Retrospective review of secondary prevention strategies for gastrointestinal bleeding and associated clinical outcomes in left ventricular assist device patients.
anticoagulation management
gastrointestinal bleeding
left ventricular assist device
mechanical circulatory support
Journal
Artificial organs
ISSN: 1525-1594
Titre abrégé: Artif Organs
Pays: United States
ID NLM: 7802778
Informations de publication
Date de publication:
Dec 2022
Dec 2022
Historique:
revised:
06
04
2022
received:
14
12
2021
accepted:
29
04
2022
pubmed:
18
5
2022
medline:
18
11
2022
entrez:
17
5
2022
Statut:
ppublish
Résumé
Gastrointestinal bleeding (GIB) is one of the most common bleeding complications associated with left ventricular assist devices (LVAD). Currently, there is no strong evidence or clear guidance for which secondary GIB prophylaxis strategy should be implemented after the discontinuation of aspirin. Our single-center study describes the outcomes of 26 LVAD patients who experienced a total of 49 GIB events: these individuals were either in Group-1 (lower INR target range) or Group-2 (lower INR target plus a hemostatic agent) as the secondary prophylaxis strategy. Each GIB event was considered an independent event. Outcomes assessed were bleeding reoccurrence rates, time to next GIB, acute GIB strategies, GIB-free days, thromboembolic events, survival, coagulation, and hematologic parameters. GIB reoccurrence rates were not statistically different: Group-1, 9 (40.9%), versus Group-2, 15 (55.6%); p = 0.308. Danazol was utilized 81.5% of the time as the designated hemostatic agent. Additionally, no significant differences were observed with all of our secondary outcome measures for bleeding, ischemic events, or survival. While our study was not powered to assess the clinical outcomes related to survival and thromboembolic events, no discernable increased risk for ischemic events including pump thrombosis were observed. Our data suggest that a lower INR target range plus danazol does not confer any additional benefit over a lower INR target range only approach. The results of this report are hypothesis-generating and additional studies are warranted to elucidate the optimal antithrombotic strategy and role of hemostatic agents in reducing the risk of recurrent GIB events.
Sections du résumé
BACKGROUND
BACKGROUND
Gastrointestinal bleeding (GIB) is one of the most common bleeding complications associated with left ventricular assist devices (LVAD). Currently, there is no strong evidence or clear guidance for which secondary GIB prophylaxis strategy should be implemented after the discontinuation of aspirin.
METHODS
METHODS
Our single-center study describes the outcomes of 26 LVAD patients who experienced a total of 49 GIB events: these individuals were either in Group-1 (lower INR target range) or Group-2 (lower INR target plus a hemostatic agent) as the secondary prophylaxis strategy. Each GIB event was considered an independent event. Outcomes assessed were bleeding reoccurrence rates, time to next GIB, acute GIB strategies, GIB-free days, thromboembolic events, survival, coagulation, and hematologic parameters.
RESULTS
RESULTS
GIB reoccurrence rates were not statistically different: Group-1, 9 (40.9%), versus Group-2, 15 (55.6%); p = 0.308. Danazol was utilized 81.5% of the time as the designated hemostatic agent. Additionally, no significant differences were observed with all of our secondary outcome measures for bleeding, ischemic events, or survival.
CONCLUSION
CONCLUSIONS
While our study was not powered to assess the clinical outcomes related to survival and thromboembolic events, no discernable increased risk for ischemic events including pump thrombosis were observed. Our data suggest that a lower INR target range plus danazol does not confer any additional benefit over a lower INR target range only approach. The results of this report are hypothesis-generating and additional studies are warranted to elucidate the optimal antithrombotic strategy and role of hemostatic agents in reducing the risk of recurrent GIB events.
Substances chimiques
Danazol
N29QWW3BUO
Hemostatics
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2423-2431Informations de copyright
© 2022 International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.
Références
Savarese G, Lund LH. Global public health burden of heart failure. Card Fail Rev. 2017 Apr;3(1):7-11. https://doi.org/10.15420/cfr.2016:25:2
Allen LA, Stevenson LW, Grady KL, Goldstein NE, Matlock DD, Arnold RM, et al. Decision making in advanced heart failure: a scientific statement from the American Heart Association. Circulation. 2012 Apr 17;125(15):1928-52. https://doi.org/10.1161/CIR.0b013e31824f2173
Sajgalik P, Grupper A, Edwards BS, Kushwaha SS, Stulak JM, Joyce DL, et al. Current status of left ventricular assist device therapy. Mayo Clin Proc. 2016 Jul;91(7):927-40. https://doi.org/10.1016/j.mayocp.2016.05.002
den Exter PL, Beeres S, Eikenboom J, Klok FA, Huisman MV. Anticoagulant treatment and bleeding complications in patients with left ventricular assist devices. Expert Rev Cardiovasc Ther. 2020 Jun;18(6):363-72. https://doi.org/10.1080/14779072.2020.1773803
Eisen HJ. Left ventricular assist devices (LVADS): history, clinical application and complications. Korean Circ J. 2019 Jul;49(7):568-85. https://doi.org/10.4070/kcj.2019.0161
Long B, Robertson J, Koyfman A, Brady W. Left ventricular assist devices and their complications: a review for emergency clinicians. Am J Emerg Med. 2019 Aug;37(8):1562-70. https://doi.org/10.1016/j.ajem.2019.04.050
Molina TL, Krisl JC, Donahue KR, Varnado S. Gastrointestinal bleeding in left ventricular assist device: octreotide and other treatment modalities. ASAIO J. 2018 Jul/Aug;64(4):433-9. https://doi.org/10.1097/mat.0000000000000758
Houston BA, Schneider AL, Vaishnav J, Cromwell DM, Miller PE, Faridi KF, et al. Angiotensin II antagonism is associated with reduced risk for gastrointestinal bleeding caused by arteriovenous malformations in patients with left ventricular assist devices. J Heart Lung Transplant. 2017 Apr;36(4):380-5. https://doi.org/10.1016/j.healun.2016.12.016
Aggarwal A, Pant R, Kumar S, Sharma P, Gallagher C, Tatooles AJ, et al. Incidence and management of gastrointestinal bleeding with continuous flow assist devices. Ann Thorac Surg. 2012 May;93(5):1534-40. https://doi.org/10.1016/j.athoracsur.2012.02.035
Draper KV, Huang RJ, Gerson LB. GI bleeding in patients with continuous-flow left ventricular assist devices: a systematic review and meta-analysis. Gastrointest Endosc. 2014 Sep;80(3):435-46.e1. https://doi.org/10.1016/j.gie.2014.03.040
Hollis IB, Doligalski CT, Jennings DJ. Pharmacotherapy for durable left ventricular assist devices. Pharmacotherapy. 2021 Jan;41(1):14-27. https://doi.org/10.1002/phar.2491
Plazak ME, Hankinson SJ, Sorensen EN, Reed BN, Ravichandran B, Ton V-K. Novel use of tamoxifen to reduce recurrent gastrointestinal bleeding in patients with left ventricular assist devices. J Cardiovasc Transl Res. 2020;14:484-91. https://doi.org/10.1007/s12265-020-10084-7
Sieg AC, Moretz JD, Horn E, Jennings DL. Pharmacotherapeutic management of gastrointestinal bleeding in patients with continuous-flow left ventricular assist devices. Pharmacotherapy. 2017 Nov;37(11):1432-48. https://doi.org/10.1002/phar.2016
Lopilato AC, Doligalski CT, Caldeira C. Incidence and risk factor analysis for gastrointestinal bleeding and pump thrombosis in left ventricular assist device recipients. Artif Organs. 2015 Nov;39(11):939-44. https://doi.org/10.1111/aor.12471
Morici N, Varrenti M, Brunelli D, Perna E, Cipriani M, Ammirati E, et al. Antithrombotic therapy in ventricular assist device (VAD) management: from ancient beliefs to updated evidence. A narrative review. Int J Cardiol Heart Vasc. 2018 Sep;20:20-6. https://doi.org/10.1016/j.ijcha.2018.06.005
Kapuria D, Khumri T, Shamim S, Surana P, Khan S, al-Khalisi N, et al. Characterization and timing of gastrointestinal bleeding in continuous-flow left ventricular assist device recipients. Heliyon. 2020 Sep;6(9):e04695. https://doi.org/10.1016/j.heliyon.2020.e04695
Thohan V, Shi Y, Rappelt M, Yousefzai R, Sulemanjee NZ, Hastings TE, et al. The association between novel clinical factors and gastrointestinal bleeding among patients supported with continuous-flow left ventricular assist device therapy. J Card Surg. 2019 Jun;34(6):453-62. https://doi.org/10.1111/jocs.14062
Katz JN, Adamson RM, John R, Tatooles A, Sundareswaran K, Kallel F, et al. Safety of reduced anti-thrombotic strategies in HeartMate II patients: a one-year analysis of the US-TRACE study. J Heart Lung Transplant. 2015 Dec;34(12):1542-8. https://doi.org/10.1016/j.healun.2015.06.018
Converse MP, Sobhanian M, Taber DJ, Houston BA, Meadows HB, Uber WE. Effect of angiotensin II inhibitors on gastrointestinal bleeding in patients with left ventricular assist devices. J Am Coll Cardiol. 2019 Apr 16;73(14):1769-78. https://doi.org/10.1016/j.jacc.2019.01.051
Jennings DL, Truby LK, Littlefield AJ, Ciolek AM, Marshall D, Topkara VK, et al. Impact of heart failure drug therapy on rates of gastrointestinal bleeding in LVAD recipients: an INTERMACS analysis. Int J Artif Organs. 2021 May;44(12):965-71. https://doi.org/10.1177/03913988211013366