Balloon pulmonary angioplasty (BPA) has naturally become safer due to its increasing usage over the years, a new analysis shows.
These data were reported by Nishant Jain, MD, of the University of Michigan, and colleagues in a manuscript published Wednesday online in JACC: Cardiovascular Interventions.
Patients with chronic thromboembolic pulmonary hypertension (CTEPH) are often treated with BPA, but when the treatment was introduced in 2001, it was reported to have a 6% mortality rate and roughly 17% mechanical ventilation rate. Clinicians were skeptical of the procedure until refined procedural techniques were introduced in 2012 and 2018. BPA currently has a Class 1 recommendation for residual and/or inoperable CTEPH.
The investigators performed a systematic review of the global trends in BPA usage, as well as global progress and outcomes of the procedure. All articles reporting BPA outcomes since the Matsubara report (2012) were included in the study, and subgroups defined as the first and second five-year periods (2013-2017; 2018-2022).
Between 2013 and 2022, 26 published articles from 18 countries around the world were used for this study. There were 7,561 total BPA procedures performed on 1,714 patients, with an average follow-up time of 7.3 months. Comparing the first and second time periods (2013-2017 vs 2018-2022), the total instances of hemoptysis/vascular injury decreased (14.1% to 7.7% [p < 0.01]); rates of lung injury/reperfusion edema went down (11.3% to 1.4% [p < 0.01]); rates of invasive mechanical ventilation decreased (0.7% to 0.1% [p <0.01]) and overall mortality decreased (2.0% to 0.8% [p<0.01]).
The investigators noted several limitations of the study, including that patients could have experienced higher rates of complications with BPA early-on, thereby skewing later complication rates. They also noted that the lack of standardized definitions of each outcome across studies is a major limitation because outcome definitions have evolved over the years.
Overall, complications from BPA — hemoptysis/vascular injury, lung injury/reperfusion edema, mechanical ventilation and death — occurred more frequently in the first group of observed patients than in the second group.
In an accompanying editorial, Ehtisham Mahmud, MD, and Lawrence Ang, MD, of the University of California, San Diego, acknowledged the evolution of the safety of BPA over the last decade while discussing the need for further research beyond this study.
“Identifying the exact reasons for the lower rate of BPA complications over time is a limitation of the present analysis,” the editorialists wrote. Several procedural or mechanical reasons could account for this, such as guidewire lengths, anticoagulation goals and remodeling of totally occluded vessels.
The editorialists wrote they are encouraged by the reduction rates of mechanical ventilation and mortality between the two groups, demonstrating the improved safety of BPA in the modern era.
Mahmud and Ang concluded, “The investigators should be congratulated for completing this analysis demonstrating the improved safety profile of BPA. Now it is incumbent on the interventional and CTEPH community that the parameters of BPA procedural success and definitions of complications are standardized.”
Jain N, Sheikh MA, Bajaj D, et al. Periprocedural Complications With Balloon Pulmonary Angioplasty. JACC Cardiovasc Interv. 2023 Mar 22 (Article in press).
Mahmud E, Ang L. Time to Standardize Definitions for the Success and Complications of Balloon Pulmonary Angioplasty. JACC Cardiovasc Interv. 2023 Mar 22 (Article in press).
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