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Economic Implications of Continuous Hemodynamic Monitoring on Heart Failure Care
The 9th Annual Scientific Meeting
•
HFSA
S191
378
380
Anemia in a Hospitalized Heart Failure Population: Characteristics and Relationship to Outcomes. A Report from OPTIMIZE-HF J. Young1, W. Stough2, N. M. Albert1, L. She2, G. Fonarow3; 1Dept of Cardiovascular Med, Cleveland Clinic Foundation; 2Duke Clinical Research Institue; 3University of California Los Angeles
Continuous Hemodynamic Monitoring in the Management of Advanced Heart Failure Patients Jose A. Tallaj1, Robert C. Bourge1, Mark F. Aaron2, William T. Abraham3, Juan M. Aranda4, Anthony Magalski5, Amy D. Roettger6, Sue Dale6, Jason Grimes1; 1 Cardiology, University of Alabama, Birmingham, AL; 2Cardiology, Saint Thomas Hospital/ The Heart Group, Nashville, TN; 3Cardiology, The Ohio State University Heart Center, Columbus, OH; 4Cardiovascular Medicine, University of Florida Shands, Gainsville, FL; 5Cardiology, Mid America Hospital, Kansas City, MO; 6Medtronic Inc, Minneapolis, MN
Introduction: Anemia is associated w/ increased symptoms and adverse outcomes in heart failure(HF), but little is known regarding the prevalence of anemia and its relationship to outcomes in patients(pts) hospitalized with HF. Hypothesis: Low hemoglobin(hgb) is correlated with HF severity and adverse outcomes. Methods: OPTIMIZE-HF is a registry and performance improvement program for hospitalized HF pts and includes a subgroup w/ 60–90 day follow-up (f/u) data. Admit hgb was analyzed by quartiles. Comparisons were analyzed by Pearson chi-square test and analysis of variance. Results: Data includes 48612 pts at 259 hospitals. Pts w/ low hgb tended to be older, female, Caucasian, have preserved systolic function, and elevated serum Cr. There was no difference in troponin. They were less likely to receive ACEI and BB, but more likely to receive ARB. Pts w/ lower hgb had higher in-hospital and f/u mortality, longer LOS and more readmissions. Conclusions: Data reveal a higher prevalence of low hgb than in randomized HF trials. Low hgb is associated w/ worse outcomes in hospitalized HF pts. Admit Hgb, g/dL Characteristic % (SD)
5.0–ⱕ10.7 ⬎10.7–ⱕ12.1 ⬎12.1–ⱕ13.5 ⬎13.5–ⱕ20.0 N ⫽ 12099 N ⫽ 12277 N ⫽ 11723 N ⫽ 11507
Mean Age, y Female Caucasian LVSD Mean EF Mean HR Admit Mean SBP Admit Ischemic Etiology Mean Hgb Mean BNP Mean Troponin I Mean serum Cr ACEI DC ARB DC BB DC All Cause Mortality Inhosp All Cause Mortality f/u Mean LOS d Readmissions
74.1 (13.4) 58.9 72.8 45.5 43.2 (16.8) 83.7 (19.5)
74.8 (13.4) 57.9 74.5 49.5 40.4 (17.6) 84.9 (20.6)
141.4 (32.1) 142.8 (32.5) 47.1
46.8
9.6 (.95) 11.5 (.40) 1372 (1362) 1326 (1369) .50 (1.44) .46 (1.43) 2.1 (1.8) 1.8 (1.6) 45.3 49.8 12.0 13.1 62.2 64.4 4.8 3.9 11.9 6.5 (6.0) 33.1
9.9 5.7 (5.4) 33.0
73.7 (13.8) 51.3 74.0 54.4 37.9 (17.7) 87.4 (21.7)
P
70.1 (14.8) ⬍ .0001 37.8 ⬍ .0001 75.0 .0101 59.4 ⬍ .0001 34.9 (17.3) ⬍ .0001 90.9 (23.3) ⬍ .0001
143.1 (33.0) 144.1 (34.3) ⬍ .0001 45.4 12.8 (.40) 1250 (1321) .48 (1.45) 1.6 (1.4) 55.9 12.1 64.6 3.2 9.0 5.3 (5.0) 28.6
43.0 14.8 (1.04) 1152 (1221) .50 (1.43) 1.5 (1.1) 60.5 11.3 66.5 3.0 8.6 5.3 (5.4) 24.2
⬍ .0001 ⬍ .0001 ⬍ .0001 NS ⬍ .0001 ⬍ .0001 .0003 ⬍ .0001 ⬍ .0001 .0166 ⬍ .0001 ⬍ .0001
379 Economic Implications of Continuous Hemodynamic Monitoring on Heart Failure Care William T. Abraham1, Mark F. Aaron2, Juan M. Aranda3, Mark A. O’Shaughnessy4, Mariell L. Jessup5, Krista Calfee1, Sergio Cavaglia6, Brandon Sparks6, Robert C. Bourge7, COMPASS-HF Investigators; 1Cardiology, The Ohio State University Heart Center, Columbus, OH; 2Cardiology, Saint Thomas Hospital/ The Heart Group, Nashville, TN; 3Cardiovascular Medicine, University of Florida Shands, Gainsville, FL; 4Cardiology, Parkview Memorial, Fort Wayne, IN; 5 Cardiology, Hospital of the University of Pennsylvania, Philadelphia, PA; 6Medtronic Inc, Minneapolis, MN; 7Cardiology, University of Alabama, Birmingham, AL Background: Over the past 2–3 decades, the number of hospitalizations for heart failure (HF) has relentlessly increased resulting in severe economic consequences. Hospitalizations for HF account for approximately two-thirds of the total cost of HF care, estimated between $28 billion and more than $60 billion annually. This growing burden of heart failure can be expected to increase during the next decade unless innovative interventions are implemented. Methods: The COMPASS-HF trial randomized 274 moderate to severe HF patients (85% NYHA III) to standard medical therapy (SMT) complemented by continuous hemodynamic monitoring (Chronicle group) versus SMT alone (control group). HF-related hospitalizations were evaluated in the whole population and as pre-specified in the protocol, in the NYHA class III patients. Results: Overall the event rate in the control group was 0.8 per 6 months and was reduced by 25% (p ⫽ 0.22) in the Chronicle group. In the Class III patients the hospitalizations were reduced by 43% (p ⫽ 0.028). The percentage of patients experiencing HF-related hospitalizations during the study was 39% in the control group and 26% (p ⫽ 0.029) in the Chronicle group (38% vs. 25% respectively when NYHA class III pts only are considered, p ⫽ 0.023). A 5-year model based on the result obtained for NYHA class III patients would suggest $18.8M saving in hospitalizations for every 1,000 patients monitored (considering an average DRG of $5,456 per discharge). Conclusion: A HF management strategy based on continuous hemodynamic monitoring on top of standard HF care results in significant reduction of HF-related hospitalizations. Given the high costs associated to HF hospitalizations, continuous hemodynamic monitoring could favorably impact health care expenses.
Background: COMPASS-HF is a single blind randomized trial in 274 NYHA Class III and IV patients designed to prove safety and clinical effectiveness on a heart failure (HF) management strategy based on continuous hemodynamic monitoring on top of optimized HF care (Chronicle group) vs. optimized HF care (control group). In the pre-specified subgroup analysis of NYHA class III patients (85% of the entire population) a HF management strategy guided by Chronicle resulted in 41% reduction of HF-related events (HFRE ⫽ Admission or Emergency Visit Rx with IV therapy) (p ⫽ 0.03). In contrast to all other sub-groups, the trend of improved outcomes in the Chronicle Group was not seen in Class IV patients (8 of the 22 Chronicle and 8 of the 18 Control patients had a HFRE). Aim: NYHA class IV patients in COMPASSHF were analyzed to better characterize this study population and the impact of continuous hemodynamic monitoring on this group. Results: Out of 274 patients enrolled in the COMPASS-HF study, a total of 40 patients (15%) were in NYHA class IV at baseline. Conclusions: In this subset of COMPASS-HF, the Chronicle and the control groups were significantly different at baseline with sicker patients assigned, by chance, to the Chronicle group as demonstrated by higher creatinine levels and lower exercise tolerance. This may partially explain the unexpected outcome in the NYHA Class IV patients than in other pre-specified subgroups. Additional analysis of this subgroup is ongoing, including an analysis of hemodynamics at baseline and leading to admission.
Baseline Creatinine Baseline 6min HWT (m) Baseline Minnesota QoL Event rate/ 6-month Clinical composite response Worsened Unchanged Improved
Control Group
Chronicle Group
P Value
1.2 ⫾ 0.4 227 ⫾ 137 68.6 ⫾ 23.5 0.88
1.9 ⫾ 0.7 107 ⫾ 84 79.2 ⫾ 23.6 1.66
0.0014 0.005 0.166 0.23 0.60
69% 0% 31%
57% 7% 36%
HWT ⫽ hall walk test; QoL ⫽ quality of life questionnaire
381 Sleep Disordered Breathing Detection in Congestive Heart Failure Subjects with Chronicle쑓 Implantable Hemodynamic Monitors Mark F. Aaron1, Yong K. Cho2, Jennifer A. Vance2, Tom Bennett2, Brooke H. Yorke1, Beth Davidson1, Jon Tumen1, Sue Dale2; 1Tennessee Cardiovascular Research Institute, St. Thomas Heart Institute, Nashville, TN; 2New Therapies and Diagnostics, Medtronic, Inc., Minneapolis, MN Background: A significant fraction of patients (pts) with heart failure (HF) suffer from undiagnosed sleep apnea (SA). The hemodynamic effects of SA can cause HF disease progression. Recently, the Chronicle has been demonstrated to decrease hospitalizations in HF pts through continuous hemodynamic monitoring. An algorithm to detect SA with the Chronicle could decrease HF morbidity further. Methods: In the ongoing Chronicle SA study, 7 pts underwent diagnostic sleep study (SS). Six pts were diagnosed with SA (Apnea Hypopnea Index ⬎5) and subsequently underwent a second SS for continuous positive airway pressure (CPAP) titration. The Chronicle hemodynamic data were simultaneously recorded with polysomnography (PSG) during SS. Twelve paired (PSG/Chronicle) datasets were used to develop a SA episode (⬎5 minutes of periodic apnea-recovery cycles)detection algorithm for the Chronicle. The algorithm using the development dataset was then evaluated against three metrics: (a) diagnosis of SA using apnea episode index (AEI) ⬎5, (b) episodeby-episode comparison (PSG/Chronicle) of detected apnea episodes, and (c) detection
•
HFSA
S191
378
380
Anemia in a Hospitalized Heart Failure Population: Characteristics and Relationship to Outcomes. A Report from OPTIMIZE-HF J. Young1, W. Stough2, N. M. Albert1, L. She2, G. Fonarow3; 1Dept of Cardiovascular Med, Cleveland Clinic Foundation; 2Duke Clinical Research Institue; 3University of California Los Angeles
Continuous Hemodynamic Monitoring in the Management of Advanced Heart Failure Patients Jose A. Tallaj1, Robert C. Bourge1, Mark F. Aaron2, William T. Abraham3, Juan M. Aranda4, Anthony Magalski5, Amy D. Roettger6, Sue Dale6, Jason Grimes1; 1 Cardiology, University of Alabama, Birmingham, AL; 2Cardiology, Saint Thomas Hospital/ The Heart Group, Nashville, TN; 3Cardiology, The Ohio State University Heart Center, Columbus, OH; 4Cardiovascular Medicine, University of Florida Shands, Gainsville, FL; 5Cardiology, Mid America Hospital, Kansas City, MO; 6Medtronic Inc, Minneapolis, MN
Introduction: Anemia is associated w/ increased symptoms and adverse outcomes in heart failure(HF), but little is known regarding the prevalence of anemia and its relationship to outcomes in patients(pts) hospitalized with HF. Hypothesis: Low hemoglobin(hgb) is correlated with HF severity and adverse outcomes. Methods: OPTIMIZE-HF is a registry and performance improvement program for hospitalized HF pts and includes a subgroup w/ 60–90 day follow-up (f/u) data. Admit hgb was analyzed by quartiles. Comparisons were analyzed by Pearson chi-square test and analysis of variance. Results: Data includes 48612 pts at 259 hospitals. Pts w/ low hgb tended to be older, female, Caucasian, have preserved systolic function, and elevated serum Cr. There was no difference in troponin. They were less likely to receive ACEI and BB, but more likely to receive ARB. Pts w/ lower hgb had higher in-hospital and f/u mortality, longer LOS and more readmissions. Conclusions: Data reveal a higher prevalence of low hgb than in randomized HF trials. Low hgb is associated w/ worse outcomes in hospitalized HF pts. Admit Hgb, g/dL Characteristic % (SD)
5.0–ⱕ10.7 ⬎10.7–ⱕ12.1 ⬎12.1–ⱕ13.5 ⬎13.5–ⱕ20.0 N ⫽ 12099 N ⫽ 12277 N ⫽ 11723 N ⫽ 11507
Mean Age, y Female Caucasian LVSD Mean EF Mean HR Admit Mean SBP Admit Ischemic Etiology Mean Hgb Mean BNP Mean Troponin I Mean serum Cr ACEI DC ARB DC BB DC All Cause Mortality Inhosp All Cause Mortality f/u Mean LOS d Readmissions
74.1 (13.4) 58.9 72.8 45.5 43.2 (16.8) 83.7 (19.5)
74.8 (13.4) 57.9 74.5 49.5 40.4 (17.6) 84.9 (20.6)
141.4 (32.1) 142.8 (32.5) 47.1
46.8
9.6 (.95) 11.5 (.40) 1372 (1362) 1326 (1369) .50 (1.44) .46 (1.43) 2.1 (1.8) 1.8 (1.6) 45.3 49.8 12.0 13.1 62.2 64.4 4.8 3.9 11.9 6.5 (6.0) 33.1
9.9 5.7 (5.4) 33.0
73.7 (13.8) 51.3 74.0 54.4 37.9 (17.7) 87.4 (21.7)
P
70.1 (14.8) ⬍ .0001 37.8 ⬍ .0001 75.0 .0101 59.4 ⬍ .0001 34.9 (17.3) ⬍ .0001 90.9 (23.3) ⬍ .0001
143.1 (33.0) 144.1 (34.3) ⬍ .0001 45.4 12.8 (.40) 1250 (1321) .48 (1.45) 1.6 (1.4) 55.9 12.1 64.6 3.2 9.0 5.3 (5.0) 28.6
43.0 14.8 (1.04) 1152 (1221) .50 (1.43) 1.5 (1.1) 60.5 11.3 66.5 3.0 8.6 5.3 (5.4) 24.2
⬍ .0001 ⬍ .0001 ⬍ .0001 NS ⬍ .0001 ⬍ .0001 .0003 ⬍ .0001 ⬍ .0001 .0166 ⬍ .0001 ⬍ .0001
379 Economic Implications of Continuous Hemodynamic Monitoring on Heart Failure Care William T. Abraham1, Mark F. Aaron2, Juan M. Aranda3, Mark A. O’Shaughnessy4, Mariell L. Jessup5, Krista Calfee1, Sergio Cavaglia6, Brandon Sparks6, Robert C. Bourge7, COMPASS-HF Investigators; 1Cardiology, The Ohio State University Heart Center, Columbus, OH; 2Cardiology, Saint Thomas Hospital/ The Heart Group, Nashville, TN; 3Cardiovascular Medicine, University of Florida Shands, Gainsville, FL; 4Cardiology, Parkview Memorial, Fort Wayne, IN; 5 Cardiology, Hospital of the University of Pennsylvania, Philadelphia, PA; 6Medtronic Inc, Minneapolis, MN; 7Cardiology, University of Alabama, Birmingham, AL Background: Over the past 2–3 decades, the number of hospitalizations for heart failure (HF) has relentlessly increased resulting in severe economic consequences. Hospitalizations for HF account for approximately two-thirds of the total cost of HF care, estimated between $28 billion and more than $60 billion annually. This growing burden of heart failure can be expected to increase during the next decade unless innovative interventions are implemented. Methods: The COMPASS-HF trial randomized 274 moderate to severe HF patients (85% NYHA III) to standard medical therapy (SMT) complemented by continuous hemodynamic monitoring (Chronicle group) versus SMT alone (control group). HF-related hospitalizations were evaluated in the whole population and as pre-specified in the protocol, in the NYHA class III patients. Results: Overall the event rate in the control group was 0.8 per 6 months and was reduced by 25% (p ⫽ 0.22) in the Chronicle group. In the Class III patients the hospitalizations were reduced by 43% (p ⫽ 0.028). The percentage of patients experiencing HF-related hospitalizations during the study was 39% in the control group and 26% (p ⫽ 0.029) in the Chronicle group (38% vs. 25% respectively when NYHA class III pts only are considered, p ⫽ 0.023). A 5-year model based on the result obtained for NYHA class III patients would suggest $18.8M saving in hospitalizations for every 1,000 patients monitored (considering an average DRG of $5,456 per discharge). Conclusion: A HF management strategy based on continuous hemodynamic monitoring on top of standard HF care results in significant reduction of HF-related hospitalizations. Given the high costs associated to HF hospitalizations, continuous hemodynamic monitoring could favorably impact health care expenses.
Background: COMPASS-HF is a single blind randomized trial in 274 NYHA Class III and IV patients designed to prove safety and clinical effectiveness on a heart failure (HF) management strategy based on continuous hemodynamic monitoring on top of optimized HF care (Chronicle group) vs. optimized HF care (control group). In the pre-specified subgroup analysis of NYHA class III patients (85% of the entire population) a HF management strategy guided by Chronicle resulted in 41% reduction of HF-related events (HFRE ⫽ Admission or Emergency Visit Rx with IV therapy) (p ⫽ 0.03). In contrast to all other sub-groups, the trend of improved outcomes in the Chronicle Group was not seen in Class IV patients (8 of the 22 Chronicle and 8 of the 18 Control patients had a HFRE). Aim: NYHA class IV patients in COMPASSHF were analyzed to better characterize this study population and the impact of continuous hemodynamic monitoring on this group. Results: Out of 274 patients enrolled in the COMPASS-HF study, a total of 40 patients (15%) were in NYHA class IV at baseline. Conclusions: In this subset of COMPASS-HF, the Chronicle and the control groups were significantly different at baseline with sicker patients assigned, by chance, to the Chronicle group as demonstrated by higher creatinine levels and lower exercise tolerance. This may partially explain the unexpected outcome in the NYHA Class IV patients than in other pre-specified subgroups. Additional analysis of this subgroup is ongoing, including an analysis of hemodynamics at baseline and leading to admission.
Baseline Creatinine Baseline 6min HWT (m) Baseline Minnesota QoL Event rate/ 6-month Clinical composite response Worsened Unchanged Improved
Control Group
Chronicle Group
P Value
1.2 ⫾ 0.4 227 ⫾ 137 68.6 ⫾ 23.5 0.88
1.9 ⫾ 0.7 107 ⫾ 84 79.2 ⫾ 23.6 1.66
0.0014 0.005 0.166 0.23 0.60
69% 0% 31%
57% 7% 36%
HWT ⫽ hall walk test; QoL ⫽ quality of life questionnaire
381 Sleep Disordered Breathing Detection in Congestive Heart Failure Subjects with Chronicle쑓 Implantable Hemodynamic Monitors Mark F. Aaron1, Yong K. Cho2, Jennifer A. Vance2, Tom Bennett2, Brooke H. Yorke1, Beth Davidson1, Jon Tumen1, Sue Dale2; 1Tennessee Cardiovascular Research Institute, St. Thomas Heart Institute, Nashville, TN; 2New Therapies and Diagnostics, Medtronic, Inc., Minneapolis, MN Background: A significant fraction of patients (pts) with heart failure (HF) suffer from undiagnosed sleep apnea (SA). The hemodynamic effects of SA can cause HF disease progression. Recently, the Chronicle has been demonstrated to decrease hospitalizations in HF pts through continuous hemodynamic monitoring. An algorithm to detect SA with the Chronicle could decrease HF morbidity further. Methods: In the ongoing Chronicle SA study, 7 pts underwent diagnostic sleep study (SS). Six pts were diagnosed with SA (Apnea Hypopnea Index ⬎5) and subsequently underwent a second SS for continuous positive airway pressure (CPAP) titration. The Chronicle hemodynamic data were simultaneously recorded with polysomnography (PSG) during SS. Twelve paired (PSG/Chronicle) datasets were used to develop a SA episode (⬎5 minutes of periodic apnea-recovery cycles)detection algorithm for the Chronicle. The algorithm using the development dataset was then evaluated against three metrics: (a) diagnosis of SA using apnea episode index (AEI) ⬎5, (b) episodeby-episode comparison (PSG/Chronicle) of detected apnea episodes, and (c) detection