Evidence map›Paper›PMID 33866829›Full record

Trial reportCirculation. Heart failure2021

Two-Year Follow Up of the LATERAL Clinical Trial: A Focus on Adverse Events.

Georg M Wieselthaler, Liviu Klein, Anson W Cheung, Matthew R Danter, Martin Strueber, Claudius Mahr, Nahush A Mokadam, Simon Maltais, Edwin C McGee

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

Trial report in Circulation. Heart failure, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02268942 (A Prospective, Single-Arm, Multi-Center Study in Collaboration With INTERMACS to Evaluate the Thoracotomy Implant Technique of the HeartWare™ HVAD™ System in Patients With Advanced Heart Failure), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT02268942 nacompletednot on this map

A Prospective, Single-Arm, Multi-Center Study in Collaboration With INTERMACS to Evaluate the Thoracotomy Implant Technique of the HeartWare™ HVAD™ System in Patients With Advanced Heart Failure

TypeinterventionalSponsorMedtronic Cardiac Rhythm and Heart FailureRan2014 to 2018Enrolled144ConditionsLeft Sided Heart FailureArmsHeartWare HVAD, Thoracotomy
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. What happens when a disruptive technology gets disrupted?American heart journal plus : cardiology research and practice · 2021
    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

9 authors.

Georg M Wieselthaler *Division of Cardiothoracic Surgery (G.M.W.), University of California San Francisco Medical Center, CA.
Liviu Klein *Department of Medicine (L.K.), University of California San Francisco Medical Center, CA.
Anson W CheungDepartment of Surgery, St. Paul's Hospital, Vancouver, British Columbia (A.W.C.).
Matthew R DanterDepartment of Cardiac Surgery, University of Kansas Medical Center (M.R.D.).
Martin StrueberDepartment of Cardiovascular and Thoracic Surgery, Baptist Heart Institute, Memphis, TN (M.S.).
Claudius MahrDivision of Cardiology, University of Washington Medical Center, Seattle (C.M.).
Nahush A MokadamDivision of Cardiac Surgery, Ohio State University Wexner Medical Center, Columbus (N.A.M.).
Simon MaltaisCardiac Surgery, Los Robles Regional Medical Center, Thousand Oaks, CA (S.M.).
Edwin C McGeeDepartment of Thoracic and CV Surgery, Loyola University Medical Center, Maywood, IL (E.C.M.).

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe LATERAL trial validated the safety and efficacy of the thoracotomy approach for implantation of the HeartWare HVAD System, leading to Food and Drug Administration approval. We sought to analyze 24-month adverse event (AE) rates, including a temporal analysis of the risk profile, associated with the thoracotomy approach for the HVAD system.

methodsAEs from the LATERAL trial were evaluated over 2 years postimplant. Data was obtained from the Interagency Registry for Mechanically Assisted Circulatory Support database for 144 enrolled United States and Canadian patients. Temporal AE profiles were expressed as events per patient year.

resultsDuring 162.5 patient years of support, there were 25 driveline infections (0.15 events per patient year), 50 gastrointestinal bleeds (0.31 events per patient year), and 21 strokes (0.13 events per patient year). Longitudinal AE analysis at follow-up intervals of <30 and 30 to 180 days, and 6 to 12 and 12 to 24 months revealed the highest AE rate at <30 days, with a decrease in total AEs within the first 6 months. After 6 months, most AE rates either stabilized or decreased through 2 years, including a 95% overall freedom from disabling stroke.

conclusionsTwo-year follow-up of the LATERAL trial revealed a favorable morbidity profile in patients supported with the HVAD system, as AE rates were more likely to occur in the first 30 days postimplant, and overall AE rates were significantly reduced after 6 months. Importantly, 2-year freedom from disabling stroke was 95%. These data further support the improving AE profile of patients on long-term HVAD support. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02268942.

Indexed as

ThoracotomyAgedCanadaDevice ApprovalFemaleFollow-Up StudiesGastrointestinal HemorrhageHeart-Assist DevicesHeart FailureHumansMaleMiddle AgedRegistriesStrokeUnited StatesUnited States Food and Drug Administrationheart failuremorbiditysternotomythoracotomy

Identifiers

PMID33866829
PMCPMC8059760

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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.