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Over 700 patients with drug-refractory paroxysmal atrial fibrillation were randomly assigned to cryoballoon or radiofrequency ablation. Cryoballoon ablation was noninferior to radiofrequency for the composite of recurrent atrial arrhythmia, use of antiarrhythmic drugs, or repeat ablation. According to a 2012 expert consensus statement, catheter ablation of drug-refractory paroxysmal atrial fibrillation is a class I level A indication, 1 and pulmonary-vein isolation is the standard approach. 1 – 3 The two most frequently used ablation technologies for pulmonary-vein isolation differ in the energy source and mode of application. The most common method is the use of radiofrequency current applied in a point-by-point mode, which leads to cellular necrosis by tissue heating; the other method is the use of cryogenic energy applied with a balloon in a single-step mode, which leads to necrosis by freezing (Figure 1). Radiofrequency ablation for atrial . . .

BackgroundEndobiliary 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.MethodsPatients 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).ResultsA 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.ConclusionEB-RFA with a temperature-controlled catheter followed by SEMS placement for patients with inoperable MBS can be safe and feasible with acceptable biliary patency.

Renal denervation (RDN) is a minimally invasive, endovascular catheter-based procedure using radiofrequency, ultrasound, or alcohol-mediated ablation to treat resistant hypertension. RDN gained popularity in 2009 when it was shown to have an antihypertensive effect. However, concerns about the efficacy of RDN were raised in the HTN-3 trial published in 2014, and the development of several RDN devices was then discontinued. In the process, new randomized controlled trials were conducted after the development of some of the RDN devices, the quality assurance of the procedure, changes in ablation points, and improvements in study design. In November 2023, the U.S. Food and Drug Administration approved a radiofrequency RDN device and an ultrasound RDN device. The results of a randomized controlled trial of an alcohol-mediated RDN device have been published, and future trends are being watched closely. In this mini-review, we summarize the differences in the antihypertensive effect and safety of the different RDN devices and the endpoints of the procedure in order to contribute to the further development of RDN devices Currently available renal denervation device. A multielectrode radiofrequency ablation (Spyral), ( B ) ultrasound denervation (Paraise), and ( C ) alcohol-mediated perivascular denervation (Peregrine). ASBP ambulatory systolic blood pressure, ADBP ambulatory diastolic blood pressure, OSBP office systolic blood pressure, ODBP office diastolic blood pressure. Analysis according to types of renal denervation device (radiofrequency, ultrasound, or alcohol-mediated device). P values for interaction were 0.578 (ambulatory SBP), 0.499 (ambulatory diastolic BP), 0.853 (office SBP), and 0.870 (office diastolic BP). Currently available renal denervation device. (A) multielectrode radiofrequency ablation (Spyral), (B) ultrasound denervation (Paraise), and (C) alcohol-mediated perivascular denervation (Peregrine). ASBP; ambulatory systolic blood pressure, ADBP; ambulatory diastolic blood pressure, OSBP; office systolic blood pressure, ODBP; office diastolic blood pressure. Analysis according to types of renal denervation device (radiofrequency, ultrasound, or alcohol-mediated device). P values for interaction were 0.578 (ambulatory SBP), 0.499 (ambulatory diastolic BP), 0.853 (office SBP), and 0.870 (office diastolic BP).

Electrical coupling index (ECI) and contact force (CF) have been developed to aid lesion formation during catheter ablation. ECI measures tissue impedance and capacitance whilst CF measures direct contact. The aim was to determine whether the presence of catheter / tissue interaction information, such as ECI and CF, reduce time to achieve bidirectional cavotricuspid isthmus block during atrial flutter (AFL) ablation. Patients with paroxysmal or persistent AFL were randomised to CF visible (range 5-40g), CF not visible, ECI visible (change of 12%) or ECI not visible. Follow-up occurred at 3 and 6 months and included a 7 day ECG recording. The primary endpoint was time to bidirectional cavotricuspid isthmus block. 114 patients were randomised, 16 were excluded. Time to bidirectional block was significantly shorter when ECI was visible (median 30.0 mins (IQR 31) to median 10.5mins (IQR 12) p 0.023) versus ECI not visible. There was a trend towards a shorter time to bidirectional block when CF was visible. Higher force was applied when CF was visible (median 9.03g (IQR 7.4) vs. 11.3g (5.5) p 0.017). There was no difference in the acute recurrence of conduction between groups. The complication rate was 2%, AFL recurrence was 1.1% and at 6 month follow-up, 12% had atrial fibrillation. The use of tissue contact information during AFL ablation was associated with reduced time taken to achieve bidirectional block when ECI was visible. Contact force data improved contact when visible with a trend towards a reduction in the procedural endpoint. ClinicalTrials.gov trial identifier: NCT02490033.

Objectives This study aimed at exploring how using different kinds of sheaths will affect the very first ablation procedure of apprentices. Methods 15 patients with paroxysmal atrial fibrillation were randomized to used fixed-curve, conventional steerable or visualized steerable sheath, and received complete isolation of pulmonary veins. All ablations were the very first procedure performed by 15 ablation apprentices. The use of fluoroscopy and catheter stability during the PVI were analyzed. Results Procedure duration was much longer in the fixed-curve group (116.8 ± 27 vs. 62.2 ± 17 vs. 60.4 ± 17, p  < 0.001). X-ray exposure was lowest with visualized sheath (17.6 ± 5 vs. 18.6 ± 6 vs. 5.2 ± 6, p  < 0.001). CF SD differed significantly, especially at the anterior aspect of LSPV (7.90 ± 2.90 vs. 5.04 ± 2.18 vs. 4.52 ± 2.40, p  < 0.001) and posterior aspect of RSPV (6.84 ± 2.79 vs. 3.42 ± 2.04 vs. 3.50 ± 2.30, p  < 0.001) in the fixed-curve group. Impedance drop was significantly smaller in the fixed-curve group at the anterior aspect of LSPV (8.74 ± 3.02 vs. 11.49 ± 5.48 vs. 12.57 ± 5.96, p  = 0.005). Conclusion Even for the very first ablation procedure of an ablation apprentice, the use of steerable sheaths will significantly reduce the procedure duration and improve the catheter stability, but only visualized steerable sheath can reduce fluoroscopic time.

Three-dimensional (3D) mapping and navigation systems have been widely used for the ablation of atrial fibrillation and ventricular tachycardia, but the applicability of these systems for the ablation of supraventricular tachycardia (SVT) due to right-sided accessory pathways (RAPs) remains unknown. The goal of this prospective randomized study was to compare the safety, efficiency, and efficacy of nonfluoroscopic and conventional fluoroscopic mapping techniques in guiding catheter ablation of SVT due to RAPs. Of the 393 consecutive patients with SVT who were randomized to receive either conventional fluoroscopic or Ensite NavX mapping-guided ablation, 64 patients with RAPs were included for analysis. Endpoints for ablation were no evidence of RAP conduction and no inducible atrioventricular reentrant tachycardia (AVRT). The 3D group showed fewer ablation pulses and a shorter total ablation time compared to the conventional group, although the acute procedural success did not differ significantly between the two groups. Total procedure time, electrophysiological study time, total fluoroscopy time, and cumulative radiation doses were also significantly reduced in the 3D group. Patients in the conventional group with a right atrium diameter (RAD) ≥ 47 mm required a longer fluoroscopy time. There was no significant difference in the recurrence rates between the two groups over a follow-up period of 3 to 29 months. There were no permanent complications. The 3D mapping system may be a preferred alternative for patients with AVRT due to RAPs, especially for patients with a large RAD (≥ 47 mm).

Dysplasia in a Barrett's esophagus (BE) is associated with an increased risk for developing esophageal adenocarcinoma. Ablation using the HALO system has shown promise for the treatment of BE with dysplasia. The objective of this study was to assess the safety and efficacy of a stepwise regimen of circumferential and focal ablation using the HALO system for the treatment of BE with dysplasia. BE patients with low-grade dysplasia (LGD) or high-grade dysplasia (HGD) were enrolled. Primary circumferential ablation was followed every 3 months by further circumferential ablation or focal ablation until complete endoscopic eradication of BE was achieved. At 3- or 6-month intervals, depending on baseline grade, targeted and four quadrant random biopsies were obtained to assess the histological response to ablation. A complete response (CR) is defined as all biopsies negative for intestinal metaplasia (IM) (CR-IM) or dysplasia (CR-D) at last available follow-up. A total of 63 patients were treated (57 men; median age 71 years; median BE length 5 cm), with worst grade of dysplasia being LGD (n=39) and HGD (n=24). Follow-up is available for 62 patients (median 24 months). Overall, CR-IM is 79% and CR-D is 89%. For the LGD cohort, CR-IM is 87% and CR-D is 95%. For the HGD cohort, CR-IM is 67% and CR-D is 79%. Stepwise circumferential and focal ablation of BE containing dysplasia appears to be a safe and effective intervention, achieving a CR for dysplasia in 95% and 79% of LGD and HGD patients, respectively.

Purpose To compare the ablation area produced by a single application of a microwave ablation (MWA) system, equipped with a miniaturized device on the tip of the antenna entrapping reflected microwaves, with that produced by an internally cooled radiofrequency ablation (RFA) system. Materials and Methods Forty patients with primary or secondary inoperable liver tumors, selected to undergo percutaneous thermal ablation, were randomly assigned to MWA or RFA procedure. The ablation areas produced by a single application of MWA (ablation time 10 min) or RFA (ablation time 12 min) energy were assessed by contrast-enhanced ultrasonography immediately after the end of the procedure. The long- and short-axis diameters of the ablation areas were measured and compared using Student t test. Results Long- and short-axis diameters of the ablation areas produced by MWA were significantly greater than those produced by RFA: 48.5 ± 6.7 versus 30.9 ± 1.1 mm ( p  < 0.0001) and 38.5 ± 4.6 versus 26.8 ± 2.9 mm ( p  < 0.0001), respectively. Conclusion The MWA system can achieve significantly larger ablation areas than the internally cooled RFA system. Broader randomized trials are strongly warranted to investigate whether such superiority can translate into better long-term outcome of the ablation procedure.

The aim of this study is to evaluate the safety and feasibility of using the Amigo Remote Catheter System (RCS) in arrhythmia ablation procedures. Because Amigo allows the physician to operate all catheter function outside of the radiation field, operator exposure time was also evaluated. This is a nonrandomized, prospective clinical trial conducted at 1 site (identifier: NCT01834872). The study prospectively enrolled 50 consecutive patients (mean age 59 ± 15 years, 72% men) with any type of arrhythmia (23 atrial fibrillation ablation, 12 common atrial flutters, 10 patients with other supraventricular tachycardia, 4 ventricular tachycardia, and 1 patient with palpitations with no arrhythmia induced) referred for catheter ablation, in which we used RCS. Fifty matched ablation procedures (mean age 57 ± 14 years, 70% men) performed during the same time period, without RCS, were enrolled into the control group. Acute ablation success was 96% with RCS and 98% in the manual group. In only 2 cases, the physician switched to manual ablation (1 ventricular tachycardia and 1 accessory pathway) to complete the procedure. There were no complications related to the use of RCS. No differences were observed in total procedure time, total fluoroscopy time, or total radiofrequency delivery compared with the manual group. In procedures performed with RCS, the operator's fluoroscopy exposure time was reduced by 68 ± 16%. In conclusion, arrhythmia ablation with RCS is safe and feasible. Furthermore, it significantly reduces operator's exposure to radiation.

Introduction. The value of contact force information for ablation of LA anterior line is unknown. In a prospective randomized clinical trial, we investigated if information on contact force during left atrial (LA) anterior line ablation reduces total radiofrequency time and results in higher rates of bidirectional line block in patients undergoing pulmonary vein isolation (PVI) plus substrate modification. Methods. We included patients with indication for pulmonary vein isolation (PVI) and additional substrate modification. For LA anterior line ablation, patients were randomized to contact force information visible (n=35) or blinded (n=37). Patients received contrast enhanced cardiac magnetic resonance imaging (cMRI) before and 3-6 months after ablation to visualize the LA anterior line. Primary endpoint was radiofrequency time to achieve bidirectional line block. Secondary endpoints were completeness of the LA anterior line on cMRI, distribution of contact force, procedural data, adverse events, and 12 months success rate. Results. In 72 patients (64±9 years, 68% male), bidirectional LA anterior line block was achieved in 70 (97%) patients. Radiofrequency time to bidirectional block did not differ significantly across groups (contact force information visible 23±18min versus contact force information blinded 21±15min, p=0.50). The LA anterior line was discernable on cMRI in 40 patients (82%) without significant differences across randomization groups (p=0.46). No difference in applied contact force was found depending on cMRI line visibility. Twelve-month success and adverse event rates were comparable across groups. Conclusion. Information on contact force does not significantly improve the ablation of LA anterior lines. Clinical Trial Registration. The trial was registered at http://www.clinicaltrials.gov by identifier: NCT02217657.