A looming wave of bioprosthetic transcatheter valve failure?—rethinking lifetime management and reintervention in aortic stenosis

Indications for transcatheter aortic valve replacement (TAVR) have rapidly expanded to include younger and lower-risk patients with severe aortic stenosis (AS). Many of these patients are expected to live more than 20 years, and thus the long-term durability of TAVR remains a significant clinical concern, raising questions about whether a “pandemic of bioprosthetic failure” may emerge in the coming decades. Consequently, reintervention—including redo surgical aortic valve replacement (SAVR) and valve-in-valve (ViV) TAVR—will no longer represent a rare bailout therapy but a predictable and planned strategy in the lifetime management of AS.

Recent data seem to add legitimacy to this prediction. Forrest et al. reported 6-year clinical outcomes from the Evolut Low Risk trial, which examined the safety and effectiveness of TAVR using the self-expanding CoreValve Evolut R or PRO systems (Medtronic) compared with SAVR in low-risk patients with severe AS, with an exploratory analysis incorporating available 7-year data (1). At 6 years, rates of disabling stroke and mortality were similar between transcatheter vs. surgical valve replacement; however, reintervention rates occurred more frequently in the TAVR group than in the surgical group. An exploratory 7-year analysis demonstrated further divergence in cumulative incidence (9.8% vs. 6.0%, P=0.02).

Seven-year data from the PARTNER 3 trial, which examined the safety and effectiveness of the Edwards Sapien 3 TAVR versus SAVR in low risk subjects, showed the primary endpoint of death from any cause, stroke, or rehospitalization occurred in 37.2% of subjects randomized to TAVR and 34.6% of those treated with surgery [hazard ratio (HR) 0.87, 95% confidence interval (CI): 0.70–1.08] (2). Rates of all-cause bioprosthetic valve failure were 7.5% in the surgical arm and 6.9% in the TAVR group, which was not statistically significant. Rates of valve thrombosis were higher in the TAVR group (2.8% vs. 0.5%), although overall reintervention rates were low and comparable.

In the Evolut Low Risk trial, reintervention after surgery often involved explant surgery (65%) (1). Although 30-day mortality after reintervention was low (3.3%), most procedures were performed in low surgical-risk patients at higher-volume centers, suggesting that these results might not be reproducible in other patient populations or less experienced centers. In PARTNER 3, the rate of aortic valve reintervention (including both surgical explant and redo-TAVR) was 6.7% in the TAVR group (2). In another study following subjects after TAVR explant, the 30-day mortality rate was 13.1% (3), underscoring the importance of expertise in surgical TAVR explant procedures.

In this issue of Annals of Cardiothoracic Surgery, Dr. Fukuhara presents surgical techniques for explanting transcatheter aortic valves in both native and ViV settings (4). Although TAVR explantation has historically been regarded as a high-risk bailout procedure with mortality rates approaching 20% (5), it may become a more manageable procedure as surgical experience increases (6). A key insight is that a TAVR valve removed from within a SAVR valve, so-called ViV explantation, is often technically easier than native TAVR removal because the original surgical bioprosthesis or Dacron graft acts as a shield, preventing severe adhesions between the TAVR stent frame and the native aortic wall. This protection allows surgeons to use a rapid single Kocher clamp and twisting maneuver for ViV removal, whereas native TAVR explants often require a more complex double Kocher clamp technique to compress the stent frame and avoid injury to adherent native tissue. Importantly, redo surgical procedures also provide an opportunity to correct prior anatomical constraints by aortic root enlargement, thereby optimizing long-term hemodynamic performance. This technical information is undoubtedly important in the current era of increasing bioprosthetic failure.

In the following sections, we review the pathological mechanisms of bioprosthetic valve failure and summarize current evidence comparing redo SAVR vs. ViV TAVR in terms of patient selection, procedural risks, and longitudinal outcomes.

Etiologies and pathological mechanisms of bioprosthetic valve failure

Standardized definitions categorize bioprosthetic valve dysfunction into four primary etiologies: structural valve deterioration (SVD), non-structural valve deterioration (NSVD), thrombosis, and endocarditis (Figure 1) (7,8). SVD is the primary cause of bioprosthetic valve failure and refers to intrinsic, permanent changes to the prosthetic leaflets, stent, or strut—such as leaflet wear and tears, disruption, flail leaflet, leaflet fibrosis and/or calcification, as well as strut fracture or deformation—that lead to progressive stenosis or regurgitation.

Figure 1 The VARC-3 criteria for BVD after TAVR. Schematic overview illustrating the major categories of BVD, including SVD, NSVD, thrombosis, and endocarditis. Adopted from Généreux et al. (7), J Am Coll Cardiol 2021;77:2717-2746. with permission. BVD, bioprosthetic valve dysfunction; NSVD, non-structural valve deterioration; SVD, structural valve deterioration; TAVR, transcatheter aortic valve replacement.

NSVD involves abnormalities not intrinsic to the valve itself, most notably prosthesis-patient mismatch (PPM) and paravalvular leaks, which typically occur at the time of procedure and remain stable during follow-up. Thrombosis involves the development of blood clots on the valve structure, which may manifest as subclinical hypo-attenuated leaflet thickening or reduced leaflet motion. Finally, endocarditis represents an infection of the valve structure that can lead to vegetations, abscesses, or leaflet perforation (7,8).

The pathogenesis of SVD is no longer viewed as a passive process of mechanical wear but as a dynamic biological cascade in which thrombosis, endothelial dysfunction, and chronic inflammation converge, ultimately leading to fibrosis and calcification (9,10). We have examined more than 200 TAVR valves obtained from either surgical explants or autopsy cases and have reported insights into the pathology of bioprosthetic valve failure. Pathological evaluation of explanted devices suggests that this cycle often begins with early thrombus formation, which eventually organizes into pannus—a proteoglycan- and collagen-rich matrix resistant to medical therapy—resulting in permanent leaflet stiffening (10,11). Furthermore, we previously reported that although intrinsic calcification within the leaflet typically becomes symptomatic after a decade, nearly half of observed leaflet calcification is extrinsic, derived from these organized thrombi formed early in the valve lifecycle (11).

This biological progression is further driven by persistent host immune responses to residual xenogeneic glycans—particularly galactose-α-1,3-galactose (α-Gal) and N-glycolylneuraminic acid (NeuGc)—which are not adequately masked by glutaraldehyde fixation, thereby promoting chronic inflammation and macrophage recruitment (12,13). Activated immune cells release proteolytic enzymes such as matrix metalloproteinases that degrade collagen integrity and facilitate mineralization (13).

Mechanical and procedural factors further accelerate degeneration. In the Evolut Low Risk trial, rates of stenosis-related reintervention were similar between the two arms at 7 years, whereas regurgitation-related reintervention was more frequent in the TAVR arm (1). In their analysis, Forrest et al. proposed a possible mechanistic hypothesis: post-dilatation exceeding the valve waist could potentially injure the leaflets and predispose to later valve regurgitation. During that trial, there were no specific instructions regarding the maximum balloon size for post-dilatation; however, the instructions for use (IFU) were updated in 2020 following concerns about excessive post-dilatation beyond the valve waist. Regurgitation-related reintervention occurred in 4.8% of valves without post-dilatation, 4.3% in valves with IFU-guided post-dilatation, and 9.3% with off-guidance post-dilatation. The impact of post-dilatation on leaflet integrity and valve performance should not be ignored and underscores the need for pathology-based examination of all explanted valves. Such understanding may help identify strategies to further improve valve durability. In ViV settings, incomplete stent expansion within a rigid surgical frame can lead to leaflet distortion, regions of elevated stress, and flow stagnation (14). These mechanical deformations promote thrombus deposition and serum inspissation, ultimately triggering a vicious cycle of accelerated structural failure (14).

Redo SAVR vs. ViV TAVR

There are no randomized trials that provide definitive indications for redo SAVR versus ViV TAVR. However, current recommendations generally favor redo SAVR in patients with symptomatic severe bioprosthetic stenosis unless surgical risk is high or prohibitive (15,16). ViV TAVR is often preferred in older patients (typically ≥80 years), those at high or extreme surgical risk, or individuals with significant frailty. In contrast, redo SAVR is preferred for younger, low-risk patients (<75 years), those requiring concomitant surgical procedures, or patients with anatomical features unfavorable for TAVR—such as a high risk of coronary obstruction or a small surgical valve frame likely to result in severe PPM (17).

Each strategy carries distinct procedural risks. ViV TAVR is associated with lower rates of early perioperative complications, including reduced major bleeding, acute kidney injury, and shorter hospital stays (18-20). However, it presents procedure-specific risks such as coronary obstruction, which occurs in approximately 2% of cases and is associated with 30-day mortality approaching 50% (20). ViV TAVR is also associated with a higher incidence of permanent pacemaker implantation and elevated residual transvalvular gradients due to constrained valve expansion within the rigid surgical ring (18).

In contrast, redo SAVR, although more invasive, permits removal of the failed prosthesis and potentially allows implantation of a larger valve, often combined with aortic root enlargement. A review of the Society of Thoracic Surgery (STS) Database from 2011–2021 has demonstrated that the number of SAVR after TAVR is increasing. Risk-adjusted analyses showed that SAVR after TAVR is associated with increased operative mortality and major morbidity compared with SAVR after SAVR (21). Although less common, SAVR in patients who have previously undergone TAVR in SAVR (SAVR-TAVR-SAVR) appears to carry an intermediate risk compared to TAVR-SAVR and SAVR-SAVR. Continued observations in the EXPLANT-TAVR registry will provide further insight into the outcomes of these interventions and may help guide future strategies (3,21).

Clinical outcomes demonstrate a temporal divergence between the two approaches. ViV TAVR provides superior early outcomes, with lower 30-day mortality and fewer perioperative complications (18-20,22). However, long-term data suggests better survival following redo SAVR. Although mortality rates are comparable during the first two years, survival curves separate thereafter; at five years, redo SAVR is associated with significantly lower all-cause mortality (13.3% vs. 23.4%) (18). This late survival benefit appears largely attributable to hemodynamic factors. Constrained expansion in ViV TAVR frequently leads to residual gradients and severe PPM in up to half of cases, which are associated with increased late heart failure events (18). Indeed, ViV TAVR patients experience nearly a fourfold higher risk of heart failure hospitalization beyond two years (18). In contrast, surgical redo enables correction of anatomical limitations and optimization of effective orifice area. Nevertheless, some degree of selection bias between these groups is likely.

Importantly, these comparative data are derived from earlier-generation transcatheter heart valve (THV) platforms, and there are currently no comparative studies evaluating ViV procedures using newer-generation TAVR platforms vs. redo SAVR. The SAPIEN 3 Ultra RESILIA (Edwards Lifesciences) incorporates several design refinements, including an enhanced sealing skirt to minimize paravalvular regurgitation and anti-calcification treatment intended to delay SVD. Previous studies have demonstrated favorable early clinical and hemodynamic outcomes compared with earlier balloon-expandable valves, including lower all-cause mortality and superior hemodynamic performance at 1 year after TAVR (23-25). Similarly, the Evolut FX platform (Medtronic) includes refinements to the delivery catheter system and radiopaque stent markers to improve implantation precision, with studies reporting high procedural success and low complication rates (26,27). Taken together, these newer-generation TAVR platforms demonstrate important procedural and hemodynamic advances; however, long-term durability data—including primary TAVR vs. SAVR and ViV TAVR vs. redo SAVR—remain limited and warrant further investigation.

Leaflet modification and coronary rescue strategies

To mitigate the risk of coronary obstruction in ViV TAVR, several transcatheter modification techniques have been developed. “Chimney” stenting has traditionally been used as a bailout or preventive strategy. In this approach, a coronary stent is placed across the prosthetic leaflet and extended above the THV frame to maintain coronary flow (28). Although effective in the short term, concerns remain about long-term stent patency and the risk of the stent compression during valve post-dilatation.

The BASILICA technique (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction) utilizes an electrified guidewire to traverse and lacerate the target leaflet before THV deployment. The split leaflet then opens in a V shape, allowing blood flow to reach the coronary ostia that might otherwise be obstructed by the prosthetic frame (29). More recently, the ShortCut device has been developed as a dedicated leaflet-modification system. Unlike BASILICA, it mechanically splits failed bioprosthetic leaflets in a controlled manner before ViV implantation. Early clinical data have shown high technical success in preventing coronary obstruction (30). Although these strategies expand treatment options for high-risk anatomy, they increase procedural complexity and require further long-term evaluation to confirm safety and durability.

Conclusion

The expanding use of TAVR as the initial treatment for AS has changed the management of aortic valve disease. It is therefore essential to incorporate a lifetime management strategy into the care of these patients. As younger and lower-risk patients increasingly receive transcatheter bioprosthetic valves, structural failure has become an expected part of the disease course. Although ViV TAVR offers important short-term advantages, long-term outcomes—particularly hemodynamic performance— remain less favorable than redo SAVR for patients with longer life expectancy. Careful patient selection, anatomical assessment, and procedural planning within the context of a heart team approach are therefore essential when managing bioprosthetic valve failure. In this evolving era, a clear understanding, standardization, and continued refinement of surgical techniques—particularly valve explantation and aortic root enlargement when indicated—are increasingly important to ensure safe and durable long-term outcomes.

Acknowledgments

None.

Footnote

Provenance and Peer Review: This article was commissioned by the editorial office, Journal of Visualized Surgery. The article has undergone external peer review.

Peer Review File: Available at https://jovs.amegroups.com/article/view/10.21037/jovs-2026-0017/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jovs.amegroups.com/article/view/10.21037/jovs-2026-0017/coif). T.H. received Young Investigator Grant from Ionis Pharmaceuticals outside of this work. R.A.R. is a co-PI for a multi-institutional clinical trial using the Angiovac device to remove vegetations from Tricuspid valve, which is part of the PAVE trial and supported by Angiodynamics, and a co-PI in the SENTINEL trial which is a pilot study funded by the US Air Force to test an in-ear device for rapid triage of patients with neurological damage or injury. R.A.R. has also attended a scientific symposium supported by Angiodynamics, and is an active duty member of the US Air Force. His involvement in this manuscript is not supported by the DOD or USAF. R.V. and A.V.F. report receiving institutional research support from Leducq Foundation, Abbott Vascular, Ablative Solutions, Absorption Systems, Advanced NanoTherapies, Aerwave Medical, Alivas, Amgen, Asahi Medical, Aurios Medical, Avantec Vascular, BD, Biosensors, Biotronik, Bolt Medical, Boston Scientific, EndoVascular, Chansu Vascular Technologies, Children’s National, Concept Medical, Cook Medical, Cooper Health, Cormaze, CRL, Croivalve, CSI, Dexcom, Edwards Lifesciences, Elucid Bioimaging, eLum Technologies, Emboline, Endotronix, Envision, Filterlex, Innovalve, Innovative Cardiovascular Solutions, Intact Vascular, Interface Biologics, Intershunt Technologies, Invatin, Lahav, MedAlliance, Medanex, Medtronic, Mercator, Microvention, Neovasc, OrbusNeich, Pi-Cardia, Polares Medical, Polyvascular, Profusa, Protembis, Pulse Biosciences, Recor Medical, Shockwave, SMT, SoundPipe, Spectrawave, Surmodics, Terumo Corporation, The Jacobs Institute, UCSF, UPMC, Vascudyne and Xeltis outside the submitted work. R.V. reports serving as a consultant to Xeltis, Quotient Therapeutics, and University of Nebraska. A.V.F. also received institutional research support from NIH-HL141425, Leducq Foundation Grant, 4C Medical, 4Tech, Biotyx Medical, Canon, Cardiac Implants, Cardiawave, CardioMech, Cardionomic, CeloNova, Cerus, Edwards, Imperative Care, Limflow, L&J Bio, Lyra Therapeutics, Mayo Clinic, Maywell, Microport, Nephronyx, Nova Vascular, Nyra Medical, Occultech, Olympus, Ohio Health, OrbusNeich, Ossiso, Phenox, Pi-Cardia, Polares Medical, Polyvascular, Profusa, ProKidney, LLC, Protembis, Pulse Biosciences, Qool Therapeutics, Recombinetics, Recor, Regencor, Renata Medical, Restore Medical, Ripple Therapeutics, Rush University, Sanofi, Shockwave, SMT, SoundPipe, Spartan Micro, Spectrawave, Surmodics, Terumo, The Jacobs Institute, Transmural Systems, Transverse Medical, TruLeaf, UCSF, UPMC, Vascudyne, Vesper, Vetex Medical, Whiteswell, WL Gore, Xeltis. A.V.F. has received honoraria from Abbott Vascular, Biosensors, Boston Scientific, CeloNova, Cook Medical, CSI, Lutonix Bard, Sinomed, and Terumo Corporation; and is a consultant to Amgen, Abbott Vascular, Boston Scientific, CeloNova, Cook Medical, Lutonix Bard, and Sinomed. The views expressed in this manuscript are solely of the authors and do not reflect the views of the United States Air Force or the Department of Defense. The other authors have no conflicts of interest to declare.

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