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ORIGINAL ARTICLE Noninvasive ventilation in acute heart failure: patient characteristics and clinical course in cases treated in a hospital emergency department JOSÉ MANUEL CARRATALÁ, PERE LLORENS, BENJAMÍN BROUZET, JOSÉ CARBAJOSA, ALEJANDRO R. ALBERT, ELENA MARTÍNEZ-BELOQUI, ROGELIO PASTOR, INMACULADA JIMÉNEZ, FRANCISCO ROMÁN Servicio de Urgencias, Unidad de Corta Estancia y Unidad de Hospitalización a Domicilio. Hospital General Universitario de Alicante, Spain. CORRESPONDENCE José Manuel Carratalá Perales Servicio de Urgencias-Unidad de Corta Estancia Hospital General Universitario de Alicante Calle Pintor Baeza, 12 03010 Alicante, Spain E-mail: [email protected] RECEIVED: 15-1-2010 ACCEPTED: 26-4-2010 CONFLICT OF INTEREST: None Objectives: Our aim was to analyze patient characteristics and clinical course in acute cardiogenic pulmonary edema (PE) treated with noninvasive ventilation (NIV) in our hospital emergency department (ED) and to find out factors related to NIV failure and mortality. Methods: Prospective, observational study of all patients with acute CPE requiring NIV in our ED. We analyzed clinical characteristics and blood gas analyses on admission and at 60 minutes, type of ventilation applied, destination on discharge, complications, need for orotracheal intubation, and duration of stay in the ED. Comorbidity was assessed on the Charlson and Barthel indices. Mortality in the emergency department, on the ward, or 7 and 21 days after discharge was registered on follow-up. Results: We studied 133 patients; 69 (51%) were men and the mean (SD) age was 76.2 (10.9) years. Continuous positive airway pressure was used in 60% of the cases. Symptoms and results of arterial blood gas analysis improved 1 hour after starting NIV. Meanduration of NIV was 4.25 (2.54) hours. Dry mucus membranes (69%) and erythematous facial sores (50%) were the most common complications. NIV failed in 9,8% of patients. ED mortality was 3%. Risk factors for death due to heart failure were age >65 years, blood pressure <120 mm Hg, urea >45 mg/dL, sodium <136 mEq/L, and respiratory frequency >35 breaths/min on admission. Choice of NIV modality was not a factor in clinical or blood gas improvements, mortality, or failure of NIV treatment. Forty-five (33.8%) patients were admitted to the short-stay unit, 35 (26.3%) to the cardiology ward, 25 (18.8%) to the internal medicine ward, and 7 (5.2%) to the intensive care unit. Conclusions: Early application of NIV to treat acute CPE improves symptoms and blood gases quickly, with few complications and short ED stays. The NIV modality chosen does not affect mortality or failure of the technique. The possibility of using NIV in all hospital ED should be considered. [Emergencias 2010;22:187-192] Key words: Acute pulmonary edema. Noninvasive ventilation. Emergency health services. Complications. Mortality. Introduction Acute heart failure (AHF) in the form of acute pulmonary edema (APE) is the most common cause of acute respiratory failure (ARF) in an emergency department (ED) 1. It accounts for a large percentage of hospital admissions, and is the leading cause of hospitalization and ED consultation in patients over 65 years2. In a recent reEmergencias 2010; 22: 187-192 view of data from the United States and Europe, between 18-40% of patients with APE required admission to the intensive care unit (ICU) and 6.7% required ventilatory support (72.4% non-invasive and 27.6% invasive)3. Non-invasive ventilation (NIV) has been used in recent decades as an alternative method of oxygenation in the treatment of APE. Compared to traditional systems, NIV improves early clinical parameters and blood 187 J. M. Carratalá et al. gases, decreases the rate of orotracheal intubation (OTI) and ICU admissions, with few complications and without increasing the risk of a coronary event4-7. There is sufficient evidence that NIV reduces mortality of patients with APE treated with CPAP, but not with the BiPAP mode, but in daily clinical practice this is not so8. No meta-analysis concludes that one mode of ventilation is superior to the other in the treatment of APE9. The aim of this study was to define the epidemiological and clinical profile of patients with APE treated with NIV in the ED, differences between ventilatory modes used, clinical response and arterial blood gases at 60 minutes, total ventilation time, need for OTI during ED stay, patient destination, mortality and risk factors. Method We performed a prospective, observational study of all patients with APE treated with NIV in the ED between January 2006 and March 2009. We included patients over 18 years with AHF and moderate-severe dyspnea (modified Borg scale)10, use of accessory muscles (Patrick scale > 3)11, arterial oxygen saturation (SaO 2 ) <90%, ratio PaO2/FIO2 <300, PaCO2> 45 mmHg and infiltration shown by bilateral chest X-ray. We excluded patients under 18 years, patients with an immediate need for OTI, systolic pressure <90 mmHg, acute myocardial infarction (MI) or uncontrolled ventricular arrhythmia, pneumothorax and uncooperative patients. Informed consent was verbally obtained from all patients or family caregivers and the study was approved by the Hospital Ethics Committee. We calculated the Charlson comorbidity index12 and Barthel Index (BI)13, the data being obtained directly from the patient when possible or, in cases of cognitive impairment or confusion, from the primary caregiver. Pharmacological treatment was performed without intervention following the recommendations of the European Society of Cardiology10. NIV modes used were CPAP (Boussignac® valve) and BiPAP (Vision by Respironics®) S/T with naso-oral interfaces. The choice of ventilatory mode depended on clinical criteria and the experience of the attending physician. Ventilation parameters were selected following our ED protocol without waiting for response to conventional therapy before initiating NIV 15. Inspired oxygen fraction (FIO2) used in each patient was that required to maintain SaO2 > 90%. 188 On ED arrival, the following data were recorded: respiratory frequency (RF), heart rate (HR), systolic and diastolic blood pressure (SBP, DBP), SaO2, temperature, degree of dyspnea and use of accessory muscles, and on admission ABG was performed, noting the FIO2 at the time. After 60 minutes of NIV, we re-scored the above parameters and obtained a new ABG. In addition, we monitored SaO2, heart rate, SBP and patient comfort every 15 minutes during the first hour. After the initial adjustment period (first 10-15 min), we recorded CPAP values, inspiratory positive pressure in alveoli (IPAP), expiratory positive pressure in alveoli (EPAP), tidal volume (TV), ramp and volume leakage (VF), and scheduled a breathing rate of 15 breaths minutes for BIPAP mode. We recorded the same parameters at 60 minutes after starting NIV. During ED stay, we requested a chest X-ray, a 12-lead electrocardiogram, complete blood test, and lab tests including creatinase, troponin T, glucose, sodium, potassium, creatinine, urea, CRP, aspartate aminotransferase and basic coagulation with D-dimer. Mortality and its causes was recorded during ED stay, NIV failure defined as need for OTI, complications related to the technique, which included myocardial infarction, total NIV time in the ED, destination, hospital mortality, and outcome at 7 and 21 days after discharge by telephone contact. The EFFECT scale was used to analyze 16 mortality risk factors in AHF. Results are expressed as mean ± standard (quantitative variables) and as absolute values and percentages (qualitative variables). For comparisons between variables, Student's t-test for related samples was used for the former and chisquare or exact Fisher test (as required) for the latter. Results Of 133 patients, 69 (51.8%) were male, and mean age was 76.2 ± 10.9 years. More than half (56%) had high comorbidity (Charlson 3). The most frequent pathologies were associated with hypertension (HT) (76.2%), chronic heart failure (68.4%), diabetes mellitus (DM) (43.6%) and chronic obstructive pulmonary disease (COPD) (33.8%). Nearly two thirds (65.4%) had a severe limitation for daily living activities (BI ≤ 80 points). The most frequently used mode of ventilation was CPAP (60.1%) with average pressure of 8.4 Emergencias 2010; 22: 187-192 NONINVASIVE VENTILATION IN ACUTE HEART FAILURE: PATIENT CHARACTERISTICS AND CLINICAL COURSE IN CASES TREATED IN A HOSPITAL EMERGENCY DEPARTMENT Table 1. Clinical parameters and blood gases on ED admission and after 1 hour of non-invasive ventilation (NIV) cm H2O. With BiPAP, average pressure was 9cm H2O. Most patients had severe dyspnea and used accessory muscles on admission (81.3 and 93.2% respectively) and showed great improvement after 60 min of NIV (3% severe dyspnea, 11.2% use of accessory muscles). RF, HR, SaO2 and blood gas parameters improved after one hour of NIV (Table 1) regardless of ventilatory mode used (Data not shown). Average time on NIV in the ED was 4.25 hours, 3.75 h for CPAP and 5.45 hours for BIPAP. The most common complications were dry mucous and facial erythema (Table 2) which proved similar in both modes except that significantly more dry mucous membranes were found in patients receiving BiPAP (P <0.05). Only two cases of discomfort and headache were found, which signalled failure of the technique. There were no cases of barotrauma, superinfection or AMI. Four patients died in the ED (3%), 3 by cardiogenic shock and 1 from sepsis secondary to pneumonia. Hospital mortality was 12% (16 patients) and, after discharge, 3% and 1% at 7 and 21 days, respectively; 70% of the deceased had a Barthel index 80 (48 ± 35) (Table 3). We did not find any particular variable associated with increased mortality (Table 4). The use of BiPAP was not associated with greater mortality (Table 4). The NIV technique failed in 9.8% (13 patients). The most common causes were discomfort, intolerance of the mask interface and poor control of secretions. We did not identify any particular factor (clinical, analytical, comorbidity, functional status or mode of ventilation) associated with failure other than a low respiratory rate (Table 5). The risk factor most frequently associated with NIV failure in the emergency department was no improvement in pH and persistence of hypercapnia after 1 hour of NIV. In terms of destination, most patients entered the short stay unit (33.8%), followed by cardiolo- ED admission Mean (SD) 60 min NIV Mean (DE) P HR, beats pm 115 (26.8) 92 (18.9) < 0.001 RF, breaths pm 36.3 (8.1) 25.6 (6.1) < 0.001 SBP, mmHg 156 (40.4) 135 (24) < 0.001 67.2 (20.5) 87.3 (18.5) < 0.001 PaO2, mmHg PaCO2, mmHg 57.5 (22.2) 50 (14.8) < 0.001 pH 7.26 (0.16) 7.35 (0.07) < 0.001 PaO2/FIO2 214 (71) * HCO3, mEq/L 27 (7.7) 28.2 (6.7) NS SaO2, % 83.7 (12.8) 93.7 (6.7) < 0.001 ED: Emergency department. HR: Heart rate. pm: per minute. RF: respiratory frequency. SBP: systolic blood pressure. PaO2: arterial oxygen pressure. PaCO2: arterial pressure of carbon dioxide. PaO2/FIO2: Quotient arterial oxygen pressure / inspired oxygen fraction. COH3: Bicarbonate. SaO2 % blood oxygen saturation. *The value at 60 minutes was not assessable since a value of FIO2 0.85 was applied to all patients. NS: not significant. gy department 26.3%, internal medicine 18.8% and ICU 5.2%. Discussion The present study is one of the first to analyze the use of NIV in the treatment of APE in a Spanish ED, and confirms that early use rapidly improves clinical and blood gas parameters, with a reduced number of complications, minimal shortterm mortality and no differences between types of NIV. A recent publication describes the epidemiological profile of patients with AHF as an older male (65-80 years) 17 with high comorbidity 18, which is repeated in this series. In addition, in this case, most of these patients had significant constraints on basic daily life activities, typical of a progressively aging population. The rapid improvement in cardiopulmonary symptoms is consistent with various studies showing that the early use of NIV (both CPAP and BIPAP) versus conventional oxygen therapy for APE rapidly improves clinical parameters and blood Table 2. Complications following the use of noninvasive ventilation Complications Total N = 133 Dry mucous [n (%)] 92 (69) Nasal skin rash [n (%)] 50 (37.6) Headache[n (%)] 10 (7.5) Eye irritation [n (%)] 6 (4.5) Discomfort [n (%)] 6 (4.5) Vomiting [n (%)] 3 (2.2) Gastric distension [n (%)] 3 (2.2) Other [n (%)] 3 (2.2) Other: 2 epistaxis, 1 hypotension. NS: not significant. Emergencias 2010; 22: 187-192 CPAP N = 80 49 (61.25) 35 (38.75) 6 (7.5) 5 (6.25) 5 (6.25) 1 (1.25) 3 (3.75) 2 (2.50) BiPAP N = 53 43 (81.13) 15 (28.30) 4 (7.54) 1 (1.88) 1 (1.88) 2 (3.77) 0 (0) 1 (1.88) P < 0.05 NS NS NS NS NS NS NS 189 J. M. Carratalá et al. Table 3. Differential characteristics of patients who died during the episode of heart failure Risk Factor Total N = 133 Total deaths N = 24 ED deaths N=4 Hospital deaths N = 16 7-day mortality N=3 21-day mortality N=1 Age > 65 years [n (%)] 112 (84.2) 20 (83.3) 2 (50) 14 (87.5) 3 (100) 1 (100) RF > 35 bpm [n (%)] 94 (70.7) 13 (54.1) 3 (75) 9 (56.2) 1 (33.3) 0 SBP < 120 mmHg [n (%)] 26 (18.5) 7 (29.1) 2 (50) 4 (25) 0 1 (100) Urea > 45 mg / dl [n (%)] 91 (68.4) 18 (75) 4 (100) 11 (68.7) 2 (66.7) 1 (100) Na < 136 mEq / L [n (%)] 54 (40.6) 10 (41.6) 2 (50) 7 (43.7) 0 1 (100) Hb < 10 g / dl [n (%)] 18 (13.5) 4 (16.6) 1 (25) 3 (18.7) 0 0 COPD [n (%)] 45 (3.8) 8 (33.3) 2 (50) 3 (18.7) 2 (66.7) 1 (100) Cancer [n (%)] 12 (9.0) 4 (16.6) 1 (25) 3 (18.7) 0 0 Barthel Index <80 points [n (%)] 92 (69.2) 17 (70.8) 3 (75) 11 (68.7) 2 (66.7) 1 (100) RF: respiratory frequency. bpm: breaths per minute. SBP: Systolic Blood Pressure. Na: Plasma Sodium plasma. Hb: Plasma Hemoglobin. COPD: Chronic obstructive pulmonary disease. gases and reduces the number and percentage of OTI and ICU admission rates19-23. With regard to mortality, there is not sufficient evidence to be able to affirm the superiority of NIV over conventional oxygen therapy, although in two meta-analyses and a study with 89 APE patients over 75 years, reduced early mortality (first 24-48 hours) was found with the use of CPAP and BiPAP, but not significantly so24-26. Surprisingly, in a questionable study by Gray et al, no benefit was found in the use of NIV (both CPAP and BiPAP modes) versus conventional oxygen for the treatment of the APE (no differences in mortality and percentage of OTI) 27. Our results show low ED mortality and in-hospital mortality similar to that previously reported. Overall mortality was not influenced by the ventilatory mode selected, which is consistent with the studies cited above, although high severity patients (extreme dyspnea, hypoventilation, hypoxemic-hypercapnic respiratory failure) required BiPAP at entry or as rescue therapy when CPAP failed, which has also been noted elsewhere9. However, recent reviews fail to recommended one NIV mode over the other28,29. Certain risk factors have been associated with NIV failure in the treatment of ARF30,31. In our se- ries, we found no such factors (Table 5) and no differences in the ventilatory technique failure, as in other studies. Predicting prognosis and mortality of AHF patients in the ED is difficult; etiology, functional status, age, comorbidity and various biological data must be considered together32,33. As an example of this difficulty, this study did not allow us to predict poor outcome. A notable finding was the low percentage of patients admitted to the ICU and the high number of patients admitted to the short-stay unit; this reflects the attention needed by the APE patients and the role of these units in the management of elderly patients with multiple comorbidity and functional dependency often associated with this acute disease34,35. Limitations of this study include the observational study design and non-randomization which preclude drawing conclusions on the best mode of ventilation. Second, the choice of NIV mode or even the use of conventional oxygenation systems was made by the attending ED physician. Third, the limited sample size does not allow us to deduce a decrease in mortality so our results cannot be extrapolated to other populations. However, we can conclude that the use of NIV rapidly im- Table 4. Study of factors associated with mortality during the episode of acute heart failure treated with invasive ventilation Factors studied Total N = 133 Survival N = 109 Deaths N = 24 P Age > 65 años n (%) 112 (84.2) 92 (84.4) 20 (83.3) NS RF > 35 rpm n (%) 94 (70.7) 81 (74.3) 13 (54.2) NS SBP < 120 mmHg n (%) 26 (18.5) 19 (17.4) 7 (29.2) NS Urea > 45 mg/dl n (%) 91 (68.4) 73 (66.9) 18 (75.0) NS Na < 136 mEq/L n (%) 54 (40.6) 44 (40.3) 10 (41.6) NS Hb < 10 g/dl n (%) 18 (13.5) 14 (12.8) 4 (16.6) NS COPD. n (%) 45 (3.8) 37 (33.9) 8 (33.3) NS Cancer n (%) 12 (9.0) 8 (7.3) 4 (16.6) NS Barthel Index <80 points n (%) 92 (69.2) 75 (68.8) 17 (70.8) NS BiPAP as a form of VNI n (%) 53 (39.8) 39 (35.7) 14 (58.3) NS NS: not significant. RF: respiratory frequency. bpm: breaths per minute. SBP: systolic blood pressure. Na: Plasma Sodium. Hb: Plasma Hemoglobin. COPD: chronic obstructive pulmonary disease. 190 Emergencias 2010; 22: 187-192 NONINVASIVE VENTILATION IN ACUTE HEART FAILURE: PATIENT CHARACTERISTICS AND CLINICAL COURSE IN CASES TREATED IN A HOSPITAL EMERGENCY DEPARTMENT Table 5. Study of factors associated with failure of non-invasive ventilation (NIV) Factors associated Total N = 133 Tolerate NIV N = 120 Not tolerate NIV N = 13 P Age > 65 años [n (%)] 112 (84.2) 103 (85.9) 9 (69.2) NS RF > 35 rpm [n (%)] 94 (70.7) 92 (70.7) 2 (15.3) < 0.001 SBP < 120 mmHg [n (%)] 26 (18.5) 24 (20.0) 2 (15.3) NS Urea > 45 mg/dl [n (%)] 91 (68.4) 80 (66.7) 11 (84.6) NS Na < 136 mEq/L [n (%)] 54 (40.6) 49 (40.8) 5 (38.4) NS Hb < 10 g/dl [n (%)] 18 (13.5) 15 (12.5) 3 (23) NS COPD [n (%)] 45 (3.8) 41 (34.1) 4 (30.7) NS Cancer [n (%)] 12 (9.0) 11 (9.1) 1 (7.7) NS Barthel Index < 80 points n (%) 92 (69.2) 82 (68.3) 6 (46.1) NS BiPAP as the form of VNI n (%) 53 (39.8) 45 (37.5) 8 (61.5) NS NS: not significant. RF: respiratory frequency. bpm: breaths per minute. SBP: systolic blood pressure. Na: Plasma Sodium. Hb: Plasma hemoglobin. COPD: chronic obstructive pulmonary disease. proved clinical and blood gas parameters in APE patients, with few complications, short ventilation times in the ED and low failure rate, and no differences between ventilatory modes in incidence of complications, mortality or technical failure, so the possibility of implementing NIV in all EDs should be considered. References 1 Richter CA, Kalenga JC, Rowe BH, Bresee LC, Tsuyuki RT. Practice patterns and outcomes in patients presenting to the emergency department with acute heart failure. Can J Cardiol. 2009;25:e173-8. 2 Llorens P, Martín-Sánchez FJ, González-Armengol JJ, Herrero P, Jacob J, Álvarez AB, et al. Perfil clínico de los pacientes con insuficiencia cardíaca aguda en los servicios de urgencias. Datos preliminares del Estudio EAHFE (Epidemiology Acute Heart Failure Emergency). 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Beyond pulmonary edema: diagnostic, risk stratification, and treat- 191 J. M. Carratalá et al. ment challenges of acute heart failure management in the emergency department. Ann Emerg Med. 2008;51:45-57. 33 Miró O, Llorens P, Martín-Sánchez FJ, Herrero P, Pavón J, Pérez-Dura MJ, et al. Factores pronósticos a corto plazo en los ancianos atendidos en urgencias por insuficiencia cardiaca aguda. Rev Esp Cardiol. 2009;62:757-64. 34 Llorens P, Murcia J, Laghzaoui F, Martínez-Beloqui E, Pastor R, Marquina V, et al. Estudio epidemiológico de la neumonía adquirida en la comunidad desde un servicio de urgencias de un hospital de tercer nivel: ¿influye el índice pronostico de Fine en la toma de decisiones? Emergencias. 2009;21:247-54. 35 González-Armengol JG, Fernández-Alonso CM, Martín-Sánchez FJ, González-Del Castillo J, López-Farré A, Elvira C. Actividad de una unidad de corta estancia en urgencias de un hospital terciario: cuatro años de experiencia. Emergencias. 2009;21:87-94. Ventilación no invasiva en insuficiencia cardiaca aguda: perfil clínico y evolución de pacientes atendidos en un servicio de urgencias hospitalario Carratalá JM, Llorens P, Brouzet B, Carbajosa J, Albert AR, Martínez-Beloqui E, Pastor R, Jiménez I, Román F Objetivos: El objetivo es evaluar el perfil clínico y la evolución de los pacientes con edema agudo de pulmón (EAP) tratados con ventilación no invasiva (VNI) en un servicio de urgencias hospitalario (SUMH) y los factores asociados con el fracaso de la técnica y la mortalidad. Método: Estudio observacional y prospectivo que incluyó a todos los pacientes atendidos en el SUMH por con EAP que precisaron VNI. Se analizaron los parámetros clínicos y gasométricos al ingreso y a los 60 minutos, el modo ventilatorio, destino, complicaciones, necesidad de intubación orotraqueal, y tiempo de permanencia en urgencias. Se calcularon el índice de comorbilidad de Charlson y el índice de Barthel (IB). Se evaluó la mortalidad en el SUH, durante el ingreso hospitalario y a los 7 y 21 días tras el alta. Resultados: Se estudió a 133 pacientes, 69 varones (51%), la edad media fue de 76,2 ± 10,9 años. En el 60% se utilizó la presión positiva constante en la vía aérea (CPAP) como modo ventilatorio. Los parámetros clínicos y gasométricos mejoraron tras una hora de VNI. El tiempo de tratamiento de VNI fue 4,25 ± 2,54 horas. La sequedad de mucosas y el eritema facial fueron las complicaciones más frecuentes (69 y 50% respectivamente). La técnica fracasó en el 9,8% y la mortalidad en urgencias fue del 3%. Los factores de riego de mortalidad asociada a insuficiencia cardiaca fueron la edad > 65 años, la presión arterial < 120 mmHg, la urea > 45 mg/dl, el sodio < 136 mEq/L y la frecuencia respiratoria al ingreso > 35 rpm. La modalidad ventilatoria no influyó en la mejoría clínico-gasométrica, mortalidad ni en el fracaso de la técnica. El 33,8% (45) de los pacientes ingresó en la unidad de corta estancia (UCE), 26,3% (35) en cardiología, 18,8% (25) en medicina interna y el 5,2% (7) de cuidados intensivos. Conclusión: El uso precoz de la VNI en el EAP mejora de forma rápida los parámetros clínicos y gasométricos del paciente, con escasas complicaciones, y estancia en urgencia corta, sin influir el modo ventilatorio en la mortalidad y el fracaso de la técnica. Debería valorarse su incorporación en todos los SUH. [Emergencias 2010;22:187-192] Palabras clave: Edema agudo de pulmón. Ventilación no invasiva. Servicio de urgencias. Complicaciones. Mortalidad. 192 Emergencias 2010; 22: 187-192