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Eur J Cardiothorac Surg 2006;30:953-954
© 2006 Elsevier Science NL

Letters to the Editor

What is the risk that I will have a major complication after my valve operation?

YingXing Wu*, Gary L. Grunkemeier

Providence Health System, Portland, OR, United States

Received 5 September 2006; accepted 15 September 2006.

* Corresponding author. Address: Medical Data Research Center, 9205 SW Barnes, Suite #33, Portland, OR 97225, United States. Tel.: +1 503 216 7117; fax: +1 503 216 7274. (Email: yingxing.wu{at}providence.org).

Key Words: Actuarial analysis • Actual analysis • Cumulative incidence

In a recent article comparing clinical outcomes of mechanical versus bioprosthetic valves, Kulik et al. [1] posed the above question. The authors reported the freedom from major adverse prosthesis-related events (MAPE) using Kaplan–Meier curves (a type of ‘actuarial’ analysis), and suggested that a randomized controlled trial would be the ideal method to address this question. In fact, although a randomized controlled trial would help to balance the difference in clinical characteristics between the two groups of patients, using Kaplan–Meier analysis still would not give the correct answer to the question. There is an established statistical method, ‘cumulative incidence’ analysis (often called ‘actual’ analysis in the cardiac literature), available to give an estimate of the probability of MAPE [2].

The actuarial method is correctly used to estimate the probability of death, which is an inevitable event; but it is necessary to use the ‘actual’ method to get the correct probability of an event that may itself be precluded by death. A specific feature of time-to-event data is censoring, which is applied to patients who have not yet had the event because they are either: (1) lost-to-follow-up before having the event; (2) free from event at the end of the study; or (3) precluded from having the event due to the occurrence of the competing risk of death. The Kaplan–Meier method assumes a censored patient is still at risk of having the event in the future; this is true if the event-of-interest is death. But for events like MAPE, death itself precludes a MAPE-free patient from having MAPE in the future.

The Kaplan–Meier estimate for such events assumes that all the patients are immortal, and therefore overestimates the risk of MAPE in the real world. The cumulative incidence method gives the proper estimate, which acknowledges the fact that dead patients are precluded from having MAPE in the future, and, unlike the Kaplan–Meier method, can answer the question ‘What is the risk that I will have a major complication after my valve operation?’

References

  1. Kulik A, Bedard P, Lam BK, Rubens FD, Hendry PJ, Masters RG, Mesana TG, Ruel M. Mechanical versus bioprosthetic valve replacement in middle-aged patients. Eur J Cardiothorac Surg 2006;30:485-491Epub 2006 Jul 20.[Abstract/Free Full Text]
  2. Grunkemeier GL, Wu Y. Interpretation of nonfatal events after cardiac surgery: actual versus actuarial reporting. J Thorac Cardiovasc Surg 2001;122:216-219.[Abstract/Free Full Text]



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Home page
 Eur. J. Cardiothorac. Surg.Home page
A. Kulik and M. Ruel
Reply to Wu and Grunkemeier
Eur. J. Cardiothorac. Surg., December 1, 2006; 30(6): 954 - 954.
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