Elsevier

The Annals of Thoracic Surgery

Volume 88, Issue 6, December 2009, Pages 1993-1998
The Annals of Thoracic Surgery

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A Feasibility and Safety Study of Bronchoscopic Thermal Vapor Ablation: A Novel Emphysema TherapyDisclaimer

https://doi.org/10.1016/j.athoracsur.2009.06.038Get rights and content

Purpose

This study reports the feasibility and safety of novel second-generation bronchoscopic lung volume reduction (LVR) technology, independent of collateral ventilation.

Description

Eleven patients with severe heterogeneous emphysema underwent unilateral bronchoscopic application of vapor thermal energy (mean 4.9 cal/g alveolar tissue; range, 3 to 7.5) with bronchial thermal vapor ablation (BTVA) aiming to induce a controlled inflammatory airway and parenchymal response with resultant LVR.

Evaluation

Nine women and 2 men, with a mean age of 61 years, forced expiratory volume in 1 second (FEV1) of 0.77 ± 0.17 L (32% predicted), residual volume (RV) of 4.1 ± 0.9 L (219% predicted), and gas transfer of 7.8 ± 2.2 (34% predicted), underwent unilateral upper lobe treatments. Serious adverse events in 5 included probable bacterial pneumonia and exacerbations of airways disease in 2. Although no important FEV1 or RV changes occurred during 6 months of follow-up, gas transfer improved, 16% to 9.0% ± 2.1% (38% predicted), the Medical Research Council Dyspnoea Score improved from 2.6 to 2.1, and the St. George Respiratory Questionnaire Total Score improved from 64.4 at baseline to 49.1.

Conclusions

These preliminary data on unilateral BTVA therapy confirm feasibility, an acceptable safety profile, and the potential for efficacy.

Section snippets

Patient Selection Criteria

Eleven patients on optimal medical management for severe heterogeneous upper lobe emphysema underwent unilateral upper lobe BLVR. All patients were assessed according to standard acceptance criteria for surgical LVR and BLVR [1, 2, 3]. Key inclusion and exclusion criteria are outlined in Table 1. The study was approved by Alfred Hospital and Prince Charles Hospital Institutional Ethics Committees.

Device Description

The Uptake Medical BTVA treatment system consists of a multiuse generator with a fiberoptic

Procedure Description

Anesthesia was according to local standard techniques using a large (size 9 or 10) single-lumen endotracheal tube or laryngeal mask. Two operators performed the procedure, one controlled the fiberoptic bronchoscope (Olympus BF type 1T180, Tokyo, Japan) and the other controlled and manipulated the catheter system and handpiece. The vapor catheter was then introduced into the target segmental airway, the occlusion balloon was inflated (0.5 to 1.5 mL) to create a seal, and the desired dose of

Clinical Experience

Patient demographics and base line characteristics are outlined in Table 3.

Comment

This assessment demonstrates the technical feasibility and safety of applying thermal energy unilaterally to targeted segmental airways in patients with severe heterogeneous emphysema. The inflammatory response induced by the steam has effects on the proximal airways and distal lung parenchyma. The adverse effects reflected this, with relatively minor airway-predominant COPD exacerbations and two potentially more important bouts of pneumonitis. CT scan analyses demonstrated loss of volume in

Disclosures and Freedom of Investigation

Financial, technical, and equipment support was provided from the sponsor Uptake Medical Corp, Seattle, Washington, to undertake this study. The authors had full control of the study design, methods used, outcome parameters, data analysis and the production of this report.

References (10)

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  • Bronchoscopic Lung Volume Reduction: A New Hope for Patients With Severe Emphysema and Air Trapping

    2021, Mayo Clinic Proceedings
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    Alternative bronchoscopic methods to achieve LVR are being explored. Bronchoscopic thermal vapor ablation (BTVA)23,24 may represent an alternative method for BLVR when fissure completeness is less than 80%. BTVA results in atelectasis of the targeted lobe by applying heated water vapor to produce a thermal reaction, resulting in an intense but localized inflammatory response that results in lobar atelectasis.

  • Bronchoscopic Lung Volume Reduction

    2018, Clinics in Chest Medicine
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    This technique administers steam vapor directly to the segmental airways most affected by emphysema, using a reusable vapor generator and a disposable bronchoscopic catheter that delivers heated water vapor. The goal is to cause a local inflammatory reaction that causes occlusion and atelectasis of each chosen segment.37 A recent multicenter randomized controlled study using thermal vapor ablation, the STEP-UP trial (Sequential Staged Treatment of Emphysema with Upper Lobe Predominance), showed a significant improvement in FEV1 and SGRQ at 6 months.38

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Disclaimer

The Society of Thoracic Surgeons, the Southern Thoracic Surgical Association, and The Annals of Thoracic Surgery neither endorse nor discourage use of the new technology described in this article.

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