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Digoxin and Outcomes in Patients with Advanced Heart Failure and Contemporary Optimal Treatment
The 12th Annual Scientific Meeting Conclusion: Compared to patients with ADHF and normal admission glucose, those with elevated admission glucose did not have worse outcomes even though they presented with a worse hemodynamic profile and more inotropic usage. Our data implied that hyperglycemia might result from (rather than a contributor to) severity of illness.
315 Digoxin and Outcomes in Patients with Advanced Heart Failure and Contemporary Optimal Treatment Vasiliki Georgiopoulou1, Syed A. Agha1, Andreas Kalogeropoulos1, Grigorios Giamouzis1, Digant D. Bhatt1, Sana Waheed1, Sonjoy R. Laskar1, Andrew L. Smith1, Javed Butler1; 1Cardiology, Emory University, Atlanta, GA Background: Use of digoxin is debated in the treatment of patients with advanced heart failure (HF) who are on contemporary optimal medical and device therapy. Methods: We retrospectively collected data on 455 consecutive patients with advanced HF (52.0 6 12.5yrs, 68.8% males, 52.2% white, ejection fraction 18.3 6 8.0%, NYHA class 2.5 6 0.7) referred for cardiac transplantation. Of these, 227 (49.9%) were on digoxin therapy at baseline. The predefined endpoint was death (n 5 101) or urgent (UNOS IA) transplantation (n 5 14) or left ventricular assist device implantation (n 5 4). Propensity score matching on clinical variables, laboratory data, medications, and device therapy was used to identify matched pairs of patients on digoxin at baseline (n 5 157) and patients without digoxin treatment (n 5 157). Results: The propensity score-matched groups had similar characteristics:
HFSA
S97
We compared the one year heart failure hospitalization rates between CRT-D patients (pts) managed using device diagnostic data including Z to a group of CRT-D pts with no intrathoracic impedance monitoring. Methods: Two groups of previously implanted CRT-D pts were randomly identified from a single center. All pts were managed in the same HF clinic. In group 1, (n 5 124) device recorded diagnostics, including Z (OptiVol, Medtronic) were routinely interrogated during standard follow-up visits. Group 2 (n 5 66) pts had CRT-D devices with device diagnostic data, but no Z monitoring capabilities. HF hospitalizations were identified from the medical record over a follow-up of one year during 2005e06. Results: The average follow-up period was 328 and 365 days for group 1 and 2, respectively. Pts from group 1 and group 2 were matched in terms of age at time of implant and gender. Despite having lower EF (table), the proportion of pts hospitalized, the annual hospitalization rate and the days hospitalized were all significantly (p ! 0.05) lower for CRT-D pt managed with heart failure diagnostics that included Z, than the group without this capability (table). In the group with Z diagnostics, 11 pts were hospitalized 14 times for a total duration of 74 days. In the group without Z diagnostics, 15 pts were hospitalized 21 times for a total duration of 80 days. CRT-D with Impedance (n 5 124) Age (yr) Male (%) EF (%) Hospitalization Rate (per pt per year) Patients Hospitalized (per year) Days Hospitalized (per year)
CRT-D (n 5 66)
P
74 6 9 80 27 6 9 0.11 (0.05, 0.17)*
72 6 12 80 34 6 12 0.26 (0.14, 0.38)*
0.30 0.90 !0.001 0.02
0.08
0.20
0.01
0.58
1.03
0.02
*95% Confidence Interval Conclusions: In this retrospective single center comparison, the rate of heart failure hospitalization was lower for CRT-D pts managed with device diagnostics, including intrathoracic impedance compared to a population of CRT-D pts without impedance monitoring. Prospective trials are required to confirm the potential benefits of devicebased heart failure monitoring.
317
Characteristic
Digoxin: YES (n 5 157)
Digoxin : NO (n 5 157)
Age, yrs Sex, % male Race, % white NYHA Class Ejection Fraction, % Ischemic, % Atrial Fibrillation, % Creatinine, mg/dl BUN, mg/dl Sodium, meq/l Potassium, meq/l Cardiac Device, % ACE Inhibitors/ARB, % Beta Blockers, % Aldosterone Antagonists, % Amiodarone, % Diuretics, %
52.4 6 12.7 68.8 51.0 2.5 6 0.7 18.5 6 8.5 38.9 35.0 1.3 6 0.9 22 6 12 138 6 3 4.1 6 0.5 71.3 94.3 93.0 47.1 20.4 87.3
51.7 6 11.9 68.8 52.9 2.5 6 0.7 18.4 6 8.0 39.5 35.0 1.3 6 0.7 22 6 14 138 6 3 4.1 6 0.6 73.2 93.6 92.4 45.9 18.5 87.3
Add-On Hydralazine and Isosorbide Dinitrate in Ambulatory Patients with Advanced Heart Failure: Potential Improvements in Secondary Pulmonary Hypertension Maria M. Patarroyo1, Wilfried Mullens1, Randall C. Starling1, David O. Taylor1, W.H. Wilson Tang1; 1Heart Failure and Cardiac Transplant, Cleveland Clinic Foundation, Cleveland, OH p value 0.595 1.000 0.736 0.899 0.907 0.908 1.000 0.913 0.869 0.945 0.952 0.706 0.550 0.829 0.822 0.670 1.000
Median follow-up time was 29 months. Fifty out of 157 patients [31.8%, annual rate: 11.8% (95% CI: 9.0%e15.6%)] on digoxin met the primary endpoint vs. 23 out of 157 (14.6%, annual rate: 5.5% (95% CI: 3.6%e8.2%) patients who were not on digoxin, HR 2.12 (95% CI: 1.27e3.56), p 5 0.004. Conclusions: Use of digoxin was associated with worse outcomes in this cohort of advanced HF patients on contemporary optimal therapy.
Background: Patients with advanced heart failure, particularly those with secondary pulmonary hypertension, often progress despite optimal medical therapy including ACE- Inhibitors and beta-blockers. Add-on fixed-dose hydralazine and nitrates (H/ I) has been utilized in African American patients with symptomatic heart failure to reduce morbidity and mortality. We examined the potential of oral H/I as add-on therapy to improve hemodynamics in the ambulatory setting. Methods: We reviewed 62 consecutive ambulatory patients with advanced heart failure (LVEF !40%, NYHA III-IV) with at least two right heart catheterizations (RHC) for symptoms evaluation at the Cleveland Clinic. Among them 26 patients had Pulmonary Hypertension and received H/I following RHC. Results: In our cohort study (mean age 54 years, 70% male, 85% Caucasian, 57% ischemic etiology, mean LVEF 20%, LVIDd 6.7 cm, mean BNP 1011 pg/mL), 12 patients (46%) demonstrated improvement in the mean pulmonary artery pressure (MPA, defined as $10% reduction at second RHC, mean follow-up 6.5 months). This was associated with a corresponding improvement in the mean right atrial pressure (from 17 6 6 to 11 6 5 mmHg), transpulmonary gradient (from 12.6 6 4 to 9.6 6 4 mmHg), and mean cardiac index (from 2.0 6 0.4 to 2.7 6 1 l/min/m2). Baseline clinical, demographic, and hemodynamic variables were similar between those who improved versus those who did not improve with H/I, except for the BMI (27.1 6 7 kg/m2 vs 31.4 6 6.5 kg/m2), incidence of Diabetes Mellitus (33.3%vs 64.2%) and history of smoking (66.6% vs 35.7%). Conclusion: In ambulatory patients with advanced decompensated heart failure, add-on hydralazine and isosorbide dinitrate therapy may contribute to hemodynamic improvements in the setting of secondary pulmonary hypertension. However, such response to therapy cannot be predicted by baseline variables.
316
318
Can Monitoring Heart Failure Status with Intrathoracic Impedance Reduce the Rate of Heart Failure Hospitalization? Roy S. Small1, Lisa D. Rathman1, Jill L. Repoley1, Kelly J. Trynosky1, Jon G. Echterling1, Sherri S. Delgado1, Jeffrey M. Hardin1, Karin Bolinger2, Doug A. Hettrick2; 1CHF Clinic, The Heart Group, Lancaster, PA; 2Medtronic-New Therapies & Device Diagnostics, Medtronic, Minneapolis, MN
Interferon beta-1b Therapy in Patients Suffering from Dilated Cardiomyopathy and Chronic Virus Persistence e No Benefit for Specific Therapy? Oliver Zimmermann1, Christoph Rodewald1, Magdalena Bienek-Ziolkowski1, Vinzenz Hombach1, Jan Torzewski1; 1Internal Medicine II, University of Ulm, Ulm, Germany
Introduction: The potential for implantable device diagnostic data, including intrathoracic impedance (Z), to influence heart failure (HF) hospitalizations is unknown.
Myocardial biopsy can be utilized for differential diagnosis and detection of viral genome in patients suffering from dilated cardiomyopathy (DCM). Results from phase II studies report safety and feasibility of an antiviral therapy using interferon beta-1b.
315 Digoxin and Outcomes in Patients with Advanced Heart Failure and Contemporary Optimal Treatment Vasiliki Georgiopoulou1, Syed A. Agha1, Andreas Kalogeropoulos1, Grigorios Giamouzis1, Digant D. Bhatt1, Sana Waheed1, Sonjoy R. Laskar1, Andrew L. Smith1, Javed Butler1; 1Cardiology, Emory University, Atlanta, GA Background: Use of digoxin is debated in the treatment of patients with advanced heart failure (HF) who are on contemporary optimal medical and device therapy. Methods: We retrospectively collected data on 455 consecutive patients with advanced HF (52.0 6 12.5yrs, 68.8% males, 52.2% white, ejection fraction 18.3 6 8.0%, NYHA class 2.5 6 0.7) referred for cardiac transplantation. Of these, 227 (49.9%) were on digoxin therapy at baseline. The predefined endpoint was death (n 5 101) or urgent (UNOS IA) transplantation (n 5 14) or left ventricular assist device implantation (n 5 4). Propensity score matching on clinical variables, laboratory data, medications, and device therapy was used to identify matched pairs of patients on digoxin at baseline (n 5 157) and patients without digoxin treatment (n 5 157). Results: The propensity score-matched groups had similar characteristics:
HFSA
S97
We compared the one year heart failure hospitalization rates between CRT-D patients (pts) managed using device diagnostic data including Z to a group of CRT-D pts with no intrathoracic impedance monitoring. Methods: Two groups of previously implanted CRT-D pts were randomly identified from a single center. All pts were managed in the same HF clinic. In group 1, (n 5 124) device recorded diagnostics, including Z (OptiVol, Medtronic) were routinely interrogated during standard follow-up visits. Group 2 (n 5 66) pts had CRT-D devices with device diagnostic data, but no Z monitoring capabilities. HF hospitalizations were identified from the medical record over a follow-up of one year during 2005e06. Results: The average follow-up period was 328 and 365 days for group 1 and 2, respectively. Pts from group 1 and group 2 were matched in terms of age at time of implant and gender. Despite having lower EF (table), the proportion of pts hospitalized, the annual hospitalization rate and the days hospitalized were all significantly (p ! 0.05) lower for CRT-D pt managed with heart failure diagnostics that included Z, than the group without this capability (table). In the group with Z diagnostics, 11 pts were hospitalized 14 times for a total duration of 74 days. In the group without Z diagnostics, 15 pts were hospitalized 21 times for a total duration of 80 days. CRT-D with Impedance (n 5 124) Age (yr) Male (%) EF (%) Hospitalization Rate (per pt per year) Patients Hospitalized (per year) Days Hospitalized (per year)
CRT-D (n 5 66)
P
74 6 9 80 27 6 9 0.11 (0.05, 0.17)*
72 6 12 80 34 6 12 0.26 (0.14, 0.38)*
0.30 0.90 !0.001 0.02
0.08
0.20
0.01
0.58
1.03
0.02
*95% Confidence Interval Conclusions: In this retrospective single center comparison, the rate of heart failure hospitalization was lower for CRT-D pts managed with device diagnostics, including intrathoracic impedance compared to a population of CRT-D pts without impedance monitoring. Prospective trials are required to confirm the potential benefits of devicebased heart failure monitoring.
317
Characteristic
Digoxin: YES (n 5 157)
Digoxin : NO (n 5 157)
Age, yrs Sex, % male Race, % white NYHA Class Ejection Fraction, % Ischemic, % Atrial Fibrillation, % Creatinine, mg/dl BUN, mg/dl Sodium, meq/l Potassium, meq/l Cardiac Device, % ACE Inhibitors/ARB, % Beta Blockers, % Aldosterone Antagonists, % Amiodarone, % Diuretics, %
52.4 6 12.7 68.8 51.0 2.5 6 0.7 18.5 6 8.5 38.9 35.0 1.3 6 0.9 22 6 12 138 6 3 4.1 6 0.5 71.3 94.3 93.0 47.1 20.4 87.3
51.7 6 11.9 68.8 52.9 2.5 6 0.7 18.4 6 8.0 39.5 35.0 1.3 6 0.7 22 6 14 138 6 3 4.1 6 0.6 73.2 93.6 92.4 45.9 18.5 87.3
Add-On Hydralazine and Isosorbide Dinitrate in Ambulatory Patients with Advanced Heart Failure: Potential Improvements in Secondary Pulmonary Hypertension Maria M. Patarroyo1, Wilfried Mullens1, Randall C. Starling1, David O. Taylor1, W.H. Wilson Tang1; 1Heart Failure and Cardiac Transplant, Cleveland Clinic Foundation, Cleveland, OH p value 0.595 1.000 0.736 0.899 0.907 0.908 1.000 0.913 0.869 0.945 0.952 0.706 0.550 0.829 0.822 0.670 1.000
Median follow-up time was 29 months. Fifty out of 157 patients [31.8%, annual rate: 11.8% (95% CI: 9.0%e15.6%)] on digoxin met the primary endpoint vs. 23 out of 157 (14.6%, annual rate: 5.5% (95% CI: 3.6%e8.2%) patients who were not on digoxin, HR 2.12 (95% CI: 1.27e3.56), p 5 0.004. Conclusions: Use of digoxin was associated with worse outcomes in this cohort of advanced HF patients on contemporary optimal therapy.
Background: Patients with advanced heart failure, particularly those with secondary pulmonary hypertension, often progress despite optimal medical therapy including ACE- Inhibitors and beta-blockers. Add-on fixed-dose hydralazine and nitrates (H/ I) has been utilized in African American patients with symptomatic heart failure to reduce morbidity and mortality. We examined the potential of oral H/I as add-on therapy to improve hemodynamics in the ambulatory setting. Methods: We reviewed 62 consecutive ambulatory patients with advanced heart failure (LVEF !40%, NYHA III-IV) with at least two right heart catheterizations (RHC) for symptoms evaluation at the Cleveland Clinic. Among them 26 patients had Pulmonary Hypertension and received H/I following RHC. Results: In our cohort study (mean age 54 years, 70% male, 85% Caucasian, 57% ischemic etiology, mean LVEF 20%, LVIDd 6.7 cm, mean BNP 1011 pg/mL), 12 patients (46%) demonstrated improvement in the mean pulmonary artery pressure (MPA, defined as $10% reduction at second RHC, mean follow-up 6.5 months). This was associated with a corresponding improvement in the mean right atrial pressure (from 17 6 6 to 11 6 5 mmHg), transpulmonary gradient (from 12.6 6 4 to 9.6 6 4 mmHg), and mean cardiac index (from 2.0 6 0.4 to 2.7 6 1 l/min/m2). Baseline clinical, demographic, and hemodynamic variables were similar between those who improved versus those who did not improve with H/I, except for the BMI (27.1 6 7 kg/m2 vs 31.4 6 6.5 kg/m2), incidence of Diabetes Mellitus (33.3%vs 64.2%) and history of smoking (66.6% vs 35.7%). Conclusion: In ambulatory patients with advanced decompensated heart failure, add-on hydralazine and isosorbide dinitrate therapy may contribute to hemodynamic improvements in the setting of secondary pulmonary hypertension. However, such response to therapy cannot be predicted by baseline variables.
316
318
Can Monitoring Heart Failure Status with Intrathoracic Impedance Reduce the Rate of Heart Failure Hospitalization? Roy S. Small1, Lisa D. Rathman1, Jill L. Repoley1, Kelly J. Trynosky1, Jon G. Echterling1, Sherri S. Delgado1, Jeffrey M. Hardin1, Karin Bolinger2, Doug A. Hettrick2; 1CHF Clinic, The Heart Group, Lancaster, PA; 2Medtronic-New Therapies & Device Diagnostics, Medtronic, Minneapolis, MN
Interferon beta-1b Therapy in Patients Suffering from Dilated Cardiomyopathy and Chronic Virus Persistence e No Benefit for Specific Therapy? Oliver Zimmermann1, Christoph Rodewald1, Magdalena Bienek-Ziolkowski1, Vinzenz Hombach1, Jan Torzewski1; 1Internal Medicine II, University of Ulm, Ulm, Germany
Introduction: The potential for implantable device diagnostic data, including intrathoracic impedance (Z), to influence heart failure (HF) hospitalizations is unknown.
Myocardial biopsy can be utilized for differential diagnosis and detection of viral genome in patients suffering from dilated cardiomyopathy (DCM). Results from phase II studies report safety and feasibility of an antiviral therapy using interferon beta-1b.