Evidence map›Paper›PMID 26058718›Full record

Trial reportCirculation. Cardiovascular quality and outcomes2015

Temporal Trends in Quality of Life Outcomes After Transapical Transcatheter Aortic Valve Replacement: A Placement of AoRTic TraNscathetER Valve (PARTNER) Trial Substudy.

Hemal Gada, Ajay J Kirtane, Kaijun Wang, Yang Lei, Elizabeth Magnuson, Matthew R Reynolds, Mathew R Williams, Susheel Kodali, Torsten P Vahl, Suzanne V Arnold and 5 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation. Cardiovascular quality and outcomes, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00530894 (THE PARTNER TRIAL), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing 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.

NCT00530894 nacompletednot on this map

THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve

TypeinterventionalSponsorEdwards LifesciencesRan2007 to 2017Enrolled1,057ConditionsCritical Aortic StenosisArmsEdwards SAPIEN Transcatheter Heart Valve, Surgical Valve Replacement, medical management and/or balloon aortic valvuloplasty
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. A Review of Alternative Access for Transcatheter Aortic Valve Replacement.Current treatment options in cardiovascular medicine · 2018
    Review
  10. Article
  11. Review
  12. Review
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

15 authors.

Hemal GadaFrom the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
Ajay J KirtaneFrom the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
Kaijun WangFrom the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
Yang LeiFrom the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
Elizabeth MagnusonFrom the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
Matthew R ReynoldsFrom the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
Mathew R WilliamsFrom the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
Susheel KodaliFrom the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
Torsten P VahlFrom the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
Suzanne V ArnoldFrom the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
Martin B LeonFrom the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
Vinod ThouraniFrom the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
Wilson Y SzetoFrom the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.).
David J CohenFrom the Rutgers - Robert Wood Johnson Medical School, New Brunswick, NJ (H.G.); Columbia University Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY (A.J.K., S.K., T.P.V., M.B.L.); Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine (K.W., Y.L., E.M., S.V.A., D.J.C.); Lahey Hospital & Medical Center, Burlington, MA and Harvard Clinical Research Institute, Boston, MA (M.R.R.); NYU Langone Medical Center, New York, NY (M.R.W.); Emory University School of Medicine, Atlanta, GA (V.T.); and University of Pennsylvania School of Medicine, Philadelphia (W.Y.S.). dcohen@saint-lukes.org.
PARTNER Investigators

Funding

Optimal Decision Making in Aortic Valve ReplacementK23HL116799 · NHLBI · SAINT LUKE'S HOSPITAL · PI ARNOLD, SUZANNE VICTORIA · 2014 to 2018
$635k
NHLBI NIH HHS K23 HL116799
6 · The paper itself

Abstract

backgroundIn the Placement of AoRTic TraNscathetER Valve (PARTNER) randomized controlled trial (RCT), which represented the first exposure to transapical transcatheter aortic valve replacement (TA-TAVR) for many clinical sites, high-risk patients undergoing TA-TAVR derived similar health-related quality of life (HRQoL) outcomes when compared with surgical aortic valve replacement (SAVR). With increasing experience, it is possible that HRQoL outcomes of TA-TAVR may have improved. METHODS AND

resultsWe evaluated HRQoL outcomes at 1-, 6-, and 12-month follow-ups among 875 patients undergoing TA-TAVR in the PARTNER nonrandomized continued access (NRCA) registry and compared these outcomes with those of the TA-TAVR and SAVR patients in the PARTNER RCT. HRQoL was assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short-Form 12, and the EuroQoL-5D, with the KCCQ overall summary score serving as the primary end point. The NRCA TA-TAVR and RCT TA-TAVR and SAVR groups were generally similar. The primary outcome, the KCCQ summary score, did not differ between the NRCA TA-TAVR and the RCT TA-TAVR group at any follow-up timepoints, although there were small differences in favor of the NRCA cohort on several KCCQ subscales at 1 month. There were no significant differences in follow-up HRQOL between the NRCA-TAVR and the RCT SAVR cohorts on the KCCQ overall summary scale or any of the disease-specific or generic subscales.

conclusionsDespite greater experience with TA-TAVR in the NRCA registry, HRQoL outcomes remained similar to those of TA-TAVR in the original RCT cohort and no better than those with SAVR. These findings have important implications for patient selection for TAVR when transfemoral access is not an option. CLINICAL

trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

Indexed as

Heart Valve ProsthesisQuality of LifeRegistriesAged, 80 and overAortic ValveAortic Valve StenosisFemaleFollow-Up StudiesHumansMaleProsthesis DesignSurveys and QuestionnairesTranscatheter Aortic Valve ReplacementTreatment Outcomeaortic valvefollow-up studiesquality of lifetransapicaltranscatheter aortic valve replacement

Identifiers

PMID26058718
PMCPMC4786368

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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.