A versatile transapical device for aortic valvular disease: One-year outcomes of a multicenter study on the J-Valve system

Tung, Mingwui; Wang, Xu; Li, Fēi; Wang, Hao; Guo, Yingqiang; Wang, Chunsheng; Wei, Lai; Luo, Xin-lan; Wang, Xin; Wang, Wei

doi:10.1016/j.jjcc.2018.05.020

Cited by 17 publications

(19 citation statements)

References 22 publications

(21 reference statements)

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“…A total of 69 patients with severe symptomatic AS who were treated with J-Valve (JieCheng Medical Technologies, Suzhou, China) were included between March 2014 and July 2017. Of these patients, 64 participated in J-Valve China clinical trial at three cardiac centers (Fuwai Hospital, West China Hospital, and Zhongshan Hospital) 4,12) to get official approval from China Food and Drug Administration. From December 2012 to April 2016, 63 patients treated with Venus-A THV (Venus MedTech, Hangzhou, China) were also enrolled in this study.…”

Section: Patient Selectionmentioning

confidence: 99%

“…The feasibility and convincing short-term outcome of J-Valve was reported in our previous study. 4,12) However, compared with the reported results of other THVs, 13,14) it was observed that the patients treated with J-Valve showed a relatively higher transaortic pressure gradient. We speculated the phenomenon attributing to the frame design of this prosthesis.…”

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confidence: 91%

“…With the emergence of new TAVI systems, transcatheter heart valve (THV) devices with different support frame designs were used in interventional treatment for aortic disease. [3][4][5][6] THVs have their characteristic design of support frame structure such as J-Valve 7) prosthesis that consists of a trifoliate porcine aortic valve mounted in a short self-expandable cylinder nitinol stent. Edwards SAPIEN 8) prosthetic valve has a similar configuration in the support frame with J-Valve, but it was made of cobalt-chromium alloy and released by balloon dilation.…”

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confidence: 99%

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Comparison of Procedural and 1-Year Clinical Results of Transcatheter Aortic Valve Implantation Using Prostheses with Different Design of Support Frame

Wang

et al. 2020

Int. Heart J.

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Section: Patient Selectionmentioning

confidence: 99%

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confidence: 91%

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confidence: 99%

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Comparison of Procedural and 1-Year Clinical Results of Transcatheter Aortic Valve Implantation Using Prostheses with Different Design of Support Frame

Wang

et al. 2020

Int. Heart J.

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“…12) In addition, the feasibility of TAVI for patients with PAR was proven in several second-generation THV, including Evolut-R, 18) SAPIEN 3, 8) ACURATE neo, 9) Direct Flow Medical, 10) Lotus 11) et al The 1-year outcome of TAVI using a second-generation THV (J-Valve and Jenavalve) for PAR has been reported, and it presented a satisfactory outcome. 4,5,7) However, the long-term durability and efficiency of these devices were not demonstrated. Our study first reported the long-term follow-up of TAVI using J-Valve for PAR, and the dependable durability and Continuous variables were performed as mean ± standard deviation.…”

Section: Discussionmentioning

confidence: 99%

“…With the development of transcatheter heart valve (THV) devices and the technique of TAVI procedure, the second-generation THV has revolutionized the interventional treatment for PAR. 4,5) There are multiple reports presenting the feasibility of transcatheter approach for the treatment of PAR, 4,[6][7][8][9][10][11] and second-generation devices associated with an excellent procedural success rate and favorable perioperative outcomes compared with first-generation THV. In second-generation devices, the advantage is more pronounced on the "on-label" THVs (J-Valve and JenaValve) than "off-label" THVs.…”

Section: Introductionmentioning

confidence: 99%

Structural Valve Deterioration after Transcatheter Aortic Valve Implantation Using J-Valve: A Long-Term Follow-Up

Wang

et al. 2020

ATCS

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Purpose: Our study aimed to investigate the structural valve deterioration (SVD) after transcatheter aortic valve implantation (TAVI) using J-Valve. Methods: In all, 14 patients with aortic stenosis (AS) and 4 patients with pure aortic regurgitation (PAR) were available in the study. Four-year follow-up was performed in all patients, and the clinical data and echocardiographic findings were recorded and analyzed. Results: All patients survived at the 4-year follow-up. There was no evidence of morphological SVD or prosthetic valve thrombosis in enrolled patients. None of the hemodynamic SVD occurred in patients with PAR. Mean gradients decreased from 61.93 ± 15.42 mm Hg (pre-TAVI) to 19.64 ± 9.16 mm Hg (discharge) in patients with AS (p <0.001); subsequently, a slight increase was observed in the mean trans-aortic gradient throughout follow-up (p = 0.967). Overall, in patients with AS, six individuals suffered moderate (3/14, 21.4%) or severe (3/14, 21.4%) hemodynamic SVD at 4-year follow-up. Conclusions: The limited number of cases provides a preliminary indication of the longterm efficacy of TAVI using J-Valve in patients with PAR. In patients with AS, although the higher rate of SVD was observed, the overall transcatheter heart valve (THV) hemodynamics remained stable over time after prosthetic valve implantation and the longterm durability of J-Valve was convincing.

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Transcatheter aortic valve replacement for aortic regurgitation: a systematic review and meta‐analysis

Liu,

Fu,

Jiang

et al. 2024

ESC Heart Failure

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The efficacy and safety of new‐generation devices (NGDs) for severe aortic regurgitation (AR) have mostly been based on single‐arm studies with limited sample sizes. Our goal was to summarize the current evidence on NGDs and compare the safety and efficacy of ‘off‐label’ and ‘on‐label’ devices in NGDs. We searched MEDLINE, Embase, Cochrane Library, and Scopus for articles on transcatheter aortic valve replacement in patients with AR. A total of 31 studies that included 1851 patients were identified through April 2023. Among these, 1067 (57.6%) patients received treatment with ‘on‐label’ devices (JenaValve and J‐Valve). For NGDs, the total device success rate at 30 days was 94.5% (on‐label: 97.8%, off‐label: 89.9%; P < 0.001), the all‐cause mortality was 4.2% (on‐label: 2.6%, off‐label: 5.1%; P = 0.006), permanent pacemaker implantation (PPI) was 8.8% (on‐label: 6.9%, off‐label: 18.4%; P < 0.001), and the rate of greater‐than‐mild paravalvular leak (PVL) was 1.2% (on‐label: 0.9%, off‐label: 3.8%; P = 0.003). On‐label devices showed significantly better safety and efficacy in terms of the success rate, PPI, greater‐than‐mild PVL, and 30 day mortality than off‐label devices.

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A versatile transapical device for aortic valvular disease: One-year outcomes of a multicenter study on the J-Valve system

Abstract: Our study provides further evidence on the safety and efficacy of the J-Valve in high-risk patients with AS or AR for surgery.

Cited by 17 publications

References 22 publications

Comparison of Procedural and 1-Year Clinical Results of Transcatheter Aortic Valve Implantation Using Prostheses with Different Design of Support Frame

Comparison of Procedural and 1-Year Clinical Results of Transcatheter Aortic Valve Implantation Using Prostheses with Different Design of Support Frame

Structural Valve Deterioration after Transcatheter Aortic Valve Implantation Using J-Valve: A Long-Term Follow-Up

Transcatheter aortic valve replacement for aortic regurgitation: a systematic review and meta‐analysis

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