The Pipeline

ACC 2014: Renal denervation results call for further investigation

Vanessa Lo, Service Line Strategy Advisor

This year’s American College of Cardiology (ACC) conference reviewed the latest in CV service advancements. Here we highlight one of the four key takeaways from our coverage of this year’s sessions.

Renal denervation was in the spotlight at the ACC conference. In January, Medtronic announced that their SYMPLICITY HTN-3 trial, which evaluated the safety and efficacy of renal denervation device in patients with treatment-resistant hypertension compared to a sham-control group, had failed to meet its primary efficacy endpoint for blood pressure reduction.

For the first time ever, investigators presented the detailed results of the trial. Potential explanations for the trial’s failure to demonstrate device efficacy included the placebo effect, Hawthorne effect, patient selection issues, operator inexperience, and potential problems with the device itself.

Panelists remain optimistic

While these results were a major blow to renal denervation’s potential to manage hypertensive patients, panelists remain cautiously optimistic for its future. During a different scientific session, investigators presented the positive results from the Global SYMPLICITY Registry, demonstrating that renal denervation patients with uncontrolled high blood pressure exhibited low rates of adverse events and significant blood pressure reduction at six months. 

The technology may play a role in the future, but hospital leaders maintain a “watch and wait” approach to renal denervation adoption.

Other opportunities for renal denervation

Ultimately, with varying study results, experts stress the need to identify which patients respond positively and further understand the biological denervation process. In terms of clinical practice outside the U.S., interventionalists must carefully weigh the negative SYMPLCITY HTN-3 results with positive results from previous positive trials when determining the appropriate treatment pathway for a hypertensive patient. 

While the application of renal denervation may be limited for hypertensive patients, there is still opportunity for use in other patient populations such as heart failure and atrial fibrillation.

More from ACC 2014

Want more information on innovations highlighted at ACC? Check out the other posts in our series.

ACC 2014: Promising future for TAVR’s efficacy and LOS
ACC 2014: Radial PCI learning curve may be overstated
ACC 2014: The future of aortic aneurysm care—PEVAR in the cath lab