TY - JOUR
T1 - A multicenter evaluation of external outflow graft obstruction with a fully magnetically levitated left ventricular assist device
AU - Wert, Leonhard
AU - Stewart, Garrick C.
AU - Mehra, Mandeep R.
AU - Milwidsky, Assi
AU - Jorde, Ulrich P.
AU - Goldstein, Daniel J.
AU - Selzman, Craig H.
AU - Stehlik, Josef
AU - Alshamdin, Faisal D.
AU - Khaliel, Feras H.
AU - Gustafsson, Finn
AU - Boschi, Silvia
AU - Loforte, Antonio
AU - Ajello, Silvia
AU - Scandroglio, Anna M.
AU - Tučanová, Zuzana
AU - Netuka, Ivan
AU - Schlöglhofer, Thomas
AU - Zimpfer, Daniel
AU - Zijderhand, Casper F.
AU - Caliskan, Kadir
AU - Dogan, Günes
AU - Schmitto, Jan D.
AU - Maier, Sven
AU - Schibilsky, David
AU - Jawad, Khalil
AU - Saeed, Diyar
AU - Faerber, Gloria
AU - Morshuis, Michiel
AU - Hanuna, Maja
AU - Müller, Christoph S.
AU - Mulzer, Johanna
AU - Kempfert, Jörg
AU - Falk, Volkmar
AU - Potapov, Evgenij V.
N1 - Publisher Copyright:
© 2022 The American Association for Thoracic Surgery
PY - 2024/4
Y1 - 2024/4
N2 - 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.
AB - 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.
KW - HeartMate 3
KW - left ventricular assist device
KW - outflow graft obstruction
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U2 - 10.1016/j.jtcvs.2022.09.051
DO - 10.1016/j.jtcvs.2022.09.051
M3 - Article
C2 - 36562497
AN - SCOPUS:85140954631
SN - 0022-5223
VL - 167
SP - 1322-1330.e6
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 4
ER -