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Anticipating FDA action, SCAI drafts guidance for adoption of renal denervation


 

Procedural and technical considerations

The statement also provided direction on a protocol for RDN procedures. The preprocedure evaluation should include noninvasive imaging to rule out disqualifying secondary causes of HTN, such as renal artery stenosis or fibromuscular dysplasia.

Patient characteristics should drive the selection of imaging modality, and availability as well as local expertise should be taken into account. The statement gave CT angiography or magnetic resonance angiography the edge over duplex ultrasound.

The statement also noted a number of anatomic considerations, citing preclinical analyses that “consistently reinforce” circumferential, perivascular RDN to ablate the renal nerves. In planning the procedure, consideration should be given to accessory renal arteries.

Additionally, operators should have training in obtaining access, and they should be familiar with different catheters and console devices as well as troubleshooting.

Training, competency, and institutional requirements

Interventional cardiologists who want to perform RDN should demonstrate proficiency in a number of specific skill sets germane to the procedure, from arterial vascular access and hemostasis to recognizing and treating potential renovascular complications.

For institutions that want to offer RDN, the statement offered a number of requirements. One is to designate a primary physician stakeholder who’s well versed in HTN management to oversee the long-term management of RDN patients.

The institution must have a dedicated HTN program and a multidisciplinary team to manage treated patients. Requirements for RDN referral centers range from operators experienced with FDA-approved RDN devices to an infrastructure that includes CT or MR angiography to identify appropriate candidates.

“Renal denervation has been a long time coming, and it’s a great example of how academicians, clinicians and industry leaders can partner to move the cardiovascular field forward, addressing a major public health issue for which alternative solutions are greatly needed,” Dr. Aronow said.

Dr. Aronow has served as an unpaid council member for Medtronic and as a paid moderator for ReCor.

A version of this article first appeared on Medscape.com.

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