Safe introduction and quality control of new methods in coronary surgery.

INTRODUCTION

The first part of the paper analyses off pump coronary bypass surgery (OPCAB), which is compared with traditional on-pump procedures (ONCAB). Furthermore ,the paper evaluates the use of a new automatic device for performance of the proximal anastomosis and finally the effect of intracoronary shunt on myocardial ischemia during OPCAB. The main goal of the paper is to demonstrate the importance of careful clinical studies during introduction of the new techniques in cardiac surgery.

METHODS

Statistical analysis was performed on a large clinical database from Buffalo, NY, USA comparing OPCAB and ONCAB. Subsequently, a sequential controlled clinical study compared patients operated with a new automatic connector device to patients operated with classic suture technique. Finally a randomized study was performed to evaluate the effect of the use of an intracoronary shunt during construction of distal anastomosis.

RESULTS

The studies from Buffalo demonstrated reduced complications rates in high risk patients when OPCAB techniques were used. The use of connector devices in saphenous venous anastomosis was clearly inferior to standard technique. Intracoronary shunt was found to be beneficial by preventing ischemia.

DISCUSSION

Numerous studies have studied the results of OPCAB vs ONCAB and although results are variable it seems that OPCAB is advantageous in high risk patients, while in low risk patients there are much less if any benefit. The results of the studies of connector devices caused the product to be taken off the market. The value of shunt in OPCAB was clearly demonstrated by the randomized studies.

CONCLUSION

The investigations presented in this paper clearly demonstrates the importance of well-designed studies when new surgical methods are introduced. In the present period of rapid technological development, carefully controlled, un-biased clinical trials are crucial to preserve patient safety and avoid unjustified societal cost.