Balloon pulmonary angioplasty complication rates decreased from 7.8% to 4.2% over a decade, with elderly patients' complications aligning with younger patients in recent years.
Does balloon pulmonary angioplasty performed in a more recent era (2018-2022) reduce procedural complications compared to an earlier era (2013-2017) in patients with CTEPH?
The safety profile of balloon pulmonary angioplasty for CTEPH has significantly improved over the past decade in Japan, mitigating the excess risk previously observed in elderly patients and allowing for expanded indications.
Abstract Background Balloon pulmonary angioplasty (BPA) has been established as a treatment modality for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are ineligible for surgical intervention within the past decade. However, the progression of BPA safety remains to be elucidated. Purpose This study aimed to clarify changes in patient demographics and safety of BPA in patients who underwent the procedure in Japan over the past decade. Methods From the Japanese Cardiovascular Disease All-Case Registry database in fiscal years 2013 to 2022, we analyzed data from 14,429 BPA procedures performed on 3700 patients (median Q1–Q3 age 68 57-75 years) at 149 hospitals. The study period was divided into an early period (2013–2017) and a late period (2018–2022). The primary endpoint was the complication rate in each period, and the secondary endpoint was the proportion and complication rate of elderly patients (≥80 years) in each period. Complications were defined as a composite of the following major adverse events occurring within 30 days after the procedure: death, initiation of mechanical ventilation, initiation of extracorporeal membrane oxygenation, initiation of continuous hemodiafiltration, transfusion, cardiac tamponade, or surgery. Results The complication rate for BPA significantly decreased from 7.8% in the early period to 4.2% in the late period (P0.001). The proportion of elderly patients increased from 7.6% in the early period to 13.6% in the late period (P0.001). In multivariable logistic regression adjusted for age group (≥80 vs. 80 years), sex, and symptoms, an interaction term between age group and study period was included. In this model, the adjusted odds ratio for complications in the late period was 0.62 (95% confidence interval: 0.53–0.74). The interaction term was not statistically significant. Elderly patients had a significantly higher complication rate than younger patients in the early period (10.6% vs. 7.6%, P=0.017); however, in the late period, the difference between the two groups was not statistically significant (4.8% vs. 4.1%, P=0.267). Conclusions The safety profile of BPA has significantly improved in recent years. Previously, elderly patients were at a higher risk of complications. However, in recent years, the difference in risk associated with age between elderly and younger patients has decreased. As a result, BPA indications have been broadened to include a more diverse elderly patient population.
Takano et al. (2025) studied this question. Balloon pulmonary angioplasty complication rates decreased from 7.8% to 4.2% over a decade, with elderly patients' complications aligning with younger patients in recent years.