Improved diagnostic performance of insertable cardiac monitors by an artificial intelligence-based algorithm.

AIMS: The increasing use of insertable cardiac monitors (ICM) produces a high rate of false positive (FP) diagnoses. Their verification results in a high workload for caregivers. We evaluated the performance of an artificial intelligence (AI)-based ILR-ECG Analyzer™ (ILR-ECG-A). This machine-learning algorithm reclassifies ICM-transmitted events to minimize the rate of FP diagnoses, while preserving device sensitivity. METHODS AND RESULTS: We selected 546 recipients of ICM followed by the Implicity™ monitoring platform. To avoid clusterization, a single episode per ICM abnormal diagnosis (e.g. asystole, bradycardia, atrial tachycardia (AT)/atrial fibrillation (AF), ventricular tachycardia, artefact) was selected per patient, and analyzed by the ILR-ECG-A, applying the same diagnoses as the ICM. All episodes were reviewed by an adjudication committee (AC) and the results were compared. Among 879 episodes classified as abnormal by the ICM, 80 (9.1%) were adjudicated as 'Artefacts', 283 (32.2%) as FP, and 516 (58.7%) as 'abnormal' by the AC. The algorithm reclassified 215 of the 283 FP as normal (76.0%), and confirmed 509 of the 516 episodes as abnormal (98.6%). Seven undiagnosed false negatives were adjudicated as AT or non-specific abnormality. The overall diagnostic specificity was 76.0% and the sensitivity was 98.6%. CONCLUSION: The new AI-based ILR-ECG-A lowered the rate of FP ICM diagnoses significantly while retaining a > 98% sensitivity. This will likely alleviate considerably the clinical burden represented by the review of ICM events.

Active periodic electrograms in remote monitoring of pacemaker recipients: the PREMS study.

AIMS: Remote monitoring (RM) is considered as a standard of care for pacemaker recipients. Remote monitoring systems provide calendar-based intracardiac electrogram recordings (IEGM) only with the current pacemaker settings (passive IEGM). PREMS (Pacemaker Remote Electrogram Monitoring Study), an observational, multicentre trial, prospectively evaluated the clinical value of an active IEGM (aIEGM), including three 10-s sections (passive IEGM, encouraged sensing, and encouraged pacing), compared to other RM data and to its passive IEGM section. Secondary objectives included the added value of the aIEGM to fully assess the sensing and pacing functions of each lead. METHODS AND RESULTS: Patients were enrolled within 3 months after pacemaker implantation and followed until the first transmitted aIEGM, which was analysed together with all other RM data. In total, 567 patients were enrolled (79 ± 9 years, 62% men, 19% single-chamber, and 81% dual-chamber pacemakers). Of 547 aIEGMs transmitted in 547 patients, 161 [29.4%; 95% confidence interval (95% CI) 25.6-33.3%] indicated at least one anomaly non-detectable with certainty-or at all-on other RM data, including atrial arrhythmia, extrasystoles, undersensing, oversensing, and loss of capture. In 21.7% of cases the detected events deserved a corrective action. The sensing and pacing function of each lead could be fully assessed in 77.3% of aIEGM (95% CI 72.6-82.0%) vs. 15.5% (95% CI 11.4-19.6%) when considering only the passive IEGM section (P < 0.001). CONCLUSION: An active IEGM improves the clinical value of remote pacemaker follow-up. Furthermore, compared to a passive IEGM, the aIEGM increases the capability to fully assess remotely the sensing and pacing functions.

Role of medical reaction in management of inappropriate ventricular arrhythmia diagnosis: the inappropriate Therapy and HOme monitoRiNg (THORN) registry.

AIMS: Implantable cardioverter-defibrillators (ICDs) reduce sudden cardiac death in selected patients but inappropriate ICD shocks have been associated with increased mortality. The THORN registry aims to describe the rate of inappropriate ventricular arrhythmia diagnoses and therapies in patients followed by remote monitoring, as well as the following delay to next patient contact (DNPC). METHODS AND RESULTS: One thousand eight hundred and eighty-two patients issued from a large remote monitoring database first implanted with an ICD for primary or secondary prevention in 110 French hospitals from 2007 to 2014 constitute the THORN population. Among them, 504 patients were additionally followed prospectively for evaluation of the DNPC. Eight hundred and ninety-five out of 1551 (58%) patients had ischaemic heart disease and 358/771 (46%) were implanted for secondary prevention. During 13.7 ± 3.4 months of follow-up, the prevalence of first inappropriate diagnosis in a ventricular arrhythmia zone with enabled therapy was 162/1882 (9%). Among those patients, 122/162 (75%) suffered at least one inappropriate therapy and 58/162 (36%) at least one inappropriate shock. Eighty-three out of 162 (51%) of first inappropriate diagnosis occurred during the first 4 months following implantation. The median DNPC was 8 days (interquartile range 1-26). At least one other day with recording of an inappropriate diagnosis of the same cause occurred in 13/43 (30%) of available DNPC periods, with an inappropriate therapy in 7/13 (54%). CONCLUSION: Inappropriate diagnoses occurred in 9% of patients implanted with an ICD during the first 14 months. The DNPC after inadequate ventricular arrhythmia diagnoses remains long in daily practice and should be optimized. CLINICALTRIALS.GOV IDENTIFIER: NCT01594112.

Incidence and predictors of sudden death, major conduction defects and sustained ventricular tachyarrhythmias in 1388 patients with myotonic dystrophy type 1.

AIMS: To describe the incidence and identify predictors of sudden death (SD), major conduction defects and sustained ventricular tachyarrhythmias (VTA) in myotonic dystrophy type 1 (DM1). METHODS AND RESULTS: We retrospectively enrolled 1388 adults with DM1 referred to six French medical centres between January 2000 and October 2013. We confirmed their vital status, classified all deaths, and determined the incidence of major conduction defects requiring permanent pacing and sustained VTA. We searched for predictors of overall survival, SD, major conduction defects, and sustained VTA by Cox regression analysis. Over a median 10-year follow-up, 253 (18.2%) patients died, 39 (3.6%) suddenly. Analysis of the cardiac rhythm at the time of the 39 SD revealed sustained VTA in 9, asystole in 5, complete atrioventricular block in 1 and electromechanical dissociation in two patients. Non-cardiac causes were identified in the five patients with SD who underwent autopsies. Major conduction defects developed in 143 (19.3%) and sustained VTA in 26 (2.3%) patients. By Cox regression analysis, age, family history of SD and left bundle branch block were independent predictors of SD, while age, male sex, electrocardiographic conduction abnormalities, syncope, and atrial fibrillation were independent predictors of major conduction defects; non-sustained VTA was the only predictor of sustained VTA. CONCLUSIONS: SD was a frequent mode of death in DM1, with multiple mechanisms involved. Major conduction defects were by far more frequent than sustained VTA, whose only independent predictor was a personal history of non-sustained VTA. ClinicalTrials.gov no: NCT01136330.

Early Detection and Treatment of Atrial Arrhythmias Alleviates the Arrhythmic Burden in Paced Patients: The SETAM Study.

BACKGROUND: Remote monitoring (RM) can remotely detect atrial tachyarrhythmias (ATAs). The benefit of RM compared to conventional follow-up in the detection and management of ATA was assessed in recipients of dual-chamber pacemakers. METHODS: The multicenter randomized SETAM study enrolled 595 patients in sinus rhythm with a CHA2 DS2 -VASc score ≥2, without ATA history and untreated with antiarrhythmics and antithrombotics, randomly assigned to RM (RM-ON; n = 291) versus ambulatory follow-up (RM-OFF; n = 304) during 12.8 ± 3.3 months. ATA occurrence, burden, and management were analyzed together with adverse clinical events. RESULTS: Patients were 79 ± 8 years old, 63% men, with a CHA2 DS2 -VASc score of 3.7± 1.2. ATA were detected in 83 patients (28%) in the RM-ON versus 66 (22%) in the RM-OFF group (P = 0.06). The median time between the pacemaker implantation and the first treated ATA was 114 days [44; 241] in the RM-ON versus 224 days [67; 366] in the RM-OFF group (hazard ratio [HR] = 0.56; 95% confidence interval [CI]: 0.37-0.86; P = 0.01). Therapies for ATA were initiated in 92 patients and the time to treatment of ATA was shortened by 44% in the RM-ON group (HR = 0.565; 95% CI: 0.37-0.86; P = 0.01). Over the last 4 months of follow-up, the mean ATA burden was alleviated by 4 hours/day (18%) in the RM-ON group. The rate of adverse clinical events was similar in both groups. CONCLUSION: Remotely monitored patients were diagnosed and treated earlier for ATA, and subsequently had a lower ATA burden.

Safety and efficiency of ventricular pacing prevention with an AAI-DDD changeover mode in patients with sinus node disease or atrioventricular block: impact on battery longevity-a sub-study of the ANSWER trial.

AIMS: This ANSWER (EvaluAtioN of the SafeR mode in patients With a dual chambER pacemaker indication) sub-study assesses safety and effectiveness of SafeR™ and the impact of ventricular pacing (VP) prevention on anticipated device longevity and replacement rate. METHODS AND RESULTS: Patients implanted for atrioventricular block (AVB, n = 310) or sinus node dysfunction (SND, n = 336) were randomly assigned to SafeR (n = 314) or DDD (n = 318) and followed for 36 months. Safety, median VP, estimated device longevity (mean difference, 95% confidence interval [CI]), and anticipated replacement rates were analysed by pacing mode and implant indication. No difference in mortality, syncope, or mode intolerance was observed between randomization groups regardless of the indication. Ventricular pacing on SafeR vs. DDD was 11.5 vs. 93.6% in the overall population (P < 0.001), 89.2 vs. 83.8% in permanent AVB (P = 0.944), 53.5 vs. 98.2% in intermittent AVB (P < 0.001), and 2.2 vs. 84.7% in SND (P < 0.001). Anticipated median device longevity increased on SafeR by 14 [Q1 10; Q3 17] months [10; 17] (P < 0.001) in the overall population, 9 months [-5; 22] (P = 0.193) in permanent AVB, 14 months [8; 19] (P < 0.001) in intermittent AVB, and 14 months [9; 19] (P < 0.001) in SND. In intermittent AVB and SND, prolonged estimated battery longevity translated into the prevention of one anticipated replacement in at least 23% of patients. CONCLUSION: SafeR was effective in reducing VP in intermittent AVB and in SND. No effect was observed in permanent AVB. No safety issue was observed. Ventricular pacing reduction by SafeR translated into relevant estimated prolongation of device longevity and anticipated reduction of required replacements.

Comparison of a radiofrequency powered flexible needle with a classic rigid Brockenbrough needle for transseptal punctures in terms of safety and efficacy.

INTRODUCTION: This study aimed to evaluate the safety and efficacy of utilising an innovative radiofrequency (RF) powered flexible needle to achieve transseptal puncture (TSP). METHODS AND RESULTS: A RF powered flexible needle (Toronto catheter, Baylis Medical Company Inc.) associated with a stiffer dilator (Torflex Superstrong, Baylis Medical Company Inc.) was used in 125 consecutive patients referred for left sided ablations (mean age=55.6, male=86.5%) and compared with a standard transseptal set (BRK needle, SL0 sheath and dilator, St Jude Medical, Inc.) used in the previous 100 patients (mean age=56, male 82%). TSP was achieved in 95/100 patients in the Brockenbrough group and in all 125 patients in the Toronto group (p=0.01) despite an equivalent proportion of difficult situations (8 and 9% respectively) and patients with a prior TSP (17% vs 24%). 7/100 needle related events (failure, aborted attempt or pericardial effusion) occurred in the Brockenbrough group and none in the Toronto group (p=0.01). The Toronto needle crossed the septum at the first attempt in 123/125 (98.4%) patients and the Brockenbrough needle in 84/95 (88%) patients (p<0.001). CONCLUSION: Our data suggest that the Toronto RF powered flexible needle is safer and more efficient than a standard Brockenbrough needle and can be used not only in difficult situations but routinely to achieve TSP.

Using technology to improve reconnection to remote monitoring in cardiac implantable electronic device patients.

Background: Remote monitoring (RM) of cardiac implantable electronic device (CIED) patients is now considered standard of care. However, a fundamental requirement of RM is continuous connectivity between the patient's implanted device and the CIED manufacturer's central server. This study examined the rate of RM disconnections in CIED recipients and the impact of short message service (SMS) to facilitate reconnections. Methods: Using a platform that collects RM data from CIED manufacturers, we retrospectively examined the disconnection and reconnection events in 6085 patients from 20 medical centers. Each medical center reported their usual practice regarding RM disconnections, which consisted of either an automatic SMS from the platform to patients who were disconnected for 2 weeks or the standard of care (SC) of a phone call to patients. Results: During a 1-year period, 43% of patients had at least 1 disconnection. Half of these patients experienced multiple disconnections. The use of SMS reduced the time to reconnection by 43% in comparison to SC. The median time to reconnect a disconnected patient was 11.0 [3.2, 29.0] days for SC vs 6.3 [1.3, 22.0] days for SMS (P < .0001). Furthermore, there was a high rate of reconnections within the first 48 hours of the SMS message, which was nearly double that in the SC arm. Conclusion: This study demonstrates the feasibility of an automatic system to deliver an SMS to patients with a disconnected CIED to facilitate early reconnection to RM.

CRT-D replacement strategy: results of the BioCONTINUE study.

BACKGROUND: In patients with cardiac resynchronization therapy defibrillators (CRT-Ds), the need for implantable cardioverter-defibrillator (ICD) back-up may be questionable at time of CRT-D replacement (REP) if ICD implant criteria are no longer met due to an improved left ventricular ejection fraction (LVEF) and if no major ventricular arrhythmic event (VAE) occurred during the CRT-D lifetime. The aim of our study was to assess the relevance of ICD back-up and predictors of VAE after REP in primary prevention CRT-D patients. METHODS: The prospective, observational, international BioCONTINUE study investigated the rate of patients with at least 1 sustained VAE (sVAE) post-REP and searched for predictive factors of sVAE. RESULTS: Two hundred seventy-six patients (70 ± 10 years, 77% men, mean LVEF 40.6 ± 12.6%) were followed for 28.4 ± 10.2 months. The rate of patients with sVAE was 8.3%, 10.3%, and 21.2% at 1, 2, and 4 years post-REP. Patients without persistent ICD indication at REP still had a sVAE rate of 5.7% (95% CI 2.3-11.5%) at 2 years. In multivariate analysis, predictive factors of subsequent sVAE were (i) persistent ICD indication (hazard ratio (HR) 3.6; 95% CI 1.6-8.3; p = 0.003); (ii) 64-72 years of age as compared to ≥ 79 years (HR 3.7; 95% CI 1.4-9.7; p = 0.008); and (iii) ischemic heart disease (HR 4.4; 95% CI 2.1-9.3; p < 0.0001). CONCLUSIONS: The risk of sVAE (21.2% at 4 years post-REP) depends on age, ischemic heart disease, and ICD indication at the time of REP. A non-trivial risk of sVAE remains in patients without persistent ICD indication. CLINICAL TRIAL REGISTRATION: NCT02323503.

Filtering of remote monitoring alerts transmitted by cardiac implantable electronic devices and reclassification of atrial fibrillation events by a new algorithm.

Background: Cardiac implantable electronic devices (CIEDs) are an important means of atrial fibrillation (AF) detection. However, the AF burden measurements and notifications transmitted by CIEDs are not directly related to the clinical classification of paroxysmal, persistent, or permanent AF. Moreover, AF alerts are the most frequent form of notification, imposing a time-consuming review on caregivers. Objective: The purpose of this study was to compare the incidence of standard AF burden-related notifications in remotely monitored (RM) patients with the incidence of events detected after filtering by a new proprietary algorithm implementing the standard European Society of Cardiology classification of AF. Methods: Between 2017 and 2022, all RM patients with daily AF burden measurements available for ≥30 days and ≥1 AF burden-related alerts were enrolled at 68 medical centers. The incidence of CIED-transmitted alerts was compared to that of AF episodes detected by a new proprietary algorithm and classified as "first recorded episode of AF", "paroxysmal AF", "increased paroxysmal AF", "persistent AF", or "end of persistent AF back to paroxysmal AF or back to sinus rhythm." Results: Between January 2017 and September 2022, this retrospective study analyzed data from 4162 recipients of an Abbott, Biotronik, Boston Scientific, or Medtronic CIED, RM over mean follow-up of 605 ± 386 days. The algorithm broke down 67,883 AF burden-related alerts into 9728 (14.3%) clinically relevant AF events. Conclusion: A new AF alert algorithm successfully identified clinically significant AF events in RM CIED recipients and would markedly limit the total number of transmitted alerts that require review by caregivers.

Electrophysiological study with prophylactic pacing and survival in adults with myotonic dystrophy and conduction system disease.

CONTEXT: Up to one-third of patients with myotonic dystrophy type 1 die suddenly. Thus far, no intervention has effectively prevented sudden death. OBJECTIVE: To determine whether an invasive strategy based on systematic electrophysiological studies and prophylactic permanent pacing is associated with longer survival in patients presenting with myotonic dystrophy type 1 and major infranodal conduction delays than a noninvasive strategy. DESIGN, SETTING, AND PATIENTS: A retrospective study, the DM1 Heart Registry included 914 consecutive patients older than 18 years with genetically confirmed myotonic dystrophy type 1 who were admitted to the Neurological Unit of the Myology Institute of Pitié-Salpêtrière Hospital, a teaching medical center in Paris, France, between January 2000 and December 2009. INTERVENTIONS: Among 486 patients whose electrocardiogram showed a PR interval greater than 200 milliseconds, a QRS duration greater than 100 milliseconds, or both, the outcome of 341 (70.2%) who underwent an invasive strategy was compared with 145 (29.8%) who underwent a noninvasive strategy. A propensity score risk adjustment and propensity-based matching analysis was used to account for selection biases. MAIN OUTCOME MEASURES: Rates of overall survival (main outcome measure) and sudden death, respiratory death, and other deaths (secondary outcome measures). RESULTS: Over a median follow-up of 7.4 years (range, 0-9.9 years), 50 patients died in the invasive strategy group and 30 died in the noninvasive strategy group (hazard ratio [HR], 0.74 [95 CI, 0.47-1.16]; P = .19), corresponding to an overall 9-year survival of 74.4% (95% CI, 69.2%-79.9%). Regardless of the technique used to adjust for between-group differences in baseline characteristics, the invasive strategy was associated with a longer survival, with adjusted HRs ranging from 0.47 (95% CI, 0.26-0.84; P = .01) for a covariate-adjusted analysis of propensity-matched data to 0.61 (95% CI, 0.38-0.99; P = .047) for an analysis adjusted for propensity score quintiles. The survival difference was largely attributable to a lower incidence of sudden death, which occurred in 10 patients in the invasive strategy group and in 16 patients in the noninvasive strategy group, with HRs ranging from 0.24 (95% CI, 0.10-0.56; P = .001) for an analysis adjusted for propensity score quintiles and covariates to 0.28 (95% CI, 0.13-0.61; P = .001) for an unadjusted analysis of propensity-matched data. CONCLUSION: Among patients with myotonic dystrophy type 1, an invasive strategy was associated with a higher rate of 9-year survival than a noninvasive strategy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01136330.

A Visual Approach to Measure Cloth-Body and Cloth-Cloth Friction.

Measuring contact friction in soft-bodies usually requires a specialised physics bench and a tedious acquisition protocol. This makes the prospect of a purely non-invasive, video-based measurement technique particularly attractive. Previous works have shown that such a video-based estimation is feasible for material parameters using deep learning, but this has never been applied to the friction estimation problem which results in even more subtle visual variations. Because acquiring a large dataset for this problem is impractical, generating it from simulation is the obvious alternative. However, this requires the use of a frictional contact simulator whose results are not only visually plausible, but physically-correct enough to match observations made at the macroscopic scale. In this paper, which is an extended version of our former work A. H. Rasheed, V. Romero, F. Bertails-Descoubes, S. Wuhrer, J.-S. Franco, and A Lazarus, "Learning to measure the static friction coefficient in cloth contact," in Proc. IEEE/CVF Conf. Comput. Vis. Pattern Recognit., 2020, pp. 9909-9918, we propose to our knowledge the first non-invasive measurement network and adjoining synthetic training dataset for estimating cloth friction at contact, for both cloth-hard body and cloth-cloth contacts. To this end we build a protocol for validating and calibrating a state-of-the-art frictional contact simulator, in order to produce a reliable dataset. We furthermore show that without our careful calibration procedure, the training fails to provide accurate estimation results on real data. We present extensive results on a large acquired test set of several hundred real video sequences of cloth in friction, which validates the proposed protocol and its accuracy.

Implantable cardioverter-defibrillators in France: practices and regional variability.

AIMS: The rates of cardiac defibrillator implantation (ICD) in Europe and within countries are heterogeneous. We examined the characteristics of ICD recipients and device implantation rates in France, with the goal of identifying patterns and regional differences in medical practices. METHODS AND RESULTS: We compiled the information available on devices and patients from a manufacturer's database for the years 2008 and 2009 and the Stidefix national registry from January 2008 to April 2010 and reported the descriptive statistics and comparisons of implantation practices among regions. We analysed data from 10 766 patients enrolled in Stidefix (mean age=63 ± 13 years; 83% men) after implantation of single-chamber (24%), dual-chamber (33%), or triple-chamber (43%) ICD. Implantation was for primary prevention in 63% of patients. Between 2008 and 2009, the national implant rate increased from 126 to 147 per million inhabitants, with regional variations related to the number of cardiologists and of implant centres. Patients were significantly older and more likely to undergo implantation for primary prevention or for cardiac resynchronization therapy (CRT) in higher-volume regions. In Ile de France (Paris and its suburbs), patients tended to be younger, as in low-implantation regions, but with a high rate of CRT implants, as in high-implantation regions. A comparison of the Stidefix data with the manufacturer's database revealed that only 57% of all ICD implanted in 2009 were reported to Stidefix. CONCLUSION: Despite an increasing rate of ICD implantation in France, important regional disparities persist, with a median position occupied by Ile de France.

Effect of non-ideal clamping shape on the resonance frequencies of silicon nanocantilevers.

In this paper, we investigate the effects of non-ideal clamping shapes on the dynamic behavior of silicon nanocantilevers. We fabricated silicon nanocantilevers using silicon on insulator (SOI) wafers by employing stepper ultraviolet (UV) lithography, which permits a resolution of under 100 nm. The nanocantilevers were driven by electrostatic force inside a scanning electron microscope (SEM). Both lateral and out-of-plane resonance frequencies were visually detected with the SEM. Next, we discuss overhanging of the cantilever support and curvature at the clamping point in the silicon nanocantilevers, which generally arises in the fabrication process. We found that the fundamental out-of-plane frequency of a realistically clamped cantilever is always lower than that for a perfectly clamped cantilever, and depends on the cantilever width and the geometry of the clamping point structure. Using simulation with the finite-elements method, we demonstrate that this discrepancy is attributed to the particular geometry of the clamping point (non-zero joining curvatures and a flexible overhanging) that is obtained in the fabrication process. The influence of the material orthotropy is also investigated and is shown to be negligible.

Leadless intracardiac transcatheter pacing system: 20 months follow up in adult Duchenne muscular dystrophy.

Duchenne muscular dystrophy (DMD) is an X-linked muscular dystrophy in relation with dystrophin deficient. Heart and respiratory function are classically involved and affect long-term prognosis. Significant atrio-ventricular block may occur in some patients. Implantation of traditional pacemaker may be challenging in patients with tracheotomy and on permanent home mechanical ventilation. We report the first case of a successful leadless intra-cardiac trans-catheter pacing system implantation in an adult DMD on wheelchair and on permanent home mechanical ventilation.

Use of a radiofrequency guidewire to simplify workflow for left atrium access: a case series.

PURPOSE: Transseptal puncture (TSP) is widely used in catheter-based cardiac procedures to gain left atrial access, but its workflow has remained largely unchanged in the last 50 years. This study evaluated the safety and efficacy of a novel, simplified technique for TSP with a radiofrequency (RF)-powered guidewire that eliminates multiple exchanges required with standard needles. METHODS: TSP was performed in 84 patients undergoing left-sided procedures (72 atrial fibrillation ablations [32 RF, 40 cryoballoon], 4 atrial tachycardia ablations, 2 ventricular arrhythmia ablations, 6 left atrial appendage closure) utilizing a stiff, exchange length RF guidewire. Under fluoroscopic and echocardiographic guidance, the RF guidewire was used to facilitate septal puncture with RF energy and provide a rail for advancing catheters to the left atrium without exchange. All procedures were performed under general anesthesia or sedation. RESULTS: TSP was achieved in all patients with no complications. The RF guidewire allowed catheters to be tracked back up to the superior vena cava without exchange in cases where another dropdown was desired to locate a preferred puncture site. The stiffness of the wire provided adequate support to advance all sheaths to the left side regardless of outer diameter. CONCLUSION: TSP was performed safely and successfully for various left heart procedures with a RF guidewire that served as an RF transseptal device and a stiff guidewire. This allowed for a more efficient and potentially safer technique without the need for re-wiring or an over the wire sheath exchange. This provides substantial savings in both time and materials.

Risk factors related to infections of implanted pacemakers and cardioverter-defibrillators: results of a large prospective study.

BACKGROUND: The Prospective Evaluation of Pacemaker Lead Endocarditis study is a multicenter, prospective survey of the incidence and risk factors of infectious complications after implantation of pacemakers and cardioverter-defibrillators. METHODS AND RESULTS: Between January 1, 2000, and December 31, 2000, 6319 consecutive recipients of implantable systems were enrolled at 44 medical centers and followed up for 12 months. All infectious complications were recorded, and their occurrence was related to the baseline demographic, clinical, and procedural characteristics. Among 5866 pacing systems, 3789 included 2 and 117 had >2 leads; among 453 implantable cardioverter-defibrillators, 178 were dual-lead systems. A total of 4461 de novo implantations occurred and 1858 pulse generator or lead replacements. Reinterventions were performed before hospital discharge in 101 patients. Single- and multiple-variable logistic regression analyses were performed to identify risk factors; adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were calculated. At 12 months, device-related infections were reported in 42 patients (0.68%; 95% CI, 0.47 to 0.89). The occurrence of infection was positively correlated with fever within 24 hours before the implantation procedure (aOR, 5.83; 95% CI, 2.00 to 16.98), use of temporary pacing before the implantation procedure (aOR, 2.46; 95% CI, 1.09 to 5.13), and early reinterventions (aOR, 15.04; 95% CI, 6.7 to 33.73). Implantation of a new system (aOR, 0.46; 95% CI, 0.24 to 0.87) and antibiotic prophylaxis (aOR, 0.4; 95% CI, 0.18 to 0.86) were negatively correlated with risk of infection. CONCLUSIONS: This study identified several factors of risk of device infection and confirmed the efficacy of antibiotic prophylaxis in recipients of new or replacement pacemakers or implantable cardioverter-defibrillators.

Bending transition in the penetration of a flexible intruder in a two-dimensional dense granular medium.

We study the quasistatic penetration of a flexible beam into a two-dimensional dense granular medium lying on a horizontal plate. Rather than a buckling-like behavior we observe a transition between a regime of crack-like penetration in which the fiber only shows small fluctuations around a stable straight geometry and a bending regime in which the fiber fully bends and advances through series of loading and unloading steps. We show that the shape reconfiguration of the fiber is controlled by a single nondimensional parameter L/L_{c}, which is the ratio of the length of the flexible beam L to L_{c}, a bending elastogranular length scale that depends on the rigidity of the fiber and on the departure from the jamming packing fraction of the granular medium. We show, moreover, that the dynamics of the bending transition in the course of the penetration experiment is gradual and is accompanied by a symmetry breaking of the granular packing fraction in the vicinity of the fiber. Together with the progressive bending of the fiber, a cavity grows downstream of the fiber and the accumulation of grains upstream of the fiber leads to the development of a jammed cluster of grains. We discuss our experimental results in the framework of a simple model of bending-induced compaction and we show that the rate of the bending transition only depends on the control parameter L/L_{c}.

Inverse design of an isotropic suspended Kirchhoff rod: theoretical and numerical results on the uniqueness of the natural shape.

Solving the equations for Kirchhoff elastic rods has been widely explored for decades in mathematics, physics and computer science, with significant applications in the modelling of thin flexible structures such as DNA, hair or climbing plants. As demonstrated in previous experimental and theoretical studies, the natural curvature plays an important role in the equilibrium shape of a Kirchhoff rod, even in the simple case where the rod is isotropic and suspended under gravity. In this paper, we investigate the reverse problem: can we characterize the natural curvature of a suspended isotropic rod, given an equilibrium curve? We prove that although there exists an infinite number of natural curvatures that are compatible with the prescribed equilibrium, they are all equivalent in the sense that they correspond to a unique natural shape for the rod. This natural shape can be computed efficiently by solving in sequence three linear initial value problems, starting from any framing of the input curve. We provide several numerical experiments to illustrate this uniqueness result, and finally discuss its potential impact on non-invasive parameter estimation and inverse design of thin elastic rods.