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Outcomes of ICU Patients With Cardiomyopathy and Severe Sepsis
The 16th Annual Scientific Meeting
HFSA
S75
240
242
Drug and Device Effects on Short Term Markers as Predictors of Long Term Therapeutic Effect on Mortality and Hospitalization for Heart Failure in Patients With Heart Failure and Reduced Ejection Fraction Kevin Morine, Benjamin Wessler, Daniel Kramer, Marvin Konstam, James Udelson; Cardiology, Tufts Medical Center, Boston, MA
Among Patients Admitted for Acute Systolic Congestive Heart Failure, Presence of Human Immunodeficiency Virus Is Associated With Increased Incidence of Readmissions for Heart Failure Exacerbation Maryam Afshar, Raza Alvi, Manjeet Singh, Manoj Bhandari, Jonathan Bella, Narendra Bhalodkar; Cardiology, Bronx-Lebanon Hospital Center, Bronx, NY
Introduction: We have previously shown that in large scale trials of patients with heart failure (HF) and reduced ejection fraction, therapy induced changes in LV remodeling parameters correlate with drug or device induced effects in all cause mortality, while short term changes in six minute walk (6MW), peak VO2 and natriuretic peptides do not. It is not known how well therapy induced changes in biochemical and functional parameters correlate with composite endpoints in clinical trials for patients with HF and reduced ejection fraction. Methods: Drug or device therapies for which at least one randomized, controlled trial (RCT) assessing the composite endpoint of all cause mortality and HF hospitalization over at least six months and with at least 500 patients were identified. For each therapy, short term RCTs assessing changes in left ventricular ejection fraction (LVEF), end diastolic volume (EDV), end systolic volume (ESV), peak oxygen consumption (peak VO2), 6MW, natriuretic peptides were also identified. The correlation between the odds ratio for the composite endpoint and the placebo-corrected change in short term markers was then assessed by unweighted Spearman coefficients. Results: RCTs of twelve distinct therapies evaluating the composite endpoint (n533,006 patients) directed the search for RCTs of the short term effect of those therapies on the markers. There were 55 LVEF reports (n511,844 patients), 35 EDV reports (n59,147), 28 ESV reports (n59147), 23 peak VO2 reports (n52858), 25 6MW reports (n58233), 8 BNP reports (n53261) and 6 NT-proBNP reports (n52010) included in this analysis. Therapy induced change in EDV (Spearman coefficient r50.44, P50.01) and 6MW (r50.55, P50.003) were correlated with the odds ratio for the composite endpoint. There were no significant correlations between the therapy induced change in LVEF (r5-0.12, P50.35), ESV (r50.09, P50.62), peak VO2 (r5-0.06, P50.80), NT proBNP (r50.49, P50.36) or BNP (r50.07, P50.88) and the odds ratio for the composite endpoint. Conclusions: Therapy induced placebocorrected change in EDV and 6MW, but not LVEF, ESV, peak VO2 and natriuretic peptides, correlates with the composite endpoint of mortality and HF hospitalization in large RCTs of patients with HF and reduced ejection fraction, and thus may provide a short-term probability signal of the longer-term effect of a therapy on morbidity and mortality.
Introduction: With advancement in antiviral therapy, patients (pts) with HIV are living longer and mostly dying of non-infectious etiology. Cardiac involvement specifically Left Ventricular (LV) systolic dysfunction tend to occur mostly late in the course of disease. Hypothesis: Presence of HIV in pts who are admitted for an acute decompensated systolic congestive heart failure (ADSCHF) could affect the rate of CHF readmissions (re-ad) and mortality. Methods: On a retrospective analysis of 1,953 pts with a primary diagnosis of ADCHF on admission, 1,329 pts had LV systolic dysfunction with LVEF of #50 %. Those with recent history of MI # 3 months (mn), cardiac surgery, PCI/revascularization, acute myocarditis or pericarditis and those with new EKG changes were excluded (n5213). Among the remaining 1,116 pts, 162 were HIV+. The incidence of re-ad for CHF exacerbation over 6 mn and all cause mortality rate over a two years (yr) period was compared in the HIV+ pts (n5162) and HIV- pts (n5954). HIV+ group was then subdivided by CD4 count to $200 (n575) and !200 (n583). Results: Demographics for the whole study population: mean age 66 6 18 yr, 51% males, 41.4% Hispanics, 45% African Americans, 34% diabetics, 66% hypertensive, 40% dyslipidemic and 54% smokers, were similar among both groups (pO0.05). There was no significant difference in mean LVEF in both groups (33.5610.3 vs 32.8610.9, p50.448). Readmissions due to ADSCHF over a 6 mn (55% vs 31%, p! 0.001), single re-ad (24% vs 13%) as well as multiple re-ad (31 % vs 17%) both with p!0.001 were significantly higher in the HIV+ group. Furthermore, among HIV+, those who had a CD4! 200 as compared to those with CD4 $200 (71% vs 35%) had significant higher rates of re-ad for ADSCHF in 6 mn, single re-ad (25% vs 19%) and multiple re-ad (31% vs 17%) with p!0.001 for all endpoints. The re-ad rates were independent of the gender (pO0.05). All cause mortality over the span of 2 yr was also higher in HIV+ compared to HIV- group (36% vs 26 % with p!0.001). Similarly, within HIV+ group, the 2 yr all cause mortality was higher in pts with CD4!200 compared to CD4$200 (47% vs 25% with p!0.001) Conclusion: Presence of HIV among those who are admitted with ADSCHF, is associated with higher rates of CHF related readmission and a poor prognosis with a greater risk for all cause mortality. The incidence for both end points is even higher if CD4!200.
241 Outcomes of ICU Patients With Cardiomyopathy and Severe Sepsis Monique Tanna, Hyun Ah Yoon, Caroline Kwon, Yan Yan Sally Xie, Darlene LeFrancois, Sharon Leung; Internal Medicine, Montefiore Medical Center, Bronx, NY Introduction: Myocardial depression in septic patients is a known phenomenon first described in 1984. Despite normal or increased cardiac output, these patients often develop a depressed ejection fraction and stroke volume. Although generalized cardiovascular dysfunction in sepsis has been associated with increased mortality, there is limited data on the survival of septic patients with cardiomyopathy. Methods: This is a nested case control study from a retrospective cohort analysis of hospitalized patients admitted for severe sepsis over a one year period at two tertiary hospitals of the Montefiore Medical Center, Bronx, New York. The inclusion criterion was patients admitted with severe sepsis based on the ICD-9 codes indicative of infection concurrent with new onset organ dysfunction who were admitted to an ICU. Cases were defined as patients with cardiomyopathy and controls were defined as patients without cardiomyopathy (CM). CM was categorized as mild (ejection fraction (EF) 540-54%), moderate (EF530-39%) and severe (EF!30%). All statistical analyses were performed using Stata version 11.2. Results: Between January 1, 2007 and December 31, 2007, there were 83 patients (43 mild, 23 moderate and 17 severe) with CM and 227 patients without CM. The median (IQR) Mortality in Emergency Department Sepsis (MEDS) score, APACHE II score upon ICU admission and Charlson’s score were 7 (4, 10), 25 (21, 29) and 5 (3, 8), respectively. There was no difference in age (p50.18), gender (p50.44), race (p50.31), ethnicity (p50.83), MEDS score (p50.67), APACHE II score (p50.41), Charlson’s score (p50.36) and foci of infection (pO0.05) among groups. There was no difference in code status among groups (p50.70); 41.4% of patients with CM and 38.6% of patients without CM had a do not resuscitate (DNR) code status during the hospitalization. The crude 28-day all-cause mortality was 26.4% for patients without CM, 30.2% for mild CM, 43.5% for moderate CM and 47.1% for severe CM. In the adjusted analysis, the 28-day all-cause mortality was associated with APACHE II score (hazard ratio (HR) 1.03 [95% C.I. 1.01-1.06]), MEDS score (HR 1.08 [95% C.I. 1.03-1.14]), mild CM (HR 1.61 [95% C.I. 0.88-2.97]), moderate CM (HR 2.03 [95% C.I. 1.01-4.08]) and severe CM (HR 2.56 [95% C.I. 1.20-5.48]) after adjusting for age, Charlson’s score and DNR status. Conclusions: In critically ill patients with severe sepsis, moderate to severe cardiomyopathy, defined as an EF less than 40%, was an independent predictor of all-cause mortality at 28-days.
243 Left Ventricular Systolic Function and Outcome after Cardiopulmonary Resuscitation in Patients Hospitalized for Acute Heart Failure Syndromes e Data from Romanian Acute Heart Failure Syndromes Study (RO-AHFS Study) Ionela Codoiu1, Anca Florian1, Serban Bubenek1, Daniela Filipescu1, Dragos Vinereanu2, Andrew Ambrosy3, Mihai Gheorghiade4, Cezar Macarie1; 1Institute of Emergency for Cardiovascular Diseases C.C.Iliescu, Bucharest, Romania; 2 Universitary Emergency Hospital, Bucharest, Romania; 3Stanford University School of Medicine, Stanford, IL; 4Center for Cardiovascular Innovation, Northwestern University, Feinberg School of Medicine, Chicago, IL Background: Survival rate after in-hospital cardiopulmonary resuscitation (CPR) is influenced by clinical setting and by prompt application of advanced cardiac life support therapies. Limited data exist as regard to prognosis of CPR in relation to LV systolic function in patients hospitalized with acute heart failure syndromes (AHFS). Objective: To evaluate the epidemiology and outcome of CPR by LVEF measured at admission in a cohort of AHFS patients. Methods: Over a 12 month period, the Romanian Acute Heart Failure Syndromes (RO-AHFS) registry enrolled 3224 consecutive patients at 13 medical centers admitted with diagnosis of AHFS. CPR has been considered as event during hospitalization and all the data were prospectively collected. Patients with CPR were divided in two groups based on LVEF determined at admission: LVEF!45% and LVEFO45%. Results: CPR was attempted in 274 patients (8.5% of total cohort) and pre-arrest LVEF was documented in 238 patients. Pre-arrest preserved LVEF (LVEFO45%)
CPR characteristics by LVEF LVEF!45% (n5162) CPR in the first 24 hours of admission (%) PAM-Cardiac (%) First detected pulseless electrical rhythm VF/VT (%) Asystole (%) PEA (%) Immediate success after CPR (%) Discharged alive after CPR (%)
LVEF$45% (n576)
p
61 92
50 90
0.04 0.1
14.4 32.5 53.1 23.4 11.6
26.3 21.1 52.6 27.1 15.8
0.03 0.05 0.6 0.08 0.02
HFSA
S75
240
242
Drug and Device Effects on Short Term Markers as Predictors of Long Term Therapeutic Effect on Mortality and Hospitalization for Heart Failure in Patients With Heart Failure and Reduced Ejection Fraction Kevin Morine, Benjamin Wessler, Daniel Kramer, Marvin Konstam, James Udelson; Cardiology, Tufts Medical Center, Boston, MA
Among Patients Admitted for Acute Systolic Congestive Heart Failure, Presence of Human Immunodeficiency Virus Is Associated With Increased Incidence of Readmissions for Heart Failure Exacerbation Maryam Afshar, Raza Alvi, Manjeet Singh, Manoj Bhandari, Jonathan Bella, Narendra Bhalodkar; Cardiology, Bronx-Lebanon Hospital Center, Bronx, NY
Introduction: We have previously shown that in large scale trials of patients with heart failure (HF) and reduced ejection fraction, therapy induced changes in LV remodeling parameters correlate with drug or device induced effects in all cause mortality, while short term changes in six minute walk (6MW), peak VO2 and natriuretic peptides do not. It is not known how well therapy induced changes in biochemical and functional parameters correlate with composite endpoints in clinical trials for patients with HF and reduced ejection fraction. Methods: Drug or device therapies for which at least one randomized, controlled trial (RCT) assessing the composite endpoint of all cause mortality and HF hospitalization over at least six months and with at least 500 patients were identified. For each therapy, short term RCTs assessing changes in left ventricular ejection fraction (LVEF), end diastolic volume (EDV), end systolic volume (ESV), peak oxygen consumption (peak VO2), 6MW, natriuretic peptides were also identified. The correlation between the odds ratio for the composite endpoint and the placebo-corrected change in short term markers was then assessed by unweighted Spearman coefficients. Results: RCTs of twelve distinct therapies evaluating the composite endpoint (n533,006 patients) directed the search for RCTs of the short term effect of those therapies on the markers. There were 55 LVEF reports (n511,844 patients), 35 EDV reports (n59,147), 28 ESV reports (n59147), 23 peak VO2 reports (n52858), 25 6MW reports (n58233), 8 BNP reports (n53261) and 6 NT-proBNP reports (n52010) included in this analysis. Therapy induced change in EDV (Spearman coefficient r50.44, P50.01) and 6MW (r50.55, P50.003) were correlated with the odds ratio for the composite endpoint. There were no significant correlations between the therapy induced change in LVEF (r5-0.12, P50.35), ESV (r50.09, P50.62), peak VO2 (r5-0.06, P50.80), NT proBNP (r50.49, P50.36) or BNP (r50.07, P50.88) and the odds ratio for the composite endpoint. Conclusions: Therapy induced placebocorrected change in EDV and 6MW, but not LVEF, ESV, peak VO2 and natriuretic peptides, correlates with the composite endpoint of mortality and HF hospitalization in large RCTs of patients with HF and reduced ejection fraction, and thus may provide a short-term probability signal of the longer-term effect of a therapy on morbidity and mortality.
Introduction: With advancement in antiviral therapy, patients (pts) with HIV are living longer and mostly dying of non-infectious etiology. Cardiac involvement specifically Left Ventricular (LV) systolic dysfunction tend to occur mostly late in the course of disease. Hypothesis: Presence of HIV in pts who are admitted for an acute decompensated systolic congestive heart failure (ADSCHF) could affect the rate of CHF readmissions (re-ad) and mortality. Methods: On a retrospective analysis of 1,953 pts with a primary diagnosis of ADCHF on admission, 1,329 pts had LV systolic dysfunction with LVEF of #50 %. Those with recent history of MI # 3 months (mn), cardiac surgery, PCI/revascularization, acute myocarditis or pericarditis and those with new EKG changes were excluded (n5213). Among the remaining 1,116 pts, 162 were HIV+. The incidence of re-ad for CHF exacerbation over 6 mn and all cause mortality rate over a two years (yr) period was compared in the HIV+ pts (n5162) and HIV- pts (n5954). HIV+ group was then subdivided by CD4 count to $200 (n575) and !200 (n583). Results: Demographics for the whole study population: mean age 66 6 18 yr, 51% males, 41.4% Hispanics, 45% African Americans, 34% diabetics, 66% hypertensive, 40% dyslipidemic and 54% smokers, were similar among both groups (pO0.05). There was no significant difference in mean LVEF in both groups (33.5610.3 vs 32.8610.9, p50.448). Readmissions due to ADSCHF over a 6 mn (55% vs 31%, p! 0.001), single re-ad (24% vs 13%) as well as multiple re-ad (31 % vs 17%) both with p!0.001 were significantly higher in the HIV+ group. Furthermore, among HIV+, those who had a CD4! 200 as compared to those with CD4 $200 (71% vs 35%) had significant higher rates of re-ad for ADSCHF in 6 mn, single re-ad (25% vs 19%) and multiple re-ad (31% vs 17%) with p!0.001 for all endpoints. The re-ad rates were independent of the gender (pO0.05). All cause mortality over the span of 2 yr was also higher in HIV+ compared to HIV- group (36% vs 26 % with p!0.001). Similarly, within HIV+ group, the 2 yr all cause mortality was higher in pts with CD4!200 compared to CD4$200 (47% vs 25% with p!0.001) Conclusion: Presence of HIV among those who are admitted with ADSCHF, is associated with higher rates of CHF related readmission and a poor prognosis with a greater risk for all cause mortality. The incidence for both end points is even higher if CD4!200.
241 Outcomes of ICU Patients With Cardiomyopathy and Severe Sepsis Monique Tanna, Hyun Ah Yoon, Caroline Kwon, Yan Yan Sally Xie, Darlene LeFrancois, Sharon Leung; Internal Medicine, Montefiore Medical Center, Bronx, NY Introduction: Myocardial depression in septic patients is a known phenomenon first described in 1984. Despite normal or increased cardiac output, these patients often develop a depressed ejection fraction and stroke volume. Although generalized cardiovascular dysfunction in sepsis has been associated with increased mortality, there is limited data on the survival of septic patients with cardiomyopathy. Methods: This is a nested case control study from a retrospective cohort analysis of hospitalized patients admitted for severe sepsis over a one year period at two tertiary hospitals of the Montefiore Medical Center, Bronx, New York. The inclusion criterion was patients admitted with severe sepsis based on the ICD-9 codes indicative of infection concurrent with new onset organ dysfunction who were admitted to an ICU. Cases were defined as patients with cardiomyopathy and controls were defined as patients without cardiomyopathy (CM). CM was categorized as mild (ejection fraction (EF) 540-54%), moderate (EF530-39%) and severe (EF!30%). All statistical analyses were performed using Stata version 11.2. Results: Between January 1, 2007 and December 31, 2007, there were 83 patients (43 mild, 23 moderate and 17 severe) with CM and 227 patients without CM. The median (IQR) Mortality in Emergency Department Sepsis (MEDS) score, APACHE II score upon ICU admission and Charlson’s score were 7 (4, 10), 25 (21, 29) and 5 (3, 8), respectively. There was no difference in age (p50.18), gender (p50.44), race (p50.31), ethnicity (p50.83), MEDS score (p50.67), APACHE II score (p50.41), Charlson’s score (p50.36) and foci of infection (pO0.05) among groups. There was no difference in code status among groups (p50.70); 41.4% of patients with CM and 38.6% of patients without CM had a do not resuscitate (DNR) code status during the hospitalization. The crude 28-day all-cause mortality was 26.4% for patients without CM, 30.2% for mild CM, 43.5% for moderate CM and 47.1% for severe CM. In the adjusted analysis, the 28-day all-cause mortality was associated with APACHE II score (hazard ratio (HR) 1.03 [95% C.I. 1.01-1.06]), MEDS score (HR 1.08 [95% C.I. 1.03-1.14]), mild CM (HR 1.61 [95% C.I. 0.88-2.97]), moderate CM (HR 2.03 [95% C.I. 1.01-4.08]) and severe CM (HR 2.56 [95% C.I. 1.20-5.48]) after adjusting for age, Charlson’s score and DNR status. Conclusions: In critically ill patients with severe sepsis, moderate to severe cardiomyopathy, defined as an EF less than 40%, was an independent predictor of all-cause mortality at 28-days.
243 Left Ventricular Systolic Function and Outcome after Cardiopulmonary Resuscitation in Patients Hospitalized for Acute Heart Failure Syndromes e Data from Romanian Acute Heart Failure Syndromes Study (RO-AHFS Study) Ionela Codoiu1, Anca Florian1, Serban Bubenek1, Daniela Filipescu1, Dragos Vinereanu2, Andrew Ambrosy3, Mihai Gheorghiade4, Cezar Macarie1; 1Institute of Emergency for Cardiovascular Diseases C.C.Iliescu, Bucharest, Romania; 2 Universitary Emergency Hospital, Bucharest, Romania; 3Stanford University School of Medicine, Stanford, IL; 4Center for Cardiovascular Innovation, Northwestern University, Feinberg School of Medicine, Chicago, IL Background: Survival rate after in-hospital cardiopulmonary resuscitation (CPR) is influenced by clinical setting and by prompt application of advanced cardiac life support therapies. Limited data exist as regard to prognosis of CPR in relation to LV systolic function in patients hospitalized with acute heart failure syndromes (AHFS). Objective: To evaluate the epidemiology and outcome of CPR by LVEF measured at admission in a cohort of AHFS patients. Methods: Over a 12 month period, the Romanian Acute Heart Failure Syndromes (RO-AHFS) registry enrolled 3224 consecutive patients at 13 medical centers admitted with diagnosis of AHFS. CPR has been considered as event during hospitalization and all the data were prospectively collected. Patients with CPR were divided in two groups based on LVEF determined at admission: LVEF!45% and LVEFO45%. Results: CPR was attempted in 274 patients (8.5% of total cohort) and pre-arrest LVEF was documented in 238 patients. Pre-arrest preserved LVEF (LVEFO45%)
CPR characteristics by LVEF LVEF!45% (n5162) CPR in the first 24 hours of admission (%) PAM-Cardiac (%) First detected pulseless electrical rhythm VF/VT (%) Asystole (%) PEA (%) Immediate success after CPR (%) Discharged alive after CPR (%)
LVEF$45% (n576)
p
61 92
50 90
0.04 0.1
14.4 32.5 53.1 23.4 11.6
26.3 21.1 52.6 27.1 15.8
0.03 0.05 0.6 0.08 0.02