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74 Gastrointestinal Bleeding Is Not Associated with Pump Speed and Aortic Valve Opening in Patients Supported with the HeartMate II LVAD
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The Journal of Heart and Lung Transplantation, Vol 31, No 4S, April 2012
AC to treat GI bleeding influences subsequent risk of TE events during LVAD support is not known. Methods and Materials: Between July 2003 and September 2011, 389 pt (308 male) underwent continuous flow LVAD implant at University of Michigan Hospital and Mayo Clinic. Median age was 60 years (range, 18-79). Outcomes were analyzed for the association of GI bleeds and subsequent TE events defined as stroke, TIA, hemolysis, or pump thrombosis. Median survival was 10 months (max. 7.2 years, total 439 patient years). Overall survival and freedom from an event was performed using the Kaplan-Meier method. Association of GI bleed and subsequent TE events, and survival impact was analyzed as a time-dependent covariate. Results: One hundred ninety-nine GI bleeds occurred in 116/389 pt (30%) for an event rate of 0.45 GI bleeds/pt years of support. One hundred thirty-eight TE events occurred in 97/389 pt (25%) for an event rate of 0.31 TE events/pt years of support. Median time from LVAD implant to 1st GI bleed was 5 months (range, 1 to 116 months) and to 1st TE event was 6 months (range, 1 to 29 months). For patients who had TE event after GI bleed, median interval was 5 months (range, 0.5 to 25 months). TE events were 7.4 times more likely in pt who had a prior GI bleed [4.9-11.1] (p⬍0.001), however, neither the presence of GI bleeding [0.7-1.2], a TE event [0.8-2.0], nor the combination of GI bleed and TE event [.5-1.3] portended a lower overall survival (p⫽0.2, p⫽0.4, and p⫽0.4, respectively). Conclusions: Pt who had GI bleeding were at significantly higher risk for having a subsequent TE event. Although the exact association is unknown, it suggests that alteration in anticoagulation and antiplatelet management to treat GI bleeds may contribute to this risk. 74 Gastrointestinal Bleeding Is Not Associated with Pump Speed and Aortic Valve Opening in Patients Supported with the HeartMate II LVAD S.R. Patel,1 A. Rivera,1 J. Patel,1 O. Saeed,1 M. Camacho-Rivera,2 S. Maybaum,1 D. Goldstein.1 1Montefiore Medical Center, Bronx, NY; 2 Harvard School of Public Health, Boston, MA. Purpose: Decreased arterial pulsatility and lack of aortic valve (AV) opening have been implicated in the high rates of gastrointestinal bleeding (GIB) observed with continuous flow (CF) LVADs. As such, there is a belief that decreased LV unloading via lower LVAD speeds may increase arterial pulsatility, promote AV opening, and thus, decrease GIB. We reviewed our single center experience to explore the association between these parameters and GIB. Methods and Materials: The records of all HeartMate (HM) II implanted at our institution were reviewed. Baseline demographics, average HMII speed, AV opening, and Pulsatility Index (PI) - a measure of the native pulsatility seen by HMII were collected and analyzed through logistic regression for their ability to predict the likelihood of GIB. In the GIB group, HMII speed and PI were averaged up until the time of bleed and the most recent echo prior to bleed was reviewed for AV opening. Results: Between June 2006 and August 2011, 72 patients received a HMII. Nineteen (26%) patients experienced at least one GIB for an event rate of 0.52 per patient year of support. Median time to first GIB was 11.5d (IQ: 21-46). There were a total of 18 readmissions for GIB in this cohort. Of the variables analyzed, only age was a significant predictor of GIB while ischemic etiology of cardiomyopathy trended towards an association. Median time from echo to GIB was 7d (IQ: 0 ⫺27).
Conclusions: In our experience, GIB is not associated with HMII speed, AV opening or PI. This is an important consideration to define the optimal
speed of the HMII that balances the competing risks of GIB and aortic insufficiency versus thrombosis and recovery. These findings warrant further investigation. 75 von Willebrand Factor in Recipients of Different VAD Systems and Its Clinical Relevance N. Dranishnikov, A. Stepanenko, A. Frumkin, J. Vierecke, E.V. Potapov, T. Krabatsch, R. Hetzer. Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Berlin, Germany. Purpose: Von Willebrand factor (vWF) is one of the key factors in the coagulation system. We studied the impact of different types of continuous left ventricular assist devices (LVADs) on vWF and its clinical relevance during up to 12 months of support. Methods and Materials: Between January 2010 and July 2011 blood samples were prospectively collected from 80 LVAD recipients (HeartWare HVAD, n⫽60; HeartMate II, n⫽20). We analyzed levels of vWF antigen (vWF:Ag), collagen-binding capacity (vWF:CBC), and presence of HMW multimers before implantation, after 7 days and after 1, 3, 6, and 12 months of support. Platelet (PLT) function was estimated using the PFA-100 test. Bleeding complications were analyzed with regard to changes in vWF profile and PLT function. Results: There were no significant differences between groups in preoperative demographic parameters. There were also no significant differences (p⬎0.05) between groups in the parameters measured at any time of support, except in vWF:CBC/Ag ratio on the 7th postoperative day (POD). A significant increase of vWF:Ag (p⫽0.002) and a trend towards an increase of vWF:CBC (p⫽0.1) were observed in both groups on the 7th POD. vWF:Ag level and vWF:CBC decreased significantly starting from the 7th POD. vWF:CBC/Ag dropped in both groups during the first month, but recovered during the further follow-up. A loss of large multimers was already observed after 7 days of support. Impairment of vWF-dependent platelet function was observed in both groups on the 7th POD and seemed to advance during the further time of support. Bleeding complications in VAD recipients occurred mostly after 6 months of support and did not seem to correlate with the development of acquired vWF deficiency (AvWD) and impairment of platelet function. Conclusions: Implantation of LVADs leads to the development of AvWD. Both types of LVAD have similar impact on vWF profile. Bleeding complications that occurred in the studied cohort did not correlate with the development of AvWD and impairment of platelet function. 76 Thrombus Formation at the Pump Inflow Area in Heart Mate II Patients M.E.I. Schipper,1 A. Vink,1.H.F.J. Dullens,1 R.A. de Weger,1 N. de Jonge,2 J.R. Lahpor.3 1Department of Pathology, University Medical Centre, Utrecht, Netherlands; 2Department of Cardiology, University Medical Centre, Utrecht, Netherlands; 3Department of Cardio-Thoracic Surgery, University Medical Centre, Utrecht, Netherlands. Purpose: Initially aggressive anticoagulant therapy was recommended for continuous flow left ventricle assist devices (c-LVAD, Heart Mate II). However several reports have described the same low thrombo-embolic risks as for Heart Mate I pulsatile LVADS. The aim of the present study was to examine the prevalence of thrombosis in our c-LVAD patient cohort. Methods and Materials: Since 2006 81 c-LVADS were implanted as a bridge to transplantation (HTx) in 62 male and 19 female patients. Four male (33-64 years) and 2 female (44-57 years) c-LVAD patients developed clinical signs of pump failure, like haemolysis (4), ventricular tachycardia and ventricular fibrillation (3) and outflow failure (2). INR varied between 2-2,5 in 4 patients, in 2 patients INR was between 1,5-2. Both early (2-4 months after pump implantation) and late (29-41 months) complications were seen. Inspection of the different parts of the pump was possible after HTx (4) and at autopsy (2). Results: In this group of 81 c-LVAD patients, 6 developed clinical evidence of pump failure. Macroscopically and microscopically the same
The Journal of Heart and Lung Transplantation, Vol 31, No 4S, April 2012
AC to treat GI bleeding influences subsequent risk of TE events during LVAD support is not known. Methods and Materials: Between July 2003 and September 2011, 389 pt (308 male) underwent continuous flow LVAD implant at University of Michigan Hospital and Mayo Clinic. Median age was 60 years (range, 18-79). Outcomes were analyzed for the association of GI bleeds and subsequent TE events defined as stroke, TIA, hemolysis, or pump thrombosis. Median survival was 10 months (max. 7.2 years, total 439 patient years). Overall survival and freedom from an event was performed using the Kaplan-Meier method. Association of GI bleed and subsequent TE events, and survival impact was analyzed as a time-dependent covariate. Results: One hundred ninety-nine GI bleeds occurred in 116/389 pt (30%) for an event rate of 0.45 GI bleeds/pt years of support. One hundred thirty-eight TE events occurred in 97/389 pt (25%) for an event rate of 0.31 TE events/pt years of support. Median time from LVAD implant to 1st GI bleed was 5 months (range, 1 to 116 months) and to 1st TE event was 6 months (range, 1 to 29 months). For patients who had TE event after GI bleed, median interval was 5 months (range, 0.5 to 25 months). TE events were 7.4 times more likely in pt who had a prior GI bleed [4.9-11.1] (p⬍0.001), however, neither the presence of GI bleeding [0.7-1.2], a TE event [0.8-2.0], nor the combination of GI bleed and TE event [.5-1.3] portended a lower overall survival (p⫽0.2, p⫽0.4, and p⫽0.4, respectively). Conclusions: Pt who had GI bleeding were at significantly higher risk for having a subsequent TE event. Although the exact association is unknown, it suggests that alteration in anticoagulation and antiplatelet management to treat GI bleeds may contribute to this risk. 74 Gastrointestinal Bleeding Is Not Associated with Pump Speed and Aortic Valve Opening in Patients Supported with the HeartMate II LVAD S.R. Patel,1 A. Rivera,1 J. Patel,1 O. Saeed,1 M. Camacho-Rivera,2 S. Maybaum,1 D. Goldstein.1 1Montefiore Medical Center, Bronx, NY; 2 Harvard School of Public Health, Boston, MA. Purpose: Decreased arterial pulsatility and lack of aortic valve (AV) opening have been implicated in the high rates of gastrointestinal bleeding (GIB) observed with continuous flow (CF) LVADs. As such, there is a belief that decreased LV unloading via lower LVAD speeds may increase arterial pulsatility, promote AV opening, and thus, decrease GIB. We reviewed our single center experience to explore the association between these parameters and GIB. Methods and Materials: The records of all HeartMate (HM) II implanted at our institution were reviewed. Baseline demographics, average HMII speed, AV opening, and Pulsatility Index (PI) - a measure of the native pulsatility seen by HMII were collected and analyzed through logistic regression for their ability to predict the likelihood of GIB. In the GIB group, HMII speed and PI were averaged up until the time of bleed and the most recent echo prior to bleed was reviewed for AV opening. Results: Between June 2006 and August 2011, 72 patients received a HMII. Nineteen (26%) patients experienced at least one GIB for an event rate of 0.52 per patient year of support. Median time to first GIB was 11.5d (IQ: 21-46). There were a total of 18 readmissions for GIB in this cohort. Of the variables analyzed, only age was a significant predictor of GIB while ischemic etiology of cardiomyopathy trended towards an association. Median time from echo to GIB was 7d (IQ: 0 ⫺27).
Conclusions: In our experience, GIB is not associated with HMII speed, AV opening or PI. This is an important consideration to define the optimal
speed of the HMII that balances the competing risks of GIB and aortic insufficiency versus thrombosis and recovery. These findings warrant further investigation. 75 von Willebrand Factor in Recipients of Different VAD Systems and Its Clinical Relevance N. Dranishnikov, A. Stepanenko, A. Frumkin, J. Vierecke, E.V. Potapov, T. Krabatsch, R. Hetzer. Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Berlin, Germany. Purpose: Von Willebrand factor (vWF) is one of the key factors in the coagulation system. We studied the impact of different types of continuous left ventricular assist devices (LVADs) on vWF and its clinical relevance during up to 12 months of support. Methods and Materials: Between January 2010 and July 2011 blood samples were prospectively collected from 80 LVAD recipients (HeartWare HVAD, n⫽60; HeartMate II, n⫽20). We analyzed levels of vWF antigen (vWF:Ag), collagen-binding capacity (vWF:CBC), and presence of HMW multimers before implantation, after 7 days and after 1, 3, 6, and 12 months of support. Platelet (PLT) function was estimated using the PFA-100 test. Bleeding complications were analyzed with regard to changes in vWF profile and PLT function. Results: There were no significant differences between groups in preoperative demographic parameters. There were also no significant differences (p⬎0.05) between groups in the parameters measured at any time of support, except in vWF:CBC/Ag ratio on the 7th postoperative day (POD). A significant increase of vWF:Ag (p⫽0.002) and a trend towards an increase of vWF:CBC (p⫽0.1) were observed in both groups on the 7th POD. vWF:Ag level and vWF:CBC decreased significantly starting from the 7th POD. vWF:CBC/Ag dropped in both groups during the first month, but recovered during the further follow-up. A loss of large multimers was already observed after 7 days of support. Impairment of vWF-dependent platelet function was observed in both groups on the 7th POD and seemed to advance during the further time of support. Bleeding complications in VAD recipients occurred mostly after 6 months of support and did not seem to correlate with the development of acquired vWF deficiency (AvWD) and impairment of platelet function. Conclusions: Implantation of LVADs leads to the development of AvWD. Both types of LVAD have similar impact on vWF profile. Bleeding complications that occurred in the studied cohort did not correlate with the development of AvWD and impairment of platelet function. 76 Thrombus Formation at the Pump Inflow Area in Heart Mate II Patients M.E.I. Schipper,1 A. Vink,1.H.F.J. Dullens,1 R.A. de Weger,1 N. de Jonge,2 J.R. Lahpor.3 1Department of Pathology, University Medical Centre, Utrecht, Netherlands; 2Department of Cardiology, University Medical Centre, Utrecht, Netherlands; 3Department of Cardio-Thoracic Surgery, University Medical Centre, Utrecht, Netherlands. Purpose: Initially aggressive anticoagulant therapy was recommended for continuous flow left ventricle assist devices (c-LVAD, Heart Mate II). However several reports have described the same low thrombo-embolic risks as for Heart Mate I pulsatile LVADS. The aim of the present study was to examine the prevalence of thrombosis in our c-LVAD patient cohort. Methods and Materials: Since 2006 81 c-LVADS were implanted as a bridge to transplantation (HTx) in 62 male and 19 female patients. Four male (33-64 years) and 2 female (44-57 years) c-LVAD patients developed clinical signs of pump failure, like haemolysis (4), ventricular tachycardia and ventricular fibrillation (3) and outflow failure (2). INR varied between 2-2,5 in 4 patients, in 2 patients INR was between 1,5-2. Both early (2-4 months after pump implantation) and late (29-41 months) complications were seen. Inspection of the different parts of the pump was possible after HTx (4) and at autopsy (2). Results: In this group of 81 c-LVAD patients, 6 developed clinical evidence of pump failure. Macroscopically and microscopically the same