Arrhythmic Risk in Biventricular Pacing Compared With Left Bundle Branch Area Pacing: Results From the I-CLAS Study.

BACKGROUND: Left bundle branch area pacing (LBBAP) may be associated with greater improvement in left ventricular ejection fraction and reduction in death or heart failure hospitalization compared with biventricular pacing (BVP) in patients requiring cardiac resynchronization therapy. We sought to compare the occurrence of sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) and new-onset atrial fibrillation (AF) in patients undergoing BVP and LBBAP. METHODS: The I-CLAS study (International Collaborative LBBAP Study) included patients with left ventricular ejection fraction ≤35% who underwent BVP or LBBAP for cardiac resynchronization therapy between January 2018 and June 2022 at 15 centers. We performed propensity score-matched analysis of LBBAP and BVP in a 1:1 ratio. We assessed the incidence of VT/VF and new-onset AF among patients with no history of AF. Time to sustained VT/VF and time to new-onset AF was analyzed using the Cox proportional hazards survival model. RESULTS: Among 1778 patients undergoing cardiac resynchronization therapy (BVP, 981; LBBAP, 797), there were 1414 propensity score-matched patients (propensity score-matched BVP, 707; propensity score-matched LBBAP, 707). The occurrence of VT/VF was significantly lower with LBBAP compared with BVP (4.2% versus 9.3%; hazard ratio, 0.46 [95% CI, 0.29-0.74]; P<0.001). The incidence of VT storm (>3 episodes in 24 hours) was also significantly lower with LBBAP compared with BVP (0.8% versus 2.5%; P=0.013). Among 299 patients with cardiac resynchronization therapy pacemakers (BVP, 111; LBBAP, 188), VT/VF occurred in 8 patients in the BVP group versus none in the LBBAP group (7.2% versus 0%; P<0.001). In 1194 patients with no history of VT/VF or antiarrhythmic therapy (BVP, 591; LBBAP, 603), the occurrence of VT/VF was significantly lower with LBBAP than with BVP (3.2% versus 7.3%; hazard ratio, 0.46 [95% CI, 0.26-0.81]; P=0.007). Among patients with no history of AF (n=890), the occurrence of new-onset AF >30 s was significantly lower with LBBAP than with BVP (2.8% versus 6.6%; hazard ratio, 0.34 [95% CI, 0.16-0.73]; P=0.008). The incidence of AF lasting >24 hours was also significantly lower with LBBAP than with BVP (0.7% versus 2.9%; P=0.015). CONCLUSIONS: LBBAP was associated with a lower incidence of sustained VT/VF and new-onset AF compared with BVP. This difference remained significant after adjustment for differences in baseline characteristics between patients with BVP and LBBAP. Physiological resynchronization by LBBAP may be associated with lower risk of arrhythmias compared with BVP.

Clinical outcomes of left bundle branch area pacing compared to His bundle pacing.

INTRODUCTION: His bundle pacing (HBP) is the most physiologic form of pacing and has been associated with reduced risk for heart failure hospitalization (HFH) and mortality compared to right ventricular pacing. Left bundle branch area pacing (LBBAP) is a safe and effective alternative option for patients needing ventricular pacing. The aim of this study was to compare the clinical outcomes between LBBAP and HBP among a large cohort of patients undergoing permanent pacemaker implantation. METHODS: This observational registry included consecutive patients with AV block/AV node ablation who underwent de novo permanent pacemaker implantations with successful LBBAP or HBP between April 2018 and October 2020. The primary outcome was the composite endpoint of time to death from any cause or HFH. Secondary outcomes included the composite endpoint among patients with prespecified ventricular pacing burden and individual outcomes. RESULTS: The study population included 359 patients who met the inclusion criteria (163 in the HBP and 196 in the LBBAP group). Paced QRSd during LBBAP was similar to HBP (125 ± 20.2 vs. 126 ± 23.5 ms, p = .643). There were no statistically significant differences in the primary composite outcome in LBBAP (17.3%) compared to HBP (24.5%) (hazard ratio [HR]: 1.15, 95% CI: 0.72-1.82, p = .552). Secondary outcomes of death (10% vs. 17%; HR: 1.3, 95% CI: 0.73-2.33, p = .38) and HFH (10% vs. 12%; HR: 1.02, 95% CI: 0.54-1.94, p = .94) were not different among both groups. CONCLUSIONS: There were no statistically significant differences in the clinical outcomes of death or HFH in LBBAP when compared to HBP.

Cardiac troponin release following left bundle branch pacing.

Left bundle branch pacing (LBBP) has emerged as an alternative to His bundle pacing (HBP) to achieve physiologic ventricular stimulation. The extent of myocardial injury during permanent LBBP implantation is currently not known. The aim of the study was to prospectively assess the extent of myocardial injury during LBBP implantation. Cardiac troponin (cTn) levels were measured at baseline and 6-12 h following permanent LBBP. The number of attempts to achieve LBBP was documented. Troponin levels were measured in a control population undergoing other electrophysiology procedures including HBP, other devices involving right ventricular (RV) pacing, radiofrequency ablation for atrial fibrillation (AF) and supraventricular tachycardia (SVT). Significant elevation of troponin (SET) was defined as threefold increase above the upper reference limit (URL) for cTn. Between December 2019 and April 2020, 204 were prospectively enrolled: LBBP in 98 and Control group 106 (SVT, 55; AF, 20; HBP, 17; other devices, 14). SET (>3× URL) was seen in 49.4% of patients in the LBBP group compared to 58.4% in the control group (p = .23). Peak troponin levels were greater in the control group compared to the LBBP group (230.3 ± 320.1 vs. 87.4 ± 71.3 pg/ml; p = .0001). Compared to LBBP (49.4%), SET was observed less frequently following HBP (17.5%; p = .01), and other device implantation (29%; p = .15). Patients requiring >2 attempts (n = 33) had significantly higher incidence of SET compared to <2 attempts (n = 56; 66.7% vs. 39.3%; p = .01). LBBP implantation is associated with myocardial injury. Asymptomatic troponin release following LBBP is less than or comparable to other interventional electrophysiology procedures.

His bundle pacing capture threshold stability during long-term follow-up and correlation with lead slack.

AIMS: His bundle pacing (HBP) is the most physiologic form of pacing. Long-term HBP capture threshold stability and its relation to lead characteristics at the time of implantation have not been adequately described. The aim of this study was to characterize HB capture threshold in follow-up and to identify potential lead characteristics predictive of lead capture instability. METHODS AND RESULTS: Consecutive patients with successful HBP for bradycardia indications were identified from the Geisinger HBP registry. His bundle capture thresholds, baseline comorbidities, and radiographic lead slack characteristics were analysed. An increase in HB capture threshold ≥1 V above implant values at any time during follow-up was tracked. Forty-four of the 294 studied (15%) experienced HB capture threshold increase by ≥ 1 V. Threshold increase was seen early (41% by 8 weeks, 66% by 1 year). Eighteen (6%) patients required lead revision in follow-up. Abnormal slack shape was associated with a trend toward capture threshold increase [hazard ratio (HR) 2.07; 95% confidence interval (CI) 0.9-4.6; P = 0.08]. Non-perpendicular angle of lead insertion on radiography was associated with the capture threshold increase (HR 2.81, 95% CI 1.4-5.8; P < 0.01). CONCLUSION: His bundle capture threshold remains stable in the majority (85%) of patients. Implant characteristics may predict the threshold rise. Further evaluation of the aetiology of threshold increase and design changes in lead and delivery systems may lead to chronically stable capture thresholds.

Long term performance and safety of His bundle pacing: A multicenter experience.

INTRODUCTION: Several single-center short-term studies have demonstrated the feasibility, safety, and positive clinical outcomes of permanent His bundle pacing (HBP). We performed a retrospective study to evaluate long-term technical and safety performances of HBP in a large population of pacemaker patients from two different centers. METHODS AND RESULTS: The analysis includes 844 patients (345 female, mean age = 75 ± 9 years) who underwent successful permanent HBP for pacemaker indications from 2004 to 2016. The main endpoints were long term electrical performances including pacing threshold, sensing, impedance, and freedom from pacing related complications. The pacing indication was AV Block in 348 (41.2%) patients, sinus node disease in 147 (17.4%), any bradycardia indication in patients with atrial fibrillation in 335 (39.7%) patients and need for cardiac resynchronization therapy in 14 (1.7%) patients. Mean pacing capture thresholds and sensed R waves were 1.6 V and 5.8 mV, respectively at implant and 2.0 V and 6.1 mV at chronic follow-up. During the median follow up of 3 years (interquartile range = 1-6 years), HBP was free of any complication in 91.6% of patients. In the first 368 patients, HBP was achieved using a deflectable curve delivery system, while in 476 using the fixed curve sheath. A significant difference was found in the thresholds (2.4 ± 1.0 V and 1.7 ± 1.1 V, P < .001, respectively) and complications (11.9% and 4.2%, P < .001, respectively) between the two groups. CONCLUSIONS: Permanent HBP was safe and effective during long-term follow-up. The fixed curved delivery sheath offered significantly better electrical parameters and reliability over time. The results of this multicenter study are consistent with recent studies.

His-Bundle Pacing and LV Endocardial Pacing as Alternatives to Traditional Cardiac Resynchronization Therapy.

PURPOSE OF REVIEW: Cardiac resynchronization therapy (CRT) using biventricular pacing (BVP) is the cornerstone of treatment for patients with heart failure and left bundle branch block. Up to a third of patients do not respond to BVP. This article reviews the utility of His-bundle pacing (HBP) and Left ventricular (LV) endocardial pacing as alternatives to BVP to provide ventricular synchrony. RECENT FINDINGS: HBP has shown promising results in observational studies. By significantly narrowing or normalizing QRS, HBP has improved clinical outcomes including ejection fractions both as a rescue option in patients who failed BVP or as a primary alternative. LV endocardial pacing has also shown promise with improved clinical outcomes. Using traditional pacing leads or novel technology, direct stimulation of the LV endocardium allows for better site selection as well as a more physiological activation of the LV compared to traditional epicardial LV stimulation. HBP and LV endocardial pacing are valuable alternatives to traditional BVP to achieve CRT. Randomized clinical trials in progress will allow for a deeper understanding of how they can benefit our patients.

Atrioventricular node ablation and His bundle pacing.

AIMS: Atrioventricular node ablation (AVNA) and right ventricular pacing (RVP) are effective therapies for patients with atrial fibrillation (AF) and rapid ventricular rates. His bundle pacing (HBP) is a physiologic alternative to RVP. The aim of our study is to assess the feasibility and safety of HBP in patients undergoing AVNA and its effect on left ventricular (LV) function. METHODS AND RESULTS: Permanent HBP is the preferred form of ventricular pacing at our institute. Atrioventricular node ablation and HBP were performed in patients with AF and difficulty in rate control. His bundle pacing implant characteristics and thresholds were recorded. Fluoroscopic relationship of AVNA site to HBP lead electrodes was documented. Left ventricular ejection fraction (LVEF) and New York Heart Association (NYHA) functional class at baseline and during follow-up were assessed. Forty-two patients underwent HBP and AVNA: age 74 ± 11 years; men 45%; HTN 64%; DM 19%; CAD 36%; permanent AF 40%; cardiomyopathy 55%. His bundle pacing was successful in 40 of 42 patients (95%). Successful AVNA site was at or below the ring electrode in 22 (no acute change in HBP threshold); above the ring electrode in 13 and left side in 2 pts (acute increase in HBP threshold in 7 of 15 pts). Final HBP threshold at implant was 1 ± 0.8 V@1 ms and increased to 1.6 ± 1.2 V@1 ms during a mean follow-up of 19 ± 14 months. Left ventricular ejection fraction increased from 43 ± 13% to 50 ± 11% (P = 0.01). New York Heart Association functional status improved from 2.5 ± 0.5 to 1.9 ± 0.5 (P = 0.04). CONCLUSION: Atrioventricular node ablation and HBP were successful in 95% of patients. His bundle pacing lead characteristics remained relatively stable. Left ventricular ejection fraction improved significantly during follow-up. His bundle pacing is feasible, safe and effective in pts undergoing AVNA.

Sex-Specific Outcomes of LBBAP Versus Biventricular Pacing: Results From I-CLAS.

BACKGROUND: Cardiac resynchronization therapy (CRT) using biventricular pacing (BVP) has been associated with greater clinical improvement in women than men. Recently, left bundle branch area pacing (LBBAP) has been shown to be an alternative form of CRT. OBJECTIVES: The purpose of this study was to investigate sex-specific outcomes for death and heart failure events in a large, international, multicenter, cohort of patients undergoing CRT with BVP or LBBAP. METHODS: In this international study of 1,778 patients (575 female and 1203 male), sex-specific survival analysis was performed to compare the effect of LBBAP-CRT relative to BVP-CRT on the combined endpoint of death or heart failure hospitalization (HFH), and secondary endpoints of HFH only, and death alone. RESULTS: Female patients were more likely to have nonischemic cardiomyopathy and left bundle branch block (LBBB) and less likely to have hypertension, diabetes, or coronary artery disease than were male patients. Overall, female patients had a better result with LBBAP compared with BVP than did male patients, with a significant 36% reduction in death or HFH (HR: 0.64; 95% CI: 0.43 to 0.97; P = 0.03) and a significant 60% reduction in HFH alone (HR: 0.4; 95% CI: 0.24 to 0.69, P < 0.01). Women had a greater reduction in death or HFH among those with nonischemic cardiomyopathy (HR: 0.45 95% CI: 0.26 to 0.79; P < 0.01) and LBBB (HR: 0.49; 95% CI: 0.27 to 0.87; P < 0.01). Sex-specific echocardiographic outcomes were better in women than in men. CONCLUSIONS: Women obtained significantly greater reductions in the combined endpoint of death or HFH (primarily driven by reduction in HFH) with LBBAP compared with BVP among patients requiring CRT than did men.

Giant Interventricular Septal Hematoma Complicating Left Bundle Branch Pacing: A Cautionary Tale.

An 88-year-old woman underwent atrioventricular node ablation and left bundle branch pacing for atrial fibrillation. She presented to the emergency room several hours after discharge with dyspnea. An echocardiogram revealed a giant interventricular septal hematoma. The patient was successfully treated with conservative medical therapy, with eventual complete resolution of the hematoma. (Level of Difficulty: Intermediate.).

His-Purkinje Conduction System Pacing Optimized Trial of Cardiac Resynchronization Therapy vs Biventricular Pacing: HOT-CRT Clinical Trial.

BACKGROUND: His-Purkinje conduction system pacing (HPCSP) using His bundle pacing (HBP) or left bundle branch pacing (LBBP) has emerged as an alternative to biventricular pacing (BVP) in patients requiring cardiac resynchronization therapy (CRT). OBJECTIVES: The aim of the study was to compare the feasibility and clinical efficacy of HOT-CRT (His-Purkinje conduction system pacing Optimized Trial of Cardiac Resynchronization Therapy) with BVP in patients with heart failure, reduced ejection fraction, and indication for CRT. METHODS: This was a prospective, randomized, controlled trial of HOT-CRT and BVP in patients with LVEF <50% and indications for CRT. If HPCSP resulted in incomplete electrical resynchronization, a coronary sinus (CS) lead was added. The primary outcome was the change in left ventricular ejection fraction (LVEF) at 6 months. The primary safety endpoint was freedom from major complications. RESULTS: A total of 100 patients (female 31%, aged 70 ± 12 years, LVEF 31.5% ± 9.0%) were randomized. HOT-CRT was successful in 48 of 50 (96%) and BVP-CRT in 41 of 50 (82%) patients (P = 0.03). QRS duration significantly decreased from 164 ± 26 ms to 137 ± 20 ms with HOT-CRT and 166 ± 28 ms to 141 ± 19 ms with BVP. Fluoroscopy results (18.8 ± 12.4 min vs 23.8 ± 12.4 min, P = 0.05) and procedure duration (119 ± 42 min vs 114 ± 36 min, P = 0.5) were similar. The primary outcome of change in LVEF at 6 months was greater in HOT-CRT than in BVP (12.4% ± 7.3% vs 8.0% ± 10.1%, P = 0.02). The primary safety endpoint was similar (98% vs 94%, P = 0.62). Echocardiographic response of improvement in LVEF >5% occurred in 80% vs 61% (P = 0.06). Complications occurred in 3 (6%) in HOT-CRT vs 10 (20%) in BVP (P = 0.03). CONCLUSIONS: HPCSP-guided CRT resulted in greater change in LVEF compared with BVP. Randomized clinical trials with long-term follow-up are necessary. (His-Purkinje Conduction System Pacing Optimized Trial of Cardiac Resynchronization Therapy [HOT-CRT]; NCT04561778).