Findings

As noted at the outset, this case gave rise to the following questions:

• Was there an inappropriate delay between the time of Gary's diagnosis and the date of the operation on his heart?
• Was his mother provided with sufficient information to allow her to give informed consent to the procedure?
• Was Gary healthy enough to undergo an operation?
• Did the length of surgery contribute to his death?
• Did the post-operative abdominal drainage procedure contribute to his death?
• What was the cause of death and was it preventable?

Was there an inappropriate delay between the time of Gary's diagnosis and the date of the operation on his heart?

One of the reasons for Gary's death advanced by the consultants engaged to review this case for the Inquest was his weakness at the time of operation. A question therefore arises over the wisdom of not performing surgery in December 1993, when the condition was first diagnosed. Although there was no surgeon available in Winnipeg to perform the operation, arrangements could have been made for Gary to be sent to another heart program in another province.

Giddins testified that experience had shown that in young children, small holes in the heart could close on their own, without any surgical intervention. At the time, Giddins was unable to come to a conclusion as to whether or not surgery was required or if Gary's defect might heal on its own. Giddins believed that the possibility of the holes closing on their own was preferable to surgery, particularly in light of Gary's already frail condition. As well, Giddins thought that Gary's overall condition could be improved with medical assistance.

Finding

Allowing a septal defect to heal on its own is a better course than closing it surgically. Surgery has many pitfalls, including a certain degree of risk-albeit sometimes small-of a fatal outcome. Giddins's decision to wait to see if the defect in the septum would close on its own was a sensible medical decision.

Was Gary's mother provided with sufficient information to allow her to give informed consent to the procedure?

Finding

No one told Charlotte Caribou that the surgeon had never before performed this type of surgery on this type of patient without supervision. She was unaware of the fact that the surgical team had performed only a very few simple operations together. Additionally, she was never told that her son's chest condition placed him at increased risk for the procedure he was undergoing.

All of this clearly might have influenced a reasonable person in her decision when giving consent to this operation being performed by this surgeon in this setting and therefore, should have been shared with her. The fact that this information was not shared tends to suggest that Gary's mother was not provided with sufficient information to allow her to give informed consent to the procedure.

Was Gary healthy enough to undergo an operation?

Several of the consulting witnesses who testified laid considerable stress on Gary's pre-operative condition. Cornel wrote: "The possibility of an important contribution to the demise by an intercurrent [ongoing] viral illness cannot be ruled out." (Exhibit 353, page 12) Dr. Walter Duncan² concluded that Gary had experienced severe heart failure pre-operatively and died of lack of blood flow or low cardiac output post-operatively.

Finding

There is some evidence to suggest that Gary might have had a chest condition at the time that the operation was scheduled. While some significant features of an infection may not have been present (notably a fever), the evidence suggests that the surgeon and the cardiologist did not gather enough information to completely discount the existence of an infection.

Because of the tremendous importance that has been placed on the impact of infections on the recovery of pediatric cardiac patients, and the valid concerns raised about this issue by the consulting witnesses, Drs Giddins, Odim and McNeill should have ensured that proper tests were conducted to exclude the possibility of a chest infection before proceeding with the operation.

Did the length of surgery contribute to his death?

Considerable weight was also placed on the damage that was done to Gary by the length of the procedure.

Hudson wrote that:

. . . the need to leave the chest open because the patient cannot tolerate the hemodynamic effects of sternal closure is also more common after unduly prolonged CPB. Such severe cardiac failure in the early post CPB period suggests that there was significant myocardial injury during CPB. (Exhibit 307, page 1.14)

In their joint report, Cornel and Duncan stated that:

The etiology of the demise of this child remains uncertain. Contributing factors may have been an abnormal coagulation status, abnormal lung function and a relatively long surgical procedure. (Exhibit 354, page 2)

Dr. Christian Soder³ indicated in his report for this Inquest that:

The skill and dexterity of the surgeon performing these operations were insufficient for the challenge of successfully repairing infant hearts with complex malformations. Surgical factors were the prime determinants of fatal outcome in 9 of the 12 deaths. (Boldface in original) (Exhibit 345, page 8)

The case of Gary Caribou was one of the nine that Soder identified in which surgical factors were a prime determinant in a fatal outcome. In particular, he identified the lengthy bypass and cross-clamp time, and the excessive bleeding.

Finding

While a clear cause of death cannot firmly be established, it appears from the available evidence that the child was in a significantly compromised state when he entered the operating room, and the length of the operation seems to have been a significant contributing factor in his death. The evidence suggests that the length of the operation appears to have been directly related to the ability and inexperience of the surgeon.

Did a post-operative abdominal drainage procedure contribute to his death?

During the course of this Inquest, questions were raised about the peritoneal dialysis. The wisdom of the rapid drainage of a large volume of peritoneal or ascitic fluid was questioned by Cornel. In his view, given Gary's fragile state, any significant change in blood pressures would be difficult for Gary to cope with. In his written evidence, Cornel stated: "Rapid drainage of a large volume of ascitic fluid following the insertion of peritoneal dialysis catheter was associated with the final demise of the infant." (Exhibit 353, page 12)

The dialysis procedure involved draining ascitic fluid, injecting dialysis fluid into Gary's abdominal cavity, and then draining the dialysis fluid to relieve pressures and remove impurities. What was most important during the procedure was to ensure that there was close monitoring of any changes in pressure in the abdomen (from the fluid) on the function of the heart. This would appear as changes in heart rate and blood pressure. For example, a sudden increase or decrease in fluid pressure in the abdomen could produce a decrease in blood flow to the internal organs and to the heart itself. Thus, the key to the procedure was to ensure that flow of fluid into or out of the abdomen occurred at a rate that the heart could handle.

In many other facilities, including the Children's Hospital of Eastern Ontario where Cornel is the chief of pediatric cardiac surgery, a surgeon carries out the dialysis procedure on post-cardiac surgery patients, with the assistance of a nephrologist. In particular, Cornel said, it was important to limit the volume of liquid used and the rate at which it was drained.

Grimm testified that this was a procedure that he had performed many times previously and that in Gary's case he had followed all of the usual procedures. Grimm was assisted by Birk and by at least one PICU nurse. Neither Odim nor Hancock, (the intensivist on duty that evening) nor Dr. Ellsabete Doyle, the PICU resident, were present during the procedure.

Grimm was of the view that nothing done in the course of the dialysis procedure was a factor in Gary's death. He rejected any suggestion that the removal of fluid was conducted too quickly, pointing to the fact that while the initial fluid was being removed, Gary's blood pressure did not change, and there was no adverse reaction to the insertion of the catheter. He pointed out that the initial volume of dialysis fluid had been inserted and removed without incident as well, and that the second volume was in Gary's abdomen when Gary began to deteriorate. However, Grimm did not disagree with Cornel's view about the need to proceed slowly in the removal and replacement of fluids in this type of procedure.

Finding

It would appear that nothing Grimm did during the dialysis procedure was inappropriate. It is uncertain as to whether or not the dialysis procedure caused such a sudden change in Gary's blood pressure from which he was unable to recover. However, it would have been desirable for Odim or one of the intensivists to have been present while this procedure was being undertaken.

What was the cause of death and was it preventable?

It is unfortunate that an autopsy was not held. It will remain unclear if the medical issues that were part of Gary's demise could have been better determined. Coming to a conclusion as to exactly why Gary died will remain speculative, although there is sufficient information to reach some solid conclusions.

Findings

There is no suggestion that the surgical repair of the VSD was not successful. Although an autopsy was not performed, the available evidence suggests that the VSD was successfully patched.

However, the operation appears to have taken too long. The evidence suggests that the lengthy bypass and cross-clamp times may have significantly compromised the baby's chances of recovery. There seems to have been little more that could have been done for the baby post-operatively than was done in this case.

For these reasons, the evidence suggests that this death was possibly preventable.