Five-Year Outcome in Patients Treated with Heart Transplantation with Advanced Age Donors versus Patients on Waiting List for Heart Transplantation Implanted with Left Ventricular Assist Device

Abstracts S107 Columbia, SC; 6Heart Transplant, Children National Health System, Washington, DC; 7Heart Transplant, Boston Children's Hospital, Boston, MA; 8US Food and Drug Administration, Silver Spring, MD; 9Heart Transplant, Stanford Hospital, Palo Alto, CA. Purpose: Tacrolimus is a life-saving transplant medication required to prevent organ rejection. Anecdotal reports suggest errors in compounding tacrolimus into a liquid solution, to administer to children who cannot swallow capsules, has been associated with serious safety issues. We conducted a survey of US heart transplant programs to determine the scope of the problem, and to engage centers regarding potential solutions. Methods: US pediatric heart transplant programs were surveyed to determine whether pediatric heart transplant centers had experienced medication errors attributed to extemporaneously prepared liquid tacrolimus and whether those errors had resulted in patient harm. Results: Among 20 of 52 pediatric HT programs responding to the survey, 95% reported at least one medication error attributed to erroneous compounding of liquid tacrolimus that presented a threat to patient safety, 75% of programs reported safety incidents at least yearly; one program at least monthly. Overall 95% of centers reported the incidents resulted in unscheduled blood draws/labs, 45% of programs unscheduled echocardiograms, 35% unscheduled cardiac catheterizations with endomyocardial biopsy; 10% graft rejection, including one cardiac arrest and one death. Sixty percent of centers deemed compounding errors involving liquid tacrolimus to be a “serious” or “very serious” safety problem. Eighty percent of programs indicated they would be “very likely” or “extremely likely” to use a standardized commercial preparation of liquid tacrolimus if it were available in the US. Conclusion: There is substantial concern among US pediatric heart transplant programs that extemporaneous preparation of liquid tacrolimus poses a significant threat to the safety of pediatric transplant patients. Access to a standardized commercial preparation of liquid tacrolimus would benefit US patients. 2( 63) Clinical Outcomes with Heartmate 3 as Treatment for Advanced HF: First Data from the European ELEVATE Registry F. Gustafsson ,1 M. Morshuis,2 D. Zimpfer,3 J. Lavee,4 T. Krabatsch,5 S. Shaw,6 D. Saeed,7 L. Damme,8 J. Garbade.9  1Rigshospitalet, Copenhagen, Denmark; 2HDZ NRW, Bad Oyenhausen, Germany; 3Medical University Vienna, Vienna, Austria; 4Sheba Medical Center, Ramat Aviv, Israel; 5Deutsches Herz Zentrum, Berlin, Germany; 6Wythenshawe Hospital, Manchester, United Kingdom; 7Heinrich-Heine Universität Düsseldorf, Dusseldorf, Germany; 8St Jude Medical, Zaventem, Belgium; 9Herzzentrum Leipzig GmbH, Leipzig, Germany. Purpose: Heartmate 3 (HM3), a fully magnetically levitated continuous flow left ventricular assist device (CF-LVAD) was recently approved for use in EU. The ELEVATE registry was planned to study post approval outcomes with HM3 in Europe and it will ultimately include 500 patients. Methods: We report 6 months outcome of the first 100 patients (first-time implants) who provided informed consent to participate in the registry. Thirty seven additional patients were implanted with the device during that period, but were not included in the registry due to lack of consent. Adverse events including major bleeding, infection, stroke, pump thrombosis, RV failure were assessed as well as efficacy data such as NYHA class, quality of life and 6 minute walk test (6MWT). Results: The 100 patients were implanted in 17 centers (2-19 per center) in 7 countries. Mean age was 57 ± 12 years, 94 % were male and 51 % had ischemic etiology. Mean BSA was 2.06 ± 0.23 m2. Most were inotrope dependent as 31 % were in INTERMACS 1-2, 29 % were INTERMACS 3 and 6 % were implanted from ECMO. Mean 6MWT showed poor functional capacity (66 ± 127 m) and measures of quality of life were significantly impaired (EQ5D VAS 35 ± 24). Indication was BTT in 58 %, DT in 31 % and bridge to decision or candidacy in 11%. Main hemodynamics before implant were: CI 1.9 ± 0.5 l/min/m2, PCWP 26 ± 9 mmHg, CVP 18 ± 7 mmHg. None of the patients in ELEVATE were transplanted or explanted for recovery during 6 month follow-up. For the 37 implanted patients who were excluded from ELEVATE due to lack of consent only data on survival is available from company device tracking provided by the centers. Six month survival rate of the entire cohort comprising the ELEVATE registry and the device tracking data (n= 137) was 90 ± 3 %.

Conclusion: Six month survival of patients implanted with Heartmate 3 in the ELEVATE registry was consistent with that reported in the CE mark study. The ELEVATE registry will provide detailed analysis of important adverse events and measures of efficacy for the initial commercial experience with HM3. 2( 64) Bridging to Transplantation with Contemporary Continuous-Flow Left Ventricular Assist Devices: A Decade Experience L.K. Truby , R. Givens, A.R. Garan, M. Yuzefpolskaya, M. Flannery, H. Takayama, K. Takeda, J. Haythe, F. Latif, S. Restaino, M. Maurer, D.M. Mancini, Y. Naka, M. Farr, P.C. Colombo, V.K. Topkara.  Columbia University College of Physicians and Surgeons, New York, NY. Purpose: New generation continuous flow left ventricular assist devices (CF-LVADs) have been increasingly utilized as a bridge to transplantation (BTT) over the last decade. While non-inferior survival has been previously demonstrated, other important long-term post-transplant outcomes such as rejection, cardiac allograft vasculopathy (CAV), and renal dysfunction have been underreported. Methods: 608 patients who underwent heart transplant (HT) at our institution between January 2005 and December 2015 were retrospectively reviewed. Post-transplant outcomes included acute cellular rejection, severe CAV (ISHLT Grade 2 or 3), renal dysfunction defined as serum creatinine greater than 2.5 mg/dL, and mortality. Patients who were bridged-to-transplantation with an FDA approved contemporary CF-LVAD were comparatively analyzed to patients who were medically bridged. Results: 210 patients (34.4%) were bridged to transplant with a CF-LVAD (194 Heartmate II, 16 Heartware HVAD). CF-LVAD patients tended to be older (54.6 ± 12.6 vs. 51.6 ± 13.1 years, p= 0.007) with a higher BMI (26.9 ± 4.8 vs. 25.6 ± 4.8 kg/m2, p= 0.002). MELD-Xi score, as an index of disease severity, tended to be lower in the CF-LVAD group (12.5 (9.4 - 15.8) vs. 13.3 (10.5 - 16.3), p= 0.056). Post-transplantation long-term survival was comparable (81% CF-LVAD vs. 77% Medical at 5 years, log rank p= 0.230, Figure 1A). There were no significant differences in the incidence of cellular rejection 1B and above (42% vs. 47% at 5 years, p= 0.271, Figure 1B), severe CAV (4% vs. 5% at 5 years, p= 0.468, Figure 1C), or renal dysfunction (47% vs. 48% at 5 years, p= 0.540, Figure 1D) between CF-LVAD and medically managed groups during follow-up. Conclusion: CF-LVAD patients have similar long-term mortality as those treated with standard medical therapy. In addition, BTT with CF-LVAD does not appear to increase the development of cellular rejection, allograft vasculopathy, or renal dysfunction.

2( 65) Five-Year Outcome in Patients Treated with Heart Transplantation with Advanced Age Donors versus Patients on Waiting List for Heart Transplantation Implanted with Left Ventricular Assist Device E. Ammirati , M. Cipriani, E. Perna, M. Varrenti, T. Colombo, A. Garascia, A. Cannata, G. Pedrazzini, F. Milazzo, F. Oliva, M.P. Gagliardone, C.F. Russo, M. Frigerio.  De Gasperis CardioCenter, Niguarda Hospital, Milan, Italy.

S108

The Journal of Heart and Lung Transplantation, Vol 36, No 4S, April 2017

Purpose: In Italy an increasing number of heart donors are above 55 years and the mean age is approximately 10-year older compared with heart donors in the United States. In a previous study we observed that at 2-year follow up, the outcome of patients treated with a left ventricular assist device (LVAD) with indication as bridge to transplantation (BTT) was better compared to that of recipients of HTx with the donor’s age above 55 years (HTx with donors > 55years). We evaluated the long-term outcome at 5 years of patients treated with LVAD as BTT vs. HTx with donors > 55years. Methods: We prospectively evaluated 101 consecutive patients with advanced HF treated with LVAD as bridge to transplantation (BTT) or HTx with donors> 55 years (median age of donors 60 years) in our hospital from January 2006 to January 2015 with at least 20 months of follow up (data were completed for all patients). We compared the long-term outcome of patients treated with CF-LVAD that were on the list at the time of implantation or were enlisted for HTx on CF-LVAD support (n= 57, median age 53 years) vs. HTx with donors> 55 years without prior bridging (n= 45, median age of recipients 57 years). Five-year survival was evaluated according to the first operation. Results: Kaplan-Meier (KM) curves estimated a 1, 3 and 5-year survival rate for CF-LVAD of 95.8%, 58.6% and 58.6% respectively vs. 68.9%, 66.6% and 63.6% in HTx with donors> 55 years without significant differences (hazard ratio [HR] of 0.67; 95% confidence interval [CI] 0.31-1.42; p= 0.30, Log-rank test). Considering also the post-HTx outcome, KM curves estimated a 1, 3 and 5-year survival rate for LVAD of 87.4%, 66.9% and 66.9% respectively vs. 68.9%, 66.6% and 63.6% in HTx with donors> 55 years without significant differences (HR of 0.78; 95%CI 0.40-1.59; p= 0.49). Median time on support before HTx was 419 days (interquartile range 257-846 days). In the LVAD group, 32 patients were transplanted (56%) and 8 died after HTx (8/32: 25%). In 18 cases (18/32: 56%) HTx was performed on high priority status due to LVAD-related complications. Conclusion: Five-year survival of patients with LVAD implanted as BTT was similar compared to patients who performed HTx with donors> 55 years. In both groups the outcome was suboptimal, but still acceptable, with a 5-year survival around 65%.

these risk factors may help determine whether IM 4-7 patients should receive mechanical support.

2( 67) 2( 66) Which INTERMACS 4-7 Patients Are at Low Risk for Mortality at One Year? Insights from the INTERMACS Database J.J. Teuteberg ,1 A.D. Althouse,1 M. Shullo,1 N. Kunz,1 K. Lockard,1 E. Dunn,1 L. Lagazzi,1 C. Sciortino,1 J. Cowger,2 S. Joseph,3 R.L. Kormos.1  1University of Pittsburgh, Pittsburgh, PA; 2St. Vincent, Indianapolis, IN; 3Baylor Medical Center, Houston, TX. Purpose: Implanting non-inotrope dependent patients with mechanical support remains controversial, however the risk factors for one year mortality in this group of patients is poorly described. Methods: Patients in the INTERMACS (IM) database were reviewed and classified as IM profiles 4-7 (n= 2986), only patients not on an inotrope, pressor or any form of temporary support prior to implant (n= 1793) were included in the analysis. Outcomes at one year were categorized as a success (survival, transplant or explant for recovery) or failure (death) and risk factors were assessed using a CART analysis. In the CART algorithm the best-fitting tree is chosen based on which clusters of predictor variables sort the patients into groups. Results: Of the 1793 patients, IM4: 1403 (78%), IM5: 245 (18%), IM6: 95 (5%), and IM7: (3%). There was no difference in one year survival between IM profiles 4-7. Overall 82.3% were male and 77% were white. There was no difference in pre-implant RA pressure (10.6 +/- 7.19), PAS (46.4 +/- 15.3), PAD (21.9 +/- 8.56), or CO (4.3 +/- 1.35) based on outcome, but those with a successful outcomes had a lower RA pressure (10.6 v. 12.2, p= 0.012). Those with a successful outcome were more likely to be BTT listed (30.6% v 16.9%) and less likely to be DT (40.5% v 57.4%). The CART analysis demonstrated that age was the most powerful predictor of outcomes for IM 4-7. Those patients who were less than 60 and had an RA pressure less than 22.5 had a 92% one-year survival. The one year survival for patients 60 and older who had a creatinine greater than 1.92 was only 59%. Conclusion: Patients who are IM profiles 4-7 have similar outcomes after mechanical support as well as similar hemodynamics prior to implant, however there a number of common baseline characteristics such as age, creatinine and RA pressure that seem to be the major determinants of risk, with the lowest risk group having a 92% one-year survival. Knowledge of

Outcomes of Jarvik 2000 LVAD as a Bridge to Heart Transplantation: Data from the Japanese Registry for Mechanically Assisted Circulatory Support (J-MACS) H. Kohno ,1 G. Matsumiya,1 Y. Sawa,2 M. Ono,3 Y. Saiki,4 A. Shiose,5 K. Yamazaki,6 Y. Matsui,7 H. Niinami,8 H. Matsuda,9 S. Kitamura,10 T. Nakatani,11 S. Kyo.12  1Cardiovascular Surgery, Chiba University Graduate School of Medicine, Chiba, Japan; 2Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan; 3Cardiac Surgery, The University of Tokyo, Tokyo, Japan; 4Cardiovascular Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan; 5Cardiovascular Surgery, Kyushu University Faculty of Medical Sciences, Fukuoka, Japan; 6Cardiovascular Surgery, Tokyo Women's Medical University Hospital, Tokyo, Japan; 7Cardiovascular and Thoracic Surgery, Hokkaido University Graduate School of Medicine, Sapporo, Japan; 8Cardiovascular Surgery, Saitama Medical University International Medical Center, Hidaka, Japan; 9Higashi-Takarazuka Satoh Hospital, Takarazuka, Japan; 10National Cerebral and Cardiovascular Center, Osaka, Japan; 11Maki Health Care Group, Maki Hospital, Osaka, Japan; 12Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology, Tokyo, Japan. Purpose: The Jarvik 2000 FlowMaker features a miniaturized intraventricular pump equipped with intermittent low speed (ILS) mode to facilitate aortic valve opening. Despite its long history of use, little is known regarding the post-implant outcome of this device. Methods: Data were extracted from the national registry database to analyze the following: (1) mortality; (2) morbidity; and (3) de novo aortic regurgitation (AR). 85 patients (from 13 hospitals) who received the Jarvik LVAD implant (April 2013 - June 2016) were reviewed. 19 of them were being treated with other VADs prior to the implant. Mean age was 40.5 (SD 16.7). Mean follow-up was 8.3 months (max 25.8). All patients underwent the implant for the purpose of bridge-to-transplant. Results: Survival at 1 and 2 years was 83.2% and 77.3%, respectively. Nine patients were in INTERMACS Level 1 at the time of implant. One resulted in concomitant RVAD at implant. Causes of death were stroke, device malfunction, and infection. Two were successfully bridged to transplant. A summary