title: Operability assessment in CTEPH: Lessons from the CHEST-1 study.
abstract: Pulmonary endarterectomy is the gold standard treatment for chronic thromboembolic pulmonary hypertension and is potentially curative, although some patients are unsuitable for pulmonary endarterectomy and require alternative management. Lack of standardized assessment of pulmonary endarterectomy eligibility risks suboptimal treatment in some patients. We discuss the implications for future clinical trials and practice of a unique operability assessment in patients who have chronic thromboembolic pulmonary hypertension and were initially screened for inclusion in the CHEST-1 (Chronic Thromboembolic Pulmonary Hypertension Soluble Guanylate Cyclase Stimulator Trial-1) study. The CHEST-1 study evaluated riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent/recurrent pulmonary hypertension after pulmonary endarterectomy. Screened patients who were initially considered "inoperable" underwent central independent adjudication by a committee of experienced surgeons, or local adjudication in collaboration with an experienced surgeon. Operability decisions were based on accessibility of thrombi and the association between pulmonary vascular resistance (PVR) and the extent of obstruction, using pulmonary angiography/computed tomography with ventilation/perfusion scintigraphy as the minimum diagnostic tests. Of 446 patients screened for CHEST-1, a total of 188 and 124 underwent central and local adjudication, respectively, after being initially considered to be "inoperable." After a second assessment by an experienced surgeon, 69 of these 312 "inoperable" patients were deemed operable. Rigorous measures in CHEST-1 guaranteed that only technically inoperable patients, or patients who had persistent/recurrent pulmonary hypertension, were enrolled, thus ensuring that only patients for whom surgery was not an option were enrolled. This study design sets new standards for future clinical trials and practice in CTEPH, helping to ensure that patients who have CTEPH receive optimal treatment.
authors.affiliation: National Pulmonary Endarterectomy Service, Department of Cardiothoracic Surgery, Papworth Hospital, Cambridge, United Kingdom. Electronic address: david.jenkins@papworth.nhs.uk.
authors.forename: David P
authors.initials: DP
authors.lastname: Jenkins
authors.affiliation: Department of Cardiac Surgery, Allenort Hospital, Warsaw, Poland.
authors.forename: Andrzej
authors.initials: A
authors.lastname: Biederman
authors.affiliation: Division of Cardiothoracic Surgery, Foundation "I.R.C.C.S. Policlinico San Matteo," University of Pavia School of Medicine, Pavia, Italy.
authors.forename: Andrea M
authors.initials: AM
authors.lastname: D'Armini
authors.affiliation: Department of Thoracic and Vascular Surgery and Heart Lung Transplantation, Marie-Lannelongue Hospital, Paris-Sud University, Le Plessis-Robinson, France.
authors.forename: Philippe G
authors.initials: PG
authors.lastname: Dartevelle
authors.affiliation: Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, Beijing Institute of Heart, Lung, and Blood Vessel Disease, Beijing, China.
authors.forename: Hui-Li
authors.initials: HL
authors.lastname: Gan
authors.affiliation: Department of Cardiothoracic Surgery, Vienna General Hospital, Medical University of Vienna, Vienna, Austria.
authors.forename: Walter
authors.initials: W
authors.lastname: Klepetko
authors.affiliation: 2nd Surgical Department-Clinical Department of Cardiovascular Surgery, First Faculty of Medicine and General Teaching Hospital, Charles University Prague, Prague, Czech Republic.
authors.forename: Jaroslav
authors.initials: J
authors.lastname: Lindner
authors.affiliation: Kerckhoff Heart and Lung Center, Bad Nauheim, Germany.
authors.forename: Eckhard
authors.initials: E
authors.lastname: Mayer
authors.affiliation: Division of Cardiovascular and Thoracic Surgery, University of California San Diego Medical Center, San Diego, Calif.
authors.forename: Michael M
authors.initials: MM
authors.lastname: Madani
mesh_terms: D002908:Chronic Disease; D017128:Embolectomy; D004691:Endarterectomy; D006801:Humans; D006976:Hypertension, Pulmonary / Q000601:surgery*; D011655:Pulmonary Embolism; D016278:Ventricular Function, Right
keywords: chronic thromboembolic pulmonary hypertension; operability assessment; pulmonary endarterectomy