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J Thorac Cardiovasc Surg 2009;137:1415-1421
© 2009 The American Association for Thoracic Surgery

General Thoracic Surgery

Safety and efficacy of video-assisted versus conventional lung resection for lung cancer

^a Surgical Outcomes Research Center, Department of Surgery, University of Washington, Seattle, Wash
^b Division of Cardiothoracic Surgery, Department of Surgery, University of Washington, Seattle, Wash
^c Department of Biostatistics, University of Washington, Seattle, Wash
^d Division of General Surgery, Department of Surgery, University of Washington, Seattle, Wash

Received for publication May 19, 2008; revisions received September 28, 2008; accepted for publication November 22, 2008.

^_* Address for reprints: David R. Flum, MD, MPH, Department of Surgery, University of Washington, 1959 NE Pacific, Box 356410, Seattle, WA 98195-6310. (Email: daveflum{at}u.washington.edu).

	Abstract

Top Abstract Introduction Materials and Methods Results Discussion Appendix 1 References

 
Objective: We sought to evaluate the use of video-assisted thoracoscopy among patients with lung cancer and its safety and effectiveness relative to conventional resection.

Methods: A cohort study (1994–2002) was conducted by using the Surveillance, Epidemiology, and End-Results Medicare database. Video-assisted thoracoscopy and conventional resection were hypothesized to be equivalent in terms of risks of death. Equivalency was defined by a confidence interval of 0.72 to 1.28 for the odds of 30-day death and 0.89 to 1.11 for the hazard of death, corresponding to a difference of no more than 1% for 30-day mortality and 5% for 5-year survival, respectively.

Results: Among 12,958 patients who underwent segmentectomy or lobectomy (mean age, 74 ± 5 years), 6% underwent video-assisted thoracoscopy. The use of video-assisted thoracoscopy increased from 1% to 9% between 1994 and 2002. Compared with those who underwent conventional resection, patients who underwent video-assisted thoracoscopy more frequently had smaller tumors (P < .001) and stage I disease (P = .03), underwent lymphadenectomy (P < .001), and were cared for by higher-volume surgeons (P < .001) and at higher-volume hospitals (P < .001). After adjusting for differences in patient, cancer, management, and provider characteristics, the odds of early death were not significantly different between patients undergoing video-assisted thoracoscopy and those undergoing conventional resection, although equivalency was not demonstrated (adjusted odds ratio, 0.93; 95% confidence interval, 0.57–1.50). The hazard of death was equivalent for video-assisted thoracoscopy and conventional resection (adjusted hazard ratio, 0.99; 95% confidence interval, 0.90–1.08).

Conclusions: Video-assisted thoracoscopy was uncommonly used to manage lung cancer, although its use has increased over time. Video-assisted thoracoscopy and conventional resection were equivalent in terms of long-term survival.

	Introduction

Top Abstract Introduction Materials and Methods Results Discussion Appendix 1 References

 
Although an increasing body of evidence supports the use of video-assisted thoracoscopy (VATS) in lung cancer management,^1-16 it is unclear how widely it is being used. Additionally, it is unknown whether the safety and effectiveness of this relatively new procedure is equivalent to that of open thoracotomy.

New technology and therapeutic interventions can offer advantages over standard treatment without compromising well-established safety and efficacy benchmarks, but determining whether 2 competing therapies are equivalent is methodologically challenging. Standard hypothesis testing cannot prove equivalence, even when the outcomes of 2 treatments are not significantly different. A well-accepted method of evaluating equivalency is a noninferiority randomized trial: a study designed to rule out the possibility of prespecified, clinically important differences in outcomes between treatment groups.¹⁷ Because the feasibility of a randomized trial of VATS versus conventional resection has been questioned, a noninferiority-based analysis of observational data might be informative.

Using a nationally representative tumor registry linked to Medicare claims and a noninferiority-based analytic framework, we described the use and associated outcomes of VATS among patients with lung cancer who underwent segmentectomy or lobectomy. We hypothesized that the safety (30-day case fatality) and effectiveness (long-term survival) of VATS and conventional resection would be equivalent. Clinically important differences of 1% for 30-day case fatality and 5% for 5-year survival were specified a priori.

	Materials and Methods

Top Abstract Introduction Materials and Methods Results Discussion Appendix 1 References

 
The Surveillance, Epidemiology, and End-Results (SEER) Medicare database was used to perform a retrospective cohort study of patients given diagnoses of lung cancer from 1994 through 2002. SEER captures approximately 14% of incident malignancies in the United States. Tumor registry data have been linked to claims data among SEER patients who were Medicare beneficiaries. The utility, quality, and validity of the SEER-Medicare database have been described previously.¹⁸ The University of Washington Institutional Review Board approved this study and waived consent.

Among 191,024 patients given diagnoses of lung cancer from 1994 through 2002, the following sequential exclusions were made: patients given diagnoses at autopsy/death (n = 4379), patients who did not undergo segmentectomy or lobectomy (n = 170,258), patients less than 66 years old (n = 1370), diagnosis of a second malignancy between 3 months before and 6 months after lung cancer diagnosis (n = 812), and patients with only part A or part B, concurrent health maintenance organization enrollment, or both between 1 year before and 6 months after lung cancer diagnosis (n = 1247). These exclusions were made to ensure the accuracy and completeness of claims data when used for the purposes of research, and the specific reasons for the exclusions have been described previously.¹⁹

Outcomes included long-term survival, death within 30 days of the operation, length of stay (LOS), and Medicare expenditures. Death data were available through the Medicare Enrollment Database with follow-up through 2005. LOS and Medicare expenditure information were available from the Medicare Provider Analysis and Review file. Costs were defined by the actual dollar amount paid by Medicare to the hospital (expenditures) rather than hospital charges and adjusted for inflation by using the Consumer Price Index for Medical Care.

Patient and disease characteristics were available through the SEER registry, and management and provider information was available through Medicare claims. Indicators of low income or education were based on the lowest quartiles of median income and proportion with a high-school education within a given zip code. Geography was defined by the SEER registry where the patient was diagnosed. Residence refers to the population size of the area where the patient lived. Claims within the carrier and outpatient files in the year before diagnosis were used to ascertain the Klabunde-modified Charlson Comorbidity Index.²⁰ Tumor size, stage (American Joint Committee on Cancer, sixth edition), and histology were based on all available information within 4 months of diagnosis. The use of mediastinal staging modalities was ascertained by using claims defined by the Healthcare Common Procedure Coding System (HCPCS) and present within the carrier claims files, outpatient files, or both. Resection type, radiation therapy, and chemotherapy were defined by using the carrier claim files with relevant HCPCS; by using the outpatient files with relevant HCPCS codes, International Classification of Diseases (Ninth Revision) procedure codes, and Revenue Center Codes (Appendix 1); or both. Hospital teaching status was determined by linkage to Medicare hospital files. Volume measurements reflected average yearly provider volume among SEER-Medicare patients but not total provider volume.²¹ A dichotomous variable was created to indicate higher-volume providers based on those within the highest quartile of volume.

STATA (Special Edition 9.2; StataCorp, College Station, Tex) was used for all statistical analyses. Continuous and categorical variables were compared by using a t test for independent samples and the ² test, respectively. The Kaplan–Meier method was used to obtain unadjusted survival estimates. A priori designated potential confounders included patient (age, sex, race, and comorbidity index), cancer (stage, histology, and tumor size), management (mediastinoscopy, mediastinal lymphadenectomy, and neoadjuvant therapy), and provider (surgeon volume and hospital volume and teaching status) characteristics. The analytic strategy was to sequentially add groups of variables to regression models to better understand how these variables might confound unadjusted comparisons. Cox proportional-hazards models were used to evaluate the relationship between approach to resection and overall survival while providing adjustment for potential confounders. Survival time was defined as the interval between the date of diagnosis and the date of death or censoring. The proportional-hazards assumption was tested by using Schoenfeld residuals. In the event the assumption was not satisfied, extended (stratified) Cox regression models were used. Logistic regression models were used to examine the relationship between approach to resection and 30-day mortality while providing adjustment for potential confounders. Linear regression was used to evaluate the relationship between approach to resection and LOS and expenditures while providing adjustment for potential confounders. Because the distributions of LOS and expenditures were not normal, both variables were log transformed, and geometric means were reported. All multivariable regression models adjusted for clustering at the hospital level.

Confidence interval (CI) inspection was used to conduct a noninferiority-based analysis. Because regression models estimate relative risk, prespecified noninferiority risk differences were expressed in terms of relative risk by using the conventional resection group's outcomes as baseline. CIs defining equivalence were 0.72 to 1.28 for the odds of early death and 0.89 to 1.11 for the hazard of death, corresponding to a difference of no greater than 1% for 30-day mortality and 5% for 5-year survival, respectively. Derived CIs falling within these ranges indicated equivalence. If the upper bounds of the derived CIs exceeded the upper bounds of the predetermined equivalency intervals, then inferiority could not be excluded. Similarly, if the lower bounds of derived CIs exceeded the lower bounds of prespecified equivalency intervals, then superiority could not be excluded.

	Results

Top Abstract Introduction Materials and Methods Results Discussion Appendix 1 References

 
Between 1994 and 2002, 12,958 patients with lung cancer underwent segmentectomy or lobectomy performed by 1600 surgeons at 781 hospitals. Six percent of patients underwent VATS resection by 7% of surgeons and at 13% of hospitals. The frequency of VATS use increased over time among patients, surgeons, and hospitals (Figure 1 ).

View larger version (10K): [in this window] [in a new window]   Figure 1. Temporal trends in the use of video-assisted thoracoscopy (VATS) among patients, surgeons, and hospitals.

In the unadjusted analysis VATS was associated with significantly higher 5-year overall survival rates compared with those after conventional resection (48% vs 44%, P = .02), although 30-day mortality rates were not significantly different (3.2% vs 3.6%, P = .53). VATS was associated with shorter LOS (4 vs 8 days, P < .001) but higher Medicare expenditures ($20,519 vs $19,786, P = .008).

After adjustment, the odds of 30-day death were not significantly different when comparing VATS with open resection, although equivalency was not established based on noninferiority criteria (Table 3 ). In models evaluating survival, the hazards of death for VATS and open resection were equivalent in the fully adjusted model. In an exploratory analysis VATS and open resection were also equivalent in terms of the hazards of lung cancer cause-specific death (adjusted hazard ratio, 0.99; 95% CI, 0.88–1.11; noninferiority bounds, 0.86–1.14). VATS was associated with a significantly shorter LOS compared with conventional resection (adjusted risk difference, –5 days; 95% CI, –7 to –2 days), although Medicare expenditures were not significantly different (adjusted risk difference, $290; 95% CI, –$1603 to $2182). Adjustment for all measured variables (eg, income and education) had no substantial bearing on any of the findings from the primary analyses. Sensitivity analyses with 3 different methods of propensity scoring (ie, adjustment matching, stratification, and regression) yielded results that were largely similar to those of our primary analysis.

	Discussion

Top Abstract Introduction Materials and Methods Results Discussion Appendix 1 References

Several reasons might explain the infrequent use of VATS for lung cancer management. Surgeons might be uncomfortable performing VATS because of insufficient training or experience with this minimally invasive procedure. Some surgeons might believe that there is an insufficient level of evidence to confirm the safety and efficacy of VATS compared with standard resection and might be skeptical about its purported benefits. In the setting of malignancy in particular, surgeons might demand higher levels of evidence than they might for benign conditions. This notion might explain the relatively slow adoption of a laparoscopic approach to colon cancer resection,²² despite rapid adoption of laparoscopy for conditions such as symptomatic cholelithiasis, obesity, and gastroesophageal reflux.^23-25 The lack of operating room resources or staff might also be a barrier to the use of VATS.

Several lines of evidence support the notion that VATS is at least as safe as conventional resection. By avoiding rib spreading, muscle splitting, and the use of a retractor, VATS is believed to result in less pain, earlier ambulation, fewer postoperative complications, and possibly fewer early deaths. Consistent with this claim, several reports show lower rates of postoperative complications associated with VATS when compared with conventional resection.^1,6,16 Equivalent risks of early death were not demonstrated in this study for several possible reasons. First, most investigations, including this one, were probably underpowered to exclude the possibility of small prespecified differences in rare events, such as death.²⁶ Alternatively, large variability in risks of early death might reflect actual variability in outcomes rather than statistical noise. If true, this explanation would suggest that the quality of a VATS procedure is unnecessarily variable, perhaps by provider. This possibility could not be further explored because there were too few events among the relatively few patients who underwent VATS by a low-volume surgeon or at a low-volume hospital.

VATS and conventional resection were equivalent in terms of long-term survival, but 2 caveats are worthy of mention. A key concern regarding the use of VATS is that enthusiasm over minimally invasive surgery and its purported benefits might come at the expense of oncologic principles of pulmonary resection: dissecting and ligating individual bronchovascular structures, obtaining negative margins, and performing adequate intraoperative staging of mediastinal lymph nodes. Although it has been demonstrated that an oncologic resection is possible with VATS,^9,14,22,27 there remains concern that not all surgeons who perform VATS adhere to these principles. Although this dataset did not provide an opportunity to evaluate the appropriateness of a VATS operation, it did allow for indirect examination of clinically important departures from standard oncologic principles measured in terms of patient survival. Even though the overall analysis supported the equivalence of a VATS approach, stratified analyses suggested higher risks of death associated with VATS when performed by low-volume surgeons. Although volume might have been a requisite for achieving equivalent outcomes with VATS, a more likely explanation is that it was a surrogate for appropriately performed VATS resections. The findings from this study are consistent with the notion that VATS was at least as good as conventional resection but only to the extent that VATS was performed according to appropriate oncologic principles. A second caveat is that this study was not a randomized noninferiority trial and is therefore subject to the usual limitations of an observational study, including unmeasured confounding (patient selection factors known or suspected to affect outcomes and possibly result in bias).

Findings from this investigation are consistent with prior descriptions of an association between VATS and shorter LOS^1,3 but challenge the notion that shorter LOS results in cost savings. Shorter LOS is plausibly explained by less pain, earlier ambulation, and fewer complications after a VATS resection,^1,6,16 and if true, these benefits would reasonably be expected to translate into cost savings. One explanation for why there were no observed cost savings associated with VATS is that Medicare expenditures were likely related to an episode of care (ie, hospitalization for lung cancer resection) rather than specific attributes of that care, such as type of operation performed, LOS, or frequency of adverse events. Had expenditures for subsequent care (beyond the index hospitalization) been evaluated and adverse event rates truly been lower for VATS, then cost savings might have been observed. Also, although it appears that shorter LOS might not have resulted in cost savings for Medicare, it is likely that hospitals profited from patients who spent less time in the hospital. VATS might have been associated with shorter LOS because surgeons who commonly perform VATS might also frequently use clinical pathways and algorithms expediting postoperative care.²⁸ It would be important to know how much of the association between VATS and shorter LOS is explained by the use of such pathways because these algorithms might also be applicable to patients who undergo open resection. Unfortunately, the limitations of the dataset precluded a more detailed health economic analysis.

This study had a number of limitations. Because Medicare claims were created for administrative rather than research purposes, we were unable to measure important clinical variables, such as lung function, performance status, and severity of underlying comorbidities. This might have resulted in inadequate risk adjustment and possibly biased our noninferiority-based analyses. Although clinical databases, such as the one maintained by the Society of Thoracic Surgeons, likely allow for better risk adjustment, the SEER-Medicare database more likely provides a nationally representative description of patterns of care and associated outcomes, at least at this time. Yet even the SEER-Medicare database might be somewhat limited in its generalizability if patterns of care and outcomes are different for patients 65 years and younger or those enrolled in health maintenance organizations or other health plans. However, because the median age of lung cancer is 70 years²⁹ and Medicare provides health care coverage for 97% of elderly Americans, SEER-Medicare data might very well be generalizable. Finally, missing data varied by approach to resection (17% for standard resection and 13% for VATS) and might have biased our results. Because patients with missing covariate data had lower survival rates (40% vs 45%, P < .001) and were excluded from the analysis, outcomes associated with the standard resection group might have been too optimistic in the case-complete analysis. Any such bias might have resulted in VATS appearing equivalent to conventional resection when in truth VATS might have been associated with better outcomes.

The findings from this study have several implications for clinical practice, surgical education, policy, and future research. In counseling patients on the risks and benefits of pulmonary resection, results from this study can be cited as additional evidence, limitations notwithstanding, supporting the equivalency of VATS and standard resection in terms of effectiveness. Because there might be variability in VATS outcomes across surgeons and hospitals, greater efforts should be taken to mandate standardized VATS training within cardiothoracic training programs. Additionally, hospitals and organizations might choose to require credentialing of surgeons in the appropriate use of VATS. Given the limitations of this and other studies, future investigations would ideally confirm the equivalence of VATS and standard resection in a randomized noninferiority trial. The feasibility of such a trial has been questioned on the basis of sample size and lack of clinical equipoise among individual surgeons.²⁷ Demonstrating noninferiority in terms of safety will not likely be feasible because it would require 13,888 patients to demonstrate a 1% difference in 30-day mortality rates. In contrast, 2982 patients would be needed to demonstrate a 5% difference in overall survival rates. Given the high incidence of lung cancer, a multicenter approach might be a realistic option if equipoise were to exist. The feasibility of conducting multicenter noninferiority trials in surgical oncology has been demonstrated previously in the setting of operable colon cancer.³⁰ In the interim, prospective observational studies should aim to re-evaluate the noninferiority of VATS by using clinical data for risk adjustment and quantify its purported benefits by using validated metrics for quality of life and functional status.

	Appendix 1

Top Abstract Introduction Materials and Methods Results Discussion Appendix 1 References

 

Billing codes used to define staging and therapy

Resection  HCPCS 32480 32484 32663 Chemotherapy  HCPCS 95549 96400 96404 96406 96410 96412 96414 96420 96420 96422 96423 96425 96440 96445 96450 96542 96545 C9017 J0182 J8510 J8530 J8560 J8610 J899 J9000 J9001 J9010 J9045 J9060 J9062 J9070 J9080 J9090 J9091 J9092 J9093 J9094 J9095 J9096 J9097 J9170 J9180 J9181 J9182 J9190 J9201 J9206 J9208 J9230 J9250 J9260 J9265 J9280 J9290 J9291 J9350 J9360 J9370 J9375 J9380 J9390 J9999 Q0083 Q0084 Q0085 Q0125 Q0127 Q0128 Q0129 S0178 S0182 S9329 S9330 S9331  ICD-9 V58.1 V66.2 V67.2 99.25  RCC 0331 0332 0335 Radiation therapy  HCPCS 31643 77300 77301 77305 77310 77315 77321 77326 77327 77328 77331 77332 77333 77334 77336 77370 77380 77381 77399 77401 77402 77403 77404 77406 77407 77408 77409 77411 77412 77413 77414 77416 77417 77418 77419 77420 77425 77427 77430 77431 77432 77470 77499 77520 77522 77523 77525 77750 77761 77762 77763 77781 77782 77783 77784 77799 C1716 C1717 C1718 C1719 C1720 C1790 C1791 C1792 C1793 C1794 C1795 C1796 C1797 C1798 C1799 C1800 C1801 C1802 C1803 C1804 C1805 C1806 C2616 G0126 G0173  ICD-9 V58.0 V66.1 V67.1 92.20 92.21 92.22 92.23 92.24 92.26 92.27 9.28 92.29 92.30 92.31 92.32 92.33 92.39 PET  HCPCS G0125 G0126 G0210 G0211 G212 G0234 78810 Mediastinoscopy  HCPCS 39400 Mediastinal lymphadenectomy  HCPCS 38746

HCPCS, Healthcare Common Procedure Coding System; ICD-9, International Classification of Diseases, Ninth Revision; RCC, Revenue Center Codes; PET, positron emission tomography.

	Acknowledgments

 
This study used the linked SEER-Medicare database. The interpretation and reporting of these data are the sole responsibility of the authors. The authors acknowledge the efforts of the Applied Research Program, National Cancer Institute; the Office of Research, Development and Information, Centers for Medicare and Medicaid Services; Information Management Services, Inc; and the SEER Program tumor registries in the creation of the SEER-Medicare database. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health. The authors are also grateful for additional resources made available through the University of Washington's Department of Surgery and the Surgical Outcomes Research Center, and the generosity of the Schilling Family.

	Footnotes

 
Dr Farjah was supported by a Cancer Epidemiology and Biostatistics Training Grant (T32 CA09168-30) and Ruth L. Kirschstein National Research Service Award (F32 CA130434-01) from the National Cancer Institute.

	References

Top Abstract Introduction Materials and Methods Results Discussion Appendix 1 References

 

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