Evidence map›Paper›PMID 25495073›Full record

ArticleJournal of interventional cardiology2015

How to adapt the implantation technique for the new SAPIEN 3 transcatheter heart valve design.

Gerhard Schymik, Holger Schröfel, Martin Heimeshoff, Armin Luik, Martin Thoenes, Lazar Mandinov

Open access · hybridAbstract read
In one paragraph

Article in Journal of interventional cardiology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 12% 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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. A model of fluid-structure and biochemical interactions for applications to subclinical leaflet thrombosis.International journal for numerical methods in biomedical engineering · 2023
    Article
  7. Article
  8. Article
  9. Review
  10. Review
  11. Article
  12. Article
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  15. Simultaneous Stenting With Edwards SAPIEN Transcatheter Pulmonary Valve Replacement.Journal of the Society for Cardiovascular Angiography & Interventions
    Article
  16. 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

6 authors at 4 institutions in 3 countries.

Gerhard SchymikMedical Clinic IV, Department of Cardiology, Municipal Hospital Karlsruhe, Germany.
Holger Schröfel
Martin Heimeshoff
Armin Luik
Martin Thoenes
Lazar Mandinov
Klinik für Herzchirurgie Karlsruhe · DEStädtisches Klinikum Karlsruhe · DEEdwards Lifesciences (United States) · USLeman University · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The new balloon-expandable Edwards SAPIEN 3 THV has significant design improvements requiring adjustments in the implantation technique as compared to the previous generation SAPIEN XT. Basically, the new valve requires less oversizing due to the outer skirt, which, if positioned underneath the annulus, can reduce the occurrence and severity of paravalvular leak (PVL). As with any transcatheter vale, a thorough assessment of the device-landing-zone, the surrounding structures, and the distribution of calcifications is of vast importance. Once the SAPIEN 3 valve is positioned with the initial orientation of the middle balloon marker at the level of the leaflet hinge points, the outer skirt will remain under the annulus, despite the foreshortening of the lower inflow portion of the valve. If there is an incomplete apposition, the outer skirt can conform to the anatomy, close the gaps, and reduce the risk of PVL. When calcifications are located on the edges of the annulus, PVL is common with the SAPIEN XT THV but dramatically reduced with the SAPIEN 3 THV. If the calcification extends from the annulus into the entire LVOT, there is always an incomplete apposition of the either valve frame; however, the resulting PVL is reduced by the outer skirt of the SAPIEN 3. In 165 consecutive SAPIEN 3 patients, 89.7% (n = 145) had none or a trace PVL and there were no patients with moderate or severe PVL. The new generation SAPIEN 3 valve allows more challenging anatomies to be treated, requires less oversizing, and can reduce PVL.

Indexed as

BioprosthesisHeart Valve ProsthesisProsthesis DesignProsthesis FittingAged, 80 and overAortic Valve StenosisFemaleHumansMalePatient SelectionTranscatheter Aortic Valve ReplacementVascular Calcification

Identifiers

PMID25495073
PMCPMC4359039
OpenAlexW1617597346

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.