Three Year Follow Up of the Randomized SCHEDULE Trial With

Abstracts S129 and PS groups; survival at 6 months was 74% for the CS group and 83% in the PS group (p= 0.44, Figure 1). Adverse events were comparable between support strategies: gastrointestinal bleeding (CS 17% vs PS 43%, p= 0.17); neurological events (CS 12% vs PS 14%, p= 0.52) and cardiac-related readmissions (CS 22% vs PS 43%, p= 0.30). Pump thrombus and driveline infections did not occur in either group during study follow-up. Conclusion: A partial support sternal-sparing strategy using the HVAD can be utilized to support bridged patients with a history of prior sternotomy. Results suggest comparable early survival and a similar adverse event profile. These initial findings should be utilized as a platform for larger trials evaluating the effectiveness of both strategies. 

3( 30) The Use of a Portable Driver for the Total Artificial Heart in the United States: The Freedom Driver System Study V. Kasirajan ,1 F. Arabia.2  1Surgery, Va Commonwealth Univ Med, Pauley Heart Center, Richmond, VA; 2Cardiac Surgery, Cedars Sinai Medical Center, Los Angeles, CA. Purpose: The pneumatic pulsatile Total Artificial Heart (TAH-t) has emerged as an effective, life-saving means of bridging to transplantation (BTT) patients at imminent risk of death from bi-ventricular failure. On the TAH-t, patients typically recover rapidly, becoming ambulatory. The initial configuration of the TAH-t system has required patients to remain in the hospital tethered to a large, heavy pneumatic driver (CSS console), with limited mobility. Recently a new portable (13 lb) electromechanical driver (Freedom Driver) has been developed to provide mobile pneumatic power for the TAHt, affording patients complete ambulatory freedom. We hypothesized that the Freedom Driver would operate within the specification of the CSS, providing adequate drive power, allowing successful discharge from the hospital and eventual transplantation. This is the report on the first 66 patients to complete the multi center, prospective, non randomized, single arm trial sponsored by Syncardia Systems, Inc, Tuczon, Az in the United States. Methods: TAH-t pts stable on the CSS were transitioned to the Freedom driver. Efficacy success indicators include: 1. A Cardiac Index (CI) on the Freedom driver averaging > 2.2 L/min/m2 throughout 90 d. 2. Clinical outcomes in the in hospital patients on Freedom driver compared to a similar cohort from the TAH-t Post Market Study (PMSS), 3. Clinical outcomes in out of hospital Freedom patients compared to in hospital Freedom patients. Results: 66 patients were successfully transitioned and maintained on Freedom driver. Mean CI was 3.4 +/- 0.4 L/mim/m2 (2.8-4.5). 47 pts were discharged home. All pts met the overall pre-specified success of maintenance on the Freedom driver for 90d or Transplant within that period. The rate of adverse events (AE) in the in-hospital Freedom driver cohort was not significantly different from the stable PMSS cohort. The AE rate in the out of hospital Freedom cohort was not different than the in-hospital cohort within 90 days of the study period and none precluded transplant.

Conclusion: Using a portable Freedom driver, TAH-t patients are increasingly mobile, allowing discharge from the hospital with successful bridge to transplantation, while residing in a home environment. 3( 31) Hemodynamic Response to Nitroprusside as Predictor of Right Ventricular Failure After LVAD Implantation D. Mikhalkova , A. Godishala, M. Nassif, J. Vader, G. Ewald, S. LaRue, K. Lavine.  Barnes Jewish Hospital Washington University, St Louis, MO. Purpose: Left ventricular assist devices (LVADs) have emerged as a standard of care for patients with end stage heart failure refractory to medical therapy. Right ventricular (RV) failure is a major cause of morbidity and mortality following LVAD implantation. This study aims to determine if nitroprusside (NTP) induced hemodynamic changes can predict acute right ventricular failure after LVAD implantation. Methods: A cohort of 100 patients who received NTP with hemodynamic monitoring prior LVAD implantation were retrospectively evaluated. Hemodynamic parameters included pulmonary vascular resistance (PVR), mean pulmonary (mPA), wedge, right atrial (RA), and mean arterial (MAP) pressures, cardiac index (CI), and RV stroke work index (RVSWI). A response to NTP was considered adequate by previously accepted parameters which include decreases in PCWP to 18 mmHg, mean pulmonary arterial pressure (mPAP) by at least 20%, and right atrial pressure to 8 mmHg, improvement in CI to 2.2 l/min/m2, and maintenance of MAP 65 mmHg. RV failure was defined as need for post-operative ionotropic support >  14 days, extracorporeal membrane oxygenation (ECMO) support, or right ventricular assist device (RVAD). Results: Of 100 patients with LVAD implants and prior NTP administration with invasive hemodynamic monitoring, 28 developed RV failure. Prior to NTP administration, there was no difference in PVR (4.1mm Hg vs 4.0), RA (12mmHg vs 11 mmHg), Wedge (25 mmHg vs 25 mmHg), MAP, CI (2.1 vs 2.0), or RVSWI (15.3 vs 8.4) in patients who developed RV failure and those who did not, respectively. However, the group that developed RV failure did have a higher mPA pressure (30 mmHg vs 26 mmHg, p =  0.03) after NTP. PVR, RA pressure, wedge, MAP, and CI were similar after NTP administration in patients who developed RV failure and those who did not. Furthermore, comparing patients who had at least a 20% decrease in mPA pressure after NTP administration to those whose mPA pressure did not decrease, did not predict mortality during follow-up period of up to 1040 +/- 447 days, p= 0.49. Conclusion: Multiple predictors of RV failure post LVAD implantation have been previously suggested. In this study, sustained elevation in mPA pressure after administration of NTP was associated with increased risk of RV failure. Otherwise, NTP induced hemodynamic changes in PVR, RA, and Wedge pressures did not predict RV failure. 3( 32) Three Year Follow Up of the Randomized SCHEDULE Trial With Everolimus Initiation and Early Withdrawal of Calcineurin Inhibitor Therapy in De Novo Heart Transplant Recipients - A Multicenter, Randomized Scandinavian Trial A.K. Andreassen ,1 B. Andersson,2 F. Gustafsson,3 H. Eiskjær,4 G. Rådegran,5 E. Gude,1 K. Jansson,6 D. Solbu,7 K. Karason,2 S. Arora,1 G. Dellgren,8 l. Gullestad.1  1Dept. of Cardiology, Oslo University Hospital Olso University Hospital, Oslo, Norway; 2Dept. of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden; 3Dept. of Cardiology, Rigshospitalet, Copenhagen, Denmark; 4Dept. of Cardiology, Aarhus University Hospital, Skejby, Denmark; 5Dept. of Cardiology, The Clinic of Heart Failure and Valvular Disease, Skåne University Hospital and Lund University, Lund, Sweden; 6Dept. of Cardiology, Heart and Medicine Center County Council of Ostergotland and Linkoping University, Linkoping, Sweden; 7Novartis Norge AS, Novartis, Oslo, Norway; 8Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden. Purpose: 1. Sponsor of the trial: Novartis 2. Completion data of the trial. The three year follow up data will be completed medio November 2014. The database closes 15/1-2015. 3. Summary of objectives. Calcineurin inhibitors remain the mainstay of immunosuppression following heart transplantation, but are associated

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The Journal of Heart and Lung Transplantation, Vol 34, No 4S, April 2015

with significant long term complications. We conducted a randomized, open-label, parallel group clinical trial to assess whether early introduction of everolimus followed by withdrawal of cyclosporine would lead to superior renal function in de novo heart transplant (HTx) recipients, compared to a standard protocol of cyclosporine-based immunosuppression. We will present the 3 year follow up data. Methods: A total of 115 patients were randomly assigned within 5 days postoperatively to low dose everolimus and reduced dose cyclosporine (n= 56) or standard cyclosporine dosage (n= 59). All received mycophenolate mofetil and corticosteroids. In the former group, cyclosporine was withdrawn and full-dose everolimus initiated after 7-11 weeks. 110 patient (54 EVR and 56 CsA) completed 12 mo follow up and entered into an extension phase of 2 more years. Results: The primary efficacy end point was renal function assessed by measured glomerular filtration rate (mGFR) after 12 months. Secondary objectives included progression of cardiac-allograft vasculopathy (as assessed by intravascular ultrasound (IVUS)), left ventricular function (assessed by echocardiography and NT-proBNP), number of rejections and serious adverse effects. Conclusion: This abstract is submitted in the category of late breaking clinical science and our final results will be completed within time for the 35th annual meeting. 3( 33) Neutrophil Gelatinase-Associated Lipocalin (NGAL) in Heart Transplant Recipients After Conversion to Everolimus Therapy J. Stypmann ,1 M. Fobker,2 K. Rosing,2 M. Engelen,1 S. Gunia,3 A. Dell’Aquila,4 J. Nofer.2  1Department of Cardiovascular Medicine, University Hospital Münster, Muenster, Germany; 2Center of Laboratory Medicine, University Hospital Münster, Muenster, Germany; 3Internal Medicine D, Department of Nephrology, Hypertension and Rheumatology, University Hospital Münster, Muenster, Germany; 4Department of Cardiothoracic Surgery, University Hospital Münster, Muenster, Germany. Purpose: Due to lack of nephrotoxic activity proliferation signal inhibitors (PSI) such as everolimus are recommended for immunosuppression after heart transplantation, but the assessment of renal function in patients receiving PSI led to conflicting results. We here examined kidney integrity and function using neutrophil gelatinase-associated lipocalin (NGAL) and conventional markers (plasma creatinine and cystatin C, urine albumin and α 1-microglobulin (α 1M)) in heart transplanted patients, who underwent conversion to everolimus due to allograft vasculopathy, graft rejection episodes, or renal function deterioration and patients maintained on calcineurin inhibitors (CNI). Methods: This cross-sectional study included 121 consecutive heart transplant recipients: 44 patients received CNI-free immunosuppressive therapy with everolimus and 77 patients received CNI in addition to mycophenolate mofetil and steroids. Renal parameters were determined in plasma and urine using standard enzymatic or immunochemical methods. Results: Heart transplant recipients receiving everolimus therapy presented with significantly lower NGAL concentrations in plasma (128 (97 - 176) vs. 252 (224 283) ng/mL, median (95% CI), p