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Anterior spine decompression and reconstruction with bone grafts and fusion is a routine spinal surgery. The intervertebral fusion cage can maintain intervertebral height and provide a bone graft window. Titanium fusion cages are the most widely used metal material in spinal clinical applications. However, there is a certain incidence of complications in clinical follow-ups, such as pseudoarticulation formation and implant displacement due to nonfusion of bone grafts in the cage. With the deepening research on metal materials, the properties of these materials have been developed from being biologically inert to having biological activity and biological functionalization, promoting adhesion, cell differentiation, and bone fusion. In addition, 3D printing, thin-film, active biological material, and 4D bioprinting technology are also being used in the biofunctionalization and intelligent advanced manufacturing processes of implant devices in the spine. This review focuses on the biofunctionalization of implant materials in 3D printed intervertebral fusion cages. The surface modifications of implant materials in metal endoscopy, material biocompatibility, and bioactive functionalizationare summarized. Furthermore, the prospects and challenges of the biofunctionalization of implant materials in spinal surgery are discussed. Fig.a.b.c.d.e.f.g As a pre-selected image for the cover, I really look forward to being selected. Special thanks to you for your comments., (© 2021. The Author(s).)

While spinal interbody cage options have proliferated in the past decade, relatively little work has been done to explore the comparative potential of biomaterial technologies in promoting stable fusion. Innovations such as micro-etching and nano-architectural designs have shown purported benefits in in vitro studies, but lack clinical data describing their optimal implementation. Here, we critically assess the pre-clinical data supportive of various commercially available interbody cage biomaterial, topographical, and structural designs. We describe in detail the osteointegrative and osteoconductive benefits conferred by these modifications with a focus on polyetheretherketone (PEEK) and titanium (Ti) interbody implants. Further, we describe the rationale and design for two randomized controlled trials, which aim to address the paucity of clinical data available by comparing interbody fusion outcomes between either PEEK or activated Ti lumbar interbody cages. Utilizing dual-energy computed tomography (DECT), these studies will evaluate the relative implant-bone integration and fusion rates achieved by either micro-etched Ti or standard PEEK interbody devices. Taken together, greater understanding of the relative osseointegration profile at the implant-bone interface of cages with distinct topographies will be crucial in guiding the rational design of further studies and innovations., (© 2021. The Author(s).)

Objective: The dissemination of mitral valve repair as the first-line treatment and the introduction of MitraClip for patients who have a prohibitive risk for surgery have changed the landscape of mitral valve intervention. The aim of this study is to provide current and generalizable data regarding the trend of mitral valve interventions and outcomes from 2000 to 2016., Methods: Patients ≥18 years of age who underwent mitral-valve interventions were identified using the National Inpatient Sample database. National estimates were generated by means of discharge weights; comorbid conditions were identified using Elixhauser methods. All trends were analyzed with JoinPoint software., Results: A total of 656,030 mitral valve interventions (298,102 mitral valve replacement, 349,053 mitral valve repair, and 8875 MitraClip) were assessed. No changes in rate of procedures (per 100,000 people in the United States) were observed over this period (annual percent change, -0.4; 95% confidence limit, -1.1 to 0.3; P = .3). From 2000 to 2010, the number of replacements decreased by 5.6% per year (P < .001), whereas repair increased by 8.4% per year from 2000 to 2006 (P < .001). MitraClip procedures increased by 84.4% annually from 2013 to 2016 (P < .001). The burden of comorbidities increased throughout the study for all groups, with the greatest score for MitraClip recipients. Overall, length of stay has decreased for all interventions, most significantly for MitraClip. In-hospital mortality decreased from 8.5% to 3.7% for all interventions, with MitraClip having the most substantial decrease from 3.6% to 1.5%., Conclusions: Over a 17-year period, mitral-valve interventions were associated with improved outcomes despite being applied to an increasingly sicker population., (Copyright © 2020 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Contemporary practice patterns and outcomes for aortic valve replacement (AVR) among young and middle-aged adults are unknown given guideline modifications for surgical AVR (SAVR) and increasing transcatheter AVR (TAVR) acceptance. This study describes SAVR and TAVR use and outcomes using The Society of Thoracic Surgeons (STS) National Databases., Methods: Adults 18 to 55 years of age in the Congenital Heart Surgery Database (CHSD) and the Adult Cardiac Surgery Database (ACSD) who underwent SAVR or TAVR from 2013 to 2018 were included. Perioperative characteristics and early outcomes were described by valve type. Multivariable regression identified determinants of death, length of hospital stay, and a composite end point of renal failure, persistent neurologic deficit, readmission, and reoperation., Results: The study analyzed 1580 unique CHSD and 44,173 ACSD operations, 16% of which were performed in patients with congenital heart disease. Valve use included the following: TAVR, 1%; mechanical, 42%; bioprosthetic, 55%; autograft, 0.6%; homograft, 1.2%; and Ozaki, 0.4%. Over time, TAVR volumes increased by 167%. The 30-day mortality was as follows: TAVR, 3.8%; mechanical, 3.2%; bioprosthetic, 3.7%; autograft, 0.6%; homograft, 9%; and Ozaki, 3.4%. Stroke rate was lower for isolated SAVR vs isolated TAVR (0.9% vs 2.4%; P = .002). In multivariable analyses, mortality risk was lower with mechanical valves, congenital morbidity risk was higher with TAVR, and length of stay was shorter with TAVR., Conclusions: TAVR is increasingly used for adults younger than 55 years of age. Given the uniformly excellent results with SAVR, including both mortality and morbidity-particularly regarding stroke, our data favor SAVR in this population, but a prospective trial is needed. Ongoing efforts to harmonize variables and outcomes definitions between the ACSD and CHSD are valuable., (Copyright © 2021 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: External anal sphincter contractility significantly contributes to control the passage of stool. An artificial anal sphincter placed into the intersphincteric space is a safe and effective procedure to treat fecal incontinence, even if its mechanism of action has not been fully elucidated., Objective: The aim of this study was to evaluate external anal sphincter contractility changes after a self-expandable hyexpan prostheses was implanted into the intersphincteric space of the anal canal and clinical outcomes compared., Design: This was a prospective clinical study., Settings: The study was conducted at a university teaching hospital., Patients: Consecutive patients affected by fecal incontinence for at least 6 months after failure of conservative treatment were included., Interventions: All of the patients underwent 10-prostheses implantation and were examined preoperatively and postoperatively by endoanal ultrasound and anorectal manometry., Main Outcome Measures: Fecal incontinence symptoms were assessed by severity scores. The external anal sphincter muscle tension was calculated using a specific equation., Results: Thirty-nine patients (34 women; median age = 68 y) were included in the study; no morbidity was registered. After a median follow-up period of 14 months, both the median maximum voluntary squeeze pressure and the median inner radius of the external anal sphincter significantly increased. A statistically significant increase of external anal sphincter muscle tension was detected. A decrease of any fecal incontinence symptom and an improvement in severity scores were observed at the last follow-up examination. The external anal sphincter contractility was significantly higher in patients reducing incontinence episodes to solid stool by >50% and improving their ability to defer defecation for >15 minutes., Limitations: This was a single-center experience with a relatively small and heterogeneous sample size, patients with a potentially more severe disease because our institution is a referral center, and an absence of quality-of-life evaluation., Conclusions: Artificial anal sphincter implantation improved the external anal sphincter muscle tension; there was a positive correlation between its increase and the clinical outcome. See Video Abstract at http://links.lww.com/DCR/B468., Implante De Esfnter Anal Artificial Autoexpandible En Pacientes Con Incontinencia Fecal Mejora La Contractilidad Del Esfnter Anal Externo: ANTECEDENTES:La contractilidad del esfínter anal externo contribuye significativamente al control del paso de las heces. Un esfínter anal artificial colocado en el espacio interesfinteriano es un procedimiento seguro y eficaz para tratar la incontinencia fecal, incluso si su mecanismo de acción no se ha definido por completo.OBJETIVO:El objetivo de este estudio fue evaluar los cambios en la contractilidad del esfínter anal externo después de la implantación de una prótesis de hyexpan autoexpandible en el espacio interesfinteriano del canal anal y comparar los resultados clínicos.DISEÑO:Estudio clínico prospectivo.ENTORNO CLINICO:El estudio se realizó en un hospital universitario.PACIENTES:Pacientes consecutivos afectados por incontinencia fecal durante al menos 6 meses, tras fracaso de tratamiento conservador.INTERVENCIONES:Todos los pacientes fueron sometidos a la implantación de 10 prótesis, y fueron examinados pre y postoperatoriamente mediante ecografía endoanal y manometría anorrectal.PRINCIPALES MEDIDAS DE VALORACION:Los síntomas de incontinencia fecal se evaluaron mediante puntuaciones de gravedad. La tensión del músculo del esfínter anal externo se calculó mediante una formula específica.RESULTADOS:Treinta y nueve pacientes (34 mujeres; mediana de edad 68 años) fueron incluidos en el estudio; no se registró morbilidad. Después de un período de seguimiento medio de 14 meses, tanto la presión de compresión voluntaria máxima media como el radio interior medio del esfínter anal externo aumentaron significativamente. Se detectó un aumento estadísticamente significativo de la tensión del músculo del esfínter anal externo. En el último examen de seguimiento se observó una disminución de cualquier síntoma de incontinencia fecal y una mejora en las puntuaciones de gravedad. La contractilidad del esfínter anal externo fue significativamente mayor en los pacientes que redujeron los episodios de incontinencia a heces sólidas en más del 50% y mejoraron la capacidad para diferir la defecación durante más de 15 minutos.LIMITACIONES:Experiencia de un solo centro; tamaño de muestra relativamente pequeño y heterogéneo; pacientes con una enfermedad potencialmente más grave porque nuestra institución es un centro de referencia; ausencia de evaluación de la calidad de vida.CONCLUSIONES:La implantación del esfínter anal artificial mejoró la tensión muscular del esfínter anal externo; hubo una correlación positiva entre su aumento y el resultado clínico. Consulte Video Resumen en http://links.lww.com/DCR/B468., (Copyright © The ASCRS 2021.)

Background: The impact of various stents on patients with intracranial aneurysms who undergo stent-assisted coiling has been debated. We conducted this study to compare follow-up outcomes of coiling procedures involving braided or laser-cut stents with closed-cell design. A propensity score-matched case-controlled analysis was applied., Methods: A total of 413 intracranial aneurysms consecutively coiled using laser-cut (n=245) or braided stents (n=168) in procedures performed between September 2012 and June 2017 were eligible for study. Time-of-flight magnetic resonance angiography, catheter angiography, or both were used to gauge occlusive status after coiling. Recanalization was determined by Raymond classification (complete occlusion vs recanalization). A propensity score-matched analysis was conducted, based on probability of stent type in use., Results: Ultimately, 93 coiled aneurysms (22.5%) showed some recanalization (minor, 51; major, 42) during the follow-up period (mean 21.7±14.5 months). Patient gender (P=0.042), hyperlipidemia (P=0.015), size of aneurysm (P=0.004), neck size (P<0.001), type of aneurysm (P<0.001), and packing density (P=0.024) differed significantly by group. Midterm and cumulative recanalization incidence rates in the braided-stent group were initially lower than those of the laser-cut stent group (P=0.009 and P=0.037, respectively) but they did not differ significantly after 1:1 propensity score matching (midterm OR=0.88, P=0.724; cumulative HR=0.91, P=0.758)., Conclusion: In stent-assisted coiling of intracranial aneurysms, laser-cut and braided stent groups produced similar outcomes in follow-up. Consequently, product selection may hinge on suitability for deployment rather than anticipated results., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: We herein report a single-centre experience with the SAPIEN 3 Ultra balloon-expandable transcatheter aortic valve implantation (TAVI) system., Methods: Between March 2019 and January 2020, a total of 79 consecutive patients received transfemoral TAVI using the SAPIEN 3 Ultra device. Data were retrospectively analysed according to updated Valve Academic Research Consortium-2 definitions. Detailed analysis of multislice computed tomography data was conducted to identify potential predictors for permanent pacemaker (PPM) implantation and residual paravalvular leakage (PVL) post TAVI., Results: Device success and early safety were 97.5% (77/79) and 94.9% (75/79) with resulting transvalvular peak/mean pressure gradients of 21.1 ± 8.2/10.9 ± 4.4 and PVL >mild in 0/79 patients (0%). Mild PVL was seen in 18.9% (15/79) of cases. Thirty-day mortality was 2.5% (2/79). The Valve Academic Research Consortium-2 adjudicated clinical end points disabling stroke, acute kidney injury and myocardial infarction occurred in 1.3% (1/79), 5.1% (4/79) and 0% (0/79) of patients. Postprocedural PPM implantation was necessary in 7.6% (6/79) of patients. Multislice computed tomography analysis revealed significantly higher calcium amounts of the right coronary cusp in patients in need for postprocedural PPM implantation and a higher eccentricity index in patients with postinterventional mild PVL., Conclusions: First experience with this newly designed balloon-expandable-transcatheter heart valve demonstrates adequate 30-day outcomes and haemodynamic results with low mortality, low rates of PPM implantation and no residual PVL >mild. The herein-presented multislice computed tomography values with an elevated risk for PPM implantation and residual mild PVL may help to further improve outcomes with this particular transcatheter heart valve in TAVI procedures., (© The Author(s) 2020. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: Anal inserts and percutaneous tibial nerve stimulation may be offered to those with fecal incontinence in whom other conservative treatments have failed., Objective: We aimed to compare anal inserts and percutaneous tibial nerve stimulation., Design: This was an investigator-blinded randomized pilot study., Settings: The study was conducted at a large tertiary care hospital., Patients: Adult patients with passive or mixed fecal incontinence were recruited., Interventions: Patients were randomly assigned to receive either the anal inserts or weekly percutaneous tibial nerve stimulation for a period of 3 months., Main Outcome Measures: The primary end point was a 50% reduction of episodes of fecal incontinence per week as calculated by a prospectively completed 2-week bowel diary. Secondary end points were St Mark's incontinence score, International Consultation on Incontinence Questionnaire-Bowel scores (for bowel pattern, bowel control, and quality of life), use of antidiarrheal agents, estimates of comfort and acceptability., Results: Fifty patients were recruited: 25 were randomly assigned to anal inserts and 25 were randomly assigned to percutaneous tibial nerve stimulation. All completed treatment. A significant improvement of scores in the 2-week bowel diary, the St Mark's scores and the International Consultation on Incontinence Questionnaire-Bowel scores, was seen in both groups after 3 months of treatment. A reduction of ≥50% fecal incontinence episodes was reached by 76% (n = 19/25) by the anal insert group, compared with 48% (n = 12/25) of those in the percutaneous tibial nerve stimulation group (p = 0.04). The St Mark's fecal incontinence scores and the International Consultation on Incontinence Questionnaire-Bowel scores for bowel pattern, bowel control, and quality of life (p = 0.01) suggest similar improvement for each group., Limitations: A realistic sample size calculation could not be performed because of the paucity of objective prospective studies assessing the effect of the insert device and percutaneous tibial nerve stimulation., Conclusions: Both anal insert and percutaneous tibial nerve stimulation improved the symptoms of fecal incontinence after 3 months of treatment. The insert device appeared to be more effective than percutaneous tibial nerve stimulation. Larger studies are needed to investigate this further. See Video Abstract at http://links.lww.com/DCR/B460., Trial Registration Number: Clinicaltrials.gov No. NCT04273009., Estudio Piloto Aleatorizado De Inserciones Anales Contra La Estimulacin Percutnea Del Nervio Tibial En Pacientes Con Incontinencia Fecal: ANTECEDENTES:Las inserciones anales y la estimulación percutánea del nervio tibial (PTNS) se pueden ofrecer a las personas con incontinencia fecal que han fallado en otros tratamientos conservadores.OBJETIVO:Nuestro objetivo fue comparar inserciones anales y estimulación percutánea del nervio tibial.DISEÑO:Este fue un estudio piloto aleatorio ciego para investigadores.AJUSTE:El estudio se realizó en un hospital de atención terciaria.PACIENTES:Se reclutaron pacientes adultos con incontinencia fecal pasiva o mixta.INTERVENCIONES:Los pacientes fueron asignados al azar para recibir inserciones anales o estimulación del nervio tibial percutáneo semanal durante un período de tres meses.PRINCIPALES MEDIDAS DE RESULTADO:El principal resultado fue una reducción del 50% de los episodios de incontinencia fecal por semana, según lo calculado mediante un diario intestinal de dos semanas completado de forma prospectiva. Los criterios de valoración secundarios fueron la puntuación de incontinencia de St Mark, las puntuaciones del ICIQ-B (para patrón intestinal, control intestinal y calidad de vida), uso de agentes antidiarreicos, estimaciones de comodidad y aceptabilidad.RESULTADOS:Se reclutaron 50 pacientes: 25 fueron asignados al azar a inserciones anales y 25 a PTNS. Todo el tratamiento completado. Se observó una mejora significativa de las puntuaciones en el diario intestinal de dos semanas, la puntuación de St Mark y la puntuación del ICIQ-B en ambos grupos después de 3 meses de tratamiento. Se alcanzó una reducción de ≥ 50% de los episodios de incontinencia fecal en un 76% (n = 19/25) en el grupo de inserción anal, en comparación con el 48% (n = 12/25) de los del grupo de estimulación percutánea del nervio tibial (p = 0,04). Las puntuaciones de incontinencia fecal de St Mark, las puntuaciones del ICIQ-B para el patrón intestinal, el control intestinal y la calidad de vida (p = 0,01) sugieren una mejora similar para cada grupo.LIMITACIONES:No se pudo realizar un cálculo realista del tamaño de la muestra debido a la escasez de estudios prospectivos objetivos que evaluaran el efecto del dispositivo de inserción y la estimulación percutánea del nervio tibial.CONCLUSIONES:Tanto la inserción anal como la estimulación percutánea del nervio tibial mejoraron los síntomas de incontinencia fecal después de 3 meses de tratamiento. El dispositivo de inserción parecia ser más efectivo que la estimulación percutánea del nervio tibial. Se necesitan estudios más amplios para investigar esto más a fondo. Consulte Video Resumen en http://links.lww.com/DCR/B460.NÚMERO DE REGISTRO DE PRUEBA:Clinicaltrials.gov No. NCT04273009., (Copyright © The ASCRS 2021.)

Background: Outcomes data for a durable-polymer everolimus-eluting stent (EES) at extended long-term follow-up in patients with ST-segment elevation myocardial infarction (STEMI) are unknown., Objectives: The aim of this study was to assess the 10-year outcomes of patients enrolled in the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial., Methods: The EXAMINATION-EXTEND (10-Years Follow-Up of the EXAMINATION Trial) study is an investigator-driven 10-year follow-up of the EXAMINATION trial, which randomly assigned 1,498 patients with STEMI in a 1:1 ratio to receive either EES (n = 751) or bare-metal stents (n = 747). The primary endpoint was a patient-oriented composite endpoint of all-cause death, any myocardial infarction, or any revascularization. Secondary endpoints included a device-oriented composite endpoint of cardiac death, target vessel myocardial infarction, or target lesion revascularization; the individual components of the combined endpoints; and stent thrombosis., Results: Complete 10-year clinical follow-up was obtained in 94.5% of the EES group and 95.9% of the bare-metal stent group. Rates of the patient-oriented composite endpoint and device-oriented composite endpoint were significantly reduced in the EES group (32.4% vs. 38.0% [hazard ratio: 0.81; 95% confidence interval: 0.68 to 0.96; p = 0.013] and 13.6% vs. 18.4% [hazard ratio: 0.72; 95% confidence interval: 0.55 to 0.93; p = 0.012], respectively), driven mainly by target lesion revascularization (5.7% vs. 8.8%; p = 0.018). The rate of definite stent thrombosis was similar in both groups (2.2% vs. 2.5%; p = 0.590). No differences were found between the groups in terms of target lesion revascularization (1.4% vs. 1.3%; p = 0.963) and definite or probable stent thrombosis (0.6% vs. 0.4%; p = 0.703) between 5 and 10 years., Conclusions: At 10-year follow-up, EES demonstrated confirmed superiority in combined patient- and device-oriented composite endpoints compared with bare-metal stents in patients with STEMI requiring primary percutaneous coronary intervention. Between 5- and 10-year follow-up, a low incidence of adverse cardiovascular events related to device failure was found in both groups. (10-Years Follow-Up of the EXAMINATION Trial; NCT04462315)., Competing Interests: Funding Support and Author Disclosures The EXAMINATION trial was partially funded by an unrestricted grant from Abbott Vascular to the Spanish Heart Foundation (promoter) during the first 5 years of follow-up. The EXAMINATION-EXTEND study was funded by an unrestricted grant from Abbott Vascular to the Spanish Heart Foundation (promoter). Dr. Brugaletta is a consultant for Boston Scientific and iVascular. Dr. Sabaté has receiving consulting and speaker fees from Abbott Vascular and iVascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Upper limb amputations, ranging from transhumeral to partial hand, can be devastating for patients, their families, and society. Modern paradigm shifts have focused on reconstructive options after upper extremity limb loss, rather than considering the amputation an ablative procedure. Surgical advancements such as targeted muscle reinnervation and regenerative peripheral nerve interface, in combination with technological development of modern prosthetics, have expanded options for patients after amputation. In the near future, advances such as osseointegration, implantable myoelectric sensors, and implantable nerve cuffs may become more widely used and may expand the options for prosthetic integration, myoelectric signal detection, and restoration of sensation. This review summarizes the current advancements in surgical techniques and prosthetics for upper limb amputees. Cite this article: Bone Joint J  2021;103-B(3):430-439.

Purpose of Review: To discuss mechanical and surgical innovations in inflatable penile prosthesis (IPP) surgery and their implications on reservoir placement and patient outcomes., Recent Findings: The past decade has seen a new emphasis on optimizing outcomes and minimizing complications associated with IPP reservoirs. Innovations in device design have accordingly yielded safer, more durable IPP outcomes over the past four decades. Modifications in surgical approach for reservoir placement abound for both traditional space of Retzius and ectopic reservoir placement techniques. Surgical and medical history, patient anatomy, and patient preference should all be considered when choosing approach for IPP reservoir placement. Prosthetic urologists should be proficient in multiple approaches to provide the best care to their patients.

Use of transcatheter mitral valve replacement (TMVR) using transcatheter aortic valves in clinical practice is limited to patients with failing bioprostheses and rings or mitral valve disease associated with severe mitral annulus calcification. Whereas the use of valve-in-valve TMVR appears to be a reasonable alternative to surgery in patients at high surgical risk, much less evidence supports valve-in-ring and valve-in-mitral annulus calcification interventions. Data on the results of TMVR in these settings are derived from small case series or voluntary registries. This review summarizes the current evidence on TMVR using transcatheter aortic valves in clinical practice from the characteristics of the TMVR candidates, screening process, performance of the procedure, and description of current results and future perspectives. TMVR using dedicated devices in native noncalcified mitral valve diseases is beyond the scope of the article.

Modern breast implant design emphasizes the host response at the surface. Implant surfaces are characterized by their roughness, surface area, and potential for bacterial attachment. The future of implant design may lie in the ability of bioengineers to transform both the structure and chemical properties of the device surface and therefore affect potential long-term outcomes., Competing Interests: Disclosure Dr C.A. Glicksman is the Medical Director of the Motiva Clinical Trial (Establishment Labs, Alejuela, Costa Rica)., (Copyright © 2020 Elsevier Inc. All rights reserved.)

In the original edition of Prosthetics and Orthotics International , Dr Sidney Fishman identified what he anticipated as foundational educational needs for the emerging field of clinical prosthetics and orthotics. Within the broader construct of the physical sciences, this included mathematics, physics, chemistry, biomechanics, and material sciences. The clinical application of these disciplines to expanding the collective understanding within the field is described, including the biomechanics of able-bodied and prosthetic gait, the material science of socket construction, the physics of suspension and load distribution, and the engineering of prosthetic components to mimic human biomechanics. Additional applications of the physical sciences to upper limb prosthetics and lower limb orthotics are also described. In contemplating the continued growth and maturation of the field in the years to come, mechatronics and statistics are suggested as future areas where clinical proficiency will be required.

The human-prosthesis interface is one of the most complicated challenges facing the field of prosthetics, despite substantive investments in research and development by researchers and clinicians around the world. The journal of the International Society for Prosthetics and Orthotics, Prosthetics and Orthotics International , has contributed substantively to the growing body of knowledge on this topic. In celebrating the 50th anniversary of the International Society for Prosthetics and Orthotics, this narrative review aims to explore how human-prosthesis interfaces have changed over the last five decades; how research has contributed to an understanding of interface mechanics; how clinical practice has been informed as a result; and what might be potential future directions. Studies reporting on comparison, design, manufacturing and evaluation of lower limb prosthetic sockets, and osseointegration were considered. This review demonstrates that, over the last 50 years, clinical research has improved our understanding of socket designs and their effects; however, high-quality research is still needed. In particular, there have been advances in the development of volume and thermal control mechanisms with a few designs having the potential for clinical application. Similarly, advances in sensing technology, soft tissue quantification techniques, computing technology, and additive manufacturing are moving towards enabling automated, data-driven manufacturing of sockets. In people who are unable to use a prosthetic socket, osseointegration provides a functional solution not available 50 years ago. Furthermore, osseointegration has the potential to facilitate neuromuscular integration. Despite these advances, further improvement in mechanical features of implants, and infection control and prevention are needed.

Fifty years ago, the International Society for Prosthetics and Orthotics was founded in recognition that this unique niche in rehabilitation would benefit from multidisciplinary interactions between specialists in engineering, therapy, and medicine.Since then, field evolved from having a craft orientation toward a technology and clinical specialty. This anniversary provides an opportunity to look back on advances in prosthetics and orthotics, and the clear impact they have had on changing the skills needed by the prosthetist/orthotist as new technology and techniques have emerged. The balance has clearly shifted from mechanical skills to clinical care. The training and skills of the prosthetist/orthotist remain unique and valued in the rehabilitation team, and the primary motivation remains the same as it has been since the creation of the International Society for Prosthetics and Orthotics: the application of external devices where they are suitable to address the many varied needs of persons with disability. This historical perspective puts into context why and how the profession has changed, while also reinforcing that it is the goals set for restoring patient functions that best defines what it is to be a prosthetist/orthotist, not the means we use.

Background: Three-dimensional (3D) printing has revolutionized training, education, and device testing. Understanding the design and physical properties of 3D-printed models is important., Objective: To systematically review the design, physical properties, accuracy, and experimental outcomes of 3D-printed vascular models used in neurointervention., Methods: We conducted a systematic review of the literature between January 1, 2000 and September 30, 2018. Public/Publisher MEDLINE (PubMed), Web of Science, Compendex, Cochrane, and Inspec databases were searched using Medical Subject Heading terms for design and physical attributes of 3D-printed models for neurointervention. Information on design and physical properties like compliance, lubricity, flow system, accuracy, and outcome measures were collected., Results: A total of 23 articles were included. Nine studies described 3D-printed models for stroke intervention. Tango Plus (Stratasys) was the most common material used to develop these models. Four studies described a population-representative geometry model. All other studies reported patient-specific vascular geometry. Eight studies reported complete reconstruction of the circle of Willis, anterior, and posterior circulation. Four studies reported a model with extracranial vasculature. One prototype study reported compliance and lubricity. Reported circulation systems included manual flushing, programmable pistons, peristaltic, and pulsatile pumps. Outcomes included thrombolysis in cerebral infarction, post-thrombectomy flow restoration, surgical performance, and qualitative feedback., Conclusion: Variations exist in the material, design, and extent of reconstruction of vasculature of 3D-printed models. There is a need for objective characterization of 3D-printed vascular models. We propose the development of population representative 3D-printed models for skill improvement or device testing., (Copyright © 2020 by the Congress of Neurological Surgeons.)

The completely subcutaneous implantable cardioverter defibrillator (S-ICD) is rapidly evolving to become a complete alternative for the transvenous ICD (TV-ICD) leaving the heart and vasculature untouched. Newer trials and registries in cohorts that are similar to real-world ICD patient populations confirm the initial data on safety and efficacy. Technical improvements have resulted in reduced inappropriate shock rates, although more data are warranted, and new developments such as substernal lead positioning, communication between the S-ICD and a leadless cardiac pacemaker and remote monitoring options have evolved to overcome the shortcomings of S-ICD therapy. With these continuing developments, it is expected that within the next years the S-ICD will continue to evolve to a treatment option for ventricular arrhythmia as effective as the TV-ICD overcoming the shortcomings of transvenous leads as well as the drawbacks of the initial system, providing effective shock therapy, pacing capabilities, low complication and inappropriate therapy rates, and automated remote monitoring., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

As the number of patients afflicted by chronic limb-threatening ischemia (CLTI) continues to grow, new solutions are necessary to provide effective, durable treatment options that will lead to improved outcomes. The diagnosis of CLTI remains mostly clinical, and endovascular revascularization remains mostly balloon-based. Multiple innovative techniques and technologies are in development or in early usage that may provide new solutions. This review categorizes areas of advancement, highlights recent developments in the management of CLTI and looks forward to novel devices that are currently under investigation.

Early generation left ventricular assist devices (LVAD) for treatment of refractory heart failure attempted to mimic the pulsatility of a native heart and were bulky and less durable due to valves within the inflow and outflow pathways. The next disruption came with the introduction of continuous flow pumps characterized by a low-pulse pressure circulation. Since the mechanism of action did not involve displacement of blood, these pumps were much smaller and less noisy in part due to fewer moving parts. Such devices include the HeartMate II axial-flow pathway pump which is implanted thoraco-abdominally and the HVAD, a centrifugal-flow pathway pump which is smaller and is implanted entirely within the thoracic cavity and uses a combination of hydrodynamic and magnetic levitation of the internal rotor. These pumps improved survival compared with the early generation LVADs and in a trial, the HVAD demonstrated non-inferiority compared with the HeartMate II but with an increase in ischemic and hemorrhagic strokes. The HeartMate 3 LVAD is an intrapericardial centrifugal-flow pathway pump with a full magnetically levitated, frictionless rotor with a fixed intrinsic pulse. In a randomized trial, the HeartMate 3 "hybrid" pump was associated with near-elimination of pump thrombosis, a reduction in strokes of any type or severity and lower mucosal bleeding rates. Despite improvements in hemocompatibility, right heart failure and infections contribute to significant morbidity, and devices designed to be internally contained with a wireless power source and physiological flow characteristics are still required despite great strides in the field., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Transcatheter electrosurgery refers to a family of procedures using radiofrequency energy to vaporize and traverse or lacerate tissue despite flowing blood. The authors review theory, simulations, and benchtop demonstrations of how guidewires, insulation, adjunctive catheters, and dielectric medium interact. For tissue traversal, all but the tip of traversing guidewires is insulated to concentrate current. For leaflet laceration, the "Flying V" configuration concentrates current at the inner lacerating surface of a kinked guidewire. Flooding the field with non-ionic dextrose eliminates alternative current paths. Clinical applications include traversing occlusions (pulmonary atresia, arterial and venous occlusion, and iatrogenic graft occlusion), traversing tissue planes (atrial and ventricular septal puncture, radiofrequency valve repair, transcaval access, Potts and Glenn shunts), and leaflet laceration (BASILICA, LAMPOON, ELASTA-Clip, and others). Tips are provided for optimizing these techniques. Transcatheter electrosurgery already enables a range of novel therapeutic procedures for structural heart disease, and represents a promising advance toward transcatheter surgery., (Published by Elsevier Inc.)

Background: Periprosthetic fractures are increasingly encountered in hip arthroplasty. The Vancouver classification system is widely used. Little knowledge exists regarding the association of the Vancouver classification with either cemented or uncemented stems. The aim was to analyse a series of fractures and determine associations., Methods: A series of consecutive patients over 8 years was identified including only post-operative fractures of primary hip arthroplasties. Baseline and radiographic characteristics were recorded including the type of stem fixation (cemented or uncemented) and Vancouver classification. Statistical analysis was performed to determine the association of the Vancouver classification between cemented and uncemented stems., Results: A total of 172 patients were identified (84 cemented stems, 88 uncemented stems). There were 30 Vancouver A fractures (12 cemented vs.18 uncemented, p > 0.05), 125 Vancouver B fractures (63 cemented vs. 62 uncemented, p > 0.05) and 17 Vancouver C fractures (9 cemented vs. 8 uncemented, p > 0.05). The Vancouver B2 fracture occurred most frequently (N = 95; 44 cemented vs. 51 uncemented, p > 0.05) and consists of four distinct fracture patterns: the previously described comminuted 'burst', clamshell and spiral patterns and the newly observed 'reverse' clamshell. The burst and spiral fracture patterns are significantly associated with cemented stems, and the clamshell pattern is significantly associated with uncemented stems., Conclusions: Vancouver A, B and C fractures occur equally in cemented and uncemented stems. Awareness of four distinct Vancouver B2 fracture patterns, including the newly observed reverse clamshell, will aid surgeons in predicting stem instability.

Objectives: To describe the contemporary trends in the use of mechanical circulatory support (MCS) in patients with acute myocardial infarction and cardiogenic shock (AMICS). To evaluate survival benefit with early application of intra-aortic balloon pump (IABP) or Impella CP., Methods: A cohort study of all consecutive patients with AMICS undergoing percutaneous coronary intervention (PCI) <24 hours of symptom onset (early PCI) in southeastern Denmark from 2010 to 2017. A matched case-control study comparing 30-day mortality between patients receiving early-IABP or early-Impella CP and their respective control group. Controls were matched on age, left ventricular ejection fraction, arterial lactate, estimated glomerular filtration rate and cardiac arrest before PCI. Early-IABP/Impella CP was defined as applied before PCI if shock developed pre-PCI, or immediately after PCI if shock developed during PCI., Results: 903 patients with AMICS undergoing early PCI were identified. Use of MCS decreased from 50% in 2010 to 25% in 2017, p for trend of <0.001. The IABP was abandoned in 2012 and replaced mostly by Impella CP. Patients receiving MCS in 2013-2017 had more compromised haemodynamics compared with patients receiving MCS in 2010-2012. 40 patients received early IABP, and 40 patients received early Impella CP. Only the group receiving early Impella CP was associated with lower 30-day mortality compared with their matched control group (30-day mortality 40% vs 77.5%, plog-rank of<0.001)., Conclusion: Use of MCS decreased by 50% from 2010 to 2017. Patients receiving MCS had more compromised haemodynamics in recent years. Early application of Impella CP was associated with reduced 30-day mortality compared with a matched control group., Competing Interests: Competing interests: OKLH and NLJU received travel compensation from Abiomed. JEM received research grants and speaker’s fee from Abiomed., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To report the early and mid-term results of patients who underwent minimally invasive aortic valve replacement (MI-AVR) with a sutureless prosthesis from an international prospective registry., Methods: Between March 2011 and September 2018, among 957 patients included in the prospective observational SURE-AVR (Sorin Universal REgistry on Aortic Valve Replacement) registry, 480 patients underwent MI-AVR with self-expandable Perceval aortic bioprosthesis (LivaNova PLC, London, UK) in 29 international institutions through either minithoracotomy ( n = 266) or ministernotomy ( n = 214). Postoperative, follow-up, and echocardiographic outcomes were analyzed for all patients., Results: Patient age was 76.1 ± 7.1 years; 64.4% were female. Median EuroSCORE I was 7.9% (interquartile range [IQR], 4.8 to 10.9). Median cardiopulmonary bypass and cross-clamp times were 81 minutes (IQR 64 to 100) and 51 minutes (IQR 40 to 63). First successful implantation was achieved in 97.9% of cases. Two in-hospital deaths occurred, 1 for noncardiovascular causes and 1 following a disabling stroke. In the early (≤30 days) period, stroke rate was 1.4%. Three early explants were reported: 2 due to nonstructural valve dysfunction (NSVD) and 1 for malpositioning. One mild and 1 moderate paravalvular leak were reported. In 16 patients (3.3%) pacemaker implantation was needed. Mean follow-up was 2.4 years (maximum = 7 years). During follow-up 5 explants were reported, 3 due to endocarditis and 2 due to NSVD. Follow-up stroke rate was 2.5%. Three structural valve deteriorations not requiring reintervention were reported. Five-year survival was 91.45%., Conclusions: In this large prospective international registry, MI-AVR with Perceval valve confirmed to be safe, reproducible, and effective in an intermediate-risk population, providing excellent clinical recovery both in early and mid-term follow-up.

Background: Several modern designs of metal-backed glenoids (MBG) have been devised to overcome flaws such as loosening and a high failure rate. This review aimed to compare rates of complications and revision surgeries between cemented polyethylene glenoid (PEG) and three examples of modern MBG designs., Methods: Literature search was carried out using PubMed, Cochrane Library, EMBASE, and Google Scholar using MeSH terms and natural keywords. A total of 1186 articles were screened. We descriptively analyzed numerical data between the groups and statistically analyzed the categorical data, such as the presence of radiolucent line, loosening, and revision surgery (failure). Articles were divided into three groups based on follow-up duration: < 36-month, 36-72-month, and > 72-month subgroups., Results: This study included 35 articles (3769 shoulders); 25 on cemented PEG and ten on the modern MBG. Mean age was 66.4 (21-93) and 66.5 years (31-88). The mean duration of follow-up was 73.1 (12-211) and 56.1 months (24-100). Overall, the rate of the radiolucent line was 354/1302 (27%) and 47/282 (17%), the loosening rate was 465/3185 (15%) and 22/449 (5%), and the failure rate was 189/3316 (6%) and 11/457 (2%), for PEG and MBG, respectively. The results of < 36-month and 36-72-month subgroups showed lower rates of radiolucency and loosening in the cemented PEG group, but there was no significant difference in failure rate (P = 0.754 and 0.829, respectively). In the > 72-month subgroup, MBG was better in terms of loosening (P < 0.001) and failure rates (P = 0.006)., Conclusions: The modern MBG component, especially TM glenoid, seems to be a promising alternative to cemented PEGs, based on subgroup revision rates according to the follow-up duration and overall results of ROM and clinical scores. All polyethylene glenoids tend to increase loosening and failure over time. Three modern MBG designs seem to have no difference in failure, at least in the < 36-month and 36-72-month subgroups compared to the cemented PEG. More long-term follow-up studies on modern MBG should be ultimately conducted., Level of Evidence: Level IV, systematic review.

Lumbar degenerative disc disease is a pathologic process that affects a large portion of our aging population. In the recent past, surgical treatment has involved fusion procedures. However, lumbar disc arthroplasty and replacement provides an alternative for carefully selected patients. It provides the major advantage of motion preservation and thus keeps adjacent segments from significantly progressive degeneration. The history of lumbar disc replacement has roots that start in the 1960s with the implantation of stainless-steel balls. Decades later, multiple implants with different material design and biomechanical properties were introduced to the market. New third-generation implants have made great strides in improved biomechanics and clinical outcomes. Although there is room for further advancement and studies are warranted to assess the long-term durability and sustainability of lumbar disc arthroplasty, it has certainly proven to be a very acceptable alternative within the surgical armamentarium that should be offered to patients who meet indications. In this review we present an overview of lumbar disc arthroplasty including its history, indications, biomechanics, challenges, and future directions., (Copyright © 2019 by the Congress of Neurological Surgeons.)

Since their popularization, genitourinary prosthetics have remained a gold-standard therapy for the treatment of erectile dysfunction and stress urinary incontinence and in cases of testicular loss or dysfunction. They have also represented an area of significant innovation, which has contributed to excellent long-term outcomes. Given this history, the objective of the current review was to provide a 5-10-year outlook on anticipated trends and developments in the field of genitourinary prosthetics. To accomplish this objective, a PubMed and patent search was performed of topics relating to penile and testicular prostheses and urinary sphincters. In regard to penile prostheses, findings demonstrated several new concepts including temperature-sensitive alloys, automated pumps, devices designed specifically for neophalluses, and improved malleable designs. With artificial urinary sphincters, new concepts include the ability to add or remove fluid from an existing system, two-piece systems, and new mechanisms to occlude the urethra. For testicular prosthetics, future implementations may not only better replicate the feel of a biological testicle but also add endocrinological functions. Beyond device innovation, the future of prosthetics is also one of expanding geographic boundaries, which necessitates variable cost modeling and regulatory considerations. Surgical trends are also changing, with a greater emphasis on nonnarcotic, postoperative pain control, outpatient surgeries, and adjunctive techniques to lengthen the penis and address concomitant stress incontinence, among others. Concomitant with device and surgical changes, future considerations also include a greater need for education and training, particularly given the rapid expansion of sexual medicine into developing nations., Competing Interests: None

Purpose of Review: The purpose of this review is to explore the evolution of the coronary stent, from the advent of bare-metal stents, to the newest adopted technology of bioresorbable vascular scaffolds (BVS) used in bioresorbable stents. To date, there have been conflicting data regarding the safety and efficacy of BVS stents, especially when compared to current-generation drug-eluting stents (DES). This review will cover the data that exist regarding current BVS stents, as well as the active clinical trials for future iterations of BVS., Recent Findings: The ABSORB BVS, the most widely circulated stent of its class, was promised to decrease rates of stent thrombosis and target vessel revascularization. Several randomized control trials, however, found the opposite to be true, with the ABSORB BVS demonstrating higher rates of thrombosis, target vessel revascularization, and even target lesion myocardial infarctions when compared to current-generation DES. These data caused the product to be pulled from all markets, leaving the field with uncertainty as to the role of BVS in coronary interventions. Coronary stents have evolved significantly from 1977, when they were first introduced. The original bare-metal stent was later fitted with a drug-eluting polymer, to prevent restenosis and thrombosis over time. Subsequent iterations of the stent attempted to further mitigate that risk by replacing the durable polymer to one that is bioresorbable. The final step in this progression was to create a stent that was fully bioresorbable, which Abbott did with the creation of their ABSORB BVS stent. The product, however, was found to perform poorly when compared to current-generation drug-eluting stents, with several trials showing high rates of stent thrombosis (ST), late stent thrombosis (LST), target-lesion myocardial infarction, and target vessel revascularization. Observational studies of BVS stents have proposed several mechanisms for their thrombogenicity, including higher stent-strut profiles leading to turbulent flow, low radial strength leading to strut disruption, and a higher propensity for neoatherosclerosis. Given the failure of the first-generation BVS stent, but the lingering desire for fully bioresorbable scaffolds, various manufacturers have proposed their solutions with new stents. Until data from their clinical trials emerge, it remains unclear whether fully bioresorbable stents will play any role in coronary interventions.

Purpose of Review: Innovation for transcatheter aortic valve replacement (TAVR) has transformed a medically complex treatment into a standardized procedure. While Edwards SAPIEN and Medtronic CoreValve occupy the market for TAVR in the United States (US), additional valve systems are being developed. The Boston Scientific Lotus Valve system was recently FDA-approved and will represent the third valve in the US market. This evidence-based review will summarize advantages, disadvantages, and projected impact of this new TAVR system., Recent Findings: The Lotus Valve system demonstrates superiority in terms of rates of paravalvular leak, with similar rates of mortality and disabling stroke. This benefit is at the expense of increased pacemaker implantation rates, though preliminary data from subsequent iterations of the Lotus Valve suggest decreasing rates over time. There is much anticipation from ongoing trials utilizing the Lotus Edge system, which may perform best for those with pre-existing pacemakers or anatomy that increases likelihood of paravalvular leak.

Background: The Birmingham Hip Resurfacing (BHR) system (Smith and Nephew) was developed as an alternative to conventional total joint replacement for younger, more active patients. Among other complications exists the risk for femoral component failure. The only marketed revision option for such a complication involves exchange of all components for a total replacement arthroplasty. This presents as a considerable and potentially unnecessary operative burden where revision of only the femoral prosthesis would suffice. We have analysed revision options for BHR in the context of periprosthetic femoral fractures with a stable acetabular component., Methods: Technical details of dual mobility hip systems available in Australia were collated and analysed to assess for potential 'off label' use with an existing BHR acetabular component. These data were then compared with the custom-made Smith and Nephew dual mobility implant with respect to clearance and sizing., Results: Two dual mobility articulation modalities from two companies were identified as appropriate for potential usage with four products analysed in detail. These two demonstrated acceptable sizing and clearance measurements., Conclusion: Comparison between readily available dual mobility prostheses with custom-made implants showed off label dual mobility prosthetic use to be a viable alternative for femoral-only revisions with in situ BHR. Single component revision has several advantages which include: a less complex surgical procedure, shorter operative time, decreased blood loss and the expectation of resultant lower morbidity. Furthermore, this less complex revision surgery should give comparable results to that of primary total hip arthroplasty., (© 2019 Royal Australasian College of Surgeons.)

Introduction: Percutaneous coronary intervention (PCI) for complex lesions, including unprotected left main (ULM) and bifurcations, is gaining a relevant role in treating coronary artery disease with good outcomes, also thanks to new generation stents. The daily risk of adverse cardiovascular events and their temporal distribution after these procedures is not known., Methods: All consecutive patients presenting with a critical lesion of ULM or bifurcation treated with very thin struts stents, enrolled in the RAIN-Cardiogroup VII study, were analyzed. The daily risk of major acute cardiovascular events (MACE), target lesion revascularization (TLR) and stent thrombosis (ST) and their temporal distribution in the first year of follow-up was the primary endpoint. Differences among subgroups (ULM, patient presentation, kind of stent polymer) were the secondary endpoint., Results: 2745 patients were included, mean age 68 ± 11 years, 33.3% diabetics, 54.5% had an acute coronary syndrome (ACS); 88.5% of treated lesions were bifurcations, 27.2% ULM. Average daily risk was 0.022% for MACE, 0.005% for TLR and 0.004% for ST, in the first year. Bimodal distribution of adverse events, especially TLR, with an early peak in the first 50 days and a late one after 150 days, was observed. Patients with ULM presented a significantly higher daily risk of events, and ACS patients presented higher MACE risk. No difference emerged according to the type of stent polymer., Conclusions: The daily risk of adverse events in the first year after complex PCI in our study is acceptably low. PCI on ULM carries a higher risk of complications., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Background: Data on long-term outcomes in patients undergoing transcatheter aortic valve implantation (TAVI) is scarce., Methods: We investigated long term outcomes of consecutive patients undergoing TAVI with balloon- and self-expandable bioprostheses (Edwards SAPIEN (ESV), Edwards Lifesciences Inc., Irvine, CA, USA; Medtronic Corevalve system (MCS), Medtronic Inc., Minneapolis, MN, USA)., Results: Among 628 patients (mean age 82.4 ± 5.8 years, 55% female), 489 (77.8%) underwent transfemoral TAVI. 309 (63.2%) patients received a MCS prosthesis, whereas 180 (36.8%) patients were treated with an ESV prosthesis. The median duration of follow-up amounted to 5.2 years (range 3.4-8.3 years). All-cause mortality did not differ between the two groups (MCS 46.9%, ESV 53.4%, CI 95%: RR 1.21 [0.93-1.57], P = 0.15), whereas cardiac mortality was higher in the ESV cohort after 5 years of follow-up (MCS 35.1%, ESV 45.4%, CI 95%: RR 1.37 [1.01-1.86], P = 0.04). Structural valve deterioration, which was on average diagnosed 41.9 months (range 18-60 months) after TAVI, occurred in 8 cases (1.6%), resulting in one repeat intervention., Conclusions: While half of all patients died within 5 years after TAVI with no significant differences in all-cause mortality, structural valve deterioration was documented in <2% of cases., (Copyright © 2019 Elsevier B.V. All rights reserved.)

We compared graft outcome between two types of a novel composite three-layer carp-collagen-coated vascular graft in low-flow conditions in a sheep model. Collagen in group A underwent more cycles of purification than in group B in order to increase the ratio between collagen and residual fat. The grafts were implanted end-to-side in both carotid arteries in sheep (14 grafts in 7 sheep in group A, 18 grafts in 9 sheep in group B) and artificially stenosed on the right side. The flow in the grafts in group A decreased from 297±118 ml/min to 158±159 ml/min (p=0.041) after placement of the artificial stenosis in group A, and from 330±164ml/min to 97±29 ml/min (p=0.0052) in group B (p=0.27 between the groups). From the five surviving animals in group A, both grafts occluded in one animal 3 and 14 days after implantation. In group B, from the six surviving animals, only one graft on the left side remained patent (p=0.0017). Histology showed degradation of the intimal layer in the center with endothelization from the periphery in group A and formation of thick fibrous intimal layer in group B. We conclude that the ratio between collagen and lipid content in the novel three-layer graft plays a critical role in its patency and structural changes in vivo.

Background: The aims of this study were to propose a novel implant design for the proximal interphalangeal joint (PIPJ) of the hand using a rolling contact joint (RCJ) mechanism and to derive an optimal implant design based on human PIPJ kinematics., Methods: In total, 10 participants with normal PIPJs were enrolled in this study. True lateral finger radiographs were obtained in 10° increments from 0º (full extension) to 120° flexion of PIPJ. Radiographs were used to determine the average center of rotation, which formed the basis of a mathematical expression of the PIPJ kinematics. The variations in extensor tendon excursions in relation to the range of motion of PIPJ were determined using results from previous cadaveric studies. As the next step, a PIPJ implant design using an RCJ mechanism that was most consistent with the mathematically expressed PIPJ kinematics and tendon excursions was determined using a constrained optimization algorithm., Results: The final proposed PIPJ implant had a relatively constant center of rotation over the entire PIPJ range of motion among the participants. In addition, the extensor tendon excursions of the proposed implant as applied to the phalangeal bones were similar to those of the human tendon. The proposed PIPJ implant achieved an acceptable position of the RCJ surface on the proximal and middle phalanges, which was derived from the constrained optimization algorithm., Conclusions: A novel PIPJ implant design using an RCJ mechanism demonstrated acceptable outcomes in terms of PIPJ human kinematics and tendon excursions.

Transcatheter mitral valve replacement with the Intrepid device is intended for patients who need mitral valve replacement and who are at an increased risk for conventional surgery. The early published results of the early feasibility trial are reviewed as well as device design and the implant procedure. The Apollo trial is reviewed: a randomized trial of the Intrepid device versus conventional surgery including a single arm study for inoperable patients. The mitral valve structure, pathophysiology, and postimplant physiology pose unique hurdles for any transcatheter implant., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Mitral regurgitation is the most commonly occurring valvular heart disease in developed countries. Transcatheter mitral valve replacement (TMVR) has emerged as a novel potential therapy for patients with severe mitral valve disease who are unsuitable candidates for conventional surgery or transcatheter edge-to-edge mitral repair. TMVR with the Tendyne prosthesis has shown potential at short-term follow-up to be an effective and safe treatment alternative for high-risk patients with severe mitral valve disease., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Objective: The purpose of this study was to review treatment trends and outcomes of patients who underwent fenestrated-branched endovascular aneurysm repair (F-BEVAR) of pararenal aneurysms (PRAs) or thoracoabdominal aortic aneurysms (TAAAs) using physician-modified endografts (PMEGs) or company-manufactured devices (CMDs)., Methods: We reviewed the clinical data of 316 consecutive patients (242 male patients; mean age, 75 ± 8 years) who underwent F-BEVAR between 2007 and 2016. F-BEVAR was performed under two prospective investigational device exemption protocols since 2013. End points were mortality, major adverse events (MAEs), patient survival, reintervention, branch instability, aneurysm-related mortality, renal function deterioration, and target vessel patency., Results: There were 145 patients (46%) treated by PMEGs (84 PRAs, 26 extent IV and 35 extent I-III TAAAs) and 171 patients (54%) who had CMDs (88 PRAs, 42 extent IV and 41 extent I-III TAAAs). Choice of endograft evolved from PMEGs in 131 patients (83%) treated in the first half of experience to CMDs in 144 patients (91%) treated in the second half of experience (P < .001). Patients treated by PMEGs had significantly (P < .05) larger aneurysms, more chronic pulmonary and kidney disease, and higher comorbidity severity scores. A total of 1081 renal-mesenteric arteries were targeted in both groups. Technical success was lower for PMEGs (98% vs 99.5%; P = .02). Thirty-day mortality was 5.5% for PMEGs (PRAs, 1.2%; extent IV 3.8% and extent I-III, 17.1%) and 0% for CMDs (P = .0018). Patients treated by PMEGs had significantly more (P < .001) MAEs (48% vs 23%) and longer hospital stay (9 ± 10 days vs 6 ± 6 days; P = .001). Mean follow-up was significantly longer for patients treated by PMEGs (38 ± 26 months vs 14 ± 12 months; P < .001). At 3 years, patient survival (68% ± 4% vs 67% ± 8%; P = .11), freedom from reintervention (68% ± 4% vs 68% ± 8%; P = .17), primary (94% ± 2% vs 92% ± 2%; P = .64) and secondary target vessel patency (98% ± 1% vs 98% ± 1%; P = .89), and freedom from renal function deterioration (75% ± 4% vs 65% ± 6%; P = .24) were similar for patients treated by PMEGs or CMDs, respectively., Conclusions: Choice of F-BEVAR evolved from PMEGs to almost exclusively CMDs under physician-sponsored investigational device exemption protocols. PMEG patients had more comorbidities and larger aneurysms. CMDs were performed with higher technical success, no mortality, and fewer MAEs., (Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: An increased occurrence of cortical hypertrophy (CH) was observed 1-2 years after implanting short curved Fitmore hip stems. There are no published data about either the clinical relevance or the progression of CH over the long term., Methods: Ninety-six primary total hip arthroplasties were performed between 2008 and 2010 using the Fitmore hip stem. Clinical and radiological parameters were recorded preoperatively and at 1, 2, 3, and 5 year follow-up., Results: CH appeared mainly on antero-posterior radiographs in Gruen Zones 2, 3, 5, and 6. After 1 year, the diameter was 10 ± 2 mm and remained constant thereafter. The CH rate after 1 year was 69% and after 5 years 71%. Subsidence after 1 year was 1.6 ± 1.55 mm and 1.93 ± 1.72 mm after 5 years. Cortical thinning was 46% after 1 year and 56% after 5 years, mainly in Gruen Zones 7 and 8. In the first year radiolucencies were found in 51% in all Gruen Zones, and in 20% after 5 years. Patient, implant, and surgical factors did not correlate with radiological outcomes except that larger stems had more CH. After 5 years, the Harris Hip Score had improved from 59 to 94 and the Oxford Hip Score from 22 to 41. Radiographic parameters, notably CH, were not associated with clinical outcomes except that cortical thinning correlated with lower outcome scores., Conclusions: CH correlated neither with clinical outcome nor with patient, surgical or implant factors, except for a positive correlation with stem size. The Fitmore hip stems settled within the first year to a stable fixation and then remained almost unchanged. However, cortical thinning is common in Gruen Zone 7 and 8 meaning that there is stress-shielding.

Background: Single-radius (SR) prostheses and multi-radius (MR) prostheses have different theoretical advantages; however, there has been a paucity of evaluations comparing the two. This study was designed to compare the 10-year clinical, radiological, and survival outcomes of SR and MR posterior-stabilized prostheses in total knee arthroplasty (TKA)., Methods: In this retrospective cohort study, 220 consecutive patients undergoing TKA between October 2006 and October 2007 were divided into the SR group (106 patients, Stryker Scorpio NRG) and the MR group (114 patients, DePuy Sigma PFC), with a minimum follow-up of 10 years. Clinical, functional, and radiological outcomes, as well as satisfaction rates and survival results, were evaluated., Results: Hospital for Special Surgery and Short Form-12 health survey scores were all significantly improved in both groups at the final follow-up (P < 0.05), but the groups did not differ. The SR group had significantly less anterior knee pain (AKP) and painless crepitation (P < 0.05). Radiological results in terms of radiolucent lines and component position angle showed no differences between groups. The Kaplan-Meier survival curve estimates at 10 years were not significantly different between the groups (P = 0.4172)., Conclusion: Both SR and MR posterior-stabilized prostheses can lead to satisfactory outcomes. The SR prosthesis design gave less anterior knee pain than did the MR prostheses. Two prostheses showed no differences in terms of clinical scales, radiological results, satisfaction rates, and survival results at a long-term follow-up. More accurate measurements are required.

There is an interesting and long history of prostheses designed for those with upper-limb difference, and yet issues still persist that have not yet been solved. Prosthesis needs for children are particularly complex, due in part to their growth rates. Access to a device can have a significant impact on a child's psychosocial development. Often, devices supporting both cosmetic form and user function are not accessible to children due to high costs, insurance policies, medical availability, and their perceived durability and complexity of control. These challenges have encouraged a grassroots effort globally to offer a viable solution for the millions of people living with limb difference around the world. The innovative application of 3D printing for customizable and user-specific hardware has led to open-source Do It Yourself "DIY" production of assistive devices, having an incredible impact globally for families with little recourse. This paper examines new research and development of prostheses by the maker community and nonprofit organizations, as well as a novel case study exploring the development of technology and the training methods available. These design efforts are discussed further in the context of the medical regulatory framework in the United States and highlight new associated clinical studies designed to measure the quality of life impact of such devices.

Background: The main aims of this study were to examine the incidence and in-hospital outcomes of mechanical and bioprosthetic surgical mitral valve replacement (SMVR) among patients with and without T2DM., Methods: We performed a retrospective study using the Spanish National Hospital Discharge Database from 2001 to 2015. We included patients with SMVR codified in their discharge report. We grouped admissions by diabetes status. Propensity score matching (PSM) was used to compare outcomes of isolated SMVR., Results: We identified 42,937 patients (16.41% with T2DM). Incidence rates of mechanical and bioprosthetic SMVR were higher among T2DM patients than among non-T2DM patients. In both groups of patients, the use of bioprosthetic SMVR increased over time. The use of mechanical valves remained stable among T2DM patients. In T2DM and non-T2DM patients with mechanical SMVR, in hospital mortality (IHM) and MACCE decreased significantly (p < 0.001) from 2001 to 2015. T2DM patients had an overall 11.37% IHM, compared with 10.76% among non-T2DM patients (p = 0.176). Regarding MACCE figures were 14.72% vs. 14.22% (p = 0.320) after mechanical SMVR. Total crude IHM were 14.29% for T2DM patients and 15.13% for those without T2DM with bioprosthetic SMVR (p = 0.165) and 18.22 vs. 19.64%, for a MACCE (p = 0.185). Using PSM we found that the IHM and the MACCE of isolated SMVR did not differ significantly between patients with or without T2DM beside the type of valve replacement. Among T2DM patients, those who received bioprosthetic valves had higher IHM (14.29% vs. 11.37%; p = 0.003) and a higher rate of MACCE (18.22% vs. 14.72%; p = 0.001) than T2DM patients with mechanical SMVR., Conclusions: In Spain from 2001 to 2015, the incidence rates of hospitalization to undergo mechanical or bioprosthetic SMVR were higher among the population suffering T2DM than among the non-T2DM population. In both groups of patients the use of bioprosthetic SMVR increased over time and the use of mechanical valves remained stable in T2DM. T2DM patients have IHM and MACCE after mechanical and bioprosthetic SMVR which are not significantly different to those found among non-diabetic patients. Among T2DM patients, the crude IHM was significantly higher in those who received a bioprosthetic SMVR than those with mechanical SMVR.

Fenestrated endovascular aortic repair (FEVAR) stent grafting is a minimally invasive procedure and an alternative to open surgical repair for abdominal aortic aneurysm repair, particularly with unideal neck anatomy. Planning and implementing a custom FEVAR graft is complicated, requiring advanced training and years of practice. As such, a method for creating a patient-specific, to-scale, cost-effective, 3-dimensional abdominal aortic aneurysm model for use in preoperative planning is presented. The model can be used to help physicians create custom FEVAR grafts, thus eliminating the currently used difficult and technical method for creating custom grafts. It also can assist physicians in visualizing and practicing their surgical approach for a specific patient., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Ureteral stents are an indispensable tool in contemporary urologic patient care. They have become first-line devices for maintenance of ureteral patency postoperatively and in cases of ureteral narrowing. Despite their widespread use, these implants are associated with multiple complications including stent colic, infection, and encrustation. There is no ideal ureteric stent currently available. The aim of most recent stent innovation has been to make steps toward properties of an ideal stent. This article reviews recent technological advances in stent design and how they have attempted to tackle issues that urologists and patients face with ureteral stents., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Due to its bone preserving philosophy, short-stem total hip arthroplasty (THA) has primarily been recommended for young and active patients. However, there may be benefits for elderly patients given a less invasive operative technique due to the short curved implant design. The purpose of this study was to compare the clinical and radiological outcomes as well as perioperative complications of a calcar-guided short stem between a young (< 60 years) and a geriatric (> 75 years) population., Methods: Data were collected in a total of 5 centers, and 400 short-stems were included as part of a prospective multicentre observational study between 2010 and 2014 with a mean follow-up of 49.2 months. Preoperative femur morphology was analysed using the Dorr classification. Clinical and radiological outcomes were assessed in both groups as well as perioperative complications, rates and reasons for stem revision., Results: No differences were found for the mean visual analogue scale (VAS) values of rest pain, load pain, and satisfaction, whereas Harris Hip Score (HHS) was slightly better in the young group. Comparing both groups, none of the radiological parameters that were assessed (stress-shielding, cortical hypertrophy, radiolucency, osteolysis) reached differences of statistical significance. While in young patients aseptic loosening is the main cause of implant failure, in the elderly group particularly postoperative periprosthetic fractures due to accidental fall have to be considered to be of high risk. The incidence of periprosthetic fractures was found to be 0% in Dorr type A femurs, whereas in Dorr types B and C fractures occurred in 2.1 and 22.2% respectively., Conclusions: Advanced age alone is not necessarily to be considered as contra-indications for calcar-guided short-stem THA, although further follow-up is needed. However, markedly reduced bone quality with femur morphology of Dorr type C seems to be associated with increased risk for postoperative periprosthetic fractures, thus indication should be limited to Dorr types A and B., Trial Registration: German Clinical Trials Register; DRKS00012634 , 07.07.2017 (retrospectively registered).