Lead Dislodgement Research Articles

Abstract 13720: Safety Follow Up in Cardiovascular Implantable Electronic Devices After Catheter Based Ablation Procedures

Background: Catheter ablation is effective in the treatment of arrhythmias. The effect of ablation on Cardiovascular Implantable Electronic Devices (CIED) in long-term follow-up is unknown. Objectives: To study the impact of radiofrequency catheter ablation on various arrhythmias in patients with pacemakers and implantable cardiac defibrillators. Methods: We studied 119 consecutive patients with pacemakers and defibrillators who underwent various catheter-based procedures from 2011 to 2018. Various generator and lead parameters were compared before and after the procedure using paired sample t-test. Incidence of device-related complications was recorded as a percentage. Results: The mean age was 64.5 years. 88 patients had CHF (73.9 %). 63 Patients had CAD (52.9 %). 8.93 % and 41.3 % of patients had single and dual-chamber ICDs respectively. The rest of the patients had dual-chamber or biventricular pacemakers. 63.2 % of patients had Pulmonary Vein Isolation, Atrial Tachycardia, or Atrial Flutter ablation. 13.5 % of patients had AVNRT ablation and 20.3 % of patients had PVC or VT ablation. The Median follow-up interval was 8 weeks. No changes in before or after the ablation procedure in the atrial sensing ( 3.37± 1.60mV vs 3.40 ± 1.95 mV , P .52) and pacing thresholds ( 0.85mV± 0.46mV vs 0.82± 0.43 mV, P .35) , impedance (471.83± 106 ohm vs 447.57± 88.64 ohm , P .07) was noticed. Similarly, there was no difference in RV lead sensing and pacing threshold, but paradoxically there was a decrease in RV impedance after ablation (549.77± 173ohm vs 507.40 ± 129.0 ohms, p <0.004). There was no difference in the LV lead parameters. There were no complications as lead dislodgement, stroke, hypotension, or death. Conclusion: Any type of catheter-related ablation is safe and efficacious in patients with pacemakers and defibrillators and there was no generator or lead-related complications noticed on interval follow-up.

Abstract 14249: Response to Cardiac Resynchronization Therapy in Cancer Patients With Heart Failure

Introduction: Heart failure is associated with poor clinical outcomes in cancer patients. Cardiac resynchronization therapy (CRT) provides a therapeutic avenue to improve left ventricular function and decrease symptoms. Historically, CRT has been underutilized in cancer patients. We assessed the hypothesis that cancer patients have a similar response to cardiac resynchronization therapy as the general heart failure population. Methods: This study included 37 patients with cancer who underwent CRT implantation between 2012 and 2020. The primary endpoints were response to CRT as measured by an improvement in left ventricular ejection fraction (LVEF) by >=10% or decrease in left ventricular end systolic volume index (LVESVi) by >=15% over 3 to 24 months. Secondary endpoints were change in LVEF, LVESVi, and New York Heart Association (NYHA) class. Results: Of 37 patients, primary and secondary endpoints were available for 34 patients (mean [SD] age, 68 [9] years; 24 men (71%); 26 nonischemic cardiomyopathy (76%), 8 ischemic (24%); mean QRSd 152 ms; 10 patients with NYHA II symptoms (29%), 24 NYHA III (71%)). 20 patients met the primary endpoint (65% [46%-80%]). This response rate is not significantly different than published response rates to CRT of 70% in the general heart failure population. The average improvement in LVEF was 12.9% ([9.4%-16.4%], p<0.001). The average decrease in LVESVi was 25.4% ([17.2%-33.5%], p<0.001). 23 of 34 patients had an improvement in NYHA classification (20 by one class, 3 by two), whereas 9 patients had no improvement and 2 patients had worsening symptoms (mean improvement 0.7 [0.46-0.96], p<0.001). 2 of 37 patients had a complication (one late device infection, one right atrial lead dislodgment requiring reimplantation). 4 of 37 patients (10.8%) died within 12 months of primary oncologic cause. 4 of 34 (11.7%) CRT-D patients had received appropriate therapies on device interrogation at time of submission. Conclusions: CRT improves left ventricular function, reverses left ventricular remodeling, and improves exertional dyspnea in patients with cancer. Response rate is similar to that of a general heart failure population. Oncologic prognoses of over 12 months life expectancy at time of implant were reasonably accurate.

Abstract 13984: The Feasibility and Safety of Left Bundle Branch Pacing in Patients With Tricuspid Valve Disease

Background: Although left bundle branch pacing (LBBP) has emerged as a novel physiological pacing strategy, it is still challenging in cases with tricuspid valve disease. Meanwhile, the influence of LBBP lead on tricuspid regurgitation has not been well established in these patients. In the present study, we evaluate the feasibility and safety of LBBP in patients with tricuspid valve disease. Methods: We enrolled 24 patients with tricuspid valve disease who received LBBP procedure in Zhongshan Hospital, Fudan University, between January 2018 and July 2020. Regular follow-ups were conducted (at 1 and 12 months), and the echocardiography data of the patients were collected and analyzed. Results: One postoperative lead dislodgements (1/24, 4.2%) occurred during the follow-up. Mean fluoroscopy time of placing LBBP lead was 19.75±08.23 minutes. Mean follow-up period was 9.64±4.17 months. Pacing parameters were stable during follow-up in all cases. The severity of tricuspid regurgitation(TR) (no 0, slight 1. mild 2, medium 3 and severe 4) under echocardiography were measured and compared at baseline and 1-year follow-up post-procedure. No significant aggravation occurred (2.88±1.57 vs 3.00±1.44, P=0.13). Left ventricular ejection fraction remain stable from baseline to 1-year follow-up(56.27±11.73% vs 59.30±8.17%, P=0.09). Conclusion: LBBP was feasible and safety in patients with tricuspid valve disease though these cases were always challenging such as longer fluoroscopy time, more technocratic requirements, higher rates of failure and procedure-related complications than HBP. Lead parameters were stable during follow-up. No significant aggravation of TR was found.

Lead dislodgement complicated with paroxysmal atrial fibrillation as a rare cause of inappropriate implantable cardioverter defibrillator shock: a case report.

Lead dislodgement complicated with paroxysmal atrial fibrillation as a rare cause of inappropriate implantable cardioverter defibrillator shock: a case report.

His bundle pacing: safety, performance, and clinical outcomes in a single centre experience

Abstract Background Permanent His bundle pacing (HBP) is a more physiological technique for cardiac stimulation and has recently emerged as an alternative for anti-bradycardia pacing and cardiac resynchronization therapy (CRT). Its main advantages over “classical” pacing are both its protective role over pacing-induced cardiomyopathy and the possibility of resynchronization by normalization of His-Purkinje activation. Objective To evaluate the intermediate-term outcomes of HBP in terms of safety, performance, and clinical outcomes. Methods Between December 2018 and July 2020, we enrolled a series of consecutive patients with indication for pacing in whom HBP was attempted. A specific lead (3830 Select Secure MRI SureScan) and sheath (C315His) were used. At follow-up clinical, safety and performance outcomes were evaluated. A significant rise in HBP pacing threshold was defined as an increase of at least 1V@1msec in the minimum voltage that could produce an effective myocardial depolarization. Remote or in-hospital device interrogation was performed by an experienced electrophysiologist. Results HBP was attempted in 99 patients and all implantations were performed by the same two operators. 82 procedures were successful (83%). The main reasons for HBP failure were high pacing-thresholds (n=8, 47%), infra-hisian block (n=5, 29,4%), difficult HB location (n=3, 17,6%), unsatisfactory sensing (n=1, 5,9%) or lead instability (n=1, 5,9%). During a mean follow up of 9,5±5.9 months, the overall technical and clinical complication rates were 39% and 13,3% respectively. 3 (3.6%) patients underwent His lead extraction and subsequent conventional right ventricular septum (RV) lead implantation because of lead dislodgement (n=2) or rise in pacing threshold (n=1), while 2 (2.4%) patients required His lead repositioning because of lead dislodgement (n=1) and phrenic nerve stimulation (n=1). 19 patients (23,2%) experienced a significant rise in Hisian pacing threshold and 1 of these patients also had poor sensing parameters. Oversensing was noted in 8 (9.7%) patients and in 7 of them (87.5%) it was due to both atrioventricular and ventriculoatrial crosstalk events. As regards clinical outcomes, 7 patients (8.5%) were diagnosed with new onset atrial fibrillation (AF), one of them complicated by stroke. 3 patients (3.6%) were hospitalized for acute heart failure, 1 of them after His lead dislodgement. Finally, 5 patients (6.1%) died during follow-up, but no death was related to cardiovascular events. Conclusions HBP is an effective technique to obtain a more physiological cardiac pacing but it is limited by a moderate rate of procedural failure and follow-up complications, mainly rising in pacing threshold and oversensing events. This is probably due to suboptimal implantation tools and lack of specific programming algorithms. New dedicated tools, increased experience and knowledge of device limitations and optimal programming are needed to improve future outcomes. Funding Acknowledgement Type of funding sources: None.

Subclavian versus axillary vein puncture for implantation of cardiac electronic devices. A meta-analysis

Abstract Background Implantation of CIED has become a daily practice for patients with rhythm disturbances, those with an indication for primary or secondary sudden cardiac death prevention as well as for patients with heart failure and marked ventricular dyssynchrony. Most of the complications observed following implantation seem to be procedure-related. The latter has led many physicians to replace the classic subclavian approach with alternative techniques such as cephalic vein cut-down and axillary vein puncture (AVP). Recent data support that these techniques may be associated with similar success rates and lower adverse events. Purpose This meta-analysis was performed to compare axillary to subclavian vein puncture (SVP) for implantation of cardiac implantable electronic devices (CIED), in terms of safety and efficacy. Methods We searched MedLine, via PubMed, for studies comparing subclavian to axillary vein approach in terms of safety and efficacy. Safety endpoints were considered the incidence of pneumothorax, device related infections and major bleeding events. Efficacy and feasibility were assessed by the incidence of lead failure (lead dislodgement, lead fracture or insulation defects) and the number of successfully cannulated veins, respectively. Studies were judged as eligible if they reported at least one of the predefined outcomes. Effect size was calculated using the risk difference along with the corresponding 95% confidence interval (CI). A random- effects DerSimonian-Laird model was adopted. Results Seven studies fulfilled the inclusion criteria and were included in the final analysis, resulting in 3642 patients (59.1% males) with a pooled mean (SD) age of 66.1 (12.7) years. Axillary vein puncture (AVP) was performed in 45.8% of them. All, but one study, used fluoroscopic guidance (with or without venography) for axillary vein cannulation. The CIED most commonly implanted was a permanent pacemaker (73%). Both techniques resulted in similar percentages of successful cannulations (1066/1099 for AVP and 906/931 for SVP, RD: 0; 95% CI: −0.01–0.01, I2: 0%, Figure 1A). There was a significantly higher risk for pneumothorax with the subclavian approach (RD: 0.02; 95% CI: 0.01–0.03, I2: 49.31%, Figure 2A). No significant differences were observed regarding the incidence of bleeding and infections (Figure 2B, 2C). SVP was also associated with a significantly increased risk for lead failure (RD: 0.01; 95% CI: 0.00–0.03, I2: 48.47%, Figure 1B). Conclusions AVP seems to be a feasible approach for implantation of CIED. Moreover, it seems to be both a more safe and effective choice compared to SVP, as it is associated with reduced risk for pneumothorax and lead failure. More data especially comparing AVP to cephalic cut-down are needed to safely guide the daily practice. Funding Acknowledgement Type of funding sources: None. Figure 1Figure 2

INTERMEDIATE TERM PERFORMANCE AND SAFETY OF LEFT BUNDLE BRANCH AREA CONDUCTION SYSTEM PACING LEADS: A MULTICENTER PROSPECTIVE STUDY

<h3>BACKGROUND</h3> Left bundle branch area pacing (LBBAP) has shown to be a reliable alternative to His bundle pacing (HBP) for physiologic pacing. There are limited data on the intermediate term performance of LBBA pacing leads. Objective: To evaluate the intermediate term performance and safety of LBBAP. <h3>METHODS AND RESULTS</h3> Patients referred for pacemaker implantation at two academic centers between 02/2019 - 1/2021 were considered for LBBAP. LBBAP was performed by implanting the 3830 lumenless lead using the C315 fixed curve or C304 His deflectable sheath (Medtronic, MN). Implant success rates, complications and electrophysiological parameters were assessed. LBBAP was successful in 566/619 patients (91%). Mean age was 73±12 yrs, 46% were women. 37% had QRSd >130 ms, 25% RBBB, 11% LBBB, 4% IVCD. Pacing indications include sinus node dysfunction in 27%, AV block 56%, CRT 7% and refractory AF 10%. Mean procedural duration was 73±32 mins (median 70 mins) and fluoroscopic time was 10±7 mins (median 8 mins). Baseline QRSd was 119±31ms vs paced QRSd was 113±12ms (p < 0.001). Mean LV activation time was 73±12ms at high output and 76±12ms at low output. LBB potentials were noted in 175 (31%) patients. Transition from non-selective to selective LBBA or septal pacing was noted in 393 (74%). Pacing threshold and R waves were 0.74±0.3V@0.4ms and 11±5mV at implant and 0.83±0.2V@0.4ms and 15± 5mV at a mean follow-up of 167±172 days (range 25-662 days) (Fig). The only complication was LBBAP lead dislodgement in 6 (1%) patients occurring within 24-72 hours. <h3>CONCLUSION</h3> LBBA pacing is safe and feasible with high success rates and low complication rates during intermediate term follow-up.

Single Centre Experience in Pediatric Pacing

Abstract Corresponding author hosnihosni5627@gmail.com ( Hosny Hosny Elsayed Arafa) Background Permanent Pacemakers have a growing use in the pediatric population due to congenital and surgically acquired rhythm disturbances but they present unique problems and implications. Their implantation, follow up, the diversity and complexity of pediatric patients and congenital heart disease make device management a highly individualized art in pediatric pacing. Certain challenges are posed in adult-like somatic growth and active lifestyle susceptibility to infection and generally anticipated long survival. Objective The current study aims to present our institute's experience in pediatric and adolescent pacemaker implantation and long term outcome. Patients and Methods The study included 100 patients who have cardiac devices (permanent pacemaker)that were implanted in AinShams University and visit our patient clinic for regular programming during the period from July 2018 to December 2019. All patients were subjected to history taking, clinical examination, ECG recording then Echocardiography and device programming. Results The study included 100 patients,49 females and 51 males with a mean age of 13.12 ± 5.04. Patients weighted from 8 to 85 kg, measured from 40 to 185 cm in height. According to the mode of pacing, 67 were in the VVIR group while 33 in the DDDR group. According to the indication of pacing, two cases were due to sinus node dysfunction,52 due to congenital complete heart block and 46 due to postoperative CHB. 59 patients underwent cardiac surgery. 53 were admitted to CCU by syncope or presyncope. As Regards the complications,2 cases had superficial infection after 2 weeks relived by antibiotic, 2 patients suffered from pocket hematoma after 2 weeks, 10 cases of lead fracture from 1 to 8 years after implantation due to external trauma, 3 cases of lead dislodgment from 1 to 6 months postprocedure,1 case developed LV dysfunction and upgraded to CRT,1 case had psychological trauma and 3 cases had insulation breaks. The device with the longest longevity duration is Medtronic and Tendril leads had the most common complications. Conclusion Implantation of a pacemaker in children is generally safe. It could be justified to implant the pacemaker to improve the hemodynamic situation in individual patients or to consider biventricular pacing in LV dysfunctiont

Lead dislodgement after a very long-term period of cardiac implantable electronic device implantation.

A 74‐year‐old man was admitted for a second replacement of a transvenous implantable cardioverter‐defibrillator (ICD) generator at 15 years after implantation. Postoperatively, electrocardiographic monitoring showed atrial lead malfunction. Chest X‐ray revealed that the tip of the active fixation atrial lead was dislocated. We present a case of atrial lead dislodgement after a very long‐term period of an ICD implantation.

Outcomes of temporary pacing using active fixation leads and externalized permanent pacemakers in patients with cardiovascular implantable electronic device infection and pacemaker dependency

The incidence of cardiac implantable electronic device (CIED) infections is increasing. Complete device and lead removal are recommended for all patients with definite CIED system infection. In patients with pacemaker dependency, temporary pacing before reimplantation is necessary. In this study, temporary pacing using active fixation leads (TPAFL) was evaluated. We reviewed data from consecutive patients implanted with TPAFL after transvenous lead extraction at our center between November 2014 and October 2020. TPAFL were placed in 334 patients. The mean age was 64.5 ± 16.4 years and 76.3% were males. Two hundred and forty (72%) were treated due to local pocket infection and 94 (28%) systemic infection. The indication for temporary pacing was sick sinus syndrome in 135 (40.4%) patients and complete or high-grade atrioventricular (AV) block in 199 (59.6%) patients. The most common access site for lead implantation was the ipsilateral subclavian or axillary vein (78.9%). A new permanent CIED was reimplanted at 10.3 ± 9.2 days (median 10, range: 2-70) after implantation of the temporary pacing. There were five (1.5%) adverse events related to the temporary pacing during hospitalization. The median follow-up duration was 23.1 months (interquartile range [IQR], 7.2-43.4 months). Only one patient (0.3%) developed recurrent CIED infection. TPAFL is safe and effective in pacemaker-dependent patients after infected CIED removal. The rate of temporary pacing-related complications, including lead dislodgment and reinfection of CIED is relatively low.

B-PO04-055 LEAD DISLODGEMENT EVENTS: REAL WORLD EXPERIENCE FROM MEDTRONIC’S PRODUCT SURVEILLANCE REGISTRY (PSR)

Lead dislodgement has been one of the most common early complications after cardiovascular implantable electronic device (CIED) implant. However, limited data is available on the clinical characteristics and outcomes of lead dislodgement events. To study the risk factors and clinical significance of lead dislodgement events after CIED implant. Retrospective cohort analysis of 20,896 patients who underwent CIED implant between January 1st, 2010 and January 31st, 2020 in Medtronic’s Product Surveillance Registry (PSR), with a mean follow-up time of 3.3 years. The study population was divided into two groups: Group A with lead dislodgement events (N=351) and Group B without lead dislodgement events (N=20,545). During this period, 351 patients (1.68%) had lead dislodgement events involving a total of 373 leads (0.94%), among a total of 39,608 leads implanted. Female sex (Group A 42.7% vs. Group B 30.4%, P<0.001) and higher body-mass index (mean BMI: Group A 31.7 ± 7.4 vs. Group B 29.5 ± 8.2, P<0.001) were associated with increased risk of lead dislodgement events. Predictors for lead dislodgement at the time of implant included lower lead impedance (Group A 558 ± 146 Ω vs. Group B 608 ± 186 Ω, P=0.006) and lower P wave amplitude (Group A 2.60 ± 1.43 mV vs. Group B 2.97 ± 2.18 mV, P=0.045) for RA leads and lower R wave amplitude for RV endocardial leads (Group A 8.05 ± 3.86 mV vs. Group B 10.32 ± 5.75 mV, P=0.006). The risks of cardiac and overall mortality were similar between the two groups. Female sex and obesity were associated with higher risk of lead dislodgement events in the PSR registry. Lead dislodgement events did not have a significant impact in overall mortality.

B-PO02-048 INCIDENCE OF PERI-PROCEDURE LEAD DISLODGEMENT IN CARDIAC RHYTHM DEVICES

As the population ages and indications for cardiac rhythm devices continue to expand, more people are receiving cardiac rhythm devices (CRD). With experienced implanters, complications associated with implantations is exceedingly rare. Micro lead dislodgement (changes in pacing parameters) and macro lead dislodgement (clear locational changes) remain a driver for repeat procedures in the perioperative, post implant period. Identify which device and lead type, as well as lead placement location, are most prone to dislodgement. A retrospective analysis performed for de novo CRD implanted at an academic, tertiary care referral center from 2014 to 2020. Lead dislodgement was categorized by both the device and lead type implanted as well as lead location. 3315 CRD and 6728 unique leads were implanted by 10 electrophysiologists. Dual chamber permanent pacemakers (DC PPM) were the most commonly implanted CRD with 1457 (44%) unique devices followed by cardiac resynchronization therapy defibrillator (CRT-D) (15.5%). Macro lead dislodgement was most common in CRT-D implantations with 23 dislodgements (4.47%) out of 515 unique device implants. Implantation of a coronary sinus (CS) lead resulted in 12 dislodgements (1.44%, P-Value is < .00001) out of 835 unique CS lead implantations. Macro lead dislodgement was more common following CRT-D and CRT-P CS lead implantations, attributed to lack of fixation mechanisms with CS leads. However, rates of CS lead dislodgement were significantly less than the 10.6% reported in the literature.

B-AB14-02 INTERMEDIATE TERM PERFORMANCE AND SAFETY OF LEFT BUNDLE BRANCH AREA CONDUCTION SYSTEM PACING LEADS: A MULTICENTER PROSPECTIVE STUDY

Left bundle branch area pacing (LBBAP) has shown to be a reliable alternative to His bundle pacing (HBP) for physiologic pacing. There are limited data on the intermediate term performance of LBBAP leads. To evaluate the intermediate term performance and safety of LBBAP. Patients referred for pacemaker implantation at two academic centers between 02/2019 - 1/2021 were considered for LBBAP. LBBAP was performed by implanting the 3830 lumenless lead using the C315 fixed curve or C304 His deflectable sheath (Medtronic, MN). Implant success rates, complications and electrophysiological parameters were assessed. LBBAP was successful in 566/619 patients (91%). Mean age was 73±12 yrs, 46% were women. 37% had QRSd >130 ms, 25% RBBB, 11% LBBB, 4% IVCD. Pacing indications include sinus node dysfunction in 27%, AV block 56%, CRT 7% and refractory AF 10%. Mean procedural duration was 73±32 mins (median 70 mins) and fluoroscopic time was 10±7 mins (median 8 mins). Baseline QRSd was 119±31ms vs paced QRSd was 113±12ms (p<0.001). Mean LV activation time was 73±12ms at high output and 76±12ms at low output. LBB potentials were noted in 175 (31%) patients. Transition from non-selective to selective LBBA or septal pacing was noted in 393 (74%). Pacing threshold and R waves were 0.74±[email protected] and 11±5mV at implant and 0.83±[email protected] and 15± 5mV at a mean follow-up of 167±172 days (range 25-662 days) (Fig). The only complication was LBBAP lead dislodgement in 6 (1%) patients occurring within 24-72 hours. LBBA pacing is safe and feasible with high success rates and low complication rates during intermediate term follow-up.

B-PO01-034 CLINICAL PERFORMANCE OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD MONITORING FEATURES

Implantable cardioverter defibrillator (ICD) lead monitoring diagnostic alerts (LMA) facilitate diagnosis of structural lead failure (LF). A prespecified WRAP-IT study was conducted to prospectively study LMA in ICD patients. To assess the real-world performance of LMA in detecting structural LF. We studied ICD patients with all LMAs enabled. At each study visit, investigators reported possible lead system events (LSEs), and device/clinical data were reviewed. LMAs, programming changes, adverse events and system modifications were recorded. An independent committee classified events as a LF, other LSE or non-lead event (NLE). In 4942 patients with a right ventricle defibrillation lead followed for 19.4 ± 8.7 mo, there were 124 LMA (65 LSEs, 59 NLEs) and 19 LSEs that did not trigger LMA. Of 84 LSEs, 48 were structural LFs. LMA had 100% sensitivity for the 48 LFs (95%, confidence interval: 92.6-100%) and also for the 10 events adjudicated as either possible LF or connection issue. The positive predictive value of LMA for LF was 38.7% (48/124). However, sensitivity was only 13.6% (3/22) for lead dislodgements or perforations, which comprised all LSEs that did not trigger LMA. For the 34 pace-sense LFs, the Lead Integrity Alert™ (LIA) was more sensitive than the pacing impedance-threshold alert (33 patients, 97.1% vs. 9 patients, 26.5%, p < 0.0001). Inappropriate shocks occurred in 2 patients with pace-sense LF (5.9%). Of 59 LMAs activated by NLEs, 23 (39.0%) were impedance alerts and 36 (61.0%) were LIA oversensing alerts, triggered by rapid cardiac activation in ventricular tachyarrhythmias (n=17) or oversensing of either electromagnetic interference (n=11) or physiologic signals (n=8). No patient had unnecessary lead replacement for an LMA unrelated to LF. In this first, real-world prospective study, LMA had 100% sensitivity for structural LFs. Although positive predictive value was modest, no false-positive alert resulted in unnecessary lead replacement. For diagnosis of pace-sense LF, an alert that incorporates oversensing was more sensitive than a pacing impedance-threshold alert. Present LMA are insensitive for lead dislodgements and perforations.

Success and failure for implantation of left bundle branch pacing using stylet-driven pacing leads : a single center experience

Abstract Funding Acknowledgements Type of funding sources: None. Background/Introduction :Left bundle area pacing is a new modality of physiological pacing. By screwing the pacing lead deep into the interventricular septum, the left bundle branch could be recruited for pacing purpose. Initially left bundle area pacing was performed with fixed helix lead supported by the delivery catheter. On the other hand, there are studies showing the feasibility of using a style-driven extendable helix with the new delivery sheath for left bundle area pacing. Purpose :To study the feasibility of left bundle area pacing and explore factors associated with success and failure Methods :This is a retrospective study from September 2020 to January 2021 in a local hospital. Baseline patient characters, procedural characters, acute complication and reason for failure were recorded. Logistic regression was done to explore factors associated with success and failure. Results :In 14 patients, the mean age is 81 +/- 6.8 years with 28% female. Pacing indications were sick sinus syndrome (n = 3) and atrio-ventricular block (n = 11). The success rate is 64% (n = 9/14). The average R wave sensing was 11.4 +/- 4.5mV, the average V pacing threshold was 0.88 +/- 0.23V @ 0.4ms and average impedance was 633 +/- 93.6 Ohm. There were no septal perforation nor pericardial effusion after implantation. The most common reason for failure is lead dislodgement during implantation (n = 4) and the other reason is failure to locate and capture the left bundle (n = 1). In logistic regression, there was no clinical risk factor identified to predict failure for implantation , i.e. diabetics ( OR 0.95, p =0.15), hyperlipidaemia (OR 0.87, p =0.94), chronic renal disease (OR 0.88, p = 0.94), coronary heart disease (OR 0.37, p = 0.66). Gender(OR 4.5, p = 0.37), age(OR 1.1, p = 0.32) and hypertension(OR 25, p = 0.25) may appear to predict failure for implantation but the results were not statistically significant. Conclusion :Left bundle area pacing could be feasible and safely implanted using style-driven lead with good pacing parameters. No clinical factor is identified to predict the failure of implantation, the main reason for failure is dislodgement of lead during implantation. Similar finding was noted in a study comparing lumen-less lead and stylet-driven lead.2 In this study found that reason for failure of left bundle area pacing using style-driven lead was due to repetitive lead dislodgement after slitting the delivery sheath, fail advancement of lead into septum and loose septal endocardium. Stability and ability to screw into septum remain a great obstacle for left bundle area pacing using stylet-driven lead. This study is limited by small sampling size and single center retrospective study. Further studies are needed to see the long term outcome of left bundle area pacing using style-driven lead and investigate other methods to predict success/ failure of implantation, such as the role of imaging.

Initial experience, feasibility and safety of permanent left bundle branch pacing; a retrospective single centre study

Abstract Funding Acknowledgements Type of funding sources: None. Background Physiologic pacing by left bundle branch pacing (LBBP) is characterized by direct stimulation of the intrinsic His-Purkinje system and results in physiologic ventricular depolarization and repolarization. This technique has emerged as an alternative to both traditional right ventricular pacing for bradycardia and classic cardiac resynchronization therapy (CRT). High success rates and low complication rates are reported, however the majority of literature is reported by relatively few, highly experienced centres. Purpose This retrospective study aims to describe success rate, feasibility and safety of LBBP for both bradycardia and CRT indications in a high volume referral centre, performed by three physicians without previous experience with LBBP. Methods 100 patients who underwent attempted LBBP from January 2020 to September 2020 were analysed. LBBP was performed using the Medtronic SelectSecure 3830 pacing lead and the Medtronic C315HIS delivery sheath. The primary end points are acute LBBP success rates and LBBP related complications within 3-6 months from implantation. Success was defined as a paced QRS with QR or RSr’ in V1 and left ventricular activation time (LVAT) &amp;lt;90ms. Device follow-up data was acquired at 1 month and 3-6 months after implantation. Results The mean age was 70 ± 11.4 years and 67% were men. 57% had a left ventricular ejection fraction &amp;lt;0.50 and QRS was 146 ± 33.7ms. Pacing indication was CRT in 48, bradycardia in 42 and planned AV node ablation in 9. LBBP was successful in 83/100 patients (83%), with paced QRS of 121 ± 19.7ms and LVAT of 81 ± 13.8ms. A learning curve could not be demonstrated; the success rates in the first and latter half were 78% and 88% respectively (p = 0.183). Pacing parameters at implantation were satisfactory; R-wave 11.9 ± 5.9mV, impedance 736 ± 153Ω and capture threshold 0.7 ± 0.4V. R-wave increased to 14.6 ± 6.3mV at 1 month (p &amp;lt; 0.001) and remained stable at 13.6 ± 5.5mV after 3-6 months (p = 0.829). Impedance decreased to 572 ± 82Ω at 1 month (p &amp;lt; 0.001) and further decreased to 536 ± 81Ω after 3-6 months (p &amp;lt; 0.001). Capture threshold remained stable at 1 and 3-6 months (0.7 ± 0.2V (p = 0.287) and 0.8 ± 0.2V (p = 0.055), respectively). No LBBP related complications, e.g. lead perforation or dislodgement, occurred during the follow-up of 249 ± 64 days. The main reasons for unsuccessful implantation (n = 17) were insufficient reach of the delivery sheath (n = 8) and inability to penetrate the septum due to fibrosis (n = 5). Conclusion This study shows that LBBP is a safe and feasible method for delivering physiological pacing. Without previous experience, our initial success rate is comparable to highly experienced centres. Pacing parameters remained stable after 6 months and no LBBP complications occurred. Success rate of implantation could further improve with dedicated LBBP delivery sheaths. Large randomized controlled trials are needed to further confirm safety and efficacy of LBBP.

Use of steroid therapy as a bridge to decision-making in patients with late rising pacing threshold after pacemaker implantation?

The late rising pacing threshold is an alarming situation in which a possibility of lead dislodgement is usually considered first. This condition is usually picked up on routine follow-up interrogation; however, it can clinically manifest as syncope due to bradyarrhythmia. We report such a case in a 59-year-old male presenting to the emergency with syncope with a double chamber pacemaker in situ. He had a history of pacemaker implantation 16 years back and a pulse generator replacement (PGR) 6 years back with desirable parameters found immediately and up to 4 years after PGR. He was found to have a complete heart block on an electrocardiogram following the evaluation of presyncope and subsequently on his pacemaker interrogation high threshold was found which improved to acceptable levels after 4 weeks of steroid therapy.

Procedure-Related Complications of Left Bundle Branch Pacing: A Single-Center Experience.

Background: Although left bundle branch pacing (LBBP) has emerged as a novel physiological pacing strategy with a low and stable threshold, its safety has not been well-documented. In the present study, we included all the patients with procedure-related complications at our centre to estimate these LBBP cases with unique complications.Methods: We enrolled 612 consecutive patients who received the procedure in Zhongshan Hospital, Fudan University, between January 2018 and July 2020. Regular follow-ups were conducted (at 1, 3, and 6 months in the first year and every 6–12 months from the second year), and the clinical data of the patients with complications were collected and analyzed.Results: With a mean follow-up period of 12.32 ± 5.21 months, procedure-related complications were observed in 10 patients (1.63%) that included two postoperative septum perforations (2/612, 0.33%), two postoperative lead dislodgements (2/612, 0.33%), four intraoperative septum injuries (4/612, 0.65%), and two intraoperative lead fractures (2/612, 0.33%). Pacing parameters were stable during follow-up, and no major complications were observed after lead repositioning in the cases of septum perforation and lead dislodgement.Conclusion: The incidence of procedure-related complications for LBBP, namely postoperative septum perforation, postoperative lead dislodgement, intraoperative septum injury, and intraoperative lead fracture, were low. No adverse clinical outcomes were demonstrated after successful repositioning of the lead and appropriate treatment.

An Interesting Case of Acute Asymptomatic Lead Perforation of a Permanent Cardiac Pacemaker

Acute complications of pacemaker implantation such as lead dislodgement, pneumothorax, and myocardial perforation are not uncommon. Management of these usually requires reintervention. We herein describe lead perforation after a single chamber pacemaker implantation, which was successfully managed conservatively. This case underscores that vigilant monitoring post lead perforation can avoid a redo procedure.

Delayed management of atrial lead dislodgment after pacemaker implantation: a case report

BackgroundPacemaker lead dislodgement may cause malfunction in the pacing system, which may lead to severe adverse events. For patients with sick sinus syndrome but normal atrioventricular conduction, atrial lead dislocation may cause excessive unnecessary ventricular pacing, resulting in nonphysiological pacing leading to heart failure. The longer the unwanted ventricular pacing continues, the greater the chances that irreversible heart failure may occur. Ironically, we admitted a patient who had been refusing dislodged lead relocation for 7 years. The symptoms of heart failure were significantly resolved after new atrial lead implantation. We reviewed her clinical data before and after the procedure and believed the case was worthy of reflection.Case presentationAn 83-year-old Han Chinese woman presented with heart failure symptoms for 7 years due to the late macro-dislodgement of an atrial pacing lead. Her echocardiogram showed average left ventricular ejection fraction (LVEF) but reduced left ventricular end-diastolic volume (LVEDV) during right ventricular pacing, indicating heart failure with preserved ejection fraction (HFpEF). After 7 years of refusal, she finally agreed to implantation of a new atrial lead. She has been doing well since the operation.ConclusionsFor patients with sick sinus syndrome with dual-chamber pacemaker indication, atrial lead dislodgement should be appropriately managed if the atrioventricular function is normal. As the consequences are subtle and appear gradually, they might be overlooked by patients and even doctors. Implanting a new atrial lead is the right thing to do rather than just passively waiting or treating with symptom relief medications.