Chest
Volume 130, Issue 1, July 2006, Pages 190-199
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Original Research
Transbronchoscopic Pulmonary Emphysema Treatment: 1-Month to 24-Month Endoscopic Follow-up

https://doi.org/10.1378/chest.130.1.190Get rights and content

Objective

Describe the results of a 1- to 24-month follow-up of individuals undergoing transbronchoscopic placement of one-way valves.

Design

Longitudinal, noncomparative study.

Setting

University hospital.

Patients

Nineteen heterogeneous emphysema patients.

Measurements and results

Pulmonary function testing, imaging examination, and videobronchoscopy were performed at 1, 3, 6, 12, and 24 months after the insertion of one-way valves. Mean age was 67.63 ± 8.71 years, mean body mass index (BMI) was 24.02 ± 2.65, and mean exposure to smoking was 65.32 ± 27.46 pack-years (± SD). Baseline BODE index (BMI, degree of airflow obstruction and dyspnea, exercise capacity as measured by the 6-min walk test [6MWT]) was 7 to 10 in 10 patients (estimated 4-year mortality, 80%) and 5 to 6 in 9 patients (estimated 4-year mortality, 40%). Sixty-four valves were inserted. There was no procedure-related mortality. Nonsustained atelectasis was observed within 48 h in 2 of 12 patients with right upper lobe occlusion. Fifty-six bronchoscopic examinations were performed in 24 months. Granulomas not requiring treatment were the main complication. Mucus clogging the valve, mainly at 1 month, was easily cleaned. Eighteen patients completed the 1- and 3-month follow-ups, 14 patients completed the 6-month follow-up, 11 patients completed the 12-month follow-up, and 5 patients completed the 24-month follow-up. Improvement was observed in the 6MWT after 1 month (p = 0.028) and in the BODE index at 3 months (p = 0.002). FEV1 or FVC improvement ≥ 12% or ≥ 150 mL was observed, respectively, in 4 of 18 patients and 8 of 18 patients at 1 month, 4 of 18 patients and 7 of 18 patients at 3 months, and in 3 of 14 patients and 5 of 14 patients at 6 months. After 24 months, one of five patients and three of five patients, respectively, retained an FEV1 and FVC change ≥ 12% or ≥ 150 mL. Significant improvement (decrease ≥ 4%) in the St. George Respiratory Questionnaire was observed at 3 months and 6 months in three of four domains.

Conclusion

Endobronchial valves are safe, but the criteria to measure improvement and to select patients should be refined. Atelectasis should be reconsidered as primary treatment goal.

Section snippets

Materials and Methods

This longitudinal, noncomparative study was designed for prospective selection of 20 patients with severe COPD for TPET. From January 2002 to September 2004 (33 months), 73 patients were referred to us by the COPD clinic at Hospital de Clinicas de Porto Alegre. Inclusion criteria were clinical and radiologic diagnoses of heterogeneous upper lobe emphysema, dyspnea during usual tasks in the presence of optimal clinical care, absence of other diseases that could cause dyspnea, not smoking for at

Protocol

After clinical assessment by a pulmonologist, surgeon, radiologist, and anesthesiologist, patients underwent blood collection, pulmonary function testing, 6-min walk testing (6MWT), chest radiography, high-resolution CT, and scintigraphy. The 6MWT followed established guidelines,13 except that patients walked a 27-m distance and were monitored while walking using digital oximetry. Starting with the seventh patient, the 3-month version of the St. George Respiratory Questionnaire (SGRQ) validated

Procedure

Topical anesthesia was performed with 1% lidocaine. Anesthesia was achieved with continuous infusion of dexmedetomidine (1 μg/kg/min for 10 min; 0.5 to 0.7 μg/kg/h plus low doses of propofol and remifentanil for maintenance). Patients were kept on spontaneous ventilation with a fraction of inspired oxygen of 1.0. A flexible bronchoscope (model 1T30; Olympus; Tokyo, Japan) with a 2.8-mm channel was used. Images were captured using a videobronchoscope (model VB1830; Pentax; Montvale, NJ).

Airway

Postoperative Care and Follow-up

A chest radiograph was performed right after the procedure. On waking up, the patients were encouraged to cough to clear mucus. At 24 h, arterial blood gas analysis and high-resolution CT were performed. On discharge, the patients were instructed to immediately call the investigators or go the hospital in the presence of any acute event. Routine evaluations (pulmonary function tests, imaging examinations, and bronchoscopy) were performed at 1, 3, 6, 12, and 24 months.

Statistical Analysis

Statistical software (version 12.0; SPSS; Chicago, IL) was used for data analysis. Continuous variables were expressed as mean ± SD. Student t test was used to compare means. Dichotomic variables were described based on their distribution, with comparison of frequency.18

Results

Between April 2002 and October 2004 (30 months), 64 valves were inserted (26 EBVs and 38 TS-EBVs) in the lungs of 19 patients (13 men, 68.42%). Treatment was reversed in one patient (all valves removed), who was excluded from the analysis. Table 1summarizes the demographic characteristics, smoking history, comorbidities, and BODE index of these individuals. Mean age was 67.63 ± 8.71 years (range, 51 to 88 years). The mean BMI was 24.02 ± 2.65 (range, 19.14 to 28.89). Mean exposure to smoking

Procedure

The duration of the procedure decreased from 90 to 30 min, as we acquired experience and began to use TS-EBVs. No adverse hemodynamic or respiratory events compromising the development of the procedure were recorded. Table 2shows the duration of postoperative hospital stay, valve insertion sites, number and type of valves used, postoperative complications, and events observed in the follow-up period. Right upper lobe (RUL) exclusion (occlusion of all lobe segments) was performed in 12 patients

Complications

Pneumothorax developed in one patient 48 h after the procedure (Table 2). Three days after chest drainage, the lung had not re-expanded and the EBV inserted in B3 of the RUL was removed. The pneumothorax then resolved, and the patient was discharged on the ninth postoperative day.

Another patient presented with bronchial hypersecretion with worsening of clinical status. The EBVs inserted in B1 and B2 of the RUL were removed 12 days after the procedure. The patient was discharged on the same day.

Bronchoscopic Follow-up

From a maximum number of 74 possible bronchoscopic examinations, 56 were performed in this study (75.7%). Seven bronchoscopic examinations were not performed because of treatment reversal (one patient), death (one patient, due to a massive digestive hemorrhage caused by a peptic ulcer), and a broken leg (one patient). In the other patients, bronchoscopy was not performed for logistical reasons, and the patients were well enough to forgo the examination. Figures 14show several aspects of

Functional Follow-up

Eighteen patients completed the 1-month and 3-month follow-ups, 14 patients completed the 6-month follow-up, 11 patients completed the 12-month follow-up, and 5 patients completed the 24-month follow-up. Concerning pulmonary function, statistical improvement was observed in the 6MWT after 1 month (Table 3). It should be noted that the clinically minimal important difference of 54 m proposed by Solway et al19 and Redelmeier et al20 was met for 6 of 18 patients, but not for the group as a whole.

Discussion

The present study reports the results of a 1- to 24-month follow-up of emphysema patients submitted to TPET. Our study suggests that the treatment of severe heterogeneous emphysema predominantly affecting the upper lobes using TPET/EBV is a safe, potentially reversible procedure associated with a low complication rate and no mortality, which promoted a transient but significant improvement in quality of life as measured by the SGRQ and the multidimensional BODE index. We also provide important

Acknowledgment

We are grateful for the technical assistance provided by Brigitta Hund Prates, Ligia T. M. dos Santos, Julio Cesar S. Salvador, and Anara Maria Cabral Santos; and for the extremely useful suggestions made by Professors Patrícia Rieken Macedo Rocco (Universidade Federal do Rio de Janeiro), Eduardo Bethlem (UniRio), Wilson Leite Pedreira Junior (Universidade de São Paulo), Carlos Antonio Mascia Gottschall (Universidade Federal do Rio Grande do Sul [UFRGS]), Paulo de Tarso Roth Dalcin (UFRGS),

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    Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).

    This work was carried out at Hospital de Clinicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.

    Emphasys Medical provided valves free of charge, as well as a grant to the Medical Foundation of Rio Grande do Sul, which has partially funded the salary of Drs. de Oliveira and Macedo-Neto. The company had no part in the analysis of data or in the preparation of this manuscript. At the presubmission stage, Emphasys Medical reviewed the manuscript for factual errors and to ensure that there were no patentable disclosures that they had not already had an opportunity to cover or that were considered proprietary. This review led to no changes in the manuscript.

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