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Kristine Jensen,1 Thomas Egenod,2 Daniel P Franzen,3,4 Michael Perch1,5 1Department of Cardiology, Section for Lung Transplantation and Respiratory Medicine, Rigshospitalet Heart Center, Copenhagen, Denmark; 2Department of Interventional Pulmonology, Dupuytren University Hospital, Limoges, France; 3Department of Internal Medicine, Uster Hospital, Uster, Switzerland; 4Department of Pulmonology, University of Zurich, Zurich, Switzerland; 5Department of Clinical Medicine, University of Copenhagen, Copenhagen, DenmarkCorrespondence: Michael Perch, Department of Cardiology, Section for Lung Transplantation and Respiratory Medicine, Rigshospitalet, Heart Center, Inge Lehmanns Vej 7, Copenhagen, 2100, Denmark, Email Michael.perch@regionH.dkAbstract: Endoscopic lung volume reduction (ELVR) is an established treatment option for patients with severe emphysema. Not all patients are candidates for this type of intervention, and in the context of significant airway secretions, they may be excluded from treatment. Bronchial Rheoplasty (BR) was developed to treat mucus hypersecretion by delivering nonthermal pulsed electric fields to the airway epithelium and submucosa. The literature to date demonstrates that patients treated with BR in clinical studies have a reduction in airway goblet cell hyperplasia as well as substantive clinical improvement in the setting of chronic bronchitis (CB). In this case series, we present four patients treated at three different institutions who had previously undergone ELVR with beneficial outcome. However, over time, these patients subsequently developed worsening clinical issues, including complaints of increased and thickened mucus, along with exacerbations in the setting of a loss of some ELVR-associated benefits. These patients then underwent exploratory treatment with BR with the intent of reducing their secretion burden and potentially restoring the efficacy associated with the initial placement of the airway valves. All BR procedures were well tolerated, and three of the four patients showed substantial improvement in their symptom burden. Airway examinations during the second of the two BR procedures also revealed what appeared to be less airway mucosal inflammation and a decrease in the quantity of airway secretions. Therefore, treatment with BR may have the potential to improve and restore the initial benefits associated with ELVR, thus enhancing long-term outcomes. Further clinical studies with sufficient follow-up are warranted to assess this in a larger cohort of patients, and to determine whether treatment with BR prior to ELVR may make more patients eligible for this treatment through reduction in their secretions and/or symptoms.Keywords: bronchial rheoplasty, endobronchial valves, emphysema

Category: Ankle Arthritis; Other Introduction/Purpose: Patient-reported outcomes (PROs), such as PROMIS, are a key element of evaluating success after total ankle replacement (TAR). To date, most PROs are described using absolute values or parameters like the minimum clinically important difference. However, these interpretations do not explicitly tell the surgeon the most important factor of postoperative success: is the patient satisfied with their outcome after TAR? The patient acceptable symptom state (PASS) is a novel PRO metric that attempts to bridge this gap. PASS represents the symptom threshold above which patients consider themselves well. This study aimed to establish the PROMIS thresholds for PASS in a primary cohort of TAR patients. We hypothesized that TAR patients would meet PASS and that PASS would vary with demographic variables. Methods: This is a single-institution retrospective cohort study of primary TAR patients (n=127; mean age 63.2 years; mean BMI 29.0 kg/m 2 ; 58% male) with preoperative and 2-year postoperative PROMIS scores (domains: Physical Function, Pain Interference, Pain Intensity, Global Mental Health, Global Physical Health, & Depression). At 2 years postoperatively, patients also answered 2 PASS anchor questions with Likert-scale responses: 1) Are you satisfied with the results of your surgery?; and 2) the Delighted- Terrible symptom scale. PASS thresholds with 95% confidence intervals (CI) were calculated using the anchors “Very satisfied” or “Satisfied” for question 1 and “Delighted,” “Pleased,” or “Mostly Satisfied” for question 2. Using bootstrapping technique with 1000 iterations, the Youden Index was then calculated to determine the best coordinates of specificity and sensitivity to maximize the Area Under the Curve (AUC). Finally, we analyzed preoperative variables (demographics, clinical/surgical data, and preoperative PROMIS scores) on the likelihood of achieving PASS. Results: There was a strong association between PASS thresholds and PROMIS domains, especially Physical Function (PASS threshold >44.7, AUC 0.883), Pain Interference (< 56.0, AUC 0.940), and Pain Intensity (< 48.4, AUC 0.936). Covariate stratification demonstrated that the likelihood of achieving PASS was not affected by age, race, gender, ASA score, or BMI. PASS was less likely to be achieved by patients who had undergone prior orthopaedic surgery (P=0.013). Patients with diabetes mellitus and peripheral vascular disease were less likely to meet PASS for Physical Function (P=0.010, P=0.037), but did meet PASS for Pain domains. Patients with worse preoperative Physical Function and Depression scores were less likely to meet PASS for Physical Function postoperatively (P=0.028, P=0.041), but achieved similar PASS for Pain Interference and Pain Intensity domains. Conclusion: After TAR, the ability to reach the postoperative PASS was most strongly associated with postoperative pain scores, as evidenced by the Pain Interference and Pain Intensity domains. However, the thresholds for PASS were generally lower than population means. This demonstrates that TAR patients do not need to reach normal pain or physical function levels in order to have an acceptable symptom state postoperatively. Moreover, the ability to achieve PASS was not affected by demographic variables. Further research on PASS is warranted, and may shift how surgeons and researchers evaluate TAR patients pre- and post-operatively.

Category: Ankle Arthritis; Ankle Introduction/Purpose: As the number of total ankle replacements (TAR) performed annually increases, there is an increased demand for implants that can be used in revision scenarios when primary TARs fail. As indications for TAR expand, there is increased reliance on modular systems to treat challenging conditions including bone loss, avascular necrosis, and instability. The INVISION Total Ankle Arthroplasty System (Wright Medical Technology/Stryker, Memphis, TN), released in 2018, includes modular augmented tibial trays and talar plates of varied heights to compensate for bone loss. There is limited data on early survivorship and clinical outcomes of the INVISION. This novel study aims to determine the early implant survivorship, complications, patient-reported outcomes (PROMIS), and radiographic outcomes of the INVISION implant used in both the primary and revision arthroplasty setting. Methods: This study is a single-institution retrospective review of adult patients who underwent primary or revision TAR with the INVISION implant with minimum 2-year follow-up. Demographics, reason for use of INVISION, surgical data, complications, pre- operative and 2 year post-operative radiographic data, and pre-operative and 2-year post-operative patient-reported outcome scores were collected. The primary outcome was survivorship (retention of both tibial/talar components at final follow-up). Secondary outcomes were reoperation (return to OR with retention of both tibial and talar components), radiographic complications (peri-implant lucency, cysts, or subsidence), and patient-reported outcomes (PROMIS pre-operative and 2-year post-operative). PROMIS scores were collected across the following domains: physical function, pain interference, pain intensity, global mental health, and depression score. Results: Twenty-six patients (primary=7; revision=19) underwent INVISION TAR (mean age 62 years, weight 81.kg, BMI 29.3 kg/m 2 , 15/26 male) with mean follow-up 3.5 years. Reason for INVISION primary TAR included tibial (n=1) or talar (n=5) bone loss, and take-down fusion (n=1); INVISION revision TAR was used for tibial (n=6) or talar (n=7) component subsidence, recurrent tibiotalar malalignment (valgus=1, varus=3), and post-infection bone loss (n=2). Two-year implant survivorship was 100%. There were 2 reoperations (7.7%): 1 gutter debridement and 1 irrigation, debridement and polyethylene exchange for infection. Two-year follow-up PROMIS domains improved significantly (p < 0.05) from pre-operative in both the primary (pain interference, pain intensity) and revision cohorts (pain interference, pain intensity, global physical function). Two-year radiographic follow-up yielded 1 tibial peri-implant lucency and 1 tibial cyst. Conclusion: In this single-institution series, there was excellent short-term survivorship of the INVISION TAR implant with no failures in primary or revision cases. There were significant improvements in patient-reported outcomes scores. There were low rates of peri-implant lucencies and cysts. The results of this study support the use of the INVISION implant in both the complex primary and revision TAR setting. INVISION may offer an alternate surgical solution to fusion, custom printed cage implants, and total talus replacement in this complex patient population. Further research and follow-up data are warranted to report the longer-term outcomes and survivorship of this implant.

Category: Ankle Arthritis; Ankle Introduction/Purpose: There is limited evidence regarding risk factors for medial malleolar fractures after total ankle arthroplasty (TAA). A previous study showed that patients with medial pain following TAA had significantly thinner ( 4 weeks postoperatively (cases) were identified through radiologic assessment (radiograph, CT, or MRI) and matched to a control group of 129 patients. Radiographic evaluation included pre- and post-TAA tibial coronal alignment, postoperative medial malleolar width at the tibial component, and prophylactic screw fixation. Demographics and radiographic variables were compared between cohorts using the Mann-Whitney U test for continuous variables and Pearson Chi-square for categorical variables. Logistic regression was used to investigate the association of medial malleolar stress fractures with gender, coronal tibial implant size, postoperative coronal alignment, prophylactic screw fixation, and medial malleolar width using odds ratios (OR), and standard error (SE). Results: Of 838 TAAs, 2.51% sustained a postoperative medial malleolar fracture (n = 21). Of these, 13/21 (61.9%) required reoperation: internal fixation (12) and TAA revision (1). Mean (SD) medial malleolar width was significantly smaller in the fracture cohort (8.62 mm [1.63]) than in controls (11.78mm [1.75]), P

Category: Ankle Arthritis; Ankle Introduction/Purpose: Restoring the native joint line correlates with better clinical outcomes in total knee arthroplasty. Yet, the effect of joint line elevation on clinical outcomes after total ankle arthroplasty (TAA) remains unclear. A previous study reported that pre- and post-TAA joint line heights, as measured by the joint line height ratio (JLHR), were elevated compared to non- arthritic ankles. However, the clinical impact of this has yet to be determined. Therefore, this study assessed the relationship between the TAA joint line level with post-TAA range of motion (ROM) and PROMIS scores. We hypothesized that an elevated joint line would be associated with restricted post-TAA dorsiflexion and worse postoperative PROMIS scores. Methods: This is a single-center review of 150 patients who underwent primary TAA. Patients with (1)fibular or medial malleolar osteotomy, (2) component subsidence, and (3) incomplete radiographs or outcome scores were excluded. Demographic data, surgical protocol, pre- and postoperative radiographs, and 1-year postoperative PROMIS scores were reviewed. Radiographic measurements included JLHR, pre- and post-TAA tibiotalar dorsiflexion and plantarflexion, and tibial component sagittal alignment. Two graders measured post-TAA JLHRs, and the average of the two graders was used for the analysis. Rater agreement was assessed using intraclass correlation coefficients (two-way random effects model). Relationships between JLHR, post-TAA tibiotalar ROM, and PROMIS scores were investigated using Pearson correlation. Multiple linear regression models were used to investigate the association of JLHR with post-TAA tibiotalar total ROM, dorsiflexion, and plantarflexion, after adjusting for pre- TAA ROM, tibial component sagittal alignment, gastrocnemius release (GR), Tendo-Achilles lengthening (TAL), and polyethylene size. Results: The interobserver reliability of the JLHR was excellent (r=0.98). Mean JLHR decreased from 1.66 pre-TAA to 1.55 post- TAA (P < 0.001), indicating the joint line was significantly lowered postoperatively. Greater elevation of the post-TAA JLHR was associated with significantly decreased post-TAA dorsiflexion (r=-0.26, P< 0.001) and worse 1-year PROMIS physical function (r=- 0.22, P=0.046), pain intensity (r=0.22,P=0.042), and pain interference scores (r=0.29,P=0.007). There was no correlation between JLHR and post-TAA plantarflexion (P=0.76). Regression analysis identified a 5º reduction in post-TAA dorsiflexion with each 1.0 unit increase in JLHR (Coef=-5.13, P=0.005). Post-TAA total ROM (Coef=-3.6,P=0.21) and plantarflexion (Coef=0.91, P=0.67) were not associated with JLHR. Additionally, there was no association between post-TAA total ROM and tibial component sagittal alignment, GR, TAL, or polyethylene size. Conclusion: In this study, the joint line of the ankle was lowered after TAA, and the JLHR was a reliable and clinically applicable method for assessing it. An elevated joint line significantly correlated with restricted post-TAA dorsiflexion, but this may only be clinically relevant for patients with significant (>1.0 unit) changes in the joint line level. In addition, a higher joint line was correlated with worse 1-year PROMIS scores. These results suggest that surgeons should consider the joint line level during TAA preoperative planning to obtain improved clinical outcomes and ankle dorsiflexion.

Category: Ankle Arthritis; Ankle Introduction/Purpose: As the frequency of total ankle arthroplasties (TAA) performed annually has increased significantly over the past decade, several novel TAA implants have entered the market. The Infinity TAA (Stryker, Mahwah, NJ) is a low-profile fixed- bearing implant that was approved for use in the United States in 2014. Although the short-term survivorship and complication rates of the Infinity TAA have been well documented in the literature, mid- to long-term outcome studies of this implant are limited. The aim of this study was to describe the survivorship, reoperation rate, and radiographic and clinical outcomes of the Infinity implant at minimum 5-year follow-up. We hypothesized that there would be no significant drop-off in clinical outcome or alignment from 2-year to 5-year follow-up. Methods: This is a single-institution retrospective review of patients who underwent primary TAA with the Infinity implant from July 2014 to April 2017. Four fellowship-trained foot and ankle surgeons contributed patients. Out of 74 identified ankles, 65 ankles in 64 patients had minimum clinical follow-up of 5 years (mean, 6.5; range, 5.0-8.0) and were included for analysis. Medical records were reviewed to record demographics, surgical data, complications, reoperations, and revisions. Radiographs were assessed to measure preoperative and postoperative alignment, and the incidence of postoperative peri-implant lucencies and cysts. Preoperative, 2-year, and 5-year postoperative Foot and Ankle Outcome Score (FAOS) subscores in the categories of Pain, Symptoms, Activities of Daily Living, Sports, and Quality of Life were obtained. The primary outcome was 5-year survivorship. Secondary outcomes were reoperations with retention of tibial and talar components, radiographic alignment, peri-implant lucencies/cysts, and clinical outcomes (FAOS) scores. Results: Implant survivorship at 5 years was 93.8%, with 4/65 revisions. Three revisions occurred less than 2 years from the index surgery (2/3 for tibial subsidence; 1/3 for tibial and talar subsidence). The fourth revision occurred at 7.1 years due to cystic changes with tibial and talar subsidence. There were 11 reoperations in 10 ankles. Alignment correction achieved surgically (preop coronal deformity 9.0 ± 6.8°; 1Y postop 1.6 ± 1.5°) was maintained at final radiographic follow-up (1.8 ± 1.7°; P = 0.32). There were 16 ankles (24.6%) with peri-implant radiographic abnormalities: 14 cases of lucency (14 tibia, 0 talus) and 3 cases of cysts. FAOS outcomes demonstrated significant improvement from preop to postop in all five domains at 2 years, which were maintained at 5 years. Conclusion: The mid-term outcomes of the Infinity implant in this single-institution study demonstrated good survivorship of 93.8% and improved clinical outcomes at mean 6.3-year follow-up. This was a mid-term follow-up to the 2-year outcome study published at this institution. Radiographic assessment at final follow-up demonstrated that alignment correction was maintained, and there was a 21.5% incidence of asymptomatic periprosthetic lucencies. These results demonstrate that there was no significant change in radiographic or clinical outcomes with this implant after 5 years, which is valuable for surgeons in terms of counseling and following patients in the immediate and mid-term postoperative period.

Category: Ankle; Basic Sciences/Biologics Introduction/Purpose: Although double hindfoot arthrodesis (subtalar and talonavicular) provides pain relief and deformity correction for patients with end-stage arthritis, altered ankle biomechanics may occur following these procedures. Furthermore, it has been reported that hindfoot fusions may lead to progressive ankle degenerative changes and a higher failure rate in patients undergoing total ankle arthroplasty. Previous biomechanical studies demonstrated that hindfoot fusion altered ankle joint kinematics and contact mechanics during simplified loading scenarios, but the effect during dynamic activity is unknown. Therefore, this study sought to quantify the changes in ankle kinematics after a double hindfoot arthrodesis during the stance phase of simulated gait. In addition, we sought to assess whether the sequence in which joints are fused plays a role in altering ankle kinematics. Methods: Fourteen mid-tibia specimens underwent stance phase simulations of level walking using a validated six-degree of freedom robot. All specimens had neutral hindfoot alignment. An eight-camera motion system tracked reflective markers in the tibia, talus, calcaneus, and navicular bones. Simulated arthrodeses of the subtalar and talonavicular joints were performed using two 7.0mm and two 5.5mm crossing screws, respectively. The subtalar alignment was set at 5º valgus, and the talonavicular at neutral abduction/adduction. Fluoroscopic images confirmed proper screw position and hindfoot alignment. Each specimen was tested in three conditions: pre-arthrodesis(intact), isolated arthrodesis(subtalar or talonavicular joint), and double arthrodesis(double). Specimens were further divided into two groups depending on whether the subtalar(STDouble) or talonavicular(TNDouble) joint was fused first. Ankle kinematics were calculated for each condition for the entire cohort of specimens and each of the two groups. Bias-corrected 95% confidence intervals of the difference in ankle kinematics relative to the intact condition were constructed. Results: Double hindfoot arthrodesis significantly altered ankle kinematics(Figure1A). Ankle plantarflexion decreased during heel strike by up to 2.0° on average and increased during toe-off by 6.5° compared to the intact condition. Ankle eversion increased by 1.5º and 2.5º on average during mid- and late stance, respectively. Internal rotation decreased during midstance by 1.1º on average and increased in late stance by 4.5°. The order in which hindfoot joints were fused significantly influenced ankle kinematics(Figure1B). On average, the TNDouble condition produced 2.3º and 3.5º more ankle eversion during the mid- and late stance, respectively, and 2.10° more ankle internal rotation during the early stance compared to the STDouble condition (not shown). Significant changes were also present after isolated hindfoot arthrodeses and remained consistent after the double arthrodesis. Conclusion: Double hindfoot arthrodesis significantly altered ankle kinematics throughout stance. Ankle kinematics also differed depending on which joint was fused first. Notably, the TNDouble condition produced more ankle internal rotation during early stance and more ankle eversion during mid- and late stance compared to the STDouble condition. This finding suggests that the sequence in which joints are fused affects the resultant ankle kinematics. Finally, the kinematic changes after isolated hindfoot arthrodesis remained consistent after incorporating the second joint into the fusion. It appears that once one joint needs to be fused, avoiding the double arthrodesis may not necessarily protect the ankle.

Category: Ankle Arthritis Introduction/Purpose: Talar collapse can occur from a variety of etiologies and may pose a unique challenge to the foot and ankle surgeon due to the complexity of the deformity and associated adjacent joint degenerative change. Total talus replacement (TTR) has emerged as an attractive option to help patients return to activities sooner than with arthrodesis and improve pain and joint mechanics postoperatively. However, there is limited long-term data on the most recent generation of implants. In this multi- institution case series, we present the severe complications that can occur after TTR, including instability, infection, and adjacent joint osteoarthritis. Methods: We present three cases from Duke University Hospital in Durham, North Carolina, and the Hospital for Special Surgery In New York City, New York. All three patients were treated with a total talus replacement (TTR) during their clinical course and experienced subsequent complications. Clinical data and radiographs were collected from chart review under an IRB-exempt protocol. Results: Case 1 demonstrates the risk of ligamentous insufficiency leading to dislocation following placement of a TTR. This case highlights the posterior instability due to soft tissue mobilization and division. Case 2 highlights the risk for adjacent joint degeneration with TTR. Case 3 presents an instance of non-union following a total ankle and total talus replacement (TATTR) with subtalar arthrodesis. To our knowledge, this represents the first case of nonunion following TTR in the literature. Finally, we discuss our institution’s experience with infection following TTR and possible contributing factors to this specific procedural risk. Conclusion: TTR shows promise in the properly selected patient with end-stage talar collapse. However, heterogeneous surgical techniques, implant composition, indications, and patient demographic variables complicate the interpretation of the literature. Moreover, few studies report mid-to long-term outcomes after this procedure and the occurrence of adjacent joint OA is likely underreported in the literature. Thus, until further, high-quality studies with long-term follow-up validate the positive early outcomes of TTR, we urge extreme caution in patient selection, choice of implants, and surgical techniques.

Background: The literature on survivorship and outcomes after revision total ankle replacement (TAR) in the modern era is limited. This study aimed to describe the timing to revision and survivorship after revision TAR. We hypothesized that tibial-sided failures would occur earlier after the primary TAR, and secondary revisions after failure of revision TAR would occur more due to talar-sided failures than tibial-sided failures. Methods: This is a single-institution retrospective study of TAR patients with minimum 2-year follow-up. Revision TARs (defined as exchange of tibial and/or talar components) for aseptic causes with any implant were included. Etiology of failure necessitating revision and ultimate outcomes after revision (survival of TAR revision, additional revision, conversion to fusion, and below-knee amputation [BKA]) were recorded. Results: There were 46 revision TARs, with mean age of 60.6 (range: 31-77) years and mean 3.5 years' follow-up postrevision. Revisions for tibial failure occurred significantly earlier (n = 22, 1.3 ± 0.5 years after index procedure) than those for talar failure (n = 19, 2.3 ± 1.7 years after index procedure) or combined tibial-talar failure (n = 5, 3.4 ± 3.4 years after index procedure) (P =.015). Revisions for tibial-only failure had better survival (95.5%) than revisions for talar or combined tibial-talar failures: 26% of talar failures and 20% of combined tibial-talar failures underwent ≥1 revisions. Of the 6 additional revisions after failure of the talar component, 1 ultimately underwent BKA, 2 were converted to total talus replacement, 2 were revised to modular augmented talar components, and 1 was treated with explant and cement spacer for PJI after the revision. Conclusion: TAR tibial failures occurred earlier than talar failures or combined tibial-talar failures. Revisions for talar failures and combined tibial-talar failures were more likely to require additional revision or ultimately fail revision treatment. This is important given the consequences of talar implant subsidence, bone necrosis, loss of bone stock, and limited salvage options. [ABSTRACT FROM AUTHOR]