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Outcomes in Patients Bridged With Univentricular and Biventricular Devices Prior to Heart Transplantation
S180
The Journal of Heart and Lung Transplantation, Vol 34, No 4S, April 2015
4( 75) A Novel Minimally Invasive Ovine Model of Ischemic Cardiomyopathy With Advanced Cardiac Imaging Yields Superior Results and Survival J.E. Cohen ,1 A.B. Goldstone,1 Y. Shudo,1 J.W. MacArthur,2 J.B. Patel,1 B.B. Edwards,1 W.L. Patrick,1 C.N. Aribeana,1 Y. Woo.1 1Cardiothoracic Surgery, Stanford University, Stanford, CA; 2Surgery, University of Pennsylvania, Philadelphia, PA. Purpose: Optimization of large animal heart failure models are critical to the translational science which supports development of novel cardiac failure therapeutics. Our goal was to greatly enhance the ovine ischemic cardiomyopathy model by implementing advanced cardiac imaging and closed-chest analysis including MRI, 3D transesophageal echocardiography (TEE), and left ventricular (LV) pressure-volume characterization. Additionally, we aimed to minimize morbidity and mortality by utilizing a minimally invasive approach, short operative time, and meticulous control of hemodynamics and anti-arrhythmic administration. Methods: Male Dorsett sheep (n= 18) were pretreated with oral amiodarone for 3 days. They were intubated and underwent baseline cardiac MRI and TEE. The sheep were then taken to a hybrid operating room where biventricular catheterization was performed fluoroscopically for pressure-volume analysis, including preload-independent assessment with inferior vena cava occlusion. Following data acquisition, IV amiodarone and lidocaine were given. A mean arterial pressure (MAP) greater than 60 was maintained, and a normal arterial pH was achieved. A mini 5 cm thoracotomy was performed for LV exposure. To achieve a 30-35% infarct, the second and third diagonal, and distal LAD were ligated. Sheep were recovered following pneumothorax evacuation. They survived for 8 weeks until terminal surgery where identical closed chest hemodynamics were obtained. Results: All sheep recovered from surgery yielding a 100% (18/18) operative survival, while 1 sheep expired post-operatively from respiratory failure yielding a total 94% study survival. Following catheterization, mean operative time was 98±9 min. The MAP was 70.6±3.2mmHg, mean pulmonary artery pressures were 11.3±1.0mmHg, and arterial pH was 7.49±0.02. At 8 weeks following myocardial infarction, heart failure was demonstrated by MRI, TEE, and biventricular catheterization. By MRI, the mean preoperative ejection fraction was 51.6±4.9% compared to 29.0±6.7% (p< 0.01) at 8 weeks. Conclusion: This novel ovine model of ischemic cardiomyopathy yields superior results in terms of both survival and acquisition of closed-chest physiologic hemodynamics. This is a crucial tool in translating basic science to the clinical realm for the treatment of heart failure. 4( 76) Outcomes in Patients Bridged With Univentricular and Biventricular Devices Prior to Heart Transplantation J.C. Grimm ,1 C.M. Sciortino,1 J. Magruder,1 V. Valero 3rd,1 R.J. Tedford,2 S.D. Russell,2 G.J. Whitman,1 S.C. Silvestry,3 A.S. Shah.1 1Surgery, The Johns Hopkins Medical Institution, Baltimore, MD; 2Medicine, The Johns Hopkins Medical Institution, Baltimore, MD; 3Surgery, Barnes Jewish Hospital, St. Louis, MO. Purpose: The aim of this study was to determine the comparative impact of univentricular and biventricular mechanical assistance on survival in bridged patients following orthotopic heart transplant (OHT). Methods: The United Network for Organ Sharing database was queried for adult patients (≥ 18 years of age) bridged to OHT with either a univentricular (left ventricular assist device [LVAD]) or biventricular (biventricular assist device [BiVAD] and total artificial heart [TAH]) device between 2004 and 2013. Unadjusted survival and conditional survival were calculated with the Kaplan Meier method. Cox proportional-hazards regression models were constructed to determine the relative, risk-adjusted influence of a BiVAD and TAH on mortality. Results: Of the 5,051 patients identified, 4,305 (85.2%), 592 (11.7%) and 154 (3.1%) were bridged with an LVAD, BiVAD and TAH, respectively. The BiVAD cohort experienced the shortest median wait-list duration (52 [21, 131], p< 0.001) and had the greatest percentage of patients in the intensive care unit (45.4%, p< 0.001), mechanically ventilated (9.0%, p< 0.001) and treated with inotropic agents (28.4%, p< 0.001) prior to OHT. Unadjusted 30-day (95.5% v. 91.3% v. 91.5%, p= 0.001), 1-year (88.7% v. 80.9% vs. 80.9%, p< 0.001) and 5-year (74.9% v. 66.0% v. 59.3%, p< 0.001) estimated survival was greater
in LVAD patients when compared to that of the BiVAD and TAH cohorts. Five-year survival conditional on 1-year survival was no different between the LVAD, BiVAD and TAH cohorts (84.5% v. 81.6% v. 73.3%, p= 0.08). Survival in the biventricular failure cohort did not vary based on device type. After risk adjustment, BiVAD and TAH were associated with an increased risk of 30-day (HR: 1.73, p= 0.003; HR: 1.92, p= 0.03), 1-year (HR: 1.73, p< 0.001; HR:1.62, p= 0.02) and 5-year (HR: 1.48, p< 0.001; HR: 1.66, p= 0.003) mortality. BIVAD and TAH were no longer predictive of 5-year mortality, however, after conditional 1-year survival was satisfied (HR 1.17, p= 0.35; HR: 1.68, p= 0.07). Conclusion: Patients with biventricular failure bridged to OHT with either a TAH or BiVAD experience worse short- and long-term survival. This difference is most likely due to an increase in early mortality in this cohort and is irrespective of the type of device implanted (BiVAD or TAH). 4( 77) Strategies for Bridge to Heart Transplantation (HTx) - High Urgent Listing (HU) vs. Mechanical Circulatory Support (MCS) J. Sunavsky , A. Zittermann, B. Fujita, U. Fuchs, J.F. Gummert, S. Ensminger, U. Schulz. Department for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Bad Oeynhausen, Germany. Purpose: HTx is considered the only definite treatment option for endstage heart failure (ESHF) refractory to medical therapy. Implantation of mechanical circulatory support (MCS) devices is increasingly performed as a bridge-to-transplant to overcome the problem with donor organ shortage. We compared clinical outcome in ESHF patients primary listed HU for HTx with patients primarily receiving MCS. Methods: In 268 patients who were listed HU and 348 patients who received MCS at our institution between November 2005 and November 2012, we assessed the probability of HTx and overall survival stratified by Intermacs level during a follow-up period of 12 months. Results: Compared with the MCS group, the probability of HTx was significantly higher in the HU group (80.1% vs. 17.4%, p< 0.001) and so was overall survival (86.5% vs. 54.2%, p< 0.001). The hazard ratio for failure to receive HTx was 12.0 (95% CI: 8.4-17.1; p< 0.001) for the MCS group compared with the HU group after adjustment for baseline characteristics (Intermacs, age, gender, primary diagnosis). The hazard ratio for 12-month overall survival was 3.92 (95% CI: 2.72-5.63; p< 0.001) for HU group compared to MCS. The relative risk for HTx and survival differed significantly depending on the Intermacs level at baseline (Table 1). Conclusion: Despite prolongation of waiting times, medical bridging is safe. Safety of VAD-bridging is inferior to HU-listing due to selection bias of German allocation system. In times of ongoing donor organ shortage allocation policies should be reconsidered. RR for failure to receive HTx and mortality for MCS group compared to HU group after 1 year MCS-group
Intermacs 1 Intermacs 2 Intermacs 3
Failure to receive HTx
Mortality
0.89 (95%CI 0.11-7.42) 4.6 (95%CI 1.2-17.4) 23.1 (95%CI 12.0-44.1)
0.57 (95%CI 0.28-1.18) 1.05 (95%CI 0.57-1.92) 6.36 (95%CI 3.07-13.1)
4( 78) Use of Extra-Corporeal Membrane Oxygenation in Patients Listed for Heart Transplantation A. Cheng ,1 J.R. Trivedi,1 A. Lenneman,2 E. Birks,2 M.S. Slaughter.1 1Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, KY; 2Cardiovascular Medicine, University of Louisville, Louisville, KY. Purpose: Extra-corporeal membrane oxygenation (ECMO) is used as rescue therapy for patients with cardiogenic shock. Its use in end-stage heart failure patients requiring heart transplant is less commonly reported. We aim to use United Network of Organ Sharing (UNOS) database to report and compare outcomes of patients supported with ECMO.
The Journal of Heart and Lung Transplantation, Vol 34, No 4S, April 2015
4( 75) A Novel Minimally Invasive Ovine Model of Ischemic Cardiomyopathy With Advanced Cardiac Imaging Yields Superior Results and Survival J.E. Cohen ,1 A.B. Goldstone,1 Y. Shudo,1 J.W. MacArthur,2 J.B. Patel,1 B.B. Edwards,1 W.L. Patrick,1 C.N. Aribeana,1 Y. Woo.1 1Cardiothoracic Surgery, Stanford University, Stanford, CA; 2Surgery, University of Pennsylvania, Philadelphia, PA. Purpose: Optimization of large animal heart failure models are critical to the translational science which supports development of novel cardiac failure therapeutics. Our goal was to greatly enhance the ovine ischemic cardiomyopathy model by implementing advanced cardiac imaging and closed-chest analysis including MRI, 3D transesophageal echocardiography (TEE), and left ventricular (LV) pressure-volume characterization. Additionally, we aimed to minimize morbidity and mortality by utilizing a minimally invasive approach, short operative time, and meticulous control of hemodynamics and anti-arrhythmic administration. Methods: Male Dorsett sheep (n= 18) were pretreated with oral amiodarone for 3 days. They were intubated and underwent baseline cardiac MRI and TEE. The sheep were then taken to a hybrid operating room where biventricular catheterization was performed fluoroscopically for pressure-volume analysis, including preload-independent assessment with inferior vena cava occlusion. Following data acquisition, IV amiodarone and lidocaine were given. A mean arterial pressure (MAP) greater than 60 was maintained, and a normal arterial pH was achieved. A mini 5 cm thoracotomy was performed for LV exposure. To achieve a 30-35% infarct, the second and third diagonal, and distal LAD were ligated. Sheep were recovered following pneumothorax evacuation. They survived for 8 weeks until terminal surgery where identical closed chest hemodynamics were obtained. Results: All sheep recovered from surgery yielding a 100% (18/18) operative survival, while 1 sheep expired post-operatively from respiratory failure yielding a total 94% study survival. Following catheterization, mean operative time was 98±9 min. The MAP was 70.6±3.2mmHg, mean pulmonary artery pressures were 11.3±1.0mmHg, and arterial pH was 7.49±0.02. At 8 weeks following myocardial infarction, heart failure was demonstrated by MRI, TEE, and biventricular catheterization. By MRI, the mean preoperative ejection fraction was 51.6±4.9% compared to 29.0±6.7% (p< 0.01) at 8 weeks. Conclusion: This novel ovine model of ischemic cardiomyopathy yields superior results in terms of both survival and acquisition of closed-chest physiologic hemodynamics. This is a crucial tool in translating basic science to the clinical realm for the treatment of heart failure. 4( 76) Outcomes in Patients Bridged With Univentricular and Biventricular Devices Prior to Heart Transplantation J.C. Grimm ,1 C.M. Sciortino,1 J. Magruder,1 V. Valero 3rd,1 R.J. Tedford,2 S.D. Russell,2 G.J. Whitman,1 S.C. Silvestry,3 A.S. Shah.1 1Surgery, The Johns Hopkins Medical Institution, Baltimore, MD; 2Medicine, The Johns Hopkins Medical Institution, Baltimore, MD; 3Surgery, Barnes Jewish Hospital, St. Louis, MO. Purpose: The aim of this study was to determine the comparative impact of univentricular and biventricular mechanical assistance on survival in bridged patients following orthotopic heart transplant (OHT). Methods: The United Network for Organ Sharing database was queried for adult patients (≥ 18 years of age) bridged to OHT with either a univentricular (left ventricular assist device [LVAD]) or biventricular (biventricular assist device [BiVAD] and total artificial heart [TAH]) device between 2004 and 2013. Unadjusted survival and conditional survival were calculated with the Kaplan Meier method. Cox proportional-hazards regression models were constructed to determine the relative, risk-adjusted influence of a BiVAD and TAH on mortality. Results: Of the 5,051 patients identified, 4,305 (85.2%), 592 (11.7%) and 154 (3.1%) were bridged with an LVAD, BiVAD and TAH, respectively. The BiVAD cohort experienced the shortest median wait-list duration (52 [21, 131], p< 0.001) and had the greatest percentage of patients in the intensive care unit (45.4%, p< 0.001), mechanically ventilated (9.0%, p< 0.001) and treated with inotropic agents (28.4%, p< 0.001) prior to OHT. Unadjusted 30-day (95.5% v. 91.3% v. 91.5%, p= 0.001), 1-year (88.7% v. 80.9% vs. 80.9%, p< 0.001) and 5-year (74.9% v. 66.0% v. 59.3%, p< 0.001) estimated survival was greater
in LVAD patients when compared to that of the BiVAD and TAH cohorts. Five-year survival conditional on 1-year survival was no different between the LVAD, BiVAD and TAH cohorts (84.5% v. 81.6% v. 73.3%, p= 0.08). Survival in the biventricular failure cohort did not vary based on device type. After risk adjustment, BiVAD and TAH were associated with an increased risk of 30-day (HR: 1.73, p= 0.003; HR: 1.92, p= 0.03), 1-year (HR: 1.73, p< 0.001; HR:1.62, p= 0.02) and 5-year (HR: 1.48, p< 0.001; HR: 1.66, p= 0.003) mortality. BIVAD and TAH were no longer predictive of 5-year mortality, however, after conditional 1-year survival was satisfied (HR 1.17, p= 0.35; HR: 1.68, p= 0.07). Conclusion: Patients with biventricular failure bridged to OHT with either a TAH or BiVAD experience worse short- and long-term survival. This difference is most likely due to an increase in early mortality in this cohort and is irrespective of the type of device implanted (BiVAD or TAH). 4( 77) Strategies for Bridge to Heart Transplantation (HTx) - High Urgent Listing (HU) vs. Mechanical Circulatory Support (MCS) J. Sunavsky , A. Zittermann, B. Fujita, U. Fuchs, J.F. Gummert, S. Ensminger, U. Schulz. Department for Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Bad Oeynhausen, Germany. Purpose: HTx is considered the only definite treatment option for endstage heart failure (ESHF) refractory to medical therapy. Implantation of mechanical circulatory support (MCS) devices is increasingly performed as a bridge-to-transplant to overcome the problem with donor organ shortage. We compared clinical outcome in ESHF patients primary listed HU for HTx with patients primarily receiving MCS. Methods: In 268 patients who were listed HU and 348 patients who received MCS at our institution between November 2005 and November 2012, we assessed the probability of HTx and overall survival stratified by Intermacs level during a follow-up period of 12 months. Results: Compared with the MCS group, the probability of HTx was significantly higher in the HU group (80.1% vs. 17.4%, p< 0.001) and so was overall survival (86.5% vs. 54.2%, p< 0.001). The hazard ratio for failure to receive HTx was 12.0 (95% CI: 8.4-17.1; p< 0.001) for the MCS group compared with the HU group after adjustment for baseline characteristics (Intermacs, age, gender, primary diagnosis). The hazard ratio for 12-month overall survival was 3.92 (95% CI: 2.72-5.63; p< 0.001) for HU group compared to MCS. The relative risk for HTx and survival differed significantly depending on the Intermacs level at baseline (Table 1). Conclusion: Despite prolongation of waiting times, medical bridging is safe. Safety of VAD-bridging is inferior to HU-listing due to selection bias of German allocation system. In times of ongoing donor organ shortage allocation policies should be reconsidered. RR for failure to receive HTx and mortality for MCS group compared to HU group after 1 year MCS-group
Intermacs 1 Intermacs 2 Intermacs 3
Failure to receive HTx
Mortality
0.89 (95%CI 0.11-7.42) 4.6 (95%CI 1.2-17.4) 23.1 (95%CI 12.0-44.1)
0.57 (95%CI 0.28-1.18) 1.05 (95%CI 0.57-1.92) 6.36 (95%CI 3.07-13.1)
4( 78) Use of Extra-Corporeal Membrane Oxygenation in Patients Listed for Heart Transplantation A. Cheng ,1 J.R. Trivedi,1 A. Lenneman,2 E. Birks,2 M.S. Slaughter.1 1Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, KY; 2Cardiovascular Medicine, University of Louisville, Louisville, KY. Purpose: Extra-corporeal membrane oxygenation (ECMO) is used as rescue therapy for patients with cardiogenic shock. Its use in end-stage heart failure patients requiring heart transplant is less commonly reported. We aim to use United Network of Organ Sharing (UNOS) database to report and compare outcomes of patients supported with ECMO.