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1.
ESC Heart Fail ; 2020 Apr 14.
Artigo em Inglês | MEDLINE | ID: mdl-32285648

RESUMO

AIMS: Patients with non-ischaemic dilated cardiomyopathy (DCM) are at increased risk of sudden cardiac death. Identification of patients that may benefit from implantable cardioverter-defibrillator implantation remains challenging. In this study, we aimed to determine predictors of sustained ventricular arrhythmias in patients with DCM. METHODS AND RESULTS: We searched MEDLINE/Embase for studies describing predictors of sustained ventricular arrhythmias in patients with DCM. Quality and bias were assessed using the Quality in Prognostic Studies tool, articles with high risk of bias in ≥2 areas were excluded. Unadjusted hazard ratios (HRs) of uniformly defined predictors were pooled, while all other predictors were evaluated in a systematic review. We included 55 studies (11 451 patients and 3.7 ± 2.3 years follow-up). Crude annual event rate was 4.5%. Younger age [HR 0.82; 95% CI (0.74-1.00)], hypertension [HR 1.95; 95% CI (1.26-3.00)], prior sustained ventricular arrhythmia [HR 4.15; 95% CI (1.32-13.02)], left ventricular ejection fraction on ultrasound [HR 1.45; 95% CI (1.19-1.78)], left ventricular dilatation (HR 1.10), and presence of late gadolinium enhancement [HR 5.55; 95% CI (4.02-7.67)] were associated with arrhythmic outcome in pooled analyses. Prior non-sustained ventricular arrhythmia and several genotypes [mutations in Phospholamban (PLN), Lamin A/C (LMNA), and Filamin-C (FLNC)] were associated with arrhythmic outcome in non-pooled analyses. Quality of evidence was moderate, and heterogeneity among studies was moderate to high. CONCLUSIONS: In patients with DCM, the annual event rate of sustained ventricular arrhythmias is approximately 4.5%. This risk is considerably higher in younger patients with hypertension, prior (non-)sustained ventricular arrhythmia, decreased left ventricular ejection fraction, left ventricular dilatation, late gadolinium enhancement, and genetic mutations (PLN, LMNA, and FLNC). These results may help determine appropriate candidates for implantable cardioverter-defibrillator implantation.

2.
Biom J ; 62(3): 777-789, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-31544262

RESUMO

Individualized therapies for patients with biomarkers are moving more and more into the focus of research interest when developing new treatments. Hereby, the term individualized (or targeted) therapy denotes a treatment specifically developed for biomarker-positive patients. A network meta-analysis model for a binary endpoint combining the evidence for a targeted therapy from individual patient data with the evidence for a non-targeted therapy from aggregate data is presented and investigated. The biomarker status of the patients is either available at patient-level in individual patient data or at study-level in aggregate data. Both types of biomarker information have to be included. The evidence synthesis model follows a Bayesian approach and applies a meta-regression to the studies with aggregate data. In a simulation study, we address three treatment arms, one of them investigating a targeted therapy. The bias and the root-mean-square error of the treatment effect estimate for the subgroup of biomarker-positive patients based on studies with aggregate data are investigated. Thereby, the meta-regression approach is compared to approaches applying alternative solutions. The regression approach has a surprisingly small bias even in the presence of few studies. By contrast, the root-mean-square error is relatively greater. An illustrative example is provided demonstrating implementation of the presented network meta-analysis model in a clinical setting.

3.
Pharm Stat ; 18(2): 166-183, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30458579

RESUMO

The analysis of adverse events (AEs) is a key component in the assessment of a drug's safety profile. Inappropriate analysis methods may result in misleading conclusions about a therapy's safety and consequently its benefit-risk ratio. The statistical analysis of AEs is complicated by the fact that the follow-up times can vary between the patients included in a clinical trial. This paper takes as its focus the analysis of AE data in the presence of varying follow-up times within the benefit assessment of therapeutic interventions. Instead of approaching this issue directly and solely from an analysis point of view, we first discuss what should be estimated in the context of safety data, leading to the concept of estimands. Although the current discussion on estimands is mainly related to efficacy evaluation, the concept is applicable to safety endpoints as well. Within the framework of estimands, we present statistical methods for analysing AEs with the focus being on the time to the occurrence of the first AE of a specific type. We give recommendations which estimators should be used for the estimands described. Furthermore, we state practical implications of the analysis of AEs in clinical trials and give an overview of examples across different indications. We also provide a review of current practices of health technology assessment (HTA) agencies with respect to the evaluation of safety data. Finally, we describe problems with meta-analyses of AE data and sketch possible solutions.


Assuntos
Ensaios Clínicos como Assunto/métodos , Interpretação Estatística de Dados , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Ensaios Clínicos como Assunto/estatística & dados numéricos , Determinação de Ponto Final , Seguimentos , Humanos , Projetos de Pesquisa , Avaliação da Tecnologia Biomédica/métodos , Fatores de Tempo
4.
Heart Vessels ; 33(11): 1390-1402, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-29721674

RESUMO

The wearable cardioverter-defibrillator (WCD) was introduced to provide protection from sudden cardiac death (SCD) in patients with transiently elevated risk or during ongoing risk stratification. Benefits and clinical characteristics of routine WCD use remain to be assessed in larger patient populations. This study aims to identify determinants of WCD compliance, therapies, and inappropriate alarms in a real-life cohort. A total of 106 cases (68.9% male) were included between 11/2010 and 04/2016. WCD therapies, automatically recorded arrhythmia episodes, inappropriate WCD alarms, patient compliance, and outcome after WCD prescription were analyzed. Median duration of WCD use was 58.5 days. Average daily wearing time was 22.7 h. Compliance was reduced in patients ≤ 50 years. Three patients received WCD therapies (2.8%). In one case ventricular fibrillation (VF) was appropriately terminated with the first shock. Two patients received inappropriate WCD therapies due to WCD algorithm activation during ventricular pacemaker stimulation. One patient died of asystole while carrying a WCD (0.9%). Additional arrhythmias detected comprised self-terminating sustained ventricular tachycardia (VT; 2.8%), non-sustained VT (2.8%), and supraventricular arrhythmias (5.7%). Inappropriate WCD alarms due to over-/undersensing occurred in 77/106 patients (72.6%), of which 41 (38.7%) experienced ≥ 10 inappropriate WCD alarms during the prescription period. Thirteen patients (12.3%) displayed a mean of > 1 inappropriate alarms/day. WCD use was associated with high compliance and provided protection from VT/VF-related SCD. The majority of patients experienced inappropriate WCD alarms. Alterations in QRS morphology during pacemaker stimulation require consideration in WCD programming to prevent inappropriate alarms.


Assuntos
Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Monitorização Fisiológica/instrumentação , Cooperação do Paciente , Medição de Risco , Fibrilação Ventricular/terapia , Dispositivos Eletrônicos Vestíveis , Idoso , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/etiologia , Eletrocardiografia , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Taxa de Sobrevida/tendências , Fibrilação Ventricular/complicações , Fibrilação Ventricular/fisiopatologia
5.
Surg Endosc ; 32(4): 1656-1667, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29435749

RESUMO

BACKGROUND: There is limited evidence on the transferability of conventional laparoscopic and open surgical skills to robotic-assisted surgery. The primary aim of this study was to evaluate the transferability of expertise in conventional laparoscopy and open surgery to robotic-assisted surgery using the da Vinci Skills Simulator (dVSS). Secondary aims included evaluating the influence of individual participants' characteristics. METHODS: Participants performed four tasks on the dVSS: Peg Board 1 (PB), Pick and Place (PP), Thread the Rings (TR), and Suture Sponge 1 (SS). Participants were classified into three groups (Novice, Intermediate, Experts) according to experience in laparoscopic and open surgery. All tasks were performed twice except for SS. Performance was assessed using the built-in scoring system. RESULTS: 37 medical students and 25 surgeons participated. Experts did not perform significantly better than less experienced participants on the dVSS. Specifically, with regard to laparoscopic experience, total simulator scores were: Novices 68.2 ± 28.8; Intermediates 65.1 ± 31.2; Experts 65.1 ± 30.0; p = 0.611. Regarding open surgical experience, scores were: Novices 68.6 ± 28.7; Intermediates 68.2 ± 30.8; Experts 63.2 ± 30.3; p = 0.305. Although there were some significant differences among groups for single parameters in specific tasks, there was no constant superiority of one group. Laparoscopic and open surgical Novices improved significantly in overall score and time for all three tasks (p < 0.05). Laparoscopic intermediates improved only in PP time (4.64 ± 3.42; p = 0.006), open Intermediates in PB score (11.98 ± 13.01; p = 0.025), and open Experts in PP score (6.69 ± 11.48; p = 0.048). Laparoscopic experts showed no improvement. Participants with gaming experience had better overall scores than non-gamers when comparing all second attempts (Gamer 83.62 ± 7.57; Non-Gamer 76.31 ± 12.78; p = 0.008) as well as first and second attempts together (Gamer 72.08 ± 8.86; Non-Gamer 65.45 ± 11.68; p = 0.039). Musical and sports experience showed no correlation with robotic performance. CONCLUSIONS: Robotic-assisted surgery requires skills distinct from conventional laparoscopy or open surgery. Basic robotic skills training prior to patient contact should be required.


Assuntos
Competência Clínica/normas , Internato e Residência , Laparoscopia/educação , Procedimentos Cirúrgicos Robóticos/educação , Treinamento por Simulação , Cirurgiões/educação , Feminino , Humanos , Laparoscopia/métodos , Estudos Prospectivos , Procedimentos Cirúrgicos Robóticos/normas , Análise e Desempenho de Tarefas
6.
Clin Res Cardiol ; 107(1): 30-41, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28840316

RESUMO

BACKGROUND: Hypertrophic cardiomyopathy (HCM) is the most common genetic cardiovascular disease, which goes along with increased risk for sudden cardiac death (SCD). Despite the knowledge about the different causal genes, the relationship between individual genotypes and phenotypes is incomplete. METHODS AND RESULTS: We retrieved PubMed/Medline literatures on genotype-phenotype associations in patients with HCM and mutations in MYBPC3, MYH7, TNNT2, and TNNI3. Altogether, 51 studies with 7675 HCM patients were included in our meta-analysis. The average frequency of mutations in MYBPC3 (20%) and MYH7 (14%) was higher than TNNT2 and TNNI3 (2% each). The mean age of HCM onset for MYH7 mutation positive patients was the beginning of the fourth decade, significantly earlier than patients without sarcomeric mutations. A high male proportion was observed in TNNT2 (69%), MYBPC3 (62%) and mutation negative group (64%). Cardiac conduction disease, ventricular arrhythmia and heart transplantation (HTx) rate were higher in HCM patients with MYH7 mutations in comparison to MYBPC3 (p < 0.05). Furthermore, SCD was significantly higher in patients with sarcomeric mutations (p < 0.01). CONCLUSION: A pooled dataset and a comprehensive genotype-phenotype analysis show that the age at disease onset of HCM patients with MYH7 is earlier and leads to a more severe phenotype than in patient without such mutations. Furthermore, patients with sarcomeric mutations are more susceptible to SCD. The present study further supports the clinical interpretation of sarcomeric mutations in HCM patients.


Assuntos
Miosinas Cardíacas/genética , Cardiomiopatia Hipertrófica/genética , Morte Súbita Cardíaca/prevenção & controle , Mutação , Cadeias Pesadas de Miosina/genética , Adulto , Idade de Início , Idoso , Cardiomiopatia Hipertrófica/diagnóstico , Cardiomiopatia Hipertrófica/fisiopatologia , Cardiomiopatia Hipertrófica/terapia , Proteínas de Transporte/genética , Estudos de Casos e Controles , Morte Súbita Cardíaca/etiologia , Feminino , Estudos de Associação Genética , Predisposição Genética para Doença , Transplante de Coração , Humanos , Masculino , Pessoa de Meia-Idade , Fenótipo , Fatores de Risco , Resultado do Tratamento , Troponina I/genética , Troponina T/genética , Adulto Jovem
7.
World J Surg ; 41(11): 2746-2757, 2017 11.
Artigo em Inglês | MEDLINE | ID: mdl-28634842

RESUMO

BACKGROUND: Adrenalectomy can be performed via open and various minimally invasive approaches. The aim of this systematic review was to summarize the current evidence on surgical techniques of adrenalectomy. METHODS: Systematic literature searches (MEDLINE, EMBASE, Web of Science, Cochrane Library) were conducted to identify randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing at least two surgical procedures for adrenalectomy. Statistical analyses were performed, and meta-analyses were conducted. Furthermore, an indirect comparison of RCTs and a network meta-analysis of CCTs were carried out for each outcome. RESULTS: Twenty-six trials (1710 patients) were included. Postoperative complication rates did not show differences for open and minimally invasive techniques. Operation time was significantly shorter for open adrenalectomy than for the robotic approach (p < 0.001). No differences were found between laparoscopic and robotic approaches. Network meta-analysis showed open adrenalectomy to be the fastest technique. Blood loss was significantly reduced in the robotic arm compared with open and laparoscopic adrenalectomy (p = 0.01). Length of hospital stay (LOS) was significantly lower after conventional laparoscopy than open adrenalectomy in CCTs (p < 0.001). Furthermore, both retroperitoneoscopic (p < 0.001) and robotic access (p < 0.001) led to another significant reduction of LOS compared with conventional laparoscopy. This difference was not consistent in RCTs. Network meta-analysis revealed the lowest LOS after retroperitoneoscopic adrenalectomy. CONCLUSION: Minimally invasive adrenalectomy is safe and should be preferred over open adrenalectomy due to shorter LOS, lower blood loss, and equivalent complication rates. The retroperitoneoscopic access features the shortest LOS and operating time. Further high-quality RCTs are warranted, especially to compare the posterior retroperitoneoscopic and the transperitoneal robotic approach.


Assuntos
Adrenalectomia/métodos , Laparoscopia , Procedimentos Cirúrgicos Robóticos , Adrenalectomia/efeitos adversos , Perda Sanguínea Cirúrgica , Humanos , Laparoscopia/efeitos adversos , Laparoscopia/métodos , Tempo de Internação , Metanálise em Rede , Duração da Cirurgia , Ensaios Clínicos Controlados Aleatórios como Assunto , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Procedimentos Cirúrgicos Robóticos/métodos
8.
Int J Infect Dis ; 58: 96-109, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28341436

RESUMO

OBJECTIVE: To compare the efficacy and safety of different pivmecillinam (PIV) regimes for uncomplicated lower urinary tract infections (UTIs). METHODS: The MEDLINE, Embase, and Cochrane Library databases were searched. Randomized controlled clinical trials (RCTs) involving adults or children with symptoms suggestive of uncomplicated UTI and that compared different PIV regimes or PIV versus other antibiotics were included. Meta-analyses were conducted to obtain direct and indirect efficacy estimates. PIV regimes were categorized into high total dosage, moderate total dosage, and low total dosage. The risk of bias was evaluated using the Cochrane tool. RESULTS: Twenty-four RCTs were identified. No difference in clinical cure was found for the high vs. moderate (short-term: risk ratio (RR) 1.01, p=0.813; long term: RR 1.09, p=0.174) or high vs. low dosage comparisons (mean difference 0, 95% confidence interval -0.44 to 0.45, p=1). For bacteriological cure, comparisons of high vs. moderate dosage (short term: RR 1.05, p=0.056; long term: RR 1.05, p=0.131) and high vs. low dosage (short term: RR 1.02, p=0.759; long term: RR 1.13, p=0.247) showed a trend in favor of the high dosage treatment. Results for relapse, re-infection, and failure were inconclusive and not statistically significant. Patients treated with high dosages were 40% (p=0.062) and 44% (p=0.293) more likely to report mild to moderate adverse events. CONCLUSIONS: There is insufficient evidence to support the use of an optimal combination of dosage, frequency, and duration of PIV therapy for the treatment of uncomplicated lower UTI. Evidence is limited due to the high risk of bias, poor reporting, and heterogeneous study data.


Assuntos
Andinocilina Pivoxil/administração & dosagem , Anti-Infecciosos Urinários/administração & dosagem , Infecções Urinárias/tratamento farmacológico , Relação Dose-Resposta a Droga , Esquema de Medicação , Humanos
9.
Surg Endosc ; 31(10): 4058-4066, 2017 10.
Artigo em Inglês | MEDLINE | ID: mdl-28281111

RESUMO

BACKGROUND: Touch Surgery™ (TS) is a serious gaming application for cognitive task simulation and rehearsal of key steps in surgical procedures. The aim was to establish face, content, and construct validity of TS for laparoscopic cholecystectomy (LC). Furthermore, learning curves with TS and a virtual reality (VR) trainer were compared in a randomized trial. METHODS: The performance of medical students and general surgeons was compared for all three modules of LC in TS to establish construct validity. Questionnaires assessed face and content validity. For analysis of learning curves, students were randomized to train on VR or TS first, and then switched to the other training modality. Performance data were recorded. RESULTS: 54 Surgeons and 51 medical students completed the validation study. Surgeons outperformed students with TS: patient preparation (students = 45.0 ± 19.1%; surgeons = 57.3 ± 15.2%; p < 0.001), access and laparoscopy (students = 70.2 ± 10.9%; surgeons = 75.9 ± 9.7%; p = 0.008) and LC (students = 69.8 ± 12.4%; surgeons = 77.7 ± 9.6%; p < 0.001). Both groups agreed that TS was a highly useful and realistic application. 46 students were randomized for learning curve analysis. It took them 2-4 attempts to reach a 100% score with TS. Training with TS first did not improve students' performance on the VR trainer; however, students who trained with VR first scored significantly higher in module 3 of TS. CONCLUSION: TS is an accepted serious gaming application for learning cognitive aspects of LC with established construct, face, and content validity. There appeared to be a synergy between TS and the VR trainer. Therefore, the two training modalities should accompany one another in a multimodal training approach to laparoscopy.


Assuntos
Colecistectomia Laparoscópica/educação , Educação Médica/métodos , Aplicativos Móveis/estatística & dados numéricos , Cirurgiões/educação , Realidade Virtual , Adulto , Competência Clínica/estatística & dados numéricos , Cognição/fisiologia , Simulação por Computador , Feminino , Humanos , Curva de Aprendizado , Masculino , Projetos Piloto , Reprodutibilidade dos Testes , Estudantes de Medicina/estatística & dados numéricos , Inquéritos e Questionários , Jogos de Vídeo
10.
Surg Endosc ; 31(5): 2155-2165, 2017 05.
Artigo em Inglês | MEDLINE | ID: mdl-27604368

RESUMO

INTRODUCTION: Training and assessment outside of the operating room is crucial for minimally invasive surgery due to steep learning curves. Thus, we have developed and validated the sensor- and expert model-based laparoscopic training system, the iSurgeon. MATERIALS: Participants of different experience levels (novice, intermediate, expert) performed four standardized laparoscopic knots. Instruments and surgeons' joint motions were tracked with an NDI Polaris camera and Microsoft Kinect v1. With frame-by-frame image analysis, the key steps of suturing and knot tying were identified and registered with motion data. Construct validity, concurrent validity, and test-retest reliability were analyzed. The Objective Structured Assessment of Technical Skills (OSATS) was used as the gold standard for concurrent validity. RESULTS: The system showed construct validity by discrimination between experience levels by parameters such as time (novice = 442.9 ± 238.5 s; intermediate = 190.1 ± 50.3 s; expert = 115.1 ± 29.1 s; p < 0.001), total path length (novice = 18,817 ± 10318 mm; intermediate = 9995 ± 3286 mm; expert = 7265 ± 2232 mm; p < 0.001), average speed (novice = 42.9 ± 8.3 mm/s; intermediate = 52.7 ± 11.2 mm/s; expert = 63.6 ± 12.9 mm/s; p < 0.001), angular path (novice = 20,573 ± 12,611°; intermediate = 8652 ± 2692°; expert = 5654 ± 1746°; p < 0.001), number of movements (novice = 2197 ± 1405; intermediate = 987 ± 367; expert = 743 ± 238; p < 0.001), number of movements per second (novice = 5.0 ± 1.4; intermediate = 5.2 ± 1.5; expert = 6.6 ± 1.6; p = 0.025), and joint angle range (for different axes and joints all p < 0.001). Concurrent validity of OSATS and iSurgeon parameters was established. Test-retest reliability was given for 7 out of 8 parameters. The key steps "wrapping the thread around the instrument" and "needle positioning" were most difficult to learn. CONCLUSION: Validity and reliability of the self-developed sensor-and expert model-based laparoscopic training system "iSurgeon" were established. Using multiple parameters proved more reliable than single metric parameters. Wrapping of the needle around the thread and needle positioning were identified as difficult key steps for laparoscopic suturing and knot tying. The iSurgeon could generate automated real-time feedback based on expert models which may result in shorter learning curves for laparoscopic tasks. Our next steps will be the implementation and evaluation of full procedural training in an experimental model.


Assuntos
Laparoscopia/educação , Treinamento por Simulação , Competência Clínica , Retroalimentação , Humanos , Reprodutibilidade dos Testes , Técnicas de Sutura/educação
11.
Pharm Stat ; 15(4): 306-14, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-27313144

RESUMO

When analysing primary and secondary endpoints in a clinical trial with patients suffering from a chronic disease, statistical models for time-to-event data are commonly used and accepted. This is in contrast to the analysis of data on adverse events where often only a table with observed frequencies and corresponding test statistics is reported. An example is the recently published CLEOPATRA study where a three-drug regimen is compared with a two-drug regimen in patients with HER2-positive first-line metastatic breast cancer. Here, as described earlier, primary and secondary endpoints (progression-free and overall survival) are analysed using time-to-event models, whereas adverse events are summarized in a simple frequency table, although the duration of study treatment differs substantially. In this paper, we demonstrate the application of time-to-event models to first serious adverse events using the data of the CLEOPATRA study. This will cover the broad range between a simple incidence rate approach over survival and competing risks models (with death as a competing event) to multi-state models. We illustrate all approaches by means of graphical displays highlighting the temporal dynamics and compare the obtained results. For the CLEOPATRA study, the resulting hazard ratios are all in the same order of magnitude. But the use of time-to-event models provides valuable and additional information that would potentially be overlooked by only presenting incidence proportions. These models adequately address the temporal dynamics of serious adverse events as well as death of patients. Copyright © 2016 John Wiley & Sons, Ltd.


Assuntos
Antineoplásicos/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/mortalidade , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/mortalidade , Modelos Teóricos , Receptor ErbB-2 , Anticorpos Monoclonais Humanizados/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/genética , Método Duplo-Cego , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/genética , Feminino , Seguimentos , Humanos , Receptor ErbB-2/genética , Taxa de Sobrevida/tendências , Fatores de Tempo
12.
Clin Orthop Relat Res ; 474(7): 1697-706, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-27130649

RESUMO

BACKGROUND: Excessive early migration of cemented stems and cups after THA has been associated with poor long-term survival and allows predictable evaluation of implant performance. However, there are few data regarding the relationship between early migration and aseptic loosening of cementless femoral components, and whether early migration might predict late failure has not been evaluated, to our knowledge. Einzel-Bild-Röntgen-Analyse-femoral component analysis (EBRA-FCA) is a validated technique to accurately measure axial femoral stem migration without the need for tantalum markers, can be performed retrospectively, and may be a suitable tool to identify poor performing implants before their widespread use. QUESTIONS/PURPOSES: We asked: (1) Is axial migration within the first 24 months as assessed by EBRA-FCA greater among cementless stems that develop aseptic loosening than those that remain well fixed through the second decade; (2) what is the diagnostic performance of implant migration at 24 months postoperatively to predict later aseptic loosening of these components; and (3) how does long-term stem survivorship compare between groups with high and low early migration? METHODS: We evaluated early axial stem migration in 158 cementless THAs using EBRA-FCA. The EBRA-FCA measurements were performed during the first week postoperatively (baseline measurement) and at regular followups of 3, 6, and 12 months postoperatively and annually thereafter. The mean duration of followup was 21 years (range, 18-24 years). The stems studied represented 45% (158 of 354) of the cementless THAs performed during that time, and cementless THAs represented 34% (354 of 1038) of the THA practice during that period. No patient enrolled in this study was lost to followup. Multivariate survivorship analysis using Cox's regression model was performed with an endpoint of aseptic loosening of the femoral component. Loosening was defined according to the criteria described by Engh et al. and assessed by two independent observers. Patients with a diagnosis of prosthetic joint infection were excluded. Receiver operating characteristic (ROC) curve analysis was used to evaluate diagnostic performance of axial stem migration 1, 2, 3, and 4 years postoperatively as a predictor of aseptic loosening. Survivorship of hips with high (≥ 2.7 mm) and low (< 2.7 mm) migration was compared using a competing-events analysis. RESULTS: Femoral components that had aseptic loosening develop showed greater mean distal migration at 24 months postoperatively than did components that remained well fixed throughout the surveillance period (4.2 mm ± 3.1 mm vs 0.8 mm ± 0.9 mm; mean difference, 3.4 mm, 95% CI, 2.5-4.4; p ≤ 0.001). Distal migration at 24 months postoperatively was a strong risk factor for aseptic loosening (hazard ratio, 1.98; 95% CI, 1.51-2.57; p < 0.001). The associated overall diagnostic performance of 2-year distal migration for predicting aseptic loosening was good (area under the ROC curve, 0.86; 95% CI, 0.72-1.00; p < 0.001). Sensitivity of early migration measurement was high for the prediction of aseptic loosening during the first decade after surgery but decreased markedly thereafter. Stems with large amounts of early migration (≥ 2.7 mm) had lower 18-year survivorship than did stems with little early migration (29% [95% CI, 0%-62%] versus 95% [95% CI, 90%-100%] p < 0.001). CONCLUSIONS: Early migration, as measured by EBRA-FCA at 2 years postoperatively, has good diagnostic capabilities for detection of uncemented femoral components at risk for aseptic loosening during the first and early second decades after surgery. However, there was no relationship between early migration patterns and aseptic loosening during the late second and third decades. EBRA-FCA can be used as a research tool to evaluate new cementless stems or in clinical practice to evaluate migration patterns in patients with painful femoral components. LEVEL OF EVIDENCE: Level III, diagnostic study.


Assuntos
Acetábulo/cirurgia , Artroplastia de Quadril/efeitos adversos , Artroplastia de Quadril/instrumentação , Fêmur/cirurgia , Migração de Corpo Estranho/etiologia , Prótese de Quadril , Falha de Prótese , Acetábulo/diagnóstico por imagem , Adulto , Idoso , Área Sob a Curva , Bases de Dados Factuais , Feminino , Fêmur/diagnóstico por imagem , Migração de Corpo Estranho/diagnóstico por imagem , Humanos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Valor Preditivo dos Testes , Modelos de Riscos Proporcionais , Desenho de Prótese , Curva ROC , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
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