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Ann Thorac Surg 2005;79:411-416
© 2005 The Society of Thoracic Surgeons

Original article: General thoracic

Bronchoscopic Lung-Volume Reduction With One-Way Valves in Patients With Heterogenous Emphysema

Federico Venuta, MDa,*, Tiziano de Giacomo, MDa, Erino A. Rendina, MDa, Anna Maria Ciccone, MDa, Daniele Diso, MDa, Alessandro Perrone, MDb, Daniela Parola, MDb, Marco Anile, MDa, Giorgio F. Coloni, MDa

a Department of Thoracic Surgery, University of Rome "La Sapienza," Rome, Italy
b Department of Pulmonology, University of Rome "La Sapienza," Rome, Italy

Accepted for publication July 19, 2004.

* Address reprint requests to Dr Venuta, University of Rome "La Sapienza," Department of Thoracic Surgery, Policlinico Umberto I, V.le del Policlinico, 00100 Rome, Italy (E-mail: sofed{at}libero.it).


   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
 References
 
BACKGROUND: We evaluated the feasibility and short-term functional outcome after bronchoscopic lung-volume reduction performed with one-way valves in patients with severe heterogeneous emphysema.

METHODS: Thirteen patients entered this pilot study. Endobronchial one-way valves were placed in the segmental bronchi supplying the most hyperinflated parts of the emphysematous lungs to allow lung deflation, reduce lung volume, and alleviate symptoms. The valves and delivery catheter were inserted under intravenous anesthesia and spontaneous assisted ventilation, with visual control through a flexible bronchoscope. We performed unilateral bronchoscopic lung-volume reduction in 11 patients and staged bilateral procedures in 2. Preoperative median forced expiratory volume in 1 second (FEV1) was 0.75 L/s (22%), residual volume was 5.3 L (233%), total lung capacity, 7.9 L (123%); intrathoracic gas volume, 6.5 L (176%); and 6-minute walk test, 223 meters. All patients required supplemental oxygen at rest (1.4 L/min). The median preoperative Medical Research Council (MRC) scale dyspnea score was 4.

RESULTS: Six complications occurred in 3 patients: two bilateral and one contralateral pneumothorax, one pneumonia, and two episodes of bronchospasm. Functional results at 1 and 3 months showed a significant improvement in FEV1, residual volume, and 6-minute walk test; 43% of the patients were able to completely stop supplemental oxygen. The posttreatment MRC median dyspnea score at 1 and 3 months was 2. Bronchoscopic follow up at 1 and 3 months showed that the valves were correctly in place with no granulation.

CONCLUSIONS: Bronchoscopic lung-volume reduction with one-way valves can be performed with acceptable short-term safety and worthwhile functional benefits.


   Introduction
Top
 Abstract
 Introduction
Material and Methods
 Results
 Comment
 Acknowledgments
 References
 
Emphysema is a debilitating lung disease with a significant morbidity and mortality that affects 2 million people in the United States[1–3]. The medical treatment currently available clearly shows some limitations in the most advanced phases of the disease. For this reason, a number of surgical procedures are currently performed to improve quality of life and survival. According to the characteristics of the disease and the clinical status of the patients they include bullectomy [4], lung transplantation [5], and more recently, surgical lung-volume reduction (LVRS) [6, 7]. There is no doubt that LVRS allows a significative functional improvement in a selected group of patients; however, it still carries a substantial morbidity, even if mortality is low at the centers with the larger experience [8]. Patients with a most advanced functional deterioration show a higher surgical mortality and less impressive functional results, suggesting that LVRS should be considered more carefully in these situations [9].

Bronchoscopic alternatives to the surgical approach have been recently proposed [10–12]; in particular, bronchoscopic lung-volume reduction (BLVR) with one-way valves has been attempted in the experimental laboratory [13] and in selected clinical settings [14, 15]. The one-way valve allows air to be vented from the isolated lung segment during normal expiration and prevents air from refilling the lung during inspiration. It has been postulated that the placement of these valves in the segmental bronchi could functionally isolate the airway that supplies the most hyperinflated parts of the emphysematous lungs, favoring deflation and even atelectasis, and thus mimicking LVRS in its contribution to alleviate symptoms.

We report our initial clinical experience with this newly developed endoscopic procedure.


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 Acknowledgments
 References
 
We conducted a prospective, nonrandomized, single-center longitudinal study to evaluate the safety and short-term efficacy of BLVR performed by placing one-way endobronchial valves (Emphasys, Redwood City, CA) in the bronchi supplying the most hyperinflated parts of the emphysematous lungs. Thirteen patients (12 men, 1 woman; median age, 56 years; range, 32 to 71) entered this pilot study during a 14-month period.

Patient Selection
The protocol was approved by the ethical committee of the University of Rome "La Sapienza." Most of the patients were borderline candidates for LVRS. All patients knew of the surgical LVR procedure and understood it, or it was explained to them. Bronchial LVR was offered to them as a new investigational procedure that possibly was an alternative to LVRS. They understood that LVRS could remain an option, if indicated, should the bronchoscopic procedure fail. All patients that were given a choice of therapy did not decline this procedure when it was offered, although it was stressed that it was experimental. Four patients formally refused any surgical approach (either LVRS or transplantation). Formal informed consent was obtained from each patient.

We performed unilateral BLVR in 11 and staged bilateral BLVR in 2 (15 treatments). The inclusion and exclusion criteria are listed in Table 1. Critical selection criteria were marked hyperinflation and regional variations in the distribution of emphysema to provide "target areas" of useless lung ("surgical" heterogeneous emphysema) to be excluded from ventilation with one-way valves. Almost all patients had one or more lobes clearly more compromised than the rest of the lung, which is why complete lobar occlusion was undertaken in all of the patients. In 2 patients, a small area of the posterior segment of the right upper lobe was less destroyed than the rest of the lobe, but it was occluded to prevent collateral ventilation refilling of the surrounding areas.


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  		Table 1. Patient Criteria for the Bronchoscopic Lung-Volume-Reduction Study
 
All patients received optimal medical treatment at the time of inclusion and no changes were made in their medications during the study period. They had been under long-term rehabilitation before the procedure, but a specific program was not designed for this study. All patients required supplemental oxygen. The preoperative functional variables of the patients enrolled in this study are reported in Table 2. The stratification of patients according to forced expiratory volume in 1 second (FEV1) is reported in Figure 1.


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  		Table 2. Preoperative Functional Variables of Study Patients
 


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  		Fig 1. Stratification of patients according to forced expiratory volume in 1 second (FEV1).

 
The on-site evaluation process included a physical examination, pulmonary function tests performed with body plethysmography, carbon monoxide diffusion (DLCO) measurement and reversibility test, arterial blood gas analysis, exercise tolerance measured with the 6-minute walk test (6MWT), chest roentgenogram, computed tomography scan, perfusion lung scan, and transthoracic echocardiogram. The degree of dyspnea was measured by the Medical Research Council (MRC) dyspnea grading system. Arterial blood gas analysis and chest roentgenogram were performed again 24 hours after the procedure, and after 1 and 3 months; spirometry was performed 24 to 72 hours after the procedure and repeated after 1 and 3 months. The MRC score was also recorded at these time points. Fiberoptic bronchoscopy was repeated after 1 and 3 months.

The Emphasys endobronchial valve (EBV) is an endobronchial prosthesis designed to both control and redirect airflow. The EBV is a one-way, polymer, duckbill valve that is mounted inside a stainless steel cylinder which is attached to a nickel-titanium (nitilol) self-expanding retainer (Fig 2A). It prevents air entering the target lung but allows air and mucous to exit. The EBV is provided in three sizes, each intended for a different range of target bronchial lumen diameters: 4.0 to 5.5 mm (inner–outer diameter), 5.0 to 7.0 mm, and 6.5 to 8.5 mm; the valve is 10 mm long.



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  		Fig 2. (A) One-way valves specifically designed for bronchoscopic lung-volume reduction. (B) Newly designed delivery catheter for one-way valve deployment.

 
All the procedures were performed in the operating room with the patient intubated (tracheal tube size 8 or 9) under intravenous anesthesia (propofol infusion) and spontaneous assisted ventilation. Local anesthesia (lydocaine 2%) was generously administered before inserting the valves to prevent coughing.

Operative Technique for Valve Placement
After the patient is intubated, the flexible bronchoscope is advanced into the endotracheal tube and the target bronchi are chosen. The valves are usually placed in the segmental bronchi, but subsegmental orifices can also be stented to obtain complete lobar occlusion. A guidewire is inserted through the operating channel of the bronchoscope and left in place while the bronchoscope is withdrawn; a flexible delivery catheter (Fig 2B) is guided to the targeted bronchus by the guidewire. The fiberoptic bronchoscope is reinserted after the advancement of the delivery catheter; the tip of the delivery catheter containing the valve is pushed with a gentle rotation in the selected bronchial orifice, and the valve is delivered.

Fiberoptic bronchoscopy performed after removal of the delivery catheter confirms the correct placement of the valve. Gentle suction through the bronchoscope ensures the correct opening of the valve to allow deflation of the lung and clearance of secretions. No fluoroscopy is required. The valves can be removed easily if placement is not satisfactory using a rat-tooth grasper through the working channel of the bronchoscope.

Statistical Analysis
In view of the limited number of observations, all descriptive statistics were expressed as median and range. The Wilcoxon signed rank test was used to assess the significance of differences between the medians of the variables measured at the different time points during follow-up. A p value of less than 0.05 was considered to indicate statistical significance.


   Results
Top
 Abstract
 Introduction
 Material and Methods
 Results
Comment
 Acknowledgments
 References
 
Fifty-nine valves were placed (median 4 per patient; range 2 to 6); the devices were placed in the right upper lobe in 6 treatments (40%), in the right upper and middle lobe in 1 (7%), in the left upper lobe in 3 (20%), and in the right and left lower lobes in 3 (20%) and 2 (13%) cases, respectively. The median operative time was 45 minutes (range 20 to 95 minutes). No intraoperative complications were observed.

All patients were extubated immediately after the procedure and returned to the ward. The median postoperative stay was 6 days (range 2 to 110). No deaths occurred. We observed 6 complications in 3 patients (23% of the patients, 20% of the treatments; 0.46 complications per patient). One contralateral pneumothorax developed 15 days postprocedure while the patient was at home. Two bilateral simultaneous pneumothoraces occurred 2 and 7 days postprocedure, one of which occurred during spirometry. This patient was intubated, admitted to the intensive care unit, and required prolonged hospitalization. Both patients with bilateral pneumothorax had diffuse bronchospasm that required the intravenous infusion of bronchodilators immediately after the procedure. One patient had pneumonia in the lobe adjacent to that where valves were inserted (valves were in the right upper and middle lobe and pneumonia was in the right inferior lobe).

The 3-month functional evaluation was available in all but 2 patients (for logistic reasons). No significant modification was noted of the functional variables measured 24 to 48 hours after the procedure. Functional results at 1 month and 3 months showed a significant improvement in terms of FEV1 and a decrease of residual volume (Table 2). Total lung capacity and intrathoracic gas volume decreased, and the 6MWT was significantly improved as well as DLCO. Overall, all the patients showed an improvement of the MRC dyspnea score at 30 days and 3 months, indicating a significant reduction in symptoms.

Most of the patients (67%) required less supplemental oxygen and 6 (46%) were able to stop it. The partial arterial pressures of oxygen and carbon dioxide remained stable, although these values were obtained with less supplemental oxygen. The 2 patients that showed bilateral pneumothorax improved their FEV1 from 0.6 L/s (22%) to 1.4 L/s (44%) and from 0.7 L/s (29%) to 1.2 L/s (45%). At 3 months, 3 patients showed an FEV1 improvement of 50% or more, 3 were at 30% or more, one was 20% or more, 2 were at 10% or more, and 2 had spirometric values similar to preoperative measurements

No granulation tissue was present at fiberoptic bronchoscopy performed after 1 and 3 months (Fig 3). Chest roentgenograms confirmed that all the valves were correctly in place (Fig 4).



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  		Fig 3. Endoscopic view of the one-way endobronchial valve.

 


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  		Fig 4. Chest roentgenogram shows the one-way endobronchial valves placed in the segmental orifices of the right upper lobe.

 

   Comment
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
Acknowledgments
 References
 
Surgical lung-volume reduction (LVRS) can now be considered an effective palliation for a selected group of patients with advanced emphysema [6, 7]. It provides improved pulmonary function, quality of life, and exercise tolerance [16, 17] with an accepted mortality of 5% to 10% [18]. Morbidity has still an impact, with a significant percentage of patients showing prolonged air leaks [16, 18]. LVRS is not always indicated, however. In fact, patients with the most advanced disease show a higher mortality and achieve less favorable results, suggesting caution in patients with low FEV1 and either homogeneous emphysema or a very low DLCO [9]. Lower-lobe emphysema is predictive of a less favorable functional improvement [8].

Surgery may not be required in the future to perform lung volume-reduction, because similar results could be achieved with deflation and atelectasis of the target areas obtained with bronchoscopic procedures. Some new options have been recently described [10–15, 19, 20] and they could play an important role in the future.

The group at the Washington University School of Medicine in St. Louis [10] recently proposed that the creation of artificial communications between the lung parenchyma and segmental bronchi would facilitate lung deflation and improve expiratory air flow and respiratory mechanics. This can be safely achieved bronchoscopically by puncturing the wall of segmental bronchi and inserting a stent to create internal bronchopulmonary communications. This procedure would be ideal for patients with homogeneous emphysema, in which collateral ventilation allows a preferential route for airflow with a more uniform expiratory deflation of the lung.

Patients with heterogeneous emphysema may not be suitable for this procedure. For this specific subset of patients, BLVR with one-way valves could represent a useful option [14, 15, 20]. This procedure allows deflation of the target areas, thus reducing the volume of the lung and improving mechanics. We did not, however, observe the complete collapse of the target lobe in our early experience, probably because of the presence of a certain degree of interlobar collateral ventilation that allows airflow between lobes when fissures are incomplete. However, the shape of the chest was redesigned after the procedure (Fig 5) in most of the patients.



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  		Fig 5. Chest roentgenograms of a patient that underwent bilateral, staged bronchoscopic lung-volume reduction (A) before bilateral treatment and (B) after bilateral treatment.

 
A few complications have been observed, of which bilateral tension pneumothorax was certainly the most serious. Ipsilateral pneumothorax was probably caused by a tear in the remodeling lung owing to acute volume loss secondary to valve placement. Concomitant pleural adhesions were always visible after the onset of pneumothorax and probably contributed to limit the sliding movements of the parenchyma that did not rise up to occupy the space. The diffuse bronchospasm showed by 2 patients could have contributed to the onset of pneumothorax; in one of them, the onset was certainly facilitated by the expiratory maneuvers during spirometry, as already mentioned. The treatment of this complication required the placement of multiple chest tubes, with prolonged air leaks and hospitalization. In both patients that showed contralateral pneumothorax (bilateral in one case) valves were placed also on that side to facilitate closure of the air leak, which was achieved shortly thereafter. This could be a useful indication to valve placement in the future and certainly requires further investigation. Incidentally, the patients with bilateral pneumothorax showed the best functional results (from 22% predicted to 44% and from 29% to 45%). Overall, the valves were well tolerated and bronchoscopic controls did not show any mucous plugs or granulation tissue around the valve.

The functional improvement was statistically significant. In particular, FEV1 markedly improved and residual volume decreased: at 3 months, more than 50% of the patients still show at least a 30% functional improvement and most of the patients required less supplemental oxygen and 6 (46%) were able to stop it. Exercise tolerance was also improved and remained stable after 3 months of follow-up.

Patients were so satisfied that most of them are now willing to receive treatment on the contralateral side, but lung morphology will not allow it in all of them. Contralateral BLVR could be attempted to obtain a second functional improvement when pulmonary function tests start again to deteriorate. We performed a second treatment on the contralateral side only in two patients, but neither was required for functional reasons. Both patients had pneumothorax on the contralateral side and valves were placed with the aim of stopping the air leak. This result was easily obtained, along with further functional improvement as mentioned.

The results of this pilot study demonstrate that bronchoscopic lung volume reduction can be safely performed with encouraging short-term results; long term follow up is mandatory as well as randomized control studies. This procedure may be considered in the future in conjunction with other similar bronchoscopic options such as "airway bypass," according to the characteristics of the distribution of emphysema in the different areas of the lung.


   Acknowledgments
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
References
 
This clinical study was sponsored by Emphasys Medical, Redwood City, CA.


   References
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Acknowledgments
 References
 

  1. American Lung Association. Facts about emphysema. New York: American Lung Association. 1990..
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