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Are LVAD Support and Cardiac Transplantation Approaching Equipoise?
S38 Journal of Cardiac Failure Vol. 17 No. 8S August 2011 based upon differences in patient groups and intention to treat crossovers. Nevertheless, disparity in outcomes and cost between the procedures has narrowed over time.
120 Scaffold Delivery of Neonatal Cardiomyocyte Results in Prolonged Cellular Survival and Improvements in Left Ventricular Function in Rats with Chronic Heart Failure Jordan J. Lancaster, Elizabeth Juneman, Nicholle M. Johnson, Joseph J. Bahl, Steven Goldman; Cardiology, Southern Arizona VA Health Care System, Tucson, AZ
Thresholds for LVAD varied markedly according to different life expectancy and functional limitation scenarios. Over 70% of patients equally valued an LVAD’s impact on survival and quality of life. The top three concerns about LVAD were stroke, infection, and device durability. Conclusions: Ambulatory advanced HF patients are open to considering LVAD therapy and most have acceptable implant risk. Patients should be educated about both LVAD therapy and survival with HF, then engaged about their thresholds for considering LVAD prior to becoming inotrope-dependent.
119 Are LVAD Support and Cardiac Transplantation Approaching Equipoise? Robert M. Adamson1, Brian Jaski2, Peter Hoagland2, Joseph Chammas1, Sam Baradarian1, Vanjah Norman1, Walter P. Dembitsky1; 1Cardiothoracic Surgery, Sharp Memorial Hospital, San Diego, CA; 2Cardiology, Sharp Memorial Hospital, San Diego, CA Introduction: Cardiac transplantation (Tx) is the standard of care for terminal heart failure although limited donor availability, recipient selection restrictions and complications related to immunosuppression have made its impact epidemiologically trivial. The utility of LVAD support has been limited by poor survival, device complications and expense. Recently however, outcomes with the HeartMate II (HMII) have approached those of Tx making direct comparisons timely. Methods: All patients having a HMII implant (102) or Tx (59) at a single institution since 2006 were reviewed. Patient length of stay, survival, and hospital cost/procedure were compared. Results: Compared to Tx, HMII patients were older (62.9+/- 14.0 years vs. 51.6+/- 13.6 years, p!.001) and more frequently male (88/102 vs. 38/59, p!.05). Length of stay for the HMII was 22.3+/- 13.9 days vs. 18.2+/- 7 days for Tx (NS). 95% (97/102) of HMII were discharged alive vs. 97% (57/59) of Tx (NS). Survival at 1 and 3 years was 82% and 69% for HMII vs. 95% and 88% for Tx (log rank p50.016), but lost significance when age adjusted (p50.059). Hospital costs changed for HMII/Tx from $315,972/$100,436 in 2006 to $187,551/$117,903 in 2010. Of all 98 patients listed for Tx during the study period, 32/98 (33%) required an LVAD for bridging to decision or transplant and overall 59/98 (60%) were transplanted of which 11/59 (19%) were on device at the time of transplant. Pre-LVAD mortality was 0/102 vs. pre-Tx mortality 15/ 98 (15%), p!.05. Post-operatively 9/28 (32%) HMII deaths were unrelated to mechanical support whereas all 6/6 deaths in the Tx group were immunosuppression related.
Conclusions: LVAD patients are older and sicker with more associated non-cardiac life threatening comorbidities. Donor shortages limit Tx intention to treat survival and often require LVAD bridging. Equipoise is impossible to accurately determine
Introduction: Tissue engineered scaffolds used for cell delivery enhance improvements in cardiac function by providing structural and nutrient support for transplanted cell survival, integration, and re-population of injured tissues. Previously, our laboratory reported improvements in left ventricular (LV) function in rats with chronic heart failure (CHF) after placement of a neonatal cardiomyocyte seeded 3-dimensional fibroblast construct (NCM-3DFC). The current report focuses on NCM survival and LV improvements out to 7 weeks post NCM-3DFC implantation. Hypothesis: Implantation of a neonatal cardiomyocyte scaffold promotes transplanted cell survival and prolongs improvements in left ventricular function in rats with chronic heart failure. Methods: Cardiomyocytes were isolated from neonatal rat hearts. Briefly, hearts were excised, atria removed and ventricles minced, and digested in a pancreatin/collagenase solution. Cardiomyocytes were collected and resuspended in DMEM with 10% FBS. The NCM-3DFC were cultured in 10% FBS in DMEM-LG, maintained under standard culture conditions. Results: We evaluated NCM-3DFC in vitro for cellular organization and the presence of functional gap junctions, which demonstrated extensive cell-to-cell connectivity. At 5 days in culture, the seeded patch contracted spontaneously in a rhythmic and directional fashion, beating at 4363 beats/min with a mean displacement of 1.360.3 mm and contraction velocity of 0.860.2 mm/sec. The seeded patch could be electrically paced at 270630 beats/min while maintaining coordinated, directional contractions. For in vivo evaluation, NCM-3DFC were implanted 3 weeks after ligation and evaluated 3 and 7 weeks later (6 and 10 weeks after ligation respectively). Live cell tracking of implanted NCM revealed w9% survival of transplanted cells 3 weeks after implantation and improved LV function by increasing (p!0.05) ejection fraction 26% and cardiac index 33%, while decreasing (p!0.05) LV end diastolic pressure 38%. Improvements in LV function continued at 7 weeks after implantation of the NCM-3DFC by increasing (p!0.05) ejection fraction 37%. Conclusion: A multicellular, electromechanically organized, cardiomyocyte scaffold, engineered in vitro can improve LV function when implanted directly on the hearts of rats with CHF; the transplanted cells survive and improve LV function chronically.
121 Survival of INTERMACS Profile 4-6 Patients after Left Ventricular Assist Device Implant Is Improved Compared to Seattle Heart Failure Model Estimated Survival Peter Eckman1, Andrew Rosenbaum1, Haree Vongooru2, Jagroop Basraon3, Forum Kamdar1, Ranjit John1, Wayne Levy4; 1University of Minnesota, Minneapolis, MN; 2University of Louisville, Louisville, KY; 3UCSF-Fresno, Fresno, CA; 4 University of Washington, Seattle, WA Introduction: Left ventricular assist devices (LVADs) are well-established for patients with severe heart failure, but their role for heart failure patients characterized by INTERMACS (IM) profiles 4-6 is controversial and highly variable across centers. Hypothesis: Heart failure patients with IM profiles 4-6 who undergo implant of continuous flow (CF) LVAD will have improved survival compared to medical therapy as estimated by the Seattle Heart Failure Model (SHFM). Methods: 89 consecutive patients with IM profile of 4-6 who were undergoing de novo CF-LVAD implant at a single center were identified. Clinical parameters used to determine SHFM score were
120 Scaffold Delivery of Neonatal Cardiomyocyte Results in Prolonged Cellular Survival and Improvements in Left Ventricular Function in Rats with Chronic Heart Failure Jordan J. Lancaster, Elizabeth Juneman, Nicholle M. Johnson, Joseph J. Bahl, Steven Goldman; Cardiology, Southern Arizona VA Health Care System, Tucson, AZ
Thresholds for LVAD varied markedly according to different life expectancy and functional limitation scenarios. Over 70% of patients equally valued an LVAD’s impact on survival and quality of life. The top three concerns about LVAD were stroke, infection, and device durability. Conclusions: Ambulatory advanced HF patients are open to considering LVAD therapy and most have acceptable implant risk. Patients should be educated about both LVAD therapy and survival with HF, then engaged about their thresholds for considering LVAD prior to becoming inotrope-dependent.
119 Are LVAD Support and Cardiac Transplantation Approaching Equipoise? Robert M. Adamson1, Brian Jaski2, Peter Hoagland2, Joseph Chammas1, Sam Baradarian1, Vanjah Norman1, Walter P. Dembitsky1; 1Cardiothoracic Surgery, Sharp Memorial Hospital, San Diego, CA; 2Cardiology, Sharp Memorial Hospital, San Diego, CA Introduction: Cardiac transplantation (Tx) is the standard of care for terminal heart failure although limited donor availability, recipient selection restrictions and complications related to immunosuppression have made its impact epidemiologically trivial. The utility of LVAD support has been limited by poor survival, device complications and expense. Recently however, outcomes with the HeartMate II (HMII) have approached those of Tx making direct comparisons timely. Methods: All patients having a HMII implant (102) or Tx (59) at a single institution since 2006 were reviewed. Patient length of stay, survival, and hospital cost/procedure were compared. Results: Compared to Tx, HMII patients were older (62.9+/- 14.0 years vs. 51.6+/- 13.6 years, p!.001) and more frequently male (88/102 vs. 38/59, p!.05). Length of stay for the HMII was 22.3+/- 13.9 days vs. 18.2+/- 7 days for Tx (NS). 95% (97/102) of HMII were discharged alive vs. 97% (57/59) of Tx (NS). Survival at 1 and 3 years was 82% and 69% for HMII vs. 95% and 88% for Tx (log rank p50.016), but lost significance when age adjusted (p50.059). Hospital costs changed for HMII/Tx from $315,972/$100,436 in 2006 to $187,551/$117,903 in 2010. Of all 98 patients listed for Tx during the study period, 32/98 (33%) required an LVAD for bridging to decision or transplant and overall 59/98 (60%) were transplanted of which 11/59 (19%) were on device at the time of transplant. Pre-LVAD mortality was 0/102 vs. pre-Tx mortality 15/ 98 (15%), p!.05. Post-operatively 9/28 (32%) HMII deaths were unrelated to mechanical support whereas all 6/6 deaths in the Tx group were immunosuppression related.
Conclusions: LVAD patients are older and sicker with more associated non-cardiac life threatening comorbidities. Donor shortages limit Tx intention to treat survival and often require LVAD bridging. Equipoise is impossible to accurately determine
Introduction: Tissue engineered scaffolds used for cell delivery enhance improvements in cardiac function by providing structural and nutrient support for transplanted cell survival, integration, and re-population of injured tissues. Previously, our laboratory reported improvements in left ventricular (LV) function in rats with chronic heart failure (CHF) after placement of a neonatal cardiomyocyte seeded 3-dimensional fibroblast construct (NCM-3DFC). The current report focuses on NCM survival and LV improvements out to 7 weeks post NCM-3DFC implantation. Hypothesis: Implantation of a neonatal cardiomyocyte scaffold promotes transplanted cell survival and prolongs improvements in left ventricular function in rats with chronic heart failure. Methods: Cardiomyocytes were isolated from neonatal rat hearts. Briefly, hearts were excised, atria removed and ventricles minced, and digested in a pancreatin/collagenase solution. Cardiomyocytes were collected and resuspended in DMEM with 10% FBS. The NCM-3DFC were cultured in 10% FBS in DMEM-LG, maintained under standard culture conditions. Results: We evaluated NCM-3DFC in vitro for cellular organization and the presence of functional gap junctions, which demonstrated extensive cell-to-cell connectivity. At 5 days in culture, the seeded patch contracted spontaneously in a rhythmic and directional fashion, beating at 4363 beats/min with a mean displacement of 1.360.3 mm and contraction velocity of 0.860.2 mm/sec. The seeded patch could be electrically paced at 270630 beats/min while maintaining coordinated, directional contractions. For in vivo evaluation, NCM-3DFC were implanted 3 weeks after ligation and evaluated 3 and 7 weeks later (6 and 10 weeks after ligation respectively). Live cell tracking of implanted NCM revealed w9% survival of transplanted cells 3 weeks after implantation and improved LV function by increasing (p!0.05) ejection fraction 26% and cardiac index 33%, while decreasing (p!0.05) LV end diastolic pressure 38%. Improvements in LV function continued at 7 weeks after implantation of the NCM-3DFC by increasing (p!0.05) ejection fraction 37%. Conclusion: A multicellular, electromechanically organized, cardiomyocyte scaffold, engineered in vitro can improve LV function when implanted directly on the hearts of rats with CHF; the transplanted cells survive and improve LV function chronically.
121 Survival of INTERMACS Profile 4-6 Patients after Left Ventricular Assist Device Implant Is Improved Compared to Seattle Heart Failure Model Estimated Survival Peter Eckman1, Andrew Rosenbaum1, Haree Vongooru2, Jagroop Basraon3, Forum Kamdar1, Ranjit John1, Wayne Levy4; 1University of Minnesota, Minneapolis, MN; 2University of Louisville, Louisville, KY; 3UCSF-Fresno, Fresno, CA; 4 University of Washington, Seattle, WA Introduction: Left ventricular assist devices (LVADs) are well-established for patients with severe heart failure, but their role for heart failure patients characterized by INTERMACS (IM) profiles 4-6 is controversial and highly variable across centers. Hypothesis: Heart failure patients with IM profiles 4-6 who undergo implant of continuous flow (CF) LVAD will have improved survival compared to medical therapy as estimated by the Seattle Heart Failure Model (SHFM). Methods: 89 consecutive patients with IM profile of 4-6 who were undergoing de novo CF-LVAD implant at a single center were identified. Clinical parameters used to determine SHFM score were