Trial report in Circulation. Cardiovascular quality and outcomes, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01296022 (Randomized Trial to Study the Efficacy and Adverse Effects of the Subcutaneous and Transvenous Implantable Cardioverter Defibrillator), which is not on this map. Cited by 5 papers.
0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–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.
Randomized Trial to Study the Efficacy and Adverse Effects of the Subcutaneous and Transvenous Implantable Cardioverter Defibrillator (ICD) in Patients With a Class I or IIa Indication for ICD Without an Indication for Pacing
TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2011 to 2023Enrolled850ConditionsVentricular ArrhythmiasArmsImplantation of subcutaneous ICD, Implantation of transvenous ICD
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
48 authors.
Reinoud E Knops *Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias, Amsterdam University Medical Centers Location University of Amsterdam, Heart Center, the Netherlands (R.E.K., J.A.d.V., L.V.A.B., T.F.B., S.P., A.-F.B.E.Q., L.S., W.v.d.S., A.d.W., J.R.d.G., K.M.K., J.G.P.T., A.A.M.W., L.R.A.O.N.).ORCID 0000-0002-0772-3573
Jolien A de Veld *Department of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias, Amsterdam University Medical Centers Location University of Amsterdam, Heart Center, the Netherlands (R.E.K., J.A.d.V., L.V.A.B., T.F.B., S.P., A.-F.B.E.Q., L.S., W.v.d.S., A.d.W., J.R.d.G., K.M.K., J.G.P.T., A.A.M.W., L.R.A.O.N.).ORCID 0009-0004-4200-8075
Abdul GhaniDepartment of Cardiology, Isala Heart Centre, Zwolle, the Netherlands (A.G.).
Lucas V A BoersmaDepartment of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias, Amsterdam University Medical Centers Location University of Amsterdam, Heart Center, the Netherlands (R.E.K., J.A.d.V., L.V.A.B., T.F.B., S.P., A.-F.B.E.Q., L.S., W.v.d.S., A.d.W., J.R.d.G., K.M.K., J.G.P.T., A.A.M.W., L.R.A.O.N.).ORCID 0000-0003-4591-4220
Juergen KuschykFirst Department of Medicine, University Medical Center Mannheim, Germany (J.K.).ORCID 0000-0002-6687-6924
Mikhael F El ChamiDivision of Cardiology, Section of Electrophysiology, Emory University, Atlanta, GA (M.F.E.C.).ORCID 0000-0003-4978-7177
Hendrik BonnemeierKlinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Germany (H.B.).ORCID 0009-0003-6071-5139
Tom F BrouwerDepartment of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias, Amsterdam University Medical Centers Location University of Amsterdam, Heart Center, the Netherlands (R.E.K., J.A.d.V., L.V.A.B., T.F.B., S.P., A.-F.B.E.Q., L.S., W.v.d.S., A.d.W., J.R.d.G., K.M.K., J.G.P.T., A.A.M.W., L.R.A.O.N.).ORCID 0000-0001-8379-7470
Stefan KääbDepartment of Medicine I, Ludwig-Maximillians University Hospital, München, Germany (S.K.).ORCID 0000-0001-8824-3581
Shari PepplinkhuizenDepartment of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias, Amsterdam University Medical Centers Location University of Amsterdam, Heart Center, the Netherlands (R.E.K., J.A.d.V., L.V.A.B., T.F.B., S.P., A.-F.B.E.Q., L.S., W.v.d.S., A.d.W., J.R.d.G., K.M.K., J.G.P.T., A.A.M.W., L.R.A.O.N.).ORCID 0000-0001-7530-7048
Anne-Floor B E QuastDepartment of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias, Amsterdam University Medical Centers Location University of Amsterdam, Heart Center, the Netherlands (R.E.K., J.A.d.V., L.V.A.B., T.F.B., S.P., A.-F.B.E.Q., L.S., W.v.d.S., A.d.W., J.R.d.G., K.M.K., J.G.P.T., A.A.M.W., L.R.A.O.N.).ORCID 0000-0003-2360-984X
Lonneke SmedingDepartment of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias, Amsterdam University Medical Centers Location University of Amsterdam, Heart Center, the Netherlands (R.E.K., J.A.d.V., L.V.A.B., T.F.B., S.P., A.-F.B.E.Q., L.S., W.v.d.S., A.d.W., J.R.d.G., K.M.K., J.G.P.T., A.A.M.W., L.R.A.O.N.).ORCID 0000-0002-7558-9011
Willeke van der StuijtDepartment of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias, Amsterdam University Medical Centers Location University of Amsterdam, Heart Center, the Netherlands (R.E.K., J.A.d.V., L.V.A.B., T.F.B., S.P., A.-F.B.E.Q., L.S., W.v.d.S., A.d.W., J.R.d.G., K.M.K., J.G.P.T., A.A.M.W., L.R.A.O.N.).ORCID 0000-0002-2236-3983
Anouk de WegerDepartment of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias, Amsterdam University Medical Centers Location University of Amsterdam, Heart Center, the Netherlands (R.E.K., J.A.d.V., L.V.A.B., T.F.B., S.P., A.-F.B.E.Q., L.S., W.v.d.S., A.d.W., J.R.d.G., K.M.K., J.G.P.T., A.A.M.W., L.R.A.O.N.).ORCID 0009-0000-8959-8536
Nick R BijsterveldDepartment of Cardiology, Flevoziekenhuis, Almere, the Netherlands (N.R.B.).ORCID 0000-0002-9792-3359
Sergio RichterDepartment of Electrophysiology, Heart Center at University of Leipzig, Germany (S.R.).ORCID 0000-0001-7128-6411
Marc A BrouwerDepartment of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands (M.A.B.).
Joris R de GrootDepartment of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias, Amsterdam University Medical Centers Location University of Amsterdam, Heart Center, the Netherlands (R.E.K., J.A.d.V., L.V.A.B., T.F.B., S.P., A.-F.B.E.Q., L.S., W.v.d.S., A.d.W., J.R.d.G., K.M.K., J.G.P.T., A.A.M.W., L.R.A.O.N.).ORCID 0000-0002-8122-7017
Kirsten M KooimanDepartment of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias, Amsterdam University Medical Centers Location University of Amsterdam, Heart Center, the Netherlands (R.E.K., J.A.d.V., L.V.A.B., T.F.B., S.P., A.-F.B.E.Q., L.S., W.v.d.S., A.d.W., J.R.d.G., K.M.K., J.G.P.T., A.A.M.W., L.R.A.O.N.).ORCID 0000-0003-3633-4486
Pier D LambiaseOffice of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre, United Kingdom (P.D.L.).ORCID 0000-0002-9055-9267
Petr NeuzilDepartment of Cardiology, Homolka Hospital, Prague, Czech Republic (P. Neuzil).ORCID 0000-0003-4334-8165
Kevin VernooyDepartment of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, the Netherlands (K.V.).ORCID 0000-0002-8818-5964
Marco AlingsDepartment of Cardiology, Amphia Hospital, Breda, the Netherlands (M.A.).ORCID 0000-0003-2090-4683
Timothy R BettsOxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, United Kingdom (T.R.B.).ORCID 0000-0001-9063-9905
Frank A L E BrackeDepartment of Electrophysiology, Catharina Hospital Eindhoven, the Netherlands (F.A.L.E.B.).ORCID 0000-0002-2726-4327
Ward P J JansenDepartment of Cardiology, Tergooi Medisch Centrum, Blaricum, the Netherlands (W.P.J.J.).ORCID 0009-0007-1169-0739
Zachary I WhinnettNational Heart and Lung Institute, Imperial College London, United Kingdom (Z.I.W.).ORCID 0000-0002-2775-5126
Peter NordbeckUniversity and University Hospital Würzburg, Germany (P. Nordbeck).ORCID 0000-0002-2560-4068
Michael KnautHeart Surgery, Heart Center Dresden, Carl Gustav Carus Medical Faculty, Dresden University of Technology, Germany (M.K.).ORCID 0009-0006-9511-9195
Berit T PhilbertDepartment of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Denmark (B.T.P.).ORCID 0000-0001-9479-7601
Jurren M van OpstalMedical Spectrum Twente, Enschede, the Netherlands (J.M.v.O.).ORCID 0000-0002-3492-1807
Alexandru B ChicosDivision of Cardiology, Northwestern Memorial Hospital, Northwestern University, Chicago, IL (A.B.C.).ORCID 0000-0002-0291-4434
Cornelis P AllaartDepartment of Cardiology, and Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, Location VUMC, the Netherlands (C.P.A.).ORCID 0000-0002-0506-9512
Alida E Borger van der BurgMedisch Centrum Leeuwarden, the Netherlands (A.E.B.v.d.B.).ORCID 0009-0008-0779-2369
Jose M DizonDepartment of Medicine-Cardiology, Columbia University Irving Medical Center, New York, NY (J.M.D.).ORCID 0009-0005-5467-1664
Marc A MillerIcahn School of Medicine at Mount Sinai, Mount Sinaï Hospital, New York, NY (M.A.M.).
Dmitry NemirovksyCardiac Electrophysiology Division, Department of Medicine, Englewood Hospital and Medical Center, NJ (D.N.).
Ralf SurberDepartment of Internal Medicine I, Jena University Hospital, Germany (R.S.).ORCID 0009-0001-9077-8515
Gaurav A UpadhyayCenter for Arrhythmia Care, Heart and Vascular Institute, University of Chicago Pritzker School of Medicine, IL (G.A.U.).ORCID 0000-0002-3493-2100
Jan G P TijssenDepartment of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias, Amsterdam University Medical Centers Location University of Amsterdam, Heart Center, the Netherlands (R.E.K., J.A.d.V., L.V.A.B., T.F.B., S.P., A.-F.B.E.Q., L.S., W.v.d.S., A.d.W., J.R.d.G., K.M.K., J.G.P.T., A.A.M.W., L.R.A.O.N.).ORCID 0000-0003-1707-2628
Arthur A M WildeDepartment of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias, Amsterdam University Medical Centers Location University of Amsterdam, Heart Center, the Netherlands (R.E.K., J.A.d.V., L.V.A.B., T.F.B., S.P., A.-F.B.E.Q., L.S., W.v.d.S., A.d.W., J.R.d.G., K.M.K., J.G.P.T., A.A.M.W., L.R.A.O.N.).ORCID 0000-0002-0528-0852
Louise R A Olde NordkampDepartment of Cardiology, Amsterdam Cardiovascular Sciences Heart Failure and Arrhythmias, Amsterdam University Medical Centers Location University of Amsterdam, Heart Center, the Netherlands (R.E.K., J.A.d.V., L.V.A.B., T.F.B., S.P., A.-F.B.E.Q., L.S., W.v.d.S., A.d.W., J.R.d.G., K.M.K., J.G.P.T., A.A.M.W., L.R.A.O.N.).ORCID 0000-0003-2306-603X
PRAETORIAN Investigators
Funding
No grant is acknowledged in the PubMed record.
6 · The paper itself
Abstract
backgroundThe subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to overcome the risk of lead-related complications associated with the transvenous implantable cardioverter-defibrillator (TV-ICD). In contrast to the TV-ICD, the S-ICD is a completely extrathoracic device. Subsequently, complications differ between these 2 implantable cardioverter-defibrillators, which might impact patient perceptions of the therapies. This prespecified secondary analysis of the PRAETORIAN trial evaluates differences in quality of life.
methodsThe PRAETORIAN trial (A Prospective, Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) randomized patients with an implantable cardioverter-defibrillator indication, without the need for pacing to S-ICD or TV-ICD therapy. Two questionnaires were collected at baseline, discharge, 12 months, and 30 months. The Duke Activity Status Index measures cardiac-specific physical functioning, and the 36-Item Short Form Health Survey measures physical and mental well-being, with the subscales bodily pain and mental health being of interest in this analysis. Mann-Whitney
resultsPatients were randomized to S-ICD (n=426) and TV-ICD (n=423). In the S-ICD group, 20% were women versus 19% in the TV-ICD group. The median age was 63 (interquartile range, 54-69) years in the S-ICD group versus 64 (interquartile range, 56-69) years in the TV-ICD group. There were no significant differences in the Duke Activity Status Index and 36-Item Short Form Health Survey subscales for bodily pain and mental health between the groups at any time point. Patients with a shock in the last 90 days had significantly lower scores for social functioning (
conclusionsIn a large randomized cohort of patients with an S-ICD or TV-ICD, no difference in overall quality of life was observed. However, implantable cardioverter-defibrillator shocks resulted in a reduction in quality of life, regardless of the device type or appropriateness. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01296022.
Indexed as
Defibrillators, ImplantableElectric CountershockMental HealthQuality of LifeAgedArrhythmias, CardiacDeath, Sudden, CardiacFemaleFunctional StatusHealth StatusHumansMaleMiddle AgedProspective StudiesProsthesis DesignRisk Factorsarrhythmias, cardiacdefibrillators, implantablemental healthquality of life
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.
Quality of Life in Subcutaneous or Transvenous Implantable Cardioverter-Defibrillator Patients: A Secondary Analysis of the PRAETORIAN Trial. · full record | OpenQuestion