scholarly journals Incidence of Pump Thrombosis in HeartMate II during Destination Therapy

2016 ◽  
Author(s):  
Rohan Samson ◽  
Abhishek Jaiswal ◽  
Frank Smart ◽  
Thierry H. LeJemtel

Pump thrombosis occurs during destination therapy (DT) with HeartMate II, a continuous blood flow left ventricular assist device (St Jude, Pleasanton, CA, USA). With adherence to stringent post-operative and long-term anticoagulation a low incidence of pump thrombosis was initially reported during DT. The increased PT incidence during DT that was reported in early 2013 was attributed to lenient anticoagulation. A wide range of pump thrombosis incidence during DT is being reported since the return to stringent post-operative and long-term anticoagulation. We searched PubMed from January 2008 to February 2016 for reports of pump thrombosis during mechanical circulatory support with HeartMate II and focus on the incidence rate of pump thrombosis from DT approval by the Food and Drug Administration to present. Pump thrombosis which may have been initially underestimated continues to complicate DT with HeartMate II despite stringent post-operative and long-term anticoagulation.

Author(s):  
Laurie J Lambert ◽  
Georgeta Sas ◽  
Nataliya Dragieva ◽  
Lucy J Boothroyd ◽  
Anique Ducharme ◽  
...  

Introduction: After a review of the evidence, our publicly funded cardiology evaluation unit recommended to the Quebec Ministry of Health that use of long-term left ventricular assist devices (LVAD) should be carefully monitored and not limited to bridge-to-transplant patients. Herein, we describe use of LVAD and 1-year results in Quebec compared with the INTERMACS registry. Methods: A retrospective review of all pertinent hospital data sources of all LVAD-implanted patients in 20102-12 was performed. Variables, definitions and time points (pre-implant, implant, 1 month, 1 year) were based on the INTERMACS registry and results were compared during the same period. Major clinical outcomes (death, transplant, recovery) and adverse events were determined during 1-year follow up for the entire cohort. Results: During 2010-2012, 53 LVADs were implanted in Quebec (3 centers). Patients were mostly male (77 %) with a median age of 57 years (interquartile range, IQR: 50-60); 34% were ≥60 years old compared to 47% in INTERMACS. The proportion of Quebec patients with an INTERMACS profile 1 (critical cardiogenic shock; 13%) and 2 (progressive decline; 40%) were very similar to INTERMACS. However, the proportion with INTERMACS profile 3 (stable, inotrope-dependent) was higher in Quebec (43%) than in INTERMACS (27%); in the latter, more patients had INTERMACS profiles 4 (symptoms at rest) to 7 (NYHA Class III). Forty-nine percent of Quebec patients were not on the transplant list at the time of implantation compared to 75% in INTERMACS. LVAD as destination therapy was much less frequent in Quebec (11%) than in INTERMACS (36%). After LVAD implantation, median intensive care unit stay was 7 days (IQR: 5-14) and median hospital stay for patients who were discharged on support was 24 days (IQR: 20 - 41). At 1-year, major clinical outcomes of Quebec patients (alive on support 57%; died on support 17%; transplant 24%; explant 2%) were virtually identical to those in INTERMACS. One-year survival for patients on versus not on the transplant list at the time of implantation was not significantly different (p=0.13). As in INTERMACS patients, the most frequent adverse events in Quebec patients were infection, hemorrhage, arrhythmia and right heart failure. Conclusion: In comparison with INTERMACS patients, Quebec LVAD patients are younger but sicker and less likely to be implanted as destination therapy. Despite low volumes, clinical results in Quebec hospitals are very similar to those reported for INTERMACS. Only half of Quebec LVAD patients were on the transplant list at the time of implant. Similar clinical results for patients on and off the transplant list in Quebec support the recommendation that transplant eligibility should not be an essential criterion for selection of patients for LVAD. Continued independent monitoring in collaboration with hospitals will be important to optimize quality of care.


2019 ◽  
Vol 43 (2) ◽  
pp. 109-118 ◽  
Author(s):  
Marian Urban ◽  
John Um ◽  
Michael Moulton ◽  
Douglas Stoller ◽  
Ronald Zolty ◽  
...  

In selected patients with left ventricular assist device–associated infection or malfunction, pump exchange may become necessary after conservative treatment options fail and heart transplantation is not readily available. We examined the survival and complication rate in patients (⩾19 years of age) who underwent HeartMate II to HeartMate II exchange at our institution from 1 January 2010 to 28 February 2018. Clinical outcomes were analyzed and compared for patients who underwent exchange for pump thrombosis (14 patients), breach of driveline integrity (5 patients), and device-associated infection (2 patients). There were no differences in 30-day mortality (p = 0.58), need for temporary renal replacement therapy (p = 0.58), right ventricular mechanical support (p = 0.11), and postoperative stroke (p = 0.80) among groups. Survival at 1 year was 90% ± 7% for the whole cohort and 85% ± 10% for those who underwent exchange for pump thrombosis. In patients exchanged for device thrombosis, freedom from re-thrombosis and survival free from pump re-thrombosis at 1 year were 49% ± 16% and 42% ± 15%, respectively. No association of demographic and clinical variables with the risk of recurrent pump thrombosis after the first exchange was identified. Survival after left ventricular assist device exchange compares well with published results after primary left ventricular assist device implantation. However, recurrence of thrombosis was common among patients who required a left ventricular assist device exchange due to pump thrombosis. In this sub-group, consideration should be given to alternative strategies to improve the outcomes.


2015 ◽  
Vol 30 (10) ◽  
pp. 775-780 ◽  
Author(s):  
Charles T. Klodell ◽  
H. Todd Massey ◽  
Robert M. Adamson ◽  
David A. Dean ◽  
Douglas A. Horstmanshof ◽  
...  

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