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Octreotide Reduces the Reoccurrence of Ventricular Assist Device Related Gastrointestinal Bleeding
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The Journal of Heart and Lung Transplantation, Vol 36, No 4S, April 2017
hemoglobin, and platelet count. When validated with 5-fold cross validation, the Bayesian model (Figure 1) had 88% accuracy and ROC AUC of 70%. The most predictive features were: age group, device strategy, previous cardiac operations, hemoglobin, device type, and BUN. It was noted that pre-implant INR was not found to be predictive. Conclusion: This study suggests that a Bayesian-based risk model derived from pre-implant variables could help the clinician determine the risk of recurrent GI bleeding following VAD implantation, and hence could help guide post-implant anticoagulation. Ongoing analysis is evaluating risk stratification using post-implant data, combined with prior history of bleeding, etiologic indicators as well as the effect of medical interventions upon recurrence.
3( 09) Octreotide Reduces the Reoccurrence of Ventricular Assist Device Related Gastrointestinal Bleeding K.B. Shah ,1 G. Sampath,1 S. Emani,2 M.K. Kanwar,3 N. Uriel,4 P.C. Colombo,5 P.A. Uber,1 M.L. Sears,1 J. Chuang,6 D.J. Farrar,6 G.B. Smallfield.1 1Virginia Commonwealth Univ, Richmond, VA; 2Ohio State University, Columbus, OH; 3Allegheny General Hospital, Pittsburgh, PA; 4University of Chicago, Chicago, IL; 5Columbia University, New York, NY; 6St. Jude Medical, St. Paul, MN.
3( 08) Comparison of Gastrointentional Bleeding Rates Between Axial Flow (HeartMate II) and Centrifugal (HeartWare) Flow Pumps at a Single Institution M. Kawabori , C. Kurihara, T. Sugiura, L. Cunningham, A.B. Civitello, W.E. Cohn, O.H. Frazier, J.A. Morgan. Texas Heart Institute, Baylor College of Medicine, Houston, TX. Purpose: Continuous flow left ventricular assist devices (CF-LVADs) have improved outcomes of end stage heart failure patients support. However, significant rates of gastrointestinal bleeding (GIB) have been observed during CF-LVAD support. The aim of this study was to assess the incidence of GIB during support of two different CF-LVADs, HeartMate II (ThoratecCorp, Pleasanton, CA) and HeartWare (HeartWare InternationalInc, Framingham, MA) devices. Methods: From November 2003 through March 2016, 526 patients with chronic heart failure underwent implantation of a CF-LVAD in our single center (HeartMate II (HM-II); 403, HeartWare(HW); 123). Records were reviewed to determine the prevalence of post-implant GIB. Patients were considered to have GIB if having 1 or more of the following symptoms; guaiac-positive stool; hematemesis; melena; active bleeding at the time of endoscopy or colonoscopy; and blood within the stomach at endoscopy or colonoscopy. The location of the GIB was identified as upper GI or/and lower GI tract according to esophagogastroduodenoscopy, colonoscopy, and small-bowel enteroscopy. Results: GIB was occurred in 140 patients with 216 events; 119 upper GI (77 HM-II, 42 HW) and 99 lower GI (71 HM-II, 28 HW). Median time LVAD support before GIB was 144 days (6-2217) in HM-II, 196 days (1-2589) in HW. Event number was 148 in HM II and 70 HW (0.199 events per patient year (EPPY) in HM-II and 0.327 EPPY in HW). 119 events of upper GIB from 26 gastric AVMs, 23 gastric ulcers, and 15 duodenal ulcers. 99 events of lower GIB from 25 jejunal AVMs, 24 colon diverticulosis, and 8 rectal ulcers. HW had higher an incidence of total GIB (p< 0.001), upper GIB (p< 0.001), and lower GIB (p< 0.001) compared to HM-II (Table 1). Overall survival in patients with or without GIB was not significantly different (Figure 1, p = 0.60). Conclusion: Although there was a significant difference in GIB rates between HM II and HW, GIB did not impact overall survival of CF-LVAD patients.
Purpose: Gastrointestinal bleeding (GIB) is a frequent complication after implantation of a left ventricular assist device (LVAD). In patients without an LVAD, octreotide is used to treat GIB as well as bleeding prophylaxis for vascular ectasias. We evaluated the efficacy of outpatient administration of octreotide to prevent reoccurrence of an LVAD related GIB. Methods: We studied 51 HeartMate II (HMII) patients from 5 centers who were discharged from the hospital with subcutaneous or depot (LAR) injectable octreotide to treat patients with at least one acute GIB event from 2009 to 2015 (51% had 1 event and 49% had > 1 event prior to treatment). This treatment group was compared to a historical control group of 240 patients from the HMII Clinical Trials who experienced a GIB from 2005 to 2011. Differences in freedom from re-bleeding between the treatment and historical control groups were analyzed with the log-rank test. The reference time in the treatment group was the GIB event first treated with octreotide, and it was the first GIB event for patients in the historical control. Results: Patients received octreotide (38% LAR depot, 62% daily subcutaneous) for median [IQR] of 34 [3-196] days after hospital discharge. When compared to patients in the HMII clinical trial, patients treated with octreotide were of similar age (median[IQR]: 65 [60-71] vs. 66 [58-72] yrs, p= 0.7), gender (69% vs 71% male, p= 0.7) and etiology of heart failure (65% vs 60% ischemic, p= 0.6). But more had previous GIB events before the reference event (49% vs 0%, p< 0.001) and they were on device support for longer duration of time at the time of treatment (197 [66-761] vs. 91 [29-344] days, p= 0.004). Freedom from re-bleeding at six months in the octreotide group was 73±6% compared to the historical control group of 57±6% (p= 0.02 log rank). Conclusion: Data compared to historical controls are encouraging and suggest that LVAD patients treated with octreotide for GI bleeding may be less likely to re-bleed within 6 months. A randomized trial should be conducted to directly determine the effectiveness of octreotide on GIB in LVAD patients in a controlled study. 3( 10) Pre-Implant Moderate-Severe Fibrosis on Liver Biopsy Predicts Adverse Outcomes After Mechanical Circulatory Support R. Mohan , J. Neyer, J. Patel, M. Kittleson, T. Aintablian, R. Levine, D. Chang, L. Czer, J. Moriguchi, J.A. Kobashigawa, F. Arabia. Cedars-Sinai Heart Institute, Los Angeles, CA. Purpose: Patients (pts) awaiting mechanical circulatory support (MCS) implantation who have known liver disease from congestive hepatopathy
The Journal of Heart and Lung Transplantation, Vol 36, No 4S, April 2017
hemoglobin, and platelet count. When validated with 5-fold cross validation, the Bayesian model (Figure 1) had 88% accuracy and ROC AUC of 70%. The most predictive features were: age group, device strategy, previous cardiac operations, hemoglobin, device type, and BUN. It was noted that pre-implant INR was not found to be predictive. Conclusion: This study suggests that a Bayesian-based risk model derived from pre-implant variables could help the clinician determine the risk of recurrent GI bleeding following VAD implantation, and hence could help guide post-implant anticoagulation. Ongoing analysis is evaluating risk stratification using post-implant data, combined with prior history of bleeding, etiologic indicators as well as the effect of medical interventions upon recurrence.
3( 09) Octreotide Reduces the Reoccurrence of Ventricular Assist Device Related Gastrointestinal Bleeding K.B. Shah ,1 G. Sampath,1 S. Emani,2 M.K. Kanwar,3 N. Uriel,4 P.C. Colombo,5 P.A. Uber,1 M.L. Sears,1 J. Chuang,6 D.J. Farrar,6 G.B. Smallfield.1 1Virginia Commonwealth Univ, Richmond, VA; 2Ohio State University, Columbus, OH; 3Allegheny General Hospital, Pittsburgh, PA; 4University of Chicago, Chicago, IL; 5Columbia University, New York, NY; 6St. Jude Medical, St. Paul, MN.
3( 08) Comparison of Gastrointentional Bleeding Rates Between Axial Flow (HeartMate II) and Centrifugal (HeartWare) Flow Pumps at a Single Institution M. Kawabori , C. Kurihara, T. Sugiura, L. Cunningham, A.B. Civitello, W.E. Cohn, O.H. Frazier, J.A. Morgan. Texas Heart Institute, Baylor College of Medicine, Houston, TX. Purpose: Continuous flow left ventricular assist devices (CF-LVADs) have improved outcomes of end stage heart failure patients support. However, significant rates of gastrointestinal bleeding (GIB) have been observed during CF-LVAD support. The aim of this study was to assess the incidence of GIB during support of two different CF-LVADs, HeartMate II (ThoratecCorp, Pleasanton, CA) and HeartWare (HeartWare InternationalInc, Framingham, MA) devices. Methods: From November 2003 through March 2016, 526 patients with chronic heart failure underwent implantation of a CF-LVAD in our single center (HeartMate II (HM-II); 403, HeartWare(HW); 123). Records were reviewed to determine the prevalence of post-implant GIB. Patients were considered to have GIB if having 1 or more of the following symptoms; guaiac-positive stool; hematemesis; melena; active bleeding at the time of endoscopy or colonoscopy; and blood within the stomach at endoscopy or colonoscopy. The location of the GIB was identified as upper GI or/and lower GI tract according to esophagogastroduodenoscopy, colonoscopy, and small-bowel enteroscopy. Results: GIB was occurred in 140 patients with 216 events; 119 upper GI (77 HM-II, 42 HW) and 99 lower GI (71 HM-II, 28 HW). Median time LVAD support before GIB was 144 days (6-2217) in HM-II, 196 days (1-2589) in HW. Event number was 148 in HM II and 70 HW (0.199 events per patient year (EPPY) in HM-II and 0.327 EPPY in HW). 119 events of upper GIB from 26 gastric AVMs, 23 gastric ulcers, and 15 duodenal ulcers. 99 events of lower GIB from 25 jejunal AVMs, 24 colon diverticulosis, and 8 rectal ulcers. HW had higher an incidence of total GIB (p< 0.001), upper GIB (p< 0.001), and lower GIB (p< 0.001) compared to HM-II (Table 1). Overall survival in patients with or without GIB was not significantly different (Figure 1, p = 0.60). Conclusion: Although there was a significant difference in GIB rates between HM II and HW, GIB did not impact overall survival of CF-LVAD patients.
Purpose: Gastrointestinal bleeding (GIB) is a frequent complication after implantation of a left ventricular assist device (LVAD). In patients without an LVAD, octreotide is used to treat GIB as well as bleeding prophylaxis for vascular ectasias. We evaluated the efficacy of outpatient administration of octreotide to prevent reoccurrence of an LVAD related GIB. Methods: We studied 51 HeartMate II (HMII) patients from 5 centers who were discharged from the hospital with subcutaneous or depot (LAR) injectable octreotide to treat patients with at least one acute GIB event from 2009 to 2015 (51% had 1 event and 49% had > 1 event prior to treatment). This treatment group was compared to a historical control group of 240 patients from the HMII Clinical Trials who experienced a GIB from 2005 to 2011. Differences in freedom from re-bleeding between the treatment and historical control groups were analyzed with the log-rank test. The reference time in the treatment group was the GIB event first treated with octreotide, and it was the first GIB event for patients in the historical control. Results: Patients received octreotide (38% LAR depot, 62% daily subcutaneous) for median [IQR] of 34 [3-196] days after hospital discharge. When compared to patients in the HMII clinical trial, patients treated with octreotide were of similar age (median[IQR]: 65 [60-71] vs. 66 [58-72] yrs, p= 0.7), gender (69% vs 71% male, p= 0.7) and etiology of heart failure (65% vs 60% ischemic, p= 0.6). But more had previous GIB events before the reference event (49% vs 0%, p< 0.001) and they were on device support for longer duration of time at the time of treatment (197 [66-761] vs. 91 [29-344] days, p= 0.004). Freedom from re-bleeding at six months in the octreotide group was 73±6% compared to the historical control group of 57±6% (p= 0.02 log rank). Conclusion: Data compared to historical controls are encouraging and suggest that LVAD patients treated with octreotide for GI bleeding may be less likely to re-bleed within 6 months. A randomized trial should be conducted to directly determine the effectiveness of octreotide on GIB in LVAD patients in a controlled study. 3( 10) Pre-Implant Moderate-Severe Fibrosis on Liver Biopsy Predicts Adverse Outcomes After Mechanical Circulatory Support R. Mohan , J. Neyer, J. Patel, M. Kittleson, T. Aintablian, R. Levine, D. Chang, L. Czer, J. Moriguchi, J.A. Kobashigawa, F. Arabia. Cedars-Sinai Heart Institute, Los Angeles, CA. Purpose: Patients (pts) awaiting mechanical circulatory support (MCS) implantation who have known liver disease from congestive hepatopathy