Evidence map›Paper›PMID 38757027›Full record

ArticleArchives of medical science : AMS2024

Clinical outcomes of the Myval transcatheter heart valve system in patients with severe aortic valve stenosis: a two-year follow-up observational study.

Teoman Kilic, Alfonso Ielasi, Vlasis Ninios, Levent Korkmaz, Demosthenes Panagiotakos, Gokhan Yerlikaya, Ahmet Ozderya, Carolina Montonati, Maurizio Tespili, Senol Coskun and 6 more

Abstract read
In one paragraph

Article in Archives of medical science : AMS, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

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

  1. Pooled it
  2. Article
  3. Article
  4. Observational
  5. Article
  6. Article
  7. Review
  8. 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

16 authors.

Teoman KilicDepartment of Cardiology, Medical Faculty, Kocaeli University, Kocaeli, Turkey.
Alfonso IelasiU.O. Cardiologia Ospedalirea, IRCCSOspedale Galeazzi Sant'Ambrogio, Italy.
Vlasis NiniosDepartment of Cardiology, Interbalkan European Medical Center, Thessaloniki, Greece.
Levent KorkmazDepartment of Cardiology, University of Health Sciences, Trabzon Ahi Evren Cardiovascular and Thoracic Surgery Training and Research Hospital, Turkey.
Demosthenes PanagiotakosSchool of Health Sciences and Education, Harokopio University, Athens, Greece.
Gokhan YerlikayaDepartment of Cardiology, University of Health Sciences, Trabzon Ahi Evren Cardiovascular and Thoracic Surgery Training and Research Hospital, Turkey.
Ahmet OzderyaDepartment of Cardiology, University of Health Sciences, Trabzon Ahi Evren Cardiovascular and Thoracic Surgery Training and Research Hospital, Turkey.
Carolina MontonatiU.O. Cardiologia Ospedalirea, IRCCSOspedale Galeazzi Sant'Ambrogio, Italy.
Maurizio TespiliU.O. Cardiologia Ospedalirea, IRCCSOspedale Galeazzi Sant'Ambrogio, Italy.
Senol CoskunDepartment of Cardiology, Medical Faculty, Kocaeli University, Kocaeli, Turkey.
Tayfun SahinDepartment of Cardiology, Medical Faculty, Kocaeli University, Kocaeli, Turkey.
Ilias NiniosDepartment of Cardiology, Interbalkan European Medical Center, Thessaloniki, Greece.
Konstantina VlasopoulouDepartment of Cardiology, National and Kapodistrian University of Athens, Hippokration General Hospital, Athens, Greece.
Ali Hakan KonusDepartment of Cardiology, University of Health Sciences, Trabzon Ahi Evren Cardiovascular and Thoracic Surgery Training and Research Hospital, Turkey.
Selim KulDepartment of Cardiology, University of Health Sciences, Trabzon Ahi Evren Cardiovascular and Thoracic Surgery Training and Research Hospital, Turkey.
Ali Riza AkyuzDepartment of Cardiology, University of Health Sciences, Trabzon Ahi Evren Cardiovascular and Thoracic Surgery Training and Research Hospital, Turkey.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Limited data exist on long-term follow-up of severe aortic stenosis (SAS) patients who have undergone transcatheter aortic valve implantation (TAVI) with a new generation, balloon expandable Myval transcatheter heart valve (THV). Thus, we sought to investigate the performance and 2-year clinical outcome of the Myval THV system based on Valve Academic Research Consortium-3 (VARC-3) criteria. Material and methods: A multi-centre, registry-based, observational study was conducted, which included 207 consecutive degenerative SAS patients, from Turkey ( Results: Technical success was observed in 204 (99%), device success was observed in 189 (91%), early safety was observed in 161 (78%), and clinical efficacy was observed in 163 (79%) patients. The 30-day death rate was 7.7%; of these, 3.4% were due to cardiovascular reasons. All-cause and cardiovascular mortality rates were 9.7% and 4.3% at 1-year follow-up, and 17.4% and 9.7% at 2-year follow-up, respectively. Incidence of ≥ moderate paravalvular leak (PVL) at 30 days, 1 year and 2 years of follow-up were 3.4%, 4.3% and 4.8%. A total of 11.1% of patients required a permanent pacemaker implantation (PPI) at 30 days after implantation, while the cumulative rate of PPI at 2 years was 12.1%. Conclusions: In this cohort of patients with SAS, the Myval was found to be safe and effective in up to 2 years of follow-up.

Indexed as

aortic valve stenosisMyval valvetranscatheter aortic valve implantation

Identifiers

PMID38757027
PMCPMC11094825

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
Read underepoch 390

Registered trials

None linked

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.