Stent migration is one of the common complications following transcatheter valve implantation. This study aims to design a "drum-shaped" balloon-expandable aortic valve stent to address this issue and conduct a mechanical analysis. The implantation process of the stent was evaluated using a method that combines numerical simulation and in vitro experiments. Furthermore, the fatigue process of the stent under pulsatile cyclic loading was simulated, and its fatigue performance was assessed using a Goodman diagram. The process of the stent migrating toward the left ventricular side was simulated, and the force-displacement curve of the stent was extracted to evaluate its anti- migration performance. The results showed that all five stent models could be crimped into a 14F sheath and enabled uniform expansion of the native valve leaflets. The stress in each stent was below the ultimate stress, so no fatigue fracture occurred. As the cell height ratio decreased, the contact area fraction between the stent and the aortic root gradually decreased. However, the mean contact force and the maximum anti-migration force first decreased and then increased. Specifically, model S5 had the smallest contact area fraction but the largest mean contact force and maximum anti-migration force, reaching approximately 0.16 MPa and 10.73 N, respectively. The designed stent achieves a "drum-shaped" change after expansion and has good anti-migration performance.
Stents ; Prosthesis Design ; Heart Valve Prosthesis ; Humans ; Aortic Valve/surgery* ; Stress, Mechanical ; Transcatheter Aortic Valve Replacement/instrumentation*

A 91-year-old male patient was admitted with a history of mitral valve prolapse diagnosed by physical examination ten years prior and recent onset of exertional chest discomfort persisting for over one month. Transthoracic echocardiography showed that the anterior leaflet of mitral valve was thickened and prolapsed with severe regurgitation, and transesophageal echocardiography further confirmed that the anterior and posterior leaflets of mitral valve were prolapsed with massive regurgitation (A1, A2, A3, P1 and P2 were all prolapsed). Thus, the diagnosis of Barlow syndrome was considered. Transcatheter edge-to-edge mitral repair was performed with two MitraClip^TM G4 XTWs. After a 10 months follow-up, the patient's cardiac function was significantly improved, and the degree of mitral regurgitation was mild.
Humans ; Male ; Aged, 80 and over ; Mitral Valve Insufficiency/surgery* ; Mitral Valve Prolapse/diagnostic imaging* ; Cardiac Catheterization/methods* ; Mitral Valve/surgery* ; Heart Valve Prosthesis Implantation/methods*

Transcatheter aortic valve replacement (TAVR) has emerged as the standard treatment for severe aortic stenosis, demonstrating comparable efficacy to traditional surgery in low and intermediate-risk patients. However, the bioprosthetic valves utilized in TAVR have a limited lifespan, and bioprosthetic valve failure, including calcification, rupture or infection may develop, leading to poor clinical outcomes. Elevated blood pressure has been identified as a key factor in aortic valve calcification, and its role in bioprosthetic valve failure is gaining increasing attention. Hypertension may accelerate the calcification process and exacerbate valve failure due to increased mechanical stress on the valve, activation of the renin-angiotensin system, and enhanced thrombus formation. Furthermore, elevated blood pressure interacts with prosthesis mismatch and paravalvular leak, jointly affecting valve durability. This review explores the impact of elevated blood pressure on bioprosthetic valve calcification and failure after TAVR, and emphasizes the importance of blood pressure control, optimized preoperative assessment, and appropriate valve selection in reducing valve failures.
Humans ; Transcatheter Aortic Valve Replacement/adverse effects* ; Calcinosis/etiology* ; Bioprosthesis ; Heart Valve Prosthesis/adverse effects* ; Prosthesis Failure ; Aortic Valve Stenosis/surgery* ; Aortic Valve/surgery* ; Hypertension/physiopathology*

OBJECTIVES: To evaluate the short-term clinical efficacy of transcatheter edge-to-edge repair (TEER) in patients with moderate to severe mitral regurgitation. METHODS: Clinical data of patients with moderate to severe mitral regurgitation who underwent TEER in the Department of Cardiology, the First Affiliated Hospital of Xi'an Jiaotong University from April 2021 to May 2024, were retrospectively analyzed, including preoperative baseline clinical and echocardiography data, intraoperative data and 6-month postoperative follow-up data. RESULTS: A total of 67 patients' (47 males and 20 females) data were included, of whom 62 completed 6-month follow-up. The immediately postoperative success rate was 88.1% (59/67), and 83.9% (52/62) patients exhibited mitral regurgitation ≤2+ at 6 months postoperatively, showing significant improvement compared with preoperative (P<0.05). The proportion of patients with mitral regurgitation ≤2+ at 6 months was significantly higher in the degenerative mitral regurgitation (DMR) group than that in the functional mitral regurgitation (FMR) group (P<0.05). The mean mitral valve gradient (MVG) in DMR group was increased from (3.1±1.2) mmHg (1 mmHg=0.133 kPa) to (3.7±1.2) mmHg 6 months after operation (P<0.05), while there was no significant change in FMR group (P>0.05). Compared with those before operation, the N-terminal pro-B-type natriuretic peptide levels in both FMR and DMR groups were significantly lower at 6 months postoperatively (all P<0.05), and the left atrial volume index and left atrial anteroposterior diameter were also significantly lower (all P<0.05). The left ventricular end-diastolic diameter and left ventricular end-systolic diameter were significantly reduced 6 months after operation in the FMR group (all P<0.05), but no significant changes were observed in the DMR group (all P>0.05). The ejection fraction was not significantly changed before and after operation in both groups (all P>0.05). The mitral regurgitation, tricuspid regurgitant, and pulmonary artery pressure were significantly reduced in both groups at 6 months postoperatively (all P<0.05). CONCLUSIONS TEER is effective for moderate to severe mitral regurgitation. The improve-ments in left ventricular remodeling are more pronounced in patients with FMR while the degree of mitral regurgitation is more significant in DMR patients. However, MVG elevation is more common during the follow-up.
Humans ; Mitral Valve Insufficiency/surgery* ; Male ; Female ; Retrospective Studies ; Middle Aged ; Aged ; Treatment Outcome ; Mitral Valve/surgery* ; Cardiac Catheterization/methods* ; Heart Valve Prosthesis Implantation/methods* ; Adult ; Follow-Up Studies

OBJECTIVES: To analyze the early clinical outcomes of the Xcor^TM transcatheter aortic valve replacement (TAVR) system in treating severe aortic stenosis. This study has been registered at Chinese Clinical Trial Registry (ChiCTR2200065593). METHODS: This single-arm, prospective clinical trial enrolled patients with severe aortic stenosis treated with the Xcor^TM TAVR system at the Section of Heart Valve & Coronary Artery Surgery, Guangdong Provincial People's Hospital. Perioperative and follow-up parameters were compared to evaluate differences in hemodynamic outcomes. All-cause mortality, aortic regurgitation, paravalvular leakage, cerebrovascular events, and reoperation were analyzed. RESULTS: Thirty-two patients with severe aortic stenosis were included (20 males, 12 females), with (70.9±4.3) years old and a Society of Thoracic Surgeons (STS) score of 6.45% (6.07%, 7.28%). Notably, 87.5% of patients had New York Heart Association (NYHA) class≥Ⅲ. All patients underwent successful Xcor^TM bioprosthesis implantation, achieving an immediate technical success rate of 100.0% and device success rate of 96.9%. Mean aortic valve gradient decreased from (55.21±23.17) mmHg (1 mmHg=0.133 kPa) to (8.45±5.30) mmHg, peak aortic jet velocity decreased from (4.66±0.85) m/s to (1.99±0.48) m/s, aortic valve area increased from (0.66±0.21) cm² to (2.09±0.67) cm² (all P<0.01). Intraoperative ventricular fibrillation occurred in one patient, while one case exhibited moderate prosthetic valve regurgitation and paravalvular leakage post-procedure. At 12-month follow-up, sustained improvements were observed in cardiac function, left ventricular ejection fraction, hemodynamic parameters, and SF-12 quality-of-life scores (all P<0.01). All-cause mortality was 12.5% (4/32), with 13.8% (4/29) developing moderate paravalvular leakage. CONCLUSIONS The Xcor^TM TAVR system demonstrated favorable early outcomes in severe aortic stenosis patients, significantly improving symptoms and hemodynamics while exhibiting excellent performance in preventing malignant arrhythmias and coronary obstruction.
Humans ; Male ; Female ; Aortic Valve Stenosis/surgery* ; Transcatheter Aortic Valve Replacement/methods* ; Aged ; Follow-Up Studies ; Prospective Studies ; Treatment Outcome ; Aged, 80 and over ; Heart Valve Prosthesis ; Middle Aged

OBJECTIVES: To analyze the efficacy and safety of concomitant left atrial appendage clipping during heart valve surgery for valvular heart disease patients with atrial fibrillation. METHODS: Fifty-eight patients who underwent concomitant left atrial appendage clipping during cardiac valve surgery in the Second Affiliated Hospital of Nanchang University from January 2017 to June 2023 were included in the analysis, including 1 case who underwent aortic valve replacement, 49 cases who underwent mitral valve replace-ment (or valvuloplasty)+tricuspid valvuloplasty, and 8 cases who underwent double valve replacement+tricuspid valvuloplasty (3 cases combined with coronary artery bypass grafting). The patients were followed up for 3-36 months [(16.69±6.61) months] after operation, and the changes of cardiac function and the occurrence of serious adverse complications were evaluated. RESULTS: The cardiopulmonary bypass time ranged from 75 to 145 min [(102.50±21.03) min], and the aortic cross-clamp time ranged from 35 to 80 min [(58.02±14.63) min]. The length of postoperative intensive care unit stay was 1 to 5 days [(2.47±0.82) d], and the length of postoperative hospital stay was 7 to 22 days [(10.84±2.69) d]. Cardiac ultrasound indicated complete closure of the left atrial appendage in all cases. During the follow-up, New York Heart Association (NYHA) functional classifications were improved in 54 patients. No left atrial appendage-related bleeding events or other perioperative complications were observed; and no cerebral infarction, limb embolism events, or mortality cases occurred during the follow-up. CONCLUSIONS For valvular heart disease patients with atrial fibrillation, concomitant left atrial appendage clipping during cardiac valve surgery demonstrates efficacy and safety, with no severe adverse events during a medium-term follow-up.
Humans ; Atrial Appendage/surgery* ; Atrial Fibrillation/complications* ; Male ; Female ; Heart Valve Diseases/complications* ; Aged ; Middle Aged ; Heart Valve Prosthesis Implantation/methods* ; Treatment Outcome ; Cardiac Surgical Procedures/methods* ; Mitral Valve/surgery*

OBJECTIVES: To compare the efficacy of transcatheter tricuspid valve replacement (TTVR) using Lux-Valve and Lux-Valve Plus in patients with severe tricuspid regurgitation. METHODS: A total of 28 consecutive patients with severe tricuspid regurgitation who underwent TTVR with Lux-Valve (n=14) or Lux-Valve Plus (n=14) in the First Affiliated Hospital of the Air Force Medical University from August 2019 to November 2023 were enrolled. Transthoracic echocardiography was performed in all patients before and 6 months after the TTVR. The ultrasound indexes were compared before and 6 months after the TTVR in all patients and between Lux-Valve and Lux-Valve Plus groups. RESULTS: Compared with the Lux-Valve group, the Lux-Valve Plus group showed significantly reduced intraoperative bleeding and shorter postoperative hospital stays (both P<0.05). Six months after the TTVR, none of the patients exhibited more than a mild tricuspid valve regurgitation, and none of the patients had moderate or above perivalvular leakage except for one patient in the Lux-Valve Plus group who had a separation of the clamping member from the anterior tricuspid leaflet. The incidence of perivalvular leakage was significantly lower in the Lux-Valve Plus group (14.29%, 2/14) than in the Lux-Valve group (64.29%, 9/14, P<0.05). At 6 months after operation, the right chamber volume and right ventricle middle transverse diameter were reduced (both P<0.05); the peak blood flow velocity across the tricuspid valve, peak pressure gradient across the tricuspid valve, mean blood flow velocity of tricuspid valve, mean pressure gradient across the tricuspid valve and velocity time integral were increased in both groups (all P<0.05).Compared with the Lux-Valve group, the Lux-Valve Plus group showed higher left ventricular ejection fraction at 6 months postoperatively (P<0.05), while the rest of the indicators were not statistically different (all P>0.05). CONCLUSIONS The efficacy of using Lux-Valve and Lux-Valve Plus for TTVR in patients with severe tricuspid regurgitation is comparable. Six months after the TTVR, the right side of the heart has undergone reverse remodeling.While Lux-Valve Plus offers greater minimally invasive benefits, valve selection should consider device-specific characteristics and differences in individual patients.
Humans ; Tricuspid Valve Insufficiency/surgery* ; Male ; Female ; Heart Valve Prosthesis Implantation/methods* ; Middle Aged ; Aged ; Tricuspid Valve/surgery* ; Heart Valve Prosthesis ; Treatment Outcome ; Echocardiography ; Adult ; Cardiac Catheterization/methods*

Structural valve deterioration (SVD) refers to intrinsic and irreversible pathological changes in the components of prosthetic heart valves, manifesting as fibrosis, calcification, wear and tear, loosening, as well as strut fracture or deformation of the valve framework. These changes ultimately lead to valve stenosis and/or regurgitation.The mechanisms may be related to mechanical stress, immune response and abnormal calcium-phosphorus metabolism. Studies have shown that risk factors for SVD include patient factors (such as age, underlying cardiovascular disease and comorbidities), valve factors (such as material properties, processing techniques, and valve type), and surgical factors (such as valve injury, suboptimal stent expansion, and irregular stent release morphology). Clinical imaging assessment of SVD demonstrates complementary advantages among echocardiography, multi-detector spiral CT and cardiac magnetic resonance imaging, with distinct diagnostic objectives. The primary management strategies for SVD after trans-catheter aortic valve replacement (TAVR) include drug therapy, redo-TAVR, surgical aortic valve replacement (SAVR) and the novel SURPLUS technique. Among them, redo-TAVR has become a common method because of its minimally invasive nature, but it is still necessary to further clarify the patient indications and optimize the surgical strategy. SAVR is reserved for young, low-risk patients; SURPLUS combines the advantages of SAVR and TAVR, making it suitable for cases where redo-TAVR is unfeasible or contraindicated, while the risk of SAVR is excessively high. This article reviews the latest progress of SVD following TAVR treatment to provide reference for research into the durability of bioprosthetic valve and clinical intervention of SVD.
Humans ; Transcatheter Aortic Valve Replacement/adverse effects* ; Heart Valve Prosthesis/adverse effects* ; Prosthesis Failure ; Aortic Valve/pathology* ; Aortic Valve Stenosis/surgery*

OBJECTIVES: To evaluate the short-term outcomes of transcatheter pulmonary valve replacement (TPVR) using the Venus-P valve in patients with moderate-to-severe pulmonary regurgitation and right ventricular systolic dysfunction (RVSD) following surgical repair of complex congenital heart disease. METHODS: A retrospective analysis was conducted on patients undergoing Venus-P valve implantation (TPVR group, n=28) or surgical pulmonary valve replacement (SPVR group, n=19) at Fuwai Hospital between February 2014 and February 2024. All patients had moderate-to-severe pulmonary regurgitation with right ventricular ejection fraction less than 45% preoperatively. Postoperative pulmonary valve function and ventricular parameters were assessed at discharge and during a 6-month follow-up. RESULTS: All procedures were successfully completed with no early mortality. At 6 months, the TPVR group demonstrated significantly lower pulmonary valve transvalvular pressure gradients compared to the SPVR group (P<0.05). Both groups exhibited significant improvements from baseline in New York Heart Association (NYHA) functional class, biventricular ejection fractions, and right ventricular end-diastolic volume index (all P<0.05). The reduction in right ventricular end-diastolic diameter differed between the two groups (P<0.01). However, multivariable analysis revealed no association between this difference and surgical approach (β=4.4, P>0.05). In the TPVR group, QRS duration was significantly shortened postoperatively (P<0.01), with improvements in left ventricular end-diastolic volume index and cardiac index (both P<0.01), but these improvements did not differ significantly from the SPVR group (all P>0.05). During the follow-up, one patient in each group developed infective endocarditis within 1-month post-procedure; both were successfully treated with antibiotics. No other major complications were observed. CONCLUSIONS For patients with moderate-to-severe pulmonary regurgitation and RVSD, TPVR using the Venus-P valve effectively improves short-term pulmonary valve function and ventricular performance with a favorable safety profile, demonstrating potential as a minimally invasive alternative to SPVR .
Humans ; Pulmonary Valve Insufficiency/surgery* ; Retrospective Studies ; Pulmonary Valve/surgery* ; Heart Valve Prosthesis Implantation/methods* ; Ventricular Dysfunction, Right/physiopathology* ; Treatment Outcome ; Female ; Male ; Child ; Adult ; Heart Valve Prosthesis ; Adolescent ; Cardiac Catheterization/methods* ; Child, Preschool

OBJECTIVES: To evaluate the early clinical efficacy and safety of trans-catheter aortic valve replacement (TAVR) for patients with severe pure native aortic regurgitation (PNAR) who are not suitable for conventional surgical aortic valve replace-ment. METHODS: A retrospective analysis was conducted on 48 patients with PNAR who underwent TAVR at the Department of Cardiac Surgery, the First Affiliated Hospital of Sun Yat-sen University between March 2019 and February 2025. These included 25 cases with transfemoral approach (TF-TAVR group) and 23 cases with transapical approach (TA-TAVR group). Efficacy and safety were assessed by analyzing baseline characteristics, all-cause mortality, and procedure-related complications. RESULTS: Compared with the TA-TAVR group, the TF-TAVR group exhibited significantly smaller aortic annulus circumference and diameter, left ventricular outflow tract circumference and diameter, diameters of the left, right, and non-coronary sinuses, and sinotubular junction (STJ) diameter, along with a shorter distance from the STJ to the aortic annular plane ring plane, a smaller annulus angle (all P<0.05). Additionally, the TF-TAVR group showed a deeper prosthesis implantation depth relative to the aortic annular plane (P<0.01). The overall technical success rate was 91.67%, and the device success rate was 83.33%. Post-TAVR, both groups demonstrated significant improvement in left ventricular end-diastolic diameter (both P<0.05), while only the TA-TAVR group showed significant reduction in left ventricular end-systolic diameter (P<0.05). For primary outcomes, in-hospital mortality occurred in 2 patients (4.17%). No additional deaths were reported at 60 or 90 d after surgery. During 90-180 d after surgery, one patient in the TF-TAVR group died of sudden cardiac death, and one in the TA-TAVR group died of gastroin-testinal bleeding. During 180 d-1 year after surgery, one patient in the TF-TAVR group died of low cardiac output syndrome. No statistically significant differences were observed in 1-year Kaplan-Meier survival curves between the two groups (P>0.05). No conduction block events occurred in TA-TAVR group during hospitalization or 1-year follow-up, while high-grade atrioventricular block, left bundle branch block, permanent pacemaker implantation occurred in TF-TAVR group during hospitalization (12.00%, 4.00%, and 12.00%, respectively). CONCLUSIONS TAVR demonstrates high feasibility and acceptable safety for severe PNAR patients who are not suitable for conventional SAVR. Both TF-TAVR and TA-TAVR show comparable early postoperative efficacy and safety profiles.
Humans ; Transcatheter Aortic Valve Replacement/adverse effects* ; Aortic Valve Insufficiency/surgery* ; Retrospective Studies ; Male ; Female ; Aged ; Treatment Outcome ; Aortic Valve/surgery* ; Aged, 80 and over ; Heart Valve Prosthesis