The efficacy of renal denervation is in doubt and should be confirmed or ruled out in treating resistant hypertension, according to an expert panel in a debate over the once high-flying technology at the Transcatheter Cardiovascular Therapeutics conference in Washington.
Once widely regarded as the next big thing in medical devices, after early studies showed dramatic benefits for patients whose high blood pressure didn’t respond for medication, RDN’s fortunes were dealt a blow when the Medtronic (NYSE:MDT) Symplicity-3 trial failed to meet its main efficacy endpoint.
The results shocked other medtech companies with RDN programs to sit back and reconsider the technology, with at least 1 opting to bow out of the field altogether. Debating whether the treatment is a viable option for resistant hypertension or ought to be abandoned, Drs. David Kandzari of the Piedmont Heart Institute in Atlanta and Dr. Sripal Bangalore of the New York University School of Medicine seemed to agree that the procedure deserves further scrutiny.
"The answer, clearly, is yes," Kandzari said, according to heartwire. "The results of HTN-3 are welcome, in a sense, because they provide an opportunity to revisit the basic science of this technology."
Bangalore, whose view of RDN in hypertension is considerably dimmer, said that the Symplicity-3 results represent a turning point for the technology.
"The time has come to turn the page on renal denervation in its current form, but I want to emphasize, by all means, not to close the book," he said, according to the website. "Let’s not forget that even leeches can reduce blood pressure. … What we really need is a therapy that can reduce morbidity and mortality."
One aspect of Syplicity-3 that should be explored is the relative paucity of patients with 4-quadrant circumferential denervation in both renal arteries, Kandzari noted. Just 19 of 364 patients, or 5.2%, in the trial hit that mark, he said.