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762 Use of Sealed Grafts in the HeartMate II Inflow and Outflow Conduits
S260
The Journal of Heart and Lung Transplantation, Vol 31, No 4S, April 2012
761
763
Two CircuLite Pumps as Bi-Ventricular Assist Device (BVAD) in an Ovine Animal Model J.D. Schmitto,1 D. Burkhoff,2,3 M. Avsar,1 O. Fey,3 P. Ziehme,1 G. Buechler,1 A. Haverich,1 M. Strueber.1 1Dept. of Cardiothoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany; 2Dept. of Cardiology, Columbia University, New York, NY; 3CircuLite Inc., Aachen, Germany.
Extracorporeal Membrane Oxygenation Support after Pediatric Heart Transplantation: Predictors of Survival to Hospital Discharge J.A. Su, R.B. Kelly, J. Alejos. Pediatrics, Mattel Children’s Hospital UCLA, Los Angeles, CA.
Purpose: The purpose of this study was to investigate the use of two CircuLite micro-pumps for full biventricular assist in sheep. We therefore examined right and left sided hemodynamic parameters over a range of right and left sided pump speeds. Methods and Materials: Five juvenile sheep (mean-weight 43kg) were implanted with CircuLite pumps in the RV and the LV through a median sternotomy. The RVAD outflow graft was anastomosed end-to-side to the pulmonary artery, and the LVAD outflow to the ascending aorta. After surgical implantation of both pumps we induced ventricular fibrillation and hemodynamic changes were measured using nine different levels of RVAD pump speed (from 20-28k rpm at 1k increments) while the speed of the LVAD was set constant at 24k, then at 26k and finally at 28k rpm. Results: Average results from the 5 sheep with LVAD speed fixed at 24K are shown in the Figure. At any given LVAD speed, both RVAD and LVAD flow increased identically as RVAD speed was increased. Results were similar with LVAD set at the higher speeds. At the highest LVAD and RVAD speeds, flow averaged 3.1⫾0.7 L/min, and pressures in the right atrium, pulmonary artery, left atrium and aorta averaged 2.2⫾3.7, 24.4⫾6.5, 22.4⫾5.5, and 56.6⫾8.5 mmHg, respectively. Conclusions: Biventricular assist with the two CircuLite pumps is feasible and able to provide full hemodynamic support in sheep. This approach holds promise for providing biventricular partial support in humans and, in particular, for full support in small adults and children. 762 Use of Sealed Grafts in the HeartMate II Inflow and Outflow Conduits I. Gregoric, R. Radovancevic, M. Patel, L. Fenik, W. Cohn, O.H. Frazier. Center for Cardiac Support, Texas Heart Institute at St. Luke’s Episcopal Hospital, Houston, TX. Purpose: This study was conducted to assess differences in major adverse events in patients with an implanted HeartMate II LVAD (HMII) with either the new non-porous sealed graft (S-graft) or a porous non-sealed graft (NS-graft) on the inflow and outflow conduits. Methods and Materials: Data were analyzed from 122 patients consecutively implanted with the HMII between February 2010 and September 2011. Postoperative blood product transfusions and values for hemoglobin (Hgb), lactic dehydrogenase (LDH), and infection and stroke rates were compared between the S-graft (n⫽47) and NS-graft (N⫽75) groups. Results: Blood product transfusions were required significantly less often in the S-graft group than in the NS-graft group: RBCs, 4.1⫾3.5 vs 6.3⫾5.5 (P⫽0.011); FFP, 5.1⫾2.7 vs 8.6⫾8.9 (P⫽0.002); platelets, 3.8⫾1.9 vs 5.2⫾3.9 (P⫽0.011); and cryoprecipitate, 1.3⫾1.0 vs 2.0⫾1.9 (P⫽0.007). Hemoglobin levels 12 hours postop were significantly lower in the NSgroup than in the S-group (10.9⫾1.4 vs 11.9⫾1.1 g/dl; P⫽0.003), even though the NS-group received more blood product transfusions. The LDH values were not different between the S-group and NS-group at 14 days (514.4⫾219.4 vs 522.8⫾301.6 U/L, P⫽0.899) and 30 days (476.7⫾232.2 vs 446.5⫾289.4 U/L, P⫽0.805) after implantation. No device-related infections occurred in the S-group, but the NS-group had 3 driveline infections: 28, 40, and 66 days post-implant. Fewer strokes occurred in the S-group (1/47, 2%) as compared to the NS-group (5/75, 7%), P⫽0.404. The 30-day survival rate was not significantly different between groups (P⫽0.087), but the proportion alive favored the S-group (46/47, 98%) over the NS-group (66/75, 88%). Conclusions: Use of a HMII with a sealed rather than a non-sealed graft on the inflow and outflow conduits is associated with less postoperative bleeding, and there is a trend for patients with the sealed graft to have fewer infection and stroke events.
Purpose: Extracorporeal membrane oxygenation (ECMO)can provide hemodynamic support in the setting of cardiac failure and can be used successfully after pediatric orthotopic heart transplant (OHT) for primary graft dysfunction or rejection. The objective of our study is to analyze variables predictive of survival to hospital discharge following ECMO in the pediatric OHT population. Methods and Materials: In this retrospective cohort study, clinical and laboratory data from 29 pediatric patients (age ⬍21 years) who underwent OHT between 1998 and 2010 at our institution and required subsequent ECMO were reviewed and analyzed using logistic regression. Results: Of the 29 patients reviewed, 18 survived to hospital discharge (62%). Survival to hospital discharge was not associated with gender, age, ischemic time, or duration of ECMO. Mortality was independently associated with end-organ complications sustained while on ECMO. Pulmonary (14% survival, p⫽0.012) and renal (41% survival, p⫽0.017) complications were highly associated with death. Hemorrhagic, metabolic (hypoand hyperglycemia, hyperbilirubinemia), and cardiac complications (arrhythmia, CPR requirement, hypertension) were also associated with mortality (p⫽0.024, p⫽0.045, and p⫽0.049, respectively). A higher PaO2 prior to institution of ECMO (p⫽0.03) and a higher post-transplant ejection fraction (EF) prior to the institution of ECMO (p⫽0.046) correlated with improved survival. Conclusions: The success of ECMO in the pediatric OHT population is affected by the development of secondary end-organ injury, with pulmonary and renal complications resulting in the highest mortality rates. With improved survival associated with a higher PaO2 and post-OHT EF prior to institution of ECMO, early ECMO intervention and the lack of pulmonary and renal complications after cannulation may predict optimal survival. 764 Is There Adequate Knowledge about LVAD Patients among First Responders? A Survey from North Western Italy A. Municinò, A. Torriglia, On Behalf of Rete per l’Emergenza-Urgenza. Dept. of Cardiology, Ospedale A. Gallino ASL3 Genovese, Genova, Italy. Purpose: Latest generation LVAD (Left Ventricular Assist Devices) represent a growing reality for patients with end stage heart failure (HF). The number of continuous flow (CF) LVAD implants has sharply increased in the last decade and it is expected to double over the next 5 years due to donor organ shortage and to the increased number of older pts reaching end stage HF. After LVAD implant many pts are discharged home, able to resume their normal lifestyle. They can drive, go back to work, and take part to social life as same age population: therefore they are exposed to the same risks and rely on the first responders care in case of emergency. Aim. To evaluate awareness among first responders and EMD personnel that CF LVAD pts are usually pulseless and that chest compressions may damage the device. Methods and Materials: A survey based on a 7 items questionnaire was delivered to first responders and EMD personnel from North Western Italy. The questionnaire tested 3 knowledge areas about continuous flow LVAD pts. 1. LVAD implant is a surgical therapy for end stage HF that allows pts to be discharged home and to resume a normal life style. 2. Continuous flow LVAD pts are usually pulseless and their systolic BP is reliably measurable by Doppler flow probe. 3. Chest compressions may damage the device. Results: We received 240 completed questionnaires. The percentage of correct answers for each of the 3 knowledge areas was respectively 55,0% (134 vs 106 for area 1), 4,1% (10 vs 230 for area 2), 1,6% (4 vs 236 for area 3). Conclusions: The present Survey shows that first responders and EMD personnel are not aware of basic concepts about CF LVAD pts. Their key
The Journal of Heart and Lung Transplantation, Vol 31, No 4S, April 2012
761
763
Two CircuLite Pumps as Bi-Ventricular Assist Device (BVAD) in an Ovine Animal Model J.D. Schmitto,1 D. Burkhoff,2,3 M. Avsar,1 O. Fey,3 P. Ziehme,1 G. Buechler,1 A. Haverich,1 M. Strueber.1 1Dept. of Cardiothoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany; 2Dept. of Cardiology, Columbia University, New York, NY; 3CircuLite Inc., Aachen, Germany.
Extracorporeal Membrane Oxygenation Support after Pediatric Heart Transplantation: Predictors of Survival to Hospital Discharge J.A. Su, R.B. Kelly, J. Alejos. Pediatrics, Mattel Children’s Hospital UCLA, Los Angeles, CA.
Purpose: The purpose of this study was to investigate the use of two CircuLite micro-pumps for full biventricular assist in sheep. We therefore examined right and left sided hemodynamic parameters over a range of right and left sided pump speeds. Methods and Materials: Five juvenile sheep (mean-weight 43kg) were implanted with CircuLite pumps in the RV and the LV through a median sternotomy. The RVAD outflow graft was anastomosed end-to-side to the pulmonary artery, and the LVAD outflow to the ascending aorta. After surgical implantation of both pumps we induced ventricular fibrillation and hemodynamic changes were measured using nine different levels of RVAD pump speed (from 20-28k rpm at 1k increments) while the speed of the LVAD was set constant at 24k, then at 26k and finally at 28k rpm. Results: Average results from the 5 sheep with LVAD speed fixed at 24K are shown in the Figure. At any given LVAD speed, both RVAD and LVAD flow increased identically as RVAD speed was increased. Results were similar with LVAD set at the higher speeds. At the highest LVAD and RVAD speeds, flow averaged 3.1⫾0.7 L/min, and pressures in the right atrium, pulmonary artery, left atrium and aorta averaged 2.2⫾3.7, 24.4⫾6.5, 22.4⫾5.5, and 56.6⫾8.5 mmHg, respectively. Conclusions: Biventricular assist with the two CircuLite pumps is feasible and able to provide full hemodynamic support in sheep. This approach holds promise for providing biventricular partial support in humans and, in particular, for full support in small adults and children. 762 Use of Sealed Grafts in the HeartMate II Inflow and Outflow Conduits I. Gregoric, R. Radovancevic, M. Patel, L. Fenik, W. Cohn, O.H. Frazier. Center for Cardiac Support, Texas Heart Institute at St. Luke’s Episcopal Hospital, Houston, TX. Purpose: This study was conducted to assess differences in major adverse events in patients with an implanted HeartMate II LVAD (HMII) with either the new non-porous sealed graft (S-graft) or a porous non-sealed graft (NS-graft) on the inflow and outflow conduits. Methods and Materials: Data were analyzed from 122 patients consecutively implanted with the HMII between February 2010 and September 2011. Postoperative blood product transfusions and values for hemoglobin (Hgb), lactic dehydrogenase (LDH), and infection and stroke rates were compared between the S-graft (n⫽47) and NS-graft (N⫽75) groups. Results: Blood product transfusions were required significantly less often in the S-graft group than in the NS-graft group: RBCs, 4.1⫾3.5 vs 6.3⫾5.5 (P⫽0.011); FFP, 5.1⫾2.7 vs 8.6⫾8.9 (P⫽0.002); platelets, 3.8⫾1.9 vs 5.2⫾3.9 (P⫽0.011); and cryoprecipitate, 1.3⫾1.0 vs 2.0⫾1.9 (P⫽0.007). Hemoglobin levels 12 hours postop were significantly lower in the NSgroup than in the S-group (10.9⫾1.4 vs 11.9⫾1.1 g/dl; P⫽0.003), even though the NS-group received more blood product transfusions. The LDH values were not different between the S-group and NS-group at 14 days (514.4⫾219.4 vs 522.8⫾301.6 U/L, P⫽0.899) and 30 days (476.7⫾232.2 vs 446.5⫾289.4 U/L, P⫽0.805) after implantation. No device-related infections occurred in the S-group, but the NS-group had 3 driveline infections: 28, 40, and 66 days post-implant. Fewer strokes occurred in the S-group (1/47, 2%) as compared to the NS-group (5/75, 7%), P⫽0.404. The 30-day survival rate was not significantly different between groups (P⫽0.087), but the proportion alive favored the S-group (46/47, 98%) over the NS-group (66/75, 88%). Conclusions: Use of a HMII with a sealed rather than a non-sealed graft on the inflow and outflow conduits is associated with less postoperative bleeding, and there is a trend for patients with the sealed graft to have fewer infection and stroke events.
Purpose: Extracorporeal membrane oxygenation (ECMO)can provide hemodynamic support in the setting of cardiac failure and can be used successfully after pediatric orthotopic heart transplant (OHT) for primary graft dysfunction or rejection. The objective of our study is to analyze variables predictive of survival to hospital discharge following ECMO in the pediatric OHT population. Methods and Materials: In this retrospective cohort study, clinical and laboratory data from 29 pediatric patients (age ⬍21 years) who underwent OHT between 1998 and 2010 at our institution and required subsequent ECMO were reviewed and analyzed using logistic regression. Results: Of the 29 patients reviewed, 18 survived to hospital discharge (62%). Survival to hospital discharge was not associated with gender, age, ischemic time, or duration of ECMO. Mortality was independently associated with end-organ complications sustained while on ECMO. Pulmonary (14% survival, p⫽0.012) and renal (41% survival, p⫽0.017) complications were highly associated with death. Hemorrhagic, metabolic (hypoand hyperglycemia, hyperbilirubinemia), and cardiac complications (arrhythmia, CPR requirement, hypertension) were also associated with mortality (p⫽0.024, p⫽0.045, and p⫽0.049, respectively). A higher PaO2 prior to institution of ECMO (p⫽0.03) and a higher post-transplant ejection fraction (EF) prior to the institution of ECMO (p⫽0.046) correlated with improved survival. Conclusions: The success of ECMO in the pediatric OHT population is affected by the development of secondary end-organ injury, with pulmonary and renal complications resulting in the highest mortality rates. With improved survival associated with a higher PaO2 and post-OHT EF prior to institution of ECMO, early ECMO intervention and the lack of pulmonary and renal complications after cannulation may predict optimal survival. 764 Is There Adequate Knowledge about LVAD Patients among First Responders? A Survey from North Western Italy A. Municinò, A. Torriglia, On Behalf of Rete per l’Emergenza-Urgenza. Dept. of Cardiology, Ospedale A. Gallino ASL3 Genovese, Genova, Italy. Purpose: Latest generation LVAD (Left Ventricular Assist Devices) represent a growing reality for patients with end stage heart failure (HF). The number of continuous flow (CF) LVAD implants has sharply increased in the last decade and it is expected to double over the next 5 years due to donor organ shortage and to the increased number of older pts reaching end stage HF. After LVAD implant many pts are discharged home, able to resume their normal lifestyle. They can drive, go back to work, and take part to social life as same age population: therefore they are exposed to the same risks and rely on the first responders care in case of emergency. Aim. To evaluate awareness among first responders and EMD personnel that CF LVAD pts are usually pulseless and that chest compressions may damage the device. Methods and Materials: A survey based on a 7 items questionnaire was delivered to first responders and EMD personnel from North Western Italy. The questionnaire tested 3 knowledge areas about continuous flow LVAD pts. 1. LVAD implant is a surgical therapy for end stage HF that allows pts to be discharged home and to resume a normal life style. 2. Continuous flow LVAD pts are usually pulseless and their systolic BP is reliably measurable by Doppler flow probe. 3. Chest compressions may damage the device. Results: We received 240 completed questionnaires. The percentage of correct answers for each of the 3 knowledge areas was respectively 55,0% (134 vs 106 for area 1), 4,1% (10 vs 230 for area 2), 1,6% (4 vs 236 for area 3). Conclusions: The present Survey shows that first responders and EMD personnel are not aware of basic concepts about CF LVAD pts. Their key