Evidence map›Paper›PMID 35619238›Full record

Observational studyESC heart failure2022

Synchronized diaphragmatic stimulation for heart failure using the VisONE system: a first-in-patient study.

Ana Jorbendaze, Robin Young, Tamaz Shaburishvili, Vitaly Demyanchuk, Roman Buriak, Borys Todurov, Kostyantyn Rudenko, Michel Zuber, Simon F Stämpfli, Felix C Tanner and 5 more

Registry-linked trialAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in ESC heart failure, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07392749 (Feasibility Study of Diaphragm Synchronized Pacing), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT07392749 narecruitingnot on this mapstarted 2025, after this paper: background citation

Feasibility Study of Diaphragm Synchronized Pacing (DSP) Via the Left Inferior Phrenic Vein (LIPV) Approach

TypeinterventionalSponsorRenJi HospitalRan2025 to 2026Enrolled10ConditionsHeart FailureArmsDSP
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Observational
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.

Ana JorbendazeHeart and Vascular Clinic, Tbilisi, Georgia.
Robin YoungRobertson Centre for Biostatistics and Clinical Trials, University of Glasgow, University Avenue, Glasgow, G12 8QQ, UK.
Tamaz ShaburishviliHeart and Vascular Clinic, Tbilisi, Georgia.
Vitaly DemyanchukHeart Institute, Ministry of Health of Ukraine, Kiev, Ukraine.
Roman BuriakAmosov National Institute of Cardiovascular Surgery, Kiev, Ukraine.
Borys TodurovHeart Institute, Ministry of Health of Ukraine, Kiev, Ukraine.
Kostyantyn RudenkoAmosov National Institute of Cardiovascular Surgery, Kiev, Ukraine.
Michel ZuberHeart Center, University Hospital, Zurich, Switzerland.
Simon F StämpfliHeart Center, University Hospital, Zurich, Switzerland.ORCID 0000-0003-3690-8216
Felix C TannerHeart Center, University Hospital, Zurich, Switzerland.
Paul ErneFaculty of Biomedical Sciences, University Svizzera Italiana, Lugano, Switzerland.
Michael MirroSchool of Medicine, University of Indiana, Fort Wayne, IN, USA.
Marat FudimDepartment of Medicine, Duke University Medical Center, Durham, NC, USA.
Lee R GoldbergSection of Advanced Heart Failure and Cardiac Transplant, Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, PA, USA.
John G F ClelandRobertson Centre for Biostatistics and Clinical Trials, University of Glasgow, University Avenue, Glasgow, G12 8QQ, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsSynchronized diaphragmatic stimulation (SDS) modulates intrathoracic and intra-abdominal pressures with favourable effects on cardiac function for patients with a reduced left ventricular ejection fraction (LVEF) and heart failure (HFrEF). VisONE-HF is a first-in-patient, observational study assessing the feasibility and 1 year effects of a novel, minimally invasive SDS device. METHODS AND

resultsThe SDS system comprises a pulse generator and two laparoscopically delivered, bipolar, active-fixation leads on the inferior diaphragmatic surface. Fifteen symptomatic men with HFrEF and ischaemic heart disease receiving guideline-recommended therapy were enrolled (age 60 [56, 67] years, New York Heart Association class II [53%] /III [47%], LVEF 27 [23, 33] %, QRSd 117 [100, 125] ms, & N terminal pro brain natriuretic peptide [NT-proBNP] 1779 [911, 2,072] pg/mL). Implant success was 100%. Patients were evaluated at 3, 6, and 12 months for device-related or lead-related complications, quality of life (SF-36 QOL), 6 min hall walk distance (6MHWd), and by echocardiography. No implant procedure or SDS-related adverse event occurred, and patients were unaware of diaphragmatic stimulation. By 12 months, left ventricular end-systolic volume decreased (136 [123, 170] mL to 98 [89, 106] mL; P = 0.05), 6MHWd increased (315 [300, 330] m to 340 [315, 368] m; P = 0.004), and SF-36 QOL improved (physical scale 0 [0, 0] to 25 [0, 50], P = 0.006; emotional scale 0 [0, 33] to 33 [33, 67], P = 0.001). Although neither reached statistical significance, LVEF decreased (28 [23, 40]% vs. 34 [29, 38]%; P = ns) and NT-proBNP was lower (1784 [920, 2540] pg/mL vs. 1492 [879, 2028] pg/mL; P = ns).

conclusionsThese data demonstrate the feasibility of laparoscopic implantation and delivery of SDS without raising safety concerns. These encouraging findings should be investigated further in adequately powered randomized trials.

Indexed as

Heart FailureMyocardial IschemiaHumansMaleMiddle AgedQuality of LifeStroke VolumeVentricular Function, LeftAcute cardiac haemodynamicsCongestive heart failureSynchronized diaphragmatic stimulation

Identifiers

PMID35619238
PMCPMC9288796

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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.