In patients with severe hypertension, the use of chemical renal denervation with alcohol appears to be a safe and feasible alternative to energy-based renal denervation, according to recent findings.
In the first-in-human, single-center, prospective feasibility study, researchers evaluated 18 patients aged 18 to 75 years with refractory hypertension despite a stable regimen of at least three antihypertensive medications and a suitable renal artery anatomy.
These patients underwent chemical renal sympathetic denervation using a novel three-needle delivery device (Peregrine System Infusion Catheter, Ablative Solutions Inc.). This procedure involved the bilateral infusion of microdoses (0.3 mL per renal artery) of dehydrated alcohol into the adventitial space of 37 arteries. The researchers conducted clinical and laboratory evaluations in the hospital and at 1, 3 and 6 months after procedure.
The study’s primary safety endpoints was procedure- and device-related adverse events and postprocedure CV or vascular complications, decrement in renal function or renal artery abnormality on angiographic follow-up at 6 months. The secondary performance endpoint was defined as a decrease in systolic BP at 6 months vs. baseline.
Procedural success, defined as successful infusion of the neurolytic agent without serious procedural adverse events, was achieved in 100% of patients and arteries. No cases of perforation, dissection or significant spasm were observed on visual assessment. No device- or intervention-related complications or adverse events were seen. There was one death 9 weeks after procedure owing to a mechanical small bowel obstruction. Although this was treated surgically, the patient developed peritonitis 5 days later, followed by septic shock and organ failure. This event was adjudicated to be unrelated to the device or procedure.
In angiographic data of 32 treated vessels in 16 participants accessible for 6-month follow-up, there was no evidence of renal artery stenosis, aneurysms, thrombi, pseudoaneurysms or dissections, and no significant change from baseline angiography in any vessel.
At the 6-month follow-up, the researchers observed a mean decrease in office BP of 24 ± 22 mm Hg (systolic) and 12 ± 9 mmHg (diastolic).
“Chemical renal denervation may provide a safe alternative to radiofrequency renal denervation and may allow more consistent renal denervation,” the researchers wrote. “Additional clinical evaluation of renal denervation, in general, and chemical renal denervation, will be required using ABPM and randomized and sham controlled trials to further evaluate the safety and efficacy of renal denervation.” – by Jennifer Byrne
Disclosure: Two researchers are principals in and cofounders of Ablative Solutions and hold equity in the company. Two other researchers report consulting for Ablative Solutions.