Device Replacement Research Articles

Management of the Inflatable Penile Prosthesis Reservoir at time of revision surgery: remove, retain, or recycle?

Three common strategies exist for managing the inflatable penile prosthesis reservoir during revision surgery: the original reservoir can be (a) removed, (b) deactivated and left in situ, sometimes referred to as "drain and retain" (DR), or (c) validated and reconnected to new cylinders, which we have termed "reservoir recycling" (RR). To compare the efficacy and safety of the RR approach to penile prosthesis revision against DR and the recommended approach of complete device removal and replacement. A retrospective chart review of our single-surgeon inflatable penile prosthesis database between 2007 and 2022 was performed, identifying revision surgeries. Cases were stratified by reservoir management technique. Patients who had undergone at least 1 follow-up visit and had complete documentation regarding reservoir handling were included. Reservoir-related complications necessitating surgical intervention such as infection and device failure were compared between the 3 groups using a chi-square test. Mean follow-up duration, time to revision, and operative time were also assessed. The primary outcome was theincidence of reservoir-related complications requiring surgical intervention and secondary outcomes included time to revision surgery and operative time. Among 140 patients meeting inclusion criteria, 62 underwent full reservoir replacement (FR), 48 DR, and 30 RR. Compared to FR, DR and RR groups had similar mean time to revision and intraoperative time. Follow-up duration was similarly limited for all 3 groups at a median of approximately 4.5months. There were no postoperative infections in the RR cohort. However, when compared to the DR and FR groups, this did not reach significance (P = .398). There was no difference in mechanical failure rate between the 3 groups (P = .059). Nonmechanical failure was also similar between all 3 groups (P = .165). These results suggest that RR exhibits comparable outcomes to DR and FR, making it a viable option during select penile prosthesis revision surgeries, potentially decreasing morbidity without compromising outcomes. This is the first study to evaluate outcomes after RR. Limitations include small sample size, limited follow-up, and single-surgeon experience. There was no difference in reservoir-related complications when comparing the 3 methods. These preliminary results suggest that reservoir recycling may provide a safe and effective reservoir-handling alternative in inflatable penile prosthesis revision surgery.

Incidence of ventricular arrhythmias after implantable cardioverter-defibrillator implantation or replacement, and driving restriction consequences

BackgroundFollowing implantation/replacement of an implantable cardioverter-defibrillator, patients are legally subjected to variable lengths of driving restrictions based on the indication (1 and 3 months after primary and secondary prevention, respectively; 1 week after device replacement). AimTo assess the incidence of ventricular arrhythmia during the theoretical driving restriction period in a large cohort of patients. MethodsPatients who underwent implantable cardioverter-defibrillator implantation for primary or secondary prevention or device replacement between 2015 and 2021 were included retrospectively. The primary endpoint was the occurrence of ventricular arrhythmia during the theoretical driving restriction period, as defined by guidelines. ResultsA total of 914 patients were analysed, including 654 first implantations (438 and 216 for primary and secondary prevention, respectively) and 260 device replacements. The primary outcome occurred in 2/438 patients (0.004%) during the 1-month period following device implantation for primary prevention and in 25/216 patients (11.5%) during the 3-month period following device implantation for secondary prevention; it did not occur in the 1-week period following device replacement. The monthly calculated risk of harm remained below the accepted threshold of 0.005% for each group. ConclusionsPrimary prevention patients, such as those who have undergone device replacement, have a low risk of ventricular arrhythmia, which could lead to a reduction in their driving restriction period. Secondary prevention patients experienced a higher risk of recurrent ventricular arrhythmia, supporting the 3-month driving restriction period.

A propensity-matched cohort study examining the impact of gentamycin-collagen sponge on the prevention of infections in patients with implantable cardioverter defibrillator undergoing revision surgery

Abstract Introduction Despite the obvious benefits, the use of implantable cardioverter defibrillators (ICDs) is associated with serious complications, including infections. In particular, device replacement or revision procedures are associated with an increased risk of infection. Aim of the study was to compare the cardiac device infection rate with and without the use of the gentamycin-collagen sponge (GCS) in patients undergoing device replacement or revision procedures of implanted ICDs. Methods This cohort study analyzed ICD patients from a prospective single-centre ICD-registry who underwent elective device replacement, system upgrade or lead revision between 2014 and 6/2023. From September 2020 onwards, a GCS was inserted into the device pocket (GCS group, n = 204). Each patient of the GCS group was matched to a control without GCS. Results The baseline characteristics and the PADIT score were well matched except for the rate of submuscular device pockets which was lower in the GCS group (Table 1). The GCS was well tolerated and there were no complications associated with the GCS. The Kaplan-Meier estimated infection rate after one year was 1.0% in the GCS group and 6.5% in the control group (p < 0.001, Figure 1). Time from revision to infection was 144 + 134 days in the GCS group vs. 334 + 261 days in the control group. Conclusion Adjunctive use of a GCS was associated with a lower incidence of device infections than standard-of-care infection-prevention strategies alone.Table 1Figure 1

Microbial specturm and antibiotic sensitivity of pocket swabs in ICD patients undergoing device replacement or lead revision surgery- findings from a ICD registry observational study

Abstract Introduction Infection is a serious complication of implantable cardioverter defibrillator (ICD) therapy, necessitating effective preventive measures during implantation or revision surgery. The intraoperative use of antibacterial envelopes containing rifampicin and minocycline has shown promising results in reducing infection, yet, it is expensive and not cost-effective. Gentamicin sponges might be an alternative to the antibacterial envelope, however its efficacy on targeting the specific microbial spectrum found in device infection must be further investigated. Aim of the study was to identify the bacterial species obtained from pocket swabs of ICD patients undergoing revision surgery, and assess their sensitivity to gentamicin, rifampicin and minocycline. Methods A total of 459 intraoperative pocket swabs were collected from consecutive ICD patients who underwent elective device replacement, system upgrade or lead revision between 2017 and 6/2023. The baseline characteristics were similar in both groups (Table 1). Results Out of the 459 swabs analysed: 416 (90.6%) were negative for microbial growth. The remaining 43 swabs (9.4%) were tested positive for microbial growth (Table 2). Coagulase-negative- staphylococci (CoNS) were the most commonly isolated bacteria, accounting for 56% of cases. Bacteria with available antibiograms exhibited a sensitivity of 92% to gentamicin, 96% to rifampicin and 96% to Minocycline (Table 2). Conclusion The antibiotic sensitivity of the bacteria obtained from the pocket swabs to gentamycin, rifampicin and minocycline was similar. Thus, gentamicin sponges might be an alternative to the antibacterial envelope in patients with ICD undergoing generator replacement or revision surgery.

Predictive value of a positive pocket swab for the occurrence of device infection in implantable cardioverter defibrillator patients undergoing generator replacement or lead revision

Abstract Introduction Bacterial colonization of generator pockets in implantable cardioverter defibrillator (ICD) patients plays a key role in the development of device infection after revision surgery. Pocket swabs taken at revision may be useful for predicting device infection, but their prognostic value is not precisely known. Aim of the study was to evaluate the predictive value of positive pocket swabs for cardiac device infection in ICD patients undergoing revision surgery. Methods A total of 646 consecutive ICD patients from a prospective single-centre ICD-registry who underwent elective device replacement, system upgrade or lead revision between 2014 and 6/2023 were analyzed. Independent predictors for device infection were evaluated by a Cox regression analysis adjusting for age, gender, EF, insulin dependent diabetes, anticoagulation, multiple leads, revision surgery and the PADIT score. Results Positive pocket swabs were obtained in 12% of patients. The baseline characteristics of ICD patients with positive versus negative pocket swabs were similar (Table 1). With an average follow-up of 3 years, the infection rate in patients with positive pocket swabs was around 5 times higher than in patients with negative swabs (19% versus 4%, p < 0.001). In a Cox regression analysis, a positive pocket swab was the strongest independent predictor for device infection during follow-up (hazard ratio 4.26, 95% confidence interval 2.15 – 8.45, Table 2). Conclusion A positive swab from ICD-pockets in patients undergoing generator replacement or lead revision is an independent predictor of device infection during follow-up. These results support the routine collection of pocket swabs from patients undergoing revision surgery.Table 1Table 2

Results of endoscopic electrode removal surgery in patients with cardiovascular implantable electronic devices

Introduction: The increasing popularity of permanent pacemakers and implantable cardioverter defibrillators (ICDs) has improved the quality of life and long-term prognosis of cardiovascular patients. However, there is also an increase in infections of cardiac implantable devices (CIEDs). The infection rate after the first implant is 4.82/1000 people, and after the device replacement is 12.12/1000. With the development of endoscopic techniques, a method of thoroughly treating infections of cardiac implantable devices is opened without increasing the severity of the patient’s condition. Method: Cross-sectional study, 08 patients with pacemaker infection underwent endoscopic surgery at the Cardiovascular Center, E Hospital from January 2020 to July 2024. Result: In 08 patients, the male ratio is mainly 06 patients, the oldest age was 85 years old and the youngest is 25 years old. There are 07 cases with permanent pacemaker implantation, 1 case of ICD placement Brugada syndrome. All cases have bacterial cultures: 05 patients have Staphylococcus aureus and 03 cases have cultured Staphylococcus epidermidis. All patients have pacemaker examination and underwent endoscopic surgery to remove the electrode. The average surgical time is 68,71± 18.3 minutes (97-40), in which 01 case has only electrode probe infection, the remaining cases has both the pacemaker and electrode probe infection. Most stable cases are discharged from hospital with an average time of 16,2± 7,8 days (11-30), 01 severe case due to sepsis in a patient with heart failure EF: 30%, kidney failure, diabetes, hypertension has to stay in treatment for additional 30 days. Conclusion: Endoscopic electrode removal surgery in patients with pacemaker infection initially achieved good results, with low complications and mortality, but a larger number of patients and long-term follow-up and evaluation are needed.

TriVAD: Successful use of Impella 5.5 and Protek Duo CentriMag RVAD following Heartware HVAD thrombosis as a bridge to heart transplant.

Pump thrombosis remains a feared complication following placement of durable left ventricular assist devices (LVAD) and can be particularly detrimental to individuals being bridged to heart transplantation. Complications associated with this malfunction not only increase morbidity related to right heart failure, hemolysis, and other organ failure, but may ultimately jeopardize a patient's heart transplant candidacy. Additionally, reoperation for durable ventricular device replacement not only poses additional surgical risks to patients but can potentially complicate or even prohibit transplantation in the future. This case report describes a novel configuration of temporary, groin-free, percutaneously-deployed biventricular mechanical circulatory devices to support a patient with biventricular failure due to partial LVAD thrombosis. The use of less invasive mechanical support measures, such as the approach described here, may help patients achieve adequate hemodynamic support while allowing them to remain ambulatory and facilitate successful bridging to heart transplantation.

TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System: Results from an FDA Post-Market Surveillance Prospective Cohort Study

BackgroundCustom-designed and patient-fitted temporomandibular joint replacement devices (TMJR) are employed to manage end-stage TMJ pathology, distorted bony TMJ architecture, or in patients who have undergone multiple prior failed TMJ surgeries. PurposeThis study aimed to measure the frequency of revision or replacement over time, estimate the 1, 2, and 3-year survival rate of implants, and determine what demographic, anatomical, or operative variables may be associated with a device adverse event. Study design, setting, and sampleA prospective cohort study was conducted on consenting adults who could read English, implanted with the TMJ Concepts TMJR prostheses between 2013 and 2015 by private or academic surgeons. Patients under the age of 18 and those who were incapable, unwilling, or unable to complete the perioperative forms were excluded. Outcome variablesThe primary outcome variable was the frequency of adverse events, which is defined as device revision or replacement. The secondary outcome variable was the survival rate for the TMJ Concepts devices. AnalysesDevice survival at 1, 2, and 3 years was estimated using the Kaplan-Meyer methodology. Cox proportional hazards regression was used to analyze the effects of the predictor variables for the device survival rate. A p-value of <0.05 was considered significant. ResultsA total of 738 subjects (1098 joints) were enrolled in the study with 102 (14%) males and 636 (86%) females. The mean age was 45.4 (+ 14.8) years. The median follow-up period was 36.2 months (95% CI: 36.1 – 36.2 months). A total of 187 subjects (25.3%) were lost to follow-up during; the study period. Forty-nine devices (4.46%) were associated with an adverse event at 3 years. The; 3-year device survival was 95.1 % (95% CI: 93.6 – 96.3%). The only significant risk factor for an adverse event was the asymmetry of the mandible (hazard rate ratio = 1.989, p = 0.03). The primary diagnosis was not associated with the time to an adverse event (p-value = 0.8685). Infection (44.7 %, 21 joints) and material sensitivity (12.8 %, 6 joints) were the most common reasons specifically for device removal/replacement in the study cohort. ConclusionsInfection was the primary reason reported for device revision or replacement followed by material sensitivity. In the study cohort, the device survival following implantation of the TMJ Concepts prosthesis was not significantly different than reported by the TMJR stock device.

Cost savings associated with extended battery longevity in cardiac resynchronization therapy defibrillators (CRT-D)

BackgroundCardiac resynchronization therapy-defibrillators (CRT-D) are devices established as treatment for symptomatic heart failure patients at risk of sudden cardiac death. Battery depletion poses a significant clinical and economic burden; extended service life may reduce costs due to generator changes and associated complications. ObjectiveThis study estimated cost-savings associated with extended battery longevity in Medicare patients receiving CRT-D implantation. MethodsA decision tree was used to explore three battery capacities: 1.0 ampere-hours (Ah), 1.6Ah, and 2.1Ah. Yearly risk of all-cause mortality, device-related complications, and end of battery life were estimated. Over 6 years, estimated costs included device implantation, replacement, follow-up appointments, and complications. ResultsThe average total costs to Medicare over 6 years were $41,527, $48,515, and $56,647 per person (USD 2023) for the 2.1Ah, 1.6Ah, and 1.0Ah, respectively. The total per-person replacement cost for the 1.0Ah devices was more than 4 times that of the 2.1Ah devices ($20,126 versus $5,006). When extrapolated to the total number of CRT-D implants over a 6-year period, the difference in costs between 2.1Ah1.0Ah battery capacity exceeded $500 million. ConclusionExtended longevity CRT-D batteries demonstrate significant cost savings to Medicare over 6 years. These data indicate long-term economic considerations should be included in device selection.

Sacral neuromodulation therapy: a retrospective observational study of reasons for battery depletion diagnosis in implanted pulse generators

When the battery of a sacral neuromodulation pulse generator (IPG) is nearing depletion, it is possible to experience a loss of clinical efficacy of chronic electrical stimulation. It is currently unknown if, how often and how long after the diagnosis of battery depletion the patient may experience a recurrence of symptoms previously controlled by the therapy. The aim of this work was to retrospectively evaluate the main reasons leading to the diagnosis of IPG battery depletion. We investigated the reasons leading to the diagnosis of battery depletion in all patients who underwent device replacement between January 2021 and January 2023 at our Tertiary Referral Center for Sacral Neuromodulation in Turin (Italy) via medical record analysis and telephone interviews. Data related to the initial diagnosis and the waiting time for IPG replacement were also collected. Fifty-two patients were enrolled. The diagnosis of battery depletion was attributed to the recurrence of symptoms previously managed with sacral neuromodulation (35 patients, 67.3%), self-diagnosis by the patient at home via the Smart Programmer® (12 patients, 23.1%), and a diagnosis made by the clinician during routine outpatient visits (5 patients, 9.6%). Among patients who had good symptom control at the time of battery depletion diagnosis, eight patients (47.1%) experienced a recurrence of symptoms while waiting for the intervention, whereas nine patients (52.9%) were able to replace the stimulator without losing clinical efficacy. Taken together, the diagnosis of an exhausted stimulator is often secondary to the recurrence of symptoms, or frequently manifests even while awaiting replacement intervention.

The fragile urethra: what to do next?-a narrative review.

Although the artificial urinary sphincter (AUS) has demonstrated successful outcomes in treating male stress urinary incontinence (SUI) for the past five decades, this procedure also carries inherent risks, including recurrent SUI, device malfunction, local tissue compromise, and infection/erosion, all of which may require revision surgery with or without device replacement. Patients that are at the highest risk for such untoward events often possess unhealthy urethral tissue (termed a "fragile urethra") that is compromised and unable to provide optimal cuff coaptation and continence. Accordingly, there are several techniques to address recalcitrant SUI in the setting of a fragile urethra to afford an improved chance of return to continence. Here, we review characteristics of patients that are at higher risk for an untoward outcome following AUS implantation and further define strategies to promote optimal success with device implantation. The aim of this paper is to review the available literature and describe surgical options for male SUI in patients with known or anticipated urethral tissue compromise. A thorough literature review was completed by querying PubMed for relevant articles. Search terms included artificial urinary sphincter, failure, recalcitrant, urethral atrophy, fragile urethra, revision, radiation, cystectomy, incontinence, and/or urethroplasty published between 1975 and 2022. Options for management of the fragile urethra include cuff relocation, cuff downsizing, tandem cuff placement, transcorporal cuff placement, pressure regulating balloon exchange with increased or decreased pressure, bulbospongiosus preservation, sub-cuff ventral capsulotomy, urethral wrapping with graft, and in select cases, urinary diversion, or complete device removal with a return to SUI. Proper patient selection is paramount to optimize outcomes. Advantages and disadvantages of each strategy are reviewed. Numerous techniques are viable options for patients with recalcitrant SUI in the setting of a fragile urethra, but high-quality evidence with reproducible outcomes for many of these strategies remain limited. Proper patient selection as well as adequate counseling by experienced implant surgeons may help optimize outcomes. Further multi-institutional investigations with longer term outcomes are needed to improve patient selection and counseling with shared decision-making prior to any intervention.

A rate-responsive duty-cycling protocol for leadless pacemaker synchronization

Dual-chamber leadless pacemakers (LLPMs) consist of two implants, one in the right atrium and one in the right ventricle. Inter-device communication, required for atrioventricular (AV) synchrony, however, reduces the projected longevity of commercial dual-chamber LLPMs by 35–45%. This work analyzes the power-saving potential and the resulting impact on AV-synchrony for a novel LLPM synchronization protocol. Relevant parameters of the proposed window scheduling algorithm were optimized with system-level simulations investigating the resulting trade-off between transceiver current consumption and AV-synchrony. The parameter set included the algorithm’s setpoint for the target number of windows per cardiac cycle and the number of averaging cycles used in the window update calculation. The sensing inputs for the LLPM model were derived from human electrocardiogram recordings in the MIT-BIH Arrhythmia Database. Transceiver current consumption was estimated by combining the simulation results on the required communication resources with electrical measurements of a receiver microchip developed for LLPM synchronization in previous work. The performance ratio given by AV-synchrony divided by current consumption was maximized for a target of one window per cardiac cycle and three averaging cycles. Median transceiver current of both LLPMs combined was 166 nA (interquartile range: 152–183 nA) and median AV-synchrony was 92.5%. This corresponded to median reduction of 18.3% and 3.2% in current consumption and AV-synchrony, respectively, compared to a non-rate-responsive implementation of the same protocol, which prioritized maximum AV-synchrony. In conclusion, adopting a rate-responsive communication protocol may significantly increase device longevity of dual-chamber LLPMs without compromising AV-synchrony, potentially reducing the frequency of device replacements.

(Invited) Influence of the Semiconductor Thin Film Morphologies on Dntt Organic Electronic Devices Performances

Interest in organic semiconductors has grown enormously in the last few years, indeed their use in microelectronics is continuously rising up in a large range of fields, spanning from academic to industrial new applications [1]. They provide a large number of interesting properties that have pushed a gradual replacement of classical amorphous silicon-based devices with organic ones [2], as they promise to be the best candidates as drivers of the necessary green and digital transition and become the building blocks in a huge number of future applications.In most devices, particularly in OTFTs, the quality and properties of the interface between semiconductor and dielectric are of fundamental importance for the device electrical characteristics [3-4]. Dinaphtho [2,3-b:2′,3′-f] thieno [3,2-b] thiophene (DNTT)-based OTFTs are among the best-known devices as they provide good performances in terms of charge mobility, good stability as well as easy processing and they are particularly suitable to study deeper the role of insulator/semiconductor interface [5-6]. It has been widely reported that the best performances of the small molecule organic based transistors, in terms of charge mobility as well as stability, are obtained when the molecules align with their long axis almost perpendicular to the growth surface. The DNTT molecules deposited on SiO2, align to form a homogeneous film, which results to be highly crystalline and provides good transport properties. However, in DNTT-based OTFTs different insulator surfaces, above which the active layer is grown, can provide different properties in terms of morphology and surface energy so that the electrical performances of the resulted devices can span in a wide range [7].In this work, we have studied the growth of DNTT semiconductor thin films on two different dielectric materials relating the ordered DNTT thin film structure to the OTFTs' electrical characteristics. OTFTs have been fabricated with Bottom Gate Top Contact (BGTC) configuration using thermal SiO2 or a double layer of SiO2/CytopTM as gate dielectrics. Semiconductor thin films, with thicknesses ranging from 3 nm to 50 nm, were detailed analyzed with high resolution AFM and XRD measurements (Fig. 1a, b, c, d) for different growth conditions to understand the morphologies of the films starting by the very first ordered layers of DNTT semiconductors. Our measurements show that DNTT molecules on SiO2 and Cytop pack into ordered structures placing themselves with their long axis perpendicular to the plane of the substrate (edge-on). However, in the case of DNTT on SiO2, a portion of ordered molecules can lie horizontally on the substrate (face-on). This causes an increase of defective states for the majority carriers in the conductive channel of the transistor, with a consequent reduction of the field-effect mobility (Fig. 1a, b). Numerical simulations were performed to analyze the effects of different semiconductor film morphologies on the electrical characteristics of the OTFTs. We also show that the morphological semiconductor differences lead to better performances for organic phototransistors based on DNTT/Cytop interface [8].[1] C. Wang et al., Chemical reviews 2012, 112 (4), 2208-2267.[2] Y. Bonnassieux et al., Flexible and Printed Electronics 2021, 6 (2), 023001.[3] H. I. Un et al., Advanced Science 2019, 6 (20), 1900375.[4] H. Sirringhaus et al., Advanced materials 2014, 26 (9), 1319-1335.[5] H. Chang et al., Org. Electron., 2015, 22, 86-91.[6] Q. Wang et al., ACS applied materials & interfaces 2018, 10 (26), 22513-22519.[7] M. Geiger et al., Advanced Materials Interfaces 2020, 7 (10), 1902145.[8] S. Calvi, et al., Org. Electron., 2022, 102, 106452. Figure 1

Optimizing Healthcare Expenditure for Spinal Cord Stimulation in Italy: The Value of Battery Longevity Improvement and a Direct-to-Implant Approach.

Background: Spinal cord stimulation (SCS) is a treatment for chronic intractable pain powered by an implantable pulse generator that may be rechargeable or not rechargeable (NR). It is performed in 2 stages (a trialing phase followed by permanent device implantation) and necessitates 2 hospitalizations, which may increase infection risk. Objective: This analysis explores the cost impact of improvements in battery longevity and the adoption of 1-step (direct-to-implant [DTI]) SCS implantation. Methods: Since 2019, 3 leading NR-SCS devices have been launched: Device A (2019), Device B (2020), and Device C (2021). The battery longevity of the newest Device C was estimated at comparable stimulation settings for Devices A and B. A Markov model simulated individual patient pathways across 2 scenarios: Device A vs Device C and Device B vs Device C (both with the DTI approach and 2-step approach). Costs considered were the initial device implantation procedure, device replacements, and serious adverse event (SAE) management. Italian diagnosis-related group (DRG) tariffs were applied for costs, and a 15-year time horizon was used. Results: Over 15 years, using a DTI approach, the undiscounted total costs for Device A vs Device C were €26 860 and €22 633, respectively, and €25 111 and €22 399 for Device B vs Device C, respectively. Compared with Devices A and B, Device C offered savings of €4227 and €2712, respectively; similar savings were predicted with a 2-step implant approach. Discussion: The battery longevity of NR-SCS devices directly impacts long-term costs to a payer. The longer the device lasts, the lower mean total cumulative costs the patient will have, especially with regard to device replacement costs. With novel devices and specific programming settings, the lifetime cost per patient to a payer can be decreased without compromising the patient's safety and positive clinical outcome. Conclusions: Extended SCS battery longevity can translate into tangible cost savings for payers. The DTI approach for SCS supports National Healthcare System cost efficiencies and offers the additional benefits of optimizing operating room time while having only one recovery period for the patient.

Optimizing Healthcare Expenditure for Spinal Cord Stimulation in Italy: The Value of Battery Longevity Improvement and a Direct-to-Implant Approach

Background: Spinal cord stimulation (SCS) is a treatment for chronic intractable pain powered by an implantable pulse generator that may be rechargeable or not rechargeable (NR). It is performed in 2 stages (a trialing phase followed by permanent device implantation) and necessitates 2 hospitalizations, which may increase infection risk. Objective: This analysis explores the cost impact of improvements in battery longevity and the adoption of 1-step (direct-to-implant [DTI]) SCS implantation. Methods: Since 2019, 3 leading NR-SCS devices have been launched: Device A (2019), Device B (2020), and Device C (2021). The battery longevity of the newest Device C was estimated at comparable stimulation settings for Devices A and B. A Markov model simulated individual patient pathways across 2 scenarios: Device A vs Device C and Device B vs Device C (both with the DTI approach and 2-step approach). Costs considered were the initial device implantation procedure, device replacements, and serious adverse event (SAE) management. Italian diagnosis-related group (DRG) tariffs were applied for costs, and a 15-year time horizon was used. Results: Over 15 years, using a DTI approach, the undiscounted total costs for Device A vs Device C were €26 860 and €22 633, respectively, and €25 111 and €22 399 for Device B vs Device C, respectively. Compared with Devices A and B, Device C offered savings of €4227 and €2712, respectively; similar savings were predicted with a 2-step implant approach. Discussion: The battery longevity of NR-SCS devices directly impacts long-term costs to a payer. The longer the device lasts, the lower mean total cumulative costs the patient will have, especially with regard to device replacement costs. With novel devices and specific programming settings, the lifetime cost per patient to a payer can be decreased without compromising the patient’s safety and positive clinical outcome. Conclusions: Extended SCS battery longevity can translate into tangible cost savings for payers. The DTI approach for SCS supports National Healthcare System cost efficiencies and offers the additional benefits of optimizing operating room time while having only one recovery period for the patient.

Efficacy of a gentamycin-collagen sponge to prevent infection in implantable cardioverter defibrillator patients undergoing revision surgery - results of a monocentric ICD registry observational study

Abstract Introduction Despite the obvious benefits, the use of implantable cardioverter defibrillators (ICDs) is associated with serious complications, including infections. In particular, device replacement or revision procedures are associated with an increased risk of infection. Aim of the study was to compare the cardiac device infection rate with and without the use of the gentamycin-collagen sponge (GCS) in patients undergoing device replacement or revision procedures of implanted ICDs. Methods A total of 491 consecutive ICD patients from a prospective single-centre ICD-registry who underwent elective device replacement, system upgrade or lead revision between 2017 and 6/2023 were analyzed. From September 2020 onwards, a GCS was inserted into the device pocket (GCS group, n = 256). These patients were compared to the patients implanted/ revised between 2017 and 8/2020 (control group, n = 235). Results The baseline characteristics and the PADIT score were similar in both groups (Table 1). The GCS was well tolerated and there were no complications associated with the GCS. The mean follow-time was 15 + 10 months in the GCS group and 30 + 11 months in the control group. The Kaplan-Meier estimated infection rate after one year was 1.0% in the GCS group and 3.5% in the control group (p = 0.03, Figure 1). Time from revision to infection was 144 + 134 days in the GCS group vs. 362 + 297 days in the control group. Conclusion Adjunctive use of a GCS was associated with a lower incidence of device infections than standard-of-care infection-prevention strategies alone.

A new fabrication method for enhancing the yield of linear micromirror arrays assisted by temporary anchors

As one of the most common spatial light modulators, linear micromirror arrays (MMAs) based on microelectromechanical system (MEMS) processes are currently utilized in many fields. However, two crucial challenges exist in the fabrication of such devices: the adhesion of silicon microstructures caused by anodic bonding and the destruction of the suspended silicon film due to residual stress. To solve these issues, an innovative processing method assisted by temporary anchors is presented. This approach effectively reduces the span of silicon microstructures and improves the Euler buckling limit of the silicon film. Importantly, these temporary anchors are strategically placed within the primary etching areas, enabling easy removal without additional processing steps. As a result, we successfully achieved wafer-level, high-yield manufacturing of linear MMAs with a filling factor as high as 95.1%. Demonstrating superior capabilities to those of original MMAs, our enhanced version boasts a total of 60 linear micromirror elements, each featuring a length-to-width ratio of 52.6, and the entire optical aperture measures 5 mm × 6 mm. The linear MMA exhibits an optical deflection angle of 20.4° at 110 Vdc while maintaining exceptional deflection flatness and uniformity. This study offers a viable approach for the design and fabrication of thin-film MEMS devices with high yields, and the proposed MMA is promising as a replacement for digital micromirror devices (DMDs, by TI Corp.) in fields such as spectral imaging and optical communication.

Factors associated with cardiac implantable electronic device-related infections, New South Wales, 2016-21: a retrospective cohort study.

To quantify the rate of cardiac implantable electronic device (CIED)-related infections and to identify risk factors for such infections. Retrospective cohort study; analysis of linked hospital admissions and mortality data. All adults who underwent CIED procedures in New South Wales between 1 January 2016 and 30 June 2021 (public hospitals) or 30 June 2020 (private hospitals). Proportions of patients hospitalised with CIED-related infections (identified by hospital record diagnosis codes); risk of CIED-related infection by patient, device, and procedural factors. Of 37 675 CIED procedures (23 194 men, 63.5%), 500 were followed by CIED-related infections (median follow-up, 24.9 months; interquartile range, 11.2-40.8 months), including 397 people (1.1%) within twelve months of their procedures, and 186 of 10 540 people (2.5%) at high risk of such infections (replacement or upgrade procedures; new cardiac resynchronisation therapy with defibrillator, CRT-D). The overall infection rate was 0.50 (95% confidence interval [CI], 0.45-0.54) per 1000 person-months; it was highest during the first month after the procedure (5.60 [95% CI, 4.89-6.42] per 1000 person-months). The risk of CIED-related infection was greater for people under 65 years of age than for those aged 65-74 years (adjusted hazard ratio [aHR], 1.71; 95% CI, 1.32-2.23), for people with CRT-D devices than for those with permanent pacemakers (aHR, 1.46; 95% CI, 1.02-2.08), for people who had previously undergone CIED procedures (two or more v none: aHR, 1.51; 95% CI, 1.02-2.25) or had CIED-related infections (aHR, 11.4; 95% CI, 8.34-15.7), or had undergone concomitant cardiac surgery (aHR, 1.62; 95% CI, 1.10-2.39), and for people with atrial fibrillation (aHR, 1.33; 95% CI, 1.11-1.60), chronic kidney disease (aHR, 1.54; 95% CI, 1.27-1.87), chronic obstructive pulmonary disease (aHR, 1.37; 95% CI, 1.10-1.69), or cardiomyopathy (aHR 1.60; 95% CI, 1.25-2.05). Knowledge of risk factors for CIED-related infections can help clinicians discuss them with their patients, identify people at particular risk, and inform decisions about device type, upgrades and replacements, and prophylactic interventions.

Value of nutritional indices in predicting survival free from pump replacement and driveline infections in centrifugal left ventricular assist devices

ObjectiveThere is a paucity of data assessing the impact of nutritional status on outcomes in patients supported with the HeartMate 3 (HM3) left ventricular assist device (LVAD). MethodsPatients ≥18 years of age who underwent HM3 LVAD implantation between 2015 and 2020 were identified from a single tertiary care center. The primary outcome assessed was death or device replacement. A secondary outcome of driveline infection was also evaluated. Kaplan-Meier survival analysis and a multivariate Cox-proportional hazards model were used to identify predictors of outcome. ResultsOf the 289 patients identified, 94 (33%) experienced a primary outcome and 96 (33%) a secondary outcome during a median follow-up time of 2.3 years. Independent predictors of the primary outcome included peripheral vascular disease (hazard ratio [HR], 3.40; 95% confidence interval [CI], 1.66-6.97, P < .01), diabetes mellitus (HR, 0.46; 95% CI, 0.27-0.80, P < .01), body mass index ≥40 kg/m2 (HR, 2.63 per 1 kg/m2 increase; 95% CI, 1.22-5.70, P < .05), preoperative creatinine level (HR, 1.86 per 1 mg/dL increase; 95% CI, 1.31-2.65, P < .01), and preoperative prognostic nutritional index (PNI) score (HR, 0.88 per 1-point increase; 95% CI, 0.81-0.96, P < .01). Independent predictors of driveline infection included age at the time of implantation (HR, 0.97; 95% CI, 0.96-0.99, P < .01) and diabetes mellitus (HR, 1.79; 95% CI, 1.17-2.73, P < .01). ConclusionsPreoperative PNI scores may independently predict mortality and the need for device replacement in patients with HM3 LVAD. Routine use of the PNI score during preoperative evaluation and, when possible, supplementation to PNI >33, may be of value in this population.

Additive manufacturing of hydrogel-based lunar regolith pastes: A pathway toward in-situ resource utilization and in-space manufacturing

Additive Manufacturing (AM), combined with efficient in-situ resource utilization, has the potential to enable sustained presence on the Moon through in-situ production and replacement of construction blocks, engineered parts, and devices in the lunar terrain. As an initial step toward realizing this vision, this work proposes a new material formulation utilizing lunar regolith simulants (LHS-1), water, and a hydrophilic hydrogel-forming polymer (Pluronic F127) to produce a hydrogel-based lunar regolith paste suitable for material extrusion AM. This formulation enables the use of water as another potential lunar in-situ resource for the first time in the literature, considering the recent confirmation of large quantities of water-ice in the shadowed craters around the lunar poles and the presence of water on the sunlit surface of the Moon. To systematically investigate the viability of the proposed hydrogel-based lunar regolith material feedstock and the application of material extrusion AM, this work introduces a three-stage design of experiment (DOE) framework to achieve two fundamental objectives. First, the viable range of lunar regolith simulant in the hydrogel-based material formulation is identified using a categorical quality evaluation of single and multi-layer material depositions. Second, the material printability window is established in terms of printing speed and extrusion rate for different viable material compositions through hierarchically designed experiments. The observed porosity of the sintered parts decreased with increasing regolith content in the material composition, while the density and compressive strength increased with higher regolith content. For material compositions consisting of 25–40 vol% regolith simulants, the observed porosity of the sintered parts decreased from 6.4 to 2.18 %, their density increased from 0.78 to 0.89 g/cm3, and their average compressive strength ranged between 0.68 and 1.32 MPa. Finally, the printability of the material was demonstrated by producing various prototype hand tools and lab-scale construction blocks with varying geometrical complexities. This work represents a crucial step toward in situ resource utilization and sustainable in-space manufacturing, sets the stage for future investigations, and the introduced DOE driven framework offers a pathway toward systematically identifying the optimal material compositions and the corresponding process parameters to enable high-quality prints.