Background: Renal sympathetic denervation was introduced as a treatment for resistant hypertension. TIVUS™ (Cardiosonic, Israel), an innovative ultrasonic energy catheter-based renal denervation technology, is currently being studied in humans. Patients with renal artery stenosis were excluded from all studies of RDN, due to inherent limitations of both Radiofrequency (RF) and otherUltrasound occlusive technologies. We now present the first two reported cases of human renal denervations performed through a renal stent.
Methods: TIVUS™ presents an advanced modality for renal denervation, enabling efficient RDN while preserving arterial integrity. Pre-clinical studies performed in a swine model confirmed thermal,angiographic and histological safety for multiple activation sites of the TIVUS catheter inside renal artery metal stents. We recently used the TIVUS™ System for treatment of 2 patients with severe resistant hypertension post previous renal stenting.
Results: Patient A-70 YO Male, diabetic, post right renal stenting (2007), severe resistant HTN despite 4 daily anti-HTN medications. Baseline Office BP (OBP) 178/68 mmHg, mean 24-hr Systolic ABPM 160 mmHg.
Patient B- 67 YO Male, diabetic, post left renal stenting (2009), resistant HTN despite 4 daily anti-HTN medications. Baseline OBP 150/83 mmHg, mean 24-hr Systolic ABPM 135 mmHg. Both patients underwent bilateral ultrasonic renal denervation, including multiple in-stent applications. Ultrasonic excitations were administered both within and further distally to the stented segment. The procedure was technically successful and uneventful.
During Follow up (FU): No adverse events were recorded for both patients. Patient A: At 1 & 3-month FU, OBP decreased by 43/7 and 51/7 mmHg, respectively. Patient B: At 1-month FU, OBP decreased by 14/9 mmHg.
Conclusion: The TIVUS ultrasound-based technology presents an advanced modality for RDN, avoiding vessel wall contact and sparing the endothelium. Its advantages now include a promise for safe and effective in-stent treatment in high risk, resistant HTN patients post renal artery stenting.
