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Serial Evaluation of Von Willebrand Factor Performance with a Fully Magnetically Levitated Centrifugal Continuous Flow Left Ventricular Assist Device
Abstracts S83 0.8±1.10 events/patient-year over a total 62.4 patient-years. 12/24 (50%) of the patients had more than 3 bleeding episodes prior to receiving octreotide while only 3/24 (12%) experienced more than 3 bleeds after octreotide initiation. No bleeds occurred after the first 2 months of octreotide initiation. 14/24 (58%) patients did not experience any GI bleeding events after the octreotide initiation over 0.99 patient years. Conclusion: The use of long-acting octreotide is safe in CF-LVAD outpatients and reduces the frequency of GI bleeding in patients with recurrent events. Larger prospective studies concerning secondary and primary prevention of GI bleeding using octreotide are warranted.
2( 04) Danazol for the Treatment of Gastrointestinal Bleeding in Left Ventricular Assist Device (LVAD) Patients: A Multicenter Experience S. Schettle ,1 B. Al Bawardy,2 S. Sherazi,3 C. Cheyne,3 S. Kushwaha,4 E. Rajan,2 N. Pereira.4 1Cardiovascular Surgery, Mayo Clinic Rochester, Rochester, MN; 2Gastroenterology, Mayo Clinic Rochester, Rochester, MN; 3Cardiovascular Surgery, University of Rochester Medical Center, Rochester, NY; 4Cardiology, Mayo Clinic Rochester, Rochester, MN.
2( 03) Serial Evaluation of Von Willebrand Factor Performance with a Fully Magnetically Levitated Centrifugal Continuous Flow Left Ventricular Assist Device I. Netuka ,1 J. Kvasnička,2 T. Kvasnička,2 I. Hrachovinová,3 P. Ivák,1 J. Bílková,2 I. Malíková,2 M. Jančová,4 F. Mareček,3 J. Malý,1 J.M. Connors,5 M.R. Mehra.6 1Cardiac Surgery, Institute for Clinical & Experimental Medicine, Prague, Czech Republic; 2Thrombotic Centre and Central Hematology Laboratory, Institute of Medical Biochemistry and Laboratory Diagnostics of The General University Hospital and of The First Faculty of Medicine of Charles University in Prague, Prague, Czech Republic; 3NRL for Hemostasis, Institute of Hematology and Blood Transfusion, Prague, Czech Republic; 4Laboratory Methods, Institute for Clinical & Experimental Medicine, Prague, Czech Republic; 5Hematology, Brigham Women’s Hospital, Boston, MA; 6Heart and Vascular Center, Brigham and Women’s Hospital, Boston, MA. Purpose: Incidence of non-surgical bleeding in continuous-flow left ventricular assist device (CF-LVAD) patients is in part attributed to acquired von Willebrand’s syndrome. Contemporary CF-LVADs have demonstrated significantly reduced or absent high molecular weight vWF multimers (HMWM) and functional defects in decreased ristocetin cofactor activity (RCo) to antigen (vWFAg) ratio. We hypothesized that the HeartMate 3 fully magentically levitated (FML) LVAD with wider consistent flowpath and designed intrinsic pulsatility to reduce blood shear stress may cause less damage to vWF multimers, a critical component in platelet adhesion and aggregation. Methods: Thirteen consecutive patients underwent implantation of the HeartMate 3 FML LVAD and were maintained on warfarin (INR 2.0-3.0) with antiplatelet therapy. Serial hematological indices and blood serum sample collection were obtained pre-implant and POD 2, 7, 30 and 45. vWF multimers were separated on SDS-1.6% agarose gel and detected by chemiluminiscence; HMWM expressed as relative to normal values (%). RCo (BCS XP, Siemens) and vWF:Ag ELISA (MRX, Dynatech) were measured according to standard protocols. Results: The mean age was 69±3 years (11 males, 12 DT). RCo at predefined timepoints were 241±77, 224±82, 373±164 (p< 0.05), 204±137, 260±200. RCo/vWFAg ratio was significantly decreased from baseline only at POD 30 (p= 0.05) but remained within normal functional range above 0.65. All patients exhibited an initial loss of HMWM post implant which further remained stable at 59% of normal values (Fig 1). Conclusion: This is the first reported analysis of serial vWF activity with this novel CF-LVAD. These findings suggest improved preservation of vWF activity and HMWM compared with prior reports of contemporary CF-LVADs. Further analysis of HeartMate 3 patients through POD 180, and comparison with a contemporary axial flow device patients, is underway to understand clinical implications.
Purpose: Recurrent gastrointestinal bleeding (GIB) occurs with continuous flow LVADs despite repeat endoscopic therapy. Danazol is used to treat recurrent GIB due to intestinal angiodysplasia in von Willebrand disease. We evaluated safety and effectiveness of danazol in reducing morbidity due to recurrent GIB in LVAD patients. Methods: A prospectively maintained database of LVAD patients from 2 centers in the US was reviewed. LVAD patients who received danazol for GIB secondary to intestinal angiodysplasia were included. Patients were defined as responders if hospitalizations and packed red blood cell (pRBC) transfusions were reduced by 50% post-danazol. Results: There were 19 LVAD patients (mean age 61.9 ±9.7 years, 84% male). Prior to danazol, patients underwent endoscopic evaluation and therapy (Table 1). The mean follow up time post-danazol was 12.5 ± 10.5 months. Antithrombotic use is summarized in Table 2. The average number of GIB hospitalizations pre and post danazol was 3.3 and 1.2 respectively with a reduction in hospitalizations per month by a median of 0.12 (0.08-0.25) (p< 0.0001) after danazol was initiated. Mean pRBC transfusions pre and post danazol therapy were 8.1 and 2.8 respectively with transfusion requirements per month decreasing by a median of 0.38 (0.100.75) (p= 0.0002) with danazol therapy. A total of 11 patients (69%) were responders to danazol. Unadjusted analysis showed that age, gender, history of GIB prior to LVAD, LVAD as destination therapy (DT) did not predict response to danazol. In 5 patients danazol was discontinued for underlying renal failure, failure to see benefit, or resolution of GIB. Conclusion: This proof of concept observational study suggests that danazol is effective in reducing pRBC transfusions and hospitalizations in LVAD patients with recurrent GIB due to intestinal angiodysplasia and lays the foundation for a clinical trial to test its efficacy.
2( 04) Danazol for the Treatment of Gastrointestinal Bleeding in Left Ventricular Assist Device (LVAD) Patients: A Multicenter Experience S. Schettle ,1 B. Al Bawardy,2 S. Sherazi,3 C. Cheyne,3 S. Kushwaha,4 E. Rajan,2 N. Pereira.4 1Cardiovascular Surgery, Mayo Clinic Rochester, Rochester, MN; 2Gastroenterology, Mayo Clinic Rochester, Rochester, MN; 3Cardiovascular Surgery, University of Rochester Medical Center, Rochester, NY; 4Cardiology, Mayo Clinic Rochester, Rochester, MN.
2( 03) Serial Evaluation of Von Willebrand Factor Performance with a Fully Magnetically Levitated Centrifugal Continuous Flow Left Ventricular Assist Device I. Netuka ,1 J. Kvasnička,2 T. Kvasnička,2 I. Hrachovinová,3 P. Ivák,1 J. Bílková,2 I. Malíková,2 M. Jančová,4 F. Mareček,3 J. Malý,1 J.M. Connors,5 M.R. Mehra.6 1Cardiac Surgery, Institute for Clinical & Experimental Medicine, Prague, Czech Republic; 2Thrombotic Centre and Central Hematology Laboratory, Institute of Medical Biochemistry and Laboratory Diagnostics of The General University Hospital and of The First Faculty of Medicine of Charles University in Prague, Prague, Czech Republic; 3NRL for Hemostasis, Institute of Hematology and Blood Transfusion, Prague, Czech Republic; 4Laboratory Methods, Institute for Clinical & Experimental Medicine, Prague, Czech Republic; 5Hematology, Brigham Women’s Hospital, Boston, MA; 6Heart and Vascular Center, Brigham and Women’s Hospital, Boston, MA. Purpose: Incidence of non-surgical bleeding in continuous-flow left ventricular assist device (CF-LVAD) patients is in part attributed to acquired von Willebrand’s syndrome. Contemporary CF-LVADs have demonstrated significantly reduced or absent high molecular weight vWF multimers (HMWM) and functional defects in decreased ristocetin cofactor activity (RCo) to antigen (vWFAg) ratio. We hypothesized that the HeartMate 3 fully magentically levitated (FML) LVAD with wider consistent flowpath and designed intrinsic pulsatility to reduce blood shear stress may cause less damage to vWF multimers, a critical component in platelet adhesion and aggregation. Methods: Thirteen consecutive patients underwent implantation of the HeartMate 3 FML LVAD and were maintained on warfarin (INR 2.0-3.0) with antiplatelet therapy. Serial hematological indices and blood serum sample collection were obtained pre-implant and POD 2, 7, 30 and 45. vWF multimers were separated on SDS-1.6% agarose gel and detected by chemiluminiscence; HMWM expressed as relative to normal values (%). RCo (BCS XP, Siemens) and vWF:Ag ELISA (MRX, Dynatech) were measured according to standard protocols. Results: The mean age was 69±3 years (11 males, 12 DT). RCo at predefined timepoints were 241±77, 224±82, 373±164 (p< 0.05), 204±137, 260±200. RCo/vWFAg ratio was significantly decreased from baseline only at POD 30 (p= 0.05) but remained within normal functional range above 0.65. All patients exhibited an initial loss of HMWM post implant which further remained stable at 59% of normal values (Fig 1). Conclusion: This is the first reported analysis of serial vWF activity with this novel CF-LVAD. These findings suggest improved preservation of vWF activity and HMWM compared with prior reports of contemporary CF-LVADs. Further analysis of HeartMate 3 patients through POD 180, and comparison with a contemporary axial flow device patients, is underway to understand clinical implications.
Purpose: Recurrent gastrointestinal bleeding (GIB) occurs with continuous flow LVADs despite repeat endoscopic therapy. Danazol is used to treat recurrent GIB due to intestinal angiodysplasia in von Willebrand disease. We evaluated safety and effectiveness of danazol in reducing morbidity due to recurrent GIB in LVAD patients. Methods: A prospectively maintained database of LVAD patients from 2 centers in the US was reviewed. LVAD patients who received danazol for GIB secondary to intestinal angiodysplasia were included. Patients were defined as responders if hospitalizations and packed red blood cell (pRBC) transfusions were reduced by 50% post-danazol. Results: There were 19 LVAD patients (mean age 61.9 ±9.7 years, 84% male). Prior to danazol, patients underwent endoscopic evaluation and therapy (Table 1). The mean follow up time post-danazol was 12.5 ± 10.5 months. Antithrombotic use is summarized in Table 2. The average number of GIB hospitalizations pre and post danazol was 3.3 and 1.2 respectively with a reduction in hospitalizations per month by a median of 0.12 (0.08-0.25) (p< 0.0001) after danazol was initiated. Mean pRBC transfusions pre and post danazol therapy were 8.1 and 2.8 respectively with transfusion requirements per month decreasing by a median of 0.38 (0.100.75) (p= 0.0002) with danazol therapy. A total of 11 patients (69%) were responders to danazol. Unadjusted analysis showed that age, gender, history of GIB prior to LVAD, LVAD as destination therapy (DT) did not predict response to danazol. In 5 patients danazol was discontinued for underlying renal failure, failure to see benefit, or resolution of GIB. Conclusion: This proof of concept observational study suggests that danazol is effective in reducing pRBC transfusions and hospitalizations in LVAD patients with recurrent GIB due to intestinal angiodysplasia and lays the foundation for a clinical trial to test its efficacy.