Explantation Of Prosthesis Research Articles

Abstract 4112591: Delayed Migration of a Valve-in-Valve Transcatheter Aortic Valve Replacement

Introduction: Migration of a transcatheter aortic valve replacement (TAVR) is a rare, life-threatening complication that typically occurs during or shortly after the procedure. We present a unique case of an exceptionally rare, delayed migration of a valve-in-valve TAVR three years post-procedure that was subsequently treated with surgical explantation of the TAVR prosthesis and surgical aortic valve replacement (SAVR). Clinical Case: A 64-year-old male presented to an outpatient cardiology visit with one month of exertional dyspnea and near-syncopal episodes with a new diastolic murmur. Notable history included aortic regurgitation due to bicuspid aortic valve resulting in subcoronary implantation of a 27 mm Medtronic Freestyle stentless porcine bioprosthesis 20 years prior to presentation. Following the development of severe bioprosthetic regurgitation, a valve-in-valve TAVR with a 26 mm Edwards SAPIEN 3 Ultra was implanted 3 years prior to presentation with no evidence of stenosis or regurgitation on transthoracic echocardiograms completed 1 month and 1 year after implantation. Transesophageal echocardiogram now demonstrated migration of the TAVR valve into the left ventricular outflow tract 2 cm proximal to the surgical bioprosthesis. Severe eccentric transvalvular regurgitant flow through the surgical bioprosthesis and severe paravalvular regurgitation around the TAVR valve was seen with an unstable “rocking appearance”. No evidence of abscess or endocarditis was appreciated and blood cultures showed no growth. Following a short hospitalization, the patient underwent TAVR explantation and implantation of a 25 mm Edwards Inspiris Resilia stented bovine bioprosthesis with subsequent resolution of his symptoms. Discussion: Recognizing atypical presentations of TAVR complications such as delayed valve migration is facilitated by understanding key risk factors. This case highlights notable risk factors for TAVR migration including a valve-in-valve TAVR over a degenerative regurgitant bioprosthesis, decreased aortic annulus calcification resulting in suboptimal anchoring, the patient’s younger age, and the lack of a radiopaque marker on the stentless bioprosthesis which increases the potential for malpositioning.

Trends in the use of testicular prostheses in Germany: a total population analysis from 2006-2021.

Testicular tumors are the most common malignancies in young adults and their incidence is growing. The implantation of a testicular prosthesis, for example, during orchiectomy is a standard procedure but its frequency in Germany is unknown. This study aims to analyze trends of testicular prosthesis implantation in recent years in Germany. The nationwide German hospital billing database and the German hospital quality reports from 2006 to 2021 were studied. A total of 12,753 surgical procedures with implantation of testicular prosthesis and 1,244 procedures with testicular prosthesis explantation were included. Testicular prosthesis implantation increased in total from 699 cases in 2006 to 870 cases in 2020 (+11.4 cases/year; p<0.001). The share of implantation of testicular prosthesis due to testicular tumor decreased from 72.6% in 2006 to 67.5% in 2020 (p<0.001). The share of implantation due to gender affirming surgery increased from 6.8% in 2006 to 23.3% in 2020 (p<0.001). The share of implantation due to testicular atrophy decreased from 11.4% in 2006 to 3.4% in 2020 (p<0.001). Simultaneous implantation of testicular prosthesis during orchiectomy for testicular cancer increased from 7.8% in 2006 to 11.4% in 2020 (p<0.001). In 2006, 146 hospitals (85%) performed<5 testicular prosthesis implantation, while 20 hospitals (12%) performed 5-15 implantation procedures and 6 hospitals (3%) performed>15 testicular implantation surgeries. In 2021, 115 hospitals (72%) performed<5 testicular prosthesis implantation, while 39 hospitals (25%) performed 5-15 implantation procedures and 5 hospitals (3%) performed>15 testicular implantation surgeries. This study shows that implantation of testicular prostheses is steadily increasing. Explantation rates are low. Besides testicular cancer transgender surgeries were the main driver for increasing case numbers in recent years.

Periprosthetic Joint Infections of the Knee Lastingly Impact the Bone Homeostasis.

After periprosthetic joint infection (PJI)-dependent revision surgery, a significantly elevated number of patients suffer from prosthesis failure due to aseptic loosening and require additional revision surgery despite clearance of the initial infection. The mechanisms underlying this pathology are not well understood, as it has been assumed that the bone stock recovers after revision surgery. Despite clinical evidence suggesting decreased osteogenic potential in PJI, understanding of the underlying biology remains limited. In this study, we investigated the impact of PJI on bone homeostasis in a two-stage exchange approach at explantation and reimplantation. Sixty-four human tibial and femoral specimens (20 control, 20 PJI septic explantation, and 24 PJI prosthesis reimplantation samples) were analyzed for their bone microstructure, cellular composition, and expression of relevant genetic markers. Samples were analyzed using X-ray microtomography, Alcian blue and tartrate-resistant acid phosphatase staining, and RT-qPCR. In patients with PJI, bone volume (BV/TV; 0.173 ± 0.026; p < 0.001), trabecular thickness (164.262 ± 18.841 μm; p < 0.001), and bone mineral density (0.824 ± 0.017 g/cm2 ; p = 0.049) were reduced; trabecular separation (1833.939 ± 178.501 μm; p = 0.005) was increased. While prevalence of osteoclasts was elevated (N.Oc/BS: 0.663 ± 0.102, p < 0.001), osteoblast cell numbers were lower at explantation (N.Ob/BS: 0.149 ± 0.021; p = 0.047). Mean expression of bone homeostasis markers osteocalcin, osteopontin, Runx2, TSG-6, and FGF-2 was significantly reduced at prosthesis explantation. Despite partial recovery, all analyzed parameters were still significantly impacted at reimplantation. In contrast, mean expression of osteoclastogenesis-stimulating cytokine IL-17a was significantly increased at both explantation and reimplantation. In this study, we found a strong and lasting impact of PJI on the bone homeostasis on a molecular, cellular, and microstructural level. These changes may be responsible for the increased risk of prosthesis failure due to aseptic loosening. Our data suggest there is significant potential in modulating bone homeostasis to improve prosthesis fixation and long-term clinical outcome in affected patients. © 2023 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

(247) Complication Rates After Penile Prostheses In Men with History of Priapism – A Retrospective Claims Database Cohort Analysis

Abstract Introduction Penile prostheses can be placed in men with a history of priapism who develop erectile dysfunction, or as initial management of acute ischemic priapism. However, little is known about long-term complications associated with prostheses in these men. Objective To assess the risk of penile prosthesis complications in men with a history of priapism. Methods We searched the TriNetX insurance claims database to create a cohort of men ages ≥16 years old with 1) a diagnosis of priapism (ICD-10: N48.4), 2) a diagnosis of erectile dysfunction (ICD-10: N52), and 3) had undergone prosthesis placement (insertion of penile prosthesis inflatable and self-contained [CPT: 54401], insertion of semi-rigid penile prosthesis [CPT 54400], or insertion of multiple component inflatable penile prosthesis [CPT: 54405]). Three complications were assessed: penile prosthesis infection (ICD-10: T83.61), penile prosthesis mechanical breakdown (ICD-10: T83.410A), and penile prosthesis displacement or migration (ICD-10: T83.420). Rates of and duration to IPP removal (CPT: 54415-17, 54406, 54410-11) were also assessed. To compare rates of complications, the priapism cohort was compared to a cohort of men with a diagnosis of erectile dysfunction and prosthesis placement but without a history of priapism or corpora cavernosal irrigation, matched by age, race, diabetes status, and obesity (E66). When assessing risk of prosthesis complications, we utilized 1:1 greedy nearest-neighbor propensity score matching to control for confounding variables. Results A total of 665 men were identified with a diagnosis of priapism and erectile dysfunction who subsequently received a penile prosthesis. A control group of 31,345 patients with erectile dysfunction and a penile prosthesis but without priapism or history of irrigation was identified, and ultimately 660 men in the case and control cohorts were matched by age, race, diabetes status, and obesity. Men of with a history of priapism were more likely to experience penile prosthesis infection (5.0% vs 2.7%; Risk Ratio (RR): 1.83, 95% Confidence Interval (CI) 1.04-3.22) and mechanical breakdown of the prosthesis (7.3% vs 3.8%, RR: 1.92, 95%CI 1.20-3.08). There was no difference in the rate of penile prosthesis displacement or migration (3.5% vs 2.4%, RR: 0.76, 95%CI 0.77-2.70). Overall rates of penile prosthesis explantation were higher in men with a history of priapism 14.6% vs 8.4% (RR: 1.73, 95%CI 1.27-2.36). Rates of early explantation (within 6 months of placement) were similar between the two groups, 3.3% vs 2.9% (RR: 1.16, 95%CI 0.63-2.11). Rate of explantation of semi-rigid prostheses were significantly higher in men with a history of priapism, 27% vs 9.6% (RR: 2.54, 95%CI 1.62-3.93). Of the 17 men undergoing explantation of semi-rigid prosthesis with history of priapism, only 4 men (23%) went on to have a 3-piece penile prosthesis placed. Conclusions In this US claims-based database comparison between prosthetic complications in men with and without a history of priapism, men with priapism were more likely to experience infection, mechanical breakdown and explantation. There was no difference in rate of device displacement or migration, or in timing of device explantation. This real-world data provides context for counseling men with priapism who undergo prosthesis placement. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Urogen Pharma, Janssen Global Services, Regeneron Pharmaceuticals

Immune modulation as a potential treatment strategy to salvage the bone metabolism after periprosthetic joint infection

Background: In arthroplasty, periprosthetic joint infection (PJI) is one of the most disastrous postoperative complications with high long-term failure rates despite successful revision surgery. PJI causes a pro-inflammatory environment in the surrounding bone stock that subsequently results in compromised bone metabolism. This increases the risk for unstructured bone-resorption potentially leading to aseptic loosening. We hypothesize that PD-1-positive monocytes and monocyte-derived osteoclasts play a significant role in this pathology. In this study, we assessed the presence of PD-1-positive monocytes and their osteoclastogenic differentiation potential, as well as resulting osteoclast activity in PJI. We also investigated anti-PD-1-antibody as a potential salvage therapy. Material and Methods: Peripheral blood specimens were collected from 15 patients undergoing knee arthroplasty (ctrl) or prosthesis explantation due to PJI. Peripheral blood mononuclear cells were isolated and stained for CD33, CD11b, and CD14. Osteoclastic differentiation was induced ± PD-L1 and ± anti-PD-1-antibody. Osteoclast number and function were determined by pit assay, TRAP staining and qPCR. Results: Monocyte cell count (0.86±0.35 v 0.21±0.03/nl, p=.02) and PD-1 expression on monocytes (92.50±6.83 v 35.34±15.43%, p&lt;.01) waselevated in patients with PJI. After differentiation, in PJI, total osteoclast surface area was larger (47.40±3.19% v 26.75±3.49%, p&lt;.01) and increased significantly further (+64.04±1.72%, p&lt;.01) after PD-L1 stimulation. Addition of PD-1 inhibitor reduced osteoclast surface area in PJI (36.51±3.95 v 64.04±1.72%, p&lt;.01). Expression of osteoclast differentiation marker Nfatc1 and Ctsk were higher in the PJI group ( Nfatc1: 1.09±0.20 v 0.45±0.06, p&lt;.01; Ctsk: 2.27±1.00 v 0.73±0.23, p=.02), but did not differ in Mmp9 and Acp5 expression. In PJI, the expression of all four genes were upregulated after PD-L1 stimulation, while PD-1 inhibitor treatment reversed this effect. PD-L1 stimulation led to increased osteoclast bone resorption compared to without stimulation (7.65±3.15 v 2.49±0.67%, p=.05), while addition of PD-1 inhibitor showed no influence in the ctrl group. In PJI, osteoclast surface resorption was increased after PD-L1 stimulation (20.69±6.54 v 8.06±1.54, p=.01). Conversely, osteoclast function was reduced after treatment with PD-1 inhibitor (4.23±0.55 v 8.06±1.54, p=.03). Conclusion: Elevated numbers of monocytic osteoclast-progenitor cells and increased osteoclastic differentiation and function may contribute to decreased bone volume and impact prosthesis osseointegration in patients with PJI. Our results show PD-L1 can stimulate osteoclast generation and function and that this can be reversed by PD-1 inhibitor. This effect is particularly prominent in PJI. Targeting PD-1 can be a potential therapy to inhibit monocyte-mediated osteoclastogenesis while retaining anti-microbial activity of macrophages to limit the impact of PJI on the bone stock. Dr. Arne Kienzle is participant in the BIH-Charité Junior Clinician Scientist Program funded by the Charité - Universitätsmedizin Berlin and the Berlin Institute of Health. The authors wish to acknowledge the support of the non-profit German Arthritis Society (Deutsche Arthrose-Hilfe e.V.) and its president Helmut H. Huberti, MD by grant P482. This is the full abstract presented at the American Physiology Summit 2023 meeting and is only available in HTML format. There are no additional versions or additional content available for this abstract. Physiology was not involved in the peer review process.

Inflammation of Bone in Patients with Periprosthetic Joint Infections of the Knee.

In this study, we analyzed 75 human bone and bone-marrow specimens (obtained from 65 patients undergoing revision arthroplasty with cement for the treatment of PJI) for markers of inflammation. Samples were analyzed using hematoxylin and eosin overview staining, fluorescent immunohistochemical staining, flow cytometry, and polymerase chain reaction (PCR). Leukocyte prevalence was significantly elevated at explantation (femur, +218.9%; tibia, +134.2%). While leukocyte prevalence decreased at reimplantation (femur, -49.5%; tibia, -34.2%), the number of cells remained significantly higher compared with the control group (femur, +61.2%; tibia, +54.2%). Expression of inflammatory markers interleukin (IL)-1α (femur, +2,748.7%; tibia, +1,605.9%), IL-6 (femur, +2,062.5%; tibia, +2,385.7%), IL-10 (femur, +913.7%; tibia, +897.5%), IL-12 (femur, +386.1%; tibia, +52.5%), IL-18 (femur, +805.3%; tibia, +547.7%), and tumor necrosis factor (TNF)-α (femur, +296.9%; tibia, +220.9%) was significantly elevated at prosthesis explantation in both femoral and tibial specimens. Expression remained significantly elevated at reimplantation for all inflammatory markers except IL-12 compared with the control group. Conversely, there were only limited inflammatory changes in the bone marrow environment. The present study demonstrated a strong and lasting upregulation of the proinflammatory environment in the joint-surrounding osseous scaffold in patients with PJI. Our data suggest that modulating the inflammatory environment has substantial potential to improve the clinical outcome in affected patients.

Complications related to the access site after transaxillary implantation of a microaxial left ventricular assist device

Impella 5.0 and 5.5 (summarized as Impella 5+) are microaxial, catheter-based left ventricular assist devices (LVAD) that are implanted via a vascular graft sutured to the axillary artery and provide blood flow of up to 5.5 liter/min. This study aims to investigate the incidence of long-term complications following circulatory support with Impella 5+. A single-center retrospective analysis of 203 consecutive adult patients treated between January 2017 and September 2021 with a surgically implanted Impella 5.0 or 5.5 via a vascular graft sutured to the axillary artery. The median Impella support duration was 8 days. Of 203 patients, 78 (38.4%) died while on temporary mechanical circulatory support. Fifty-five (27.1%) were successfully weaned from Impella 5+ and 70 (34.5%) were bridged to a durable LVAD with a median follow-up time of 232 (IQR 68.5, 597) days after Impella 5+ explantation. In 119 of these patients, the Impella was explanted and the vascular graft was shortened, ligated, and pushed under the pectoralis muscle; in 6 patients early graft infection prompted complete graft removal during explantation. In addition, 13 patients (10.9%) developed a late-onset graft infection after a median of 86 days, requiring complete (n=10) or partial (n=2) explantation of the retained graft. In 1 patient, the graft infection was successfully treated by conservative therapy. Our analysis identified no specific risk factors for graft infections. Of the 203 patients, 5 (2.5%) developed a brachial plexus injury resulting in neurological dysfunction. In 10.9% of patients, retaining the vascular graft was complicated by a late graft infection. Complete explantation of the graft prosthesis may decrease the infection rate, but may in turn increase the risk of brachial plexus injury. On the other hand, this method offers the possibility of bedside explantation.

991. Single Center, Exploratory, Open-label Prospective Study Using the Minimally Invasive LysinDAIR Procedure (Lysin Administration During an Arthroscopic DAIR Procedure) in Patients with Suspected Relapsing Chronic Coagulase-Negative Staphylococci (CNS) Prosthetic Hip Infection (PHI)

Abstract Background Exebacase, a recombinant staphylococcal lysin, has: (i) reported proof-of-concept data in Phase II in S. aureus bacteremia; (ii) demonstrated antibiofilm activity in vitro against S. epidermidis; and (iii) been used as salvage therapy in 4 patients with relapsing multidrug-resistant (MDR) S. epidermidis knee prosthetic joint infection (PJI) using the LysinDAIR (arthroscopic administration of exebacase [Lysin] with Debridement and Antibiotics Implant Retention) procedure. Surgical treatment of recurrent PHIs has high risk of morbidity and loss of function. We now report our experience with the LysinDAIR procedure for PHIs. Methods We performed a single center, exploratory, open-label prospective study using LysinDAIR and suppressive antimicrobial therapy (SAT) in patients with recurrent, chronic (inoculation &amp;gt;3 months prior to treatment) CNS PHI. In agreement with the French Health authority, exebacase (2 to 3.5 total mg in 30-50 ml [∼0.067 – 0.075 mg/ml]) was arthroscopically administered directly into the joint. Results Three consecutive patients were included (55 to 75 years). All had previous iterative hip prosthesis exchange with a high total number of surgeries (from 6 to 10) and recent persistent or intermittent fistula (Figure). All refused hip prosthesis explantation or surgeon considered explantation too high risk for loss of function and severe post-operative complications. Patients A and B had MDR S. epidermidis; Patient B had P. aeruginosa co-infection at the time of LysinDAIR. Patient C had a prior persistent S. lugdunensis PHI and relapse on arthrocentesis; K. pneumoniae was cultured at the time of LysinDAIR. No adverse events related to exebacase or the procedure were reported. At 2 years follow up, all patients had resolution of fistula and no clinical signs of infection on SAT (tedizolid (+/- ciprofloxacin [Patient B] or cotrimoxazole [Patient C]). Description of the patients treated with the LysinDAIR procedure Local signs of infection with discharge of the three patients (A, B and C) with complex relapsing prosthetic hip infection with X-ray before the LysinDAIR procedure and at 2 years of follow-up Conclusion The LysinDAIR procedure was easy-to-perform, safe and may have therapeutic potential to facilitate the success of SAT salvage therapy for chronic relapsing CNS PJIs, and potential cure of initial chronic PJI. Randomized clinical trials evaluating the LysinDAIR procedure in these clinical situations are clearly warranted. Disclosures Tristan Ferry, MD, PhD, Contrafect: Advisor/Consultant Camille Kolenda, n/a, Contrafect: Research grant frederic Laurent, n/a, Contrafect: Research grant cara cassino, n/a, Contrafect: Employee.

Fold Flaps to the Rescue in Postmastectomy Breast Reconstruction.

Ischemic complications following postmastectomy breast reconstruction are not uncommon and can lead to reconstructive failure, especially with implant reconstruction. The authors propose a simple local flap for management of such complications. This flap is easily raised from the upper abdomen or lateral chest as a medially or laterally based fasciocutaneous flap, and the donor site is hidden in the inframammary or lateral mammary fold. The authors present a case series of these "fold flaps" that were used to manage complications following implant-based breast reconstruction. All patients between 2007 and 2021 who underwent a fold flap for breast reconstruction salvage were queried from a prospectively maintained database. Demographic variables, clinical factors, and surgical details were analyzed. Outcomes assessed included complications, appropriate wound healing, and reconstructive salvage. Fourteen patients underwent thoracoepigastric or thoracoabdominal fold flaps following breast reconstruction for soft-tissue coverage with an underlying prosthesis. The mean age was 54 years, mean body mass index was 30 kg/m 2 , and mean follow-up duration was 18.5 months. Fold flap indications included mastectomy skin flap necrosis ( n = 9), infection ( n = 4), and chronic seroma ( n = 1). Eleven reconstructions (79%) were salvaged and three (21%) required eventual prosthesis explantation secondary to infection or delayed wound healing. Fold flaps are a reliable option for managing ischemic complications following postmastectomy breast reconstruction. The benefits include improved soft-tissue coverage with a high salvage rate. These flaps are simple to raise, and their donor site is concealed within the folds. Furthermore, they provide a reliable early option to manage complications and potentially prevent reconstructive failure. Therapeutic, IV.

Single Institution Evolution in Defining an Algorithm for Prevention and Management of Severe Complications in Direct-to-Implant Breast Reconstruction

Complications including infection and wound dehiscence are major concerns for direct-to-implant breast reconstruction. However, the risk factors associated with severe complications and implant salvage remain unclear. This was a retrospective study of all patients undergoing unilateral direct-to-implant breast reconstruction from 2014 through 2019. The risk factors associated with complications and prosthesis explantation were identified using multivariate logistic regression modeling and interaction analyses. Among 1027 patients enrolled, 90 experienced severe complications, 41 of whom underwent prosthesis explantation; 49 were successfully salvaged. Multivariate analysis demonstrated that patients with larger implant size ( p = 0.003), use of bovine mesh ( p < 0.001), adjuvant radiotherapy ( p = 0.047), low plasma albumin ( p = 0.013), and elevated blood glucose ( p = 0.006) were significantly more likely to have complications. Adjuvant radiation therapy (OR, 7.44; 95 percent CI, 1.49 to 37.18; p = 0.014) and obesity (OR, 4.17; 95 percent CI, 1.17 to 14.88; p = 0.028) were associated with significantly lower rates of implant salvage and surgical-site infection and wound dehiscence, whereas mastectomy skin flap necrosis was not associated with device explantation. There were no differences in complication and explantation rates between nipple-sparing and skin-sparing mastectomies. However, the combined impact of surgical-site infection and wound dehiscence added a greater than 14-fold higher risk of prosthesis explantation (95 percent CI, 9.97 to 19.53). Success in direct-to-implant breast reconstruction is multifactorial. Larger implant size, adjuvant radiation therapy, diabetes, and malnutrition demonstrate increased risk of complications in the direct-to-implant approach. Surgical-site infections and wound dehiscence should be treated aggressively, but the combination of both complications portends poor salvage rates. Risk, III.

The Effect of Early versus Late Manipulation Under Anesthesia on Opioid Use, Surgical Complications, and Revision Following Total Knee Arthroplasty.

Previous studies of early versus late manipulation under anesthesia (MUA) do not report on postoperative opioid utilization or revisions and focused on small single-institution retrospective cohorts. The PearlDiver Research Program (www.pearldiverinc.com), which uses an all-inclusive insurance database, was used to identify patients undergoing primary total knee arthroplasty (TKA) who received (1) late MUA (>12 weeks), (2) early MUA (≤12 weeks), or (3) TKA only. To develop the control group cohort of TKA-only patients, 3:1 matching was conducted using 11 risk factor variables deemed significant by chi-squared analysis. Complications and opioid utilization were compared through multivariate regression analysis, controlling for age, gender, and Charlson Comorbidity Index. The risk of TKA revision was assessed through Cox-proportional hazards modeling and Kaplan-Meier survival analysis with log-rank test. Between 2011 and 2017, 2,062 TKA patients with early MUA, 1,112 TKA patients with late MUA, and a control cohort of 8,327 TKA-only patients were identified in the database. The percent of patients registering opioid use decreased from 54.6% 1 month pre-MUA to 4.6% (p < 0.0001) 1 month post-MUA following early MUA, whereas only from 32.6 to 10.4% (p < 0.0001) following late MUA. Late MUA was associated with higher risk of repeat MUA at 6 months (adjusted odds ratio [aOR] = 2.74, p < 0.0001), 1 year (aOR = 2.66, p < 0.0001), and 2 years (aOR = 2.63, p < 0.0001) following index MUA. Hazards modeling and survival analysis showed increased risk of TKA revision following late MUA (adjusted hazard ratio [aHR] = 3.50, 95% confidence interval [CI]: 2.77-4.43, p < 0.0001) compared to early MUA (aHR = 2.15, 95% CI: 1.72-2.70, p < 0.0001), with significant differences in survival to revision curves (p < 0.0001). When compared to early MUA at 1 year, late MUA was associated with a significantly increased risk of prosthesis explantation (aOR = 2.89, p = 0.0026 vs. aOR = 0.93, p = 0.8563). MUA within 12 weeks after index TKA had improved pain resolution and significant curtailing of opioid use. Furthermore, late MUA was associated with prolonged opioid use, increased risks of revision, as well as prosthesis explantation, supporting screening and early intervention in cases of slow progression and stiffness. The level of evidence of this study is III.

The International Penile Prosthesis Implant Consensus Forum: clinical recommendations and surgical principles on the inflatable 3-piece penile prosthesis implant.

Despite significant scientific advances in the modern three-piece inflatable penile prosthesis implant surgery, it is not without surgical risks and can carry additional cosmetic and psychosocial consequences in poorly selected and consented individuals. To address this problem, an international group of key opinion leaders and high-volume prosthetic surgeons reviewed the current guidelines and clinical evidence, discussed their experiences, and formed a consensus regarding inflatable penile prosthesis surgery. The findings of this consensus panel were presented at the 17th biennial Asia Pacific Society of Sexual Medicine scientific meeting. The experts concluded that proper patient selection, informed consent and strict adherence to safe surgical principles are important to optimize clinical outcomes. Furthermore, most intraoperative complications, if recognized, can be addressed intraoperatively to enable placement of the device at the time of initial surgery. Men with significant corporal fibrosis due to Peyronie's disease, prior prosthesis explantation and priapism, and men who have undergone construction of a neophallus, as well as men who receive concurrent continence surgery, are complex cases requiring additional care and advanced techniques to obtain optimal surgical outcomes. Variability in patient care - in terms of postoperative antibiotic use, pain management, scrotal care, and cycling of the penile prosthesis implant - must be reduced to enable optimization and assessment of outcomes across patient groups.

Repeated prosthetics of the ascending aorta and aortic arch with a homograft for prosthesis infection and ruptured aorta after Bentalla de Bono operation

Prosthetic vascular graft infection is a formidable complication after cardiac surgery. Until now, the question on the tactics of managing such patients remains open, as well as the timing of each of the treatment methods such as conservative antibiotic therapy and surgery. In addition, the choice of a method of surgical treatment in itself poses new questions for specialists in regard to what methods to adhere to including prosthesis-preserving technique, prosthesis explantation and its replacement with a synthetic or biological graft, and the use of omentum to cover the infected bed. We present a case of treating a patient with an infected synthetic valve-containing conduit after Bentall de Bono operation and aortic rupture with the formation of false aneurysms. Attention is drawn to the prolonged clinical patient condition manifesting with fever, and the lack of data suggesting an infectious process according to positron-emission tomography and blood cultures. We chose a homograft of the ascending aortic and aortic arch with aortic valve as a conduit. It is also of interest that cultures of infectious prosthesis and aortic valve did not reveal any infectious agent. Aggressive antibiotic therapy in combination with surgical replacement of the infected prosthesis with a cryoprepared allograft allowed for successful treatment of patient without complications.

The Failed Breast Implant in Postmastectomy Reconstruction: A Systematic Literature Review of Complications of Implant-Based Breast Reconstruction.

Breast cancer is the most diagnosed malignant neoplasia of female patients worldwide in 2019. Survival has increased making it necessary to offer breast reconstructive procedures to improve quality of life and self-esteem. Implant-based breast reconstruction is the most common approach, making it necessary to quantify the associated complications. A systematic literature review of the PubMed, Cochrane, and Web of Science databases was performed. A total of 9608 citations were identified, and 44 studies met the inclusion criteria. Studies included reported the incidence of complications either per patient or per breast leading consequently to 2 complication rates depending on the type of reporting. A total of 14.3% of patient-related and 28.8% of breast-related complications while undergoing implant-based reconstruction were reported.Among total complications reported, 72.6% of patient-related and 48.5% of breast-related complications were classified as major complications.A total of 37.6% of patients respectively 15.1% of breasts required prosthesis explantation due to severe complications. Depending on reporting, 9.7% of patients and 4% of breasts required autologous flap reconstruction due to reconstructive failure. High complication and failure rates are associated with implant-based breast reconstruction. Lacking randomized controlled trials, the choice between implant-based and autologous breast reconstruction has to be made individually for each patient.

Two-stage exchange for PJI with co-existing cerclages for fracture: higher rates of early re-infections and difficult to treat microbes

IntroductionPeriprosthetic joint infections (PJI) with osteosynthesis material for contemporaneous fractures are a challenging, yet poorly described condition. This study will analyze PJI with co-existing fractures treated with cerclages and two-stage exchange.Materials and methodsPatients with and without cerclages for coexisting periprosthetic fractures, undergoing two-stage exchange for PJI of hip or knee, between 06/2013 and 02/2016, were compared concerning baseline characteristics and re-infection rate in the course of a 2 year follow-up. All patients were treated with a standardized two-stage protocol. A PJI was defined according to the EBJIS criteria. All foreign material, including cerclages, was sent in for sonication for microbiological analysis.ResultsNinety-six patients treated with two-stage exchange for PJI could be included. Co-existing fractures treated with cerclage were identified in nine patients (9.3%, study group). Diaphyseal femoral simple in five cases (AO2A3) and proximal intertrochanteric in three cases (AO1A3) were the leading fracture locations. In one patient, cerclage implantation was performed prior to prosthesis explantation, in six, during prosthesis explantation, and in two, in the course of prosthesis reimplantation. The study group showed a significantly higher rate of difficult to treat microbes (44.4%; 8.0%; p = .001), Charlson Comorbidity Index (5.4; 3.7; p = .033), relapse infections with the same microbe (22.2%; 1.1%; p = .001), and early-onset infections (< 30 days) (11.1%; 1.1%; p = .046), than the comparison two-stage exchange group without fractures. In contrast, age (72.5 study group; 68.2 comparison group; p = .224), rate of revisions for PJI in the past (55.5%; 51.7%; p = .827), and total re-infection rate (22.2%; 10.3%; p = .287) did not show a difference.ConclusionPJI with co-existing cerclages for fractures were associated with multi-resistant microbes, relapse by the same microbe and early-onset re-infections. Cerclages might be considered a potential source of re-infection during a two-stage exchange. However, statistical weaknesses and a small study group must be considered limitations of the study.

Antibiotic Therapy in 2-Stage Revision for Periprosthetic Joint Infection: A Systematic Review.

Patients undergoing total joint arthroplasty (TJA) are at risk for developing periprosthetic joint infection (PJI). To treat PJI, orthopaedic surgeons can perform 1-stage or 2-stage revision arthroplasty. Although 2-stage revision yields superior long-term outcomes, the optimal antibiotic therapy duration and route of administration between stages remain uncertain. In this systematic review, we aimed to identify if variations in antibiotic therapy, duration, and administration during 2-stage hip or knee revision arthroplasty affect PJI eradication rates and surgical outcome measures. A literature search was performed using the PubMed and Google Scholar databases to identify all original reports from January 2000 to June 2021 involving 2-stage revision arthroplasty to treat PJI. Studies were included if they specified antibiotic duration, an intravenous (IV) route of antibiotic administration, type of antibiotic, and 2-stage revision PJI eradication rate and had a mean or median follow-up of at least 2 years after the second-stage operation. Included studies were classified into 3 groups based on the length of IV antibiotic therapy after prosthesis explantation: prolonged IV antibiotic therapy of 4 to 6 weeks, shortened IV antibiotic therapy of ≤2 weeks, and shortened course of IV antibiotic therapy followed by 6 to 12 weeks of oral antibiotics. Nine studies were included. Three studies utilizing a prolonged IV antibiotic therapy had PJI eradication rates of 79% to 96%. Four studies using a shortened IV antibiotic therapy showed PJI eradication rates of 88% to 100%. Finally, 2 studies utilizing a shortened course of IV antibiotic therapy with oral antibiotics had PJI eradication rates of 95% and 97%. There was no significant difference in eradication rates across IV antibiotic duration strategies, despite a diverse array of cultured microorganisms across the studies. Although the numbers are small, this systematic review suggests that prolonged IV antibiotic duration, shortened IV antibiotic duration, and shortened IV antibiotic duration supplemented with oral antibiotics confer similar PJI eradication rates after hip or knee arthroplasty. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Ventral acetabular augmentation for management of caudoventral luxation following total hip replacement in dogs.

To report ventral acetabular augmentation with an internal fixator for management of caudoventral luxation following total hip replacement in dogs and to report clinical outcomes. Clinical records from three UK-based referral hospitals were reviewed retrospectively between 2010 and 2020 to identify dogs with caudoventral hip luxation managed by ventral acetabular augmentation. Hip prosthesis component orientation was radiographically assessed to identify potential risk factors associated with the luxation. Clinical and radiographic assessments were performed at short-term (≤12 weeks) and long-term (>12 months) follow-up and all complications were recorded. A standardised owner telephone questionnaire was used to assess long-term outcomes when a clinical assessment was unavailable. Nine dogs were included. Risk factors contributing to the luxation could not be defined. Implants used included a string-of-pearls plate (6/9), a polyaxial locking plate combined with a polyethylene implant (1/9) or a polyethylene implant alone (2/9). Complications occurred in two of nine dogs, including recurrent luxation and femoral stem loosening; both dogs had received a polyethylene implant alone, of which one received explantation of the hip prosthesis. Median long-term follow-up was 39 months (range 13.5-62). Seven dogs who received a ventral acetabular plate achieved full function of the operated limb and the overall outcome was good for eight dogs. Follow-up radiographs revealed stable hip prostheses in dogs who received a ventral plate, with the longest assessment at 37 months postoperatively. Owner satisfaction was good for all cases. Ventral acetabular augmentation can successfully manage caudoventral luxation following total hip replacement in dogs.

Arthroscopic "Debridement and Implant Retention" With Local Administration of Exebacase (Lysin CF-301) Followed by Suppressive Tedizolid as Salvage Therapy in Elderly Patients for Relapsing Multidrug-Resistant S. epidermidis Prosthetic Knee Infection.

Exebacase, a recombinantly produced lysin has recently (i) reported proof-of-concept data from a phase II study in S. aureus bacteremia and (ii) demonstrated antibiofilm activity in vitro against S. epidermidis. In patients with relapsing multidrug-resistant (MDR) S. epidermidis prosthetic knee infection (PKI), the only surgical option is prosthesis exchange. In elderly patients who have undergone several revisions, prosthesis explantation could be associated with definitive loss of function and mortality. In our BJI reference regional center, arthroscopic debridement and implant retention with local administration of exebacase (LysinDAIR) followed by suppressive tedizolid as salvage therapy is proposed for elderly patients with recurrent MDR S. epidermidis PKI with no therapeutic option or therapeutic dead end (for whom revision or transfemoral amputation is not feasible and no other oral option is available). Each use was decided in agreement with the French health authority and in accordance with the local ethics committee. A written consent was obtained for each patient. Exebacase (75 mg/mL; 30 mL) was administered directly into the joint during arthroscopy. Four patients (79–89 years old) were treated with the LysinDAIR procedure. All had several previous prosthetic knee revisions without prosthesis loosening. Three had relapsing PKI despite suppressive antibiotics following open DAIR. Two had clinical signs of septic arthritis; the two others had sinus tract. After the LysinDAIR procedure, no adverse events occurred during arthroscopy; all patients received daptomycin 8 mg/kg and linezolid 600 mg bid (4–6 weeks) as primary therapy, followed by tedizolid 200 mg/day as suppressive therapy. At 6 months, recurrence of the sinus tract occurred in the two patients with sinus tract at baseline. After >1 year follow up, the clinical outcome was favorable in the last two patients with total disappearance of clinical signs of septic arthritis even if microbiological persistence was detected in one of them. Exebacase has the potential to be used in patients with staphylococci PKI during arthroscopic DAIR as salvage therapy to improve the efficacy of suppressive antibiotics and to prevent major loss of function.

Security and reliability of CUSTOMBONE cranioplasties: A prospective multicentric study

BackgroundRepairing bone defects generated by craniectomy is a major therapeutic challenge in terms of bone consolidation as well as functional and cognitive recovery. Furthermore, these surgical procedures are often grafted with complications such as infections, breaches, displacements and rejections leading to failure and thus explantation of the prosthesis. ObjectiveTo evaluate cumulative explantation and infection rates following the implantation of a tailored cranioplasty CUSTOMBONE prosthesis made of porous hydroxyapatite. One hundred and ten consecutive patients requiring cranial reconstruction for a bone defect were prospectively included in a multicenter study constituted of 21 centres between December 2012 and July 2014. Follow-up lasted 2 years. ResultsMean age of patients included in the study was 42±15 years old (y.o), composed mainly by men (57.27%). Explantations of the CUSTOMBONE prosthesis were performed in 13/110 (11.8%) patients, significantly due to infections: 9/13 (69.2%) (p<0.0001), with 2 (15.4%) implant fracture, 1 (7.7%) skin defect and 1 (7.7%) following the mobilization of the implant. Cumulative explantation rates were successively 4.6% (SD 2.0), 7.4% (SD 2.5), 9.4% (SD 2.8) and 11.8% (SD 2.9%) at 2, 6, 12 and 24 months. Infections were identified in 16/110 (14.5%): 8/16 (50%) superficial and 8/16 (50%) deep. None of the following elements, whether demographic characteristics, indications, size, location of the implant, redo surgery, co-morbidities or medical history, were statistically identified as risk factors for prosthesis explantation or infection. ConclusionOur study provides relevant clinical evidence on the performance and safety of CUSTOMBONE prosthesis in cranial procedures. Complications that are difficulty incompressible mainly occur during the first 6 months, but can appear at a later stage (>1 year). Thus assiduous, regular and long-term surveillances are necessary.

Surgical outcomes of testicular prostheses implantation in transgender men with a history of prosthesis extrusion or infection

Background: Testicular prostheses implantation may be used for neoscrotal augmentation in transgender men. In current literature, explantation rates range from 0.6% to 30% and most are a result of infection or extrusion. Information on the surgical path of individuals after prosthesis explantation is scarce. Aim: To assess the frequency and success rate of testicular prosthesis implantation after previous explantation due to infection or extrusion. Methods: All transgender men who underwent testicular prosthesis explantation between January 1991 and December 2018 were retrospectively identified from a departmental database. A retrospective chart study was conducted, recording demographics, surgical and prosthesis characteristics, reoperations, and outcomes. Results: A total of 41 transgender men were included who underwent testicular prosthesis explantation in the study time period. Of these, 28 (68%) opted for new prosthesis implantation. Most explanted prosthesis had a volume ≥30cc and were replaced with an equally sized one. The postoperative course was uneventful in 19 out of 28 (68%) individuals. Explantation of one or both prostheses occurred in 7 out of 28 (25%) individuals, because of infection (n = 3, 11%) or extrusion (n = 4, 14%). Patients that experienced complications had more often a history of smoking (p = 0.049). The explantation rate was lower if a smaller or lighter prosthesis was reimplanted (p = 0.020). Discussion: Most patients opt for testicular prosthesis implantation after previous explantation due to extrusion or infection. Explantation rates are higher than after the primary implantation procedure. Results of current study can be used to inform individuals on postoperative outcomes.