Abstract
Introduction
Positive volume–outcome relationships in esophagectomy have prompted support for regionalization of care; however, outcomes have not recently been analyzed. This study examines national trends in provision of esophagectomy and reassesses the volume–outcome relationship in light of changing practice patterns and training paradigms.
Methods
The Nationwide Inpatient Sample was queried from 1998 to 2006. Quantification of patients’ comorbidities was made using the Charlson Index. Using logistic regression modeling, institutions’ annual case volumes were correlated with risk-adjusted outcomes over time, as well as presence or absence of fellowship and residency training programs.
Results
A nationwide total of 57,676 esophagectomies were recorded. In-hospital unadjusted mortality fell from 12% to 7%. Adjusting for comorbidities, greater esophagectomy volume was associated with improvements in the incidence of most measured complications, though mortality increased once greater than 100 cases were performed. Hospitals supporting fellowship training or a surgical residency program did not have higher rates of mortality or total complications.
Conclusions
The current national mortality rate of 7% following esophagectomy is higher than is reported in most contemporary case series. A greater annual esophagectomy volume improves outcomes, but only up to a point. Current training paradigms are safe.
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Dr. Geoffrey Paul Kohn, presenter (University of North Carolina at Chapel Hill, NC, USA).
Discussant
Dr. Jeff Peters (Rochester): This is about the esophagectomy outcome relationships that have been hammered home over the past few years. As you will see a little bit later today, the other side of that equation is the people that do not get resected, and there are a fair number of them. In fact, your observation that the mortality went down—it plateaued, I should say, at about 30 cases per year. Interestingly, this mirrors the number that is true in high resection prevalence institutions as well, and of course, that is much higher than the leapfrog criteria which is 13 and the five per year that have been talked about, and I think a more realistic number.
A couple of questions for you, perhaps one observation and a couple of questions. You interestingly showed that there is no change in the number of esophagectomies per year, and of course you started off we have the thesis that the prevalence of this cancer has increased dramatically over the last 10 or 15 years. Does that imply that we are not operating on the growth in this disease, or the relative proportion of patients that are coming to surgery is less?
You also showed that there was a shift in the number of high-volume hospitals that took care of these patients. So slowly over the decade, I think that you studied, more patients were taken care of in high-volume hospitals. You showed almost a 50% reduction in mortality, 12% to 7%, although you highlighted the 7% as still too high, which is true.
How much of that decrease—that 50% decrease in mortality—was due to that shift? Did you do that analysis?
Lastly, I just quibble with one of your conclusions. You said surgical residents are safe. You showed that resident hospitals were safe. You have no data on who actually did the operation. So, you might want to clarify that a little bit.
Closing Discussant
Dr. Geoffry Paul Kohn (University of North Carolina at Chapel Hill, NC): Thank you, Dr. Peters, for your comments. Addressing the first, the increasing prevalence of esophageal cancer is indeed a real phenomenon, though there is no doubt that the numbers of esophagectomies performed in this country have been relatively stable over the study period.
Data I presented showed the decreasing mean comorbidity score over the period. I think this probably highlights the improved patient selection criteria that we have. Unfortunately, these types of national administrative databases do not have provide any indication as to whether the patients have undergone neoadjuvant therapy. We also do not have very good staging information. However, with the decreasing comorbidity scores, I think we do show that we currently have better or at least more restrictive patient selection, and I think that is the reason that the total case numbers have not increased.
Regarding the cause for the decrease in mortality, we have demonstrated that up to somewhere around 80–100 annual cases, each and every esophagectomy performed in a specific center will improve in-hospital mortality. We did not specifically control for the number of hospitals in each case volume group, but we would expect the observed decrease in mortality to have resulted at least in part from a shift to higher-volume centers.
With regards to the residency point, I completely agree. Again, administrative databases can only determine hospitals in which fellowship programs or residency program exist. No data are available about who actually performed the operation. Your comment is valid and it applies both to the residency institutions and the fellowship institutions.
Our hypothesis, which we have actually started investigating further in a new study, is that the actual vital technical components of the procedure, for example, the construction of the anastomosis, are probably being performed more times by the fellow than by the residents in those institutions. A resident is also probably more strictly supervised by the attending staff. We do not have anything yet to back it up, but I think that is least a possible explanation about data.
Discussant
Dr. Tom Demeester (USC, Los Angeles (Los Angeles, CA)): Dr. Kohn, thank you for the opportunity to review the preprinted manuscript. It is well written and I compliment you for getting the prize for the best manuscript of the meeting.
Your study is based on administrative data with all the shortcomings that are associated with such a database. Yet, you have been able to use the data to help clarify some of the issues regarding esophagectomy for the treatment of esophageal cancer. I have four questions.
Your basic theme has been supportive of other prior investigations that greater hospital volume is related to better outcome. At the recent American Surgical Meeting, a paper by Birkmeyer’s group at Michigan suggests that hospitals with large volumes have better outcomes because they are more able to rescue patients from complications. Does your data provide any evidence that high-volume hospitals have better services to allow a better capacity to rescue patients with complications? For instance, surgical intensivists as opposed to medical intensivists, dedicated esophageal anesthesiologists, 24-h availability of interventional radiologists, 24-h operating room availability for surgical therapy of complications, and 24-h surgical endoscopy support to name a few.
My second question focuses on your observation that the survival associated with increasing volume improves to a point, up to about 100 cases. Do you conclude that a hospital will go beyond a safe limit if it exceeds 100 cases per year? In other words, there is an upper limit to the benefit of volume.
My third question regards your statement that overall mortality is going down from roughly 12% to 7%. In the manuscript, you did not show that the reduction was across the board. Was it only due to the effect of the improved mortality in the high-volume hospitals? What happened to mortality in those hospitals that did less than 13, between 13 and 20, and over 20?
The key part of the operation is the esophagogastric anastomosis. Was anastomotic breakdown and sepsis more common in hospitals with resident or fellow? I believe you stated, the leak rate was significantly higher, in fact 50% higher in hospitals with training programs. Further, tracheostomies were more common in teaching hospitals which may be a surrogate for a greater complication rate. If this is true, is it correct to conclude that house officers and teaching programs do not alter safety? Could you comment on this?
My last question deals with where are all these studies going? We continue to talk about high-volume hospitals have better outcomes. Will a point come when organized surgical societies of surgery will recommend criteria for hospitals in order to perform esophagectomies? That completes my questions. I enjoy reading the paper. It was very thought provoking.
Closing Discussant
Dr. Geoffrey Paul Kohn: I think your first and fourth questions are very closely related. The first one was about whether rescue of complications are better at high-volume hospitals and whether the anastomotic leak rates are a concern in fellowship and residency offering hospitals.
Dr. Birkmeyer’s group at that meeting did report that, while total complication rates can be similar in high-volume institutions as compared to lower-volume institutions, the outcomes are often superior, probably because of earlier detection and better management. I think that is exactly what our data show. We do show that higher anastomotic leak, and we do show higher risk of certain complications. Some of that might be selection bias because of more attention being paid by the residents in training hospitals, for example, to myocardial infarction. But we do have higher rates of leak, though it does not affect the mortality.
I think there is an improvement in the management of the complications at some of these big institutions. That is the main focus of our next paper that we are in the process of drafting—to look at the outcomes following the index complication.
The second question is, are we doing too many cases? We came into this with the hypothesis that the more cases you did, the better. We discovered that U-shaped curve and we thought that perhaps there was a problem with our analysis; perhaps, the high-volume institutions are choosing more difficult cases. The Charlson Index is a validated comorbidity score, but the specific validation for esophageal cancer has not been attempted. However, since our results have come out, I have had correspondence with surgeons at some of the larger volume institutions. It seems, anecdotally, that this U-shaped curve is a real phenomenon. I am told that when their institutions are ramping up case volume for the first 2 or 3 years, they are noticing a higher morbidity–mortality rate. They think it is probably due to an inability of the facility to accommodate the large increase in volume. It may also be a staffing or personnel issue. The increased mortality seems to settle down over a few years. This is an interesting phenomenon which has not previously been reported and requires further study.
With regard to your case volume groups question, I think ours is a very powerful model using logistic regression with no artificially allocated case volume groups. We show that, up to a point, each and every single esophagectomy does cause a benefit.
The last question, why are we doing this and what is the likely outcome of this? I think centralization of care is probably going to be forced on us from external regulators to a certain degree. This is already occurring for example in the UK. However, I think we have to be very wary of volume being the only criterion. I think the volume we are using is only a surrogate marker for quality. There are other effects on quality. Additionally, we have to be very aware that by moving cases to high-volume institutions, we are usually moving them to seats of surgical training, and therefore, we have to look at both the effect of and the effect on our educational training system for surgeons.
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Kohn, G.P., Galanko, J.A., Meyers, M.O. et al. National Trends in Esophageal Surgery—Are Outcomes as Good as We Believe?. J Gastrointest Surg 13, 1900–1912 (2009). https://doi.org/10.1007/s11605-009-1008-2
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DOI: https://doi.org/10.1007/s11605-009-1008-2