Renal Artery Denervation in Resistant Hypertension: The Good, The Bad and The Future.

Early studies of renal artery denervation (RAD) demonstrated efficacy in treating resistant hypertension patients with significant reduction in office blood pressure (BP). This resulted in a growing enthusiasm in the field and a rapid evolution of technology with expanding procedural indications. However, the first randomised sham-controlled trial, Symplicity HTN-3, failed to demonstrate a significant difference in BP reduction between the RAD and the sham control arm, which subsequently led to a major reduction in the clinical application of this procedure. Additionally, the results generated further interest into understanding the mechanism and factors affecting procedural success and identifying the limitations within the field. Many lessons were learned from Symplicity HTN-3 trial, and with recent evidence emerging for RAD in hypertension treatment, the field continues to be refined.

Renal Artery Branch Denervation: Evaluation of Lesion Characteristics Using a Thermochromic Liquid Crystal Phantom Model.

BACKGROUND: Lately, combined main vessel and branch ablation has been recommended during radiofrequency (RF) renal artery denervation. Utilising a validated renal artery phantom model, we aimed (1) to determine thermal injury extent (lesion depth, width and circumferential coverage) and electrode-tissue interface temperature for branch renal artery ablation, and (2) to compare the extent of thermal injury for branch versus main vessel ablation using the same RF System. METHODS: We employed a gel based renal artery phantom model simulating variable vessel diameter and flow, which incorporated a temperature sensitive thermochromic-liquid-crystal (TLC) film for assessing RF ablation thermodynamics. Ablations in a branch renal artery model (n = 32) were performed using Symplicity Spyral (Medtronic, Minneapolis, MN, USA). Lesion dimensions defined by the 51 °C isotherm, circumferential injury coverage, and electrode-tissue interface temperature were measured for all ablations at 60 seconds. RESULTS: Lesion dimensions were 2.13 ± 0.13 mm and 4.13 ± 0.18 mm for depth and width, respectively, involving 23% of the vessel circumference. Maximum electrode-tissue interface temperature was 68.31 ± 2.29 °C. No significant difference in lesion depth between branch and main vessel ablations was found (Δ = 0.02 mm, p = 0.60). However, lesions were wider in the branch (Δ=0.49 mm, p < 0.001) with a larger circumferential coverage compared to main vessel (arc angle of 82.02±3.27° versus 54.90±4.36°, respectively). CONCLUSIONS: In the phantom model, branch ablations were of similar depth but had larger width and circumferential coverage compared to main vessel ablations. Concerning safety, no overheating at the electrode-tissue interface was observed.

Comparison of two different radiofrequency ablation systems for renal artery denervation: Evaluation of short-term and long-term follow up.

OBJECTIVES: To assess the clinical efficacy of renal artery denervation (RAD) in our center and to compare the efficacy of two different radiofrequency (RF) systems. BACKGROUND: Several systems are available for RF renal denervation. Whether there is a difference in clinical efficacy among various systems remains unknown. METHODS: Renal artery denervation was performed on 43 patients with resistant hypertension using either the single electrode Symplicity Flex (n = 20) or the multi-electrode EnligHTN system (n = 23). Median post-procedural follow-up was 32.93 months. The primary outcome was post-procedural change in office blood pressure (BP) within 1 year (short-term follow-up). Secondary outcomes were change in office BP between 1 and 4 years (long-term follow-up) and the difference in office BP reduction between the two systems at each follow-up period. RESULTS: For the total cohort, mean baseline office BP (systolic/diastolic) was 174/94 mmHg. At follow-up, mean changes in office BP from baseline were -19.70/-11.86 mmHg (P < 0.001) and -21.90/-13.94 mmHg (P < 0.001) for short-term and long-term follow-up, respectively. The differences in office BP reduction between Symplicity and EnligHTN groups were 8.96/1.23 mmHg (P = 0.42 for systolic BP, P = 0.83 for diastolic BP) and 9.56/7.68 mmHg (P = 0.14 for systolic BP, P = 0.07 for diastolic BP) for short-term and long-term follow-up, respectively. CONCLUSIONS: In our cohort, there was a clinically significant office BP reduction after RAD, which persisted up to 4 years. No significant difference in office BP reduction between the two systems was found.

Comparison of new-generation renal artery denervation systems: assessing lesion size and thermodynamics using a thermochromic liquid crystal phantom model.

AIMS: The aim of this study was to evaluate and compare lesion dimensions and thermodynamics of the new-generation multi-electrode Symplicity Spyral and the new-generation multi-electrode EnligHTN renal artery denervation systems, using a thermochromic liquid crystal phantom model. METHODS AND RESULTS: A previously described renal artery phantom model was used as a platform for radiofrequency ablation. A total of 32 radiofrequency ablations were performed using the multi-electrode Symplicity Spyral (n=16) and the new-generation EnligHTN systems (n=16). Both systems were used as clinically recommended by their respective manufacturer. Lesion borders were defined by the 51°C isotherm. Lesion size (depth and width) was measured and compared between the two systems. Mean lesion depth was 2.15±0.02 mm for the Symplicity Spyral and 2.32±0.02 mm for the new-generation EnligHTN (p-value <0.001). Mean lesion width was 3.64±0.08 mm and 3.59±0.05 mm (p-value=0.61) for the Symplicity Spyral and the new-generation EnligHTN, respectively. CONCLUSIONS: The new-generation EnligHTN system produced lesions of greater depth compared to the Symplicity Spyral under the same experimental conditions. Lesion width was similar between both systems. Achieving greater lesion depth by use of the new-generation EnligHTN may result in better efficacy of renal artery denervation.

Magnetic guidance versus manual control: comparison of radiofrequency lesion dimensions and evaluation of the effect of heart wall motion in a myocardial phantom.

BACKGROUND: Magnetic navigation system (MNS) ablation was suspected to be less effective and unstable in highly mobile cardiac regions compared to radiofrequency (RF) ablations with manual control (MC). The aim of the study was to compare the (1) lesion size and (2) stability of MNS versus MC during irrigated RF ablation with and without simulated mechanical heart wall motion. METHODS: In a previously validated myocardial phantom, the performance of Navistar RMT Thermocool catheter (Biosense Webster, CA, USA) guided with MNS was compared to manually controlled Navistar irrigated Thermocool catheter (Biosense Webster, CA, USA). The lesion dimensions were compared with the catheter in inferior and superior orientation, with and without 6-mm simulated wall motion. All ablations were performed with 40 W power and 30 ml/ min irrigation for 60 s. RESULTS: A total of 60 ablations were performed. The mean lesion volumes with MNS and MC were 57.5 ± 7.1 and 58.1 ± 7.1 mm(3), respectively, in the inferior catheter orientation (n = 23, p = 0.6), 62.8 ± 9.9 and 64.6 ± 7.6 mm(3), respectively, in the superior catheter orientation (n = 16, p = 0.9). With 6-mm simulated wall motion, the mean lesion volumes with MNS and MC were 60.2 ± 2.7 and 42.8 ± 8.4 mm(3), respectively, in the inferior catheter orientation (n = 11, p = <0.01*), 74.1 ± 5.8 and 54.2 ± 3.7 mm(3), respectively, in the superior catheter orientation (n = 10, p = <0.01*). During 6-mm simulated wall motion, the MC catheter and MNS catheter moved 5.2 ± 0.1 and 0 mm, respectively, in inferior orientation and 5.5 ± 0.1 and 0 mm, respectively, in the superior orientation on the ablation surface. CONCLUSIONS: The lesion dimensions were larger with MNS compared to MC in the presence of simulated wall motion, consistent with greater catheter stability. However, similar lesion dimensions were observed in the stationary model.

Evaluation of lesion and thermodynamic characteristics of Symplicity and EnligHTN renal denervation systems in a phantom renal artery model.

AIMS: Radiofrequency renal artery denervation has been used effectively to treat resistant hypertension. However, comparison of lesion and thermodynamic characteristics for different systems has not been previously described. We aimed to assess spatiotemporal lesion growth and ablation characteristics of Symplicity and EnligHTN systems. METHODS AND RESULTS: A total of 39 ablations were performed in a phantom renal artery model using Symplicity (n=17) and EnligHTN (n=22) systems. The phantom model consisted of a hollowed gel block surrounding a thermochromic liquid crystal (TLC) film, exhibiting temperature sensitivity of 50-78°C. Flow was simulated using 37°C normal saline with impedance equal to blood. Radiofrequency ablations with each system were delivered with direct electrode tip contact to the TLC. Lesion size was interpreted from the TLC as the maximum dimensions of the 51°C isotherm. Mean lesion depth was 3.82 mm±0.04 versus 3.44 mm±0.03 (p<0.001) for Symplicity and EnligHTN, respectively. Mean width was 7.17 mm±0.08 versus 6.23 mm±0.07 (p<0.001), respectively. With EnligHTN, steady state temperature was achieved 20 sec earlier, and was 15°C higher than Symplicity. CONCLUSIONS: In this phantom model, Symplicity formed larger lesions compared to EnligHTN with lower catheter-tip temperature. The clinical significance of our findings needs to be explored further.