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Okay, I will admit that I do not like to change. It is difficult to see that what you have done for years may not be the right way and then head in a different direction, whether with respect to medical treatment of a particular nature, in a relationship, or in practicing surgery for congenital heart disease. I think this is particularly true for surgical techniques, where there are very few randomized studies proving that one technique is better than another (actually, that's also true for relationships). Having said that, many changes have occurred in the techniques used for congenital heart surgery—arterial switch instead of atrial switch, for example. However, perhaps no procedure has gone through as many modifications as the Fontan procedure. For the most part, these modifications seem to have improved the short- and long-term results for patients with single-ventricle lesions. The early mortality for the Fontan procedure in 2 early studies was very similar at 12%.
Over the past decade, most surgeons in the United States have performed the Fontan using either the lateral tunnel intra-atrial (LT) or extracardiac (EC) technique. These 2 procedures account for >99% of all Fontan procedures performed, with the EC technique used in 88% of cases and the LT technique used in the other 12%.
from Boston Children's Hospital report that the LT Fontan technique is associated with lower mortality and morbidity compared with the EC Fontan technique. Their large series spans many years. Although this is not a randomized study, the groups undergoing each operation appear similar in all respects, with the exception of the era in which most of the operations in each group were performed. The data certainly seem compelling. Is this one study sufficient to mandate that I (and apparently most US surgeons, including those in Boston) change from the EC to the LT Fontan technique?
This is not the first time that these 2 techniques have been compared. Previously published studies comparing the LT and EC techniques have shown no clear-cut winner but a trend toward improved results with the EC Fontan technique. These studies are listed in the references provided by the authors.
Why are the results from Boston different? One troubling point is that the early mortality for the EC Fontan group was 3.1%, double the mortality reported in the most recent STS registry (and, coincidentally, the same as the last 50 patients in Fontan's originally reported series from 1983).
The most common cause of death was related to the thromboembolic issue (baffle thrombosis and cerebral infarct) in the EC group, whereas Fontan failure was the most common cause of death in the LT group. Interestingly, none of the deaths in the EC group was attributable to Fontan failure. Certainly, baffle thrombosis is a serious complication of the Fontan procedure, but it is generally rare, and Fontan failure as a cause of death is generally common.
Why was there so much trouble with thromboembolic complications at Boston Children's Hospital? More synthetic graft material is used in the EC technique compared with the LT technique, but unless there is a fenestration, there is no connection to the left-sided circulation. However, with LT a great deal more of this foreign material is exposed to the pulmonary venous side of the circulation, where thrombotic events could be disastrous. The authors list aspirin as the sole anticoagulation strategy in the vast majority of patients. Perhaps a closer look at this is in order.
So now is decision time: change or not. We now we have this new study from a reputable center with historically excellent results. Is this single study sufficient to promote wholesale changes for the vast majority of surgeons in the United States—or even in Boston? Are the data compelling enough to abandon the extracardiac Fontan technique? For now, in deference to Churchill, I will not “improve by changing” and certainly will not approach perfection.