New Scientific Statement Seeks to Standardize Cardiac Surgery Trials

In an effort to bolster the level of evidence produced by randomized clinical trials in cardiac surgery, a new statement from the American Heart Association (AHA) outlines specific methodological challenges and offers solutions.

“Randomized trials are the highest level of evidence—they inform practice, but most importantly, they affect patient outcomes,” lead author Mario Gaudino, MD, PhD (Weill Cornell Medicine, New York, NY), told TCTMD. “However, randomized trials in surgery, and in cardiac surgery in particular, face unique challenges compared to drug trials.”

While pharmaceutical trials compare “pill a versus pill b,” surgical trial outcomes can be affected by the experience and preferences of each individual operator involved—what Gaudino termed the “surgeon effect.”

“We’ve seen in the past examples of important large trials that, in the end, were not able to provide the answer they were supposed to provide because of methodological issues and because of the lack of attention to the details such as . . . deliverability,” Gaudino said, although he declined to provide examples.

To prevent this from happening in the future, this statement, sponsored by the AHA and published this week in Circulation, provides guidance around standardizing processes so that trial outcomes can not only reliably change practice but can also be pooled with those from other trials in larger meta-analyses. Of note, the document was generated by the AHA’s surgical council and did not involve the major surgical societies. Joint documents, said Gaudino, are “very complicated” and take more time to pull together.

Timing of conducting surgical trials is also critically important, according to Gaudino. “It's complicated because surgical technique tends to evolve with time; it is initially described then subsequently modified to make them better and better,” he said. “So if you do your trial too early after the introduction of the procedure, the procedure may not be mature [enough] to be tested. But then if you wait too much, you take the risk that the community adopts the procedure even in absence of solid data to a point that then there is no equipoise of a trial comparing it to the old standard of care because nobody is using the old standard of care anymore.”

The document also addresses quality-of-life and patient-reported outcomes “that are kind of neglected in surgical trials, but I think they are very important,” Gaudino said.

Gaudino said he expects this statement, the first of its kind, to be updated as approaches to clinical trials continue to change. “The pandemic has really accelerated the use of new trial design, looking at platform trials [for example],” he said. “So, it is possible that in the future, in a few years, there will be more to be said.”

Going forward, Gaudino said he would like to not only see cardiac surgeons performing more RCTs but also see them using this document as a “guidebook” to make future trials even better.