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J Thorac Cardiovasc Surg 1996;112:1319-1330
© 1996 Mosby, Inc.

GENERAL THORACIC SURGERY

RESULTS OF 150 CONSECUTIVE BILATERAL LUNG VOLUME REDUCTION PROCEDURES IN PATIENTS WITH SEVERE EMPHYSEMA

Received for publication May 6, 1996; revisions requested June 3, 1996; revisions received July 12, 1996; Accepted for publication July 15, 1996. Address for reprints: Joel D. Cooper, MD, Suite 3108, Queeny Tower, One Barnes Hospital Plaza, St. Louis, MO 63110.

Abstract

Between January 1993 and February 1996, we performed 150 bilateral lung volume reduction procedures for patients with severe emphysema. Patients were selected on the basis of severe dyspnea, increased lung capacity, and a pattern of emphysema that included regions of severe destruction, hyperinflation, and poor perfusion. Twenty percent to 30% of the volume of each lung was excised with the use of a linear stapler and bovine pericardial strips attached to buttress the staple line. Patients were between 36 and 77 years old, with an average 1-second forced expiratory volume of 25% of predicted, total lung capacity of 142% of predicted, and residual volume of 283% of predicted. Ninety-three percent of patients required supplemental oxygen, continuously or with exertion. All patients but one were extubated at the end of the procedure. The 90-day mortality was 4%. Hospital stay progressively decreased with experience, and for the last 50 patients the median hospital stay was 7 days. Prolonged air leakage was the major complication. Results at 6 months show a 51% increase in the 1-second forced expiratory volume and a 28% reduction in the residual volume. The Pao₂increased by an average of 8 mm Hg, and 70% of the patients who had previously required continuous supplemental oxygen no longer had this requirement. The improvements in measured pulmonary function were paralleled by a significant reduction in dyspnea and an improvement in the quality of life. Reevaluation at 1 year and 2 years after operation showed the benefit to be well maintained. We conclude that lung volume reduction offers benefits not achievable by any means other than lung transplantation for highly selected patients with severe emphysema. (J THORACCARDIOVASCSURG1996;112:1319-30)

Chronic obstructive pulmonary disease resulting from emphysema is a major cause of morbidity and mortality. ^1,2 As the disease progresses, physical activities become increasingly limited, and patients in advanced stages become dyspneic with minor exertion or even at rest. Many patients require supplemental oxygen. The major therapeutic modalities consist of bronchodilator and antiinflammatory drugs, ^3,4 directed at decreasing airway resistance, and antibiotics to treat acute and chronic infection. Pulmonary rehabilitation techniques and exercise training have produced significant palliation. ⁵ Supplemental oxygen therapy for the hypoxemic patient improves exercise performance and improves survival in patients with cor pulmonale. ^6,7 Despite all available therapies, the course of the disease is one of progressive limitation, increasing dyspnea, and significant increase in overall mortality. After the 1-second forced expiratory volume (FEV₁) falls below 30% of the predicted value, the overall survival at 3 years is only 60%. ^8,9

Emphysema interferes with respiratory function because of parenchymal destruction and changes in the mechanics of respiration. The progressive loss of lung elastic recoil leads to a decrease in the expiratory flow rate and to progressive overexpansion of the lung, with an increase in residual volume and total lung capacity. Because of the progressive increase in thoracic volume, chest wall and diaphragmatic function become impaired, increasing the work of breathing.

The lung volume reduction procedure is based on the proposals and the limited experience reported by Dr. Otto Brantigan more than 35 years ago. ¹⁰ He suggested that excision of some of the most destroyed portions of the lung could improve elastic recoil, reduce airflow limitation, and improve the mechanics of respiration. His limited experience with unilateral lung volume reduction, combined with the radical hilar stripping that was then in vogue, produced subjective improvements in a number of his patients. On the basis of Brantigan's proposals and our own observations of improved chest wall and diaphragmatic position after lung transplantation in patients with severe emphysema, we initiated a program for bilateral lung volume reduction in highly selected emphysema patients. This study was undertaken to evaluate the intermediate-term results of this procedure at our center.

Methods

Patient population.
Between January 1993 and February 1996, 150 patients underwent bilateral lung volume reduction at the Washington University Medical Center. One hundred forty-nine procedures were carried out through a median sternotomy, and one procedure, in a patient who had previously undergone coronary bypass surgery, used bilateral muscle-sparing thoracotomies. One additional patient underwent median sternotomy for a bilateral procedure, but extensive bilateral pleural adhesions were encountered and significant air leakage occurred after completion of volume reduction on the right side. Therefore the procedure was terminated without the contralateral reduction. This patient had a satisfactory result but is not included in this series.

Eligibility criteria include significant dyspnea and respiratory limitation despite maximum medical management, lung hyperinflation, and a favorable anatomic situation in which zones of relatively destroyed, hyperinflated lung coexist with other regions of lesser destruction. This pattern affords the opportunity of excising 20% to 30% of the volume of each lung, consisting of nonfunctional regions, to improve respiratory mechanics and distribution of the ventilation to the remaining lung. Several patients with diffuse disease and severe hyperinflation are included in this series.

The evaluation process, including physiologic and radiologic criteria, has been reviewed. ^11,12 In summary, thoracic distention is evaluated by inspiratory and expiratory chest radiographs, distribution of function by quantitative ventilation/perfusion lung scanning, and relative degree of parenchymal destruction in the various regions by computed tomography (CT) scanning of the chest. Eligibility criteria are summarized in Table I. None of these criteria was considered absolute, and exceptions were made for individual circumstances.

The physiologic profile of patients undergoing this procedure is shown in Table III. Pulmonary function studies were measured with a Medgraphics 1085 apparatus (Medical Graphics Corp, St. Paul, Minn.) before and after administration of aerosolized albuterol. The highest values obtained for forced vital capacity (FVC) and FEV₁ were chosen for data analysis. Lung volumes were measured with a Medgraphic 1085 plethysmograph. Oxygen requirement at rest was defined as a requirement for supplemental O₂ to maintain oxygen saturation at 88% or better while at rest (NELLCOR N10 pulse oximeter, Nellcor Inc., Pleasanton, Calif.). Oxygen requirement with exercise was defined as the maximum amount of supplemental oxygen required to maintain saturation at 90% or better during the 6-minute test. Dyspnea was quantified by the modified Medical Research Council (MRC) of Great Britain Dyspnea Scale ¹³ and the Mahler Dyspnea Index. ¹⁴ The modified MRC scale has five grades that describe the activity that provokes dyspnea; lower numbers correlate with less dyspnea. On the Mahler index, functional impairment is graded at baseline, but in contrast to the MRC, higher numbers correspond to less dyspnea. A transition index was used to assess changes from the baseline value at a later date.

Statistical analysis.
Pulmonary function data were analyzed with paired Student's t test. Quality-of-life questionnaires were analyzed with repeated measures of analysis of variance and Tukey's pairwise comparisons to examine significant time effects.

Operative technique.
A left-sided double-lumen tube was used to provide isolated ventilation to either lung. Before induction of anesthesia, a thoracic epidural catheter was placed under fluoroscopic guidance. This was used to reduce the amount of narcotic required intraoperatively and to provide optimal postoperative pain relief with a minimal need for narcotics or respiratory depressants. The technique was designed to permit extubation at the end of the procedure, and this goal was accomplished for all patients, except one patient who was successfully extubated the following morning. The anesthetic management used for these patients has been described elsewhere. ¹⁷

The operative technique has evolved over the past 3 years. A linear stapler was used to excise the desired portions of the lung. In the first several patients, intraoperative air leaks were apparent at the proximal staple line when reexpansion of the lung caused tears in the visceral pleura at the staple puncture sites. This finding was associated with prolonged postoperative air leaks. The technique of reinforcing the staple line with strips of bovine pericardium (Peri-strips, Bio-Vascular, Inc., St. Paul, Minn.) attached to the surfaces of the stapler before its application virtually eliminated air leakage at the staple line. This technique has previously been reported. ¹⁸ In the early part of this series, multiple independent wedge excisions were performed. However, the intervening pleura between such staple lines was often tense and subject to injury and rupture. To avoid this problem most resections are now performed with a continuous line of excision with successive application of the linear stapler. This operative technique has been reported elsewhere. ¹⁹

In 15 patients (10%), a complete anatomic lobectomy was used as part of the volume reduction procedure. Indications included known lung cancers in two and intraoperative findings of complete lobar destruction with a technically favorable situation for a lobectomy in the remaining patients.

The major focus of disease in most patients was in the upper lobes, in keeping with the known pattern of centrilobular emphysema in smokers. However, the region of most severe destruction in 18 patients was in the lower lobes, including 11 with known ₁-antitrypsin deficiencies and 7 with normal enzyme levels.

A residual space at the apex of the chest is not uncommon after the volume reduction procedure. We have often created an apical pleural tent so that parietal and visceral pleura can be in apposition, even if the residual lung fails to expand sufficiently to completely fill the chest. Although we have not evaluated the value of such a procedure in a randomized fashion, creation of a pleural tent is recommended when a sizable apical space remains at the end of the procedure. Two 28F chest tubes are placed in each pleural space. Tubes are brought out through the upper abdomen in a subxiphoid position.

Our postoperative management was previously reviewed. ¹⁹ The most significant change during the course of this series was the avoidance of suction on the chest tubes in the postoperative period. All tubes are attached to a water-seal drainage system. Suction is applied only if the postoperative chest x-ray film reveals a pneumothorax greater than 30%; the underlying lung appears restricted or compressed, as evidenced by increased density on the x-ray film; or marked subcutaneous emphysema develops. Only 10 (20%) of the last 50 patients required chest tube suction at any time in the postoperative period. If a modest air leak persisted beyond the first 4 to 5 postoperative days, the chest tube was connected to a Heimlich valve to facilitate patient mobility and discharge from the hospital.

The continuous epidural administration of bupivacaine, initiated intraoperatively, was continued in the recovery room, and a patient-controlled analgesia system (Baxter Healthcare Corp., Deerfield, Ill.) that delivered morphine sulfate (80 mg/40 ml) was initiated. Several hours later, if further pain control was required, ketorolac was administered systemically, with an initial dose of 30 mg followed by 15 to 30 mg every 6 hours for 48 hours. The sympathectomy effect frequently associated with the epidural bupivicaine was counteracted as necessary with a continuous infusion of phenylephrine for 24 to 48 hours. Antibiotics, usually a cephalosporin, were administered intravenously for 5 days on a routine basis. Antibiotic coverage was broadened at the first suggestion of pulmonary infection. A team of chest physiotherapists supplemented the efforts of the experienced thoracic surgical nurses to provide vigorous chest physiotherapy and early ambulation. Patients began ambulation on a mobile treadmill brought to the bedside on the day after the operation. This permitted early ambulation of the patient without the need to provide portable oxygen and monitoring equipment or to disconnect the patient from the many attachments. Despite an intensive program of chest physiotherapy, we found it useful to insert a minitracheostomy tube (Mini-Trach II, Portex, Keene, N.H.) for tracheal suction, because many of these patients had thick secretions and a feeble cough. In the last 50 patients in this series, minitracheostomy was used in 11 (22%).

Results

Morbidity, mortality, and complications.
Operative mortality was 4% (6 patients) and included all deaths from any cause occurring within 90 days of operation or at a later date if the patient was never discharged from the hospital or a chronic care facility. Late deaths were defined as any death occurring more than 90 days after the procedure for patients who had been discharged from hospital or a chronic care facility. Four such late deaths occurred in this series: one at 92 days and one at 270 days, both of pneumonia; one at 235 days of a stroke; and one at 13 months of respiratory failure. Mean follow-up time for survivors was 14 months and the median follow-up time 13 months. Actuarial survival, shown in Fig. 1, and was 93% at 1 year and 92% at 2 years.

View larger version (19K): [in this window] [in a new window]   Fig. 1. Kaplan-Meier survival curve for 150 patients after lung volume reduction. Survival is 93% at 1 year and 92% at 2 years.

View larger version (55K): [in this window] [in a new window]   Fig. 2. Mean and median hospital stay for successive groups of 50 patients after bilateral lung volume reduction.

View larger version (28K): [in this window] [in a new window]   Fig. 3. Histogram of postoperative hospitalization for the last group of 50 patients after bilateral lung volume reduction.

Functional results.
Median follow-up time was 415 days. Clinical follow-up information was available for all surviving patients, and postoperative measurement of pulmonary function at 3 or 6 months was available for all but 1 of the 127 patients who survived 6 months or longer after the operation.

After lung volume reduction, maximum improvement in measured lung function appeared to occur between 3 and 6 months preoperatively. Table V demonstrates the improvement seen in spirometry, lung volumes, and gas exchange 6 months after the procedure. The FEV₁ increased by an average of 51%, the residual volume declined by 28%, and the mean Po₂ increased by 8 mm Hg. Seventy percent of the patients who required continuous oxygen administration preoperatively were relieved of this necessity. Fifty-two percent of the patients who formerly required supplemental oxygen with maximum exertion required none at 6 months. This requirement was determined during the most vigorous pace of walking possible. Many patients who require oxygen under those circumstances do not require oxygen during routine, submaximal exertion. Overall functional improvement was measured with the 6-minute walk test. The results are shown in Table VI. Exercise capacity was significantly improved by the rehabilitation program, as has previously been demonstrated. ²⁰ After the procedure there was a further significant increase in overall performance. Oxygen requirements during exercise increased during the preoperative rehabilitation phase because of the higher achievable level of activity without concomitant improvement in pulmonary function. After surgery, oxygen requirements during exercise diminished significantly despite further significant increases in exercise capacity.

Our original report of bilateral lung volume reduction surgery in 20 patients showed encouraging early results. ²¹ Subsequent experience has confirmed the benefit achieved with this procedure in selected patients and has indicated that subjective and objective improvement persist for at least 2 years. It is assumed that the progressive deterioration in lung function known to occur over time with emphysema will continue, but many patients continue to exhibit subjective and objective benefit, and five of the initial patients who have been followed 3 or more years show well-sustained benefit.

We consider the preoperative rehabilitation program to be essential for three reasons. First, a decision to operate should only be made after optimum medical management has proved insufficient. Second, the improved stamina and nutritional status facilitates postoperative recovery. It has not been uncommon for patients who are initially totally wheelchair dependent to progress to the point of 30 minutes of continuous exercise on a treadmill at 1 mile per hour for 30 minutes at the conclusion of the rehabilitation phase. Third, optimized preoperative medical management provides an appropriate baseline for evaluation of the benefits produced by the operation.

We use the median sternotomy because this approach provides excellent bilateral exposure, permits a bilateral approach through single incision, and allows continuous surveillance of both pleural cavities throughout the procedure. In tandem with our analgesic protocol, we believe median sternotomy is associated with minimum morbidity. It is the ultimate muscle-sparing incision, because none of the chest wall muscles is incised, retracted, or penetrated. No painful intercostal nerve injury can result from the operative approach or from chest tube placement sites located in the subxyphoid region.

Miller and associates have reported an experience with bilateral volume reduction similar to our own. ²² Several other teams have reported their experience with volume reduction conducted by a unilateral thoracoscopic approach. The results confirm the benefits of the volume reduction concept, although objective improvement of a lesser magnitude has generally been accomplished with this unilateral approach. ^23-25 As a result, a bilateral thoracoscopic approach has been proposed at some centers. Our own experience includes 24 cases of unilateral volume reduction, all undertaken because of contraindications to a bilateral procedure or because of a marked discrepancy in the degree of emphysematous changes in the two lungs. A muscle-sparing thoracotomy approach was used in these 24 patients. None of these patients has died, and significant benefit has been achieved, although of lesser magnitude than that achieved with the bilateral procedure (Table XII).

Two of the major issues that remain unresolved for the lung volume reduction procedure are how to select appropriate candidates and how to assess and interpret the results. We continue to be quite conservative in our selection process, requiring significant functional limitation, marked thoracic distention, and a favorable anatomic situation that permits excision of areas of marked destruction while retaining regions with lesser disease. With some exceptions, we have excluded the much greater proportion of patients whose emphysema is rather uniformly distributed. Although several such patients with satisfactory results are included in this series, it remains our assumption that the magnitude of improvement and the duration of benefit are related to the amount of lung with minimal to moderate disease that remains at the end of the procedure. To prove whether this assumption is correct would require further experience with liberalized selection criteria.

Objective evaluation of the degree and pattern of lung destruction remains imprecise. Despite considerable experience, our selection process admittedly contains a significant subjective component. Techniques are available to objectively quantify the degree and distribution of lung damage, such as high-resolution CT scan or quantitative CT in which a computerized program breaks down each lung slice into small pixels and analyzes each pixel for lung density. Such an analysis is capable of expressing the percentage of lung in each region that has severe, moderate, or minimal destruction. However, this technique is of more theoretical than practical value.

In the current series, the most severely diseased lung usually was in the upper lobes, consistent with the known distribution of centrilobular emphysema in smokers. However, the most severe areas of destruction were located in the lower lobes of 18 patients. Eleven had ₁-antitrypsin deficiency, and seven did not. In these 18 patients the mean improvement in FEV₁ has been 27%, the reduction in residual volume was 28%, and the increase in Pao₂ was 5 mm Hg. These values are significantly less than for the overall series, but nonetheless most of these patients have experienced significant functional improvement.

The physiologic alterations responsible for the subjective and functional improvement observed after lung volume reduction remain unclear. There is often a lack of correlation in the degree of objective improvement achieved with each of the parameters. For any individual patient a minor increase in the FEV₁ may be associated with a marked reduction in residual volume or with a very significant increase in the Pao₂. The overall benefit, as perceived by the patient, occasionally correlates poorly with the changes in physiologic measurements. However, the significant improvement seen in virtually all objective parameters measured in the group as a whole confirms that the benefits perceived by the patients are related to alterations produced by the procedure and not to a "sham effect," such as has been associated with numerous procedures performed earlier in this century and for which no demonstrable objective improvement could be documented. It is probable that the measurements we have made do not fully reflect the physiologic alterations brought about by the volume reduction procedure. More sophisticated studies, including measurement of the work of breathing and lung elastic recoil, have been made by others and have shown significant improvement after the operation. ^22,27,28

It has been suggested that the benefits achieved with the volume reduction procedure might accrue with a longer period of medical management and exercise rehabilitation and without an operative procedure. This is not the case. Each patient in this series served as his or her own control after receiving maximum medical therapy as outlined in the American Thoracic Society Guidelines for the management of chronic obstructive pulmonary disease. ²⁹ Other publications have documented that, notwithstanding the important benefits of a rehabilitation program in terms of increased mobility, stamina, and somewhat lessened dyspnea, no improvement in measurable lung function or gas exchange occurred as a result of such a program. ^9,30,31

A second question has been raised regarding the benefits of this procedure and the anticipated duration of improvement achieved. Only complete follow-up of these patients will provide an answer. We hope with this procedure to "turn back the clock" by a number of years, while recognizing that the natural progression of the underlying process will continue. Whether this progression will be at the rate usually anticipated, slower because of improved lifestyle and medical management, or accelerated because of the increased distending force on the residual diseased lung remains to be seen.

We have not yet undertaken a formal study of the ongoing medical costs associated with the management of these patients, but our patients report that visits to physicians and to emergency wards and the frequency of hospitalization have all been markedly diminished after the operation. Prolongation of life expectancy, although not the goal of lung volume reduction, appears to be another significant potential benefit. Given the known correlation between FEV₁ and life expectancy, ^8,9 the mean improvement in FEV₁ demonstrated in this series may have a significant impact on the patients' longevity. The actuarial survival of 92% at 24 months compares favorably with the anticipated death rate for patients with this degree of chronic obstructive pulmonary disease. However, this discrepancy may be related to a selection bias. Only a randomized, controlled study in which one half of the eligible patients are denied the volume reduction procedure for a number of years would address this issue from a rigorous scientific standpoint. However, given the results achieved, the absence of any alternative therapy for these patients, and the fact that improved quality of life, not longevity, is the goal of this procedure, such a randomized trial poses serious ethical and moral issues. One method for evaluating the impact of lung volume reduction on life expectancy would be to compare results achieved after lung volume reduction with the results for a cohort of patients who have been equivalently assessed for the procedure and found to be suitable in all respects except for the presence of a homogeneous pattern of destruction throughout the lungs. This would render them unsuitable for the volume reduction procedure by our current criteria. This cohort of patients would then be similar in all other respects, including severity of disease and absence of surgical contraindications, to the operative group and could serve as the best "natural history" control group.

The relationship between lung volume reduction and lung transplantation for severe emphysema remains an important issue. Approximately two thirds of the patients in this series would not have qualified for lung transplantation because of age, coexisting medical problems, or insufficient severity of disease to justify transplantation. Similarly, approximately two thirds of patients with obstructive lung disease evaluated for lung transplantation at our center are considered unsuitable for lung volume reduction, usually because of severe diffuse disease, associated small airways disease, or chronic infection. For the remaining patients, lung transplantation and lung volume reduction surgery can both be considered. Under these circumstances, the patients are informed of the risks and benefits of each procedure, and virtually all have chosen to undergo lung volume reduction, with the understanding that this does not, in our opinion, preclude the chances for successful lung transplantation should it subsequently be deemed appropriate.

At the time of this operation, 48 patients were considered suitable candidates for lung transplantation on the basis of age, severity of lung function, and absence of apparent contraindications. None of these patients has received a lung transplant. Four of the patients in this series are actively listed for a lung transplantation, and eight others, who were listed for a transplant before their operations, are not currently considered active candidates because of the improvement in lung function after the reduction procedure.

The lung volume reduction procedure has, temporarily at least, shifted a number of potential lung transplant recipients to an alternative procedure and has had the effect of increasing the number of available donors for patients suffering from other conditions, such as cystic fibrosis and pulmonary hypertension, for whom no alternative to transplantation exists.

The risks of lung volume reduction for disabling emphysema should not be underestimated. Selection, preparation, and postoperative care of these patients requires the coordinated activity of thoracic surgeons, anesthesiologists, pulmonologists, nurses experienced in the management of thoracic operative patients, respiratory therapists, and others. In the absence of such a team approach, the morbidity and mortality associated with this procedure may well exceed that which we have reported.

The lung volume reduction operation is logical, physiologically sound, and of proven benefit for a selected group of patients with no alternative therapy except lung transplantation, for which only a minority qualify. Further refinements in selection, operative technique, and postoperative management are anticipated. Accurate collection and reporting of data from different centers will permit a comparison of different selection criteria, various operative approaches and techniques, and refinements in postoperative management. Current results confirm an important albeit palliative role for the lung volume reduction procedure.

Appendix: Discussion

Dr. John R. Benfield (Sacramento, Calif.)
Out of respect for the Program Committee's desire not to have slides shown, I selected three slides that I am not going to show you. The first shows Joel Cooper at the Toronto General Hospital with his first successful lung transplantation patient and our Past President, Griff Pearson; the second is a letter I received from one of our patients. The patient says that he is a 73-year-old farmer who is back mowing hay and playing with his grandchildren after lung reduction. The third is a letter from that same patient to our Senator, Diane Feinstein, telling her that he cannot understand why the Health Care Financing Agency (HCFA) is not paying for lung reduction. I admire Joel Cooper's boundless energy and enthusiasm for the treatment of end-stage lung disease.

The manuscript contains three points I would like to address. The first is that long-term outcome after lung volume reduction remains unknown. To this I say that the absence of such data is being ameliorated daily as short-term and intermediate-length outcome data accumulate. The second point is that there are no data about medical costs of emphysema with the lung volume reduction procedure compared with nonoperative management, including pulmonary rehabilitation. To this I respond that we have eclipsed the past, when any new, beneficial health care measure was affordable. The need to contain cost requires that the value of lung volume reduction be measured by outcome divided by cost. We must determine whether the initial high cost of lung volume reduction is balanced by lesser long-term costs for medication and medical care for patients who are treated nonoperatively. The third point is that only about 20% of patients referred were accepted for operation. This underscores the need to undertake lung volume reduction as a team approach to avoid significantly higher morbidity and mortality than reported by the Washington University group.

I close with a comment about the current lack of Medicare funding for lung volume reduction and with a question. The organizations that are the national forums for science and continuing education in thoracic surgery and in pulmonary medicine have advised HCFA that they do not consider lung volume reduction experimental. Hospital costs and professional fees therefore should be paid by Medicare when the procedure is offered to properly selected patients in centers that have track records successfully conducted, credible clinical research. There is no doubt that further research on the treatment of end-stage lung disease needs to be done and that lung volume reduction is a prime example for HCFA and the National Institutes of Health (NIH) to come together. HCFA should fund the patient care aspects of the treatment, and the NIH should support the needed research costs. Organized thoracic surgery spearheaded by the Society of Thoracic Surgeons and supported by the American Association for Thoracic Surgery and respiratory medicine have stepped forward and offered help to HCFA and the NIH in this regard. I hope that these agencies will accept this offer on behalf of patients whose dyspnea deserves palliation. I believe that a randomized study in the early 1970s to compare aortocoronary bypass to the then best available nonoperative treatment would have resulted in far quicker acceptance of the operation than occurred. We are at a similar stage with lung volume reduction, because it remains possible and perhaps likely that the benefits of lung volume reduction will prove to be transient.

Dr. Cooper, would it not be best to proceed with a randomized, prospective evaluation of lung volume reduction surgery compared with the best available pulmonary rehabilitation?

Dr. Cooper
Thank you, Dr. Benfield. You raised the issue of values. The scientific issues, such as how does this operation work, and how long will it last, all require careful scrutiny and the usual process by which, over the years, we decide which therapies are or are not of value. I believe these questions can be answered without randomization. The issues of value, such as how much is it worth to feel better and how long does the patient have to feel better to make it cost effective, probably cannot be answered by a randomized trial.

A randomized trial may not be the best approach for evaluating the medical benefits of the procedure. Lung volume reduction produces changes in FEV₁, residual volume, and other objective measurements which cannot be achieved by any current nonsurgical treatment. Therein is the dilemma of denying it to patients for whom it is the only possible choice. I completely subscribe to careful scrutiny and evaluation, and I have no objection to any center conducting a compassionate and randomized trial as long as scientific evaluation is not used as a disguise for rationing or access limitation to a procedure for which there is no alternative.

Dr. Cecil C. Vaughn(Phoenix, Ariz.)
I wish to comment on the technique of minimizing air leakage after the lung volume reduction procedure. I heartily endorse the need for staple line reinforcement and staple wedge resections of emphysematous lung. My colleagues and I use quadrangular sleeves of expanded polytetrafluoroethylene (PTFE)* that fit on the anvil and cartridge of the stapler. These sleeves have tear seams and grasping flaps at each end to facilitate removal of the excess PTFE after firing the stapler. These sleeves have been used in 21 open and thoracoscopic procedures at our center in Phoenix and at the University of Vienna, and they represent another technique for the reduction of air leak.

Dr. Cooper, what has been your experience with bovine pericardium, and how long did bovine pericardium last after its application?

Dr. Cooper.
When we initially reported the use of bovine pericardium, we summarized many of the different patching techniques and buttressing techniques that have been documented by others over the years, and I suppose it is a matter of personal preference. I have had the opportunity to reexplore two patients a month or more after the initial procedures, and the bovine pericardium seemed totally inert and well incorporated. I can only judge it on the basis of previous studies done during the last 10 or 15 years in which many persons have studied the material as a bioprosthesis and as a tissue support. I agree with you that some form of buttressing the staple line in emphysematous lungs produces benefit, but I am concerned about the use of nonabsorbable foreign material in the potential presence of a prolonged air leak or pleural infection.

Acknowledgments

We acknowledge the essential contributions made to the success of the lung volume reduction program by cardiothoracic anesthesia staff; the nursing service of the Division of Cardiothoracic Surgery; the chest physiotherapists and respiratory therapists, Dottie Biggar, RN, and the staff of the pulmonary rehabilitation team; Veronica Richardson Higgins, RN, the nurse coordinator; and many other members of the clinical team who provided experienced and tireless support for the complicated care for this group of patients. We also acknowledge Ms. Kathy Stroud for her expert secretarial support.

Footnotes

From the Divisions of Cardiothoracic Surgery^a and Pulmonary and Critical Care Medicine,^b Washington University School of Medicine, St. Louis, Mo.

Read at the Seventy-sixth Annual Meeting of The American Association for Thoracic Surgery, San Diego, Calif., April 28–May 1, 1996.

* Seamguard Material, W. L. Gore & Associates, Inc., Newark, Del.

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