Permanent Implants Research Articles

The biointegration profile of fiber-reinforced plates following tibial implantation in sheep.

Biointegrative, mineral fiber-reinforced bone fixation implants recently introduced in orthopedic surgery have expanded available treatment options for fractures and bone deformities. This new technology aims to address the disadvantages of permanent metallic implants while overcoming inherent concerns of adverse inflammatory reactions when using polymer-based orthopedic implants. The purpose of this double-arm preclinical study was to evaluate the safety, biocompatibility, and biointegration of fiber-reinforced plates, following implantation on the tibias of eight sheep. Left tibias underwent periosteal elevation, allowing for implant attachment directly onto the cortical surface; right tibia plates were implanted over intact periosteum. Microcomputed tomography and histopathology were performed at 13, 26, 52, 78, 104, and 134 weeks postimplantation. All animals were evaluated clinically at each time point, with no evidence of local adverse reactions. Histopathology demonstrated anti-inflammatory M2-like macrophages and multinucleated giant cells corresponding to implant bioabsorption, similar for both groups at each time point, and indicating expected implant biocompatibility. Inflammatory cells (i.e., eosinophils, lymphophyctes, plasma cells, and M1-like macrophages) were absent throughout the study. The bioabsorption process had started at 13 W, with the highest rate at 52-78 W. At 104 W, only residual polymer material was left (∼5% of implant area). Low amounts of mineral fibers were evident at 78 W and were absent (fully remodeled) by 104 W. At 134 W, implants at both sites were fully bioabsorbed. In conclusion, these new fiber-reinforced implants demonstrated bone remodeling and complete biointegration, with no adverse tissue response. Clinical significance: In this double-arm, 2.5-year study, a biointegrative, fiber-reinforced plate implanted on the tibias of sheep was fully absorbed within 134 weeks, with no adverse tissue reaction. Bioabsorption was similar, with or without periosteal elevation, mimicking conditions like those observed in traumatic injuries disrupting the periosteum, open reduction and internal fixation, or minimally invasive surgeries. These results demonstrate the feasibility, versatility, and safety of this new class of biointegrative bone implants. This newly developed technology avoids the complications of the removal of metal implants.

Patients ‘ perspectives on bone replacement materials in a German university hospital setting

BackgroundThe challenges in developing new bone replacement materials and procedures reside not solely in technological innovation and advancement, but also in a broader patient therapy acceptance. Therefore, there is a need to assess patients’ perspectives on the materials and approaches in use as well as the ones being developed to better steer future progress in the field.MethodsA self-initiating cross-sectional questionnaire aimed at people seeking treatment at the university hospital environment of Charité Berlin was formulated. The survey contained 15 close-ended questions directed toward the participant’s epidemiological profile, willingness, acceptance, and agreement to receive different bone replacement materials, as well as, worries about the post-surgical consequences that can arise post bone replacement surgery. Descriptive and categorical analysis was performed to compare the observed number of subjects, their profile and each related response (Pearson’s chi-square test or Fischer’s test, p < 0.05).ResultsA total of 198 people engaged with the questionnaire, most of them Millennials. Overall patients trusted scientifically developed biomaterials designed for bone replacement, as demonstrated by their willingness to participate in a clinical trial, their acceptance of alloplastic materials, and the none/few worries about the presence of permanent implants. The data revealed the preferences of patients towards autologous sources of cells and blood to be used with a biomaterial. The data have also shown that both generation and education influenced willingness to participate in a clinical trial and acceptance of alloplastic materials, as well as, worries about the presence of permanent implants and agreement to receive a material with pooled blood and cells.ConclusionPatients were open to the implantation of biomaterials for bone replacement, with a preference toward autologous sources of blood and/or tissue. Moreover, patients are concerned about strategies based on permanent implants, which indicates a need for resorbable materials. The knowledge gained in this study supports the development of new bone biomaterials.

Tumor Shape-Specific Brachytherapy Implants by 3D-Printing, Precision Radioactivity Painting, and Biomedical Imaging.

In brachytherapy (BT), or internal radiation therapy, cancer is treated by radioactive implants. For instance, episcleral plaques (EPs) for the treatment of uveal melanoma, are designed according to generic population approximations. However, more personalized implants can enhance treatment precision through better adjustment of dose profiles to the contours of cancerous tissues. An original approach integrating biomedical imaging, 3D printing, radioactivity painting, and biomedical imaging, is developed as a workflow for the development of tumor shape-specific BT implants. First, computer-aided design plans of EP are prepared according to guidelines prescribed by the Collaborative Ocular Melanoma Study protocol. Polyetheretherketone (PEEK), a high-performance polymer suitable for permanent implants, is used to 3D-print plaques and the geometrical accuracy of the printed design is evaluated by imaging. The possibility to modulate the dose distribution in a tridimensional manner is demonstrated by painting the inner surfaces of the EPs with radioactive 103Pd, followed by dose profile measurements. The possibility to modulate dose distributions generated by these 3D-printed plaques through radioactivity painting is therefore confirmed. Ex vivo surgical tests on human eyeballs are performed as an assessment of manipulation ease. Overall, this work provides a solution for the fabrication of tumor-specific radioactive implants requiring higher dose precision.

Real World Characterization of Chronic Pain, Success Rates and Implant Rates: Evidence from a Digital Health Platform of Patients Undergoing Spinal Cord Stimulation Evaluations

Spinal cord stimulation is an effective treatment for those experiencing chronic back and leg pain but requires a temporary evaluation period (SCSeval) before permanent implantation. We present real-world data from 7,000 patients who underwent SCSeval while utilizing a mobile digital health platform for education, feedback, and outcomes collection during their surgical journey. We analyzed preoperative patient demographics, characterized patient pain profiles using the patient-reported outcomes measurement information system-29 surveys, and calculated the rates of conversion from temporary to permanent spinal cord stimulation (SCS) implantation. Between August 1, 2021, and March 2, 2023, 7,000 patients (mean age 59.1, 59.6% female) underwent SCSeval procedures while utilizing a mobile application. Patients commonly experienced aching, sharp, stabbing, tingling, numb, and burning pain. Patients had tried multiple prior therapies and wanted to reduce their use of opioids and pain medications. Overall, 90.1% of the patients had a successful SCSeval, and 80.4% of those converted to permanent implant, with the highest rates among those who underwent SCSeval in a hospital setting. There was a significant improvement in all domains of pain as evaluated by pre and postoperative patient-reported outcomes measurement information system-29 surveys. This study supports the use of digital health technology as part of the SCS journey to improve the patient experience and allow for robust patient-reported outcomes collection. The overall rate of SCSeval to permanent SCS in our study of 72.4% was higher than national rates of 64%, suggesting that an app may allow clinicians to better quantify changes in chronic pain and provide more insight into choosing to implant SCS permanently. PerspectiveThis article presents real-world evidence from a digital health platform for therapy education and outcomes collection from patients undergoing spinal cord stimulation evaluation procedures. Such tools could allow for better pain characterization and allow for more nuanced tracking of patient outcomes among those with chronic pain.

Detailing the influence of PEO-coated biodegradable Mg-based implants on the lacuno-canalicular network in sheep bone: A pilot study.

An increasing prevalence of bone-related injuries and aging geriatric populations continue to drive the orthopaedic implant market. A hierarchical analysis of bone remodelling after material implantation is necessary to better understand the relationship between implant and bone. Osteocytes, which are housed and communicate through the lacuno-canalicular network (LCN), are integral to bone health and remodelling processes. Therefore, it is essential to examine the framework of the LCN in response to implant materials or surface treatments. Biodegradable materials offer an alternative solution to permanent implants, which may require revision or removal surgeries. Magnesium alloys have resurfaced as promising materials due to their bone-like properties and safe degradation in vivo. To further tailor their degradation capabilities, surface treatments such as plasma electrolytic oxidation (PEO) have demonstrated to slow degradation. For the first time, the influence of a biodegradable material on the LCN is investigated by means of non-destructive 3D imaging. In this pilot study, we hypothesize noticeable variations in the LCN caused by altered chemical stimuli introduced by the PEO-coating. Utilising synchrotron-based transmission X-ray microscopy, we have characterised morphological LCN differences around uncoated and PEO-coated WE43 screws implanted into sheep bone. Bone specimens were explanted after 4, 8, and 12 weeks and regions near the implant surface were prepared for imaging. Findings from this investigation indicate that the slower degradation of PEO-coated WE43 induces healthier lacunar shapes within the LCN. However, the stimuli perceived by the uncoated material with higher degradation rates induces a greater connected LCN better prepared for bone disturbance.

Materials and Design Approaches for a Fully Bioresorbable, Electrically Conductive and Mechanically Compliant Cardiac Patch Technology.

Myocardial infarction (MI) is one of the leading causes of death and disability. Recently developed cardiac patches provide mechanical support and additional conductive paths to promote electrical signal propagation in the MI area to synchronize cardiac excitation and contraction. Cardiac patches based on conductive polymers offer attractive features; however, the modest levels of elasticity and high impedance interfaces limit their mechanical and electrical performance. These structures also operate as permanent implants, even in cases where their utility is limited to the healing period of tissue damaged by the MI. The work presented here introduces a highly conductive cardiac patch that combines bioresorbable metals and polymers together in a hybrid material structure configured in a thin serpentine geometry that yields elastic mechanical properties. Finite element analysis guides optimized choices of layouts in these systems. Regular and synchronous contraction of human induced pluripotent stem cell-derived cardiomyocytes on the cardiac patch and ex vivo studies offer insights into the essential properties and the bio-interface. These results provide additional options in the design of cardiac patches to treat MI and other cardiac disorders.

Proximity of percutaneous tibial nerve stimulation needle insertion to surrounding anatomic structures: a cadaveric study

Percutaneous tibial nerve stimulation is a third-line treatment for overactive bladder and urgency urinary incontinence. During the procedure, a needle is inserted cephalad to the medial malleolus and posterior to the tibia. In recent years, permanent implants and leads have been developed for insertion into the medial ankle via a small incision. There are many important structures present in the medial compartment of the ankle, including the great saphenous vein, saphenous nerve, tibial nerve, posterior tibial vessels, and tendons of the posterior compartment leg muscles. The primary objective of this study was to identify the proximity of the percutaneous tibial nerve stimulation needle placed per Food and Drug Administration-approved device instructions to nearby important anatomic structures. The secondary objectives were to identify the proximity of the tibial nerve to the needle site, identify clinically relevant ankle anatomic structures, and confirm the tibial nerve and posterior tibial vasculature by histologic analysis. Detailed medial ankle dissections were performed bilaterally on 10 female lightly embalmed anatomic donors (cadavers) obtained from the Willed Body Program at the University of Louisville. A pin was inserted at the percutaneous tibial nerve stimulation needle site, and the medial ankle was minimally dissected so the surrounding anatomic structures were visible but not disrupted. The shortest distance from the pin to the selected structures of the medial ankle region was measured. On completion of each dissection and set of measurements, tissue was harvested for histologic examination. The distances between the pin and each structure were assessed using means and standard deviations. A paired t test was used to assess the difference in the locations between the left and right ankles. Statistical analysis was performed on left-sided, right-sided, and combined measurements. An 80% prediction interval was found to represent the expected range of values for the measurement of a new cadaver or patient, and the 95% confidence interval of the mean was computed to characterize the average distance across all cadavers or patients. The medial ankle of 10 adult female lightly embalmed cadavers were examined bilaterally. Dissections were completed from October 2021 to July 2022. Of note, 80% prediction intervals for the tibial nerve, the posterior tibial artery or vein, and the flexor digitorum longus tendon had a lower range of 0.0 mm from the pin and extending to 12.1, 9.5, and 13.9 mm, respectively. Moreover, 2 of the structures were found to be asymmetrical between the right and left ankles. The great saphenous vein was further from the pin on the left (20.5 mm [standard deviation of 6.4 mm] on the left vs 18.1 mm [standard deviation of 5.3 mm] on the right; P=.04). The calcaneal (Achilles) tendon was further from the pin on the right side (13.2 mm [standard deviation of 6.8 mm] vs 7.9 mm [standard deviation of 6.7 mm]; P=.04). Tibial neurovascular structures were confirmed with microscopic analysis. The anatomic structures within the medial ankle lie unexpectedly close to the percutaneous tibial nerve stimulation needle site as noted per Food and Drug Administration-approved device instructions. There is a possibility that some medial ankle structures are not symmetrical. It is crucial that practitioners understand medial ankle anatomy when performing percutaneous tibial nerve stimulation or permanent device insertion.

Radiofrequency induced heating of biodegradable orthopaedic screw implants during magnetic resonance imaging.

Magnesium (Mg)-based implants have re-emerged in orthopaedic surgery as an alternative to permanent implants. Literature reveals little information on how the degradation of biodegradable implants may introduce safety implications for patient follow-up using medical imaging. Magnetic resonance imaging (MRI) benefits post-surgery monitoring of bone healing and implantation sites. Previous studies demonstrated radiofrequency (RF) heating of permanent implants caused by electromagnetic fields used in MRI. Our investigation is the first to report the effect of the degradation layer on RF-induced heating of biodegradable orthopaedic implants. WE43 orthopaedic compression screws underwent in vitro degradation. Imaging techniques were applied to assess the corrosion process and the material composition of the degraded screws. Temperature measurements were performed to quantify implant heating with respect to the degradation layer. For comparison, a commercial titanium implant screw was used. Strongest RF induced heating was observed for non-degraded WE43 screw samples. Implant heating had shown to decrease with the formation of the degradation layer. No statistical differences were observed for heating of the non-degraded WE43 material and the titanium equivalent. The highest risk of implant RF heating is most pronounced for Mg-based screws prior to degradation. Amendment to industry standards for MRI safety assessment is warranted to include biodegradable materials.

Risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma in Patients with Textured Tissue Expanders.

The association between textured implants and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is well established, but the risk of BIA-ALCL in patients with transient exposure to a textured tissue expander (TE) is not as well documented. The aim of this study was to assess the incidence and risk of BIA-ALCL in patients with temporary exposure to a textured TE with subsequent smooth implant placement. This single-institution retrospective cohort study included all female patients who underwent two-stage breast reconstruction with placement of a textured TE from 1995 to 2016 with subsequent exchange to a smooth permanent implant. Primary outcome of interest was development of BIA-ALCL. Patients with exposure to textured implants were excluded. Follow-up was determined by last documented visit. The authors calculated summary statistics for exposure time and follow-up intervals. Overall, 3310 patients had temporary exposure to a textured TE with exchange to a smooth implant, totaling 5201 textured TEs. Average textured TE exposure time was 6.7 months (median, 5.8 months). Average follow-up was 6.8 years (median, 6.3 years), ranging from 3.7 months to 18 years. No cases of BIA-ALCL were identified. As no cases of BIA-ALCL were identified, the risk of BIA-ALCL with short exposure to textured TEs is likely lower than the risk from exposure to permanent textured implants. Although longer follow-up is needed, these results can help counsel patients with previous exposure to textured TEs who are concerned about their risk of BIA-ALCL and can contribute to discussions on potential continued utility of textured TEs. Risk, IV.

Staged Mastopexy before Nipple-Sparing Mastectomy: Improving Safety and Appearance in Breast Reconstruction.

Breast reconstruction following nipple-sparing mastectomy (NSM) in patients with large or ptotic breasts remains challenging because of the risk of ischemic complications and the difficulty in managing the redundant skin envelope. Staged mastopexy or breast reduction before the mastectomy/reconstruction has been shown to decrease the risk of complications and improve clinical outcomes. A retrospective analysis was conducted of patients with a genetic predisposition to breast cancer who underwent staged breast reduction/mastopexy before NSM and reconstruction in the authors' institution. In patients with in situ disease or invasive cancer, the first stage consisted of lumpectomy and oncoplastic reduction/mastopexy. Breast reconstruction at the second stage was performed with free abdominal flaps or breast implants and acellular dermal matrix. Data regarding the ischemic complications were recorded. In total, 47 patients (84 breasts) underwent this staged approach. All patients had a genetic predisposition to breast cancer. The time interval between the two stages was 11.5 months (range, 1.3 to 23.6 months). Twelve breasts (14.3%) were reconstructed with free abdominal flaps, six (7.1%) with tissue expanders, and 66 (78.6%) with permanent subpectoral implants and acellular dermal matrix. There was one case of postoperative superficial nipple-areola complex epidermolysis (1.2%), and two cases of partial mastectomy skin flap necrosis (2.4%). The mean follow-up time after completion of reconstruction was 8.3 months. Mastopexy or breast reduction before NSM and reconstruction is a safe procedure with a low risk of ischemic complications. Therapeutic, IV.

ID: 212183 Bimodal Sensory and Motor 60-day PNS of Suprascapular and Axillary Nerves for Chronic Shoulder Pain

Chronic shoulder pain is costly and painful, affecting between 18-22% of the United States population. There are very few treatments and many gaps in the care continuum for these patients. The opportunity to delay and often prevent surgical interventions, permanent implants, and/or neurolytic procedures is a tremendous benefit while evading the addictive challenges presented by opioids. In normal bodily function, sensory and motor signals are coordinated to balance the central nervous system. After musculoskeletal diseases or trauma occur, peripheral pain signals activate protective mechanisms including arthrogenic inhibition, which reduces activity to protect and assist with recovery. After extended periods of inactivity, normal proprioceptive information to the cortex is diminished and central sensitization may play a larger role in refractory pain states.

ID: 206170 Spinal Cord Stimulator Leads Migrate During Trials Regardless of Anchoring Technique

A spinal cord stimulator (SCS) trial is essential to identify patients who may benefit from the therapy, determine optimal stimulation configuration, and establish the lead position for the permanent implant. During the trial, lead migration is associated with numerous negative consequences, including inadequate programming, false-negative lack of efficacy, and suboptimal lead placement at the time of the permanent implantation. As such, it is critical to define the ideal technique for securing leads to limit migration.

Systemic Allergic Reaction to a Spinal Cord Stimulator Trial: A Case Report

BACKGROUND: Spinal cord stimulation (SCS) is commonly used for the management of chronic pain conditions, such as intractable axial and radicular back pain, complex regional pain syndrome, and painful peripheral vascular disease. Patients have had adverse complications with SCS trials and permanent implants. Cases of contact dermatitis from SCS devices have been reported, but a systemic allergic reaction to an SCS trial has not yet been published to date. CASE REPORT: A 52-year-old woman with complex regional pain syndrome type II and a history of a presumed infectious reaction to a previous SCS trial 8 years prior presented with chronic right L5, S1 radicular pain. Having failed conservative measures, she underwent a repeat SCS trial. The lead was placed at the T8 vertebral body, migrated several days later to the T9 vertebral body, and was subsequently adjusted back to T8 under fluoroscopic guidance. The patient reported improvement in her back and leg pain. Three days later, she presented to the emergency department with subjective fever, headache, rigors, chills, diaphoresis, nausea, vomiting, and diarrhea. The lead was removed, and the patient’s acute symptoms resolved within 48 hours. CONCLUSIONS: Systemic allergic reactions to SCS can be significant and lead to device removal despite improvement in pain symptoms. Further case reports and studies are needed to elucidate the risks associated with SCS placement, such as allergic reaction, infection, and neurologic injury. KEY WORDS: Case report, spinal cord stimulator, chronic pain, allergic reaction

Recent Developments in Engineered Magnesium Scaffolds for Bone Tissue Engineering.

Significant attention has been drawn in recent years to develop porous scaffolds for tissue engineering. In general, porous scaffolds are used for non-load bearing applications. However, various metallic scaffolds have been investigated extensively for hard tissue repair due to their favorable mechanical and biological properties. Stainless steel (316L) and titanium (Ti) alloys are the most commonly used material for metallic scaffolds. Although stainless steel and Ti alloys are employed as scaffold materials, it might result in complications such as stress shielding, local irritation, interference with radiography, etc. related to the permanent implants. To address the above-mentioned complications, degradable metallic scaffolds have emerged as a next generation material. Among the all metallic degradable scaffold materials, magnesium (Mg) based material has gained significant attention owing to its advantageous mechanical properties and excellent biocompatibility in a physiological environment. Therefore, Mg based materials can be projected as load bearing degradable scaffolds, which can provide structural support toward the defected hard tissue during the healing period. Moreover, advanced manufacturing techniques such as solvent cast 3D printing, negative salt pattern molding, laser perforation, and surface modifications can make Mg based scaffolds promising for hard tissue repair. In this article, we focus on the advanced fabrication techniques which can tune the porosity of the degradable Mg based scaffold favorably and improve its biocompatibility.

Tumor therapeutic response monitored by telemetric temperature sensing, a preclinical study on immunotherapy and chemotherapy

Temperature in the body and the tumor reflects physiological and pathological conditions. A reliable, contactless, and simplistic measurement system can be used for long-term monitoring of disease progression and therapy response. In this study, miniaturized battery-free wireless chips implanted into growing tumors on small animals were used to capture both basal and tumor temperature dynamics. Three preclinical models: melanoma (B16), breast cancer (4T1), and colon cancer (MC-38), were treated with adoptive T cell transfer, AC-T chemotherapy, and anti-PD-1 immunotherapy respectively. Each model presents a distinctive pattern of temperature history dependent on the tumor characteristic and influenced by the administered therapy. Certain features are associated with positive therapeutic response, for instance the transient reduction of body and tumor temperature following adaptive T cell transfer, the elevation of tumor temperature following chemotherapy, and a steady decline of body temperature following anti-PD-1 therapy. Tracking in vivo thermal activity by cost-effective telemetric sensing has the potential of offering earlier treatment assessment to patients without requiring complex imaging or lab testing. Multi-parametric on-demand monitoring of tumor microenvironment by permanent implants and its integration into health information systems could further advance cancer management and reduce patient burden.

A review on titanium and titanium alloys with other metals for biomedical applications prepared by powder metallurgy techniques

Titanium-based materials are of growing interest as biocompatible structural materials with improved mechanical properties and biocompatibility in various biomedical applications. Traditionally, one of the main factors hindering the broader use of this class of materials has been the relatively high manufacturing cost. Manufacturing such alloys via powder metallurgy allows for reducing costs and developing innovative compositions that are not otherwise achievable. However, titanium alloys are expensive and, unless surface treated, generally cannot prevent surgical infections related to bacteria which can damage the integrity of the implant. This paper aims to classify the research undertaken to define the manufactured Titanium-based materials that fulfill the requirements for structural and biomedical implants, which have antibacterial responses making their potential applications for permanent medical implants.

Development, Processing and Aging of Novel Zn-Ag-Cu Based Biodegradable Alloys.

The use of biodegradable materials for implants is a promising strategy to overcome known long-term clinical complications related to permanent implants. Ideally, biodegradable implants support the damaged tissue for a certain period and then degrade, while the physiological function of the surrounding tissue is restored. Although Mg-based alloys nearly ideally lend themselves to biodegradable implants, a few critical shortcomings promoted the development of alternative alloy systems. Due to their reasonably good biocompatibility, moderate corrosion rate without hydrogen evolution and adequate mechanical properties, increasing attention has been paid to Zn alloys. In this work, precipitation-hardening alloys in the system Zn-Ag-Cu were developed relying on thermodynamic calculations. After casting the alloys, their microstructures were refined by thermomechanical treatment. The processing was tracked and directed, respectively, by routine investigations of the microstructure, associated with hardness assessments. Although microstructure refinement increased the hardness, the material proved to be susceptible to aging as the homologous temperature of zinc is at 0.43 Tm. Besides mechanical performance and corrosion rate, long-term mechanical stability is another crucial factor that must be taken into consideration to ensure the safety of the implant and thus requires a profound understanding of the aging process.

MP51-15 TEMPORARILY IMPLANTED NITINOL DEVICE VERSUS PROSTATIC URETHRAL LIFT FOR MINIMALLY INVASIVE SURGICAL TREATMENT OF BENIGN PROSTATIC HYPERPLASIA WITH LOWER URINARY TRACT SYMPTOMS: A MATCHING-ADJUSTED INDIRECT COMPARISON

You have accessJournal of UrologyCME1 Apr 2023MP51-15 TEMPORARILY IMPLANTED NITINOL DEVICE VERSUS PROSTATIC URETHRAL LIFT FOR MINIMALLY INVASIVE SURGICAL TREATMENT OF BENIGN PROSTATIC HYPERPLASIA WITH LOWER URINARY TRACT SYMPTOMS: A MATCHING-ADJUSTED INDIRECT COMPARISON Kenneth M. Kernen, Shalina Omar, Bradley Goodnight, Paul Skodny, Stuart Bruce, and Tiffany M. Yu Kenneth M. KernenKenneth M. Kernen More articles by this author , Shalina OmarShalina Omar More articles by this author , Bradley GoodnightBradley Goodnight More articles by this author , Paul SkodnyPaul Skodny More articles by this author , Stuart BruceStuart Bruce More articles by this author , and Tiffany M. YuTiffany M. Yu More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003299.15AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To compare the safety and efficacy of the temporarily implanted nitinol device (iTind) versus prostatic urethral lift (PUL) for minimally invasive surgical treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. iTind treatment uses a single temporary implant removed after 5-7 days, while PUL uses multiple permanent implants. METHODS: Matching-adjusted indirect comparison (MAIC) was used to account for population differences across seven clinical trials identified by systematic literature review. Individual patient data from two iTind trials and aggregated data from five PUL trials were included. Safety and efficacy outcomes at 12 months post-treatment were compared between the matching-adjusted iTind population and pooled PUL population. RESULTS: iTind patients were significantly less likely than PUL patients to experience treatment-related adverse events (AEs) within three months (25.0% vs 79.8%; p<0.001), including dysuria (17.8% vs 34.7%; p=0.001), hematuria (12.0% vs 25.9%; p=0.002), and pain (9.5% vs 18.7%; p=0.023). Rates of treatment-related AEs from three to 12 months were also significantly lower among iTind than PUL patients (2.6% vs 24.4%; p<0.001). iTind and PUL efficacy outcomes were statistically equivalent on changes from baseline to 12 months on the International Prostate Symptom Score (IPSS, p=0.56), quality of life (QoL, p=0.21), Qmax (p=0.39), post-void residual volume (PVR, p=0.16), and the Sexual Health Inventory for Men (SHIM, p=0.14). CONCLUSIONS: This MAIC found superior safety and reduced risks of early and later treatment-related AEs with iTind versus PUL. The twelve-month efficacy was equivalent on subjective urinary symptoms (IPSS, QoL) and objective urinary symptoms (Qmax, PVR) and preservation of sexual function (SHIM). This study finds that the iTind temporary device provides an improved safety profile with equivalent efficacy compared to PUL permanent implants for patients with benign prostatic hyperplasia with lower urinary tract symptoms. Source of Funding: Financial support for this research was provided by Olympus Corporation of the Americas © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e699 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kenneth M. Kernen More articles by this author Shalina Omar More articles by this author Bradley Goodnight More articles by this author Paul Skodny More articles by this author Stuart Bruce More articles by this author Tiffany M. Yu More articles by this author Expand All Advertisement PDF downloadLoading ...

Pain Relief With Peripheral Nerve Stimulation of Superficial Cervical Plexus: A Case Report and Literature Review

BACKGROUND: Neuropathic head and facial pain are relatively common and difficult to treat pain syndromes encountered in pain clinics throughout the world. Atypical syndromes with overlapping nerve distributions can be particularly frustrating for patients and providers. In recent years, as providers search for alternatives to medications, advances in neuromodulation technology, including spinal cord stimulation and peripheral nerve stimulation (PNS), have shown promise in treating neuropathic pain confined to specific nerve distributions, such as the greater and lesser occipital nerves. However, there is limited literature describing the use of PNS for atypical facial pain. We report the first known case of PNS to the superficial cervical plexus in a 45-year-old woman with bilateral ear and postauricular pain. CASE REPORT: A 45-year-old woman presented with over 6 years of bilateral ear and periauricular pain in the auriculotemporal and lesser occipital nerve distribution. Conservative management, including neuropathic pain agents, ketamine infusions, nasal sprays, opioids, nonsteroidal anti-inflammatory medications, ice, heat, and transcutaneous neurostimulation, provided limited relief. She had excellent pain control with a series of nerve blocks to the superficial cervical plexus; however, relief was short term. In an attempt for a more long-term solution, she underwent implantation of the SPRINT PNS (MicroLead, SPR Therapeutics, Cleveland, OH), which resulted in 100% pain relief, improved function at work, and improved sleep tolerance throughout the 60-day treatment. Unfortunately, her symptoms returned shortly after treatment course completion. CONCLUSIONS: To our knowledge, this is the first case utilizing PNS of the superficial cervical plexus to treat atypical facial pain. The 60-day trial resulted in 100% pain relief of previously debilitating and functionally limiting pain symptoms during the treatment phase suggesting that the superficial cervical plexus may be a reasonable target for permanent PNS implants. KEY WORDS: Peripheral nerve stimulator, peripheral nerve stimulation, superficial cervical plexus, atypical facial pain, anesthetic blockade, pain relief, neuropathic pain, neuromodulation, SPRINT

Predicting Final Implant Volume in Two-Stage Prepectoral Breast Reconstruction

Introduction: Two-stage implant based breast reconstruction remains the most commonly performed post-mastectomy reconstruction. While prior studies have explored the relationship between tissue expander (TE) features and permanent implant (PI) size in subpectoral reconstruction, recent trends have demonstrated a shift towards prepectoral implant placement with acellular dermal matrix (ADM). This study aims to identify pertinent TE characteristics and evaluate their correlations with PI size for prepectoral implant-based reconstructions. Materials and Methods: This study analyzed patients who underwent two-stage prepectoral tissue expansion for breast reconstruction followed by implant placement at single institution. Exclusion criteria were delayed, autologous, and direct-to-implant breast reconstruction patients. Clinical and demographic patient data were collected for the cohort. TE and PI features were recorded, along with mean TE size, PI size, and mean mastectomy weights. Significant predictors for PI volume were identified with regression analysis. Results: We identified 177 patients and 296 breast reconstructions that met the inclusion criteria. Multivariate analysis identified significant variables for PI size prediction, including mastectomy weight (R2=0.42; p<0.0001), TE size (R2=0.60; p<0.0001), and TE final fill (R2=0.57; p<0.0001). The prediction expression was calculated to model the correlation: PI size = 26.6 + 0.38*(TE final fill) + 0.61*(TE size). Conclusion: Tissue expander size, final expansion volume, and mastectomy weight were significant variables for implant size prediction. The formula yielded significant regression coefficient values for TE size and final fill. With prepectoral implant placement gaining popularity, this algorithm may help optimize preoperative planning for prepectoral reconstructions.