vs. 14.2 ± 3.95 mmHg; P < 0.001) and 3 years (28.5 ± 20.1 vs. 13.7 ± 4.13 mmHg; P = 0.006).
<figure><img src="image_7.png" /><figcaption>**Fig. 4.** Change in New York Heart Association (NYHA) score over time. Re-SAVR: redo surgical aortic valve replacement; ViV-TAVR: valve-in-valve transcatheter aortic valve implantation.</figcaption></figure>

<figure><img src="image_8.png" /><figcaption>**Fig. 5.** Haemodynamic performance over time (overall). P-value for mixed-effect models over time. AV: aortic valve; Re-SAVR: redo surgical aortic valve replacement; ViV-TAVR: valve-in-valve transcatheter aortic valve implantation.</figcaption></figure>

A significant difference in mean gradient was observed between ViV-SEV and ViV-BEV at 1 year (P = 0.012), whereas at 3 years, this difference was not statistically significant (P = 0.054).

**5. Discussion**

The primary findings of our study are as follows:

* there was no discernible difference in long-term deaths in relation to long-term haemodynamic performance between the Re-SAVR and ViV-TAVR groups, despite the fact that patients who underwent ViV-TAVR were older and had a greater prevalence of co-morbidities;

* ViV-TAVR appeared to be a feasible and effective approach among patients with small degenerative bi prostheses, particularly when self-expandable valves were used.

**5.1. Death rates**

Firstly, there was no significant difference in 30-day death rates between the Re-SAVR and ViV-TAVR groups. These rates are consistent with those reported in the literature, which range from 2.8% to 8.4% for ViV-TAVR [10,12,13] and up to 4.6% for Re-SAVR [7]. Two recent patient-matched analyses [12,13] and a meta-analysis [16] demonstrated that ViV-TAVR, which is considered a less invasive approach, is associated with improved 30-day survival. The present study underscores the heightened prevalence of severe bleeding and acute renal failure among patients who underwent Re-SAVR. However, this does not exert a significant influence on early death (within 1 month), probably because of the selection of less vulnerable patients for surgery or limitations in the study's statistical power. Nevertheless, each approach entails inherent risks associated with the procedure itself. The ViV-TAVR procedure carries the inherent risks of coronary occlusion and tamponade. The risk of coronary occlusion in ViV-TAVR may be greater than that of transcatheter aortic valve implantation in native valves (2.3–3.5% vs. < 1%), particularly when managing a prosthesis with externally mounted leaflets [21]. Although this type of prosthesis was well represented in our study, with 13.1% having stentless valves, 36.8% having Mitroflow (Sorin, Milan, Italy) and 3.3% having Trifecta (St. Jude Medical, Inc., Saint Paul, MN, USA), in our analysis of the data we observed that the ViV-TAVR procedure resulted in only one instance of coronary occlusion, which ultimately led to the patient's demise on the third day. This occlusion occurred in a stentless Medtronic Freestyle valve. New techniques may eventually extend the boundaries of current practices. For instance, the BASILICA technique [22] and the new leaflet-splitting device (ShortCut) create a
<figure><img src="image_9.png" /><figcaption>**Fig. 6.** Haemodynamic performance over time (large and small degenerated bioprosthesis). A. Haemodynamic performance in large degenerated bioprosthesis over time. B. Haemodynamic performance in small degenerated bioprosthesis over time. *P*-values for mixed-effect models over time. AV: aortic valve; Re-SAVR: redo surgical aortic valve replacement; ViV-BEV: valve-in-valve transcatheter aortic valve implantation with a balloon-expandable valve; ViV-SEV: valve-in-valve transcatheter aortic valve implantation with a self-expandable valve.</figcaption></figure>

<table><caption>**Table 5**

Clinical and echocardiographic data at baseline and follow-up for small prostheses (true internal diameter ≤ 20 mm).</caption><thead><tr><th></th><th>All (n = 151)</th><th>Re-SAVR (n = 80)</th><th>ViV-TAVR (n = 71)</th><th>P</th><th>Adjusted P (Bonferroni)</th></tr></thead><tbody><tr><td>True ID (mm)</td><td>17.0 (17.0; 19.0)</td><td>17.0 (16.5; 18.5)</td><td>18.5 (17.0; 19.0)</td><td>0.000733</td><td>0.0028</td></tr><tr><td>Age (years)</td><td>81.7 (76.8; 84.5)</td><td>79.1 (74.4; 81.7)</td><td>84.0 (82.0; 86.8)</td><td>&lt; 0.001</td><td>0.0028</td></tr><tr><td>Male sex</td><td>65 (43.0)</td><td>30 (37.5)</td><td>35 (49.3)</td><td>0.14</td><td>0.18</td></tr><tr><td>Logistic EuroSCORE (%)</td><td>17.1 (12.4; 26.0)</td><td>13.7 (10.0; 19.5)</td><td>24.0 (16.0; 31.0)</td><td>0.000317</td><td>0.0028</td></tr><tr><td>Timing after previous surgery (years)</td><td>8.00 (5.90; 10.0)</td><td>7.14 (4.90; 9.17)</td><td>8.90 (7.00; 11.0)</td><td>0.000330</td><td>0.002805</td></tr><tr><td>Device success</td><td>111 (73.5)</td><td>63 (78.8)</td><td>48 (67.7)</td><td>0.12</td><td>0.17</td></tr><tr><td>Three-year all-cause death</td><td>31 (20.6)</td><td>16 (20.0)</td><td>15 (21.1)</td><td>0.86</td><td>0.86</td></tr><tr><td>Postoperative echocardiographic data<sup>a</sup></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>LVEF (%)</td><td>57.4 ± 9.30</td><td>58.7 ± 7.32</td><td>56.1 ± 11.0</td><td>0.25</td><td>0.28</td></tr><tr><td>Mean gradient (mmHg)</td><td>16.5 ± 7.71</td><td>15.4 ± 6.14</td><td>17.7 ± 8.94</td><td>0.08</td><td>0.13</td></tr><tr><td>Mean gradient &gt; 20 mmHg</td><td>27 (19.6)</td><td>10 (14.3)</td><td>17 (25.0)</td><td>0.11</td><td>0.17</td></tr><tr><td>Severe PPM</td><td>13 (15.3)</td><td>3 (9.1)</td><td>10 (19.2)</td><td>0.21</td><td>0.26</td></tr><tr><td>One-year echocardiographic data<sup>b</sup></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>LVEF (%)</td><td>60.1 ± 9.84</td><td>63.9 ± 8.55</td><td>57.4 ± 9.89</td><td>0.004</td><td>0.0085</td></tr><tr><td>Mean gradient (mmHg)</td><td>17.1 ± 9.44</td><td>14.2 ± 3.95</td><td>19.2 ± 11.5</td><td>0.004</td><td>0.0085</td></tr><tr><td>Mean gradient &gt; 20 mmHg</td><td>19 (21.6)</td><td>3 (8.1)</td><td>16 (31.4)</td><td>0.01</td><td>0.0028</td></tr><tr><td>Three-year echocardiographic data<sup>c</sup></td><td></td><td></td><td></td><td></td><td></td></tr><tr><td>LVEF (%)</td><td>59.6 ± 10.9</td><td>63.0 ± 10.1</td><td>55.9 ± 10.6</td><td>0.005</td><td>0.0094</td></tr><tr><td>Mean gradient (mmHg)</td><td>16.3 ± 10.4</td><td>13.7 ± 4.13</td><td>19.2 ± 14.0</td><td>0.36</td><td>0.38</td></tr><tr><td>Mean gradient &gt; 20 mmHg</td><td>15 (20.8)</td><td>2 (5.3)</td><td>13 (38.2)</td><td>0.000583</td><td>0.00283</td></tr></tbody></table>

Qualitative data are expressed as number (%); quantitative data are expressed as median (interquartile range) or mean ± standard deviation. ID: internal diameter; LVEF: left ventricle ejection fraction; PPM: prosthesis-patient mismatch; Re-SAVR: redo surgical aortic valve replacement; ViV-TAVR: valve-in-valve transcatheter aortic valve replacement.

controlled laceration of the aortic leaflets [23], whereas the “chimney” technique involves protecting the coronary ostia by placing one or two stents between the ostia and the leaflets of the degenerated bioprosthesis [24]. These techniques were not employed in the course of this study.

Despite the older age and greater number of co-morbidities among the patients who underwent ViV-TAVR, there was no difference in all-cause death rates at 3 years. The IPTW analysis provides support for the apparent safety of ViV-TAVR use by adjusting for the majority of confounding factors, particularly patient age, thus enabling a more accurate comparison between patients. Studies with long-term follow-up have yielded similar results, as evidenced by the findings of Deharo et al. [12]. Nevertheless, an alternative IPTW study reported an elevated death rate after

2 years in the ViV-TAVR cohort relative to the Re-SAVR group [25]. The authors proposed that the high proportion (41%) of non-transfemoral approaches in this study may have contributed to the observed death rate. Moreover, adjustments through matching or IPTW may obscure certain co-morbidities not captured in the baseline characteristics table, which could influence death and prompt the heart team to favour a less invasive approach (e.g., history of cancer, liver disease, etc.). Moreover, Tam et al. demonstrated an enhanced survival rate for ViV-TAVR in a matched analysis [26]. In these two studies, the composite endpoint of all-cause death, stroke or aortic valve reintervention did not differ between the two groups in our study. These conflicting results underscore the necessity for further research with longer follow-up periods, extending beyond 3 years, to substantiate or challenge these findings.

<footnote><sup>a</sup> All, n = 138; Re-SAVR, n = 70; ViV-TAVR, n = 68.</footnote>

<footnote><sup>b</sup> All, n = 88; Re-SAVR, n = 37; ViV-TAVR, n = 51.</footnote>

<footnote><sup>c</sup> All, n = 72; Re-SAVR, n = 38; ViV-TAVR, n = 34.</footnote>
It is noteworthy that the 3-year death rate was consistent with previous reports on ViV-TAVR [27] and Re-SAVR [12,28].

## 5.2. Morbidity and clinical outcomes

In addition to similar long-term survival rates, ViV-TAVR demonstrated a trend towards lower incidence of acute renal failure, despite a higher prevalence of baseline renal impairment. In general, baseline creatinine was identified as a predictor of death, whereas the specific type of procedure was not. Moreover, the Re-SAVR group exhibited elevated incidences of major bleeding and the need for transfusions [13,29]. Conversely, patients undergoing ViV-TAVR were observed to have an elevated risk of minor vascular complications, which are an inherent aspect of the procedure. These risks must be taken into account when the heart team is making decisions regarding performing the procedure in older and frail patients. The pacemaker implantation rate was found to be similar in the two groups, which is consistent with the findings of a recent large-scale study [13]. It is noteworthy that ViV-TAVR is associated with a significantly lower rate of pacemaker implantation than transcatheter aortic valve implantation in native valves [30].

## 5.3. Haemodynamic performance

The primary concern associated with the ViV-TAVR technique is the elevation of gradients, which is a consequence of the affixing of the new valve in the former, thereby reducing the aortic outflow chamber. There is a paucity of comparative studies examining mid- and long-term haemodynamic performance. This report presents the first head-to-head 3-year longitudinal comparison of consecutive patients who underwent either Re-SAVR or ViV-TAVR. No difference was observed between the two techniques at any point during the follow-up period. These findings are inconsistent with those of a recent meta-analysis [14], which included seven studies with postimplantation echocardiographic data, and reported a higher mean gradient for ViV-TAVR than for Re-SAVR. With the exception of one study [11], all other studies reported a more frequent use of BEVs than in our study. SEVs are the most commonly implanted valves in patients undergoing ViV-TAVR, as it is anticipated that gradients will be lower than those associated with BEVs, because of their supra-annular position [31,32]. Indeed, the use of BEVs in the event of stenosis failure resulted in a higher mean gradient in ViV-TAVR [31,33]. In our study, the haemodynamic performance of ViV-TAVR at 1 year and 3 years is similar to that observed by Bleiziffer et al. [27], who reported mean gradients of 17.2 ± 10.2 mmHg and 16.6 ± 10.0 mmHg at 1 year and between 3 and 5 years, respectively. Moreover, the PARTNER-2 ViV study yielded similar outcomes at the 3-year mark, although it exclusively encompassed BEVs with a labelling size of ≥ 21 mm [34]. A longer clinical follow-up period of 5 years in the PARTNER-2 ViV study provides further support for the long-term efficacy of this approach and the absence of gradient elevation [35]. Although the gradients were slightly elevated, they remained stable over time, thereby confirming the continued haemodynamic stability of the procedure. These findings align with those of our study, which observed no significant deterioration in haemodynamic performance after 1 and 3 years. Although the mean gradient values were identical, the ViV-TAVR group exhibited a greater number of mean gradients > 20 mmHg postoperatively and at follow-up (Table 2). A postoperative gradient rate > 20 mmHg was reported in 28.4% of cases in the Global ViV Registry, 34.4% of cases in the PARTNER-2 ViV Registry [36] and up to 36% of cases in the Spaziano study [31]. It can be surmised, therefore, that there may be a tendency towards some degree of mismatch between the patient and the prosthesis in the ViV-TAVR group. It is possible that ViV-TAVR may cause

or exacerbate an initial patient-prosthesis mismatch, whereas Re-SAVR may serve to rectify this potential initial mismatch. It was observed that patients who underwent Re-SAVR benefited from the use of larger bioprostheses than those employed during the index surgery, which may account for this discrepancy. In either case, haemodynamic performance had no impact on cardiac outcomes.

To circumvent the elevated postprocedural gradients (> 20 mmHg) and patient-prosthesis mismatch, novel procedural approaches are being developed, including percutaneous fracture of the degenerated bioprosthesis [37] and even anticipatory strategies using surgical devices with an expandable metallic support [38].

## 5.4. Small degenerated bioprosthesis

The management of small degenerated bioprosthesis is a prevalent and challenging issue. Underexpansion of the transect catheter valve in the old bioprosthesis may result in a significant patient-prosthesis mismatch [33]. Nevertheless, surgical intervention is frequently the preferred option. In our study, Re-SAVR was performed on 70% of patients with small prostheses (true ID ≤ 20 mm) compared with 54% of patients who underwent ViV-TAVR (P = 0.011). Nevertheless, the haemodynamic performance of the two techniques was similar at the 3-year mark (Fig. 6). These encouraging outcomes may be attributed to the extensive use of SEVs, with no discernible distinction between Re-SAVR and ViV-SEV at each follow-up interval. Conversely, ViV-BEV exhibited elevated mean gradients compared with Re-SAVR (P = 0.006). The findings were consistent at both the immediate postoperative period (31) and at 30 days [39]. A recent randomized study comparing the management of small degenerated bioprostheses using ViV-BEV versus ViV-SEV reported similar overall outcomes, but significantly higher echocardiography-assessed mean gradients were observed in the ViV-BEV group. However, when intraprocedural haemodynamic measurements were performed, no notable differences in gradients were observed between the two types of valves [39]. Some authors posit that these discrepancies can be attributed to the phenomenon of pressure recovery, which is more pronounced in the BEV design, and may result in an overestimation of mean gradients when assessed by echocardiography [40]. In the LYTEN study, no differences were observed in terms of death, functional outcomes or quality of life at both 30 days and 1 year [41]. Although the mean gradients associated with ViV-BEV were higher, these gradients remained stable over time, suggesting that this increase did not impact clinical outcomes, and may indeed be overestimated. Our findings are consistent with these results, although it should be noted that our study was retrospective in nature and there were no invasive haemodynamic measurements. Nevertheless, no notable discrepancies in 3-year death rates were identified, and the haemodynamic characteristics of these valves demonstrated consistent stability over time.

Consequently, the number of patients with a mean gradient > 20 mmHg was markedly higher throughout the follow-up period in the ViV-TAVR group. However, these gradients appeared to be stable over time, and cardiovascular outcomes were similar. Further investigation is required to determine whether a mean gradient > 20 mmHg will have an impact on long-term functional status or accelerate early prosthetic degeneration.

## 5.5. Study limitations

The present study is limited by a number of factors. The study was conducted in two centres, which restricted the number of patients included and, consequently, the statistical power of the
study. The analysis was retrospective, although the majority of data were collected through prospective registries. It should be noted that the two populations are not directly comparable in terms of age and frailty, as the Re-SAVR procedure is no longer offered to patients who are frail or very elderly since the emergence of TAVR. It is reasonable to conclude that this evident recruitment bias will result in a comparative reduction in the safety and performance of the ViV-TAVR procedure compared with Re-SAVR. This is also the primary source of bias identified in previous studies on this topic.

## 6. Conclusions

Despite the older age and greater number of co-morbidities among patients undergoing ViV-TAVR, all-cause 3-year death rates and haemodynamics were similar between ViV-TAVR and Re-SAVR. The ViV-TAVR procedure demonstrated a lower incidence of operative morbidity. The haemodynamic performance of ViV-TAVR in the management of small degenerative bioprosthesis was satisfactory, particularly when self-expandable valves were used (Central Illustration).

<figure><img src="image_10.png" /></figure>

**Central Illustration.** Three-year outcomes in 266 patients with degenerated bioprosthesis treated by Re-SAVR or ViV-TAVR. Survival was similar between groups (left panel). Hemodynamics were comparable in large valves (top right panel) while ViV-BEV showed higher but acceptable gradients in small valves (≤ 20 mm) (bottom right panel). No significant gradient differences were found at 3 years. AV: aortic valve; Re-SAVR: redo surgical aortic valve replacement; TAVR: transcatheter aortic valve implantation; ViV-BEV: valve-in-valve transcatheter aortic valve implantation with a balloon-expandable valve; ViV-SEV: valve-in-valve transcatheter aortic valve implantation with a self-expandable valve; ViV-TAVR: valve-in-valve transcatheter aortic valve implantation.
## Sources of funding

None.

## Data availability

The data are available upon request from the Clinical Research Centre of Angers University Hospital.

## Appendix A. Supplementary data

Supplementary data associated with this article can be found, in the online version, at https://doi.org/10.1016/j.acvd.2025.03.124.

## Disclosure of interest

The authors declare that they have no competing interest.

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