concomitant sildenafil and nitrates for treatment of pulmonary hypertension in patients with heart...

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265 Concomitant Sildenafil and Nitrates for Treatment of Pulmonary Hypertension in Patients with Heart Failure Could Be Safe Nirmanmoh Bhatia 1 , Ziad Alnabki 1 , Sameh Sayfo 2 , Haree Vongooru 3 , Emma Birks 4 , Kelly C. McCants 4 , Ihab Hamzeh 5 ; 1 University of Louisville, Louisville, KY; 2 University of Louisville, Louisville, KY; 3 University of Minnesota, Minneapolis, MN; 4 University of Louisville, Louisville, KY; 5 Baylor College of Medicine, Houston, TX Background: Severe heart failure may cause secondary pulmonary hypertension. Pulmonary hypertension signifies a worse prognosis and may also preclude heart transplantation. Sildenafil is used in the treatment of pulmonary hypertension. Com- bination of sildenafil and systemic nitrates is purported to cause severe hypotension and considered contraindicated. Hypothesis: The combination of sildenafil and ni- trates would be safe in patients with secondary pulmonary hypertension from severe heart failure due to relatively selective action of sildenafil on pulmonary vasculature and right ventricle. Methods: A retrospective chart review was conducted to identify all patients with systolic heart failure and pulmonary hypertension who were treated with both systemic nitrates and sildenafil concomitantly for any duration of time in our heart failure center from June 2008 to October 2011. Safety endpoints included symptomatic hypotension resulting in hospitalization or discontinuation of the com- bination, or death from any cause. Efficacy of treatment was assessed using pulmo- nary arterial pressure (PAP), pulmonary capillary wedge pressure (PCWP), pulmonary vascular resistance (PVR) and right ventricular failure score (RVFS). Stu- dent t-test was used to compare changes in hemodynamic measurements before and after combined therapy. Results: Seven patients (5 men) with a mean age of 51 6 8 years met the inclusion criteria. Five patients had ischemic cardiomyopathy. Mean left ventricular ejection fraction was 21.7 6 13.8 %. Left ventricular assist device (LVAD) was required for the treatment of all patients during some or all of the study period. Patients were treated with isosorbide dinitrate (average dose of 73 6 45 mg daily) and sildenafil (dose range 75 mg to 100 mg daily in divided doses). Patients on concomitant treatment were followed up for an average duration 7.8 months without LVAD (n52) and 12.5 months with LVAD support (n55). The combination was not discontinued in any patient due to hypotension. The Combination therapy led to small non-significant reductions in mean PAP, mean PCWP, and mean PVR. There was no significant difference in RVFS. Conclusions: Concomitant use of sildenafil and sys- temic nitrates appears to be safe in select patients with heart failure and pulmonary hypertension, especially in those with LVAD support. Larger studies are needed to evaluate the safety and efficacy of this combination. 266 Use of Electronic Heart Failure Order Set and Post Discharge Outcomes in a Large Urban Health System Glen Sumner, Patricia M. Campbell, Sandeep Aggarwal, Jonathan Howlett; University of Calgary, Calgary, AB, Canada Background: Care pathways and other decision support tools such as electronic medical records (EMR) have been advocated for use in management of acute heart failure. We sought to determine the clinical impact of introduction of a specifically designed order set for acute heart failure in a health care region with electronic charting. Methods: Data from a metropolitan hospital group for all unique hospi- talizations with a primary diagnosis of acute heart failure from January 2010 to De- cember 2012 were reviewed. An electronic chart was universally employed for all ordering and testing functions, and included clinical documentation supplemented by paper record. The heart failure order set was created by a multidisciplinary team and tested for compatibility within the EMR by dedicated personnel. Elements in the order set (in addition to routine admission orders) included items and reminders relating to standard investigations and treatments as well as discharge planning and post discharge follow up. All clinical orders and results were recorded in the EMR and interrogated for this study. Results: Demographic and clinical data were col- lected on 3946 unique individuals. There were 2045 (52%) females, the average age 75.5 years, creatinine 131 umol/L and heart rate 81 bpm. The median length of stay was 10 days. The electronic order set was utilized in 705 cases and was as- sociated with cardiology involvement as attending or consulting physician (41% vs. 29%, p, 0.001). No other baseline differences were seen. Overall, in-hospital mor- tality was 10% and 30 day readmission rate 20%. In unadjusted analysis, use of the order set was associated with 1 less day length of stay and 7% lower 7 and 30 day readmission rates. After adjustment for demographic and clinical variables, there persisted a significantly lower 7 and 30 day composite clinical (mortality plus all cause readmission) rates, driven by outcomes occurring in the first 7 days post discharge. Conclusions: Introduction of an electronic heart failure order set within the context of a hospital medical record is associated with lower early rehospitali- zation and mortality, primarily driven by outcomes in the first week post discharge. Further studies are warranted to evaluate the impact of a larger implementation of this order set. 267 A Randomized Controlled Pilot Study of the Japanese Heart Failure Self- Management Program: Impacts on Heart Failure Knowledge and Clinical Outcomes Naoko Kato 1 , Koichiro Kinugawa 1 , Miho Sano 2 , Masaru Hatano 2 , Atsushi Yao 1 , Keiko Kazuma 1 , Issei Komuro 1 , Ryozo Nagai 3 ; 1 The University of Tokyo Graduate School of Medicine, Tokyo, Japan; 2 The University of Tokyo Hospital, Tokyo, Japan; 3 Jichi Medical University, Tochigi, Japan Background: Unlike in Western countries, effectiveness of disease management pro- grams on heart failure (HF) patients has not yet been established in Japan so far. We therefore developed HF educational program and evaluated its efficacy in a randomized controlled trial among Japanese patients. Methods: We developed a new program fo- cused on enhancing patients’ self-care. We also incorporated health behavior theories into the program. It took about 60 minutes for our multidisciplinary team to provide the new program. We randomized patients 1:1 to receive usual care (control) or the new program in addition (intervention). Primary outcome was self-care behavior as- sessed by the European Heart Failure Self-Care Behavior Scale (EHFScBS). Secondary outcomes were (a) hospitalization for HF and/or cardiac death, (b) knowledge about HF, (c) number of HF hospitalization, and (d) medical cost for 2 years. To evaluate level of HF knowledge, we used a 15-item Japanese HF knowledge scale. Higher score indicated greater knowledge. Results: Data of 29 patients were analyzed. There were no significant differences in patients’ characteristics between the two groups at base- line. Mean age was 64 years, and 72% were male. Most patients were treated with beta-blocker (83%) and angiotensin converting enzyme inhibitors and/or angiotensin II receptor blockers (90%). One month after discharge, the total EHFScBS scores were not different between the intervention and control groups (29.569.7 vs.27.569.8), but the HF knowledge score had significantly improved in the interven- tion group (p50.04, Fig A). After a median follow-up period of 2-years, the composite endpoint rate in the intervention group was significantly lower than the control group (14% vs. 48%, p50.04, Fig B). Even after adjustment for age, sex, plasma levels of B-type natriuretic peptide, the beneficial effect of the new program remained to be sig- nificant (hazard ratio50.18, p50.04). Additionally, compared with the control group, the number of HF hospitalization was likely to be smaller (0.961.2 vs.0.260.6, p50.06), and HF-related cost for 2 years was significantly less in the intervention group (median, 1,221,630 JPY vs. 197,570 JPY, p50.02). Conclusions: Our pilot study suggests that the new self-management program with health behavior theories im- proves knowledge regarding HF with significant reduction in cardiac events and med- ical costs among Japanese HF patients. Outcome 7 Day Readmission 7 day readmission/mortality 30 Day Readmission 30 Day Readmission/Mortality Hospital Length of Stay Odds Ratio (+/- 95% CI) Order set use 0.67 (0.52-0.87) 0.54 (0.37-0.80) 0.72 (0.57-.95) 0.79 (0.63-0.99) 0.59 (0.48-0.73) The 17 th Annual Scientific Meeting HFSA S91

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Page 1: Concomitant Sildenafil and Nitrates for Treatment of Pulmonary Hypertension in Patients with Heart Failure Could Be Safe

The 17th Annual Scientific Meeting � HFSA S91

265Concomitant Sildenafil and Nitrates for Treatment of Pulmonary Hypertensionin Patients with Heart Failure Could Be SafeNirmanmoh Bhatia1, Ziad Alnabki1, Sameh Sayfo2, Haree Vongooru3, Emma Birks4,Kelly C. McCants4, Ihab Hamzeh5; 1University of Louisville, Louisville, KY;2University of Louisville, Louisville, KY; 3University of Minnesota, Minneapolis,MN; 4University of Louisville, Louisville, KY; 5Baylor College of Medicine,Houston, TX

Background: Severe heart failure may cause secondary pulmonary hypertension.Pulmonary hypertension signifies a worse prognosis and may also preclude hearttransplantation. Sildenafil is used in the treatment of pulmonary hypertension. Com-bination of sildenafil and systemic nitrates is purported to cause severe hypotensionand considered contraindicated. Hypothesis: The combination of sildenafil and ni-trates would be safe in patients with secondary pulmonary hypertension from severeheart failure due to relatively selective action of sildenafil on pulmonary vasculatureand right ventricle. Methods: A retrospective chart review was conducted to identifyall patients with systolic heart failure and pulmonary hypertension who were treatedwith both systemic nitrates and sildenafil concomitantly for any duration of time inour heart failure center from June 2008 to October 2011. Safety endpoints includedsymptomatic hypotension resulting in hospitalization or discontinuation of the com-bination, or death from any cause. Efficacy of treatment was assessed using pulmo-nary arterial pressure (PAP), pulmonary capillary wedge pressure (PCWP),pulmonary vascular resistance (PVR) and right ventricular failure score (RVFS). Stu-dent t-test was used to compare changes in hemodynamic measurements before andafter combined therapy. Results: Seven patients (5 men) with a mean age of 51 6 8years met the inclusion criteria. Five patients had ischemic cardiomyopathy. Meanleft ventricular ejection fraction was 21.7 6 13.8 %. Left ventricular assist device(LVAD) was required for the treatment of all patients during some or all of the studyperiod. Patients were treated with isosorbide dinitrate (average dose of 73 6 45 mgdaily) and sildenafil (dose range 75 mg to 100 mg daily in divided doses). Patients onconcomitant treatment were followed up for an average duration 7.8 months withoutLVAD (n52) and 12.5 months with LVAD support (n55). The combination was notdiscontinued in any patient due to hypotension. The Combination therapy led to smallnon-significant reductions in mean PAP, mean PCWP, and mean PVR. There was nosignificant difference in RVFS. Conclusions: Concomitant use of sildenafil and sys-temic nitrates appears to be safe in select patients with heart failure and pulmonaryhypertension, especially in those with LVAD support. Larger studies are needed toevaluate the safety and efficacy of this combination.

266Use of Electronic Heart Failure Order Set and Post Discharge Outcomes ina Large Urban Health SystemGlen Sumner, Patricia M. Campbell, Sandeep Aggarwal, Jonathan Howlett;University of Calgary, Calgary, AB, Canada

Background: Care pathways and other decision support tools such as electronicmedical records (EMR) have been advocated for use in management of acute heartfailure. We sought to determine the clinical impact of introduction of a specificallydesigned order set for acute heart failure in a health care region with electroniccharting. Methods: Data from a metropolitan hospital group for all unique hospi-talizations with a primary diagnosis of acute heart failure from January 2010 to De-cember 2012 were reviewed. An electronic chart was universally employed for allordering and testing functions, and included clinical documentation supplementedby paper record. The heart failure order set was created by a multidisciplinary teamand tested for compatibility within the EMR by dedicated personnel. Elements inthe order set (in addition to routine admission orders) included items and remindersrelating to standard investigations and treatments as well as discharge planning andpost discharge follow up. All clinical orders and results were recorded in the EMRand interrogated for this study. Results: Demographic and clinical data were col-lected on 3946 unique individuals. There were 2045 (52%) females, the averageage 75.5 years, creatinine 131 umol/L and heart rate 81 bpm. The median lengthof stay was 10 days. The electronic order set was utilized in 705 cases and was as-sociated with cardiology involvement as attending or consulting physician (41% vs.29%, p, 0.001). No other baseline differences were seen. Overall, in-hospital mor-tality was 10% and 30 day readmission rate 20%. In unadjusted analysis, use of theorder set was associated with 1 less day length of stay and 7% lower 7 and 30 dayreadmission rates. After adjustment for demographic and clinical variables, therepersisted a significantly lower 7 and 30 day composite clinical (mortality plus allcause readmission) rates, driven by outcomes occurring in the first 7 days post

Outcome

7 Day

Readmission

7 day

readmission/mortality

30 Day

Readmission

30 Day

Readmission/Mortality

Hospital Length

of Stay

Odds Ratio (+/- 95% CI)

Order

set use

0.67

(0.52-0.87)

0.54

(0.37-0.80)

0.72

(0.57-.95)

0.79

(0.63-0.99)

0.59

(0.48-0.73)

discharge. Conclusions: Introduction of an electronic heart failure order set withinthe context of a hospital medical record is associated with lower early rehospitali-zation and mortality, primarily driven by outcomes in the first week post discharge.Further studies are warranted to evaluate the impact of a larger implementation ofthis order set.

267A Randomized Controlled Pilot Study of the Japanese Heart Failure Self-Management Program: Impacts on Heart Failure Knowledge and ClinicalOutcomesNaoko Kato1, Koichiro Kinugawa1, Miho Sano2, Masaru Hatano2, Atsushi Yao1,Keiko Kazuma1, Issei Komuro1, Ryozo Nagai3; 1The University of TokyoGraduate School of Medicine, Tokyo, Japan; 2The University of Tokyo Hospital,Tokyo, Japan; 3Jichi Medical University, Tochigi, Japan

Background: Unlike in Western countries, effectiveness of disease management pro-grams on heart failure (HF) patients has not yet been established in Japan so far. Wetherefore developed HF educational program and evaluated its efficacy in a randomizedcontrolled trial among Japanese patients. Methods: We developed a new program fo-cused on enhancing patients’ self-care. We also incorporated health behavior theoriesinto the program. It took about 60 minutes for our multidisciplinary team to providethe new program. We randomized patients 1:1 to receive usual care (control) or thenew program in addition (intervention). Primary outcome was self-care behavior as-sessed by the European Heart Failure Self-Care Behavior Scale (EHFScBS). Secondaryoutcomes were (a) hospitalization for HF and/or cardiac death, (b) knowledge aboutHF, (c) number of HF hospitalization, and (d) medical cost for 2 years. To evaluatelevel of HF knowledge, we used a 15-item Japanese HF knowledge scale. Higher scoreindicated greater knowledge. Results: Data of 29 patients were analyzed. There wereno significant differences in patients’ characteristics between the two groups at base-line. Mean age was 64 years, and 72% were male. Most patients were treated withbeta-blocker (83%) and angiotensin converting enzyme inhibitors and/or angiotensinII receptor blockers (90%). One month after discharge, the total EHFScBS scoreswere not different between the intervention and control groups (29.569.7vs.27.569.8), but the HF knowledge score had significantly improved in the interven-tion group (p50.04, Fig A). After a median follow-up period of 2-years, the compositeendpoint rate in the intervention group was significantly lower than the control group(14% vs. 48%, p50.04, Fig B). Even after adjustment for age, sex, plasma levels ofB-type natriuretic peptide, the beneficial effect of the new program remained to be sig-nificant (hazard ratio50.18, p50.04). Additionally, compared with the control group,the number of HF hospitalization was likely to be smaller (0.961.2 vs.0.260.6,p50.06), and HF-related cost for 2 years was significantly less in the interventiongroup (median, 1,221,630 JPY vs. 197,570 JPY, p50.02).Conclusions: Our pilot studysuggests that the new self-management program with health behavior theories im-proves knowledge regarding HF with significant reduction in cardiac events and med-ical costs among Japanese HF patients.