Septal venous channel perforation during left bundle branch area pacing: a prospective study.

AIMS: To characterize the diagnosis, frequency, and procedural implications of septal venous channel perforation during left bundle branch area pacing (LBBAP). METHODS AND RESULTS: All consecutive patients undergoing LBBAP over an 8-month period were prospectively studied. During lead placement, obligatory septal contrast injection was performed twice, at initiation (implant entry zone) and at completion (fixation zone). An intuitive fluoroscopic schema using orthogonal views (left anterior oblique/right anterior oblique) and familiar landmarks is described. Using this, we resolved zonal distribution (I-VI) of lead position on the ventricular septum and its angulation (post-fixation angle θ). Subjects with and without septal venous channel perforation were compared. Sixty-one patients {male 57.3%, median age [interquartile range (IQR)] 69.5 [62.5-74.5] years} were enrolled. Septal venous channel perforation was observed in eight (13.1%) patients [male 28.5%, median age (IQR) 64 (50-75) years]. They had higher frequency of (i) right-sided implant (25% vs. 1.9%, P = 0.04), (ii) fixation in zone III at the mid-superior septum (75% vs. 28.3%, P = 0.04), (iii) steeper angle of fixation-median θ (IQR) [19 (10-30)° vs. 5 (4-19)°, P = 0.01], and (iv) longer median penetrated-lead length (IQR) [13 (10-14.8) vs. 10 (8.5-12.5) mm, P = 0.03]. Coronary sinus drainage of contrast was noted in five (62.5%) patients. Abnormal impedance drops during implantation (12.5% vs. 5.7%, P = NS) were not significantly different. CONCLUSION: When evaluated systematically, septal venous channel perforation may be encountered commonly after LBBAP. The fiducial reference framework described using fluoroscopic imaging identified salient associated findings. This may be addressed with lead repositioning to a more inferior location and is not associated with adverse consequence acutely or in early follow-up.

Result of the left bundle branch area pacing data collection registry, an international multicenter study of conduction system pacing with a Tendril STS 2088 stylet-driven lead.

INTRODUCTION: Left bundle branch area (LBBA) pacing (LBBAP) has been proposed as an alternative therapy option in patients indicated for cardiac pacing to treat bradycardia or heart failure. The aim of the study was to evaluate the safety and effectiveness of LBBAP in patients implanted with a Tendril 2088 stylet-driven lead. METHODS: The international retrospective data collection registry included 11 sites from 5 countries globally. Patients with attempted implants of the Tendril lead in the LBBA were followed for at least 6 months post the implant attempt. The primary safety and efficacy endpoints were freedom from LBBAP lead-related serious adverse events and the composite of LBBA capture threshold of ≤2.0 V and R-wave amplitudes ≥5 mV (or ≥value at implant), respectively. RESULTS: Of 221 patients with attempted implants of the Tendril 2088 lead in the LBBA, 91.4% (202/221) had successful implants for LBBAP. Regardless of the LBBAP implant success, all patients were followed for at least 6 months (8.7 ± 7.3 months). Baseline characteristics: 44% female, 84% ≥65 years old, 34% coronary artery disease, and 86% of primary indications for pacemaker implant. Both primary safety and effectiveness endpoints were met (freedom from LBBAP lead-related serious adverse device effects of 99.5% and electrical performance composite success rate of 93%). The capture thresholds in LBBAP at implant and 6 months were 0.8 ± 0.3 V@0.4 ± 0.1 ms and 0.8 ± 0.3 V@0.4 ± 0.1 ms. The rate of patients with capture threshold rise ≥1 V was 1.5% through 6 months. The R-wave amplitudes in LBBAP at implant and 6 months were 9.3 ± 3.2 mV and 10.6 ± 3.0 mV. CONCLUSIONS: This large multicenter study demonstrates that the stylet-driven Tendril™ STS 2088 lead is safe and effective for LBBAP with high success and low complication rates.

Clinical/Electrophysiological Characteristics of Infra-Nodal Wenckebach in Patients with Indication for Permanent Ventricular Pacing: A Prospective Study.

BACKGROUND: Infra-nodal Wenckebach is rare and is not well characterized. OBJECTIVES: We prospectively studied clinical and electrophysiological characteristics of patients with atrioventricular (AV) Wenckebach with an indication for permanent ventricular pacing. METHODS: Over a 2-year-period, all subjects with an indication for permanent ventricular pacing underwent targeted pre-implant electrophysiological study. Clinical/electrophysiologic characteristics at presentation and ventricular pacing percentage at 6-month follow-up were evaluated. RESULTS: A total of 163 patients [median age 68 (IQR 60-74) years, male 59%, median QRS duration 110 (90-130) ms, complete AV block in 123 (69.3%)] were included. AV Wenckebach was noted in 22 (13.4%) patients [median age 70 (63-76.5) years, male 54%, median QRS duration 120 (110-140) ms] and classified as infra-nodal (12/163 or 7.3%) vs. AV nodal (10/163 or 6.1%). Patients with infra-nodal Wenckebach (Infra-His in all), when compared to AV nodal Wenckebach, demonstrated higher frequency with LVEF <40% (41.7% vs. 0%, p=0.04), longer median HV interval (90 vs. 49 ms, p=0.005), lower frequency of isolated 1st degree AV block (8.3% vs. 60%, p=0.002), higher frequency of right bundle branch block with left-anterior fascicular block (75% vs. 10%, p=0.02), lesser PR increment at onset of AVW (20.5 vs. 80 ms, p=0.002), and onset of 2:1 AV block at longer cycle lengths (91.7% vs. 20%, p=0.002). CONCLUSIONS: Among patients referred for pacemaker implantation, infra-nodal Wenckebach was present in 27.5% (11/40) of patients without complete AV block. It was as frequent as AV nodal Wenckebach and associated with characteristic electrophysiologic findings.

A case of exaggerated exuberance: Iatrogenic atrioventricular block/intra-Hisian Wenckebach during conduction system pacing.

Isolated sinus node dysfunction with its pursuant long-term risk for atrioventricular (AV) conduction disease poses a unique dilemma for proponents of CSP due to paucity of imprimatur guidelines. In such scenarios, the risk and prognosis of iatrogenic AV block is not well elucidated but is a valid concern. We report a case where CSP was complicated by iatrogenic AV block and peculiarly the rare phenomenon of intra-Hisian Wenckebach.

An unusual site of ablation for a ventricular tachycardia.

Scar-related ventricular tachycardia (VT) ablation involves localizing the critical isthmuses by overdrive pacing maneuvers and three-dimensional activation mapping. Implantable prosthetic devices have been known to complicate this by covering sites of potential isthmuses. We herein present a sentinel report of scar-VT ablation with a protected isthmus localized over an endothelialized post-myocardial infarction ventricular septal defect occluder device.

Open window mapping for redo accessory pathway ablation in Ebstein anomaly.

Accessory pathway ablation in Ebstein anomaly can be significantly more challenging than in structurally normal hearts. An alternative to the conventional approach to mapping APs is to detect points with a high-density mapping catheter based on an automated detection algorithm using open window mapping. It detects the sharpest signal at each point with high-density mapping rather than relying on the origin of the local electrogram to localize the pathway and determine a site for successful ablation. We herein report the first case in literature of a redo-accessory pathway ablation in Ebstein anomaly using this technique.

Characteristics of the phenotype of mixed cardiomyopathy in patients with implantable cardioverter-defibrillators.

BACKGROUND OR PURPOSE: The prognosis of m ixed cardiomyopathy (CMP) in patients with implanted cardioverter-defibrillators (ICDs) has not been investigated. We aim to study the demographic, clinical, device therapies and survival characteristics of mixed CMP in a cohort of patients implanted with a defibrillator. METHODS: The term mixed CMP was used to categorise patients with impaired left ventricular ejection fraction attributed to documented non-ischemic triggers with concomitant moderate coronary artery disease. This is a single center observational cohort of 526 patients with a mean follow-up of 8.7 ± 3.5 years. RESULTS: There were 42.5% patients with ischemic cardiomyopathy (ICM), 26.9% with non-ischemic cardiomyopathy (NICM) and 30.6% with mixed CMP. Mixed CMP, compared to NICM, was associated with higher mean age (69.1 ± 9.6 years), atrial fibrillation (55.3%) and greater incidence of comorbidities. The proportion of patients with mixed CMP receiving device shocks was 23.6%, compared to 18.4% in NICM and 27% in ICM. The VT cycle length recorded in mixed CMP (281.6 ± 43.1 ms) was comparable with ICM (282.5 ± 44 ms; p = 0.9) and lesser than NICM (297.7 ± 48.7 ms; p = 0.1). All-cause mortality in mixed CMP (21.1%) was similar to ICM (20.1%; p = 0.8) and higher than NICM (15.6%; p = 0.2). The Kaplan-Meier curves revealed hazards of 1.57 (95% CI: 0.91, 2.68) for mixed CMP compared to NICM. CONCLUSION: In a cohort of patients with ICD, the group with mixed CMP represents a phenotype predominantly comprised of the elderly with a higher incidence of comorbidities. Mixed CMP resembles ICM in terms of number of device shocks and VT cycle length. Trends of long-term prognosis of patients with mixed CMP are worse than NICM and similar to ICM.

Caveats related to conduction system pacing utilizing a proprietary deflectable mapping catheter with a stylet-driven lead.

BACKGROUND: Hitherto, lumen less leads (LLLs) were routinely utilized for conduction system pacing (CSP). We report the largest experience using stylet-driven leads (SDLs) with a deflectable mapping catheter for CSP. METHODS: Patients were prospectively and sequentially enrolled for CSP with SDL between June, 2021 and November, 2022 to (i) a novel deflectable mapping catheter (AgilisHisProTM, Abbott) (Group A) or (ii) a fixed curve sheath (Selectra3D, Biotronik) (Group B) in a 1:1 non-randomized fashion. The primary aim was to evaluate safety, feasibility, and efficacy of the CSP using SDL and deflectable mapping catheter (Group A) while reporting procedural success and intermediate-term follow-up. RESULTS: Seventy-nine patients (59.4%M, mean age 67.2+/-10.6 years) were allocated to either (i) Group A (n = 40) or (ii) Group B (n = 39). In Group A (n = 40, 50% M, mean age 67.2+/-9.5 years, follow-up 210.7 + 25.1days), His bundle pacing (HBP) was the default strategy with left bundle branch area pacing (LBBaP) for bailout. Procedural success with HBP was feasible in 17/40 (42.5%) patients with remaining 23/40 (57.5%) needing LBBaP bailout. After initial learning curve, a manual septal curve was introduced to successfully aid LBBaP in 6/23 (26.1%) cases. Procedural and follow-up parameters did not differ significantly in HBP vs. LBBaP. Head-to-head comparison was not performed between the groups owing to different default protocols (HBP-Group A, Discretionary-Group B). CONCLUSIONS: Use of SDL with single-curve deflectable mapping catheter was safe, feasible and yielded moderate procedural success with HBP and frequently needed a LBBaP bailout strategy. In approximately one-fourth of the latter, an out-of-plane manual septal curve was needed to optimize LBBaP.

Interventions in the diagnosis and adoption of pacemaker therapy in sinus node dysfunction patients: Results from the IMPROVE Brady study.

AIMS: IMPROVE Brady assessed whether a process improvement intervention could increase adoption of guideline-based therapy in sinus node dysfunction (SND) patients. METHODS: /Results: IMPROVE Brady was a sequential, prospective, quality improvement initiative conducted in India and Bangladesh. Patients with symptomatic bradycardia were enrolled. In Phase I, physicians assessed and treated patients per standard care. Phase II began after implementing educational materials for physicians and patients. Primary objectives were to evaluate the impact of the intervention on SND diagnosis and pacemaker (PPM) implant. SF-12 quality of life (QoL) and Zarit burden surveys were collected pre- and post-PPM implant. A total of 978 patients were enrolled (57.7 ± 14.8 years, 75% male), 508 in Phase I and 470 in Phase II. The diagnosis of SND and implantation of PPM increased significantly from Phase I to Phase II (72% vs. 87%, P < 0.001 and 17% vs. 32%, P < 0.001, respectively). Pacemaker implantation was not feasible in 41% of patients due to insurance/cost barriers which was unaltered by the intervention. Both patient QoL and caregiver burden improved at 6-months post-PPM implant (P < 0.001). CONCLUSIONS: A process improvement initiative conducted at centers across India and Bangladesh significantly increased the diagnosis of SND and subsequent treatment with PPM therapy despite the socio-economic constraints.

Identifying high risk patients post myocardial infarction with reduced left ventricular function using loop recorders INSPIRE-ELR clinical study.

AIMS: Sudden cardiac death (SCD) continues to be a devastating complication amongst survivors of myocardial infarction (MI). Mortality is high in the initial months after MI. The aims of the INSPIRE-ELR study were to assess the proportion of patients with significant arrhythmias early after MI and the association with mortality during 12 months of follow-up. METHODS: The study included 249 patients within 14 days after MI with left ventricular ejection fraction (LVEF) ≤35% at discharge in 11 hospitals in India. Patients received a wearable external loop recorder (ELR) 5 ± 3 days after MI to monitor arrhythmias for 7 days. RESULTS: Patients were predominantly male (86%) with a mean age of 56 ± 12 years. In 82%, reperfusion had been done and all received standard of care cardiovascular medications at discharge. LVEF was 32.2 ± 3.9%, measured 5.1 ± 3.0 days after MI. Of the 233 patients who completed monitoring (7.1 ± 1.5 days), 81 (35%) experienced significant arrhythmias, including Ventricular Tachycardia/Fibrillation (VT/VF): 10 (4.3%); frequent Premature Ventricular Contractions (PVCs): 65 (28%); Atrial Fibrillation (AF): 8 (3.4%); chronic atrial flutter: 4 (1.7%); 2nd or 3rd degree Atrioventricular (AV) block: 4 (1.7%); and symptomatic bradycardia: 8 (3.4%). In total, 26 patients died. Mortality was higher in patients with clinically significant arrhythmia (at 12 months: 23.6% vs 4.8% with 19 vs 7 deaths, hazard ratio (HR) = 5.5, 95% confidence interval (CI) 2.3 to 13.0, p < 0.0001). Excluding 7 deaths during ELR monitoring, HR = 4.5, p < 0.001. CONCLUSION: ELR applied in patients with acute MI and LV dysfunction at the time of discharge identifies patients with high mortality risk.