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Temporary MCS versus Durable MCS as a Bridge to Heart Transplantation
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The Journal of Heart and Lung Transplantation, Vol 38, No 4S, April 2019
861 Novel Extracorporeal Continuous-Flow Ventricular Assist System for Patients with Advanced Heart Failure O. Seguchi,1 T. Fujita,2 Y. Kumai,1 K. Kuroda,1 S. Nakajima,1 T. Watanabe,1 M. Yanase,1 Y. Matsumoto,2 S. Fukushima,2 T. Tsukiya,3 T. Mizuno,3 N. Katagiri,3 Y. Kakuta,3 Y. Takewa,3 T. Hamasaki,4 H. Yamamoto,5 E. Tatsumi,3 J. Kobayashi,3 and N. Fukushima.1 1Department of Transplant Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan; 2Department of Cardiovascular Surgery, National Cerebral and Cardiovascular Center, Osaka, Japan; 3 Department of Artificial Organs, National Cerebral and Cardiovascular Center, Osaka, Japan; 4Office of Biostatistics and Data Management, National Cerebral and Cardiovascular Center, Osaka, Japan; and the 5 Department of Advanced Medical Technology Development, National Cerebral and Cardiovascular Center, Osaka, Japan. Purpose: Ventricular Assist devices are essential but challenging therapeutic options for advanced heart failure patients with critical conditions including cardiogenic shock. In such cases, bridge to decision (BTD) strategies using temporary mechanical circulatory (MCS) support should be introduced to stabilize the systemic conditions and to connect to the next therapeutic stages. We conducted a clinical study (NCVC-BTD_01, National Cerebral and Cardiovascular Center-Bridge to Decision_01) to assess the safety and effectiveness of the novel developed extracorporeal continuous-flow ventricular assist system employing a disposable and hydrodynamically leviated centrifugal pump (BR16010) for BTD strategies. Methods: NCVC-BTD_01 is a single-center, single-arm, open-label, exploratory, medical device, investigator-initiated clinical study. The study was planned using Simon’s minimax two-stage phase design. The primary endpoint is a composite of survival free of device-related serious adverse events and complications during device support. Results: A total of nine patients (6 males, average 47.7§8.1 years) were enrolled for the study. Study subjects included 3 dilated cardiomyopathy, 3 fulminant myocarditis, 2 acute myocardial infarction and 1 chronic ischemic cardiomyopathy. Six patients were interagency registry for mechanically circulatory support (INTERMACS) profile 1 with temporary MCS and all remaining were INTERMACS profile 2. Eight patients received left ventricular support of which 3 initially received concomitant right ventricular support using extracorporeal membrane oxygenation circuit due to severe respiratory failure. One patient with fulminant myocarditis received biventricular support both using BR16010. After average of 19.0§ 13.5 days of support (Range, 9 to 48 days), 3 patients weaned from BR16010 because of native cardiac recovery, whereas 6 patients without cardiac recovery required conversion to durable implantable LVAD for bridge to transplantation. Although 1 patient developed non-disabling ischemic stroke, no patient died during the study period. Conclusion: From the result of NCVC-BTD_01, BTD strategies using BR16010 safely and successfully bridged patients with advanced heart failure to the next therapeutic stages.
862 Temporary MCS versus Durable MCS as a Bridge to Heart Transplantation F. Esmailian, S. Dimbil, R. Levine, M. Kittleson, R. Cole, L. Czer, D. Chang, D. Geft, J. Chung, D. Ramzy, J. Moriguchi and J. Kobashigawa. Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA. Purpose: The waiting time for heart transplantation can be long. Patients that are deemed ineligible for heart transplantation may become candidates due to the beneficial effects of MCS. Choosing to bridge with a short-term temporary device or a long-term durable device is a very important decision. We sought to evaluate the outcome of patients who were bridged with temporary versus durable MCS devices. Methods: Between 2010 and 2017, we assessed 52 patients that were placed on temporary MCS devices (IABP, Impella, and ECMO) and 150 patients that were bridged with durable devices (LVAD, BiVAD, and TAH) prior to heart transplantation. A control non-bridged population was
included (n=521). Endpoints included 30-day, 6-month and 1-year survival; 1-year freedom from cardiac allograft vasculopathy (CAV) as defined by stenosis ≥ 30% by angiography; 1-year freedom from non-fatal major adverse cardiac events (NF-MACE: myocardial infarction, new congestive heart failure, percutaneous coronary intervention, implantable cardioverter defibrillator/pacemaker implant, stroke); and 1-year freedom from anytreated rejection, acute cellular rejection and antibody-mediated rejection. Results: There was no significant difference in survival, CAV, NF-MACE, or rejection between patients bridged with temporary and durable MCS devices. Conclusion: Bridging with either temporary or long-term durable devices appears to have great outcome. A larger sample size is needed to confirm these findings.
Endpoints 30-Day Survival 6-Month Survival 1-Year Survival 1-Year Freedom from CAV 1-Year Freedom from NF-MACE 1-Year Freedom from Any-Treated Rejection 1-Year Freedom from Acute Cellular Rejection 1-Year Freedom from AntibodyMediated Rejection
Temporary MCS (n=52)
Durable MCS (n=150)
HTx Alone (n=521)
Log-Rank P-Value
96.2% 92.3% 90.4% 96.2% 98.1% 94.2%
95.3% 94.0% 89.3% 96.0% 98.0% 89.3%
96.3% 93.8% 90.6% 92.9% 95.2% 87.5%
0.847 0.898 0.819 0.361 0.270 0.439
96.2%
97.3%
94.2%
0.370
98.1%
98.0%
96.5%
0.631
863 Preoperative Computational Fluid Dynamics Simulation of the Best Anastomosis Site and Angle of the Outflow Graft and Ascending Aorta in Continuous Flow Mechanical Assist Devices A. Giacomini,1 A. Esposito,2 T. Nisi,1 E. Lapenna,1 S. Bartesaghi,3 D. Redaelli,3 F. Pappalardo,4 G. Colombo,3 and M. De Bonis.1 1CardioThoracic and Vascular Surgery, San Raffaele Scientific Institute, Milan, Italy; 2Experimental Imaging Center, San Raffaele Scientific Institute, Milan, Italy; 3Department of Mechanical Engineering, Politecnico di Milano, Milan, Italy; and the 4Cardio-Vascular Intensive Care Unit, San Raffaele Scientific Institute, Milan, Italy. Purpose: Left ventricle assist devices (LVAD) have contributed to improve survival and quality of life in patients with advanced heart failure, in temporary or lifetime support. Despite technological, bio-compatibility and hemodynamic progress, patients with LVAD have still a relevant incidence of adverse events, such as disabling stroke. The outflow cannula (OC) position and angulation, and the anastomosis site seem to modify the flow in the ascending aorta (AA), and consequently the incidence of cerebral embolism and aortic cusps stress. Methods: We evaluated the combination of LVAD flow and the residual cardiac output pulsatile flow with computational fluid dynamics (CFD) software based on CT Scan images. Results: Two patients with centrifugal pump LVAD underwent CT Scan regardless of this study, respectively at 7 months and 1.5 years after LVAD implant. We analyzed CT images and made a CFD reconstruction of the anastomosis site, to evaluate the flow in AA. At the same time, in a bench validation test we anastomosed a dacron 32 mm graft (reproducing the AA) and a 14 mm graft (reproducing the OC). We simulated the difference in flow and turbulence, according to different angles of the anastomosis, and the alternative distances from the major cranial branches. Following results of the CFD analysis, we can affirm that it is possible to simulate the optimal flow, improving the laminar flow and reducing the turbulence in the aortic lumen. Moreover, based on the desired angle of the aortic-graft anastomosis, the surgeon can perform the anastomosis with the best shape of the OC (cutting the graft with the angle obtained by the CFD simulation, and incising the AA with the right extension).
The Journal of Heart and Lung Transplantation, Vol 38, No 4S, April 2019
861 Novel Extracorporeal Continuous-Flow Ventricular Assist System for Patients with Advanced Heart Failure O. Seguchi,1 T. Fujita,2 Y. Kumai,1 K. Kuroda,1 S. Nakajima,1 T. Watanabe,1 M. Yanase,1 Y. Matsumoto,2 S. Fukushima,2 T. Tsukiya,3 T. Mizuno,3 N. Katagiri,3 Y. Kakuta,3 Y. Takewa,3 T. Hamasaki,4 H. Yamamoto,5 E. Tatsumi,3 J. Kobayashi,3 and N. Fukushima.1 1Department of Transplant Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan; 2Department of Cardiovascular Surgery, National Cerebral and Cardiovascular Center, Osaka, Japan; 3 Department of Artificial Organs, National Cerebral and Cardiovascular Center, Osaka, Japan; 4Office of Biostatistics and Data Management, National Cerebral and Cardiovascular Center, Osaka, Japan; and the 5 Department of Advanced Medical Technology Development, National Cerebral and Cardiovascular Center, Osaka, Japan. Purpose: Ventricular Assist devices are essential but challenging therapeutic options for advanced heart failure patients with critical conditions including cardiogenic shock. In such cases, bridge to decision (BTD) strategies using temporary mechanical circulatory (MCS) support should be introduced to stabilize the systemic conditions and to connect to the next therapeutic stages. We conducted a clinical study (NCVC-BTD_01, National Cerebral and Cardiovascular Center-Bridge to Decision_01) to assess the safety and effectiveness of the novel developed extracorporeal continuous-flow ventricular assist system employing a disposable and hydrodynamically leviated centrifugal pump (BR16010) for BTD strategies. Methods: NCVC-BTD_01 is a single-center, single-arm, open-label, exploratory, medical device, investigator-initiated clinical study. The study was planned using Simon’s minimax two-stage phase design. The primary endpoint is a composite of survival free of device-related serious adverse events and complications during device support. Results: A total of nine patients (6 males, average 47.7§8.1 years) were enrolled for the study. Study subjects included 3 dilated cardiomyopathy, 3 fulminant myocarditis, 2 acute myocardial infarction and 1 chronic ischemic cardiomyopathy. Six patients were interagency registry for mechanically circulatory support (INTERMACS) profile 1 with temporary MCS and all remaining were INTERMACS profile 2. Eight patients received left ventricular support of which 3 initially received concomitant right ventricular support using extracorporeal membrane oxygenation circuit due to severe respiratory failure. One patient with fulminant myocarditis received biventricular support both using BR16010. After average of 19.0§ 13.5 days of support (Range, 9 to 48 days), 3 patients weaned from BR16010 because of native cardiac recovery, whereas 6 patients without cardiac recovery required conversion to durable implantable LVAD for bridge to transplantation. Although 1 patient developed non-disabling ischemic stroke, no patient died during the study period. Conclusion: From the result of NCVC-BTD_01, BTD strategies using BR16010 safely and successfully bridged patients with advanced heart failure to the next therapeutic stages.
862 Temporary MCS versus Durable MCS as a Bridge to Heart Transplantation F. Esmailian, S. Dimbil, R. Levine, M. Kittleson, R. Cole, L. Czer, D. Chang, D. Geft, J. Chung, D. Ramzy, J. Moriguchi and J. Kobashigawa. Smidt Heart Institute at Cedars-Sinai, Los Angeles, CA. Purpose: The waiting time for heart transplantation can be long. Patients that are deemed ineligible for heart transplantation may become candidates due to the beneficial effects of MCS. Choosing to bridge with a short-term temporary device or a long-term durable device is a very important decision. We sought to evaluate the outcome of patients who were bridged with temporary versus durable MCS devices. Methods: Between 2010 and 2017, we assessed 52 patients that were placed on temporary MCS devices (IABP, Impella, and ECMO) and 150 patients that were bridged with durable devices (LVAD, BiVAD, and TAH) prior to heart transplantation. A control non-bridged population was
included (n=521). Endpoints included 30-day, 6-month and 1-year survival; 1-year freedom from cardiac allograft vasculopathy (CAV) as defined by stenosis ≥ 30% by angiography; 1-year freedom from non-fatal major adverse cardiac events (NF-MACE: myocardial infarction, new congestive heart failure, percutaneous coronary intervention, implantable cardioverter defibrillator/pacemaker implant, stroke); and 1-year freedom from anytreated rejection, acute cellular rejection and antibody-mediated rejection. Results: There was no significant difference in survival, CAV, NF-MACE, or rejection between patients bridged with temporary and durable MCS devices. Conclusion: Bridging with either temporary or long-term durable devices appears to have great outcome. A larger sample size is needed to confirm these findings.
Endpoints 30-Day Survival 6-Month Survival 1-Year Survival 1-Year Freedom from CAV 1-Year Freedom from NF-MACE 1-Year Freedom from Any-Treated Rejection 1-Year Freedom from Acute Cellular Rejection 1-Year Freedom from AntibodyMediated Rejection
Temporary MCS (n=52)
Durable MCS (n=150)
HTx Alone (n=521)
Log-Rank P-Value
96.2% 92.3% 90.4% 96.2% 98.1% 94.2%
95.3% 94.0% 89.3% 96.0% 98.0% 89.3%
96.3% 93.8% 90.6% 92.9% 95.2% 87.5%
0.847 0.898 0.819 0.361 0.270 0.439
96.2%
97.3%
94.2%
0.370
98.1%
98.0%
96.5%
0.631
863 Preoperative Computational Fluid Dynamics Simulation of the Best Anastomosis Site and Angle of the Outflow Graft and Ascending Aorta in Continuous Flow Mechanical Assist Devices A. Giacomini,1 A. Esposito,2 T. Nisi,1 E. Lapenna,1 S. Bartesaghi,3 D. Redaelli,3 F. Pappalardo,4 G. Colombo,3 and M. De Bonis.1 1CardioThoracic and Vascular Surgery, San Raffaele Scientific Institute, Milan, Italy; 2Experimental Imaging Center, San Raffaele Scientific Institute, Milan, Italy; 3Department of Mechanical Engineering, Politecnico di Milano, Milan, Italy; and the 4Cardio-Vascular Intensive Care Unit, San Raffaele Scientific Institute, Milan, Italy. Purpose: Left ventricle assist devices (LVAD) have contributed to improve survival and quality of life in patients with advanced heart failure, in temporary or lifetime support. Despite technological, bio-compatibility and hemodynamic progress, patients with LVAD have still a relevant incidence of adverse events, such as disabling stroke. The outflow cannula (OC) position and angulation, and the anastomosis site seem to modify the flow in the ascending aorta (AA), and consequently the incidence of cerebral embolism and aortic cusps stress. Methods: We evaluated the combination of LVAD flow and the residual cardiac output pulsatile flow with computational fluid dynamics (CFD) software based on CT Scan images. Results: Two patients with centrifugal pump LVAD underwent CT Scan regardless of this study, respectively at 7 months and 1.5 years after LVAD implant. We analyzed CT images and made a CFD reconstruction of the anastomosis site, to evaluate the flow in AA. At the same time, in a bench validation test we anastomosed a dacron 32 mm graft (reproducing the AA) and a 14 mm graft (reproducing the OC). We simulated the difference in flow and turbulence, according to different angles of the anastomosis, and the alternative distances from the major cranial branches. Following results of the CFD analysis, we can affirm that it is possible to simulate the optimal flow, improving the laminar flow and reducing the turbulence in the aortic lumen. Moreover, based on the desired angle of the aortic-graft anastomosis, the surgeon can perform the anastomosis with the best shape of the OC (cutting the graft with the angle obtained by the CFD simulation, and incising the AA with the right extension).