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J Thorac Cardiovasc Surg 2010;139:85-91
© 2010 The American Association for Thoracic Surgery

Acquired Cardiovascular Disease

Bosentan as a bridge to pulmonary endarterectomy for chronic thromboembolic pulmonary hypertension

Herre J. Reesink, MD, PhDa, Sulaiman Surie, MDa, Jaap J. Kloek, MDb, Hanno L. Tan, MD, PhDc, Robert Tepaske, MD, PhDd, Peter F. Fedullo, MDe, Paul Bresser, MD, PhDa,*

a Department of Pulmonology, University of Amsterdam, Amsterdam, The Netherlands
b Department of Cardiothoracic Surgery, University of Amsterdam, Amsterdam, The Netherlands
c Department of Cardiology, University of Amsterdam, Amsterdam, The Netherlands
d Department of Intensive Care Medicine of the Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
e Division of Repiratory and Critical Care Medicine, University of California San Diego, San Diego, Calif

Received for publication October 20, 2008; revisions received March 23, 2009; accepted for publication March 29, 2009.

* Address for reprints: P. Bresser, MD, PhD, Academic Medical Center, University of Amsterdam, Department of Pulmonology, F5-144, PO Box 22700, 1100 DE Amsterdam, The Netherlands. (Email: P.Bresser{at}amc.uva.nl).

Objectives: In proximal chronic thromboembolic pulmonary hypertension, pulmonary endarterectomy is the treatment of first choice. In general, medical treatment before pulmonary endarterectomy is not indicated. However, selected "high-risk" patients might benefit by optimization of pulmonary hemodynamics. Moreover, in patients whose surgery is delayed owing to limited medical resources, pretreatment may prevent clinical deterioration. The primary objective of this study was to determine whether the dual endothelin-1 antagonist bosentan improves pulmonary hemodynamics and functional capacity in patients with proximal chronic thromboembolic pulmonary hypertension waiting for pulmonary endarterectomy.

Methods: We used an investigator-initiated, randomized, controlled single-blind study. Patients were randomized to receive bosentan (n = 13) or no bosentan (n = 12) for 16 weeks, next to "best standard of care." The primary end point was change in total pulmonary resistance. Secondary end points included changes in 6-minute walk distance, mean pulmonary artery pressure, and cardiac index.

Results: After 16 weeks, the mean differences in change from baseline between the groups were as follows: total pulmonary resistance 299 dynes · s · cm–5 (P = .004), 6-minute walk distance 33 m (P = .014), mean pulmonary artery pressure 11 mm Hg (P = .005), and cardiac index 0.3 L · min–1 · m–2 (P = .08). Treatment with bosentan was safe. After pulmonary endarterectomy, 4 patients died (no-bosentan group: n = 3); the short-term in-hospital postoperative clinical course was similar in both groups of patients.

Conclusions: Patients with proximal chronic thromboembolic pulmonary hypertension may benefit hemodynamically and clinically from treatment with bosentan before pulmonary endarterectomy. Individual factors predictive of a beneficial response and whether this influences either morbidity or mortality associated with pulmonary endarterectomy remain to be established.

Abbreviations and Acronyms 6-MWD = six-minute walk distance; BNP = brain natriuretic peptide; CI = cardiac index; CTEPH = chronic thromboembolic pulmonary hypertension; ET-1 = endothelin-1; mPAP = mean pulmonary artery pressure; mRAP = mean right atrial pressure; PEA = pulmonary endarterectomy; TPR = total pulmonary resistance




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