Serial right heart catheter assessment between balloon pulmonary angioplasty sessions identify procedural factors that influence response to treatment

https://doi.org/10.1016/j.healun.2021.06.011Get rights and content

Background

Balloon pulmonary angioplasty (BPA) is delivered as a series of treatments for patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) however, there is little published data on the procedural determinants of outcome.

Methods

Pre- and post-BPA clinical and hemodynamic data, as well as serial hemodynamic and procedural data at each BPA session were evaluated to determine patient and procedure-related factors that influence hemodynamic response.

Results

Per procedure data from 210 procedures in 84 patients and per patient data from 182 procedures in 63 patients with completed treatment and 3-month follow-up were analyzed. A median of 3 (range 1-6) BPA procedures treating a median of 2 segments per procedure (range 1-3) were performed per patient with a median interval between procedures of 42 (range 5-491) days. Clinical outcome correlated with hemodynamic change (pulmonary vascular resistance [ΔPVR] vs Cambridge Pulmonary Hypertension Outcome Review [CAMPHOR] symptom score: p < 0.001, Pearson's r = 0.48, n = 49). Responders to BPA had more severe disease at baseline and 37.5 % of non-responders were post-PEA. There was a dose-response relationship between per procedure and total number of segments treated and hemodynamic improvement (ΔPVR: 1 segment: -0.9%, 2: -14.5%, 3 or more: -16.1%, p < 0.001). Treating totally occluded vessels had a greater hemodynamic effect (mean pulmonary artery pressure [ΔmPAP]: sessions with occlusion: -8.0%, without occlusion treated: -3.2%, p < 0.05) without an increased complication rate.

Conclusions

The magnitude of clinical benefit is related to the hemodynamic effect of BPA which in turn is related to the number of segments treated and lesion severity. Patients who were post-PEA were less likely to respond to BPA.

Introduction

Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) has a 3-year survival rate as low as 70 %.1 Pulmonary endarterectomy (PEA) is the guideline recommended treatment method and associated with improvement in mortality, functional status and haemodynamics.2 However, about a third of patients are not suitable for PEA.3,4 For those patients, medical therapy has shown modest benefit in the past with the recently introduced drug Riociguat showing a potential greater benefit.5

Balloon Pulmonary Angioplasty (BPA) has emerged as an alternative treatment for patients with inoperable CTEPH or those having persistent or recurrent disease despite PEA. The evaluation of BPA has confirmed significant benefits for patients, with improvements in symptoms, quality of life, exercise capacity, hemodynamic values and RV size and geometry.6, 7, 8, 9, 10, 11, 12 To minimize complications patients often need to complete a course of sequential procedures. When compared to Riociguat medical therapy in a randomized controlled trial, BPA achieved superior reduction in pulmonary vascular resistance (PVR) and improvement in World Health Organization functional class (WHO-FC) at a cost of more adverse events.13 BPA has been reported to be associated with an equivalent 2-year mortality when compared to PEA, although no head-to-head randomized trial has been undertaken to date.14,15

BPA is now an established treatment for patients with inoperable CTEPH and demand is increasing. Identifying those patients most likely to respond and determining procedural factors that predict efficacy, will improve the risk benefit ratio and procedural efficiency. We report for the first time serial hemodynamic data between successive BPA procedures assessing the impact of treating different lesion types, locations, disease burden and technique at a per-procedural level in patients with inoperable and post-PEA residual CTEPH. Furthermore, we report overall response BPA at a patient-level to define demographic predictors of responders. Together we hope this will help better guide patient selection for BPA and strategy/technique employed.

Section snippets

Methods

Successive patients with inoperable CTEPH or residual PH post-PEA surgery on stable PH-targeted medical therapy who underwent BPA at the UK National BPA Centre, Royal Papworth Hospital between October 2015 and March 2020 were included in this registry. Data were collected prospectively.

Results

In total, data from 84 patients who had BPA intervention were included. Twelve were post-PEA and 72 had inoperable CTEPH either due to inaccessible lesions for PEA or an unfavorable risk/benefit-relationship for surgery. This yielded 210 procedures for analysis at a procedural level. Of those patients who completed a full course of BPA and 3-month FU investigations (n = 63), a median of 3 (range 1-6) BPA procedures treating a median of 2 segments per procedure (range 1-3) were performed per

Discussion

We have demonstrated by analyzing patient level data and serial procedural level hemodynamic data prior to each BPA session that (1) changes in hemodynamic values correlate with clinical outcomes; (2) BPA responders were more likely to have more severe CTEPH disease and non-responders were more likely to be post-PEA; (3) a greater change in hemodynamic values were recorded when more segments were opened per procedure and in total, and when totally occluded vessels were treated although (4)

Conclusions

The magnitude of hemodynamic change achieved with BPA is predictive of the improvement in exercise capacity, symptoms and RV metrics. The magnitude of hemodynamic benefit correlates with the number of territories successfully treated per session. In particular, opening occlusive disease was more likely to result in greater hemodynamic benefit, whereas BPA non-responders were more likely to be post-PEA.

Author contributions

SPH conceived the study. KPH performed the analysis with the assistance of SPH. KPH and SPH wrote the manuscript. JGM, JC, DT, MT, KS, AR, NS, DJ, JP contributed to the analysis of the results and commented on the manuscript.

Disclosure statement

KPH was supported by Dr. Ernst und Anita Bauer Stiftung. None of the authors have conflicts to disclose.

Acknowledgments

The authors would like to acknowledge their patients and the care provided by the catheter laboratory and ward staff at Royal Papworth Hospital.

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