Transvenous extraction of conduction system pacing leads: An international multicenter (TECSPAM) study.

BACKGROUND: Conduction system pacing (CSP) by His bundle pacing or left bundle branch area pacing (LBBAP) is incorporated into Heart Rhythm Society guidelines for the management of bradycardia and cardiac resynchronization therapy. Despite increasing adoption with both lumenless leads and stylet-driven leads, concerns regarding the feasibility and safety of the extraction of CSP leads remain. OBJECTIVE: The aim of the study was to report on the safety, feasibility, and clinical outcomes of the extraction of CSP leads. METHODS: Patients undergoing the extraction of CSP leads from 10 international centers were enrolled in this retrospective study. Data regarding indications, lead location, lead type, extraction tools, procedural success, complications, and reimplantation in the conduction system were collected. RESULTS: Overall, 341 patients (age 69 ± 15 years; female 34%; cardiomyopathy 46%; lead dwell time 22 ± 26 months) underwent the extraction of 224 His bundle pacing and 117 LBBAP leads (lumenless leads 321; stylet-driven leads 20). Complete procedural success was achieved in 338 (99%), while clinical success was 100% with retained distal fragments in 3 patients (1%). Among patients with a lead dwell time of >6 months (6-193 months; n = 226), manual extraction was successful in 198 (87%), mechanical tools in 22 (10%), and laser in 6 (3%). Femoral tools were necessary in 3 patients. Minor complications occurred in 7 patients (2.1%). CSP reimplantation was successful in 233 of 244 patients attempted (95%). CONCLUSION: The overall success rates of the extraction of CSP leads were very high (although the LBBAP lead dwell time was <3 years), with a low need for extraction tools and minimal complication. Reimplantation in the conduction system is feasible and safe.

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.

Left bundle branch pacing lead for sensing ventricular arrhythmias in implantable cardioverter-defibrillator: A pilot study (LBBP-ICD study).

BACKGROUND: Left bundle branch pacing (LBBP) has been suggested as an alternative modality for biventricular pacing in cardiac resynchronization therapy (CRT)-eligible patients. As it provides stable R-wave sensing, LBBP has been recently used to provide sensing of ventricular arrhythmia in patients receiving implantable cardioverter-defibrillator (ICD) with CRT. OBJECTIVE: The aim of this study was to analyze the long-term safety and efficacy of the LBBP lead for appropriate detection of ventricular arrhythmia and delivery of antitachycardia pacing (ATP) in patients requiring defibrillator therapy with CRT. METHODS: CRT-eligible patients who underwent successful LBBP-optimized ICD and LBBP-optimized CRT with defibrillator were enrolled. The LBBP lead was connected to the right ventricular-P/S port after capping the IS-1 connector plug of the DF-1-ICD lead. LBBP-optimized ICD or LBBP-optimized CRT with defibrillator was decided on the basis of correction of conduction system disease. Documented arrhythmic episodes and therapy delivered were analyzed. RESULTS: Thirty patients were enrolled. The mean age was 59.7 ± 10.5 years. LBBP resulted in an increase in left ventricular ejection fraction from 29.9% ± 4.6% to 43.9% ± 11.2% (P < .0001). During a mean follow-up of 22.9 ± 12.5 months, 254 ventricular arrhythmic events were documented. Appropriate events (n = 225 [89%]) included nonsustained ventricular tachycardia (VT) (n = 212 episodes [94%]), VT (n = 8 [3.5%]), and ventricular fibrillation (n = 5 [2.5%]). ATP efficacy in terminating VT was 75%. Eleven percent of episodes (n = 29) were inappropriately detected because of T-wave oversensing. Inappropriate therapy (ATP) was delivered for 14 episodes (5.5%). Three patients (10%) had worsening of tricuspid regurgitation. CONCLUSION: Sensing from the LBBP lead for arrhythmia detection is safe as ∼90% of the episodes were detected appropriately. Future studies with a dedicated LBBP-defibrillator lead along with algorithms to avoid oversensing can help in combining defibrillation with conduction system pacing.

Right sided approach for left bundle branch pacing using lumen-less lead: Technical considerations and follow-up outcome.

INTRODUCTION: Left bundle branch pacing has gained significant momentum in the last few years. The procedure involves deploying the lead deep inside the interventricular septum through left subclavian vein. We aimed at analyzing the feasibility, efficacy and long-term outcome of left bundle branch pacing (LBBP) using lumen-less lead through the right subclavian vein. METHODS: This was a retrospective-institutional, single center observational study done in consecutive patients who underwent LBBP using 3830 selectsecuretm lead. Left subclavian venous access was the primary strategy for lead implantation. Patients requiring right sided approach due to venous obstruction or persistent left superior-vena-cava (PLSVC) for LBBP were included in the study. RESULTS: Right sided approach was successful in 16 out of 19 (84%) attempted patients. C315-His catheter was used in all patients without modifying its curvature. PLSVC (n = 7), left venous obstruction (n = 7), right sided device upgradation (n = 1) and left pocket infection (n = 1) were the reasons for right sided approach. Mean follow-up duration was 17 ± 12 months. LBBP resulted in reduction in QRS duration from 137.3 ± 37.8 ms to 122.3 ± 9.5 ms (p -.13) and increase in LV ejection fraction from 46.2 ± 16.3% to 54.4 ± 11.6% (p -.11). The mean fluoroscopy duration and radiation dose were significantly high in right sided approach (n = 16) as compared to left sided approach (n = 293). In patients requiring cardiac-resynchronization therapy (CRT), right sided LBBP resulted in reduction in QRS duration from 171.8 ± 18.5 to 125.5 ± 11.9 ms (p -.0001) and increase in LVEF from 29.1 ± 3.8 to 45.1 ± 11.9% (p -.005). CONCLUSION: Right sided LBBP is feasible, safe and effective in patients requiring pacing for symptomatic bradyarrhythmia and CRT. Further development in dedicated tools for right-sided approach would help in reducing the fluoroscopy-duration and radiation-dose.

Observations of interventricular septal behavior during left bundle branch pacing.

INTRODUCTION: Left bundle branch pacing (LBBP) involves the deployment of the lead deep inside the septum. Penetration of the septum by the lead depends on the texture of the septum, rapidity of rotations, operator experience, and implantation tools. OBJECTIVES: The aim of our study was to assess the behavior of the lumenless lead during rapid rotations and the physiological property of the interventricular septum(IVS) during LBBP. METHODS: Patients undergoing LBBP between January 2021 and December 2022 were retrospectively included in the study. RESULTS: Among 255 attempted patients, 20 (7.9%) had procedural failure(no LBB capture-four, inability to penetrate septum-seven, and dislodgements after sheath removal-nine). Septal penetration achieved in 248/255 patients (97.2%). Lead movement inside the IVS was assessed by lead traverse time. Based on the behavior of the IVS (n = 255), three different responses were noted. Type-I response(normal/firm septum) in 93.7% (n = 239) characterized by constant and progressive movement of lead. Neither perforation nor further change in premature-ventricular-complex morphology beyond M-beat were observed despite additional few unintentional rotations indicating the protective mechanism of LV-endocardium. Type-II response(soft/cheesy septum) in 3.5% (n = 9) characterized by hyper-movement of lead without resistance due to altered texture of septum and poor LV subendocardial barrier resulting in perforation. No patients in this group had LV dysfunction or associated coronary artery disease. In type-III response, seen in 2.8% (n = 7), lead could not be penetrated due to scar in IVS. CONCLUSION: Three different patterns of responses were observed during LBBP. The most distinct type-ll response was associated with soft/cheesy septum with hyper-movement of the lead predisposing for future dislodgments in patients without structural heart disease.

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.

MAgnetic resonance imaging based DUal lead cardiac Resynchronization therapy: A prospectIve Left Bundle Branch Pacing study (MADURAI LBBP study).

BACKGROUND: Cardiac resynchronization therapy (CRT) is a class I indication for left ventricular ejection fraction (LVEF) ≤35% and heart failure (HF). Left bundle branch block (LBBB)-associated nonischemic cardiomyopathy (LB-NICM) with minimal or no scar by cardiac magnetic resonance (CMR) imaging may be associated with excellent prognosis following CRT. Left bundle branch pacing (LBBP) can achieve excellent resynchronization in LBBB patients. OBJECTIVES: The purpose of this study was to prospectively assess the feasibility and efficacy of LBBP with or without a defibrillator in patients with LB-NICM and LVEF ≤35%, risk stratified by CMR. METHODS: Patients with LB-NICM, LVEF ≤35%, and HF were prospectively enrolled from 2019 to 2022. If the scar burden was <10% by CMR then LBBP only (group I) and if ≥10% then LBBP + implantable cardioverter-defibrillator (ICD) (group II) was performed. Primary endpoints were (1) echocardiographic response (ER) [ΔLVEF ≥15%] at 6 months; and (2) composite of time to death, heart failure hospitalization (HFH), or sustained ventricular tachycardia (VT)/ventricular fibrillation (VF). Secondary endpoints were (1) echocardiographic hyperresponse (EHR) [LVEF ≥50% or ΔLVEF ≥20%] at 6 and 12 months; and (2) indication for ICD upgrade [persistent LVEF <35% at 12 months or sustained VT/VF]. RESULTS: One hundred twenty patients were enrolled. CMR showed <10% scar burden in 109 patients (90.8%). Four patients opted for LBBP+ICD and withdrew. LBBP-optimized dual-chamber pacemaker (LOT-DDD-P) was performed in 101 patients and LOT-CRT-P in 4 patients (group I; n = 105). Eleven patients with scar burden ≥10% underwent LBBP+ICD (group II). During mean-follow-up of 21 ± 12 months, the primary endpoint of ER was observed in 80% (68/85 patients) in group I vs 27% (3/11 patients) in group II (P = .0001). Primary composite endpoint of death, HFH, or VT/VF occurred in 3.8% in group I vs 33.3% in group II (P <.0001). Secondary endpoint of EHR (LVEF≥50%) was observed in 39.5% vs 0%, 61.2% vs 9.1%, and 80% vs 33.3% at 3, 6, and 12 months in groups I and II, respectively. CONCLUSION: CMR-guided CRT using LOT-DDD-P seems to be a safe and feasible approach in LB-NICM and has the potential to reduce health care costs.

Pacing induced cardiomyopathy: recognition and management.

Right ventricle (RV) apex continues to remain as the standard pacing site in the ventricle due to ease of implantation, procedural safety and lack of convincing evidence of better clinical outcomes from non-apical pacing sites. Electrical dyssynchrony resulting in abnormal ventricular activation and mechanical dyssynchrony resulting in abnormal ventricular contraction during RV pacing can result in adverse LV remodelling predisposing some patients for recurrent heart failure (HF) hospitalisation, atrial arrhythmias and increased mortality. While there are significant variations in the definition of pacing induced cardiomyopathy (PIC), combining both echocardiographic and clinical features, the most acceptable definition for PIC would be left ventricular ejection fraction (LVEF) of <50%, absolute decline of LVEF by ≥10% and/or new-onset HF symptoms or atrial fibrillation (AF) after pacemaker implantation. Based on the definitions used, the prevalence of PIC varies between 6% and 25% with overall pooled prevalence of 12%. While most patients undergoing RV pacing do not develop PIC, male sex, chronic kidney disease, previous myocardial infarction, pre-existing AF, baseline LVEF, native QRS duration, RV pacing burden, and paced QRS duration are the factors associated with increased risk for PIC. While conduction system pacing (CSP) using His bundle pacing and left bundle branch pacing appear to reduce the risk for PIC compared with RV pacing, both biventricular pacing and CSP may be used to effectively reverse PIC.

Predictors of procedural failure of left bundle branch pacing in scarred left ventricle.

INTRODUCTION: Presence of scar at the implantation-site is considered as a major factor in determining the success of left bundle branch pacing (LBBP). We aimed at analyzing the predictors of procedural failure in patients with scarred-left ventricle (LV) as demonstrated by cardiac-magnetic resonance-imaging (CMR). METHODS: This was a retrospective, observational single-center-study that included consecutive cardiomyopathy patients with LV-scar as demonstrated by late-gadolinium-enhancement (LGE) in CMR requiring LBBP. Procedural-failure was defined as the inability to penetrate the septum to reach the LV subendocardium RESULTS: A total of 25 cardiomyopathy patients demonstrated LGE in CMR and were included in the study. LBBP was successful in 16 patients (group-I; 64% acute-procedural-success). In the remaining 9 patients (group-II) lead could not be penetrated and hence biventricular-pacing was done. LBBP resulted in reduction in QRS-duration and improvement in LV ejection fraction in group-I patients during a mean follow-up of 11.2 ± 3.7 months. Computed-tomography-angiography after LBBP showed the successful lead deployment site (LBBP-Zone) as the overlapping areas of inferior aspect of antero-septum and superior aspect of infero-septum (segment 2/3; AHA-model) in short-axis view(figure-1C). CMR showed LGE in significantly more number of LV-segments and high scar-burden in group-II as compared to group-I (figure-1). A total scar score value of >1.0 predicted failure with 100%-sensitivity and 75%-specificity. CMR revealed transmural-scar in the LBBP-Zone in all patients in group-II (n = 9; 100%). Transmural scar in LBBP-Zone by CMR had 100%-sensitivity and 100%-specificity for predicting the procedural-failure. CONCLUSION: CMR helps in predicting the procedural failure of LBBP in patients with scarred LV. Presence of transmural-LGE in the LBBP-Zone predicts failure with high sensitivity and specificity.

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.