Korean J Intern Med > Epub ahead of print
Kook and Lim: Transcatheter aortic valve implantation for symptomatic severe aortic stenosis and its expanding clinical indications

Abstract

Transcatheter aortic valve implantation (TAVI) is a minimally invasive treatment for symptomatic severe aortic stenosis (AS) that was initially developed for patients with prohibitive surgical risk. Since the first-in-human procedure in 2002, TAVI has gained global acceptance owing to its favorable clinical outcomes and faster recovery than those associated with surgical aortic valve replacement. Landmark trials have demonstrated the noninferiority or superiority of TAVI across high-, intermediate-, and low-surgical risk populations, leading to guideline endorsement as a recommended option for appropriately selected patients across all surgical risk groups. Furthermore, long-term follow-up data support the durability of contemporary TAVI devices. Beyond its current established indications, TAVI is being explored for broader applications such as asymptomatic severe AS, moderate AS with heart failure, and pure aortic regurgitation; however, these uses remain investigational and are not yet part of formal guidelines. This review summarizes TAVI’s historical evolution, pivotal clinical trial evidence, and procedural innovations that have enabled its widespread use. We explore Korea-specific experiences with TAVI implementation, highlighting national registry data, healthcare policy considerations, and institutional adoption. Future perspectives include long-term device performance, lifetime valve management strategies, and the integration of artificial intelligence into transcatheter valve therapy.

INTRODUCTION

Aortic stenosis (AS) is a common, life-threatening valvular heart disease [1]. Once symptoms develop, severe AS has a grave prognosis, with a 1-year mortality rate of 30–50% if left untreated [2]. Surgical aortic valve replacement (SAVR) had been the only effective treatment for severe AS for several decades. This paradigm began to shift in 2002 when Cribier performed the first transcatheter aortic valve implantation (TAVI) in a patient with inoperable AS [3]. TAVI (also known as transcatheter aortic valve replacement, TAVR) involves delivering a bioprosthetic valve to the diseased aortic valve via a catheter, most often through the femoral artery. The advent of TAVI has revolutionized AS management and offers a less invasive alternative to SAVR.
Initially, TAVI was restricted to patients with prohibitive or high surgical risk; however, its use rapidly expanded as device technology and clinical outcomes improved. By 2015, over 70,000 TAVI procedures were performed annually worldwide, more than double the volume in 2012, and utilization is projected to continue growing to nearly 300,000 procedures by 2025 [4]. Accumulating evidence from randomized trials has progressively moved the indication toward lower-risk and younger patients. TAVI has transformed from a niche therapy to the preferred treatment for many patients with severe AS, supported by guidelines that now consider TAVI a Class I indication alongside SAVR in a broad range of risk profiles [5,6].
This review outlines the evolution of TAVI from its inception to current practice and explores the expanding indications for this technology. First, we summarize the key clinical trials and risk stratifications that have guided the use of TAVI in high-, intermediate-, and low-risk severe AS. Risk categories follow the Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) classification and include high (≥ 8%), intermediate (4–8%), and low (< 4%). We then discuss procedural advances and device iterations that have improved outcomes and expanded the applicability of TAVI. Next, we examine emerging indications, including asymptomatic severe AS, moderate AS with heart failure (HF), and pure aortic regurgitation (AR) by reviewing the latest evidence supporting these new frontiers. A dedicated section addresses the current status of TAVI in Korea, highlighting local registry data, reimbursement issues, and challenges. Finally, we discuss future perspectives on TAVI, including long-term valve durability and lifetime management strategies for patients with AS.

EVOLUTION OF TAVI: FROM HIGH-RISK TO LOW-RISK PATIENTS (TABLE 1)

Early experience in high-risk patients

TAVI was initially reserved for patients deemed inoperable or at extremely high risk for SAVR. The seminal PARTNER 1 trial established TAVI as a lifesaving option for this cohort. In PARTNER 1B, TAVI yielded a substantially lower 1-year mortality rate in inoperable patients compared to that observed with standard therapy (30.7% vs. 50.7%, p < 0.001) [2]. In high-risk but operable patients (PARTNER 1A), TAVI was similar to SAVR in terms of survival at 1 year (24.2% vs. 26.8% mortality, p = 0.44) [7]. These results provided landmark evidence that transcatheter therapy matches surgery in terms of efficacy for severe AS. The U.S. CoreValve High Risk Study further showed that a self-expanding TAVI device was superior to SAVR in high-risk patients, with significantly lower 1-year mortality (14.2% vs. 19.1%, p = 0.04), demonstrating TAVI’s potential to improve outcomes even in patients who could undergo surgery [8]. Based on these early trials, TAVI quickly became the standard of care for inoperable and high-surgical risk patients with symptomatic severe AS, earning Class I and IIa recommendations in the guidelines for these groups [9,10].

Expansion to intermediate risk

As operator experience increased and devices improved, attention turned to patients with intermediate surgical risk. The PARTNER 2A and SURTAVI trials demonstrated that TAVI was noninferior to SAVR in intermediate-risk patients in terms of the primary endpoints of death or disabling stroke [11,12]. In PARTNER 2A, the outcomes of TAVI at 2 years were comparable to those of surgery, with no significant differences in mortality or major stroke. TAVI was associated with higher rates of vascular complications and paravalvular leak (PVL), whereas SAVR was associated with higher rates of bleeding and new-onset atrial fibrillation, reflecting the trade-offs between the two approaches. Similarly, SURTAVI, using self-expanding TAVI valves, found no difference in 2-year survival or stroke between TAVI and SAVR in intermediate-risk patients, while TAVI yielded better early quality-of-life recovery. By 2017, the guidelines endorsed TAVI for patients with severe AS and intermediate surgical risk [13,14].

TAVI in low-risk patients

The final barrier fell in trials with low-risk patients (STS PROM < 4%). The NOTION trial in Denmark was an early all-comers study in mostly low-risk patients (mean STS PROM, ~3%), suggesting that TAVI might be as good as surgery even in younger, lower-risk individuals [15]. NOTION showed no significant difference in survival or stroke within 5 years between patients who underwent TAVI and those who underwent SAVR [16]. However, NOTION’s sample size was modest (n = 280), and early-generation valves were used; therefore, larger-scale trials were needed. The PARTNER 3 trial using SAPIEN 3 and the Evolut Low Risk trial using Medtronic Evolut R/PRO showed that TAVI is noninferior and even superior to SAVR in the short term in patients with low surgical risk [17,18]. The PARTNER 3 trial reported a composite primary endpoint of death, stroke, or rehospitalization at 1 year of 8.5% for TAVI versus 15.1% for surgery (p = 0.001 for superiority). Patients undergoing TAVI also experienced quicker recovery, shorter hospital stays, and better early quality of life than those undergoing SAVR. The Evolut Low Risk trial likewise met its noninferiority endpoint for 2-year death or disabling stroke (5.3% TAVI vs. 6.7% SAVR) and showed no difference in outcomes over 4 years [19]. A key issue for low-risk (and generally younger) patients is the long-term durability of transcatheter valves. Reassuringly, mid-term follow-up data have been positive; at 5 years, PARTNER 3 showed no significant difference in the composite of death, stroke, or rehospitalization between TAVI and SAVR (22.8% vs. 27.2%, p = 0.07) [20]. Structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) rates at 5 years were low and similar for TAVI and surgery (approximately 3–4% in both groups). In the NOTION 10-year analysis, no difference in all-cause mortality or stroke was found between TAVI and SAVR; notably, TAVI had lower rates of SVD than SAVR (1.5% vs. 10% severe SVD, p = 0.02). The excellent performance of modern TAVI devices over 5–10 years in trials supports the expansion of TAVI to lower-risk younger patients, although continued surveillance is needed. Current guidelines endorse TAVI as an alternative to surgery, even in low-risk patients aged 65–75 years, after shared decision-making by the Heart Team, considering anatomy, comorbidities, and patient preferences [5,6].

Device iterations and improved outcomes (Table 2)

The progressive success of TAVI in a broader population has been facilitated by iterative improvements in device technologies and procedural techniques. First-generation TAVI devices proved the concept but had limitations, such as large profiles (22–24 French delivery systems), which led to more frequent vascular complications and a higher incidence of PVL due to suboptimal sealing. Over the past decade, transcatheter valves have evolved over multiple generations with significant design enhancements.
The SAPIEN 3 valve introduced an outer sealing skirt that substantially reduced significant PVL rates. In PARTNER 3, moderate-or-worse PVL occurred in only 0.9% of patients who underwent TAVI at 5 years [20], while the incidence was 4.1% at 5 years using the previous SAPIEN XT valve [21]. Self-expanding valves such as the Evolut PRO also incorporated outer skirts, achieving similarly low rates of significant PVL [22]. Device profiles have shrunk (now compatible with 14–18 French sheaths), contributing to a marked decline in access-site complications and major bleeding.
Concurrently, most TAVI procedures (> 95%) are performed via the transfemoral route under local anesthesia with conscious sedation, eliminating the need for general anesthesia and surgical incisions [23]. This “minimalist” TAVI approach has further streamlined recovery, often allowing discharge within 1–3 days for uncomplicated cases [24].

Complication trends

Some TAVI-specific complications have improved over time, although certain challenges remain. PVL has dramatically decreased with new valve designs. Moderate-or-severe PVL is now rare, whereas it was more common and associated with worse outcomes in first-generation devices [25,26].
Conduction disturbances requiring permanent pacemaker implantation occur more frequently with TAVI than with SAVR, especially with self-expanding valves. In early trials, new pacemaker implantation was required in < 10% of patients who underwent TAVI with balloon-expandable valves and in up to 20% of those with self-expanding valves [2,7,8]. Efforts such as refined implantation techniques (e.g., the cusp overlap view to minimize depth) and newer-generation self-expanding valves aim to reduce pacemaker rates. In Evolut Low Risk, approximately 17% of patients who underwent TAVI still required pacemakers [18]. However, long-term data suggest that the need for a pacemaker after TAVI has not translated into differences in mortality at 5 years [27].
Stroke has also been a concern in TAVI, with early trials showing a slightly higher periprocedural stroke risk than SAVR [7]. With refined technique and the possible use of adjunctive embolic protection in select cases, stroke rates have declined and are now comparable between TAVI and SAVR (~1–3% at 30 days in recent low-risk studies) [17,18]. However, despite the overall procedural learning curve achieved in recent years, the residual risk of stroke after TAVI remains an unresolved challenge [28,29]. Ongoing research is warranted to better identify patient populations who may benefit from cerebral embolic protection as well as to evaluate the efficacy and safety of next-generation cerebral embolic protection devices.
Overall, as the field matures, TAVI outcomes have steadily improved to the point that, in experienced centers, 30-day mortality is consistently < 2–3%, even in elderly patients, and complication rates are acceptably low.

EXPANDING INDICATIONS BEYOND SYMPTOMATIC SEVERE AS

TAVI in asymptomatic severe AS

Rationale

Some patients with severe AS remain asymptomatic; however, the timing of intervention in such cases is controversial. Historically, watchful waiting has been advised until symptom onset, given the risks of early surgery. However, recent surgical studies have suggested benefits of early AVR in select asymptomatic patients. The RECOVERY and AVATAR trials randomized asymptomatic patients with severe AS to early SAVR or observation; early surgery led to superior survival, suggesting that waiting for symptoms could be harmful [30,31].

Clinical trials

The EARLY TAVR trial (Evaluation of Transcatheter Aortic Valve Replacement Compared to Clinical Surveillance in Asymptomatic Severe Aortic Stenosis; NCT03042104) enrolled 910 asymptomatic patients with severe AS who were at low surgical risk [32]. Participants were randomized to undergo early TAVI with a balloon-expandable valve (n = 455) or conservative management with close surveillance (n = 455). At a median follow-up of 3.8 years, the primary endpoint, a composite of all-cause death, stroke, or unplanned cardiovascular hospitalization, occurred in 26.8% of patients in the TAVI group and in 45.3% of patients in the surveillance group (hazard ratio, 0.50; 95% confidence interval, 0.40 to 0.63; p < 0.001). These findings suggest that preemptive TAVI in asymptomatic patients with severe AS can be performed safely, resulting in improved clinical outcomes compared to those seen with watchful waiting. These results represent a paradigm shift in the management of severe AS, suggesting that early intervention could prevent irreversible myocardial damage and sudden decompensation. EASY-AS is an ongoing trial and is expected to further support the findings of the EARLY TAVR trial [33].

Current perspective

The 2021 European Society of Cardiology (ESC) guidelines provide a Class IIa recommendation for AVR in asymptomatic patients with very severe AS or in those with highrisk features [6]. The potential benefits must be balanced against procedural risks and the finite lifespan of bioprosthetic valves. The ongoing trials will help clarify whether “the sooner the better” holds true for TAVI in patients with severe AS.

TAVI in moderate AS with HF

Rationale

Moderate AS has traditionally been managed medically, as SAVR has been reserved for severe AS. However, moderate AS is not benign, particularly when accompanied by HF [1]. In patients with HF and reduced ejection fraction (HFrEF), even moderate stenosis may contribute additional afterload to the left ventricle, potentially worsening HF symptoms and outcomes. Retrospective studies have shown that patients with HFrEF and coexisting moderate AS have worse prognoses than those without AS [34,35]. This has raised the question of whether intervention on the valve via TAVI could benefit patients who do not yet meet the criteria for severe AS and advanced HF.

TAVR UNLOAD trial

To address this question, the Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in patients with Advanced Heart Failure (TAVR UNLOAD) trial was designed [36]. TAVR UNLOAD enrolled 178 patients with moderate AS and left ventricular ejection fraction ≤ 50%, all of whom were on guideline-directed medical therapy for HF. Participants were randomized to receive TAVI plus medical therapy or medical therapy alone, with the hypothesis that unloading the valve would improve outcomes. The primary endpoint was a hierarchical composite of all-cause death, disabling stroke, hospitalization for HF, and change in quality of life at 1 year.
The results of TAVR UNLOAD showed that while TAVI in moderate AS was feasible and improved valve hemodynamics, it did not significantly reduce clinical events at 1 year compared to those observed with medical therapy alone [37]. The trial failed to meet its primary composite endpoint, as the rates of death and HF hospitalization were not significantly different between the TAVI and medical therapy groups at 1 year. The trial had slower enrollment and analyzed fewer patients than planned, which may have limited its power. Notably, 43% of patients in the medical therapy group underwent TAVI at a median of 12 months after randomization, mainly because of progression to severe AS.

Implications and future directions

The neutral results of TAVR UNLOAD place brakes on the immediate expansion of TAVI to moderate AS in patients with HFrEF. Performing TAVI “preemptively” in moderate AS does not appear to be universally beneficial. However, subgroup analyses are ongoing to determine whether certain patients (for example, those with more severe “moderate” AS or specific flow characteristics) did benefit. Other trials are underway or planned. The EXPAND II trial (NCT05149755) is enrolling patients with symptomatic moderate AS to determine whether early TAVI using a self-expanding valve delays disease progression or improves outcomes. Another study, the PROGRESS trial (NCT04889872), is evaluating Edwards’ newest-generation balloon-expandable valve in populations with moderate AS.

TAVI for pure AR

Challenges in pure AR

Until recently, severe AR has remained the domain of surgery because its anatomy and pathophysiology differ from those of AS. In pure AR, the aortic valve leaflets are often non-calcified but flail or prolapsed, leading to a large regurgitant orifice. Transcatheter valves rely on calcified leaflets or annular calcifications to secure the prosthesis. In a pure AR setting, early-generation TAVI devices implanted off-label had high complication rates, including acute valve embolization or migration due to lack of anchoring, and significant residual regurgitation due to incomplete sealing of a non-calcified annulus [38]. Consequently, conventional TAVI has not been approved for native AR, and patients at high surgical risk without surgical options have had limited treatment choices.

Dedicated TAVI devices for AR

To address this unmet need, new transcatheter valve designs specific to AR have been developed. One such device is the JenaValve Trilogy system, which uses dedicated anchor mechanisms to grasp the native leaflets and secure the valve in a regurgitant setting. The ALIGN-AR trial, a single-arm pivotal study, evaluated JenaValve Trilogy for treating native AR in patients at high surgical risk [39]. ALIGN-AR enrolled 180 symptomatic patients with moderate-to-severe or severe AR who were poor candidates for surgery. Technical success was 95%, and the 30-day composite safety endpoint, including death, stroke, and major complications, occurred in 27% of patients, comfortably meeting the performance goal for safety. By day 30, all-cause mortality and disabling stroke rates were 2% and 1%, respectively. Importantly, the device effectively eliminated significant regurgitation in the vast majority of patients (< 1%). At 1 year, the all-cause mortality rate was 7.8%, which met the pre-specified efficacy benchmark (expected mortality < 25%). Approximately 24% of patients required a new permanent pacemaker after 30 days. The favorable outcomes of ALIGN-AR indicate that a transcatheter solution for pure AR is feasible and effective in high-risk patients.

Current status

In clinical practice, off-label TAVI for AR has been performed in select cases using available devices, with mixed results. A recent multicenter analysis showed acute success in approximately 80% of off-label TAVI cases for AR using newer valves but also highlighted the frequent need for a second valve in about 20% of cases and higher pacemaker rates [40]. Thus, a purpose-built valve such as JenaValve is highly anticipated. Dedicated TAVI systems for AR are progressing toward potential clinical applications. The JenaValve Trilogy received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) and may obtain regulatory approval for use in high-risk AR in the near future based on the results of the ALIGN-AR trial. This development has the potential to address an important unmet need for the treatment of patients with inoperable AR.

TAVI in patients with bicuspid AS

Many younger patients (< 70 yr) with severe AS have a bicuspid aortic valve (BAV), a congenital valve abnormality that often causes calcification and stenosis in the 6th or 7th decade of life. BAV presents anatomical challenges for TAVI, including an elliptical annulus, asymmetric bulky calcification, and often-associated aortopathy. Early TAVI procedures in patients with bicuspid AS showed higher rates of complications such as PVL and the need for a second valve owing to suboptimal expansion [41]. However, newer-generation valves and refined techniques have substantially improved the outcomes of TAVI in this population [42].
Registries of TAVI in patients with BAV demonstrate that, with careful case selection, TAVI can achieve a prognosis equivalent to that of tricuspid valves [43,44]. A propensity-matched analysis using data from European databases showed no significant difference in 30-day mortality or stroke between bicuspid and tricuspid AS TAVI cases using contemporary valves, although bicuspid cases had a slightly more frequent need for pre- and post-dilation [45]. In China and India, where bicuspid AS is very common, TAVI has been widely performed in bicuspid anatomies with encouraging results, as reported in local series [46,47].
Thus, while younger patients with bicuspid AS are generally advised to undergo SAVR, TAVI is emerging as a reasonable alternative treatment option for this population.

Valve-in-valve (ViV) TAVI

An established and increasingly utilized application of TAVI is the ViV procedure for degenerative bioprosthetic valves (surgical or transcatheter). An increasing number of patients have previously undergone surgical bioprosthetic AVR, which has a limited lifespan. TAVI can be used to treat BVF by implanting a new transcatheter valve inside the old valve, thereby avoiding reoperation.
ViV TAVI has become standard practice and is included in guidelines as a recommended option for high-risk patients with failed surgical bioprostheses [5,6]. Outcomes from global ViV registries show high procedural success and good intermediate-term results [48], although transvalvular gradients can be higher if the original surgical valve is small [49].
This expanded indication has been a major contributor to the concept of “lifetime management” of AS, as some surgeons now choose a bioprosthetic surgical valve instead of a mechanical valve for younger patients, with the plan that a ViV TAVI can extend the valve’s life when it eventually fails. The expanding experience with ViV TAVI reinforces the versatility of transcatheter valves in a range of scenarios beyond de novo AS.

CURRENT STATUS OF TAVI IN KOREA

TAVI was introduced in South Korea in the early 2010s, with initial cases performed at a few hospitals soon after the therapy gained worldwide approval. However, widespread adoption lagged slightly behind that of other countries because of regulatory and reimbursement hurdles. As of 2025, approximately 50 government-authorized hospitals in Korea perform TAVI, reflecting the broad diffusion of this technology across the country. Authorized TAVI centers are required to establish specialized Heart Teams comprising interventional and imaging cardiologists, cardiothoracic surgeons, radiologists, and anesthesiologists.

K-TAVI registry findings

The Korean Transcatheter Aortic Valve Implantation (K-TAVI) registry provides valuable insights into real-world TAVI outcomes and trends in Korea. The first report from this registry included 576 patients who underwent TAVI between June 2015 and June 2017 in 17 hospitals [50]. The patient population had a mean STS PROM of 5.2%, and only 34.7% were at high surgical risk (STS PROM ≥ 8%). Data showed that 98.3% of the procedures were performed via transfemoral access. Device success was high (92.5%), and the need for a second valve or serious complications was low.
Complication rates were comparable to those in global trials, with 5.6% of patients required a new pacemaker, 30-day stroke occurred in 1.2%, and access-site complications occurred in 6.8%. Importantly, outcomes improved with experience over those two years, with later cases having significantly lower rates of PVL and major bleeding than earlier cases. The 1-year survival rate was 91.1%, and 1-year outcomes were significantly better in low- and intermediate-risk patients than in high-risk patients (mortality, 5.4% vs. 15.5%, p < 0.001). Independent predictors of 1-year mortality included advanced age, end-stage renal disease, and moderate or worse residual PVL.

Reimbursement and policy

A key factor in South Korea has been reimbursement. Initially, TAVI was not covered by the National Health Insurance, meaning that only self-paying patients (or research participants) could receive it, which limited access. In 2015, partial insurance reimbursement was granted for high-risk patients meeting specific criteria (such as STS PROM ≥8% or porcelain aorta). This enabled more patients to undergo the procedure. Over time, as evidence accumulated, the reimbursement criteria expanded.
Currently, Korean insurance covers TAVI for patients with severe AS who are elderly (≥ 80 yr), at high surgical risk (STS PROM ≥ 8%), or contraindicated for surgery. Lower-risk and younger patients may still face limited insurance reimbursement. Economic analyses have shown that TAVI is cost-effective and even cost-saving relative to surgery when considering shorter hospital stays and the avoidance of prolonged recovery [51-53]. Korean policy is evolving with these considerations, and the continued collection of local cost and outcome data will inform future reimbursement decisions.

FUTURE PERSPECTIVES

Long-term durability and lifetime management

Perhaps the most crucial question for the future of TAVI is how long transcatheter bioprosthetic valves will last, especially when used in younger patients. Early evidence on durability is reassuring. No significant differences in the composite of death, stroke, or myocardial infarction were observed between the TAVI and SAVR groups at 10 years in the NOTION trial [54]. Importantly, the incidence of SVD was lower in TAVI valves than in surgical valves (1.5% vs. 10% for severe SVD, p = 0.02), although this may partly reflect differences in the performance of self-expandable TAVI valves relative to surgical bioprostheses. The BVF rates were similar. In the 5-year follow-up of PARTNER 3, freedom from BVF was 96.7% for TAVI, which was not significantly different from that for surgery [20]. These findings suggest that TAVI valves are as durable as surgical tissue valves in elderly patients.
While these findings are encouraging, noting that most patients enrolled in these trials were of advanced age (mean age 80 yr in NOTION, 73 yr in PARTNER 3) remains important. We still lack data on TAVI durability in younger patients, as they have not been routinely treated with this approach. Although favorable long-term durability data for older patients are reassuring, extrapolation to younger populations requires caution. Younger individuals typically have higher activity levels and longer life expectancies, which may subject the prosthetic valve to greater mechanical stress and increase the likelihood of requiring reintervention during their lifetime, even with devices demonstrating > 10-year durability.
This leads to the concept of lifetime management [55]. For a 60-year-old patient with severe AS, options include SAVR with a mechanical valve (unlikely to require reintervention but necessitating lifelong anticoagulation with substantial bleeding risk), SAVR with a tissue valve (expected degeneration in 10–15 yr, then possibly a TAV-in-SAV), or TAVI (less invasive initially but may require another TAVI or SAVR later when the valve fails). However, the sequence that yields the best long-term outcomes and quality of life remains unknown. A “TAVI-first” strategy followed by a second TAVI (TAV-in-TAV) could potentially allow a patient to live another 20–25 years with only two minimally invasive procedures, which may be preferable to an initial SAVR and later reoperation.
However, performing TAV-in-TAV presents technical challenges [56]; the cumulative frame may elevate gradients or obstruct the coronaries, and may hinder future coronary access because of multiple overlapping layers of stent struts. Some bench studies suggest that up to two or three TAVI layers are feasible, but careful planning is required. Alternatively, SAVR after an initial TAVI explantation is another strategy, but it is a complex reoperation with substantial surgical risk [57]. Computational modeling and imaging techniques are being actively researched to optimize these sequences [56,58].
Currently, most Heart Teams approach lifetime management on an individual basis, considering each patient’s age, anatomy, and preferences. In the future, more refined guidelines are anticipated, perhaps algorithms that incorporate variables such as patient age, valve type, life expectancy to suggest optimal initial treatment and plans for possible subsequent interventions.

Artificial intelligence (AI) integration

AI and machine learning are poised to make significant contributions to the TAVI field in several ways [59,60]. First, patient selection and risk stratification can be improved by AI algorithms, which better predict which patients would benefit most from TAVI versus SAVR by analyzing large datasets of clinical variables, imaging, and frailty metrics beyond what traditional risk scores provide. Second, preprocedural planning can be greatly enhanced by AI through automating the analysis of CT scans used for TAVI sizing. Current practice requires meticulous manual measurement of factors such as annular dimensions, leaflet calcification, and vessel size. AI software can quickly provide precise measurements, detect issues such as low coronary height or bicuspid morphology, and recommend the best projection angles and implant depths. This can standardize planning and reduce errors. Third, intraprocedural guidance can benefit from AI integration with imaging modalities to guide valve deployment, providing real-time feedback on alignment and predicting the risk of complications such as annular rupture or coronary obstruction during the procedure. Fourth, post-procedure follow-up can be enhanced by AI algorithms that analyze echocardiography and clinical data to detect early signs of TAVI valve degeneration or complications, prompting timely interventions.

CONCLUSION

TAVI has evolved remarkably, transitioning from an alternative therapy for SAVR in patients with inoperable severe AS to a widely adopted treatment across the full spectrum of symptomatic severe AS, including patients at low surgical risk. Accumulated data from randomized controlled trials and real-world registries have consistently demonstrated that TAVI offers outcomes comparable to those of SAVR, with added benefits in terms of lower procedural invasiveness and faster recovery.
Beyond its established indications, TAVI is increasingly being investigated in broader clinical contexts such as asymptomatic severe AS, moderate AS with HF, and isolated AR, although these applications have not yet been incorporated into current guidelines. These exploratory efforts reflect the growing recognition of the potential for earlier and more individualized transcatheter interventions.
The future trajectory of TAVI will likely depend on two critical domains: ensuring the long-term durability of transcatheter bioprosthetic valves and developing optimized lifetime management strategies, particularly for younger and more physically active patients. Ongoing innovations such as next-generation valve platforms and enhanced cerebral embolic protection devices aim to address some of the current procedural limitations. Furthermore, the incorporation of advanced imaging modalities and AI-driven machine learning algorithms holds promise for improving patient selection, procedural planning, and individualized care pathways.
The role of the multidisciplinary Heart Team will remain essential in balancing procedural benefits against long-term risks, especially as TAVI expands into increasingly complex and heterogeneous patient populations. As the field continues to evolve, ongoing research and longitudinal data will be key to informing best practices and ensuring optimal outcomes for patients undergoing aortic valve replacement.

Notes

CRedit authorship contributions
Hyungdon Kook: conceptualization, methodology, resources, investigation, data curation, formal analysis, validation, writing - original draft; Young-Hyo Lim: conceptualization, methodology, resources, investigation, formal analysis, validation, writing - review & editing, visualization, supervision
Conflicts of interest
The authors disclose no conflicts.
Funding
None

Table 1.
Landmark TAVI clinical trials
Surgical risk group Trial Comparator Key outcomes Interpretation
High/inoperable PARTNER 1A SAVR 1-year mortality: TAVI 24.2%, SAVR 26.8%, p = 0.44 Noninferior
PARTNER 1B Medical 1-year mortality: TAVI 30.7%, medical 50.7%, p < 0.001 Superior
U.S. CoreValve High Risk Study SAVR 1-year mortality: TAVI 14.2%, SAVR 19.1%, p = 0.04 Superior
Intermediate PARTNER 2A SAVR 2-year mortality/stroke: no significant difference Noninferior
SURTAVI 2-year mortality/stroke: no significant difference Noninferior; faster recovery
Low NOTION SAVR 10-year outcomes: no significant difference Noninferior
PARTNER 3 1-year outcomes (composite endpoint: death, stroke, rehospitalization): TAVI 8.5%, SAVR 15.1%, p = 0.001 Superior in short-term clinical outcomes, shorter hospitalization
5-year outcomes: TAVI 22.8%, SAVR 27.2%, p = 0.07 Noninferior in long-term clinical outcomes
Evolut-LR 2-year mortality/stroke: no significant difference Noninferior
4-year mortality/stroke: no significant difference

TAVI, transcatheter aortic valve implantation; SAVR, surgical aortic valve replacement.

Table 2.
Procedural comparison between TAVI and SAVR
TAVI SAVR
Access site Transfemoral Sternotomy
Anesthesia Local anesthesia / conscious sedation General anesthesia
30-day mortality < 2–3% Similar or slightly higher
Recovery time 1–3 days, shorter length of stay 5–7 days
Major complications Stroke Stroke
Access site bleeding Surgical site bleeding
Pacemaker Atrial fibrillation
Ease of reintervention Valve-in-valve TAVI Redo-surgery required
Valve-in-valve TAVI feasible in bioprosthetic SAVR
Long-term durability Proven up to 8–10 years; longer-term data awaited Bioprosthetic SAVR: 10–15 years
Mechanical SAVR: lifelong, anticoagulation mandatory

TAVI, transcatheter aortic valve implantation; SAVR, surgical aortic valve replacement.

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