Durable pulmonary vein isolation with optimized high-power and very high-power short-duration temperature-controlled ablation: A step-by-step guide.

INTRODUCTION: Through systematic scientific rigor, the CLOSE guided workflow was developed and has been shown to improve pulmonary vein isolation durability. However, this technique was developed at a time when using power-controlled ablation catheters with conventional power ranges was the norm. There has been increased adoption of a high-power and very high-power short-duration ablation practice propelled by the availability of the temperature-controlled radiofrequency QDOT MICRO catheter. METHODS: There are fundamental differences in biophysics between very high-powered temperature guided ablation and conventional ablation strategy that may impact patient outcomes. The catheter's design and ablation modes offer flexibility in technique while accommodating the individual operator's clinical discretion and preference to deliver a durable, transmural, and contiguous lesion set. RESULTS: Here, we provide recommendations for 3 different workflows using the QDOT MICRO catheter in a step-by-step manner for pulmonary vein isolation based on our cumulative experience as early adopters of the technology and the data available in the scientific literature. CONCLUSIONS: With standardization, temperature-controlled ablation with the QDOT MICRO catheter provides operators the flexibility of implementing different ablation strategies to ensure durable contiguous pulmonary vein isolation depending on patient characteristics.

In Vivo Findings of a Novel Focal Ablation Catheter: Focused Electric Field Catheter Tip.

Current catheter designs used for radiofrequency (RF) in cardiac tissue achieve limited ablation depth as lesion size is driven heavily by resistive heating at the tissue surface. A catheter with a truncated, dome-shaped tip with a toroidal surface designed for focal RF ablation was recently described. This in vivo study compares lesion characteristics between a second-generation focused electric field (FEF) catheter vs a standard irrigated catheter using RF energy in a beating heart model. We performed in vivo ablations using RF energy with the FEF ablation catheter tip (Focused Therapeutics) and an irrigated Blazer catheter (Boston Scientific) under identical power, duration, and irrigation rates. In addition, RF dosing at high power and duration was examined using the FEF catheter. Intracardiac echocardiography was used to evaluate steam pops and catheter tip angle relative to the tissue surface. Studies were terminal and lesion size was measured following 2,3,5-triphenyltetrazolium chloride staining. Ablations were performed in 6 swine (FEF, n = 31; control, n = 8). FEF ablation lesions (n = 7) were deeper (15.6 ± 2.6 mm vs 7.5 ± 1.9 mm; P < 0.001) and wider (18.4 ± 2.9 mm vs 12.6 ± 2.4 mm; P < 0.001) than lesions delivered with the control irrigated catheter (n = 8) under the same parameters. Thirty-two percent (n = 10 of 31) of lesions delivered from the left ventricle endocardial surface using the FEF catheter were transmural. No steam pops were observed with delivery of FEF lesions (n = 31). The angle of incidence did not significantly affect FEF lesion size. In this in vivo preclinical study, the FEF catheter, which provides focused energy delivery, resulted in significantly larger lesions than the irrigated control catheter without steam pops. Approximately one-third of ablations with the FEF catheter delivered from the endocardial left ventricular surface resulted in transmural lesions.

Technical advance in silico and in vitro development of a new bipolar radiofrequency ablation device for renal denervation.

BACKGROUND: Renal denervation with radiofrequency ablation has become an accepted treatment for drug-resistant hypertension. However, there is a continuing need to develop new catheters for high-accuracy, targeted ablation. We therefore developed a radiofrequency bipolar electrode for controlled, targeted ablation through Joule heating induction between 60 and 100 °C. The bipolar design can easily be assembled into a basket catheter for deployment inside the renal artery. METHODS: Finite element modeling was used to determine the optimum catheter design to deliver a minimum ablation zone of 4 mm (W) × 10 mm (L) × 4 mm (H) within 60 s with a 500 kHz, 60 Vp-p signal, and 3 W maximum. The in silico model was validated with in vitro experiments using a thermochromic phantom tissue prepared with polyacrylamide gel and a thermochromic ink additive that permanently changes from pink to magenta when heated over 60 °C. RESULTS: The in vitro ablation zone closely matched the size and shape of the simulated area. The new electrode design directs the current density towards the artery walls and tissue, reducing unwanted blood temperature increases by focusing energy on the ablation zone. In contrast, the basket catheter design does not block renal flow during renal denervation. CONCLUSIONS: This computational model of radiofrequency ablation can be used to estimate renal artery ablation zones for highly targeted renal denervation in patients with resistant hypertension. Furthermore, this innovative catheter has short ablation times and is one of the lowest power requirements of existing designs to perform the ablation.

A Novel Visually Guided Radiofrequency Balloon Ablation Catheter for Pulmonary Vein Isolation: One-Year Outcomes of the Multicenter AF-FICIENT I Trial.

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Comparison of lesion characteristics between conventional and high-power short-duration ablation using contact force-sensing catheter in patients with paroxysmal atrial fibrillation.

BACKGROUND: Transmural lesion creation is essential for effective atrial fibrillation (AF) ablation. Lesion characteristics between conventional energy and high-power short-duration (HPSD) setting in contact force-guided (CF) ablation for AF remained unclear. METHODS: Eighty consecutive AF patients who received CF with conventional energy setting (power control: 25-30 W, force-time integral = 400 g s, n = 40) or with HPSD (power control: 40-50 W, 10 s, n = 40) ablation were analyzed. Of them, 15 patients in each conventional and HPSD group were matched by age and gender respectively for ablation lesions analysis. Type A and B lesions were defined as a lesion with and without significant voltage reduction after ablation, respectively. The anatomical distribution of these lesions and ablation outcomes among the 2 groups were analyzed. RESULTS: 1615 and 1724 ablation lesions were analyzed in the conventional and HPSD groups, respectively. HPSD group had a higher proportion of type A lesion compared to conventional group (P < 0.01). In the conventional group, most type A lesions were at the right pulmonary vein (RPV) posterior wall (50.2%) whereas in the HPSD group, most type A lesions were at the RPV anterior wall (44.0%) (P = 0.04). The procedure time and ablation time were significantly shorter in the HPSD group than that in the conventional group (91.0 ± 12.1 vs. 124 ± 14.2 min, P = 0.03; 30.7 ± 19.2 vs. 57.8 ± 21 min, P = 0.02, respectively). At a mean follow-up period of 11 ± 1.4 months, there were 13 and 7 patients with recurrence in conventional and HPSD group respectively (P = 0.03). CONCLUSION: Optimal ablation lesion characteristics and distribution after conventional and HPSD ablation differed significantly. HPSD ablation had shorter ablation time and lower recurrence rate than did conventional ablation.

Renal denervation in a patient with a highly tortuous renal artery using a guide extension catheter: a case report.

BACKGROUND: Catheter-based renal denervation (RDN) has been introduced to treat resistant hypertension. Although the technology of RDN has been largely improved, denervation of tortuous renal arteries remains challenging. CASE PRESENTATION: This is a case report of a 49-year-old man with drug resistant hypertension. The patient was selected for RDN after ruling out possible causes of secondary hypertension. Computed tomography angiography showed a highly tortuous left renal artery. An Iberis multielectrode ablation catheter failed to reach the target vessel with a regular guiding catheter. A 5-French extension catheter was introduced into the proximal segment of the main left renal artery to provide extra support force, which enabled successful ablation of the highly tortuous left renal artery. His ambulatory blood pressure was significantly decreased at 1 month follow-up. CONCLUSIONS: It is feasible and effective to use a guide extension catheter for denervation of highly tortuous renal arteries. The present study provides a useful method to ablate tortuous and angled renal arteries and branches.

In vivo preliminary test of a new biparietal bidirectional bipolar radiofrequency magnetic coupling system.

BACKGROUND: To test in vivo a new design prototype for radio frequency (RF) ablation. METHODS: A prototype based on a concept of endo-epicardial biparietal bipolar RF ablation with the atrial tissue interposed and consisting of two specular endocardial-epicardial catheters was tested in four pigs (80±5 kg). The endocardial catheter was introduced into the left atrium through the left atrial appendage on the beating heart. The epicardial counterpart was placed manually on the atrial epicardial surface. The coupling of the two catheters was achieved using a neodymium magnet around the gold plate electrode, and RF was applied to the interposed tissue. The hearts were excised, and the lesions were examined using morphometric evaluation. RESULTS: The RF application resulted in transmural lesions in all of the four animals tested. In these animals the maximum endocardial width (Wendo ) was 6.34 ± 0.25, 6.54 ± 0.33, 6.36 ± 0.57, and 6.49 ± 0.96 mm. The pericardial width (Wepi ) was similar: 6.37 ± 0.47, 6.58 ± 0.32, 6.35 ± 0.56 and 6.53 ± 0.94 mm. The lesion area was 924.78, 949.25, 944.25, and 926.05 mm2 , and the lesion volume was 92.47, 94.92, 94.42, and 92.60 mm3 , respectively. CONCLUSIONS: The idea of an endocardial-epicardial bidirectional biparietal bipolar radiofrequency tool such that the atrial tissue is fully interposed between the two RF poles might be promising for future clinical applications. Further research is warranted.

Feasibility and effectiveness of endoscopic irreversible electroporation for the upper gastrointestinal tract: an experimental animal study.

Irreversible electroporation (IRE) is a local non-thermal ablative technique currently used to treat solid tumors. Here, we investigated the clinical potency and safety of IRE with an endoscope in the upper gastrointestinal tract. Pigs were electroporated with recently designed endoscopic IRE catheters in the esophagus, stomach, and duodenum. Two successive strategies were introduced to optimize the electrical energy for the digestive tract. First, each organ was electroporated and the energy upscaled to confirm the upper limit energy inducing improper tissue results, including bleeding and perforation. Excluding the unacceptable energy from the first step, consecutive electroporations were performed with stepwise reductions in energy to identify the energy that damaged each layer. Inceptive research into inappropriate electrical intensity contributed to extensive hemorrhage and bowel perforation for each tissue above a certain energy threshold. However, experiments performed below the precluded energy accompanying hematoxylin and eosin staining and terminal deoxynucleotidyl transferase dUTP nick-end labeling assays showed that damaged mucosal area and depth significantly decreased with decreased energy. Relevant histopathology showed infiltration of inflammatory cells with pyknotic nuclei at the electroporated lesion. This investigation demonstrated the possibility of endoscopic IRE in mucosal dysplasia or early malignant tumors of the hollow viscus.

Assessing the Relationship of Applied Force and Ablation Duration on Lesion Size Using a Diamond Tip Catheter Ablation System.

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A novel noncontact high-resolution charge density mapping system to guide ablation of complex atrial arrhythmias: overview of device technology and application.

Introduction: Despite advances in imaging technology to guide ablative therapies, catheter ablation of more complex arrhythmias continues to be a challenge in part due to suboptimal mechanistic understanding of these arrhythmias by conventional mapping systems. A novel noncontact charge density mapping system has been designed to overcome some of these limitations.Areas covered: Hereby, we present an overview of this novel, charge density-based global chamber mapping approach. We initially highlight the concept of charge density, describe further the device technology and finally summarize the clinical application of this system.Expert opinion: Noncontact charge density mapping provides a more localized, high-resolution global panoramic assessment of cardiac activation. This might contribute to uncover the mechanisms of more complex arrhythmias such as persistent atrial fibrillation or unstable atrial tachycardias with the ultimate goal to guide the ablation therapy.

Pivotal Study of a Novel Motor-Driven Endoscopic Ablation System.

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Circular Multielectrode Pulsed Field Ablation Catheter Lasso Pulsed Field Ablation: Lesion Characteristics, Durability, and Effect on Neighboring Structures.

BACKGROUND: Pulsed field ablation (PFA) is a nonthermal energy with potential safety advantages over radiofrequency ablation. This study investigated a novel PFA system-a circular multielectrode catheter (PFA lasso) and a multichannel generator designed to work with Carto 3 mapping system. METHODS: A 7.5F bidirectional circular catheter with 10 electrodes and variable expansion was designed for PFA (biphasic, 1800 Volts). This study included a total of 16 swine used to investigate the following 3 experimental aims: Aim 1 examined the feasibility to create a right atrial ablation line of block from the superior vena cava to the inferior vena cava. Aim 2 examined the effect of PFA on lesion maturation including durability after a 30-day survival period. Aim 3 examined the effect of high-intensity PFA (10 applications) on esophageal and phrenic nerve tissue in comparison to normal intensity radiofrequency ablation (1-2 applications). Histopathologic analysis of all cardiac, esophageal, and phrenic nerve tissue was performed. RESULTS: Acute line of block was achieved in 12/12 swine (100%) and required a total PFA time of 14 seconds (interquartile range [IQR], 9-24.5) per line. Ablation line durability after 28±3 days was maintained in 11/12 (91.7%) swine. PFA resulted in transmural lesions in 179/183 (97.8%) sections and a median lesion width of 14.2 mm. High-intensity PFA (9 [IQR, 8-14] application) had no effect on the esophagus while standard intensity radiofrequency ablation (1.5 [IQR, 1-2] applications) resulted in deep esophageal tissue injury involving the muscularis propria and adventitia layers. High-intensity PFA (16 [IQR, 10-28] applications) has no effect on phrenic nerve function and structure while standard dose radiofrequency ablation (1.5 [IQR, 1-2] applications) resulted in acute phrenic nerve paralysis. CONCLUSIONS: In this preclinical model, a multielectrode circular catheter and multichannel generator produced durable atrial lesions with lower vulnerability to esophageal or phrenic nerve damage.

Feasibility and short-term complication rate of mechanochemical ablation for epifascial tributaries of incompetent great saphenous veins.

OBJECTIVE: The aim of the present study was to investigate the occurrence of skin complications after mechanochemical ablation with the ClariVein device (Merit Medical, South Jordan, Utah) for incompetent great saphenous veins (GSVs) and compare the results in terms of the target vein characteristics, especially in the presence of an epifascial GSV tributary. METHODS: A single-center, retrospective study was performed. We reviewed 33 limbs of 32 patients with GSV insufficiency who had undergone mechanochemical ablation with the ClariVein device from December 2017 to February 2020. The 33 limbs were divided into two groups: the epifascial group, comprising 11 limbs of 11 patients, and the nonepifascial group, comprising 22 limbs of 21 patients. The patients underwent postoperative follow-up examinations at 1 week and 1, 3, 6, and 12 months. The skin complication counts and scores on a four-point scale were recorded. RESULTS: Regarding the baseline characteristics, the epifascial group showed a significantly lower GSV depth in the distal thigh region compared with the nonepifascial group (2.64 ± 0.5 mm vs 7.05 ± 2.57 mm; P < .001). No statistically significant difference was found between the two groups in terms of the sclerosant (sodium tetradecyl sulfate) volume (5.45 ± 2.02 mL vs 6.59 ± 1.79 mL; P = .109) or ablation length (31.82 ± 3.92 cm vs 32.95 ± 4.05 cm; P = .449). All ClariVein procedures were technically successful (33 of 33 limbs; 100%), and no major complications were reported. The hyperpigmentation score was significantly greater in the epifascial group than in the nonepifascial group (score, 0.18 ± 0.4 vs 0 ± 0; P = .0401), although the hyperpigmentation count was not significantly different between the two groups (2 of 11 limbs [18.2%] vs 0 of 22 limbs [0.0%]; P = .1042). Although marginally higher counts and scores were observed in terms of phlebitis and bruising in the epifascial group, these differences were not statistically significant. CONCLUSIONS: Endovenous treatment with the ClariVein device for incompetent GSVs can be performed safely. However, caution should be exercised when the epifascial GSV tributary is treated during the ClariVein procedure because of its predilection to result in hyperpigmentation.

Efficacy and safety of palliative endobiliary radiofrequency ablation using a novel temperature-controlled catheter for malignant biliary stricture: a single-center prospective randomized phase II TRIAL.

BACKGROUND: Endobiliary radiofrequency ablation (EB-RFA) has emerged as a palliative treatment for malignant biliary strictures (MBSs); however, concerns about complications related to thermal injury remain. In this study, we evaluated the efficacy and safety of EB-RFA with a novel catheter for MBS. METHODS: Patients with inoperable cancer causing MBS were randomly assigned to either the radiofrequency ablation (RFA) group or the non-RFA group. The RFA group underwent EB-RFA at the stricture site with a temperature-controlled catheter (ELRA™; STARmed Co., Goyang, Korea) followed by deployment of a self-expanding metal stent (SEMS). For the non-RFA group, only SEMS placement was performed. The duration of stent patency, overall survival (OS), and 30-day complication rate were evaluated. This trial was registered at ClinicalTrials.gov (number NCT02646514). RESULTS: A total of 48 patients were enrolled (24 in each group). During a median follow-up period of 135.0 days (RFA group) and 119.5 days (non-RFA group), the 90-day stent patency rate, median duration of stent patency, and median OS were not different between the groups (58.3% vs. 45.8% [P = 0.386], 132.0 days vs. 116.0 days [P = 0.440], and 244.0 days vs. 180.0 days [P = 0.281], respectively). In the RFA group, procedure-related complications including thermal injury-related complications, such as bile duct perforation or hemobilia, were not reported. The early complication (< 7 days) rates were not different between the groups (4.2% vs. 12.5%, P = 0.609), and there were no late complications (7-30 days) in both groups. CONCLUSION: EB-RFA with a temperature-controlled catheter followed by SEMS placement for patients with inoperable MBS can be safe and feasible with acceptable biliary patency.

The Same is Not the Same: Device Effect during Bipolar Radiofrequency Ablation of Atrial Fibrillation.

BACKGROUND: Different ablation devices deliver the same type of energy but use individual control mechanisms to estimate efficacy. We compared patient outcome after the application of radiofrequency ablation systems, using temperature- or resistance-control in paroxysmal and persistent atrial fibrillation (AF). METHODS: This is an unselected all-comers study. Patients underwent standardized left atrial (paroxysmal atrial fibrillation, [PAF] n = 31) or biatrial ablation (persistent atrial fibrillation [persAF] n = 61) with bipolar RF from October 2010 to June 2013. Patients with left atrial dilatation (up to 57 mm), reduced left ventricular (LV) function, and elderly were included. We used resistance-controlled (RC) or temperature-controlled (TC) devices. We amputated atrial appendices and checked intraoperatively for completeness of pulmonary vein exit block. All patients received implantable loop recorders. Follow-up interval was every 6 months. Antiarrhythmic medical treatment endured up to month 6. RESULTS: We reached 100% freedom from atrial fibrillation (FAF) in PAF. In perAF 19% of the RC but 82% of the TC patients reached FAF (12 months; p < 0.05). TC patients exhibited higher creatine kinase-muscle/brain (CK-MB) peak values. In persAF, CK-MB-levels correlated to FAF. No and no mortality (30 days) was evident. Twelve-month mortality did not correlate to AF type, AF duration, LV dimension, or function and age. Prolonged need of oral anticoagulants was 90.1% (RC) and 4.5% (TC). CONCLUSION: In patients with persAF undergoing RF ablation, TC reached higher FAF than RC. Medical devices are not "the same" regarding effectiveness even if used according to manufacturer's instructions. Thus, putative application of "the same" energy is not always "the same" efficacy.

Radiofrequency Ablation by a 21-Gauge Internally Cooled Electrode: Ex Vivo and In Vivo Evaluation by Rat Liver.

PURPOSE: To evaluate the coagulative performance of a 21-gauge (G) internally cooled radiofrequency (RF) electrode using ex vivo and in vivo rat liver. MATERIALS AND METHODS: We developed a prototype of 21-G internally cooled monopolar RF electrode with 5.0 mm active tip length. The ablative zone size created by this electrode was evaluated in ex vivo and in vivo rat liver. Five RF powers (3 W, 5 W, 7 W, 9 W, and 11 W) were applied with and without circulation of chilled water within the electrode. The ablation zone sizes were compared. Histopathological evaluation of the ablation zone was also performed at 24 h and at 7 days after RF ablation. RESULTS: From ex vivo experiments, the ablation volume was found to increase significantly when RF energy was applied with the chilled water circulation. Results of in vivo experiments demonstrate that the ablation volume reached its maximum value when RF power of 7 W was applied (532.3 ± 110.3 mm3). Histopathological examination showed delineated coagulation necrosis at 24 h after RF ablation, which clarified the ablation zone border. Fibrotic change was also observed at 7 days after RF ablation. CONCLUSION: RF ablation using a 21-gauge electrode produced coagulation necrosis in the rat liver. The ablation volume became maximum when RF power of 7 W was applied with chilled water circulation.

Transseptal access through atrial flow regulator device during ventricular tachycardia ablation.

Novel interventional therapies for heart failure patients are emerging like atrial flow regulator (AFR). Our case showed that endocardial ventricular tachycardia (VT) ablation could be performed safely by passing through the AFR device lumen without additional transseptal puncture in these patients.