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Differences in Regional Recipient Waitlist Time and Pre- and Post-Transplant Mortality Following the 2006 UNOS Policy Changes in the Donor Heart Allocation Algorithm
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The Journal of Heart and Lung Transplantation, Vol 32, No 4S, April 2014 hospitalier Pitié-Salpétrière, Paris, France; 12Division of Cardiothoracic Surgery, Massachusetts General Hospital, Boston, MA; 13Division of Cardiothoracic Surgery, Papworth Hospital, Cambridge, United Kingdom; 14Thoracic Transplantation and Mechanical Support, Harefield Hospital, Harefield, United Kingdom; 15Cardiac Surgery and Transplantation Unit, “Santa Maria della Misericordia” University Hospital, Udine, Italy; 16Advanced Heart Disease Section,Heart Transplant Program, CedarsSinai Medical Center, Los Angeles, CA.
3( 07) Differences in Regional Recipient Waitlist Time and Pre- and PostTransplant Mortality Following the 2006 UNOS Policy Changes in the Donor Heart Allocation Algorithm S. Kitada ,1 P. Schulze,2 K. Clerkin,1 Z. Jin,1 D.M. Mancini.1 1Columbia University Medical Center, New York, NY; 2Department of Medicine, Division of Cardiology, Columbia University Medical Center, New York, NY. Purpose: In 2006, a UNOS thoracic organ allocation policy change was implemented allowing for greater regional sharing of organs. Our current analysis examined the impact of these changes on regional differences in waitlist time and mortality before and after heart transplantation (HTx). Methods: We analyzed 36,789 patients who were listed for HTx from January 1999 through April 2012 separated into two eras centered on the July 12, 2006 UNOS policy change date. Pre- and post transplantation characteristics were compared overall and by UNOS regions. Results: Waitlist mortality decreased nationally (up to 180 days: 13.3 versus 7.9% after the UNOS policy change, p< 0.001) and within each region. Similarly, two-year post-transplant mortality decreased nationally (2 year mortality: 17.3% vs. 14.6%; p< 0.001) as well as regionally. Waitlist time for UNOS status 1A & 1B candidates increased nationally 17.8 days on average (p< 0.001) with variability between the regions. The greatest increases were in Region 9 (59.2 day increase, p< 0.001) and Region 4 (41.2 day increase, p< 0.001). While the use of mechanical circulatory support increased nearly 2.3-fold nationally in Era 2, significant differences were present on a regional basis. In Regions 6, 7 and 10, nearly 40% of those transplanted required LVAD bridging while only 19.6%, 22.3% and 15.5% required an LVAD in regions 3, 4, and 5, respectively. Conclusion: Significant regional heterogeneity with respect to waitlist time and reliance on mechanical circulatory support as a bridge to transplantation exists even after the 2006 UNOS allocation policy change. Overall both waitlist mortality and post-transplant survival are improved. 3( 08) The Proceed II International Heart Transplant Trial with the Organ Care System (OCS™) Technology A. Ardehali ,1 F. Esmailian,2 M. Deng,3 E. Soltesz,4 E. Hsich,5 Y. Naka,6 D. Mancini,7 M. Camacho,8 D. Baran,9 M. Zucker,10 P. Leprince,11 J. Madsen,12 S. Tsui,13 A. Simon,14 U. Livi,15 G. Guzzi,15 J. Kobashigawa.16 1Division of Cardiothoracic Surgery, UCLA Medical Center, Los Angeles, CA; 2Heart Transplantation, Cedars-Sinai Heart Institute, Los Angeles, CA; 3Advanced Heart Failure, Heart Transplant Program, UCLA Medical Center, Los Angeles, CA; 4Division of Cardiothoracic Surgery, Cleveland Clinic Foundation, Cleveland, OH; 5Heart Transplantation, Cleveland Clinic Foundation, Cleveland, OH; 6Department of Cardiac Surgery, Columbia University, New York, NY; 7Heart Failure, Heart Transplant Program, Columbia University, New York, NY; 8Cardiac Transplantation and Mechanical Device Program, Barnabas Health Heart Center at Newark Beth Israel Medical Center, Newark, NJ; 9Heart Failure and Transplant Research, Barnabas Health Heart Center at Newark Beth Israel Medical Center, Newark, NJ; 10Heart Failure Treatment and Transplant, Barnabas Health Heart Center at Newark Beth Israel Medical Center, Newark, NJ; 11Chirurgie Thoracique et Cardiovasculaire,
Purpose: The PROCEED II Trial is an international, FDA-approved pivotal trial to assess the clinical efficacy and safety of the OCS™ Heart technology for heart transplantation. Methods: PROCEED II is a prospective, multicenter, international trial comparing OCS™ technology to cold storage to preserve donor hearts for transplantation. A total of 128 heart transplant recipients have been transplanted. Donor inclusion criteria: age 60 mmHg, satisfactory ECHO assessment. Donor exclusion criteria: abnormal coronary angiogram, unstable hemodynamic requiring high-inotropic support , and donor/recipient weight ratio of< 0.6. Recipient inclusion criteria: age ≥ 18 years, primary heart transplant recipient, signed informed consent. Recipient exclusion criteria: > 4 sternotomies, renal failure (Cr> 3.0 mg/dL), ventilator dependency, PRA > 40% with positive cross match, presence of VAD line sepsis, intra-cranial hemorrhage, or documented heparin induced thrombocytopenia, and the use of another investigational drug/device. Results: Primary endpoint: 30-day patient and graft survival; Secondary endpoints: Incidences of cardiac SAEs, grade 2R/3R rejection and ICU time. Conclusion: 128 patients have been transplanted to date. We will report the trial results at the ISHLT late breaking session. 3( 09) Heart Transplantation With Organs Procured After Cardio-Circulatory Death and the Organ Care System. Assessment and Reconditioning of Hearts in a Porcine Model D. García Sáez ,1 A. Elbetanony,2 P. Lezberg,2 A. Hassanein,2 B. Zych,1 A. Sabashnikov,1 P. Mohite,1 N. Patil,1 A. Weymann,1 A.R. Simon.1 1Harefield Hospital NHS Trust, Harefield, London, United Kingdom; 2TransMedics, Boston, MA. Purpose: Donation after cardiac death (DCD) has lead to an increase in organ availability. For obvious reasons, DCD hearts could not be used for transplantation. A number of scenarios have been suggested in which DCD hearts could be used, most involving the re-establishing of blood flow within the donor by a variety of means. This leads to enormous ethical challenges based on the physiological situation within the donor. We propose to procure the heart alongside the other organs in a standard manner followed by an ex vivo assessment and reconditioning using the Organ Care System (OCS) (TransMedics, Andover, MA, USA). The OCS is a mobile unit which allows for preservation and transport of a continuously perfused, beating heart, thereby avoiding the effects of cold ischemic storage and providing further assessment options, which is used in clinical transplantation for extended criteria donors by us. Methods: The study protocol reflects the UK’s current clinical DCD protocol and practice. 5 pigs were anaesthetized with isofluorane. No heparin was administered. Cardio circulatory death was induced by cessation of mechanical ventilation. Agonal time (AT) was calculated as the time between a reduction of blood pressure below 50 mmHg or a fall in saturation beneath 70% and the cessation of electrical activity. After a further 15 min. of warm ischemia, hearts were procured and implanted into the OCS, mimicking the actual clinical scenario for other organs. Thus procured grafts were reconditioned in the OCS and assessed over a period of 4 hrs. Results: 4 hearts were successfully resuscitated in the system (AT 8, 15, 20 and 34 min.) with an overall time from withdrawal to OCS perfusion (WtP) of 41, 50, 67and 79 min., respectively. 3/4 had excellent contractility and lactate trends and were considered to be transplantable. 1/4 (AT 34 min, WtP 79 min.) had an increased lactate and abnormal contractility being unsuitable for transplantation. One heart with 48 min. AT and a WtP of 90 min. could not be resuscitated. Conclusion: Our data show that hearts from not heparinized, DCD donors can be successfully reconditioned using the OCS in a scenario simulating actual clinical conditions. Based on the results we plan to assess the model in a clinical DCD environment. The study was funded by TransMedics, Andover, MA, USA.
The Journal of Heart and Lung Transplantation, Vol 32, No 4S, April 2014 hospitalier Pitié-Salpétrière, Paris, France; 12Division of Cardiothoracic Surgery, Massachusetts General Hospital, Boston, MA; 13Division of Cardiothoracic Surgery, Papworth Hospital, Cambridge, United Kingdom; 14Thoracic Transplantation and Mechanical Support, Harefield Hospital, Harefield, United Kingdom; 15Cardiac Surgery and Transplantation Unit, “Santa Maria della Misericordia” University Hospital, Udine, Italy; 16Advanced Heart Disease Section,Heart Transplant Program, CedarsSinai Medical Center, Los Angeles, CA.
3( 07) Differences in Regional Recipient Waitlist Time and Pre- and PostTransplant Mortality Following the 2006 UNOS Policy Changes in the Donor Heart Allocation Algorithm S. Kitada ,1 P. Schulze,2 K. Clerkin,1 Z. Jin,1 D.M. Mancini.1 1Columbia University Medical Center, New York, NY; 2Department of Medicine, Division of Cardiology, Columbia University Medical Center, New York, NY. Purpose: In 2006, a UNOS thoracic organ allocation policy change was implemented allowing for greater regional sharing of organs. Our current analysis examined the impact of these changes on regional differences in waitlist time and mortality before and after heart transplantation (HTx). Methods: We analyzed 36,789 patients who were listed for HTx from January 1999 through April 2012 separated into two eras centered on the July 12, 2006 UNOS policy change date. Pre- and post transplantation characteristics were compared overall and by UNOS regions. Results: Waitlist mortality decreased nationally (up to 180 days: 13.3 versus 7.9% after the UNOS policy change, p< 0.001) and within each region. Similarly, two-year post-transplant mortality decreased nationally (2 year mortality: 17.3% vs. 14.6%; p< 0.001) as well as regionally. Waitlist time for UNOS status 1A & 1B candidates increased nationally 17.8 days on average (p< 0.001) with variability between the regions. The greatest increases were in Region 9 (59.2 day increase, p< 0.001) and Region 4 (41.2 day increase, p< 0.001). While the use of mechanical circulatory support increased nearly 2.3-fold nationally in Era 2, significant differences were present on a regional basis. In Regions 6, 7 and 10, nearly 40% of those transplanted required LVAD bridging while only 19.6%, 22.3% and 15.5% required an LVAD in regions 3, 4, and 5, respectively. Conclusion: Significant regional heterogeneity with respect to waitlist time and reliance on mechanical circulatory support as a bridge to transplantation exists even after the 2006 UNOS allocation policy change. Overall both waitlist mortality and post-transplant survival are improved. 3( 08) The Proceed II International Heart Transplant Trial with the Organ Care System (OCS™) Technology A. Ardehali ,1 F. Esmailian,2 M. Deng,3 E. Soltesz,4 E. Hsich,5 Y. Naka,6 D. Mancini,7 M. Camacho,8 D. Baran,9 M. Zucker,10 P. Leprince,11 J. Madsen,12 S. Tsui,13 A. Simon,14 U. Livi,15 G. Guzzi,15 J. Kobashigawa.16 1Division of Cardiothoracic Surgery, UCLA Medical Center, Los Angeles, CA; 2Heart Transplantation, Cedars-Sinai Heart Institute, Los Angeles, CA; 3Advanced Heart Failure, Heart Transplant Program, UCLA Medical Center, Los Angeles, CA; 4Division of Cardiothoracic Surgery, Cleveland Clinic Foundation, Cleveland, OH; 5Heart Transplantation, Cleveland Clinic Foundation, Cleveland, OH; 6Department of Cardiac Surgery, Columbia University, New York, NY; 7Heart Failure, Heart Transplant Program, Columbia University, New York, NY; 8Cardiac Transplantation and Mechanical Device Program, Barnabas Health Heart Center at Newark Beth Israel Medical Center, Newark, NJ; 9Heart Failure and Transplant Research, Barnabas Health Heart Center at Newark Beth Israel Medical Center, Newark, NJ; 10Heart Failure Treatment and Transplant, Barnabas Health Heart Center at Newark Beth Israel Medical Center, Newark, NJ; 11Chirurgie Thoracique et Cardiovasculaire,
Purpose: The PROCEED II Trial is an international, FDA-approved pivotal trial to assess the clinical efficacy and safety of the OCS™ Heart technology for heart transplantation. Methods: PROCEED II is a prospective, multicenter, international trial comparing OCS™ technology to cold storage to preserve donor hearts for transplantation. A total of 128 heart transplant recipients have been transplanted. Donor inclusion criteria: age 60 mmHg, satisfactory ECHO assessment. Donor exclusion criteria: abnormal coronary angiogram, unstable hemodynamic requiring high-inotropic support , and donor/recipient weight ratio of< 0.6. Recipient inclusion criteria: age ≥ 18 years, primary heart transplant recipient, signed informed consent. Recipient exclusion criteria: > 4 sternotomies, renal failure (Cr> 3.0 mg/dL), ventilator dependency, PRA > 40% with positive cross match, presence of VAD line sepsis, intra-cranial hemorrhage, or documented heparin induced thrombocytopenia, and the use of another investigational drug/device. Results: Primary endpoint: 30-day patient and graft survival; Secondary endpoints: Incidences of cardiac SAEs, grade 2R/3R rejection and ICU time. Conclusion: 128 patients have been transplanted to date. We will report the trial results at the ISHLT late breaking session. 3( 09) Heart Transplantation With Organs Procured After Cardio-Circulatory Death and the Organ Care System. Assessment and Reconditioning of Hearts in a Porcine Model D. García Sáez ,1 A. Elbetanony,2 P. Lezberg,2 A. Hassanein,2 B. Zych,1 A. Sabashnikov,1 P. Mohite,1 N. Patil,1 A. Weymann,1 A.R. Simon.1 1Harefield Hospital NHS Trust, Harefield, London, United Kingdom; 2TransMedics, Boston, MA. Purpose: Donation after cardiac death (DCD) has lead to an increase in organ availability. For obvious reasons, DCD hearts could not be used for transplantation. A number of scenarios have been suggested in which DCD hearts could be used, most involving the re-establishing of blood flow within the donor by a variety of means. This leads to enormous ethical challenges based on the physiological situation within the donor. We propose to procure the heart alongside the other organs in a standard manner followed by an ex vivo assessment and reconditioning using the Organ Care System (OCS) (TransMedics, Andover, MA, USA). The OCS is a mobile unit which allows for preservation and transport of a continuously perfused, beating heart, thereby avoiding the effects of cold ischemic storage and providing further assessment options, which is used in clinical transplantation for extended criteria donors by us. Methods: The study protocol reflects the UK’s current clinical DCD protocol and practice. 5 pigs were anaesthetized with isofluorane. No heparin was administered. Cardio circulatory death was induced by cessation of mechanical ventilation. Agonal time (AT) was calculated as the time between a reduction of blood pressure below 50 mmHg or a fall in saturation beneath 70% and the cessation of electrical activity. After a further 15 min. of warm ischemia, hearts were procured and implanted into the OCS, mimicking the actual clinical scenario for other organs. Thus procured grafts were reconditioned in the OCS and assessed over a period of 4 hrs. Results: 4 hearts were successfully resuscitated in the system (AT 8, 15, 20 and 34 min.) with an overall time from withdrawal to OCS perfusion (WtP) of 41, 50, 67and 79 min., respectively. 3/4 had excellent contractility and lactate trends and were considered to be transplantable. 1/4 (AT 34 min, WtP 79 min.) had an increased lactate and abnormal contractility being unsuitable for transplantation. One heart with 48 min. AT and a WtP of 90 min. could not be resuscitated. Conclusion: Our data show that hearts from not heparinized, DCD donors can be successfully reconditioned using the OCS in a scenario simulating actual clinical conditions. Based on the results we plan to assess the model in a clinical DCD environment. The study was funded by TransMedics, Andover, MA, USA.