TY - JOUR
T1 - Early intervention for lactate dehydrogenase elevation improves clinical outcomes in patients with the HeartMate II left ventricular assist device
T2 - Insights from the PREVENT study
AU - Thenappan, Thenappan
AU - Stulak, John M.
AU - Agarwal, Richa
AU - Maltais, Simon
AU - Shah, Palak
AU - Eckman, Peter
AU - Emani, Sitaramesh
AU - Katz, Jason N.
AU - Gregoric, Igor
AU - Keebler, Mary E.
AU - Uriel, Nir
AU - Adler, Eric
AU - Chuang, Joyce
AU - Farrar, David J.
AU - Sundareswaran, Kartik S.
AU - John, Ranjit
N1 - Funding Information:
The PREVENT study (Clinical Trial Registry Number NCT02158403) was sponsored and conducted by Thoratec Corporation (now Abbott). S.M. is a consultant for Abbott and Medtronic. P.S. has received grant support from Haemonetics and Medtronic. P.E. is a consultant for Abbott and Medtronic. S.E. is consultant for Abbott. N.U. is a consultant for Novartis and Medtronic, and has received grant support from Abbott, Medtronic and Novartis. J.C., D.F. and K.S. are employees of Abbott. R.J. has received grant support from Abbott. The remaining authors have no conflicts of interest to disclose.
Publisher Copyright:
© 2018 International Society for Heart and Lung Transplantation
PY - 2018/1
Y1 - 2018/1
N2 - Background Hemolysis, assessed by elevated serum lactate dehydrogenase (LDH), is strongly associated with HeartMate II pump thrombosis (PT). However, it is unknown whether early intervention for elevated LDH circumvents the risk of serious PT requiring pump exchange. We sought to evaluate the relationship between elevated LDH and clinical outcomes, the effectiveness of early medical intervention, and risk factors for elevated LDH. Methods We studied 268 patients in the prospective, multicenter PREVENT study who had 2 or more LDH measurements at ≥30 days post-implant. Elevated LDH was defined as LDH ≥2.5× upper limit of normal (ULN) for 2 consecutive measurements. Results Fourteen percent of patients had elevated LDH. Stroke-free survival at 6 months was lower in patients with elevated LDH vs patients with normal LDH (83 ± 6% vs 93 ± 2%, p = 0.035). Elevated LDH resolved without intervention in 19% of patients, with intensified medical therapy in 43% and required surgical intervention in 38%. For patients receiving only medical therapy, survival was 94 ± 6% at 6 months post-treatment. In this subgroup, resolution of symptoms with intensified medical therapy was sustained in 15 of 16 patients, with PT occurring in 1 patient at 171 days after initial treatment for elevated LDH (202 days post-implant). Early medical intervention at moderately elevated LDH (2.5× to 3.2× ULN), as compared with higher levels (>3.2× ULN), led to more sustained resolution of symptoms without subsequent PT or need for surgical intervention (91% vs 26% at 6 months post-treatment, p = 0.002). Conclusions Early medical intervention can successfully resolve moderate LDH elevations (2.5× to 3.2× ULN) with a low incidence of death or PT at 6 months post-treatment.
AB - Background Hemolysis, assessed by elevated serum lactate dehydrogenase (LDH), is strongly associated with HeartMate II pump thrombosis (PT). However, it is unknown whether early intervention for elevated LDH circumvents the risk of serious PT requiring pump exchange. We sought to evaluate the relationship between elevated LDH and clinical outcomes, the effectiveness of early medical intervention, and risk factors for elevated LDH. Methods We studied 268 patients in the prospective, multicenter PREVENT study who had 2 or more LDH measurements at ≥30 days post-implant. Elevated LDH was defined as LDH ≥2.5× upper limit of normal (ULN) for 2 consecutive measurements. Results Fourteen percent of patients had elevated LDH. Stroke-free survival at 6 months was lower in patients with elevated LDH vs patients with normal LDH (83 ± 6% vs 93 ± 2%, p = 0.035). Elevated LDH resolved without intervention in 19% of patients, with intensified medical therapy in 43% and required surgical intervention in 38%. For patients receiving only medical therapy, survival was 94 ± 6% at 6 months post-treatment. In this subgroup, resolution of symptoms with intensified medical therapy was sustained in 15 of 16 patients, with PT occurring in 1 patient at 171 days after initial treatment for elevated LDH (202 days post-implant). Early medical intervention at moderately elevated LDH (2.5× to 3.2× ULN), as compared with higher levels (>3.2× ULN), led to more sustained resolution of symptoms without subsequent PT or need for surgical intervention (91% vs 26% at 6 months post-treatment, p = 0.002). Conclusions Early medical intervention can successfully resolve moderate LDH elevations (2.5× to 3.2× ULN) with a low incidence of death or PT at 6 months post-treatment.
KW - Heart failure
KW - HeartMate II
KW - anticoagulation
KW - cardiac transparent
KW - cardiomyopathy
KW - hemolysis
KW - pump thrombosis
KW - serum lactate dehydrogenase
KW - thrombosis
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U2 - 10.1016/j.healun.2017.10.017
DO - 10.1016/j.healun.2017.10.017
M3 - Article
C2 - 29153636
AN - SCOPUS:85033778006
SN - 1053-2498
VL - 37
SP - 25
EP - 32
JO - Journal of Heart and Lung Transplantation
JF - Journal of Heart and Lung Transplantation
IS - 1
ER -