New atrial arrhythmia occurrence in single chamber implantable cardioverter defibrillator patients: A real-world investigation.

INTRODUCTION: A current limitation of single chamber implantable cardioverter defibrillators (ICDs) is the lack of an atrial lead to reliably detect atrial fibrillation (AF) episodes. A novel ventricular based atrial fibrillation (VBAF) detection algorithm was created for single chamber ICDs to assess R-R variability for detection of AF. METHODS: Patients implanted with Visia AF™ ICDs were prospectively enrolled in the Medtronic Product Surveillance Registry from December 15, 2015 to January 23, 2019 and followed with at least 30 days of monitoring with the algorithm. Time to device-detected daily burden of AF ≥ 6 min, ≥6 h, and ≥23 h were reported. Clinical actions after device-detected AF were recorded. RESULTS: A total of 291 patients were enrolled with a mean follow-up of 22.5 ± 7.9 months. Of these, 212 (73%) had no prior history of AF at device implant. However, 38% of these individuals had AF detected with the VBAF algorithm with daily burden of ≥6 min within two years of implant. In these 80 patients with newly detected AF by their ICD, 23 (29%) had a confirmed clinical diagnosis of AF by their provider. Of patients with a clinical diagnosis of AF, nine (39%) were newly placed on anticoagulation, including five of five (100%) patients having a burden >23 h. CONCLUSIONS: Continuous AF monitoring with the new VBAF algorithm permits early identification and actionable treatment for patients with undiagnosed AF that may improve patient outcomes.

Safety and Performance of the Micra VR Leadless Pacemaker in a Japanese Cohort　- Comparison With Global Studies.

BACKGROUND: The Micra leadless pacemaker has demonstrated favorable outcomes in global trials, but its real-world performance and safety in a Japan-specific population is unknown.Methods and Results: Micra Acute Performance (MAP) Japan enrolled 300 patients undergoing Micra VR leadless pacemaker implantation in 15 centers. The primary endpoint was the acute (30-day) major complication rate. The 30-day and 6-month major complication rates were compared to global Micra studies. All patients underwent successful implantation with an average follow-up of 7.23±2.83 months. Compared with previous Micra studies, Japanese patients were older, smaller, more frequently female, and had a higher pericardial effusion risk score. 11 acute major complications were reported in 10 patients for an acute complication rate of 3.33% (95% confidence interval: 1.61-6.04%), which was in line with global Micra trials. Pericardial effusion occurred in 4 patients (1.33%; 3 major, 1 minor). No procedure or device-related deaths occurred. Frailty significantly improved from baseline to follow-up as assessed by Japan Cardiovascular Health Study criteria. CONCLUSIONS: In a Japanese cohort, implantation of the Micra leadless pacemaker had a high success rate and low major complication rate. Despite the Japan cohort being older, smaller, and at higher risk, the safety and performance was in line with global Micra trials.

Prospective, Randomized Study of Direct Anterior Approach vs Posterolateral Approach Total Hip Arthroplasty: A Concise 5-Year Follow-Up Evaluation.

BACKGROUND: Interest in direct anterior approach (DAA) has increased over the last decade. In our previously published study comparing DAA to posterolateral approach (PA), early 3-month benefits were noted in terms of pain and function. There was no difference noted at 6 or 12 months. This study reports average 5-year follow-up of our original study. METHODS: Originally there were 43 DAA patients and 44 PA patients. At an average 5-year follow-up, patients were evaluated clinically with a University of California at Los Angeles activity score, Harris hip score, and Hip Disability and Osteoarthritis Outcome Score Jr Survivorship analysis was calculated. Radiographs were evaluated for loosening and evidence of radiolucent lines. RESULTS: There were 2 deaths 1 in each group, neither was related to the implant or procedure. Four patients were lost to follow-up: 2 in the DAA group and 2 in the PA group. There was no statistical difference between surgical approaches in terms of Harris hip score, University of California at Los Angeles activity score, and Hip Disability and Osteoarthritis Outcome Score Jr. The 7-year survivorship was not significantly different. There were no loose implants at average 5-year follow-up. CONCLUSION: Both DAA and PA yield good results at an average 5-year follow-up in terms of survivorship, function, rate of complications, and radiographic analysis.

3D Orientational Control in Self-Assembled Thin Films with Sub-5 nm Features by Light.

While self-assembled molecular building blocks could lead to many next-generation functional organic nanomaterials, control over the thin-film morphologies to yield monolithic sub-5 nm patterns with 3D orientational control at macroscopic length scales remains a grand challenge. A series of photoresponsive hybrid oligo(dimethylsiloxane) liquid crystals that form periodic cylindrical nanostructures with periodicities between 3.8 and 5.1 nm is studied. The liquid crystals can be aligned in-plane by exposure to actinic linearly polarized light and out-of-plane by exposure to actinic unpolarized light. The photoalignment is most efficient when performed just under the clearing point of the liquid crystal, at which the cylindrical nanostructures are reoriented within minutes. These results allow the generation of highly ordered sub-5 nm patterns in thin films at macroscopic length scales, with control over the orientation in a noncontact fashion.

Surface Micropatterning of Uniaxially Oriented Polyethylene Films Using Interference Holography for Strain Sensors.

A new procedure is presented for direct generation of surface micropatterns on uniaxially oriented polyethylene (PE) films using interference holography with a nanosecond pulsed laser. An ultraviolet absorber, 2-(2H-benzotriazol-2-yl)-4,6-di-tert-pentylphenol (BZT) is incorporated into PE prior to stretching to generate absorption at the wavelength of the laser. Illumination with an interference pattern in the absorption band of BZT leads to an obvious height variation in the exposed regions and consequently relief gratings are generated. The height in the exposed regions is strongly dependent on the angle between the grating direction and the film orientation direction. This phenomenon is attributed to a combination of events such as melting, entropic contraction, recrystallization, thermal evaporation of BZT, and anisotropic thermal conductivity. It is shown that the relief height increases with increasing BZT concentration and exhibits a linear dependence on the energy dose above a certain threshold. Additionally, the oriented PE films with the surface micropatterns are explored for strain sensors. The results demonstrate that small strains below 10% are monitored accurately in tensile deformation of the micropatterned, oriented PE films which makes these films potentially useful as strain sensors.

Exploring spatio-temporal changes in coastal recreational fisheries and potential links to extreme weather events.

Extreme weather events across coastal environments are expected to increase in frequency under predicted climate change scenarios. These events can impact coastal recreational fisheries and their supporting ecosystems by influencing the productivity of fish stocks or altering behaviours and decision-making among fishers. Using off-site telephone/diary survey data on estuarine and oceanic recreational fishing activity in eastern Australia, we analyse interannual and geographic variability in bream (Acanthopagrus spp) and snapper (Chrysophrys auratus) catch, total effort and total catch per unit effort (CPUE) through a period (2013/2014, 2017/2018 and 2019/2020) that encompassed severe drought, bushfires and flooding. Interacting spatial and temporal differences were detected for bream and may reflect spatial variation in the intensity and extent of some of the extreme weather events. The catch of snapper did not change temporally, providing little evidence that this species' catch may be influenced by the extreme weather events. Independent bioregional and temporal effects on effort were detected, while CPUE only showed significant bioregional differences. Although adverse conditions created by the extreme weather events may have dissuaded fisher participation and impacted effort, we propose that the observed temporal patterns in effort reflect the early influence of socio-economic changes brought on by the COVID-19 pandemic on coastal recreational fishing, over and above the impacts of extreme weather events. This study demonstrates how interrelated ecological, social and economic factors can shape coastal recreational fisheries and facilitates development of management strategies to address future threats to the sector.

Clinical and kinematic outcomes of a rotating platform posterior stabilized total knee system.

Early post-operative clinical outcomes were analyzed for subjects having a rotating platform (RP) posterior stabilized (PS) total knee arthroplasty (TKA); a subset of which underwent in vivo kinematics and produced kinematic results that compare well with subjects in previous fluoroscopic studies that were deemed excellent in nature. In total, 153 subjects (180 knees) were enrolled in the prospective clinical study. TKAs were performed by three surgeons at three North American centers. Ten subjects were randomly chosen and evaluated under fluoroscopic surveillance. Average active flexion increased from 113.3 (SD=16.6) degrees before surgery to 118.3 (SD=9.9) degrees 12-months post-operatively. American Knee Society (AKS) function score increased from an average of 57.6 (SD=18.8) points pre-operatively to 85.3 (SD=16.6) points 12-months post-operatively. For the kinematic subset, post-operative weight-bearing flexion was 115.9 (SD=8.4),while subjects achieved an average posterior femoral rollback of their lateral condyle of -5.4mm. The average femorotibial axial rotation from full extension to maximum weight-bearing flexion was 3.9 degrees (SD=3.9). Certain kinematic parameters were deemed statistically significant when determining early post-operative clinical success.

Effect of implant design on knee flexion.

From March 2006 to August 2008, 93 subjects (186 knees) underwent simultaneous bilateral total knee arthroplasty performed by eight surgeons at North American centers. This randomized study was conducted to determine whether non-weight-bearing passive flexion was superior for knees receiving a posterior stabilized high flexion device compared to a posterior stabilized standard device in the contra-lateral knee. Weight-bearing single leg active flexion was one secondary endpoint. Follow-up compliance was 92.5%. Results show small, but significant superiority in the motion metrics for the high flexion device compared to the standard device 12 months after surgery, especially for a subgroup of patients with pre-operative flexion less than 120° in both knees. Thus, the ideal candidate for the high flexion device may be one with lesser pre-operative flexion.

Density doubling of block copolymer templated features.

Block copolymers can be used to template large arrays of nanopatterns with periodicities equal to the characteristic spacing of the polymer. Here we demonstrate a technique capitalizing on the multilayered arrangement of cylindrical domains to effectively double the pattern density templated by a given polymer. By controlling the initial thickness of the film and the solvent annealing conditions, it was possible to reproducibly create density doubled lines by swelling the film with solvent until bilayers of horizontal cylinders were obtained. This process was also demonstrated to be compatible with graphoepitaxy.

Subglottic secretion drainage for preventing ventilator associated pneumonia: a meta-analysis.

BACKGROUND: Ventilator associated pneumonia (VAP) in the intensive care unit (ICU) has been shown to be associated with significant morbidity and mortality.(1-3) It has been reported to affect between 9 and 27% of intubated patients receiving mechanical ventilation.(4-6) OBJECTIVE: A meta-analysis was undertaken to combine information from published studies of the effect of subglottic drainage of secretions on the incidence of ventilated associated pneumonia in adult ICU patients. DATA SOURCES: Studies were identified by searching MEDLINE (1966 to January 2011), EMBASE (1980-2011), and CINAHL (1982 to January 2011). REVIEW METHODS: Randomized trials of subglottic drainage of secretions compared to usual care in adult mechanically ventilated ICU patients were included in the meta-analysis. RESULTS: Subglottic drainage of secretions was estimated to reduced the risk of VAP by 48% (fixed-effect relative risk (RR)=0.52, 95% confidence interval (CI), 0.42-0.65). When comparing subglottic drainage and control groups, the summary relative risk for ICU mortality was 1.05 (95% CI, 0.86-1.28) and for hospital mortality was 0.96 (95% CI, 0.81-1.12). Overall subglottic drainage effect on days of mechanical ventilation was -1.04 days (95% CI, -2.79-0.71). CONCLUSION: This meta-analysis of published randomized control trials shows that almost one-half of cases of VAP may be prevented with the use of specialized endotracheal tubes designed to drain subglottic secretions. Time on mechanical ventilation may be reduced and time to development of VAP may be increased, but no reduction in ICU or hospital mortality has been observed in published trials.

Short- and Long-Term Risk of Lead Dislodgement Events: Real-World Experience From Product Surveillance Registry.

BACKGROUND: Lead dislodgement (LD) has been one of the most common early complications after cardiovascular implantable electronic device implant. However, limited data are available on the clinical characteristics and long-term outcomes of LD events. The aim of this study was to examine the risk factors, clinical significance, and management strategies of LD events after cardiovascular implantable electronic device implant. METHODS: This study was a retrospective cohort analysis of 20 683 patients who underwent cardiovascular implantable electronic device implant between January 1, 2010 and January 31, 2020 in Medtronic's Product Surveillance Registry, with a mean follow-up time of 3.3±2.5 SD years. The study population was divided into 2 groups: group A with LD events (N=350) and group B without LD events (N=20 333). RESULTS: During this period, 350 patients (1.69%) had LD events involving 371 leads (0.95%), among a total of 39 060 leads implanted. Passive fixation type (right atrium pacing lead, P=0.041), lower sensing amplitude (right ventricle defibrillating lead, P=0.020), and lower lead impedance at implant (right atrium pacing lead, P=0.009) were associated with increased LD risk. Multivariate analysis showed female sex (hazard ratio, 1.520, P=0.008) and higher body mass index (hazard ratio, 1.012, P=0.001) were independently associated with increased risk of LD events. LD events were not associated with significant changes in the long-term risks of cardiac and overall mortality. In group A, repositioning the dislodged leads increased the risk of a second LD event compared with implanting new leads (P=0.012). CONCLUSIONS: Female sex and higher body mass index were associated with higher risk of LD events in the Product Surveillance Registry. Among patients with dislodged leads, implanting new leads was associated with lower risk of future LD events. Further studies on how to reduce LD risk and to improve management of these events are needed. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01524276.

THA with Delta ceramic on ceramic: results of a multicenter investigational device exemption trial.

UNLABELLED: Although the published studies on the outcomes of total hip arthroplasty (THA) performed with currently available ceramic components show high survivorship and low bearing wear at midterm followup, concern over ceramic fracture and squeaking persist. For these reasons, the use of ceramic is limited. Recently, a new alumina matrix composite material (Delta ceramic) with improved material properties was developed to address these concerns. We report the early outcomes and complications of a prospective, randomized, multicenter trial of 263 patients (264 hips) at eight centers, comparing a Delta ceramic-on-ceramic (COC) articulation with a Delta ceramic head-crosslinked polyethylene bearing combination (COP). There were 177 COC hips and 87 COP hips. Complications were reported for all patients, whereas clinical and radiographic results were provided for the 233 patients with minimum 2-year followup (average, 31.2 months; range, 21-49 months). The Harris hip scores and clinical, radiographic, and survivorship outcomes were similar in both groups. There were four (2%) revisions in the COC group and two (2%) in the COP group. We encountered three intraoperative ceramic liner-related events. In addition, one patient receiving the COC underwent revision for chipping of the ceramic liner, and a second had ceramic fragmentation on followup radiographs but has not undergone revision. These liner related complications remain a concern. No patient reported squeaking in either group; this leaves us hopeful the new material will lessen the frequency of squeaking. In the short term, the Delta COC articulation provided similar functional scores and survivorship and complication rates with the ceramic head mated with crosslinked polyethylene. LEVEL OF EVIDENCE: Level I, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

On the nature of DNA self-assembled monolayers on Au: measuring surface heterogeneity with electrochemical in situ fluorescence microscopy.

The creation of gold surfaces modified by single- or double-stranded DNA self-assembled monolayers (SAMs) is shown to produce heterogeneous surface packing densities through the use of electrochemical studies coupled with fluorescence imaging. The modified surfaces created by direct adsorption of thiolate DNA [followed by passivation with mecaptohexanol (MCH)] resulted in regions covered by a monolayer of DNA SAM and other regions that were coated by large particles of DNA. The difference in fluorescence intensity measured from these regions was dramatic. More importantly, a regional variance in fluorescence intensity in response to electrochemical potential was observed: the large aggregates showing a significantly different modulation of fluorescence intensity than the monolayer-coated regions. Electrochemical desorption and detection of the fluorescently tagged DNA provided clear evidence of a complete surface modification. These studies have implications for biosensor/biochip development using DNA SAMs. A modification in the method used to produce the DNA SAMs resulted in a significantly different surface with much fewer aggregates and more significant electromodulation of the fluorescence intensity, though at much lower DNA surface density (ca. 1% of maximum theoretical coverage). This method for forming the modified surfaces has clear advantages over the currently accepted practice and emphasizes the importance of studying the nonaveraged nature of the sensor surface using in situ imaging tools like electrofluorescence microscopy.

Long-term results of the DelIVery for Pulmonary Arterial Hypertension trial.

BACKGROUND: The DelIVery for Pulmonary Arterial Hypertension clinical trial was a multi-center, prospective, single arm, Investigational Device Exemption study utilizing a fully implantable, programmable intravascular delivery system consisting of a pump and a catheter for intravenous treprostinil. The study met its primary endpoint and demonstrated that the intravascular delivery system significantly reduced catheter related complications at 22,000 subject-days of follow-up compared with a predefined objective performance criterion. Here we summarize the results obtained during a 6.4-year follow-up period. METHODS: Throughout study follow-up, participants had clinic visits and medication refills at least every 12 weeks (dependent on the subjects' dose). All adverse events and intravascular delivery system complications were evaluated and recorded. RESULTS: Sixty pulmonary arterial hypertension subjects were followed post device implantation for approximately 282 patient-years (range 87 days to 6.4 years). Of the 60 subjects, 14 died (1 related to intravascular delivery system pump failure), 2 withdrew after lung transplants, and 2 withdrew due to pump pocket infection. No catheter-related bloodstream infections, catheter thrombosis or occlusions, or catheter kinks occurred through 282 patient-years. Two participants had adverse events of abdominal pain, rash, due to subcutaneous treprostinil "leaks" after one catheter puncture and one catheter laceration during pump refill and replacement, respectively. Eight pump failure events occurred: seven pump motor stalls and one early replacement (faulty battery). CONCLUSION: Delivery of treprostinil with an intravascular delivery system is a safe alternative to an external delivery system, while providing enhanced life experiences. To preserve the risk-benefit ratio, treatment at specialized pulmonary arterial hypertension centers is recommended until training is disseminated at other sites.

The effect of varus and valgus deformity on results of cementless mobile bearing TKA.

We aimed to determine whether preoperative angular deformity affects survivorship or postoperative alignment after cementless mobile bearing total knee arthroplasty. Nine hundred seventeen knees were grouped according to preoperative mechanical alignment: normal, 0-5 degrees ; abnormal, 6-10 degrees ; severely abnormal, >10 degrees. Ten-year survival estimates were 89.7% for the severely abnormal alignment group, 95.5% for the abnormal alignment group, and 94.9% for the normal alignment group. Postoperatively, normal alignment was restored in 95.6% of knees in the severely abnormal group and 94.5% of knees in the abnormal group. For the normal alignment group, 99.2% of knees remained normally aligned after TKA. These differences in postoperative alignment may explain the severely abnormal alignment group's inferior survivorship outcome. This study shows that cementless mobile bearing implants can be successfully used in a wide range of angulated deformed knees, although preoperatively deformed knees did not do as well as preoperatively undeformed knees.

Photonic Shape Memory Polymer with Stable Multiple Colors.

A photonic shape memory polymer film that shows large color response (∼155 nm) in a wide temperature range has been fabricated from a semi-interpenetrating network of a cholesteric polymer and poly(benzyl acrylate). The large color response is achieved by mechanical embossing of the photonic film above its broad glass transition temperature. The embossed film, as it recovers to its original shape on heating through the broad thermal transition, exhibits multiple structural colors ranging from blue to orange. The relaxation behavior of the embossed film can be fully described using a Kelvin-Voigt model, which reveals that the influence of temperature on the generation of colors is much stronger than that of time, thereby producing stable multiple colors.

Sub-5 nm Patterning by Directed Self-Assembly of Oligo(Dimethylsiloxane) Liquid Crystal Thin Films.

Highly ordered nanopatterns are obtained at sub-5 nm periodicities by the graphoepitaxial directed self-assembly of monodisperse, oligo(dimethylsiloxane) liquid crystals. These hybrid organic/inorganic liquid crystals are of high interest for nanopatterning applications due to the combination of their ultrasmall feature sizes and their ability to be directed into highly ordered domains without additional annealing.

Automated Defect and Correlation Length Analysis of Block Copolymer Thin Film Nanopatterns.

Line patterns produced by lamellae- and cylinder-forming block copolymer (BCP) thin films are of widespread interest for their potential to enable nanoscale patterning over large areas. In order for such patterning methods to effectively integrate with current technologies, the resulting patterns need to have low defect densities, and be produced in a short timescale. To understand whether a given polymer or annealing method might potentially meet such challenges, it is necessary to examine the evolution of defects. Unfortunately, few tools are readily available to researchers, particularly those engaged in the synthesis and design of new polymeric systems with the potential for patterning, to measure defects in such line patterns. To this end, we present an image analysis tool, which we have developed and made available, to measure the characteristics of such patterns in an automated fashion. Additionally we apply the tool to six cylinder-forming polystyrene-block-poly(2-vinylpyridine) polymers thermally annealed to explore the relationship between the size of each polymer and measured characteristics including line period, line-width, defect density, line-edge roughness (LER), line-width roughness (LWR), and correlation length. Finally, we explore the line-edge roughness, line-width roughness, defect density, and correlation length as a function of the image area sampled to determine each in a more rigorous fashion.

Comparative effectiveness of antibiotic-impregnated shunt catheters in the treatment of adult and pediatric hydrocephalus: analysis of 12,589 consecutive cases from 287 US hospital systems.

OBJECT: The real-world effectiveness of antibiotic-impregnated shunt catheters to reduce the incidence of shunt infections is still debated. The literature to date consists mostly of small, single-institution studies. The aim of this study was to assess the incidence of infection for antibiotic-impregnated catheters (AICs) versus standard shunt catheters in a large nationwide administrative database. METHODS: The authors retrospectively reviewed hospital discharge and billing records from the Premier Perspective Database from April 2003 to July 2009 to identify all adult and pediatric patients undergoing de novo ventricular shunt placement. The primary end point was the incidence of shunt infection within 1 year of implantation. Multivariate logistical regression was performed to determine factors associated with increased incidence of infection. RESULTS: A total of 10,819 adult (AIC, 963; standard catheter, 9856) and 1770 pediatric (AIC, 229; standard catheter, 1541) patients underwent ventricular shunt placement in 287 US hospitals. Overall, the incidence of infection was 3.5% in adults (n=380) and 6.6% in pediatric patients (n=116). AICs were associated with significant reduction in infection for both adult (2.2% vs 3.6%, p=0.02) and pediatric (2.6% vs 7.1%, p<0.01) patients. AIC use was associated with reduced infection regardless of hospital size, annual shunt volume, hospital location, or patient risk factors and remained associated with a reduced infection in multivariate analysis for both adult (p=0.02) and pediatric (p=0.02) patients. CONCLUSIONS: The use of antibiotic-impregnated shunt catheters was associated with a reduction in shunt infections for both adult and pediatric patients. This provides further support that AICs may represent a reliable means of reducing shunt infections for both adult and pediatric patients.

Cost savings associated with antibiotic-impregnated shunt catheters in the treatment of adult and pediatric hydrocephalus.

BACKGROUND: Cerebrospinal fluid (CSF) shunt infection is a major cause of morbidity and mortality in the treatment of hydrocephalus and is associated with significant medical cost. Several studies have demonstrated the efficacy of antibiotic-impregnated (AI) shunt catheters in reducing CSF shunt infection; however, providers remain reluctant to adopt AI catheters into practice because of the increased upfront cost. The objective of this study was to determine if the use of AI catheters provided cost savings in a large nationwide database. METHODS: Hospital discharge and billing records from the Premier Perspective Database from 2003-2009 were retrospectively reviewed to identify all adult and pediatric patients undergoing de novo ventricular shunt placement. The incidence of shunt infection within 1 year of implantation was determined. Shunt infection-related cost was defined as all inpatient billing costs incurred during hospitalization for treatment of shunt infection. RESULTS: In 287 U.S. hospitals, 10,819 adult (AI catheters, 963; standard catheters, 9856) and 1770 pediatric (AI catheters, 229; standard catheters, 1541) patients underwent ventricular shunt placement. AI catheters were associated with significant reduction in infection for both adult (2.2% vs. 3.6%, P = 0.02) and pediatric (2.6% vs. 7.1%, P < 0.01) patients. Total infection-related costs were $17,371,320 ($45,714 ± $49,745 per shunt infection) for adult patients and $6,508,064 ($56,104 ± $65,746 per shunt infection) for pediatric patients. Infection-related cost per 100 de novo shunts placed was $120,534 for AI catheters and $162,659 for standard catheters in adult patients and $165,087 for AI catheters and $395,477 for standard catheters in pediatric patients. CONCLUSIONS: In analysis of this large, nationwide database, AI catheters were found to be associated with a significant reduction in infection incidence, resulting in tremendous cost savings. AI catheters were associated with a cost savings of $42,125 and $230,390 per 100 de novo shunts placed in adult and pediatric patients, respectively.