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Heart Transplantation from Donors Outside Standard Acceptability Criteria Using Ex-Vivo Normothermic Preservation
Abstracts S85 having OTR INR. More research is needed to fully understand how management of INR could be personally tailored based on these and other clinical predictors.
2( 08) Early Results of Heart Transplantation Using Donation after Circulatory Death Donors M.B. Connellan , H. Chew, A. Iyer, A. Watson, C. Soto, A. Dinale, P. Nair, E. Granger, P. Jansz, A. Jabbour, E. Kotlyar, A. Keogh, C. Hayward, P. Spratt, P. MacDonald, K. Dhital. Heart and Lung Transplant Unit, St. Vincent’s Hospital, Sydney, Australia. Purpose: Heart transplantation utilizing Donation after Circulatory Death (DCD) donors is now a clinical reality and offers an alternative pathway in expanding the cardiac donor pool. The number of transplants performed to date nevertheless remains small, and medium to long-term outcomes are unknown. We report the one-year results of our DCD heart transplant program. Methods: From July 2014 to November 2015, 13 potential donors (11 male, mean age 26± 3.9 years) meeting the criteria for DCD heart donation were referred to St Vincent’s Hospital, Sydney for possible retrieval. Nine were procured onto the TransMedics Organ Care System (OCS) after a mean donor warm ischaemic time of 22.5 minutes. Six of these were then successfully transplanted after 266±36 minutes of ex-vivo perfusion and mean cold ischaemic time of 93±23minutes. Results: Four male and 2 female recipients (mean age 57 ± 6 years) with transpulmonary gradients of 6±2.5mmHg, received an orthotopic heart transplant from a DCD donor. There was no recipient mortality, with all patients demonstrating normal cardiac function at discharge (EF 66±5%). The duration of intensive care and hospital stay was 6.5±2 and 23±7 days, with one patient requiring post-operative extracorporeal membrane oxygenation support for 4 days. At a follow-up period 316±97 of days, three patients required treatment for ISHLT 2R rejection and all recipients remain with good biventricular graft function (EF 65±5%). No recipient has had any histological evidence of ischaemic myocardial injury on endomyocardial biopsy to date. Conclusion: This pioneering series of DCD heart transplants using the OCS platform for physiological preservation and transportation of donor hearts demonstrates that good graft function and recipient survival, comparable to hearts from brain dead donors, can be achieved. Over the follow-up period of up to 15 months, we have not seen any adverse events or negative sequelae that may be attributed to the DCD procurement process, and further clinical application of this technique is warranted. 2( 09) Heart Transplantation from Donors Outside Standard Acceptability Criteria Using Ex-Vivo Normothermic Preservation D. García Sáez , B. Zych, P. Mohite, A. Sabashnikov, F. De Robertis, A.F. Popov, T. Bahrami, N.R. Banner, A.R. Simon. Heart Lung Transplantation and Mechanical Circulatory Support, Harefield Hospital NHS Trust, Harefield, London, United Kingdom.
Purpose: Utilization of the donor hearts outside of the standard criteria may increase the number of heart transplants (HTx), however, with possible detrimental effect on outcomes. Ex-vivo normothermic preservation considerably reduces the cold ischemic time with potential benefit when transplanting high risk allografts. In this study we analyze HTx outcome from donors outside standard criteria following ex-vivo perfusion. Methods: Between February 2013 and June 2015 (n= 60) patients underwent HTx at our institution using normothermic ex-vivo preservation. Twenty four patients received grafts from standard criteria donors (group I) and thirty six from extended criteria donors (group II) with at least one risk factor; LVEF ≤ 50%, LV hypertrophy (LVH); interventricular septum in diastole > 14 mm, donor cardiac arrest, coronary artery disease, known cocaine abuse or donation following circulatory death. Results: Donor age: 41±11 (17-59 yo) gender F/M: 25 / 75%. Transport time was ≥ 2.5 hours in 26 donors. Twelve donors had reduced LVEF ≤ 50%, nine had LVH, four donors with known cocaine use, sixteen had a previous cardiac arrest; 30±12 min, six had palpable coronary artery disease and three donors following circulatory death. Both groups (standard vs. extended criteria) were statistically comparable regarding recipient characteristics. There was a trend towards increased IMPACT score for group I with estimated mortality at 1 year of 14,5% (8,9; 20.6) for group I vs 10.3% (7.6; 15.3) p= 0.061 in group II. Ex vivo perfusion parameters and ischemic times were also comparable. There was an increased requirement of ecmo support in the standard donor group 33% vs 11% (p= 0.05). Rest of postoperative variables (ICU/hospital stay, length inotropes/mechanical ventilation, blood loss and blood transfusion requirements) were comparable. 1-month, 1-year and 2-year survival (group I vs. II) were also similar: 83.3 vs. 91.7; 78.9 vs. 82.7 and 72.9 vs. 77.2% (log rank p= 0.832) Conclusion: Transplantation of hearts from extended criteria donors with moderate left ventricular dysfunction, donor cardiac arrest, left ventricular hypertrophy or coronary artery disease is safe and feasible with normothermic ex vivo preservation as a method of graft assessment and should be considered for transplantation in times of donor shortage. 2( 10) Utility of Heart Transplant by Waitlist Mortality and Donor/Recipient Match V. Nguyen , J. Beckman, R. Cheng, W. Levy, C. Mahr, N. Mokadam, J. Pal, T. Dardas. University of Washington, Seattle, WA. Purpose: As the demand for donor hearts increases for the treatment of advanced heart failure, assuring that hearts are maximally utilized becomes increasingly important. Suboptimal donor heart matches for status 2 heart transplant candidates have an unjustified high post-transplant mortality risk compared to continued waiting. Methods: We identified 19,933 transplant candidates in the Organ Procurement and Transplant Network database from July 2006 to August 2013. The Donor Risk Index (DRI, Weiss et. al.) was calculated for all heart transplant recipients and divided into quartiles of ascending risk (Q4= highest risk). Time-dependent covariate Cox models were used to evaluate the relative effect of estimated donor risk on post-transplant survival versus continued waiting. Results: The overall sample of 11,893 transplant recipients had a median DRI (IQR) of 4 (1,5). The lowest quartile of donor hearts by the DRI comprised 21.8% of all status 1A, 24.0 % of all status 1B and 33.4% of all status 2 heart transplants. For the entire cohort of candidates and recipients, transplant was associated with improved survival over waiting regardless of DRI score over the study time (Q1 HR 0.49, p< 0.0001; Q2 HR 0.55, p< 0.0001; Q3 HR 0.69, p< 0.0001; Q4 HR 0.81, p< 0.0001). Among status 1A and status1B candidates/recipients, transplant showed a significant survival benefit for every DRI quartile (all p< 0.0001). Among status 2 candidates/recipients, transplants of the highest two quartiles of risk resulted in non-significant reduction in post-transplant versus waiting mortality (Q1 HR 0.60, p< 0.0001; Q2 HR 0.75, p< 0.0001; Q3 HR 0.92 p= 0.373; Q4 HR 0.92, p= 0.295). Conclusion: Heart acceptance should be the favored strategy when a suitable heart is available for status 1A or 1B candidates, as transplant offers significantly improved survival over waiting. Status 2 registrants may not have a survival benefit when matched with a suboptimal donor heart. The DRI may be a useful tool for considering the utility of donor hearts for status 2 candidates.
2( 08) Early Results of Heart Transplantation Using Donation after Circulatory Death Donors M.B. Connellan , H. Chew, A. Iyer, A. Watson, C. Soto, A. Dinale, P. Nair, E. Granger, P. Jansz, A. Jabbour, E. Kotlyar, A. Keogh, C. Hayward, P. Spratt, P. MacDonald, K. Dhital. Heart and Lung Transplant Unit, St. Vincent’s Hospital, Sydney, Australia. Purpose: Heart transplantation utilizing Donation after Circulatory Death (DCD) donors is now a clinical reality and offers an alternative pathway in expanding the cardiac donor pool. The number of transplants performed to date nevertheless remains small, and medium to long-term outcomes are unknown. We report the one-year results of our DCD heart transplant program. Methods: From July 2014 to November 2015, 13 potential donors (11 male, mean age 26± 3.9 years) meeting the criteria for DCD heart donation were referred to St Vincent’s Hospital, Sydney for possible retrieval. Nine were procured onto the TransMedics Organ Care System (OCS) after a mean donor warm ischaemic time of 22.5 minutes. Six of these were then successfully transplanted after 266±36 minutes of ex-vivo perfusion and mean cold ischaemic time of 93±23minutes. Results: Four male and 2 female recipients (mean age 57 ± 6 years) with transpulmonary gradients of 6±2.5mmHg, received an orthotopic heart transplant from a DCD donor. There was no recipient mortality, with all patients demonstrating normal cardiac function at discharge (EF 66±5%). The duration of intensive care and hospital stay was 6.5±2 and 23±7 days, with one patient requiring post-operative extracorporeal membrane oxygenation support for 4 days. At a follow-up period 316±97 of days, three patients required treatment for ISHLT 2R rejection and all recipients remain with good biventricular graft function (EF 65±5%). No recipient has had any histological evidence of ischaemic myocardial injury on endomyocardial biopsy to date. Conclusion: This pioneering series of DCD heart transplants using the OCS platform for physiological preservation and transportation of donor hearts demonstrates that good graft function and recipient survival, comparable to hearts from brain dead donors, can be achieved. Over the follow-up period of up to 15 months, we have not seen any adverse events or negative sequelae that may be attributed to the DCD procurement process, and further clinical application of this technique is warranted. 2( 09) Heart Transplantation from Donors Outside Standard Acceptability Criteria Using Ex-Vivo Normothermic Preservation D. García Sáez , B. Zych, P. Mohite, A. Sabashnikov, F. De Robertis, A.F. Popov, T. Bahrami, N.R. Banner, A.R. Simon. Heart Lung Transplantation and Mechanical Circulatory Support, Harefield Hospital NHS Trust, Harefield, London, United Kingdom.
Purpose: Utilization of the donor hearts outside of the standard criteria may increase the number of heart transplants (HTx), however, with possible detrimental effect on outcomes. Ex-vivo normothermic preservation considerably reduces the cold ischemic time with potential benefit when transplanting high risk allografts. In this study we analyze HTx outcome from donors outside standard criteria following ex-vivo perfusion. Methods: Between February 2013 and June 2015 (n= 60) patients underwent HTx at our institution using normothermic ex-vivo preservation. Twenty four patients received grafts from standard criteria donors (group I) and thirty six from extended criteria donors (group II) with at least one risk factor; LVEF ≤ 50%, LV hypertrophy (LVH); interventricular septum in diastole > 14 mm, donor cardiac arrest, coronary artery disease, known cocaine abuse or donation following circulatory death. Results: Donor age: 41±11 (17-59 yo) gender F/M: 25 / 75%. Transport time was ≥ 2.5 hours in 26 donors. Twelve donors had reduced LVEF ≤ 50%, nine had LVH, four donors with known cocaine use, sixteen had a previous cardiac arrest; 30±12 min, six had palpable coronary artery disease and three donors following circulatory death. Both groups (standard vs. extended criteria) were statistically comparable regarding recipient characteristics. There was a trend towards increased IMPACT score for group I with estimated mortality at 1 year of 14,5% (8,9; 20.6) for group I vs 10.3% (7.6; 15.3) p= 0.061 in group II. Ex vivo perfusion parameters and ischemic times were also comparable. There was an increased requirement of ecmo support in the standard donor group 33% vs 11% (p= 0.05). Rest of postoperative variables (ICU/hospital stay, length inotropes/mechanical ventilation, blood loss and blood transfusion requirements) were comparable. 1-month, 1-year and 2-year survival (group I vs. II) were also similar: 83.3 vs. 91.7; 78.9 vs. 82.7 and 72.9 vs. 77.2% (log rank p= 0.832) Conclusion: Transplantation of hearts from extended criteria donors with moderate left ventricular dysfunction, donor cardiac arrest, left ventricular hypertrophy or coronary artery disease is safe and feasible with normothermic ex vivo preservation as a method of graft assessment and should be considered for transplantation in times of donor shortage. 2( 10) Utility of Heart Transplant by Waitlist Mortality and Donor/Recipient Match V. Nguyen , J. Beckman, R. Cheng, W. Levy, C. Mahr, N. Mokadam, J. Pal, T. Dardas. University of Washington, Seattle, WA. Purpose: As the demand for donor hearts increases for the treatment of advanced heart failure, assuring that hearts are maximally utilized becomes increasingly important. Suboptimal donor heart matches for status 2 heart transplant candidates have an unjustified high post-transplant mortality risk compared to continued waiting. Methods: We identified 19,933 transplant candidates in the Organ Procurement and Transplant Network database from July 2006 to August 2013. The Donor Risk Index (DRI, Weiss et. al.) was calculated for all heart transplant recipients and divided into quartiles of ascending risk (Q4= highest risk). Time-dependent covariate Cox models were used to evaluate the relative effect of estimated donor risk on post-transplant survival versus continued waiting. Results: The overall sample of 11,893 transplant recipients had a median DRI (IQR) of 4 (1,5). The lowest quartile of donor hearts by the DRI comprised 21.8% of all status 1A, 24.0 % of all status 1B and 33.4% of all status 2 heart transplants. For the entire cohort of candidates and recipients, transplant was associated with improved survival over waiting regardless of DRI score over the study time (Q1 HR 0.49, p< 0.0001; Q2 HR 0.55, p< 0.0001; Q3 HR 0.69, p< 0.0001; Q4 HR 0.81, p< 0.0001). Among status 1A and status1B candidates/recipients, transplant showed a significant survival benefit for every DRI quartile (all p< 0.0001). Among status 2 candidates/recipients, transplants of the highest two quartiles of risk resulted in non-significant reduction in post-transplant versus waiting mortality (Q1 HR 0.60, p< 0.0001; Q2 HR 0.75, p< 0.0001; Q3 HR 0.92 p= 0.373; Q4 HR 0.92, p= 0.295). Conclusion: Heart acceptance should be the favored strategy when a suitable heart is available for status 1A or 1B candidates, as transplant offers significantly improved survival over waiting. Status 2 registrants may not have a survival benefit when matched with a suboptimal donor heart. The DRI may be a useful tool for considering the utility of donor hearts for status 2 candidates.