Hospital costs of Balloon Pulmonary Angioplasty (BPA) procedure and management for CTEPH patients: An observational study based on the French national hospital discharge database (PMSI)

Introduction Since 2014, Balloon Pulmonary Angioplasty (BPA) has become an emerging and complementary strategy for chronic thromboembolic hypertension (CTEPH) patients who are not suitable for pulmonary endarterectomy (PEA) or who have recurrent symptoms after the PEA procedure. Objective To assess the hospital cost of BPA sessions and management in CTEPH patients. Methods An observational retrospective cohort study of CTEPH-adults hospitalized for a BPA between January 1st, 2014 and June 30th, 2016 was conducted in the 2 centres performing BPA in France (Paris Sud and Grenoble) using the French national hospital discharge database (PMSI-MCO). Patients were followed until 6 months or death, whichever occurred first. Follow-up stays were classified as stays with BPA sessions, for BPA management or for CTEPH management based on a pre-defined algorithm and a medical review using type of diagnosis (ICD-10), delay from last BPA procedure stay and length of stay. Hospital costs (including medical transports) were estimated from National Health Insurance perspective using published official French tariffs from 2014 to 2016 and expressed in 2017 Euros. Results A total of 191 patients were analysed; mainly male (53%), with a mean age of 64,3 years. The first BPA session was performed 1.1 years in median (IQR 0.3–2.92) after the first PH hospitalisation. A mean of 3 stays with BPA sessions per patient were reported with a mean length of stay of 8 days for the first stay and 6 days for successive stays. The total hospital cost attributable to BPA was € 4,057,825 corresponding to €8,764±3,435 per stay and €21,245±12,843 per patient. Results were sensitive to age classes, density of commune of residence and some comorbidities. Conclusions The study generated robust real-world data to assess the hospital cost of BPA sessions and management in CTEPH patients within its first years of implementation in France.

Diffusing Capacity for Carbon Monoxide Predicts Response to Balloon Pulmonary Angioplasty in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension

Background: The hemodynamic results of balloon pulmonary angioplasty vary among patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). Previous studies revealed that microvasculopathy accounted for residual pulmonary hypertension after pulmonary endarterectomy, which could be reflected by the diffusing capacity for carbon monoxide (DLCO). We aimed to identify whether the DLCO could predict the BPA response.Materials and Methods: We retrospectively analyzed 75 consecutive patients with inoperable CTEPH who underwent BPA from May 2018 to January 2021 at Fuwai Hospital. According to the hemodynamics at follow-up after the last BPA, patients were classified as “BPA responders” (defined as a mean pulmonary arterial pressure ≤ 30 mmHg and/or a reduction of pulmonary vascular resistance ≥ 30%) or “BPA nonresponders.”Results: At the baseline, BPA responders had significantly higher DLCO values than nonresponders, although the other variables were comparable. In BPA responders, the DLCO decreased after the first BPA session and then returned to a level similar to the baseline at follow-up. Conversely, the DLCO increased constantly from the baseline to follow-up in nonresponders. Multivariate logistic analysis showed that a baseline DLCO of <70% and a percent change in DLCO between the baseline and the period within 7 days after the first BPA session (ΔDLCO) of > 6% were both independent predictors of an unfavorable response to BPA. Receiver operator characteristic analysis showed that the combination of a baseline DLCO < 70% and ΔDLCO > 6% demonstrated a better area under the curve than either of these two variables used alone.Conclusions: A baseline DLCO < 70% and ΔDLCO > 6% could independently predict unfavorable responses to BPA. Measuring the DLCO dynamically facilitates the identification of patients who might have unsatisfactory hemodynamic results after BPA.

45 Experience of 5 years of balloon pulmonary angioplasty in a single centre: safety and short-term results

Aims Balloon pulmonary angioplasty (BPA) has recently been developed as a treatment strategy for chronic thromboembolic pulmonary hypertension (CTEPH) but efficacy and technical safety have to be established. We examine the effects of BPA on patients with inoperable disease or residual pulmonary hypertension (PH) after pulmonary endarterectomy (PEA). Methods and results From 2015 to 2020 we enrolled symptomatic inoperable CTEPH patients and patients with residual PH after PEA. At baseline and 3 months after last BPA session patients underwent clinical evaluation, 6-min walking distance (6MWD), and right heart catheterization. Friedman test with Bonferroni post-hoc pairwise analysis was used. Fifty patients [male 42%, median age 68 (51–74) years, 42 inoperable, and 8 with residual PH after PEA] were treated for a total of 156 sessions (median 2 sessions/patient); during each session we treated 2.3 (2.2–2.7) vessels. Results are shown in the Table. Forty-nine patients were treated with medical therapy before BPA (19 with combination therapy). Five pulmonary artery dissection and two haemoptysis with clinical impairment were documented during the procedures; 37 patients had lung injury (radiographic opacity with/without haemoptysis and/or hypoxaemia), none had renal dysfunction, 7 patients had access site complications. Seven patients died during follow-up (none within 30 days from the procedure) because of sepsis (1), heart failure (1), cancer (2), arrhythmic storm (2), and sudden death in patients with severe coronary atherosclerosis (1). Conclusions BPA is a safe and effective treatment able to improve symptoms and haemodynamic profile. 45 Table 16MWD, six minute walking distanceCI, cardiac index; mPAP, mean pulmonary arterial pressure; PAC, pulmonary arterial compliance; PVR, pulmonary vascular resistance; RAP, right atrial pressure; SvO2, mixed venous oxygen saturation; WHO-FC, World Health Organization functional class.

Balloon pulmonary angioplasty combined with riociguat for the treatment of inoperable chronic thromboembolic pulmonary hypertension (PRACTICE study): study protocol for a randomized controlled trial

Background Management of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) remains a clinical challenge. Currently, riociguat, a soluble guanylate-cyclase stimulator is recommended by international guidelines. More recently, balloon pulmonary angioplasty (BPA) develops as an alternative treatment for inoperable CTEPH. Method This study is a single-center randomized controlled trial. Subjects with inoperable CTEPH are randomized into either a BPA combined with riociguat or riociguat monotherapy group (2:1) and observed for 12 months after initiation of treatment. The primary endpoint is the change in pulmonary vascular resistance from baseline to 12 months after initiation of treatment. The secondary endpoints include 6-min walk distance (6MWD), WHO-FC, NT-proBNP, SF-36, and other hemodynamic parameters. Safety endpoints are analyzed too. Discussion This study aims to compare the efficacy and safety of BPA combined with riociguat and riociguat monotherapy for inoperable CTEPH. Trial registration Chinese Clinical Trial Registry ChiCTR2000032403. Registered on 27 April 2020.