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.

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.

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).

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.).

Comparison of Left Bundle Branch Area Pacing and Biventricular Pacing in Candidates for Resynchronization Therapy.

BACKGROUND: Cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) is a well established therapy in patients with reduced left ventricular ejection fraction (LVEF), heart failure, and wide QRS or expected frequent ventricular pacing. Left bundle branch area pacing (LBBAP) has recently been shown to be a safe alternative to BVP. OBJECTIVES: The aim of this study was to compare the clinical outcomes between BVP and LBBAP among patients undergoing CRT. METHODS: This observational study included patients with LVEF ≤35% who underwent BVP or LBBAP for the first time for Class I or II indications for CRT from January 2018 to June 2022 at 15 international centers. The primary outcome was the composite endpoint of time to death or heart failure hospitalization (HFH). Secondary outcomes included endpoints of death, HFH, and echocardiographic changes. RESULTS: A total of 1,778 patients met inclusion criteria: 981 BVP, 797 LBBAP. The mean age was 69 ± 12 years, 32% were female, 48% had coronary artery disease, and mean LVEF was 27% ± 6%. Paced QRS duration in LBBAP was significantly narrower than baseline (128 ± 19 ms vs 161 ± 28 ms; P < 0.001) and significantly narrower compared to BVP (144 ± 23 ms; P < 0.001). Following CRT, LVEF improved from 27% ± 6% to 41% ± 13% (P < 0.001) with LBBAP compared with an increase from 27% ± 7% to 37% ± 12% (P < 0.001) with BVP, with significantly greater change from baseline with LBBAP (13% ± 12% vs 10% ± 12%; P < 0.001). On multivariable regression analysis, the primary outcome was significantly reduced with LBBAP compared with BVP (20.8% vs 28%; HR: 1.495; 95% CI: 1.213-1.842; P < 0.001). CONCLUSIONS: LBBAP improved clinical outcomes compared with BVP in patients with CRT indications and may be a reasonable alternative to BVP.

Acute performance of stylet driven leads for left bundle branch area pacing: A comparison with lumenless leads.

Background: Lumenless leads (LLLs) are widely used for left bundle branch area pacing (LBBAP). Recently, stylet-driven leads (SDLs) have also been used for LBBAP. Objective: The purpose of this study was to evaluate the acute performance of SDLs during LBBAP in comparison with LLLs. Methods: Consecutive patients undergoing LBBAP for bradycardia or cardiac resynchronization therapy indications at 2 high-volume, early conduction system pacing adopters, tertiary centers were included from January 2019 to July 2023. Patients received either SDLs or LLLs at the discretion of the implanting physician. Acute performance and follow-up data of both lead types were evaluated. Results: A total of 925 LBBAP implants were included, 655 using LLLs and 270 using SDLs. Overall, LBBAP acute success was significantly higher with LLLs than SDLs (95.3% vs 85.1%, respectively; P <.001) even after the learning curve (97% vs 86%; P = .013). LLLs were implanted in more mid-basal septal positions in comparison with SDLs, which tended to be implanted in more inferior and mid-apical septal positions. Acute lead-related complications were higher with SDLs than LLLs (15.9% vs 6.1%, respectively; P <.001) with 15 cases of lead damage during implant (4.4% vs 0.5%; P <.001) but decreased with acquired experience and were comparable in the last 100 patients included in each group. Lead implant and fluoroscopy times were shorter for SDLs, with lead dislodgment occurring in 0.9% with LLLs and 1.5% with SDLs (P = .489). Conclusion: Acute lead performance proved to be different between LLLs and SDLs. A specific learning curve should be considered for SDLs even for implanters with extensive previous experience with LLLs.

Left bundle branch area pacing in patients with heart failure and right bundle branch block: Results from International LBBAP Collaborative-Study Group.

Background: Cardiac resynchronization therapy (CRT) using biventricular pacing has limited efficacy in patients with heart failure (HF) and right bundle branch block (RBBB). Left bundle branch area pacing (LBBAP) is a novel physiologic pacing option. Objective: The aim of the study was to assess the feasibility and outcomes of LBBAP in HF patients with RBBB and reduced left ventricular systolic function, and indication for CRT or ventricular pacing. Methods: LBBAP was attempted in patients with left ventricular ejection fraction (LVEF) <50%, RBBB, HF, and indications for CRT or ventricular pacing. Procedural, pacing, and electrocardiographic parameters; clinical response (no HF hospitalization and improvement in NYHA class); and echocardiographic response (≥5% increase in ejection fraction) to LBBAP were assessed. Results: LBBAP was attempted in 121 patients and successful in 107 (88%). Patient characteristics included age 74 ± 12 years, female 25%, ischemic cardiomyopathy 49%, and ejection fraction 35% ± 9%. QRS axis at baseline was normal in 24%, left axis 63%, right axis 13%. LBBAP threshold and R-wave amplitudes were 0.8 ± 0.3 V @ 0.5 ms and 10 ± 9 mV at implant and remained stable during mean follow-up of 13 ± 8 months. LBBAP resulted in narrowing of QRS duration (156 ± 20 ms to 150 ± 24 ms (P = .01) with R-wave peak times in V6 of 85 ± 16 ms. LVEF improved from 35% ± 9% to 43% ± 12% (P < .01). Clinical and echocardiographic response was observed in 60% and 61% of patients, respectively. Female sex and reduction in QRS duration with LBBAP were predictive of echocardiographic response and super-response. Conclusion: LBBAP is a feasible alternative to deliver CRT or physiologic ventricular pacing in patients with RBBB, HF, and LV dysfunction.

Conduction system pacing versus conventional pacing in patients undergoing atrioventricular node ablation: Nonrandomized, on-treatment comparison.

Background: Atrioventricular node ablation (AVNA) with right ventricular or biventricular pacing (conventional pacing; CP) is an effective therapy for patients with refractory atrial fibrillation (AF). Conduction system pacing (CSP) using His bundle pacing or left bundle branch area pacing preserves ventricular synchrony. Objective: The aim of our study is to compare the clinical outcomes between CP and CSP in patients undergoing AVNA. Methods: Patients undergoing AVNA at Geisinger Health System between January 2015 and October 2020 were included in this retrospective observational study. CP or CSP was performed at the operators' discretion. Procedural, pacing parameters, and echocardiographic data were assessed. Primary outcome was the combined endpoint of time to death or heart failure hospitalization (HFH) and was analyzed using Cox proportional hazards. Secondary outcomes were individual outcomes of time to death and HFH. Results: AVNA was performed in 223 patients (CSP, 110; CP, 113). Age was 75 ± 10 years, male 52%, hypertension 67%, diabetes 25%, coronary disease 40%, and left ventricular ejection fraction (LVEF) 43% ± 15%. QRS duration increased from 103 ± 30 ms to 124 ± 20 ms (P < .01) in CSP and 119 ± 32 ms to 162 ± 24 ms in CP (P < .001). During a mean follow-up of 27 ± 19 months, LVEF significantly increased from 46.5% ± 14.2% to 51.9% ± 11.2% (P = .02) in CSP and 36.4% ± 16.1% to 39.5% ± 16% (P = .04) in CP. The primary combined endpoint of time to death or HFH was significantly reduced in CSP compared to CP (48% vs 62%; hazard ratio 0.61, 95% confidence interval 0.42-0.89, P < .01). There was no reduction in the individual secondary outcomes of time to death and HFH in the CSP group compared to CP. Conclusion: CSP is a safe and effective option for pacing in patients with AF undergoing AVNA in high-volume centers.

Clinical outcomes of conduction system pacing compared to biventricular pacing in patients requiring cardiac resynchronization therapy.

BACKGROUND: Cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) is well-established therapy in patients with reduced left ventricular ejection fraction (LVEF) and bundle branch block or indication for pacing. Conduction system pacing (CSP) using His-bundle pacing (HBP) or left bundle branch area pacing (LBBAP) has been shown to be a safe and more physiological alternative to BVP. OBJECTIVE: The purpose of this study was to compare the clinical outcomes between CSP and BVP among patients undergoing CRT. METHODS: This observational study included consecutive patients with LVEF ≤35% and class I or II indications for CRT who underwent successful BVP or CSP at 2 major health care systems. The primary outcome was the composite endpoint of time to death or heart failure hospitalization (HFH). Secondary outcomes included subgroup analysis in left bundle branch block as well as individual endpoints of death and HFH. RESULTS: A total of 477 patients (32% female) met inclusion criteria (BVP 219; CSP 258 [HBP 87, LBBAP 171]). Mean age was 72 ± 12 years, and mean LVEF was 26% ± 6%. Comorbidities included hypertension 70%, diabetes mellitus 45%, and coronary artery disease 52%. Paced QRS duration in CSP was significantly narrower than BVP (133 ± 21 ms vs 153 ± 24 ms; P <.001). LVEF improved in both groups during mean follow-up of 27 ± 12 months and was greater after CSP compared to BVP (39.7% ± 13% vs 33.1% ± 12%; P <.001). Primary outcome of death or HFH was significantly lower with CSP vs BVP (28.3% vs 38.4%; hazard ratio 1.52; 95% confidence interval 1.082-2.087; P = .013). CONCLUSION: CSP improved clinical outcomes compared to BVP in this large cohort of patients with indications for CRT.

Rescue left bundle branch area pacing in coronary venous lead failure or nonresponse to biventricular pacing: Results from International LBBAP Collaborative Study Group.

BACKGROUND: Cardiac resynchronization therapy (CRT) using biventricular pacing (BVP) is effective in patients with heart failure, left bundle branch block (LBBB), and reduced left ventricular function. Left bundle branch area pacing (LBBAP) has been reported as an alternative option for CRT. OBJECTIVE: The purpose of this study was to assess the feasibility and outcomes of LBBAP in patients who failed conventional BVP because of coronary venous (CV) lead complications or who were nonresponders to BVP. METHODS: At 16 international centers, LBBAP was attempted in patients with conventional CRT indication who failed BVP because of CV lead complications or lack of therapeutic response to BVP. Heart failure hospitalization (HFH) and death, echocardiographic outcomes, procedural data, pacing parameters, and lead complications including CV lead failure are reported. RESULTS: LBBAP was successfully performed in 200 patients (CV lead failures 156; nonresponders 44) (age 68 ± 11 years; female 35%; LBBB 55%; right ventricular pacing 23%; ischemic cardiomyopathy 28%; nonischemic cardiomyopathy 63%; left ventricular ejection fraction [LVEF] ≤35% in 80%). Procedural duration was 119.5 ± 59.6 minutes, and fluoroscopy duration was 25.7 ± 18.5 minutes. LBBAP threshold and R-wave amplitudes were 0.68 ± 0.35 V @ 0.45 ms and 10.4 ± 5 mV at implant, respectively, and remained stable during mean follow-up of 12 ± 10.1 months. LBBAP resulted in significant QRS narrowing from 170 ± 28 ms to 139 ± 25 ms (P <.001) with V6 R-wave peak times of 85 ± 17 ms. LVEF improved from 29% ± 10% at baseline to 40% ± 12% (P <.001) during follow-up. The risk of death or HFH was lower in those with CV lead failure than in nonresponders (hazard ratio 0.357; 95% confidence interval 0.168-0.756; P = .007) CONCLUSION: LBBAP is a viable alternative to CRT in patients who failed conventional BVP due to CV lead failure or who were nonresponders.

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.

His-Purkinje Conduction System Pacing in Atrioventricular Block: New Insights Into Site of Conduction Block.

OBJECTIVES: This study aims to assess the safety and feasibility of achieving His-Purkinje conduction system pacing (HPCSP) in consecutive patients with atrioventricular block (AVB) and to describe the site of conduction block in patients with infranodal AVB. BACKGROUND: HPCSP has evolved as the preferred form of physiologic pacing. Left bundle branch area pacing (LBBAP) has emerged as an effective alternative to His bundle pacing (HBP). METHODS: Consecutive patients with AVB referred for pacemaker implantation were included in the study. HBP or LBBAP was attempted in all patients. Site of conduction block was identified as nodal or infranodal (intra-Hisian or infra-Hisian) AVB. RESULTS: HPCSP was attempted in 333 consecutive patients with AVB and was successful in 322 (97%) patients. HBP was achieved in 140 patients, LBBAP in 179 patients, and both in 3 patients. Site of conduction block was nodal in 55% and infranodal in 45% (intra-Hisian 89%; infra-Hisian 4%; indeterminate 7%). QRS duration at baseline was 111 ± 27 versus 129 ± 31 (P < 0.001) compared to 126 ± 24 vs 125 ± 21 milliseconds (P = 0.75) during HBP and LBBAP, respectively. HBP thresholds at implant were higher compared to LBBAP (1.2 ± 0.7 V at 0.9 milliseconds vs 0.6 ± 0.3 V at 0.5 milliseconds; P < 0.001) but remained stable during follow-up. Lead revision was required in 3% and 2% of patients with HBP and LBBAP, respectively. CONCLUSIONS: HPCSP pacing was successfully performed in 97% of unselected patients with AVB irrespective of the site of conduction block. True infra-Hisian block (distal His-Purkinje conduction disease) is rare. HBP and LBBAP were complementary in achieving stable and low capture thresholds.

Clinical outcomes of left bundle branch area pacing compared to right ventricular pacing: Results from the Geisinger-Rush Conduction System Pacing Registry.

BACKGROUND: Left bundle branch area pacing (LBBAP) has been shown to be a feasible option for patients requiring ventricular pacing. OBJECTIVE: The purpose of this study was to compare clinical outcomes between LBBAP and RVP among patients undergoing pacemaker implantation METHODS: This observational registry included patients who underwent pacemaker implantations with LBBAP or RVP for bradycardia indications between April 2018 and October 2020. The primary composite outcome included all-cause mortality, heart failure hospitalization (HFH), or upgrade to biventricular pacing. Secondary outcomes included the composite endpoint among patients with a prespecified burden of ventricular pacing and individual outcomes. RESULTS: A total of 703 patients met inclusion criteria (321 LBBAP and 382 RVP). QRS duration during LBBAP was similar to baseline (121 ± 23 ms vs 117 ± 30 ms; P = .302) and was narrower compared to RVP (121 ± 23 ms vs 156 ± 27 ms; P <.001). The primary composite outcome was significantly lower with LBBAP (10.0%) compared to RVP (23.3%) (hazard ratio [HR] 0.46; 95%T confidence interval [CI] 0.306-0.695; P <.001). Among patients with ventricular pacing burden >20%, LBBAP was associated with significant reduction in the primary outcome compared to RVP (8.4% vs 26.1%; HR 0.32; 95% CI 0.187-0.540; P <.001). LBBAP was also associated with significant reduction in mortality (7.8% vs 15%; HR 0.59; P = .03) and HFH (3.7% vs 10.5%; HR 0.38; P = .004). CONCLUSION: LBBAP resulted in improved clinical outcomes compared to RVP. Higher burden of ventricular pacing (>20%) was the primary driver of these outcome differences.

Coronary Venous Visualization During Deep Septal Lead Placement: An Unexpected Finding.

Left bundle branch area pacing has emerged as a safe and feasible alternative to conventional pacing. Acute septal injury, septal perforation, and arteriovenous fistula are potential risks of deep septal implants. Contrast drainage through the lesser cardiac veins and subsequent filling of major epicardial vessels may be benign observations noted during forceful hand injection. (Level of Difficulty: Advanced.).

Imaging-Based Localization of His Bundle Pacing Electrodes: Results From the Prospective IMAGE-HBP Study.

OBJECTIVES: This study sought to evaluate the correlation between His bundle (HB) pacing (HBP) implantation characteristics, lead-tip location, and association of intraprocedural His recordings with approximated HB anatomic landmarks using computed tomography (CT) imaging. BACKGROUND: HBP continues to grow in clinical practice due to offering true physiological pacing. However, a clear understanding of HB anatomy and the lead-tip location's influence on pacing characteristics is lacking. METHODS: The IMAGE-HBP study (Imaging Study of Lead Implant for His Bundle Pacing) was a prospective, multicenter study designed to assess implantation characteristics of the SelectSecure Model 3830 lead placed at the HB, evaluate protocol-specified HBP success (His recording present on electrogram and HBP threshold ≤2.5 V at 1 ms), and correlation between lead-tip location by CT imaging and HBP characteristics as well as lead-related complications through 12 months. RESULTS: Sixty-nine patients underwent a lead implantation attempt at the HB. Of these, 61 patients (88%) had a lead successfully implanted at the HB, and 52 patients (75%) met the pre-specified definition of successful HBP. In 51 patients with CT imaging, 11 leads (22%) were placed in the atrial aspect of the HB region (36% selective HBP), and 40 leads (78%) were placed in the ventricular aspect (28% selective HBP). Four of the 51 patients had P-wave oversensing, all with leads in the atrium. Freedom from lead-related complication at 12 months was 93%. CONCLUSIONS: Successful HBP could be achieved at lead-tip locations in the atrium or ventricle but is preferable in the ventricle to eliminate risk of oversensing. The IMAGE-HBP study offers better insight into approximated HB anatomic landmarks, lead-tip location, and correlation with pacing characteristics. (Imaging Study of Lead Implant for His Bundle Pacing [IMAGE-HBP]; NCT03294317).