Author + information
- Joost Daemen1,
- Felix Mahfoud2,
- Karl-Heinz Kuck3,
- Felix Meincke3,
- Bert Andersson4,
- Michael Böhm2,
- Tobias Graf5,
- Horst Sievert6,
- Philipp Kahlert7 and
- Thomas Zeller8
- 1Erasmus MC - Thoraxcenter, Rotterdam, Netherlands
- 2Universitätsklinikum des Saarlandes, Homburg, Germany
- 3Asklepios, Hamburg, Germany
- 4Sahlgrenska University Hospital, Gothenberg, Sweden
- 5Universitätsklinikum Schleswig - Holstein, Luebeck, Germany
- 6CardioVasculäres Centrum Frankfurt, Frankfurt, Germany
- 7University hospital Essen, Essen, Germany
- 8Universitäts-Herzzentrum Freiburg, Bad Krozingen, Germany
The efficacy of first-generation radiofrequency renal denervation devices may have been limited due to incomplete circumferential denervation and dependence on individual operator technique. The Paradise Renal Denervation System (ReCor Medical, Palo Alto, CA) was designed to maximize nerve coverage by delivering targeted circumferential ultrasound energy to perform renal sympathetic denervation.
The ACHIEVE study was a prospective, multi-center, non-randomized, post-market study to evaluate the clinical outcome of renal denervation with the Paradise System in patients with resistant hypertension. Inclusion criteria included non-pregnant adult patients who met established ESH/ESC guidelines for resistant hypertension. Major exclusion criteria included renal artery stenosis and moderate to severe renal insufficiency. Patients were treated with the Paradise system and followed for 12 months. Safety and efficacy endpoints included procedural and renal safety, changes in systolic office and 24-hour ambulatory BP measurement (ABPM), and changes in antihypertensive medication.
The study included 96 patients from 8 European sites. Mean age at treatment was 64±10 years, and 41% of patients were female. Baseline mean office systolic BP was 176±19 mmHg and mean 24-hour ambulatory systolic BP was 156±15 mmHg. At 12 months, patients had an average office BP change of -15±27 mmHg (p<0.001) and an average 24-hour systolic ABPM change of -7.5±18 mmHg (p<0.001). At 1 year, there was a single patient death (1%) that was unrelated to the device or procedure. Full safety and efficacy results will be presented at the meeting.
This single-arm study represents the largest cohort of patients treated with the Paradise Renal Denervation System to date. Within the ACHIEVE trial, the therapy appeared to be safe and effective and resulted in sustained reductions in both office BP and 24-hour ABPM. The ongoing randomized RADIANCE-HTN trial is designed to demonstrate efficacy of this therapy as compared to sham in both resistant hypertension (TRIO group) and non-resistant hypertension (SOLO group).