BACKGROUND: Long term safety and efficacy data of multi-electrode ablation system for renal denervation (RDN) in patients with drug resistant hypertension (dRHT) are limited. METHODS AND RESULTS: We studied 46 patients (age: 60 ± 10 years, 4.7 ± 1.0 antihypertensive drugs) with drug resistant hypertension (dRHT). Reduction in office BP at 24 months from baseline was -29/-13 mmHg, while the reduction in 24-hour ambulatory BP and in home BP at 24 months were -13/-7 mmHg and -11/-6 mmHg respectively (p<0.05 for all). A correlation analysis revealed that baseline office and ambulatory BP were related to the extent of office and ambulatory BP drop. Apart from higher body mass index (33.3 ± 4.7 vs 29.5 ± 6.2 kg/m(2), p<0.05), there were no differences in patients that were RDN responders defined as ≥10 mmHg decrease (74%, n=34) compared to non-responders. Stepwise logistic regression analysis revealed no prognosticators of RDN response (p=NS for all). At 24 months there were no new serious device or procedure related adverse events. CONCLUSIONS: The EnligHTN I study shows that the multi-electrode ablation system provides a safe method of RDN in dRHT accompanied by a clinically relevant and sustained BP reduction.
BACKGROUND: Long term safety and efficacy data of multi-electrode ablation system for renal denervation (RDN) in patients with drug resistant hypertension (dRHT) are limited. METHODS AND RESULTS: We studied 46 patients (age: 60 ± 10 years, 4.7 ± 1.0 antihypertensive drugs) with drug resistant hypertension (dRHT). Reduction in office BP at 24 months from baseline was -29/-13 mmHg, while the reduction in 24-hour ambulatory BP and in home BP at 24 months were -13/-7 mmHg and -11/-6 mmHg respectively (p<0.05 for all). A correlation analysis revealed that baseline office and ambulatory BP were related to the extent of office and ambulatory BP drop. Apart from higher body mass index (33.3 ± 4.7 vs 29.5 ± 6.2 kg/m(2), p<0.05), there were no differences in patients that were RDN responders defined as ≥10 mmHg decrease (74%, n=34) compared to non-responders. Stepwise logistic regression analysis revealed no prognosticators of RDN response (p=NS for all). At 24 months there were no new serious device or procedure related adverse events. CONCLUSIONS: The EnligHTN I study shows that the multi-electrode ablation system provides a safe method of RDN in dRHT accompanied by a clinically relevant and sustained BP reduction.
Authors: Amy E Burchell; Kenneth Chan; Laura E K Ratcliffe; Emma C Hart; Manish Saxena; David J Collier; Ajay K Jain; Anthony Mathur; Charles J Knight; Mark J Caulfield; Julian F R Paton; Angus K Nightingale; Melvin D Lobo; Andreas Baumbach Journal: J Clin Hypertens (Greenwich) Date: 2016-02-09 Impact factor: 3.738
Authors: Sara I Al Raisi; Jim Pouliopoulos; Pierre Qian; Patricia King; Karen Byth; Michael T Barry; John Swinnen; Aravinda Thiagalingam; Pramesh Kovoor Journal: Catheter Cardiovasc Interv Date: 2018-12-14 Impact factor: 2.692
Authors: C Tsioufis; A Ziakas; K Dimitriadis; P Davlouros; M Marketou; A Kasiakogias; C Thomopoulos; D Petroglou; D Tsiachris; M Doumas; E Skalidis; C Karvounis; D Alexopoulos; P Vardas; I Kallikazaros; C Stefanadis; V Papademetriou; D Tousoulis Journal: Clin Res Cardiol Date: 2016-12-12 Impact factor: 5.460