Balloon Pulmonary Angioplasty in Patients with Chronic Thromboembolic Pulmonary Hypertension: Impact on Clinical and Hemodynamic Parameters, Quality of Life and Risk Profile

Abstract

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%.

Epidemiology of chronic thromboembolic pulmonary hypertension (CTEPH) in the Czech Republic

“…5,8,10,16,33,49 BPA has been performed routinely in the Czech Republic since 2017 and a recent study that included 25 patients with CTEPH who completed their series of BPA procedures between 2013 and 2019 reported significant improvements in their NYHA FC, 6MWD, PVR and quality of life following the procedure (median of 4 months [95% CI: 2.0; 14.0] after the last BPA). 25 The strengths of this study are the national coverage afforded by the single national expert center, the use of comprehensive data from the national databases (IHIS CR), and the ability of the study to provide a basis for future studies by virtue of being conducted when PEA was the only treatment option. In this study, survival was estimated since diagnosis for all groups.…”

“… 5 , 8 , 10 , 16 , 33 , 49 BPA has been performed routinely in the Czech Republic since 2017 and a recent study that included 25 patients with CTEPH who completed their series of BPA procedures between 2013 and 2019 reported significant improvements in their NYHA FC, 6MWD, PVR and quality of life following the procedure (median of 4 months [95% CI: 2.0; 14.0] after the last BPA). 25 …”

“…This national coverage allows the collection of comprehensive data on all CTEPH patients in the country. The only treatment option available to patients with CTEPH in the Czech Republic was PEA (introduced 2004) 24 until BPA was introduced in 2013 (with routine use from 2017 onward), 25 and riociguat became commercially available in the Czech Republic in 2015. Off‐label use is not permitted in the Czech Republic, and unlicensed treatments are therefore only available through participation in clinical trials.…”

Global trends in chronic thromboembolic pulmonary hypertension clinical trials and dissemination of results

“…18 The use of BPA in Europe is increasing but is being reported primarily in retrospective studies with few entries identified in the clinical trial databases. [19][20][21] (Table 1). In addition to BPA, our search identified pulmonary artery denervation as the subject of two clinical trials based in Russia and China, with results having been recently published by Romanov et al 22 Around one in four patients will have residual pulmonary hypertension after PEA and it remains unclear how best to integrate medical therapy or BPA.…”

Prognostic Value of Pulmonary Artery Pulsatility Index in Right Ventricle Failure-Related Mortality in Inoperable Chronic Thromboembolic Pulmonary Hypertension

“…A pulmonary endarterectomy (PEA) is the treatment of choice for operable patients. However, some patients are ineligible for surgery due to distal localization of thromboembolic lesions, comorbidities, or functional status [ 4 , 5 ]. Available treatment options for these CTEPH patients include targeted medical therapy and interventional technique—percutaneous balloon pulmonary angioplasty (BPA), which has become a promising treatment modality [ 6 , 7 , 8 , 9 , 10 , 11 , 12 ].…”