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21

Lung Volume Reduction Surgery in

the Candidate for Lung Transplantation

Christine L. Lau and Bryan F. Meyers

chapter to review the specifi c evidence support- ing lung transplantation or LVRS as a therapy for emphysema. While this work will presuppose eligibility for either procedure and address the evidence guiding selection of an initial opera- tion, the tables supporting the text will reiterate commonly accepted exclusion criteria for either procedure.

21.1. Patient Selection for Lung Volume Reduction Surgery Versus Lung Transplantation

Lung transplantation and LVRS are invasive pro- cedures with a risk of both morbidity and mortal- ity to patients receiving such operations, thus both procedures are directed only at patients who remain symptomatic despite optimal medical treatment. Pulmonary rehabilitation programs have been shown to relieve subjective dyspnea, increase functional capabilities, and improve subjective quality of life. All patients considered for surgical treatment of emphysema should be enrolled in a supervised pulmonary rehabilita- tion program and their subsequent consideration for surgery should be based on their compliance and progress with rehabilitation. Because lung transplantation and LVRS carry an increased perioperative risk of morbidity and mortality, and because increased life expectancy has only been shown in a subset of patients undergoing LVRS, patients considering an operation must be willing to accept the possibility of a shortened life in exchange for an anticipated relief from dyspnea Emphysema is a progressive, unrelenting disease

that results in a continued decline in pulmonary function. When pulmonary function testing documents a forced expiratory volume in 1s (FEV1) of less than 30% predicted values, the 3- year mortality risk has been estimated at 40% to 50%.1–4 Because of the increased mortality and the decreased quality of life seen with severe emphysema, multiple surgical treatments have been devised for patients with emphysema. The majority of these surgical interventions have been subsequently abandoned because of the lack of reproducible benefi ts and the false physiologi- cal principles upon which they were based. An excellent published review on the history of emphysema surgery has been provided by Deslau- riers.5 As surgeons and physicians gained a better understanding of the pathophysiology of emphy- sema, most of these procedures would be consid- ered of historical interest with no current practical value. Today, two surgical options exist for patients with severe emphysema: lung volume reduction surgery (LVRS) and lung transplanta- tion. In the properly identifi ed recipient, both procedures provide an improvement in quality of life, exercise tolerance, and, possibly, survival.

Combinations of LVRS and lung transplantation, either simultaneously or sequentially, may be considered under rare circumstances. This chapter will review the results achieved with lung transplantation and LVRS and then attempt to address the specifi c question: which of the two surgical strategies is best supported by the evi- dence as the initial approach for the candidate with dual eligibility? It is beyond the scope of this

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and an improvement in quality of life. Specifi c indications for lung transplantation or LVRS are mentioned with regard to each operation.

21.1.1. Transplantation for End-stage Emphysema

Pulmonary emphysema was once thought to be a contraindication for lung transplantation. During the era preceding bilateral transplantation, the perceived diffi culties of ventilation and perfusion mismatching with the native and newly trans- planted lung were thought to be too great an obstacle. After the initial success with single- lung transplantation for emphysema was reported6 and after the development of tech- niques to allow safer bilateral lung transplanta- tion,7,8 the use of lung transplantation for patients with emphysema quickly increased. Emphysema quickly became the leading diagnosis cited as an indication for transplant, partly due to the pre- valence of emphysema and partly due to the survival advantage that emphysema patients demonstrate while awaiting lungs after being listed for transplantation.

Emphysema and α1-antitrypsin defi ciency have become the most common indications for pulmonary transplantation. These two indica- tions together account for 61.2% of the adult single-lung transplants and 32.1% of the bilateral lung transplants reported in the 2005 Registry of the International Society for Heart and Lung Transplantation (ISHLT), as reported by Trulock and colleagues.9 General criteria for transplanta- tion in these patients have been reported by Trulock.10 Most patients considered for trans- plant have deteriorated to a point at which oxygen supplementation is required. In experience described by Trulock, the mean supplemental oxygen requirement at the time of transplanta- tion was slightly in excess of 4L/min. The obstruc- tive physiology in these patients resulted in a FEV1 of well under 1L, or approximately 16% of predicted normal values for the average patient.

This particular patient group usually has a stable course with excellent survival on the waiting list while awaiting pulmonary transplantation. Pro- gressive elevation in PCO2 has been observed in some patients, however, with several of these individuals undergoing transplantation with the

PCO2 in excess of 100mmHg. The current criteria used at Washington University for evaluating potential lung transplant candidates are recorded in Table 21.1.

The advantages of lung transplantation are obvious: complete replacement of the diseased and nonfunctional lung with a new and healthy donor lung. Initial and long-term function of patients with single- or bilateral lung transplants for emphysema show a dramatic improvement in pulmonary function and exercise tolerance with elimination of the need for supplementary oxygen. The experience at Washington Univer- sity is recorded in Table 21.2, showing survival of 88% at 1 year and 59% at 5 years after transplant for emphysema. Together, patients with emphy- sema and α1-antitrypsin defi ciency emphysema comprise 55% of those undergoing transplanta- tion over the past 16 years and the results in this subset are superior to those observed in the overall cohort of transplant recipients.

The disadvantages of lung transplant are well known but worth reviewing. First, the lack of

TABLE 21.1. Indications and contraindications for lung volume reduction surgery and lung transplantation.

Indications common to both procedures Emphysema with destruction and hyperinflation Marked impairment (FEV1<35% predicted) Marked restriction in activities of daily living

Failure of maximal medical treatment to correct symptoms Contraindications to both procedures

Abnormal body weight (<70% or >130% of ideal) Co-existing major medical problems increasing surgical risk Inability or unwillingness to participate in pulmonary rehabilitation Unwillingness to accept the risk of morbidity and mortality of surgery Tobacco use within the last 6 months

Recent or current diagnosis of malignancy

Increasing age (>65 years for transplant, >70 years for volume reduction)

Psychological instability, such as depression or anxiety disorder Discriminating conditions favoring lung volume reduction surgery Marked thoracic distension

Heterogeneous disease with obvious apical target areas FEV1>20% predicted

Age between 60 and 70 years

Discriminating conditions favoring lung transplantation Diffuse disease without target areas

FEV1<20% predicted

Hypercarbia with Paco2>55mmHg Pulmonary hypertension Age less than 60 years α1-Antitrypsin deficiency

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available donor lungs has created a situation in which the waiting time for a transplant recipient in our program routinely exceeds 2 years. The changes in the lung allocation rules in May 2005 may make this waiting time even longer for emphysema patients as it has been devised to pri- oritize patients based on severity of disease rather than time on the list. There have not been reports on the disease-specifi c impact of the new alloca- tion algorithm, but most suspect that patients with emphysema will suffer decreased donor lung availability. Once lungs become available, the initial morbidity and mortality of lung trans- plant is higher than that reported for lung volume reduction, with mortality variously described as 5% to 15% for the fi rst 30 days and somewhat higher for the fi rst year. For the survivors, the presence of allograft lungs creates the need for lifelong immunosuppression, which carries with it high medical costs to the individual and society and an increased risk of hypertension, renal dys- function, hyperlipidemia, neoplasm, and infec- tion when compared with nonimmunosuppressed patients. Finally, the risk of developing chronic allograft dysfunction, or bronchiolitis obliterans syndrome (BOS), increases with time since trans- plant and reaches 50% to 60% by 5 years after transplant. The cumulative 5-year survival of our lung transplant experience for emphysema is 58%, a fact that clearly demonstrates the imper- fect solution that transplant offers to emphysema patients.

Early reports on the effi cacy of lung transplant for pulmonary emphysema compared the merits and risks of bilateral (BLT) versus single (SLT) lung transplantation and demonstrated a higher perioperative risk for the bilateral operation without a demonstrable functional benefi t to the

recipients.11,12 For that reason and for the reason of better utilization of graft lungs, SLT quickly became the preferred operation for obstructive lung disease. More recent reports, however, have made BLT appear a better option for obstructive lung disease, although the comparisons are not randomized. The 2005 ISHLT registry data reports signifi cantly improved survival of bilat- eral rather than single-lung procedures over 10 years after transplantation for chronic obstruc- tive pulmonary disease (COPD; p < 0.001) and for α1-antitrypsin defi ciency emphysema (p = 0.007).9 Single center data from Washington Uni- versity shows a 5-year survival of 65% for patients undergoing bilateral lung transplantation for emphysema compared to only 45% for those undergoing single-lung transplantation (p

<0.001). The in-hospital mortality is not different between SLT (7.0%) and BLT (5.9%; p = 0.79). The freedom from BOS for patients transplanted for emphysema was 30.6% at 5 years for SLT com- pared to 53.0% of BLT (p = 0.006).13 The Duke Lung Transplant group has also shown an increased rate of BOS in recipients undergoing SLT compared to those receiving BLT.14 Table 21.2 shows the survival data for all patients with lung transplants performed by Washington Univer- sity. As demonstrated, COPD and α1-antitrypsin defi ciency emphysema affect more than half of the total recipients and have outcomes that meet or exceed the group of transplant recipients as a whole. The functional status of transplant recipi- ents in our program was reviewed by Gaissert and colleagues.15 Figure 21.1 shows the effect of BLT and SLT on the FEV1, with both groups start- ing below 20% of predicted values and both enjoying a sustained benefi t over the fi rst 12 months of observation. Figure 21.2 shows the results of the measured 6-min walk for the same patients.

21.1.2. Lung Volume Reduction Surgery

The advantages of lung volume reduction for suitable candidates are numerous, including the relief of dyspnea and improvement of functional capabilities without the cost and adverse side effects of organ transplantation. There is no built-in waiting time as seen with transplan- tation; as soon as candidates can reach the TABLE 21.2. Patient actuarial survival: Washington University

Lung Transplant Program, 1988–2004.

Kaplan–Meier Survival

Diagnosis Number 1 year 3 years 5 years

COPD 316 88% 76% 59%

ATDef 108 83% 73% 59%

All transplants 764 85% 73% 58%

Abbreviations: ATDef, α1-antitrypsin deficiency; COPD, chronic obstruc- tive pulmonary disease.

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pulmonary rehabilitation exercise goals they are ready for the procedure. The early and late mor- tality for lung volume reduction are lower than those reported for transplantation. Without the concern for distribution of a scarce commodity such as donor lungs, lung volume reduction can be offered with slightly less rigid adherence to selection criteria. For example, a 72-year-old who is otherwise an acceptable volume reduction can- didate would be considered for the procedure, whereas such a patient would likely not be added to a transplant waiting list. The drawback of volume reduction is that it is dependent on strin- gent anatomical and pathological characteristics in the patient’s lungs. Early work has shown that the lack of specifi c target areas and, to a lesser extent, the absence of apical target areas in par- ticular decrease the likelihood of a good result.

Specifi c indications and contraindications for

lung volume reduction surgery are listed in Table 21.1. The refi nements of the selection criteria that resulted from the National Emphysema Treat- ment Trial (NETT)16 have made the overlap in indications for LVRS and transplant even smaller.

Patients deemed at high risk for death after LVRS include those with an FEV1 less than 20% pre- dicted and either homogeneous emphysema or a diffusing capacity of carbon monoxide (DLCO) less than 20% predicted. The specifi c subgroup of FEV1 less than 20% and DLCO less than 20%

with ideal heterogeneity of emphysematous obstruction was not specifi cally addressed by the NETT high-risk paper, but it is likely the risk in not greatly elevated over baseline risk faced by most patients.17

Multiple prospective observational studies as well as several randomized, controlled trials have shown the benefi ts of LVRS, including

SLT

0

Eval 3 mo. 6 mo.

TIME

BLT +

VR 12 mo.

20 40

* 60

FEV1(%) 80

100 FIGURE 21.1. Percentage of predicted forced

expiratory volume in 1s (FEV1) before and after volume reduction (VR), single-lung transplantation (SLT), and bilateral lung transplantation (BLT). At evaluation (Eval): VR vs. SLT, p < 0.05; VR vs. BLT, p < 0.001. At 6 months: VR vs. SLT, p < 0.001; VR vs.

BLT, p < 0.001. (From Gaissert et al.15)

SLT

600

Eval Pre-Op 3 mo. 6 mo.

TIME

BLT VR

12 mo.

*

+

SIX MINUTE WALK DISTANCE (FEET) 2000 1800 1600 1400 1200 1000 800

FIGURE 21.2. Comparison of 6-min walk distance before and after volume reduction (VR), single-lung transplantation (SLT), and bilateral lung transplantation (BLT). At evaluation: VR vs. SLT, not significant; VR vs.

BLT, p < 0.05. At 6 months: VR vs. SLT, not significant;

VR vs. BLT, p < 0.001. (From Gaissert et al.15)

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improvement in functional status and quality of life.18–20 Most studies in the literature report a postoperative mortality of 3% to 8% for LVRS.21 The remarkable fi nding is that these fairly uniform results have been obtained despite the use of a wide array of surgical strategies including bilateral and unilateral approaches, open and thoracoscopic operations, and but- tressed or unbuttressed staple lines. The consis- tent theme among reports of successful lung volume reduction programs has been meticulous patient selection, methodical patient preparation with reduction of risk factors, and attentive post- operative care.

Even prior to the recent release of the NETT results, at least fi ve randomized and controlled trials compared medical treatment to LVRS and showed improvements in physiological and func- tional parameters in the surgically treated arm.

These studies were all designed to evaluate the short-term benefi ts.22–26 The results of the NETT, a multi-institutional randomized trial compar- ing medical treatment to LVRS for select patients with emphysema, were released in 2003.16 Although the trialists had originally planned to enroll 4700 patients, poor recruitment resulted in substantially fewer enrollees (1218 patients).27

Following an interim analysis of results,28 140 patients with high risk of death following surgery were excluded. After excluding this group, the 538 non–high-risk patients that were randomly assigned to surgery were more likely to have improvements in exercise capacity and quality of life compared to the 540 non–high-risk patients randomly assigned to medical therapy. For the entire group there was no reduction in mortality in the surgical group during an average 29 months of follow-up (risk ratio, 0.89; p = 0.31).16 Exercise capacity was improved in the surgically treated group, with an improvement after 24 months in the surgical group of more than 10W in 16% of patients, as compared to 3% of patients in the medically treated group (p < 0.001).

Subgroup analysis of results revealed some interesting fi ndings among distinct cohorts within the trial participants.29 Four subgroups were defi ned according to the presence or absence of upper lobe predominant emphysema and the exercise capacity (low or high) at the time of baseline evaluation. The effect of LVRS surgery

on mortality varied among these four subgroups.

An improvement in survival was seen for LVRS recipients in the subgroup of patients with predominantly upper-lobe emphysema and low baseline exercise tolerance. In this group the risk ratio of death in the LVRS-treated group com- pared to the medically treated group was 0.47 (p

= 0.005), showing a signifi cant survival benefi t of surgery. In the subgroup with non–upper-lobe predominance emphysema and high exercise capacity, the risk of death was signifi cantly higher in the surgical group compared to the medical group (risk ratio 2.06; p = 0.02). In the two remain- ing subgroups, surgery appeared to have little effect on the risk of death [risk ratio of LVRS to medical care in the subgroup with upper-lobe emphysema and high baseline exercise tolerance was 0.98 (p = 0.70), while in the subgroup with non–upper-lobe predominance emphysema and low exercise capacity the risk ratio was 0.81 (p = 0.49)]. All four subgroups experienced improve- ment in exercise capability and self-reported quality of life.

The NETT trial added additional weight to the preponderance of evidence in support of LVRS for properly selected patients. The specifi c inclu- sion and exclusion criteria for the NETT have been adopted in the national coverage decision for LVRS by the Center for Medicare Services.

Therefore, pending any adjustments, the criteria for LVRS are well mapped out and the question remains: what does one offer a patient who appears to be a suitable candidate for both procedures?

21.2. Optimal Surgical Management of End-Stage Emphysema

There are several permutations in which lung transplantation and lung volume reduction can be combined to optimize treatment for patients with emphysema. These combinations have all been tried and have been anecdotally reported for clusters of patients. The combined approaches can be summarized as follows: volume reduction as a bridge to transplant, simultaneous single- lung transplant and unilateral volume reduction to prevent native lung hyperexpansion, early post-transplant unilateral volume reduction to

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treat acute native lung hyperexpansion, and late unilateral volume reduction to treat chronic native lung hyperexpansion. Todd and colleagues reported the Toronto experience30 with simulta- neous unilateral volume reduction to improve overall lung function prospectively after a single- lung transplant. They experienced no postopera- tive problems, and the pulmonary function at 3 months was better than expected based on historical controls receiving a single lung for emphysema. Yonan and colleagues retrospec- tively analyzed 27 patients who received 31 single- lung transplants for emphysema.31 They identifi ed 12 patients who experienced early or late native lung hyperexpansion, and they performed two early lung volume reduction operations to combat this problem. Their analysis included an assess- ment of risk factors, and they concluded that low pretransplant FEV1, high residual volume, and relative pulmonary hypertension were all associ- ated with a higher risk for native lung hyperex- pansion. They did not perform or advocate volume reduction simultaneous with a single- lung transplant for emphysema. The use of LVRS for late native lung hyperexpansion after single- lung transplantation can be described as rare and anecdotal. Kroshus and colleagues reported three patients who were treated with unilateral LVRS for native lung hyperinfl ation and post- transplant dyspnea that was not attributable to infection or rejection. The patients represented a small fraction of the 66 single-lung transplants performed at that center for emphysema. The volume reduction operations were performed 12, 17, and 42 months after the initial lung transplan- tation; and all patients experienced substantial relief of their dyspnea with an improvement in exercise tolerance and in the appearance of the chest radiograph.32 A similar report by Le Pimpec- Barthes and coworkers described successful treatment of symptomatic native lung hyperex- pansion by volume reduction of the native side in the form of a right upper lobectomy.33

The use of volume reduction as a bridge to transplant is the form of combined procedures that has been most frequently attempted. The concept was introduced to the medical literature by Zenati and colleagues in 1995 when they reported two patients who received single-lung

transplants 17 months and 4 months, respec- tively, after laser ablation of emphysematous bullae.34 One group has prospectively performed volume reduction in patients thought to be also eligible for transplantation.35 This center found 31 patients eligible for both procedures; at the same time, they identifi ed 20 patients who were suitable for LVRS alone and 139 who were thought to be transplant candidates only. Twenty-four patients had successful LVRS, and 7 (including 1 death) were considered LVRS failures. Follow-up was too short at the time of the report to know how frequently late transplants would be per- formed and the series has not been followed-up with the long-term results.

Our own results with LVRS in transplant- eligible patients have been reported.36 We retro- spectively identifi ed 99 of 200 patients who underwent bilateral LVRS and who were thought to have been transplant eligible. With a median follow-up of 5.1 years, 32 of the 99 had been listed for transplant, and 15 had undergone transplan- tation without a peri-operative mortality. The only preoperative or operative factor that was predictive for the subsequent need for transplan- tation was a lower-lobe, rather than an upper- lobe, LVRS procedure. The actuarial survival results from the Washington University Lung Volume Reduction Program are shown in Figure 21.3.37 Pulmonary function and the 6-min walk test results before and after lung volume reduc- tion are shown in Table 21.3.37

Others have shown prior LVRS does not pre- clude subsequent successful lung transplanta- tion.38,39 Bilateral LVRS appears to be a more effective bridge.39 Initial LVRS in candidates for LVRS or transplantation should have the goal of providing relief from dyspnea, improved func- tional status, and allow the patients to get into improved physical condition for transplantation.

Lung volume reduction surgery is used to palliate these patients during their long waiting period.

Senbaklavaci and colleagues38 reported their results of 27 patients who underwent LVRS fol- lowed by lung transplantation at their institution.

In the group that had a FEV1 increase greater than 20% after LVRS, they found these patients were brought into a better pretransplant condi- tion that resulted in a decreased mortality at the

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time of lung transplantation. Patients who failed LVRS, however, were poor candidates for lung transplantation as their pretransplant condition was not improved. In a multi-institutional expe- rience of 35 lung transplant patients who had previously undergone LVRS, the median time from LVRS to transplant was 4.1 years (range, 1.1–8.2).40

Many patients have had LVRS as a functional bridge to transplant, but it has occurred not so much as part of an a priori plan to bridge them

as it was additional treatment for crippling dyspnea that was not improved suffi ciently by lung volume reduction. The concept is attractive on the surface: patients obtain volume reduction initially and relieve part of the crunch for avail- able lungs to transplant. The benefi t for the patient successfully volume reduced initially is the possibility that transplant might be avoided altogether by an excellent response to the reduc- tion. A second possibility is that transplant is delayed by several years and the patient is

0 1 2 3

Time (years)

4 5

20 40 60 80

Survival (%)

100

93.6%(n = 235)

89.6%(n = 223)

84.4%(n = 187)

76.4%(n = 141)

67.7%(n = 108) FIGURE 21.3. Kaplan–Meier survival of 250 patients

after bilateral lung volume reduction surgery at Washington University School of Medicine. Data were censored for missing data (1 patient), lung transplantation (18 patients), or end of follow-up.

(From Ciccone et al37).

TABLE 21.3. Pulmonary function and exercise test results before and after surgery.

Evaluation After rehabilitation 6-month PO 1-year 3-year PO 5-year PO

baseline (n = 249) (n = 249) (n = 231) PO (n = 225) (n = 178) (n = 106)

Time from surgery −124 ± 79 −6 ± 5 193 ± 36 401 ± 60 1076 ± 133 1799 ± 217

(days, mean ± SD)

FEV1 Mean ± SD (L) 0.7 ± 0.2 0.7 ± 0.3 1.1 ± 0.5 1.0 ± 0.5 0.9 ± 0.5 0.8 ± 0.5

% predicted 25%* 26% 39%** 38%** 34%** 30%***

RV Mean ± SD (L) 5.9 ± 1.4 5.8 ± 1.3 4.0 ± 1.2 4.1 ± 1.3 4.2 ± 1.3 4.8 ± 1.8

% predicted 282%* 277% 189%** 193%** 198%** 222%**

RV/total lung capacity 72 ± 7* 70 ± 7 −57 ± 9** −58 ± 10** −61 ± 11** −66 ± 11**

(%, mean ± SD)

DLCO Mean ± SD 9.1 ± 3.7 8.9 ± 3.9 10.4 ± 4.6 10.3 ± 4.3 9.2 ± 4.1 8.6 ± 4.2 (mL/[min • mm Hg])

% predicted 34%* 33% 39%* 39%** 36%* 34%*

6-min walk −919 ± 335** 1142 ± 291 1345 ± 316* −1341 ± 310** 1271 ± 305** 348*

(mean ± SD, ft)

Abbreviation: DLCO, diffusine capacity of carbon monoxide; PO, postoperative.

*p ≥ 0.05 for paired analyses with scores after rehabilitation.

**p ≤ 0.001 for paired analyses with scores after rehabilitation.

***p 0.02 for paired analyses with scores after rehabilitation.

Source: Ciccone et al.37

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given a transplant with a later cohort, with the possibility of improved techniques, better immunosuppression, and overall better survival.

Finally, because the falloff in the survival curve is steeper for lung transplant recipients that it is for LVRS recipients, anything that can safely delay entry onto the steeper survival curve is worth pursuing.

The logic of the potential benefi ts of LVRS as a bridge to transplant falls apart when faced with some aspects of reality. First, the anatomical and physiological criteria for volume reduction are much more restrictive than those for transplan- tation, so it is unlikely that a large fraction of transplant candidates could be safely and suc- cessfully treated with volume reduction. Also, the dilemma remains as to how to treat a patient at the upper limit of acceptability with regard to age. It is possible that a patient who is acceptable for both procedures at age 62 might face ineligi- bility for future lung transplantation years later when lung function declines. Results have con- fi rmed this: of the 15 patients in one center who have undergone transplantation after bilateral LVRS, only one was older than 60 years of age at the time of LVRS evaluation. The next oldest was 58, and the mean age for the group was 54 years.36

It is worth noting that some factors in this decision-making process are in fl ux. The system of allocation of graft lungs to potential recipients was formally changed in the United States in May 2005. As a result, priority for donor lungs is based on a score determined by an algorithm that favors patients with high risk of pretransplant death and high likelihood of pretransplant survival.

It is unclear how this will affect emphysema patients, but it is likely to lower the priority of most emphysema patients when compared to patients with other diagnoses leading to trans- plantation. The system is too new to allow meaningful conclusions, but it certainly has the potential to change strategies for the patients who are the subjects of this review.

21.3. Conclusions

There are currently two surgical therapies aimed at crippling, end-stage emphysema: lung trans-

plantation and LVRS. We favor a meticulous selection process in which both options are considered and the best option is selected for each patient. Patients with ideal circumstances for LVRS have hyperinfl ation, heterogeneous dis- tribution of disease, FEV1 20% or greater, and a normal PCO2; they are offered LVRS (level of evi- dence 4; recommendation grade D). In contrast, patients with diffuse disease, low FEV1, hyper- capnia, and associated pulmonary hypertension are directed toward a transplant (level of evi- dence 4; recommendation grade D). Lung volume reduction surgery has not been a satisfactory option for patients with α1-antitrypsin defi ciency, and transplantation must be considered in these cases (level of evidence 4; recommendation grade D). With these considerations, we fi nd that few patients are serious candidates for both proce- dures. The literature supporting decision making in this fi eld is mostly the case-series level of evi- dence (Table 21.4) Lessons from prospective randomized trials are available, but applying them to decision making in treatment allocation requires creativity because they are usually side issues or subset analyses that apply to the patients in question here. Finally, the recent changes in the allocation system for lung transplantation may have an impact on decision making for the patients who are currently viewed as viable can- didates for the two procedures.

Patients with ideal circumstances for LVRS have hyperinfl ation, heterogeneous distribu- tion of disease, FEV1 20% or greater, and a normal PCO2; they should be offered LVRS (level of evidence 4; recommendation grade D).

Patients with diffuse disease, low FEV1, hypercapnia, and associated pulmonary hypertension are directed towards lung trans- plantation (level of evidence 4; recommenda- tion grade D).

Lung reduction volume surgery has not been a satisfactory option for patients with α1-antitrypsin defi ciency, and transplanta- tion should be considered in these cases (level of evidence 4; recommendation grade D).

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References

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5. Deslauriers J. History of surgery for emphysema.

Semin Thorac Cardiovasc Surg 1996;8:43–51.

6. Mal H, Andreasian B, Pamela F. Unilateral lung transplantation in end stage pulmonary emphy- sema. Am Rev Respir Dis 1989;140:797–802.

7. Patterson GA, Cooper JD, Goldman B, et al. Tech- nique of successful clinical double-lung trans- plantation. Ann Thorac Surg 1988;45:626–633.

8. Pasque MK, Cooper JD, Kaiser LR, Haydock DA, Triantafi llou A, Trulock EP. An improved tech- nique for bilateral lung transplantation: rationale and initial clinical experience. Ann Thorac Surg 1990;49:785–791.

9. Trulock EP, Edwards LB, Taylor DO, Boucek MM, Keck BM, Hertz MI. The Registry of the Interna- tional Society for Heart and Lung Transplanta- tion: twenty-second offi cial adult lung and TABLE 21.4. Evidence table for the decision of lung volume reduction surgery versus lung transplantation for severe emphysema.

Patient subset LVRS considered? Lung transplant considered? Evidence level FEV1 greater than 40% No, disease not severe enough No, disease not severe enough Opinion favors no surgical therapy

Evidence level: 4 Recommendation

grade: D

FEV1 25%–40% Yes, depending on symptoms No, disease not severe enough Opinion favors LVRS as initial approach

predicted Evidence level: 3 Recommendation

grade: D

FEV1 20%–25% Yes, depending on anatomy Yes, depending on anatomy and Opinion favors LVRS as initial approach and symptoms. symptoms. Youth, fewer Evidence level: 3 Recommendation Increasing age, additional comorbidities, homogeneous grade: D

comorbidities, emphysema and history of

heterogeneous target pleural space surgery would

areas all favor LVRS favor transplant

FEV1 less than 20%, Yes. Increasing age, additional Yes. Youth, fewer comorbidities, Opinion favors LVRS as initial approach upper lobe comorbidities, homogeneous emphysema Evidence level: 4 Recommendation predominant, DLCO heterogeneous target and history of pleural grade: D

greater than 20% areas all favor LVRS space surgery would favor

predicted transplant

FEV1 less than 20%, No, considered too high risk Yes, if free from contraindications RCT suggests high risk for LVRS in

and either DLCO this subset

less than 20% or Evidence level: 2+ Recommendation

homogeneous grade: C

emphysema

FEV1 20%–25%, Yes, but these factors increase Yes Opinion favors lung transplant as α1-antitrypsin risk and decrease long-term initial approach when pulmonary

deficiency, benefit comorbidities are high

hypercapnea, or Evidence level: 4 Recommendation

pulmonary grade: D

hypertension

FEV1 20%–40%, High No, increased risk of death No, exercise capacity suggests RCT suggests no LVRS in this group;

exercise capacity, versus medical therapy insufficient impairment to opinion suggest no transplant

non-upper-lobe alone justify transplant Evidence level: 2+ Recommendation

predominant grade: C

emphysema

Abbreviations: DLCO, diffusine capacity of carbon monoxide; FEV1, forced expiratory volume in 1s; LVRS, lung volume reducing surgery; RCT, random- ized, controlled trial.

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heart-lung transplant report – 2005. J Heart Lung Transplant 2005;24:956–967.

10. Trulock EP. Lung transplantation. Am J Respir Crit Care Med 1997;155:789–818.

11. Low DE, Trulock EP, Kaiser LR, et al. Morbidity, mortality, and early results of single versus bilat- eral lung transplantation for emphysema. J Thorac Cardiovasc Surg 1992;103:1119–1126.

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