Background: Hypertension (HTN) is a world-wide epidemic. Catheter-based renal denervation (RDN) is in growing use for treatment of resistant HTN. The innovative TIVUS™System (Cardiosonic, Israel) applies ultrasonic energy for catheter-based RDN. It enables rapid, efficient RDN while preserving the vascular endothelium and artery integrity, in contradistinction to RF-based technology. Following extensive histology and physiology studies in swine, the TIVUS™ System was now evaluated in a clinical First-In-Man (FIM) study.
Method: TIVUS™-I -a prospective, multicenter, non-randomized, single-arm, open-label clinical FIM study, designed to assess safety and performance of the TIVUS™ System. Study patients met the following eligibility criteria: >3 anti-HTN medication including a diuretic, mean office blood pressure (OBP) >160mmHg, average 24-hour systolic ambulatory BP monitoring (ABPM) >135mmHg and confirmed patient compliance. Clinical endpoints include procedural, cardiac and kidney safety endpoints with efficacy OBP and ABPM measurements. Patients to be followed for 1-year.
Results: A total of 18 patients underwent TIVUS RDN. Fifteen patients were enrolled in the clinical study and 3 treated under compassionate use applications (post renal stent and impaired renal function). All patients presented with resistant hypertension based on 2-weeks monitoring period, medication compliance and 24-hour ABPM. Clinical characteristics are representative of hypertensive patients resistive to drug therapy. Baseline mean OBP was 174.3/88.4mmHg. Patients
underwent bilateral ultrasonic RDN. The procedures were technically uneventful with no device-related complications. At 1, 3-month follow-up, patients’ OBP decreased by 28/10mmHg (N=18), 24/9mmHg (N=15), respectively. Two patients required anti-HTN
medication reduction. Follow up is ongoing.
Conclusion: The current data presents technical success with absence of device-related complications and positive lasting BP reductions for TIVUS treated patients.The novel ultrasound based TIVUS™ performed safely with BP reductions well within the RDN expected range. Large scale TIVUS trial is enrolling, and may hopefully advance the therapeutic options for resistant HTN.
