Two-year Clinical Follow-up Research Articles

Two-year clinical follow-up enhances the diagnosis of early-stage hip osteoarthritis: data from check cohort

ObjectiveTo provide a set of diagnostic criteria for early-stage hip osteoarthritis (OA) in primary care, using signs and symptoms monitored over 2 years in individuals with hip pain and/or stiffness....

#1694 The Cl-/HCO3-ratio as a predictor of decompensated metabolic acidosis in CKD stages G4 and G5

Abstract Background and Aims Metabolic acidosis (MA) is a common disorder in patients with chronic kidney disease (CKD) and is associated with both a normal anion gap (AGMA) and a high anion gap (HAGMA). AGMA is typically detected early in the course of CKD, whereas HAGMA appears later in the course of CKD due to the accumulation of non-chloride anions such as phosphate, sulphate, and an array of organic acids. The anion gap (AG) is usually calculated as the difference between serum concentration of cations and anions using the formula AG=Na+-(Cl−+HCO3−). The most important anions in serum are chlorides (Cl−) and bicarbonates (HCO3−). The more advanced the CKD, the higher the AG. As eGFR decreases, a reciprocal decrease in HCO3− and an increase in chloride concentration is observed to correct the AG. The aim of this study is to determine whether the Cl−/HCO3− ratio can be used to predict decompensated metabolic acidosis with pH decline in CKD stages G4 and G5. Method A total of 115 patients (median age 63 ± 17 years), with CKD stage G4 or G5 were enrolled in this cross-sectional study. Demographic and comorbidity data was obtained from medical records, and the Charlson Comorbid Index (CCI) was calculated. A two-year clinical follow-up was conducted to assess the clinical status of each patient. The number of patients, the time dialysis was started, and deaths were all recorded. All patients were qualified for arteriovenous fistula creation in predialysis period. The arterial (A) and venous (V) blood samples were taken during surgery, directly after vessel dissection, and evaluated in a point of care testing analyzer (POCT). The ratio of arterial Cl− and HCO3− concentration were calculated. According to mean arterial pH (pH-A) the group was divided into Group A pH-A<7.33 and Group B pH-A≥7.33 (Table 1). Results In Group A was significantly lower pH-A, pH-V, HCO3−-A, HCO3−-V, pCO2-A, pCO2-V, and significantly higher both arterial and venous Cl− and the Cl−/HCO3− ratios compared to Group B. No such differences were observed in the case of AG. Cl−/HCO3−-A ratio negatively correlated with pH (r = −0.77, p < 0.01) (Fig. 1A). The discriminative power of Cl−/HCO3−-A ratio for predicting pH-A≤7.33 was 0.917 (95% confidence interval [CI] = 0.87–0.97; p < 0.01) which provided 87% sensitivity and 84% specificity (Fig. 1B). The best cut-off was 6.22 (mmol/l)/(mmol/l). Conclusion The Cl−/HCO3− ratio lower than 6.22 (mmol/l)/(mmol/l) may be used as predictor of decompensated metabolic acidosis.

Two-Year Results of Ceramic-on-Ceramic Hip Resurfacing in an International Multicenter Cohort

BackgroundHip resurfacing arthroplasty (HRA) is a bone-conserving alternative to total hip arthroplasty. We present the 2-year clinical and radiographic follow-up of a novel ceramic-on-ceramic HRA in an international multicenter cohort. MethodsPatients undergoing HRA between September 2018 and January 2021 were prospectively included. Patient-reported outcome measures (PROMs) in the form of the Forgotten Joint Score, Hip Disability and Osteoarthritis Outcome Score Jr., Western Ontario and McMaster Universities Arthritis Index, Oxford Hip Score, and University of California, Los Angeles, Activity Score were collected preoperatively, and at 1 and 2 years postoperation. Serial radiographs were assessed for migration, component alignment, evidence of osteolysis or loosening, and heterotopic ossification formation. ResultsThe study identified 200 patients who reached a minimum 2-year follow-up (mean 3.5 years). Of these, 185 completed PROMs follow-up at 2 years. There was a significant improvement in Hip Disability and Osteoarthritis Outcome Score (P < .001) and Oxford Hip Score (P < .001) between the preoperative, 1-year, and 2-year outcomes. Patients had improved activity scores on the University of California, Los Angeles, Active Score (P < .001), with 45% reporting a return to high-impact activity at 2 years. At 1 and 2 years, the Forgotten Joint Score was not significantly different (P = .38). There was no migration, osteolysis, or loosening of any of the implants. No fractures were reported over the 2-year follow-up, with only 1 patient reporting a sciatic nerve palsy. There were 2 revisions, 1 for unexplained pain at 3 months due to acetabular component malposition and 1 at 33.5 months for acetabular implant failure. ConclusionsThe ceramic-on-ceramic resurfacing at 2 years postoperation demonstrates promising results with satisfactory outcomes in all recorded PROMs. Further long-term data are needed to support the widespread adoption of this prosthesis as an alternative to other HRA bearings.

Lateralization of the humerus in reverse total shoulder arthroplasty: can preoperative planning software predict postoperative lateralization and does lateralization influence outcomes?

IntroductionReverse total shoulder arthroplasty (RTSA) can result in varying amounts of humeral medialization or lateralization. The amount of medial or lateral change-in-arm-position can be predicted using 3D CT planning software. It is not clear if the preoperatively-predicted change-in-arm-position correlates with the actual, radiographically-measured change-in-arm-position or if predicted or actual change-in-arm-position correlates with patient-reported outcomes or complications. MethodsPatients undergoing RTSA underwent preoperative 3D CT planning to predict the postoperative medial-to-lateral change-in-arm-position (PCAP). Preoperative and postoperative radiographs were used to calculate the actual medial-to-lateral change-in-arm-position using the measurement of the lateral edge of the greater tuberosity to the lateral edge of the acromion (RCAP-LHO). The Western Ontario Osteoarthritis Score (WOOS), American Shoulder and Elbow Surgeons score (ASES) and Single Assessment Numeric Evaluation (SANE) were recorded at baseline, 1-year, and 2-years. Rates of complications were recorded. ResultsTwo-hundred-and-fifty patients were eligible for this study including 189 patients reaching the one-year clinical follow-up point and 144 patients reaching the two-year clinical follow-up point. One-year and two-year follow-up rates were 89 percent and 91 percent, respectively. The mean PCAP was 3+5 mm and RCAP-LHO was 1+8 mm. There was moderate correlation between PCAP and RCAP-LHO. There was weak correlation between increased PCAP lateralization and higher WOOS and ASES at two years and improvement from baseline to 2 years in WOOS. There was very weak correlation between increased PCAP lateralization and improvement compared to baseline in 1 year SANE and improvement compared to baseline in 2 year SANE. There was weak correlation between lateralized RCAP-LHO and 2 year postoperative SANE. There was superior 2-year WOOS, ASES, and SANE, and improvement in SANE at 1-year compared to baseline in patients with a lateralized PCAP compared to a medialized or neutral PCAP. There was superior 2-year WOOS, improvement in WOOS from baseline to 2-year follow-up, and SANE at 2-years in patients with a lateralized RCAP-LHO compared to a medialized or neutral RCAP-LHO. Overall complication rates were similar between groups although the dislocation rate in shoulders with a lateralized change-in-arm-position was significantly less compared to shoulders with a medial or neutral change-in-arm-position. ConclusionsPCAP correlated with actual RCAP-LHO. Correlations exist with increased humeral lateralization and improved patient-determined outcomes. Patient-determined outcomes were the same or better in patients with a lateralized change-in-arm-position compared to those that were medialized or remained neutral. A lateralized change-in-arm-position did not result in increased overall complications and was protective against postoperative instability.

Brait–Fahn–Schwarz disease (result of two-year clinical follow-up)

The article presents the result of a two-year follow-up of a patient with a combination of parkinsonism syndromes and amyotrophic lateral sclerosis, a rare form of a neurodegenerative disease of the central nervous system called “Bright–Fan–Schwarz disease”. The diversity and polymorphism of symptoms in this disease can lead to diffi culties in diagnosis and therapy. The data of the patient’s anamnesis, the dynamics of the clinical picture during the stay in the hospital, the diagnostic and therapeutic measures taken, and the subsequent follow-up are given. In conclusion, a generalization of the features of the clinical picture and the progression of the disease in question is presented.

Medial wall reconstruction using metal disc augments in revision total hip arthroplasty.

Medial acetabular bone defects are frequently encountered in revision total hip arthroplasty (THA), but few studies have focused on their reconstruction. This study aimed to report the radiographic and clinical results after medial acetabular wall reconstruction using metal disc augments in revision THA. Forty consecutive revision THA cases using metal disc augments for medial acetabular wall reconstruction were identified. Post-operative cup orientation, the centre of rotation (COR), stability of acetabular components and peri-augments osseointegration were measured. The pre-operative and post-operative Harris Hip Score (HHS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) were compared. The mean post-operative inclination and anteversion were 41.88 ± 6.70° and 16.73 ± 5.35°, respectively. The median vertical and lateral distance between the reconstructed CORs and the anatomic CORs were -3.45 mm (interquartile range [IQR]: -11.30 mm, -0.02 mm) and 3.18 mm (IQR: -0.03 mm, 6.99 mm). Thirty-eight cases completed the minimum twoyear clinical follow-up, whereas 31 had a minimum twoyear radiographic follow-up. Acetabular components were radiographically stable with bone ingrowth in 30 cases (30/31, 96.8%) while one case was classified as radiographic failure. Osseointegration around disc augments was observed in 25 of 31 cases (80.6%). The median HHS improved from 33.50 (IQR: 27.50-40.25) pre-operatively to 90.00 (IQR: 86.50-96.25) (p < 0.001), whereas the median WOMAC significantly improved from 38.02 (IQR: 29.17-46.09) to 85.94 (IQR: 79.43-93.75) (p < 0.001). In revision THA with severe medial acetabular bone defect, disc augments could provide favorable cup position and stability, peri-augments osseointegration, with satisfactory clinical scores.

Do Patient Outcomes Predict Loss to Long-Term Follow-Up After Spine Surgery?

To determine if spine surgery patients with greater improvement in patient-reported outcomes measures (PROMs) at early postoperative follow-up are more likely to be lost to follow-up at the 1-year and 2-year postoperative visits. All patients older than 18 years who underwent primary or revision decompression or fusion surgery for degenerative spinal conditions at an academic institution were retrospectively identified. Univariate analysis compared patient demographics, surgical factors, and changes in short-term and long-term postoperative PROMs (Neck Disability Index, Oswestry Disability Index, visual analog scale [VAS] neck, VAS arm, VAS back, VAS leg, and Short-Form 12 Physical and Mental Component Scores) across groups with and without 1 year and 2 years follow-up. Logistic regression isolated predictors of loss to follow-up. A total of 1412 patients were included. Younger patient age, primary surgery, and single surgical approach independently predicted loss at 1 year follow-up. Female sex predicted loss at 2 years follow-up, whereas multilevel fusion surgery predicted attendance at 2 years clinical follow-up. In patients lost at 1 year follow-up compared with those who attended, preoperative to 3-month Mental Component Score and VAS neck pain improvement was significantly greater. When comparing patients based on 2 years follow-up status, VAS back pain improvement at 1 year postoperatively was significantly greater in patients lost to 2 years follow-up. All other changes in PROMs did not differ significantly by 1 or 2 years follow-up attendance. Overall patient outcomes were not found to affect loss to long-term follow-up after spine surgery. The general lack of association between postoperative follow-up status and clinical outcome may limit bias introduced in retrospective PROM studies.

No difference in range of motion in reverse total shoulder arthroplasty using standard or constrained liners: a matched cohort study.

Prosthetic instability is one of the most common short-term complications following reverse total shoulder arthroplasty (RTSA). Numerous strategies exist to attempt to mitigate this complication, including utilization of constrained polyethylene humeral liners. A concern of constrained humeral liners is that they may come at the expense of restricted rotational range of motion (ROM). The purpose of the present study is to compare range of ROM and patient-reported outcomes (PROs), and satisfaction among matched cohorts using constrained vs. unconstrained liners after RTSA. A multicenter shoulder arthroplasty registry was retrospectively reviewed to identify patients with two-year clinical follow-up after RTSA with constrained liners used at the surgeon's discretion. All patients had the same inlay humeral prosthesis with a 135° neck shaft angle. This study cohort was matched 1:2 to control patients who underwent RTSA with standard liners based on age, sex, total glenoid-sided lateralization, glenosphere diameter, and surgery performed on the dominant arm. Improvement in PROs and ROM was compared between groups. Twenty-two patients were identified who underwent RTSA with a constrained humeral liner; these were compared to 44 matched patients with standard liners. The groups were found to have no notable differences in demographics, baseline PROs and ROM. At two years postoperatively, both cohorts demonstrated improvements in all PROs without statistically significant differences between the two groups. There were no differences between groups in improvement in any ROM measure, including forward flexion (constrained: 54°, standard: 57°, P=.771), external rotation at the side (constrained: 42°, standard: 41°, P=.906) or internal rotation at 90° of abduction (constrained: 24°, standard: 20°, P=.587). For an inlay humeral prosthesis with a 135° neck shaft angle, utilization of a constrained liner for RTSA demonstrates no significant difference in ROM or PROs compared to a well-matched cohort of patients who underwent RTSA with a standard polyethylene humeral liner. These are reassuring data for using constrained liners when there is intraoperative concern for prosthetic instability.

Humeral osteophyte size and clinical outcomes after anatomic total shoulder arthroplasty

BackgroundThe severity of primary glenohumeral osteoarthritis (PGOA) has been associated with advanced radiographic findings including inferior humeral head osteophytes. The primary objective of this study is to analyze for any correlation between the size of the inferior humeral head osteophyte and functional outcomes in patients undergoing anatomic total shoulder arthroplasty (TSA) for PGOA. MethodsA retrospective review of a multi-surgeon database was performed to identify all patients with PGOA from 2015 to 2019 with a minimum of two-year clinical follow-up. Preoperative anteroposterior and Grashey views were used for all included patients to obtain measurements of the inferior humeral osteophyte. Two groups at the extremes of osteophyte width were identified: 1) patients with absent or minimal osteophytes (lowest quartile of width, < 4.9 mm) and those with large osteophytes (highest quartile of width, > 10.1 mm). Change in active range of motion (ROM) from baseline, patient-reported outcomes (PROs), strength and complications were assessed at a minimum of 2 years postoperatively and compared between the two groups. ResultsDemographics were similar for the large osteophyte group (n = 57) and small osteophyte group (n = 56). There was a higher percentage of patients with more significant glenoid deformity in the large osteophyte group compared to the small osteophyte group (P = .009 for A1 deltoid). The large osteophyte group had significantly more restricted preoperative ROM for all measures (P < .05 for all). There were no significant differences in final ROM achieved between the two groups. Patients in the large osteophyte group had greater improvement from baseline for external rotation at the side (31° vs 21°, P = .015), external rotation at 90° abduction (38° vs 20°, P = .004), and internal rotation at 90° abduction (30° vs 12°, P < .001) compared to the small osteophyte group. Overall, there were very few differences between the small and large osteophyte groups in final PROs, with the exception of a higher American Shoulder and Elbow Surgeons score in the large osteophyte group (90.8 vs 85.9, P = .048). ConclusionPatients with large humeral osteophytes have significantly greater restrictions in preoperative ROM compared to patients with small osteophytes. Patients with large osteophytes experience greater improvements in rotational motion after anatomic TSA compared to patients with small osteophytes, although the final ROM achieved was similar between groups. Overall, PROs after anatomic TSA were similar between patients with small and large osteophytes preoperatively.

Reverse total shoulder arthroplasty for patients with preserved active elevation and moderate-to-severe pain: a matched cohort study.

BackgroundPatients undergoing reverse total shoulder arthroplasty (RTSA) predictably report reduced pain and improved function postoperatively. However, it is not known if patients with differing preoperative active motion achieve the same benefit after surgery. The purpose of the present study is to evaluate patient-reported outcomes (PROs), range of motion (ROM), and satisfaction after RTSA in patients with moderate-to-severe pain with preserved active preoperative ROM compared with matched controls with restricted preoperative active ROM.MethodsA multicenter shoulder arthroplasty registry was utilized to identify patients with at least two-year clinical follow-up after RTSA with a 135° implant. The study cohort with preserved motion included patients with greater than one standard deviation above the overall mean for preoperative forward elevation (FE) (140°) as well as a preoperative visual analog pain scale (VAS) ≥ 5.0. The control cohort with more restricted motion had preoperative FE of less than 140° and also with preoperative VAS ≥5.0. The control patients were matched 2:1 to study patients by age (±2 years), sex, and preoperative VAS (±1.5). Outcomes measured were as follows: PROs, ROM, strength, and strength and satisfaction.ResultsTwenty-seven patients were identified that comprised the preserved preoperative FE study cohort; 54 patients were included in the restricted elevation cohort as controls. The groups were similar at baseline for demographics, surgical diagnoses, and most PROs, other than the Constant-Murley, which was higher in the preserved motion cohort. At two years postoperatively, both cohorts demonstrated similar PROs, strength, and ROM (other than internal rotation with the arm abducted 90 degrees) and had a similar number of patients who rated the RTSA as meeting or exceeding their expectations. The change in ROM from preoperatively was significantly different with the restricted cohort, achieving a larger increase in forward flexion (51 ± 26° vs. −13 ± 35°, P < .001).ConclusionPatients indicated for RTSA with preserved preoperative FE and moderate pain achieve similar final ROM, pain reduction, increases, and strength compared with patients who undergo RTSA with restricted preoperative FE. Despite losing on average 13 degrees of FE from preoperatively by two years postoperatively, patients with preserved preoperative FE are comparably satisfied with their outcome.

Comparing porous tantalum fusion implants and iliac crest bone grafts for spondylodesis of thoracolumbar burst fractures: Prospectice Cohort study

The aim of this study was to compare two different techniques of performing one-level spondylodesis for thoracolumbar burst fractures using either an autologous iliac crest bone graft (ICBG) or a porous tantalum fusion implant (PTFI). In a prospective nonrandomized study, 44 patients (20 women, 24 men; average age 43.1 ± 13.2 years) suffering from severe thoracolumbar burst fractures were treated with combined anterior–posterior stabilization. An ICBG was used in 21 cases, and a PTFI was used in the other 23 cases. A two-year clinical and radiographic follow-up was carried out. There were no statistically significant differences in age, sex, localization/classification of the fracture, or visual analog scale (VAS) before injury between the two groups. All 44 patients were followed up for an average period of 533 days (range 173–1567). The sagittal spinal profile was restored by an average of 11.1° (ICBG) vs. 14.3° (PTFI) (monosegmental Cobb angle). Loss of correction until the last follow-up tended to be higher in the patients treated with ICBG than in those treated with PTFI (mean: 2.8° vs. 1.6°). Furthermore, significantly better restoration of the sagittal profile was obtained with the PTFI than with the iliac bone graft at the long-term follow-up (mean: ICBG 7.8°, PTFI 12.3°; p < 0.005). Short-segment posterior instrumentation combined with anterior one-level spondylodesis using either an ICBG or a PTFI resulted in sufficient correction of posttraumatic segmental kyphosis. PTFI might be a good alternative for autologous bone grafting and prevent donor site morbidities.

Percutaneous suture-mediated patent foramen ovale closure: two-year clinical follow-up.

Percutaneous suture-mediated patent foramen ovale (PFO) closure has been recently introduced in clinical practice showing a favorable efficacy and safety profile in most PFO cases. The aim of this study was to assess the long-term outcomes of PFO closure by direct suture in a large consecutive series of patients. We extracted all consecutive patients who underwent percutaneous closure of the PFO by suture technique (HeartStitch, Fountain Valley, CA, USA) from June 2016 with a follow-up of at least 2 years. After PFO closure, patients were followed-up clinically at 1, 6 and up to 12 months and microbubble transthoracic echocardiography (TTE) scheduled between 3 and 6 months, and at 12-month follow-up. After 12 months, patients were clinically checked every 6 months. As of September 1, 2020, 187 patients had undergone PFO closure with suture for at least two years and, of these, 181 (121 women and 60 men, mean age 45±13 years, range 15-75 years) had complete clinical and instrumental follow-up (97%). There were no peri-procedural complications. Mean follow-up was 1076±251 days (range 727-1574). At 12-month TTE, a significant residual atrial shunt was found in 39 patients (21%). At follow-up no recurrent thromboembolic or cerebral event occurred, no instrumental evidence of suture dehiscence detected and, 18 months after the procedure, one patient had an episode of transient atrial fibrillation lasting less than 24 hours and resolved spontaneously. Long-term follow-up data indicate that PFO closure by direct suturing is safe and effective. Two years after the procedure, there were no significant complications, no permanent arrhythmic complications and evidence of suture dehiscence.

Two-year follow-up of bioresorbable vascular scaffolds in severe infra-popliteal arterial disease.

To assess the safety, efficacy, and durability of the Absorb bioresorbable vascular scaffold in predominantly complex, infra-popliteal lesions for the management of chronic limb ischemia at two-year clinical follow-up. Bioresorbable vascular scaffold are biodegradable scaffolds that provide short-term vascular support before undergoing intravascular degradation. A recent trial reported excellent 36-month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb bioresorbable vascular scaffold. This single-center, retrospective study evaluated the use of the Absorb bioresorbable vascular scaffold (everolimus impregnated poly-L-lactic scaffold) in patients with infra-popliteal peripheral arterial disease (PAD) with respect to safety (thrombosis and TIMI bleeding), technical success, and freedom from clinically driven target vessel failure at 24 months. 31 patients (51.6% male) with a median age of 67 years with predominantly advanced infra-popliteal disease were treated with 49 bioresorbable vascular scaffold in 41 vessels. The mean stenosis was 94% (80-100), with 49% of lesions being chronic thrombotic occlusions. No scaffold thrombosis or peri-procedural bleeding was observed. Procedural success was achieved in all patients; 93.5% of patients experienced freedom from clinically driven target vessel failure at 24 months, driven by one revascularization and one amputation. Primary patency was 96.7% at 12 months and 87.1% at 24 months. All patients were alive at 12 and 24 months. At 24 months, our study found that patients with predominantly advanced infra-popliteal PAD who were treated with Absorb bioresorbable vascular scaffold reported improved clinical status and a low and durable rate of clinically driven target vessel failure extending out to 24 months.

Reassessing the minimum two-year follow-up standard after total shoulder arthroplasty-Is one year sufficient?

US Food and Drug Administration Investigation Device Exemption studies and academic journals emphasize the importance of two-year follow-up data in reporting outcomes of total shoulder arthroplasty, but there is limited data evaluating appropriate follow-up length. We aim to evaluate change in postoperative outcomes and complications between one and two years following anatomic and reverse total shoulder arthroplasties. We retrospectively identified 250 patients who underwent anatomic and reverse total shoulder arthroplasties between 2013 and 2016 from a single surgeon arthroplasty registry. Patients without both one- and two-year follow-up data were excluded. We compared American Shoulder and Elbow Surgeons (ASES) score, Visual Analog Scale for pain, and goniometer-measured range of motion. Patient-reported outcome measurements (p > 0.05) did not change between one and two years postoperatively following both reverse (n = 146) and anatomic (n = 104) total shoulder arthroplasties. Range of motion increased slightly (p < 0.05), but this change was not clinically relevant. There were no additional complications. Minimum two-year clinical follow-up may not be necessary for future shoulder arthroplasty Investigation Device Exemption and other peer-reviewed investigations. Patient-reported outcomes (ASES and pain score) and range of motion plateau at one year postoperatively without additional complications. One-year follow-up is an acceptable minimum follow-up length. Level III-retrospective analysis.

Two-year clinical follow-up from the onset of complaints is predictive for the early diagnosis of hip osteoarthritis

Purpose: The aim of this study was to assess whether the course of signs and symptoms over the first two years after consulting with hip complaints for the first time in primary care is predictive for clinically relevant hip osteoarthritis (OA) 5 to 10 years later.

Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch: the Nordic-Baltic Bifurcation Study IV

BackgroundIt is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple)...

P5630Morphometric and qualitative differences in neointimal tissue six months after implantation of bioresorbable scaffolds versus conventional everolimus eluting stents in ISAR-Absorb MI trial

Abstract Background Bioresorbable scaffolds (BRS) are novel devices designed to overcome the long-term limitations of permanent metallic stent implantation. Optical coherence tomography (OCT) surveillance can provide important insights on the process of vessel wall healing at follow-up. Purpose We sought to compare OCT-assessed healing at 6 months after implantation of everolimus-eluting BRS and everolimus-eluting metallic stents (EES) in patients treated for acute myocardial infarction (AMI). Methods ISAR-Absorb MI is a multicentre, 2:1 randomized trial comparing outcomes of patients with AMI stented with BRS or conventional EES. Angiographic surveillance was planned for all patients at 6–8 months follow-up. Patients who had OCT surveillance at follow-up were included for the present analysis. Analysis of contiguous OCT cross-sections- 1 mm apart was performed at a centralized core laboratory. Tissue characterisation using a 256-level grey-scale signal intensity (GSI) analysis was also performed for all neointimal regions of interest (ROI) with thickness of 100 to 400 μm. ROI's were classified as mature using a standard cut-off GSI score of 109.7. Generalised linear mixed model (GLMM) was used as appropriate. Statistical analysis was performed using R software. Data is presented as numbers, percentages or median (Interquartile range, IQR). Results Median follow-up interval was 216 days. 70 patients in the BRS arm and 33 patients in the EES arm were available for analysis. Stented length was 19.8 mm (13.6, 24.5) and 22.3 mm (16.7, 26.4) in BRS and EES arms respectively (p=0.73). Minimum lumen area [5.13 (3.95, 6.71) vs. 4.83 (3.63, 6.92) mm2] and minimum stent area [5.78 (4.88, 7.34) vs. 6.36 (4.70, 7.45) mm2] were comparable between BRS and EES. 2,262 frames (1,529 in BRS, 733 in EES) with 20,033 struts (12,704 in BRS, 7,329 in EES) were assessed. Overall strut coverage was better with BRS compared to EES (97.5% vs. 91.1% respectively, p&lt;0.001). Malapposed (1.1% vs. 0.5%, p=0.54) and uncovered struts (7.3% vs. 1.3%, p&lt;0.001) were more common with EES. Neointimal coverage was comparable amongst both stent groups [85.5 (61.9, 124.1) vs. 71.5 (33.4, 133.0) μm in BRS and EES groups respectively, p=0.50]. GSI analysis in 95 cases (65 cases, 2,233 ROIs in BRS; 30 cases, 1,210 ROIs in EES) showed that immature ROIs were numerically more common in the EES group as compared to the BRS group (75.4 vs. 57.0% respectively; p=0.35). Two-year clinical follow-up and analysis of correlation of clinical outcomes with OCT findings will also be available for presentation at ESC Congress 2019. Conclusions In selected patients undergoing OCT imaging at 6–8 months after implantation of BRS and conventional EES for AMI, we observed generally favourable healing characteristics with high rates of strut coverage, low rates of strut malapposition and fewer areas of immature neointimal areas with BRS in comparison to EES. Acknowledgement/Funding The study was predominantly funded by Deutsches Herzzentrum München and in part by a grant from Abbott Vascular

Prophylactic Tibial Stem Fixation in the Obese: Comparative Early Results in Primary Total Knee Arthroplasty.

PurposeObesity is a risk factor for aseptic loosening after total knee arthroplasty (TKA). Prophylactic use of tibial stems may enhance tibial fixation in obese patients. The aim of this study was to determine whether a tibial stem extension decreases rates of early failure in obese patients.Materials and MethodsThis study included 178 consecutive primary TKAs (143 patients) with a body mass index ≥35 kg/m2. Fifty TKAs were performed with the use of a 30 mm tibial stem extension, and 128 TKAs were performed with a standard tibial component. Patients with two-year clinical follow-up were included. The primary outcome was revision for aseptic loosening. Secondary outcomes were all-cause revision and radiolucent lines (RLLs) on radiographs.ResultsAverage follow-up was 34 months (range, 24 to 46 months). No failures for aseptic loosening occurred. The occurrence of secondary procedures was not significantly different between groups. Quantification of RLLs revealed no difference between groups.ConclusionsAt early follow-up, no difference was measured in revision rates, need for subsequent procedures, or RLLs between groups.

Two-year clinical follow-up of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in The Netherlands (MR CLEAN): design and statistical analysis plan of the extended follow-up study.

BackgroundMR CLEAN was the first randomized trial to demonstrate the short-term clinical effectiveness of endovascular treatment in patients with acute ischemic stroke caused by large vessel occlusion in the anterior circulation. Several other trials confirmed that endovascular treatment improves clinical outcome at three months. However, limited data are available on long-term clinical outcome. We aimed to estimate the effect of endovascular treatment on functional outcome at two-year follow-up in patients with acute ischemic stroke. Secondly, we aimed to assess the effect of endovascular treatment on major vascular events and mortality during two years of follow-up.MethodsMR CLEAN is a multicenter clinical trial with randomized treatment allocation, open-label treatment, and blinded endpoint evaluation. Patients included were 18 years or older with acute ischemic stroke caused by a proven anterior proximal artery occlusion who could be treated within six hours after stroke onset. The intervention contrast was endovascular treatment and usual care versus no endovascular treatment and usual care. The current study extended the follow-up duration from three months to two years.The primary outcome is the score on the modified Rankin scale at two years. Secondary outcomes include all-cause mortality and the occurrence of major vascular events within two years of follow-up.DiscussionThe results of our study provide information on the long-term clinical effectiveness of endovascular treatment, which may have implications for individual treatment decisions and estimates of cost-effectiveness.Trial registration NTR1804. Registered on 7 May 2009; ISRCTN10888758. Registered on 24 July 2012 (main MR CLEAN trial); NTR5073. Registered on 26 February 2015 (extended follow-up study).

Clinical Outcomes Following Arthroscopic Micro Fracture of the Hip

Objectives:Objective and clinical results of microfracture for treatment of chondral defects of the knee is well documented, yet outcomes for microfracture of the hip have not been extensively studied. Recently, several studies demonstrated clinical improvements in patients treated with microfracture of the hip. The purpose of this study is to examine clinical outcomes and survivorship in patients who underwent microfracture during arthroscopic hip surgery.Methods:A retrospective analysis of a prospectively collected database was performed. Thirty-eight patients with a mean age of 41 (range, 17-64) who underwent microfracture during arthroscopic hip surgery by a single surgeon (senior author) were identified. Demographic data, diagnosis, and details regarding operative procedures were collected. All patients were indicated for hip arthroscopy based on standard pre-operative examination as well as routine and advanced imaging. Baseline pre-operative modified Harris Hip Scores (mHHS) and Non-Arthritic Hip Scores (NAHS) were compared to mHHS and NAHS at two-year follow-up. Additionally, survivorship data was assessed to determine failure, defined as any subsequent revision arthroscopic surgery and/or hip arthroplasty of the same hip.Results:Thirty-four of the 38 (89.5%) patients were available for two-year clinical follow-up. Baseline mean mHHHS and NAHS for all patients improved from 50.6 (+/- 12.7) and 46.9 (+/-12.8) to 84.7 (+/- 12.5) and 85.6 (+/- 11.2) respectively. Both improvements were statistically significant (p < 0.05). Eight patients (23.5%) met failure criteria and underwent additional surgery at an average of 23.9 months. Two patients (5.8%) underwent revision arthroscopic surgery, and six patients (17.7%) underwent hip arthroplasty.Conclusion:Significant improvements in clinical outcomes are seen at two-year follow-up after microfracture treatment of chondral lesions of the hip. Despite overall success, failure rates are relatively high. As with microfracture of the knee, results favor short-term clinical improvements, but results may decline at two years. Larger studies are needed to fully assess the efficacy of microfracture in arthroscopic hip surgery.