Evidence map›Paper›PMID 28599667›Full record

Trial reportCardiovascular diabetology2017

Multipolar pacing by cardiac resynchronization therapy with a defibrillators treatment in type 2 diabetes mellitus failing heart patients: impact on responders rate, and clinical outcomes.

Celestino Sardu, Michelangela Barbieri, Matteo Santamaria, Valerio Giordano, Cosimo Sacra, Pasquale Paolisso, Alessandro Spirito, Raffaele Marfella, Giuseppe Paolisso, Maria Rosaria Rizzo

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cardiovascular diabetology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03095196 (Multipolar Pacing by Cardiac Resynchronization Therapy With a Defibrillator as Treatment in Type 2 Diabetes Mellitus Failing Heart Patients), which is not on this map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing 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.

NCT03095196 completednot on this map

Multipolar Pacing by Cardiac Resynchronization Therapy With a Defibrillator as Treatment in Type 2 Diabetes Mellitus Failing Heart Patients: Impact on Responders Rate, and Clinical Outcomes.

TypeobservationalSponsorCelestino SarduRan2012 to 2015Enrolled190ConditionsDiabetes, Heart Failure, Heart Failure NYHA Class II, Heart Failure NYHA Class IIIArmsMultipolar CRT-d, plus conventional drug therapy for HF., Bipolar CRT-d, plus conventional drug therapy for HF., HF drugs
3 · Its place in the literature

Who cites it

29 citing papers in PubMed.

  1. Trial
  2. Observational
  3. Article
  4. Review
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  10. Article
  11. Review
  12. Article
  13. Review
  14. Review
  15. Oral Health Messiers: Diabetes Mellitus Relevance.Diabetes, metabolic syndrome and obesity : targets and therapy · 2021
    Review
  16. Review
  17. Article
  18. Article
  19. Article
  20. 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

10 authors.

Celestino SarduDepartment of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania "Luigi Vanvitelli", Piazza Miraglia, 2, 80138, Naples, Italy. drsarducele@gmail.com.
Michelangela BarbieriDepartment of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania "Luigi Vanvitelli", Piazza Miraglia, 2, 80138, Naples, Italy.
Matteo SantamariaCardiovascular and Arrhythmias Department, John Paul II Research and Care Foundation, Campobasso, Italy.
Valerio GiordanoCardiovascular and Arrhythmias Department, John Paul II Research and Care Foundation, Campobasso, Italy.
Cosimo SacraCardiovascular and Arrhythmias Department, John Paul II Research and Care Foundation, Campobasso, Italy.
Pasquale PaolissoDepartment of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania "Luigi Vanvitelli", Piazza Miraglia, 2, 80138, Naples, Italy.
Alessandro SpiritoCardiovascular Department, Inselspital of Bern University, Bern, Switzerland.
Raffaele MarfellaDepartment of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania "Luigi Vanvitelli", Piazza Miraglia, 2, 80138, Naples, Italy.
Giuseppe PaolissoDepartment of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania "Luigi Vanvitelli", Piazza Miraglia, 2, 80138, Naples, Italy.
Maria Rosaria RizzoDepartment of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania "Luigi Vanvitelli", Piazza Miraglia, 2, 80138, Naples, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundType 2 diabetes mellitus (T2DM) is a multi factorial disease, affecting clinical outcomes in failing heart patients treated by cardiac resynchronization therapy with a defibrillator (CRT-d).

methodsOne hundred and ninety-five T2DM patients received a CRT-d treatment. Randomly the study population received a CRT-d via multipolar left ventricle (LV) lead pacing (n 99, multipolar group), vs a CRT-d via bipolar LV pacing (n 96, bipolar group). These patients were followed by clinical, and instrumental assessment, and telemetric device control at follow up. In this study we evaluated, in a population of failing heart T2DM patients, cardiac deaths, all cause deaths, arrhythmic events, CRT-d responders rate, hospitalizations for HF worsening, phrenic nerve stimulation (PNS), and LV catheter dislodgment events (and re-intervention for LV catheter re-positioning), comparing multipolar CRT-d vs bipolar CRT-d group of patients at follow up.

resultsAt follow up there was a statistical significant difference about atrial arrhythmic events [7 (7%) vs 16 (16.7%), p value 0.019], hospitalizations for HF worsening [15 (15.2% vs 24 (25%), p value 0.046], LV catheter dislodgments [1 (1%) vs 9 (9.4%), p value 0018], PNS [5 (5%) vs 18 (18.7%), p value 0.007], and LV re-positioning [1 (1%) vs 9 (9.4%), p value 0.018], comparing multipolar CRT-d vs bipolar CRT-d group of patients. Multipolar pacing was an independent predictor of all these events.

conclusionsCRT-d pacing via multipolar LV lead vs bipolar LV lead may reduce arrhythmic burden, hospitalization rate, PNS, LV catheters dislodgments, and re-interventions in T2DM failing heart patients. Clinical trial number NCT03095196.

Indexed as

Ventricular Function, LeftAdolescentAdultAgedArrhythmias, CardiacCardiac Resynchronization TherapyCardiac Resynchronization Therapy DevicesDefibrillators, ImplantableDiabetes Mellitus, Type 2Disease ProgressionElectric CountershockFemaleHeart FailureHumansItalyKaplan-Meier Estimate

Identifiers

PMID28599667
PMCPMC5466779

What Socratic holds

Textmetadata
LicenceCC BY
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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 Socratic graph.