Impact of contact force on the lesion characteristics of very high-power short-duration ablation using a QDOT-MICRO catheter.

Background: Lesion size is reported to become larger as contact force (CF) increases. However, this has not been systematically evaluated in temperature-guided very high-power short-duration (vHPSD) ablation, which was therefore the purpose of this study. Methods: Radiofrequency applications (90 W/4 s, temperature-control mode) were performed in excised porcine myocardium with four different CFs of 5, 15, 25, and 35 g using QDOT-MICRO™ catheter. Ten lesions for each combination of settings were created, and lesion metrics and steam-pops were compared. Results: A total of 320 lesions were analyzed. Lesion depth, surface area, and volume were smallest for CF of 5 g than for 15, 25, and 35 g (depth: 2.7 mm vs. 2.9 mm, 3.0 mm, 3.15 mm, p < .01; surface area: 38.4 mm2 vs. 41.8 mm2, 43.3 mm2, 41.5 mm2, p < .05; volume: 98.2 mm3 vs. 133.3 mm3, 129.4 mm3, 126.8 mm3, p < .01 for all pairs of groups compared to CF = 5 g). However, no significant differences were observed between CFs of 15-35 g. Average power was highest for CF of 5 g, followed by 15, 25, and 35 g (83.2 W vs. 82.1 W vs. 77.1 W vs. 66.1 W, p < .01 for all pairs), reflecting the higher incidence of temperature-guided power titration with greater CFs (5 g:8.8% vs. 15 g:52.5% vs. 25 g:77.5% vs. 35 g:91.2%, p < .01 for all pairs except for 25 g vs. 35 g). The incidence of steam-pops did not significantly differ between four groups (5 g:3.8% vs. 15 g:10% vs. 25 g:6.2% vs. 35 g:2.5%, not significant for all pairs). Conclusions: For vHPSD ablation, lesion size does not become large once the CF reaches 15 g, and the risk of steam-pops may be mitigated through power titration even in high CFs.

Endocardial Pulsed Field Ablation and the Oesophagus: Are Atrio-oesophageal Fistulas Now History?

Pulsed field ablation (PFA) is a novel energy form for the catheter ablation of cardiac arrhythmias, which uses electrical fields to mediate myocardial death via irreversible electroporation and other modalities. It is believed to offer relative tissue specificity, lowering - or even eliminating - the risk of complications associated with thermal energy, such as atrio-oesophageal fistulas. The proposed superior safety profile compared to thermal ablation has contributed to the enthusiastic implementation of PFA into clinical practice and is supported by early preclinical and clinical data. However, data about the effects of PFA on the oesophagus remain limited. This organ's susceptibility to PFA has important clinical ramifications and there are two highly relevant questions. First, is the oesophagus absolutely spared by PFA or is there susceptibility to injury at higher field strengths? Second, if oesophageal injury can occur, can atrio-oesophageal fistulas ensue? The aim of this article is to provide a literature review on the effects of PFA on the oesophagus and to address these questions based on the data described.

Effect of reference electrode on intracardiac electrograms: Close indifferent electrode vs Wilson central terminal.

BACKGROUND: Unipolar electrograms (uni-EGMs) are an essential part of intracardiac mapping. Although Wilson central terminal (WCT) is conventionally used as a reference for signals, avoidance of contamination by far-field and nonphysiologic signals is challenging. OBJECTIVE: The aim of the study was to explore the impact of an intracardiac indifferent reference electrode close to the recording electrodes, in lieu of WCT, on electrograms. METHODS: Sinus node activation was mapped in patients undergoing catheter ablation by a multielectrode array with a close indifferent electrode (CIE) embedded in the distal end of the catheter shaft. An equal number of points was sequentially acquired at each site with use of CIE as a reference first and subsequently with WCT. Uni-EGMs, bipolar EGMs, and the earliest activation area (defined as the area activated in the first 10 ms of the beat) were compared between CIE- and WCT-based activation maps. RESULTS: Seventeen patients (61 ± 18 years; 76% male) were studied. Uni-EGM voltages acquired with CIE were significantly larger than (n = 11) or comparable to (n = 4) those acquired with WCT. When points from the entire cohort were analyzed altogether, unipolar voltages and their maximum negative dV/dT and bipolar voltages recorded with CIE were significantly larger than those recorded with WCT (2.36 [1.42-3.79] mV vs 1.96 [1.25-3.03] mV, P < .0001; 0.40 [0.18-0.77] mV/s vs 0.35 [0.15-0.71] mV/s, P < .0001; and 1.46 [0.66-2.81] mV vs 1.33 [0.54-2.64] mV, P < .0001, respectively). The earliest activation area was significantly smaller in CIE-based activation maps than in WCT-based ones (0.3 [0.7-1.4] cm2 vs 0.6 [1.0-1.8] cm2, P = .01). CONCLUSION: CIE-based maps were associated with an approximately 20% increase in unipolar voltage and may highlight the origin of a focal activation more clearly than WCT-based ones.

Severity of Ischemic Stroke After Left Atrial Appendage Closure vs Nonwarfarin Oral Anticoagulants.

BACKGROUND: Strokes after left atrial appendage closure (LAAC) prophylaxis are generally less severe than those after warfarin prophylaxis-thought to be secondary to more hemorrhagic strokes with warfarin. Hemorrhagic strokes are similarly infrequent with direct oral anticoagulant (DOAC) prophylaxis, so the primary subtype after either LAAC or DOAC prophylaxis is ischemic stroke (IS). OBJECTIVES: The purpose of this study was to compare the severity of IS using the modified Rankin Scale in atrial fibrillation patients receiving prophylaxis with DOACs vs LAAC. METHODS: A retrospective analysis was performed of consecutive patients undergoing LAAC at 8 centers who developed an IS (ISLAAC) compared with contemporaneous consecutive patients who developed IS during treatment with DOACs (ISDOAC). The primary outcome was disabling/fatal stroke (modified Rankin Scale 3-5) at discharge and 3 months later. RESULTS: Compared with ISDOAC patients (n = 322), ISLAAC patients (n = 125) were older (age 77.2 ± 13.4 years vs 73.1 ± 11.9 years; P = 0.002), with higher HAS-BLED scores (3.0 vs 2.0; P = 0.004) and more frequent prior bleeding events (54.4% vs 23.6%; P < 0.001), but similar CHA2DS2-VASc scores (5.0 vs 5.0; P = 0.28). Strokes were less frequently disabling/fatal with ISLAAC than ISDOAC at both hospital discharge (38.3% vs 70.3%; P < 0.001) and 3 months later (33.3% vs 56.2%; P < 0.001). Differences in stroke severity persisted after propensity score matching. By multivariate regression analysis, ISLAAC was independently associated with fewer disabling/fatal strokes at discharge (OR: 0.22; 95% CI: 0.13-0.39; P < 0.001) and 3 months (OR: 0.25; 95% CI: 0.12-0.50; P < 0.001), and fewer deaths at 3 months (OR: 0.28; 95% CI: 0.12-0.64; P < 0.001). CONCLUSIONS: Ischemic strokes in patients with atrial fibrillation are less often disabling or fatal with LAAC than DOAC prophylaxis.

Ultrastructural insights from myocardial ablation lesions from microsecond pulsed field vs radiofrequency energy.

BACKGROUND: Ultrastructural findings immediately after pulsed field ablation (PFA) of the myocardium have not been described. OBJECTIVES: The purpose of this study was to elucidate ultrastructural characteristics and differences between microsecond PFA at the 1- and 4-hour timepoints after pulse delivery and to compare them to irrigated radiofrequency ablation (RFA) lesions. METHODS: Healthy swine underwent endocardial PFA or RFA followed by necropsy. Discrete microsecond PFA and irrigated RFA lesions were created in the ventricles with a lattice tip ablation catheter. Lesions were delivered in a manner so as to allow sampling to occur 1 and 4 hours after ablation. All lesions were located at necropsy, and samples were carefully obtained from within the lesion core, lesion periphery, and adjacent healthy myocardium. Transmission electron microscopic assessment was performed after fixation using paraformaldehyde and glutaraldehyde. RESULTS: One hour after microsecond PFA delivery, myocytes were noted to be significantly and uniformly disrupted. Clustered, misaligned, swollen mitochondria coupled with degenerating nuclei and condensed chromatin were visualized. These findings progressed over the subsequent few hours with worsening edema. Similar changes were seen with RFA but reduced in severity. However, there was prominent extravasation of red blood cells with occlusion of capillaries that was not seen in PFA. At the lesion periphery, an abrupt change in the degree of myocyte damage was observed with PFA but not RFA. CONCLUSION: Transmission electron microscopy demonstrates evidence of widespread destruction of myocytes as early as an hour after PFA and corroborates known histologic features such as sparing of vessels and sharp lesion margins.

Transcoronary mapping with an over-the-wire multielectrode catheter in scar-related ventricular tachycardia patients.

AIMS: The usefulness of coronary venous system mapping has been reported for assessing intramural and epicardial substrates in patients with scar-related ventricular tachycardia (VT). However, there has been little data on mapping from coronary arteries. We investigated the safety and utility of mapping from coronary arteries with a novel over-the-wire multielectrode catheter in scar-related VT patients. METHODS AND RESULTS: Ten consecutive scar-related VT patients with non-ischaemic cardiomyopathy who underwent mapping from a coronary artery were analysed. Six patients underwent simultaneous coronary venous mapping. High-density maps were created by combining the left ventricular endocardium and coronary vessels. Substrate maps were created during the baseline rhythm with 2438 points (IQR 2136-3490 points), including 329 (IQR 59-508 points) in coronary arteries. Abnormal bipolar electrograms were successfully recorded within coronary arteries close to the endocardial substrate in seven patients. During VT, isthmus components were recorded within the coronary vessels in three patients with no discernible isthmus components on endocardial mapping. The ablation terminated the VT from an endocardial site opposite the earliest site in the coronary arteries in five patients. CONCLUSION: The transcoronary mapping with an over-the-wire multielectrode catheter can safely record abnormal bipolar electrograms within coronary arteries. Additional mapping data from the coronary vessels have the potential to assess three-dimensional ventricular substrates and circuit structures in scar-related VT patients.

The effect of half-normal saline irrigation on lesion characteristics in temperature-flow-controlled ablation.

PURPOSE: Radiofrequency (RF) ablation with half-normal saline (HNS) irrigation is reported to potentially enlarge local lesion compared to normal saline (NS) in power-controlled ablation (PC-Abl). However, the effect of HNS-irrigation in temperature-flow-controlled ablation (TFC-Abl) on lesion characteristics is unknown. We compared this between TFC-Abl with QDOT-Micro™ catheter and PC-Abl with Thermocool SmartTouch SF™ catheter (STSF). METHODS: RF-application with NS (n = 480) and HNS (n = 480) irrigation were performed on swine myocardium placed in a circulating saline bath. Lesion characteristics without steam-pops under various conditions (target AI, 400/550; ablation power, 30/50 W; contact force, 10/20/30 g; catheter orientation, perpendicular/parallel) were assessed and compared between two irrigants. RESULTS: After matching, 343 lesions without steam-pops in each group were evaluated. In PC-Abl, lesion size did not differ between two groups (NS, 188 ± 97 vs. HNS, 200 ± 95 mm3, p = 0.28 in volume; 33.9 ± 7.3 vs. 34.8 ± 9.5 mm2, p = 0.34 in surface area; and 4.0 ± 1.0 vs. 4.0 ± 1.0 mm, p = 0.81 in depth), but steam-pops were more frequently observed with HNS-irrigation (23.8% vs. 37.9%, p = 0.001). Contrary, in TFC-Abl, HNS-irrigation produced significantly larger (214 ± 106 vs. 243 ± 128 mm3, p = 0.017) and deeper (4.0 ± 1.0 vs. 4.3 ± 1.1 mm, p = 0.002) lesions without increasing the risk of steam-pops (15.0% vs 15.0%, p = 0.99). Automatic temperature-guided titration was more frequently observed in HNS-irrigation (54.8% vs. 78.5%, p < 0.001). CONCLUSIONS: TFC-Abl with QDOT-Micro™ catheter utilizing HNS-irrigation might increase volume and depth of local lesion without increasing the risk of stem-pops compared to NS-irrigation. Power-controlled ablation with HNS-irrigation showed similar focal lesion with higher incidence of steam-pops (SPs) compared to normal saline (NS) irrigation. Contrary, temperature-flow-controlled ablation with HNS-irrigation provided larger and deeper lesion than NS-irrigation with similar incidence of SPs. ns, p > 0.05; *, 0.01 < p ≤ 0.05; **, 0.005 < p ≤ 0.01. HNS, half-normal saline; NS, normal saline.

Superiority of the Combination of Input and Output Parameters to the Single Parameter for Lesion Size Estimation.

BACKGROUND: For lesion size prediction, each input parameter, including ablation energy (AE), and output parameter, such as impedance, is individually used. We hypothesize that using both parameters simultaneously may be more optimal.Methods and Results: Radiofrequency applications at a range of power (30-50 W), contact force (10 g and 20 g), duration (10-60 s), and catheter orientation with normal saline (NS)- or half-normal saline (HNS)-irrigation were performed in excised porcine hearts. The correlations, with lesion size of AE, absolute impedance drop (∆Imp-drop), relative impedance drop (%Imp-drop), and AE*%Imp-drop were examined. Lesion size was analyzed in 283 of 288 lesions (NS-irrigation, n=142; HNS-irrigation, n=141) without steam pops. AE*%Imp-drop consistently showed the strongest correlations with lesion maximum depth (NS-irrigation, ρ=0.91; HNS-irrigation, ρ=0.94), surface area (NS-irrigation, ρ=0.87; HNS-irrigation, ρ=0.86), and volume (NS-irrigation, ρ=0.94; HNS-irrigation, ρ=0.94) compared with the other parameters. Moreover, compared with AE alone, AE*%Imp-drop significantly improved the strength of correlation with lesion maximum depth (AE vs. AE*%Imp-drop, ρ=0.83 vs. 0.91, P<0.01), surface area (ρ=0.73 vs. 0.87, P<0.01), and volume (ρ=0.84 vs. 0.94, P<0.01) with NS-irrigation. This tendency was also observed with HNS-irrigation. Parallel catheter orientation showed a better correlation with lesion depth and volume using ∆Imp-drop, %Imp-drop, and AE*%Imp-drop than perpendicular orientation. CONCLUSIONS: The combination of input and output parameters is more optimal than each single parameter for lesion prediction.

Reversible Pulsed Electrical Fields as an In Vivo Tool to Study Cardiac Electrophysiology: The Advent of Pulsed Field Mapping.

BACKGROUND: During electrophysiological mapping of tachycardias, putative target sites are often only truly confirmed to be vital after observing the effect of ablation. This lack of mapping specificity potentiates inadvertent ablation of innocent cardiac tissue not relevant to the arrhythmia. But if myocardial excitability could be transiently suppressed at critical regions, their suitability as targets could be conclusively determined before delivering tissue-destructive ablation lesions. We studied whether reversible pulsed electric fields (PFREV) could transiently suppress electrical conduction, thereby providing a means to dissect tachycardia circuits in vivo. METHODS: PFREV energy was delivered from a 9-mm lattice-tip catheter to the atria of 12 swine and 9 patients, followed by serial electrogram assessments. The effects on electrical conduction were explored in 5 additional animals by applying PFREV to the atrioventricular node: 17 low-dose (PFREV-LOW) and 10 high-dose (PFREV-HIGH) applications. Finally, in 3 patients manifesting spontaneous tachycardias, PFREV was applied at putative critical sites. RESULTS: In animals, the immediate post-PFREV electrogram amplitudes diminished by 74%, followed by 78% recovery by 5 minutes. Similarly, in patients, a 69.9% amplitude reduction was followed by 84% recovery by 3 minutes. Histology revealed only minimal to no focal, superficial fibrosis. PFREV-LOW at the atrioventricular node resulted in transient PR prolongation and transient AV block in 59% and 6%, while PFREV-HIGH caused transient PR prolongation and transient AV block in 30% and 50%, respectively. The 3 tachycardia patients had atypical atrial flutters (n=2) and atrioventricular nodal reentrant tachycardia. PFREV at putative critical sites reproducibly terminated the tachycardias; ablation rendered the tachycardias noninducible and without recurrence during 1-year follow-up. CONCLUSIONS: Reversible electroporation pulses can be applied to myocardial tissue to transiently block electrical conduction. This technique of pulsed field mapping may represent a novel electrophysiological tool to help identify the critical isthmus of tachycardia circuits.

ECG characteristics of "true" left bundle branch block: Insights from transcatheter aortic valve-related LBBB and His-Purkinje conduction system pacing-correctable LBBB.

BACKGROUND: Left bundle branch block (LBBB) pattern on the electrocardiogram includes patients with both complete conduction block in the His-Purkinje system as well as nonspecific left ventricular conduction delay without discrete block. OBJECTIVE: The purpose of this study was to characterize electrocardiographic morphological features of LBBB patterns in patients with (1) LBBB after transcatheter aortic valve replacement (TAVR) and (2) LBBB correctable by conduction system pacing (CSP). METHODS: Consecutive patients with post-TAVR (n = 123) or CSP-correctable LBBB (n = 58) from 2 centers were included in this retrospective evaluation. QRS durations as well as detailed morphological features, including notching and slurring, of QRS complexes in leads I, aVL, V1, V2, V5, and V6 and in all 3 inferior leads were recorded. RESULTS: The mean age of the entire cohort was 78.3 ± 10.1 years, with 48% of the cohort being male (87/181). In the CSP-correctable group (n = 58), 14 (24.1%) underwent His-bundle pacing and 44 (75.9%) left bundle branch area pacing. A total of 17 of 181 (9.4%) of the combined cohort failed to completely meet the Strauss criteria. QRS morphology in lead V1/V2 was always either rS or QS, and there were no q/Q waves noted in lead V5/V6. Although dominant R waves were seen in leads I and aVL of 176 of 181 (97.2%), q/Q waves were present in only 21 of 181 (11.6%). Importantly, notched or slurred QRS complexes were identified in at least 1 lead of 4 leads I, aVL, V5, and V6 in 181 of 181 (100%). CONCLUSION: Strauss criteria and QRS notching are highly prevalent in LBBB after TAVR and in LBBB correctable by CSP.

A Novel ECG-Based Deep Learning Algorithm to Predict Cardiomyopathy in Patients With Premature Ventricular Complexes.

BACKGROUND: Premature ventricular complexes (PVCs) are prevalent and, although often benign, they may lead to PVC-induced cardiomyopathy. We created a deep-learning algorithm to predict left ventricular ejection fraction (LVEF) reduction in patients with PVCs from a 12-lead electrocardiogram (ECG). OBJECTIVES: This study aims to assess a deep-learning model to predict cardiomyopathy among patients with PVCs. METHODS: We used electronic medical records from 5 hospitals and identified ECGs from adults with documented PVCs. Internal training and testing were performed at one hospital. External validation was performed with the others. The primary outcome was first diagnosis of LVEF ≤40% within 6 months. The dataset included 383,514 ECGs, of which 14,241 remained for analysis. We analyzed area under the receiver operating curves and explainability plots for representative patients, algorithm prediction, PVC burden, and demographics in a multivariable Cox model to assess independent predictors for cardiomyopathy. RESULTS: Among the 14,241-patient cohort (age 67.6 ± 14.8 years; female 43.8%; White 29.5%, Black 8.6%, Hispanic 6.5%, Asian 2.2%), 22.9% experienced reductions in LVEF to ≤40% within 6 months. The model predicted reductions in LVEF to ≤40% with area under the receiver operating curve of 0.79 (95% CI: 0.77-0.81). The gradient weighted class activation map explainability framework highlighted the sinus rhythm QRS complex-ST segment. In patients who underwent successful PVC ablation there was a post-ablation improvement in LVEF with resolution of cardiomyopathy in most (89%) patients. CONCLUSIONS: Deep-learning on the 12-lead ECG alone can accurately predict new-onset cardiomyopathy in patients with PVCs independent of PVC burden. Model prediction performed well across sex and race, relying on the QRS complex/ST-segment in sinus rhythm, not PVC morphology.

Worldwide Experience With an Irrigated Needle Catheter for Ablation of Refractory Ventricular Arrhythmias: Final Report.

BACKGROUND: We previously reported feasibility of irrigated needle ablation (INA) with a retractable 27-G end-hole needle catheter to treat nonendocardial ventricular arrhythmia substrate, an important cause of ablation failure. OBJECTIVES: The purpose of this study was to report outcomes and complications in our entire INA-treated population. METHODS: Patients with recurrent sustained monomorphic ventricular tachycardia (VT) or high-density premature ventricular contractions (PVCs) despite radiofrequency ablation were prospectively enrolled at 4 centers. Endpoints included a 70% decrease in VT frequency or PVC burden decrease to <5,000/24 h at 6 months. RESULTS: INA was performed in 111 patients (median: 2 failed prior ablations, 71% nonischemic heart disease, and left ventricular ejection fraction 36% ± 14%). INA acutely abolished targeted PVCs in 33 of 37 patients (89%), and PVCs were reduced to <5,000/day in 29 patients (78%). During 6-month follow-up, freedom from hospitalization was observed in 50 of 72 patients with VT (69%), and improvement or abolition of VT occurred in 47%. All patients received multiple INA applications, with more in the VT group than in the PVC group (median: 12 [IQR: 7-19] vs 7 [5-15]; P < 0.01). After INA, additional endocardial standard radiofrequency ablation was required in 23% of patients. Adverse events included 4 pericardial effusions (3.5%), 3 cases of (anticipated) atrioventricular block (2.6%), and 3 heart failure exacerbations (2.6%). During 6-month follow-up, 5 deaths occurred; none were procedure-related. CONCLUSIONS: INA achieves improved arrhythmia control in 78% of patients with PVCs and avoids hospitalization in 69% of patients with VT refractory to standard ablation at 6-month follow-up. Procedural risks are acceptable. (Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia, NCT01791543; Intramural Needle Ablation for the Treatment of Refractory Ventricular Arrhythmias, NCT03204981).

Interatrial Block Association With Adverse Cardiovascular Outcomes in Patients Without a History of Atrial Fibrillation.

BACKGROUND: Interatrial block (IAB) is associated with thromboembolism and atrial arrhythmias. However, prior studies included small patient cohorts so it remains unclear whether IAB predicts adverse outcomes particularly in context of atrial fibrillation (AF)/atrial flutter (AFL). OBJECTIVES: This study sought to determine whether IAB portends increased stroke risk in a large cohort in the presence or absence of AFAF/AFL. METHODS: We performed a 5-center retrospective analysis of 4,837,989 electrocardiograms (ECGs) from 1,228,291 patients. IAB was defined as P-wave duration ≥120 ms in leads II, III, or aVF. Measurements were extracted as .XML files. After excluding patients with prior AF/AFL, 1,825,958 ECGs from 458,994 patients remained. Outcomes were analyzed using restricted mean survival time analysis and restricted mean time lost. RESULTS: There were 86,317 patients with IAB and 355,032 patients without IAB. IAB prevalence in the cohort was 19.6% and was most common in Black (26.1%), White (20.9%), and Hispanic (18.5%) patients and least prevalent in Native Americans (9.2%). IAB was independently associated with increased stroke probability (restricted mean time lost ratio coefficient [RMTLRC]: 1.43; 95% CI: 1.35-1.51; tau = 1,895), mortality (RMTLRC: 1.14; 95% CI: 1.07-1.21; tau = 1,924), heart failure (RMTLRC: 1.94; 95% CI: 1.83-2.04; tau = 1,921), systemic thromboembolism (RMTLRC: 1.62; 95% CI: 1.53-1.71; tau = 1,897), and incident AF/AFL (RMTLRC: 1.16; 95% CI: 1.10-1.22; tau = 1,888). IAB was not associated with stroke in patients with pre-existing AF/AFL. CONCLUSIONS: IAB is independently associated with stroke in patients with no history of AF/AFL even after adjustment for incident AF/AFL and CHA2DS2-VASc score. Patients are at increased risk of stroke even when AF/AFL is not identified.

SGLT2 inhibitors reduce sudden cardiac death risk in heart failure: Meta-analysis of randomized clinical trials.

INTRODUCTION: Multiple randomized controlled trials have demonstrated sodium-glucose cotransporter-2 inhibitors (SGLT2i) decrease the composite endpoint of cardiovascular death or heart failure hospitalizations in all heart failure patients. It is uncertain whether SGLT2i impacts the risk of sudden cardiac death in patients with heart failure. METHODS: A comprehensive search was performed to identify relevant data published before August 28, 2022. Trials were included if: (1) all patients had clinical heart failure (2) SGLT2i and placebo were compared (3) all patients received conventional medical therapy and (4) reported outcomes of interest (sudden cardiac death [SCD], ventricular arrhythmias, atrial arrhythmias). RESULTS: SCD was reported in seven of the eleven trials meeting selection criteria: 10 796 patients received SGLT2i and 10 796 received placebo. SGLT2i therapy was associated with a significant reduction in the risk of SCD (risk ratios [RR]: 0.68; 95% confidence intervals [CI]: 0.48-0.95; p = .03; I2 = 0%). Absent dedicated rhythm monitoring, there were no significant differences in the incidence of sustained ventricular arrhythmias not associated with SCD (RR: 1.03; 95% CI: 0.83-1.29; p = .77; I2 = 0%) or atrial arrhythmias (RR: 0.91; 95% CI: 0.77-1.09; p = .31; I2 = 29%) between patients receiving an SGLT2i versus placebo. CONCLUSION: SGLT2i therapy is associated with a reduced risk of SCD in patients with heart failure receiving contemporary medical therapy. Prospective trials are needed to determine the long-term impact of SGLT2i therapy on atrial and ventricular arrhythmias.

PV Isolation Using a Spherical Array PFA Catheter: Preclinical Assessment and Comparison to Radiofrequency Ablation.

BACKGROUND: A multielectrode spherical array catheter capable of single-shot mapping and ablation has been introduced. OBJECTIVES: This study sought to compare the efficacy and safety of circumferential, linear, and focal ablation using either microsecond pulsed field (PF) and radiofrequency (RF) ablation in preclinical model. METHODS: Under general anesthesia, a 122 gold-plated multielectrode array was introduced into the left atrium. Twenty-nine canines underwent isolation of two pulmonary veins (PVs), with linear and focal left atrial ablation with both RF (n = 12) and PF (n = 17). PF was also delivered within the superior vena cava and atop the esophagus in three swine. Animals were sacrificed acutely (immediately for RF [6 of 12] and 3 days for PF [6 of 17]) and the remaining (n = 17) at 14 to 30 days. Detailed necropsy and histopathology were performed. RESULTS: All PVs were acutely (58 of 58) and durably (34 of 34) isolated and exhibited wide confluent lesions. Lesions were transmural for 97% to 100% of sections with depths of 2.5 to 3.4 mm and 2.5 to 3.5 mm in the acute and chronic cohorts, respectively. Linear and focal lesions displayed transmurality rates of 85% to 100% with depths of 3.5 millimeters to 4.2 millimeters in the acute cohort. In the chronic cohorts, linear lesions created with RF, PF+RF, and PF had no significant differences in depth (3.5 ± 1.8 mm, 4.0 ± 1.4 mm, and 3.9 ± 0.9 mm) or transmurality (83.3%, 100%, and 80%). Current of injury was seen on local unipolar electrogram immediately after PF and RF, and this occurred to a wider extent with PF. PF but not RF elicited bradycardia from ganglionated plexi stimulation. There were no instances of phrenic palsy, venous stenosis, esophageal damage, or thromboembolism. CONCLUSIONS: Circumferential, linear, and focal mapping and ablation can be achieved with this novel catheter using both PF and RF, with excellent efficacy and safety.

Preclinical assessment of the feasibility, safety and lesion durability of a novel 'single-shot' pulsed field ablation catheter for pulmonary vein isolation.

AIMS: Single-shot pulmonary vein isolation can improve procedural efficiency. To assess the capability of a novel, expandable lattice-shaped catheter to rapidly isolate thoracic veins using pulsed field ablation (PFA) in healthy swine. METHODS AND RESULTS: The study catheter (SpherePVI; Affera Inc) was used to isolate thoracic veins in two cohorts of swine survived for 1 and 5 weeks. In Experiment 1, an initial dose (PULSE2) was used to isolate the superior vena cava (SVC) and the right superior pulmonary vein (RSPV) in six swine and the SVC only in two swine. In Experiment 2, a final dose (PULSE3) was used for SVC, RSPV, and left superior pulmonary vein (LSPV) in five swine. Baseline and follow-up maps, ostial diameters, and phrenic nerve were assessed. Pulsed field ablation was delivered atop the oesophagus in three swine. All tissues were submitted for pathology. In Experiment 1, all 14/14 veins were isolated acutely with durable isolation demonstrated in 6/6 RSPVs and 6/8 SVC. Both reconnections occurred when only one application/vein was used. Fifty-two and 32 sections from the RSPVs and SVC revealed transmural lesions in 100% with a mean depth of 4.0 ± 2.0 mm. In Experiment 2, 15/15 veins were isolated acutely with 14/15 veins (5/5 SVC, 5/5 RSPV, and 4/5 LSPV) durably isolated. Right superior pulmonary vein (31) and SVC (34) sections had 100% transmural, circumferential ablation with minimal inflammation. Viable vessels and nerves were noted without evidence of venous stenosis, phrenic palsy, or oesophageal injury. CONCLUSION: This novel expandable lattice PFA catheter can achieve durable isolation with transmurality and safety.

Electrophysiology, Pathology, and Imaging of Pulsed Field Ablation of Scarred and Healthy Ventricles in Swine.

BACKGROUND: Pulsed field ablation (PFA) has recently been shown to penetrate ischemic scar, but details on its efficacy, risk of arrhythmias, and imaging insights are lacking. In a porcine model of myocardial scar, we studied the ability of ventricular PFA to penetrate scarred tissue, induce ventricular arrhythmias, and assess the influence of QRS gating during pulse delivery. METHODS: Of a total of 6 swine, 5 underwent coronary occlusion and 1 underwent radiofrequency ablation to create infarct scar and iatrogenic scar models, respectively. Two additional swine served as healthy controls. An 8 Fr focal PFA catheter was used to deliver bipolar, biphasic PFA (2.0 kV) lesions guided by electroanatomical mapping, fluoroscopy, and intracardiac echocardiography over both scarred and healthy myocardium. Swine underwent magnetic resonance imaging 2-7 days post-PFA. RESULTS: PFA successfully penetrated scar without significant difference in lesion depth between lesion at the infarct border (5.9±1.0 mm, n=41) and healthy myocardium (5.7±1.3 mm, n=26; P=0.53). PFA penetration of both infarct and iatrogenic radiofrequency abalation scar was observed in all examined sections. Sustained ventricular arrhythmias requiring defibrillation occurred in 4 of 187 (2.1%) ungated applications, whereas no ventricular arrhythmias occurred during gated PFA applications (0 of 64 [0%]). Dark-blood late-gadolinium-enhanced sequences allowed for improved endocardial border detection as well as lesion boundaries compared with conventional bright-blood late-gadolinium-enhanced sequences. CONCLUSIONS: PFA penetrates infarct and iatrogenic scar successfully to create deep lesions. Gated delivery eliminates the occurrence of ventricular arrhythmias observed with ungated porcine PFA. Optimized magnetic resonance imaging sequences can be helpful in detecting lesion boundaries.

Preclinical evaluation of semi-automated laser ablation for pulmonary vein isolation: A comparative study.

INTRODUCTION: Visually-guided laser balloon ablation (VGLA) currently requires careful manual rotation of the laser to create overlapping lesions. A novel semi-automated VGLA may reduce ablation times and lesion gaps. We aimed to compare semi-automated (SA) VGLA to that of manual (MN) VGLA. METHODS: Acute: Nine swine underwent right superior pulmonary vein isolation (PVI) using either SA (n = 3, 13-18 W), MN (n = 3, 8.5-12 W), or radiofrequency (RF, n = 3, 25-40 W) and were killed acutely. Chronic: 16 swine, underwent PVI using either SA (n = 8, 15 W) or MN (n = 8, 10 W), and were survived for 1 month before being killed. All hearts were then submitted for pathological evaluation. RESULTS: Acute: PVI was successful in all 9/9 swine with lesion counts significantly lower in the SA arm (5.3 ± 5.9, 33.7 ± 10.0, and 28.0 ± 4.4 in SA, MN, and RF arms; p = .007 for SA and MN). At necropsy, circumferentiality and transmurality were 98% and 94% in SA, 98% and 80% in MN, and 100% and 100% in RF arms. A single steam pop was noted on sectioning in the SA arm swine and occurred in the high dose (18 W) strategy. Chronic: PVI was acutely successful in 16/16 swine with no difference in PVI durability rates (62.5% vs. 75.0%), lesion transmurality (95.8 ± 17.4% vs.91.9 ± 25.9%), and circumferentiality (95.8 ± 6.6% vs. 94.8 ± 6.3%) between SA and MN arms. Catheter use time and lesion counts were lower in the SA arm compared to the MN arm (11.5 ± 12.7 vs. 21.8 ± 3.8 min, p = .046 and 4.8 ± 3.83 vs. 35.4 ± 4.4, p < .001). CONCLUSION: Motor-assisted semi-automated laser balloon ablation can improve upon procedural efficiency by reducing ablation time.