Abstract
Background
Transcatheter aortic valve replacement (TAVR) has already been recommended for some high-risk patients with aortic valve regurgitation, but there is still a lack of evidence regarding its early-term and medium-term safety and effectiveness compared with surgical aortic valve replacement (SAVR).
Methods
This retrospective study included patients who underwent bioprosthetic aortic valve replacement for severe aortic regurgitation (AR) at a single centre between January 2018 and December 2023. All patients in the TAVR group received the J-Valve system via transapical (TA) approach. Propensity score matching (PSM) was used to balance the groups. The primary endpoint was 2-year all-cause mortality. Secondary endpoints included other clinical events, left ventricular (LV) function recovery and prosthesis haemodynamics, assessed by transthoracic echocardiography.
Results
A total of 369 patients (median age 68 years, 26.6% female) were enrolled. Of these, 256 underwent TA-TAVR and 113 underwent SAVR. After 1:1 PSM, 76 matched pairs were included. There were no statistical differences between the groups in all-cause mortality, cardiovascular mortality, stroke, heart failure rehospitalisation, permanent pacemaker implantation or moderate to severe paravalvular leakage at 30 days or 2 years. Before PSM, left ventricular ejection fraction (LVEF) improved in the TAVR group (57% (IQR: 45–63%) vs 61% (IQR: 55–65%), p<0.001), with no significant change in the SAVR group (61% (IQR: 55–65%) vs 62% (IQR: 59–66%), p>0.05). After PSM, LVEF improvement was comparable between groups (+4.0% (IQR: −1.5 to 10.0) vs +2.0% (IQR: −3.0 to 9.5), p=0.430). Haemodynamics was superior in the TAVR group (p<0.001), while regression of LV dimensions was greater in the SAVR group.
Conclusion
In patients with severe AR, using the J-Valve for TA-TAVR showed comparable outcomes to SAVR regarding mortality and other clinical events. TAVR provided superior valve haemodynamics and was an effective treatment that significantly improved LV function, especially in high-risk patients.
Keywords: Heart Valve Prosthesis Implantation, Aortic Valve Insufficiency, Transcatheter Aortic Valve Replacement
WHAT IS ALREADY KNOWN ON THIS TOPIC
Compared with surgical aortic valve replacement, transcatheter aortic valve replacement (TAVR) is emerging as a promising treatment option for severe aortic regurgitation (AR), warranting further investigation.
WHAT THIS STUDY ADDS
Transapical TAVR with the J-Valve is an effective treatment for elderly and high-risk surgical patients with severe AR.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY
Provides more robust evidence for clinical decision-making and enhances patient understanding of TAVR’s role in managing severe AR.
Introduction
Transcatheter aortic valve replacement (TAVR) has rapidly emerged as a viable alternative to surgical aortic valve replacement (SAVR) for patients with symptomatic severe aortic stenosis1 2 and has also shown benefits for patients with pure aortic regurgitation (AR).3 4 Severe AR leads to progressive myocardial fibrosis and cardiac remodelling, contributing to decreased left ventricular (LV) compliance and systolic dysfunction.5 6 As the condition advances to a decompensated stage, patients with severe, even transient, symptoms face a high risk during conservative management, with an annual mortality rate of 24.6%.7 In China, approximately 2.66 million individuals are affected by valvular heart disease, with aortic valve disease accounting for about 26%, and the incidence of AR surpassing that of aortic stenosis.8 As the population ages, the number of patients with AR requiring TAVR is expected to rise.
Currently, TAVR for AR is indicated only in high-risk surgical patients, and outcomes vary depending on the anchoring mechanisms of transcatheter heart valves (THVs).9 The J-Valve, a self-expanding THV specifically designed for AR, features three U-shaped locators that engage the aortic sinuses, grasp the aortic valve leaflets and enhance valve stability through bidirectional anchoring via axial positioning force and radial support force. This makes the use of the J-Valve in treating severe AR feasible.10,12 Compared with SAVR, TAVR is emerging as a promising treatment option for severe AR, warranting further investigation. This study aims to systematically evaluate the safety and efficacy of transapical (TA) TAVR with the J-Valve, comparing its outcomes with those of conventional SAVR in patients with severe AR to provide more robust evidence for clinical decision-making and enhance patient understanding of TAVR’s role in managing severe AR.
Methods
Study population and design
This retrospective study analysed clinical data from patients who underwent aortic valve replacement (AVR) at the Second Affiliated Hospital of Army Medical University between January 2018 and December 2023. Patients with severe AR and >60 years were included. Exclusion criteria include: (1) undergoing concomitant cardiac surgery for other indications; (2) redo AVR; (3) mechanical prosthesis; and (4) not a J-Valve THV.
Endpoints
The primary endpoint was all-cause mortality at 2 years. Secondary endpoints were other clinical outcomes such as cardiovascular mortality, stroke, heart failure hospitalisations, major bleeding, vascular complications, acute kidney injury (AKI) and permanent pacemaker implantation (PPI) as defined by the Valve Academic Research Consortium 3 criteria.13 Other endpoints included echocardiographic assessments of cardiac function at follow-up. Patient data were collected by reviewing the medical record system and conducting telephone follow-ups. The follow-up time points were 1 month, 6 months, 12 months after the operation and every year thereafter.
Statistical analysis
Baseline characteristics were compared between the TAVR and SAVR groups. Categorical variables were presented as counts (percentages) and compared using the χ² test or Fisher’s exact test, as appropriate. Continuous variables were tested for normality using the Shapiro-Wilk test. Normally distributed variables were presented as mean±SD, while non-normally distributed variables were expressed as median (IQR). These continuous variables were compared using a two-sample Student’s t-test for normally distributed data or the Mann-Whitney U test for non-normally distributed data.
The cumulative incidences of clinical events were assessed using Kaplan-Meier survival estimates and compared between groups using the log-rank test. For repeated measures data, within-group comparisons were performed using the Friedman test, followed by pairwise comparisons using the Wilcoxon signed-rank test with Bonferroni correction to adjust for multiple comparisons.
To account for baseline confounding variables, patients in the TAVR and SAVR groups were matched using 1:1 propensity score matching (PSM) with a calliper width of 0.03, the balance of covariates after matching was then evaluated by standardized mean difference (SMD). Matching variables included: (1) age; (2) New York Heart Association (NYHA) functional class III–IV; (3) comorbidities including coronary artery disease, chronic obstructive pulmonary disease, pulmonary hypertension and atrial fibrillation; and (4) baseline echocardiographic parameters including left ventricular end-systolic dimension (LVESD) and LVESD index (LVESDi).
Statistical significance was defined as a p value <0.05, and all statistical analyses were conducted using SPSS software (V.26, IBM SPSS Statistics).
Results
Baseline characteristics
From January 2018 to December 2023, a total of 4889 patients underwent AVR at our institution. Among these, 396 patients underwent bioprosthetic valve replacement due to severe AR. After excluding 27 patients who received TA-TAVR without the J-Valve, 369 patients were ultimately enrolled in the study (SAVR: n=113, TAVR: n=256) (figure 1).
Figure 1. Flow diagram of patient inclusion. AR, aortic regurgitation; AVR, aortic valve replacement; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.
The baseline characteristics of patients in the TAVR and SAVR groups are summarised in table 1. Patients in the TAVR group were older (70 (IQR: 67–74) years vs 63 (IQR: 61–67) years, p<0.001) and had more comorbidities. The TAVR cohort also presented with a higher European system cardiac operative risk evaluation (EuroSCORE II) (2.1 (IQR: 1.4–3.0)% vs 1.2 (IQR: 1.0–1.7)%, p<0.001) and a greater proportion of individuals with NYHA functional class III–IV (91.8% vs 79.6%, p=0.001). Additionally, the TAVR group exhibited significantly larger LVESD (39.9 (IQR: 35.6–47.6) mm vs 37.8 (IQR: 34.2–41.6) mm, p=0.015), larger LVESDi (25.2 (IQR: 21.9–30.7) mm/m² vs 22.9 (IQR: 21.0–27.4) mm/m², p=0.001) and a lower left ventricular ejection fraction (LVEF) (58.0% (IQR: 46.0–63.0%) vs 61.0% (IQR: 55.0–67.0%), p=0.003) compared with the SAVR group.
Table 1. Baseline characteristics before and after PSM.
| Before PSM | After PSM | |||||
|---|---|---|---|---|---|---|
| SAVR n=113 |
TAVR n=256 |
P value | SAVR n=76 |
TAVR n=76 |
P value | |
| Baseline characteristics | ||||||
| Age (years) | 63 (61, 67) | 70 (67, 74) | <0.001 | 65 (61, 68) | 66 (65, 68) | 0.485 |
| Female | 27 (23.9) | 71 (27.7) | 0.441 | 19 (25.0) | 25 (32.9) | 0.283 |
| Height (cm) | 161.5 (157.0, 167.5) | 161.0 (154.5, 167.0) | 0.469 | 160.6±8.3 | 160.0±8.1 | 0.433 |
| Weight (kg) | 61.0 (55.0, 69.0) | 60.3 (52.4, 67.4) | 0.272 | 60.5±9.9 | 61.1±10.0 | 0.708 |
| BMI (kg/m2) | 23.3 (21.6, 25.8) | 23.3 (21.2, 25.9) | 0.530 | 23.4±3.1 | 24.0±3.4 | 0.274 |
| Pulse pressure (mm Hg) | 59 (46, 73) | 61 (50, 76) | 0.060 | 52 (42, 71) | 63 (43, 73) | 0.067 |
| CAD | 28 (24.8) | 100 (39.1) | 0.008 | 20 (26.3) | 15 (19.7) | 0.335 |
| PCI or CABG | 0 | 9 (3.5) | 0.099 | 0 | 0 | – |
| Hypertension | 27 (23.9) | 83 (32.4) | 0.099 | 18 (23.7) | 22 (28.9) | 0.461 |
| Diabetes | 7 (6.2) | 25 (9.8) | 0.261 | 5 (6.6) | 8 (10.5) | 0.384 |
| eGFR<60 mL/min | 9 (8.0) | 64 (25.0) | <0.001 | 7 (9.2) | 14 (18.4) | 0.100 |
| COPD | 6 (5.3) | 53 (20.7) | <0.001 | 3 (3.9) | 9 (11.8) | 0.071 |
| Pulmonary hypertension | 2 (1.8) | 27 (10.5) | 0.004 | 2 (2.6) | 4 (5.3) | 0.681 |
| AF | 4 (3.5) | 34 (13.3) | 0.005 | 3 (3.9) | 3 (3.9) | 1.000 |
| PPI | 0 | 1 (0.4) | 1.000 | 0 | 0 | – |
| NYHA functional class III–IV | 90 (79.6) | 235 (91.8) | 0.001 | 66 (86.8) | 66 (86.8) | 1.000 |
| EuroSCORE II* | 1.2 (1.0, 1.7) | 2.1 (1.4, 3.0) | <0.001 | 1.4 (1.0, 1.9) | 1.5 (1.2, 2.3) | 0.024 |
| Echocardiography | ||||||
| LVEDD (mm) | 56.0 (52.0, 60.5) | 57.0 (53.0, 64.0) | 0.115 | 57.0 (52.0, 61.5) | 57.0 (52.0, 63.0) | 0.906 |
| LVESD (mm) | 37.8 (34.2, 41.6) | 39.9 (35.6, 47.6) | 0.015 | 38.8 (34.2, 44.5) | 38.3 (34.8, 47.6) | 0.436 |
| LVESDi (mm/m2) | 22.9 (21.0, 27.4) | 25.2 (21.9, 30.7) | 0.001 | 23.0 (21.8, 29.6) | 24.5 (21.8, 29.6) | 0.441 |
| Aortic sinus (mm) | 36 (30, 38) | 35 (32, 39) | 0.339 | 37.6±5.7 | 36.9±5.2 | 0.391 |
| Ascending aorta (mm) | 38.2±4.1 | 38.6±5.0 | 0.573 | 38.2±4.4 | 37.6±4.7 | 0.422 |
| Annulus (mm) | 22 (22, 24) | 23 (21, 25) | 0.551 | 23 (22, 25) | 23 (21, 25) | 0.173 |
| Interventricular septal (mm) | 13 (12, 14) | 12 (12, 14) | 0.515 | 12.6±2.3 | 12.4±1.6 | 0.590 |
| LVOT (mm) | 22 (21, 25) | 22 (21, 24) | 0.642 | 23 (22, 25) | 22 (21, 24) | 0.320 |
| LVEF (%) | 61 (55, 67) | 58 (46, 63) | 0.003 | 60 (54, 65) | 59 (50, 64) | 0.278 |
| LVEDV (mL) | 168 (134, 202) | 177 (135, 223) | 0.457 | 181 (141, 223) | 165 (124, 219) | 0.472 |
| LVESV (mL) | 60 (49, 88) | 73 (53, 109) | 0.059 | 68 (55, 110) | 64 (45, 107) | 0.984 |
| VC (mm) | 6.3 (6.0, 7.0) | 6.6 (6.0, 7.4) | 0.145 | 6.2 (6.0, 7.2) | 6.5 (6.0, 7.3) | 0.148 |
Values are mean±SD or M (P25, P75) or n (%).
A risk assessment model to predict 30-day mortality after cardiac sugery in adults.
AF, atrial fibrillation; BMI, body mass index; CABG, coronary artery bypass grafting; CAD, coronary artery disease; COPD, chronic obstructive pulmonary disease; eGFR, estimated glomerular filtration rate; EuroSCORE, European System Cardiac Operative Risk Evaluation; LVEDD, left ventricular end-diastolic dimension; LVEDV, left ventricular end-diastolic volume; LVEF, left ventricular ejection fraction; LVESD, left ventricular end-systolic dimension; LVESDi, LVESD index; LVESV, left ventricular end-systolic volume; LVOT, left ventricular outflow tract; NYHA, New York Heart Association; PCI, percutaneous coronary intervention; PPI, permanent pacemaker implantation; PSM, propensity score matching; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement; VC, vena contracta.
After 1:1 PSM, 76 matched pairs of patients were enrolled; the absolute SMD values of all covariates after matching are within the acceptable range, as detailed in table 1 and online supplemental table S1.
Clinical outcomes before PSM
Among the 261 patients who underwent TA-TAVR with the J-Valve, the technical success rate was 98.1% (256/261), with five cases requiring conversion to SAVR (four for valve migration and one for coronary obstruction). At a median follow-up of 22 months (IQR: 10–37), 20 patients in the TAVR group died, including 11 cardiovascular deaths and five deaths due to COVID-19; three cardiovascular deaths occurred in the SAVR group.
Clinical outcomes at the 30-day and 2-year follow-ups are summarised in table 2. No statistical differences were observed between the TAVR and SAVR groups in all-cause mortality (9.7% vs 2.7%, p=0.108), cardiovascular mortality (5.2% vs 2.7%, p=0.552), stroke (4.0% vs 0%, p=0.058), heart failure rehospitalisation (4.1% vs 0%, p=0.089), PPI (6.3% vs 1.0%, p=0.053) or moderate to severe paravalvular leakage (PVL) (1.5% vs 1.2%, p=0.922). The Kaplan-Meier curves for 2-year follow-up are shown in figure 2.
Table 2. Clinical outcomes before PSM.
| 30 days | P value | 2 years | P value | |||
|---|---|---|---|---|---|---|
| TAVR | SAVR | TAVR | SAVR | |||
| All-cause mortality | 5 (2.0) | 3 (2.7) | 0.653 | 20 (9.7)* | 3 (2.7) | 0.108 |
| Cardiovascular mortality | 4 (1.6) | 3 (2.7) | 0.471 | 11 (5.2)† | 3 (2.7)‡ | 0.552 |
| Death due to COVID-19 | 0 | 0 | – | 5 (3.1) | 0 | 0.175 |
| Stroke | 3 (1.2) | 0 | 0.251 | 9 (4.0) | 0 | 0.058 |
| Heart failure rehospitalisation | 0 | 0 | – | 8 (4.1) | 0 | 0.089 |
| Major bleeding | 0 | 1 (0.9) | 0.132 | 0 | 1 (0.9) | 0.132 |
| Vascular complications | 0 | 0 | – | 0 | 0 | – |
| AKI | 0 | 1 (0.9) | 0.130 | 0 | 1 (0.9) | 0.130 |
| Moderate or severe PVL§ | 3 (1.2) | 1 (0.9) | 0.812 | 3 (1.5) | 1 (1.2) | 0.922 |
| PPI | 9 (3.6) | 1 (1.0) | 0.162 | 14 (6.3) | 1 (1.0) | 0.053 |
Values are n (%).
Excluding death due to COVID-19, the all-cause mortality in TAVR was 6.8%, p=0.267.
3 for cardiac arrest and 1 for myocardial infarction at 30 days. 1 for heart failure, 1 for myocardial infarction, 1 for aortic dissection and 4 for unknown cause after 30 days.
1 for heart failure and 2 for cardiac arrest at 30 days.
All the patients had moderate PVL and no severe PVL.
AKI, acute kidney injury; PPI, permanent pacemaker implantation; PSM, propensity score matching; PVL, paravalvular leakage; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.
Figure 2. Kaplan–Meier curves were displayed for 2-year clinical outcomes: (A) all-cause mortality, (B) cardiovascular mortality, (C) stroke, (D) heart failure rehospitalisation, (E) PPI, (F) moderate or severe PVL. PPI, permanent pacemaker implantation; PVL, paravalvular leakage; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.
Echocardiographic changes before PSM
Follow-up echocardiographic data were available for 293 patients, including 214 in the TAVR group and 79 in the SAVR group. The changes in left ventricular end-diastolic dimension (LVEDD), LVESD and LVEF within both groups from baseline to 24-month follow-up were significant (p<0.01). Both groups exhibited reductions in LVEDD and LVESD at 1-month and 24-month follow-ups compared with baseline (p<0.001). However, no significant change in LVEF was observed at 1-month follow-up compared with baseline in either group (p>0.05). At the 24-month follow-up, LVEF in the TAVR group increased significantly from 57% (IQR: 45–63%) to 61% (IQR: 55–65%), p<0.001. In contrast, no significant change was observed in the SAVR group (61% (IQR: 55–65%) vs 62% (IQR: 59–66%), p>0.05), as shown in figure 3 and online supplemental table S2.
Figure 3. The change of echocardiographic parameters before PSM. (A) TAVR, (B) SAVR. *P for trend <0.01. **P for trend <0.001. aCompared with baseline, p<0.001. bCompared with discharge, p<0.001. LVEDD, left ventricular end-diastolic dimension; LVEF, left ventricular ejection fraction; LVESD, left ventricular end-systolic dimension; PSM, propensity score matching; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.
Clinical outcomes after PSM
During the 2-year postoperative follow-up, matched TAVR and SAVR groups showed no significant differences in all-cause mortality (10.3% vs 1.4%, p=0.089), cardiovascular mortality (3.4% vs 1.4%, p=0.644), stroke (4.3% vs 0%, p=0.077), heart failure rehospitalisation (1.7% vs 0%, p=0.337) or PPI (5.1% vs 0%, p=0.337), as detailed in online supplemental table S3.
Echocardiographic outcomes after PSM
Among matched patients, the TAVR group had a significantly shorter hospital stay compared with the SAVR group (9 days (IQR: 7–12) vs 13 days (IQR: 10–15), p<0.001). At 1-month follow-up, no significant differences were observed between the two groups in LVEDD, LVESD or LVEF (p>0.05), as shown in table 3.
Table 3. Echocardiographic outcomes after PSM.
| 1-month follow-up | 24-month follow-up | |||||
|---|---|---|---|---|---|---|
| TAVR n=75 |
SAVR n=70 |
P value | TAVR n=69 |
SAVR n=56 |
P value | |
| LVEDD (mm) | 50.5 (45.0, 52.0) | 48.0 (45.0, 52.0) | 0.052 | 50.0 (45.5, 53.5) | 46.0 (43.5, 48.0) | 0.001 |
| ΔLVEDD (mm) | −7.0 (−10.5, −3.0) | −10.0 (−13.0, −6.0) | 0.001 | −7.0 (−13.8, −3.0) | −11.0 (−15.0, −5.5) | 0.045 |
| LVESD (mm) | 35.0 (30.2, 41.6) | 32.6 (29.3, 35.5) | 0.068 | 32.5 (29.5, 39.4) | 30.4 (28.3, 32.5) | 0.002 |
| ΔLVESD (mm) | −4.3 (−7.4, −1.7) | −6.0 (−9.5, −2.9) | 0.021 | −6.1 (−11.0, −2.0) | −7.2 (−13.8, −3.4) | 0.132 |
| LVEF (%) | 59 (50, 62) | 59 (55, 63) | 0.062 | 61 (51, 64) | 62 (59, 66) | 0.055 |
| ΔLVEF (%) | −1 (−8, 4) | 0 (−4, 6) | 0.266 | 2.0 (−3.0, 9.5) | 4.0 (−1.5, 10.0) | 0.430 |
| LVEDV (mL) | 132 (99, 181) | 111 (94, 144) | 0.100 | 125 (95, 164) | 105 (84, 131) | 0.051 |
| ΔLVEDV (mL) | −39 (−64, −6) | −62 (−86, −17) | 0.029 | −47 (−91, −15) | −53 (−105, −24) | 0.303 |
| LVESV (mL) | 54 (41, 90) | 44 (35, 61) | 0.071 | 49 (34, 70) | 39 (32, 48) | 0.030 |
| ΔLVESV (mL) | −12 (−34, 3) | −20 (−39, −2) | 0.054 | −20 (−51, −4) | −25 (−56, −8) | 0.550 |
| Peak flow velocity (cm/s) | 185 (165, 225) | 241 (214, 273) | <0.001 | 201 (174, 228) | 247 (223, 274) | <0.001 |
| Peak transvalvular pressure gradients (mm Hg) | 14 (11, 20) | 24 (18, 30) | <0.001 | 16 (12, 21) | 23 (20, 30) | <0.001 |
| Mean transvalvular pressure gradients (mm Hg) | 7 (5,10) | 12 (9, 15) | <0.001 | 8 (6, 10) | 13 (10, 16) | <0.001 |
Values are mean±SD or M (P25, P75).
Δ denotes the difference between follow-up and baseline.
LVEDD, left ventricular end-diastolic dimension; LVEDV, left ventricular end-diastolic volume; LVEF, left ventricular ejection fraction; LVESD, left ventricular end-systolic dimension; LVESV, left ventricular end-systolic volume; PSM, propensity score matching; SAVR, surgical aortic valve replacement; TAVR, transcatheter aortic valve replacement.
During a median follow-up of 21 months (IQR: 12–26), echocardiographic data were available for 125 patients (table 3). The SAVR group demonstrated superior recovery in LVEDD (p<0.05), while the change in LVEF was similar between the two groups (+4.0% (IQR: −1.5 to 10.0) vs +2.0% (IQR: −3.0 to 9.5), p=0.430). At both 1-month and 24-month follow-ups, the TAVR group exhibited lower peak flow velocity, peak transvalvular pressure gradients and mean transvalvular pressure gradients than the SAVR group (p<0.001). Despite these differences, all echocardiographic parameters remained within acceptable ranges during follow-up.
Discussion
The 2025 European Society of Cardiology/European Association for Cardio-Thoracic Surgery Guidelines highlight the growing role of TAVR for patients with severe AR at high surgical risk, emphasising its importance in AR management.14 These guidelines also extend the indication for intervention to asymptomatic patients with severe AR at low surgical risk when LVEF≤55%, LVESDi>22 mm/m² and/or left ventricular end-systolic volume index >45 mL/m².14 These thresholds aim to improve long-term outcomes and reduce the risk of persistent postoperative LV diastolic dysfunction.6 15 16 Consequently, early intervention for low-risk patients with severe AR and minimally invasive treatment for high-risk patients have become emerging trends.
For patients with severe AR at high surgical risk, TAVR has shown comparable short-term outcomes to SAVR.17 18 This study found that, both before and after PSM, there were no statistical differences in all-cause mortality, cardiovascular mortality, stroke, heart failure rehospitalisation, PPI, moderate to severe PVL, major bleeding or AKI between the TAVR and SAVR groups at either the 30-day or 2-year follow-up. Even though the TAVR group exhibited a numerically higher all-cause mortality compared with the SAVR group at the 2-year follow-up before PSM, the difference was not statistically significant. Further analysis revealed that five deaths were COVID-19 related, excluding these cases that reduced the TAVR group’s all-cause mortality from 9.7% to 6.8%. This finding, combined with the seven cardiovascular deaths occurring between 30 days and 2 years, suggests that the TAVR group’s greater age and comorbidity burden at baseline did not lead to excess early deaths but were associated with an increased risk of medium-term to long-term cardiovascular mortality. These findings provide supportive evidence for the safety of TAVR in patients with severe AR. Similarly, compared with the SAVR group, the rates of stroke and PPI were higher in the TAVR group, but the differences between the groups did not reach statistical significance. The THVs can mechanically stimulate the conduction system during implantation, leading to perioperative conduction block and increased risk of PPI.19 Furthermore, in patients with severe AR and LV dilation, postoperative reverse cardiac remodelling may cause relative displacement of THVs, potentially leading to delayed conduction disturbances.
Both TAVR and SAVR initiated cardiac remodelling in the early postoperative period, with reductions in LV diameter, but without immediate improvements in LVEF. Chronic severe AR can maintain a high LVEF through the Frank-Starling mechanism preoperatively. After intervention, a sudden reduction in LV preload results in a compensatory decrease in stroke volume, which transiently obscures the improvement in cardiac function in the short term. During follow-up, the TAVR group showed significant improvement in LVEF, which aligns with findings from previous studies.20 So, for patients with advanced age, multiple comorbidities and high surgical risk, TAVR can effectively restore cardiac function. Besides, based on the marketing approval date of the National Medical Products Administration, this study only included patients who underwent the TA approach J-Valve. A previous study showed that TA-TAVR-induced myocardial injury may have a negative impact on LV function.21 This mechanism may explain the contradictory findings observed in this study: SAVR is substantial for reversing cardiac remodelling, while TAVR provided superior prosthesis haemodynamics.
In clinical practice, next-generation THVs, specifically designed for AR, have enhanced anchoring stability through their unique positioning stent, resulting in significantly reduced rates of valve migration and PVL, particularly for the JenaValve.4 22 This study demonstrated that using the J-Valve for TA-TAVR in patients with severe AR achieved a technical success rate of 98.1%. The 30-day all-cause mortality was 2.0%, with a PPI rate of 3.6%. Over the 2-year follow-up, the all-cause mortality was 9.7%, and the PPI rate was 6.3%, both of which are lower than those reported in comparable studies.1123,25 A meta-analysis further supports that dedicated valves for severe AR, such as the J-Valve and JenaValve, show favourable outcomes in terms of high technical success rates, low adverse event rates at 30 days and 1-year all-cause mortality, and the TA approach has demonstrated superior safety characteristics.26 Therefore, J-Valve for TA-TAVR for severe AR is both safe and effective. Meta-analyses have confirmed that TAVR is associated with shorter postoperative hospital stays and a reduced risk of complications such as bleeding, stroke and AKI.27 Furthermore, the effective orifice area of TAVR is generally larger than that of SAVR,28 providing more potential room for future valve-in-valve procedures. Therefore, TAVR for severe AR may be more widely applied.
However, as a single-centre retrospective study with a limited sample size, this research may still be subject to unmeasured biases, despite using PSM to control confounding factors. Also, the sample size may have limited statistical power to detect differences in low frequency but clinically important complications such as stroke and PPI. Furthermore, the median follow-up duration of only 22 months is insufficient to evaluate valve durability and long-term prognosis. Future large-scale, multicentre randomised controlled trials are needed to validate the long-term efficacy of TAVR in the treatment of AR and further assess the differential benefits of TAVR versus SAVR across various subgroups. Such studies will help refine personalised treatment strategies.
In conclusion, this study confirms that in patients with severe AR, using the J-Valve for TA-TAVR shows no statistical differences compared with SAVR in terms of 30-day and 2-year all-cause mortality, cardiovascular mortality, stroke, heart failure rehospitalisation, PPI or moderate to severe PVL. Additionally, TAVR provided superior valve haemodynamics and was an effective treatment that significantly improved LV function, especially in high-risk patients. Thus, J-Valve for TA-TAVR is a safe and effective treatment option for elderly and high-risk patients with severe AR.
Supplementary material
None of the funding sources had any influence on the production of this manuscript.
Footnotes
Funding: The study was funded by Chongqing Talent Project (CQYC20220303476) and Chongqing Natural Science Foundation (CSTB2022NSCQ-LZX0076).
Provenance and peer review: Not commissioned; externally peer reviewed.
Patient consent for publication: Not applicable.
Ethics approval: This study involves human participants and was approved by the Ethics Committee at the Second Affiliated Hospital of Army Medical University (2025-Research No 453-01). Participants gave informed consent to participate in the study before taking part.
Data availability statement
Data are available upon reasonable request.
References
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Data Availability Statement
Data are available upon reasonable request.