Treatment of Heterogeneous Emphysema Using the Spiration IBV Valves

doi:10.1016/j.thorsurg.2009.02.005

Thoracic Surgery Clinics

Volume 19, Issue 2, May 2009, Pages 247-253

https://doi.org/10.1016/j.thorsurg.2009.02.005 Get rights and content

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Study Population

This case series includes all patients where the intent was bilateral treatment of UL-predominant emphysema. Details on inclusion and exclusion criteria have been published,³ and these remained consistent throughout the study. In summary, patients who had severe airflow obstruction, hyperinflation, and severe UL predominant emphysema were selected. The National Emphysema Treatment Trial (NETT) method for determination for UL predominance was used.¹

Patients were on maximal medical management

Results

Ninety-eight subjects were enrolled for bilateral treatment at 13 clinical centers from January 2004 to August 2006. There were 57% males, and the mean age was 65 plus or minus 8 years. Average procedure time for the initial procedure was 58 minutes (range 15 to 187). Valves were placed in segmental airways 74% of the time and 26% in subsegmental airways. Six hundred fifty-nine valves were placed, and all desired airways were treated with the exception of two instances where the catheter could

Discussion

This series of pilot studies with the umbrella-shaped IBV valve showed acceptable safety and risk factors for complications, along with significant effectiveness in over half of the subjects, and a novel mechanism of action. This is the only published experience with bronchial valves where multicenter studies were done prospectively with a common protocol. An equal sized series using the Emphasys valve is a summary of data from selected sites using variable selection criteria and different

Note

The IBV Valve System has been approved by the Food and Drug Administration as a humanitarian device for use in the control of prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy and LVRS. The effectiveness for this use has not been demonstrated. Please see the Instructions for Use available at http://www.fda.gov/cdrh/ode/H060002sum.html, or contact Spiration Inc. for further information. The IBV Valve System

IBV vavle pilot trials research teams

Cedars Medical Center, Los Angeles: Robert McKenna, MD (principal investigator); Zab Mohsenifar, MD (coprincipal investigator); Carol Geaga, RN (principal clinic coordinator); Cleveland Clinic Foundation (CCF), Cleveland, Ohio: Atul Mehta, MD (principal investigator); Thomas Gildea, MD (coprincipal investigator); Yvonne Meli, RN (principal clinic coordinator); Michael Machuzak, MD; Sudish Murthy, MD; Columbia University Medical Center New York: Roger Maxfield, MD (principal investigator); Mark

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There are more references available in the full text version of this article.

Cited by (63)

Sequential Bilateral Bronchoscopic Lung Volume Reduction with One-Way Valves for Heterogeneous Emphysema
2016, Annals of Thoracic Surgery
Clinical benefits of bronchoscopic lung volume reduction with one-way endobronchial valves have been reported for heterogeneous emphysema after unilateral treatment. We assessed the potential role of contralateral treatment to prolong the benefits obtained with the first procedure.
This was a retrospective multicenter study including consecutive patients with heterogeneous emphysema undergoing bronchoscopic valves deployment during the last 4 years. Patients were split into two groups depending on the procedure (unilateral versus bilateral). The intergroup differences were evaluated to assess the viability, effectiveness, and safety of the bilateral procedure.
Forty-nine patients were enrolled. Of these, 14 (28%) had a sequential bilateral procedure mainly due to loss of the clinical benefits obtained with the first treatment. A significant improvement of forced expiratory volume in 1 second (p < 0.05), forced vital capacity (p < 0.05), residual volume (p < 0.05), 6-minute walking test (p < 0.05), and St. George respiratory questionnaire (p < 0.02) was achieved after the second procedure. These results were maintained during follow-up. There was no significant difference regarding the changes of forced expiratory volume in 1 second (p = 0.4), forced vital capacity (p = 0.08), residual volume (p = 0.9), 6-minute walking test (p = 0.3), and St. George respiratory questionnaire (p = 0.1) between the bilateral and unilateral groups.
A sequential bilateral approach seems to be a valid strategy to improve respiratory function in patients with bilateral heterogeneous emphysema who have lost the benefits obtained with the first procedure.
Diffusing capacity for carbon monoxide correlates best with tissue volume from quantitative CT scanning analysis
2015, Chest
Quantitative analysis of high-resolution chest CT scan (QCT) is an established method for determining the severity and distribution of lung parenchymal destruction in patients with emphysema. Diffusing capacity of the lung for carbon monoxide (Dlco) is a traditional physiologic measure of emphysema severity and is probably influenced more by destruction of the alveolar capillary bed than by membrane diffusion per se. We reasoned that Dlco should correlate with tissue volume from QCT.
A total of 460 patients with upper-lobe-predominant emphysema were enrolled in the study. The mean (SD) of percent predicted values for FEV₁, total lung capacity, and Dlco were 30.6% (8.0%), 129.5% (18.1%), and 6.7% (13.1%), respectively. QCT was performed using custom software; the relationship between Dlco and various metrics from QCT were evaluated using Pearson correlation coefficients.
On average, whole-body plethysmography volumes were higher by 841 mL compared with QCT-calculated total lung volume. However, there was a strong correlation between these measurements (r = 0.824, P < .0001). Dlco correlated with total lung volume (r = 0.314, P < .0001), total tissue volume (r = 0.498, P < .0001), and percentage of lung with low density (−950 Hounsfield units) (r = −0.337, P < .0001).
In patients with severe emphysema, Dlco correlates best with total tissue volume, supporting the hypothesis that pulmonary capillary blood volume is the main determinant of Dlco in the human lung. The relationships between Dlco and various anatomic metrics of lung parenchymal destruction from QCT inform our understanding of the relationship between structure and function of the human lung.
Therapeutic Bronchoscopy
2015, Murray and Nadel's Textbook of Respiratory Medicine: Volume 1,2, Sixth Edition
Noninvasive ventilation and lung volume reduction
2014, Clinics in Chest Medicine
Impact of bronchoscopic thermal vapor ablation on lung volume reduction in patients with emphysema: a meta-analysis
2023, BMC Pulmonary Medicine
Crosslink bio-adhesives for bronchoscopic lung volume reduction: Current status and future direction
2021, European Respiratory Review

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: Doctors Springmeyer and Gonzalez are employees of Spiration Incorporated. Doctors Wood and Bolliger received support for research and consulting fees. Dr. Waddell received support for research.

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Treatment of Heterogeneous Emphysema Using the Spiration IBV Valves

Section snippets

Study Population

Results

Discussion

Note

IBV vavle pilot trials research teams

First page preview

Chest

J Thorac Cardiovasc Surg

Lancet

J Thorac Cardiovasc Surg

Ann Thorac Surg

A randomized trial comparing lung volume reduction with medical therapy for severe emphysema

N Engl J Med

Development of a bronchial valve for treatment of severe emphysema

A multicenter trial of an intrabronchial valve for treatment of severe emphysema

J Thorac Cardiovasc Surg

The computed tomography assessment of lung volume changes after bronchial valve treatment

Eur Respir J