Transcatheter aortic valve replacement (TAVR), also known as transcatheter aortic valve implantation (TAVI), is an interventional technology in which an artificial aortic valve is compressed and assembled outside the body, then delivered through a catheter and implanted at the site of the diseased aortic valve, thereby functionally replacing the native valve. Two versions of the Chinese expert consensus on TAVR were issued in China in 2015 and 2020, respectively. To promptly update the field's understanding of TAVR and to promote its broader, more standardized, and higher-quality application in China, an expert panel has developed this new version of the consensus. This consensus includes substantial updates compared with the previous version, covering topics such as the epidemiology of aortic valve disease, recent advances in TAVR research, indications, procedural standards, post-procedural antithrombotic therapy, prevention and management of complications, management of special cases, and future development trends. This consensus integrates international research evidence and references international guidelines to ensure rigor and evidence-based recommendations, while also incorporating domestic research findings and clinical practice in China, thereby enhancing both its forward-looking perspective and practical applicability.
We aimed to establish a rat TR model to further investigate the mechanisms of right heart remodeling and organ damage induced by TR. Intervention group rats (n = 6) underwent coronary stent system implantation via transjugular approach. The control group (n = 6) underwent the same procedure, except for coronary stent implantation. All rats survived at 8 weeks follow-up postoperatively. TR occurred immediately after the implantation of coronary stent in the intervention group. The right ventricular fractional area change (FAC) decreased by 33.9
Heart failure (HF) presents a significant global health challenge, caused by mitochondrial dysfunction, oxidative stress, and chronic inflammation, all of which impair cardiac function. This investigation introduces a new nanoplatform, PCM-refined M2 macrophage membrane-coated CeO2 nanozyme loaded with PGAM5 siRNA (P-MM@Ps-CeO2), that can target these interconnected disease pathways. Mechanistically, silencing PGAM5 with this nanoplatform precludes the dephosphorylation of Drp1 at Ser637, thereby lessening excessive mitochondrial fission. Yet, it restores the DDX17- BCL6 control mechanism to decrease Drp1 levels, ultimately maintaining mitochondrial balance. CeO2 nanozymes break down reactive oxygen species (ROS), Attenuating cellular oxidative imbalance, while M2 macrophage membranes improve anti-inflammatory targeting to inflamed heart tissue, with PCM ensuring delivery precisely to the heart. In vitro, P-MM@Ps-CeO2 re-established baseline 90
BACKGROUND:Transcatheter tricuspid valve replacement (TTVR) is emerging as a promising surgical alternative for high-risk patients with tricuspid regurgitation (TR). Nonetheless, the feasibility of more dedicated devices and the need for additional clinical evidence warrant further exploration. OBJECTIVES:The purpose of this study was to report the 1-year outcomes of the TRAVEL (Transcatheter Right Atrial-Ventricular Valve Replacement With LuX-Valve) study with the LuX-Valve system for patients with severe TR. METHODS:A total of 126 patients with symptomatic severe TR were prospectively enrolled in the single-arm, multicenter TRAVEL study from June 2020 to August 2021. All patients underwent TTVR via the transatrial approach using the LuX-Valve system. The primary endpoint was all-cause mortality and hospitalization for heart failure at 1-year follow-up. Clinical and echocardiographic outcomes were reported. RESULTS:At baseline, all enrolled patients (mean age 65.8 ± 7.5 years, 79.4% women) were at high surgical risk (mean Society of Thoracic Surgeons score 9.2% ± 4.4%), with severe or greater TR and NYHA functional class ≥ III. In 1-year follow-up, all-cause mortality was 10.3%, and 4.0% of patients were hospitalized for heart failure. TR was reduced to mild or less in 95.2% (P < 0.001), with decreases in right atrial systolic volume (-38.3 ± 21.7 mL; P < 0.001) and mid right ventricular end-systolic diameter (-6.4 ± 2.3 mm; P < 0.001). NYHA functional class I or II was achieved in 79.8% (P < 0.001), and 6-minute walking distance increased by 71.3 ± 42.8 m (P < 0.001). CONCLUSIONS:The 1-year outcomes of the TRAVEL study showed a sustained reduction in TR among patients who underwent LuX-Valve TTVR, accompanied by significant right heart reverse remodeling and improved functional status. Favorable procedural success and survival benefits were also demonstrated. (the TRAVEL Trial: Transcatheter Right Atrial-Ventricular Valve Replacement With LuX-Valve; NCT04436653).
BACKGROUND:Transcatheter tricuspid valve replacement (TTVR) is a promising therapy for tricuspid regurgitation (TR), but comprehensive comparison of clinical outcomes stratified by annular size remains understudied. OBJECTIVES:The aim of this study was to evaluate and compare early outcomes in patients treated with transjugular TTVR stratified by annular size. METHODS:Patients with grade ≥3 TR undergoing LuX-Valve Plus TTVR were enrolled across 13 centers from May 2022 to March 2024. They were stratified into a large-annulus group (LAG) (perimeter-derived annular diameter ≥51 mm or maximal annular diameter ≥55 mm) and a small-annulus group (SAG). Early outcomes included device, procedural, or intraprocedural success; TR reduction; and 30-day primary endpoints or clinical success. RESULTS:Among 159 patients, baseline TR severity was greater in the LAG (n = 42) than the SAG (n = 117). Superior trial-defined device or procedural success (81.0% vs 97.4%; P = 0.001) and Tricuspid Valve Academic Research-defined intraprocedural success (78.6% vs 96.6%; P = 0.001) were observed in the SAG. At 30 days, primary endpoint rates were similar (trial defined, 16.7% vs 14.5% [P = 0.936]; TRISCEND II [Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device] defined, 21.4% vs 22.2% [P = 1.000]), but Tricuspid Valve Academic Research Consortium clinical success favored the SAG (73.8% vs 94.9%; P = 0.001). Severe paravalvular regurgitation (7.1% vs 0.0%; P = 0.017) occurred only in the LAG, while new-onset third-degree atrioventricular block or pacemaker implantation (0.0% vs 9.4%) was exclusive to the SAG. Severe bleeding was comparable between the groups (14.3% vs 9.4%; P = 0.391). CONCLUSIONS:LuX-Valve Plus TTVR appears to be safe and effective in TR patients regardless of annular size, but TR reduction was more significant in the SAG, with specific differences in some major adverse events between groups.
Totally thoracoscopic and beating-heart techniques used in tricuspid valve surgery (TTC-TVS) show favorable outcomes. Transcatheter tricuspid valve replacement (TTVR) is an increasingly utilized alternative for patients with tricuspid regurgitation (TR) at high surgical risk. The purpose of this study was to compare TTVR with TTC-TVS to examine the outcomes of these two different management protocols for patients with symptomatic severe TR. A total of 116 patients with symptomatic severe TR were retrospectively collected and divided into the TTVR (n = 38) and the TTC-TVS (n = 78) groups. The primary end points included 2-year all-cause mortality and the combined endpoint (all-cause mortality and hospitalizations for heart failure). At a median follow-up of 630 (IQR 450–720) days, the similar freedom from 2-year all-cause mortality (85.2
The impact of QRS duration on postoperative LBBB and its implications for the prognosis of patients undergoing transcatheter aortic valve replacement (TAVR) remained uncertain. This study enrolled consecutive patients who underwent TAVR with self-expanding prostheses in our department from September 2017 to January 2021. Based on the pro-discharge electrocardiogram, patients were categorized into 3 groups: Group-NCD (no conduction disorder), Group-sLBBB (LBBB, QRS ≥ 150 ms), and Group-mLBBB (LBBB, QRS < 150 ms). Basic characteristics were compared among these groups. Furthermore, differences in left ventricular ejection fraction (LVEF), survival rates, and clinical events were assessed at baseline, discharge, and during a one-year follow-up period. A total of 56 patients were included in the study. With 17 (30.36%) experiencing new-onset LBBB, of which eleven had a QRS duration ≥ 150 ms. Group-sLBBB exhibited a longer left ventricular end-diastolic diameter at baseline. At a one-year follow-up, the LVEF improved in Group-NCD, but not in the LBBB groups. At discharge, the LVEF of Group-sLBBB was lower than that of Group-NCD (52.82 ± 11.48 vs 61.48 ± 10.10, P = .036) and remained lower at follow-up (57.10 ± 9.49 vs 65.85 ± 7.58, P = .011). Additionally, the LVEF of Group-sLBBB was lower than that of Group-mLBBB at discharge (52.82 ± 11.48 vs 63.17 ± 4.31, P = .018). However, there were no significant differences in survival and event-free survival among the groups. The study revealed a notable occurrence of new-onset LBBB following TAVR, with a majority of cases exhibiting a significantly prolonged QRS duration (≥150 ms). While the presence of LBBB did not impact one-year survival or clinical events, it did exert adverse effects on LVEF. Notably, when QRS duration was markedly prolonged, these adverse effects manifested earlier and were more pronounced.
Dysregulated autophagic flux plays a critical role in myocardial ischemia-reperfusion injury (MIRI), complicating cardiac reperfusion therapy. In this study, we identified OTUD4 as a potential regulator of autophagic flux in MIRI using CRISPR/Cas9 sgRNA sequencing. However, the underlying mechanism is poorly understood. The purpose of this study is to investigate the effects of OTUD4 on autophagic flux in OGD-R treated AC16 cells (IRI model in vitro) and LAD artery ligation induced myocardial ischemia-reperfusion mice (MIRI model in vivo). In the in vitro IRI cell model, OTUD4 knockdown significantly reversed impaired autophagic flux, increased mitochondrial membrane potential, and decreased LDH activity, ROS production, autophagy and apoptosis. Overexpression of OTUD4 showed the opposite result. In the in vivo MIRI model, OTUD4 knockdown also significantly decreased infarct area, improved cardiac structure and function, reduced serum BNP and LDH levels, attenuated cardiac tissue injury/fibrosis/myocardial hypertrophy, and ultimately exerted myocardial protective effects against ischemia-reperfusion injury. Importantly, OTUD4 knockdown inhibited autophagosome-associated markers (LC3II/LC3I, Beclin1, ATG9), autophagy substrate p62, increased lysosomal activity marker LAMP2, and activated the autophagy pathway (AKT/mTOR), thereby promoting the recovery of impaired autophagic flux in the MIRI model. Moreover, OTUD4 showed strong interaction with UBAC1, and OTUD4 deficiency decreases UBAC1 protein expression by impairing its deubiquitination, thereby regulating autophagy. In short, blocking OTUD4 restored damaged autophagic flux in I/R induced myocardial injury both in vivo and in vitro, inhibited myocardial cell apoptosis, and greatly improved cardiac function in ischemia-reperfusion mice. KEY MESSAGES: OTUD4 was identified as a key negative regulator of autophagy flux in myocardial ischemia-reperfusion injury (MIRI) via genome-wide CRISPR/Cas9 screening. OTUD4 knockdown exerts cardioprotective effects by reducing apoptosis and ROS generation and improving heart function in both in vitro and in vivo models. The interaction between OTUD4 and UBAC1 was confirmed, and OTUD4 maintains UBAC1 stability through deubiquitination, providing new insights into the ubiquitination regulatory mechanism in myocardial injury. Targeting OTUD4 has therapeutic potential for MIRI, as OTUD4 knockdown alleviated MIRI in both in vitro and in vivo models, suggesting the possibility of developing OTUD4 inhibitors for cardiac reperfusion treatment.
Background Efficient and accurate preoperative assessment of the right-sided heart structural complex (RSHSc) is crucial for planning transcatheter tricuspid valve replacement (TTVR). However, current manual methods remain time-consuming and inconsistent. To address this unmet clinical need, this study aimed to develop and validate TRI-PLAN, the first fully automated, deep learning (DL)-based framework for pre-TTVR assessment. Methods A total of 140 preprocedural computed tomography angiography (CTA) scans (63,962 slices) from patients with severe tricuspid regurgitation (TR) at two high-volume cardiac centers in China were retrospectively included. The patients were divided into a training cohort (n = 100), an internal validation cohort (n = 20), and an external validation cohort (n = 20). TRI-PLAN was developed by a dual-stage right heart assessment network (DRA-Net) to segment the RSHSc and localize the tricuspid annulus (TA), followed by automated measurement of key anatomical parameters and right ventricular ejection fraction (RVEF). Performance was comprehensively evaluated in terms of accuracy, interobserver benchmark comparison, clinical usability, and workflow efficiency. Results TRI-PLAN achieved expert-level segmentation accuracy (volumetric Dice 0.952/0.955; surface Dice 0.934/0.940), precise localization (standard deviation 1.18/1.14 mm), excellent measurement agreement (ICC 0.984/0.979) and reliable RVEF evaluation (R = 0.97, bias<5 %) across internal and external cohorts. In addition, TRI-PLAN obtained a direct acceptance rate of 80 % and reduced total assessment time from 30 min manually to under 2 min (>95 % time saving). Conclusions TRI-PLAN provides an accurate, efficient, and clinically applicable solution for pre-TTVR assessment, with strong potential to streamline TTVR planning and enhance procedural outcomes.
Objectives:This study evaluated the impact of transcatheter tricuspid valve replacement (TTVR) on renal and hepatic function in patients with severe tricuspid regurgitation (TR). Background:TR is associated with increased morbidity, mortality, and heart failure-related hospitalizations. Venous congestion and reduced forward stroke volume can compromise hepatic and renal function. TTVR has emerged as a promising option for high-risk patients, but its effects remain understudied. Methods:In this prospective, multicenter study, 96 high-surgical-risk patients with severe TR (NYHA functional class III/IV) underwent LuX-Valve TTVR between September 2022 and March 2023. Follow-up at 7, 30, 180, and 360 days assessed cardiac, hepatic (total bilirubin (TBIL), direct bilirubin (DBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP)), and renal (serum creatinine, urea, uric acid) function. Results:Procedural success was 95.79 %, and 93 patients survived to 12 months. All survivors exhibited TR reduction to less than grade III. Significant hepatic improvement was noted at 12 months, especially among those with preoperative liver dysfunction (LD): total bilirubin decreased from 21.54 ± 11.14 to 18.33 ± 7.82 μmol/L (P = 0.044) and direct bilirubin from 7.95 ± 4.74 to 5.92 ± 2.98 μmol/L (P = 0.005). Renal function remained stable. Conclusions:TTVR is an effective, minimally invasive approach for severe TR, facilitating significant hepatic recovery in patients with preoperative dysfunction while preserving renal function. These findings underscore the reversibility of TR-induced hepatic impairment and demonstrate TTVR's potential to improve clinical outcomes.
Background:The tricuspid regurgitation (TR) syndrome, based on the extent of cardiac and extracardiac involvement, is a newly proposed staging method to evaluate the progression of TR. This study aimed to explore cardiac structural characteristics and the short-term prognosis after transcatheter tricuspid valve replacement (TTVR) in patients at different stages. Methods:A post-hoc analysis of patients enrolled in the first-in-man and confirmatory study and an investigator-initiated trial of the LuX-Valve Plus system was conducted. Patients with TR who underwent successful TTVR by the LuX-Valve Plus systems were staged according to systemic involvement. The baseline and one-month follow-up results among different stages were compared. Results:A total of 149 patients were included, of whom 23 were in stage 2, 49 were in stage 3, and 77 were in stage 4. Compared with patients in stages 2 and 3, patients in stage 4 had more severe TR (mean vena contracta width: 14.94±4.51 vs. 11.13±4.56 vs. 11.04±3.71 mm, P<0.001), greater right ventricular (RV) remodeling (RV anterior-posterior diameter, 35.63±6.04 vs. 32.35±4.95 vs. 33.56±4.43 mm, P=0.007) and annulus enlargement (tricuspid annulus, 44.87±5.41 vs. 41.54±6.21 vs. 42.13±5.26 mm, P=0.004), higher level of N-terminal pro-brain natriuretic peptide (NT-Pro-BNP) [1,063.50 (541.25, 1,791.25) vs. 631.50 (462.55, 1,409.50) vs. 587.50 (250.55, 908.55) pg/mL, P=0.03], and more extracardiac system damage [such as more lower limbs edema, higher bilirubin level and Model for End-Stage Liver Disease (MELD)-albumin score, lower hemoglobin, platelet count, and estimated glomerular filtration rate (eGFR)]. Regardless of staging, patients generally benefited from TTVR as evidenced by reverse RV remodeling, improved New York Heart Association (NYHA) classification, and improved Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. Patients in stage 4 had a higher incidence of paravalvular leakage after the procedure and all deaths were presented in the stage 4 group. No heart failure readmission was observed during short-term follow-up. Conclusions:The staging of TR syndrome may help to quantify disease severity. Although all patients can gain short-term benefits from TTVR, an early intervention may help to reduce the incidence of complications.
Transcatheter tricuspid valve replacement (TTVR) is emerging as a promising surgical alternative for high-risk patients with tricuspid regurgitation (TR). Nonetheless, the feasibility of more dedicated devices and the need for additional clinical evidence warrant further exploration. The purpose of this study was to report the 1-year outcomes of the TRAVEL (Transcatheter Right Atrial-Ventricular Valve Replacement With LuX-Valve) study with the LuX-Valve system for patients with severe TR. A total of 126 patients with symptomatic severe TR were prospectively enrolled in the single-arm, multicenter TRAVEL study from June 2020 to August 2021. All patients underwent TTVR via the transatrial approach using the LuX-Valve system. The primary endpoint was all-cause mortality and hospitalization for heart failure at 1-year follow-up. Clinical and echocardiographic outcomes were reported. At baseline, all enrolled patients (mean age 65.8 ± 7.5 years, 79.4% women) were at high surgical risk (mean Society of Thoracic Surgeons score 9.2% ± 4.4%), with severe or greater TR and NYHA functional class ≥ III. In 1-year follow-up, all-cause mortality was 10.3%, and 4.0% of patients were hospitalized for heart failure. TR was reduced to mild or less in 95.2% (P < 0.001), with decreases in right atrial systolic volume (-38.3 ± 21.7 mL; P < 0.001) and mid right ventricular end-systolic diameter (-6.4 ± 2.3 mm; P < 0.001). NYHA functional class I or II was achieved in 79.8% (P < 0.001), and 6-minute walking distance increased by 71.3 ± 42.8 m (P < 0.001). The 1-year outcomes of the TRAVEL study showed a sustained reduction in TR among patients who underwent LuX-Valve TTVR, accompanied by significant right heart reverse remodeling and improved functional status. Favorable procedural success and survival benefits were also demonstrated. (the TRAVEL Trial: Transcatheter Right Atrial-Ventricular Valve Replacement With LuX-Valve; NCT04436653).
Polymeric heart valves (PHVs) present a promising alternative to mechanical and bio-prosthetic valves, addressing critical issues such as durability and calcification. This study investigates poly(styrene-block-ethylene/butylene-block-styrene) (SEBS) block copolymers for PHV applications, focusing on material characterization, valve fabrication, in vitro durability testing, and in vivo bio-compatibility evaluation. Mechanical tests, including thermogravimetric analysis (TGA), dynamic mechanical analysis (DMA), differential scanning calorimetry (DSC), and hydrodynamic performance analysis demonstrated that SEBS offers excellent thermal stability, flexibility, and fatigue resistance. Bio-compatibility assessments conducted per ISO 10993 standards revealed minimal cytotoxicity, hemolysis, and adverse immune responses. The hydrodynamic performance tests showed favorable hemodynamics, with low transvalvular pressure gradients and effective orifice areas within acceptable limits. In vivo trials on animal models confirmed that SEBS valves maintained competent valve function, without significant structural degeneration or calcification, over the 140-day study period. Mild regurgitation, observed in a subset of models, is attributed to anatomical variations and surgical technique. These results suggest that SEBS-based PHVs are a durable, biocompatible alternative to traditional heart valves and hold promise for overcoming limitations associated with current mechanical and bioprosthetic designs.
Impaired hospitalizations for heart failure (HHF) and mortality are associated with tricuspid regurgitation (TR). The objective of this study was to investigate the benefit of transcatheter tricuspid valve replacement (TTVR) over guideline-directed medical therapy (GDMT) in patients with symptomatic severe TR. Between May 2020 and April 2023, 88 patients with symptomatic severe TR were treated in our center. Of these, 57 patients received GDMT alone, and 31 patients underwent combined TTVR and GDMT. We collected and analyzed baseline data, and follow-up information for both groups. The primary endpoints were all-cause mortality and the combined endpoint (including all-cause mortality and HHF). At a median follow-up of 20 (IQR 10–29) months, significant improvements were shown in TR severity, right ventricular function, and dimensions in TTVR group (all P < 0.001). It also resulted in superior survival rates (75.8
Transcatheter aortic valve replacement (TAVR) was initially used to treat aortic stenosis (AS), and gradually expanded into aortic regurgitation (AR) treatment. Scholars worldwide have explored the use of marketed transfemoral TAVR (TF-TAVR) valves for AR patients, offering another option for high-risk surgical patients. However, AR presents distinct challenges compared to AS, including anatomical differences, valve selection, procedural nuances, and complication profiles. Overall, TF-TAVR for AR is more complex with lower success rate than for AS. In order to promote the safe and standardized TF-TAVR for AR in China, the Structural Heart Disease Group of Chinese College of Cardiovascular Physician drafted this consensus. The writing expert team focused on key clinical challenges in TF-TAVR for AR patients, combining evidence from literature up to September 1, 2023, to formulate nine core viewpoints. These encompass indications, valve selection, preoperative evaluation, intraoperative techniques, complication prevention and management, postoperative care, and other aspects.