Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: Results of an International Multicenter Prospective Registry
- PMID: 40499982
- DOI: 10.1016/j.jacc.2025.04.021
Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: Results of an International Multicenter Prospective Registry
Abstract
Background: Chronic thromboembolic pulmonary hypertension results from mechanical obstruction of major pulmonary artery lumina with fibrotic tissue. Main treatment has been pulmonary endarterectomy, a complex surgical procedure removing vascular obstruction. However, at least 40% of patients are not candidates for pulmonary endarterectomy because of technical inoperability, comorbidities, or limited access to surgery. Balloon pulmonary angioplasty (BPA) has emerged as an interventional treatment for these patients.
Objectives: The International BPA Registry (NCT03245268) was designed to investigate BPA practice across 18 established centers in the United States, Europe, and Japan.
Methods: A total of 500 patients were prospectively and consecutively enrolled between March 2018 and March 2020, with follow-up until March 2022. Of these, 484 patients were included in the analysis set.
Results: Regional differences were seen in patient characteristics (fewer patients with prior pulmonary endarterectomy and more elderly women in Japan) and procedural details (less medical pretreatment, more jugular access, more segments and more occlusive lesions treated per session and patient, less conscious sedation, less contrast and less radiation, shorter intervals between BPA sessions in Japan). Female sex, procedure in Europe/United States, pulmonary hypertension medications at any time, and higher baseline pulmonary vascular resistance (PVR), calculated as transpulmonary pressure gradient divided by cardiac output, emerged as independent predictors of complications during BPA. After a median of 5 (Q1-Q3: 3-6) BPA sessions per patient within a median time of 4.9 months (Q1-Q3: 1.7-11.0 months), a 15-mm Hg (38%) decrease in mPAP, a 332 dynes/s/cm-5 (57%) decrease in PVR, and a 3.2% increase in arterial saturation (medians; P < 0.001) were observed, and there were significant improvements in functional class, 6-minute walk distance, serum levels of N-terminal probrain natriuretic peptide, and Borg dyspnea index. BPA complications occurred in 11.3% of sessions and 33.9% of patients and were mostly hemoptyses. No patient died within 30 days of BPA.
Conclusions: Our data are in line with previous reports on changes of clinical and hemodynamic parameters and complication rates of BPA. Centers with more experience providing BPAs were more likely to achieve a higher percentage decrease in PVR.
Keywords: balloon pulmonary angioplasty; balloon pulmonary angioplasty outcomes; balloon pulmonary angioplasty-related complication; chronic thromboembolic pulmonary hypertension.
Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Funding Support and Author Disclosures The ICA received financial support from Bayer Pharma AG to run the registry. The sponsor was not involved in the management of nor in decisions related to the Registry, and had no access to the database. Dr Lang was an investigator in trials involving the following drug companies, and also had relationships including consultancy service, research grants, and membership of scientific advisory boards: AOP-Health, Actelion-Janssen, Merck Sharp & Dohme, United Therapeutics, Pulnovo, Medtronic, Neutrolis, and Sanofi. Dr Brenot has received compensation for scientific symposia from Merck Sharp & Dohme. Dr Jaïs has received grants from Janssen; and has received speaker fees and/or consultant honoraria from Merck Sharp & Dohme. Dr Madani has received consultancy fees and royalties from Wexler Surgical; and has received consultancy fees from Actelion/Janssen and Johnson and Johnson. Dr Guth has received speaker fees and/or consultant honoraria from Actelion/Janssen, Bayer AG, Merck Sharp & Dohme, and Pfizer. Dr Kurzyna has provided consultancy services, received research grants, served as scientific advisory board member, and served as an investigator in clinical trials for drug companies including AOP-Health, Actelion-Janssen, Merck Sharp & Dohme, United Therapeutics, Pfizer, and Ferrer. Dr Wiedenroth has received speaker fees and/or consultant honoraria from Actelion/Janssen, AOP Orphan Pharmaceuticals AG, Bayer AG, BTG, Merck Sharp & Dohme, OrphaCare, and Pfizer. Dr Shimokawahara has received lecture fees from Bayer Yakuhin and Nippon Shinyaku; and has received research funding from Bayer Yakuhin. Dr Bashir has been funded by National Heart, Lung, and Blood Institute; and has an equity interest in Thrombolex Inc. Dr Delcroix has received speaker and consultant fees from Ferrer, Gossamer Bio, Janssen, and Merck Sharp & Dohme, unrelated to current work and all paid to her institution. Dr Frantz has received consulting fees from Gossamer Bio, Insmed, Merck and Liquidia; has participated in a Data Safety Monitoring or Advisory Board of Aerovate Pharmaceuticals; has received royalties or licenses from UpToDate; has received grants that were paid to his institution from National Heart, Lung, and Blood Institute and Gossamer Bio; is a member of the Pulmonary Hypertension Association Scientific Leadership Council; and holds stocks in Merck. Dr Gerges has received compensation for scientific symposia from AstraZeneca, AOPHealth, Cordis, Janssen, and Merck Sharp & Dohme; has received speaker fees from AOPHealth, AstraZeneca, Janssen, and Ferrer; and has received an educational grant from OrphaCare. Dr Godinas has received consultant/speaker honoraria from Merck Sharp & Dohme, Johnson and Johnson, Biotest, and Chiesi. Dr Heresi has received funds for investigator-initiated research as well as fees for advisory boards and non-promotional nonbranded speaking from Bayer Healthcare; and has received fees for advisory boards from Johnson and Johnson. Dr Jansa is a paid consultant and speaker for numerous pharmaceutical companies and has received financial grants from Johnson and Johnson, AOP Health, Bayer Healthcare, Merck Sharp & Dohme, and Arena Pharmaceuticals Inc. Dr Jenkins has received speaker fees and consultancy fees from Janssen. Dr Hoole has received speaker fees/honoraria from AstraZeneca. Dr Pepke-Zaba has received research grant from Merck Sharp & Dohme; has received consulting fees from Gossamer and Johnson and Johnson; and has received support for attending meetings and/or travel from Johnson and Johnson. Dr Witkin has received consultancy fees from Janssen Pharmaceuticals. Dr Kim has received consultant/speaker honoraria from Bayer, Gossamer Bio, Johnson and Johnson, Merck, Pulnovo, and United Therapeutics. Dr Matsubara has received grants from Nippon Shinyaku; has received honoraria for lectures from AOP Health, Bayer, Janssen, Kaneka Medix, Mochida, Merck Sharp & Dohme, Nippon Shinyaku, and Nipro; has received payments for expert testimony from Merck Sharp & Dohme; and has participated in advisory board meetings for Bayer, Janssen, Mochida, and Merck Sharp & Dohme. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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