Evidence map›Paper›PMID 36798028›Full record

ArticleESC heart failure2023

Identifying patients at risk: multi-centre comparison of HeartMate 3 and HeartWare left ventricular assist devices.

Lieke Numan, Daniel Zimpfer, Osnat Itzhaki Ben Zadok, Emmeke Aarts, Michiel Morshuis, Sabina P W Guenther, Julia Riebandt, Dominik Wiedemann, Faiz Z Ramjankhan, Anne-Marie Oppelaar and 5 more

Abstract readMulticenter Study
In one paragraph

Article in ESC heart failure, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

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

9 citing papers in PubMed.

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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.

Lieke NumanDepartment of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.ORCID 0000-0002-5896-7738
Daniel ZimpferDepartment of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
Osnat Itzhaki Ben ZadokDepartment of Cardiology, Rabin Medical Center, Petah Tikva, Israel.
Emmeke AartsDepartment of Methodology and Statistics, Utrecht University, Utrecht, The Netherlands.
Michiel MorshuisClinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center Northrhine Westfalia, Ruhr-University Bochum, Bad Oeynhausen, Germany.
Sabina P W GuentherClinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center Northrhine Westfalia, Ruhr-University Bochum, Bad Oeynhausen, Germany.
Julia RiebandtDepartment of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
Dominik WiedemannDepartment of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
Faiz Z RamjankhanDepartment of Cardiothoracic Surgery, University Medical Centre Utrecht, University of Utrecht, Utrecht, The Netherlands.
Anne-Marie OppelaarDepartment of Cardiothoracic Surgery, University Medical Centre Utrecht, University of Utrecht, Utrecht, The Netherlands.
Tuvia Ben-GalDepartment of Cardiology, Rabin Medical Center, Petah Tikva, Israel.
Binyamin Ben-AvrahamDepartment of Cardiology, Rabin Medical Center, Petah Tikva, Israel.
Folkert W AsselbergsDepartment of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.ORCID 0000-0002-1692-8669
Rene SchrammClinic for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center Northrhine Westfalia, Ruhr-University Bochum, Bad Oeynhausen, Germany.
Linda W Van LaakeDepartment of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsSince the withdrawal of HeartWare (HVAD) from the global market, there is an ongoing discussion if and which patients require prophylactically exchange for a HeartMate 3 (HM3). Therefore, it is important to study outcome differences between HVAD and HM3 patients. Because centres differ in patient selection and standard of care, we performed a propensity score (PS)-based study including centres that implanted both devices and aimed to identify which HVAD patients are at highest risk. METHODS AND

resultsWe performed an international multi-centre study (n = 1021) including centres that implanted HVAD and HM3. PS-matching was performed using clinical variables and the implanting centre. Survival and complications were compared. As a sensitivity analysis, PS-adjusted Cox regression was performed. Landmark analysis with conditional survival >2 years was conducted to evaluate long-term survival differences. To identify which HVAD patients may benefit from a HM3 upgrade, Cox regression using pre-operative variables and their interaction with device type was performed. Survival was significantly better for HM3 patients (P < 0.01) in 458 matched patients, with a median follow-up of 23 months. Within the matched cohort, HM3 patients had a median age of 58 years, and 83% were male, 80% of the HVAD patients were male, with a median age of 59 years. PS-adjusted Cox regression confirmed a significantly better survival for HM3 patients when compared with HVAD, with a HR of 1.46 (95% confidence interval 1.14-1.85, P < 0.01). Pump thrombosis (P < 0.01) and ischaemic stroke (P < 0.01) occurred less in HM3 patients. No difference was found for haemorrhagic stroke, right heart failure, driveline infection, and major bleeding. Landmark-analysis confirmed a significant difference in conditional survival >2 years after implantation (P = 0.03). None of the pre-operative variable interactions in the Cox regression were significant.

conclusionsHM3 patients have a significantly better survival and a lower incidence of ischaemic strokes and pump thrombosis than HVAD patients. This survival difference persisted after 2 years of implantation. Additional research using post-operative variables is warranted to identify which HVAD patients need an upgrade to HM3 or expedited transplantation.

Indexed as

Brain IschemiaHeart-Assist DevicesHeart FailureStrokeThrombosisFemaleHumansMaleMiddle AgedCentrifugal continuous flow pumpEnd-stage heart failureLeft ventricular assist deviceLVADMechanical circulatory support

Identifiers

PMID36798028
PMCPMC10192248

What OpenQuestion holds

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Registered trials

None linked

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.