Acute post-procedural inducibility is a poor predictor of clinical outcomes in high-risk patients (PAINESD > 17) undergoing scar-related ventricular tachycardia ablation.

AIMS: Ventricular tachycardia (VT) non-inducibility in response to programmed ventricular stimulation (PVS) is a widely used procedural endpoint for VT ablation despite inconclusive evidence with respect to clinical outcomes in high-risk patients. The aim is to determine the utility of acute post-ablation VT inducibility as a predictor of VT recurrence, mortality, or mortality equivalent in high-risk patients. METHODS AND RESULTS: We conducted a retrospective analysis of high-risk patients (defined as PAINESD > 17) who underwent scar-related VT ablation at our institution between July 2010 and July 2022. Patients' response to PVS (post-procedure) was categorized into three groups: Group A, no clinical VT or VT with cycle length > 240 ms inducible; Group B, only non-clinical VT with cycle length > 240 ms induced; and Group C, all other outcomes (including cases where no PVS was performed). The combined primary endpoint included death, durable left ventricular assist device placement, and cardiac transplant (Cox analysis). Ventricular tachycardia recurrence was considered a secondary endpoint (competing risk analysis). Of the 1677 VT ablation cases, 123 cases met the inclusion criteria for analysis. During a 19-month median follow-up time (interquartile range 4-43 months), 82 (66.7%) patients experienced the composite primary endpoint. There was no difference between Groups A and C with respect to the primary [hazard ratio (HR) = 1.21 (0.94-1.57), P = 0.145] or secondary [HR = 1.18 (0.91-1.54), P = 0.210] outcomes. These findings persisted after multivariate adjustments. The size of Group B (n = 13) did not permit meaningful statistical analysis. CONCLUSION: The results of post-ablation PVS do not significantly correlate with long-term outcomes in high-risk (PAINESD > 17) VT ablation patients.

Cryoballoon pulmonary vein isolation versus radiofrequency ablation of the pulmonary veins and left atrial posterior wall: Patient-reported outcomes.

BACKGROUND: Data are lacking on patient-reported outcomes (PRO) following cryoballoon ablation (CBA) versus radiofrequency ablation (RFA). We sought to evaluate QoL and clinical outcomes of cryoballoon pulmonary vein isolation only (CRYO-PVI-ONLY) versus RFA with PVI and posterior wall isolation (RF-PVI+PWI) in a large prospective PRO registry. METHODS: Patients who underwent AF ablation (2013-2016) at our institution were enrolled in an automated, prospectively maintained PRO registry. CRYO-PVI-ONLY patients were matched (1:1) with RF-PVI+PWI patients based on age, gender, and type of AF (paroxysmal vs. persistent). QoL and clinical outcomes were assessed using PRO surveys at baseline and at 1-year. The atrial fibrillation symptom severity scale (AFSSS) was the measure for QoL. Additionally, we assessed patient-reported clinical improvement, arrhythmia recurrence, and AF burden (as indicated by AF frequency and duration scores). RESULTS: A total of 296 patients were included (148 in each group, 72% paroxysmal). By PRO, a significant improvement in QoL was observed in the overall study population and was comparable between CRYO-PVI-ONLY and RF-PVI+PWI (baseline median AFSSS of 11.5 and 11; reduced to 2 and 4 at 1 year, respectively; p = 0.44). Similarly, the proportion of patients who reported improvement in their overall QoL and AF related symptoms was high and similar between the study groups [92% (CRYO-PVI-ONLY) vs. 92.8% (RF-PVI+PWI); p = 0.88]. Arrhythmia recurrence was significantly more common in the CRYO-PVI-ONLY group (39.7%) compared to RF-PVI+PWI (27.7 %); p = 0.03. Comparable results were observed in paroxysmal and persistent AF. CONCLUSION: CRYO-PVI-ONLY and RF-PVI+PWI resulted in comparable improvements in patient reported outcomes including QoL and AF burden; with RF-PVI+PWI being more effective at reducing recurrences.

Trends and disparities in ventricular tachycardia mortality in the United States.

We aimed to evaluate trends and disparities in mortality from ventricular tachycardia in patients with underlying cardiovascular disease. We performed cross-sectional analyses using publicly available data from the Center for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research database. We identified a total of 7025 deaths from ventricular tachycardia between the years 2007 and 2020. Overall, age-adjusted mortality rates increased from 0.22 in 1999 to 0.32 in 2020 (p < .05). Black female and male adults had higher age-adjusted mortality rates compared to White female and male adults, respectively (p < .05). Disproportionate age-adjusted mortality rates among male populations and Southern residents were also observed. This study demonstrated an increase in deaths related to ventricular tachycardia since 2007. Significant differences in mortality exist across racial, gender, and geographic subgroups.

Impact of redo ablation for atrial fibrillation on patient-reported outcomes and quality of life.

INTRODUCTION: Catheter ablation for atrial fibrillation (AF) is frequently used for the purpose of rhythm control and improved quality of life (QoL). Although success rates are high, a significant proportion of patients require redo ablation. Data are scarce on patient-centered outcomes and QoL in patients undergoing redo AF ablation. We aimed to assess QoL and clinical outcomes using a large prospectively maintained patient-reported outcomes (PRO) registry. METHODS: All patients undergoing redo AF ablation (2013-2016) at our center were enrolled in a prospective registry for outcomes and assessed for QoL using automated PRO surveys (baseline, 3 and 6 months after ablation, every 6 months thereafter). Data were collected over 3 years of follow-up. The atrial fibrillation symptom severity scale (AFSSS) was used as the main measure for QoL. Additional variables included patient-reported improvement, AF burden, and AF-related healthcare utilization including emergency room (ER) visits and hospitalizations. RESULTS: A total of 848 patients were included (28% females, mean age 63.8, 51% persistent AF). By automated PRO, significant improvement in QoL was noted (baseline median AFSSS of 12 [5-18] and ranged between 2 and 4 on subsequent assessments; p < .0001), with ≥70%of patients reported remarkable improvement in their AF-related symptoms. The proportion of patients in AF at the time of baseline survey was 36%, and this decreased to <8% across all time points during follow-up (p < .0001). AF burden was significantly reduced (including frequency and duration of episodes; p < .0001), with an associated decrease in healthcare utilization after 6 months from the time of ablation (including ER visits and hospitalizations; p < .0001). The proportion of patients on anticoagulants or antiarrhythmics decreased on follow-up across all time points (p < .0001 for all variables). CONCLUSION: Most patients derive significant QoL benefit from redo AF ablation; with reduction of both AF burden and healthcare utilization.

Impact of obesity on catheter ablation of atrial fibrillation: Patient characteristics, procedural complications, outcomes, and quality of life.

INTRODUCTION: Obesity is a well-known risk factor for atrial fibrillation (AF). We aim to evaluate the effect of baseline obesity on procedural complications, AF recurrence, and symptoms following catheter ablation (CA). METHODS: All consecutive patients undergoing AF ablation (2013-2021) at our center were enrolled in a prospective registry. The study included all consecutive patients with available data on body mass index (BMI). Primary endpoint was AF recurrence based on electrocardiographic documentation. Patients were categorized into five groups according to their baseline BMI. Patients survey at baseline and at follow-up were used to calculate AF symptom severity score (AFSS) as well as AF burden (mean of AF duration score and AF frequency score; scale 0: no AF to 10: continuous and 9 frequencies/durations in between). Patients were scheduled for follow-up visits with 12-lead electrocardiogram at 3, 6, and 12 months after ablation, and every 6 months thereafter. RESULTS: A total of 5841 patients were included (17% normal weight, 34% overweight, 27% Class I, 13% Class II, and 9% Class III obesity). Major procedural complications were low (1.5%) among all BMI subgroups. At 3 years AF recurrence was the highest in Class III obesity patients (48%) followed by Class II (43%), whereas Class I, normal, and overweight had similar results with lower recurrence (35%). In multivariable analyses, Class III obesity (BMI ≥ 40) was independently associated with increased risk for AF recurrence (hazard ratio, 1.30; confidence interval, 1.06-1.60; p = .01), whereas other groups had similar risk in comparison to normal weight. Baseline AFSS was lowest in normal weight, and highest in Obesity-III, median (interquartile range) 10 (5-16) versus 15 (10-21). In all groups, CA resulted in a significant improvement in their AFSS with a similar magnitude among the groups. At follow-up, AF burden was minimal and did not differ significantly between the groups. CONCLUSION: AF ablation is safe with a low complication rate across all BMI groups. Morbid obesity (BMI ≥ 40) was significantly associated with reduced AF ablation success. However, ablation resulted in improvement in QoL including reduction of the AFSS, and AF burden regardless of BMI.

Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial.

BACKGROUND: The use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra-operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant. METHODS: We designed a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra-operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life. CONCLUSION: The primary aim of this first-ever randomized trial is to assess the efficacy of intra-operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA.

Direction-aware mapping algorithms have minimal impact on bipolar voltage maps created using high-resolution multielectrode catheters.

INTRODUCTION: Direction-aware mapping algorithms improve the accuracy of voltage mapping by measuring the maximal voltage amplitude recorded in the direction of wavefront propagation. While beneficial for stationary catheters, its utility for roving catheters collecting electrograms (EGMs) at multiple angles is unknown. OBJECTIVE: To compare the directional dependence of bipolar voltage amplitude between stationary and roving catheters. METHODS: In 10 swine, a transcaval ablation line with a gap was created. The gap was mapped using an array catheter (Optrell™; Biosense Webster). In Step 1, the array was kept stationary over the gap, and four voltage maps were created during activation of the gap from superior, inferior, septal, and lateral directions. In Step 2, four additional maps were created; however, the catheter was allowed to move with points acquired at multiple angles. In Step 3, the gap was remapped; however, bipoles were computed using a direction-aware mapping algorithm. RESULTS: In a stationary catheter position, bipolar voltage distribution was influenced by the direction of activation with maximal differences obtained between orthogonal directions 32% (13%-53%). However, roving the catheter produced similar bipolar voltage maps irrespective of the direction of activation 11% (5%-18%). A direction-aware mapping algorithm was beneficial for reducing the directional dependence of voltage maps created by stationary catheters but not by roving catheters. CONCLUSION: The directional dependency of bipolar voltage amplitude is greatest when the catheter is stationary. However, when the catheter is allowed to rove and collect EGMs at multiple angles as occurs clinically, the directional dependence of bipolar voltage is minimal.

Outcomes of atrial fibrillation ablation in patients with or without silent pulmonary veins from prior ablation procedure.

INTRODUCTION: Pulmonary venous (PV) electrical recovery underlies most arrhythmia recurrences after atrial fibrillation (AF) ablation. Little is known about procedural profiles and outcomes of patients with electrically silent PVs upon redo ablation for AF. METHODS: In a prospectively maintained registry, we enrolled 838 consecutive patients (2013-2016) undergoing redo ablation procedures. Ablation procedures targeted the PVs, the PV antra, and non-PV sites at operators' discretion. Procedural profiles and clinical outcomes were assessed. The primary outcome was freedom from AF after a 3-month blanking period. The secondary outcome was improvement in quality of life. RESULTS: Most patients undergoing redo AF ablation (n = 684, 82%) had PV reconnection while the remaining 154 (18%) had electrically silent PVs. Patients with recurrent AF and electrically silent PVs were older (66 vs. 64 years, p = .02), had more prior ablation procedures (median 2 IQR 1-3 vs 1 IQR 1-2 p = .001), were more likely to have non-paroxysmal AF (62% vs. 49%, p = .004) and atrial flutter (48% vs. 29%, p = .001) and had significantly larger left atrial volumes (89 vs. 81 ml, p = .003). Patients with silent PVs underwent a more extensive non-PV ablation strategies with antral extension of prior ablation sets in addition to ablation of the roof, appendage, inferior to the right PVs, peri-mitral flutter lines, cavotricuspid isthmus lines and ablation in the coronary sinus. Upon one year of follow-up, patients with electrically silent PVs were less likely to remain free from recurrent atrial arrhythmias (64% vs. 76%, p = .008). Regardless of PV reconnection status, redo ablation resulted in improvement in quality of life. CONCLUSION: Rhythm control with extensive ablation allowed maintenance of sinus rhythm in about two thirds of patients with silent PVs during redo AF ablation procedures. Regardless of PV reconnection status, redo ablation resulted in improvement in quality of life. This remains a challenging group of patients, highlighting the need to better understand non-PV mediated AF.

A novel multielectrode catheter for high-density ventricular mapping: electrogram characterization and utility for scar mapping.

AIMS: Multielectrode mapping catheters can be advantageous for identifying surviving myocardial bundles in scar. This study aimed to evaluate the utility of a new multielectrode catheter with increased number of small and closely spaced electrodes for mapping ventricles with healed infarction. METHODS AND RESULTS: In 12 swine (four healthy and eight with infarction), the left ventricle was mapped with investigational (OctarayTM) and standard (PentarayTM) multielectrode mapping catheters. The investigational catheter has more electrodes (48 vs. 20), each with a smaller surface area (0.9 vs. 2.0 mm2) and spacing is fixed at 2 mm (vs. 2-6-2 mm). Electrogram (EGM) characteristics, mapping efficiency and scar description were compared between the catheters and late gadolinium enhancement (LGE). Electrogram acquisition rate was faster with the investigational catheter (814 ± 126 vs. 148 ± 58 EGM/min, P = 0.02) resulting in higher density maps (38 ± 10.3 vs. 10.1 ± 10.4 EGM/cm2, P = 0.02). Bipolar voltage amplitude was similar between the catheters in normal and infarcted myocardium (P = 0.265 and P = 0.44) and the infarct surface area was similar between the catheters (P = 0.12) and corresponded to subendocardial LGE. The investigational catheter identified a higher proportion of near-field local abnormal ventricular activities within the low-voltage area (53 ± 16% vs. 34 ± 16%, P = 0.03) that were considered far-field EGMs by the standard catheter. The investigational catheter was also advantageous for mapping haemodymically non-tolerated ventricular tachycardias due to its higher acquisition rate (P < 0.001). CONCLUSION: A novel multielectrode mapping catheter with higher number of small, and closely spaced electrodes increases the mapping speed, EGM density and the ability to recognize low amplitude near-field EGMs in ventricles with healed infarction.

A novel octaray multielectrode catheter for high-resolution atrial mapping: Electrogram characterization and utility for mapping ablation gaps.

INTRODUCTION: Multielectrode mapping catheters improve the ability to map within the heterogeneous scar. A novel Octaray catheter with eight spines and 48 electrodes may further improve the speed and resolution of atrial mapping. The aims of this study were to (1) establish the Octaray's baseline mapping performance and electrogram (EGM) characteristics in healthy atria and to (2) determine its utility for identifying gaps in a swine model of atrial ablation lines. METHODS AND RESULTS: The right atria of eight healthy swine were mapped with Octaray and Pentaray catheters (Biosense Webster, Irvine, CA) before and after the creation of ablation lines with intentional gaps. Baseline mapping characteristics including EGM amplitude, duration, number of EGMs, and mapping time were compared. Postablation maps were created and EGM characteristics of continuous lines and gaps were correlated with pathology. Compared with Pentaray, the Octaray collected more EGMs per map (2178 ± 637 vs 1046 ± 238; P < 0.001) at a shorter mapping duration (3.2 ± 0.79 vs 6.9 ± 2.67 minutes; P < 0.001). In healthy atria, the Octaray recorded lower bipolar voltage amplitude (1.96 ± 1.83 mV vs 2.41 ± 1.92 mV; P < 0.001) while ablation gaps were characterized by higher voltage amplitude (1.24 ± 1.12 mV vs 1.04 ± 1.27 mV; P < 0.001). Ablation gaps were similarly identified by both catheters (P = 1.0). The frequency of "false gaps," defined as intact ablation lines with increased voltage amplitude was more common with Pentaray (6 vs 2) and resulted from erroneous annotation of far-field EGMs. CONCLUSION: The Octaray increases the mapping speed and density compared with the Pentaray catheter. It is as sensitive for identifying ablation gaps and more specific for mapping intact ablation lines.

Programmed Ventricular Stimulation for Risk Stratification in the Brugada Syndrome: A Pooled Analysis.

BACKGROUND: The role of programmed ventricular stimulation in identifying patients with Brugada syndrome at the highest risk for sudden death is uncertain. METHODS AND RESULTS: We performed a systematic review and pooled analysis of prospective, observational studies of patients with Brugada syndrome without a history of sudden cardiac arrest who underwent programmed ventricular stimulation. We estimated incidence rates and relative hazards of cardiac arrest or implantable cardioverter-defibrillator shock. We analyzed individual-level data from 8 studies comprising 1312 patients who experienced 65 cardiac events (median follow-up, 38.3 months). A total of 527 patients were induced into arrhythmias with up to triple extrastimuli. Induction was associated with cardiac events during follow-up (hazard ratio, 2.66; 95% confidence interval [CI], 1.44-4.92, P<0.001), with the greatest risk observed among those induced with single or double extrastimuli. Annual event rates varied substantially by syncope history, presence of spontaneous type 1 ECG pattern, and arrhythmia induction. The lowest risk occurred in individuals without syncope and with drug-induced type 1 patterns (0.23%, 95% CI, 0.05-0.68 for no induced arrhythmia with up to double extrastimuli; 0.45%, 95% CI, 0.01-2.49 for induced arrhythmia), and the highest risk occurred in individuals with syncope and spontaneous type 1 patterns (2.55%, 95% CI, 1.58-3.89 for no induced arrhythmia; 5.60%, 95% CI, 2.98-9.58 for induced arrhythmia). CONCLUSIONS: In patients with Brugada syndrome, arrhythmias induced with programmed ventricular stimulation are associated with future ventricular arrhythmia risk. Induction with fewer extrastimuli is associated with higher risk. However, clinical risk factors are important determinants of arrhythmia risk, and lack of induction does not necessarily portend low ventricular arrhythmia risk, particularly in patients with high-risk clinical features.

Quantitative T-wave alternans analysis for sudden cardiac death risk assessment and guiding therapy: answered and unanswered questions: For: Proceedings of ICE2015 Comandatuba, Brazil, Sudden Death Symposium.

This review addresses current questions regarding use of T-wave alternans to stratify risk for sudden cardiac death. Both of the currently available commercial methodologies, namely, the frequency-domain spectral method and the time-domain modified moving average (MMA) method, are supported by guideline statements, cleared by the US FDA, and covered by the US Center for Medicare and Medicaid services. Similar numbers of patients have been enrolled in predictive studies; odds ratios generated by the two methods are similar including in a head-to-head study. However, in two prospective studies, prediction by TWA with the spectral method was negative, likely due to withdrawal of beta-blockade before the test with later resumption, while all studies with MMA have achieved prediction when the commercial software was used appropriately. Questions currently undergoing investigation include TWA's potential to guide ICD implantation, to track changes in risk during cardiac disease progression, and to evaluate the adequacy of medical therapy.

Sequence and structure-specific elements of HERG mRNA determine channel synthesis and trafficking efficiency.

Human ether-á-gogo-related gene (HERG) encodes a potassium channel that is highly susceptible to deleterious mutations resulting in susceptibility to fatal cardiac arrhythmias. Most mutations adversely affect HERG channel assembly and trafficking. Why the channel is so vulnerable to missense mutations is not well understood. Since nothing is known of how mRNA structural elements factor in channel processing, we synthesized a codon-modified HERG cDNA (HERG-CM) where the codons were synonymously changed to reduce GC content, secondary structure, and rare codon usage. HERG-CM produced typical IKr-like currents; however, channel synthesis and processing were markedly different. Translation efficiency was reduced for HERG-CM, as determined by heterologous expression, in vitro translation, and polysomal profiling. Trafficking efficiency to the cell surface was greatly enhanced, as assayed by immunofluorescence, subcellular fractionation, and surface labeling. Chimeras of HERG-NT/CM indicated that trafficking efficiency was largely dependent on 5' sequences, while translation efficiency involved multiple areas. These results suggest that HERG translation and trafficking rates are independently governed by noncoding information in various regions of the mRNA molecule. Noncoding information embedded within the mRNA may play a role in the pathogenesis of hereditary arrhythmia syndromes and could provide an avenue for targeted therapeutics.

Ventricular Tachycardia Ablation Endpoints: Moving Beyond Noninducibility.

In patients with structural heart disease and ventricular tachycardia (VT) undergoing catheter ablation, the response to programmed electrical stimulation (PES) at the end of the procedure has been traditionally used to evaluate the acute success and predict long-term outcomes. Although noninducibility at PES has been extensively investigated and validated in clinical trials and large multicenter registries, its performance in predicting long-term freedom from VT is suboptimal. In addition, PES has inherent limitations related to the influence of background antiarrhythmic drug therapy, periprocedural use of anesthesia, and the heterogeneity in PES protocols. The increased utilization of substrate-based ablation approaches that focus on ablation of abnormal electrograms identified with mapping in sinus or paced rhythm has been paralleled by a need for additional procedural endpoints beyond VT noninducibility at PES. This article critically appraises the relative merits and limitations of different procedural endpoints according to different ablation techniques for catheter ablation of scar-related VT.

Thirty-day readmission after catheter ablation for ventricular tachycardia: associated factors and outcomes.

BACKGROUND: Patients with ventricular tachycardia (VT) who require VT ablation are at high risk for readmission. This study aimed to identify the causes and outcomes of 30-day readmission after VT ablation and to analyze the predictors of recurrent VT that required rehospitalization. METHODS: Using the Nationwide Readmission Database, our study included patients aged ≥ 18 years who underwent VT catheter ablation between 2017 and 2020. Based on the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM), we identified the causes of 30-day readmission by organ systems and analyzed their outcomes. Additional analysis was performed to determine the independent predictors of 30-day readmission for recurrent VT. RESULTS: Of the 4228 patients who underwent VT ablation, 14.2% were readmitted within 30 days of the procedure. The most common cause of readmission was cardiac events (73.6%). Among the cardiac-related readmissions, recurrent VT (47.7%) and congestive heart failure (CHF) (12.9%) were the most common etiologies. Among the readmissions, patients readmitted for CHF had the highest rate of readmission mortality (9.2%). Of the patients readmitted within 30 days of the procedure, 278 patients (6.8%) were readmitted for recurrent VT. Via multivariable analysis, CHF (OR: 1.97; 95% CI: 1.12-3.47; P = 0.02) and non-elective index admissions (OR: 1.63; 95% CI: 1.04-2.55; P = 0.03) were identified as the independent predictors predictive of 30-day readmissions for recurrent VT. CONCLUSIONS: Recurrent VT was the most common cause of readmission after the VT ablation procedure, and CHF and non-elective index admissions were the significant predictors of these early readmissions. Readmission due to CHF had the highest mortality rate during readmission.

Efficacy of Pulsed Field vs Radiofrequency for the Reablation of Chronic Radiofrequency Ablation Substrate: Redo Pulsed Field Ablation.

BACKGROUND: The efficacy of pulsed field ablation (PFA) for redo procedures is unknown. OBJECTIVES: In this study, the authors aimed to evaluate the effectiveness of PFA when performing PFA over chronic RFA (redo environment). METHODS: This was a 3-step in vivo study. In step 1 (creation of redo environment), 6 swine underwent radiofrequency ablation (RFA) with a local impedance measuring catheter and a contact force-enabled catheter in 3 different sites: the right atrium (RA) (intercaval line with intentional gaps), the left atrium (LA) (pulmonary vein isolation [PVI] with intentional gaps and superficial posterior wall ablations), and the left ventricle (LV) (short RFA applications [chronic RFA]). In step 2 (re-ablation), following a survival period of ≈5 weeks, animals were retreated as follows: in the RA, a focal PFA catheter over the prior intercaval line; in the LA, PVI using a pentaspline PFA catheter; and in the LV, animals were randomized to focal PFA or RFA. In each arm, 2 types of lesions were performed: acute or acute over chronic. In step 3 (remapping and euthanization), following an additional 3 to 5 days, all animals were remapped and sacrificed. RESULTS: In the RA, re-ablation with PFA resulted in a complete intercaval block in all animals, expanding and homogenizing the disparate chronic RFA lesions from a width of 4 to 7 mm (chronic RFA) to a width of 16 to 28 mm (PFA over chronic RFA). In the LA, re-ablation with PFA resulted in complete PVI and transmural ablation of the PW. In the LV, the mean depth for acute RFA (post 2-5 days survival) was 7.6 ± 1.3 mm vs 3.9 ± 1.6 mm in the acute over chronic RFA lesions (P < 0.01). In contrast, the mean depth for acute PFA was 7.0 ± 1.6 mm, similar to when ablating with PFA over RFA (7.1 ± 1.3 mm; P = 0.94). CONCLUSIONS: PFA is highly efficient for ablation following prior RFA, which may be beneficial in patients presenting for redo procedures. In the ventricle, PFA resulted in lesions that are deeper than RFA when ablating over chronic superficial RFA lesions.

Efficacy of balloon-expandable extreme-low-temperature ventricular epicardial cryoablation: A preclinical proof of concept evaluation.

BACKGROUND: Current epicardial ablation technologies are limited by the inability to create adequate depth lesions and risk of collateral injury to extracardiac structures. OBJECTIVE: The purpose of this study was to evaluate the feasibility and efficacy of ventricular epicardial ablation with a novel balloon-expandable extreme-low-temperature (XLT) cryoablation catheter with an embedded insulation pontoon for protection of extracardiac structures, which has been specifically designed for epicardial ablation. METHODS: Ten healthy swine underwent surgical (n = 6) and subxiphoid percutaneous (n = 4) epicardial access. A total of 3-6 sites were targeted in the right and left ventricular wall for different exposure durations. Ablation was performed with a large footprint (surgical) and smaller footprint (percutaneous) version of the HeartPad (Corfigo Inc., Montclair, NJ) XLT system. The system consists of the balloon-expandable cryoablation catheter and a console. The console vaporizes liquid helium (-269°C) and controls continuous delivery of extremely cold helium gas at high flow rates through a high-efficiency ablation element mounted on an expandable insulation pontoon to protect extracardiac structures. Ablation lesions were assessed by gross pathology and histologic examination. RESULTS: A total of 42 epicardial lesions were created. Mean lesion depth increased progressively with ablation time (surgical catheter: 11 ± 2 mm at ≤30 seconds, 13 ± 4 mm at 60 seconds, 15 ± 3 mm at ≥120 seconds, P = .001; percutaneous catheter: 10 ± 2 mm at 30 seconds, 14 ± 2 mm at 60 seconds, 16 ± 2 mm at 120 seconds, P = .001). Lesion geometry seemed unaffected by presence and thickness of epicardial fat. One episode of ventricular fibrillation occurred after ablation over the atrioventricular groove and 2 adjacent obtuse marginal arteries. CONCLUSION: Surgical or percutaneous epicardial ablation using the HeartPad XLT cryoablation system is feasible and can efficiently produce deep ventricular lesions in different epicardial locations.

Comparative Efficacy and Safety of Pulsed Field Ablation Versus Radiofrequency Ablation of Idiopathic LV Arrhythmias.

BACKGROUND: Comparative efficacy and safety data on radiofrequency ablation (RFA) versus pulsed field ablation (PFA) for common idiopathic left ventricular arrhythmia (LV-VAs) locations are lacking. OBJECTIVES: This study sough to compare RFA with PFA of common idiopathic LV-VAs locations. METHODS: Ten swine were randomized to PFA or RFA of LV interventricular septum, papillary muscle, LV summit via distal coronary sinus, and LV epicardium via subxiphoid approach. Ablations were delivered using an investigational dual-energy (RFA/PFA) contact force (CF) and local impedance-sensing catheter. After 1-week survival, animals were euthanized for lesion assessment. RESULTS: A total of 55 PFA (4 applications/site of 2.0 KV, target CF ≥10 g) and 36 RFA (CF ≥10 g, 25-50 W targeting ≥50 Ω local impedance drop, 60-second duration) were performed. LV interventricular septum: average PFA depth 7.8 mm vs RFA 7.9 mm (P = 0.78) and no adverse events. Papillary muscle: average PFA depth 8.1 mm vs RFA 4.5 mm (P < 0.01). Left ventricular summit: average PFA depth 5.6 mm vs RFA 2.7 mm (P < 0.01). Steam-pop and/or ventricular fibrillation in 4 of 12 RFA vs 0 of 12 PFA (P < 0.01), no ST-segment changes observed. Epicardium: average PFA depth 6.4 mm vs RFA 3.3 mm (P < 0.01). Transient ST-segment elevations/depressions occurred in 4 of 5 swine in the PFA arm vs 0 of 5 in the RFA arm (P < 0.01). Angiography acutely and at 7 days showed normal coronaries in all cases. CONCLUSIONS: In this swine study, compared with RFA, PFA of common idiopathic LV-VAs locations produced deeper lesions with fewer steam pops. However, PFA was associated with higher rates of transient ST-segment elevations and depressions with direct epicardium ablation.

Left ventricular mass as a modulator of ventricular arrhythmia risk and sex differences after CRT for nonischemic cardiomyopathy and LBBB.

BACKGROUND: The risk of ventricular arrhythmias (VAs) after cardiac resynchronization therapy (CRT) has been associated with ischemic disease/scar, sex, and possibly left ventricular mass (LVM). OBJECTIVE: The purpose of this study was to evaluate sex differences and baseline/postimplant change in LVM on VA risk after CRT implantation in patients with nonischemic cardiomyopathy and left bundle branch block. METHODS: In patients meeting the criteria, baseline and follow-up echocardiographic images were obtained for LVM assessment. VA events were reported from device diagnostics and therapies. VA risk was stratified by receiver operating characteristic (Youden index cutoff point) for baseline LVM and baseline/postimplant change in LVM. Multivariate Cox regression model was also used for VA risk stratification. RESULTS: One hundred eighteen patients (71 female patients [60.2%]; mean age 60.5 ± 11.3 years; left ventricular ejection fraction 19.2% ± 7.0%; QRS duration 165.6 ± 20 ms; LVM 313.9 ± 108.8 g) were enrolled and followed up for a median of 90 months (interquartile range 44-158 months). Thirty-five patients (29.6%) received appropriate shocks or antitachycardia pacing at a median of 73.5 months (interquartile range 25-130 months) postimplantation. Males had a higher VA incidence (male patients 18 of 47 [38.3%] vs female patients 17 of 71 [23.9%]; P = .02). Baseline LVM > 308.9 g separated patients with higher VA risk (P = .001). Less than a 20% decrease in LVM increased VA risk (P < .001). Baseline LVM was the only baseline characteristic predicting VA events in the Cox regression model (hazard ratio 1.01; 95% confidence interval 1.001-1.009; log-rank, P = .003). Sex differences in VA risk were eliminated by the baseline LVM parameters. CONCLUSION: VA risk after CRT implantation in nonischemic cardiomyopathy was associated with baseline LV > 308.9 g and a decrease in LVM ≤ 20%, without sex differences.

Impact of Contact Force on Pulsed Field Ablation Outcomes Using Focal Point Catheter.

BACKGROUND: Conventional focal radiofrequency catheters may be modified to enable multiple energy modalities (radiofrequency or pulsed field [PF]) with the benefit of contact force (CF) feedback, providing greater flexibility in the treatment of arrhythmias. Information on the impact of CF on lesion formation in PF ablations remains limited. METHODS: An in vivo study was performed with 8 swine using an investigational dual-energy CF focal catheter with local impedance. Experiment I: To evaluate atrial lesion formation, contiguity, and width, a point-by-point approach was used to create an intercaval line. The distance between the points was prespecified at 4±1 mm. Half of the line was created with radiofrequency energy, whereas the other half utilized PF (single 2.0 kV application with a proprietary waveform). Experiment II: To evaluate single application lesion dimensions with a proprietary waveform, discrete ventricular lesions were performed with PFA (single 2.0 kV application) with targeted levels of CF: low, 5 to 15 g; medium, 20 to 30 g; and high, 35 to 45 g. Following 1 week of survival, animals underwent endocardial/epicardial remapping, and euthanasia to enable histopathologic examination. RESULTS: Experiment I: Both energy modalities resulted in a complete intercaval line of transmural ablation. PF resulted in significantly wider lines than radiofrequency: minimum width, 14.9±2.3 versus 5.0±1.6 mm; maximum width, 21.8±3.4 versus 7.3±2.1 mm, respectively; P<0.01 for each. Histology confirmed transmural lesions with both modalities. Experiment II: With PF, lesion depth, width, and volume were larger with higher degrees of CF (depth: r=0.82, P<0.001; width: r=0.26, P=0.052; and volume: r=0.55, P<0.001), with depth increasing at a faster rate than width. The mean depths were as follows: low (n=17), 4.3±1.0 mm; medium (n=26), 6.4±1.2 mm; and high (n=14), 9.1±1.4 mm. CONCLUSIONS: Using the same focal point CF-sensing catheter, a novel PF ablation waveform with a single application resulted in transmural atrial lesions that were significantly wider than radiofrequency. Lesion depth showed a significant positive correlation with CF with depths of 6.4 mm at moderate CF.