116 Gastrointestinal Bleeding Risk in Patients with Ventricular Assist Devices

116 Gastrointestinal Bleeding Risk in Patients with Ventricular Assist Devices

Abstracts S47 non-responders (11% vs. 21%; p⫽0.001), although 95% of the DT cohort improved by at least 1 NYHA functional class to NYHA Class III. A...

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Abstracts

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non-responders (11% vs. 21%; p⫽0.001), although 95% of the DT cohort improved by at least 1 NYHA functional class to NYHA Class III. After multivariable adjustment, only history of diabetes and COPD were associated with non-response (p⫽0.042 and 0.005 respectively) (Table 1). Age, hemodynamic variables, and RV failure scores did not identify responders. Risk Factors for Depressed Functional Capacity Post-LVAD

Risk Factor COPD Diabetes Ischemic Heart Disease

Univariate Odds Ratio [5%-95%]

p-value

1.89 1.49 1.67

0.005 0.047 0.013

Multivariate Odds Ratio [5%-95%] 1.92 1.52

p-value 0.005 0.042 NS

Conclusions: Co-morbidities such as diabetes and COPD are associated with impaired functional capacity following LVAD implantation and should be considered as risk factors for depressed functional improvement during pt selection for LVAD therapy. 114 Pre-Implantation Echocardiographic Indices of Right Ventricular Adverse Remodeling Predict Death and Right Ventricular Failure in Patients with Continuous-Flow Left Ventricular Assist Devices R.P. Vivo, M. Aldeiri, U. Qamar, A.M. Cordero-Reyes, B. Elias, M. Loebe, B. Bruckner, G. Torre-Amione, A. Bhimaraj, J.D. Estep. The Methodist DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, TX. Purpose: Echocardiographic predictors of adverse outcomes in patients with left ventricular assist devices (LVAD) have not been fully elucidated. We aimed to evaluate pre-implant echo parameters associated with 30-day mortality and right ventricular failure (RVF). Methods and Materials: Transthoracic echocardiograms (TTE) before continuous-flow LVAD implantation were analyzed from 109 patients. Two-dimensional and Doppler echo parameters were assessed for their association with the primary composite outcome of 30-day death or RVF, defined as requirement of an RVAD or ⱖ14 consecutive days of inotropic support. Ventricular diameters were measured at end diastole from standard echo views. Univariate analysis using a logistic regression model was done to determine predictors of outcome. Receiver operating characteristic (ROC) curves identified thresholds for binary values. Kaplan-Meier survival analysis was performed. Results: Overall, 27 (24.8%) patients reached the primary composite outcome. Increased RV/LV diameter ratio (OR: 3.03, CI 1.19 to 7.72, P⫽0.020) and enlarged RV basal diameter (OR: 5.8, CI 1.28 to 26.3, P⫽0.023) were significant predictors for the endpoint of 30-day mortality or RVF (Figure 1).

No Doppler variables had significant correlation. Based on the ROC curve, the optimal threshold for the RV/LV diameter ratio and RV basal diameter to predict the composite outcome were 0.75 and 4.3 cm, respectively. Conclusions: An RV/LV diameter ratio ⱖ0.75 and RV basal diameter ⱖ4.3 cm, TTE indices reflective of pre-LVAD adverse RV remodeling, are associated with increased 30-day death or RVF.

115 Bivalirudin Is a Safe and Effective Anticoagulant for Post-Operative Bridging to Warfarin in LVAD Patients N. Moazami,1 L.B. Richardson,2 B. Sun,1 B. Cabuay,2 E. Shao,2 K.M. Hryniewicz,2 D. Feldman.2 1Cardiothoracic Surgery, Minneapolis Heart Institute, Minneapolis, MN; 2Cardiology, Minneapolis Heart Institute, Minneapolis, MN. Purpose: Repeat exposure to heparin in LVAD recipients is a risk factor for heparin induced thrombocytopenia (HIT). Bivalirudin is a direct thrombin inhibitor with pharmacologic properties that are superior to heparin. We used a bivalirudin infusion protocol in post-operative VAD Patients. Our objective is to assess the utilization, effectiveness, and safety of this therapy as an alternative to heparin. Methods and Materials: 43 patients were implanted with continuous flow LVAD at our institution over an 18 month period [35 (81%) HM2, 5 (12%) Duraheart, 3 (7%) HeartWare. Bivalirudin was started at 0.04mg/kg/hr and titrated to achieve therapeutic PTT goals. All patients were started on aspirin and warfarin post-operatively. Chromogenic factor X assay was used to adjust warfarin dosing while bridging with bivalirudin. Outcomes were assessed during infusion and until hospital discharge. Results: 28 (65%) of patients were started on bivalirudin during the post-operative period [POD1 (39%); POD2 (43%); POD⬎2 (18%)]. Bivalirudin rapidly achieved goal PTT (40% at 4 hours, 80% at 8 hours, and 100% by 12 hours) and maintained therapeutic ranges 88% of the time. Bivalirudin demonstrated stable dosing, with a mean of 0.044 mg/kg/hr (0.02-0.07 mg/kg/hr). For all 28 patients, there was a total sum of 163 anticoagulation days on bivalirudin. In this time period there were no major bleeding episodes, no hemorrhagic strokes, and no bleeding episodes requiring re-operation. There were seven episodes of minor bleeding during bivalirudin therapy. There were no thrombotic complications (TIA, ischemic stroke, or pump thrombosis). The mean number of postoperatively transfused PRBC was 1.18 units per patient. None of the patients exhibited any clinical evidence of HIT. Conclusions: Bivalirudin use is effective and safe in continuous flow LVAD patients. Our protocol achieves rapid anticoagulation within 12 hours and is currently used as a bridge to coumadin in all patients receiving LVADS. 116 Gastrointestinal Bleeding Risk in Patients with Ventricular Assist Devices J.B. French,1 S.V. Pamboukian,2 G.B. Smallfield,3 S. Peter,3 J.A. Tallaj,2 R.N. Brown,4 M.C. Smallfield,2 J.K. Kirklin,4 J.F. George.4 1Graduate Medical Education Department of Internal Medicine Residency Program, University of Alabama, Birmingham, AL; 2Department of Medicine: Division of Cardiovascular Disease, University of Alabama, Birmingham, AL; 3Department of Medicine: Division of Gastroenterology and Hepatology, University of Alabama, Birmingham, AL; 4Department of Surgery, Cardiovascular/Surgery, University of Alabama, Birmingham, AL. Purpose: Ventricular Assist Device (VAD) implantation is associated with an increased risk of gastrointestinal bleeding (GIB) events. Better characterization of the GIB events in patients with VADs is needed. Methods and Materials: Records of 166 adult patients with VADs, implanted between January 1, 2000 and December 31, 2010 at a single center and followed through May 31, 2011, were reviewed. GIB was classified as minor or major based on units (U) of packed red blood cells transfused: ⬍ 4U vs. ⬎ 4U, respectively. Hazard models were calculated for the time to first GIB, as well freedom from subsequent GIB events. Recipient age, bleeding location, and current anticoagulation were investigated. Results: Thirty-eight patients experienced 84 GIB events (ranging from 1-9 events per patient). Maximal total hazard for the first bleeding event was 2.3 events/pt-yr at 21 days and rapidly dropped to a constant hazard by 44 days post-implantation (figure). The hazard for subsequent GIB events was highest immediately following the first bleed and declined to baseline by 6 months after the previous bleed. Among first GIB events, 20 were minor, 14 were major, and 4 were not characterized due to lack of data. Of the 84 total GIB events, 51 were minor, 28 were major, and 5 were not characterized. Seventeen patients experienced 2 or more GIB events. For

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The Journal of Heart and Lung Transplantation, Vol 31, No 4S, April 2012

age, the relative risk was 1.8 (p⫽.04) for ages 45 vs 65 at implant. Most first GIB events were proximal (75%). Patients with continuous flow devices showed fewer bleeding events, but the difference was not significant. Conclusions: The actuarial risk of initial gastrointestinal bleeding events peaks in the first 3 months following VAD implantation. Risk for subsequent GIB is substantially elevated after an initial bleed.

prised the cohort (n⫽435). Preoperative HMRS were calculated according to the formula: HMRS ⫽ln(1.29)*decade of age ⫹ ln(0.71)*Albumin ⫹ ln(1.37)*Cr ⫹ ln(1.86)*INR ⫹ ln(0.52)*LVAD Center Volume ⬎⫽15 ⫹ ln(0.67)*Implant after 2007. Patients were grouped into high (HMRS ⬎1.0), medium (HMRS 0.50-1.0), and low (HMRS ⬍⫽0.50) HMRS risk categories (as previously defined). The primary endpoint was survival at 1 year following LVAD, estimated using Kaplan-Meier methods. Results: The mean cohort age was 71⫾4 years and 84% (n⫽372) had devices implanted for DT. The table shows the HMRS along with mean⫾stddev values for the HMRS’s components. All between-group differences were statistically significant (Kruskal-Wallis p⬍0.05), although differences in age were not clinically significant. Survival based on HMRS strata is shown in the figure. Patients in the low and medium risk groups had survivals ⬎80% at 1 year following LVAD. Conclusions: The HMRS can be used to identify elderly patients with survivals comparable to that of the general LVAD population. Early referral for LVAD evaluation prior to onset of end-organ dysfunction is obligatory. 118

117 Patient Selection for Ventricular Assist Device Therapy in the Elderly: Application of the HeartMate II Risk Score J.A. Cowger,1 K. Sundareswaran,2 J.G. Rogers,3 S.S. Kushwaha,4 F.D. Pagani,1 A. Tatooles,5 R.M. Adamson,6 M.S. Slaughter,7 D.J. Farrar.2 1Univ. of Michigan Health System, Ann Arbor, MI; 2 Thoratec Corporation, Pleasanton, CA; 3Duke University Medical Center, Durham, NC; 4Mayo Clinic, Rochester, MN; 5Advocate Christ Medical Center, Oak Lawn, IL; 6Sharp Memorial Hospital, San Diego, CA; 7Univ. of Louisville, Jewish Hospital, and St. Mary’s HealthCare, Louisville, KY. Purpose: Advanced age is associated with poor outcome following left ventricular assist device (LVAD) implant. Identifying elderly patients with acceptable LVAD mortality risk remains difficult. The HeartMate II (HMII) Risk Score (HMRS) was recently developed and validated, demonstrating good HMII survival risk discrimination. We hypothesize that the HMRS will provide utility for risk stratification of elderly LVAD candidates.

Effectiveness of Platelet Aggregation Inhibitor (Tirofiban) in Treating Continuous Flow Ventricular Assist Device (VAD) Thrombus K.M. Lam,1 H. Hayes,1 J. Barber,1 G. Green,2 L. Dembo,1 G. O’Driscoll.3 1Advanced Heart Failure and Cardiac Transplant Unit, Royal Perth Hospital, Perth, WA, Australia; 2Cardiology, Royal Perth Hospital, Perth, WA, Australia; 3Notre Dame University, Fremante, WA, Australia. Purpose: VAD thrombus formation can cause hemodynamic compromise requiring urgent treatment. We report our experience with tirofiban hydrochloride, a platelet glycoprotein IIb/IIIa receptor antagonist to treat device thrombus. Methods and Materials: We had 9 cases of suspected VAD device thrombus in patients implanted with HeartWare VAD between 2006-2011. All received treatment with Tirofiban for 3.7 ⫾ 1.8 days. The diagnosis of thrombus was made from echo evidence (thrombus detection, increase mitral regurgitation & LV diameter) rising VAD power, clinical features of heart failure (dyspnea, fatigue, weight gain) & biochemical markers of haemolysis (bilirubin, plasma free Hb, LDH, D dimer, haptoglobin). At time of diagnosis: 5 patients received routine anticoagulation therapy with aspirin, clopidogrel & warfarin (INR 2.0-2.5). 2 patients received 2 agents, 1 patient was only on clopidogrel, 2 were not anticoagulated. Results: Time of tirofiban administration average 397.9 ⫾ 198.9 days post LVAD implant. 8 patients received single course treatment; one patient received a second dose of tirofiban. At 1 month, 89% (8/9) were alive & free of clinical features of heart failure. 4/9 patients presented with dyspnoea/fatigue that resolved post tirofiban. 5/9 patients lost ⬎2kg weight post tirofiban without increase diuretics. There was a significant reduction in ventricular size (pre 6.5 ⫾ 1.0 vs post 6.0⫾1.0 cm, p⫽0.005). There was reduction in plasma free Hb (pre 201⫾192 vs post 29⫾24, p ⫽0.05). There was a 68% reduction LDH, 12% increase haptoglobin, 35% reduction bilirubin, 61% reduction BNP post tirofiban. There was 31% decrease in VAD power. Complications: GI bleed 22%, haematuria 22%, PR bleed 11%, blood transfusion 44%. 1 patient died from device related sepsis. Conclusions: Tirofiban was an effective treatment of VAD thrombus, producing successful long term resolution of VAD obstruction on clinical, echo, and biochemical parameters. This was associated with GI bleeding& haematuria but no intracranial bleeding. 119 Proposed Echocardiographic Algorithm To Predict Elevated Left Ventricular Filling Pressures in Patients Supported with ContinuousFlow Left Ventricular Assist Devices J.D. Estep, R.P. Vivo, J.H. Flores-Arredondo, S.R. Krim, M. Aldeiri, B. Elias, B. Kurchock, M. Loebe, B. Bruckner, G. Torre-Amione, A. Bhimaraj. The Methodist DeBakey Heart and Vascular Center, The Methodist Hospital, Houston, TX.

Methods and Materials: Elderly patients (age ⱖ65 years) enrolled into the HMII Destination Therapy (DT) and Bridge to Transplant trials com-

Purpose: The accuracy of echocardiography in evaluating left and right ventricular (RV) hemodynamics in the presence of a continuous-flow left