1.Structural design and mechanical analysis of a "drum-shaped" balloon-expandable valve stent in expanded configuration.
Youzhi ZHAO ; Qianwen HOU ; Jianye ZHOU ; Shiliang CHEN ; Hanbing ZHANG ; Aike QIAO
Journal of Biomedical Engineering 2025;42(5):945-953
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*
2.Transcatheter edge-to-edge repair using MitraClipTM G4 for severe mitral regurgitation in an advanced elderly patient with Barlow disease.
Fei LUO ; Jiafeng WANG ; Zhifu GUO ; Yongwen QIN ; Yuan BAI
Journal of Zhejiang University. Medical sciences 2025;54(2):199-203
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 MitraClipTM 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*
3.Impact of elevated arterial blood pressure on bioprosthetic valve calcification and failure after transcatheter aortic valve replacement.
Wenjing SHENG ; Qifeng ZHU ; Hanyi DAI ; Dao ZHOU ; Xianbao LIU
Journal of Zhejiang University. Medical sciences 2025;54(2):154-160
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*
4.Short-term clinical efficacy of transcatheter edge-to-edge repair for moderate to severe mitral regurgitation.
Yunlong MA ; Ruifeng LI ; Mingjun HE ; Shun WANG ; Xiaozhen ZHUO ; Ke HAN
Journal of Zhejiang University. Medical sciences 2025;54(2):204-212
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
5.Single-center experience in the treatment of severe aortic stenosis with XcorTM transcatheter aortic valve replacement system: 1-year follow-up results.
Shengwen WANG ; Haozhong LIU ; Haijiang GUO ; Tong TAN ; Hanxiang XIE ; Xiang LIU ; Hailong QIU ; Jimei CHEN ; Huiming GUO ; Jian LIU
Journal of Zhejiang University. Medical sciences 2025;54(2):141-148
OBJECTIVES:
To analyze the early clinical outcomes of the XcorTM 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 XcorTM 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 XcorTM 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 XcorTM 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
6.Efficacy and safety of concomitant left atrial appendage clipping during heart valve surgery: a report of 58 cases.
Zheng XU ; Haiyan XIANG ; Jiwei WANG ; Chen LIU ; Yanhua TANG ; Juesheng YANG
Journal of Zhejiang University. Medical sciences 2025;54(2):250-256
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*
7.Left bundle branch pacing in a patient with decreased cardiac function after transcatheter aortic valve replacement.
Xinghong LI ; Jubo JIANG ; Sheng'an SU ; Fang ZHOU
Journal of Zhejiang University. Medical sciences 2025;54(2):149-153
A case of an elderly patient with severe aortic insufficiency who carried high risks for surgical valve replacement. After a detailed preoperative evaluation, the patient successfully received transapical transcatheter aortic valve replacement. Postoperatively, complete left bundle branch block developed, resulting in impaired left ventricular function. Despite guideline-directed medical therapy for heart failure, cardiac function showed no significant recovery. At 4.5 months post-surgery, left bundle branch pacing was performed, leading to a marked improvement in cardiac function.
Aged
;
Humans
;
Male
;
Aortic Valve Insufficiency/surgery*
;
Bundle-Branch Block/etiology*
;
Cardiac Pacing, Artificial
;
Postoperative Complications/therapy*
;
Transcatheter Aortic Valve Replacement/adverse effects*
8.A case of coronary artery protection in transcatheter aortic valve replacement of quadricuspid aortic valve.
Zhipeng CHEN ; Dong YANG ; Han ZHANG
Journal of Zhejiang University. Medical sciences 2025;54(2):161-166
A 72-year-old patient with quadricuspid aortic valve underwent transcatheter aortic valve replacement due to severe valve stenosis accompanied by moderate insufficiency. As initially planned, the right coronary artery was protected during the procedure. However, after the artificial valve was released, the left coronary artery was found to be blocked, so a coronary protection stent was implanted in the left coronary artery ostium under the guidance of intravascular ultrasonography. This case indicates that for patients with a quadricuspid aortic valve undergoing transcatheter aortic valve replacement, in addition to preoperative measurement of the aortic root, attention should also be paid to the coronary artery obstruction caused by the displacement of the artificial valve frame during the procedure.
Aged
;
Humans
;
Aortic Valve/surgery*
;
Aortic Valve Stenosis/surgery*
;
Coronary Vessels
;
Stents
;
Transcatheter Aortic Valve Replacement/methods*
9.Efficacy of the transcatheter tricuspid valve replacement for patients with severe tricuspid regurgitation: Lux-Valve versus Lux-Valve Plus.
Yandan SUN ; Liang CAO ; Wei BAI ; Yuxi LI ; Jian YANG ; Guomeng JIANG ; Yang LIU ; Ping JIN ; Liwen LIU ; Xin MENG
Journal of Zhejiang University. Medical sciences 2025;54(2):213-218
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*
10.Advances in stroke after transcatheter aortic valve replacement.
Journal of Zhejiang University. Medical sciences 2025;54(2):167-174
With the clinical generalization and popularization of transcatheter aortic valve replacement (TAVR), cerebrovascular events related to TAVR occur more frequently, which significantly impairs neurocognitive function, increases mortality, and seriously affects prognosis and quality of life in these patients. However, the reported incidence rates of TAVR-related stroke differ in literature due to inconsistent diagnostic criteria. According to the onset time, TAVR-related stroke can be divided into acute (≤24 h), subacute (24 h-30 d), early (31 d-1 year) and late (>1 year) types, and the cause of stroke generally varies according to the onset time. Both surgical (balloon aortic valvuloplasty, types of transcatheter heart valve, alternative access) and non-surgical (valvular calcium burden, bicuspid aortic valve, subclinical leaflet thrombosis, postoperative new-onset atrial fibrillation) can be related to the occurrence of TAVR-related stroke. Postprocedural monitoring, postprocedural antithrombotic therapy, and cerebral embolic protection devices are important for the prevention of TAVR-related stoke. This article reviews the research progress on TAVR-related stroke, focusing on its epidemiology, risk factors and preventive measures, aiming to provide reference for the clinical management of stroke in TAVR.
Humans
;
Transcatheter Aortic Valve Replacement/adverse effects*
;
Stroke/epidemiology*
;
Postoperative Complications/etiology*
;
Aortic Valve Stenosis/surgery*
;
Risk Factors

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