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Ann Thorac Surg 1998;66:331-336
© 1998 The Society of Thoracic Surgeons

Original articles: general thoracic

Outcome of Medicare patients with emphysema selected for, but denied, a lung volume reduction operation

Bryan F. Meyers, MDa, Roger D. Yusen, MDa, Stephen S. Lefrak, MDb, G. Alexander Patterson, MDa, Mary S. Pohl, BSNa, Veronica J. Richardson, BSNa, Joel D. Cooper, MDa

a Division of Cardiothoracic Surgery, Washington University School of Medicine, St. Louis, Missouri, USA
b Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, Missouri, USA

Address reprint requests to Dr Meyers, Division of Cardiothoracic Surgery, Washington University School of Medicine, Suite 3107 Queeny Tower, One Barnes-Jewish Hospital Pl, St. Louis, MO 63110

Presented at the Forty-fourth Annual Meeting of the Southern Thoracic Surgical Association, Naples, FL, Nov 6–8, 1997.


   Abstract
Top
 Abstract
Introduction
 Patients and methods
 Results
 Comment
 References
 
Background. Lung volume reduction operation shows promise in relieving symptoms and improving function in highly selected patients with emphysema. Withdrawal of Medicare funding for patients selected for operation by standard criteria created a matched control group with which to compare lung volume reduction recipients.

Methods. A retrospective study was done comparing 22 volume reduction candidates denied operation with 65 contemporaneous and comparable volume reduction recipients. Baseline physiologic characteristics were compared and longitudinal measures of pulmonary function were followed up for 24 months.

Results. Patients denied operation were similar to volume reduction recipients in all baseline measurements. Patients denied operation experienced a progressive worsening of their function, whereas volume reduction patients experienced sustained improvements. Absolute survival to date is 82% for the surgical group and 64% for the medical group.

Conclusions. The improvement seen in volume reduction patients cannot be attributed to the effects of patient selection or preoperative and postoperative rehabilitation.


   Introduction
Top
 Abstract
 Introduction
Patients and methods
 Results
 Comment
 References
 
The concept of lung volume reduction (LVR) for emphysema was initially conceived by Dr Otto Brantigan and colleagues [1, 2]. They proposed that resection of the functionless, overinflated portion of the lung might improve respiratory function. Several years ago, we reported our preliminary experience with the bilateral LVR operation [3]. Subsequent encouraging results from our own and other centers demonstrate significant improvements in pulmonary function tests, reduction in oxygen use, reduction in subjective dyspnea, and improvement in subjective quality of life [4–6]. In the absence of a randomized, clinical trial, however, the overall value of the procedure, as compared with the results of continued medical management in a similar group of patients, could not be determined. Patients offered a volume reduction operation are highly selected from the population of patients with severe emphysema; thus no historic cohort exists to provide meaningful comparison regarding survival and functional status. Moreover, many centers, including our own, incorporate a rigorous preoperative and postoperative physical rehabilitation program, raising questions as to what portion ofthe measured benefit is attributable to the operation and what portion is the result of the on-going rehabilitation.

We began performing LVR operations in January 1993, and performed 150 such operations over the next 37 months. The detailed results of this cohort of patients has been described [4]. As of December 1995, the Health Care Financing Agency (HCFA) issued a noncoverage policy for LVR operations. At the time of the funding withdrawal, we had evaluated and approved 24 patients who met our candidacy criteria for LVR operation. An additional 6 Medicare patients were evaluated and approved over the subsequent 11 months. In total 30 Medicare patients were evaluated from April 1994 to November 1996, deemed acceptable candidates for operation, but denied operation by the change in HCFA funding. Of these 30 patients, 8 patients chose to proceed with the operation without Medicare funding and were thus considered "self-pay" patients. The remaining 22 Medicare patients, selected for, but denied, LVR operation because of withdrawal of HCFA support, form the basis of this report. This study compares this group of patients with a comparable group of patients who underwent LVR operation. This comparison helps define the natural history of chronic obstructive pulmonary disease (COPD) in the highly selected population of patients deemed suitable for LVR operation.


   Patients and methods
Top
 Abstract
 Introduction
 Patients and methods
Results
 Comment
 References
 
Patient population
Patients with severe COPD were selected on the basis of the presence of a distended thorax and significant functional limitation despite optimal standard medical therapy. Patients who underwent operation for larger emphysematous bullae, in the presence of normal underlying compressed lung, were excluded from this report. None of the patients in this series had {alpha}1-antitrypsin deficiency. Patients who continued to smoke were excluded from consideration. The details of the evaluation process have been fully described [7]. The eligibility criteria can be summarized as follows:

Emphysema with hyperinflation and target areas
Marked physiologic impairment (forced expiratory volume in 1 second less than 35%)
Marked restriction in activity despite maximal med ical therapy
Age less than 75 years
Body weight between 70% and 130% ideal
Ability to participate in vigorous pulmonary rehabil itation program
No coexisting major medical problems
Willingness to undertake risk of morbidity and mor tality
Abstinence from cigarette smoking

Our program evaluated and approved for operation 87 Medicare patients between April 1994 and November 1996. Thirty of these approved patients did not complete the evaluation and the necessary preoperative preparation before the HCFA suspension of coverage. Eight of these stranded patients chose to proceed with operation despite the funding withdrawal, leaving 22 selected, but nonoperative, patients who comprise group I. The 8 self-pay patients, added to the 57 Medicare patients who were evaluated, accepted, and given LVR operation before the HCFA pullout, comprise the 65 patients in group II.

Assessment
Physiologic assessment included standard pulmonary function studies, standardized 6-minute walk test, arterial blood gas values, quantitative nuclear lung perfusion and ventilation scans, radionuclide cardiac ventriculogram, and lung volume measurements by plethysmography and by nitrogen washout.

Anatomic assessment included posteroanterior and lateral chest x-ray films taken in inspiration and expiration, chest computed tomographic scan, and, in some patients, dynamic magnetic resonance imaging evaluation of chest wall and diaphragmatic movement and coordination. If pulmonary hypertension was suspected on the basis of the results of radionuclide cardiac ventriculography, right heart catheterization was performed. If significant coronary artery disease was suspected, catheterization of the left side of the heart was also done.

Timing of operation
After evaluation, all patients were enrolled in a structured, supervised exercise rehabilitation program for a minimum of 6 weeks. In addition to the required 6-week rehabilitation delay between evaluation and operation, additional delays were introduced on an individual patient basis to address issues raised at the time of evaluation. Such issues included, but were not limited to weight loss or gain to meet parameters of 70% to 130% ideal body weight, follow-up serial chest computed tomographic scans to assess suspicious pulmonary lesions, or a more detailed cardiology evaluation. Patients in both groups were subject to these delays, as it was not uncommon for months to pass from the time of evaluation to the actual day of operation.

In the LVR operation patients, the shortest elapsed time from evaluation to operation was 30 days in a patient for whom a portion of the preoperative rehabilitation was waived. The longest waiting period among these patients was 349 days, with the mean waiting time for all 65 patients being 137 days. Comparable figures are difficult to report for the nonoperated group, in that no operation occurred to mark the end point of their waiting time. The mean delay from the day of evaluation to the day of the HCFA pull-out was 246 days (range, 25 to 634 days) for the 16 patients evaluated before the suspension.

The 22 patients denied operation fall into three arbitrary classifications: 11 patients evaluated well in advance of the HCFA suspension, 5 patients evaluated too close to the HCFA suspension to reasonably complete rehabilitation and obtain operation, and 6 patients evaluated after the HCFA suspension in the hope that the decision would be rescinded. Table 1 contains summary information for the former group, those who should have had time (more than 2 months) to complete 6 weeks of rehabilitation and obtain operation before the cessation of funding. In all patients of both groups, the issues causing delay were resolved and each patient was deemed fit for operation to be included in this report.


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  		Table 1. Reasons for Delay in Early Medicare Patients Denied Operation

 
Technique of operation
The techniques used for the operation performed have previously been described [4]. A thoracic epidural catheter was placed immediately before the operation, thereby eliminating the need for intraoperative systemic narcotic agents. A left-sided double-lumen endotracheal tube was used. The anesthetic management of these patients has been previously described [8]. A standard median sternotomy incision was made and the lung that showed the worse preoperative lung function, according to pulmonary perfusion scans, was usually reduced first. The mediastinal pleura was incised longitudinally, several centimeters posterior to the sternum to facilitate subsequent closure of the pleura at the end of the procedure. Care was taken to avoid incising the pleura too far cephalad to avoid injury to the phrenic nerve. The lung was deflated and one-lung ventilation was directed to the contralateral side. Under these conditions, after a few minutes, the relatively healthy portions of lung undergo absorption atelectasis, whereas the most destroyed portions remain inflated because of the poor or absent pulmonary blood flow.

A linear stapler was used to excise the selected diseased areas of the lung. The staplers were buttressed with strips of bovine pericardium (Peri-strips; Bio-Vascular, Inc, St. Paul, MN) by a technique previously reported [9]. Two 28F chest drains are placed in the pleural space and brought out in the subxiphoid position at the conclusion of the operation. Postoperative care has also been discussed in detail elsewhere [4].

Follow-up evaluation
Follow-up evaluation of all patients in both groups included telephone interviews and office visits to assess general health and subjective levels of dyspnea and quality of life. These interviews included questions regarding oxygen use at rest and during exercise, as well as steroid use. Patients were also studied on a regular basis every 6 months with spirometry. Survival data are extended to 3 years and functional data are recorded to 2 years for the simple reason that it is logistically easier to verify survival than it is to coordinate pulmonary function tests for a large group of patients.

Statistical analysis
The unpaired Student’s t test was used to compare the continuous numerical characteristics of the two groups preoperatively. Fisher’s exact test was used to test for significance in the difference in prevalence of oxygen use or steroid use within or between cohort groups. The Kaplan-Meier estimates were used to graphically display survival for both groups, with the starting point for both groups being the day of initial evaluation [10]. The Mantel statistic was used to test the significance of survival differences.


   Results
Top
 Abstract
 Introduction
 Patients and methods
 Results
Comment
 References
 
The physiologic criteria measured at the time of evaluation for the 22 patients denied operation and the 65 patients operated on are provided in Table 2. There are no statistically significant differences between groups I and II with regard to age, spirometry, measured lung volumes, arterial blood gases, or results of a standardized 6-minute walk test.


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  		Table 2. Comparison of Group I and Group II at Time of Evaluation

 
The follow-up data for group I are provided in Table 3. These data demonstrate the lack of any improvement in forced expiratory volume in 1 second (FEV1) provided by the postevaluation rehabilitation or the maintenance physical therapy provided to these patients. At 1-year follow-up, the FEV1 showed a 16% decrease from evaluation. In 17 evaluable patients at 24 months after evaluation, the FEV1 demonstrated a statistically significant 10% decline from baseline values. Oxygen use, as measured by the percentage of patients using oxygen at rest, increased from 32% at initial evaluation to 48% for those evaluable at 12 months. By 24 months, 88% of the evaluable patients were using oxygen at rest. Steroid use remained stable throughout the follow-up period.


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  		Table 3. Follow-up of Medicare Patients Not Receiving a Lung Volume Reduction Operation

 
Similar follow-up data for group II are provided in Table 4. In 51 patients available for follow-up at 12 months, the FEV1 had improved by 50%, whereas the number of patients requiring oxygen at rest had decreased by 49%, the number requiring oxygen during exercise had decreased by 23%, and the number requiring daily oral steroids decreased by 41%. At 24 months, the 45 evaluable patients show maintenance of the beneficial effects with a sustained improvement in FEV1 and continued reductions in oxygen and steroid use.


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  		Table 4. Follow-up of Medicare Patients Receiving a Lung Volume Reduction Operation

 
A direct comparison between the two groups at 12 and 24 months is shown in Table 5. This demonstrates the significant improvement in FEV1 for the LVR operation group at both time periods, as well as the sustained improvements in the frequency of oxygen use at rest and at exercise, and the durable decrease in steroid requirements.


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  		Table 5. Comparison of Follow-up Results for Groups With and Without Lung Volume Reduction

 
The actuarial survival curves of the two groups are shown in Figures 1 and 2 . The survival for group I is 100% at 12 months and 64% at 36 months, with 5 patients alive and evaluable at 36 months. Group II survival is 89% at 12 months and 83% at 36 months, with 37 patients evaluable at 36 months. The Mantel test of significance for the differences between the two curves found no significant differences at the 12- or 36-month intervals. The absolute survival for these two groups is 82% for group II and 64% for group I, with a mean follow-up of 976 days and 867 days, respectively.



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  		Fig 1. Kaplan-Meier actuarial survival for 22 Medicare patients selected for, but denied, a lung volume reduction operation.

 


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  		Fig 2. Kaplan-Meier actuarial survival for 65 Medicare patients selected for and provided a lung volume reduction operation.

 

   Comment
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
References
 
The prognosis for patients with severe COPD has been studied in many large longitudinal studies [11–14]. These studies demonstrate that patients with severe COPD have increased mortality compared with the general population and that age and FEV1 are the strongest predictors of mortality. Bilateral or unilateral LVR operation has been offered to a small subset of patients with COPD to relieve subjective dyspnea and improve functional status. This report documents the natural history of the disease in 22 patients who were judged suitable for LVR operation but who were denied the procedure by the withdrawal of Medicare funding. Our findings show a progressive clinical decline, as would be expected, in the patients denied LVR operation. This is in contrast to findings by ourselves and other investigators that the LVR operation produces a functionally and statistically significant improvement in FEV1 [4, 6, 15–17]. Because these two groups of patients were comparable at selection and exposed to equivalent rehabilitation requirements, these findings give support to the assertion that patient selection and continued rehabilitation do not account for the improved physiologic function seen in patients after the LVR procedure.

Two major reservations have been expressed regarding the effectiveness of LVR operations in improving function and survival. First, the highly selected nature of the patients offered operation makes it difficult to draw meaningful conclusions as to the effect of LVR operation on the survival curves of these patients postoperatively. Having excluded from operation the obese, the underweight, the unmotiviated, the anginal, the cigarette addicted, and the sufferer of multiple systemic diseases, it is expected that the survival of the postoperative LVR patient is better than that of unselected historical controls with severe COPD. The current report describes the natural history of a group of patients who are indistinguishable, at the time of evaluation, from those given LVR operation. As a result, the difference in survival is smaller in magnitude, but perhaps more meaningful clinically. In addition, the benefit of LVR operation on functional outcome is readily apparent when the outcome of operation is contrasted with the progressive deterioration in a group of highly selected patients thought suitable for LVR operation.

The second criticism of claimed LVR operation benefits is that the operation is delivered in a "bundled" fashion along with intensive preoperative and postoperative pulmonary rehabilitation programs. Critics claim that the effects observed are cumulative effects of the entire process, with the actual LVR operation being merely a component that adds nearly all the risk of morbidity and mortality while contributing an unquantifiable portion of the measured benefits. Because our group I received the same evaluation, the same preoperative physical rehabilitation, and comparable "postoperative" rehabilitation as the operative group II, the difference in outcome is a closer approximation of the benefits attributable to the operation itself. The lack of improvement in the spirometry or in the oxygen requirements of the rehabilitated but nonoperated patients is consistent with our own unpublished observations that rehabilitation can improve subjective dyspnea and objective functional performance, but it cannot cause a measureable objective improvement in spirometry or reduction in oxygen requirements. Other researchers [18–20] also have reported this finding, but here we report it in the setting of patients subjected to the rigorous selection process surrounding LVR operation.

It is arguable that the eventual acceptance of LVR operation as standard therapy for a subset of patients with severe emphysema will depend on the results of a large-scale, multicenter, prospective, randomized trial with a postintervention follow-up of many years. We postulate that LVR operation, in patients considered "ideal," is at least as safe as standard medical therapy, as demonstrated by the 83% actuarial survival in our operative group compared with the 64% survival in the patients denied operation. If one accepts the safety of the operation, and one weighs the numerous reports of the durable spirometric and functional benefits of the operation, one can only conclude that a randomized, prospective trial for ideal patients would simply be depriving half the patients of an effective treatment alternative to accomplish a "perfect" scientific experiment. The role for a trial may be to explore the risk-to-benefit ratio in patients at higher risk (age >75 years, patients with systemic diseases other than COPD) or in patients with less potential benefit (patients with homogeneous diffuse disease).


   References
Top
 Abstract
 Introduction
 Patients and methods
 Results
 Comment
 References
 

  1. Brantigan O.C., Mueller E. Surgical treatment of pulmonary emphysema. Am Surg 1957;23:789-804.[Medline]
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  9. Cooper J.D. Technique to reduce air leaks after resection of emphysematous lung. Ann Thorac Surg 1994;57:1038-1039.[Abstract]
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Bryan F. Meyers
G. Alexander Patterson
Mary S. Pohl
Joel D. Cooper
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