Evidence map›Paper›PMID 35942626›Full record

ArticleEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2022

Impact of moderate or severe left ventricular outflow tract calcification on clinical outcomes of patients with severe aortic stenosis undergoing transcatheter aortic valve implantation with self- and balloon-expandable valves: a post hoc analysis from the SOLVE-TAVI trial.

Serdar Farhan, Georg Stachel, Steffen Desch, Thomas Kurz, Hans-Josef Feistritzer, Philipp Hartung, Ingo Eitel, Holger Nef, Oliver Doerr, Alexander Lauten and 12 more

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02737150 (CompariSon of secOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in Transcatheter Aortic Valve Implantation), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 15% 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.

NCT02737150 naunknown statusnot on this map

CompariSon of secOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in Transcatheter Aortic Valve Implantation (SOLVE-TAVI)

TypeinterventionalSponsorHelios Health Institute GmbHRan2016 to 2021Enrolled444ConditionsAortic StenosisArmsCoreValve Evolut R, Edwards Sapien 3, Local anesthesia with conscious sedation, General anesthesia
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Impact of prosthesis oversizing on clinical outcomes of transcatheter aortic valve implantation using a self-expandable Evolut R valve.The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology · 2024
    Article
  5. Review
  6. Is transcatheter aortic valve implantation safe in patients with left ventricular outflow tract calcification?EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2022
    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

22 authors at 5 institutions in 2 countries.

Serdar FarhanThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Georg StachelDepartment of Internal Medicine and Cardiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany.
Steffen DeschDepartment of Internal Medicine and Cardiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany.
Thomas KurzUniversity Clinic Schleswig-Holstein, Kiel, Germany and University Heart Center Lübeck, Lübeck, Germany.
Hans-Josef FeistritzerDepartment of Internal Medicine and Cardiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany.
Philipp HartungDepartment of Internal Medicine and Cardiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany.
Ingo EitelUniversity Clinic Schleswig-Holstein, Kiel, Germany and University Heart Center Lübeck, Lübeck, Germany.
Holger NefMedizinische Klinik I, Abteilung für Kardiologie, Universitätsklinikum Marburg/Gießen, Gießen, Germany.
Oliver DoerrMedizinische Klinik I, Abteilung für Kardiologie, Universitätsklinikum Marburg/Gießen, Gießen, Germany.
Alexander LautenDepartment of Cardiology and Intensive Care Medicine, Helios Klinikum Erfurt, Erfurt, Germany.
Ulf LandmesserGerman Center for Cardiovascular Research (DZHK), Campus Lübeck, Lübeck, Germany.
Marcus SandriDepartment of Internal Medicine and Cardiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany.
David HolzheyDepartment of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.
Michael BorgerDepartment of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.
Hüseyin InceMedizinische Klinik I im Zentrum fuer Innere Medizin (ZIM), Universitaetsklinikum Rostock, Rostock, Germany.
Alper ÖnerMedizinische Klinik I im Zentrum fuer Innere Medizin (ZIM), Universitaetsklinikum Rostock, Rostock, Germany.
Roza Meyer-SaraeiUniversity Clinic Schleswig-Holstein, Kiel, Germany and University Heart Center Lübeck, Lübeck, Germany.
Harm WienbergenKlinikum Links der Weser, Herzzentrum Bremen, Bremen, Germany.
Andreas FachKlinikum Links der Weser, Herzzentrum Bremen, Bremen, Germany.
Norbert FreyGerman Center for Cardiovascular Research (DZHK), Campus Lübeck, Lübeck, Germany.
Suzanne de Waha-ThieleDepartment of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.
Holger ThieleDepartment of Internal Medicine and Cardiology, Heart Center Leipzig, University of Leipzig, Leipzig, Germany.
Leipzig Heart Institute · DEUniversitätsklinikum Gießen und Marburg · DECardiovascular Institute of the South · USCharité - Universitätsmedizin Berlin · DEHeidelberg University · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLeft ventricular outflow tract (LVOT) calcification has been associated with worse outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) and may influence the selection of prosthetic valve type.

aimsWe aimed to evaluate the impact of LVOT calcification on outcomes after TAVI with a self-expanding valve (SEV) versus a balloon-expandable valve (BEV).

methodsPatients of the SOLVE-TAVI trial, randomised to Edwards SAPIEN 3 or Medtronic Evolut R, were divided according to LVOT calcification into no/mild (≤1 calcium nodule extending <5 mm and covering <10% of the LVOT perimeter) and moderate/severe LVOT calcification groups. The primary endpoint was a composite of death, stroke, moderate/severe paravalvular regurgitation, permanent pacemaker implantation and annulus rupture at 30 days. Additional endpoints included all-cause and cardiovascular mortality at 1 year.

resultsOut of 416 eligible patients, moderate/severe LVOT calcification was present in 143 (34.4%). Moderate/severe LVOT calcification was associated with significantly longer fluoroscopy time and higher rates of pre- and post-dilation. Regardless of the LVOT calcification group, there was no significant difference in the primary endpoint associated with the valve type (no/mild LVOT calcification group: SEV 25.0% vs BEV 27.0%; hazard ratio [HR] 1.10, 95% confidence interval [95% CI]: 0.68-1.73; p=0.73 and moderate/severe LVOT calcification group: SEV 25.0% vs BEV 19.4%; HR 0.76, 95% CI: 0.38-1.61; p=0.49), no significant interaction between LVOT calcification and valve type (p

conclusionsModerate/severe LVOT calcification was associated with longer fluoroscopy time and an increased need for pre- and post-dilation, but not with a higher incidence of early and mid-term adverse clinical outcomes, regardless of valve type. (ClinicalTrials.gov: NCT02737150).

Indexed as

Aortic Valve StenosisCalcinosisHeart Valve ProsthesisTranscatheter Aortic Valve ReplacementAortic ValveCalciumFluoroscopyHumansMultidetector Computed TomographyProsthesis DesignTreatment OutcomeCalcium

Identifiers

PMID35942626
PMCPMC11064680
OpenAlexW4301882932

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.