National workflow experience with pulsed field ablation for atrial fibrillation: learning curve, efficiency, and safety.

BACKGROUND: Recent data on pulsed field ablation (PFA) for atrial fibrillation (AF) ablation suggest a progressive reduction in procedural times. Real-world data regarding the relationship between the learning curve of PFA and clinical outcomes are scarce. The objective was to evaluate the PFA learning curve and its impact on acute outcomes. METHODS: Consecutive patients undergoing AF ablation with the FARAPULSE™ PFA system were included in a prospective, non-randomized multicenter study. Procedural times were stratified on the operators' learning curve. Comparative analysis of skin-to-skin time was conducted with radiofrequency (RF) and cryoablation (CB) pulmonary vein isolation (PVI) procedures performed by the same operators in the previous year. RESULTS: Among 752 patients, 35.1% were females, and 66.9% had paroxysmal AF; mean age was 62.2 ± 10 years. A total of 62.5% of procedures were performed by operators with > 20 PFA procedures. Both time to PVI (25.6 ± 10 min vs 16.5 ± 8, p < 0.0001) and fluoroscopy time (19.8 ± 8 min vs 15.9 ± 8 min, p = 0.0045) significantly improved after 10 associated with consistent linear trend towards procedural time reduction (R2 0.92-0.68 across various procedural metrics). Current PFA skin-to-skin time was lower than the historical skin-to-skin one in 217 (62.4%) procedures; it was similar in 112 (32.2%) cases and higher than the historical skin-to-skin one in 19 (5.5%). No major complications were reported. CONCLUSIONS: In this nationwide multicentric experience, the novel PFA system proved to be fast, safe, and acutely effective in both paroxysmal and persistent AF patients. The learning curve appears to be rapid, as improvements in procedural parameters were observed after only a few procedures. CLINICAL TRIAL REGISTRATION: Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA). URL: http://clinicaltrials.gov/ Identifier: NCT05617456.

Pulsed field vs very high-power short-duration radiofrequency ablation for atrial fibrillation: Results of a multicenter, real-world experience.

BACKGROUND: Pulsed field ablation (PFA) and very high-power short-duration (vHPSD) radiofrequency ablation are the most recently introduced technologies for atrial fibrillation (AF) ablation. The procedural performance, safety, and effectiveness of PFA vs vHPSD are currently unknown. OBJECTIVE: The study aimed to compare PFA with vHPSD for the treatment of paroxysmal or persistent AF. METHODS: We conducted an observational, multicenter study enrolling 534 consecutive patients (63 ± 9 years; 36% female) with paroxysmal (n = 368 [69%]) or persistent (n = 166 [31%]) AF undergoing ablation by either PFA (Farawave; n = 192) or vHPSD (90 W/4 seconds; QDOT Micro; n = 342) between 2020 and 2023. Atrial tachyarrhythmia recurrence after a 1-month blanking period was the primary efficacy end point and was assessed both overall and in propensity score-matched patients. The primary safety end point was a composite of procedure-related complications. RESULTS: Successful pulmonary vein isolation was achieved in all patients, with shorter procedure duration (PFA,70 minutes; vHPSD, 100 minutes; P < .001) but longer fluoroscopy time (PFA, 15 minutes; vHPSD, 7 minutes; P < .001) in the PFA group. PFA was associated with more frequent use of general anesthesia (P < .001). Primary safety outcome events occurred in 19 patients (3.5%), with similar prevalence in both groups (PFA, 4%; vHPSD, 3%; P = .745). After a median follow-up of 12 (9-12) months, survival free from recurrent atrial tachyarrhythmia was similar between the PFA and vHPSD groups, both overall (12-month estimate: PFA, 75%; vHPSD, 76%; log-rank P = .73) and in propensity score-matched patients (n = 342; 12-month estimate: PFA, 75%; vHPSD, 77%; log-rank P = .980). CONCLUSION: In a large, multicenter experience, PFA was associated with more common use of general anesthesia, shorter procedural times, and longer fluoroscopy exposure compared with vHPSD ablation, with both techniques displaying superimposable safety and efficacy.

Pulsed field ablation technology for pulmonary vein and left atrial posterior wall isolation in patients with persistent atrial fibrillation.

INTRODUCTION: Limited data exist on pulsed-field ablation (PFA) in patients with persistent atrial fibrillation (PeAF) undergoing left atrial posterior wall isolation (LAPWI). METHODS: The Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA) prospective registry included consecutive patients referred for PeAF catheter ablation at 9 Italian centers, treated with the FARAPULSETM-PFA system. The primary efficacy and safety study endpoints were the acute LAPWI rate, freedom from arrhythmic recurrences and the incidence of major periprocedural complications. Patients undergoing pulmonary vein isolation (PVI) alone, PWI + LAPWI and redo procedures were compared. RESULTS: Among 249 patients, 21.7% had long-standing PeAF, 79.5% were male; mean age was 63 ± 9 years. LAPWI was performed in 57.6% of cases, with 15.3% being redo procedures. Median skin-to-skin times (PVI-only 68 [60-90] vs. PVI + LAPWI 70 [59-88] mins) did not differ between groups. 45.8% LAPWI cases were approached with a 3D-mapping system, and 37.3% with intracardiac echocardiography. LAPWI was achieved in all patients by means of PFA alone, in 88.8% cases at first pass. LAPWI was validated either by an Ultrahigh-density mapping system or by recording electrical activity + pacing maneuvers. No major complications occurred, while 2.4% minor complications were detected. During a median follow-up of 273 [191-379] days, 41 patients (16.5%) experienced an arrhythmic recurrence after the 90-day blanking period, with a mean time to recurrence of 223 ± 100 days and no differences among ablation strategies. CONCLUSION: LAPWI with PFA demonstrates feasibility, rapidity, and safety in real-world practice, offering a viable alternative for PeAF patients. LAPWI is achievable even with a fluoroscopy-only method and does not significantly extend overall procedural times.

Intracardiac echocardiography-guided pulsed-field ablation for successful ablation of atrial fibrillation: a propensity-matched analysis from a large nationwide multicenter experience.

BACKGROUND: Intracardiac echocardiography (ICE) is increasingly employed in atrial fibrillation (AF) ablation procedures, with the potential to enhance procedural efficacy. Nevertheless, there is currently a lack of evidence assessing the impact of ICE on the efficiency, effectiveness, and safety outcomes in the context of novel pulsed-field ablation (PFA) for AF. PURPOSE: We aimed to assess whether the use of ICE could improve procedural parameters in a large population undergoing AF ablation with FARAPULSE™ catheter. METHODS: Consecutive patients who had undergone PFA of AF from nine Italian centers were included. In procedures where the ICE catheter was employed for guidance (ICE-guided group), it was used to maneuver the PFA catheter within the left atrium to achieve optimal contact with atrial structures. RESULTS: We analyzed 556 patients: 357 (66%) with paroxysmal AF, 499 (89.7%) de novo PVI. ICE-guided procedures (n = 138) were propensity matched with patients with a standard approach (n = 138), and their outcomes were compared. During ICE-guided procedures, no improvement in procedural metrics was recorded (ICE vs Standard, 23 ± 6 min vs 18.5 ± 9 min for time to PVI, p < 0.0001; 38.8 ± 7 vs 32.5 ± 5 number of PFA deliveries to achieve PVI, p < 0.0001; 68.8 ± 19 min vs 71.8 ± 29 min for primary operator time, p = 0.5301; 16.1 ± 8 min vs 18.2 ± 10 min for fluoroscopy time, p = 0.5476) except for support time (76.8 ± 26 min vs 91.4 ± 37 min, p = 0.0046). No major procedure-related adverse events were reported. CONCLUSION: Our findings confirmed that PFA could be consistently performed in a rapid, safe, and efficacious manner. The use of ICE to guide PFA was not associated with an improvement in procedural metrics.

An annotation-independent algorithm based on electrogram characteristics to guide the identification of ventricular tachycardia isthmuses in patients with structural heart disease.

BACKGROUND: Criteria such as electrograms voltage or late potentials have been largely utilized in the past to help identify areas of substrate maps that are within the ventricular tachycardia (VT) isthmus; yet their specificity and positive predictive value are quite low. The Lumipoint fractionation tool of the Rhythmia system illuminates regions with fractionated electrograms irrespective of their timing and annotation. We aimed to ascertain whether the use of this tool can rapidly identify areas within VT isthmuses from substrate maps. METHODS: Thirty patients with structural cardiomyopathy in whom a complete right ventricular-paced substrate map and a full reconstruction of the diastolic isthmus during VT could be obtained were enrolled. The VT isthmus border was projected on each substrate map to verify whether the areas illuminated by Lumipoint fell within those borders. The behavior of the electrograms detected at the illuminated areas of the substrate maps was studied during a right ventricular drive train and extra stimulus protocol: if the near field potentials showed a delayed conduction after a single extra stimulus, defined as a minimum of 10 ms increase of the time interval between the far field and the near field activation measured during the drive train, the electrogram was said to have a "decremental" behavior. RESULTS: The logistic analysis showed that areas with fractionated electrograms illuminated by the Lumipoint software and showing the greatest decremental behavior fell within the VT isthmus borders (OR = 1.66, CI: 1.41-1.75, p<0.001; OR=1.57 CI: 1.32-1.72, p<0.001, respectively) with a sensitivity, specificity, and positive predictive value of 87%, 96%, and 97%, respectively. CONCLUSIONS: Fractionated electrograms illuminated by the automated Lumipoint software on right ventricular-paced substrate maps showing the greatest decremental behavior fall within the VT isthmus borders with a probability of 0.97, irrespective of their timing, annotation, or voltage, without any need for subjective assessment of their involvement in slow conduction areas.

Tissue thickness measured with dielectric-based technology during radiofrequency catheter ablation.

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.

Combining contact force and local impedance to treat idiopathic premature ventricular contractions from the outflow tracts: impact of ablation strategy on outcomes.

BACKGROUND: Contact force (CF)-sensing catheters have not proved superior to standard catheters in the ablation of premature ventricular contractions (PVCs) from the right and left ventricular outflow tract (RVOT, LVOT). In this context, the utility of measuring local impedance (LI) is not known. We aimed to ascertain whether the use of a catheter combining LI and CF information was associated with superior outcomes in comparison with other catheter technologies. METHODS: We compared three groups of 40 propensity-matched patients with PVCs from the OTs, ablated by means of different catheter technologies: a CF-plus LI-featured catheter, an LI-featured catheter, and a standard irrigated catheter. RESULTS: The CF + LI group displayed a significantly lower risk of PVC recurrence than the standard ablation group (HR, 0.22; 95%CI, 0.07-0.71; p = 0.01). In the CF + LI group, LI drop and RF time were the only predictors of successful lesions (OR = 1.19, CI: 1.13-1.26, p < 0.001; OR = 1.06 CI: 1.01-1.07, p = 0.044, respectively). In the coronary cusps, unlike the RVOT/LVOT region, CF was not associated with LI drop (p = 0.48), and RF duration showed a linear relationship with LI drop (p < 0.001). CONCLUSIONS: The use of ablation catheters that combine CF and LI information is associated with increased success in the RF ablation of PVCs from the OTs. LI drop is the most important predictor of effective lesions, but its behavior depends on the ablation site: in the coronary cusps, unlike the RVOT/LVOT region, longer RF application times are needed in order to achieve LI drops associated with successful outcomes. REGISTRY AND REGISTRATION NO. OF THE STUDY/TRIAL: NCT03793998.

One-year outcomes in patients undergoing very high-power short-duration ablation for atrial fibrillation.

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.

Implantable cardioverter defibrillator lead performance: A systematic review and individual patient data Meta-analysis.

BACKGROUND: Reliable post-approval surveillance of implantable cardioverter-defibrillator (ICD) lead performance remains a challenge. In the past, two ICD leads were recalled due to a high frequency of failures. In this meta-analysis, we sought to provide a combined estimate of failure-free rate for ICD leads by reconstructing individual patient data from published Kaplan-Meier (KM) curves and to investigate whether estimates could be influenced by the characteristics of the study. METHODS: Observational studies assessing failure-free estimates of transvenous ICD leads with KM method, were identified through a systematic search up to November 2021. RESULTS: Forty-four studies were eligible that included 41,870 (63.1%) non-recalled leads and 24,493 (36.9%) recalled leads. The 8-year cumulative failure-free rate was 94.1% (CI, 93.6% - 94.6%) for contemporary non-recalled leads and 81.2% (80.3% - 82.0%) for recalled leads (hazard ratio [HR], 3.15 [2.85-3.47], p < 0.001). Failure-free rate was lower in single-center studies in both the non-recalled (HR, 0.28 [0.15-0.51], p < 0.001) and recalled (HR, 0.54 [0.33-0.88], p = 0.014) group compared with multicenter studies. Similarly, estimates were significantly lower in small (i.e. extracted KM curve with <312 leads) versus large studies (HR non-recalled group, 0.54 [CI, 0.33-0.89], p = 0.015; HR recalled group, 0.62 [CI, 0.43-0.89], p = 0.009). CONCLUSIONS: In this meta-analysis including >66,000 leads, we provide pooled survival curves that may play a role in generating evidence-based standards for assessing clinically acceptable failure rates for ICD leads. Lead performance was underestimated with single-center and small-sized studies; multicenter studies remain the main tool to reliably conduct post-market surveillance of ICD leads.

Prospective evaluation of local impedance drop to guide left atrial posterior wall ablation with high power.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Dielectric-based tissue thickness measured during radiofrequency catheter ablation.

INTRODUCTION: 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. METHODS AND RESULTS: 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. CONCLUSIONS: Thenew KODEX-EPD function, Wall Viever, allowed us to assess atrial wall thickness during atrial flutter radio frequency ablation.

Targeted ablation of residual pulmonary vein potentials in atrial fibrillation ablation through ultra-high-density mapping: Insights from the CHARISMA registry.

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Improved procedural workflow for catheter ablation of paroxysmal AF with high-density mapping system and advanced technology: Rationale and study design of a multicenter international study.

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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).

Cavotricuspid isthmus ablation by means of very high power, short-duration, temperature-controlled lesions.

BACKGROUND: 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). METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.

When local impedance meets contact force: preliminary experience from the CHARISMA registry.

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.

Fluoroscopy and contrast media use in cryoballoon ablation of atrial fibrillation using a novel imaging system.

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 < 0.001) were significantly lower in the KODEX-EPD Group. No 30-day complications were observed. At 12-month follow-up 7/37 (19%) patients had an atrial arrhythmias recurrence, without any difference between the two study groups (17.6% vs. 23.5%, p = 0.68). The use of a new dielectric imaging system allowed a significantly reduction in radiation exposure and dye use during CB ablation in patients with AF.

In vivo biophysical characterization of very high power, short duration, temperature-controlled lesions.

INTRODUCTION: A very high-power short-duration (vHPSD) strategy of radiofrequency (RF) ablation aims to minimize conductive heating and increase resistive heating. This study aimed to clarify the contribution of contact force (CF) and temperature and their interrelationship in making an adequate lesion with the vHPSD catheter. METHODS: We enrolled 46 consecutive patients undergoing first catheter ablation for atrial fibrillation (AF). The vHPSD ablation was performed applying 90 W, for 4 s, with an irrigation of 8 ml/min. During an application, an impedance drop (ID) ≥10 Ω was regarded as an adequate lesion formation. RESULTS: The mean procedural time was 95 ± 15 min. First-pass isolation was reached in 89% of patients and at the end of the procedure all pulmonary veins were isolated. No steam pop nor procedural complication occurred. A total of 3829 qualified RF points were analyzed and the median values of ID, CF and maximum temperature were respectively 10.6 (IQR 8.6-13.1) Ohm, 9 (5.8-13.8) g, 46.8 (44.1-49.8) °C. The mean ID significantly increased in parallel with the increasing CF as well as with the increasing maximum temperature. In the multivariable analysis only the CF and the maximum temperature were independent predictors of ID. From receiver operating characteristic curve analysis, a CF of 8 g and a maximum temperature of 47°C are the optimal cutoff discriminatory value for adequate lesion formation. CONCLUSIONS: The vHPSD ablation is highly effective and safe. The CF and the maximum temperature are independent predictors of adequate lesion formation assessed by means of ID.

High-density mapping and ablation of an incessant ventricular tachycardia with endo-epicardial involvement in a patient with situs inversus totalis and left ventricular noncompaction.

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.

Effective nonapical left ventricular pacing with quadripolar leads for cardiac resynchronization therapy.

BACKGROUND: Current guidelines recommend avoiding apical left ventricular (LV) pacing for cardiac resynchronization therapy (CRT). AIMS: We investigated the feasibility of nonapical pacing with the current quadripolar LV lead technology. METHODS: We analyzed consecutive patients who received CRT with an LV quadripolar lead. The post--implantation position of each electrode of the LV lead was designated as basal, mid, or apical. The pacing capture threshold (PCT) and phrenic nerve stimulation (PNS) threshold were assessed for each electrode. RESULTS: We enrolled 168 patients. A total of 8 CRT defibrillators were from Biotronik (with Sentus OTW QP leads), 98 were from Boston Scientific (with 21 Acuity X4 Spiral and 77 Acuity X4 Straight leads), and 62 from St. Jude Medical (with Quartet leads). The median (interquartile range) number of electrodes at nonapical segments per patient was 3 (1-4) with Biotronik Sentus leads, 4 (3-4) with spiral -design Boston Scientific leads, 4 (3-4) with straight Boston Scientific leads, and 3 (3-4) with St. Jude Medical Quartet leads (P = 0.045). Three patients (38%) with Biotronik Sentus leads, 21 (100%) with spiral -design Boston Scientific leads, 69 (90%) with straight -design Boston Scientific leads, and 49 (79%) with St. Jude Medical Quartet leads (P <0.001) had at least 1 electrode located at nonapical segments linked with a PNS -PCT safety margin of more than 2 V. During the 6-month follow -up, PNS was detected in 4 patients and was eliminated with reprogramming. No significant changes in PCT were detected during follow -up. CONCLUSIONS: Quadripolar leads allowed nonapical pacing with acceptable electrical parameters in the majority of CRT recipients, although differences were found among the currently available devices.