It happened tomorrow—transcatheter treatments in the lifetime management of aortic valve diseases

Introduction

Since the first-in-human transcatheter aortic valve replacement (TAVR) performed in 2002, TAVR became a progressively common treatment of choice for severe aortic stenosis, across the spectrum of surgical risk. Advancements in the available technology, evidence from randomized clinical trials, as well as increase in surgeon-level and center-level volume allowed for progressive expansion in the use of TAVR towards intermediate- as well as low-risk patients, regardless of age. As a result, the number of TAVR procedures performed in the USA in 2015 exceeded the number of isolated surgical aortic valve replacement (SAVR), and in 2019 the overall TAVR volume even exceeded the total number of SAVR procedures combined with other procedures (i.e., coronary artery bypass, or surgical procedure involving other valves) (1). With these options being offered also to patients whose life expectancy exceeds the half-life of the implanted prosthesis, cardiothoracic surgeons are nowadays referred an increasing number of patients with structural valve degeneration (SVD) requiring interventions. In this frame, the importance of optimizing hemodynamics and durability across all ages becomes imperative.

Durability of aortic bioprosthesis

Surgical biological aortic valve prosthesis has shown excellent outcomes in terms of durability and hemodynamics at 10, 15 and 20 years. As a landmark exemplum, single-center data from 2,659 patients assessing the long-term durability of the Carpentier-Edwards (Edwards Lifesciences, Irvine, CA, USA) bovine pericardial valve demonstrated that structural valve deterioration (SVD) occurred in less than a fifth of patients at 15 years (2). Even better results have been reported with the Carpentier-Edwards PERIMOUNT bovine pericardial prosthesis (Edwards Lifesciences, Irvine, CA, USA), where across a cohort of 12,569 patients, SVD requiring reoperation occurred in 1.9% and 15% at 10 and 20 years, respectively (3). Similarly, seven-year follow-up data in 689 patients who underwent SAVR with the more recent Inspiris Resilia bioprosthetic valve (Edwards Lifesciences, Irvine, CA, USA) demonstrated a remarkable freedom from SVD of 99.3% (4).

Regarding porcine bioprosthesis, a series of 855 patients who underwent SAVR with the Epic valve (Saint Jude, Little Canada, MN, USA) showed a SVD rate of 0.6% at 10 years and 1.6% at 15 years; similarly, in patients treated with the Mosaic porcine valve (Medtronic, Minneapolis, MN, USA), freedom from SVD requiring explantation at 17-year was 89.1% in the subgroup of patients older than 60 years (5). More recent surgical platform like the Perceval sutureless valve (Corcym, London, UK) showed in a series of 784 patients an incidence of severe SVD at 13 years of 1.9%, with an overall incidence of 0.54% per patient-year and a freedom from aortic valve reintervention at 10 years of 94% (6).

There is now a growing body of evidence demonstrating overall very low evidence of SVD in TAVR, with clinical trials such as the REVIVE (Randomized Multicenter Evaluation of Intravenous Levosimendan Efficacy) II, TRAVERCE (Trial for Trans-Apical Aortic-Valve Implantation), and PARTNER EU (Placement of Aortic Transcatheter Valves Trial Europe) trials reporting no cases of SVD in more than 400 patients overall (7). Systematic reviews pooling data from multiple TAVR studies have demonstrated an overall incidence of SVD up to 1.34/100 patient-years, with only a fraction of those patients (12%) eventually undergoing valve reintervention (8). Within the available TAVR options, some differences have been noted when stratifying outcomes by type of prosthesis—for example, the FRANCE-2 registry including 4,201 patients demonstrated that no severe SVD occurred at 5 years in patient who received a self-expandable TAVR versus 4.1% in those who received a balloon expandable one (9).

When compared to SAVR, the 5-year durability of TAVR seems to be non-inferior. For example, the CoreValve US High Risk Pivotal and the SURTAVI-IR studies showed a significant lower rate of SVD in TAVR compared to SAVR at 5 years (2.2% in the TAVI cohort versus 4.4% in the SAVR cohort) (10). However, this data may be biased by the inclusion in the surgical groups of patients undergoing SAVR with bioprosthetic valves that are known to early SVD, like the Crown valve and Trifecta valve. Similarly, the NOTION (Nordic Aortic Valve Intervention) trial in low-risk patients with severe aortic stenosis showed a significantly lower incidence of SVD at 5 years in patients treated with TAVR versus SAVR (3.9% vs. 26.1%; P<0.0001). In this frame, it is essential to reflect on the strength and accuracy of this growing evidence, as a standardized definition of SVD has been introduced in the surgical literature only lately (11). As a consequence, the adoption of a unified definition has been inconsistent, and studies have reported SVD in terms of the need for reoperation itself or a composite of death, reoperation, or clinical investigation due to suspected SVD. An additional bias in direct comparisons between TAVR and SAVR durability is related to intrinsic differences in the durability across different surgical bioprosthesis—with options like the Carpentier-Edwards Perimount valve (Edwards Lifesciences, Irvine, CA, USA) lasting as late as 19 years (12) and options like the Sorin Mitroflow prosthesis (Sorin Group, Aravada, CO, USA) having an average detection of SVD of 4 years (13).

Finally, recent studies have elucidated the role of hypo-attenuating leaflet thickening (HALT) with or without hypo-attenuation affecting motion (HAM) in both TAVR and SAVR (14,15). The evidence supports the concept that HALT and HAM—radiologic proxies of subclinical thrombosis—could both develop and regress at variable intervals. Controversially, the maintenance of chronic oral anticoagulation does not seem to be a significant predictor of HALT regression (15). Well-balanced, controlled comparison of data from real-world practice comparing TAVR and SAVR are warranted to elucidate durability, and freedom from SVD, and optimal anticoagulation strategies.

The treatment of SVD

Reintervention strategies after a degenerated SAVR include TAVR valve-in-valve (ViV) procedure or redo SAVR. Reintervention strategies after a degenerated TAVR with no signs of active infective endocarditis (IE) include TAVR-in-TAVR (TiT) or TAVR explant followed by SAVR.

In case of degenerated SAVR, a ViV procedure is generally preferred because of the overall lower procedural risk. Its feasibility depends on serval factors—the type of surgical prosthetic valve as dock, the risk for patient-prosthesis mismatch, the patient’s age and overall risk profile including anatomic criteria such as the coronary arteries height and related risk for coronary occlusion. The Valve-in-Valve International Data (VIVID) registry showed a procedural mortality rate of 1%, major vascular complications of 3.4%, major bleeding of 7.7%, major stroke of 1.9%, acute kidney injury and coronary obstruction of 7.8% and 2.3%, respectively (16). In these patients, the need for a third ViV procedure according to CoreValve US Expanded Use Study and the PARTNER ViV trial ranges between 4.4% and 1.9% at 3 years (17,18).

If ViV is not indicated, a redo SAVR remains the treatment of choice. According to the Society of Thoracic Surgeons (STS) National Database of patients with previous aortic valve surgery undergoing redo SAVR, short-term mortality has a two-fold increase compared to first time surgery (4.6% vs. 2.3%). Major complications including postoperative stroke, permanent PPM, renal failure, and vascular complication are 1.9%, 11.0%, 4.2% and 0.06% respectively (19).

In the setting of degenerated TAVR, a TiT strategy might be considered as the first option—especially if TAVR was chosen in first place due to prohibitive surgical risk—in order to minimize both the invasiveness and the procedural risk. Concerns related to a TiT arise from the risk of acute coronary obstruction by the previous TAVR, and the impossibility of engaging the coronary arteries once the second device is in place (20). Nai Fovino et al. in a series of 137 consecutive patients undergoing TAVR implantation with self-expandable, balloon expandable and other devices found unfeasible to re-engage coronary arteries in on third of the patients, with the deployment of a suprannular valve being an independent predictor of coronary obstruction (20).

If a TiT procedure is not deemed feasible, surgical TAVR explantation followed by SAVR remains the only non-conservative option. Reasons to proceed with this pathway for TAVR explantation include infective§ endocarditis (43.1%), SVD (20.1%), presence of paravalvular leak (18.2%), and patient-prosthesis mismatch (10.8%) (21). The technique for explantation may be challenging, depending on how long the prosthesis has been in place as well as on type of prosthesis [i.e., balloon expandable (B-TAVR) or self-expandable TAVR (S-TAVR)]. TAVR explant after 1 year can be particularly complex especially for S-TAVR valves in light of the dense endothelialization of the metal frame in contact with wall of the ascending aorta; in these cases, the replacement of the whole ascending aorta or the aortic root might be needed after the TAVR explant. Indeed, Fukuhara et al. demonstrated on a nationwide level that patient undergoing SAVR for a degenerated S-TAVR require more frequently an ascending aorta replacement compared to those who had a B-TAVR implanted earlier (18.2% vs. 8.2%) (22). Data from the TAVR Explant registry showed that intraoperative and in-hospital mortality following surgical TAVR explant are 0.7% and 11.9%, respectively. Even though cross-clamp time was shown to be a predictor of both 30-day and 1-year mortality after TAVR explantation [odds ratio (OR): 1.007, 95% confidence interval (CI): 1.002–1.013 and OR: 2.7, 95% CI: 1.1–6.6, respectively], no difference in mortality has been detected in patient undergoing isolated AVR versus aortic root surgery. Overall, permanent stroke occurs in 5.9%, permanent pacemaker implantation in 18.4% and renal failure in 8.2% of the patients—regardless of the extension of the surgery towards the ascending aorta or the aortic root (23).

Redo aortic valve procedure in the setting of IE

The treatment of prosthesis-related IE

Infection of an intracardiac prosthetic material is a severe event that can lead to serious and life-threatening complications. The proportion of patients developing IE who are >80 years is increasing, and currently accounts for 10–20% of total cases (24) As reported in the PARTNER trials, the incidence of prosthetic valve endocarditis (PVE) is overall 5.06 (95% CI: 4.19–6.12) per 1,000 person-year (25). According to different meta-analysis and large retrospective studies, there seems to be no substantial difference in the early-, mid-, and log-term incidence of IE after TAVR compared to SAVR. After propensity score matching, the yearly incidence rate of IE is 1.86% in TAVR versus 1.71% in SAVR. Nevertheless, there are several mechanisms that make the diagnosis of IE in TAVR more challenging (26), including the fact that no vegetations are detected in up to 60% of cases (27), that vegetations tend to be located outside of the valve in about 30% of patients (mainly at the level of mitral valve) (27), and that in one-tenth of patients vegetations are located in the stent frame of the valve, rather than on the valve leaflets (rate that has been reported to increase up to 19% in patients with self-expanding TAVR with longer stent frames extending in to the ascending aorta) (28). Interestingly, the clinical presentation of patients with IE in TAVR is frequently atypical with Enterococci and S. Aureus being the leading etiology.

Untreated PVE faces high mortality, with rates up to 40% regardless of whether the previous valve had been implanted surgically or in a transcatheter fashion.

Outcomes for PVE after TAVR are exceedingly poor, with a 67% mortality rate at 2-year follow-up (29); as reported in the most recent Guidelines, all studies performed to date [but one (30)] failed to demonstrate the potential benefit of surgery in IE post-TAVI patients. Nevertheless, IE represents 43% of indication for TAVR explantation (31).

The optimal strategy for the management of PVE in TAVR population is still unclear. Operative mortality in patients with previous TAVR versus SAVR was proven to be 13.6% vs. 10.8% (not statistically significant); mortality with STS-index procedure [e.g., coronary artery bypass grafting (CABG)] was significantly higher in patient with a previous TAVR compared to a previous SAVR 14.3% vs. 7.9% respectively as well as the observed-to-expected ratio 2.2 vs. 1.3 (32).

In this frame, reported outcomes might be biased in the selection of treatment. It has indeed been shown that 19% to 50% of PVE after SAVR undergo surgery during the index hospitalization due to acute heart failure caused by the prosthetic valve destruction, while only 14.8% of PVE after TAVR undergo surgery in spite of presenting at least one criterion for surgical indication in 80% of cases. The overall burden of existing comorbidities, older age, and subsequent higher-risk at baseline of the TAVR population overall impact whether surgery is offered. As stated in the most recent guidelines, the decision to proceed with surgery in patients with IE after TAVI should be individualized, balancing the surgical risks with the prognosis of offering medical treatment alone.

Conclusions

Current trends in the management of aortic valve diseases demonstrate an increasing adoption of transcatheter solutions in younger and lower-risk patients. With structural valve deterioration and IE being the most two common reasons for reoperations in patients with history of aortic valve replacements, the choice of a surgical versus a transcatheter option should be individualized, and carefully weighed along the lifetime management of aortic diseases. Additional real-world, long-term, propensity score matched data are warranted to further elucidate the outcomes of surgical versus transcatheter options with regards to durability and safety.

Acknowledgments

Funding: None.

Footnote

Peer Review File: Available at https://jovs.amegroups.com/article/view/10.21037/jovs-24-6/prf

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jovs.amegroups.com/article/view/10.21037/jovs-24-6/coif). A.A. serves as an unpaid editorial board member of Journal of Visualized Surgery from September 2023 to August 2025. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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