Surely it is too late for a randomised controlled trial

EDITOR—Rigorous evaluation of surgical procedures is important. The comparative outcomes and clinical profiles in transplantation (COCPIT) study, reported by Deng et al, called for a randomised controlled trial of heart transplantation based on comparing postoperative and waiting list survival in a single year in Germany.1

The German registry's 12 month postoperative survival rate of 71% was considerably lower that that of patients at Papworth Hospital in Cambridge who have undergone transplantation since 1990 (83%) and that reported by the International Society for Heart and Lung Transplantation (82% for patients who have undergone transplantation since 1995).2 This brings into question the generalisability of the results beyond Germany. Moreover, 12 month follow up is inadequate, as risks after transplantation are greatest in the first year. The risks from end stage heart failure are cumulative.

Deng et al claim that some patients listed to receive transplants are not sick enough to derive survival benefit from the procedure. The difficulty lies in identifying the group for which equipoise exists, at least in terms of survival. With increasing waiting lists and higher proportions of patients receiving transplants who are in United Network for Organ Sharing status I, the demand of the high risk group for donated organs may leave few organs for the marginal candidates, for whom randomisation may be appropriate.

Peak oxygen uptake is an important prognostic factor in the heart failure survival score, which is widely used by transplant centres.3 However, it was available for only 16% of the patients in the study reported by Deng et al; substituting the mean for missing values is questionable. This casts doubt on the value of the score, which is unvalidated in patients taking β blockers or as a prognostic indicator in transplantation.4

Over the past 10 years compelling evidence has emerged …