A multicenter evaluation of external outflow graft obstruction with a fully magnetically levitated left ventricular assist device

Leonhard Wert*, Garrick C. Stewart, Mandeep R. Mehra, Assi Milwidsky, Ulrich P. Jorde, Daniel J. Goldstein, Craig H. Selzman, Josef Stehlik, Faisal D. Alshamdin, Feras H. Khaliel, Finn Gustafsson, Silvia Boschi, Antonio Loforte, Silvia Ajello, Anna M. Scandroglio, Zuzana Tučanová, Ivan Netuka, Thomas Schlöglhofer, Daniel Zimpfer, Casper F. ZijderhandKadir Caliskan, Günes Dogan, Jan D. Schmitto, Sven Maier, David Schibilsky, Khalil Jawad, Diyar Saeed, Gloria Faerber, Michiel Morshuis, Maja Hanuna, Christoph S. Müller, Johanna Mulzer, Jörg Kempfert, Volkmar Falk, Evgenij V. Potapov

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

1 Citation (Scopus)

Abstract

Background: The HeartMate 3 (HM 3; Abbott) left ventricular assist device (LVAD) has improved hemocompatibility-related adverse outcomes. In sporadic cases, external compression of the outflow graft causing obstruction (eOGO) can result from substance accumulation between the outflow graft and its bend relief. We sought to evaluate the prevalence, course, and clinical implications of eOGO in an international study. Methods: A multicenter retrospective analysis of HM 3 LVADs implanted between November 2014 and April 2021 (n = 2108) was conducted across 17 cardiac centers in 8 countries. We defined eOGO as obstruction >25% in the cross-sectional area in imaging (percutaneous angiography, computed tomography, or intravascular ultrasound). The prevalence and annual incidence were calculated. Serious adverse events and outcomes (death, transplantation, or device exchange) were analyzed for eOGO cases. Results: Of 2108 patients, 62 were diagnosed with eOGO at a median LVAD support duration of 953 (interquartile range, 600-1267) days. The prevalence of eOGO was 3.0% and the incidence at 1, 2, 3, 4, and 5 years of support was 0.6%, 2.8%, 4.0%, 5.2%, and 9.1%, respectively. Of 62 patients, 9 were observed, 27 underwent surgical revision, 15 underwent percutaneous stent implantation, 8 received a heart transplant, and 2 died before intervention. One patient underwent surgical revision and later stent implantation. The mortality with therapeutic intervention was 9/53 (17.0%). Conclusions: Although uncommon, HM 3 LVAD-supported patients might develop eOGO with an increasing incidence after 1 year of support. Although engineering efforts to reduce this complication are under way, clinicians must maintain a focus on early detection and remain vigilant.

Original languageEnglish
JournalJournal of Thoracic and Cardiovascular Surgery
DOIs
Publication statusE-pub ahead of print - 3 Oct 2022

Bibliographical note

Funding Information:
G.C.S.: Participation on a Data Safety Monitoring Board or Advisory Board: Procyrion Inc (chair of clinical trial safety committee [Aortix]), Abbott Laboratories (evidence base advisory board [HeartMate 3]). M.R.M.: Consulting fees: Abbot, Janssen, Paragonix, Natera, Moderna, Baim Institute for Clinical Research, and Briadview Ventures. Participation on a Data Safety Monitoring Board or Advisory Board: Mesoblast and Fineheart. Stock or stock options: Leviticus, NupulseCV, and Fineheart. A.M.: Grants or contracts from any entity: Abbott (Fellowship grant made to institution). U.P.J.: Grants or contracts from any entity: Research grant Abbott . Consulting fees: Abbott and Edwards. Support for attending meetings and/or travel: Abbott and AncoraHeart . Leadership or fiduciary role in other board, society, committee, or advocacy group, paid or unpaid: ISHLT board. Stock or stock options: Revamp Medical. D.J.G.: Consulting fees: Abbott Inc Consultant/Medical Advisory Board, Abiomed Inc Consultant. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Abiomed Inc (speaker honorarium). J.S.: Grants or contracts from any entity: Natera (Research support). Consulting fees: Medtronic, Natera, and Sanofi Aventis. F.G.: Consulting fees: Abbott Inc. A.L.: Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events: Medtronic and Abbott. Support for attending meetings and/or travel: Medtronic and Abbott . Z.T.: Grants or contracts from any entity: Abbott (payments to institution). I.N.: All support for the present report (eg, funding, provision of study materials, medical writing, article processing charges, etc): Abbott , consultant and overall principal investigator (grants, personal fees, and nonfinacial support). Grants or contracts from any entity: CARMAT SA (grants, personal fees and nonfinancial support). Consulting fees: Abbott (grants, personal fees and nonfinancial support). Support for attending meetings and/or travel: Abbott (grants, personal fees, and nonfinancial support), CARMAT SA (grants, personal fees, and nonfinancial support). Participation on a Data Safety Monitoring Board or Advisory Board: LeviticusCardio Ltd (board member, stockholder). Stock or stock options: LeviticusCardio Ltd (board member, stockholder). Other financial or nonfinancial interests: LeviticusCardio Ltd (nonfinancial support or other). T.S.: Grants or contracts from any entity: Abbott Inc (payment to institution), Medtronic (payment to institution). Consulting fees: Abbott Inc and Medtronic Inc. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events: Abbott Inc (payment to institution). Participation on a Data Safety Monitoring Board or Advisory Board: Abbott Inc and Metronic. D.Z.: Grants or contracts from any entity: Abbott , Medtronic , Berlin Heart , Corelife , and Edwards . Consulting fees: Abbott, Medtronic, Berlin Heart, Corelife, and Edwards. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events: Abbott, Berlin Heart, Corelife, and Medtronic. Support for attending meetings and/or travel: Abbott , Berlin Heart , Corelife , Medtronic , and Edwards . Participation on a Data Safety Monitoring Board or Advisory Board: Abbott and Berlin Heart. G.D.: Consulting fees: Abbott. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events: Abbott. J.D.S.: Consulting fees: Abbott and Medtronic. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events: Abbott and Medtronic. Support for attending meetings and/or travel: Abbott and Medtronic . Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: EUMS Society (president) and ESAO (Board of Governors). D.S.: Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events: Abiomed (consulting/lecture honoraria). Support for attending meetings and/or travel: Abbott (travel grants for ISHLT until 2019). Leadership or fiduciary role in other board, society, committee, or advocacy group, paid or unpaid: ISHLT. C.S.M.: Consulting fees: Abbott (proctoring contract, but no proctoring has taken place so far/no payment received). J.K.: Grants or contracts from any entity: Edwards and LivaNova . Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events: Edwards, Medtronic, Abbott, LivaNova, and Cryolife. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: TC EACTS, ECSC Board, ISMICS Board. V.F.: Grants or contracts from any entity: Medtronic GmbH , Biotronik SE & Co , Abbott GmbH & Co KG , Boston Scientific , Edwards Lifesciences , Berlin Heart , Novartis Pharma GmbH , JOTEC/Cryolife GmbH , LivaNova , and Zurich Heart (relevant [institutional] financial activities outside the submitted work with the mentioned commercial entities in relation to educational grants [including travel support], fees for lectures and speeches, fees for professional consultation, research, and study funds). E.V.P.: Consulting fees: Abbott (institutional grants), Medtronic (institutional grants), and Abiomed (institutional grants). Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events: Abbott (institutional grants), Medtronic (institutional grants), and Abiomed (institutional grants). Support for attending meetings and/or travel: Abbott (institutional grants), Medtronic (institutional grants), and Abiomed (institutional grants). Participation on a Data Safety Monitoring Board or Advisory Board: Abbott and Medtronic. All other authors reported no conflicts of interest.

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© 2022 The American Association for Thoracic Surgery

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