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a The Texas Heart Institute at St. Luke's Episcopal Hospital, Houston, Texas
b Baylor College of Medicine, Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas
c University of Houston, Houston, Texas
d University of Texas M.D. Anderson Cancer Center, Houston, Texas
Accepted for publication February 12, 2010.
* Address correspondence to Dr Chu, Department of Surgery, Division of Cardiothoracic Surgery, Baylor College of Medicine, Michael E. DeBakey Veterans Affairs Medical Center, 2002 Holcombe Blvd, OCL 112, Houston, TX 77030 (Email: dchumd{at}gmail.com).
Presented at the Fifty-sixth Annual Meeting of the Southern Thoracic Surgical Association, Marco Island, FL, Nov 4–7, 2009.
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Abstract |
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Methods: Using the 2004 and 2006 Nationwide Inpatient Sample database, we identified 13,619 discharge records of patients who underwent pulmonary lobectomy by means of thoracotomy (n = 12,860) or VATS (n = 759). Student's t and 
2 tests were used to compare the two groups. Multivariable analysis was used to identify independent predictors of outcome measures.
Results: The two groups of patients had similar demographics and preoperative comorbidities. They also had similar in-hospital mortality rates (3.1% versus 3.4%; p = 0.67); lengths of stay (9.3 ± 0.1 versus 9.2 ± 0.4 days; p = 0.84); hospitalization costs ($23,862 ± $206 versus $25,125 ± $1,093; p = 0.16); and rates of wound infection (0.8% versus 1.3%; p = 0.15), pulmonary complications (32.2% versus 31.2%; p = 0.55), and cardiovascular complications (3.4% versus 3.9%; p = 0.43). However, multivariable analysis showed that the VATS group had a significantly higher incidence of intraoperative complications than the thoracotomy group (odds ratio, 1.6; 95% confidence interval, 1.0 to 2.4; p = 0.04). A higher percentage of patients with annual income greater than $59,000 underwent VATS lobectomy than patients with income less than $59,000 (35.7% versus 25.4%; p < 0.0001).
Conclusions: Patients who underwent VATS lobectomy were 1.6 times more likely to have intraoperative complications than patients who underwent open lobectomy. However, short-term mortality, lengths of stay, and hospitalization costs were similar between the two groups of patients. There seems to be a socioeconomic disparity between VATS and open thoracotomy patients.
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Introduction |
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Soon after Mühe's success, thoracic surgeons adapted video-assisted thoracoscopic surgery (VATS) for minimally invasive pleural biopsy, wedge resection, blebectomy, and lung biopsy [2–4]. However, the use of VATS for anatomic lung resection was initially controversial from an oncologic standpoint, and the practicality of VATS lobectomy was not established until Swanson and colleagues [5, 6] demonstrated that the procedure could be performed without the need for any rib spreading.
Since that time, an increasing number of surgeons have learned to perform VATS lobectomy. However, the learning curve is steep, particularly because haptics are lost, attenuating the surgeon's ability to manually palpate the rest of the lung tissue for additional lesions. In addition, the increased use of specialized thoracoscopic instruments has raised the question of high overhead costs in performing these procedures. It has been shown that VATS may be cheaper to perform overall than open procedures, even though the operative equipment costs and operating room time may be higher [7]. Although operating room expenses are higher for a VATS lobectomy than for a conventional thoracotomy, these costs have been shown to be counterbalanced by the significantly shorter hospital stay and consequent cost savings thereof [8].
The use of VATS lobectomy as the procedure of choice for anatomic lung resection is controversial; it is gaining popularity, but it is limited by technical and potential cost factors and by uncertainty about its ability to completely clear tumor load in patients with primary malignancy. Additionally, most published studies of VATS have examined data from single institutions, mostly academic centers of excellence [9–11], which limits the extent to which the results can be generalized to the overall VATS lobectomy population. The goal of our study was to use a nationwide database that includes both community and academic centers to provide a real-world outcome analysis of VATS versus open lobectomy. We used a nonvoluntary national database that includes all nonfederal hospitals in the United States to evaluate and compare the outcomes of patients who underwent anatomic pulmonary lobar resection by means of standard open thoracotomy or VATS.
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Material and Methods |
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Five hospital sampling strata were defined according to hospital characteristics recorded in the American Hospital Association Annual Survey of Hospitals. The stratification variables were geographic region, location (urban or rural), teaching status, control (public or proprietary), and bed size. Variables available in the NIS database include patient and hospital demographics, payer information, treating and concomitant diagnoses (comorbidities and complications), inpatient procedures, in-hospital mortality, length of hospital stay (date of admission to date of discharge), overall hospitalization charges, cost-to-charge ratios, and discharge status.
This study was approved by the Institutional Review Board of Baylor College of Medicine and Michael E. DeBakey Veterans Affairs Medical Center. The reported data conform to the data-use agreement for the NIS from the Healthcare Cost and Utilization Project. Additional information about the NIS is available from the Agency for Healthcare Research and Quality, which administers the database as part of the Healthcare Cost and Utilization Project (http://www.hcup-us.ahrq.gov/nisoverview.jsp).
Patient Selection
Patient identification was based on the 2003 and 2005 International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis and procedure codes [13]. We used these codes to query the 2004 and 2006 NIS database for our patient selection. The ICD-9-CM procedure code 324 was used to identify all patients who underwent pulmonary lobectomy. We excluded patients who underwent redo thoracotomy, indicated by ICD-9-CM procedure code 3403. We also excluded patients who underwent both VATS and open thoracotomy during the same procedure.
Using the 2004 and 2006 NIS data sets, we found 13,619 discharge records of patients who underwent primary pulmonary lobectomy. Of these records, 759 were identified by the presence of ICD-9-CM procedure code 3421 as the records of patients who underwent VATS lobectomy. The other 12,860 records, which lacked procedure code 3421, were identified as the records of patients who underwent open thoracotomy lobectomy.
Patient Characteristics
The Deyo Index was used to compare the two groups in terms of preoperative morbidity [14]. Deyo Index scores were determined by weighted scoring of comorbidities and risk factors for perioperative complications, including cardiac, vascular, pulmonary, neurologic, endocrine, renal, hepatic, gastrointestinal, and immune diseases, and any documented history of cancer. The Deyo index—a weighted comorbidity index modified from the Charlson Comorbidity Index—consists of 17 prespecified comorbidities and is specifically designed to be used with administrative databases, using more than 600 ICD-9-CM diagnosis codes to query specific comorbid diagnoses [14]. Patient comorbidities were identified from each patient's ICD-9-CM diagnosis codes, of which 15 were recorded per patient in the NIS database. These codes were then used to produce a summary Deyo Index score for each patient.
Study End Points
The primary end point of this study was in-hospital mortality. The secondary end points included length of hospital stay, rates of routine discharge, overall hospitalization costs, and in-hospital complication rates.
All-cause in-hospital complications were recorded according to their ICD-9-CM diagnosis codes. Complications were classified into eight categories [15]: wound complications, infections, cardiovascular complications, intraoperative complications, systemic complications, gastrointestinal complications, urinary complications, and pulmonary complications (Appendix).
Statistical Analysis
Statistical analysis was performed with SPSS version 16.0 (SPSS, Inc, Chicago, IL). Because the dataset contains a large number of both records and variables, the SPSS 16.0 complex module was used for all statistical analyses. Discharge weights were used to produce national estimates for all analyses. Student's t tests and 2 statistics were computed to examine intergroup differences in age, hospital length of stay, hospitalization cost, race, patient income, expected payer, mortality, disposition, and Deyo Index score. After univariate analysis, multivariable analysis with hierarchical multiple regression and logistic regression methods was performed. Hierarchic logistic regression analysis was used to examine the risk-adjusted association between type of procedure and mortality, disposition of patients, and in-hospital complications.
Three different effect size statistics were computed for this study to assess the practical implications of our large sample size. Cohen's d was calculated for continuous data by using pooled standard deviations and was appropriately weighted for unequal sample size [16]. The phi coefficient was computed for 2 tests for independence with 1 degree of freedom. Cramer's V was computed for variables with more than 1 degree of freedom [16, 17]. We used the following categories to judge the computed effect sizes: less than 0.32 (small), 0.33 to 0.55 (medium), and greater than 0.56 (large).
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Results |
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Comment |
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A significant amount of VATS data is published by authors at high-volume academic centers, which have not only established the feasibility of VATS lobectomy but also, in some cases, its superiority over the open thoracotomy approach [21]. The advantage of the high-volume center is clearly reflected by the fact that a skilled perioperative support team and operating room staff are routinely involved in the intraoperative and postoperative care of these patients. In contrast, some community hospitals do not have a team that is dedicated to performing VATS lobectomy on a routine basis.
Data from the Society of Thoracic Surgeons (STS) database suggest that approximately 20% of lobectomies performed in the United States have been done by the VATS approach [22]; in contrast, in our NIS data, the VATS approach was used in less than 6% of lobectomy procedures (759 of 13,619). The higher proportion of VATS cases in the STS data may reflect the selective and voluntary participation in the STS database by predominantly academic institutions, because certain high-volume academic centers report that approximately 80% of their lobectomies are performed by the VATS approach. This overrepresentation by academic centers of excellence in VATS lobectomy could significantly skew the STS data, making the outcomes of VATS lobectomy appear more favorable than those of open lobectomy [10]. Despite several isolated academic groups reporting excellent results with this approach, the reality remains that the procedure has not gained widespread acceptance, as evident in our study using a nonvoluntary national database. Although we have theorized that these reasons could include a steep learning curve, lack of support staff, high overhead equipment costs, concerns about lymphatic clearance, and loss of haptics, the most significant factor is probably the higher incidence of intraoperative complications. For the majority of surgeons who are still in the steep learning curve across the country, an intraoperative complication during the learning phase of the procedure is likely to have a significant impact on the surgeon's comfort level in performing the same procedure again. Moreover, some surgeons in private practice may be more hesitant to use the VATS approach for lobectomy because of the potential for longer operative times [9]. This may explain why the NIS data still show such a low frequency of use of the VATS approach instead of the standard open thoracotomy approach.
We found that the overall rate of postoperative complications and length of hospital stay were unaffected by surgical approach. In contrast, many published single-institution studies have associated VATS with a shorter length of stay [9–11]. For patients who undergo more routine minimally invasive procedures, such as laparoscopic cholecystectomy, the perioperative support systems (nursing staff, physician assistants, specialized instruments, and operating room staff) seem to be fairly streamlined in community hospitals. However, we suspect that these support systems may be of limited utility to patients who undergo VATS lobectomy. This is partly because this procedure is performed infrequently in community settings; rather, a significant percentage of cases are performed in a few renowned academic institutions. Therefore, the support staff and consultant referring physician in community hospitals may be resistant to the idea of early discharge for VATS patients when complications arise. This resistance may potentially offset the benefit of shorter hospital stay that one might otherwise observe in a streamlined, high-volume academic center.
The higher incidence of intraoperative complications with the VATS lobectomy approach is of concern. The intraoperative complications in our study were defined by ICD-9-CM diagnosis codes, which include accidental puncture or laceration that complicates surgery, foreign body accidentally left during procedure, and bleeding that complicates the procedure (Appendix). Complications could result from loss of haptics, the difficulty of manipulating instruments in the closed, rigid thoracic cavity, the steep learning curve associated with the procedure, and operator inexperience. The higher incidence of intraoperative complications alone may be sufficient to offset the presumed advantages of the VATS approach.
Although a disparity exists among socioeconomic groups in terms of the frequency with which VATS is used for lobectomy, this is probably because patients in the higher socioeconomic groups are likely to be well-informed in general and are more likely to actively inquire about and seek a less invasive approach if they have the opportunity. It has been shown that racial and socioeconomic differences exist in the use of other minimally invasive procedures, such as laparoscopic appendectomy, gastric fundoplication, and gastric bypass [23]. Patients belonging to higher socioeconomic groups tend to favor approaches with a perceived minimal detriment to overall well-being. When given a choice between open and minimally invasive approaches, it is likely that patients of higher socioeconomic status will select the less invasive approach because of its perceived—but not yet proven—general health benefits, because it involves smaller incisions, and because it enables the patient to return to work earlier. Similar decision-making may not necessarily be observed in patients of lower socioeconomic status, because these patients may be preoccupied with making ends meet. In addition, patients with higher socioeconomic status are probably able to spend more time undergoing routine screening procedures and may have more frequent access to health care, making it more likely that their cancer is diagnosed in its early stages, so that VATS is a feasible option. Patients of lower socioeconomic status probably present for evaluation in more advanced disease stages that preclude minimally invasive surgery. Furthermore, socioeconomic status may dictate the type of hospital facility at which a patient is evaluated. Patients of lower socioeconomic status are probably more likely to be evaluated in a county hospital, where having VATS capability would consume a larger part of the hospital budget and may therefore not be practical. Lack of uniform availability of advanced minimally invasive procedures and lack of health-care access could therefore be significant contributors to the socioeconomic disparity shown in our analyses.
Our study is subject to the limitations inherent in a retrospective review. For example, there may have been selection bias in terms of whether VATS or open thoracotomy was chosen for a given patient. Despite this possible bias, the two groups of patients did not differ significantly on most preoperative demographic variables and baseline comorbidities. Furthermore, we were able to control for confounding factors by using multivariable analysis to show the independent effects of the VATS approach on prespecified outcomes. Another limitation is that our data represent a snapshot of real-world surgical practice in 2004 and 2006 and may not be representative of current general thoracic surgical practice because of advances in the technology and techniques used in VATS procedures. Additionally, the length of hospital stay in our study was defined as the time from date of admission to date of discharge. As a result, we were unable to specifically identify postoperative lengths of hospital stay because the NIS database does not capture the date of the operation. The administrative nature of the NIS database precluded the analysis of other outcome measures, such as the incidence of postoperative atrial fibrillation and blood transfusion requirements. We were unable to identify the percentages of lung resections being performed by board-certified thoracic surgeons versus general surgeons by using the NIS database. There is also the possibility that certain intraoperative complications, such as vessel injuries, were underreported in open thoracotomy cases because these complications are generally considered routine, whereas vessel injuries in VATS cases are more often reported by the operating room staff and coded appropriately.
Because the NIS database is administrative in nature, there may have been reporting bias as a result of coding errors. Statistically, such a bias would have affected the two groups of patients equally because the persons responsible for coding this database are blinded to our study. Nonetheless, because of this potential coding bias, we chose to limit our outcome measures mostly to concrete end points such as mortality, hospitalization costs, and length of stay.
In summary, in our analysis of the NIS database, we found no statistical difference in short-term mortality rates, lengths of hospital stay, and overall hospitalization costs between patients who undergo pulmonary lobectomy by the VATS approach versus those having the open thoracotomy approach. However, our study showed a 60% higher incidence of intraoperative complications in the VATS lobectomy group. This increase in risk is certainly of concern and may offset the potential benefits of the VATS approach.
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Appendix |
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Discussion |
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Today I think you have presented the largest single comparison between VATS (video-assisted thoracoscopic surgery) lobectomy and open lobectomy that I am aware of that has been presented. It is interesting that there were 759 VATS lobectomies and 12,600 of your open. You showed similar mortality, length of stay, hospital cost, rate of wound infection, pulmonary and cardiovascular complications. You did point out there was a 1.6 times higher intraoperative complication with the VATS group than with the open group, and one thing that I found interesting and will ask you later in a question was the socioeconomic disparity between the two groups. Overall, you defined very well what the definition of a VATS lobectomy was. You pointed out the steep learning curve. And also I would point out that the single-institution factor for VATS lobectomy has been driven by two major groups, the Cedars Sinai group by Rob McKenna and the Duke group by Tommie D'Amico.
You have presented a unique set of data from a series of multiple nonuniversity hospitals, which probably represents a better overall picture of the general thoracic surgical population in our country. At the STS in February of 2009, data from the STS database showed that pulmonary resections in general, 80% were open, 20% were done thoracoscopically, and again pointed out most of the thoracoscopic data has been driven from the literature of two single institutions, both of which are excellent.
My questions to you are based on your data. Do you feel that VATS lobectomy will continue to increase or is it to be confined to a few individual centers? Secondly, it is a given on data from the two centers mentioned that length of stay and 5-year survival are essentially the same and that the same operation could be performed either open or by VATS. However, at 6 weeks, multiple studies have shown that there is no more pain from an open thoracotomy than a VATS procedure. Does anything in your data support this or what are your feelings? And my last question is, based on your data, what do you feel is the future of VATS lobectomy in this group of patients?
Thank you very much.
DR GOPALDAS: Thank you, Dr Miller, for a very thorough perusal of our work. To answer the first question about VATS being confined to certain centers of excellence, I think any procedure is capable of being performed in any hospital, because all surgeons are being trained to do these operations. But I don't think it is the surgeon alone that matters in the outcomes of these patients, because you need to have an entire support staff, the operating room nursing personnel, the postoperative care nurses, and paramedical staff. They play a significant role in guiding how these patients are managed and discharged, which influences the outcomes. I don't think the surgeon alone is responsible for driving this. So if a hospital wants to have a VATS program, the hospital should be able to provide all the support staff for us to be able to realize the benefits of the VATS approach compared to the open approach.
To answer the second question, about pain, the NIS database captures all data only when the patient is discharged. It does not capture any follow-up data. So that is certainly a limitation, and that question cannot be answered with this database.
As far as the future of the VATS approach goes, in our database we showed there are 5.9% of patients are having VATS done, which is certainly discrepant compared to the STS database. We know that VATS has been around for at least 10 years and it has still not been widely adopted. So I think the key factors which are going to determine how the procedure is adopted in the future is, given the current economic status, how willing hospitals are to support the overhead equipment cost and the staff necessary to help a VATS program succeed in a particular institution.
DR THOMAS A. D'AMICO (Durham, NC): I have a couple of issues. First of all, I want to dispel the notion that thoracoscopic lobectomy is not already widely adopted. That is a relative term. It is practiced in all the major free-standing cancer centers, and in 19 of the 21 NCCN (National Comprehensive Cancer Network) centers. It is practiced in community centers, it is practiced in academic centers, it is practiced in Europe, it is practiced in Asia. In the last STS data analysis, more than 30% of the lobectomies were performed thoracoscopically. I don't know what the upper limit of that should be, but if one third of lobectomies are performed thoracoscopically, that qualifies as adoption. I have a couple of questions about your methodology.
Broadly, how do you explain these results? How do you put them in the context of all the other results about the benefits of thoracoscopic lobectomy? For example, how do you explain that the length of stay for thorascopic lobectomy in this study was 9 days, three times longer than any published series? Nine days is too long for either group. Granted, it is a large database, although not the largest comparison. The STS database analysis presented at last year's AATS is a larger study. Number two, the percentage of thoracoscopic lobectomies in this study is less than 6%. Currently it is over 30% in the STS database; in this database it is less than 6%. How do you justify that difference, vis-à-vis the results? Looking at the specific complication of cardiovascular complications, which is 3% for both groups in this study; there isn't a study that isn't in the 10 to 15% range for postoperative atrial fibrillation alone. So if you are saying all cardiovascular complications are 3%, what are you actually measuring? What percentage of these lobectomies were done by board-certified thoracic surgeons? Were they being done by general surgeons?
DR GOPALDAS: That is certainly a very valid point and an important issue, and we were surprised when we saw the results. There are a couple of things to compare between the two. This NIS database is nonvoluntary, which means it captures 100% of all discharges from every participating state. The STS database is a very powerful database and certainly has a large number of patients. It is, however, a voluntary database. So there is a preferential number of data coming from academic centers, whereas the NIS database is not segregating or had any preferential participants, which formed the basis of our hypothesis. We wanted to look at how we were doing across the board on a nationwide basis. So the benefits which are realized in these centers of excellence are diluted out by some of the other centers, which probably don't have a good support system. That would explain the difference between 5.9% of VATS in our study group compared to 30% in the STS database.
We looked at all the cardiovascular complications. We did not perform a subgroup analysis in terms of who had myocardial infarctions or arrhythmias, but we grouped all of them together. That is something we can look into down the road.
DR D'AMICO: But if all cardiac complications are 3% but A-fib (atrial fibrillation) alone is 15%, the data is inaccurate.
DR GOPALDAS: Correct.
DR D'AMICO: The reason I ask it is, is everything inaccurate? If that is inaccurate, what is accurate? And how does the study record the intraoperative complications? Is that from op[erative] notes?
DR GOPALDAS: Well, the database doesn't capture intraoperative complications from operative reports, but the database has all data which is captured by reporters. All the data are entered by professional coders from each hospital, and their job is assigned to code the discharge records appropriately. Because hospitals are paid based on how each patient is coded, there is always an incentive for them to quote these things accurately, if not sometimes overcoding. But your discrepancy in terms of 15% A-fib and myocardial infarction and other operative complications need to be looked into in a detailed manner. It is possible that A-fib may not have been captured as a postoperative complication per se.
DR MICHAEL J. MACK (Dallas, TX): So this highlights another shortcoming of an administrative database and hence we need another GO grant to marry the STS with Medicare data.
DR D'AMICO: If he could just answer one question, general thoracic or cardiothoracic surgeons doing the operations versus general surgeons?
DR GOPALDAS: The database does not differentiate between the nature of the surgeon. That is a very important point.
DR WAYNE L. HOFSTETTER (Houston, TX): I believe that the database that you were looking at doesn't differentiate between hospitals that were doing low-volume versus high-volume surgery, or how much or long they had been doing VATS procedures versus open procedures.
I can tell you that now in 2009, I perform VATS procedures on both sides, segmentectomies or lobectomies, through the same three incisions regardless of what lobe I am approaching. I can also tell you that in 2003, I was still trying to figure out all of the angles. I was working on different incisions for an upper lobe versus a lower lobe, sometimes I used three incisions, sometimes two incisions or occasionally four. My point is that I would also say that the learning curve for VATS surgeries is significant. The data that you presented falls within a time period when I think many surgeons were still in some point of their learning curve.
So, overall, I think that what you have presented here today is a group of patients that are dissimilar; you are comparing apples versus oranges. Furthermore, the most important aspects in terms of the outcomes for VATS surgery is earlier return to work, earlier return to functional activity, less postoperative pain, and the amount of pain medication the patient is discharged on (albeit with equivalent oncologic outcome). And I don't mean within the first 6 weeks, with respect to Dr Miller, but within the first week. None of these important outcomes were reported on in the data that you presented today.
So the advantages of VATS I think have outweighed the disadvantages, and this has been proven in single-institution studies. Your point is well taken. You are trying to compare the outcome of VATS versus open resection as it is happening in the community. But I think that your database doesn't reflect that. I think that what your database reflects is the process of acceptance and the learning curve for VATS as it occurs in the surgical community in comparison to an established open surgical procedure that is already performed quite well.
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