Evidence map›Paper›PMID 34392336›Full record

Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2022

Combining home monitoring temporal trends from implanted defibrillators and baseline patient risk profile to predict heart failure hospitalizations: results from the SELENE HF study.

Antonio D'Onofrio, Francesco Solimene, Leonardo Calò, Valeria Calvi, Miguel Viscusi, Donato Melissano, Vitantonio Russo, Antonio Rapacciuolo, Andrea Campana, Fabrizio Caravati and 11 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology 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. Cited by 46 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 2 pooled it
10.4field-weighted citation impact, top 1% 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

46 citing papers in PubMed, 2 syntheses or guidelines pooled it, 86 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Observational
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Remote monitoring and heart failure.European heart journal supplements : journal of the European Society of Cardiology · 2025
    Article
  14. Review
  15. Review
  16. Article
  17. Article
  18. Review
  19. Biotronik Implantable Cardioverter Defibrillator for Measurement of Intrathoracic Impedance: A Report of Two Cases.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2024
    Article
  20. Personalized Heart Failure Management: Bridging Technology and Care.Journal of the American Heart Association · 2024
    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

21 authors at 12 institutions in 1 country.

Antonio D'OnofrioCardiology Department - Electrophysiology and Cardiac Pacing Unit A.O.R.N. V. Monaldi, Via L. Bianchi, Naples, Italy.
Francesco SolimeneElectrophysiology, Montevergine Clinic, Viale S. Modestino 8, 83013 Mercogliano, Italy.
Leonardo CalòCardiology Division, Policlinico Casilino, Via Casilina 1049, 00169 Rome, Italy.
Valeria CalviCardiology Department, Policlinico G. Rodolico, AOU Policlinico V. Emanuele, Via S. Sofia 78, 95125 Catania, Italy.
Miguel ViscusiCardiology Division, Sant'Anna and San Sebastiano Hospital, Via F. Palasciano, 81100 Caserta, Italy.
Donato MelissanoCardiology Division, F. Ferrari Hospital, Viale F. Ferrari 1, 73042 Casarano (LE), Italy.
Vitantonio RussoCardiology Division, SS. Annunziata Hospital, Via F. Bruno 1, 74121 Taranto, Italy.
Antonio RapacciuoloCardiology Department of Advanced Biomedical Sciences, Corso Umberto I 40, 80138 Federico II University of Naples, Italy.ORCID 0000-0002-4739-7004
Andrea CampanaCardiology Division, A.O.U. San Giovanni di Dio e Ruggi D'Aragona, Via San Leonardo 1, 84131 Salerno, Italy.
Fabrizio CaravatiDivision of Cardiology, ASST Settelaghi, Di Circolo Hospital, Via L. Borri 57, 21100 Varese, Italy.
Paolo BonfantiCardiology Division, Rho Civil Hospital, Corso Europa 250, 20017 Rho (MI), Italy.
Gabriele ZanottoCardiology Division, Mater Salutis Hospital, Via C. Gianella 1, 37045 Legnago, Italy.
Edoardo GrondaDepartment of Medicine and Medical Specialties, I.R.C.C.S. Foundation Ca' Granda, Via M. Fanti 6, 20122 Milano, Italy.
Antonello VadoCardiology Division, S. Croce e Carle Hospital, Via M. Coppino 26, 12100 Cuneo, Italy.
Vittorio CalzolariCardiology Division, Santa Maria di Ca' Foncello Hospital, Piazzale dell'Ospedale 1, 31100 Treviso, Italy.
Giovanni Luca BottoCardiology Division, Rho Civil Hospital, Corso Europa 250, 20017 Rho (MI), Italy.
Massimo ZecchinCardiology Department, Cattinara University Hospital, Strada di Fiume 447, 34149 Trieste, Italy.
Luca BontempiCardiology Division, Spedali Civili , Piazzale Spedali Civili 1, 25123 Brescia, Italy.
Daniele GiacopelliBIOTRONIK Italia, Via delle Industrie 11, 20090 Vimodrone (MI), Italy.ORCID 0000-0003-1584-7944
Alessio GargaroBIOTRONIK Italia, Via delle Industrie 11, 20090 Vimodrone (MI), Italy.ORCID 0000-0002-7327-303X
Luigi PadelettiCardiology Department, I.R.C.C.S. MultiMedica, Via Milanese 300, 20099 Sesto San Giovanni, Milano, Italy.
Medtronic (Italy) · ITAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITCa' Foncello Hospital · ITCTO Hospital · ITMultiMedica · ITOspedale di Cattinara · ITOspedale Monaldi · ITOspedale Sant'Anna · ITOspedale SS. Annunziata · ITOspedali Riuniti San Giovanni di Dio e Ruggi d'Aragona · ITPoliclinico Casilino · ITPoliclinico Universitario di Catania · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsWe developed and validated an algorithm for prediction of heart failure (HF) hospitalizations using remote monitoring (RM) data transmitted by implanted defibrillators. METHODS AND

resultsThe SELENE HF study enrolled 918 patients (median age 69 years, 81% men, median ejection fraction 30%) with cardiac resynchronization therapy (44%), dual-chamber (38%), or single-chamber defibrillators with atrial diagnostics (18%). To develop a predictive algorithm, temporal trends of diurnal and nocturnal heart rates, ventricular extrasystoles, atrial tachyarrhythmia burden, heart rate variability, physical activity, and thoracic impedance obtained by daily automatic RM were combined with a baseline risk-stratifier (Seattle HF Model) into one index. The primary endpoint was the first post-implant adjudicated HF hospitalization. After a median follow-up of 22.5 months since enrolment, patients were randomly allocated to the algorithm derivation group (n = 457; 31 endpoints) or algorithm validation group (n = 461; 29 endpoints). In the derivation group, the index showed a C-statistics of 0.89 [95% confidence interval (CI): 0.83-0.95] with 2.73 odds ratio (CI 1.98-3.78) for first HF hospitalization per unitary increase of index value (P < 0.001). In the validation group, sensitivity of predicting primary endpoint was 65.5% (CI 45.7-82.1%), median alerting time 42 days (interquartile range 21-89), and false (or unexplained) alert rate 0.69 (CI 0.64-0.74) [or 0.63 (CI 0.58-0.68)] per patient-year. Without the baseline risk-stratifier, the sensitivity remained 65.5% and the false/unexplained alert rates increased by ≈10% to 0.76/0.71 per patient-year.

conclusionWith the developed algorithm, two-thirds of first post-implant HF hospitalizations could be predicted timely with only 0.7 false alerts per patient-year.

Indexed as

Cardiac Resynchronization TherapyDefibrillators, ImplantableHeart FailureAgedFemaleHospitalizationHumansMaleStroke VolumeCardiac resynchronization therapyHeart failureHospitalizationImplantable cardioverter-defibrillatorPredictorsRemote monitoring

Identifiers

PMID34392336
PMCPMC8824514
OpenAlexW3195406645

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.