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Radiofrequency catheter ablation of the cavotricuspid isthmus is the standard treatment for patients suffering from typical atrial flutter. The aim of this study was to test the feasibility of tissue thickness and lesion transmurality measurement by a novel dielectric system. This was a retrospective multicentric non-randomized open-label, single-arm study. The atrial wall thickness was significantly higher close to the tricuspid annulus than close to the inferior vena cava and a trend towards a progressive decrease of atrial wall thickness was observed moving the mapping catheter from the tricuspid valve to the inferior vena cava. The possibility to visualize the tissue thickness could modify the way to deliver radiofrequency energy, allowing a tailored approach in cardiac ablation procedures.

A very high-power short-duration (vHPSD) strategy of radiofrequency (RF) ablation aims to minimize conductive heating and increase resistive heating. We evaluated the feasibility, efficacy and safety of the vHPSD ablation of the cavotricuspid isthmus (CTI) in patients presenting with typical atrial flutter (AFL).This prospective non-randomized study enrolled 28 consecutive patients (FAST Group) with typical AFL undergoing CTI ablation. The vHPSD ablation was performed applying 90 W, for 4 s, with an irrigation of 8 ml/min. Thirty consecutive patients who, previously, underwent CTI ablation by means of a contact force surrounding flow catheter guided by ablation index (500) served as control group (AI Group).In the FAST Group, the mean CTI length was 29 ± 6 mm, and the mean number of RF tags was 20 ± 9. The CTI bidirectional "first pass" block was reached in 25 (89%) patients. There were no major procedural complications. After a mean follow-up of 6 ± 2 months, one (3.5%) patient had arrhythmia recurrence. The vHPSD ablation was as effective as AI-guided ablation in achieving acute CTI block (rate of first pass 89% vs 93%, p = 0.59), with a shorter RF time (88 ± 40 s vs 492 ± 269 s, p 0.001) and similar procedure (30 ± 4 min vs 34 ± 10 min, p = 0.5) and fluoroscopy time (103 ± 29 vs 108 ± 52 s, p = 0.7). At 8 months, the freedom from AFL recurrence was 96% in the FAST group and 97% in the AI group.Our preliminary data show that the vHPSD ablation represents an effective and safe ablation strategy to achieve bidirectional block for the treatment of typical AFL.

Purpose Highly localized impedance (LI) measurements during atrial fibrillation (AF) ablation have emerged as a viable real-time indicator of tissue characteristics and the consequent durability of the lesions created. We investigated the impact of catheter-tissue contact force (CF) on LI behavior during pulmonary vein isolation (PVI). Methods Forty-five consecutive patients of the CHARISMA registry undergoing de novo AF radiofrequency (RF) catheter ablation with a novel open-irrigated-tip catheter endowed with CF and LI measurement capabilities (Stablepoint™ catheter, Boston Scientific) were included. Results A total of 2895 point-by-point RF applications were analyzed (RF delivery time (DT) = 8.7±4s, CF = 13 ±±8 g, LI drop = 23 ±±7 Ω). All PVs were successfully isolated in an overall procedure time of 118 ±±34 min (fluoroscopy time = 13 ±±8 min). The magnitude of LI drop weakly correlated with CF (r = 0.13, 95% confidence interval (CI): 0.09 to 0.16, p < 0.0001), whereas both CF and LI drop inversely correlated with DT (r = −0.26, 95%CI: −0.29 to −0.22, p < 0.0001 for CF; r = −0.36, 95%CI: −0.39 to −0.33, p < 0.0001 for LI). For each 10 g of CF, LI drop markedly increased from 22.4 ± 7 Ω to 24.0 ± 8 Ω at 5 to 25 g CF intervals (5–14 g of CF vs 15–24 g of CF, p < 0.0001), whereas it showed smooth transition over 25 g (24.8 ± 7Ω at ≥ 25 g CF intervals, p = 0.0606 vs 15–24 g of CF). No major complications occurred during the procedures or within 30 days. Conclusions CF significantly affects LI drop and probable consequent lesion formation during RF PVI. The benefit of higher contact (> 25 g) between the catheter and the tissue appears to have less impact on LI drop. Trial registration Catheter Ablation of Arrhythmias With High Density Mapping System in the Real World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998

Abstract Background The very high-power short-duration (vHPSD) temperature-controlled ablation (vHPSD) improves the efficiency of pulmonary vein isolation (PVI) procedures. We evaluated the procedural and 12-months outcomes in atrial fibrillation (AF) patients undergoing PVI by means of vHPSD ablation. In patients with AF or atrial tachyarrythmia (AT) recurrence undergoing a redo procedure the durability of the PVI was investigated. Methods Consecutive paroxysmal/persistent AF patients undergoing PVI with the vHPSD ablation strategy (90 W, for 4 s) were enrolled. The rate of PVI, first-pass isolation, acute reconnection, and procedural complications were evaluated. Follow-up examinations and EKG were scheduled at 3,6, and 12 months. In case of AF/AT recurrence, patients underwent a redo procedure. Results Overall, 163 AF patients (29 persistent and 134 paroxysmal) were enrolled. The PVI was reached in 100% of patients (88% at the first pass). The rate of acute reconnection was 2%. The radiofrequency, fluoroscopy and procedural times were respectively 5.5 ± 1 min, 9 ± 1 min and 75 ± 20 min. No death, tamponade nor steam pops occurred; however, 5 patients had vascular complications. The 12-months freedom from AF/AT recurrence was 86% in both paroxysmal and persistent patients. Overall, 9 patients underwent a redo procedure, and in 4 all veins were still isolated, whereas in 5 pulmonary vein reconnections were found. The PVI durability was 78%. No overt clinical complications were observed in the follow-up. Conclusions The vHPSD ablation represents an effective and safe ablation strategy to achieve PVI. The 12-months follow-up showed high freedom from AF/AT recurrence and a good safety profile.

Introduction Both radiofrequency (RF) and cryoballoon (CB) ablation are treatment options for persistent atrial fibrillation (PsAF). An important recent innovation in RF ablation is Ablation Index (AI), known also as the VISITAG SURPOINT™ Module, a composite lesion quality marker whose use has been shown to significantly reduce the incidence of acute and late pulmonary vein (PV) reconnection and the recurrence of atrial arrhythmias in PsAF. Due to a lack of direct comparative evidence between the latest generations of technologies, there is uncertainty regarding the best treatment option in PsAF. The objective of the present study was to conduct a matching-adjusted indirect treatment comparison (MAIC) using individual patient-level data (IPD) to assess the comparative effectiveness of the THERMOCOOL SMARTTOUCH™ Catheter or the THERMOCOOL SMARTTOUCH™ SF Catheter with AI/VISITAG SURPOINT™ Module (STAI) versus the second-generation CB catheter (Arctic Front Advance™; herein referred to as CB) with respect to 12-month atrial arrhythmia recurrence, fluoroscopy time, and procedural efficiency. Methods IPD for STAI were obtained from four investigator-initiated studies and were pooled. Comparable CB studies identified from a systematic literature review were also pooled. In the absence of a common treatment arm between STAI and CB studies, an unanchored MAIC was conducted. The primary analysis compared the pooled STAI IPD to the pooled CB cohort, with corrections for differences across trials, including eligibility criteria and patient baseline characteristics. Scenario and sensitivity analyses were conducted to assess the robustness of the primary analysis. Results In the primary analysis, which was adjusted for left atrial diameter (LAD), age, diabetes, and sex, STAI was associated with a statistically significant 65% relative reduction in the rate of arrhythmia recurrence compared to CB at 12-month follow-up (HR 0.35; 95% CI 0.23, 0.52). STAI was associated with shorter total fluoroscopy time than CB but longer procedure time. Results were consistent across scenario and sensitivity analyses. Conclusion Radiofrequency ablation with AI significantly reduced atrial arrhythmia recurrence at 12-month follow-up and fluoroscopy time compared to CB, with longer procedure times. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-021-01846-z.

Pulmonary vein (PV) isolation using cryoballoon (CB) catheter is generally characterized by a high radiation and contrast media exposure. A new dielectric imaging system (KODEX–EPD imaging system) allows pulmonary vein (PV) occlusion assessment without dye use. The purpose of this study was to verify the feasibility of reducing the radiation and dye use during CB ablation in patients with atrial fibrillation (AF) using the new dielectric imaging system. In a retrospective, single center study, we enrolled 34 consecutive patients with paroxysmal AF divided in two groups: 17 patients in Conventional Group underwent the procedure under fluoroscopy guidance before the new system introduction, while 17 patient in KODEX–EPD Group underwent the procedure under fluoroscopy and KODEX–EPD imaging system guidance. There were no differences in any clinical and anatomical characteristics between the two study groups. Overall procedure time was comparable between the two groups (69 [IQR 63–98] min in Conventional Group vs. 65 [IQR 58–74] min in KODEX–EPD Group, p = 0.16), while fluoroscopy time (8 [IQR 5–9] min vs. 11 [IQR 9–12] min, p = 0.014) and dye use (35 [IQR 28–45] ml vs. 70 [IQR 57–83] ml, p

BACKGROUND Highly localized impedance (LI) measurements during atrial fibrillation (AF) ablation have recently emerged as a viable real-time indicator of tissue characteristics and durability of the lesions created. We report the outcomes of acute and long-term clinical evaluation of the new DirectSense algorithm in AF ablation. METHODS Consecutive patients undergoing AF ablation were included in the CHARISMA registry. RF delivery was guided by the DirectSense algorithm, which records the magnitude and time-course of the impedance drop. The ablation endpoint was pulmonary vein isolation (PVI), as assessed by the entrance and exit block. RESULTS 3556 point-by-point first-pass RF applications of >10 s duration were analyzed in 153 patients (mean age=59 ± 10 years, 70% men, 61% paroxysmal AF, 39% persistent AF). The mean baseline LI was 105 ± 15 Ω before ablation and 92 ± 12 Ω after ablation (p

Aims This report describes the findings of the 2018 Italian Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC). Methods The Italian Catheter Ablation Registry systematically collects data on the ablation procedures performed in Italy. Data collection was retrospective. A standardized questionnaire was completed by participating centres. Results We collected data on 15 714 catheter ablation procedures performed in Italy during 2018 in 94 electrophysiology centres. In most centres (75/94, 80%), a single electrophysiology laboratory was available, and a hybrid electrophysiology laboratory was available in 15% (14/94) of centres. In most (93%) centres, at least two electrophysiologists were involved in the catheter ablation procedures. In only 13 out of 94 (14%) electrophysiology laboratories, an anaesthesiologist assists every electrophysiology procedure; in most cases (74/94, 79%), an on-demand anaesthesiology service was available. On-site cardiothoracic surgery was reported in 43 out of 94 (46%) centres.Nonfluoroscopic navigation systems were available in most centres (88/94, 93%). Intracardiac echocardiography was used in 59 out of 94 (63%) electrophysiology laboratories. Atrial fibrillation (31%) was the most frequently treated ablation target, followed by atrioventricular nodal re-entrant tachycardia (20%) and cavo-tricuspid isthmus (15%). In 61.7% of all procedures, a 3D mapping system was used. In about one-third of procedures, a near-zero approach was performed. Conclusion In most Italian electrophysiology centres, a single electrophysiology laboratory was available and at least two electrophysiologists were involved in the ablation procedures. An increasing number of procedures were performed by means of a nonfluoroscopic mapping system with a near-zero approach.

Local impedance (LI) drop predicts acute conduction block during pulmonary vein isolation (PVI). Whether the LI drop predicts also the achievement of left atrial posterior wall isolation (LAPWI) in persistent atrial fibrillation (PersAF) patients is unknown. We evaluated the efficacy and the safety of LI drop-guided LAPW ablation by using high power (50 watts) and investigated the impact of ablation parameters on the LI drop.We included consecutive PersAF patients underwent PVI and both roof line and floor line completion to achieve LAPWI with a novel contact force (CF)- and LI-featured catheter (IntellaNAV Stablepoint™). For each radiofrequency (RF) application, we targeted a LI drop of 25 ohms.Out of 30 patients, first-pass floor line block was achieved in 26 (87%) and first-pass roof line block in 17 (57%), resulting in first-pass LAPWI in 14 patients (47%). After touch-up ablations, LAPWI was achieved in 28 patients (93%) with endocardial ablation only. No procedural nor 1-month complications occurred. Overall, 877 RF applications were delivered: 787 ablation tags (89%) were associated with acute conduction block, while 90 (11%) were located at sites of acute gaps in either the roof or floor line. LI drop values were greater at segments with acute block than those with gaps (p 0.001). At multivariable analysis, only LI drop and RF time remained independently associated with the acute block (p 0.001; p = 0.001).LI drop-guided LAPWI at a fixed power of 50 W was effective and did not lead to complications. LI drop was the most important predictor of acute conduction block.

Low-voltage activity beyond pulmonary veins (PVs) may contribute to the failure of ablation of atrial fibrillation (AF) in the long term. We aimed to assess the presence of gaps (PVG) and residual potential (residual antral potential [RAP]) within the antral scar by means of an ultra-high-density mapping (UHDM) system.We studied consecutive patients from the CHARISMA registry who were undergoing AF ablation and had complete characterization of residual PV antral activity. The Lumipoint™ (Boston Scientific) map-analysis tool was used sequentially on each PV component. The ablation endpoint was PV isolation (PVI) and electrical quiescence in the antral region.Fifty-eight cases of AF ablation were analyzed. A total of 86 PVGs in 34 (58.6%) patients and 44 RAPs in 34 patients (58.6%) were found. In 16 (27.6%) cases, we found at least one RAP in patients with complete absence of PV conduction. RAPs showed a lower mean voltage than PVG (0.3 ± 0.2 mV vs. 0.7 ± 0.5 mV, p .0001), whereas the mean number of electrogram peaks was higher (8.4 ± 1.4 vs. 3.2 ± 1.5, p .0001). The percentage of patients in whom RAPs were detected through Lumipoint™ was higher than through propagation map analysis (58.6% vs. 36.2%, p = .025). Acute procedural success was 100%, with all PVs successfully isolated and RAPs completely abolished in all study patients. During a mean follow-up of 453 ± 133 days, 6 patients (10.3%) suffered an AF/AT recurrence.Local vulnerabilities in antral lesion sets were easily discernible by means of the UHDM system in both de novo and redo patients when no PV conduction was present.

Background Optimal pulmonary vein (PV) occlusion, usually verified with selective contrast injection, is mandatory to obtain an effective PV isolation during cryoballoon (CB) ablation. Aim of the study The purpose of this study was to verify the feasibility and the accuracy of a new dielectric sensing system in assessing PV occlusion during CB ablation in patients with atrial fibrillation (AF). Methods We enrolled 28 consecutive patients with paroxysmal or persistent AF. After transseptal access, a detailed image reconstruction of left atrium and PVs was achieved with an octapolar or decapolar mapping catheter (Achieve catheter, Medtronic Inc.) and KODEX-EPD system (EPD Solutions, a Philips company). The degree of PV occlusion with the inflated Arctic Front Advance Cryoballoon (Medtronic Inc.) was verified using the new "occlusion tool" software module (EPD Solutions, a Philips company) and compared to an angiogram obtained with contrast medium injection in each PV. Results A total of 105 PV CB occlusion were tested. The new occlusion tool software module showed a 91% sensitivity and 76% specificity in assessing a complete PV occlusion verified with contrast medium injection. The positive predictive value was 80%, and the negative predictive value was 88.6%. Mean procedure time was 81 ± 17 minutes. Mean fluoroscopy time was 6 ± 2 minutes. No 30-day complications were observed. Conclusion The new dielectric imaging system was able to assess the degree of PV occlusion during a CB ablation with good sensitivity and specificity.

Aims Ablation index (AI) is a marker of lesion quality during catheter ablation that incorporates contact force, time, and power in a weighted formula. This index was originally developed for pulmonary vein isolation as well as other left atrial procedures. The aim of our study is to evaluate the feasibility and efficacy of the AI for the ablation of the cavotricuspid isthmus (CTI) in patients presenting with typical atrial flutter (AFL). Methods and results This prospective multicentre non-randomized study enrolled 412 consecutive patients with typical AFL undergoing AI-guided cavotricuspid isthmus ablation. The procedure was performed targeting an AI of 500 and an inter-lesion distance measurement of ≤6 mm. The primary endpoints were CTI ‘first-pass’ block and persistent block after a 20-min waiting time. Secondary endpoints included procedural and radiofrequency duration and fluoroscopic time. A total of 412 consecutive patients were enrolled in 31 centres (mean age 64.9 ± 9.8; 72.1% males and 27.7% with structural heart disease). The CTI bidirectional ‘first-pass’ block was reached in 355 patients (88.3%), whereas CTI block at the end of the waiting time was achieved in 405 patients (98.3%). Mean procedural, radiofrequency, and fluoroscopic time were 56.5 ± 28.1, 7.8 ± 4.8, and 1.9 ± 4.8 min, respectively. There were no major procedural complications. There was no significant inter-operator variability in the ability to achieve any of the primary endpoints. Conclusion AI-guided ablation with an inter-lesion distance ≤6 mm represents an effective, safe, and highly reproducible strategy to achieve bidirectional block in the treatment of typical AFL.

Catheter-based radiofrequency (RF) ablation utilizes alternating electrical current to create a tissue lesion through the production of resistive heat and conductive heat, this latter spreading away from the point of contact. Several parameters affect lesion size: catheter tip temperature, power output, catheter diameter and orientation, the duration of ablation, and the degree of contact between the catheter and the tissue. Recently introduced catheters that can monitor the catheter–tissue contact force have been found to improve the efficiency of RF ablation in patients undergoing ablation for atrial fibrillation.1, 2, 3, 4, 5 However, only little data are available on how to monitor lesion formation during RF delivery. Recently, a new technology, the DirectSense™ tool, has been proposed that assesses the real-time effectiveness of ablation6 by means of a novel measurement of local impedance (LI) through mini-electrodes on the catheter tip of a dedicated ablation catheter (IntellaNav Mifi OI; Boston Scientific, Marlborough, MA). This system uses highly localized impedance measurements to provide insight into tissue characteristics, and may provide more useful information regarding catheter stability and lesion formation than the use of generator impedance alone.7 Here, we describe how localized impedance information can be leveraged in order to guide the successful ablation of complex arrhythmias. Key Teaching Points • Evaluation of local impedance through dedicated technology is useful not only in assessing effective lesion formation but also in directing radiofrequency (RF) applications to proper sites. • Local impedance could be more helpful than ablation signals in confirming the presence of the gap and in guiding the ablation strategy. Particularly, the highly sensitive detection of increased local impedance in the presence of gaps can be valuable in redo ablation procedures. • A multiparametric approach can better define the structural, electrical, and contact properties of the ablation target, such as the combined use of localized electrical and impedance information, and it is mandatory in order to avoid unnecessary RF lesions. • Ablation lesions in diseased tissue, unlike in healthy myocardium, are not always predicted by the amount of power and duration of the application.

INTRODUCTION Recently, a novel technology able to measure local impedance (LI) and tissue characteristics has been made available for clinical use. This analysis explores the relationships among LI and generator impedance (GI) parameters in atrial fibrillation (AF) patients. Characterization of LI among different ablation spots and procedural success were also evaluated. METHODS AND RESULTS Consecutive patients undergoing AF ablation from the CHARISMA registry at five Italian centers were included. A novel radiofrequency (RF) ablation catheter with a dedicated algorithm (DIRECTSENSE™) was used to measure LI and to guide ablation. The ablation endpoint was pulmonary vein (PV) isolation. We analyzed 2219 ablation spots created around PVs in 46 patients for AF ablation. The mean baseline tissue impedance was 105.8 ± 14 Ω for LI versus 91.8 ± 10 Ω for GI (p

BACKGROUND Which technique is better for repeat ablation in patients with atrial fibrillation (AF) remains unclear. The aim of the study was to compare long-term efficacy of repeat ablation using the alternative technique for the first redo ablation procedure: (a) cryoballoon (CB) re-ablation after a failed index pulmonary vein isolation (PVI) with radiofrequency (RF) ablation, RF-then-CB group or (b) RF repeat ablation following a failed CB ablation, CB-then-RF group. METHODS Within the 1STOP Italian Project, consecutive patients undergoing repeat ablation with a different technique from the index procedure were included. RESULTS We studied 474 patients, 349 in RF-then-CB and 125 in CB-then-RF group. Less women (21% vs 30%; P = .041), more persistent AF (33% vs 22%; P = .015), longer duration of AF (60 vs 31 months; P

A new dielectric-based method (KODEX-EPD mapping system, EPD Solutions, a Philips company) for measuring tissue thickness at the catheter-tissue interface has recently been developed. We reported preliminarydata on real-time catheter-based measuring myocardial wall thickness in vivo, during typical atrial flutter radio frequency ablation.The study population consisted of 12 consecutive patients, suffering from symptomatic paroxysmal or persistent cavo-tricuspid isthmus dependent, counter clockwise and clockwise AFL, under going a first catheter ablation between April 2021 and November 2021. The new KODEX-EPD function, Wall Viever, was used to calculate atrialwall thickness. The atrial wall thickness was significantly higher closeto the tricuspid annulus than close to the inferior vena cava (3.6 ± 0.5 mm vs 2.4 ± 0.3 mm, p .001) and a trend towards a progressive decrease of atrial wall thickness was observed moving the mapping catheter from the tricuspidvalve to the inferior vena cava.Thenew KODEX-EPD function, Wall Viever, allowed us to assess atrial wall thickness during atrial flutter radio frequency ablation.

The antral region of pulmonary veins (PV)s seems to play a key role in a strategy aimed at preventing atrial fibrillation (AF) recurrence. Particularly, low-voltage activity in tissue such as the PV antra and residual potential within the antral scar likely represent vulnerabilities in antral lesion sets, and ablation of these targets seems to improve freedom from AF. The aim of this study is to validate a structured application of an approach that includes the complete abolition of any antral potential achieving electrical quiescence in antral regions.The improveD procEdural workfLow for cathETEr ablation of paroxysmal AF with high density mapping system and advanced technology (DELETE AF) study is a prospective, single-arm, international post-market cohort study designed to demonstrate a low rate of clinical atrial arrhythmias recurrence with an improved procedural workflow for catheter ablation of paroxysmal AF, using the most advanced point-by-point RF ablation technology in a multicenter setting. About 300 consecutive patients with standard indications for AF ablation will be enrolled in this study. Post-ablation, all patients will be monitored with ambulatory event monitoring, starting within 30 days post-ablation to proactively detect and manage any recurrences within the 90-day blanking period, as well as Holter monitoring at 3, 6, 9, and 12 months post-ablation. Healthcare resource utilization, clinical data, complications, patients' medical complaints related to the ablation procedure and patient's reported outcome measures will be prospectively traced and evaluated.The DELETE AF trial will provide additional knowledge on long-term outcome following a structured ablation workflow, with high density mapping, advanced algorithms and local impedance technology, in an international multicentric fashion. DELETE AF is registered at ClinicalTrials.gov (NCT05005143).

Purpose: Ablation index (AI) is a radiofrequency lesion quality marker. The AI value that allows effective and safe pulmonary vein isolation (PVI) is still debated. We evaluated the incidence of acute and late PV reconnection (PVR) with different AI settings and its predictors. Methods: The Ablation Index Registry is a multicenter study that included patients with paroxysmal/persistent atrial fibrillation (AF) who underwent first-time ablation. Each operator performed the ablation using his preferred ablation catheter (ThermoCool® SmartTouch or Surround Flow) and AI setting (380 posterior-500 anterior and 330 posterior-450 anterior). We divided the study population into two groups according to the AI setting used: group 1 (330–450) and group 2 (380–500). Incidence of acute PVR was validated within 30 min after PVI, whereas the incidence of late PVR was evaluated at repeat procedure. Results: Overall, 490 patients were divided into groups 1 (258) and 2 (232). There was no significant difference in the procedural time, fluoroscopy time, and rate of the first-pass PVI between the two study groups. Acute PVR was observed in 5.6% PVs. The rate of acute PVR was slightly higher in group 2 (64/943, 6.8%, PVs) than in group 1 (48/1045, 4.6% PVs, p = 0.04). Thirty patients (6%) underwent a repeat procedure and late PVR was observed in 57/116 (49%) PVs (number of reconnected PV per patient of 1.9 ± 1.6). A similar rate of late PVR was found in the two study groups. No predictors of acute and late PVR were found. Conclusion: Ablation with a lower range of AI is highly effective and is not associated with a higher rate of acute and late PVR. No predictors of PV reconnection were found.

The association of situs inversus totalis and left ventricular noncompaction is very rare and poses several and unique challenges if endo-epicardial ablation has to be performed, both for anatomical access to the target area and for arrhythmia complexity. We report a case of incessant ventricular tachycardia with endo-epicardial involvement that required ablation in both surfaces to obtain final noninducibility.

Background Isthmus-dependent right atrial flutter is the most frequently encountered atrial flutter in clinical practice (80–90% of atrial flutters). Purpose The aim of our study was to assess as first experience the feasibility and safety of radiofrequency catheter ablation (RFCA) of cavo-tricuspid isthmus (CTI) guided by KODEX-EPD imaging system in patients presenting with typical atrial flutter (AFL). Methods 16 consecutive patients (mean age 68,46±7,8 years, 80% males) with diagnosis of AFL underwent RFCA guided by KODEX-EPD imaging system. In 15 patients the analysis performed during tachycardia showed a counter-clockwise activation. In 1 patient no tachycardia could be induced and the ablation was performed in sinus rhythm with fixed pacing from the coronary sinus. The KODEX-EPD imaging system was also used to guide ablation and to confirm persistent bidirectional block after ablation. Results Mean procedural time was 37,6±8,2 min, mean radiofrequency ablation time was 7,8±3,4 min, and mean fluoroscopy time was 2,1±1,2 min. All procedures were acutely successful with interruption of AFL during RFCA along the inferior CTI in 15 patients and achievement of the bidirectional conduction block in 16 patients proven by atrial pacing medial and lateral to the ablation line. There were no major procedural and 30-day complications. Over a mean follow-up of 18 months, we observed no recurrence of arrhythmia and no complications. Conclusions Our study shows that RFCA for AFL using the KODEX-EPD imaging system is feasible, safe, and effective. Funding Acknowledgement Type of funding sources: None.

Background An early, comprehensive rhythm-control therapy is needed in order to treat atrial fibrillation (AF) effectively and to improve ablation outcomes. Methods 153 consecutive patients from the CHARISMA registry undergoing AF ablation at 8 centers were included. Patients with de novo PVI were classified as having undergone early treatment (ET) if the procedure was performed within 6 months after the first AF episode, and as having undergone delayed treatment (DT) if ablation was performed over 6 months after the first AF episode. Results One-hundred fifty-three patients were enrolled (69.9% male, 59±10 years, 61.4% paroxysmal AF, 38.6% persistent AF). The time from the first AF episode to the ablation procedure was 1034±1483 days. The ET group comprised 36 patients (25.3%), the DT group 60 (39.2%) and Redo cases were 57 (37.3%). During a mean follow-up of 366±130 days, 18 patients (11.8%) suffered an AF/AT recurrence. More DT patients than ET patients suffered recurrences (15.7% vs 2.2%, p = 0.0452) and the time to AT/AF recurrence was shorter in the group of patients who received an ablation treatment after 6 months (HR = 6.19, 95%CI: 1.7 to 21.9; p = 0.0474). On multivariate Cox analysis, only hypertension (HR = 4.86, 95%CI:1.6 to 14.98, p = 0.0062) was independently associated with recurrences. Beyond the hypertension risk factor, ET was associated with a low risk of recurrence; recurrence rate ranged from 0% (ET patients without hypertension) to 25.0% (DT patients with hypertension). Conclusions An early rhythm-control ablation therapy in the absence of common risk factors was associated with the lowest rate of recurrences. Clinical trial registration Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998. This article is protected by copyright. All rights reserved.

Background A new catheter-based 3D dielectric imaging modality to guide electrophysiology ablation procedures that does not require contact or X-ray to image and offers new benefits for cryoablation procedures. Case presentation A 51-year-old male with paroxysmal atrial fibrillation was admitted to our hospital for atrial fibrillation ablation that was performed using cryoballoon fourth generation combined with a novel wide-band dielectric imaging system [KODEX-EPD (EPD Solutions, a Philips company)]. Conclusions This system allowed to visualize left common pulmonary vein before balloon positioning and then confirmed by pulmonary vein angiography.

Introduction Ablation Index, also known as VISITAG SURPOINT™, is a novel lesion-quality marker that improves outcomes in radiofrequency (RF) catheter ablation of atrial fibrillation (AF). There is no direct evidence on the comparative effectiveness of RF ablation with Ablation Index and cryoballoon (CB). The objective of the present study was to conduct a matching-adjusted indirect comparison (MAIC) using individual patient-level data (IPD) to compare the effectiveness of RF ablation with Ablation Index to that of CB on recurrence of atrial arrhythmias 12 months after catheter ablation in patients with paroxysmal AF (PAF). Methods Individual patient-level data for RF ablation with Ablation Index were obtained from two studies: Solimene et al. [J Interv Card Electrophysiol 54(1):9–15, 2019] and Hussein et al. [J Cardiovasc Electrophysiol 28(9):1037–1047, 2017]. Comparable CB studies identified from a systematic literature review were pooled. Prognostic variables for adjustment were ranked a priori by several practicing electrophysiologists. In the absence of a common treatment arm between the Ablation Index and CB studies, an unanchored MAIC was conducted. Primary analysis compared the Solimene et al. study to pooled CB studies. A secondary analysis compared pooled RF ablation with Ablation Index studies to pooled CB studies. Several scenario and sensitivity analyses were conducted. Results Primary analyses showed statistically significant reductions in the rate of arrhythmia recurrence with RF ablation with Ablation Index compared to CB in unmatched, unadjusted (HR 0.50, 95% CI 0.27–0.95) and matched (0.42, 0.21–0.86) analyses. Greater reductions in the rate of arrhythmia recurrence that favored RF ablation with Ablation Index were observed after matching and adjusting for age (0.41, 0.20–0.85), age and left ventricular ejection fraction (0.37, 0.16–0.88), and age, sex, and left ventricular ejection fraction (0.30, 0.13–0.71). Secondary and sensitivity analyses showed similar reductions. Conclusions Radiofrequency ablation with Ablation Index was associated with reductions in recurrence of atrial arrhythmias at 12 months compared to CB in unmatched and unadjusted, matched, and matched and adjusted comparisons. Electronic Supplementary Material The online version of this article (10.1007/s12325-019-01173-4) contains supplementary material, which is available to authorized users.

Aims A prolonged PR interval is known to be associated with increased mortality and a higher risk of developing atrial fibrillation (AF). We tested the hypothesis that cardiac resynchronization therapy (CRT) is superior to conventional dual-chamber pacing with algorithms for right ventricular pacing avoidance (DDD-VPA) in preserving systolic and diastolic function and in preventing new-onset AF in patients with normal systolic function, indication for pacing and prolonged atrioventricular conduction (PR interval ≥220 ms). Methods and results We randomly assigned 82 patients with ejection fraction >35%, indication for pacing and PR interval ≥220 ms to CRT or to DDD-VPA. On 12-month follow-up examination, the study and control arms did not differ in terms of left ventricular end-systolic volume (44 ± 17 mL vs. 47 ± 16 mL, P = 0.511) or ejection fraction (55 ± 6% vs. 57 ± 8%, P = 0.291). The E to A mitral wave amplitude ratio was higher in the CRT arm (1.3 ± 1.3 vs. 0.8 ± 0.4, P = 0.046) and the E wave deceleration time was longer (262 ± 83 ms vs. 205 ± 51 ms, P = 0.027). Left atrial volume was smaller in the CRT arm (64 ± 17 mL vs. 84 ± 25 mL, P = 0.035). Moreover, the functional class was lower in CRT patients (1.4 ± 0.6 vs. 1.8 ± 0.5, P = 0.010). During follow-up, CRT was associated with a lower risk of new-onset AF [hazard ratio = 0.37 (0.13–0.98), P = 0.046]. Conclusion Cardiac resynchronization therapy proved superior to DDD-VPA in terms of better diastolic function, less left atrial enlargement and lower risk of new-onset AF, at 12 months. These data need to be confirmed in a larger trial with longer follow-up. Clinical trial registration URL: http://clinicaltrials.gov/ Identifier: NCT02150538

The aim of this survey was to assess the management and organization of cardiac implantable electronic device (CIED) replacement in Italy.A questionnaire consisting of 24 questions on organizational aspects and on the peri-procedural management of anticoagulant therapies and antibiotic prophylaxis was sent via the Internet to 154 Italian arrhythmia centers.A total of 103 out of 154 centers completed the questionnaire (67% response rate). In 43% of the centers, the procedures were performed under day-case admission, in 40% under ordinary admission, and in 17% under either day-case or ordinary admission. The most frequent reason (66%) for choosing ordinary admission rather than day-case admission was to obtain full reimbursement. Although warfarin therapy was continued in 73% of the centers, nonvitamin K oral anticoagulants were discontinued, without bridging, 24 h or less prior to replacement procedures in 88%. Prophylactic antibiotic therapy was systematically administered in all centers; in 97%, the first antibiotic dose was administered 1-2 h prior to procedures. Local antibacterial envelopes were also used in 43% of the centers in patients with a higher risk of device infection.This survey provides a representative picture of how CIED replacements are organized and managed in current Italian clinical practice. The choice of the type of hospitalization (short versus ordinary) was more often motivated by economic reasons (reimbursement of the procedure) than by clinical and organizational factors. Peri-procedural management of anticoagulation and prophylactic antibiotic therapy was consistent with current scientific evidence.

ObjectivesThe association between obesity and atrial fibrillation (AF) is well-established. We aimed to evaluate the impact of index body mass index (BMI) on AF recurrence at 12 months following catheter ablation using propensity-weighted analysis. In addition, periprocedural complications and fluoroscopy details were examined to assess overall safety in relationship to increasing BMI ranges.MethodsBaseline, periprocedural and follow-up data were collected on consecutive patients scheduled for AF ablation. There were no specific exclusion criteria. Patients were categorised according to baseline BMI in order to assess the outcomes for each category.ResultsAmong 3333 patients, 728 (21.8%) were classified as normal (BMI 2), 1537 (46.1%) as overweight (BMI 25.5–29.0 kg/m2) and 1068 (32.0%) as obese (BMI ≥30.0 kg/m2). Procedural duration and radiation dose were higher for overweight and obese patients compared with those with a normal BMI (p=0.002 and p2led to a 1.2-fold increased likelihood of experiencing recurrent AF at 12-months follow-up as compared with overweight patients (HR 1.223; 95% CI 1.047 to 1.429; p=0.011), while no significant correlation was found between overweight and normal BMI groups (HR 0.954; 95% CI 0.798 to 1.140; p=0.605) and obese versus normal BMI (HR 1.16; 95% CI 0.965 to 1.412; p=0.112).ConclusionsPatients with a baseline BMI ≥30 kg/m2have a higher recurrence rate of AF following catheter ablation and therefore lifestyle modification to target obesity preprocedure should be considered in these patients.

PURPOSE A new cryoballoon (CB) technology (POLARx™; Boston Scientific) for pulmonary vein (PV) isolation in patients with atrial fibrillation (AF) has recently been introduced. The aim of this study was to evaluate procedural and biophysical parameters resulting in acute PV isolation when using this new CB. METHODS We assessed the first 69 consecutive patients indicated for AF ablation who underwent PV isolation by means of a novel CB system. Procedural metrics were prospectively recorded. RESULTS A total of 274 PVs were targeted in 69 patients. PV isolation was achieved in all patients by means of cryoablation alone. The median time to isolation (TTI) was 44 [31-68] s (median temperature at TTI = - 49 [- 53 to - 41] °C). The median duration of CB ablation was 180 [180 to 240] s. The median nadir temperature was - 56.0 [- 61 to - 52] °C, and the median thaw time to 0 °C was 18 [15-21] s. The median grade of PV occlusion was 4 [3 to 4]. On the basis of ROC analysis, we defined the following cut-off values for acute PV isolation: - 56 °C for nadir temperature (sensitivity = 73.3%, specificity = 64.6%, AUC = 0.716; positive predictive value = 88.1%), 30 s for TTT (60.2%, 53.3%, 0.578; 79.7%), thaw time > 17 s (65.3%, 70.0%, 0.709; 86.9%), and grade of PV occlusion = 4 (79.4%, 66.7%, 0.738; 88.5%). No major procedure-related adverse events were observed at 30-day post-procedure. CONCLUSIONS The new POLARx™ CB appears to be effective and safe. A nadir temperature of - 56 °C, a thaw time to 0 °C ≥ 17 s, and complete PV occlusion were the best predictors of acute PV isolation. CLINICAL TRIAL REGISTRATION Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/Identifier : NCT03793998. Registration date: January 4, 2019.

Funding Acknowledgements Type of funding sources: None. Background An early and comprehensive rhythm-control therapy emerges as a need to treat AF in an effective way and to improve the ablation outcomes, in terms of arrhythmia-free survival. Purpose We aimed to investigate the importance of timing of ablation in preventing AF recurrences. Methods 153 consecutive patients (pts) undergoing AF ablation from the CHARISMA registry at 8 Italian centres were included. Ablations were guided by a novel radiofrequency ablation catheter with local impedance (LI)-sensing capability through a dedicated algorithm (DirectSense, Boston Scientific). Pts were grouped as early treated (ET) if the procedure was performed within 1 year after the first AF episode and as delayed treated (DT) if admitted for ablation after more than 1 year. The ablation endpoint was PVI as assessed by entrance and exit block. Post-ablation follow-up was scheduled at 3, 6 and 12 months. AF and atrial tachycardia (AT) recurrences were considered as long-term endpoint. Results Of the 153 pts enrolled (69.9% male, 59 ± 10 years, 61.4% paroxysmal AF, 38.6% persistent AF), 123 (80.4%) met Class I indications, 23 (15%) Class IIa indications and 7 (4.6%) Class IIb indications according to current ESC AF guidelines. The mean time to ablation procedure from the first AF episode was 1034 ± 1483 days. Eighty pts (52.3%) were included in ET group, whereas 73 pts (47.7%) in DT group. No differences were found between AF type in terms of ablation strategy (53.3% of the cases -52 out 94- were classified as ET for paroxysmal AF vs 47.5% of the cases -28 out 59- were ET for persistent AF, p = 0.4346). At the end of the procedures, all PVs had been successfully isolated in all study pts. During a mean follow-up of 366 ± 130 days, 18 pts (11.8%) suffered an AF/AT recurrence after the 90-day blanking period. Recurrences occurred mostly in the DT group compared to the ET one (13 out 73 -17.8%- vs 5 out 80 -6.3%-, p = 0.042) and the time to AT/AF recurrence was longer in the ET group (HR = 0.2876, 95%CI: 0.1029 to 0.8038; p = 0.0181). On multivariate logistic analysis adjusted for baseline confounders, only hypertension (HR = 4.66, 95%CI: 1.5 to 14.48, p = 0.0081) was independently associated with recurrences. An early rhythm-control therapy was associated with a low risk of recurrences beyond the hypertension risk factor, ranging from 2% (no hypertension and an ET ablation therapy) to 30.3% (with hypertension and a DT procedure) (Figure 1). Conclusion A LI-guided ablation strategy for PVI proved to be safe and effective and resulted in a very high recurrence-free rate. An early rhythm-control therapy in the absence of common risk factors was associated with the lowest rate of recurrences. Abstract Figure. AT/AF Recurrence

Funding Acknowledgements Type of funding sources: None. Background. Fluoroscopy is commonly used in cryoballoon catheter ablation for pulmonary vein (PV) isolation procedures in patients with atrial fibrillation (AF). Objective The purpose of this study was to verify the feasibility of a new dielectric imaging system in reducing the radiation exposure during cryoballoon ablation in patients with AF. Methods We enrolled 26 consecutive patients with paroxysmal AF: 13 patients underwent the procedure under fluoroscopy guidance before the new system introduction, while 13 patient underwent the procedure under fluoroscopy and KODEX-EPD system guidance with its occlusion tool software. After transseptal access a detailed image reconstruction of left atrium and PVs was achieved with the Achieve octapolar circular mapping catheter and the cryoablation was performed with the Arctic Front Advance cryoballoon. Results Total time of the procedure was comparable between the two groups (90.15 ± 28.67 vs 80.77 ± 17.17 using KODEX-EPD, p = 0.34), while fluoroscopy time was significantly lower in the group using KODEX-EPD (16.92 ± 8.96 vs 5.54 ± 2.06, p Conclusion This is the first study that demonstrates the feasibility of a reduce fluoroscopy workflow using the novel KODEX-EPD system in a cryoballoon procedure. Abstract Figure. Fluoroscopy time

Funding Acknowledgements Type of funding sources: None. Background Complete electrical pulmonary vein isolation (PVI) by cryo-balloon approach is a well-established ablation strategy of atrial fibrillation (AF). Recently, a new cryoablation system (POLARx) with unique features has been made available for clinical use. To date, no data exist on procedural characteristics of this system in a multicentric clinical practice. Purpose We aimed to characterize the initial experience of this technology in the Italian clinical practice. Methods Consecutive patients (pts) undergoing AF ablation from the CHARISMA registry at 5 Italian centres were included. Protocol-directed cryoablation was delivered for 180 sec or 240 sec according to operator’s preference for isolation achieved in ≤60 sec, or 240 sec if isolation occurred >60 sec or when time to isolation (TTI) was not available. The ablation endpoint was PV isolation as assessed by entrance and exit block. Results Two-hundred sixty-two cryoapplications from 49 pts (194 PVs) were analyzed. PVI was achieved with cryoablation only in all pts. The mean number of freeze applications per pt was 5.3 ± 1.5 (1.3 ± 0.6 for LIPV, LSPV and RSPV, 1.6 ± 1.3 for RIPV), with 143 (73.7%) PVs treated in a single-shot fashion (38, 19.6% with 2 shots; 13, 6.7% with more than 2 shots). Sixteen (33%) pts were treated with a single freeze to each of the PVs. The mean nadir temperature was -55.5 ± 6.9 °C and was colder than -50°C in 83% of the PVs. TTI information was evaluable in 120 (46%) cryoapplications with a median TTI of 47 [32-75] sec (median temperature at TTI = -49 [-53 to -42] °C). The mean time to target -40 °C (TTT) was 30.1 ± 6.9 sec with a TTT < 60 sec achieved in 99.2% of the cryoapplications; the mean thaw time to 0 °C was 18.6 ± 5.8 sec (thaw time >15 sec in 70.3% of the cryoapplications). The mean PV occlusion grade (rank 1-4) was 3.6 ± 0.6 (grade 2 in 5.2% of the cases, grade 3 in 25.6% and grade 4 in 69.2%). No complications were observed at 30 days post-procedure. Conclusion In this first multicentric experience in a clinical practice setting, the novel cryo-balloon system proved to be safe and effective and resulted in a high proportion of successful single-freeze isolation. Cooling parameters seem to be slightly different from reference cryo-balloon technology.