Evidence map›Paper›PMID 41618946›Full record

ArticleJACC. Asia2026

Early Safety and Feasibility Study of a Novel Transcatheter Aortic Valve With Polymeric Leaflets.

Xiaochun Zhang, Qinchun Jin, Wenzhi Pan, Wei Li, Bin Wang, Yan Wang, Hongbo Yang, Da Zhu, Xiang Bin Pan, Bo Li and 10 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in JACC. Asia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Innovation and Challenges in Materials for Transcatheter Aortic Valves.Journal of cardiovascular translational research · 2026
    Review
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Xiaochun ZhangDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; State Key Laboratory of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Ischemic Heart Diseases Fudan University, Shanghai, China; Key Laboratory of Viral Heart Diseases, Chinese Academy of Medical Sciences, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
Qinchun JinDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; State Key Laboratory of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Ischemic Heart Diseases Fudan University, Shanghai, China; Key Laboratory of Viral Heart Diseases, Chinese Academy of Medical Sciences, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
Wenzhi PanDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; State Key Laboratory of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Ischemic Heart Diseases Fudan University, Shanghai, China; Key Laboratory of Viral Heart Diseases, Chinese Academy of Medical Sciences, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
Wei LiDepartment of Echocardiography, Zhongshan Hospital, Fudan University, Shanghai, China.
Bin WangDepartment of Cardiology, Xiamen Cardiovascular Hospital, Xiamen University, Xiamen, China.
Yan WangDepartment of Cardiology, Xiamen Cardiovascular Hospital, Xiamen University, Xiamen, China.
Hongbo YangDepartment of Cardiology, Fuwai Yunnan Cardiovascular Hospital, Kunming, China.
Da ZhuFuwai Yunnan Hospital, Chinese Academy of Medical Sciences, Affiliated Cardiovascular Hospital of Kunming Medical University, Kunming, China.
Xiang Bin PanFuwai Yunnan Hospital, Chinese Academy of Medical Sciences, Affiliated Cardiovascular Hospital of Kunming Medical University, Kunming, China; Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences, Beijing, China and Peking Union Medical College, Beijing, China.
Bo LiDepartment of Cardiology, Zibo Central Hospital, Shandong, China.
Shasha ChenDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; State Key Laboratory of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Ischemic Heart Diseases Fudan University, Shanghai, China; Key Laboratory of Viral Heart Diseases, Chinese Academy of Medical Sciences, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
Yuliang LongDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; State Key Laboratory of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Ischemic Heart Diseases Fudan University, Shanghai, China; Key Laboratory of Viral Heart Diseases, Chinese Academy of Medical Sciences, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
Lei ZhangDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; State Key Laboratory of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Ischemic Heart Diseases Fudan University, Shanghai, China; Key Laboratory of Viral Heart Diseases, Chinese Academy of Medical Sciences, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
Weijing ZhangDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; State Key Laboratory of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Ischemic Heart Diseases Fudan University, Shanghai, China; Key Laboratory of Viral Heart Diseases, Chinese Academy of Medical Sciences, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
Yun RenDepartment of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, China.
Haiyan ChenDepartment of Echocardiography, Zhongshan Hospital, Fudan University, Shanghai, China.
Xue YangDepartment of Radiology, Zhongshan Hospital, Fudan University, Shanghai, China.
Juying QianDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; State Key Laboratory of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Ischemic Heart Diseases Fudan University, Shanghai, China; Key Laboratory of Viral Heart Diseases, Chinese Academy of Medical Sciences, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
Daxin ZhouDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; State Key Laboratory of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Ischemic Heart Diseases Fudan University, Shanghai, China; Key Laboratory of Viral Heart Diseases, Chinese Academy of Medical Sciences, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China. Electronic address: zhou.daxin@zs-hospital.sh.cn.
Junbo GeDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China; State Key Laboratory of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China; NHC Key Laboratory of Ischemic Heart Diseases Fudan University, Shanghai, China; Key Laboratory of Viral Heart Diseases, Chinese Academy of Medical Sciences, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China. Electronic address: ge.junbo2@zs-hospital.sh.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTranscatheter aortic valve replacement is a promising alternative treatment for patients with severe aortic stenosis (AS), but uncertainties remain regarding its long-term durability.

objectivesThis study aimed to evaluate the safety and feasibility of Sikelia transcatheter heart valve with polymeric leaflets in AS.

methodsIn this first-in-human, prospective, nonrandomized, single-arm, multicenter study, patients with severe symptomatic AS eligible for the novel valve were recruited. Clinical outcomes and hemodynamic performance were reported at discharge and 30-day, 6-month, and 1-year follow-up.

resultsTwelve patients (73.75 ± 7.28 years, 25% female, mean Society of Thoracic Surgeons score 4.51% [4.07%-4.87%], 66.67% bicuspid valve) were enrolled. Procedural success was achieved in 83.33% (1 fully device retrieval and 1 death due to coronary obstruction). All patients successfully underwent transcatheter aortic valve replacement were in NYHA functional class I/II at the 30-day follow-up, and significant improvement was shown in 6-minute walk distance and Kansas City Cardiomyopathy Questionnaire score (all P < 0.001). At 1 year, the effective orifice area (2.31 ± 0.33 cm

conclusionsThe preliminary outcomes of the novel transcatheter heart valve demonstrated a favorable hemodynamic performance with an acceptable safety profile at 1 year. Long-term follow-up is warranted to assess its durability in treating patients with AS.

Indexed as

aortic stenosispolymeric leafletsSikeliatranscatheter heart valve

Identifiers

PMID41618946
PMCPMC13080745

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.