Cardiologist wants more rigorous testing before devices, techniques are adopted

Haider Warraich, MD, used the recently presented CABANA trial to launch into an opinion piece about the medical community’s eagerness to embrace new technologies and invasive procedures.

“There is no reason we shouldn’t require, as we almost always do for drugs, a randomized placebo-controlled trial showing improvements in ‘hard’ outcomes like mortality before approving them,” Warraich, a cardiology fellow at Duke University Medical Center, wrote in The New York Times.

In CABANA, catheter ablation of atrial fibrillation (AFib) was no more effective than cheaper medications at reducing mortality, cardiac arrest, major bleeding and stroke in the intention-to-treat analysis. But among those who actually received treatment, ablation reduced the odds of reaching the composite endpoint by 33 percent—a statistically significant reduction.

Some electrophysiologists said this was evidence of the superiority of catheter ablation, while others felt the touting of this secondary analysis was an attempt to “spin” the results toward a more positive outlook on ablation therapy.

“The fact is that years after catheter ablation hit the market, we shouldn’t have this many questions about it,” Warraich wrote.

The author pointed out the FDA is considering streamlining approval for devices even more, while instead promising to strengthen oversight after they have hit the market. This would allow potential innovations to help patients more quickly but could also expose them to risks or higher expenses without the demonstration of a clear clinical benefit, Warraich said.

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