Evidence map›Paper›PMID 30552511›Full record

Observational studyClinical research in cardiology : official journal of the German Cardiac Society2019

Characteristics and outcomes of patients ≤ 75 years who underwent transcatheter aortic valve implantation: insights from the SOURCE 3 Registry.

Derk Frank, Mohamed Abdel-Wahab, Martine Gilard, Franck Digne, Geraud Souteyrand, Christophe Caussin, Frédéric Collart, Vincent Letocart, Jochen Wöhrle, Christian Kuhn and 2 more

Registry-linked trialAbstract readMulticenter StudyObservational Study
PubMed Publisher
In one paragraph

Observational study in Clinical research in cardiology : official journal of the German Cardiac Society, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02698956 (Edwards SAPIEN 3 Aortic Bioprosthesis Multi-Region Outcome Registry), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

NCT02698956 completednot on this map

Edwards SAPIEN 3 Aortic Bioprosthesis Multi-Region Outcome Registry

TypeobservationalSponsorEdwards LifesciencesRan2014 to 2020Enrolled2,000ConditionsAortic StenosisArmsTAVI (Transcatheter Aortic Valve Implantation)
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Transcatheter aortic valve implantation under 75 years of age: only for high surgical risk patients; but for how long?Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2024
    Article
  3. Metabolomic profiling of patients with high gradient aortic stenosis undergoing transcatheter aortic valve replacement.Clinical research in cardiology : official journal of the German Cardiac Society · 2021
    Article
  4. Machine learning-based risk prediction of intrahospital clinical outcomes in patients undergoing TAVI.Clinical research in cardiology : official journal of the German Cardiac Society · 2021
    Article
  5. Prognostic impact of cancer history in patients undergoing transcatheter aortic valve implantation.Clinical research in cardiology : official journal of the German Cardiac Society · 2020
    Observational
  6. Periprocedural embolisation of a Sapien 3 TAVI prosthesis: failure and success.Clinical research in cardiology : official journal of the German Cardiac Society · 2020
    Article
  7. Review
  8. One year VARC-2-defined clinical outcomes after transcatheter aortic valve implantation with the SAPIEN 3.Clinical research in cardiology : official journal of the German Cardiac Society · 2019
    Article
  9. Percutaneous closure of a large atrial septal defect presenting with acute severe hemolysis.Clinical research in cardiology : official journal of the German Cardiac Society · 2019
    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

12 authors.

Derk FrankDepartment of Internal Medicine III (Cardiology, Angiology, and Critical Care), University Medical Center Schleswig-Holstein (UKSH), Campus Kiel, Arnold-Heller-Str. 3, Building 6, 24105, Kiel, Germany. derk.frank@uksh.de.
Mohamed Abdel-WahabCardiology Department, Heart Center, Leipzig, Germany.
Martine GilardPublic Hospital La Cavale Blanche, Brest, France.
Franck DigneCentre Cardiologique du Nord, Saint-Denis, France.
Geraud SouteyrandPublic Hospital Clermont-Ferrand, Clermont-Ferrand, France.
Christophe CaussinInstitut Mutualiste Montsouris, Paris, France.
Frédéric CollartPublic Hospital La Timone, Marseille, France.
Vincent LetocartInstitut du thorax, Public Hospital Nantes, Nantes, France.
Jochen WöhrleDepartment of Internal Medicine II, University Hospital of Ulm, Ulm, Germany.
Christian KuhnDepartment of Internal Medicine III (Cardiology, Angiology, and Critical Care), University Medical Center Schleswig-Holstein (UKSH), Campus Kiel, Arnold-Heller-Str. 3, Building 6, 24105, Kiel, Germany.
Tomas HovorkaStatistics, Edwards Lifesciences, Prague, Czech Republic.
Helmut BaumgartnerDivision of Adult Congenital and Valvular Heart Disease, Department of Cardiovascular Medicine, University Hospital Muenster, Muenster, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCurrent trials and registries of transcatheter valve implantation (TAVI) mostly include patients older than 75 years. Little is known about younger patients who undergo this treatment. We investigated comorbidities among patients < 75 years old who underwent TAVI in the SAPIEN 3™ European post-approval SOURCE 3 Registry, and analysed outcomes at 30 days and 1 year. METHODS AND

resultsThree age groups of patients were analysed for outcomes and characteristics: < 75 (n = 235), 75-80 (n = 391) and ≥ 80 years (n = 1320). Overall, the mean age was 81.6 ± 6.7 years; transfemoral access was used in 87.1% of patients treated with SAPIEN 3 transcatheter heart valves. The mean logistic EuroSCORE increased according to age group (12.6%, 17.3% and 19.7%, respectively, p < 0.001). Younger patients had a higher incidence of comorbidities, particularly those not included in surgical risk score assessment tools, e.g., severe liver disease, previous radiation therapy, and porcelain aorta. Mortality rates were similar between age groups at 30 days (1.7%, 2.0% and 2.3%, respectively, p = 0.79) and 1 year (14.2%, 9.3% and 13.3%, respectively, p = 0.08). However, sudden cardiac death rates were higher in the < 75 years age group compared with the ≥ 85 years age group (20.7% vs. 4.8%, p = 0.010).

conclusionsIn current TAVI practice, patients younger than 75 years are a minority (12%). Despite younger age and lower surgical risk scores, this cohort was characterized by comorbidities not accounted for by traditional surgical risk scores. More data are needed for this age group to guide the appropriate decision between surgery and TAVI. CLINICALTRIAL. GOV NUMBER: NCT02698956.

Indexed as

RegistriesAgedAged, 80 and overAortic ValveAortic Valve StenosisCause of DeathEuropeFemaleHumansIncidenceMalePostoperative ComplicationsRisk AssessmentRisk FactorsSurvival RateTranscatheter Aortic Valve ReplacementAortic stenosisBalloon-expandable valveCauses of deathPredictors of mortalitySAPIEN 3Transcatheter aortic valve implantation

Identifiers

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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.