1.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*
2.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
3.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*
4.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*
5.Short-term outcomes of transcatheter pulmonary valve replacement with Venus-P valve in patients with moderate-to-severe pulmonary regurgitation and right ventricular systolic dysfunction.
Haiyue XIE ; Wenhao ZHU ; Zhiyuan XIA ; Gejun ZHANG
Journal of Zhejiang University. Medical sciences 2025;54(3):390-398
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
6.Valve-in-valve transcatheter mitral valve replacement with SAPIEN 3 valve for bioprosthetic mitral valve failure: one-year outcomes in 26 patients.
Zechao RAN ; Lulu LIU ; Jun SHI ; Yuqiang WANG ; Tingqian CAO ; Siyu HE ; Xiaoting LI ; Yingqiang GUO
Journal of Zhejiang University. Medical sciences 2025;54(5):668-675
OBJECTIVES:
To evaluate the one-year outcomes of valve-in-valve transcatheter mitral valve replacement (ViV-TMVR) using SAPIEN 3 valve for treating mitral bioprosthetic valve failure.
METHODS:
A retrospective analysis was conducted on 26 patients with mitral bioprosthetic valve failure who underwent ViV-TMVR at West China Hospital, Sichuan University, between November 2022 and July 2024. The age of patients was 71.5 (64.5, 74.5) years, and 69.2% were female. Bioprosthetic valve failure occurred at (9.7±3.7) years after initial surgical implantation, with the most common failure mode being mixed stenosis and regurgitation (53.8%). The SAPIEN 3 valve was implanted via either a transseptal or transapical approach. Echocardiography was performed preoperatively, immediately post-procedure, and at 1 month, 6 months, and 1 year post-procedure. Outcomes included all-cause mortality, New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 score, and postoperative complications.
RESULTS:
The procedure was performed via the transseptal approach in 21 patients (80.8%) and the transapical approach in 5 patients (19.2%). All procedures were technically successful. No paravalvular leakage was observed immediately post-procedure, and mitral valve hemodynamics improved significantly. At the 1-year follow-up, 2 patients had died. Two patients (8.3% of survivors) were of NYHA functional class Ⅲ, and KCCQ-12 score improved to (88.4±14.6) points (both P<0.01). Echocardio-graphy at 1 year postoperatively showed significant reductions in peak mitral valve velocity [to (2.29±0.32) m/s] and mean transvalvular pressure gradient [to (9.5±3.5) mmHg, 1 mmHg=0.133 kPa] compared to baseline (both P<0.05). No moderate or severe mitral regurgitation or paravalvular leakage was observed. The proportion of patients with moderate-to-severe pulmonary hypertension decreased from 65.4% preoperatively to 13.0% at 1 year (P<0.05).
CONCLUSIONS
ViV-TMVR with the SAPIEN 3 valve for mitral biopro-sthetic valve failure is associated with high procedural success, significantly improved valve hemodynamics of the mitral value, alleviation of pulmonary hypertension, enhanced quality of life, and a low rate of complications at 1 year after the operation.
Humans
;
Female
;
Male
;
Retrospective Studies
;
Aged
;
Bioprosthesis
;
Heart Valve Prosthesis
;
Mitral Valve/surgery*
;
Heart Valve Prosthesis Implantation/methods*
;
Middle Aged
;
Prosthesis Failure
;
Treatment Outcome
;
Mitral Valve Insufficiency/surgery*
7.Preliminary experience of transcatheter pulmonary valve replacement using domestic balloon-expandable valve.
Zhen Gang ZHAO ; Rui Tao LI ; Xin WEI ; Yong PENG ; Jia Fu WEI ; Sen HE ; Qiao LI ; Xiao LI ; Yi Jian LI ; Xiang LI ; Xuan ZHOU ; Ming Xia ZHENG ; Guo CHEN ; Qi AN ; Mao CHEN ; Yuan FENG
Chinese Journal of Cardiology 2023;51(8):825-831
Objectives: To evaluate the feasibility and preliminary clinical results of transcatheter pulmonary valve replacement (TPVR) with the domestically-produced balloon-expandable Prizvalve system. Methods: This is a prospective single-center observational study. Patients with postoperative right ventricular outflow tract (RVOT) dysfunction, who were admitted to West China Hospital of Sichuan University from September 2021 to March 2023 and deemed anatomically suitable for TPVR with balloon-expandable valve, were included. Clinical, imaging, procedural and follow-up data were analyzed. The immediate procedural results were evaluated by clinical implant success rate, which is defined as successful valve implantation with echocardiography-assessed pulmonary regurgitation
Male
;
Humans
;
Pulmonary Valve/surgery*
;
Heart Valve Prosthesis/adverse effects*
;
Heart Valve Prosthesis Implantation
;
Constriction, Pathologic/surgery*
;
Prospective Studies
;
Ventricular Outflow Obstruction/surgery*
;
Treatment Outcome
;
Cardiac Catheterization/methods*
;
Transcatheter Aortic Valve Replacement
8.Preliminary experience of transcatheter pulmonary valve replacement using domestic balloon-expandable valve.
Zhen Gang ZHAO ; Rui Tao LI ; Xin WEI ; Yong PENG ; Jia Fu WEI ; Sen HE ; Qiao LI ; Xiao LI ; Yi Jian LI ; Xiang LI ; Xuan ZHOU ; Ming Xia ZHENG ; Guo CHEN ; Qi AN ; Mao CHEN ; Yuan FENG
Chinese Journal of Cardiology 2023;51(8):825-831
Objectives: To evaluate the feasibility and preliminary clinical results of transcatheter pulmonary valve replacement (TPVR) with the domestically-produced balloon-expandable Prizvalve system. Methods: This is a prospective single-center observational study. Patients with postoperative right ventricular outflow tract (RVOT) dysfunction, who were admitted to West China Hospital of Sichuan University from September 2021 to March 2023 and deemed anatomically suitable for TPVR with balloon-expandable valve, were included. Clinical, imaging, procedural and follow-up data were analyzed. The immediate procedural results were evaluated by clinical implant success rate, which is defined as successful valve implantation with echocardiography-assessed pulmonary regurgitation
Male
;
Humans
;
Pulmonary Valve/surgery*
;
Heart Valve Prosthesis/adverse effects*
;
Heart Valve Prosthesis Implantation
;
Constriction, Pathologic/surgery*
;
Prospective Studies
;
Ventricular Outflow Obstruction/surgery*
;
Treatment Outcome
;
Cardiac Catheterization/methods*
;
Transcatheter Aortic Valve Replacement
9.Hand-sewn expanded polytetrafluoroethylene valved conduit for right ventricular outflow tract reconstruction.
Tao QIAN ; Can HUANG ; Ting LU ; Hong ZHANG ; Haoyong YUAN ; Li XIE ; Zhongshi WU
Journal of Central South University(Medical Sciences) 2022;47(1):94-100
OBJECTIVES:
Due to the lack of large-sized pulmonary valved conduit products in clinical practice, hand-sewn expanded polytetrafluoroethylene (ePTFE) valved conduit has been used for right ventricular outflow tract (RVOT) reconstruction in many heart centers around the world. This study aims to summarize the early results of the ePTFE valved conduit and the sewing technology of the conduit in combination with the latest progress, and to provide a reference for the application of ePTFE valved conduit.
METHODS:
A total of 21 patients using ePTFE valved conduit for RVOT reconstruction in the Second Xiangya Hospital, Central South University from October 2018 to October 2020 were prospectively enrolled in this study. The age at the implantation of the conduit was 4.3 to 43.8 (median 15.1) years old, with weight of (38.9±4.1) kg. In this cohort, 14 patients underwent re-reconstruction of RVOT, including 12 patients with pulmonary regurgitation at 6.3 to 31.0 (median 13.8) years after tetralogy of Fallot (TOF) repair, and 2 patients with failed bovine jugular vein conduit (BJVC). Seven patients underwent Ross operations. Among them, 3 were for aortic valve stenosis, 2 were for aortic regurgitation, and 2 were for both stenosis and regurgitation. The ePTFE valved conduits were standard hand-sewn during the surgery. The 3 leaflets were equal in size with arc-shaped lower edge of the valve sinus. The free edge of the valve leaflets was straight with the length of about 1 mm longer than the diameter. The height of the valve sinus was 4/5 of the diameter. The junction of the valve leaflet was 3/4 of the height of the sinus. The designed leaflets were then continuous non-penetrating sutured into the inner surface of Gore-Tex vessel to make a valved conduit. Valved conduits with diameter of 18, 20, and 22 mm were used in 2, 9, and 10 cases, respectively. The surgical results, postoperative recovery time, and serious complications were summarized, and the changes of postoperative cardiac function status and hemodynamic status of the conduits were investigated.
RESULTS:
During the implantation of ePTFE valved conduit for RVOT reconstruction, 2 patients underwent mechanical mitral valve replacement with Ross operation, 2 patients with pulmonary regurgitation with repaired TOF underwent left and right pulmonary artery angioplasty, and 1 patient with failed BJVC underwent tricuspid valvuloplasty. The cardiopulmonary bypassing time for patients underwent re-reconstruction of RVOT was (130.9±16.9) min, with aorta clamping for 1 patient to repair the residual defect of the ventricular septum. The cardiopulmonary bypassing and aorta clamping time for Ross operation were (242.7±20.6) min and (145.6±10.5) min, respectively. The duration of postoperative ventilator assistance, intensive care unit stay, and hospital stay were 3.5 h to 7.7 d (median 17.1 h),11.2 h to 29.5 d (median 1.9 d), and 6.0 to 56.0 (median 13.0) d, respectively. All patients survived after discharge from hospital. The follow-up rate after discharge was 100% with median time at 15.0 (13.0 to 39.0) months. No death happened during the follow-up. One patient underwent stent implantation due to right coronary stenosis 2 months after Ross operation. One patient underwent balloon dilation due to right pulmonary artery ostium stenosis 1 year after re-reconstruction of RVOT. The cardiac function of all patients recovered to NYHA class I 6 months after operation. The peak pressure gradient across the valve measured by transthoracic echocardiography before discharge was (9.4±2.6) mmHg (1 mmHg=0.133 kPa), and (18.3±6.1) mmHg at the last follow-up. There was no significant increase in the gradient during the follow-up (P=0.134). No patient suffered from mild or more pulmonary regurgitation.
CONCLUSIONS
Hand-sewn ePTFE valved conduit is feasible for RVOT reconstruction. It is a promising material for RVOT reconstruction which can effectively meet clinical need. In our experience, the ePTFE valved conduit is simple to manufacture with satisfactory early outcomes.In the application of ePTFE valved conduit, attention should be paid to implantation indications and postoperative anticoagulation management, especially to the preparation details of the valved conduit, to obtain better function and durability of the conduit after implantation.
Adolescent
;
Animals
;
Cattle
;
Constriction, Pathologic/surgery*
;
Heart Valve Prosthesis/adverse effects*
;
Heart Valve Prosthesis Implantation/methods*
;
Humans
;
Infant
;
Polytetrafluoroethylene
;
Prosthesis Design
;
Pulmonary Valve Insufficiency/surgery*
;
Retrospective Studies
;
Treatment Outcome
;
Ventricular Outflow Obstruction/surgery*
10.Preliminary clinical experience of the novel transcatheter aortic valve system Prizvalve® for the treatment of severe aortic stenosis.
Jia Fu WEI ; Hao Ran YANG ; Yong PENG ; Sen HE ; Yong CHEN ; Zhen Gang ZHAO ; Wei MENG ; Xuan ZHOU ; Yu Jia LIANG ; Wen Xia ZHOU ; Xin WEI ; Xi LI ; Fei CHEN ; Zhong Kai ZHU ; Yi ZHANG ; Jing Jing HE ; Mao CHEN ; Yuan FENG
Chinese Journal of Cardiology 2022;50(2):137-141
Objective: To evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) with the novel Prizvalve® system in treating severe aortic stenosis. Methods: This is a single-center, prospective, single-arm, observational study. A total of 11 patients with severe aortic stenosis with high risk or inappropriate for conventional surgical aortic valve replacement (SAVR) were included, and TAVI was achieved with the Prizvalve® system between March 2021 and May 2021 in West China Hospital. Transthoracic echocardiography (TTE) was performed immediately after prosthesis implantation to evaluate mean transaortic gradient and maximal transaortic velocity. The device success rate was calculated, which was defined as (1) the device being delivered via the access, deployed, implanted and withdrawn, (2) mean transaortic gradient<20 mmHg (1 mmHg=0.133 kPa) or a maximal transaortic velocity<3 m/s post TAVI, and without severe aortic regurgitation or paravalvular leak post TAVI. TTE was performed at 30 days after the surgery, and all-cause mortality as well as the major cardiovascular adverse events (including acute myocardial infarction, disabling hemorrhagic or ischemic stroke) up to 30 days post TAVI were analyzed. Results: The age of 11 included patients were (78.1±6.3) years, with 8 males. A total of 10 patients were with NYHA functional class Ⅲ or Ⅳ. Devices were delivered via the access, deployed, implanted and withdrawn successfully in all patients. Post-implant mean transaortic gradient was (7.55±4.08) mmHg and maximal transaortic velocity was (1.78±0.44) m/s, and both decreased significantly as compared to baseline levels (both P<0.05). No severe aortic regurgitation or paravalvular leak was observed post TAVI. Device success was achieved in all the 11 patients. No patient died or experienced major cardiovascular adverse events up to 30 days post TAVI. Mean transaortic gradient was (9.45±5.07) mmHg and maximal transaortic velocity was (2.05±0.42) m/s at 30 days post TAVI, which were similar as the values measured immediately post TAVI (both P>0.05). Conclusions: TAVI with the Prizvalve® system is a feasible and relatively safe procedure for patients with severe aortic stenosis and at high risk or inappropriate for SAVR. Further clinical studies could be launched to obtain more clinical experience with Prizvalve® system.
Aged
;
Aged, 80 and over
;
Aortic Valve
;
Aortic Valve Stenosis/surgery*
;
Heart Valve Prosthesis
;
Heart Valve Prosthesis Implantation
;
Humans
;
Male
;
Prospective Studies
;
Transcatheter Aortic Valve Replacement/methods*
;
Treatment Outcome

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