Abstract
Background
Mid-term clinical evidence for the VitaFlow LibertyTM transcatheter aortic valve system in anatomically complex populations is limited.
Methods
This was a prospective, multicenter, single-arm Objective Performance Criteria study performed at 22 Chinese sites, with follow-up at 30 days, 6 months, 1 year, and annually through 5 years. The prespecified primary endpoint of the parent study was 1-year all-cause mortality. Other clinical events were adjudicated according to Valve Academic Research Consortium-2 definitions.
Results
A total of 163 patients underwent transcatheter aortic valve replacement (TAVR) with the VitaFlow LibertyTM system. The mean age was 76.8 ± 5.0 years, 65.0% were male, the mean STS-PROM score was 7.87 ± 2.70, and 46.6% had bicuspid aortic valve anatomy. At 2 years, all-cause mortality was 13.5%, any stroke occurred in 7.6%, and new permanent pacemaker implantation was required in 19.5%. Mean aortic valve gradient improved from 59.22 ± 19.76 mmHg at baseline to 9.04 ± 6.07 mmHg at 2 years, and effective orifice area improved from 0.57 ± 0.21 cm2 to 2.00 ± 0.51 cm2. Moderate paravalvular leak was present in 4.5% of patients at 2 years.
Conclusions
TAVR with the VitaFlow LibertyTM system demonstrated favorable 2-year safety and efficacy in a challenging population, with sustained hemodynamic performance.
Trial registration
Supplementary Information
The online version contains supplementary material available at 10.1186/s13019-026-04317-0.
Keywords: Aortic stenosis, Transcatheter aortic valve replacement, Bicuspid aortic valve, Paravalvular regurgitation
Introduction
Transcatheter aortic valve replacement (TAVR) has become an established treatment option for elderly patients with symptomatic severe aortic stenosis across a broad range of surgical-risk strata [1–4]. However, early-generation devices were associated with important procedural limitations, including paravalvular regurgitation (PVL), conduction disturbances requiring permanent pacemaker implantation (PPI), vascular injury, and occasional coronary obstruction in complex anatomy [5–7]. The VitaFlow LibertyTM transcatheter aortic valve system is a newer-generation platform developed to improve procedural control while preserving the supra-annular valve design of the earlier VitaFlow system. The delivery catheter allows partial or full recapture before final deployment and provides enhanced flexibility with distal omni-directional motion to facilitate coaxial alignment. These refinements may be particularly relevant in anatomically challenging cases, such as bicuspid valves, horizontal aorta, or heavily calcified roots, where final valve position can be difficult to optimize. The present report describes the planned 2-year follow-up results of a prospective multicenter single-arm study evaluating the clinical performance of the VitaFlow LibertyTM system in patients with severe aortic stenosis at high surgical risk or deemed unsuitable for surgery.
Materials and methods
Study design and patients
This study was a prospective, multicenter, single-arm Objective Performance Criteria study evaluating the efficacy and safety of the VitaFlow LibertyTM transcatheter aortic valve system at 22 Chinese sites. Patients were eligible if they were older than 70 years, had symptomatic severe aortic stenosis, and were considered high risk or unsuitable for conventional surgery by the local heart team. Severe aortic stenosis was defined according to the study protocol, and detailed inclusion and exclusion criteria are provided in Table S2 of the supplementary appendix. Common inclusion and exclusion criteria, protocol-defined follow-up, centralized data capture and statistical analysis, clinical monitoring, and independent echocardiographic core-laboratory assessment were used to standardize study conduct across sites. Follow-up was scheduled at 30 days, 6 months, 12 months, and then annually from 2 to 5 years after implantation. The study was conducted in accordance with the Declaration of Helsinki, Chinese Good Clinical Practice requirements for medical devices, and ISO 14155. Ethics approval was obtained at each participating center, and all patients provided written informed consent.
Study device and procedure of implantation
The VitaFlow LibertyTM TAV system comprises a bovine-pericardial supra-annular self-expanding valve mounted on a nitinol frame and a dedicated retrievable delivery catheter (Fig. 1) [8]. The valve is available in four sizes and is designed for annular diameters ranging from 17 to 29 mm. The delivery system permits partial or full recapture before final deployment and incorporates enhanced flexibility with distal omni-directional motion to improve coaxial alignment and positioning control. Procedural strategy, access selection, anesthesia choice, and adjunctive techniques were determined by the treating heart team according to the protocol and local practice during the study period. General anesthesia was used in 92% of procedures, reflecting the early multicenter adoption phase of this retrievable system, the complexity of the enrolled anatomy, and the practice pattern at many participating Chinese TAVR centers at that time to prioritize hemodynamic stability and immediate rescue readiness in high-risk cases.
Fig. 1.
The VitaFlow LibertyTM Transcatheter Aortic Valve system. (a) The VitaFlow Liberty Aortic Valve. (b) The VitaFlow Liberty Delivery System
Study end points
The prespecified primary endpoint of the parent study was cumulative all-cause mortality at 1 year. The current manuscript reports the planned 2-year follow-up outcomes of the same cohort. Secondary endpoints included device and procedural outcomes, valve hemodynamics, PVL, New York Heart Association functional class, quality-of-life measures, and major clinical events during follow-up. The original protocol and event adjudication framework were developed in the VARC-2 era. Accordingly, myocardial infarction, stroke, bleeding, acute kidney injury, major vascular complications, conduction disturbances, and other TAVR-related complications were adjudicated according to the original study definitions. In the present manuscript, outcomes are described with updated terminology where appropriate [9], while acknowledging that not all later composite endpoints were prospectively captured as standalone predefined measures. The original protocol-defined 30-day early safety endpoint included all-cause mortality, myocardial infarction, disabling stroke, life-threatening or disabling bleeding, acute kidney injury, new permanent pacemaker implantation, and major vascular complications.
Statistical analysis
The parent study used a single-arm Objective Performance Criteria design. Based on the meta-analysis of published high-risk and inoperable TAVR literature [10–14] and expert clinical judgment, the prespecified 12-month all-cause mortality performance goal was set at 27%, and the expected 12-month mortality of the investigational device was assumed to be 16%. One interim analysis was planned after the first 60 enrolled patients completed 30-day follow-up. A Lan-DeMets alpha-spending function was used to control type I error, resulting in a final two-sided alpha of 0.049. Under these assumptions, 131 evaluable patients were required; allowing for an anticipated 20% attrition rate, the final target sample size was set at 163 patients.
Categorical variables were described as frequency and proportion (%). Continuous variables were described using mean ± SD or median (IQR [25th to 75th percentile]), as appropriate. Mortality was analyzed with the use of Kaplan–Meier estimates. For descriptive follow-up endpoints, cumulative event rates were summarized at each prespecified landmark time point. For the prespecified primary endpoint, the confidence interval was compared with the prespecified performance goal in the original parent study. Statistical analyses were performed using SAS 9.4 and R 4.0.2.
Results
Patient baseline characteristics
From January 2018 to April 2022, 163 patients were enrolled and all underwent TAVR using the VitaFlow LibertyTM transcatheter aortic valve system. No patient withdrew consent, and no patient was lost to follow-up through 2 years (Fig. 2).
Fig. 2.
Study flow chart
The demographic and clinical characteristics of all patients at baseline are summarized in Table 1. Mean age was 76.80 ± 4.97 years, 65.0% of patients were male, and mean STS-PROM score was 7.87 ± 2.70. Most patients (85.9%) were in NYHA class III or IV, and 46.6% had bicuspid aortic valve anatomy. The mean baseline aortic valve gradient was 59.22 ± 19.76 mmHg and the mean effective orifice area was 0.57 ± 0.21 cm2.
Table 1.
Baseline characteristics (n = 163)
| Age (years) | 76.80 ± 4.97 |
| Male, sex | 106 (65.0%) |
| BMI (kg/m2) | 23.09 ± 3.44 |
| STS-PROM score | 7.87 ± 2.70 |
| NYHA functional ≥ class III | 140 (85.9%) |
| Hypertension | 88 (54.0%) |
| Diabetes mellitus | 41 (25.2%) |
| Atrial fibrillation | 26 (16.0%) |
| Coronary artery disease | 77 (47.2%) |
| Prior myocardial infarction | 7 (4.3%) |
| Congestive heart failure | 82 (50.3%) |
| Prior PCI | 23 (14.1%) |
| History of cerebrovascular disease | 20 (12.3%) |
| History of COPD | 45 (27.6%) |
| Pulmonary hypertension | 56 (34.4%) |
| Echocardiographic parameter | |
| Peak aortic jet velocity (m/s) | 5.00 ± 0.76 |
| Effective Orifice Area (cm2) | 0.57 ± 0.21 |
| Mean aortic valve pressure gradient (mmHg) | 59.22 ± 19.76 |
| Moderate or severe aortic regurgitation | 76 (48.4%) |
| Moderate or severe mitral regurgitation | 63 (40.1%) |
| LVEDV | 75 (54–104) |
| LVESV | 23.5 (15–41.25) |
| LVEF (%) | 67.4 (59–75) |
| CTA measurement | |
| Aortic valve morphology | |
| TAV | 87 (53.4%) |
| BAV | 76 (46.6%) |
| Type 0 | 38 (50%) |
| Type 1 | 38 (50%) |
| Height of left coronary artery from valve annulus (mm) | 15.46 ± 3.83 |
| Height of right coronary artery from valve annulus (mm) | 17.73 ± 3.51 |
| Aortic annular diameter derived from perimeter (mm) | 25.00 ± 2.58 |
Values are mean ± SD, median (Q1−Q3) or n (%)
BMI = body mass index; COPD = chronic obstructive pulmonary disease; CTA = computed tomography angiography; LVEDV = left ventricularend−diastolic volume; LVEF = left ventricular ejection fraction; LVESV = left ventricular end−systolic volume; NYHA = New York HeartAssociation; PCI = percutaneous coronary intervention; STS−PROM = Society of Thoracic Surgeons Predicted Risk of Mortality; TAV = tricuspidaortic valve; BAV = bicuspid aortic valve
Procedure outcomes
Procedural outcomes are reported in Table 2. Most procedures were performed under general anesthesia (92%), and transfemoral access was used in 95.7% of cases. A total of 171 valves were implanted in 163 patients. The retrievable function was used in 73 patients (44.8%), with 100% recapture success when attempted. Seven patients underwent intra-procedural bailout valve-in-valve implantation because of significant residual PVL after suboptimal position of the first valve. Detailed source review showed VIV cases occurred in patients with bicuspid anatomy, horizontal aorta, or hemodynamic instability during deployment. The detailed mechanisms and rescue procedures are summarized in Table S5 of the supplementary appendix. One patient underwent urgent surgical conversion for coronary obstruction and died within 24 h. A second patient underwent urgent surgery for tamponade related to mild aortic-root tearing and survived with good long-term follow-up.
Table 2.
Procedure outcomes (n = 163)
| Anesthesia type | |
| Conscious sedation | 13 (8%) |
| General anesthesia | 150 (92%) |
| Access route | |
| Transfemoral | 156 (95.7%) |
| Subclavian | 6 (3.7%) |
| Ascending aorta | 1 (0.6%) |
| Implanted valve size | N = 171 |
| 21 mm | 7 (4.1%) |
| 24 mm | 83 (48.5%) |
| 27 mm | 69 (40.4%) |
| 30 mm | 12 (7.0%) |
| Resheathing or Recapture | 73/163 (44.8%) |
| Success rate for resheath or recapture | 73/73 (100%) |
| Valve-in-valve | 7/163 (4.3%) |
| Procedure success* | 153/163 (93.9%) |
Values are n (%). *Procedure success defined as free from mortality, valve-in-valve implantation, major vascular or access related complications, cardiac structural complications or other procedural complications requiring surgery/intervention within 24 h
Clinical outcomes
Safety and key clinical outcomes at 30 days, 1 year, and 2 years are listed in Table 3. At 30 days, all-cause mortality was 3.1%. Three deaths occurred before discharge: one after coronary obstruction, one after intraprocedural tamponade followed by severe hospital-acquired infection, and one after massive postoperative pericardial effusion. Two additional deaths occurred after discharge within 30 days, both in frail patients with severe non-valve-related complications despite satisfactory prosthetic valve function before death. At 30 days, there was one coronary obstruction event (0.6%), 8 life-threatening or disabling bleeding events (4.9%), 5 major vascular complications (3.1%), 3 acute kidney injury events of AKIN stage 2 or 3 (1.9%), 2 conversions to surgery (1.2%), and 22 new permanent pacemaker implantations (13.8%). No disabling stroke occurred by 30 days. The 30-day early safety endpoint occurred in 39 patients (23.9%).
Table 3.
Safety and key clinical outcomes at 30 days, 1 year, and 2 years
| Clinical event | 30 Days | 1 Year | 2 Years |
|---|---|---|---|
| All-cause mortality | 5 (3.1%) | 10 (6.1%) | 22 (13.5%) |
| Cardiovascular mortality | 5 (3.1%) | 7 (4.3%) | 9 (5.5%) |
| Any stroke | 4 (2.5%) | 7 (4.4%) | 12 (7.6%) |
| Disabling stroke | 0 (0.0%) | 3 (1.9%) | 6 (3.8%) |
| Major vascular complications | 5 (3.1%) | 5 (3.2%) | 5 (3.3%) |
| Life-threatening or disabling bleeding | 8 (4.9%) | 12 (7.5%) | 15 (9.4%) |
| Acute kidney injury, AKIN stage 2 or 3 | 3 (1.9%) | 3 (1.9%) | 3 (1.9%) |
| Myocardial infarction | 3 (1.9%) | 3 (1.9%) | 3 (1.9%) |
| New permanent pacemaker implantation | 22 (13.8%) | 26 (16.5%) | 30 (19.5%) |
| Aortic-valve reintervention | 0 (0.0%) | 1 (0.6%) | 1 (0.7%) |
| Coronary obstruction | 1 (0.6%) | 1 (0.6%) | 1 (0.6%) |
| Infective endocarditis | 0 (0.0%) | 0 (0.0%) | 2 (1.3%) |
Values are n (%). *Per VARC−2, an additional patient had major vascular complication relevant to annulus rupture mentioned earlier # One patient may have more than one event
AKIN = Acute Kidney Injury Network
The prespecified primary endpoint of the parent study was met. The all-cause mortality calculated with a Kaplan–Meier analysis was 6.1% at 1 year and 13.5% at 2 years. The 95.1% confidence interval upper bound for the 1-year all-cause mortality endpoint was 11.1%, remaining below the prespecified performance goal of 27%. Most deaths were not directly valve-related (Table S3). Any stroke occurred in 2.5%, 4.4%, and 7.6% of patients at 30 days, 1 year, and 2 years, respectively (Fig. 3).
Fig. 3.
Cumulative all-cause mortality estimated by Kaplan-Meier method. Numbers at risk and landmark event rates are shown below the curve
The rate of PPI was 13.8% at 30 days, 16.5% at 1 year, and 19.5% at 2 years. One patient underwent aortic-valve reintervention at 9 months because of moderate PVL, severe regurgitation, and recurrent heart failure. CT and transesophageal echocardiography did not show structural degeneration, leaflet thrombosis, or endocarditis in that case. Between 1 and 2 years, 2 endocarditis events were documented; one improved after antibiotic therapy and one patient died after infective endocarditis complicated by stroke, renal dysfunction, and respiratory deterioration. No definite structural valve deterioration was documented through 2 years.
In addition, there was a significant improvement in functional capacity after TAVR. The percentage of patients with NYHA class III/IV decreased markedly after the procedure and remained low through 2 years (Fig. 4). Quality-of-life changes assessed by SF-12 physical and mental scores are summarized from baseline to 12 months (Fig. 5).
Fig. 4.
NYHA class from baseline to 2 years
Fig. 5.
SF-12 Quality of life (Physical and Mental score) from baseline to 12 months
Values are cumulative event rates (%) at each follow-up landmark.
Echocardiographic outcomes
At 2-year follow-up, the mean gradient was reduced from 59.2 ± 19.8 mmHg at baseline to 9.0 ± 6.1 mmHg (P < 0.001), and the effective orifice area (EOA) improved from 0.6 ± 0.2 cm2 to 2.0 ± 0.5 cm2 (P < 0.001) (Fig. 6). Most patients (95.5%) had mild or less PVL at 2 years after the procedure (Fig. 6). TAVR was also accompanied by favorable left ventricular remodeling, with consistent improvement in LVEF (Fig. 6, Table S4).
Fig. 6.
Echocardiography outcomes. (a) mean aortic valve gradient and mean effective orifice area up to 2 years; (b) Paravalvular leak after up to 2 years; (c) LVEDV; (d)LVESV; (e)LVEF up to 1 year
Discussion
To our knowledge, this is the largest multicenter study assessing the clinical performance of the VitaFlow LibertyTM TAV system in a high-risk cohort. The main findings were as follows. First, the VitaFlow LibertyTM system achieved a high rate of successful implantation with broad use of the retrievable function in anatomically challenging patients, including a substantial proportion with bicuspid anatomy. Second, hemodynamic performance remained excellent through 2 years, with low residual transvalvular gradients and a low rate of moderate PVL. Third, mid-term clinical outcomes, including mortality and major complications, were acceptable for a high-risk and anatomically complex cohort, although PPI remained an important consideration.
Periprocedural complication and safety
The VitaFlow LibertyTM TAV system preserves the supra-annular valve design of its predecessor while adding a retrievable delivery catheter with enhanced flexibility and distal positioning control. In the present cohort, recapture or repositioning was used in 44.8% of patients and was successful in all attempted cases. This high rate likely reflects both the anatomical complexity of the study population and the practical value of a retrievable system during the early learning phase across multiple centers. The high rate of general anesthesia should be interpreted in the context of the study period and population. Recruitment occurred from 2018 to 2022, during the early clinical introduction of this retrievable platform, and general anesthesia was often used to facilitate precise valve positioning and immediate rescue measures if catastrophic complications occurred [15]. The single coronary obstruction case occurred despite a non-prohibitive measured right coronary height because the native leaflet was broad, thickened, and approximately as tall as the coronary height, making leaflet-mediated obstruction highly likely after implantation and post-dilatation. Similarly, the tamponade cases were mechanistically heterogeneous, including procedural/device-related or pacing lead-related injury. Procedural/device-related vascular complications remain possible with the current-generation VitaFlow Liberty system. The next-generation VitaFlow Liberty Flex delivery system has recently been approved by the NMPA, and its steerable delivery system may help reduce procedural vascular complications in future practice.
Hemodynamic performance
At 2-year follow-up, the mean transvalvular gradient was reduced from 59.2 ± 19.8 mmHg at baseline to 9.0 ± 6.1 mmHg, while EOA increased from 0.57 ± 0.21 cm2 to 2.00 ± 0.51 cm2. These hemodynamic results, particularly the final EOA of 2.00 cm2, appear favorable compared with reported EOA values of 1.54 to 2.0 cm2 for other contemporary self-expanding valves [4, 5, 7]. This sustained improvement may be related to the supra-annular design and tubular-shaped frame. The rate of moderate or greater PVL was somewhat higher in this study, which may be attributable to the substantial proportion of patients with bicuspid AS (46.6%). Although bailout valve-in-valve implantation was more frequent than in some mature registries with lower bicuspid prevalence (e.g., 1.7% in the Evolut PRO US study), the detailed case analyses suggest that these events should be interpreted as rescue strategies rather than routine use of a second valve. Balloon post-dilatation was generally used to mitigate significant PVL or reduce transvalvular gradients due to valve stent under-expansion, whereas acute valve-in-valve implantation was reserved for suboptimal first-valve position or refractory PVL despite repositioning or post-dilatation. Case review showed that these scenarios often occurred in the setting of challenging anatomy, i.e., bicuspid AS with heavy or asymmetric calcification, horizontal aorta, or hemodynamic instability during repositioning [16].
Permanent pacemaker implantation
PPI remains a relevant issue with self-expanding TAVR platforms, with reported 30-day rates ranging from 15% to 23.5% [12–15, 17-20]. In the present study, PPI rates were 13.8% at 30 days, 16.5% at 1 year, and 19.5% at 2 years. Pacemakers were implanted for high-degree atrioventricular block based on ECG or cardiac monitoring. Although implantation depth is a reported risk factor for PPI after TAVR, we did not observe a significant difference between patients with and without PPI in this study (0.63 ± 0.44 cm vs 0.57 ± 0.40 cm, P = 0.55). This may have been due to measurement variability, because implantation depth was site-reported without a cohort-wide standardized measurement protocol. We acknowledge the absence of standardized depth data as a limitation. We also observed a slightly higher prevalence of baseline right bundle branch block and first-degree atrioventricular block in the PPI group, although the between-group differences were not statistically significant. Baseline untreated conduction disease requiring a pacemaker was excluded by protocol.
Clinical follow-up
We compared the clinical follow-up outcomes of the current study with published studies of the Evolut PRO TAV system, a contemporary self-expanding TAV system with recapturable function. The Evolut PRO US study included patients with severe AS at high surgical risk and reported 30-day mortality and disabling stroke rates of 1.7% and 1.7%, respectively, with a 30-day PPI rate of 11.8%; in comparison, our cohort had 30-day all-cause mortality of 3.1%, any stroke of 2.5%, and PPI of 13.8%. The 1-year all-cause mortality and stroke rates were 11.8% and 3.4% in the Evolut PRO US study, compared with 6.1% and 4.4% in our cohort. At 2 years, all-cause mortality and PPI were 13.5% and 19.5% in our study, compared with 25.8% and 20.4%, respectively, in the Evolut PRO study. Hemodynamic performance was also sustained, with a mean gradient of 9.0 mmHg and an EOA of 2.0 cm2, compared with 7.2 mmHg and 2.0 cm2 reported for the Evolut PRO platform [21, 22]. These cross-study comparisons should be interpreted cautiously because patient selection, bicuspid prevalence, baseline risk, and endpoint definitions differed substantially. Overall, these data suggest a broadly comparable safety and effectiveness profile relative to other contemporary TAVR devices.
The cohort also included a substantial proportion of patients with bicuspid morphology (46.6%), a subgroup associated with greater procedural complexity, more frequent valve malposition, and higher PVL risk [23–25]. This feature increases the relevance of the current dataset to real-world anatomical complexity, but subgroup-specific conclusions remain limited by sample size. The extended recruitment timeline reflects the dual challenges of the COVID-19 pandemic and multiple commercialized TAVR systems accessible to high-risk patients during the study period.
Study limitations
This study has several limitations. First, the single-arm design precludes direct comparison with surgery or with other TAVR devices. The historical performance-goal framework provides context for the original parent study but should not be overinterpreted in a contemporary 2-year follow-up report. Second, although 2-year follow-up offers useful mid-term information, it remains insufficient to fully assess long-term durability. Third, not all later VARC-3-style long-term composite elements, particularly formal valve-related rehospitalization as a standalone endpoint, were prospectively captured across all centers in the parent study. Fourth, complete baseline conduction-subgroup data, uniform electrophysiological testing, and cohort-wide standardized implantation-depth measurements were not available for a formal retrospective analysis. Finally, the trial was not designed or powered for a formal center-level comparison of procedural or clinical outcomes.
Conclusions
In this planned 2-year follow-up of a prospective multicenter single-arm study, TAVR with the VitaFlow LibertyTM system provided sustained hemodynamic benefit and acceptable clinical outcomes in patients with severe aortic stenosis at high surgical risk or considered unsuitable for surgery. The retrievable platform was frequently used and appeared particularly useful in complex anatomy, although PPI remained an important tradeoff. Longer follow-up and comparative studies are needed to better define long-term durability and the incremental benefit of this system compared with contemporary alternatives.
Supplementary materials
The revised supplementary appendix includes the original study-center, eligibility, death-cause, and left-ventricular remodeling tables, together with new case-based summary tables of bailout procedures and major complications (Table S5).
Supplementary Information
Abbreviations
- TAVR
Transcatheter aortic valve replacement
- AS
Aortic stenosis
- PVL
Paravalvular regurgitation
- TAV
Tricuspid aortic valve
- OPC
Objective performance criteria
- NYHA
New york heart association
- AVA
Aortic valve area
- SF-12v2
Short form 12-item health survey version 2
- CI
Confidence interval
- LVEF
Left ventricular ejection fraction
- EOA
Effective orifice area
- SAVR
Surgical aortic valve replacement
Author contributions
All authors contributed to the article and approved the submitted version. Conceptualization, D. Z., W. P. and J. G.; methodology, D. Z., W. P., S. C. and Z. Z.; formal analysis, D. Z., W. P., S. C.; Z. Z., D. C., Q. J., Y. Z. and X. Z.; investigation, S. C.; Z. Z.; data curation, D. Z., W. P., S. C.; Z. Z., D. C., Q. J., Y. Z. and X. Z.; writing—original draft preparation, S. C.; Z. Z; writing—review and editing, D. Z., W. P. and J. G; supervision, D. Z., W. P. and J. G. All authors have read and agreed to the published version of the manuscript.
Funding
This research was funded by Shanghai MicroPort CardioFlow Medtech Co., Ltd. and the Scientific Research Plan Project of the Shanghai Science and Technology Committee (No. 19DZ1930202).
Data availability
The raw data supporting the conclusions of this article will be made available by the authors on request.
Declarations
Institutional review board statement
The study was conducted in accordance with the Declaration of Helsinki, and approved by the Ethics Committee of Zhongshan Hospital, Fudan University (protocol code SUPERIOR-2017, date of approval April 24, 2017, Approval No. 2017-024R).
Informed consent
Written informed consent has been obtained from the patient(s) to publish this paper.
Competing interests
The authors declare no competing interests.
Footnotes
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Shasha Chen and Zhi Zhan these authors contribute equally.
Contributor Information
Wenzhi Pan, Email: peden@sina.com.
Daxin Zhou, Email: zhou.daxin@zs-hospital.sh.cn.
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Data Availability Statement
The raw data supporting the conclusions of this article will be made available by the authors on request.