Safety of Balloon Pulmonary Angioplasty Has Increased Significantly in Last Decade

Vikas Aggarwal, MD, MBBS
Courtesy: University of Michigan

An analysis of global studies published from 2013-2022 details declines in periprocedural complications associated with balloon pulmonary angioplasty.

Results of the review, which included data 26 studies conducted in 18 countries, suggest incidence of hemoptysis/vascular injury, lung injury/reperfusion edema, invasive mechanical ventilation, and mortality were all reduced during the time period lasting from 2018-2022 relative to the period lasting 2013-2017.¹

“Over the last decade, it is clear that balloon pulmonary angioplasty has become a more established, safer option for inoperable [chronic thromboembolic pulmonary hypertension],” said senior author Vikas Aggarwal, MBBS, interventional cardiologist at the University of Michigan Health Frankel Cardiovascular Center.² “We believe these decreased complication rates are largely due to refinement in technique, as well as patient selection. We are learning how to do this procedure in a safer manner with increasing experience over time.”

A procedure indicated for treatment of inoperable, medically refractory chronic thromboembolic pulmonary hypertension (CTEPH), balloon pulmonary angioplasty was introduced decades ago. In recent years, popularity of the procedural approach to CTEPH has grown. Citing a lack of large-scale studies on evolving safety of this treatment, investigators designed the current sudsy as a systematic review and pooled analysis of published articles reporting balloon pulmonary angioplasty since the Matsubara report with the intent of comparing procedure-related complication rates from 2013-2017 and 2017-2022.¹

Of note, the Matsubara report was a study published in 2012 that detailed improve safety outcomes for balloon pulmonary angioplasty with a refined procedural technique.¹

The primary outcome of interest was the rate of balloon procedure-related complications during each time period. Complications of interest included hemoptysis/vascular injury, lung injury/reperfusion edema, invasive mechanical ventilation, and all-cause mortality.¹

Through a search of the PubMed, Scopus, EMBASE, CINAHL Complete, and Web of Science databases, investigators identified 26 studies for inclusion in their final analysis. Investigators pointed out 164 articles underwent assessment for eligibility.¹

From the 26 studies indemnified for inclusion, Investigators obtained data related to a cohort of 1714 patients who underwent a total of 7561 balloon pulmonary angioplasty procedures. This cohort had a mean follow-up time of 7.3 months.¹

Upon analysis, results indicated the cumulative incidence of hemoptysis and/or vascular injury at 11.1%, a reperfusion edema rate of 6.0%, a mechanical ventilation rate of 0.4% per session, and an overall 1.3% mortality rate per patient. Further analysis indicated the following results were observed for cumulative incidence of the following events in the 2018-2022 period relative to the 2013-2017 period:¹

• Hemoptysis and/ orvascularinjurydecreasedfrom 14.1%(474 of 3,351)to7.7%(233 of 3,029)(P<0.01)
• Reperfusion edema incidence decreased from 11.3% (377 of 3,351) to 1.4% (57 of 3,943) (P <.01)
• Invasive mechanical ventilation decreased from 0.7% (23 of 3,195) to 0.1% (4 of 3,062) (P <.01)
• Mortality decreased from 2.0% (13 of 636) to 0.8% (8 of 1,071) (P<0.01)

In a subgroup analysis where studies that overlapped between time periods were excluded the following results were observed for cumulative incidence between the 2013-2017 and 2018-2022 periods:¹

• Hemoptysis and/or vascular injury decreased from 14.1%(474 of 3,351)to6.0%(15 of 250)(P <.01)
• Reperfusion edema incidencedecreased from 11.3% (377 of 3,351)to2.4%(6 of 250)(P <.01).
• Mortality decreased from 2.0% (13 of 636) to 0% (0 of 156) (P <.01)

“As it becomes clearer that balloon pulmonary angioplasty is a safe and effective treatment that can be carried out in both the inpatient and outpatient setting, there is potential for more centers across the country to start CTEPH programs,” said Victor Moles, MD, co-author and clinical assistant professor of internal medicine-cardiology at University of Michigan Medical School.²

References

1. 1. Jain N, Sheikh M, Bajaj D, et al. Periprocedural Complications With Balloon Pulmonary Angioplasty. J Am Coll Cardiol Intv. April 2023. https://doi.org/10.1016/j.jcin.2023.01.361
2. Michigan Medicine - University of Michigan. Complications for procedure to open clogged pulmonary arteries decrease significantly. Newswise. https://www.newswise.com/articles/complications-for-procedure-to-open-clogged-pulmonary-arteries-decrease-significantly. Published April 5, 2023. Accessed April 6, 2023.