A detached helix of pacemaker pacing lead.

Permanent pacemaker implantation is the main treatment of symptomatic bradyarrhythmia, which has been widely used. Lead implantation is a critical step. When the lead malfunctions and needs to be replaced, extraction or abandonment of the primary lead (in whole or in part) should be determined according to the situation.

Device-Related Complications Associated with Cylindrical Lead Spinal Cord Stimulator Implants: A Comprehensive Review.

PURPOSE OF REVIEW: Spinal cord stimulation (SCS) is an increasingly utilized therapy for the treatment of neuropathic pain conditions. Though minimally invasive and reversable, there are several important device-related complications that physicians should be aware of before offering this therapy to patients. The aim of this review is to synthesize recent studies in device-related SCS complications pertaining to cylindrical lead implantation and to discuss etiologies, symptoms and presentations, diagnostic evaluation, clinical implications, and treatment options. RECENT FINDINGS: Device-related complications are more common than biologic complications. Device-related complications covered in this review include lead migration, lead fracture, lead disconnection, generator failure, loss of charge, generator flipping, hardware related pain, and paresthesia intolerance. The use of SCS continues to be an effective option for neuropathic pain conditions. Consideration of complications prior to moving forward with SCS trials and implantation is a vital part of patient management and device selection. Knowledge of these complications can provide physicians and other healthcare professionals the ability to maximize patient outcomes.

Twiddler's Syndrome Causing Lead Fracture in Sacral Neuromodulation: A Case Report.

Twiddler's syndrome is the voluntary or involuntary manipulation of an implanted device, most described in cardiac literature. Lead coiling may result in device malfunction due to lead migration or, less commonly, lead fracture. There are few but increasing reports of Twiddler's syndrome resulting in lead migration in sacral neuromodulation, but lead fracture has not yet been described. A 57-year-old Latina female presented with fecal incontinence and refractory overactive bladder. She underwent successful implantation of a sacral neuromodulation device with the resolution of symptoms. Following significant weight loss and two falls, she developed a recurrence of symptoms and was found to have lead migration on pelvic radiographs. At the time of surgical intervention, radiographs demonstrated worsened Twiddler's syndrome with complete lead fracture despite no further trauma. She subsequently underwent partial lead removal and replacement with additional measures to prevent Twiddler's syndrome and its sequelae. Twiddler's syndrome resulting in lead fracture can occur in sacral neuromodulation. Preventive techniques may be applied for patients with known risk factors for Twiddler's syndrome, especially generator anchoring and lead replacement.

Lead performance of stylet-driven leads in left bundle branch area pacing: Results from a large single-center cohort and insights from in vitro bench testing.

BACKGROUND: Left bundle branch area pacing (LBBAP) requires deep septal lead deployment for left-sided conduction stimulation. Advancing leads toward deep septal positions might add mechanical stress on these leads. Concerns about lead performance and reliability remain an unanswered question. OBJECTIVE: The purpose of this study was to analyze lead performance and integrity of stylet-driven pacing leads (SDLs) for LBBAP. METHODS: This study assessed lead fracture rates of SDL in a large single-center cohort of adult LBBAP patients. Fluoroscopic analysis of lead bending angulations at the septal insertion point and in vitro bench testing of lead preconditioning were performed to simulate clinical use conditions. Lead performance was compared between LBBAP and conventional right ventricular apical pacing (RVp) sites. RESULTS: The study included 325 LBBAP patients (66% male; age 71±15 years). During median follow-up of 18 months, 2 patients (0.6%) experienced conductor fracture between tip housing and ring electrode, whereas no such fractures occurred with RVp patients (n = 149; P = .22). X-ray analysis revealed that high lead bending angulations occurred in 1.3% of the patients. Accelerated bench testing of excessive preconditioned leads showcased a higher probability of early conductor fracture compared to standard preconditioned leads. CONCLUSION: The incidence of early conductor failure in LBBAP seems higher than with conventional RVp sites. The most vulnerable lead part seems to be the interelectrode space between the tip housing and ring electrode. Excessive angulation and preconditioning might contribute to early fatigue fracture.

Incidence of Temporary Peripheral Nerve Stimulator Lead Tip Retention: A Retrospective Review of 80 Lead Placements.

OBJECTIVES: The primary objective of this study was to determine the current rate of lead fracture during temporary percutaneous peripheral nerve stimulator (PNS) lead removal at the Mayo Clinic Rochester Division of Pain Medicine. MATERIALS AND METHODS: A retrospective review of electronic medical records was performed for patients implanted with a temporary percutaneous PNS device between January 1, 2018, and December 31, 2020. Patients were included if they underwent temporary percutaneous PNS system implant, with planned lead removal at 60 days. Data collection included date of implant, diagnosis, peripheral nerve target(s), number of leads, and lead tip status at the time of removal (intact vs fractured). RESULTS: Fifty patients underwent a total of 80 temporary percutaneous PNS leads placed during the time frame analyzed. Of the 80 temporary percutaneous PNS leads implanted, there were five lead fractures at the time of intentional lead removal. CONCLUSIONS: This retrospective review of 50 patients with 80 temporary percutaneous PNS leads implanted for chronic peripheral neuropathic pain resulted in a 6.25% rate of retained lead fragment at the time of lead removal by the provider at the end of 60-day treatment. This fracture and retention rate is consistent with previous published retrospective data on PNS, which has shown a 3% to 21% lead fracture rate during intentional lead removal.

Pacemaker electrode rupture causes recurrent syncope: A case report.

BACKGROUND: Currently, the implantation of permanent cardiac pacemakers entails mostly subclavian vein puncture, which is relatively simpler and easier to master. However, due to individual differences, some patients carry a narrow space between the clavicle and the first rib. If the range of activity of the upper limb is increased, the friction between the electrode wire and the bone gap leads to the breakage of the electrode wire, which is manifested by poor pacemaker perception and pacing. CASE SUMMARY: A 68-year-old woman underwent permanent pacemaker implantation in our hospital because of third-degree atrioventricular block 6 years ago. At that time, the patient was recommended to have a dual-chamber permanent pacemaker implantation, and finally chose a single-chamber permanent pacemaker because she could not afford the cost. The patient has repeatedly lost consciousness for no obvious reason in the past 3 d, and went to our hospital for treatment. The chest X-ray showed that the pacemaker electrode was broken. After the patient was given a pacemaker electrode replacement, the patient did not continue to lose consciousness. CONCLUSION: Because the electrodes implanted in the subclavian approach are close to the clavicle and the first rib, the pacemaker electrodes may wear out. If the patient loses consciousness again after the pacemaker is implanted, we should consider whether there is a pacemaker. The possibility of electrode breakage, and timely help the patient to replace the new pacemaker electrodes.

Normal pacing function with normal impedance trends despite evident lead fracture in an implantable defibrillator - What is the mechanism?

A 63-year-old lady with a high-grade atrioventricular (AV) block and a structurally normal heart underwent permanent pacemaker implantation (dual chamber, Medtronic Ltd) 8 years back. On follow up, she had a recurrence of syncope after 3 years. The device interrogation at that time had revealed ventricular tachycardia (VT) for which she underwent implantable cardioverter defibrillator (ICD, Medtronic Ltd, Egida DR, DF1) upgradation at another center (electrograms not available). Now, she presents with episodes of presyncope after another 5 years. The Echocardiography was unremarkable. The ICD was interrogated & there was a stored ventricular fibrillation (VF) episode. But the electrograms suggested noise over a true VF electrogram noted in both near and far-field. In all probability, the VF was not a true one which might have arisen from some lead noise or from an electromagnetic interference (EMI). Fluoroscopy revealed an evident lead fracture near the superior vena cava (SVC) coil. The stored electrogram (EGM) characteristics also suggested possible lead noise rather than a true VF. She was advised for lead revision. Interestingly, all pacing parameters were normal along with normal impedance despite the evident lead fracture. This happened due to the ICD lead arrangements as there are separate electrodes for the SVC/RV coil and pacing. While the SVC coil was damaged, the pacing electrodes remained unaffected. Since the patient has no episode of true VT/NSVT and the echocardiography was normal, she was managed temporarily by changing the pacemaker to asynchronous (DOO) mode.

Strategies for the Long-Term Preservation of Site for Future Implantation of Cardiac Implantable Electronic Devices (CIEDs): Two Decades of Experience.

Introduction Implantation of cardiac implantable electronic devices (CIEDs) is an art of science. As the volume of implantation has increased worldwide, so has the rate of complications. Infection, fibrosis, lead and device erosion, lead displacement, right ventricle perforation, lead fracture, and insulation break are the common complications in the implantation process. This exposes the patient for reopening and threatens the implantation for further complication due to infection, fibrosis of veins, failure to retrieve the implanted wire, and failure to re-implant the device on the same site. We slightly changed our implantation technique to preserve the implantation site for future implantation and reduce the rate of complication in the index implantation. Methods This randomized control trial was conducted from January 2016 to September 2019 at Hayatabad Medical Complex Peshawar, Pakistan. A consecutive sampling technique was used to obtain a sample size of 602 patients keeping a 95% confidence interval and a 5% margin error. We adopted a strategy to take prick, for implantation of devices, inside the pocket, which reduces the number of sutures, hastens the procedure, prevents erosion, and minimizes the chance of subclavian crush syndrome and insulation break. We also selected the minimum possible length of leads. This will possibly decrease the chances of cumbersome fibrosis around the lead and device and will make future implantation convenient. Results There was a total of 602 procedures in the study period. About 253 (42%) procedures were done in the newly adopted strategy and 349 (58%) were performed in the conventional way. Our complication rate grossly reduces in the novel way of implantation in which we took our prick inside the pocket. Conclusion A slight modification in the implantation of CIEDs not only prevents the rate of complication in the index implantation but will also possibly preserve the site for future implantation.

Time course of oversensing and impedance changes in developing implantable cardioverter-defibrillator lead fracture.

Background: Pace-sense conductors comprise a pacing coil to the tip electrode and cable to the ring-electrode. Implantable cardioverter-defibrillator (ICD) lead-monitoring diagnostics include pacing impedance (direct current resistance [DCR]) and measures of oversensing. How they change as fractures progress is unknown. Objectives: To characterize the relationship between oversensing, impedance, and structural changes in ICD leads developing pace-sense conductor fractures. Methods: We performed bending tests on 39 leads connected to ICD generators in an electrolyte bath with simulated electrograms. DCR was recorded every 3 minutes; electrograms were telemetered continuously. Twenty-two leads were tested to develop partial or complete fracture criteria confirmed by imaging, using DCR or DCR variability measured by standard deviation (σDCR). Results are reported for 17 other test leads. Results: Initial oversensing occurred with partial pacing coil fracture vs complete ring cable fracture and correlated with bending-induced DCR peaks. These peaks were too small to be detected by clinical impedance measurements and were characterized by small increases in σDCR (≥0.5 Ω). Impedance threshold alerts occurred at complete pacing coil fracture but only later for ring cable fractures. The oversensing alert triggered before device-detected ventricular fibrillation more frequently than impedance alerts (94% vs 17%; P = .00002). Conclusions: In conductor fracture, early oversensing corresponds to partial pacing coil fracture or complete ring cable fracture and correlates with transient bending-induced impedance increases, which are detected by impedance variability but too small to trigger clinical impedance alerts. This explains why clinical oversensing alerts provide more warning for device-detected ventricular fibrillation than impedance alerts and suggests how to improve impedance diagnostics based on short-term variability.

Social Media in Physician Education.

Background Social media has fundamentally changed the practice of medicine. It has taken the medical community by storm, benefited patient care, and has become a leading source for distributing medical information. Social media platforms are a low-cost, low-barrier entry means for health systems to highlight their competitive advantage to patients and providers alike. This study aimed to assess the role of social media in the education of physicians. Methods To evaluate the utility of social media in engaging physicians, four vignettes were utilized to highlight Class 1 indications for transvenous lead extraction (TLE), an electrophysiology procedure aimed at removing infected or damaged cardiac device leads. Individuals, via Twitter, were presented with cases and multiple-choice response options to determine the next best step in management. Results The clinical vignettes were seen by more than 18,000 individuals worldwide. Survey results indicated that 83% of individuals who participated had correctly identified class 1 indications for this life-saving procedure. Sixteen percent to 21% of physicians incorrectly identified the next step in the management of Class 1 indications for lead extraction, representing a need for education and an opportunity to inform and educate. Conclusion Social media may be a useful tool in physician education. However, guidelines and further research are needed to continue to understand the role of social media within the medical field.

Trauma-induced complete pacemaker lead fracture 8 months prior to hospitalization: A case report.

Trauma-induced complete lead fracture is a rare complication of pacemaker implantation. Only a few cases have been previously reported. Common treatment included replacement of pacemaker and/or extraction of fractured lead. In this report, however, we describe this unique case of complete traumatic pacemaker lead fracture. The patient had her right-ventricular lead fractured after a bicycle accident and had lived with the fractured lead for 8 months prior to her hospitalization. After examinations, she was treated with a relatively conservative strategy. The pacemaker and fractured lead were left for further observation and follow-up.

Treatment of pacemaker-induced superior vena cava syndrome by venoplasty with a coronary balloon.

Venous thrombosis or stenosis frequently occurs after implanting transvenous pacemaker leads, and it is usually asymptomatic. The reported incidence is 30%-64%. The mandatory treatments are balloon angioplasty, stenting, thrombolytic, mechanical thrombectomy, and venous grafting. We present a case with the special cooperation of an electrophysiologist and a coronary interventionist in Ha Noi Heart Hospital, Vietnam, to treat an implanted pacemaker patient with fracture ventricular lead and superior vena cava syndrome.

A broken lead to an open heart: implantable cardioverter defibrillator vegetations with lead fracture.

Implantable cardiac devices are widely used devices that serve several purposes. Complications from devices are not uncommon and include localized or systemic infections, device-related endocarditis, and device malfunction leading to serious outcomes, including death. Another possible complication that has been reported in the literature is thrombus formation on the device leads. We present a rare case of large thrombi forming on the leads of an implantable cardioverter defibrillator leading to lead fracture and device malfunction. After the device alerted for malfunction, the patient underwent a transesophageal echocardiogram which demonstrated masses on the right atrium and ventricle. He subsequently had a right atrial exploration and lead extraction which revealed large thrombi on the leads which histologically were identified as sterile vegetations.

Twiddler's syndrome after implantation of baroreflex activation therapy: a case report.

BACKGROUND: Twiddler's syndrome is a rare complication after implantation of cardiac pacemakers or cardioverter-defibrillators that usually occurs within the first year after the procedure. However, it has not yet been described following implantation of baroreflex activation therapy (BAT). CASE SUMMARY: A 61-year-old female patient was referred to the cardiology outpatient clinic due to uncontrolled arterial hypertension despite maximal doses of several established drugs. Therefore, right-sided BAT implantation was successfully performed in February 2017 with good clinical response. Because of sustained neck pain at the site of stimulator, surgical revision was performed in November 2019 including a switch of the lead to the contralateral position. Approximately 1 month later, Twiddler's syndrome was identified on the basis of recurrent pain at the generator site necessitating pocket-revision, however, the lead was only untwisted but not replaced. A few weeks afterwards, unfortunately, lead revision was indispensable due to lead fracture. DISCUSSION: This case presents the uncommon phenomenon of Twiddler's syndrome after BAT implantation. In addition, the commonly twisted lead should always be replaced as well during surgical pocket-revision in order to ensure proper long-term function.

In vitro modeling accurately predicts cardiac lead fracture at 10 years.

BACKGROUND: Development of a cardiac lead fracture model has the potential to differentiate well-performing lead designs from poor performing ones and could aid in future lead development. OBJECTIVE: The purpose of this study was to demonstrate a predictive model for lead fracture and validate the results generated by the model by comparing them to observed 10-year implantable cardioverter-defibrillator lead fracture-free survival. METHODS: The model presented here uses a combination of in vivo patient data, in vitro conductor fatigue test data, and statistical simulation to predict the fracture-free survival of cardiac leads. The model was validated by comparing the results to human clinical performance data from the Medtronic Sprint Fidelis (Minneapolis, MN) models 6931 (single coil, active fixation) and 6949 (dual coil, active fixation), as well as the Quattro model 6947 (dual coil, active fixation). RESULTS: Median patient age in the single coil Fidelis 6931 population (64 years) was less than in the dual coil Fidelis 6949 and Quattro populations (68 years). Modeled and observed fracture-free survival for Quattro (>97%) was superior to that for Fidelis (<94%). The modeled survival agreed with the observed fracture-free survival data. The average model error was 0.3% (SD 1.2%). CONCLUSION: This model for cardiac lead fracture-free survival using in vivo lead bending measurements and in vitro bench testing can be used to predict lead performance as observed by alignment with field survival data.

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.