Abstract
Introduction
Transcatheter heart valve implantation into a failed surgical heart valve (THV-in-SHV) is an established reintervention strategy for degenerated aortic bioprostheses; however, early procedural outcomes, discharge hemodynamics, and standardized safety remain clinically relevant in routine practice.
Material and methods
We retrospectively analyzed consecutive patients who underwent aortic THV-in-SHV with the Navitor platform between 2022 and 2025. The primary endpoint was the mean aortic gradient at discharge. Secondary endpoints included peak gradient, maximum transvalvular velocity (Vmax), paravalvular leak (PVL), Valve Academic Research Consortium-3 (VARC-3) early safety, and time from surgical aortic valve replacement (SAVR) to reintervention according to leaflet mounting.
Results
Thirty patients were included (age, 72.5 ± 9.2 years; 73.3% male). At discharge, the mean and peak aortic gradients were 16.8 ± 6.7 mmHg and 30.0 ± 11.7 mmHg, respectively. Paravalvular leak was absent, trace, or mild in 96.7%, with no severe PVL. Early safety according to VARC-3 was achieved in 86.7%. Mortality and stroke occurred in 3.3% each, and bleeding type ≥ 2 occurred in 6.7%. No acute kidney injury (AKI) stage 3, renal replacement therapy (RRT), major vascular complications, device-related intervention, or new permanent pacemaker implantation occurred. Smaller surgical valves were associated with higher residual gradients, whereas outside-mounted bioprostheses showed a shorter time to reintervention than inside-mounted designs.
Conclusions
Aortic THV-in-SHV with the Navitor platform was associated with acceptable discharge hemodynamics, low rates of clinically relevant PVL, and favorable early safety according to VARC-3. Residual gradients were driven primarily by surgical valve size despite the intra-annular design.
Keywords: aortic bioprosthesis degeneration, hemodynamics, Navitor, safety, valve-in-valve
Graphical Abstract
Introduction
Degeneration of surgical aortic bioprostheses is becoming more common as SAVR with bioprosthetic valves is performed in a broader patient population. Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) has become a key reintervention strategy in suitable clinical and anatomical settings. However, THV-in-SHV remains constrained by the fixed geometry of the failed surgical valve, and residual gradients are particularly relevant in small surgical valves [1]. Standardized endpoint definitions are essential for reporting safety and device performance after TAVI. VARC-3 provides contemporary definitions for major clinical endpoints, including bleeding, AKI, vascular complications, and neurological events [2]. The Navitor transcatheter heart valve is a repositionable, self-expanding, intra-annular platform with bovine pericardial leaflets mounted in a nitinol frame. Its large open stent cells are intended to facilitate coronary access, whereas an inner cuff and a fabric outer cuff are designed to enhance sealing and reduce PVL. The valve is delivered using the low-profile FlexNav system [3]. Evidence for the Navitor platform has grown in native aortic stenosis, with emerging experience in ViV settings [3]. In the present study, we report discharge echocardiographic hemodynamics and early safety outcomes after aortic THV-in-SHV performed with the Navitor platform in a consecutive real-world cohort.
Material and methods
Study design and population
This retrospective, single-center observational study included all consecutive patients who underwent aortic THV-in-SHV with the Navitor transcatheter valve platform for failed surgical aortic bioprostheses between 2022 and 2025. Consecutive cases were identified from institutional procedural records. The mode of surgical bioprosthesis failure was classified as isolated stenosis, isolated regurgitation, or mixed stenosis and regurgitation. Baseline and procedural characteristics of the study population are summarized in Table 1.
Table 1.
Baseline and procedural characteristics
| Variable | Overall (n = 30) |
|---|---|
| Age, years | 72.5 ± 9.2 |
| Male sex, n (%) | 22 (73.3) |
| Time from SAVR to THV-in-SHV, years | 9.5 ± 3.2 |
| Surgical valve size, n | 21: 11; 23: 12; 25: 5; 27: 2 |
| Transcatheter valve size, n | 23: 21; 25: 6; 27: 3 |
| Mode of surgical bioprosthesis failure, n (%) | Isolated stenosis: 15 (50.0); isolated regurgitation: 9 (30.0); mixed stenosis and regurgitation: 6 (20.0) |
| LVEF before TAVI, % | 47.6 ± 15.2 (n = 30) |
| NYHA class at baseline, n (%) | Class II: 6 (20.0); Class III: 20 (66.7); Class IV: 4 (13.3) |
SAVR — surgical aortic valve replacement; THV-in-SHV — transcatheter heart valve implantation into a failed surgical heart valve; LVEF — left ventricular ejection fraction; NYHA — New York Heart Association; TAVI — transcatheter aortic valve implantation
Stented surgical bioprosthesis leaflet mounting (inside vs. outside)
Stented surgical bioprosthesis models were classified according to leaflet mounting configuration as internally mounted (inside-mounted) or externally mounted (outside-mounted) based on operative reports, implant cards, and manufacturer information. In this dataset, Trifecta (TF), Sorin Crown (SC), and Sorin Mitroflow (SM) were classified as outside-mounted, whereas Carpentier-Edwards Perimount (PM), Hancock (HC), Intuity (INT), and St. Jude Medical Epic (EPIC) were classified as inside-mounted. This classification was used to analyze time from SAVR to reintervention and to explore differences in discharge hemodynamics according to mounting [4].
Procedure and device platform
All THV-in-SHV procedures were performed using the Navitor transcatheter valve platform, including the device iterations used during the study period. Access strategy and procedural steps were left to the operators’ discretion in accordance with institutional practice.
Echocardiography and hemodynamic endpoints
The primary endpoint was the mean aortic gradient at discharge, measured by transthoracic echocardiography (TTE). Secondary echocardiographic endpoints included peak gradient, maximum transvalvular velocity (Vmax), and PVL grade (none, trace, mild, moderate, or severe). Left ventricular ejection fraction (LVEF) was recorded before TAVI and at discharge.
Clinical endpoints (VARC-3)
Clinical outcomes were assessed according to VARC-3 definitions. Early safety was defined as freedom from the following events during early follow-up: all-cause death, stroke, bleeding type ≥ 2, AKI stage 3 or RRT, major vascular or access-site complications, device-related intervention or surgery, and new permanent pacemaker implantation due to conduction disturbances. Additional device- and procedure-related complications were recorded when available [2].
Statistical analysis
Continuous variables are presented as mean ± standard deviation (SD) or median with interquartile range (IQR), as appropriate. Categorical variables are presented as counts and percentages. Exploratory comparisons of discharge hemodynamic parameters by surgical valve size category (21/23 vs. 25/27 mm) were performed using the Mann–Whitney U test for non-normally distributed variables or Student’s t-test when assumptions were met; categorical variables were compared using Fisher’s exact test. Due to the limited sample size, analyses were considered exploratory, and no formal adjustment for multiple comparisons was applied. Given the retrospective, descriptive design and the consecutive nature of the cohort, no a priori sample size or power calculation was performed.
Results
Baseline and procedural characteristics
Thirty consecutive patients were included (age 72.5 ± 9.2 years; 22/30 [73%] male). The mean time from SAVR to THV-in-SHV (valve-in-valve) was 9.5 ± 3.2 years. Surgical bioprosthesis sizes were 21 mm (n = 11), 23 mm (n = 12), 25 mm (n = 5), and 27 mm (n = 2). Implanted transcatheter valve sizes were 23 mm (n = 21), 25 mm (n = 6), and 27 mm (n = 3). The predominant failure mechanism was isolated stenosis in 15/30 patients (50.0%); isolated regurgitation was present in 9/30 (30.0%), and mixed stenosis and regurgitation in 6/30 (20.0%).
Discharge hemodynamic performance
Discharge echocardiography showed a mean gradient of 16.8 ± 6.7 mmHg (median 15.5; IQR 12.0–19.8; range 8–34) and a peak gradient of 30.0 ± 11.7 mmHg (median 25.5; IQR 22.3–38.0; range 11–58). Mean Vmax was 2.24 ± 0.55 m/s.
At discharge, PVL was absent in 19/30 (63.3%), trace in 7/30 (23.3%), mild in 3/30 (10.0%), and moderate in 1/30 (3.3%). No severe PVL was observed. Discharge echocardiographic hemodynamics are presented in Table 2.
Table 2.
Discharge echocardiographic hemodynamics
| Parameter | Value |
|---|---|
| Mean gradient, mmHg | 16.8 ± 6.7 (median 15.5; IQR 12.0–19.8; range 8–34) |
| Peak gradient, mmHg | 30.0 ± 11.7 (median 25.5; IQR 22.3–38.0; range 11–58) |
| Vmax, m/s | 2.24 ± 0.55 |
| LVEF at discharge, % | 50.3 ± 14.2 (n = 30) |
| PVL grade, n (%) | None 19 (63.3); Trace 7 (23.3); Mild 3 (10.0); Moderate 1 (3.3); Severe 0 |
| Mean gradient by SHV size (mmHg) | 21/23 mm: 17.83 ± 6.97 (n = 23); 25/27 mm: 13.57 ± 4.58 (n = 7) |
SHV — surgical heart valve; PVL — paravalvular leak; IQR — interquartile range; LVEF — left ventricular ejection fraction; Vmax — maximum transvalvular velocity
Hemodynamics by surgical valve size (exploratory)
Residual gradients were higher in smaller surgical valves: the mean gradient was 17.83 ± 6.97 mmHg for 21/23 mm valves (n = 23) vs. 13.57 ± 4.58 mmHg for 25/27 mm valves (n = 7).
Early safety outcomes (VARC-3)
During early follow-up, all-cause mortality occurred in 1/30 (3.3%) and stroke in 1/30 (3.3%). The single death was adjudicated as non–procedure-related (COVID-19 infection), whereas the single stroke occurred periprocedurally. No myocardial infarctions were recorded. Bleeding type ≥ 2 according to VARC-3 occurred in 2/30 (6.7%) (no bleeding type 3–4). Any AKI occurred in 1/30 (3.3%), with no AKI stage 3 and no RRT. There were no major vascular/access complications, no device-related interventions, and no new permanent pacemaker implantations due to conduction disturbances.
Early safety according to VARC-3 (composite) was achieved in 26/30 (86.7%). Early safety endpoint components according to VARC-3 are summarized in Table 3.
Table 3.
Early safety endpoints (VARC-3)
| Endpoint | n (%) | Notes |
|---|---|---|
| All-cause death | 1 (3.3) | Death cause: COVID-19 infection |
| Stroke | 1 (3.3) | Ischemic |
| Myocardial infarction | 0 (0) | |
| Bleeding type ≥ 2 | 2 (6.7) | No type 3–4 |
| AKI stage 3 or RRT | 0 (0) | Any AKI: 1 (3.3); RRT: 0 |
| Major vascular/access complication | 0 (0) | |
| Device-related intervention/surgery | 0 (0) | |
| New permanent pacemaker implantation | 0 (0) | |
| Early safety composite achieved | 26 (86.7) | Freedom from listed components |
AKI — acute kidney injury; RRT — renal replacement therapy
Surgical bioprosthesis leaflet mounting (inside vs. outside)
Among the failed stented surgical bioprostheses, 17/30 (56.7%) were classified as outside-mounted (TF, SC, SM) and 13/30 (43.3%) as inside-mounted (PM, HC, INT, EPIC). Outside-mounted valves showed a shorter interval from SAVR to THV-in-SHV reintervention compared with inside-mounted designs (7.47 ± 2.15 vs. 12.08 ± 2.29 years, respectively). Discharge hemodynamics were broadly similar between groups: mean gradient was 16.94 ± 7.14 mmHg in outside-mounted valves and 16.69 ± 6.29 mmHg in inside-mounted valves. Clinically relevant PVL (≥ moderate) occurred in 0/17 outside-mounted and 1/13 inside-mounted cases.
Clinical functional status at discharge
Clinical functional status improved markedly after TAVI. At baseline, 24/30 patients (80.0%) were in New York Heart Association (NYHA) class III or IV. New York Heart Association class at discharge was assessed in 29/30 patients because 1 patient died before assessment. Among survivors, all were in NYHA class I or II, with no residual NYHA class III or IV symptoms. Mean LVEF was 47.6 ± 15.2% before TAVI and 50.3 ± 14.2% at discharge (n = 30 for both assessments).
A graphical summary of the study design and key findings is provided in the Graphical abstract.
Discussion
In this consecutive single-center real-world cohort, aortic valve-in-valve TAVI performed using the Navitor transcatheter valve platform was associated with acceptable discharge hemodynamics and favorable early safety according to VARC-3 criteria. The central message of our study is hemodynamic: residual transvalvular gradients after THV-in-SHV were primarily driven by the geometric constraints of the failed surgical bioprosthesis, with a clear numerical signal for small surgical valves. In parallel, clinically relevant PVL (≥ moderate) was uncommon, supporting reliable early sealing in this ViV setting.
Hemodynamic performance after THV-in-SHV
Residual gradients are a core endpoint in THV-in-SHV because the transcatheter valve is deployed within a fixed surgical frame whose true internal diameter imposes an intrinsic ceiling on the achievable effective orifice area. Consequently, even technically successful THV-in-SHV may result in higher residual gradients, particularly in small surgical prostheses. This concept is supported by historical registry data and remains clinically relevant in contemporary practice [5,6]. In our cohort, mean discharge gradients were higher in 21/23-mm than in 25/27-mm surgical valves, consistent with the practical hemodynamic limitations of small surgical valves. Post-dilatation may serve as a useful procedural adjunct to optimize valve-in-valve performance by reducing residual gradients and improving sealing, thereby mitigating PVL, particularly in small surgical valves. In our cohort, it was performed in 28/30 procedures.
Beyond procedural success, residual gradients matter because they reflect the hemodynamic reserve achieved within the constrained surgical valve. Contemporary evidence links elevated post-ViV gradients to clinically important outcomes and reinforces the relevance of patient–prosthesis mismatch in small surgical valves [7]. Prospective data from the PARTNER 2 Valve-in-Valve registry also support the effectiveness of THV-in-SHV in high-risk patients while highlighting the role of valve size and residual gradients in shaping outcomes [8]. Taken together, these observations support the use of discharge hemodynamics as a primary endpoint and practical benchmark of early device performance.
Planning and valve sizing: the key modifiable factor influencing residual gradients
A key strength of the present work is the use of a pragmatic, reproducible time point (discharge echocardiography) that aligns with routine clinical workflows and decision-making. In THV-in-SHV, the main determinants of residual gradients are established before the procedure: accurate identification of the surgical valve and its true internal diameter, a sizing strategy that maximizes transcatheter valve expansion within the surgical frame, and a procedural plan that balances hemodynamic goals against coronary safety [1,6,8]. In patients with very small surgical valves, this planning challenge becomes most pronounced. When high residual gradients are anticipated, adjunc-tive approaches such as bioprosthetic valve fracture have been proposed to facilitate greater expansion and improve hemodynamics, but their use must be individualized based on the surgical valve type, anatomic constraints, and procedural risk [5]. Importantly, our data support the view that optimization of residual gradients should be approached primarily as a planning and sizing strategy rather than as a purely device-dependent outcome.
Leaflet mounting and surgical bioprosthesis durability signals
Beyond hemodynamic performance, our cohort provides a pragmatic durability signal related to surgical leaflet mounting configuration. We observed a substantially shorter SAVR-to-reintervention interval in outside-mounted than in inside-mounted stented surgical bioprostheses (7.47 vs. 12.08 years). This observation should be considered exploratory, and unmeasured confounding may have influenced the observed association given the retrospective design, heterogeneity of surgical valve models, and variability in patient characteristics and SAVR-related procedural factors. Nevertheless, the finding is directionally consistent with published reports suggesting a higher risk of early structural valve deterioration and earlier reintervention in certain externally mounted leaflet designs [4]. Clinically, this underscores the importance of structured post-SAVR surveillance and supports the integration of expected durability and future ViV feasibility into lifetime management planning when selecting a surgical bioprosthesis.
Navitor platform in context: what our real-world data adds
Evidence for the Navitor platform in native aortic stenosis has expanded, with studies reporting favorable early safety and low rates of PVL [3]. Although our study does not provide head-to-head comparisons with other transcatheter valves, it adds ViV-specific real-world data focused on discharge echocardiography, using standardized VARC-3 endpoints. In this context, our findings support the procedural utility of the Navitor platform in consecutive cases treated in routine practice.
Potential limitations of intra-annular designs in THV-in-SHV procedures include a reduced hemodynamic margin in the smallest surgical valves compared with supra-annular platforms. This has led to the hypothesis that intra-annular valves may be more prone to higher residual gradients in constrained surgical frames. In our cohort, discharge gradients remained within an acceptable range, and between-patient differences were driven primarily by surgical valve size constraints rather than by an evident platform-specific hemodynamic disadvantage. Recent comparative ViV series, including the Navitor intra-annular platform and supra-annular self-expanding valves, have reported broadly similar early gradients and safety, underscoring the importance of anatomy and sizing strategy rather than valve position alone [9,10].
PVL and early safety: supportive evidence of procedural performance
In THV-in-SHV, PVL is typically less frequent than in native-valve TAVI because the surgical frame provides a circular and stable landing zone. Nonetheless, clinically relevant PVL remains an important marker of device performance and prognosis. In our cohort, moderate or greater PVL was rare, and severe PVL did not occur, supporting the favorable early sealing performance of the Navitor platform in this ViV setting.
Early safety outcomes were favorable. The use of VARC-3 definitions enhances transparency and comparability with the contemporary TAVI literature and reduces ambiguity regarding key safety endpoints, including bleeding, AKI, vascular complications, and neurological events [2]. In our cohort, severe AKI, major vascular or access-site complications, device-related interventions, and new permanent pacemaker implantation were absent, supporting procedural feasibility and safety in experienced hands.
Lifetime management perspective: coronary risk and future coronary access
Transcatheter heart valve implantation into a failed surgical heart valve should be interpreted within a lifetime management framework. In many patients, THV-in-SHV may not represent the final intervention, and decisions made at the time of ViV may influence the feasibility of future coronary access and subsequent reinterventions. Preprocedural computed tomography planning remains essential to mitigate the risk of coronary obstruction during ViV procedures and to anticipate coronary access after implantation, particularly in anatomies with low coronary heights or constrained sinuses [5,6,11]. Dedicated prospective registry data further highlight that coronary access after transcatheter aortic valve replacement (TAVR) varies according to implantation geometry and platform and should be considered in long-term management strategies [12]. Although coronary complications were not observed in our cohort, our findings should be interpreted within a planning framework that explicitly balances hemodynamic optimization against coronary safety.
In the Polish setting, an expert consensus on ViV procedures emphasized practical aspects of ViV planning and common procedural pitfalls, consistent with our emphasis on sizing strategy and discharge hemodynamics [13]. More broadly, national consensus documents have outlined organizational and procedural standards for TAVI programs, supporting the structured implementation of best practices [14]. Beyond hemodynamics, the observed shorter time to failure in outside-mounted surgical valves is directionally consistent with comparative evidence reporting a higher risk of early structural valve deterioration and reintervention in externally mounted leaflet bioprostheses than in internally mounted designs [4].
Early symptomatic improvement
Beyond hemodynamic performance, our cohort also showed clear early symptomatic improvement after THV-in-SHV. Whereas most patients were in NYHA class III or IV before the procedure, all surviving patients were in NYHA class I or II at discharge assessment. This functional shift supports the clinical relevance of the observed hemodynamic results, although the retrospective design and limited sample size preclude firm conclusions regarding the magnitude and durability of symptomatic benefit.
Limitations
This study is limited by its retrospective design, single-center setting, and modest sample size, which restrict statistical power and preclude robust multivariable adjustment. Echocardiographic Doppler gradients are objective, but PVL grading remains semiquantitative and operator dependent. We focused on discharge measurements and early outcomes; longer-term hemodynamics, durability, and reintervention rates after THV-in-SHV require further follow-up. B-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide were not routinely measured in this retrospective cohort and therefore could not be analyzed. Finally, because only the Navitor platform was used, direct comparisons with other transcatheter valve platforms are not possible.
Clinical take-home messages
First, in aortic THV-in-SHV, residual gradients should be anticipated primarily on the basis of surgical valve size constraints; therefore, surgical valve size and true internal diameter should be considered key preprocedural hemodynamic predictors [5–7]. Second, when treating small surgical valves, the procedural goal should be explicitly defined (hemodynamic optimization vs. coronary safety), with an individualized sizing strategy and, where appropriate, adjunc-tive techniques to mitigate high residual gradients [11,15]. Third, standardized early safety reporting using VARC-3 enables transparent benchmarking and should be incorporated into routine reporting of THV-in-SHV cohorts [2]. Finally, discharge echocardiography provides a pragmatic reference point for early assessment of device performance and may help tailor the intensity of postprocedural follow-up in patients with higher residual gradients [7].
Conclusions
Aortic THV-in-SHV using the Navitor transcatheter valve platform demonstrated acceptable discharge hemodynamics, low rates of clinically relevant PVL, and favorable VARC-3 early safety in a consecutive real-world cohort. Residual gradients were primarily driven by surgical valve size, underscoring the importance of preprocedural planning in small surgical bioprostheses.
Acknowledgments
None.
Footnotes
Ethics statement: Due to the retrospective study design, the requirement for written informed consent was waived.
Author contributions: R.S.: conceptualization, data curation, investigation, writing – original draft, formal analysis, methodology, project administration; J.T.: conceptualization, data curation, investigation, writing — review and editing; P.K.: conceptualization, data curation, investigation, writing — review and editing; B.K.: supervision; M.S.: data curation, investigation; F.D.: data curation; J.K.-K.: data curation; J.L.: supervision.
Conflict of interest: The authors have no competing interests to declare.
Supplementary material: None.
Funding: None.
Data availability statement
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.