Both amyloid light chain (AL) amyloidosis and transthyretin-related (TTR) amyloid have been viewed with reluctance to proceed with heart transplant. AL amyloid in particular has been a contraindation for heart transplant as the underlying disease process progresses. In the current era of proteasome inhibitors, AL amyloid patients may now be adequately treated and undergo heart transplant with subsequent bone marrow transplant. In our program, we have treated 7 AL amyloid patients who developed end-stage heart disease. These 7 patients subsequently received a heart transplant and 3 received a bone-marrow transplant 1-year later. All AL amyloid patients were treated with bortezomib. We have also transplanted 12 TTR patients and now present their outcomes. Between 2006 and 2014, we assessed 665 heart transplant patients and found 7 patients who had AL amyloid, 12 with TTR amyloid, and compared these to 15 restrictive non-amyloid patients. The following outcomes were assessed: 1-year actuarial survival, freedom from left ventricular dysfunction, freedom from non-fatal major adverse cardiac events (NF-MACE: myocardial infarction, new congestive heart failure, percutaneous coronary intervention, implantable cardioverter defibrillator/pacemaker insertion, stroke), and freedom from any treated rejection, both cellular and antibody mediated. Among the AL amyloid, TTR, and restrictive non-amyloid patients, there was no significant difference between the 3 groups in 1 year survival, freedom from left ventricular dysfunction, NF-MACE, and treated rejections, both cellular and antibody mediated (see table). No amyloid was observed in the endomyocardial biopsies after heart transplant. AL and TTR amyloid have acceptable outcomes after heart transplant. An approach using bortezomib in AL amyloid patients allows them to suppress amyloid production while subsequently waiting to undergo bone marrow transplant 1-year later.

Introduction: Autoimmune diseases such as lupus, scleroderma, sarcoidosis, and psoriasis are associated with an increased immune response through autoantibody formation.There has been concern that this up-regulation of the immune system may increase the risk of rejection after heart transplantation. Therefore, we evaluated our patients with autoimmune diseases who subsequently underwent heart transplantation at our institution. Methods: Between 2009 and 2013 we assessed 26 patients who had a concomitant history of autoimmune disease prior to heart transplantation. Autoimmune diseases included psoriasis (5), Grave’s disease (5), sarcoidosis (5), CREST syndrome (2), Hashimoto thyroiditis (1), dermatomyositis (1), ulcerative colitis (1), systemic lupus erythematosus (1), multiple sclerosis (1), antiphospholipid syndrome (1), polymyalgia rheumatic (1), celiac disease (1), and ANCA vasculitis (1). These patients were compared to a control group of patients who did not have pre-transplant autoimmune disease (n=363). Results: Patients with pre-transplant autoimmune disease did not have any significant difference in 1- year survival, 1-year actuarial freedom from any treated rejection, 1-year actuarial freedom from treated cellular rejection, 1- year actuarial freedom from treated antibody- mediated rejection, and 1-year actuarial freedom from biopsy negative rejection (see table). Conclusions: Pre-transplant autoimmune diseases do not appear to affect post-transplant outcomes. Therefore, preexisting autoimmune disease is not a contraindication to proceed with heart transplant.

Modified BMI Does Not Predict Adverse Outcomes in Patients With Cardiac Amyloid Undergoing Heart Transplantation: A Report From iCCAT (International Consortium for Cardiac Amyloid Transplantation) M. Vaduganathan ,1 S. Tabtabai,1 J.K. Steiner,1 J.R. Stone,1 J.D. Estep,2 R.M. Witteles,3 G. Feltrin,4 M.J. Zucker,5 D.A. Baran,5 D.C. Seldin,6 J. Patel,7 M. Hanna,8 A. Cordero-Reyes,2 V. Selby,9 M.J. Semigran,1 M.S. Maurer.10 1Massachusetts General Hospital, Boston, MA; 2The Methodist Hospital, Houston, TX; 3Stanford University School of Medicine, Stanford, CA; 4University of Padua, Padua, Italy; 5Newark Beth Israel Medical Center, Newark, NJ; 6Boston University School of Medicine, Boston, MA; 7Cedars-Sinai Heart Institute, Los Angeles, CA; 8Cleveland Clinic, Cleveland, OH; 9University of California San Francisco, San Francisco, CA; 10New York-Presbyterian Hospital / Columbia University Medical Center, New York, NY.

The use of older donors in heart transplant (≥50 years old) has been reported to have less good outcome compared to younger donors (<50 years old). These older donors may have preexisting coronary artery disease, and have risk factors including hypertension, diabetes and hyperlipidemia. It has been postulated that the use of older donors with relatively short cold ischemic times may have improved outcomes. Therefore, we sought to answer this question by evaluating our older donors and cold ischemic time. Between 1994 and 2010, we evaluated 748 heart transplant patients and divided them into those who received donor hearts ≥50 years old and <50 years old. Patients were further divided into those who had a cold ischemic time of <120 minutes (short), 120-140 minutes (medium), and 240 minutes (long). Endpoints included 5-year actuarial graft survival, freedom from cardiac allograft vasculopathy (CAV), freedom from non-fatal major adverse cardiac events (NF-MACE: myocardial infarction, new congestive heart failure, percutaneous coronary intervention/angioplasty, pacemaker/ICD insertion and stroke) and freedom from 1-year treated rejection. Patients who received older donor hearts with short ischemic times appeared to have comparable long-term outcomes to patients who received a younger donor heart with short ischemic times. Patients who received an older donor heart with a cold ischemic time of 120-240 minutes and >240 minutes had poorer outcomes compared to patients who received a younger donor heart in each time group (see table). A shortened cold ischemic time appears to confer better long-term graft survival in heart transplant patients with older donors. This will be of value in selection of older donors.

Donor specific antibodies (DSA) following heart transplant has been reported to be associated with increased development of cardiac allograft vasculopathy (CAV) and risk of mortality following transplantation. In the era of virtual crossmatch, we may now elect to place donor hearts in patients with low level DSAs that are not placed as avoids. The effect of these low level DSAs on the development of CAV has not yet been established. Between 1996 and 2012, we evaluated 22 patients who had low levels of DSA with a mean fluorescence intensity (MFI) <5,000 and compared then to patients with no DSA at transplant. Endpoints included 3-year actuarial survival, freedom from CAV, freedom from non-fatal major adverse cardiac events (NF-MACE: myocardial infarction, new congestive heart failure, percutaneous coronary intervention, ICD/pacemaker implant, stroke) and freedom from any treated rejection. 3-Year actuarial survival, freedom from CAV, freedom from NF-MACE, and freedom from any treated rejection in patients with low level DSA at transplant were no different compared to patients with no DSA at transplant. (See table) Tabled 1No DSA (n=147)Low Level DSA at Transplant (n=22)P-Value3-Year Actuarial Survival87.8%94.7%0.3833-Year Actuarial Freedom from CAV84.2%75.0%0.5273-Year Actuarial Freedom from NF-MACE86.2%87.8%0.6733-Year Actuarial Freedom from Any Treated Rejection75.2%78.8%0.827 Open table in a new tab In the era of virtual crossmatch, low level DSA prior to transplant does not appear to be associated with the development of CAV and poor outcomes after heart transplant. These donors, to which the potential recipient has low level DSA, should be considered for transplant. Larger numbers and longer follow-up is needed to confirm these findings.

PurposeMore recently, the continuous flow left ventricular assist devices (LVADs) have been more commonly used in patients (pts) with severe left heart failure. However, these devices also have risk for strokes, both ischemic and hemorrhagic. The Total Artificial Heart (TAH) has also been used in patients with biventricular heart failure at our single institution. Both continuous flow LVADs and TAH patients are systemically anti-coagulated with warfarin and aspirin. We sought to compare stroke rates between the LVAD patients and TAH pts.MethodsBetween 2010 and 2014, we evaluated 128 patients who received an MCS device.95 patients received an LVAD and 33 received a TAH. 6-Month freedom from stroke, both ischemic and hemorrhagic, was assessed. The severity of these strokes was also assessed using the modified Rankin Scale (mRS).Results6-Month freedom from any stroke, and ischemic strokes in particular, was significantly greater in the TAH group compared to the LVAD group (see table). There was no significant difference in 6-month freedom from hemorrhagic strokes between the two groups. The average MRS, used to measure the degree of disability in stroke patients, was similar between the two groups. The average INR over the 6 months was also not significant between the two groups. The LVAD group was further divided into those that received a HeartWare and Heartmate II and compared. There was no difference in 6-month freedom from stroke in the two LVAD groups (93.5% vs 94.7%, p=0.874).Tabled 1LVAD (N=95)TAH (N=33)P-Value6-Month Freedom from Stroke93.8%72.2%0.0016-Month Freedom from Ischemic Stroke98.9%77.7%<0.001Average INR at Time of Ischemic Stroke1.7 ± 0.02.1 ± 0.50.5096-Month Freedom from Hemorrhagic Stroke94.8%91.6%0.490Average INR at Time of Hemorrhagic Stroke2.1 ± 0.32.8 ± 1.40.327Average mRS in Stroke Patients2.3 ± 2.34.0 ± 2.40.300Average INR over 6-Month Course2.0 ± 0.72.2 ± 0.60.154 Open table in a new tab ConclusionTAH implant is associated with a higher degree of ischemic strokes compared to LVADs. More effective anticoagulation is needed to prevent these complications. PurposeMore recently, the continuous flow left ventricular assist devices (LVADs) have been more commonly used in patients (pts) with severe left heart failure. However, these devices also have risk for strokes, both ischemic and hemorrhagic. The Total Artificial Heart (TAH) has also been used in patients with biventricular heart failure at our single institution. Both continuous flow LVADs and TAH patients are systemically anti-coagulated with warfarin and aspirin. We sought to compare stroke rates between the LVAD patients and TAH pts. More recently, the continuous flow left ventricular assist devices (LVADs) have been more commonly used in patients (pts) with severe left heart failure. However, these devices also have risk for strokes, both ischemic and hemorrhagic. The Total Artificial Heart (TAH) has also been used in patients with biventricular heart failure at our single institution. Both continuous flow LVADs and TAH patients are systemically anti-coagulated with warfarin and aspirin. We sought to compare stroke rates between the LVAD patients and TAH pts. MethodsBetween 2010 and 2014, we evaluated 128 patients who received an MCS device.95 patients received an LVAD and 33 received a TAH. 6-Month freedom from stroke, both ischemic and hemorrhagic, was assessed. The severity of these strokes was also assessed using the modified Rankin Scale (mRS). Between 2010 and 2014, we evaluated 128 patients who received an MCS device.95 patients received an LVAD and 33 received a TAH. 6-Month freedom from stroke, both ischemic and hemorrhagic, was assessed. The severity of these strokes was also assessed using the modified Rankin Scale (mRS). Results6-Month freedom from any stroke, and ischemic strokes in particular, was significantly greater in the TAH group compared to the LVAD group (see table). There was no significant difference in 6-month freedom from hemorrhagic strokes between the two groups. The average MRS, used to measure the degree of disability in stroke patients, was similar between the two groups. The average INR over the 6 months was also not significant between the two groups. The LVAD group was further divided into those that received a HeartWare and Heartmate II and compared. There was no difference in 6-month freedom from stroke in the two LVAD groups (93.5% vs 94.7%, p=0.874).Tabled 1LVAD (N=95)TAH (N=33)P-Value6-Month Freedom from Stroke93.8%72.2%0.0016-Month Freedom from Ischemic Stroke98.9%77.7%<0.001Average INR at Time of Ischemic Stroke1.7 ± 0.02.1 ± 0.50.5096-Month Freedom from Hemorrhagic Stroke94.8%91.6%0.490Average INR at Time of Hemorrhagic Stroke2.1 ± 0.32.8 ± 1.40.327Average mRS in Stroke Patients2.3 ± 2.34.0 ± 2.40.300Average INR over 6-Month Course2.0 ± 0.72.2 ± 0.60.154 Open table in a new tab 6-Month freedom from any stroke, and ischemic strokes in particular, was significantly greater in the TAH group compared to the LVAD group (see table). There was no significant difference in 6-month freedom from hemorrhagic strokes between the two groups. The average MRS, used to measure the degree of disability in stroke patients, was similar between the two groups. The average INR over the 6 months was also not significant between the two groups. The LVAD group was further divided into those that received a HeartWare and Heartmate II and compared. There was no difference in 6-month freedom from stroke in the two LVAD groups (93.5% vs 94.7%, p=0.874). ConclusionTAH implant is associated with a higher degree of ischemic strokes compared to LVADs. More effective anticoagulation is needed to prevent these complications. TAH implant is associated with a higher degree of ischemic strokes compared to LVADs. More effective anticoagulation is needed to prevent these complications.

Patients with COPD may develop severe heart disease. These patients are at risk for poor outcome after heart transplant. There have been few studies analyzing pulmonary function testing (PFTs) and specific parameters that may be used to prognosticate risk after heart transplantation. Therefore, we evaluated patients who had end stage heart disease and their pre- transplant PFTs to assess for markers for poor outcome after heart transplant. Between 1997 and 2012, we evaluated 629 heart transplant patients by their PFTs. The PFT parameters were evaluated and two parameters were found to be important for prognosis. These included FEV1/FVC and DLCO. These patients were divided into four categories, FEV1/FVC 70% . A similar finding was found for DLCO <60% (see table). PFT for patients with pulmonary disease prior to heart transplant can be a good indicator of outcome after heart transplantation. Specifically, FEV1/FVC <70% and DLCO <60% may contraindicate proceeding with heart transplant in these patients.

Background: Antiplatelet therapy (anti-PLT Rx) prevents in-stent thrombosis post percutaneous coronary intervention. Anti-PLT Rx also increases the perioperative bleeding risk. We sought to assess this bleeding risk in patients (pts) on anti-PLT Rx prior to heart transplantation (HTx). Methods: We assessed 153 HTx pts transplanted 2010-2012 and divided them based on anti-PLT Rx within 7 days of HTx: clopidogrel and aspirin, clopidogrel, aspirin, none. Endpoints included units of blood products transfused intraoperatively (packed red blood cells, frozen fresh plasma, platelets, and cryoprecipitate) and need for re-exploration for excessive bleeding. 30-day and 1-year survival, and 1-year freedom from non-fatal major cardiac event (NF-MACE: Myocardial Infarction, Congestive Heart Failure, angioplasty, pacemaker/ICD, stroke) were assessed. Results: Pts taking anti-PLT Rx had no significant increase in blood product transfusion during HTx, except that pts on clopidogrel and aspirin had significantly more platelet transfusions compared to those on no anti-PLT Rx (2.8 ± 1.1 vs. 1.6 ± 1.1, p = 0.01). Incidence of perioperative bleeding necessitating re-exploration, 30-day survival, 1-year survival, 1-year freedom from NF-MACE were comparable (see table).Table: No Caption available.* p< 0.05 compared to “No Anti-platelet Medication within 7 days of transplant” group. Conclusion: The use of anti-PLT Rx just prior to HTx does not significantly increase the risk of perioperative bleeding. However, attention should be given to those pts on both clopidogrel and aspirin prior to HTx. A larger number of pts are required to confirm these findings. DISCLOSURE:Patel, J.: Grant/Research Support, Research grant support from Alexion Pharmaceutical. Arabia, F.: Other, Consultant of Syncardia Inc., Consultant of Syncardia Inc. Moriguchi, J.: Grant/Research Support, Grant/Research Support frm Thoratec, Grant/Research Support frm Syncardia Inc. Kobashigawa, J.: Grant/Research Support, XDx Inc., Novartis, Transmedics Inc.

Background: In heart transplant (HTx) patients (pts), everolimus (EVR) may limit cardiac allograft vasculopathy, cytomegalovirus infection, and malignancy. However, there is increased nephrotoxicity when a calcineurin inhibitor (CNI) is combined with EVR. This has been well established in clinical trials using EVR in combination with cyclosporine (CSA). To compare the effect of EVR in combination with CSA vs tacrolimus (TAC), we reviewed the experience at our center. Methods: We assessed 38 HTx pts who were started on EVR in combination with either TAC or CSA between 2000 and 2012. Serum creatinine (SCr) and CNI trough levels were measured at EVR initiation and 1, 3, 6, and 12 months later. Endpoints were assessed: subsequent 1-year survival, 1-year freedom from dialysis, 1-year freedom from rejection. Results: Both TAC and CSA blood levels were maintained in the usual therapeutic range (5-10ng/ml and 100-200 ng/ml respectively) before and after EVR initiation, but pts on EVR /CSA had significantly higher SCr at follow-up (table). There was no significant difference in subsequent 1-year survival, freedom from dialysis, treated cellular rejection, or treated antibody mediated rejection.Table: No Caption available.Conclusion: When used in combination with EVR, TAC is associated with less nephrotoxicity than CSA with no increase in adverse events. Further study in a large patient sample is needed to confirm these findings. DISCLOSURES:Patel, J.: Grant/Research Support, Alexion Pharmaceuticals. Moriguchi, J.: Grant/Research Support, Grant from Thoratec and Syncardia Inc. Chang, D.: Stockholder, Abbot Pharma. Kobashigawa, J.: Grant/Research Support, Xdx Inc., Novartis Phamaceuticals, Transmedics Inc.