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Idarucizumab for the Reversal of Dabigatran in Patients Undergoing Heart Transplantation
Abstracts disease recurrence in the graft was identified in 2/13 (15%) patients with GCM as well as in 2/11 (18%) CS patients. Treatment-requiring cardiac allograft rejection was observed in 6/13 (46%) GCM patients and in 1/11 (9%) CS patients. The mean survival time was numerically higher for patients with ICM (20.2 years, 95 % CI=12.2-28.2) than for the control group (16.9 years, 95 % CI=14.5-19.4), but the difference was not statistically significant (log-rank test (p=0.75) Breslow-test (p=0.68)). Conclusion: Patients with GCM or CS with advanced heart failure who are treated with HTx or MCS have similar long-term survival as HTx recipients treated due to all other heart diseases.
724 Use of dd-cfDNA in Multiorgan Transplantation E.C. DePasquale, J. Smith, J. Fuentes, T. Khuu and M.C. Deng. UCLA, Los Angeles, CA. Purpose: Gene expression profiling testing (GEP; AlloMap) and donorderived cell free DNA (dd-cfDNA; AlloSure) each provide non-invasive means to detect possible heart allograft rejection, including acute cellular rejection (ACR). Use of dd-cfDNA in multiorgan transplantation has not previously been reported. This report describes the largest single center use of dd-cfDNA to date in this population. Methods: Post heart transplant (HT) management is standardized at our center such that endomyocardial biopsy is used for rejection surveillance in the early period with crossover to GEP testing at day 56. Elevated GEP (≥34) prompts biopsy. dd-cfDNA was utilized in conjunction with biopsy or in lieu of biopsy (barrier to biopsy). A cohort of 26 HT patients underwent dd-cfDNA testing, including 3 multiorgan (same donor) and 5 retransplant patients. The dd-cfDNA (%, AlloSure) and GEP (AlloMap, score 0-40) results were correlated patient survival. Results: Among 26 HT patients, there were 3 multiorgan transplant recipients (2 heart-kidney & 1 heart-lung). Mean dd-cfDNA was 0.9 § 0.5%. Mean GEP score was 32.8 § 4.0. dd-cfDNA usage was due to inability to biopsy (33.3%), anticoagulation (33.3%) & elevated Allomap (33.3%). Mean LVEF was 55 § 1%. Mean day post transplant for first dd-cfDNA was 153 (IQR 119-347). There were no deaths. Of the heart-kidney recipients, mean ACR & AMR biopsy grade was 0.67 & 0, respectively. The heart-lung recipient underwent 2 lung biopsies with mean grade of 0. Conclusion: In surveillance of heart allograft recipients for rejection, consideration of dd-cfDNA levels may improve patient management decisions particularly when endomyocardial biopsy may not be feasible. This is the first report of use of dd-cfDNA in multiorgan transplantation. Baseline levels of dd-cfDNA appear to be higher than that of heart-only recipients. Further study is warranted to assess the utilization of dd-cfDNA in multiorgan transplantation.
S293 725 Idarucizumab for the Reversal of Dabigatran in Patients Undergoing Heart Transplantation J.M. Van Keer, T. Vanassche, W. Droogne, S. Rex, F. Rega, J. Van Cleemput and P. Verhamme. Cardiology, University Hospitals Leuven, Leuven, Belgium. Purpose: Atrial fibrillation is common among patients listed for HTx. NOACs offer several advantages over VKAs. However, in case of HTx surgery an immediate normalization of coagulation is required. Idarucizumab is a monoclonal antibody fragment that was developed to neutralize the activity of the direct thrombin inhibitor dabigatran. Although REVERSE AD included 202 patients requiring emergent procedures, there have been only 2 reports of idarucizumab use in heart transplant surgery to date. Methods: At time of listing, patients requiring anticoagulation because of non-valvular atrial fibrillation, CHA2DS2VASc 2 and without LVAD or end-stage renal failure, were started on or switched to dabigatran. Upon availability of a donor organ, dabigatran was neutralized with 5 g of intravenous idarucizumab, immediately prior to induction of anaesthesia. Results: Dabigatran concentration and aPTT after idarucizumab are represented in Figure 1. During surgery, patients received on average 1.0 unit of packed cell transfusion, 4.1 units fresh frozen plasma, 0.9 pools platelets and 587 mL blood that was recovered via cell salvage. Two patients needed re-intervention because. No adverse reactions or unexpected events that could potentially be related to idarucizumab administration were noted. There were no thrombotic complications. Conclusion: This is the largest report describing the use of idarucizumab to normalize coagulation in patients on dabigatran awaiting HTx. Administration of idarucizumab led to a sustained and complete biochemical reversal, without thrombotic complications, and without interfering with heparinization for cardiopulmonary bypass. In conclusion, the availability of an immediately-acting complete reversal agent makes dabigatran an attractive choice for non-VAD patients with non-valvular atrial fibrillation who are listed for heart transplantation.
726 Incidence and Effect of VA-ECMO Use in Primary Graft Failure Patients after Heart Transplantation M. Kawabori,1 M.A. Mastroianni,2 J.A. Reich,1 Y. Zhan,1 K.G. Warner,1 H. Rastegar,1 A. Vest,1 D. Denofrio,1 F.Y. Chen,1 and G.S. Couper.1 1Tufts Medical Center, Boston, MA; and the 2Tufts University School of Medicine, Boston, MA. Purpose: Primary graft dysfunction (PGD) is a complication associated with high mortality after heart transplant, which may require veno-arterial extra-corporeal membrane oxygenation (VA-ECMO) support. However, the outcomes of VA-ECMO use for heart transplant recipients remains unclear in limited studies. Methods: Between September 2014 and August 2018, 169 patients underwent heart transplantation in our single center. 10 patients who required VA-ECMO support were analyzed retrospectively. Incidence, pre-opera-
724 Use of dd-cfDNA in Multiorgan Transplantation E.C. DePasquale, J. Smith, J. Fuentes, T. Khuu and M.C. Deng. UCLA, Los Angeles, CA. Purpose: Gene expression profiling testing (GEP; AlloMap) and donorderived cell free DNA (dd-cfDNA; AlloSure) each provide non-invasive means to detect possible heart allograft rejection, including acute cellular rejection (ACR). Use of dd-cfDNA in multiorgan transplantation has not previously been reported. This report describes the largest single center use of dd-cfDNA to date in this population. Methods: Post heart transplant (HT) management is standardized at our center such that endomyocardial biopsy is used for rejection surveillance in the early period with crossover to GEP testing at day 56. Elevated GEP (≥34) prompts biopsy. dd-cfDNA was utilized in conjunction with biopsy or in lieu of biopsy (barrier to biopsy). A cohort of 26 HT patients underwent dd-cfDNA testing, including 3 multiorgan (same donor) and 5 retransplant patients. The dd-cfDNA (%, AlloSure) and GEP (AlloMap, score 0-40) results were correlated patient survival. Results: Among 26 HT patients, there were 3 multiorgan transplant recipients (2 heart-kidney & 1 heart-lung). Mean dd-cfDNA was 0.9 § 0.5%. Mean GEP score was 32.8 § 4.0. dd-cfDNA usage was due to inability to biopsy (33.3%), anticoagulation (33.3%) & elevated Allomap (33.3%). Mean LVEF was 55 § 1%. Mean day post transplant for first dd-cfDNA was 153 (IQR 119-347). There were no deaths. Of the heart-kidney recipients, mean ACR & AMR biopsy grade was 0.67 & 0, respectively. The heart-lung recipient underwent 2 lung biopsies with mean grade of 0. Conclusion: In surveillance of heart allograft recipients for rejection, consideration of dd-cfDNA levels may improve patient management decisions particularly when endomyocardial biopsy may not be feasible. This is the first report of use of dd-cfDNA in multiorgan transplantation. Baseline levels of dd-cfDNA appear to be higher than that of heart-only recipients. Further study is warranted to assess the utilization of dd-cfDNA in multiorgan transplantation.
S293 725 Idarucizumab for the Reversal of Dabigatran in Patients Undergoing Heart Transplantation J.M. Van Keer, T. Vanassche, W. Droogne, S. Rex, F. Rega, J. Van Cleemput and P. Verhamme. Cardiology, University Hospitals Leuven, Leuven, Belgium. Purpose: Atrial fibrillation is common among patients listed for HTx. NOACs offer several advantages over VKAs. However, in case of HTx surgery an immediate normalization of coagulation is required. Idarucizumab is a monoclonal antibody fragment that was developed to neutralize the activity of the direct thrombin inhibitor dabigatran. Although REVERSE AD included 202 patients requiring emergent procedures, there have been only 2 reports of idarucizumab use in heart transplant surgery to date. Methods: At time of listing, patients requiring anticoagulation because of non-valvular atrial fibrillation, CHA2DS2VASc 2 and without LVAD or end-stage renal failure, were started on or switched to dabigatran. Upon availability of a donor organ, dabigatran was neutralized with 5 g of intravenous idarucizumab, immediately prior to induction of anaesthesia. Results: Dabigatran concentration and aPTT after idarucizumab are represented in Figure 1. During surgery, patients received on average 1.0 unit of packed cell transfusion, 4.1 units fresh frozen plasma, 0.9 pools platelets and 587 mL blood that was recovered via cell salvage. Two patients needed re-intervention because. No adverse reactions or unexpected events that could potentially be related to idarucizumab administration were noted. There were no thrombotic complications. Conclusion: This is the largest report describing the use of idarucizumab to normalize coagulation in patients on dabigatran awaiting HTx. Administration of idarucizumab led to a sustained and complete biochemical reversal, without thrombotic complications, and without interfering with heparinization for cardiopulmonary bypass. In conclusion, the availability of an immediately-acting complete reversal agent makes dabigatran an attractive choice for non-VAD patients with non-valvular atrial fibrillation who are listed for heart transplantation.
726 Incidence and Effect of VA-ECMO Use in Primary Graft Failure Patients after Heart Transplantation M. Kawabori,1 M.A. Mastroianni,2 J.A. Reich,1 Y. Zhan,1 K.G. Warner,1 H. Rastegar,1 A. Vest,1 D. Denofrio,1 F.Y. Chen,1 and G.S. Couper.1 1Tufts Medical Center, Boston, MA; and the 2Tufts University School of Medicine, Boston, MA. Purpose: Primary graft dysfunction (PGD) is a complication associated with high mortality after heart transplant, which may require veno-arterial extra-corporeal membrane oxygenation (VA-ECMO) support. However, the outcomes of VA-ECMO use for heart transplant recipients remains unclear in limited studies. Methods: Between September 2014 and August 2018, 169 patients underwent heart transplantation in our single center. 10 patients who required VA-ECMO support were analyzed retrospectively. Incidence, pre-opera-