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Markers of Lower Pump Flow Are Risk Factors for Pump Thrombosis with the Heartmate II Left Ventricular Assist Device
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The Journal of Heart and Lung Transplantation, Vol 32, No 4S, April 2014
Conclusion: We sought to evaluate drug tolerability and establish feasibility of monthly injections for this population. Additionally, we collected blood to examine the biological effects of octreotide on bleeding via platelet, fibrinogen, vWF level and activity, and VEGF levels at baseline, on-treatment, and after drug washout. 6( 53) Early Identification of Impending LVAD Thrombosis Utilizing an UltraHigh Predictive Serum Marker in Lactate Dehydrogenase C.M. Zalewski , J.E. Cohen, C.E. Hill, S.L. Walsh, J.P. Donnelly, M.L. O’Hara, E.C. VanderMeer, J.L. Howard, E. Laverty-Wilson, P. Atluri, Y.J. Woo. Cardiac Surgery, Hospital of the University of Pennsylvania, Philadelphia, PA. Purpose: A critical adverse event in LVAD implantation is pump thrombosis. Late identification of thrombosis based on parameters such as heart failure, LVAD power elevation, and plasma free hemoglobin is associated with high morbidity and mortality. To address this, a marker for early diagnosis is critical. Therefore, the goal of this study is to develop a predictive tool for early recognition of impending thrombosis to enhance medical and surgical intervention and improve patient outcomes. Methods: We retrospectively analyzed all continuous flow LVADs, placed between 2011- 2013 at a single center (n= 88). We focused analysis on lactate dehydrogenase (LDH) levels at several post-operative time intervals including one week, one month and peak value in relation to pump power. Changes in LDH are reported as ratios between time points. 12 patients underwent pump exchange with confirmation of LVAD thrombosis. The 76 patients without LVAD thrombosis functioned as a control. Results: Preoperative characteristics between the non-thrombotic and thrombotic groups included sex (15.5% female vs. 16.7% female), age (58.7 ± 1.6 yr vs. 55.5 ± 3.9 yr), diabetes (49.3% vs. 33.0%), and chronic kidney disease (29.6% vs. 25.0%), which were not significantly different. Analysis of patients’ ratio of post-op 1 month LDH : post-op 1 week LDH revealed a significant increase in the thrombotic group (Figure). Additionally, ratios of peak LDH level : post-op 1 week LDH and post-op 1 month were significantly increased in the thrombotic group compared to non-thrombotic (Figure). There was no difference in LVAD power ratio of post-op 1 month : post-op 1 week between the non-thrombotic and thrombotic groups (0.99 ± 0.01 vs. 0.98 ± 0.02, p > 0.5). Conclusion: Serial monitoring of LDH is an effective early predictor of LVAD thrombosis and is superior to tracking increases in pump power. The identification of this marker yields great implications with regard to employing early intervention for impending LVAD thrombosis.
6( 54) Markers of Lower Pump Flow Are Risk Factors for Pump Thrombosis with the Heartmate II Left Ventricular Assist Device A. Raina , R. Agarwal, C. Morgan, M. Kanwar, G. Sokos, E. Donalson, A. Hopwood, R.J. Moraca, S.H. Bailey, S. Murali, R.L. Benza. Cardiovascular Institute, Allegheny General Hospital, Pittsburgh, PA. Purpose: Left ventricular assist device (LVAD) thrombosis is a potentially life threatening event. Risk factors for the development of LVAD thrombosis, other than sub-therapeutic anticoagulant or antiplatelet therapy, remain poorly defined.
Methods: We retrospectively reviewed our LVAD database for Heartmate II (HM II) implants from 2008-2013 to identify cases of confirmed pump thrombosis (PT). PT cases were matched in a 3:1 fashion to an age and gender matched control cohort of contemporaneous HM II implants without PT. Demographic, clinical and echocardiographic variables in the PT group were compared to the control group. Results: Ten HM II LVAD PT patients were identified during the study period and compared to 29 control HM II patients without PT. PT patients were similar in age (54 vs. 57 yrs, p= 0.50) and gender (60% vs. 52% female, p= 0.72) to controls. There was no difference in major pre-implant laboratory variables in PT patients vs. controls including creatinine (1.12 vs. 1.29 mg/ dl, p= 0.32), bilirubin (1.0 vs. 0.81 mg/dl, p= 0.47), albumin (3.58 vs. 3.29 mg/dl, p= 0.18) and platelet count (221 vs. 182, p= 0.08). Preoperative LV size (LVEDD 67 vs. 67 mm, p= 0.88) and LVEF (14% vs. 15%, p= 0.51) were also similar in PT patients vs. controls. Mean pump speed was significantly lower in the PT vs. controls (8620 vs. 8897 rpm, p= 0.029). In addition, right ventricular (RV) function measured via fractional area change (RVFAC) was lower in PT patients (23% vs. 30%. P= 0.032) vs. controls, though TAPSE did not differ significantly (15mm vs. 17mm, p= 0.21). The product of pump speed and RVFAC was more strongly associated with PT than either measure alone (1976 vs. 2663, p= 0.014). Inflow cannula angle at implant (58o vs. 56o, p= 0.62) and pump pocket depth (108 vs. 115 mm, p= 0.52) were not associated with PT in this cohort. Cannula angle decreased 6.2o from baseline in PT patients at mean 137 days post implant but increased 1.9o in controls at mean 234 days post implant, p= 0.01. Bleeding requiring temporary cessation of anticoagulants or antiplatelet agents was more common in PT patients but this was not significant (50% vs. 41%, p= 0.72). Conclusion: Lower pump speed and RV dysfunction are risk factors for PT with the HM II LVAD. These variables may help to risk-stratify HM II LVAD patients for PT and allow for modification of anti-thrombotic therapy and augmented PT surveillance. 6( 55) Continuous Flow Left Ventricular Assist Device Thrombosis: Presentation, Management and Outcomes D. Zhao , K.B. Shah, L. Wolfe, G. Katlaps, D. Tang, V. Kasirajan, S. Harton, M. Quader. Cardio-Thoracic Surgery, Virginia Commonwealth University, Richmond, VA. Purpose: Pump thrombosis (PT) is a life threatening complication after continuous flow left ventricular assist device (CFLVAD) implantation. We sought to characterize patients who have suffered CFLVAD thrombosis. Methods: We analyzed the data on all CFLVADs (195 patients: HeartMate II: 183, HVAD:12) implanted at two institutions between 9/2008 to 10/2013. PT was a clinical diagnosis defined based on combination of patient symptoms, device alarms and signs of hemolysis. Results: Twenty-one (10.7%), patients suffered 24 PT events (Table). Time to first PT occurred at a median of 118 days (16, 555) from implantation. Mean age of patients was 58.6 +/- 5.4yrs, 86% were men. The majority of patients (79%) presented with heart failure, chest discomfort, or hematuria and 81% required inotropic support for low flow state. Device alarms were noted in 62% of patients, the majority of them were related to increased pump power. Established risk factors for PT such as sub-therapeutic anticoagulation, infection or recent gastrointestinal bleed were present in 54% of patients. LDH levels were elevated in all patients with a median of 1813 IU/L (368, 5006). Echocardiographic findings of PT were present in 58%. All patients received systemic anticoagulation with heparin or bivalrudin; in addition 29% received Eptifibatide, 65% oral anti-platelet agent, and 16% systemic thrombolytic therapy. Twelve device exchanges were required in 11 patients (52%), with one post-operative death (9%). Of the patients managed medically, two died during the hospitalization. One patient underwent device explant only and survived to hospital discharge. Conclusion: Clinically significant PT was a frequent occurrence at variable time interval after device implantation. Outcomes with intensified medical therapy were successful in selected patients, and pump exchange had low operative mortality. Majority of patients had identifiable risk factors for PT. Focused attention to these risk factors might prevent PT occurrence.
The Journal of Heart and Lung Transplantation, Vol 32, No 4S, April 2014
Conclusion: We sought to evaluate drug tolerability and establish feasibility of monthly injections for this population. Additionally, we collected blood to examine the biological effects of octreotide on bleeding via platelet, fibrinogen, vWF level and activity, and VEGF levels at baseline, on-treatment, and after drug washout. 6( 53) Early Identification of Impending LVAD Thrombosis Utilizing an UltraHigh Predictive Serum Marker in Lactate Dehydrogenase C.M. Zalewski , J.E. Cohen, C.E. Hill, S.L. Walsh, J.P. Donnelly, M.L. O’Hara, E.C. VanderMeer, J.L. Howard, E. Laverty-Wilson, P. Atluri, Y.J. Woo. Cardiac Surgery, Hospital of the University of Pennsylvania, Philadelphia, PA. Purpose: A critical adverse event in LVAD implantation is pump thrombosis. Late identification of thrombosis based on parameters such as heart failure, LVAD power elevation, and plasma free hemoglobin is associated with high morbidity and mortality. To address this, a marker for early diagnosis is critical. Therefore, the goal of this study is to develop a predictive tool for early recognition of impending thrombosis to enhance medical and surgical intervention and improve patient outcomes. Methods: We retrospectively analyzed all continuous flow LVADs, placed between 2011- 2013 at a single center (n= 88). We focused analysis on lactate dehydrogenase (LDH) levels at several post-operative time intervals including one week, one month and peak value in relation to pump power. Changes in LDH are reported as ratios between time points. 12 patients underwent pump exchange with confirmation of LVAD thrombosis. The 76 patients without LVAD thrombosis functioned as a control. Results: Preoperative characteristics between the non-thrombotic and thrombotic groups included sex (15.5% female vs. 16.7% female), age (58.7 ± 1.6 yr vs. 55.5 ± 3.9 yr), diabetes (49.3% vs. 33.0%), and chronic kidney disease (29.6% vs. 25.0%), which were not significantly different. Analysis of patients’ ratio of post-op 1 month LDH : post-op 1 week LDH revealed a significant increase in the thrombotic group (Figure). Additionally, ratios of peak LDH level : post-op 1 week LDH and post-op 1 month were significantly increased in the thrombotic group compared to non-thrombotic (Figure). There was no difference in LVAD power ratio of post-op 1 month : post-op 1 week between the non-thrombotic and thrombotic groups (0.99 ± 0.01 vs. 0.98 ± 0.02, p > 0.5). Conclusion: Serial monitoring of LDH is an effective early predictor of LVAD thrombosis and is superior to tracking increases in pump power. The identification of this marker yields great implications with regard to employing early intervention for impending LVAD thrombosis.
6( 54) Markers of Lower Pump Flow Are Risk Factors for Pump Thrombosis with the Heartmate II Left Ventricular Assist Device A. Raina , R. Agarwal, C. Morgan, M. Kanwar, G. Sokos, E. Donalson, A. Hopwood, R.J. Moraca, S.H. Bailey, S. Murali, R.L. Benza. Cardiovascular Institute, Allegheny General Hospital, Pittsburgh, PA. Purpose: Left ventricular assist device (LVAD) thrombosis is a potentially life threatening event. Risk factors for the development of LVAD thrombosis, other than sub-therapeutic anticoagulant or antiplatelet therapy, remain poorly defined.
Methods: We retrospectively reviewed our LVAD database for Heartmate II (HM II) implants from 2008-2013 to identify cases of confirmed pump thrombosis (PT). PT cases were matched in a 3:1 fashion to an age and gender matched control cohort of contemporaneous HM II implants without PT. Demographic, clinical and echocardiographic variables in the PT group were compared to the control group. Results: Ten HM II LVAD PT patients were identified during the study period and compared to 29 control HM II patients without PT. PT patients were similar in age (54 vs. 57 yrs, p= 0.50) and gender (60% vs. 52% female, p= 0.72) to controls. There was no difference in major pre-implant laboratory variables in PT patients vs. controls including creatinine (1.12 vs. 1.29 mg/ dl, p= 0.32), bilirubin (1.0 vs. 0.81 mg/dl, p= 0.47), albumin (3.58 vs. 3.29 mg/dl, p= 0.18) and platelet count (221 vs. 182, p= 0.08). Preoperative LV size (LVEDD 67 vs. 67 mm, p= 0.88) and LVEF (14% vs. 15%, p= 0.51) were also similar in PT patients vs. controls. Mean pump speed was significantly lower in the PT vs. controls (8620 vs. 8897 rpm, p= 0.029). In addition, right ventricular (RV) function measured via fractional area change (RVFAC) was lower in PT patients (23% vs. 30%. P= 0.032) vs. controls, though TAPSE did not differ significantly (15mm vs. 17mm, p= 0.21). The product of pump speed and RVFAC was more strongly associated with PT than either measure alone (1976 vs. 2663, p= 0.014). Inflow cannula angle at implant (58o vs. 56o, p= 0.62) and pump pocket depth (108 vs. 115 mm, p= 0.52) were not associated with PT in this cohort. Cannula angle decreased 6.2o from baseline in PT patients at mean 137 days post implant but increased 1.9o in controls at mean 234 days post implant, p= 0.01. Bleeding requiring temporary cessation of anticoagulants or antiplatelet agents was more common in PT patients but this was not significant (50% vs. 41%, p= 0.72). Conclusion: Lower pump speed and RV dysfunction are risk factors for PT with the HM II LVAD. These variables may help to risk-stratify HM II LVAD patients for PT and allow for modification of anti-thrombotic therapy and augmented PT surveillance. 6( 55) Continuous Flow Left Ventricular Assist Device Thrombosis: Presentation, Management and Outcomes D. Zhao , K.B. Shah, L. Wolfe, G. Katlaps, D. Tang, V. Kasirajan, S. Harton, M. Quader. Cardio-Thoracic Surgery, Virginia Commonwealth University, Richmond, VA. Purpose: Pump thrombosis (PT) is a life threatening complication after continuous flow left ventricular assist device (CFLVAD) implantation. We sought to characterize patients who have suffered CFLVAD thrombosis. Methods: We analyzed the data on all CFLVADs (195 patients: HeartMate II: 183, HVAD:12) implanted at two institutions between 9/2008 to 10/2013. PT was a clinical diagnosis defined based on combination of patient symptoms, device alarms and signs of hemolysis. Results: Twenty-one (10.7%), patients suffered 24 PT events (Table). Time to first PT occurred at a median of 118 days (16, 555) from implantation. Mean age of patients was 58.6 +/- 5.4yrs, 86% were men. The majority of patients (79%) presented with heart failure, chest discomfort, or hematuria and 81% required inotropic support for low flow state. Device alarms were noted in 62% of patients, the majority of them were related to increased pump power. Established risk factors for PT such as sub-therapeutic anticoagulation, infection or recent gastrointestinal bleed were present in 54% of patients. LDH levels were elevated in all patients with a median of 1813 IU/L (368, 5006). Echocardiographic findings of PT were present in 58%. All patients received systemic anticoagulation with heparin or bivalrudin; in addition 29% received Eptifibatide, 65% oral anti-platelet agent, and 16% systemic thrombolytic therapy. Twelve device exchanges were required in 11 patients (52%), with one post-operative death (9%). Of the patients managed medically, two died during the hospitalization. One patient underwent device explant only and survived to hospital discharge. Conclusion: Clinically significant PT was a frequent occurrence at variable time interval after device implantation. Outcomes with intensified medical therapy were successful in selected patients, and pump exchange had low operative mortality. Majority of patients had identifiable risk factors for PT. Focused attention to these risk factors might prevent PT occurrence.