Effect of Combination of Balloon Pulmonary Angioplasty and Medical Therapy on Reverse Right Ventricular Remodeling and Hemodynamics in Chronic Thromboembolic Pulmonary Hypertension.

ABSTRACT

INTRODUCTION: Chronic thromboembolic pulmonary hypertension (CTEPH) is a progressive and debilitating disorder that results from incomplete resolution of vascular obstructions resulting in pulmonary hypertension. Surgical pulmonary thromboendarterectomy (PTE) is the treatment of choice for CTEPH. Unfortunately, many CTEPH patients are ineligible for PTE or do not have access to an expert surgical center. Medical therapy imparts important symptomatic and exercise benefits for CTEPH patients, but it does not extend survival. Balloon pulmonary angioplasty (BPA) is an emerging transcatheter approach that is both safe and efficacious. However, the potential synergy between upfront BPA and medical therapy treatment approaches in patients with inoperable CTEPH is unknown. Here, we evaluated how the combination of BPA and medical therapy compared to medical therapy alone in a newly established BPA program. METHODS: Twenty-one patients with inoperable or residual CTEPH were evaluated in this single-center observational study. Ten patients underwent upfront BPA and medical therapy while 11 patients were treated with medical therapy alone. Hemodynamic and echocardiographic assessments were performed at baseline and at least 1 month after completion of therapy. Continuous variables were compared using t-test or Mann-Whitney U-test. Categorical variables were analyzed with Chi squared and Fisher's exact test where appropriate. RESULTS: Combination therapy significantly reduced mean pulmonary arterial pressure (mPAP) and pulmonary vascular resistance (PVR), but medical therapy only significantly lowered PVR. Comprehensive echocardiographic analysis revealed a more robust reverse right ventricular (RV) remodeling effect and augmentation of RV function with combination therapy. At the end of study, the combination therapy group had lower mPAP and PVR and better RV function. Importantly, there were no significant adverse effects in patients treated with BPA. CONCLUSION: Combination therapy significantly improves hemodynamics and RV function in inoperable CTEPH while carrying an acceptable risk profile, even in a newly developed program. Further studies comparing upfront combination therapy to medical therapy with larger, long-term, and randomized approaches should be considered.