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Socioeconomic Status and LVADs, Is There an Income Disparity?
S108 Journal of Cardiac Failure Vol. 22 No. 8S August 2016 an abnormal DSE can reliably predict the development of CAV or risk of death on follow up. Hypothesis: We hypothesize that among patients with cardiac transplantation, abnormal DSEs are not predictive of CAV or survival upon follow up. Methods: We retrospectively examined all patients who received a heart transplant at our institution between 2004–2013 (n = 192) if they had at least one DSE (6, 18 or 30 months posttransplant) followed by a coronary angiogram (annually) and excluded those with no DSEs (n = 62) or no follow up angiograms (n = 50). Baseline characteristics were examined at the time of transplant and DSE results were categorized as normal or abnormal (if they were suggestive of coronary disease). Cox regression models were used to examine the disease-free survival according to DSE result and adjusted for age, sex and subsequent DSE test results (time-dependent covariate). Results: A total of 80 patients were included with mean age 54 ± 27 (23% women). Upon follow up, mean 77 ± 31 months, 26 patients developed CAV and 10 patients died. A total of 187 DSEs were performed; 85% of these studies achieved adequate level of stress (>85% of agepredicted heart rate). Only 7 patients had abnormal DSE results. Of those who had an abnormal DSE test, none died and 4 developed CAV. Of the other 22 patients who developed CAV, 4 died. These 22 patients had a total of 50 DSE studies, 90% of which were adequate. Average left ventricular ejection fraction (EF) over the study period as determined by transthoracic echocardiogram did not differ significantly in patients who developed CAV compared to those who did not develop CAV on follow up (63.4 ± 5.5 vs 62.9 ± 6.0; P > .05). Overall, DSE tests had a sensitivity of 12.5% and a specificity of 93.8% for detection of CAV. An abnormal DSE test neither predicted the development of CAV (hazard ratio [HR] 1.38 with 95% confidence interval [CI] 0.52, 3.68) nor death (HR 1.70, 95% CI 0.34, 8.48). Conclusions: Abnormal DSE tests have a low sensitivity for diagnosis of CAV and do not predict the risk of CAV or death upon follow up. As such, we question the appropriateness of DSEs to be used as a screening test to detect CAV in cardiac transplant recipients.
314 Socioeconomic Status and LVADs, Is There an Income Disparity? William A. Nester, Hans J. Henriquez, Burhan Mohamedali, Nikola Dobrilovic; Rush University Medical Center, Chicago, IL Introduction: Left Ventricular Assist Devices (LVADs) are increasingly being used for the treatment of end stage heart failure. Due to the costs associated with LVADs, there may be a discrepancy in access to treatment based on socioeconomic class. In this study, we investigated the effects of socioeconomic status across Illinois on the utilization of LVADs. Methods: In this retrospective study, 740 patients were reviewed across 359 unique ZIP codes in Illinois. ZIP code data was obtained from the US Census Bureau. Patients were stratified based on their ZIP code and 2014 Illinois Median Income Level of $57,520. Only the ZIP codes where LVAD recipients resided were analyzed. Results: The study cohort was comprised of 359 unique ZIP codes, 182 below and 177 above the Illinois median income level. There was a statistically significant difference in median income between the two groups ($44,072 vs $77,751, P = .01). There was a statistically significant difference in the racial make-up of the groups (Table 1). There was no difference in the number of LVADs implanted between poor and rich ZIP codes (2.21 vs 1.82, P = .54). However, after adjusting for individual ZIP code populations, there was a statistically significant higher use of LVADs in the lower socioeconomic ZIP codes compared to affluent ZIP codes (2.7 vs 2.1 per 100,000 population, P = .03). Conclusion: Our findings indicated that there is a higher utilization of LVADs in lower income areas compared to higher income areas. These findings were contrary to our expectations and suggest that other factors associated with poorer health outcomes in these low-income areas may be resulting in higher LVAD utilization. More research to determine the causes of higher LVAD utilizations in poorer areas is indicated.
313
Table 1. LVAD Disparities
Clinical Experience in Advanced HF Patients Implanted with an Extra-Aortic Counterpulsation Device (EACD) Alan Gass 1 , Eric Lovett 2 , Dimitrios Georgakopoulos 2 , Herwig Antretter 3 , Hüsein Ince4, Christian Schlensak5, Michael Weyand6, Daniel Bujnoch6, Holger Hotz7, J. Eduardo Rame8, Leslie W. Miller9; 1Westchester Medical Center, Valhalla, NY; 2 Sunshine Heart Inc, Eden Prairie, MN; 3Medizinische Universität Innsbruck, Innsbruck, Austria; 4Vivantes Klinikum am Friedrichshain, Berlin, Germany; 5Eberhard Karls Universität Tübingen, Tubingen, Germany; 6 Universitätsklinikum Erlangen Krankenhausstrasse, Erlangen, Germany; 7UKCardio-Centrum Berlin GmbH, Berlin, Germany; 8Hospital University of Pennsylvania, Philadelphia, PA; 9Morgan Heart Institute, Tampa, FL Background: Despite optimal medical and device therapy, patients with NYHA Class III/ambulatory IV HF experience high rates of morbidity and mortality. Due to the progressive nature of the disease, some patients remain symptomatic requiring hospitalizations, transplantation or a Left Ventricular Assist Device (LVAD), exposing them to potential complications, side effects and limiting their overall survival. An Extra-aortic counterpulsation device (EACD) is a novel therapy, consisting of an extravascular cuff implanted on the ascending aorta. EACD operates on the principle of counterpulsation to enhance myocardial perfusion and reduce cardiac afterload. Previous results demonstrate these benefits may be mediated through neuro-modulatory mechanisms. Methods: Data were collected from a European multi-center, postmarket study designed to observe the clinical outcomes of advanced heart failure patients not yet on inotropic support treated with EACD. Results: EACD system implant occurred in 15 patients. EACD significantly improved QOL, 6MHWd and LV ejection fraction (Table 1). A non-significant trend was observed in pulse pressure and enddiastolic volume. No patients experienced stroke or sepsis. Drive line infection rate was 13.3% (2/15) for the entire cohort. Treatment effects were measured by paired statistical analysis. Conclusions: In this cohort of patients with advanced HF, EACD demonstrated improvements in quality of life, functional capacity and cardiac remodeling with a favorable safety profile. Changes observed in the end-systolic volume have been shown to correlate with improved outcomes from several large trials. The modular design and non-obligatory features of the device will facilitate future trials to assess the potential for weaning from therapy, delaying or avoiding cardiac transplant or as bridge to transplant.
Table 1. Baseline: Mean ± SE; Changes: Mean ± SE; *P < .05; †P < .01 Parameter
N
Baseline
Δ6 Months
NYHA Class QOL (KCCQ-OS score) 6 min Walk Distance (m) Pulse Pressure (mmHg) Cardiac Output (L/min) LV End-Systolic Volume (mL) LV End-Diastolic Volume (mL) LV Ejection Fraction (%)
8 11 12 9 7 8 8 10
3 ± 0.0 35 ± 5 237 ± 31 39 ± 4 3.4 ± 0.45 163 ± 21 218 ± 66 23 ± 2.4
−0.90 ± 0.23† +26 ± 7† +79 ± 34* +7 ± 5 +1.9 ± 1.2 −43 ± 19* −30 ± 30 +10 ± 4*
LVAD per ZIP Code LVAD per 100,000 Racial Makeup Median Income Average Population
Income < 57,520
Income ≥ 57,520
P Value
2.21 ± 2.12 2.7 ± 5.8 70% White, 21% Black $44,072 24,938
1.88 ± 1.22 2.1 ± 5.9 83% White, 7% Black $77,751 24,769
.54 .03 .02 .01 .18
315 The Effect of Pump Speed Settings on Suspected Pump Thrombosis in Patients Supported With Continuous-Flow Left Ventricular Assist Devices Christopher T. Sparrow1, David S. Raymer1, Shree L. Radhakrishnan2, Michael E. Nassif1, Justin M. Vader1, Shane J. LaRue1, Gregory A. Ewald1; 1Washington University in Saint Louis, St. Louis, MO; 2St. Johns Mercy Medical Center, St. Louis, MO Background: Pump speed is the only modifiable setting after LVAD implantation. In current practice, pump speeds are selected to optimize LV unloading while minimizing suction events. Echocardiographic and hemodynamic studies have taken an increasing role to ensure appropriate settings. Low pump speed has been theorized to increase the risk of thrombus formation in the pump. In this exploratory analysis, we sought to determine the effect of pump speed on the risk of pump thrombosis (PT) in patients supported with continuous-flow LVADs. Methods: We retrospectively identified 418 patients who underwent implantation of a HeartMate II® LVAD at our institution from 6/2005–9/2014. For each patient, pump speed settings were obtained postoperatively during index hospitalization for LVAD implantation and throughout the followup period. Patients were included for analysis if they survived index hospitalization after LVAD and were maintained on a pump speed that remained consistent for the duration of support. Patients with below median pump speed (<9400 RPM) were compared with those with above median pump speed (≥9400 RPM). Baseline characteristics were compared between groups with Fisher’s exact test and Student’s t-test used to compare categorical and continuous variables, respectively. The primary outcome was freedom from suspected PT with Kaplan-Meier analysis performed to determine outcomes over time. Results: After exclusions, 276 patients were included for analysis with 124 patients with pump speed <9400 RPM compared with 152 patients with pump speed ≥9400 RPM. Patients with low pump speed were older and more likely to be implanted as destination therapy and to have lower BMI, ischemic cardiomyopathy and tobacco use. After median follow-up of 391 days, there was a non-significant trend toward increased suspected PT in patients with low (<9400 RPM) pump speed (P = .11, Fig. 1). When comparing patients with a pump speed <9000 RPM to those with standard (9000–9600 RPM) and high (>9600 RPM) pump speeds, there was a persistent trend toward increased suspected PT at lower speeds that did not reach statistical significance. Conclusion: There was a non-significant trend toward increased suspected PT in patients with low pump speed throughout the duration of LVAD support. Further studies are needed in larger cohorts to define the role of low pump speed in the development of PT and to determine the need to consider the possibility of adverse outcomes such as PT when determining pump speed settings.
314 Socioeconomic Status and LVADs, Is There an Income Disparity? William A. Nester, Hans J. Henriquez, Burhan Mohamedali, Nikola Dobrilovic; Rush University Medical Center, Chicago, IL Introduction: Left Ventricular Assist Devices (LVADs) are increasingly being used for the treatment of end stage heart failure. Due to the costs associated with LVADs, there may be a discrepancy in access to treatment based on socioeconomic class. In this study, we investigated the effects of socioeconomic status across Illinois on the utilization of LVADs. Methods: In this retrospective study, 740 patients were reviewed across 359 unique ZIP codes in Illinois. ZIP code data was obtained from the US Census Bureau. Patients were stratified based on their ZIP code and 2014 Illinois Median Income Level of $57,520. Only the ZIP codes where LVAD recipients resided were analyzed. Results: The study cohort was comprised of 359 unique ZIP codes, 182 below and 177 above the Illinois median income level. There was a statistically significant difference in median income between the two groups ($44,072 vs $77,751, P = .01). There was a statistically significant difference in the racial make-up of the groups (Table 1). There was no difference in the number of LVADs implanted between poor and rich ZIP codes (2.21 vs 1.82, P = .54). However, after adjusting for individual ZIP code populations, there was a statistically significant higher use of LVADs in the lower socioeconomic ZIP codes compared to affluent ZIP codes (2.7 vs 2.1 per 100,000 population, P = .03). Conclusion: Our findings indicated that there is a higher utilization of LVADs in lower income areas compared to higher income areas. These findings were contrary to our expectations and suggest that other factors associated with poorer health outcomes in these low-income areas may be resulting in higher LVAD utilization. More research to determine the causes of higher LVAD utilizations in poorer areas is indicated.
313
Table 1. LVAD Disparities
Clinical Experience in Advanced HF Patients Implanted with an Extra-Aortic Counterpulsation Device (EACD) Alan Gass 1 , Eric Lovett 2 , Dimitrios Georgakopoulos 2 , Herwig Antretter 3 , Hüsein Ince4, Christian Schlensak5, Michael Weyand6, Daniel Bujnoch6, Holger Hotz7, J. Eduardo Rame8, Leslie W. Miller9; 1Westchester Medical Center, Valhalla, NY; 2 Sunshine Heart Inc, Eden Prairie, MN; 3Medizinische Universität Innsbruck, Innsbruck, Austria; 4Vivantes Klinikum am Friedrichshain, Berlin, Germany; 5Eberhard Karls Universität Tübingen, Tubingen, Germany; 6 Universitätsklinikum Erlangen Krankenhausstrasse, Erlangen, Germany; 7UKCardio-Centrum Berlin GmbH, Berlin, Germany; 8Hospital University of Pennsylvania, Philadelphia, PA; 9Morgan Heart Institute, Tampa, FL Background: Despite optimal medical and device therapy, patients with NYHA Class III/ambulatory IV HF experience high rates of morbidity and mortality. Due to the progressive nature of the disease, some patients remain symptomatic requiring hospitalizations, transplantation or a Left Ventricular Assist Device (LVAD), exposing them to potential complications, side effects and limiting their overall survival. An Extra-aortic counterpulsation device (EACD) is a novel therapy, consisting of an extravascular cuff implanted on the ascending aorta. EACD operates on the principle of counterpulsation to enhance myocardial perfusion and reduce cardiac afterload. Previous results demonstrate these benefits may be mediated through neuro-modulatory mechanisms. Methods: Data were collected from a European multi-center, postmarket study designed to observe the clinical outcomes of advanced heart failure patients not yet on inotropic support treated with EACD. Results: EACD system implant occurred in 15 patients. EACD significantly improved QOL, 6MHWd and LV ejection fraction (Table 1). A non-significant trend was observed in pulse pressure and enddiastolic volume. No patients experienced stroke or sepsis. Drive line infection rate was 13.3% (2/15) for the entire cohort. Treatment effects were measured by paired statistical analysis. Conclusions: In this cohort of patients with advanced HF, EACD demonstrated improvements in quality of life, functional capacity and cardiac remodeling with a favorable safety profile. Changes observed in the end-systolic volume have been shown to correlate with improved outcomes from several large trials. The modular design and non-obligatory features of the device will facilitate future trials to assess the potential for weaning from therapy, delaying or avoiding cardiac transplant or as bridge to transplant.
Table 1. Baseline: Mean ± SE; Changes: Mean ± SE; *P < .05; †P < .01 Parameter
N
Baseline
Δ6 Months
NYHA Class QOL (KCCQ-OS score) 6 min Walk Distance (m) Pulse Pressure (mmHg) Cardiac Output (L/min) LV End-Systolic Volume (mL) LV End-Diastolic Volume (mL) LV Ejection Fraction (%)
8 11 12 9 7 8 8 10
3 ± 0.0 35 ± 5 237 ± 31 39 ± 4 3.4 ± 0.45 163 ± 21 218 ± 66 23 ± 2.4
−0.90 ± 0.23† +26 ± 7† +79 ± 34* +7 ± 5 +1.9 ± 1.2 −43 ± 19* −30 ± 30 +10 ± 4*
LVAD per ZIP Code LVAD per 100,000 Racial Makeup Median Income Average Population
Income < 57,520
Income ≥ 57,520
P Value
2.21 ± 2.12 2.7 ± 5.8 70% White, 21% Black $44,072 24,938
1.88 ± 1.22 2.1 ± 5.9 83% White, 7% Black $77,751 24,769
.54 .03 .02 .01 .18
315 The Effect of Pump Speed Settings on Suspected Pump Thrombosis in Patients Supported With Continuous-Flow Left Ventricular Assist Devices Christopher T. Sparrow1, David S. Raymer1, Shree L. Radhakrishnan2, Michael E. Nassif1, Justin M. Vader1, Shane J. LaRue1, Gregory A. Ewald1; 1Washington University in Saint Louis, St. Louis, MO; 2St. Johns Mercy Medical Center, St. Louis, MO Background: Pump speed is the only modifiable setting after LVAD implantation. In current practice, pump speeds are selected to optimize LV unloading while minimizing suction events. Echocardiographic and hemodynamic studies have taken an increasing role to ensure appropriate settings. Low pump speed has been theorized to increase the risk of thrombus formation in the pump. In this exploratory analysis, we sought to determine the effect of pump speed on the risk of pump thrombosis (PT) in patients supported with continuous-flow LVADs. Methods: We retrospectively identified 418 patients who underwent implantation of a HeartMate II® LVAD at our institution from 6/2005–9/2014. For each patient, pump speed settings were obtained postoperatively during index hospitalization for LVAD implantation and throughout the followup period. Patients were included for analysis if they survived index hospitalization after LVAD and were maintained on a pump speed that remained consistent for the duration of support. Patients with below median pump speed (<9400 RPM) were compared with those with above median pump speed (≥9400 RPM). Baseline characteristics were compared between groups with Fisher’s exact test and Student’s t-test used to compare categorical and continuous variables, respectively. The primary outcome was freedom from suspected PT with Kaplan-Meier analysis performed to determine outcomes over time. Results: After exclusions, 276 patients were included for analysis with 124 patients with pump speed <9400 RPM compared with 152 patients with pump speed ≥9400 RPM. Patients with low pump speed were older and more likely to be implanted as destination therapy and to have lower BMI, ischemic cardiomyopathy and tobacco use. After median follow-up of 391 days, there was a non-significant trend toward increased suspected PT in patients with low (<9400 RPM) pump speed (P = .11, Fig. 1). When comparing patients with a pump speed <9000 RPM to those with standard (9000–9600 RPM) and high (>9600 RPM) pump speeds, there was a persistent trend toward increased suspected PT at lower speeds that did not reach statistical significance. Conclusion: There was a non-significant trend toward increased suspected PT in patients with low pump speed throughout the duration of LVAD support. Further studies are needed in larger cohorts to define the role of low pump speed in the development of PT and to determine the need to consider the possibility of adverse outcomes such as PT when determining pump speed settings.