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Background: Left bundle branch area pacing (LBBAP) has emerged as a novel physiological pacing method to reduce left ventricular (LV) dyssynchrony due to ventricular pacing. Only lumen-less pacing leads (LLLs) with fixed helixes could achieve LBBAP previously, but recently, LBBAP has been performed using stylet-driven leads (SDLs). This study aimed to evaluate the LV dyssynchrony between SDLs and LLLs techniques in LBBAP. Methods: We retrospectively evaluated patients who underwent LBBAP with either SDLs or LLLs. We compared both groups' electrocardiogram (ECG) findings and LV dyssynchrony parameters derived from myocardial perfusion scintigraphy. LV dyssynchrony parameters consisted of phase analysis and regional wall motion analysis. We evaluated bandwidth, phase standard deviation (PSD), and entropy in the phase analysis. The time to the end-systolic frame (TES) was calculated in regional wall motion analysis using single-photon emission computed tomography (SPECT). We also evaluated the maximum differences between segmental TES (MDTES), the standard deviation of TES (SDTES), and the difference in the TES between the lateral wall and septum (DTES-LS). Results: In total, 97 patients were enrolled. The success rate of LBBAP did not differ between the groups [SDLs: 47/48 patients (98%) vs. LLLs: 47/51 patients (92%), P=0.36]. The paced QRS duration and the stimulus to the peak LV activation time (stim-LVAT) also did not differ between SDL and LLL groups (122±10 vs. 119±12 ms, P=0.206; 69±12 vs. 66±13 ms, P=0.31, respectively). There were no differences in bandwidth, PSD, and entropy between SDL and LLL groups (73°±37° vs. 86°±47°, P=0.18; 19°±8.5° vs. 21°±9.7°, P=0.19; 0.57±0.08 vs. 0.59±0.08, P=0.17, respectively). The regional wall motion analysis parameters MDTES, SDTES, and DTES-LS also did not differ between SDL and LLL groups (19%±10% vs. 20%±10%, P=0.885; 5.0%±2.5% vs. 5.0%±2.5%, P=0.995; 5.0%±3.7% vs. 4.8%±4.2%, P=0.78, respectively). Conclusions: LBBAP using SDLs was comparable to LV electrical and mechanical synchrony with LLLs.

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Age is a risk factor for both cardiovascular disease and cancer, and as such radiation oncologists frequently see a number of patients with cardiac implantable electronic devices (CIEDs) receiving proton therapy (PT). CIED malfunctions induced by PT are nonnegligible and can occur in both passive scattering and pencil beam scanning modes. In the absence of an evidence-based protocol, the authors emphasise that this patient cohort should be managed differently to electron- and photon- external beam radiation therapy (EBRT) patients due to distinct properties of proton beams. Given the lack of a PT-specific guideline for managing this cohort and limited studies on this important topic; the process was initiated by evaluating all PT-related CIED malfunctions to provide a baseline for future reporting and research. In this review, different modes of PT and their interactions with a variety of CIEDs and pacing leads are discussed. Effects of PT on CIEDs were classified into a variety of hardware and software malfunctions. Apart from secondary neutrons, cumulative radiation dose, dose rate, CIED model/manufacturer, distance from CIED to proton field, and materials used in CIEDs/pacing leads were all evaluated to determine the probability of malfunctions. The importance of proton beam arrangements is highlighted in this study. Manufacturers should specify recommended dose limits for patients undergoing PT. The establishment of an international multidisciplinary team dedicated to CIED-bearing patients receiving PT may be beneficial.

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Background: Electrical lead abnormalities (ELAs) can result in device malfunction, leading to significant morbidity in patients with cardiac implantable electronic devices (CIEDs). Objective: We sought to determine the prevalence and management of ELAs in patients with CIEDs. Methods: This was a retrospective cohort study of patients implanted with a CIED between 2012 and 2019 at a tertiary care center. The primary outcome was ELA defined as increased capture threshold (≥2× implantation value), decreased sensing (≤0.5 implantation value), change in impedance (>50% over 3 months), or nonphysiologic potentials. A secondary outcome of device clinic utilization was also collected. Results: There were 2996 unique patients (35% female) included with 4600 leads (57% Abbott, 43% Medtronic). ELAs were observed in 135 (3%) leads, including 124 (92%) Abbott and 10 (7%) Medtronic leads (hazard ratio 9.25, P < .001). Mean follow-up was 4.5 ± 2.2 years. ELAs were associated smaller lead French size, atrial location, and Abbott leads. Lead revision was required in 28% of cases. Patients with lead abnormalities had 38% more in-clinic visits per patient year of follow-up compared with those without (P < .001). Conclusion: ELAs were more frequent in certain models, which increased rates of revision and follow-up. Identification of factors that mitigate these abnormalities to improve lead performance are required to improve care for these devices and provide efficient healthcare.

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BACKGROUND: Transvenous lead extraction (TLE) is recommended in cases of local and systemic infections related to cardiac implantable electronic devices (CIEDs). Additionally, TLE is indicated in the event of lead damage or CIED malfunction. The extraction procedure is associated with a risk of life-threatening complications. OBJECTIVES: The aim of the EVO registry was to assess the safety and efficacy of birotational Evolution tool usage. MATERIAL AND METHODS: This registry study was prospectively conducted in 8 high-volume implantation centers in Poland. The study included 133 patients aged 63.5 ±15.1 years, and 76.69% were male. Indications for the procedure were: local or systemic infection (33.1%) and lead dysfunction (66.9%). The number of leads extracted varied from 1 (39.84%) to 3 (9.77%). RESULTS: Clinical procedural success was achieved in 99.1% of cases. A total of 226 leads were extracted, and 206 used the Evolution system. Two procedural strategies were identified while using the Evolution system: (1) usage of locking stylet, propylene sheaths and the Evolution system (118 leads, 52%) - group A; (2) usage of locking stylet and Evolution (88 leads, 39%) - group B. There were no differences in the number of complications between these 2 groups. The extraction time was significantly shorter (p = 0.02) in group B than in group A. Major complications occurred in 5.2% of cases with 2 intraprocedural deaths. Minor complications occurred in 1.5% of patients. CONCLUSIONS: The registry confirmed the efficacy and relative safety of the birotational Evolution sheath. Using the rotational sheath as a first attempt significantly reduces extraction time without compromising its safety.

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AIMS: Left bundle branch area pacing (LBBAP) is a novel physiological pacing modality and is regarded as a viable alternative to His bundle pacing. LBBAP has mostly been performed with the lumen-less permanent pacing lead (SelectSecure™ Model 3830, Medtronic, Inc.) with a fixed helix. The aim of this study was to compare the non-stylet driven lumen-less lead (LLL) (Medtronic 3830) with a standard stylet-driven active fixation lead (SDL) (Tendril™ STS Model 2088TC-38, Abbott Laboratories) in terms of lead parameters, procedural success and complication rates. METHODS: Patients receiving a LBBA pacemaker in the Isala Hospital, The Netherlands, were prospectively enrolled. The majority received a standard right ventricular (RV) lead as backup, the implanter chose between LLL and SDL for the LBBAP lead. RESULTS: The study included 94 patients with a mean follow-up of 30 weeks. 30/31 LLL procedures were successful, compared with 62/63 in the SDL group. Including the participants that lost LBBAP during follow-up resulted in success rates of 90.3% for LLL versus 96.8% for SDL, P = 0.199. Mean number of deployments was significantly lower in the SDL group compared with the LLL group (2 ± 2.3 versus 4 ± 3.4, P = 0.005), implantation and procedural times were comparable. Pacing thresholds were low and remained low in both groups (at last follow-up 0.8 ± 0.30 V for LLL versus 0.6 ± 0.20 V for SDL). Complication rates did not differ significantly between both groups, P = 0.805. CONCLUSION: LBBAP using SDL is feasible and has comparable success rates with lower number of deployments of the active fixation screw.

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Active fixation for a lead in the coronary sinus may be essential to select the optimal left ventricular pacing site, maximize the effectiveness of cardiac resynchronization therapy (CRT) and avoid dislodgement. The Medtronic Attain Stability lead allows fixation through a side helix concentric with the lead body. Although electrical performance of such a lead is well known, evidence of extractability remains poor especially in the long term. We describe the removal of an Attain Stability lead 63 months after implantation which, to the best of our knowledge, is the longest implant duration that has ever been reported, in an 81-year-old male patient. It was successfully achieved using simple traction and rotation maneuvers, demonstrating the long-term removal feasibility of such device.

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BACKGROUND: Left bundle branch area pacing (LBBAP) has been performed exclusively using lumen-less pacing leads (LLL) with fixed helix design. This registry study explores the safety and feasibility of LBBAP using stylet-driven leads (SDL) with extendable helix design in a multicenter patient population. METHODS: This study prospectively enrolled consecutive patients who underwent LBBAP for bradycardia pacing or heart failure indications at eight Belgian hospitals. LBBAP was attempted using SDL (Solia S60; Biotronik) delivered through dedicated delivery sheath (Selectra3D). Implant success, complications, procedural, and pacing characteristics were recorded at implant and follow-up. RESULTS: The study enrolled 353 patients (mean age 76 ± 39 years, 43% female). The mean number of implants per center was 25 (range: 5-162). Overall, LBBAP with SDL was successful in 334/353 (94%), varying from 93% to 100% among centers. Pacing response was labeled as left bundle branch pacing in 73%, whereas 27% were labeled as myocardial capture. Mean paced QRS duration and stimulus to left ventricular activation time measured 126 ± 21 ms and 74 ± 17. SDL-LBBAP resulted in low pacing thresholds (0.6 ± 0.4 V at 0.4 ms), which remained stable at 12 months follow-up (0.7 ± 0.3, p = .291). Lead revisions for SDL-LBBAP occurred in 5 (1.4%) patients occurred during a mean follow up of 9 ± 5 months. Five (1.4%) septal coronary artery fistulas and 8 (2%) septal perforations occurred, none of them causing persistent ventricular septal defects. CONCLUSION: The use of SDL to achieve LBBAP is safe and feasible, characterized by high implant success in low and high volume centers, low complication rates, and stable low pacing thresholds.

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Left bundle branch area pacing (LBBAP) has emerged as a novel pacing modality which aims to capture the left bundle branch area and avoids the detrimental effects of right ventricular pacing. Current approaches for LBBAP have been developed using lumen-less pacing leads (LLL). Expanding the tools and leads for LBBAP might contribute to a wider adoption of this technique. Standard stylet-driven pacing leads (SDL) differ from current LLL as they are characterized by a wider lead body diameter, are stylet-supported and often have a non-isodiametric extendable helix design. Although LBBAP can be performed safely with SDL, the implant technique of LBBAP differs compared to LLL. In the current overview we describe in detail how different types of SDL can be used to target a deep septal position and provide a practical guide on how to achieve LBBAP using SDL.

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BACKGROUND: Pulmonary Artery Catheter (PAC) knotting is a rare complication of PAC insertion. In patients with dilated right heart chambers, blind insertion of PAC significantly increases the risk of catheter knotting. We demonstrate a safe and successful approach to resolving a PAC knot around pacing leads of a cardiac resynchronization device. CASE PRESENTATION: A 63-year-old African American male with dilated cardiomyopathy and a cardiac resynchronization therapy (CRT) device for severe left ventricular systolic dysfunction required PAC insertion for hemodynamic management of acute heart failure. PAC insertion was complicated by catheter knotting around the pacing leads. The PAC was successfully retrieved using a transvenous technique. CONCLUSION: Fluoroscopy-guided insertion of PAC is advisable and preferred over blind insertion in patients with high risk of PAC entanglement. LEARNING OBJECTIVE: To highlight a potential complication of blind pulmonary artery catheter insertion and provide a safe technique to resolve catheter knots.

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INTRODUCTION: Left bundle branch area pacing (LBBAP) aims to achieve physiological pacing by capturing the conduction system in the area of the left bundle branch. LBBAP has exclusively been performed using lumen-less pacing leads (LLLs) with fixed helix design. This study explores the feasibility, safety, and pacing characteristics of LBBAP using stylet-driven leads (SDLs) with an extendable helix design. METHODS: Patients, in which LBBAP was attempted for bradycardia or heart failure pacing indications, were prospectively enrolled at the Ghent University Hospital. LBBAP was attempted with two different systems: 1/LLL with fixed helix (SelectSecure 3830, Medtronic Inc.) delivered through a preshaped sheath (C315His Medtronic Inc.) and 2/SDL with extendable helix (Solia S60, Biotronik, SE & CO) delivered through a new delivery sheath (Selectra 3D, Biotronik). RESULTS: The study enrolled 50 patients (mean age: 70 ± 14 years, 44% females). LBBAP with SDL was successful in 20/23 (87%) patients compared with 24/27 (89%) of patients in the LLL group (p = 0.834). Screw attempts, screw implant depth, procedural, and fluoroscopy times were comparable among both groups. Acute LBBAP thresholds were low and comparable between SDL and LLL (0.5 ± 0.15 V vs. 0.4 ± 0.17 V, p = 0.251). Pacing thresholds remained low at 3 ± 2.1 months of follow up in both groups and no lead revisions were necessary. Postprocedural echocardiography revealed a septal coronary artery fistula in one patient with SDLLBBAP. CONCLUSION: LBBAP using stylet-driven pacing leads is feasible and yields comparable implant success to LBBAP with LLLs. LBBAP thresholds are low and comparable with both types of leads.

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OBJECTIVES: Transvenous coronary sinus leads are considered to be the gold standard for cardiac resynchronization therapy (CRT). However, in patients with abnormal coronary vein anatomy, the epicardial leads can be an alternative. Data comparing durability and performance of these 2 lead types are limited. In order to provide clarity, we investigated patients receiving CRT system in our centre. METHODS: One thousand and fifty-three consecutive patients scheduled for CRT implantation were retrospectively analysed. From these, 895 received transvenous coronary sinus and 158 epicardial left ventricular (LV) leads. Lead-specific as well as LV functional parameters have been evaluated in 60 months' follow-up. RESULTS: Technical characteristics (pacing threshold, impedance and sensing) of both lead types remained stable during the whole observation period. Whereas an early revision (<6 month) was noted in 5.4% of transvenous leads, no reintervention has been necessary for epicardial leads. During the 5-year observation period, a lead revisions rate of 10.2% for transvenous leads and 1.9% for epicardial leads were detected. Regarding CRT efficacy, excellent results were achieved for both electrode types. In both groups, a statistically significant reduction of New York Heart Association class (2.85-2.13 and 2.96-2.09), increase in left ventricular ejection fraction (24.6-32.6% and 27.2-34.6%), reduction of left ventricular end-systolic diameter/left ventricular end-diastolic diameter and reduction in degree of mitral valve insufficiency could be observed over the time. CONCLUSIONS: Our data demonstrate safety and functional efficacy of both transvenous and epicardial leads. Moreover, in long-term follow-up, a commendable durability and performance were found for both lead types. Thus, epicardial leads represent a good alternative when transvenous implantation fails.

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Background: The effect of transient electromagnetic fields on the function of pacemakers is not well-evaluated. There is a lack of effective methods for clinicians to reduce electromagnetic susceptibility (EMS) during implantation of pacemakers. This study aimed to evaluate whether a novel method of handling the excess leads in the pocket can lower the EMS of pacemakers and consequently reduce the effect of electromagnetic interference caused by transient electromagnetic fields on pacemakers. Methods: An in vitro chest model was established to simulate the clinical condition of dual-chamber pacemaker implantation. Three different intertwining patterns of excess leads were examined: parallel, twisted once, and multiple twisted-pair. Oscillated currents were injected into a copper electrical wire set horizontally above the model to create a radiated magnetic field to simulate the transient daily electromagnetic exposure of pacemakers. The electromagnetic induction of current was measured. The occurrence of EMS-related adverse events was evaluated when the induced pulsed voltage was applied. Results: Transient electromagnetic fields can induce electromagnetic noise in the pacing loop and inhibit the release of pacing pulses. The multiple twisted-pair intertwining pattern of excess leads was associated with a lower induced voltage amplitude than both the parallel and once-twisted patterns (P < 0.001). Even once twisted could significantly reduce induced voltage amplitude compared to not twisted (P < 0.001). A lower incidence of pacing inhibition was also observed in the multiple twisted-pair group than in the other two groups (P < 0.001). Conclusions: Transient electromagnetic fields can cause pacing inhibition. Twisting the excess leads for multiple turns in the pocket is an effective method to reduce the EMS of the dual-chamber pacemaker.

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BACKGROUND: Various lead designs have been developed to accommodate different coronary sinus anatomies. Our objectives were to compare electrical parameters of straight and spiral left ventricular leads, to evaluate capture thresholds and impedances using different pacing vectors, and to study evolution of thresholds over time. METHODS: The RALLY-X4 study enrolled patients implanted with a lead from the Acuity X4 family (straight, spiral short, or spiral long). Electrical parameters (including capture thresholds from all 17 vectors) were measured at baseline and follow-up. RESULTS: Data from 795 patients who were successfully implanted were analyzed. Straight and spiral leads had similar proportions of patients with thresholds <2.5 V/0.4 ms using the distal electrode (61-65% of patients) or from at least one of the proximal (E2-E4) electrodes (81-83% of patients). Unipolar vectors had significantly lower thresholds and impedances than bipolar vectors, with similar measurements compared to extended bipolar configurations. Capture thresholds increased with more proximal electrodes for all leads. Over a mean follow-up of 1 year, a slight decrease in capture thresholds was observed. CONCLUSION: Straight and spiral quadripolar leads allow to obtain clinically acceptable capture thresholds from at least one of the proximal electrodes in >80% of patients. Pacing vectors significantly affect electrical parameters, with higher thresholds in more proximal electrodes and lower thresholds with unipolar and extended bipolar configurations. Capture thresholds slightly decreased over a mean follow-up of 1 year.

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Background: Magnetic resonance imaging (MRI) in patients with cardiac pacing devices has become available despite previously being considered absolutely contraindicated. However, most institutional safety protocols have included several limitations on patient selection, leaving MRI unavailable for many patients. Purpose: To evaluate the first 1000 MRI examinations conducted on patients with cardiac pacing devices at Helsinki University Hospital for any potential safety hazards and also to evaluate the long-term functionality of the safety protocol in "real-life" clinical practice. Material and Methods: A total of 1000 clinically indicated MRI scans were performed with a 1.5-T MRI scanner according to the safety protocol. The following information was collected from the electronic medical record (EMR): patients' date of birth; sex; pacing device generator model; date of MRI scan; date of the latest pacing device generator implantation; and the body region scanned. The EMR of these patients was checked and especially searched for any pacing device related safety hazards or adverse outcomes during or after the MRI scan. Results: Only one potentially dangerous adverse event was noted in our study group. In addition, patients with abandoned leads, temporary pacing devices, and newly implanted pacing device generators were scanned successfully and safely. Conclusion: MRI scans can be performed safely in patients with cardiac pacing devices if the dedicated safety protocol is followed.

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Upper-extremity venous obstruction is not an uncommon problem encountered by electrophysiologists. The placement of any catheter including pacemaker leads can cause stenosis or total obstruction. Affected patients often require balloon venoplasty to facilitate lead implantation. If the vein is unresponsive to venoplasty, stenting of the vein should be contemplated. We report a case of permanent pacemaker implantation after balloon venoplasty of the left subclavian vein and innominate vein following total occlusion in a patient with symptomatic complete heart block. There are many case reports to date in which balloon venoplasty of the subclavian vein has been performed before upgrading a single-chamber pacemaker to a DDD-mode pacemaker, cardiac resynchronization therapy device, or implantable cardioverter-defibrillator because of chronic venous occlusion secondary to a preexisting pacing lead. Balloon venoplasty to increase the diameter of a target vein or to overcome stenosis may be a technique that implanting electrophysiologists could adopt in order to achieve success in patients with more challenging anatomies.

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BACKGROUND: The performance of Abbott/St. Jude Medical (Sylmar CA) Tendril pacing leads has not been well characterized. OBJECTIVE: We sought to assess the performance of Tendril leads as compared with that of different pacing leads. METHODS: We retrospectively identified patients implanted with the following leads: Tendril leads 1888 TC, 2088 TC, and 1688 TC, Medtronic (Fridely, MN) 4076 CapSureFix Novus, and Boston Scientific (Natick, MA) FINELINE II Sterox Pacing EZ leads (models 4469, 4470, and 4471). The primary end point was the incidence of lead malfunction assessed by Kaplan-Meier analysis. RESULTS: During the study period, 9782 leads were implanted, including 8512 Tendril leads, 731 Medtronic 4076 CapSureFix Novus leads, and 539 FINELINE II leads. A total of 540 leads (5.5%) malfunctioned during a mean follow-up of 3.6 ± 2.9 years. Lead malfunction manifested predominantly as noise and/or low impedance (95%). Lead malfunction rates were significantly higher at 5 years for Tendril vs non-Tendril leads (7.0% vs 2.1%; P < .001). The highest rate of failure at 5 years was seen in the Tendril 1888 TC leads (9.9%), followed by Tendril 1688 (5.7%) and Tendril 2088 (5.2%) leads. In contrast, malfunction rates were significantly lower for the Medtronic 4076 (2.6%) and FINELINE II (1.7%) leads. During follow-up to 10 years, the incidence of lead malfunction for Optim-insulated Tendril leads (models 1888 TC and 2088 TC) was significantly higher than that for the non-Optim-insulated Tendril 1688 TC lead (24.5% vs 7.1%) (P = .008). CONCLUSION: Tendril leads appear to have a higher rate of malfunction than do comparator leads. Optim insulation may partly explain the higher failure rate.

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BACKGROUND: Lead dislodgement (LD) is a well-recognized complication during implantation of cardiac implantable electronic devices (CIEDs). An intraprocedural protocol, referred to as reduction of LD protocol, was developed to reduce the risk of LD. METHODS: The protocol involved (1) inserting a straight stylet down the right atrial lead and applying forward pressure while monitoring for fluoroscopic stability, (2) visualizing all leads during deep inspiration to determine if there is adequate lead redundancy, and (3) having the patient take a deep breath and cough while pacing just at capture threshold to assess for loss of capture in each lead. Any intraprocedural change in the parameters fulfilling the predefined criteria for inadequate lead implantation prompted lead repositioning. Data regarding demographic factors, clinical characteristics, and incidence of LD in the first 30 days after implant was obtained from intramural CIED database. The preintervention (control) group spanned 27 months and consisted of a total of 4,294 leads while the postintervention (intervention) group spanned 17 months and consisted of 2,361 leads implanted. RESULTS: There was no significant difference in the demographic factors and clinical characteristics in the two groups. Protocol compliance was > 90%. There were 44 occurrences of LD (1.02%) before and 10 (0.4%) after implementation of the protocol. The protocol significantly reduced the incidence of LD during the 30 days after implant (P = 0.014). No clinical characteristic predicted the risk of LD. CONCLUSION: Intraprocedural maneuvers performed to assess the adequacy of lead implantation results in reduced risk of LD.

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Use of temporary epicardial pacing (TEP) leads remains a routine perioperative strategy in congenital heart surgery. Selective use of TEP in neonates and infants undergoing cardiac intervention within the first 6 months of life has, yet, to be assessed. Outcome analysis was undertaken. From August 2014 to December 2016, 112 consecutive neonates and infants underwent cardiac intervention within the first 6 months of life. Patients with STS/EACTS Congenital Heart Surgery Mortality (STAT categories) 1-5 were prospectively followed from the index cardiac operation until hospital discharge and included in the study. Patients on permanent pacemaker (PPM) prior to the definitive cardiac intervention were excluded. Selective TEP placement was pursued if specific intraoperative indications were met. Determinants associated with the postoperative use of TEP were assessed. TEP leads were placed in 11 (9.8%) (GroupA). Nine was used for diagnostic and/or therapeutic purposes; two had no use (18%). From 101 patients without TEP (GroupB), one required treatment for postoperative dysrhythmia amenable to pacing. Vasoactive-inotrope score, ICU length of stay and time-to-negative balance was not statistically different between groups (p > 0.05). None of 112 patients required PPM insertion during hospital stay. Intraoperative need for cardioversion, attenuated ventricular function, and sustained sinus/AV node dysfunction or non-resolved elevated serum lactate at the time of operating room discharge were found to be predictors for TEP postoperative use. Selective placement of TEP leads is justified during early infancy for congenital heart surgery. Nearly 20% of those with TEP leads in place, even after its selective use, will not be required following surgery. Specific intraoperative parameters can guide the necessity and potential TEP postoperative use.

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