Eleven-year Follow-up Research Articles

Alfentanil for Pain Relief in a Swedish Emergency Medical Service – An Eleven-Year Follow-up on Safety and Effect

Objectives Pain is a common symptom in prehospital emergency care and pain treatment in this context can be challenging. While previous research has assessed the use of morphine and other synthetic opioids for pain management in this setting, the evaluation of alfentanil is limited. The objective of this study was to evaluate the safety and effect of intravenous alfentanil when administered by ambulance nurses in prehospital emergency care. Methods This retrospective observational study consecutively included patients suffering from pain, treated with alfentanil in a Swedish EMS service from September 2011 to 31 September 2022. Data regarding occurrence of adverse events (AE), serious adverse events (SAE) – were used for safety evaluation and pain scores with a visual analogue scale (VAS) before and after treatment were used for evaluation of pain treatment. These data were extracted from the electronic patients’ medical records database for analysis. Univariate logistic regression analysis was used to identify significant predictors of AE following injection of alfentanil by nurses in prehospital emergency care. Results During the evaluation period 17,796 patients received pain relief with alfentanil. Adverse events affected 2.5% of the patients, while serious adverse events were identified in 25 cases (0.01%). Out of the 5970 patients with a complete VAS score for pain, the median VAS score was 8 (IQR 3) before treatment and 4 (IQR 3) after treatment. The mean reduction in pain measured by VAS was −4.1 ± 2.6 from the time before, to the evaluation after alfentanil administration. The administration frequency increased during the first year up to a steady level during the later part of the evaluation period. Conclusions This study proposes that alfentanil represents a safe and efficacious alternative for addressing urgent pain relief within the prehospital emergency context. Alfentanil demonstrates efficacy in alleviating pain across various conditions, with a relatively low risk of adverse events or serious adverse events when administered cautiously.

Neglected Developmental Hip Dysplasia Treated With External Iliofemoral Distraction, Open Reduction, and Pelvic Osteotomy: Eleven-Year Follow-Up.

Neglected untreated developmental hip dysplasia can result in severe deformities and functional disabilities. This report describes the treatment and 11-year follow-up of a patient who underwent the procedure in two stages. At the time of treatment, the patient was 7 years of age and was diagnosed with acetabular dysplasia and neglected right hip dysplasia. A stepwise treatment approach, including gradual distraction of the iliofemoral joint, open reduction, and pelvic osteotomy, was performed. Subsequent postoperative rehabilitation and regular follow-up assessments were performed over 11 years. The long-term results indicated notable improvements in hip joint congruency, functional range of motion, and overall quality of life. Early diagnosis and appropriate intervention are crucial for patients with developmental hip dysplasia, and the treatment methods described here are effective.

Better accuracy and implant survival in medial imageless robotic-assisted unicompartmental knee arthroplasty compared to conventional unicompartmental knee arthroplasty: two- to eleven-year follow-up of three hundred fifty-six consecutive knees.

Implant malpositioning, joint line (JL) lowering, and malalignment have been identified as risk factors for implant failure in unicompartmental knee arthroplasty (UKA). The aims of this study were to compare the accuracy of implant positioning in robotic-assisted UKA versus conventional UKA in a large cohort and examine the correlation with implant survival at mid-term follow-up. This retrospective study included 356 medial UKAs from 2011 to 2019. The radiological measurements performed were coronal positioning of tibial implant according to Cartier angle (Δ Cartier), posterior tibial slope (PTS), residual hip-knee-ankle (HKA), and JL restoration. Outliers were defined as follows: post-operative HKA < 175° or > 180°, Δ Cartier > 3° or < - 3°, JL change ≥ 2mm, and PTS < 2° or > 8°. The survival probability was reported at the last follow-up. Out of the 356 knees included, 159 underwent conventional UKA (44.5%) and 197 (55.5%) robotic-assisted UKA. The mean follow-up was 61.3months ± 24.0. Robotic UKA was associated with better accuracy compared to conventional UKA in relation to HKA (67% vs 56%, p = 0.023), JL restoration (70% vs 44%, p < 0.0001), PTS (83% vs 55%, p < 0.0001), and tibial varus restoration (65% vs 55%, p = 0.049). Implant survival in the robotic group was found to be superior at the last follow-up (96.4% versus 87.3% at 9years, p = 0.004). Robotic assistance in patients undergoing medial UKA was associated with better accuracy compared to conventional UKA with respect to tibial implant positioning, post-operative limb alignment, and JL restoration. This was translated in improved survival at mid-term follow-up favouring the robotic group.

Eleven-Year Follow-Up on the Effect of Thermoplastic Aggregates’ Addition to Reinforced Concrete

An experimental investigation was carried out to study the effect of thermoplastics’ addition to reinforcement corrosion and the durability of concrete. A long-term study is necessary for the final decision on the possibility of the utilization of materials, and this study is contributing to this direction. Two types of thermoplastics were used, high-density polyethylene and polypropylene. The percentage of replacement of conventional aggregates was 0% and 12% by volume. After being demolded and cured for 7 days, the specimens were immersed in 3.5 wt% NaCl solution for 240 days. Afterwards, they were left in laboratory ambient air up to 11 years. Carbonation depth and the volume of permeable voids were determined. Optical microscopy, stereoscopy, and electrochemical impedance spectroscopy measurements were performed. Results showed that replacing conventional limestone aggregates with the particular two thermoplastics does not have a negative impact on rebars’ corrosion behavior. Optical microscopy and stereoscopy of rebars’ surface revealed that the corrosion process has initiated and carbonation is observed in all mixes, but corrosion rates are negligible for all the mixes studied.

Trends in Antihypertensive Medicine Utilization in the Republic of Srpska, Bosnia and Herzegovina: An Eleven-Year Follow-Up.

Background: In last 2 decades, there have been substantial changes in the utilization patterns of antihypertensive medicines following new clinical trials and the introduction of new treatment guidelines. The aim of this study was to analyze utilization and prescribing patterns regarding antihypertensive medicines in the Republic of Srpska, Bosnia and Herzegovina during an 11-years follow-up according to national and European treatment guidelines. Methods: In this retrospective, observational study, medicine utilization data were analyzed between 2009–2019 period using the ATC/DDD methodology and expressed as the number of DDD/1,000 inhabitants/day (DID/TID). The medicine utilization 90% (DU90%) method was used for determine the quality of prescribing. Results: During the observed period, the use of antihypertensive medicines increased more than 3-times (125.97 DDD/TID in 2009 vs 414.95 DDD/TID in 2019), corresponding to a rise in the prevalence of hypertensive patients from 91.7/1,000 to 186.3/1,000 in the same period. This was mainly driven by increased use of angiotensin converting enzyme inhibitors with 241.69%, beta blockers with 146.87%, calcium channel blockers with 251.55%, and diuretics with 178.95%. Angiotensin receptor blockers were the fastest growing group of antihypertensive medicines in this period and their utilization increased nearly 40 times. Conclusions: The overall antihypertensive medicines utilization was largely influenced by national and ESH/ESC guidelines and strongly corresponded to the positive medicine list of the national health insurance fund. Antihypertensive medicines utilization is comparable with medicine utilization trends in other countries.

Survival, functional outcome and satisfaction of first revision total knee arthroplasty at a mean eleven-year follow-up

PurposeProviding long-term outcome data after rTKA and compare one- versus two-stage and septic versus aseptic revisions.MethodsThis study represents a single-center retrospective study of first rTKAs performed for any reason with a final follow-up of a minimum of five years. Outcome parameters included stability assessment ROM, radiologic assessment, HSS score, KSS score, OKS score, EQ-5D-3L and VAS. 44 patients were included in the study. Subgroups analysis of one- versus two-stage revision and septic versus aseptic revision was performed.ResultsThe leading causes of rTKA in this mean 11 year follow-up study were aseptic loosening (36%) and periprosthetic joint infection (27%). At the final follow-up, there was a 89% survivorship of the implants. Patients showed a ROM of 114 ± 13°, HSS score of 78 ± 12, KKS objective score of 77 ± 16, KSS expectation and satisfaction score of 32 ± 11, KSS functional activity score of 50 ± 20, OKS of 30 ± 9, VAS of 53 ± 25 and EQ-5D index of 0.649. Functional outcome scores were not significantly altered in the analyzed subgroups.ConclusionsIn our 11 years follow-up, we obtained 89% implant survivorship. Measurements regarding functional outcome and pain showed results in the medium range of the respective scores, while patient satisfaction lay in the upper third. No significant differences in outcome scores between one- and two-stage revisions and septic versus aseptic revisions were observed.Level of Evidence Level III, retrospective cohort study.

Eleven-Year Follow-Up of Two Cohorts of Patients Comparing Stand-Alone Porous Tantalum Cage Versus Autologous Bone Graft and Plating in Anterior Cervical Fusions

Anterior cervical discectomy and fusion with a porous tantalum cage is an accepted method to treat degenerated cervical discs, with good results, similar to those with autologous bone graft and plating at short- and mid-term follow-up. However, to date, long-term follow-up studies have been performed. We performed a retrospective, single-center study to evaluate the outcomes of 2 cohorts from a previous prospective randomized controlled trial comparing stand-alone tantalum cage (group 1, 27 patients) with autologous bone graft and plating (group 2, 30 patients) for single-level anterior cervical discectomy and fusion at 11years of follow-up. The usual clinical and radiological outcomes and "overall success," proposed by the Food and Drug Administration, were evaluated. The improvement in clinical outcomes achieved postoperatively was maintained similarly in the 2 cohorts at 11 years of follow-up. In group 1, the cage had subsided 2-3 mm in 12 patients (44%), segmental lordosis was maintained in 16 patients (59%), adjacent segment degeneration had developed or progressed in 27 of the adjacent segments (50%) in 15 patients (56%), and postoperative nonprogressive deformation of the anterior aspect of the cage was observed in 7 (26%) and minor fragmentation in 3 (11%) patients. In group 2, segmental lordosis was maintained in 90% of the patients and adjacent segment degeneration had developed or progressed in 15 patients (50%). These results show that the clinical and radiological outcomes achieved at mid-term follow-up using a tantalum cage for single-level anterior cervical discectomy and fusion will be maintained for 11 years postoperatively, similar to the results with autologous bone graft and plating.

Prognosis of depressive disorders in the general population– results from the longitudinal Finnish Health 2011 Study

BackgroundDepressive disorders are among the most pressing public health challenges worldwide. Yet, not enough is known about their long-term outcomes. This study examines the course and predictors of different outcomes of depressive disorders in an eleven-year follow-up of a general population sample. MethodsIn a nationally representative sample of Finns aged 30 and over (BRIF8901), major depressive disorder (MDD) and dysthymia were diagnosed with the Composite International Diagnostic Interview (M-CIDI) in 2000. The participants were followed up in 2011 (n=5733). Outcome measures were diagnostic status, mortality, depressive symptoms and health-related quality of life. Multiple imputation (MI) was used to account for nonresponse. ResultsAt follow-up, 33.8% of persons with baseline MDD and 42.6% with baseline dysthymia received a diagnosis of depressive, anxiety or alcohol use disorder. Baseline severity of disorder, measured by the Beck Depression Inventory, predicted both persistence of depressive disorder and increased mortality risk. In addition, being never-married, separated or widowed predicted persistence of depressive disorders, whereas somatic and psychiatric comorbidity, childhood adversities and lower social capital did not. Those who received no psychiatric diagnosis at follow-up still had residual symptoms and lower quality of life. LimitationsWe only had one follow-up point at eleven years, and did not collect information on the subjects’ health during the follow-up period. ConclusionsDepressive disorders in the general population are associated with multiple negative outcomes. Severity of index episode is the strongest predictor of negative outcomes. More emphasis should be placed on addressing the long-term consequences of depression.

Abstract P4-03-01: Role of disseminated tumor cell (DTC) in bone marrow (BM) detected at primary diagnosis on overall survival and central nervous system (CNS) recurrences in a cohort of 620 early breast cancer patients after 11 years follow up

Abstract Background: BM DTC detection is known to be a prognostic factor for distant metastasis and overall survival in early breast cancer. However, distant relapses may occur in patients with no DTC detected at time of primary cancer. In this study, we studied the impact of early breast cancer pathological features (including BM DTC status) on the incidence of CNS metastases. Methods: In a cohort (1998-2005) of 620 early breast cancer patients in whom BM DTC were detected using an anti-cytokeratin antibody (A45B/B3) (Bidard et al., 2008, Clinical Cancer Research, outcome updating (median follow up 11y) on overall survival (OS) and distant metastasis free survival (DMFS) was assessed by log rank test and uni- and multivariate analyses. 137 patients of this cohort have a later metastatic relapse. Chi2 test were performed to compare patient with CNS metastasis and patients with other metastases locations. CNS metastasis survivals were estimated using Kaplan-Meier method and compared by log-rank test. Results: At eleven-year median follow-up, the prognostic value of DTC detection was confirmed in the 620 patients cohort for OS (p=0.03 in multivariate analysis), but DTC were probably less involved in late metastatic events. Distant metastases were diagnosed in 137 (22%) patients. In the course of the metastatic disease, 55 of these patients (40%) have been diagnosed with CNS metastases (parenchymal=30, leptomeningeal=10, both localizations=15), as first metastatic or later event. Patients with CNS metastasis were mostly less than 50 years old (60% vs 38%, p=0.01), pN0 (31% vs 10%, p=0.002), hormonal receptor status negative (54% vs 30%, p=0.007) and HER2 status positive (50% vs 22%, p=0.01). Strikingly, although DTC detection was associated with development of distant metastasis in the whole cohort, the occurrence of CNS metastasis was found to be higher in patients who had no DTC detected at primary diagnosis (p=0.016). From CNS metastasis, median survival was 7.8 months (8.3 months for parenchymal and 2.4 months for leptomeningeal recurrences). For HER2+ patients, the median survival after diagnosis of CNS metastasis was 16.6 months (N=15) and 4.1 months for Her2- patients (N=15). Conclusions: After a long-term follow up, DTC remain an adverse prognostic factor in early breast cancer. Our study suggests that cancer cells with epithelial differentiation, as detected in the BM, are less prone to CNS dissemination. This study also confirmed previously reported determinants of CNS metastases (age, RH-, HER2+) in the pre-adjuvant trastuzumab era, but also showed that the outcome of HER2+ patients with CNS relapse was longer, probably due to HER2 targeted therapy during metastatic course. Citation Format: Delphine Loirat, François-Clément Bidard, Léonor Chaltiel, Frédérique Berger, Véronique Dieras, Yann de Rycke, Séverine Alran, Youlia Kirova, Paul Cottu, Anne Vincent- Salomon, Xavier Sastre-Garau, Jean-Yves Pierga. Role of disseminated tumor cell (DTC) in bone marrow (BM) detected at primary diagnosis on overall survival and central nervous system (CNS) recurrences in a cohort of 620 early breast cancer patients after 11 years follow up [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P4-03-01.

Prevalence and correlates of major depressive disorder and dysthymia in an eleven-year follow-up – Results from the Finnish Health 2011 Survey

BackgroundUp-to-date epidemiological data on depressive disorders is needed to understand changes in population health and health care utilization. This study aims to assess the prevalence of major depressive disorder (MDD) and dysthymia in the Finnish population and possible changes during the past 11 years. MethodsIn a nationally representative sample of Finns aged 30 and above (BRIF8901), depressive disorders were diagnosed with the Composite International Diagnostic Interview (M-CIDI) in 2000 and 2011. To account for nonresponse, two methods were compared: multiple imputation (MI) utilizing data from the hospital discharge register and from the interview in 2000 and statistical weighting. ResultsThe MI-corrected 12-month prevalence of MDD was 7.4% (95% CI 5.7–9.0) and of dysthymia was 4.5% (95% CI 3.1–5.9), whereas the corresponding figures using weights were 5.4% (95% CI 4.7–6.1) for MDD and 2.0% (95% CI 1.6–2.4) for dysthymia. Women (OR 2.33, 95% CI 1.6–3.4) and unmarried people (OR 1.54, 95% CI 1.2–2.0) had a higher risk of depressive disorders. There was a significant increase in the prevalence of depressive disorders during the follow-up period from 7.3% in 2000 to 9.6% in 2011. Prevalences were two percentage points higher, on average, when using MI compared to weighting. Hospital treatments for depressive disorders and other mental disorders were strongly associated with nonparticipation. LimitationsThe CIDI response rate dropped from 75% in 2000 to 57% in 2011, but this was accounted for by MI and weighting. ConclusionsDepressive disorders are a growing public health concern in Finland. Non-participation of persons with severe mental disorders may bias the prevalence estimates of mental disorders in population-based studies.

An Eleven-Year Follow-up of a Custom Talar Prosthesis After Open Talar Extrusion in an Adolescent Patient: A Case Report.

Talar extrusion is an extremely rare injury; isolated cases are reported in most instances1-8. Because of the paucity of literature pertaining to this injury, no definitive recommendations exist for treatment. General consensus among orthopaedic surgeons mandates that this injury be managed by thorough debridement of the wound and reduction of the extruded talus, if possible9. When complications like osteonecrosis and infection occur, the surgeon is left with few options outside of tibiocalcaneal arthrodesis. Often, this leaves the patient with a shortened limb and altered gait mechanics10. In 2007, Stevens et al. reported a talar extrusion in a fourteen-year-old girl who underwent an excision of the native talus because of infection, followed by replacement with a custom-made cobalt-chrome talar body prosthesis11. That case report was unique because of the age of the patient, the use of a metal implant in a previously infected wound, and the use of a custom-made metal prosthesis with a novel “snap-fit” design for purchase and stability. In this case report, we describe the same patient after eleven years of follow-up. The patient was informed that data concerning the case would be submitted for publication. A fourteen-year-old girl had been involved in a motor vehicle accident. On initial evaluation, there had been total extrusion of the right talus from a 10-cm lacerated wound on the lateral aspect of the ankle. The talus appeared intact but devoid of soft-tissue attachments, with the exception of a few capsular strands at the neck. The wound had been grossly contaminated with dirt and grass. The talus was reduced into the ankle joint in the operating room. The lateral ligaments of the ankle were reconstructed. The wound was left open and dressed under sterile conditions. The patient had debridements on days two, …

Unreconstructable acute distal humeral fractures and their sequelae treated with distal humeral hemiarthroplasty: a two-year to eleven-year follow-up

The aim of this study was to describe for the first time the medium to long-term outcome after distal humeral hemiarthroplasty (DHH). Twenty-six patients (mean age, 62; range, 29-92 years) treated with DHH for intra-articular distal humeral fractures and its sequelae were studied retrospectively. Four patients had died and 4 had been revised to total elbow arthroplasty: 2 for periprosthetic fractures and 2 for primary component loosening (all in prostheses without an anterior flange). Six other complications had occurred: ulnar neuritis, 4; stiffness, 1; and wound necrosis, 1. Seventeen patients underwent assessment at a mean of 80 months after surgery. The mean values of the American Shoulder and Elbow Surgeons (ASES) elbow score (pain, 9.93; function, 25; satisfaction, 9.06); Mayo Elbow Performance Score (90); Quick Disabilities of Arm, Shoulder and Hand (19), and EuroQol EQ5D (Index, 0.84; Visual Analog Scale, 80) outcome measures demonstrated good function and satisfaction with little pain. The mean flexion extension arc was 116°. There was no evidence of instability. Radiologic evidence of ulnar wear was seen in 13 patients and may be related to prosthetic design to some extent. Worse wear was associated with a higher ASES pain score, lower satisfaction score, and lower EuroQoL Visual Analog Scale of quality of life. Degree of wear correlates with time after surgery but not with age at the time of surgery. DHH offers a treatment option for unreconstructable distal humeral fractures and is associated with a good long-term outcome. Level IV, case series, treatment study.

Inflammatory Biomarkers as Risk Factors for Future Atrial Fibrillation. An Eleven-Year Follow-Up of 6315 Men and Women: The Tromsø Study

Inflammatory biomarkers are reported as risk factors for atrial fibrillation (AF), but their impact is uncertain. We investigated the associations between inflammatory biomarkers and future AF in a large general cohort. Available markers were white blood cells (WBCs) with subgroups, fibrinogen, high-sensitivity C-reactive protein (hs-CRP), and osteoprotegerin (OPG). A total of 6315 men and women from a population survey in Tromsø, Norway in 1994 to 1995 were followed for a mean of 10.9 years. Mean age at baseline was 60 years. Measurements of height, weight, blood pressure, heart rate, total cholesterol, high-density lipoprotein (HDL) cholesterol, WBC count, and information on diabetes, angina, myocardial infarction, and antihypertensive treatment, were obtained at baseline. Fibrinogen, hs-CRP, and OPG were obtained at a follow-up visit. The outcome measure was first-ever AF, documented on an electrocardiogram. The Cox proportional hazards regression model was used to estimate hazard ratios of AF. In the multivariable analysis, adjusted for traditional cardiovascular risk factors and other inflammatory biomarkers, hs-CRP was associated with AF in men only (hazard ratio = 1.14 for a 1 SD increase; 95% CI, 1.02-1.28). There was a significant increase in AF across quartiles of WBCs in men (P = 0.007) and in the total study population (P = 0.004). OPG was associated with AF in patients free of coronary heart disease at baseline. Fibrinogen and subgroups of WBCs showed no significant association with AF. This population-based cohort study showed that hs-CRP was independently associated with AF in men, but apparently not in women, and that patients with WBCs in the upper quartile had increased risk of AF.

Eleven-Year Follow-up of Idiotype Vaccine and DA-EPOCH-Rituximab in Untreated Mantle Cell Lymphoma: Correlation of Survival with Idiotype Immune Response

Abstract 2707 Background:We hypothesized that immunotherapy with autologous tumor-derived idiotype (Id)-vaccine may improve the outcome of mantle cell lymphoma (MCL). Some murine lymphoma models have shown that Id-vaccine can induce an anti-tumor humoral response but others indicate that eradication of tumor requires a CD4+ and/or a CD8+ T-cell response. Antitumor T-cells may produce one or many cytokines. The Th1/Tc1 cytokines (IFNγ, IL-2, TNFα, GM-CSF) are commonly believed to mediate antitumor effects. However, a recent paper (Codarri et al. Nat Immunol 2011) proposes that production of GM-CSF by helper T-cells relies on activation of RORγt and that GM-CSF secretion is required for induction of autoimmune inflammation irrespective of helper T-cell polarization. We reported the results of Id-vaccine following DA-EPOCH-R in 26 untreated MCL patients (Neelapu et al Nat Med 2005) and found no association between PFS (19%) or OS (89%) and immune responses at the median of 46 months potential follow-up. We now present an 11-year follow-up and association between OS and antitumor immune responses. Study Design: DA-EPOCH-R was administered q3 weeks × 6, followed by 5 cycles of Id-vaccine beginning at least 12 weeks later to untreated MCL patients. Id protein was produced using hybridoma technology, conjugated to keyhole limpet hemocyanin (KLH), and administered together with GM-CSF × 5 over 6 months. Pre- and post-vaccine samples were tested in parallel to assess humoral and cellular immune responses. Anti-Id and anti-KLH antibody responses were determined by ELISA. KLH-specific cellular responses were determined by intracellular cytokine assay and cellular responses against autologous tumor cells were determined by cytokine induction and IFNγ ELISPOT assays. For cytokine induction assay, PBMCs were cultured with and without autologous tumor cells. After 6 days TNFα, IFNγ and GM-CSF were assessed in culture supernatants by ELISA. Normalized post-vaccine responses were calculated for each patient. Results: Characteristics of all 26 patients: median age 57 (r 22–73), PS 1 (0–2), male sex 73%, blastoid variant 15%, and MIPI (low-65%; intermediate-16%; high-19%). Responses to DA-EPOCH-R: CR-92%, PR-8%. Immune analyses were performed in 24 patients; vaccine could not be made in one patient and one patient progressed and did not have immune analyses. The associations between OS and MIPI scores and normalized immune responses (KLH and anti-Id antibody responses, frequency of KLH-specific CD4+ T-cell responses in PBMC (intracellular IL-2 and TNFα), antitumor cytokine responses and IFNγ ELISPOT) were determined. With 122 mos median potential follow-up (r 111–132), the median PFS is 24 mos and OS is 104 mos. MIPI was significantly associated with OS (Fig 1; p=0.01); median OS: low (not reached), intermediate (84 mos) and high (44 mos). There was no association between OS and KLH humoral response or KLH-specific CD4+ T cells. There was also no association between OS and Id-specific humoral response, IFNγ ELISPOT, or antitumor TNFα, or IFNγ cytokine responses. However, there was a significant association between antitumor GM-CSF production and OS (Fig 2). The median OS at the median GM-CSF normalized value (<4.3 versus >4.3) was 79 mos versus not reached, respectively (p=0.015 (unadjusted) and p=0.045 (bonferroni adjusted)). MIPI and GM-CSF were jointly assessed in a Cox model and showed a trend toward improved OS for higher GM-CSF (p=0.10) after adjusting for MIPI (p=0.20). Conclusions: With 10-year median potential follow-up, GM-CSF cytokine response mediated by antitumor T-cells was significantly associated with OS. Recent studies support the hypothesis that antitumor T-cells that produce significant amounts of GM-CSF are uniquely polarized and that non-GM-CSF producing T-cells do not induce antitumor effects even if they produce TNFα or IFNγ. This may explain why we did not observe an association between OS and TNFα or IFNγ cytokine responses or an anti-Id-antibody response. These results provide the first evidence that Id-vaccines may improve the survival of MCL following induction with immuno-chemotherapy and need to be confirmed in future trials. [Display omitted] [Display omitted] Disclosures:Neelapu:Biovest International, Inc.: Research Funding. Kwak:Biovest International, Antigenics: Consultancy, Membership on an entity's Board of Directors or advisory committees; Biovest International: Other remuneration; Antigenics, Xeme Biopharma: Equity Ownership.

Caries Risk Assessment/Treatment Programs in U.S. Dental Schools: An Eleven‐Year Follow‐Up

The purpose of this survey was to identify the number and characteristics of caries risk assessment/treatment (CRA/ Tx) programs in U.S. dental schools in 2009 and compare the results to those of the 1998 survey. A survey of U.S. dental schools was conducted in 2009 using the same eleven-question survey instrument as in 1998. Results were analyzed using stratified random sampling and chi-square tests for six of the questions. Additionally, data from the other questions were directly compared. Two questions showed a statistically significant difference: an increase in programs supervised by one school department and the number of schools using CRA as a graduation requirement. Positive changes are occurring in the development of CRA/Tx programs in U.S. dental schools. A wide variety of approaches to teaching this subject, including use of terminology and treatment philosophies, is evident. The evolution of this subject has been slow and varied over the past eleven years. Changing from a mainly surgical approach model to a medical model is occurring, but a more integrated method is needed to clarify terminology, diagnosis, treatment, and communications with researchers, clinicians, teachers, patients, and third-party payers.

Porous-Coated Anatomic Primary Total Knee Arthroplasty: A Six- to Eleven-Year Follow-up Study

Porous-Coated Anatomic Primary Total Knee Arthroplasty: A Six- to Eleven-Year Follow-up Study

Eleven‐Year Follow‐Up of a Randomized Study of Pectoral Fascia Preservation After Mastectomy for Early Breast Cancer

The present study reports results of a randomized trial in which breast cancer patients operated with preserved pectoral fascia compared to removal of the pectoral fascia showed a trend toward an increased risk for chest wall recurrence The aim of the study was to assess whether the different procedural modes had any impact on survival or local control in breast cancer patients followed in the long term. The trial included 247 patients with breast cancer who underwent modified radical mastectomy in five Swedish hospitals between 1993 and 1997. The median follow-up time was 11years. The patients were randomized between removal (n=122) versus preservation (n=125) of the pectoral fascia. The breast-cancer-specific survival at 10years was 73%. Removal or preservation of the pectoral fascia had no significant impact on chest-wall recurrence rate or breast-cancer-specific survival. A total of 18 patients with chest-wall recurrence were seen in the group allocated to pectoral fascia preservation versus a total of 10 in patients allocated to pectoral fascia removal (hazard ratio=1.8, 95% confidence interval=0.8-4.0). The majority of the chest-wall recurrences were detected 0-5years postoperatively. The cumulative chest-wall recurrence rates at 5 and at 10years were 13 and 15%, respectively, in patients allocated to pectoral fascia preservation and 8 and 9% in patients allocated to pectoral fascia removal. With long-term follow-up neither the chest wall recurrence rate nor the breast-cancer-specific survival was significantly influenced by the preservation of the pectoral fascia. A trend toward an increased risk for chest wall recurrence was observed in patients with preserved pectoral fascia. A hazard ratio of 1.8 for a chest-wall recurrence in patients with preserved fascia indicates that fascia-sparing mastectomy may negatively affect prognosis.

Eleven-Year follow-up of Second-Generation Metal-on-Metal Total Hip Arthroplasty

To investigate the cause of failure in matte-surface cemented stems in second-generation metal-on- metal total hip arthroplasty (THA). Records of 26 men and 11 women (39 hips) aged 29 to 72 years who underwent primary cementless THAs by a single surgeon using second-generation metal-on-metal prostheses and were followed up for a mean of 122 (range, 120-141) months were reviewed. Two types of femoral stems were used: a cementless Ti-alloy stem (n=21) and a matte-surface, iron-based alloy, cemented stem (n=18). Clinical outcomes were measured using the Harris hip score. Radiographs were assessed for stem loosening and osteolysis. Patient activity levels were graded. Surfaces of the retrieved femoral stems and periprosthetic tissue samples were examined. Metallic and cement particles were studied. Hypersensitivity to metal was tested. None of the cementless stems were revised; no osteolysis or stem loosening occurred. In contrast, 7 of 18 matte-surface cemented stems were revised owing to stem loosening or osteolysis. Periprosthetic tissues revealed abundant cement-related particles; 90% were zirconium oxides but a few were iron particles. Histological examination of periprosthetic tissues showed perivascular infiltration of lymphocytes and macrophages containing tiny foreign materials. Metal hypersensitivity was not associated with aseptic loosening. Metal-on-metal THA with cementless components could be recommended for young, active patients to prevent wear and osteolysis. The matte-surface cemented stem is more likely to fail owing to friction during the earlier stage and cement-related biological processes during the later stage.

Prevention of marital instability and distress. Results of an 11-year longitudinal follow-up study

Divorce and destructive couple conflict are major risk factors for many forms of dysfunction and psychopathology in the family. Couple relationship education has been offered in an attempt to reduce those risks and enhance couple outcomes. The current effectiveness study had two aims: to assess (a) the long-term effects of relationship education and (b) the ability of partners to remember the skills typically taught during the communication skills training. One hundred and one couples from two studies, in which the effectiveness of the EPL (Ein Partnerschaftliches Lernprogramm für Paare [A Learning Program for Married Couples]) was investigated, were followed-up 11 years after the training. In the first study, EPL-takers had a significantly lower divorce and separation rate (27.5%) than non-EPL-takers (52.6%). This finding was replicated in a second study, showing a 20% dissolution rate in EPL-takers. For those couples still together, the rate of happy relationships was 80% at the eleven-year follow-up – thus, there is optimism for longer married couples who are willing to focus on improving their relationships. Only about 55% of the partners could remember at least one speaker skill whereas 70% remembered at least one listening skill taught during EPL. Consequences for prevention programs in the couple domain are discussed.

Eleven-Year Follow-Up of a Randomised Study of Pectoral Fascia Preservation after Mastectomy for Early Breast Cancer.

Abstract Background: In a previous report with 6 years follow-up a trend towards an increased risk for chest wall recurrence was seen in breast cancer patients operated with preserved pectoral fascia compared to removal of the pectoral fascia. The aim of the present study was to assess whether the preservation or removal of the pectoral fascia in the modified radical mastectomy procedure had any impact on survival or local control in breast cancer patients when followed long term.Method: The trial included 247 patients with breast cancer who underwent modified radical mastectomy in five Swedish hospitals 1993-1997. The median follow-up time was 11 years. The patients were randomised between removal (n=122) versus preservation (n=125) of the pectoral fascia.Results: The breast cancer specific survival at 10 years was 75%. Removal or preservation of the pectoral fascia had not any significant impact on the chest-wall recurrence and on breast cancer specific survival. A total of 18 patients with chest-wall recurrence were seen in the group allocated to pectoral fascia preservation versus 10 in patients allocated to pectoral fascia removal (hazard ratio=1.8, 95%CI = 0.8-4.0). The majority of the chest-wall recurrences were detected 0-5 years postoperatively. The cumulative chest-wall recurrence rates at 5 and at 10 years were 13 and 15% respectively in patients allocated to pectoral fascia preservation and 8 and 9% in patients allocated to pectoral fascia removalConclusion: Neither the chest-wall recurrence rate nor the breast cancer specific survival is significantly influenced by the preservation of the pectoral fascia when the tumor macroscopically does not involve the muscle. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 3109.