Evidence map›Paper›PMID 36773041›Full record

Observational studyHeart and vessels2023

1-year outcomes of patients implanted with the Perceval sutureless valve: the Japanese post-marketing surveillance study.

Hiroshi Niinami, Yoshiki Sawa, Tomoki Shimokawa, Satoru Domoto, Yoshitsugu Nakamura, Taichi Sakaguchi, Toshiaki Ito, Koichi Toda, Atsushi Amano, Borut Gersak

Abstract readObservational Study
In one paragraph

Observational study in Heart and vessels, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–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

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. 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

10 authors.

Hiroshi NiinamiDepartment of Cardiovascular Surgery, The Heart Institute of Japan, Tokyo Women's Medical University Tokyo, Tokyo, Japan. hniinami@twmu.ac.jp.ORCID http://orcid.org/0000-0002-3713-7372
Yoshiki SawaCardiovascular Surgery, Osaka University, Suita, Japan.
Tomoki ShimokawaCardiovascular Surgery, Sakakibara Heart Institute Tokyo/Teikyo University, Fuchu, Japan.
Satoru DomotoDepartment of Cardiovascular Surgery, The Heart Institute of Japan, Tokyo Women's Medical University Tokyo, Tokyo, Japan.
Yoshitsugu NakamuraCardiovascular Surgery, Chiba-Nishi General Hospital, Matsudo, Japan.
Taichi SakaguchiCardiovascular Surgery, The Sakakibara Heart Institute of Okayama, Okayama, Japan.
Toshiaki ItoCardiovascular Surgery, Japanese Red Cross Nagoya Daiichi Hospital, Nagoya, Japan.
Koichi TodaCardiovascular Surgery, Osaka University, Suita, Japan.
Atsushi AmanoCardiovascular Surgery, Juntendo University Hospital, Tokyo, Japan.
Borut GersakMedical Faculty/Nisteri, Medicine and Research, University of Ljubljana, Phoenix, AZ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Sutureless offers an alternative to standard valves in surgical aortic valve replacement (SAVR). We sought to confirm the efficacy and safety of the Perceval sutureless valve in Japanese patients. Prospective observational study of 204 patients who underwent SAVR with Perceval at 19 sites in Japan between March and December 2019. The primary outcomes were 30-day mortality and postoperative complications; the secondary outcome was all-cause mortality at 1 year. Efficacy outcomes were changed in New York Heart Association (NYHA) class, pressure gradients, effective orifice area (EOA), EOA indexed to body surface area (EOAi) and severity of aortic regurgitation. Mean age was 77.7 years, 62.7% were female. Procedural success rate was 99.0%. The median cross-clamp and cardiopulmonary bypass times were 68.0 and 108 min. Perceval size S and M were implanted in 95 (46.6%) and in 76 (37.3%) of patients, respectively. The 30-day and late mortality rate were 0.5% and 4.4%, while the new permanent pacemaker implantation rate was 4.4%. Mean pressure gradient was 13.0 mmHg at discharge, reaching 11.0 mmHg at 1 year; while the mean EOA was 1.5 cm

Indexed as

Aortic Valve StenosisBioprosthesisHeart Valve ProsthesisHeart Valve Prosthesis ImplantationSutureless Surgical ProceduresAgedAortic ValveEast Asian PeopleFemaleHumansMaleProduct Surveillance, PostmarketingProsthesis DesignTreatment OutcomeClinical and hemodynamic outcomesJapanSutureless aortic valve

Identifiers

PMID36773041
PMCPMC10209299

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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.