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Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: Results of an International Multicenter Prospective Registry
IM. Lang, P. Brenot, H. Bouvaist, E. Fadel, X. Jaïs, MM. Madani, S. Guth, M. Kurzyna, G. Simonneau, CB. Wiedenroth, E. Mahmud, H. Shimokawahara, R. Bashir, M. Delcroix, R. Frantz, C. Gerges, L. Godinas, GA. Heresi, P. Jansa, DP. Jenkins, SP....
Language English Country United States
Document type Journal Article, Multicenter Study
- MeSH
- Pulmonary Artery surgery MeSH
- Angioplasty, Balloon * methods MeSH
- Chronic Disease MeSH
- Middle Aged MeSH
- Humans MeSH
- Pulmonary Embolism * complications surgery MeSH
- Hypertension, Pulmonary * etiology surgery therapy physiopathology MeSH
- Prospective Studies MeSH
- Registries * MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Geographicals
- Europe MeSH
- Japan MeSH
- United States MeSH
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.
Department of Cardiology NHO Okayama Medical Center Okayama Japan
Department of Cardiology Pôle Thorax et Vaisseaux CHU Grenoble Alpes La Tronche France
Department of Cardiovascular Diseases Temple University Hospital Philadelphia USA
Department of Cardiovascular Medicine Mayo Clinic College of Medicine Rochester Minnesota USA
Department of Internal Medicine 2 Division of Cardiology Medical University of Vienna Vienna Austria
Department of Thoracic Surgery Kerckhoff Heart and Lung Center Bad Nauheim Germany
Division of Cardiovascular Medicine University of California San Diego La Jolla California USA
Division of Pulmonary and Critical Care Massachusetts General Hospital Boston Massachusetts USA
Division of Pulmonary Medicine Cleveland Clinic Cleveland Ohio USA
General University Hospital Prague Czech Republic
Health Management Center Iruma Heart Hospital Iruma Saitama Japan
Royal Papworth Hospital Cambridge United Kingdom
School of Allied Health Sciences University of Suffolk Ipswich United Kingdom
References provided by Crossref.org
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- $a Lang, Irene M $u Department of Internal Medicine II, Division of Cardiology, Medical University of Vienna, Vienna, Austria. Electronic address: irene.lang@meduniwien.ac.at
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- $a 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.
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