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Poor Glycemic Control Is Associated with Worse Outcomes in Patients with Type II Diabetes Who Undergo Left Ventricular Assist Device Implantation
S60 Journal of Cardiac Failure Vol. 19 No. 8S August 2013 INTERMACS Class 1 or 2 at time of implant, and 38 (84%) were implanted as either bridge-to-candidacy or destination therapy. 40 (89%) had isolated CF-LVAD implanted, while 5 had a concomitant temporary CF-RVAD placed. Mean BMI was 29.2+/-7.9 kg/m2. Pre-implant BMI stratification was: 31 BMI 18.5-29.9 kg/m2 (GROUP 1), 8 BMI 30.0-34.9 kg/m2 (GROUP 2), and 6 BMI $35.0 kg/m2 (GROUP 3). Post implant weights were divided into 30 day time intervals to compare data between patients. Results: Overall 1 and 2 year survival was 86% and 66% respectively. Univariate analysis of pre-implant BMI groups, showed age was significantly different (p50.0004). Group 1 patients were significantly older than either group 2 or group 3 (p50.016 and 0.002 respectively). There were no differences between groups in gender, INTERMACS classification, implant intent (BT, BTC, vs DT), or implant length of stay. Kaplan-Meier estimates of survival were similar between BMI groups. Multivariate analysis showed neither age, gender, BMI, VAD Intent, site of VAD, or implant length of stay were predictive of death. Overall percent change in BMI was -7.7+/-8.05 at 12 months. Logistic regression shows that % change in BMI neither increased nor decreased with time (r250.08, p50.2) in either the overall group (SEE FIGURE) or within each subgroup. Conclusion: Continuous flow LVAD implantation appears to be associated with neither a significant increase or decrease in BMI over time. In addition, those with high BMI (O35mg/kg2) appear to not loose significant weight but to also not be at an increase risk of death.
11wks; 2663 vs 2763, and 18wks; 2163 vs 3364 (p!0.05) after implantation. In addition, NCM-3DFC implantation improved EDP (1767 vs 2965mmHg), PDP (138612 vs. 936na mmHg) and (p!0.05) MAP (10162.9 vs 84+2.4 mmHg). NCM-3DFC rats, when compared to CHF, show an average increase in R-wave amplitude (N50.322 mV, HF50.240 mV, HF+NCM50.350 mV), slower average conduction velocities (N53.0461.8; HF50.4760.01; HF6NCM50.4160.15) and higher average signal amplitude (mV) (N512.862.1; HF52.660.8; HF+NCM54.461.3); (p!0.05). Conclusion: Tissue engineered constructs show electrical coupling and long-term improvement in cardiac function in rats with CHF.
173 Poor Glycemic Control Is Associated with Worse Outcomes in Patients with Type II Diabetes Who Undergo Left Ventricular Assist Device Implantation David S. Raymer, Timothy J. Fendler, Michael E. Nassif, Eric Novak, Gregory A. Ewald, Shane J. LaRue; Washington University, St. Louis, MO Introduction: The risk of complications associated with severity of diabetes mellitus has not yet been studied in patients with left ventricular assist devices (LVADs). Infections are common complications that increase morbidity and mortality, affecting approximately a quarter of patients. We evaluated the outcomes of patients with LVADs related to the presence and severity of DM. Hypothesis: In patients with LVADs, severity of DM as characterized by glycated hemoglobin (HA1c) is directly associated with increased infectious complications. Methods: We retrospectively identified 242 patients who received a continuous-flow LVAD and survived index hospitalization between 1/2005 and 11/2012 at a large transplant center in the Midwest. Patients were divided into those with a HA1c # 7% prior to LVAD implant (n 5 190) and those with a HA1c O 7% (n 5 52). A subgroup of poorly controlled diabetics defined as HA1c $ 8.5% were also analyzed. The primary end point was time to death or infection (i.e. driveline infection, bacteremia, sepsis, or mediastinitis). The primary end point was compared between groups using an inverse probability weighted propensity score. Results: Patients were followed for 3 years after LVAD implantation. The majority of patients were male (81%) and categorized with a median INTERMACS profile of 2 at the time of LVAD implant. There were 113 patients with death/infection events, with no significant difference found after inverse propensity score weighted adjustment: 27 out of 52 (51.9%) in the HA1c O 7% group vs. 86 out of 190 (45.3%) in the HA1c # 7% group (p 5 0.43). At 3 years, the event-free rates were 19.9% in the DM vs. 45.7% in Non-DM (p 5 0.13). In subgroup analysis of the poorly controlled diabetes, a HA1c $ 8.5% was associated with higher rates of death or infection (HR 1.871, 95% CI 1.470-2.380; p ! 0.001), after propensity score adjustment. Discussion: In this relatively large cohort of patients, well-controlled DM (HA1c ! 7%) at time of LVAD insertion was not associated with better outcomes than moderately well-controlled DM (HA1c O7%). However, in subgroup analysis, poorly controlled DM (HA1c O8.5%) was associated with higher rates of infection. More study is needed to verify these results and evaluate for potential mechanisms.
172 Implantation of an Electrically Coupled Cardiomyocyte Scaffold Improves Left Ventricular Ejection Fraction in Rats 18 Weeks after Implantation Jordan J. Lancaster1, Elizabeth Juneman1, Nicole Lahood2, Kyle Weigand2, Russell Witte2, Joseph Bahl2, Steven Goldman1; 1Southern Arizona VA, Tucson, AZ; 2 University of Arizona, Tucson, AZ Introduction: Cell-based regenerative therapies hold promise in providing new treatment strategies for heart failure. The current consensus is that tissue engineered scaffolds or patches enhance improvements in cardiac function by providing the structural and nutrient support for transplanted cell survival, integration, and re-population of injured tissues. Previously, we reported the construction of a 3 dimensional fibroblast construct (3DFC) biological scaffold seeded with rat neonatal cardiomyocytes (NCM) which spontaneously contract in a rhythmic and directional fashion, at 4363 bpm with a mean displacement of 1.360.3 mm and contraction velocity of 0.860.2 mm/sec (N510). Functional connexins are present at 48 hours and display increased connectivity through 6 days. Hypothesis: In a rat CHF model, implantation of a NCM seeded angiogenic bioengineered matrix patch results in increased myocardial blood flow, myocyte regeneration, and integration into the native heart accompanied by long-term improvements in LV function. Methods: Rats were infarcted by coronary artery ligation and allowed to recover 3wks to develop CHF. At which time, rats were screened using echocardiography and animals with ejection fraction (EF) below 35% were enrolled into the study. Scaffolds were seeded using methods developed by our laboratory and implanted within 24hrs of construction onto the LV. Echocardiography was performed at 3wks, 7wks, 11wks, and 18wks after implantation, end point hemodynamics were performed between 4-6 mo. Electrical activation data were obtained in vivo using a 12-channel microelectrode array and a 4-channel intracardiac catheter. Results: Functional benefits were evaluated in rats with CHF after placement of the NCM-3DFC. Three weeks after implantation of the NCM-3DFC, LV function improved by increasing (p!0.05) EF 26% (31%62 to 39%61) and cardiac index 33% (0.4660.05 to 0.6160.06 mL/(g min), while decreasing (p!0.05) LV end diastolic pressure 42% (2462 to 1463 mmHg). Long-term functional benefits were observed in LVEF when evaluated by echocardiography at, 7wks; 2464 vs 3364,
174 A Novel and Simple Echocardiographic Tool To Detect Malfunction of Continuous-Flow Left Ventricular Assist Devices during Speed Change Testing: The LVAD Pump Thrombosis Score Jerry D. Estep1, Rey P. Vivo1,2, Andrea M. Cordero-Reyes1, Barbara Elias1, Brian Bruckner1, Matthias Loebe1, Guillermo Torre-Amione1,3, Barry Trachtenberg1, Arvind Bhimaraj1; 1The Methodist Hospital, Houston, TX; 2University of Texas Medical Branch, Galveston, TX; 3Tecnologico De Monterrey, Monterrey, Mexico Background: Malfunction of Continuous Flow Left Ventricular Assist Devices (CFLVAD), frequently due to device thrombosis, is a potentially life-threatening event that presents a diagnostic and time consuming challenge due to limitation of imaging techniques to visualize pump interior. Hypothesis: We hypothesized that a practical echocardiographic scoring system can help diagnose malfunction of CF-LVADs secondary to pump thrombosis. Methods: From 2009-2012, consecutive patients supported with a continuous flow LVAD from a single center were prospectively
11wks; 2663 vs 2763, and 18wks; 2163 vs 3364 (p!0.05) after implantation. In addition, NCM-3DFC implantation improved EDP (1767 vs 2965mmHg), PDP (138612 vs. 936na mmHg) and (p!0.05) MAP (10162.9 vs 84+2.4 mmHg). NCM-3DFC rats, when compared to CHF, show an average increase in R-wave amplitude (N50.322 mV, HF50.240 mV, HF+NCM50.350 mV), slower average conduction velocities (N53.0461.8; HF50.4760.01; HF6NCM50.4160.15) and higher average signal amplitude (mV) (N512.862.1; HF52.660.8; HF+NCM54.461.3); (p!0.05). Conclusion: Tissue engineered constructs show electrical coupling and long-term improvement in cardiac function in rats with CHF.
173 Poor Glycemic Control Is Associated with Worse Outcomes in Patients with Type II Diabetes Who Undergo Left Ventricular Assist Device Implantation David S. Raymer, Timothy J. Fendler, Michael E. Nassif, Eric Novak, Gregory A. Ewald, Shane J. LaRue; Washington University, St. Louis, MO Introduction: The risk of complications associated with severity of diabetes mellitus has not yet been studied in patients with left ventricular assist devices (LVADs). Infections are common complications that increase morbidity and mortality, affecting approximately a quarter of patients. We evaluated the outcomes of patients with LVADs related to the presence and severity of DM. Hypothesis: In patients with LVADs, severity of DM as characterized by glycated hemoglobin (HA1c) is directly associated with increased infectious complications. Methods: We retrospectively identified 242 patients who received a continuous-flow LVAD and survived index hospitalization between 1/2005 and 11/2012 at a large transplant center in the Midwest. Patients were divided into those with a HA1c # 7% prior to LVAD implant (n 5 190) and those with a HA1c O 7% (n 5 52). A subgroup of poorly controlled diabetics defined as HA1c $ 8.5% were also analyzed. The primary end point was time to death or infection (i.e. driveline infection, bacteremia, sepsis, or mediastinitis). The primary end point was compared between groups using an inverse probability weighted propensity score. Results: Patients were followed for 3 years after LVAD implantation. The majority of patients were male (81%) and categorized with a median INTERMACS profile of 2 at the time of LVAD implant. There were 113 patients with death/infection events, with no significant difference found after inverse propensity score weighted adjustment: 27 out of 52 (51.9%) in the HA1c O 7% group vs. 86 out of 190 (45.3%) in the HA1c # 7% group (p 5 0.43). At 3 years, the event-free rates were 19.9% in the DM vs. 45.7% in Non-DM (p 5 0.13). In subgroup analysis of the poorly controlled diabetes, a HA1c $ 8.5% was associated with higher rates of death or infection (HR 1.871, 95% CI 1.470-2.380; p ! 0.001), after propensity score adjustment. Discussion: In this relatively large cohort of patients, well-controlled DM (HA1c ! 7%) at time of LVAD insertion was not associated with better outcomes than moderately well-controlled DM (HA1c O7%). However, in subgroup analysis, poorly controlled DM (HA1c O8.5%) was associated with higher rates of infection. More study is needed to verify these results and evaluate for potential mechanisms.
172 Implantation of an Electrically Coupled Cardiomyocyte Scaffold Improves Left Ventricular Ejection Fraction in Rats 18 Weeks after Implantation Jordan J. Lancaster1, Elizabeth Juneman1, Nicole Lahood2, Kyle Weigand2, Russell Witte2, Joseph Bahl2, Steven Goldman1; 1Southern Arizona VA, Tucson, AZ; 2 University of Arizona, Tucson, AZ Introduction: Cell-based regenerative therapies hold promise in providing new treatment strategies for heart failure. The current consensus is that tissue engineered scaffolds or patches enhance improvements in cardiac function by providing the structural and nutrient support for transplanted cell survival, integration, and re-population of injured tissues. Previously, we reported the construction of a 3 dimensional fibroblast construct (3DFC) biological scaffold seeded with rat neonatal cardiomyocytes (NCM) which spontaneously contract in a rhythmic and directional fashion, at 4363 bpm with a mean displacement of 1.360.3 mm and contraction velocity of 0.860.2 mm/sec (N510). Functional connexins are present at 48 hours and display increased connectivity through 6 days. Hypothesis: In a rat CHF model, implantation of a NCM seeded angiogenic bioengineered matrix patch results in increased myocardial blood flow, myocyte regeneration, and integration into the native heart accompanied by long-term improvements in LV function. Methods: Rats were infarcted by coronary artery ligation and allowed to recover 3wks to develop CHF. At which time, rats were screened using echocardiography and animals with ejection fraction (EF) below 35% were enrolled into the study. Scaffolds were seeded using methods developed by our laboratory and implanted within 24hrs of construction onto the LV. Echocardiography was performed at 3wks, 7wks, 11wks, and 18wks after implantation, end point hemodynamics were performed between 4-6 mo. Electrical activation data were obtained in vivo using a 12-channel microelectrode array and a 4-channel intracardiac catheter. Results: Functional benefits were evaluated in rats with CHF after placement of the NCM-3DFC. Three weeks after implantation of the NCM-3DFC, LV function improved by increasing (p!0.05) EF 26% (31%62 to 39%61) and cardiac index 33% (0.4660.05 to 0.6160.06 mL/(g min), while decreasing (p!0.05) LV end diastolic pressure 42% (2462 to 1463 mmHg). Long-term functional benefits were observed in LVEF when evaluated by echocardiography at, 7wks; 2464 vs 3364,
174 A Novel and Simple Echocardiographic Tool To Detect Malfunction of Continuous-Flow Left Ventricular Assist Devices during Speed Change Testing: The LVAD Pump Thrombosis Score Jerry D. Estep1, Rey P. Vivo1,2, Andrea M. Cordero-Reyes1, Barbara Elias1, Brian Bruckner1, Matthias Loebe1, Guillermo Torre-Amione1,3, Barry Trachtenberg1, Arvind Bhimaraj1; 1The Methodist Hospital, Houston, TX; 2University of Texas Medical Branch, Galveston, TX; 3Tecnologico De Monterrey, Monterrey, Mexico Background: Malfunction of Continuous Flow Left Ventricular Assist Devices (CFLVAD), frequently due to device thrombosis, is a potentially life-threatening event that presents a diagnostic and time consuming challenge due to limitation of imaging techniques to visualize pump interior. Hypothesis: We hypothesized that a practical echocardiographic scoring system can help diagnose malfunction of CF-LVADs secondary to pump thrombosis. Methods: From 2009-2012, consecutive patients supported with a continuous flow LVAD from a single center were prospectively