Comparison of TAVR and SAVR in elderly patients with pure native aortic regurgitation: outcomes and midterm results

Introduction

Transcatheter aortic valve replacement (TAVR) is a primary treatment for aortic stenosis (AS) patients deemed inoperable or at high risk for surgical aortic valve replacement (SAVR). Over the past five years, its use has broadened to include also low-intermediate-risk patients (1-9). TAVR is revolutionizing the treatment landscape for AS patients across all risk groups, yet the consensus is still that aortic regurgitation (AR) is not recommended for TAVR (10-15). The primary cause for this is the specific pathogenic mechanism of AR. Patients with AR frequently have an expanded aortic annulus and little valve calcification in their anatomical characteristics. These features challenge the secure placement of early-generation TAVR valves, frequently resulting in secondary valve implantation, valve dislocation, and paravalvular leakage after surgery (16).

Numerous clinical trials have been conducted to assess the advantages and drawbacks of both TAVR and SAVR, as well as to confirm the effectiveness of TAVR (2,4,17,18). Nevertheless, the majority of these clinical trials focus on patients with AS, and there is little research comparing the disadvantages, advantages, and effectiveness of TAVR to SAVR in pure native AR patients. As several kinds of second-generation TAVR devices have been developed, such as the Medtronic Engager (Medtronic Inc., Minneapolis, Minn, USA), the Symetis Acurate (Symetis SA, Ecublens, Switzerland), the indication for TAVR has been broadened to include inoperable or high-risk patients who have AR but no annular or leaflet calcification. J-Valve™ system (Jie Cheng Medical Technologies, Suzhou, China) is a self-expanding interventional aortic valve with a uniquely designed positioning key that enhances anchoring by autonomously positioning and clamping the valve leaflets. Because of its special valve anchoring and positioning mechanism, the J-Valve™ device may help overcome certain limitations associated with TAVR in patients with aortic valve disease. A number of clinical trials have been performed to validate its safety and short- to medium-term efficacy (19-22).

This study retrospectively analyzed patients with pure native AR at our institution who underwent either TAVR or SAVR. Using propensity score weighting, we assessed and compared the mid-term outcomes of these interventions, aiming to provide more robust evidence for employing TAVR in patients with pure native AR. We present this article in accordance with the STROCSS reporting checklist (available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-115/rc).

Methods

Study design and participants

A retrospective cohort study was conducted between January 2018 and June 2023, 220 elderly patients (age ≥65 years) with pure native AR underwent TAVR or bioprosthesis SAVR in Beijing Anzhen Hospital. Pure native AR is defined as isolated diastolic retrograde flow from the aorta into the left ventricle due to native valve incompetence, without prior aortic valve intervention or coexisting aortic stenosis requiring treatment (peak velocity <300 cm/s, mean gradient <20 mmHg on transthoracic echocardiography). Patients with a history of aortic valve intervention, TAVR in a prosthetic valve that fails may provide distinct dangers and challenges compared to native aortic valves were excluded from this study. Eighty-five of the remaining 208 patients were included in the TAVR group, while 123 patients were included in the SAVR group.

The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Research Ethics Committee of Beijing Anzhen Hospital, Capital Medical University, Beijing, China (No. 2025106X) and individual consent for this retrospective analysis was waived.

Surgical procedure

According to the latest guidelines, symptomatic patients with severe AR or asymptomatic patients with chronic severe AR and left ventricular systolic dysfunction, aortic valve surgery is indicated (6). All patients in this study were assessed as requiring surgery for AR. The indications for TAVR surgery in this study are based on the consensus of the Chinese experts, combined with previous guidelines on the timing of chronic AR intervention. Patients at high risk for surgical procedures or contraindications (such as previous chest radiotherapy, severe adhesions, etc.), advanced age (>65 years old), and multiple comorbidities [such as chronic obstructive pulmonary disease (COPD), end-stage renal disease, etc.] may be candidates for TAVR after multidisciplinary discussion considering factors such as valve durability, patient life expectancy, anatomical suitability, and surgical risk. Patients in the TAVR group underwent transapical pathway valve replacement (general anesthesia with endotracheal intubation, left intercostal incision) using the J-valve™ system, which size from 23–29, and patients in the SAVR group underwent simple aortic valve replacement with a median sternotomy approach under cardiopulmonary bypass, SAVR group was perform with biological valve, including Edwards 2800TXF™, 3300TXF™, Inspiris™ (Edwards Lifesciences, Irvine, CA, USA); Medtronic Mosaic™, HancookII Ultra™ (Medtronic Inc., Minneapolis, Minn, USA), St. Jude Medical Epic™ (SJM Epic™; St. Jude Medical Inc., St. Paul, MN, USA), and size from 21–27.

Outcomes assessment

All Patients were clinically assessed during perioperative period and up to 3 years post-implant. This study included both the in-hospital period and the follow-up of TAVR and SAVR patients. The outcomes assessment included in-hospital mortality, follow-up all-cause mortality, cardiac mortality, reoperation, postoperative all-cause stroke, postoperative acute myocardial infarction, postoperative atrial fibrillation, postoperative vascular complications, postoperative thrombosis; and the need for extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP) assistance, tracheotomy, dialysis, and permanent pacemaker placement. Cardiac mortality refers to death caused by cardiac dysfunction or structural abnormalities, including fatal complications due to heart disease, such as acute myocardial infarction, heart failure, fatal arrhythmias, and complications from cardiac surgery.

Statistical analysis

The data for this study is sourced from the retrospective review of electronic medical records. All variables involved in this study were processed first, then analyzed by descriptive statistics according to the variable type. For categorical variables, descriptive statistics were presented as frequencies with percentages, and for continuous variables, as a median interquartile range (IQR) due to the unfollowing of the normal distribution. For categorical variables and independent samples, Pearson χ² test and Fisher’s exact test were used to compare baseline characteristics; for continuous variables, a Mann-Whitney U test was used. Propensity score weighting using the overlap weighting method was applied to adjust for measured confounders. Propensity scores were estimated using a logistic regression model incorporating baseline characteristics [age, sex, body mass index (BMI), Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score], comorbidities (hypertension, atrial fibrillation, COPD, previous cardiac surgery, peripheral vascular disease, coronary artery disease, chronic hepatic disease, all-cause stroke, diabetes mellitus), and echocardiographic parameters [left ventricular ejection fraction (LVEF), left ventricular systolic diameter (LVSD), left ventricular diastolic diameter (LVDD), valve dimensions, aortic valve maximum velocity]. Variable selection was based on clinical relevance and previous literature indicating their association with both treatment assignment and clinical outcomes. The propensity score weighting approach was used to calculate the weight of each patient. Covariate balance after propensity score weighting was assessed using standardized mean differences (SMDs), with values <0.1 indicating acceptable balance (details are shown in Figure S1). Subsequently, weighted survival curves were generated using Kaplan-Meier estimates, and group comparisons were performed using a Cox proportional hazards model with robust variance estimators to account for the weighting. All analyses were performed using R version 4.1.2 (R Foundation for Statistical Computing), statistical significance was considered at P<0.05.

Results

Baseline characteristics

Between January 2018 and June 2023, this cohort study included a total of 208 elderly patients with pure native AR who underwent aortic valve replacement. Of those, 85 patients had TAVR, accounting for 40.9%, whereas 123 patients had SAVR, accounting for 59.1% of all patients. Table 1 shows the baseline characteristics of this study.

The median age in the TAVR group was 74.0 [interquartile range (IQR), 70.0–77.0] years, whereas the SAVR group was 68.0 (IQR, 66.0–70.0) years (P<0.001). Male patients represented 72.9% of in TAVR group while 77.2% in SAVR group (P=0.48). The TAVR group had lower body mass index [median 23.3 (IQR, 21.3–25.9) vs. 24.6 (IQR, 22.7–26.5) kg/m², respectively; P=0.01] and higher STS-PROM scores [median 1.9 (IQR, 1.4–3.1) vs. 1.2 (IQR, 1.0–1.8), respectively; P<0.001] compared with SAVR group. There were significant differences in the comorbidities between the TAVR and SAVR groups in the history of hypertension (70.6% vs. 89.4%, P<0.001), atrial fibrillation (18.8% vs. 1.6%, P<0.001), chronic obstructive pulmonary disease (17.6% vs. 4.9%, P=0.003), and previous cardiovascular intervention (10.6% vs. 3.3%, P=0.03). Laboratory data after admission showed the TAVR group had higher B-type natriuretic peptide (BNP) than the SAVR group [median 207 (IQR, 75–491) vs. 103 (IQR, 45–219) pg/mL; P<0.001]. Echocardiography before the surgery had lower LVEF in the TAVR group [median 55% (IQR, 48–60%) vs. 60% (IQR, 55–64%); P<0.001], and larger LVSD [median 42 (IQR, 37–49) vs. 40 (IQR, 34–44) mm; P=0.008]. Meanwhile, the percentage of patients combined with mitral or tricuspid valve regurgitation of more than a moderate degree in the TAVR group was higher (38.8% vs. 9.8%, P<0.001; 17.6% vs. 3.3%, P<0.001, respectively). Of all patients who underwent TAVR for pure or predominant aortic valve insufficiency, 1 patient (1.2%) had a bicuspid aortic valve, whereas 4 patients (3.3%) of the SAVR group had this anomaly (P=0.65).

Procedural characteristics

Patients in the TAVR group had shorter operation time than those in the SAVR group [median 190 (IQR, 150–248) vs. 240 (IQR, 210–267) min; P<0.001]. None of the patients in the TAVR group transferred to SAVR or received IABP or ECMO assistance in the operating room in this study. However, 3 patients (3.5%) underwent cardiopulmonary bypass due to unstable circulation in the TAVR group (Table 2).

In-hospital outcomes

The all-cause mortality in TAVR group during the in-hospital period was significantly higher than the SAVR group after adjustment (15.8% vs. 6.6%; P=0.003), while there was no difference in cardiac mortality (4.3% vs. 3.3%; P=0.58). The TAVR group, however, saw more adverse results in terms of the requirement for a permanent pacemaker (11.5% vs. 0.0%; P<0.001), and vascular complications (8.7% vs. 0.0%; P<0.001) after adjustment. No significant statistical difference in intensive care unit (ICU) time was seen between the TAVR and SAVR groups [median 24.3 (IQR, 12–24) vs. 28.4 (IQR, 18–26) h; P=0.15], hospitalization time [median 7.8 (IQR, 6.0–8.0) vs. 7.5 (IQR, 6.0–8.0) days; P=0.14], all-cause stroke (0.4% vs. 1.6%; P=0.18), tracheotomy (1.2% vs. 1.6%; P=0.68), acute myocardial infarction (0.0% vs. 0.6%; P=0.24), and thrombosis (0.8% vs. 0.6%; P=0.77) after adjustment (Table 3).

The TAVR group showed significantly larger effective orifice area (EOA) [median 2.1 (IQR, 2.0–2.2) vs. 1.6 (IQR, 1.5–1.8) cm²; P<0.001] and EOA index [median 1.2 (IQR, 1.1–1.3) vs. 0.9 (IQR, 0.8–1.0) cm²/m²; P<0.001] than the SAVR group before discharge after adjustment (Figure 1A). None of the patients had severe prosthesis-patient mismatch in both SAVR and TAVR groups. Consistently, post-operative before discharge, the maximum velocity of the aortic valve [median 180.6 (IQR, 151.0–208.0) vs. 236.1 (IQR, 212.0–253.0) cm/s; P<0.001] and the maximum pressure gradient [median 13.9 (IQR, 9.0–17.0) vs. 23.2 (IQR, 19.0–27.0) mmHg; P<0.001] were, after adjustment, much lower in TAVR group (Figure 1B). While the incidence of perivalvular leakage was higher in the TAVR group than in the SAVR group before discharge (17.9% vs. 0%; P<0.001), no patients in this study had a leakage of more than a moderate degree.

Figure 1 Hemodynamic characteristics in TAVR and SAVR groups during the perioperative period. (A) EOA and EOA index between the two groups after aortic valve replacement. (B) Echocardiography data between the two groups before and after operation. *, P<0.05; **, P<0.01; ***, P<0.001. AV, aortic valve; EOA, effective orifice area; LAD, left atrial diameter; LVDD, left ventricular diastolic diameter; LVEF, left ventricular ejection fraction; LVSD, left ventricular systolic diameter; MPG, maximum pressure gradient; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.

Follow-up results

After a median follow-up of 3.1 years (IQR, 1.9–4.8 years), TAVR was associated with higher unadjusted [hazard ratio (HR), 3.124; 95% confidence interval (CI), 1.336–7.307; P=0.006] and adjusted (HR, 2.786; 95% CI, 1.819–9.472; P=0.001) risk of all-cause mortality in comparison with SAVR. One year after discharge, 199 (98.0%) patients survived, comprising 78 (96.3%) in the TAVR group and 121 (99.2%) patients in the SAVR group. There was no significant statistical difference in cardiac mortality in the SAVR and TAVR groups during follow-up, both unadjusted (HR, 2.726; 95% CI, 0.797–9.327; P=0.10) and adjusted (HR, 1.680; 95% CI, 0.364–7.744; P=0.30) (Figure 2). In detail, 2 patients died of COVID-19, 2 patients died of infection, 2 patients died of stroke, and 1 patient died of malignant tumor in the TAVR group; 1 case died of stroke, and 3 cases died of malignant tumors in the SAVR group, respectively.

Figure 2 Kaplan-Meier curves for all-cause mortality and cardiac mortality before and after adjustment. (A) All-cause mortality before adjustment. The TAVR group had a higher mortality than the SAVR group before adjustment (log-rank P=0.006, HR =3.124, 95% CI: 1.336–7.307). (B) Cardiac mortality before adjustment. There is no statistical difference between the two groups (log-rank P=0.10, HR =2.726, 95% CI: 0.797–9.327). (C) All-cause mortality after adjustment. The TAVR group had a higher mortality than the SAVR group after adjustment (log-rank P=0.001, HR =2.786, 95% CI: 1.819–9.472). (D) Cardiac mortality after adjustment. There is no statistical difference between the two groups (log-rank P=0.30, HR =1.680, 95% CI: 0.364–7.744). CI, confidence interval; HR, hazard ratio; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.

There were no significant statistical differences between the SAVR and TAVR in all-cause stroke (7.4% vs. 3.3%, P=0.32), aortic valve redo (0% vs. 0.8%, P>0.99), acute myocardial infarction (1.2% vs. 0%, P=0.40), dialysis (1.2% vs. 0%, P=0.40), and permanent pacemaker implanted (1.2% vs. 0.8%, P>0.99) (details are shown in Table S1).

Echocardiography

In the TAVR group, 69.4% of patients underwent the latest echocardiographic evaluations, compared to 76.4% in the SAVR group. The maximal velocity was much lower in patients in the TAVR group [median 191.0 (IQR, 164.0–219.0) vs. 236.0 (IQR, 208.0–282.0) cm/s; P<0.001] and the maximum pressure gradient [median 15.0 (IQR, 12.0–20.0) vs. 22.0 (IQR, 18.0–32.0) mmHg; P<0.001] than those in the SAVR group in the latest follow-up, which were consistent and stable as before discharge. Regurgitations of the aortic valve and mitral valve showed non-statistical differences in the latest follow-up. Although there was a higher incidence of mild perivalvular leakage in the TAVR group compared to the SAVR group (11.9% vs. 2.1%; P=0.002), there was no statistical difference in the moderate to severe standard of the perivalvular leakage (Table 4).

Discussion

The incidence of pure native AR increases with age, and significant cases may remain undetected for a long time (23). It is reported that moderate/severe AR is reported to affects up to 4.5% of individuals over the age of 65 years, with a higher prevalence observed in men compared to women (24-26). AR occurs often due to leaflet or aortic root disease and is associated with volume overload and subsequent eccentric hypertrophy of the left ventricle. Patients often present with symptoms and signs of left ventricular dysfunction at a late stage, complicating the diagnosis and treatment of this condition. For symptomatic patients with severe AR, and for those who are asymptomatic but have concomitant left-ventricular dysfunction (6), SAVR remains the recommended approach for managing severe AR (27). However, nearly 10% of patients still decline surgery due to the increased risk of complications and death (23). Without valve replacement, patients with severe AR accompanied by left ventricular dysfunction have a poor prognosis (28% 5-year survival rate) (28).

In recent years, with constant improvements in the design of the valve devices, their materials and procedures, as well as their hemodynamic performance, the TAVR procedure has narrowed its limitations in patients with various types of aortic valve lesions. Those limitations in AR patients remain a main topic of ongoing research (6). According to the latest ACC/AHA guideline, TAVR should not be performed in patients with isolated severe AR who have indications for SAVR or are candidates for surgery (COR-3). In the United States, TAVR is currently performed in one out of every ten elective AVR cases for severe AR, representing an off-label application (29). The treatment of pure native AR with TAVR is considered a relative contraindication due to the poor outcomes, mainly valve embolization, residual AR, and the requirement for a second valve, particularly with the use of first-generation devices (30).

With the advances in techniques and the accumulating experience of operators and patients qualifying heart teams, the second-generation devices for TAVR provide credible treatment for patients with pure native AR. In 2014, the J-valve™ system was introduced as a new generation valve device (31). It is a next-generation valve device designed to treat AR in patients with non-calcified valves and an enlarged annulus, thus overcoming the current limits of TAVR. Based on extensive experience at our medical center, all J-Valve implantations for treating pure native AR were successful. The J-Valve is made up of three U-shaped “anchor rings” in addition to a porcine aortic valve within a self-expandable nitinol stent. The anchor rings permit anatomical self-alignment in the aortic sinuses and clasping of the native valve leaflets. The unique features of the J-Valve seem to solve the issue of valve embolization and provide solid anchoring. Due to superior anchoring mechanisms that lead to increased deployment success rates, this newer generation valve performs better than prior generation valves (30,32,33). Following the China Food and Drug Administration’s market approval, numerous studies have confirmed its safety and short- to medium-term effectiveness (19,20). However, the safety and efficacy of these devices have not been demonstrated when compared with the SAVR, especially in discharge follow-up. The present study is the first to report the comparison between ‘on-label’ TAVR and SAVR with the in-hospital outcomes and midterm results. Herein, TAVR exhibited similar safety and efficacy to SAVR, with superior hemodynamic performance observed in both the early postoperative period and during the midterm follow-up. Given the structural similarities between the first and second generations of the J-Valve, the results of this study may offer promising evidence to support the development of randomized controlled clinical trials for the second-generation J-Valve.

In the present study, patients with pure native AR in the TAVR group were older than those in the SAVR group, and they also had significant comorbidities, such as chronic obstructive pulmonary disease and atrial fibrillation. This is consistent with the current practice trend reported in the Euro Heart Survey (23). This survey indicated that noncardiac factors, for example, frailty, extensive comorbidities, and advanced age, were the primary reasons cited by patients for not opting for SAVR. This was the case even though the majority of these patients were in poor heart functional classes.

Although patients in the TAVR group had a higher all-cause mortality during the perioperative period than that of the SAVR group, the cardiac mortality in the TAVR group was 4.3%, which was still comparable to the SAVR group. Meanwhile, this was also consistent with the findings reported before (29,34-36). In addition, patients in the TAVR group faced an elevated risk of permanent pacemaker implantation. In the previous studies, the incidence of permanent pacemaker implantation following transapical TAVR varies but tends to be around 10% during the in-hospital period (36-38). Herein, 11.5% patients in the TAVR group received the implantation of the permanent pacemaker in this study, which was consistent with the published data. In the present study, there was no statistically significant difference in postoperative hospital stay between the two groups, both groups were discharged shortly after the surgery.

In the analysis during follow-up period after the procedure, a higher rate of all-cause mortality was noted with TAVR compared to SAVR (14.8% vs. 5.7%). Nonetheless, there was no statistically significant difference in cardiac mortality between the two groups. The higher overall mortality observed in the TAVR group, as opposed to earlier findings, could also be due to the increased incidence of moderate to severe paravalvular regurgitation post-TAVR and the greater prevalence of coronary artery disease among TAVR patients compared to the SAVR cohort (39,40). However, no difference in these causes of cardiac mortality was observed between the two groups in this study, which might be related to the device refinements and improved valve-sizing techniques (41,42). Recent studies indicated that new-generation devices were linked to significantly reduced rates of postprocedural moderate to severe paravalvular AR compared to their predecessors (5,39,43,44). Our study supports these findings. Furthermore, the comparable hospitalization and ICU durations, along with the increased all-cause mortality and vascular complication rates in the TAVR group relative to the SAVR group, may be largely explained by the use of the transapical access. These shortcomings may be mitigated via a transfemoral approach (45). In addition, patients were older and had more significant comorbidities in the TAVR group in this study, which also led to differences in all-cause mortality but not cardiac mortality during the follow-up as mentioned before.

As has been shown in previous studies (4,46), there was a significant increase in the EOA and the EOA index in TAVR group than with SAVR in this study. This was predominantly due to the variable sizing of TAVR valves, which can adjust to the native annulus size, contrasting with the inflexible sizing of SAVR’s fixed sewing ring. Additionally, TAVR may inherently provide superior hemodynamics compared to SAVR, given that TAVR allows for larger devices and the ‘oversize rate’ to anchor. However, due to the constriction of the suture during SAVR, there are limitations in sizing, especially without concomitant root enlargement surgery. The TAVR group exhibited statistically superior hemodynamic characteristics, as assessed by echocardiography, both prior to discharge and at the latest follow-up, when compared to the SAVR group. The reduced peak velocity and cross-pressure of the aortic valve we have observed in this study could minimize damage to the biological valve and extend its future lifespan (47,48). Besides this, larger valve areas with TAVR would be expected to improve the hemodynamic features both in the left ventricle and the ascending aorta (49). The possible relationship between aortic hemodynamics and remodeling following AVR is still a matter of great concern, even though the exact mechanism is yet unclear (50,51). Abnormal wall shear stress and flow patterns, which might affect the long-term prognosis after AVR (52,53), could cause extracellular matrix imbalance and elastic fiber degradation in the ascending aorta wall, resulting in aortic dilatation and the progression of aneurysms (50). In addition, better hemodynamics we observed in the TAVR group could reduce the energy loss of the left ventricle, which is of great significance for left ventricular remodeling after the surgery (54).

New biological tissue used in bioprostheses and different preservation techniques might change the longer-term durability of both TAVR and SAVR (55-57). In the near future, we plan to use four-dimensional flow cardiovascular magnetic resonance to analyze the potential changes in hemodynamic performance before and after TAVR and SAVR. This will contribute to directly observing improvements in hemodynamic parameters in the left ventricle and ascending aorta and evaluate the remodeling of the left ventricle with ascending aorta post-surgery.

Limitation

The limited follow-up duration relative to prosthetic valve lifespan makes it unclear whether the favorable hemodynamics of TAVR will ensure long-term durability. While reinterventions were rare and similar between groups, the long-term effects of paravalvular leak, pacemaker implantation, and vascular complications remain uncertain and deserve continued attention. Given the retrospective design and potential selection bias, future prospective and randomized studies are needed to better define outcomes in AR patients undergoing TAVR versus SAVR.

Conclusions

TAVR patients with pure native AR were older, had more comorbidities, and had higher STS-PROM scores than SAVR patients. Cardiac mortality was similar between groups during hospitalization and follow-up. The TAVR group had better hemodynamic performance than the SAVR group in early postoperative period, and they remained stable over the follow-up, which might potentially result in better long-term outcomes.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROCSS reporting checklist. Available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-115/rc

Data Sharing Statement: Available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-115/dss

Peer Review File: Available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-115/prf

Funding: This work was supported by the National Natural Science Foundation of China (No. 82170311).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://cdt.amegroups.com/article/view/10.21037/cdt-2025-115/coif). The 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. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Research Ethics Committee of Beijing Anzhen Hospital, Capital Medical University, Beijing, China (No. 2025106X) and individual consent for this retrospective analysis was waived.

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/.

References

1. Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 2002;106:3006-8. [Crossref] [PubMed]
2. Leon MB, Smith CR, Mack MJ, et al. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med 2016;374:1609-20. [Crossref] [PubMed]
3. Kodali SK, Williams MR, Smith CR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med 2012;366:1686-95. [Crossref] [PubMed]
4. Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med 2011;364:2187-98. [Crossref] [PubMed]
5. Mack MJ, Leon MB, Thourani VH, et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med 2019;380:1695-705. [Crossref] [PubMed]
6. Writing Committee Members. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol 2021;77:e25-e197. Erratum in: J Am Coll Cardiol 2021;77:509 Erratum in: J Am Coll Cardiol 2021;77:1275. Erratum in: J Am Coll Cardiol 2023;82:969. Erratum in: J Am Coll Cardiol 2024;84:1772. [Crossref] [PubMed]
7. Reardon MJ, Van Mieghem NM, Popma JJ, et al. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med 2017;376:1321-31. [Crossref] [PubMed]
8. Popma JJ, Deeb GM, Yakubov SJ, et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med 2019;380:1706-15. [Crossref] [PubMed]
9. Thyregod HGH, Jørgensen TH, Ihlemann N, et al. Transcatheter or surgical aortic valve implantation: 10-year outcomes of the NOTION trial. Eur Heart J 2024;45:1116-24. [Crossref] [PubMed]
10. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2017;70:252-89. [Crossref] [PubMed]
11. Praz F, Windecker S, Huber C, et al. Expanding Indications of Transcatheter Heart Valve Interventions. JACC Cardiovasc Interv 2015;8:1777-96. [Crossref] [PubMed]
12. Rahhab Z, El Faquir N, Tchetche D, et al. Expanding the indications for transcatheter aortic valve implantation. Nat Rev Cardiol 2020;17:75-84. [Crossref] [PubMed]
13. Poletti E, De Backer O, Scotti A, et al. Transcatheter Aortic Valve Replacement for Pure Native Aortic Valve Regurgitation: The PANTHEON International Project. JACC Cardiovasc Interv 2023;16:1974-85. [Crossref] [PubMed]
14. Vahl TP, Thourani VH, Makkar RR, et al. Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): a prospective, multicentre, single-arm study. Lancet 2024;403:1451-9. [Crossref] [PubMed]
15. Al Ahmad J, Danson E. Transcatheter Aortic Valve Implantation for Severe Chronic Aortic Regurgitation. J Clin Med 2024;13:2997. [Crossref] [PubMed]
16. Silaschi M, Conradi L, Wendler O, et al. The JUPITER registry: One-year outcomes of transapical aortic valve implantation using a second generation transcatheter heart valve for aortic regurgitation. Catheter Cardiovasc Interv 2018;91:1345-51. [Crossref] [PubMed]
17. Kolte D, Vlahakes GJ, Palacios IF, et al. Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients. J Am Coll Cardiol 2019;74:1532-40. [Crossref] [PubMed]
18. Liu H, Yang Y, Lu YT, et al. Transapical transcatheter aortic valve replacement for high risk pure non-calcified aortic regurgitation: two years outcome of a multi-center study. Zhonghua Wai Ke Za Zhi 2018;56:910-5. [Crossref] [PubMed]
19. Xue Y, Zhou Q, Li S, et al. Transapical Transcatheter Valve Replacement Using J-Valve for Aortic Valve Diseases. Ann Thorac Surg 2021;112:1243-9. [Crossref] [PubMed]
20. Zhu L, Guo Y, Wang W, et al. Transapical transcatheter aortic valve replacement with a novel transcatheter aortic valve replacement system in high-risk patients with severe aortic valve diseases. J Thorac Cardiovasc Surg 2018;155:588-97. [Crossref] [PubMed]
21. Zhu D, Chen Y, Guo Y, et al. Transapical transcatheter aortic valve implantation using a new second-generation TAVI system - J-Valve™ for high-risk patients with aortic valve diseases: Initial results with 90-day follow-up. Int J Cardiol 2015;199:155-62. [Crossref] [PubMed]
22. Luo X, Wang X, Li X, et al. Transapical transcatheter aortic valve implantation using the J-Valve system: A 1-year follow-up study. J Thorac Cardiovasc Surg 2017;154:46-55. [Crossref] [PubMed]
23. Iung B, Baron G, Butchart EG, et al. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J 2003;24:1231-43. [Crossref] [PubMed]
24. Maurer G. Aortic regurgitation. Heart 2006;92:994-1000. [Crossref] [PubMed]
25. Tsampasian V, Victor K, Bhattacharyya S, et al. Echocardiographic assessment of aortic regurgitation: a narrative review. Echo Res Pract 2024;11:1. [Crossref] [PubMed]
26. de Assis LU, Mondellini GM, van den Dorpel MM, et al. Incidence and Pathology of Aortic Regurgitation. Interv Cardiol 2025;20:e07. [Crossref] [PubMed]
27. Mentias A, Feng K, Alashi A, et al. Long-Term Outcomes in Patients With Aortic Regurgitation and Preserved Left Ventricular Ejection Fraction. J Am Coll Cardiol 2016;68:2144-53. [Crossref] [PubMed]
28. Dujardin KS, Enriquez-Sarano M, Schaff HV, et al. Mortality and morbidity of aortic regurgitation in clinical practice. A long-term follow-up study. Circulation 1999;99:1851-7. [Crossref] [PubMed]
29. Mentias A, Saad M, Menon V, et al. Transcatheter vs Surgical Aortic Valve Replacement in Pure Native Aortic Regurgitation. Ann Thorac Surg 2023;115:870-6. [Crossref] [PubMed]
30. Yoon SH, Schmidt T, Bleiziffer S, et al. Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation. J Am Coll Cardiol 2017;70:2752-63. [Crossref] [PubMed]
31. Zhu D, Hu J, Meng W, et al. Successful transcatheter aortic valve implantation for pure aortic regurgitation using a new second generation self-expanding J-Valve(TM) system - the first in-man implantation. Heart Lung Circ 2015;24:411-4. [Crossref] [PubMed]
32. Rawasia WF, Khan MS, Usman MS, et al. Safety and efficacy of transcatheter aortic valve replacement for native aortic valve regurgitation: A systematic review and meta-analysis. Catheter Cardiovasc Interv 2019;93:345-53. [Crossref] [PubMed]
33. Sawaya FJ, Deutsch MA, Seiffert M, et al. Safety and Efficacy of Transcatheter Aortic Valve Replacement in the Treatment of Pure Aortic Regurgitation in Native Valves and Failing Surgical Bioprostheses: Results From an International Registry Study. JACC Cardiovasc Interv 2017;10:1048-56. [Crossref] [PubMed]
34. Poletti E, De Backer O, Scotti A, et al. Transcatheter Aortic Valve Replacement for Pure Native Aortic Valve Regurgitation: The PANTHEON International Project. JACC Cardiovasc Interv 2023;16:1974-85. [Crossref] [PubMed]
35. Franzone A, Piccolo R, Siontis GCM, et al. Transcatheter Aortic Valve Replacement for the Treatment of Pure Native Aortic Valve Regurgitation: A Systematic Review. JACC Cardiovasc Interv 2016;9:2308-17. [Crossref] [PubMed]
36. Liu R, Fu Z, Jiang Z, et al. Transcatheter aortic valve replacement for aortic regurgitation: a systematic review and meta-analysis. ESC Heart Fail 2024;11:3488-500. [Crossref] [PubMed]
37. Guo R, Xie M, Yim WY, et al. Dose approach matter? A meta-analysis of outcomes following transfemoral versus transapical transcatheter aortic valve replacement. BMC Cardiovasc Disord 2021;21:358. [Crossref] [PubMed]
38. Pagnesi M, Kim WK, Baggio S, et al. Incidence, Predictors, and Prognostic Impact of New Permanent Pacemaker Implantation After TAVR With Self-Expanding Valves. JACC Cardiovasc Interv 2023;16:2004-17. [Crossref] [PubMed]
39. Thourani VH, Kodali S, Makkar RR, et al. Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. Lancet 2016;387:2218-25. [Crossref] [PubMed]
40. Kodali S, Pibarot P, Douglas PS, et al. Paravalvular regurgitation after transcatheter aortic valve replacement with the Edwards sapien valve in the PARTNER trial: characterizing patients and impact on outcomes. Eur Heart J 2015;36:449-56. [Crossref] [PubMed]
41. Jilaihawi H, Kashif M, Fontana G, et al. Cross-sectional computed tomographic assessment improves accuracy of aortic annular sizing for transcatheter aortic valve replacement and reduces the incidence of paravalvular aortic regurgitation. J Am Coll Cardiol 2012;59:1275-86. [Crossref] [PubMed]
42. Jilaihawi H, Doctor N, Kashif M, et al. Aortic annular sizing for transcatheter aortic valve replacement using cross-sectional 3-dimensional transesophageal echocardiography. J Am Coll Cardiol 2013;61:908-16. [Crossref] [PubMed]
43. Wendler O, Schymik G, Treede H, et al. SOURCE 3 Registry: Design and 30-Day Results of the European Postapproval Registry of the Latest Generation of the SAPIEN 3 Transcatheter Heart Valve. Circulation 2017;135:1123-32. [Crossref] [PubMed]
44. Kodali S, Thourani VH, White J, et al. Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis. Eur Heart J 2016;37:2252-62. [Crossref] [PubMed]
45. Garcia S, Ye J, Webb J, et al. Transcatheter Treatment of Native Aortic Valve Regurgitation: The North American Experience With a Novel Device. JACC Cardiovasc Interv 2023;16:1953-60. [Crossref] [PubMed]
46. Adams DH, Popma JJ, Reardon MJ, et al. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med 2014;370:1790-8. [Crossref] [PubMed]
47. Herrmann HC, Pibarot P, Wu C, et al. Bioprosthetic Aortic Valve Hemodynamics: Definitions, Outcomes, and Evidence Gaps: JACC State-of-the-Art Review. J Am Coll Cardiol 2022;80:527-44. [Crossref] [PubMed]
48. Mylonas KS, Angouras DC. Bioprosthetic Valves for Lifetime Management of Aortic Stenosis: Pearls and Pitfalls. J Clin Med 2023;12:7063. [Crossref] [PubMed]
49. Pibarot P, Weissman NJ, Stewart WJ, et al. Incidence and sequelae of prosthesis-patient mismatch in transcatheter versus surgical valve replacement in high-risk patients with severe aortic stenosis: a PARTNER trial cohort--a analysis. J Am Coll Cardiol 2014;64:1323-34. [Crossref] [PubMed]
50. Rong LQ, Zheng W, Martinez A, et al. Distal aortic biomechanics after transcatheter versus surgical aortic valve replacement: a hypothesis generating study. J Cardiothorac Surg 2023;18:349. [Crossref] [PubMed]
51. Komoriyama H, Kamiya K, Nagai T, et al. Blood flow dynamics with four-dimensional flow cardiovascular magnetic resonance in patients with aortic stenosis before and after transcatheter aortic valve replacement. J Cardiovasc Magn Reson 2021;23:81. [Crossref] [PubMed]
52. von Knobelsdorff-Brenkenhoff F, Trauzeddel RF, Barker AJ, et al. Blood flow characteristics in the ascending aorta after aortic valve replacement--a pilot study using 4D-flow MRI. Int J Cardiol 2014;170:426-33. [Crossref] [PubMed]
53. Anand V, Michelena HI, Pellikka PA. Noninvasive Imaging for Native Aortic Valve Regurgitation. J Am Soc Echocardiogr 2024;37:1167-81. [Crossref] [PubMed]
54. Yang HR, Xiong TY, Zhang Y, et al. Concomitant aortic regurgitation predicts better left ventricular reverse remodeling after transcatheter aortic valve replacement. BMC Cardiovasc Disord 2023;23:354. [Crossref] [PubMed]
55. De La Fuente AB, Wright GA, Olin JM, et al. Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and Safety. J Heart Valve Dis 2015;24:101-9.
56. Bartuś K, Litwinowicz R, Kuśmierczyk M, et al. Primary safety and effectiveness feasibility study after surgical aortic valve replacement with a new generation bioprosthesis: one-year outcomes. Kardiol Pol 2018;76:618-24. [Crossref] [PubMed]
57. Bartus K, Sadowski J, Litwinowicz R, et al. Changing trends in aortic valve procedures over the past ten years-from mechanical prosthesis via stented bioprosthesis to TAVI procedures-analysis of 50,846 aortic valve cases based on a Polish National Cardiac Surgery Database. J Thorac Dis 2019;11:2340-9. [Crossref] [PubMed]