Implantation Success, Electrical Performance, and Safety of an active fixation stylet-driven lead for LBBAP in Clinical Practice: A Multicenter Experience

Background: Left bundle branch area pacing (LBBAP) has emerged as a promising physiological pacing strategy. However, its feasibility and safety using conventional stylet-driven leads (SDL) such as INGEVITY+ remain under investigation. Objective: To evaluate the clinical performance, safety, and follow-up outcomes of LBBAP using the INGEVITY+ lead in a real-world electrophysiology setting. Methods: From 2021 to 2024, 207 consecutive patients underwent LBBAP implant attempts using the INGEVITY+ lead across 19 centers. Of these, 146 had bradycardia indications, and 61 had heart failure indications. A control group of 200 patients received standard right ventricular (RV) pacing with the same lead. Procedural outcomes, electrical parameters, complications, and mid-term lead performance were assessed. Results: LBBAP was successfully achieved in 201 (97%) cases. Procedural and fluoroscopy times were slightly longer for LBBAP than for RV pacing. Acute complications included one helix fracture, one atrioventricular block, and one septal perforation. During a median follow-up of 9 months, no lead fractures were reported; lead dislodgment occurred in 3 cases. Kaplan–Meier analysis showed no significant difference in time to first lead-related complication between the LBBAP and RV pacing groups (hazard ratio: 4.69, 95%CI: 0.63–34.90, p=0.139). Electrical performance remained stable, with 98% of retained leads maintaining capture thresholds ≤2 V and 92% with sensed amplitudes ≥5 mV. Conclusions : LBBAP using the INGEVITY+ SDL is feasible and safe in clinical practice, with excellent implant success and stable mid-term electrical performance. These findings support its use as a viable conduction system pacing strategy.

Left bundle branch area pacing (LBBAP) has emerged as a promising physiological pacing strategy, offering an alternative to traditional right ventricular (RV) pacing and His bundle pacing (1, 2, 3). By directly engaging the conduction system, LBBAP aims to preserve ventricular synchrony and improve clinical outcomes in patients requiring pacing therapy. Despite its growing adoption, the optimal lead design for LBBAP remains a subject of ongoing investigation. While lumenless leads (LLLs) have been commonly utilized, stylet-driven leads (SDLs) like the INGEVITY+ (Boston Scientific, Marlborough, MA) have garnered attention due to their maneuverability and compatibility with existing implantation techniques (4, 5, 6, 7). However, concerns persist regarding the long-term performance and integrity of SDLs when used for LBBAP, given that these leads were originally designed for conventional endocardial pacing sites. Recent studies have begun to address these concerns. The Lead Integrity and Failure Evaluation in (LIFE-) LBBAP study assessed LLLs and SDLs integrity across a large, real-world population, reporting low fracture rates and high overall lead survival, thereby supporting the feasibility of using SDLs for LBBAP (8). Complementing this, the ConductIoN System pacInG witH IngeviTy+ for Left Bundle Branch Area (INSIGHT-LBBA) registry evaluated the performance of the INGEVITY+ lead in a multicenter cohort, demonstrating favorable outcomes in terms of implantation success, electrical parameters, and short-term safety (9). Building upon this foundation, our retrospective study analyzed all LBBAP procedures using the INGEVITY+ lead performed in routine clinical practice across a consortium of Italian centers. We focused on evaluating implantation success rates, acute and chronic electrical performance, and the incidence of complications during follow-up. This investigation aims to provide further evidence on the real-world applicability and reliability of the INGEVITY+ lead for LBBAP. Study design Consecutive patients who underwent an LBBAP implant attempt using the INGEVITY+ lead were retrospectively included across 19 Italian centers (see Appendix). All patients who received an INGEVITY+ lead for standard RV pacing over the same period at the study centers constituted the control group. Left bundle branch area pacing could be attempted as a first-choice pacing strategy for bradycardia or heart failure pacing indications. The lead implantation for LBBAP, using a site-selective pacing catheter (SSPC), was accomplished according to each center’s routine clinical practice, as well as the pacing system programming. All operators had previous experience of LBBAP using LLLs – <50 procedures for 89% of them, ≥50 procedures for 11%, and non-INGEVITY+ SDLs – <50 procedures for 72% of them, ≥50 procedures for 28%. The follow-up period began on the day of system implantation and continued until the most recent in office visit. The registry captured only deidentified data, and no source documents were collected. Therefore, the study was exempt from institutional review board approval at participating institutions. Data processing was conducted in compliance with the European General Data Protection Regulation (GDPR, EU 2016/679), ensuring full anonymization of personal health data as mandated by European regulations. All patients had provided written consent for data use at the time of implantation. This study was conducted independently and was not industry-funded. Baseline data comprised characteristics of patients, indications for pacing and implantation variables, including procedural details and times, electrical parameters and pre-discharge device programming. The criteria to define successful LBBAP, which encompass LBB pacing and left ventricular septal pacing (LVSP), were based on institutional practices and international consensus guidelines (1). At the study centers, capture of LBB was primarily confirmed based on QRS transition during threshold testing, V6 R-wave peak times and V6-V1 interpeak interval evaluation. Follow-up data included electrical parameters, 12-lead ECG, and any complication. Procedural and follow-up lead-related complications were determined via patient-level chart review. Complications were adverse events requiring invasive correction or that led to loss of device function and included lead failure, dislodgment, loss of capture or sensing, perforation. The primary objective of this study was to report on the LBBAP success, defined as capture of left septal tissue or the left-sided conduction system, and the safety, measured as the frequency of lead-related complications. These were evaluated at the time of the procedure and during follow-up, beginning with the first implant attempt using the INGEVITY+ lead at each site. The effectiveness endpoints were the pacing capture threshold, the R-wave–sensed amplitude and the pacing impedance at the time of implantation and at last follow-up. Electrical measurements were compared between LBBAP and standard RV pacing groups. The lead The INGEVITY+ pace/sense lead is a 6Fr active fixation, stylet-driven lead with an electrically active helix (Boston Scientific, Marlborough, MA). The SSPC sheaths family includes 4 fixed curve sheaths with a 6.5Fr inner and 8Fr outer diameter and a proximal hemostatic valve designed for pacing lead delivery ( Figure 1 ). Statistical analysis Quantitative variables are reported as means±SD if normally distributed, or medians with 25th to 75th percentiles in the case of skewed distribution. Normality of distribution was tested by means of the nonparametric Kolmogorov–Smirnov test. Categorical data were expressed as percentages. Differences between mean data were compared by a t-test for Gaussian variables, and by Mann–Whitney or Wilcoxon non-parametric test for non-Gaussian variables, respectively for independent or paired samples. Differences in proportions were compared by means of a Chi-square analysis. Analysis of the time to the first event was made by means of the Kaplan–Meier method, and the log-rank test was applied to evaluate differences between trends. A P value <0.05 was considered significant for all tests. All statistical analyses were performed by means of R: a language and environment for statistical computing (R Foundation for Statistical Computing, Vienna, Austria).

Study Sample From June 2021 to December 2024, a total of 207 consecutive patients underwent LBBAP implantation attempts using an INGEVITY+ lead. Among them, 146 patients had bradycardia indications and received single-, dual-chamber, or biventricular pacemakers. The remaining 61 patients, with heart failure indications, received either pacemakers or defibrillators. During the same period, 200 patients underwent standard RV pacing with an INGEVITY+ lead connected to a pacemaker, forming the control group. Baseline characteristics of the enrolled patients are presented in Table 1 . In the LBBAP group, the most common indication for pacing was atrioventricular block (78% of bradycardia patients), which was significantly less frequent in the control group. Among heart failure patients, LBBAP was selected as an alternative to biventricular pacing, being the first-line choice in 44% of cases. Patients with bradycardia indications in the LBBAP group were more frequently male and had a higher body mass index compared to those in the control group. The median baseline unpaced QRS duration was 120 ms ( 25th-75th percentile: 100–140) for bradycardia patients and 150 ms ( 25th-75th percentile: 139–160) for heart failure patients. Implantation Procedure Table 2 summarizes the procedural variables. The vast majority of patients (99%) underwent left-sided generator implantation, with venous access most commonly obtained via the axillary or subclavian vein. The subclavian vein was more frequently used in LBBAP procedures compared to standard RV pacing. Successful LBBAP was achieved in 201 out of 207 patients (97%). Among these, 156 patients (78%) met criteria for LBBP, while LVSP was confirmed in 45 patients. Of the six patients who did not meet LBBAP criteria, two received the INGEVITY+ lead in a deep septal position and two in a standard apical RV position. The remaining two patients, both with heart failure, were managed differently: one received a coronary sinus lead for conventional cardiac resynchronization therapy (CRT), and the other a dual-chamber ICD. LBBAP procedures, particularly in heart failure patients, were associated with longer procedural and fluoroscopy times compared to standard RV pacing. Additionally, the number of screw attempts was higher in LBBAP cases ( Table 2 ). Lead-related complications during LBBAP included one helix fracture, one case of atrioventricular block, and one septal perforation (the latter occurring in the patient who ultimately received a coronary sinus lead). No adverse sequelae were reported from these events. Electrical parameters were satisfactory in both LBBAP subgroups. Compared to the control group, there were no significant differences except for slightly higher capture thresholds ( Table 3 ). In patients with bradycardia indications, QRS duration did not significantly change with LBBAP (p = 0.064 versus native QRS), while it significantly decreased in heart failure patients (p < 0.001) and significantly increased in the control group with RV pacing (p < 0.001). At pre-discharge, a minority—but still substantial proportion—of devices in the LBBAP group were programmed to deliver bipolar stimulation, with most having automatic threshold and sensing algorithms activated. Follow-Up The median follow-up duration was 9 months ( 25th-75th percentile: 4–15). In the LBBAP group, no lead fractures or malfunctions were reported. Lead-related complications included three dislodgements requiring surgical repositioning. In one of these cases, LBBAP was successfully reestablished; in the other two, standard RV pacing was adopted. In the control group, one patient developed elevated pacing thresholds during follow-up. The Kaplan–Meier analysis of time to first lead-related complication is presented in Figure 2 (hazard ratio: 4.69; 95% CI: 0.63–34.90; p = 0.139). At the final follow-up, 195 of the 199 patients (98%) with retained LBBAP had capture thresholds ≤2 V, and 183 (92%) had sensed amplitudes ≥5 mV. Both parameters remained stable throughout follow-up. Impedance showed a significant decrease over time, similar to trends observed in the control group ( Figure 3 ). No significant changes in paced QRS duration were observed between implantation and last follow-up: bradycardia patients with LBBAP: 120 ms ( 25th-75th percentile: 100–130); heart failure patients with LBBAP: 116 ms ( 25th-75th percentile: 100–121); Control group (RV pacing): 139 ms ( 25th-75th percentile: 135–141) (all p > 0.05 versus implantation).

This study confirms the feasibility of performing LBBAP using the INGEVITY+ SDL in routine clinical practice. Our implant success rate was high and comparable to that reported in the INSIGHT-LBBAP registry (9), with which we share similar methods and inclusion criteria. In patients with bradycardia indications, LBBAP procedures had longer procedural and fluoroscopy times compared to standard RV lead implantations using the INGEVITY+ lead. Nonetheless, these durations remained within acceptable limits. In patients with heart failure, the procedure duration was even longer, which can be attributed to the frequent use of LBBAP as a fallback strategy after failed attempts at conventional CRT implantation. Despite these procedural challenges, the complication rate was low. We observed only three acute lead-related events—one helix fracture, one case of atrioventricular block, and one septal perforation—consistent with complications previously reported in the literature (1, 10, 11, 12). Reported incidence rates in prior studies include up to 5% for helix damage/fracture, 9.4% (2.6% permanent) for complete heart block, and 14.1% for septal perforation. A key concern in LBBAP is the potential long-term risk to lead integrity, especially considering the unique mechanical stresses placed on leads deeply embedded in the interventricular septum. Achieving deep septal lead placement often requires significant torque and multiple screw attempts, which can increase the risk of conductor fracture (13). In the LIFE-LBBAP study (8), a higher fracture rate was observed with SDLs compared to LLLs. Of interest, all confirmed fractures in SDLs occurred at the interelectrode lead segment, that is designed to be flexible to minimize the risk of cardiac perforation. However, this flexible segment may experience severe bending against the septum when septal penetration is difficult (14). Interestingly, the fractures in the LIFE-LBBAP study were confined to a single lead model, and no fractures occurred with the INGEVITY+ lead over a median follow-up of 9.9 months. This aligns with our findings, as no lead fractures were reported during follow-up with the INGEVITY+ lead. Indeed, with the INGEVITY+ lead the stylet extends to the tip electrode, thus preventing bending of the interelectrode segment. Moreover, the number of screw attempts in our cohort was low, which may have helped preserve lead integrity. At follow-up, only three lead dislodgements were reported—consistent with the most common lead-related complication observed in the INSIGHT-LBBAP registry (9). The dislodgement rate in the registry (2.3%) was comparable to that reported in the BIOCONDUCT study (1.7%), lower than the 3.8% rate for SDLs in the MELOS study, and slightly higher than the 1.1% dislodgement rate for LLLs reported in MELOS (4, 15). Overall, among patients successfully implanted, nearly 99% maintained LBBAP throughout follow-up, with 98% achieving it at low pacing thresholds. These outcomes are particularly meaningful considering that our cohort included operators in their early experience with the INGEVITY+ lead, though they were experienced with other LBBAP systems. This reflects real-world practice and underscores the usability of this lead even during the learning curve. We also compared INGEVITY+ performance in LBBAP versus its standard use for RV pacing and found no excess lead failure or deterioration in electrical performance. These findings are consistent with the LIFE-LBBAP study (8), which showed a 5-year survival rate of 99.7% for SDLs—comparable to rates reported in manufacturer performance data for conventional pacing sites (98.4%–99.3%). Our study, however, did not apply rigorous, standardized criteria for confirming selective LBB capture, which may have introduced some variability. We reported a selective LBBP rate of 78%, slightly lower than INSIGHT-LBBAP overall, though comparable to that of operators with similar prior experience (9). Given the low number of screw attempts per procedure in our centers, it’s plausible that operators often accepted LVSP without additional efforts to achieve full LBB capture—perhaps reflecting the perception of clinical equivalence between the two in routine practice. However, recent evidence has begun to demonstrate potential additional clinical benefits associated with selective LBBP compared to LVSP (16), which may warrant reconsideration of procedural strategies in the future. In terms of indications, we observed that LBBAP was predominantly employed in patients with atrioventricular block among the bradycardia population, consistent with recent findings (17). Surprisingly, LBBAP was also frequently used as a first-line pacing strategy in heart failure patients rather than CRT, highlighting a shift in clinical preference. Device selection patterns, i.e. the use of CRT pacemakers, further suggest a degree of caution among operators, with backup leads still used in bradycardia patients and those undergoing “ablate and pace” strategies. Nevertheless, our observed lead failure rate was low and electrical performance remained high, suggesting that routine backup lead use may not be necessary in most LBBAP cases. Device programming practices reflected growing clinical confidence in automatic algorithms for threshold and sensing, confirming their usability in LBBAP as supported by recent evidence (18, 19). However, a notable proportion of devices delivered stimulation in bipolar polarity, despite the risk of anodal (non-selective) capture (20, 21).

The present study has several limitations, primarily related to the retrospective study design. Moreover, this study describes the initial experience of the operators in using the lead for LBBAP, without formal training or standardized implant techniques. Furthermore, successful lead placement was not subject to central adjudication. Finally, the sample size was relatively small. Data from a larger population and a broader base of implanting centers would have strengthened our findings and increased the generalizability of our results. It is also worth noting that the tools available during the study period were limited; the introduction of newer tools—such as the helix locking tool and new delivery catheters—may further facilitate lead delivery and potentially improve procedural success rates in future practice.

This study demonstrates that LBBAP using the INGEVITY+ SDL—a lead originally designed for conventional pacing— is feasible, safe, and effective in routine clinical practice. Implant success rates were high and complication rates remained low. Electrical performance and lead stability were comparable to standard RV pacing, with excellent mid-term follow-up outcomes. These findings support the use of INGEVITY+ as a viable option for LBBAP. DATA AVAILABILITY STATEMENT The experimental data used to support the findings of this study are available from the corresponding author upon request.

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Valenza S, De Lucia C, Marcantoni L, Mahfouz K, Deluca F, Colaiaco C, Porcelli G, Ammirati F, Santini L, Zanon F. Conduction System Pacing ”How To”: Tips and Tricks. J Cardiovasc Electrophysiol. 2025 Apr 23. doi: 10.1111/jce.16690. 21. Ali N, Saqi K, Arnold AD, Miyazawa AA, Keene D, Chow JJ, Little I, Peters NS, Kanagaratnam P, Qureshi N, Ng FS, Linton NWF, Lefroy DC, Francis DP, Boon Lim P, Tanner MA, Muthumala A, Agarwal G, Shun-Shin MJ, Cole GD, Whinnett ZI. Left bundle branch pacing with and without anodal capture: impact on ventricular activation pattern and acute haemodynamics. Europace. 2023 Oct 5;25(10):euad264. FIGURE LEGENDS Figure 1. Panel A. The INGEVITY+ pacing lead is a 6Fr steroid-eluting, endocardial pace / sense lead designed for permanent implantation for either atrial or ventricular applications including Left Bundle Branch Area pacing as an alternative to right ventricular pacing. Panel B. The site-selective pacing catheter sheaths family includes 4 fixed curve sheaths. Panel C. Distal tip fluoroscopic view and coupler joint design. Figure 2. Kaplan–Meier estimates of time to first lead-related complication. Figure 3. Comparisons (implantation versus follow-up) of medians (with 25th to 75th percentiles) pacing capture thresholds, sensed amplitudes, and impedances of LBBAP and control patients. Table 1. Baseline characteristics of enrolled patients. | Bradycardia (146) | Heart Failure (61) | (200) | p-value (vs. Bradycardia) | p-value (vs. Heart Failure) | || | Male gender, n (%) | 103 (71) | 41 (67) | 118 (59) | 0.027 | 0.250 | | | Age, n (%) | 0.062 | 0.012 | |||| | - 40 – 49 years | 3 (2) | 1 (2) | 2 (1) | ||| | - 50 – 59 years | 2 (2) | 6 (10) | 3 (1) | ||| | - 60 – 69 years | 26 (18) | 9 (15) | 16 (8) | ||| | - 70 – 79 years | 69 (47) | 24 (39) | 100 (50) | ||| | - ≥80 years | 46 (31) | 21 (34) | 79 (40) | ||| | Body Mass Index, n (%) | 0.006 | 0.029 | |||| | - < 18.5 Kg/m 2 (Underweight) | 4 (2) | 0 (0) | 22 (11) | ||| | - 18.5 – 24.9 Kg/m 2 (Healthy weight) | 63 (43) | 39 (63) | 98 (49) | ||| | - 25.0 – 29.9 Kg/m 2 (Overweight) | 61 (42) | 19 (32) | 66 (33) | ||| | - ≥ 30.0 Kg/m 2 (Obese) | 18 (13) | 3 (5) | 14 (7) | ||| | Native QRS, ms | 120 [100-140] | 150 [139-160] | 100 [95-120] | 0.001 | <0.001 | | | Pacing indication, n (%) | |||||| | - Atrioventricular block | 113 (78) | - | 130 (65) | 0.013 | - | | | - Sinus node dysfunction | 25 (17) | - | 56 (28) | 0.018 | - | | | - Other | 8 (5) | - | 7 (3) | 0.372 | - | | | - Alternative to biventricular pacing or LOT-CRT | - | 27 (44) | 4 (2) | - | <0.001 | | | - Unsuccessful coronary sinus lead implantation | - | 22 (36) | 0 (0) | - | <0.001 | | | - Ablate and pace procedure | - | 12 (20) | 3 (2) | - | <0.001 | | | LOT-CRT: Left Bundle Branch-Optimized Cardiac Resynchronization Therapy. | Table 2. Implantation variables of enrolled patients. | Bradycardia (146) | Heart Failure (61) | (200) | p-value (vs. Bradycardia) | p-value (vs. Heart Failure) | || | Device, n (%) | |||||| | - Single- or Dual-chamber pacemaker | 130 (89) | 13 (21) | 191 (95) | 0.022 | <0.001 | | | - CRT-P | 16 (11) | 9 (15) | 9 (5) | 0.022 | 0.006 | | | - ICD | 0 (0) | 4 (7) | 0 (0) | 1.000 | <0.001 | | | - CRT-D | 0 (0) | 35 (57) | 0 (0) | 1.000 | <0.001 | | | Left-sided generator implantation, n (%) | 145 (99) | 59 (97) | 195 (97) | 0.201 | 0.667 | | | Venous access, n (%) | |||||| | - Axillary | 66 (45) | 26 (43) | 99 (50) | 0.430 | 0.347 | | | - Cephalic | 29 (20) | 0 (0) | 55 (27) | 0.102 | <0.001 | | | - Subclavian | 51 (35) | 35 (57) | 46 (23) | 0.015 | <0.001 | | | Implantation duration, min | 66 [50-90] | 97 [64-130] | 45 [30-63] | <0.001 | <0.001 | | | Fluoroscopy time, min | 7 [5-15] | 19 [10-29] | 5 [3-8] | <0.001 | 1 and ≤3 | 46 (32) | 23 (38) | 64 (32) | ||| | - >3 and ≤5 | 9 (6) | 3 (5) | 0 (0) | ||| | - >5 | 0 (0) | 2 (3) | 0 (0) | ||| | CRT-P: Cardiac Resynchronization Therapy pacemaker; ICD: Implantable Cardioverter Defibrillator; CRT-D: Cardiac Resynchronization Therapy ICD. | Table 3. Capture thresholds, sensed amplitudes, and impedances at implantation, and device programming at pre-discharge for patients with successful LBBAP and the control group. | Bradycardia (144) | Heart Failure (57) | (200) | p-value (vs. Bradycardia) | p-value (vs. Heart Failure) | || | Capture threshold, V | 0.8 [0.6-1.0] | 1.0 [0.7-1.2] | 0.6 [0.5-0.8] | <0.001 | <0.001 | | | - Capture threshold ≤ 2V, n (%) | 142 (99) | 55 (96) | 198 (98) | 0.740 | 0.177 | | | Sensed amplitude, mV | 10 [8-14] | 9 [8-14] | 10 [8-16] | 0.422 | 0.208 | | | - Sensed amplitude ≥ 5mV, n (%) | 138 (96) | 54 (94) | 195 (97) | 0.386 | 0.381 | | | Impedance, Ohm | 670 [540-861] | 750 [598-865] | 746 [623-815] | 0.019 | 0.887 | | | Bipolar pacing polarity, n (%) | 44 (31) | 19 (33) | 180 (90) | <0.001 | <0.001 | | | - of which showing anodal capture | 8 (19) | 6 (32) | 1 (1) | <0.001 | <0.001 | | | Automatic threshold algorithm active, n (%) | 105 (73) | 39 (68) | 171 (85) | 0.004 | 0.003 | | | Automatic sensing algorithm active, n (%) | 105 (73) | 48 (84) | 145 (72) | 0.932 | 0.071 | | | Paced QRS duration, ms | 115 [100-125] | 117 [104-125] | 140 [130-143] | <0.001 | <0.001 | | | Capture threshold measured at 0.4ms pulse duration. | Figure 1. Figure 2. Figure 3. Information & Authors Information Version history Peer review timeline Published Journal of Cardiovascular Electrophysiology Version of Record27 Dec 2025Published Copyright This work is licensed under a Non Exclusive No Reuse License.

Authors Metrics & Citations Metrics Article Usage 361views 197downloads Citations Download citation Amato Santoro, Matteo Ziacchi, Raimondo Calvanese, et al. Implantation Success, Electrical Performance, and Safety of an active fixation stylet-driven lead for LBBAP in Clinical Practice: A Multicenter Experience. Authorea. 24 July 2025. DOI: https://doi.org/10.22541/au.175334415.59941341/v1 DOI: https://doi.org/10.22541/au.175334415.59941341/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu.