Safety of balloon pulmonary angioplasty in chronic thromboembolic pulmonary hypertension: role of the standardized definition of complications

Literature reports high complication rates in patients with chronic thromboembolic pulmonary hypertension (CTEPH) who undergo balloon pulmonary angioplasty (BPA), especially in patients with poor pulmonary hemodynamics. Here we describe complications of BPA based on the new definitions. All patients with CTEPH who completed BPA treatment before September 15th, 2023, were selected from the CTEPH database. Peri-procedural complications were collected and classified according to the 2023 consensus paper on BPA treatment. Complications were analyzed in subgroups of patients with pulmonary vascular resistance (PVR) ≤ or > 6.6 WU and mean pulmonary artery pressure (mPAP) ≤ or > 45 mmHg at first BPA. In this analysis, 87 patients (63% women; mean age 61.1±14.0 years; 62% on dual PH targeted medical therapy) underwent 426 (mean 4.9±1.6 per patient) BPAs. Only non-severe complications occurred in 14% of BPA treatments; in 47% of the patients; 31% patients had a thoracic complication. The thoracic complications were mild (71%) or moderate (29%). Patients with a PVR >6.6 WU (n=8) underwent more BPA treatments (6.6±1.5 versus 4.6±1.5, p=0.002), had more complications (88% versus 41% of patients, p=0.020), and more thoracic complications (17% vs 7% of BPAs, p=0.013) than patients with PVR ≤ 6.6 WU. Patients with mPAP >45 mmHg (n=13) also had more BPA-treatments (6.5±1.7 versus 4.6±1.4, p<0.001), more complications (77% versus 44% of patients, p=0.027) and more thoracic complications (14% versus 8% of BPAs, p=0.039) than patients with mPAP ≤ 45 mmHg. Complications occurred in 14% of BPAs and were mostly mild. Patients with severe pulmonary hemodynamics suffered more (thoracic) complications. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This research project was supported by an unrestricted research grant by Janssen-Cilag B.V. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study was approved by the local ethical committee of the hospital (MEC-U, Z18.040). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes The data that support the findings of this study are available on request from the corresponding author, D.P. Staal. The data are not publicly available due to privacy restrictions.