Durability of transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) is now utilised as a less invasive alternative to surgical aortic valve replacement (SAVR) across the whole spectrum of surgical risk. Long-term durability of the bioprosthetic valves has become a key goal of TAVI as this procedure is now considered for younger and lower-risk populations. The purpose of this article is to present a state-of-the-art overview on the definition, aetiology, risk factors, mechanisms, diagnosis, clinical impact, and management of bioprosthetic valve dysfunction (BVD) and failure (BVF) following TAVI with a comparative perspective versus SAVR. Structural valve deterioration (SVD) is the main factor limiting the durability of the bioprosthetic valves used for TAVI or SAVR, but non-structural BVD, such as prosthesis-patient mismatch and paravalvular regurgitation, as well as valve thrombosis or endocarditis may also lead to BVF. The incidence of BVF related to SVD or other causes is low (<5%) at midterm (5- to 8-year) follow-up and compares favourably with that of SAVR. The long-term follow-up data of randomised trials conducted with the first generations of transcatheter heart valves also suggest similar valve durability in TAVI versus SAVR at 10 years, but these trials suffer from major survivorship bias, and the long-term durability of TAVI will need to be confirmed by the analysis of the low-risk TAVI versus SAVR trials at 10 years.

Effect of body mass index on 30-day complication rate and implant survival rate after simultaneous bilateral unicompartmental knee arthroplasty: a multicentre retrospective study.

OBJECTIVE: The practice of simultaneous bilateral unicompartmental knee arthroplasty (SBUKA) remains a topic of debate, particularly in patients with obesity. Thus, the purpose of this study was to assess the impact of body mass index (BMI) on the 30-day complication rate and the survival rate of the implant following SBUKA. METHODS: We retrospectively examined the clinical records of 245 patients (490 knees) who underwent SBUKA at the Affiliated Hospital of Qingdao University and the Third Hospital of Hebei Medical University between January 2010 and December 2020. Patients were categorised based on their BMI at the time of surgery into four groups: normal weight (BMI 18.5 to 22.9 kg/m2), overweight (BMI 23.0 to 24.9 kg/m2), obese (BMI 25.0 to 29.9 kg/m2), and severely obese (BMI ≥30 kg/m2). Variables such as length of hospital stay, duration of surgery, and costs of hospitalisation were compared across all groups. Additionally, we recorded the 30-day postoperative complication rate and the time from surgery to any required revision. The Kaplan-Meier survival analysis was employed to evaluate and compare the implant survival rates. RESULTS: The follow-up period for the 245 patients ranged from 39 to 114 months, with an average of 77.05±18.71 months. The incidence of complications within 30 days post-surgery did not significantly differ across the groups (χ2 = 1.102, p = 0.777). The implant survival rates from the lowest to the highest BMI groups were 97.14%, 93.9%, 94.44%, and 96.43%, respectively. Both the rate of implant revision (χ2 =1.612, p = 0.657) and the survival curves of the implants (p = 0.639) showed no statistically significant differences among the groups. CONCLUSIONS: BMI did not influence the 30-day complication rate nor the survival rate of implants following SBUKA, suggesting that SBUKA should not be contraindicated based on BMI alone.

Early intraocular lens explantations: 10-year database analysis.

BACKGROUND: The aim of this study was to analyze the causes and characteristics of IOL explantation within the first year after primary implantation. METHODS: In this retrospective, cross sectional database study, a database consisting of over 2500 IOL explants sent from 199 national and international doctors over the past 10 years was analyzed. All IOLs explanted within the first year after implantation were included in this analysis. Explants with insufficient information as well as phakic and Add-on IOLs were excluded. Main outcome measures were the reason for explantation, the time between implantation and explantation, as well as IOLs' and patients' characteristics. Additionally, the explanted IOLs were microscopically and histologically analyzed, as required. RESULTS: Of all explanted IOLs from the database, 1.9% (n = 50) were explanted within the first year after implantation. The most frequent reasons for early IOL explantation were IOL dislocation (32%), visual intolerance (26%), opacification (20%), and intraoperative complications (16%). The time between implantation and explantation was the shortest in cases with intraoperative complications (1.5 ± 3.1 days), followed by IOL dislocation (90.9 ± 103.9 days), visual intolerance (98.3 ± 86.5 days), opacifications (253.5 ± 124.0 days) and other indications (249.7 ± 124.0 days). Calcification of hydrophilic IOLs was the main type of opacification (80%). Notably, seven IOLs required immediate intraoperative exchange due to an intraoperative crack in the optic or a torn off haptic. CONCLUSION: Indications for early IOL explantation were IOL dislocation, visual intolerance, opacification, and intraoperative complications. Especially intraoperative damages to the IOL and early calcification show a potential for improvement of affected IOLs and implantation systems.

Comparing the lifespan of virgin artificial urinary sphincters in radiated patients: transcorporal vs. standard placement.

PURPOSE: To compare the lifespan of first transcorporal cuff (TC) placement of an artificial urinary sphincter (AUS) versus standard placement (SP) in patients with prior radiotherapy (RT) for prostate cancer (PCa). METHODS: We reviewed first (virgin) AUS placements from two high-volume care centers between 1/2011 and 1/2021, including PCa patients with RT history. AUS lifespan was assessed via the hazard ratio of device explantation and/or revision within a ten-year timeframe for the TC vs. SP approaches. Chi-square, Fisher's exact, and t-tests compared clinicodemographic variables. Kaplan-Meier curve compared TC and SP lifespan. RESULTS: 85/314 men with AUS met inclusion criteria, with 38.8% (33/85) in the TC group and 61.2% (52/85) in the SP group. Median ages were 69.8 (IQR = 65.2-73.6) and 67.1 (61.6-72.9), respectively, p = 0.17. Over a median follow up of 51.9 (15.8-86.1) and 80.4 (28.1-128.3) months for the TC and SP, overall, 12 (36.4%) TC devices were removed (four [12.1%] due to mechanical failures; eight [24.2%] erosions, and two [6.1%] infections) vs. 29 (55.8%) in the SP group (14 [26.9%] mechanical failures; 11 [21.1%] erosions, and five [9.6%] infections). No statistically significant differences were observed between the two approaches, with HR = 0.717, 95% CI 0.37-1.44, p = 0.35. The calculated device survival probabilities for the TC vs. SP at one, five, and 10 years were 78.8% vs. 76.9%, 69.3% vs. 58.7%, and 62.1% vs. 46.7%, respectively. CONCLUSIONS: TC cuff insertion for the first AUS implantation in pre-radiated patients showed to be comparable to SP when it comes to device survival, with comparable complication rates. Current guidance for approach selection is primarily based on patient selection and surgeon preference.

[Medium- and long-term effectiveness of hip revision with SL-PLUS MIA stem in patients with Paprosky type â - â ¢ femoral bone defect].

Objective: To investigate the medium- and long-term effectiveness of hip revision with SL-PLUS MIA stem in patients with Paprosky typeⅠ-Ⅲ femoral bone defect. Methods: Between June 2012 and December 2018, 44 patients with Paprosky typeⅠ-Ⅲ femoral bone defect received hip revision using SL-PLUS MIA stem. There were 28 males and 16 females, with an average age of 57.7 years (range, 31-76 years). Indications for revision comprised aseptic loosening (27 cases) and periprosthetic joint infection (17 cases). The Harris hip scores were 54 (48, 60) and 43 (37, 52) in patients with aseptic loosening and periprosthetic joint infection, respectively. The preoperative femoral bone defects were identified as Paprosky type Ⅰ in 32 cases, type Ⅱ in 9 cases, type ⅢA in 2 cases, and type ⅢB in 1 case. Operation time and intraoperative blood transfusion volume were recorded. During follow-up after operation, the hip joint function were evaluated by Harris hip score and X-ray films, the femoral stem survival was analyzed, and the surgical related complications were recorded. Results: The operation time of infected patients was 95-215 minutes, with an average of 125.0 minutes. The intraoperative blood transfusion volume was 400-1 800 mL, with an average of 790.0 mL. The operation time of patients with aseptic loosening was 70-200 minutes, with an average of 121.0 minutes. The intraoperative blood transfusion volume was 400-1 400 mL, with an average of 721.7 mL. All patients were followed up 5.3-10.0 years (mean, 7.4 years). At last follow-up, the Harris hip scores were 88 (85, 90) and 85 (80, 88) in patients with aseptic loosening and periprosthetic joint infection, respectively, both of which were significantly higher than those before operation ( P<0.05). Radiological examination results showed that the distal end of the newly implanted femoral stem did not cross the distal end of the original prosthesis in 25 cases, and all femoral stems obtained bone fixation. Two cases experienced femoral stem subsidence and 1 case had a translucent line on the lateral side of the proximal femoral stem. When aseptic loosening was defined as the end event, the 10-year survival rate of the SL-PLUS MIA stem was 100%. When treatment failure due to any reason was defined as the end event, the survival time of the prosthesis was (111.70±3.66) months, and the 7-year survival rate was 95.5%. The 7-year survival rates were 94.1% and 96.3% in patients with aseptic loosening and periprosthetic joint infection, respectively. The incidence of postoperative complications was 9.1% (4/44), among which the prosthesis related complications were 4.5% (2/44), 1 case of dislocation and 1 case of infection recurrence. Conclusion: Hip revision with SL-PLUS MIA stem has the advantages of simple operation and few postoperative complications in the patients with Paprosky type Ⅰ-Ⅲ femoral bone defect, and the medium- and long-term effectiveness is reliable.

High revision rate of metal-backed glenoid component and impact on the overall revision rate of stemless total shoulder arthroplasty: a cohort study from the Danish Shoulder Arthroplasty Registry.

BACKGROUND AND PURPOSE: There is controversy regarding the results of stemmed and stemless total shoulder arthroplasty (TSA) used for osteoarthritis. Therefore, we aimed to compare revision rates of stemmed and stemless TSA and to examine the impact of metal-backed glenoid components. METHODS: We included all patients reported to the Danish Shoulder Arthroplasty Register from January 1, 2012 to December 31, 2022 with an anatomical TSA used for osteoarthritis. Primary outcome was revision (removal or exchange of components) for any reason. RESULTS: 3,338 arthroplasties were included. The hazard ratio for revision of stemless TSA adjusted for age and sex was 1.83 (95% confidence interval [CI] 1.21-2.78) with stemmed TSA as reference. When excluding all arthroplasties with a metal-backed glenoid component, the adjusted hazard ratio for revision of stemless TSA was 1.37 (CI 0.85-2.20). For the Eclipse stemless TSA system, the adjusted hazard ratio for revision of a metal-backed glenoid component was 8.75 (CI 2.40-31.9) with stemless Eclipse with an all-polyethylene glenoid component as reference. CONCLUSION:  We showed that the risk of revision of stemless TSAs was increased and that it was related to their combination with metal-backed glenoid components.

Complete dislodgement of a mechanical valve prosthesis: A rare but potentially life-threatening event: a case report.

RATIONALE: Complete dislodgement of a mechanical valve is extremely uncommon as a long-term issue after getting a substitute mitral valve, and this report details an incident of complete detachment of a mechanical valve. PATIENT CONCERNS: A 50-year-old woman, who underwent mitral mechanical valve replacement 2 decades earlier at another facility, was urgently admitted due to sudden cardiogenic shock. DIAGNOSES: Transthoracic echocardiograms revealed severe malfunction of the mitral valve prosthesis, characterized by significant mitral regurgitation and moderate pulmonary hypertension. Following the insertion of extracorporeal membrane oxygenation and an intra-aortic balloon pump, the hemodynamics stabilized. Coronary angiography displayed the prosthetic mitral valve ring and leaflet floating in the left atrium, as confirmed by preoperative real-time 3-dimensional transesophageal echocardiography. A complete separation of the prosthetic ring and leaflet from the suture ring was observed. INTERVENTIONS: The patient promptly underwent bioprosthetic mitral valve replacement. OUTCOMES: The patient's postoperative course was uneventful, leading to discharge in good condition. LESSONS: A crucial aspect is comprehending the structure of the prosthetic valve itself. The use of transthoracic echocardiography and real-time 3-dimensional transesophageal echocardiography provides additional structural and functional details, enhancing support for potential life-saving interventions. Echocardiography plays a significant role in evaluating the morphology and function of prosthetic valves.

Failure of the Yoke With a Rotating-Hinge Total Knee Arthroplasty: A Case Report.

CASE: A patient underwent revision of a total knee replacement to a cementless rotating-hinge prosthesis. The femoral component became loose, but due to the patient's frailty and cognitive decline, revision was not performed. Subsequently, the yoke failed, dissociating the femoral and tibial components, necessitating a single-stage revision. CONCLUSION: This case underlines the need for robust fixation of components of rotating-hinge knee replacements to avoid mechanical failures. It contributes valuable insights to the limited literature on yoke failure in total knee arthroplasty, emphasizing the importance of implant design, patient selection, and surgical technique to prevent such complications.

Periprosthetic giant cell tumour of the tibia: en bloc resection and megaprosthesis revision.

We present a case detailing the diagnosis and management of a periprosthetic giant cell tumour in a female patient in her 70s, who had undergone total knee arthroplasty (TKA) for primary osteoarthritis in her right knee 7 years prior. The patient reported 4 months of painful weight-bearing. Various imaging modalities, including plain radiographs, CT scans and MRI, revealed a sizeable lytic lesion beneath the TKA prosthesis, along with loosening of the tibial component.Blood tests and analyses of synovial fluid ruled out periprosthetic joint infection, and a biopsy confirmed the diagnosis of a giant cell tumour of the bone. Treatment entailed en bloc resection of the tumour and revision of the TKA using a hinged, oncological-type megaprosthesis. Surgical procedures involved careful resection of the proximal tibia, preservation of vasculature and the creation of a medial gastrocnemius muscle flap. Following surgery, the patient underwent supervised rehabilitation with a functional brace.

Cochlear Implant Device Failures Falling Under the 2020 FDA Voluntary Field Corrective Action: A Systematic Review and Meta-analysis.

OBJECTIVE: To compare the rate of device failure for those cochlear implants (CIs) involved in the 2020 Food and Drug Administration (FDA) voluntary field corrective action (VFCA). DATABASES REVIEWED: Medline, Embase, and Scopus. METHODS: A systematic review was performed according to the PRISMA guidelines. Publications reporting institutional experiences with implants affected by the VFCA were included. Outcomes assessed included etiology of, rate of, and time to failure and pre-/post-device failure speech perception testing. All outcomes reported in at least two independent studies were included in a meta-analysis. RESULTS: Six studies met criteria for analysis. The overall pooled failure rate was 23.7% (95% CI, 11.6-38.4%). The pooled device, inconclusive, and medical failure rates were 21.5%, 0.2%, and 0.7%, respectively. Pediatric failure rates were higher than those of adults (46.9% [95% CI, 11.2-84.5%] versus 32.6% [95% CI, 8.2-63.7%]). WRS declined with primary implant failure (55.1% [95% CI, 48.0-62.1%] to 34.1% [95% CI, 30.2-38.0%]) but improved after reimplantation (34.1% [95% CI, 30.2-38.0%] to 50.1% [95% CI, 45.2-55.1%]). CONCLUSIONS: The rate of pooled reported failure for CIs falling under the 2020 VFCA in the literature thus far is 23.7%. The overwhelming majority of these failures were device related, the rates of which were higher in children. Speech perception improved significantly after reimplantation.

[GMK rotating hinge prosthesis. A valid option for complex revision knee prosthetic surgery]. / Prótesis bisagra rotatoria GMK. Una opción válida para la cirugía de revisión protésica compleja de rodilla.

INTRODUCTION: revision joint replacement surgery presents a surgical challenge. The use of rotating hinge prostheses is an option in patients with femorotibial bone defects, ligament insufficiency, or significant deformities. The aim of this study was to evaluate the clinical, functional, and radiological outcomes of a series of patients who underwent surgery using the GMK Hinge (Medacta®) rotational hinge model. MATERIAL AND METHODS: a descriptive, retrospective, and analytical study was conducted on a series of 36 patients, with a mean age of 72.5 years (47-85), operated on by the same surgical team between January 2015 and January 2022. The etiology of revision was chronic infection in 38.9% of cases, instability in 33.3%, aseptic loosening in 19.4%, and stiffness in 8.4%. The Knee Society Score (KSS) and the Forgotten Joint Score (FJS) were used to assess functional outcomes. The degree of femorotibial bone defect was evaluated using the Anderson Orthopaedic Research Institute (AORI) classification. Postoperative complications are also recorded. RESULTS: a total of 36 patients, 17 males and 19 females, were included, with a mean follow-up of 30 months (12-66). Twelve patients had type 1 defects, ten had 2A defects, ten had 2B defects, and two had type 3 defects on the femoral side, with the use of wedges required for asymmetrical defects (21 patients). The predominant tibial defect was type 1 without the need for wedges. The majority achieved a satisfactory outcome on the KSS scale (72.2 ± 9.4), with significant differences compared to the previous KSS (54.3 ± 8.9). A score of 31 (12-67) was also obtained on the FJS scale. Postoperative complications were present in 16.7% of patients. CONCLUSIONS: complex prosthetic revision surgery using a rotating hinge prosthesis represents a suitable therapeutic option, yielding appropriate clinical and functional outcomes, albeit not without complications.

INTRODUCCIÓN: la cirugía de revisión protésica constituye un reto quirúrgico. La utilización de prótesis tipo bisagra rotatoria es una opción en pacientes con defectos óseos femorotibiales, insuficiencia ligamentosa o importantes deformidades. El objetivo del presente estudio es evaluar los resultados clínicos, funcionales y radiológicos de una serie de pacientes intervenidos mediante un modelo de bisagra rotacional GMK Hinge (Medacta®). MATERIAL Y MÉTODOS: estudio descriptivo retrospectivo y analítico que incluyó una serie de 36 pacientes, con edad media de 72.5 años (47-85) intervenidos entre Enero de 2015 y Enero de 2022 por el mismo equipo quirúrgico. La etiología de revisión fue infección crónica en 38.9%, inestabilidad en 33.3%, aflojamiento aséptico en 19.4% y rigidez en 8.4%. Para la evaluación de resultados funcionales se utiliza la escala Knee Society Score (KSS), así como la escala Forgotten Joint Score (FJS). El grado de defecto óseo femorotibial se evaluó mediante la clasificación de Anderson Orthopaedic Research Institute (AORI). También se registraron las complicaciones postquirúrgicas. RESULTADOS: se analizó un total de 36 pacientes, 17 varones y 19 mujeres, con seguimiento medio de 30 meses (12-66). Se encontraron doce pacientes con defectos tipo 1, diez con defectos 2A, diez con defectos 2B y dos con defecto tipo 3 en la vertiente femoral, siendo necesario la utilización de cuñas en defectos asimétricos (21 pacientes). El defecto tibial mayoritario fue el tipo 1 sin necesidad de cuñas. La mayoría obtuvo un resultado satisfactorio en la escala KSS (72.2 ± 9.4), con diferencias significativas respecto al KSS previo (54.3 ± 8.9). Se obtuvo también una puntuación de 31 (12-67) en la escala FJS. Presentaron complicaciones postoperatorias 16.7% de los pacientes. CONCLUSIONES: la cirugía de revisión protésica compleja mediante prótesis tipo bisagra rotacional constituye una correcta opción terapéutica, presentando resultados clínicos y funcionales adecuados, no exentos de complicaciones.

Failure in HiRes Ultra Series Recall Devices Does Not Necessarily Lead to Decrement in Performance.

OBJECTIVE: To understand the impact on speech perception for patients experiencing Advanced Bionics V1 series Ultra and Ultra 3D cochlear implant failure. STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary academic center. PATIENTS: Adult patients implanted with V1 series devices. INTERVENTIONS: Device integrity and speech perception testing. MAIN OUTCOME MEASURES: consonant-nucleus-consonant and AzBio in quiet speech recognition scores. RESULTS: At our institution, 116 V1 series cochlear implants were placed in 114 patients. Thirteen devices in prelingual patients were excluded, leaving 103 (89%) for final analysis. Forty-eight (46.6%) devices were considered as failed using the company provided EFI analysis tool. There were 36 (65.5%) of the remaining 55 devices that consistently tested within normal range; the remainder lost to follow-up with unknown status. Among the 48 device failures, 29 were revised and 19 patients were not revised. Among those not revised, 11 self-opted for observation (57.9%). Observed patients, despite impedance changes meeting failure criteria, had no subjective or objective changes in speech perception. Sentence testing scores for failure patients who elected observation (82.9 ± 11.4%) were significantly higher at failure compared with those opting for revision (55 ± 22.8%, p = 0.006). For those undergoing revision surgery, significant improvement in post-activation scores was noted as compared with time of failure with a mean improvement of 12.9% (p = 0.002, n = 24) for consonant-nucleus-consonant word scores and 17.2% (p = 0.001, n = 19) for AzBio in quiet scores. CONCLUSIONS: Proactive monitoring using EFI identifies a higher rate of Ultra Series V1 device failure than previously reported. However, about 20% of these patients may not have subjective change in hearing or objective decline in test scores and could be observed. Should performance worsen, reimplantation provides significant improvement in speech recognition.

Hydrodynamic Assessment of Explanted Degenerated Transcatheter Aortic Valves: Novel Insights Into Noncalcific and Calcific Mechanisms.

BACKGROUND: The etiology of transcatheter aortic valve (TAV) degeneration is poorly understood, particularly noncalcific mechanisms. OBJECTIVES: The authors sought to investigate noncalcific and calcific mechanisms of TAV degeneration and evaluate their impact on leaflet function by bench testing, imaging, and histology. METHODS: TAV explants were obtained from the EXPLANT THV registry and clinical institutions. Hydrodynamic assessment was performed using a heart valve pulse duplicator system under physiological conditions. Micro-computed tomography, high-resolution photography, high speed video, and hematoxylin and eosin staining were used to evaluate the morphological appearance, leaflet kinematics, and calcium burden of TAVs. RESULTS: A total of 14 explants were evaluated: 10 self-expanding CoreValve/Evolut TAVs (Medtronic), 3 balloon-expandable SAPIEN 3 TAVs (Edwards Lifesciences), and 1 mechanically expandable Lotus TAV (Boston Scientific). The median patient age at explantation was 73.0 years (Q1-Q3: 64.5-80.0 years), with a time to explantation of 4 years 1 month (1 year 5 months to 4 years 11 months). Six TAV explants were found to have leaflet calcification (162.4 mm3; 58.8-603.0 mm3), and 8 had no calcification detectable by micro-computed tomography and histology. All samples had impaired leaflet kinematics. There was no significant difference in the hydrodynamic mean gradient between calcified (47.2 mm Hg; 26.6-74.1 mm Hg) and noncalcified (27.6 mm Hg; 15.2-36.7 mm Hg; P = 0.28) TAVs. Leaflet calcification had a weak but nonsignificant association with the hydrodynamic mean gradient (r = 0.42; P = 0.14). CONCLUSIONS: TAV function can be severely impacted by noncalcific and calcific mechanisms of tissue degeneration. Importantly, functional stenosis can occur in TAVs in the absence of obvious and significant calcification.

Efficacy and safety of malleable penile prosthesis compared to inflatable penile prosthesis in erectile dysfunction patients.

INTRODUCTION: Erectile dysfunction can cause self-withdrawal and decreased quality of life. Patients who do not respond to pharmacological therapy and other conservative treatments are urged to undergo penile prosthesis implantation. Malleable penile prosthesis was the first prosthesis developed, but then inflatable penile prosthesis was developed to give a more natural erection. There is no meta-analysis comparing inflatable and malleable penile prostheses in terms of safety and efficacy. This study is conducted to evaluate patient and partner satisfaction, ease of use, mechanical failure, and infection rate in patients who underwent penile prosthesis implantation. METHOD: This meta-analysis followed Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) protocols. Five eligible studies were included from Pubmed, Scopus, ScienceDirect, and SemanticScholar databases. RESULT: In this study, patient and partner satisfaction are significantly better (OR 3.39, 95% CI 1.66-6.93, p = 0.0008) (OR 2.32, 95% CI 1.75-3.08, p < 0.00001). Mechanical failure is also significantly higher in inflatable penile prostheses (OR 5.60, 95% CI 2.02-15.53, p = 0.0009). There is no significant difference in terms of ease of use and infection rate in inflatable or malleable penile prostheses. CONCLUSIONS: This study concluded that inflatable penile prosthesis is better in terms of patient and partner satisfaction, but mechanical failures occur more frequently in this type of prosthesis.