New Research Paper
Peripheral
Periprocedural Complications With Balloon Pulmonary Angioplasty: Analysis of Global Studies

https://doi.org/10.1016/j.jcin.2023.01.361Get rights and content

Abstract

Background

Balloon pulmonary angioplasty (BPA) was introduced as a treatment modality for patients with inoperable, medically refractory chronic thromboembolic pulmonary hypertension decades ago; however, reports of high rates of pulmonary vascular injury have led to considerable refinement in procedural technique.

Objectives

The authors sought to better understand the evolution of BPA procedure-related complications over time.

Methods

The authors conducted a systematic review of original articles published by pulmonary hypertension centers globally and performed a pooled cohort analysis of procedure-related outcomes with BPA.

Results

This systematic review identified 26 published articles from 18 countries worldwide from 2013 to 2022. A total of 1,714 patients underwent 7,561 total BPA procedures with an average follow up of 7.3 months. From the first period (2013-2017) to the second period (2018-2022), the cumulative incidence of hemoptysis/vascular injury decreased from 14.1% (474/3,351) to 7.7% (233/3,029) (P < 0.01); lung injury/reperfusion edema decreased from 11.3% (377/3,351) to 1.4% (57/3,943) (P < 0.01); invasive mechanical ventilation decreased from 0.7% (23/3,195) to 0.1% (4/3,062) (P < 0.01); and mortality decreased from 2.0% (13/636) to 0.8% (8/1,071) (P < 0.01).

Conclusions

Procedure-related complications with BPA, including hemoptysis/vascular injury, lung injury/reperfusion edema, mechanical ventilation, and death, were less common in the second period (2018-2022), compared with first period (2013-2017), likely from refinement in patient and lesion selection and procedural technique over time.

Section snippets

Methods

This systematic review was created to assess safety outcomes of BPA for CTEPH patients in global PH centers. The statistical protocol was performed using prespecified subgroups of the first 5-year period (2013-2017) and the second 5-year period (2018-2022). The last year in which BPA was performed in each study was used for classification purposes. This systematic review is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-analyses standards (PRISMA).7

Results

A total of 4,825 studies were evaluated using titles and abstracts, with 164 undergoing full-text review (Figure 1). Overall, 26 studies that reported procedural and clinical outcomes on patients undergoing balloon pulmonary angioplasty met our study inclusion criteria and were included in this pooled analysis (Table 1). Our final analysis includes 26 reports from 4 continents and 18 countries, including 1,714 CTEPH patients undergoing a total of 7,561 BPA sessions. Average follow-up was

Discussion

Balloon pulmonary angioplasty is now an established treatment modality for inoperable and medically refractory CTEPH. Our pooled analysis suggests a decreasing incidence of procedure-related complications with BPA over time. More specifically, we observed a significant decline in hemoptysis and/or vascular injury, reperfusion edema, mechanical ventilation, and death rates with BPA between the first period (2013-2017) and the second period (2018-2022). These findings are reassuring and suggest a

Conclusions

BPA is undergoing natural evolution and becoming safer with increasing adoption over the years. Future work will further refine procedural technique and patient and lesion selection for BPA.

WHAT IS KNOWN? BPA is now an established treatment modality for patients with inoperable, medically refractory chronic thromboembolic pulmonary hypertension, although early studies report high procedural complication rates.

WHAT IS NEW? This study demonstrates that periprocedural complications with BPA have

Funding Support and Author Disclosures

Dr Krasuski has been a consultant to Actelion/Janssen Pharmaceuticals, Bayer Pharmaceuticals, Gore Medical and Medtronic; and has received research funding from the Adult Congenital Heart Association, Actelion, Corvia, CryoLife, Edwards Lifesciences, and Medtronic. Dr Rosenfield has been a consultant to or served on scientific advisory boards for Abbott Vascular, Althea Medical, Angiodynamics, Auxetics, Becton-Dickinson, Boston Scientific, Contego, Crossliner, Innova Vascular, Inspire MD,

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