Evidence map›Paper›PMID 35211519›Full record

ArticleFrontiers in cardiovascular medicine2021

A Novel Sutureless Integrated Stented (SIS) Graft Prosthesis for Type A Aortic Dissection: A Pilot Study for a Prospective, Multicenter Clinical Trial.

Lu Dai, Jiawei Qiu, Rui Zhao, Fangfang Cao, Juntao Qiu, De Wang, Shuya Fan, Enzehua Xie, Jian Song, Cuntao Yu

Open access · goldAbstract readCase Reports
In one paragraph

Article in Frontiers in cardiovascular medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.6field-weighted citation impact, top 33% of its field
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

6 citing papers in PubMed, 4 citations in OpenAlex.

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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

10 authors at 1 institution in 1 country.

Lu DaiDepartment of Aortic Surgery, National Center for Cardiovascular Disease, Peking Union Medical College, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Jiawei QiuDepartment of Aortic Surgery, National Center for Cardiovascular Disease, Peking Union Medical College, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Rui ZhaoDepartment of Aortic Surgery, National Center for Cardiovascular Disease, Peking Union Medical College, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Fangfang CaoAdult Surgical Intensive Care Unit, National Center for Cardiovascular Disease, Peking Union Medical College, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Juntao QiuDepartment of Aortic Surgery, National Center for Cardiovascular Disease, Peking Union Medical College, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.
De WangDepartment of Aortic Surgery, National Center for Cardiovascular Disease, Peking Union Medical College, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Shuya FanDepartment of Aortic Surgery, National Center for Cardiovascular Disease, Peking Union Medical College, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Enzehua XieDepartment of Aortic Surgery, National Center for Cardiovascular Disease, Peking Union Medical College, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Jian SongDepartment of Aortic Surgery, National Center for Cardiovascular Disease, Peking Union Medical College, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Cuntao YuDepartment of Aortic Surgery, National Center for Cardiovascular Disease, Peking Union Medical College, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Chinese Academy of Medical Sciences & Peking Union Medical College · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsVarious kinds of surgical strategies and prostheses have been advocated to improve short-term and long-term outcomes in type A aortic dissection (TAAD). Large-scale repair of the pathological aorta is hard to generalize due to complex procedures. We aimed to investigate the performance, effectiveness and safety of a novel Sutureless Integrated Stented (SIS) graft prosthesis in TAAD patients undergoing total arch replacement (TAR) and frozen elephant trunk (FET) implantation surgery.

methodsAll patients admitted to Fuwai Hospital were prospectively screened. Urgent or scheduled surgery was arranged for eligible patients. The primary endpoint was operative mortality. Key secondary endpoints included stroke, spinal cord injury, unexpected aortic reoperation, and 1-year survival. Discharged patients were followed up with computed tomography angiography and transthoracic echocardiography at 3 months, 6 months, and 1 year after surgery. Performance, effectiveness and safety analyses were performed in those patients.

resultsBetween August 1 and September 3, 2020, ten TAAD patients were enrolled in this study and successfully implanted with the SIS graft prosthesis. The median (IQR) age was 56.50 (43.75, 66.75) years (range from 31 to 75), and seven patients were male (70.0%). All patients underwent ascending aorta replacement + TAR + FET and additional procedures when necessary. The median (IQR) operation time, cardiopulmonary bypass time and cross clamp time were 270.50 (218.50, 312.50), 110.00 (88.00, 125.75), 69.50 (51.25, 82.75) min, respectively. Of note, the median (IQR) circulatory arrest time was 9.00 (8.00, 9.00) min (range from 4 to 12). The median (IQR) lowest nasopharyngeal temperature was 26.75 (25.98, 27.67) °C. Follow-up was 100% completed. During the 1-year follow-up, no patients died, no severe adverse events occurred, and rate of freedom from aortic reintervention was 100%.

conclusionsThe SIS graft prosthesis was implanted in a novel sutureless way, which simplified the surgical procedure, shortened the circulatory arrest time and avoided deep hypothermia. The preliminary clinical outcomes and follow-up outcomes demonstrated the effectiveness and safety of this prosthesis. A large-scale trial is being conducted to further assess these findings.

Indexed as

circulatory arrest timedeep hypothermiafrozen elephant trunkmortalitysurgery simplificationsutureless integrated stented graft prosthesistype A aortic dissection

Identifiers

PMID35211519
PMCPMC8860904
OpenAlexW4210884991

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.