Table 1.

Summary of device therapies used in resistant hypertension

Catheter-based renal denervationRadiofrequency ablation, RFA (Symplicitya, Spyrala)Approved for use in hypertension in several continents. Modest BP reduction (24-h BP decrease by 4.1–4.6/1.8–4.3 mm Hg at 3 mo) in patients not on medications (RFA [12], US [11]). Extensive uncontrolled registry data show sustained efficacy in hypertension (25). Only a sham-controlled, randomized trial in resistant hypertension did not show difference (24-h BP difference 2.0/1.0 mm Hg at 6 mo) (24,34).
Intravascular high-frequency ultrasound ablation, US (Paradiseb)
Transarterial alcohol ablation (Peregrinec)
Renal denervation with external ultrasoundExternally delivered ultrasound waves directed at the renal sympathetic nervesdAfter initial favorable results in an uncontrolled study (35), a sham-controlled trial was prematurely terminated for lack of efficacy on BP (24-h BP reduction at 24 wk 1.2/0.5 mm Hg versus sham) (36).
Baroreflex amplification deviceMobiusHD deviceeSignificant 24-h BP reduction after 6 mo (21/12 mm Hg) in proof-of-concept, uncontrolled trial (37). No controlled studies available yet (ongoing).
Baroreflex activation therapyCVRx Barostim Neo devicefApproved for hypertension treatment in Europe. Approved by FDA for use in advanced heart failure in August 2019. Significant office BP reduction at 6 mo (26.0/12.4 mm Hg) in an uncontrolled study (10). An older device version has sustained efficacy in RH (8,9) but high implantation complication rates (8). Ongoing randomized trials with Barostim Neo device.
Central arteriovenous fistula creationROX coupler devicegSignificant 24-h BP reduction after 6 mo (13.5/14.6 mm Hg) (38) and 1 yr (12.6/15.3 mm Hg) (39) in a controlled RH study (control group was usual care, not a sham procedure). Company terminated device trial in May 2019 owing to increased risk of heart failure. No longer in development.
  • RFA, radiofrequency ablation; US, ultrasound; RH, resistant hypertension.

  • a Medtronic, Dublin, Ireland.

  • b ReCor Medical, Palo Alto, CA.

  • c Ablative Solutions, San Jose, CA.

  • d Kona Medical, Issaquah, WA.

  • e Vascular Dynamics, Mountain View, CA.

  • f CVRx, Minneapolis, MN.

  • g ROX Medical, San Clemente, CA.