scholarly journals United States Chronic Thromboembolic Pulmonary Hypertension Registry: Protocol Design (Preprint)

2020 ◽  
Author(s):  
Kim M. Kerr ◽  
C. Greg Elliott ◽  
Raymond L. Benza ◽  
Richard N. Channick ◽  
Kelly Chin ◽  
...  

BACKGROUND Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare sequela of acute pulmonary embolism that is treatable when recognized. Awareness of this disease has increased with recent advancements in therapeutic options, but delays in diagnosis remain common and diagnostic and treatment guidelines are often not followed. Data gathered from international registries has improved our understanding of CTEPH, but this data may not be applicable to the U.S. population due to differences in demographics and medical practice patterns. OBJECTIVE The U.S. CTEPH Registry (US-CTEPH-R) was developed to provide essential information to better understand the demographics, risk factors, evaluation, and treatment of CTEPH in the United States, as well as short and long-term outcomes of surgical and non-surgical therapies in the modern treatment era. METHODS Thirty sites throughout the United States enrolled 750 subjects in this prospective, longitudinal, observational registry of newly diagnosed CTEPH patients. Enrollment criteria included a mean pulmonary artery pressure > 25 mmHg by right heart catheterization and radiologic confirmation of CTEPH by a multi-disciplinary adjudication committee. Following enrollment, subjects were followed bi-annually until the conclusion of the study. Quality of life surveys were administered at enrollment and biannually, all other testing was at the discretion of the treating clinician. Details regarding surgical therapy, balloon pulmonary angioplasty and medical therapy were collected at enrollment and at follow-up as well as information related to health care utilization and survival. RESULTS Data from this registry will improve the understanding of the demographics, risk factors, and treatment patterns of CTEPH patients and the longitudinal impact of therapies on quality of life, healthcare utilization, and survival. CONCLUSIONS This manuscript details the methodology and design of the first large, prospective, longitudinal, registry of CTEPH patients in the U.S. CLINICALTRIAL ClinicalTrials.gov ID: NCT02429284

2020 ◽  
Author(s):  
Aaron B Waxman ◽  
Aaron W Aday

More than 200,000 individuals are hospitalized with an acute pulmonary embolism in the United States annually. Despite advances in diagnosis and treatment, pulmonary embolism accounts for nearly 1% of all cardiovascular-related deaths each year in the United States alone. Those who survive an acute episode remain at a risk of recurrent events as well as ongoing dyspnea, reduced quality of life, and chronic thromboembolic pulmonary hypertension. Recognized risk factors for pulmonary embolism include advanced age, obesity, smoking, malignancy, immobilization from any cause, pregnancy and the postpartum period, oral contraceptives, and hormone replacement therapy. Numerous heritable and acquired thrombophilias increase the risk of pulmonary embolism. Additionally, inflammation and autoimmune disorders are increasingly recognized as potent risk factors for pulmonary embolism. This review contains 3 figures, 6 tables, 54 references. Key Words: anticoagulation, deep vein thrombosis, epidemiology, genetics, inflammation, malignancy, pulmonary embolism, thrombosis, venous thromboembolism


Author(s):  
Daniela Cavalet Blanco ◽  
Noris Coimbra Scaglia ◽  
Flavio Vinicius Costa Ferreira ◽  
Sabrina Rocha Machado ◽  
Luciana Zani Viegas da Silva

2020 ◽  
Author(s):  
Aaron B Waxman ◽  
Aaron W Aday

More than 200,000 individuals are hospitalized with an acute pulmonary embolism in the United States annually. Despite advances in diagnosis and treatment, pulmonary embolism accounts for nearly 1% of all cardiovascular-related deaths each year in the United States alone. Those who survive an acute episode remain at a risk of recurrent events as well as ongoing dyspnea, reduced quality of life, and chronic thromboembolic pulmonary hypertension. Recognized risk factors for pulmonary embolism include advanced age, obesity, smoking, malignancy, immobilization from any cause, pregnancy and the postpartum period, oral contraceptives, and hormone replacement therapy. Numerous heritable and acquired thrombophilias increase the risk of pulmonary embolism. Additionally, inflammation and autoimmune disorders are increasingly recognized as potent risk factors for pulmonary embolism. This review contains 3 figures, 6 tables, 54 references. Key Words: anticoagulation, deep vein thrombosis, epidemiology, genetics, inflammation, malignancy, pulmonary embolism, thrombosis, venous thromboembolism


2020 ◽  
Vol 9 (11) ◽  
pp. 3608
Author(s):  
Pavel Jansa ◽  
Samuel Heller ◽  
Michal Svoboda ◽  
Michal Pad’our ◽  
David Ambrož ◽  
...  

Balloon pulmonary angioplasty (BPA) is a novel treatment option for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are not eligible for pulmonary endarterectomy (PEA) or suffer from persistent pulmonary hypertension after PEA. The aim of this study was to evaluate the real-life efficacy and safety of BPA in a consecutive group of patients who were diagnosed and treated in the national referral center for CTEPH in the Czech Republic. Here we report data from 160 BPA procedures performed in 64 patients. Efficacy analysis was performed in the subgroup of 25 patients who completed BPA series. Significant improvements were observed in New York Heart Association functional class (4% to 79% in I/II, p < 0.001), 6 min walking test distance (+54.3 m, p < 0.001), risk profile (15.8% to 68.5% with presence of 2/3 low risk criteria, p < 0.001), pulmonary artery mean pressure (−18%, p < 0.001), pulmonary vascular resistance (−32%, p < 0.001), stroke volume (+17%, p = 0.011) and quality of life (+37% in assessment of overall health status by a patient, p < 0.001). We observed 1 fatal periprocedural complication (1.6% of all 64 patients) and 19 BPA-related non-fatal complications (11.9% of all 160 interventions) that predominantly included hemoptysis (10.0% of all sessions). Overall survival at 12 months was 94.6%.


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