Comparison of In Vivo Tissue Temperature Profile and Lesion Geometry for Radiofrequency Ablation With High Power-Short Duration and Moderate Power-Moderate Duration: Effects of Thermal Latency and Contact Force on Lesion Formation.

[Figure: see text].

Temperature- and flow-controlled ablation/very-high-power short-duration ablation vs conventional power-controlled ablation: Comparison of focal and linear lesion characteristics.

BACKGROUND: The QDOT MICRO catheter allows temperature- and flow-controlled (TFC) ablation and very-high-power short-duration (vHPSD) ablation. OBJECTIVE: The purpose of this study was to compare lesion characteristics between TFC/vHPSD ablation and standard power-controlled (PC) ablation. METHODS: Lesion characteristics in the right atrium, left atrium, and right ventricle (RV) of 6 sheep were compared between vHPSD (90 W/4 seconds, TC mode with 60°C target using QDOT) and standard radiofrequency settings (PC mode, 30 W/30 seconds with ThermoCool SmartTouch SF). Lesions in the left ventricle (LV) were compared, targeting 50 W for 60-second applications. RESULTS: Forty-six focal atrial lesions, 50 RV focal lesions, and 12 linear lesions were created by vHPSD ablation and PC ablation in each group of 6 animals. vHPSD ablation produced significantly larger focal atrial lesions in length (8.3 [6.4-9.7] mm vs 6.3 [5.2-7.4] mm; P = .0002), width (6.0 [5.3-6.9] mm vs 4.6 [3.8-5.4] mm; P <.0001), and surface area (39.4 [25.4-52.4] mm2 vs 23.6 [16.0-31.1] mm2; P = .0001), with superior transmurality (89.1% vs 69.6%; P = .04) compared to PC ablation. vHPSD ablation produced significantly larger RV lesions in length (7.7 [7.0-8.7] mm vs 6.0 [4.8-6.9] mm; P <.0001), width (6.4 [5.4-7.5] mm vs 4.3 [3.6-5.2] mm; P <.0001), and area (39.4 [29.1-50.1] mm2 vs 19.9 [14.7-25.2] mm2; P <.0001) but similar volume (P = .97) with shallower lesions (2.7 [2.2-3.4] mm vs 3.8 [3.0-4.4] mm; P <.0001). Atrial linear lesions were more homogeneous (P = .02), with fewer gaps in each line (P = .003) with vHPSD ablation. LV focal lesions (15 TFC mode; 21 PC mode) were similar in volume and depth, but lesion size showed less deviation (P <.05) in TFC than PC mode. Fewer steam pops were observed in TFC mode (0% vs 28.6%; P = .03). Hemorrhagic rings around the lesion core were generally smaller with TFC/vHPSD ablation (P <.05). CONCLUSION: TFC/vHPSD ablation produces larger, shallower, more homogeneous, and less hemorrhagic lesions. vHPSD Ablation produces more transmural and contiguous linear lesions compared to PC ablation. LV lesions are more homogeneous with fewer steam pops in TFC ablation.

Procedural and Anatomical Determinants of Multielectrode Renal Denervation Efficacy.

Radiofrequency renal denervation is under investigation for treatment of hypertension with variable success. We developed preclinical models to examine the dependence of ablation biomarkers on renal denervation treatment parameters and anatomic variables. One hundred twenty-nine porcine renal arteries were denervated with an irrigated radiofrequency catheter with multiple helically arrayed electrodes. Nerve effects and ablation geometries at 7 days were characterized histomorphometrically and correlated with associated renal norepinephrine levels. Norepinephrine exhibited a threshold dependence on the percentage of affected nerves across the range of treatment durations (30-60 s) and power set points (6-20 W). For 15 W/30 s treatments, norepinephrine reduction and percentage of affected nerves tracked with number of electrode treatments, confirming additive effects of helically staggered ablations. Threshold effects were only attained when ≥4 electrodes were powered. Histomorphometry and computational modeling both illustrated that radiofrequency treatments directed at large neighboring veins resulted in subaverage ablation areas and, therefore, contributed suboptimally to efficacy. Account for measured nerve distribution patterns and the annular geometry of the artery revealed that, regardless of treatment variables, total ablation area and circumferential coverage were the prime determinants of renal denervation efficacy, with increased efficacy at smaller diameters.

Interatrial Septum and Appendage Ostium in Atrial Fibrillation Patients: A Population Study.

Left atrial appendage (LAA) closure is performed in atrial fibrillation (AF) patients to help prevent stroke. LAA closure using an occlusion implant is performed under imaging guidance. However, occlusion can be a complicated process due to the highly variable and heterogeneous LAA shapes across patients. Patient-specific implant selection and insertion processes are keys to the success of the procedure, yet subjective in nature. A population study of the angle of entry at the interatrial septum relative to the appendage can assist in both catheter design and patient-specific implant choice. In our population study, we analyzed the inherent clusters of the angles that were obtained between the septum normal and the LAA ostium plane. The number of inherent angle clusters matched the LAA four morphological classifications reported in the literature. Further, our exploratory analysis revealed that the normal from the ostium plane does not intersect the septum in all the samples under study. The insights gained from this study can help assist in making objective decisions during LAA closure.

Arterial microanatomy determines the success of energy-based renal denervation in controlling hypertension.

Renal denervation (RDN) is a treatment option for patients with hypertension resistant to conventional therapy. Clinical trials have demonstrated variable benefit. To understand the determinants of successful clinical response to this treatment, we integrated porcine and computational models of intravascular radiofrequency RDN. Controlled single-electrode denervation resulted in ablation zone geometries that varied in arc, area, and depth, depending on the composition of the adjacent tissue substructure. Computational simulations predicted that delivered power density was influenced by tissue substructure, and peaked at the conductivity discontinuities between soft fatty adventitia and water-rich tissues (media, lymph nodes, etc.), not at the electrode-tissue interface. Electrode irrigation protected arterial wall tissue adjacent to the electrode by clearing heat that diffuses from within the tissue, without altering periarterial ablation. Seven days after multielectrode treatments, renal norepinephrine and blood pressure were reduced. Blood pressure reductions were correlated with the size-weighted number of degenerative nerves, implying that the effectiveness of the treatment in decreasing hypertension depends on the extent of nerve injury and ablation, which in turn are determined by the tissue microanatomy at the electrode site. These results may explain the variable patient response to RDN and suggest a path to more robust outcomes.

Comparison of renal artery, soft tissue, and nerve damage after irrigated versus nonirrigated radiofrequency ablation.

BACKGROUND: The long-term efficacy of radiofrequency ablation of renal autonomic nerves has been proven in nonrandomized studies. However, long-term safety of the renal artery (RA) is of concern. The aim of our study was to determine if cooling during radiofrequency ablation preserved the RA while allowing equivalent nerve damage. METHODS AND RESULTS: A total of 9 swine (18 RAs) were included, and allocated to irrigated radiofrequency (n=6 RAs, temperature setting: 50°C), conventional radiofrequency (n=6 RAs, nonirrigated, temperature setting: 65°C), and high-temperature radiofrequency (n=6 RAs, nonirrigated, temperature setting: 90°C) groups. RAs were harvested at 10 days, serially sectioned from proximal to distal including perirenal tissues and examined after paraffin embedding, and staining with hematoxylin-eosin and Movat pentachrome. RAs and periarterial tissue including nerves were semiquantitatively assessed and scored. A total of 660 histological sections from 18 RAs were histologically examined by light microscopy. Arterial medial injury was significantly less in the irrigated radiofrequency group (depth of medial injury, circumferential involvement, and thinning) than that in the conventional radiofrequency group (P<0.001 for circumference; P=0.003 for thinning). Severe collagen damage such as denatured collagen was also significantly less in the irrigated compared with the conventional radiofrequency group (P<0.001). Nerve damage although not statistically different between the irrigated radiofrequency group and conventional radiofrequency group (P=0.36), there was a trend toward less nerve damage in the irrigated compared with conventional. Compared to conventional radiofrequency, circumferential medial damage in highest-temperature nonirrigated radiofrequency group was significantly greater (P<0.001). CONCLUSIONS: Saline irrigation significantly reduces arterial and periarterial tissue damage during radiofrequency ablation, and there is a trend toward less nerve damage.

Innervation patterns may limit response to endovascular renal denervation.

BACKGROUND: Renal denervation is a new interventional approach to treat hypertension with variable results. OBJECTIVES: The purpose of this study was to correlate response to endovascular radiofrequency ablation of renal arteries with nerve and ganglia distributions. We examined how renal neural network anatomy affected treatment efficacy. METHODS: A multielectrode radiofrequency catheter (15 W/60 s) treated 8 renal arteries (group 1). Arteries and kidneys were harvested 7 days post-treatment. Renal norepinephrine (NEPI) levels were correlated with ablation zone geometries and neural injury. Nerve and ganglion distributions and sizes were quantified at discrete distances from the aorta and were compared with 16 control arteries (group 2). RESULTS: Nerve and ganglia distributions varied with distance from the aorta (p < 0.001). A total of 75% of nerves fell within a circumferential area of 9.3, 6.3, and 3.4 mm of the lumen and 0.3, 3.0, and 6.0 mm from the aorta. Efficacy (NEPI 37 ng/g) was observed in only 1 of 8 treated arteries where ablation involved all 4 quadrants, reached a depth of 9.1 mm, and affected 50% of nerves. In 7 treated arteries, NEPI levels remained at baseline values (620 to 991 ng/g), ≤20% of the nerves were affected, and the ablation areas were smaller (16.2 ± 10.9 mm(2)) and present in only 1 to 2 quadrants at maximal depths of 3.8 ± 2.7 mm. CONCLUSIONS: Renal denervation procedures that do not account for asymmetries in renal periarterial nerve and ganglia distribution may miss targets and fall below the critical threshold for effect. This phenomenon is most acute in the ostium but holds throughout the renal artery, which requires further definition.