Balloon Pulmonary Angioplasty for CTEPH
Balloon pulmonary angioplasty (BPA) should be considered for CTEPH patients who are technically inoperable or have an unfavorable risk-benefit ratio for pulmonary endarterectomy (PEA), as determined by a multidisciplinary CTEPH team that includes at least one experienced PEA surgeon. 1, 2
Treatment Hierarchy
PEA remains the first-line, potentially curative treatment for CTEPH and must always be evaluated first before considering BPA. 1, 2 The 2015 ESC/ERS guidelines assign BPA a Class IIb recommendation with Level C evidence for patients deemed technically non-operable or with unfavorable surgical risk-benefit ratio. 1, 2
Specific Indications for BPA
Primary Patient Populations
Technically inoperable disease: Patients with distal segmental or subsegmental thromboembolic disease beyond surgical reach should be considered for BPA. 1, 2
High surgical risk patients: Those with technically operable disease but an unfavorable risk-benefit ratio for PEA may be considered for BPA. 1, 2
Persistent/recurrent pulmonary hypertension post-PEA: Patients with residual PH after surgical endarterectomy are candidates for BPA. 1, 2
Critical Decision-Making Requirements
All operability assessments must be performed by a multidisciplinary CTEPH team at an experienced center (Class I, Level C recommendation). 1, 2 The team must include at least one experienced PEA surgeon to ensure accurate determination of surgical candidacy. 1, 2 This is non-negotiable—proceeding with BPA without formal multidisciplinary evaluation including an experienced PEA surgeon represents a critical error in management. 2
Technical Approach and Efficacy
BPA is a stepwise procedure requiring multiple sessions (typically 4-10 separate sessions, averaging 2.7-4.6 sessions per patient). 1, 3, 4 This staged approach is necessary to engage all under-perfused lung segments while limiting contrast burden and radiation exposure per session. 1
Hemodynamic and Functional Outcomes
Recent studies demonstrate significant improvements with refined BPA techniques:
Hemodynamic improvements: Mean pulmonary artery pressure decreases by approximately 12 mmHg, with pulmonary vascular resistance (PVR) improving by 26-246 dyn·cm·s⁻⁵. 3, 5, 4
Functional capacity: Six-minute walk distance improves by 39-72 meters, with WHO functional class improving by one class. 3, 5, 4
Cardiac function: Right ventricular strain markers (NT-proBNP, troponin T) significantly decrease, indicating reduced RV afterload. 3, 5
The most recent U.S. data from 2023 showed that independent factors associated with improved response included pre-procedural use of riociguat, reduced baseline PA compliance, and >3 BPA sessions per patient. 4
Safety Profile and Complications
Complication Rates with Refined Techniques
Modern refined BPA techniques have substantially reduced complication rates compared to earlier approaches. 1, 6 The most common serious complication is reperfusion pulmonary edema, which has been reduced to approximately 2% with refined techniques using smaller balloons and cautious targeting of only one lobe per session. 1
Specific Complications to Monitor
- Hemoptysis: Occurs in approximately 4.7% of sessions with refined techniques. 4
- Wire perforation, vessel dissection, or rupture: Life-threatening complications requiring meticulous technique. 6
- Reperfusion pulmonary edema: Reduced to 2% with refined approach versus higher rates (up to 61% in early series). 1, 5
Early studies reported periprocedural mortality rates of 10%, but these reflect older, less refined techniques. 5 Contemporary series with refined approaches show substantially improved safety profiles. 1, 4
Mandatory Prerequisites
Before Proceeding with BPA
Lifelong anticoagulation: Must be established with vitamin K antagonists (VKAs) targeted to INR 2-3. 1, 2 No data exist for direct oral anticoagulants (DOACs/NOACs) in CTEPH. 1
Comprehensive hemodynamic assessment: Right heart catheterization confirming precapillary pulmonary hypertension is required. 2
Imaging characterization: Ventilation/perfusion scanning and pulmonary angiography to characterize disease distribution are mandatory. 2
Center expertise: BPA should only be performed at experienced, high-volume CTEPH centers with appropriate expertise and equipment. 1, 2
Relationship with Medical Therapy
Riociguat is the only approved drug for inoperable CTEPH or persistent/recurrent PH after PEA (Class I, Level B recommendation). 1 BPA patients may still require riociguat or other pulmonary hypertension medications for optimal outcomes, and pre-procedural riociguat use is associated with better BPA response. 2, 4
Off-label use of other PAH-approved drugs may be considered in symptomatic inoperable patients (Class IIb, Level B recommendation). 1 However, medical therapy alone does not address the mechanical obstruction that BPA can treat. 1, 2
Critical Pitfalls to Avoid
Never use BPA as first-line therapy: PEA remains superior with potential for cure and must always be considered first. 1, 2
Never proceed without multidisciplinary evaluation: Formal assessment by a team including an experienced PEA surgeon is mandatory. 1, 2
Avoid inexperienced centers: Complication rates are significantly higher without proper expertise, equipment, and refined techniques. 1, 2
Do not assume operability based on hemodynamics alone: There is no absolute upper limit of PVR or degree of RV dysfunction that excludes patients from either PEA or BPA consideration at experienced centers. 1, 2
Advanced age is not a contraindication: Age alone should not exclude patients from BPA consideration. 1, 2