Left bundle branch area pacing using a stylet-driven, retractable-helix lead: Short-term results from a prospective multicenter IDE trial (the BIO-CONDUCT study).

BACKGROUND: Left bundle branch area pacing (LBBAP) has swiftly emerged as a safe and effective alternative to right ventricular pacing. Limited data exist on the use of retractable-helix, stylet-driven leads for LBBAP. OBJECTIVE: The objective of this study was to prospectively evaluate the performance and safety of the Solia S stylet-driven pacing lead in a rigorously controlled multicenter trial to support US market application. METHODS: A multicenter, prospective, nonrandomized trial enrolled patients with standard pacing indications. Implant procedure and lead data, including threshold, sensing, impedance, and capture type, were collected through 3 months. Primary end points were freedom from LBBAP lead-related serious complications through 3 months and LBBAP implant success according to prespecified criteria. A blinded clinical events committee adjudicated all potential end point complications. RESULTS: A total of 186 patients were included from 14 US sites. LBBAP implants were successful in 95.7% (178 of 186; 95% confidence interval 91.7%-98.1%; P < .0001 for comparison to the performance goal of 88%). Through the 3-month follow-up visit, 3 patients experienced a serious LBBAP complication (all lead dislodgments), resulting in a LBBAP lead-related complication-free rate of 98.3%. A total of 13 patients (7.8%) experienced any system- or procedure-related complication. The mean threshold was 0.89 V at 0.4 ms, the sensing value was 10.8 mV, and impedance was 608 Ω. CONCLUSION: The short-term results from this prospective trial demonstrate both high implant success and freedom from LBBAP lead-related complications using this stylet-driven retractable helix lead. This trial supports the safety, use, and effectiveness of stylet-driven leads for performing contemporary physiologic pacing.

Conduction velocity is reduced in the posterior wall of hypertrophic cardiomyopathy patients with normal bipolar voltage undergoing ablation for paroxysmal atrial fibrillation.

OBJECTIVES: We investigated characteristics of left atrial conduction in patients with HCM, paroxysmal AF and normal bipolar voltage. BACKGROUND: Patients with hypertrophic cardiomyopathy (HCM) exhibit abnormal cardiac tissue arrangement. The incidence of atrial fibrillation (AF) is increased fourfold in patients with HCM and confers a fourfold increased risk of death. Catheter ablation is less effective in HCM, with twofold increased risk of AF recurrence. The mechanisms of AF perpetuation in HCM are poorly understood. METHODS: We analyzed 20 patients with HCM and 20 controls presenting for radiofrequency ablation of paroxysmal AF normal left atrial voltage(> 0.5 mV). Intracardiac electrograms were extracted from the CARTO mapping system and analyzed using Matlab/Python code interfacing with Core OpenEP software. Conduction velocity maps were calculated using local activation time gradients. RESULTS: There were no differences in baseline demographics, atrial size, or valvular disease between HCM and control patients. Patients with HCM had significantly reduced atrial conduction velocity compared to controls (0.44 ± 0.17 vs 0.56 ± 0.10 m/s, p = 0.01), despite no significant differences in bipolar voltage amplitude (1.23 ± 0.38 vs 1.20 ± 0.41 mV, p = 0.76). There was a statistically significant reduction in conduction velocity in the posterior left atrium in HCM patients relative to controls (0.43 ± 0.18 vs 0.58 ± 0.10 m/s, p = 0.003), but not in the anterior left atrium (0.46 ± 0.17 vs 0.55 ± 0.10 m/s, p = 0.05). There was a significant association between conduction velocity and interventricular septal thickness (slope = -0.013, R2 = 0.13, p = 0.03). CONCLUSIONS: Atrial conduction velocity is significantly reduced in patients with HCM and paroxysmal AF, possibly contributing to arrhythmia persistence after catheter ablation.

Explainable SHAP-XGBoost models for in-hospital mortality after myocardial infarction.

Background: A lack of explainability in published machine learning (ML) models limits clinicians' understanding of how predictions are made, in turn undermining uptake of the models into clinical practice. Objective: The purpose of this study was to develop explainable ML models to predict in-hospital mortality in patients hospitalized for myocardial infarction (MI). Methods: Adult patients hospitalized for an MI were identified in the National Inpatient Sample between January 1, 2012, and September 30, 2015. The resulting cohort comprised 457,096 patients described by 64 predictor variables relating to demographic/comorbidity characteristics and in-hospital complications. The gradient boosting algorithm eXtreme Gradient Boosting (XGBoost) was used to develop explainable models for in-hospital mortality prediction in the overall cohort and patient subgroups based on MI type and/or sex. Results: The resulting models exhibited an area under the receiver operating characteristic curve (AUC) ranging from 0.876 to 0.942, specificity 82% to 87%, and sensitivity 75% to 87%. All models exhibited high negative predictive value ≥0.974. The SHapley Additive exPlanation (SHAP) framework was applied to explain the models. The top predictor variables of increasing and decreasing mortality were age and undergoing percutaneous coronary intervention, respectively. Other notable findings included a decreased mortality risk associated with certain patient subpopulations with hyperlipidemia and a comparatively greater risk of death among women below age 55 years. Conclusion: The literature lacks explainable ML models predicting in-hospital mortality after an MI. In a national registry, explainable ML models performed best in ruling out in-hospital death post-MI, and their explanation illustrated their potential for guiding hypothesis generation and future study design.

A Tool to Integrate Electrophysiological Mapping for Cardiac Radioablation of Ventricular Tachycardia.

Purpose: Cardiac radioablation is an emerging therapy for recurrent ventricular tachycardia. Electrophysiology (EP) data, including electroanatomic maps (EAM) and electrocardiographic imaging (ECGI), provide crucial information for defining the arrhythmogenic target volume. The absence of standardized workflows and software tools to integrate the EP maps into a radiation planning system limits their use. This study developed a comprehensive software tool to enable efficient utilization of the mapping for cardiac radioablation treatment planning. Methods and Materials: The tool, HeaRTmap, is a Python-scripted plug-in module on the open-source 3D Slicer software platform. HeaRTmap is able to import EAM and ECGI data and visualize the maps in 3D Slicer. The EAM is translated into a 3D space by registration with cardiac magnetic resonance images (MRI) or computed tomography (CT). After the scar area is outlined on the mapping surface, the tool extracts and extends the annotated patch into a closed surface and converts it into a structure set associated with the anatomic images. The tool then exports the structure set and the images as The Digital Imaging and Communications in Medicine Standard in Radiotherapy for a radiation treatment planning system to import. Overlapping the scar structure on simulation CT, a transmural target volume is delineated for treatment planning. Results: The tool has been used to transfer Ensite NavX EAM data into the Varian Eclipse treatment planning system in radioablation on 2 patients with ventricular tachycardia. The ECGI data from CardioInsight was retrospectively evaluated using the tool to derive the target volume for a patient with left ventricular assist device, showing volumetric matching with the clinically used target with a Dice coefficient of 0.71. Conclusions: HeaRTmap smoothly fuses EP information from different mapping systems with simulation CT for accurate definition of radiation target volume. The efficient integration of EP data into treatment planning potentially facilitates the study and adoption of the technique.

Comparison of combined substrate-based mapping techniques to identify critical sites for ventricular tachycardia ablation.

BACKGROUND: Established electroanatomic mapping techniques for substrate mapping for ventricular tachycardia (VT) ablation includes voltage mapping, isochronal late activation mapping (ILAM), and fractionation mapping. Omnipolar mapping (Abbott Medical, Inc.) is a novel optimized bipolar electrogram creation technique with integrated local conduction velocity annotation. The relative utilities of these mapping techniques are unknown. OBJECTIVE: The purpose of this study was to evaluate the relative utility of various substrate mapping techniques for the identification of critical sites for VT ablation. METHODS: Electroanatomic substrate maps were created and retrospectively analyzed in 27 patients in whom 33 VT critical sites were identified. RESULTS: Both abnormal bipolar voltage and omnipolar voltage encompassed all critical sites and were observed over a median of 66 cm2 (interquartile range [IQR] 41.3-86 cm2) and 52 cm2 (IQR 37.7-65.5 cm2), respectively. ILAM deceleration zones were observed over a median of 9 cm2 (IQR 5.0-11.1 cm2) and encompassed 22 critical sites (67%), while abnormal omnipolar conduction velocity (CV <1 mm/ms) was observed over 10 cm2 (IQR 5.3-16.6 cm2) and identified 22 critical sites (67%), and fractionation mapping was observed over a median of 4 cm2 (IQR 1.5-7.6 cm2) and encompassed 20 critical sites (61%). The mapping yield was the highest for fractionation + CV (2.1 critical sites/cm2) and least for bipolar voltage mapping (0.5 critical sites/cm2). CV identified 100% of critical sites in areas with a local point density of >50 points/cm2. CONCLUSION: ILAM, fractionation, and CV mapping each identified distinct critical sites and provided a smaller area of interest than did voltage mapping alone. The sensitivity of novel mapping modalities improved with greater local point density.

Catheter ablation of atrioventricular nodal reentrant tachycardia with an irrigated contact-force sensing radiofrequency ablation catheter.

INTRODUCTION: Radiofrequency ablation (RFA) slow pathway modification for catheter ablation of atrioventricular nodal reentrant tachycardia (AVNRT) is traditionally performed using a 4-mm nonirrigated (NI) RF ablation catheter. Slow pathway modification using irrigated, contact-force sensing (ICFS) RFA catheters has been described in case reports, but the outcomes have not been systematically evaluated. METHODS: Acute procedural outcomes of 200 consecutive patients undergoing slow pathway modification for AVNRT were analyzed. A 3.5-mm ICFS RFA catheter (ThermoCool SmartTouch STSF, Biosense Webster, Inc.) was utilized in 134 patients, and a 4-mm NI RFA catheter (EZ Steer, Biosense Webster, Inc.) was utilized in 66 patients. Electroanatomic maps were retrospectively analyzed in a blinded fashion to determine the proximity of ablation lesions to the His region. RESULTS: The baseline characteristics of patients in both groups were similar. Total RF time was significantly lower in the ICFS group compared to the NI group (5.53 ± 4.6 vs. 6.24 ± 4.9 min, p = 0.03). Median procedure time was similar in both groups (ICFS, 108.0 (87.5-131.5) min vs. NI, 100.0 (85.0-125.0) min; p = 0.2). Ablation was required in closer proximity to the His region in the NI group compared to the ICFS group (14.4 ± 5.9 vs. 16.7 ± 6.4 mm, respectively, p = 0.01). AVNRT was rendered noninducible in all patients, and there was no arrhythmia recurrence during follow-up in both groups. Catheter ablation was complicated by AV block in one patient in the NI group. CONCLUSION: Slow pathway modification for catheter ablation of AVNRT using an ICFS RFA catheter is feasible, safe, and may facilitate shorter duration ablation while avoiding ablation in close proximity to the His region.

Temporal trends in atrial fibrillation ablation procedures at an academic medical center: 2011-2021.

INTRODUCTION: Radiofrequency ablation technology for treating atrial fibrillation (AF) has evolved rapidly over the past decade. We investigated the impact of technological and procedural advances on procedure times and ablation outcomes at a major academic medical center over a 10-year period. METHODS: Clinical data was collected from patients who presented to NYU Langone Health between 2011 and 2021 for a first-time AF ablation. Time to redo AF ablation or direct current cardioversion (DCCV) for recurrent AF during a 3-year follow-up period was determined and correlated with ablation technology and practices, antiarrhythmic medications, and patient comorbid conditions. RESULTS: From 2011 to 2021, the cardiac electrophysiology lab adopted irrigated-contact force ablation catheters, high-power short duration ablation lesions, steady-pacing, jet ventilation, and eliminated stepwise linear ablation for AF ablation. During this time the number of first time AF ablations increased from 403 to 1074, the percentage of patients requiring repeat AF-related intervention within 3-years of the index procedure dropped from 22% to 14%, mean procedure time decreased from 271 ± 65 to 135 ± 36 min, and mean annual major adverse event rate remained constant at 1.1 ± 0.5%. Patient comorbid conditions increased during this time period and antiarrhythmic use was unchanged. CONCLUSION: Rates of redo-AF ablation or DCCV following an initial AF ablation at a single center decreased 36% over a 10-year period. Procedural and technological changes likely contributed to this improvement, despite increased AF related comorbidities.

Sex differences in outcomes of transvenous lead extraction: insights from National Readmission Database.

BACKGROUND: With the growing use of implantable cardiac devices, the need for transvenous lead extraction has increased, which translates to increased procedural volumes. Sex differences in lead extraction outcomes are not well studied. OBJECTIVE: The present study aims at evaluating the impact of sex on outcomes of lead extraction. METHODS: We identified 71,754 patients who presented between 2016 and 2019 and underwent transvenous lead extraction. Their clinical data were retrospectively accrued from the National Readmission Database (NRD) using the corresponding diagnosis codes. We compared clinical outcomes between male and female patients. Odds ratios (ORs) for the primary and secondary outcomes were calculated, and multivariable regression analysis was utilized to adjust for confounding variables. RESULTS: Compared to male patients, female patients had higher in-hospital complications including pneumothorax (OR 1.26, 95% CI (1.07-1.4), P < 0.01), hemopericardium (OR 1.39, 95% CI (1.02-1.88), P = 0.036), injury to superior vena cava and innominate vein requiring repair (OR 1.88, 95% CI (1.14-3.1), P = 0.014; OR 3.4, 95% CI (1.8-6.5), P < 0.01), need for blood transfusion (OR 1.28, 95% CI (1.18-1.38), P < 0.01), and pericardiocentesis (OR 1.6, 95% CI (1.3-2), P < 0.01). Thirty-day readmission was also significantly higher in female patients (OR 1.09, 95% CI (1.02-1.17), P < 0.01). There was no significant difference regarding in-hospital mortality (OR 0.99, 95% CI (0.87-1.14), P = 0.95). CONCLUSION: In female patients, lead extraction is associated with worse clinical outcomes and higher 30-day readmission rate.

Ambulatory atrioventricular synchronous pacing over time using a leadless ventricular pacemaker: Primary results from the AccelAV study.

BACKGROUND: Previous studies demonstrated that accelerometer-based, mechanically timed atrioventricular synchrony (AVS) is feasible using a leadless ventricular pacemaker. OBJECTIVE: The purpose of this study was to determine the performance of a leadless ventricular pacemaker with accelerometer-based algorithms that provide AVS pacing. METHODS: AccelAV was a prospective, single-arm study to characterize AVS in patients implanted with a Micra AV, which uses the device accelerometer to mechanically detect atrial contractions and promote VDD pacing. The primary objective was to characterize resting AVS at 1 month in patients with complete atrioventricular block (AVB) and normal sinus function. RESULTS: A total of 152 patients (age 77 ± 11 years; 48% female) from 20 centers were enrolled and implanted with a leadless pacemaker. Among patients with normal sinus function and complete AVB (n = 54), mean resting AVS was 85.4% at 1 month, and ambulatory AVS was 74.8%. In the subset of patients (n = 20) with programming optimization, mean ambulatory AVS was 82.6%, representing a 10.5% improvement (P <.001). Quality of life as measured by the EQ-5D-3L (EuroQol Five-Dimensions Three-Level questionnaire) improved significantly from preimplant to 3 months (P = .031). In 37 patients with AVB at both 1 and 3 months, mean AVS during rest did not differ (86.1% vs 84.1%; P = .43). There were no upgrades to dual-chamber devices or cardiac resynchronization therapy through 3 months. CONCLUSION: Accelerometer-based mechanical atrial sensing provided by a leadless pacemaker implanted in the right ventricle significantly improves quality of life in a select cohort of patients with AV block and normal sinus function. AVS remained stable through 3 months, and there were no system upgrades to dual-chamber pacemakers.

Correlation between AV synchrony and device collected AM-VP sequence counter in atrioventricular synchronous leadless pacemakers: A real-world assessment.

INTRODUCTION: Micra atrioventricular (AV) provides leadless atrioventricular synchronous pacing by sensing atrial contraction (A4 signal). Real-world operation and reliability of AV synchrony (AVS) assessment using device data have not been described. The purposes of this study were to (1) assess the correlation between AVS and atrial mechanical sensed-ventricular pacing (AM-VP) percentages in patients with permanent high-degree AV block and (2) report on the real-world effectiveness of Micra AV. METHODS: The correlation between ECG-determined AVS in-clinic and device-collected %AM-VP was assessed using data from 40 patients with high-degree AV block enrolled in the Micra Atrial tRacking using a Ventricular AccELerometer (MARVEL) 2 study. A retrospective analysis to assess continuously-sampled %AM-VP since last session, device programming, and electrical parameters was performed using Micra AV transmissions from the Medtronic CareLink database. Patients with transmissions ≥180 days postimplant were included. RESULTS: Among the 40 MARVEL 2 AV block patients with a median %VP of 99.7%, AVS was highly correlated with AM-VP (median AVS 87.1%, median AM-VP 79.1%; R2 = 0.764, p < .001). The CareLink cohort included 4384 patients programmed to VDD mode. The mean A4 amplitude was 2.3 ± 1.8 m/s2 at implant and 2.3 ± 1.6 m/s2 at 28 weeks. In patients with %VP >90% (n = 1662), the median %AM-VP was 74.7%. For the full cohort, median %VP was 65.6% and median projected battery longevity was 10.5 years. CONCLUSION: In patients with a high pacing burden, %AM-VP provides a reasonable estimation of AVS. The first large real-world analysis of Micra AV patients with >90% VP showed stable atrial sensing over time with a median %AM-VP, a correlate of AVS, of 74.7%.

Rebooting atrial fibrillation ablation in the COVID-19 pandemic.

PURPOSE: Catheter ablation procedures for atrial fibrillation (AF) were significantly curtailed during the peak of coronavirus disease 2019 (COVID-19) pandemic to conserve healthcare resources and limit exposure. There is little data regarding peri-procedural outcomes of medical procedures during the COVID-19 pandemic. We enacted protocols to safely reboot AF ablation while limiting healthcare resource utilization. We aimed to evaluate acute and subacute outcomes of protocols instituted for reboot of AF ablation during the COVID-19 pandemic. METHODS: Perioperative healthcare utilization and acute procedural outcomes were analyzed for consecutive patients undergoing AF ablation under COVID-19 protocols (2020 cohort; n=111) and compared to those of patients who underwent AF ablation during the same time period in 2019 (2019 cohort; n=200). Newly implemented practices included preoperative COVID-19 testing, selective transesophageal echocardiography (TEE), utilization of venous closure, and same-day discharge when clinically appropriate. RESULTS: Pre-ablation COVID-19 testing was positive in 1 of 111 patients. There were 0 cases ablation-related COVID-19 transmission and 0 major complications in either cohort. Pre-procedure TEE was performed in significantly fewer 2020 cohort patients compared to the 2019 cohort patients (68.4% vs. 97.5%, p <0.001, respectively) despite greater prevalence of persistent arrhythmia in the 2020 cohort. Same-day discharge was achieved in 68% of patients in the 2020 cohort, compared to 0% of patients in the 2019 cohort. CONCLUSIONS: Our findings demonstrate the feasibility of safe resumption of complex electrophysiology procedures during the COVID-19 pandemic, reducing healthcare utilization and maintaining quality of care. Protocols instituted may be generalizable to other types of procedures and settings.

ICD shocks and complications in patients with inherited arrhythmia syndromes.

BACKGROUND: There is limited information on the long-term outcomes of ICDs in patients with inherited arrhythmia syndromes. METHODS: Prospective registry study of inherited arrhythmia patients with an ICD. Incidence of therapies and complications were measured as 5-year cumulative incidence proportions and analyzed with the Kaplan-Meier method. Incidence was compared by device indication, diagnosis type and device type. Cox-regression analysis was used to identify predictors of appropriate shock and device complication. RESULTS: 123 patients with a mean follow up of 6.4 ± 4.8 years were included. The incidence of first appropriate shock was 56.52% vs 24.44%, p < 0.05 for cardiomyopathy and channelopathy patients, despite similar ejection fraction (61% vs 60%, p = 0.6). The incidence of first inappropriate shock was 13.46% vs 56.25%, p < 0.01 for single vs. multi-lead devices. The incidence of first lead complication was higher for multi-lead vs. single lead devices, 43.75% vs. 17.31%, p = 0.04. Patients with an ICD for secondary prevention were more likely to receive an appropriate shock than those with primary prevention indication (HR 2.21, CI 1.07-4.56, p = 0.03). Multi-lead devices were associated with higher risk of inappropriate shock (HR 3.99, CI 1.27-12.52, p = 0.02), with similar appropriate shock risk compared to single lead devices. In 26.5% of patients with dual chamber devices, atrial sensing or pacing was not utilized. CONCLUSION: The rate of appropriate therapies and ICD complications in patients with inherited arrhythmia is high, particularly in cardiomyopathies with multi-lead devices. Risk-benefit ratio should be carefully considered when assessing the indication and type of device in this population.