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Importance: Active search for pulmonary embolism (PE) may improve outcomes in patients hospitalized for exacerbations of chronic obstructive pulmonary disease (COPD). Objective: To compare usual care plus an active strategy for diagnosing PE with usual care alone in patients hospitalized for COPD exacerbation. Design, Setting, and Participants: Randomized clinical trial conducted across 18 hospitals in Spain. A total of 746 patients were randomized from September 2014 to July 2020 (final follow-up was November 2020). Interventions: Usual care plus an active strategy for diagnosing PE (D-dimer testing and, if positive, computed tomography pulmonary angiogram) (n = 370) vs usual care (n = 367). Main Outcomes and Measures: The primary outcome was a composite of nonfatal symptomatic venous thromboembolism (VTE), readmission for COPD, or death within 90 days after randomization. There were 4 secondary outcomes, including nonfatal new or recurrent VTE, readmission for COPD, and death from any cause within 90 days. Adverse events were also collected. Results: Among the 746 patients who were randomized, 737 (98.8%) completed the trial (mean age, 70 years; 195 [26%] women). The primary outcome occurred in 110 patients (29.7%) in the intervention group and 107 patients (29.2%) in the control group (absolute risk difference, 0.5% [95% CI, -6.2% to 7.3%]; relative risk, 1.02 [95% CI, 0.82-1.28]; P = .86). Nonfatal new or recurrent VTE was not significantly different in the 2 groups (0.5% vs 2.5%; risk difference, -2.0% [95% CI, -4.3% to 0.1%]). By day 90, a total of 94 patients (25.4%) in the intervention group and 84 (22.9%) in the control group had been readmitted for exacerbation of COPD (risk difference, 2.5% [95% CI, -3.9% to 8.9%]). Death from any cause occurred in 23 patients (6.2%) in the intervention group and 29 (7.9%) in the control group (risk difference, -1.7% [95% CI, -5.7% to 2.3%]). Major bleeding occurred in 3 patients (0.8%) in the intervention group and 3 patients (0.8%) in the control group (risk difference, 0% [95% CI, -1.9% to 1.8%]; P = .99). Conclusions and Relevance: Among patients hospitalized for an exacerbation of COPD, the addition of an active strategy for the diagnosis of PE to usual care, compared with usual care alone, did not significantly improve a composite health outcome. The study may not have had adequate power to assess individual components of the composite outcome. Trial Registration: ClinicalTrials.gov Identifier: NCT02238639.
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Enfermedad Pulmonar Obstructiva Crónica/complicaciones , Embolia Pulmonar/diagnóstico , Tromboembolia Venosa , Anciano , Causas de Muerte , Angiografía por Tomografía Computarizada/estadística & datos numéricos , Intervalos de Confianza , Progresión de la Enfermedad , Femenino , Productos de Degradación de Fibrina-Fibrinógeno/análisis , Hemorragia/etiología , Hospitalización , Humanos , Masculino , Readmisión del Paciente , Enfermedad Pulmonar Obstructiva Crónica/terapia , Embolia Pulmonar/sangre , Embolia Pulmonar/etiología , Embolia Pulmonar/terapia , Recurrencia , España , Resultado del TratamientoRESUMEN
Introduction: Venoarterial extracorporeal membrane oxygenation (ECMO) is a rescue therapy that can stabilize patients with hemodynamic compromise. Indications continue to evolve, including drug overdose. However, the indication merely for vasoplegic shock following drug overdose is controversial. Case summary: We report a case of a 57-year-old male with high-risk idiopathic pulmonary arterial hypertension treated with upfront triple combination therapy (sildenafil, bosentan, and intravenous treprostinil infusion via subcutaneous abdominal implantable pump). In one of the refills of the drug reservoir, accidental administration of 1 months's supply of treprostinil (200â mg) into the subcutaneous tissue occurred, causing refractory vasoplegic shock. He required urgent VA-ECMO for 96â h, surviving to discharge 28 days later. Discussion: Treprostinil poisoning is rare due to its less frequent use but is life-threatening. ECMO may be considered in vasoplegic shock due to overdose of vasodilatory medication. It allows organ perfusion to be maintained, with the knowledge that recovery is as rapid as drug elimination.
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Inhaled nitric oxide (iNO) is a potent and selective pulmonary vasodilator with a safety concern due to rebound pulmonary hypertension (PH) associated with its withdrawal. We report short-term pulsed iNO in patients with severe pulmonary arterial hypertension (PAH) and nonoperable chronic thromboembolic PH (nCTEPH). This is a retrospective analysis of 33 patients: 22 with PAH and 11 with nCTEPH. We assessed hemodynamic, echocardiographic, and other noninvasive variables to evaluate safety and efficacy of iNO. We performed an iNO withdrawal test during right heart catheterization and after 3 days of iNO treatment. iNO significantly improved all variables examined in 22 patients with PAH and 11 with nCTEPH. Two patterns of response were observed after sudden iNO withdrawal. Twenty-nine patients (88%) showed minimal hemodynamic, oxygenation and clinical changes. Four patients (12%) had a reduction in cardiac index ≥20% and PaO2 ≥ 5%, three patients did not show clinical deterioration, and one patient developed hemodynamic collapse that needed iNO administration. This retrospective study suggests that short-term iNO improves hemodynamics and clinical conditions in some patients with PAH an nCTPEH. However, pulsed iNO withdrawal PH rebound could be a serious concern in these patients. Given the lack of evidence, we do not recommend the use of pulsed iNO in the treatment of patients with chronic PH.
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Introduction: Pulmonary arterial hypertension (PAH) is a rare, multifactorial, chronic condition that requires ongoing monitoring and assessment. PAHcare™ is a novel, patient-centered digital platform that provides software intended for use on patients' mobile phones (downloadable application) and web-based dashboards for use by physicians and health coaches (HC). We describe herein the protocol of a clinical study aimed at evaluating the clinical benefit and safety of PAHcare™ for the routine management of patients with PAH. Methods and analysis: In this prospective, single cohort, multicenter study, 50 patients with PAH will be recruited at six specialized PAH units from reference hospitals of the public Spanish healthcare system. The PAHcare™ digital health platform allows patients to log health and lifestyle information while also providing structured content for patient education, medication reminders, and behavioral and lifestyle coaching from a remote HC. Evaluation will be primarily focused on the impact of the platform use on the patient's health-related quality of life (HRQoL) via questionnaires completion through electronic patient-reported outcomes. Moreover, the analysis of the impact on the patient's functional status, signs and symptoms of PAH, patient costs and healthcare resource utilization, satisfaction, knowledge of the disease and its management, and adherence to and safety of the platform will be secondary outcomes. The clinical investigation started in July 2021 and is expected to end by September 2022. Discussion: The PAHcare™ platform is anticipated to provide direct benefits to healthcare professionals, patients, and caregivers. These include the simplification of the multidisciplinary approach needed to tailor routine PAH management, enhancement of the patient/healthcare professional interaction, patient's empowerment to become more actively involved in the management and treatment of the disease, and increase of the patient's and caregiver's knowledge on PAH.
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Hipertensión Arterial Pulmonar , Humanos , Hipertensión Arterial Pulmonar/terapia , Calidad de Vida , Estudios Prospectivos , Enfermedad Crónica , Pacientes , Estudios Multicéntricos como AsuntoRESUMEN
INTRODUCTION: REHAP is a voluntary, observational Spanish registry of patients with pulmonary arterial hypertension. We analyzed the experience (use and effectiveness) with inhaled iloprost (inh-ILO) in real-life conditions during a 3-year period. METHODS: Patients included were those with PAH ≥14â¯years recruited during 1998-2016 who had received inh-ILO. Variables were collected at the beginning of treatment (0⯱â¯3â¯months) and 12⯱â¯3/36⯱â¯6â¯months follow-up. Effectiveness was assessed in the intent-to-treat population as changes in functional class and/or physical performance and transplant-free survival from the beginning of treatment. Stopping inh-ILO-related survival was also assessed. Subanalyses included treatment strategy (first-line therapy -monotherapy or upfront combination- or sequential therapy) and risk of clinical worsening/death. RESULTS: Inh-ILO was the most frequently used prostanoid in Spain, rendering 267 patients eligible for analysis. Median age was 54â¯years; 61% were WHO FC III. Sixty (23%) patients started inh-ILO as monotherapy, 27 (10%) as upfront combination and 180 (67%) sequentially. At 3-year follow-up significant clinical improvements were observed; however, transplant-free survival rate was 54%, being poorer in patients at high risk (63% vs. 85% in low risk patients; Pâ¯<â¯0.001) and similar in the three treatment strategies. Only 25% patients remained on inh-ILO. Three-year after stopping inh-ILO-related survival rate was 24.7%. CONCLUSION: Data from the REHAP collected during 3â¯years shows that inh-ILO has low effectiveness independently of the treatment strategy used, with a 3-year survival rate of 54% despite significant clinical improvements, probably due to the use in high-risk patients. Discontinuation rate was as high as 75%.
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Hipertensión Pulmonar/tratamiento farmacológico , Iloprost/administración & dosificación , Presión Esfenoidal Pulmonar/efectos de los fármacos , Sistema de Registros , Resistencia Vascular/efectos de los fármacos , Administración por Inhalación , Adulto , Anciano , Causas de Muerte/tendencias , Relación Dosis-Respuesta a Droga , Femenino , Estudios de Seguimiento , Volumen Espiratorio Forzado , Humanos , Hipertensión Pulmonar/mortalidad , Hipertensión Pulmonar/fisiopatología , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Estudios Retrospectivos , España/epidemiología , Factores de Tiempo , Resultado del Tratamiento , Vasodilatadores/administración & dosificación , Función Ventricular Derecha/fisiologíaRESUMEN
Pulmonary hypertension is a hemodynamic disorder defined by abnormally high pulmonary artery pressure that can occur in numerous diseases and clinical situations. The causes of pulmonary hypertension are classified into 5 major groups: arterial, due to left heart disease, due to lung disease and/or hypoxemia, chronic thromboembolic, with unclear and/or multifactorial mechanisms. This is a brief summary of the Guidelines on the Diagnostic and Treatment of Pulmonary Hypertension of the Spanish Society of Pulmonology and Thoracic Surgery. These guidelines describe the current recommendations for the diagnosis and treatment of the different pulmonary hypertension groups.
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Hipertensión Pulmonar/diagnóstico , Hipertensión Pulmonar/terapia , Algoritmos , Terapia Combinada , Enfermedades del Tejido Conjuntivo/complicaciones , Enfermedades del Tejido Conjuntivo/diagnóstico , Técnicas de Diagnóstico Cardiovascular/normas , Técnicas de Diagnóstico del Sistema Respiratorio/normas , Manejo de la Enfermedad , Quimioterapia Combinada , Medicina Basada en la Evidencia , Cardiopatías Congénitas/complicaciones , Cardiopatías/complicaciones , Cardiopatías/diagnóstico , Tabiques Cardíacos/cirugía , Unidades Hospitalarias/organización & administración , Humanos , Hipertensión Pulmonar/clasificación , Hipertensión Pulmonar/etiología , Trasplante de Pulmón , Enfermedades Metabólicas/complicaciones , Mutación , Terapia por Inhalación de Oxígeno , Derivación y Consulta/organización & administración , Trastornos Respiratorios/complicacionesRESUMEN
OBJECTIVE: Pulmonary arterial hypertension (PAH) prevalence has been reported to be between 0.5% and 17% in systemic lupus erythematosus (SLE). This study assessed PAH prevalence and predictors in an SLE cohort. METHODS: The Borg dyspnea scale, DLCO, N-terminal pro-brain natriuretic peptide (NT-proBNP), and Doppler echocardiographic (DE) were performed. An echocardiographic Doppler exercise test was conducted in selected patients. When DE systolic pulmonary arterial pressure was ≥ 45 mmHg or increased during exercise > 20 mmHg, a right heart catheterization was performed. Hemodynamic during exercise was measured if rest mean pulmonary arterial pressure was < 25 mmHg. RESULTS: Of the 203 patients with SLE, 152 were included. The mean age was 44.9 ± 12.3 years, and 94% were women. Three patients had known PAH. The algorithm diagnosed 1 patient with chronic thromboembolic pulmonary hypertension and 5 with exercise-induced pulmonary artery pressure increase (4 with occult left diastolic dysfunction). These patients had significantly more dyspnea, higher NT-proBNP, and lower DLCO. CONCLUSION: These data confirm the low prevalence of PAH in SLE. In our cohort, occult left ventricular diastolic dysfunction was a frequent diagnosis of unexplained dyspnea. Dyspnea, DLCO, and NT-proBNP could be predictors of pulmonary hypertension in patients with SLE.
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Hipertensión Pulmonar/epidemiología , Lupus Eritematoso Sistémico/epidemiología , Adulto , Ecocardiografía Doppler , Prueba de Esfuerzo , Femenino , Humanos , Hipertensión Pulmonar/sangre , Hipertensión Pulmonar/diagnóstico por imagen , Hipertensión Pulmonar/fisiopatología , Lupus Eritematoso Sistémico/sangre , Lupus Eritematoso Sistémico/diagnóstico por imagen , Lupus Eritematoso Sistémico/fisiopatología , Masculino , Persona de Mediana Edad , Péptido Natriurético Encefálico/sangre , Fragmentos de Péptidos/sangre , Prevalencia , Factores de RiesgoRESUMEN
BACKGROUND: The purpose of this study was to evaluate the long-term and midterm effects of thoracic sympathectomy on pulmonary function and to assess the influence of the sympathetic nervous system on bronchomotor tone. METHODS: Thirty-seven consecutive patients were diagnosed with primary hyperhidrosis requiring thoracic sympathectomy and were included in this study. Spirometry and methacholine challenge testing were performed before and 3 months after surgery. To assess the long-term effects of the intervention, another spirometric study was performed 1 year later. RESULTS: Spirometry 3 months after surgery showed a significant decrease in the forced vital capacity (-5.2%), the forced expiratory volume in the first second (-6.1%), and the forced expiratory flow between 25% and 75% of vital capacity (-5.1%). Whereas methacholine challenge testing before surgery was positive in 3 subjects (2 of whom were asthmatic), it was positive in 6 patients after the procedure; differences were not statistically significant. After 12 months, forced vital capacity started recovering, and forced expiratory volume in the first second and forced expiratory flow rate 25% to 75% showed a sustained and significant reduction (-2.8% and -11.2%, respectively); however, patients remained asymptomatic. CONCLUSIONS: We conclude that thoracic sympathectomy generates a mild, although significant, impairment of the bronchomotor tone, with no clinical consequences. These results suggest that the sympathetic nervous system is involved in pulmonary bronchomotor tone.
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Pulmón/fisiopatología , Ventilación Pulmonar , Simpatectomía , Nervios Torácicos/cirugía , Adolescente , Adulto , Femenino , Humanos , Hiperhidrosis/cirugía , Masculino , Persona de Mediana Edad , Factores de TiempoRESUMEN
OBJECTIVE: We sought to compare the long-term effects of conventional and simplified thoracic sympathectomy on cardiopulmonary function. METHODS: We performed a prospective and randomized study of 32 patients with diagnoses of primary hyperhidrosis who were candidates for either conventional or simplified thoracic sympathectomy. Patients were randomized according to the type of procedure: conventional thoracic sympathectomy (18 patients) and simplified thoracic sympathectomy (14 patients). Before surgical intervention, forced spirometry, body plethysmography, measurement of the diffusing capacity of the lung for carbon monoxide (DLCO), and exercise tests were carried out in all patients. These evaluations were performed again 1 year after the procedure to assess the long-term effects of sympathectomy. RESULTS: Lung function tests revealed a significant decrease in forced expiratory volume in 1 second (FEV(1)) and forced expiratory flow between 25% and 75% of vital capacity (FEF(25%-75%)) in both groups (FEV(1) of -6.3% and FEF(25%-75%) of -9.1% in the conventional thoracic sympathectomy group and FEV(1) of -3.5% and FEF(25%-75%) of -12.3% in the simplified thoracic sympathectomy group). DLCO and heart rate at rest and maximal values after exercise were also significantly reduced in both groups (DLCO of -4.2%, DLCO corrected by alveolar volume of -6.1%, resting heart rate of -11.8 beats/min, and maximal heart rate of -9.5 beats/min in the conventional thoracic sympathectomy group and DLCO of -3.9%, DLCO corrected by alveolar volume of -5.2%, resting heart rate of -10.7 beats/min, and maximal heart rate of -17.6 beats/min in the simplified thoracic sympathectomy group). Airway resistance increased significantly in the group of patients undergoing conventional thoracic sympathectomy (+13%). Despite all these changes, the patients remained asymptomatic. No significant differences were found between the conventional and simplified thoracic sympathectomy groups. CONCLUSIONS: Simplified and conventional thoracic sympathectomy resulted in a long-term reduction in FEV(1), FEF(25%-75%), DLCO, and resting and maximal heart rate, as well as a mild but significant increase in airway resistance in the conventional thoracic sympathectomy group, without any clinical consequence to the patient. These changes were unrelated to the level of transection of the thoracic sympathetic chain.
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Hiperhidrosis/fisiopatología , Hiperhidrosis/cirugía , Pulmón/fisiopatología , Simpatectomía/métodos , Nervios Torácicos/cirugía , Adolescente , Adulto , Femenino , Humanos , Masculino , Pletismografía , Estudios Prospectivos , Capacidad de Difusión Pulmonar , Ventilación Pulmonar/fisiología , Pruebas de Función Respiratoria , Espirometría , Cirugía Torácica Asistida por Video , Adulto JovenRESUMEN
BACKGROUND: Inhaled nitric oxide (iNO) is a potent pulmonary vasodilator, but therapeutic experience in patients with severe pulmonary hypertension is scarce. METHODS: Eleven patients with severe pulmonary hypertension, 6 due to pulmonary arterial hypertension and 4 due to chronic thromboembolic disease, were selected for iNO therapy. A phosphodiesterase type 5 inhibitor (PDE5i) was added in cases of clinical worsening. In this study we evaluate the clinical effectiveness and safety of long-term treatment with iNO either alone or combined with a PDE5i. RESULTS: After 1 month of iNO administration, improvements were observed in World Health Organization functional class, Borg scale (p = 0.003), brain natriuretic peptide levels (p = 0.002) and 6-minute walk test (p = 0.003). After 6 months of treatment, 7 patients had clinical deterioration that was reversed upon adding a PDE5i. One of these patients died in Month 8 and another underwent pulmonary transplantation in Month 9. The clinical condition of the remaining 9 patients was unchanged after 1 year. A second right catheterization showed improvement in mean pulmonary arterial pressure (66 +/- 15 mm Hg to 56 +/- 18 mm Hg; p = 0.01), pulmonary vascular resistance (1,234 +/- 380 dyn/s/cm(5) to 911 +/- 410 dyn/s/cm(5); p = 0.008) and cardiac index (2.0 +/- 0.4 liters/min/m(2) to 2.5 +/- 0.4 liters/min/m(2); p = 0.04). There was no significant increase in methemoglobin, no worsening of pulmonary function and no sudden withdrawal syndrome. CONCLUSIONS: We suggest that iNO therapy alone or in combination with a PDE5i could be a therapeutic alternative for severe pulmonary hypertension.
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Fosfodiesterasas de Nucleótidos Cíclicos Tipo 5/metabolismo , Hipertensión Pulmonar/tratamiento farmacológico , Óxido Nítrico/uso terapéutico , Inhibidores de Fosfodiesterasa/uso terapéutico , Administración por Inhalación , Adulto , Anciano , Anticoagulantes/uso terapéutico , GMP Cíclico/sangre , Diuréticos/uso terapéutico , Femenino , Estudios de Seguimiento , Humanos , Hipertensión Pulmonar/complicaciones , Masculino , Persona de Mediana Edad , Óxido Nítrico/administración & dosificación , Inhibidores de Fosfodiesterasa 5 , Seguridad , Tromboembolia/complicaciones , Resultado del Tratamiento , Vasodilatadores/uso terapéuticoRESUMEN
The aim of this investigation was to evaluate the contribution of cephalometry to a statistical model integrating clinical, physical, and oximetric variables, to reduce demands for polysomnographies. Two hundred and twenty-five consecutive patients that had been referred to the sleep clinic for suspected obstructive sleep apnea (OSA) were studied. The clinical assessment of all patients consisted of a sleep related questionnaire, the Epworth sleepiness scale, and a physical examination. In addition, they all underwent spirometry, cephalometry, and a full polysomnography. The clinical variables related with OSA were questions concerning witnessing of apneas by bed partners, intensity of snoring, a history of hypertension, and nocturia. A significant relation was also found with score on the Epworth scale, sex, age, body mass index, neck and waist circumferences, total number and frequency of oxygen desaturations, and the lowest oxygen saturation value. Significant cephalometric measurements were: the linear distance from gonion to gnathion, from the hyoid bone to the mandibular plane, and from the posterior nasal spine to the tip of the soft palate, and the thickness of the uvula as well. A statistical model was built to estimate a patient's probability of having OSA based on clinical variables, physical examination, pulse oximetry, and cephalometry. The validation of this model demonstrated a remarkable ability in reducing the number of polysomnographic studies. We conclude that cephalometry combined with clinical variables, physical examination, and nocturnal oximetry is useful in the diagnosis of OSA and enables the sparing of a considerable number of polysomnographies.
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Cefalometría/estadística & datos numéricos , Polisomnografía/estadística & datos numéricos , Apnea Obstructiva del Sueño/diagnóstico , Adulto , Antropometría , Índice de Masa Corporal , Estudios de Evaluación como Asunto , Femenino , Necesidades y Demandas de Servicios de Salud/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Oxígeno/sangre , Examen Físico , Valor Predictivo de las Pruebas , Valores de Referencia , Apnea Obstructiva del Sueño/psicología , España , Encuestas y Cuestionarios , Procedimientos Innecesarios/estadística & datos numéricosRESUMEN
Inhaled nitric oxide (iNO) has been shown to be a potent and selective vasodilator in pulmonary arterial hypertension (PAH). However, the clinical experience in prolonged treatment is limited. We assess the safety and effectiveness of long-term administration of iNO in severe PAH. Two female patients were admitted to our hospital because of severe dyspnea (World Health Organization functional class IV) and hypoxemia. They were diagnosed with PAH (primary and secondary to congenital heart disease) and treated with iNO for 2 years. The delivery system consisted of an NO tank of 800 ppm, a modified gas-pulsing device, and nasal cannulas. On iNO treatment the patients showed remarkable improvement of symptoms, oxygenation and 6-min walk distance. After 16 months the patients began to experience a progressive rebound of symptoms. A phosphodiesterase type 5 inhibitor (dipyridamole) was added to iNO. This intervention proved useful in improving clinical deterioration and hemodynamics. This is the first study reporting 2-year iNO therapy in 2 patients with primary and secondary pulmonary hypertension. The combination of dipyridamole with iNO augments the pulmonary vasodilatation and may be useful in managing PAH.