Ventricular fibrillation waveform properties influenced by thoracic impedance guided chest compressions in a porcine model.

BACKGROUND AND OBJECTIVE: Quantitative measures extracted from ventricular fibrillation (VF) waveform reflect the metabolic state of the myocardium and are associated with survival outcome. The quality of delivered chest compressions during cardiopulmonary resuscitation are also linked with survival. The aim of this research is to explore the viability and effectiveness of a thoracic impedance (TI) based chest compression (CC) guidance system to control CC depth within individual subjects and influence VF waveform properties. METHODS: This porcine investigation includes an analysis of two protocols. CC were delivered in 2 min episodes at a constant rate of 110 CC min-1. Subject-specific CC depth was controlled using a TI-thresholding system where CC were performed according to the amplitude (ZRMS, 0.125 to 1.250 Ω) of a band-passed TI signal (ZCC). Protocol A was a retrospective analysis of a 12-porcine study to characterise the response of two VF waveform metrics: amplitude spectrum area (AMSA) and mean slope (MS), to varying CC quality. Protocol B was a prospective 12-porcine study to determine if changes in VF waveform metrics, due to CC quality, were associated with defibrillation outcome. RESULTS: Protocol A: A directly proportional relationship was observed between ZRMS and CC depth applied within each subject (r = 0.90; p <0.001). A positive relationship was observed between ZRMS and both AMSA (p <0.001) and MS (p <0.001), where greater TI thresholds were associated with greater waveform metrics. PROTOCOL B: MS was associated with return of circulation following defibrillation (odds ratio = 2.657; p = 0.043). CONCLUSION: TI-thresholding was an effective way to control CC depth within-subjects. Compressions applied according to higher TI thresholds evoked an increase in AMSA and MS. The response in MS due to deeper CC resulted in a greater incidence of ROSC compared to shallow chest compressions.

3D Fabrication and Characterisation of Electrically Receptive PCL-Graphene Scaffolds for Bioengineered In Vitro Tissue Models.

Polycaprolactone (PCL) is a well-established biomaterial, offering extensive mechanical attributes along with low cost, biocompatibility, and biodegradability; however, it lacks hydrophilicity, bioactivity, and electrical conductivity. Advances in 3D fabrication technologies allow for these sought-after attributes to be incorporated into the scaffolds during fabrication. In this study, solvent-free Fused Deposition Modelling was employed to fabricate 3D scaffolds from PCL with increasing amounts of graphene (G), in the concentrations of 0.75, 1.5, 3, and 6% (w/w). The PCL+G scaffolds created were characterised physico-chemically, electrically, and biologically. Raman spectroscopy demonstrated that the scaffold outer surface contained both PCL and G, with the G component relatively uniformly distributed. Water contact angle measurement demonstrated that as the amount of G in the scaffold increases (0.75-6% w/w), hydrophobicity decreases; mean contact angle for pure PCL was recorded as 107.22 ± 9.39°, and that with 6% G (PCL+6G) as 77.56 ± 6.75°. Electrochemical Impedance Spectroscopy demonstrated a marked increase in electroactivity potential with increasing G concentration. Cell viability results indicated that even the smallest addition of G (0.75%) resulted in a significant improvement in electroactivity potential and bioactivity compared with that for pure PCL, with 1.5 and 3% exhibiting the highest statistically significant increases in cell proliferation.

Armband Sensors Location Assessment for Left Arm-ECG Bipolar Leads Waveform Components Discovery Tendencies around the MUAC Line.

Sudden cardiac death (SCD) risk can be reduced by early detection of short-lived and transient cardiac arrhythmias using long-term electrocardiographic (ECG) monitoring. Early detection of ventricular arrhythmias can reduce the risk of SCD by allowing appropriate interventions. Long-term continuous ECG monitoring, using a non-invasive armband-based wearable device is an appealing solution for detecting early heart rhythm abnormalities. However, there is a paucity of understanding on the number and best bipolar ECG electrode pairs axial orientation around the left mid-upper arm circumference (MUAC) for such devices. This study addresses the question on the best axial orientation of ECG bipolar electrode pairs around the left MUAC in non-invasive armband-based wearable devices, for the early detection of heart rhythm abnormalities. A total of 18 subjects with almost same BMI values in the WASTCArD arm-ECG database were selected to assess arm-ECG bipolar leads quality using proposed metrics of relative (normalized) signal strength measurement, arm-ECG detection performance of the main ECG waveform event component (QRS) and heart-rate variability (HRV) in six derived bipolar arm ECG-lead sensor pairs around the armband circumference, having regularly spaced axis angles (at 30° steps) orientation. The analysis revealed that the angular range from -30° to +30°of arm-lead sensors pair axis orientation around the arm, including the 0° axis (which is co-planar to chest plane), provided the best orientation on the arm for reasonably good QRS detection; presenting the highest sensitivity (Se) median value of 93.3%, precision PPV median value at 99.6%; HRV RMS correlation (p) of 0.97 and coefficient of determination (R2) of 0.95 with HRV gold standard values measured in the standard Lead-I ECG.

Transcutaneous Pulsed RF Energy Transfer Mitigates Tissue Heating in High Power Demand Implanted Device Applications: In Vivo and In Silico Models Results.

This article presents the development of a power loss emulation (PLE) system device to study and find ways of mitigating skin tissue heating effects in transcutaneous energy transmission systems (TETS) for existing and next generation left ventricular assist devices (LVADs). Skin thermal profile measurements were made using the PLE system prototype and also separately with a TETS in a porcine model. Subsequent data analysis and separate computer modelling studies permit understanding of the contribution of tissue blood perfusion towards cooling of the subcutaneous tissue around the electromagnetic coupling area. A 2-channel PLE system prototype and a 2-channel TETS prototype were implemented for this study. The heating effects resulting from power transmission inefficiency were investigated under varying conditions of power delivery levels for an implanted device. In the part of the study using the PLE setup, the implanted heating element was placed subcutaneously 6-8 mm below the body surface of in vivo porcine model skin. Two operating modes of transmission coupling power losses were emulated: (a) conventional continuous transmission, and (b) using our proposed pulsed transmission waveform protocols. Experimental skin tissue thermal profiles were studied for various levels of LVAD power. The heating coefficient was estimated from the porcine model measurements (an in vivo living model and a euthanised cadaver model without blood circulation at the end of the experiment). An in silico model to support data interpretation provided reliable experimental and numerical methods for effective wireless transdermal LVAD energization advanced solutions. In the separate second part of the study conducted with a separate set of pigs, a two-channel inductively coupled RF driving system implemented wireless power transfer (WPT) to a resistive LVAD model (50 Ω) to explore continuous versus pulsed RF transmission modes. The RF-transmission pulse duration ranged from 30 ms to 480 ms, and the idle time (no-transmission) from 5 s to 120 s. The results revealed that blood perfusion plays an important cooling role in reducing thermal tissue damage from TETS applications. In addition, the results analysis of the in vivo, cadaver (R1Sp2) model, and in silico studies confirmed that the tissue heating effect was significantly lower in the living model versus the cadaver model due to the presence of blood perfusion cooling effects.

Exosomal Composition, Biogenesis and Profiling Using Point-of-Care Diagnostics-Implications for Cardiovascular Disease.

Arteriosclerosis is an important age-dependent disease that encompasses atherosclerosis, in-stent restenosis (ISR), pulmonary hypertension, autologous bypass grafting and transplant arteriosclerosis. Endothelial dysfunction and the proliferation of vascular smooth muscle cell (vSMC)-like cells is a critical event in the pathology of arteriosclerotic disease leading to intimal-medial thickening (IMT), lipid retention and vessel remodelling. An important aspect in guiding clinical decision-making is the detection of biomarkers of subclinical arteriosclerosis and early cardiovascular risk. Crucially, relevant biomarkers need to be good indicators of injury which change in their circulating concentrations or structure, signalling functional disturbances. Extracellular vesicles (EVs) are nanosized membraneous vesicles secreted by cells that contain numerous bioactive molecules and act as a means of intercellular communication between different cell populations to maintain tissue homeostasis, gene regulation in recipient cells and the adaptive response to stress. This review will focus on the emerging field of EV research in cardiovascular disease (CVD) and discuss how key EV signatures in liquid biopsies may act as early pathological indicators of adaptive lesion formation and arteriosclerotic disease progression. EV profiling has the potential to provide important clinical information to complement current cardiovascular diagnostic platforms that indicate or predict myocardial injury. Finally, the development of fitting devices to enable rapid and/or high-throughput exosomal analysis that require adapted processing procedures will be evaluated.

WaSP-ECG: A Wave Segmentation Pretraining Toolkit for Electrocardiogram Analysis.

Introduction: Representation learning allows artificial intelligence (AI) models to learn useful features from large, unlabelled datasets. This can reduce the need for labelled data across a range of downstream tasks. It was hypothesised that wave segmentation would be a useful form of electrocardiogram (ECG) representation learning. In addition to reducing labelled data requirements, segmentation masks may provide a mechanism for explainable AI. This study details the development and evaluation of a Wave Segmentation Pretraining (WaSP) application. Materials and Methods: Pretraining: A non-AI-based ECG signal and image simulator was developed to generate ECGs and wave segmentation masks. U-Net models were trained to segment waves from synthetic ECGs. Dataset: The raw sample files from the PTB-XL dataset were downloaded. Each ECG was also plotted into an image. Fine-tuning and evaluation: A hold-out approach was used with a 60:20:20 training/validation/test set split. The encoder portions of the U-Net models were fine-tuned to classify PTB-XL ECGs for two tasks: sinus rhythm (SR) vs atrial fibrillation (AF), and myocardial infarction (MI) vs normal ECGs. The fine-tuning was repeated without pretraining. Results were compared. Explainable AI: an example pipeline combining AI-derived segmentation masks and a rule-based AF detector was developed and evaluated. Results: WaSP consistently improved model performance on downstream tasks for both ECG signals and images. The difference between non-pretrained models and models pretrained for wave segmentation was particularly marked for ECG image analysis. A selection of segmentation masks are shown. An AF detection algorithm comprising both AI and rule-based components performed less well than end-to-end AI models but its outputs are proposed to be highly explainable. An example output is shown. Conclusion: WaSP using synthetic data and labels allows AI models to learn useful features for downstream ECG analysis with real-world data. Segmentation masks provide an intermediate output that may facilitate confidence calibration in the context of end-to-end AI. It is possible to combine AI-derived segmentation masks and rule-based diagnostic classifiers for explainable ECG analysis.

Pediatric defibrillation shocks alone do not cause heart damage in a porcine model.

AIM: Automated external defibrillators (AEDs) use various shock protocols with different characteristics when deployed in pediatric mode. The aim of this study is to assess and compare the safety and efficacy of different AED pediatric protocols using novel experimental approaches. METHODS: Two defibrillation protocols (A and B) were assessed across two studies: Protocol A: escalating (50-75-90 J) defibrillation waveform with higher voltage, shorter duration and equal phase durations. Protocol B; non-escalating (50-50-50 J) defibrillation waveform with lower voltage, longer duration and unequal phase durations.Experiment 1: Isolated shock damage was assessed following shocks to 12 anesthetized pigs. Animals were randomized into two groups, receiving three shocks from Protocol A (50-75-90 J) or B (50-50-50 J). Cardiac function, cardiac troponin I (cTnI), creatine phosphokinase (CPK) and histopathology were analyzed. Experiment 2: Defibrillation safety and efficacy were assessed through shock success, ROSC, ST-segment deviation and contractility following 16 randomized shocks from protocol A or B delivered to 10 anesthetized pigs in VF. RESULTS: Experiment 1: No clinically meaningful difference in cTnI, CPK, ST-segment deviation, ejection fraction or histopathological damage was observed following defibrillation with either protocol. No difference was observed between protocols at any timepoint. Experiment 2: all defibrillation types demonstrated shock success and ROSC ≥ 97.5%. Post-ROSC contractility was similar between protocols. CONCLUSIONS: There is no evidence that administration of clinically relevant shock sequences, without experimental confounders, result in significant myocardial damage in this model of pediatric resuscitation. Typical variations in AED pediatric mode settings do not affect defibrillation safety and efficacy.

Real-world insight into public access defibrillator use over five years.

BACKGROUND: Public access defibrillators (PADs) represent unique life-saving medical devices as they may be used by untrained lay rescuers. Collecting representative clinical data on these devices can be challenging. Here, we present results from a retrospective observational cohort study, describing real-world PAD utilisation over a 5-year period. METHODS: Data were collected between October 2012 and October 2017. Responders voluntarily submitted electronic data downloaded from HeartSine PADs, and patient demographics and other details using a case report form in exchange for a replacement battery and electrode pack. RESULTS: Data were collected for 977 patients (692 males, 70.8%; 255 females, 26.1%; 30 unknown, 3.1%). The mean age (SD) was 59 (18) years (range <1 year to 101 years). PAD usage occurred most commonly in homes (n=328, 33.6%), followed by public places (n=307, 31.4%) and medical facilities (n=128, 13.1%). Location was unknown in 40 (4.09%) events. Shocks were delivered to 354 patients. First shock success was 312 of 350 patients where it could be determined (89.1%, 95% CI 85.4% to 92.2%). Patients with reported response times ≤5 min were more likely to survive to hospital admission (89/296 (30.1%) vs 40/250 (16.0%), p<0.001). Response time was unknown for 431 events. CONCLUSION: This is the first study to report global PAD usage in voluntarily submitted, unselected real-world cases and demonstrates the real-world effectiveness of PADs, as confirmed by first shock success.

A Data-Driven Simulator for the Strategic Positioning of Aerial Ambulance Drones Reaching Out-of-Hospital Cardiac Arrests: A Genetic Algorithmic Approach.

OBJECTIVE: The Internet of Things provide solutions for many societal challenges including the use of unmanned aerial vehicles to assist in emergency situations that are out of immediate reach for traditional emergency services. Out of hospital cardiac arrest (OHCA) can result in death with less than 50% of victims receiving the necessary emergency care on time. The aim of this study is to link real world heterogenous datasets to build a system to determine the difference in emergency response times when having aerial ambulance drones available compared to response times when depending solely on traditional ambulance services and lay rescuers who would use nearby publicly accessible defibrillators to treat OHCA victims. METHOD: The system uses the geolocations of public accessible defibrillators and ambulance services along with the times when people are likely to have a cardiac arrest to calculate response times. For comparison, a Genetic Algorithm has been developed to determine the strategic number and positions of drone bases to optimize OHCA emergency response times. CONCLUSION: Implementation of a nationwide aerial drone network may see significant improvements in overall emergency response times for OHCA incidents. However, the expense of implementation must be considered.

Prospective Assessment of Linox Implantable Cardioverter Defibrillator Leads for Structural or Electrical Abnormalities.

INTRODUCTION: Insulation failure leading to conductor externalization (CE) of a Linox (Biotronik, Berlin, Germany) implantable cardioverter defibrillator (ICD) lead has recently been reported. The aim of this study was to assess prospectively all Linox family ICD leads implanted at our center for evidence of CE or an electrical abnormality. METHODS: All patients with a Linox family ICD lead implanted at our center, between November 2007 and March 2015, were identified and all living patients were invited to attend for fluoroscopic screening and electrical assessment of the lead. RESULTS: A total of 183 patients had a Linox family ICD lead implanted at our center. Of these, 5 patients (2.7%) had the lead extracted because of electrical failure and 2 of these leads had evidence of CE. Out of 158 living patients with a Linox family ICD lead, 111 patients attended for screening (mean age 63.1 years, 22.5% female). In this group of patients, no cases of CE or electrical abnormalities of the lead were identified. CONCLUSION: In this study evaluating 183 patients with a Linox family ICD lead implanted at a single center, 5 leads (2.7%) were explanted because of electrical failure and 2 of these leads had evidence of CE. Prospective fluoroscopic assessment of 111 Linox family ICD leads, with a mean dwell time of 31.5 months, revealed no further cases of CE.

Towards Low Energy Atrial Defibrillation.

A wireless powered implantable atrial defibrillator consisting of a battery driven hand-held radio frequency (RF) power transmitter (ex vivo) and a passive (battery free) implantable power receiver (in vivo) that enables measurement of the intracardiac impedance (ICI) during internal atrial defibrillation is reported. The architecture is designed to operate in two modes: Cardiac sense mode (power-up, measure the impedance of the cardiac substrate and communicate data to the ex vivo power transmitter) and cardiac shock mode (delivery of a synchronised very low tilt rectilinear electrical shock waveform). An initial prototype was implemented and tested. In low-power (sense) mode, >5 W was delivered across a 2.5 cm air-skin gap to facilitate measurement of the impedance of the cardiac substrate. In high-power (shock) mode, >180 W (delivered as a 12 ms monophasic very-low-tilt-rectilinear (M-VLTR) or as a 12 ms biphasic very-low-tilt-rectilinear (B-VLTR) chronosymmetric (6ms/6ms) amplitude asymmetric (negative phase at 50% magnitude) shock was reliably and repeatedly delivered across the same interface; with >47% DC-to-DC (direct current to direct current) power transfer efficiency at a switching frequency of 185 kHz achieved. In an initial trial of the RF architecture developed, 30 patients with AF were randomised to therapy with an RF generated M-VLTR or B-VLTR shock using a step-up voltage protocol (50-300 V). Mean energy for successful cardioversion was 8.51 J ± 3.16 J. Subsequent analysis revealed that all patients who cardioverted exhibited a significant decrease in ICI between the first and third shocks (5.00 Ω (SD(σ) = 1.62 Ω), p < 0.01) while spectral analysis across frequency also revealed a significant variation in the impedance-amplitude-spectrum-area (IAMSA) within the same patient group (|∆(IAMSAS1-IAMSAS3)[1 Hz - 20 kHz] = 20.82 Ω-Hz (SD(σ) = 10.77 Ω-Hz), p < 0.01); both trends being absent in all patients that failed to cardiovert. Efficient transcutaneous power transfer and sensing of ICI during cardioversion are evidenced as key to the advancement of low-energy atrial defibrillation.

Improved recording of atrial activity by modified bipolar leads derived from the 12-lead electrocardiogram.

This study investigates the use of multivariate linear regression to estimate three bipolar ECG leads from the 12-lead ECG in order to improve P-wave signal strength. The study population consisted of body surface potential maps recorded from 229 healthy subjects. P-waves were then isolated and population based transformation weights developed. A derived P-lead (measured between the right sternoclavicular joint and midway along the costal margin in line with the seventh intercostal space) demonstrated significant improvement in median P-wave root mean square (RMS) signal strength when compared to lead II (94µV vs. 76µV, p<0.001). A derived ES lead (from the EASI lead system) also showed small but significant improvement in median P-wave RMS (79µV vs. 76µV, p=0.0054). Finally, a derived modified Lewis lead did not improve median P-wave RMS when compared to lead II. However, this derived lead improved atrioventricular RMS ratio. P-wave leads derived from the 12-lead ECG can improve signal-to-noise ratio of the P-wave; this may improve the performance of detection algorithms that rely on P-wave analysis.

An investigation of thrust, depth and the impedance cardiogram as measures of cardiopulmonary resuscitation efficacy in a porcine model of cardiac arrest.

OBJECTIVE: Optimising the depth and rate of applied chest compressions following out of hospital cardiac arrest is crucial in maintaining end organ perfusion and improving survival. The impedance cardiogram (ICG) measured via defibrillator pads produces a characteristic waveform during chest compressions with the potential to provide feedback on cardiopulmonary resuscitation (CPR) and enhance performance. The objective of this pre-clinical study was to investigate the relationship between mechanical and physiological markers of CPR efficacy in a porcine model and examine the strength of correlation between the ICG amplitude, compression depth and end-tidal CO2 (ETCO2). METHODS: Two experiments were performed using 24 swine (12 per experiment). For experiment 1, ventricular fibrillation (VF) was induced and mechanical CPR commenced at varying thrusts (0-60 kg) for 2 min intervals. Chest compression depth was recorded using a Philips QCPR device with additional recording of invasive physiological parameters: systolic blood pressure, ETCO2, cardiac output and carotid flow. For experiment 2, VF was induced and mechanical CPR commenced at varying depths (0-5 cm) for 2 min intervals. The ICG was recorded via defibrillator pads attached to the animal's sternum and connected to a Heartsine 500 P defibrillator. ICG amplitude, chest compression depth, systolic blood pressure and ETCO2 were recorded during each cycle. In both experiments the within-animal correlation between the measured parameters was assessed using a mixed effect model. RESULTS: In experiment 1 moderate within-animal correlations were observed between physiological parameters and compression depth (r=0.69-0.77) and thrust (r=0.66-0.82). A moderate correlation was observed between compression depth and thrust (r=0.75). In experiment 2 a strong within-animal correlation and moderate overall correlations were observed between ICG amplitude and compression depth (r=0.89, r=0.79) and ETCO2 (r=0.85, r=0.64). CONCLUSION: In this porcine model of induced cardiac arrest moderate within animal correlations were observed between mechanical and physiological markers of chest compression efficacy demonstrating the challenge in utilising a single mechanical metric to quantify chest compression efficacy. ICG amplitude demonstrated strong within animal correlations with compression depth and ETCO2 suggesting its potential utility to provide CPR feedback in the out of hospital setting to improve performance.

Fluoroscopic and electrical assessment of implantable cardioverter defibrillator leads: a prospective observational study.

BACKGROUND: Insulation defects resulting in conductor externalization (CE) have been reported in the Riata family of implantable cardioverter defibrillator (ICD) leads (St. Jude Medical, Sylmar, CA, USA). The aim of this study was to identify, prospectively, the rate of CE and outcomes following this, within a group of patients with a Riata ICD lead. METHODS: Patients with a Riata ICD lead attended for fluoroscopic screening and electrical assessment of the lead at yearly intervals between 2010 and 2012. RESULTS: One hundred and forty patients had no or borderline evidence of CE on initial assessment in 2010. These patients were prospectively followed for 3 years (304.6 patient-years). During this time, 11 patients developed definite CE, equating to an event rate of 3.6 (95% confidence intervals: 1.8-6.5) per 100 patient-years of follow-up. Of those patients developing definite CE, one patient had the ICD lead explanted (for reasons unrelated to CE) and no patients died. CE was not associated with any electrical abnormalities of the ICD lead. CONCLUSIONS: CE was observed at a rate of 3.6 per 100 patient-years of follow-up, in 140 individuals with a Riata ICD lead and no definite evidence of CE at baseline.

A support vector machine for predicting defibrillation outcomes from waveform metrics.

BACKGROUND: Algorithms to predict shock success based on VF waveform metrics could significantly enhance resuscitation by optimising the timing of defibrillation. OBJECTIVE: To investigate robust methods of predicting defibrillation success in VF cardiac arrest patients, by using a support vector machine (SVM) optimisation approach. METHODS: Frequency-domain (AMSA, dominant frequency and median frequency) and time-domain (slope and RMS amplitude) VF waveform metrics were calculated in a 4.1Y window prior to defibrillation. Conventional prediction test validity of each waveform parameter was conducted and used AUC>0.6 as the criterion for inclusion as a corroborative attribute processed by the SVM classification model. The latter used a Gaussian radial-basis-function (RBF) kernel and the error penalty factor C was fixed to 1. A two-fold cross-validation resampling technique was employed. RESULTS: A total of 41 patients had 115 defibrillation instances. AMSA, slope and RMS waveform metrics performed test validation with AUC>0.6 for predicting termination of VF and return-to-organised rhythm. Predictive accuracy of the optimised SVM design for termination of VF was 81.9% (± 1.24 SD); positive and negative predictivity were respectively 84.3% (± 1.98 SD) and 77.4% (± 1.24 SD); sensitivity and specificity were 87.6% (± 2.69 SD) and 71.6% (± 9.38 SD) respectively. CONCLUSIONS: AMSA, slope and RMS were the best VF waveform frequency-time parameters predictors of termination of VF according to test validity assessment. This a priori can be used for a simplified SVM optimised design that combines the predictive attributes of these VF waveform metrics for improved prediction accuracy and generalisation performance without requiring the definition of any threshold value on waveform metrics.

Fluoroscopic and electrical assessment of a series of defibrillation leads: prevalence of externalized conductors.

INTRODUCTION: Insulation defects with externalized conductors have been reported in the St. Jude Riata(®) family of defibrillation leads (St. Jude Medical, Sylmar, CA, USA). The objective of the Northern Ireland Riata(®) lead screening program was to identify insulation defects and externalized conductors by systematic fluoroscopic and electrical assessment in a prospectively defined cohort of patients. We sought to estimate the prevalence, identify risk factors, and determine the natural history of this abnormality. METHODS: All patients with a Riata(®) lead under follow-up at the Royal Victoria Hospital were invited for fluoroscopic imaging and implantable cardioverter-defibrillator lead parameter checks. Fluoroscopic images were read independently by two cardiologists and the presence of externalized conductors was classified as positive, negative, or borderline. RESULTS: One hundred and sixty-five of 212 patients with a Riata lead were evaluated by fluoroscopy and lead parameter measurements. The mean duration after implantation was 3.98+/-1.43 years. After screening 25 (15%) patients were classified as positive, 137 (83%) negative, and three (1.8%) borderline. Time since implantation (P = 0.001), presence of a single coil lead (P = 0.042), and patient age (P = 0.034) were significantly associated with externalized conductors. The observed rate of externalized conductors was 26.9% for 8-French and 4.7% for 7-French leads. No leads that were identified prospectively with externalized conductors had electrical abnormalities. Seven of 25 (28%) patients had a defective lead extracted by the end of this screening period. CONCLUSION: A significant proportion (15%) of patients with a Riata lead had an insulation breach 4 years after implantation. High-resolution fluoroscopic imaging in at least two orthogonal views is required to identify this abnormality.