Length Of Follow-up For Patients Research Articles

ID: 219306 Characterization, Risk, and Predictors of Pocket Infection in Deep Brain Stimulation

Although relatively rare, infection can be a serious and disabling complication for Deep Brain Stimulation (DBS) procedures, subjecting patients to additional surgical interventions. Previous meta-analyses report neurostimulator pocket infection risk rates between 3.0-7.3% for DBS procedures. However, most prior reports are based on single-center studies, utilize differing statistical methods to calculate rates, vary in length of patient follow-up, and contain limited information on the predictors and long-term clinical impact of infections.

Complete Versus Incomplete Hematologic Recovery after CAR T Cell Therapy: Implications for Relapse Free Survival and Overall Survival in Pediatric and Young Adult Patients with Relapsed/Refractory B-ALL

Background: Anti-CD19 Chimeric Antigen Receptor (CAR) T cell therapy has emerged as a mainstay in the treatment of patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (ALL). While trials have shown encouraging survival rates, up to 50% of patients receiving CART eventually relapse. Identification of risk factors for subsequent relapse is crucial, as this could allow tailored surveillance and treatment approaches for high-risk patients, potentially leading to improved morbidity and mortality. Complete remission with incomplete hematologic recovery (CRi) has been associated with decreased remission duration and overall survival in acute leukemias. As count suppression following CAR T cell therapy is frequently seen, this study evaluated CRi as a prognostic marker for worse relapse-free (RFS) and overall survival (OS) after CAR T cell therapy in comparison to complete remission with hematologic recovery (CR).Methods: Patients with r/r ALL who achieved a complete morphologic remission after receiving anti-CD19 CAR T cell treatment with the 4-1BB-containing products CTL019 or humanized CART19 in the context of a clinical trial (NCT01626495, NCT02374333, NCT02228096, NCT02435849, NCT02906371) or commercial product (tisagenlecleucel) at Children's Hospital of Philadelphia from 4/2012-4/2019 were identified. Patients who received prior CAR therapy, and those with Trisomy 21 were excluded. Demographic, disease and treatment characteristics, and outcome data were abstracted from the medical record or clinical trial datasets. CR was defined as achieving a morphologic remission with both an absolute neutrophil count (ANC) ≥1,000/µL and a transfusion-independent platelet count ≥100,000/µL at any time between 27-33 days after CAR T cell infusion, whereas those achieving a morphologic remission without complete hematologic recovery were defined as CRi. RFS and OS were described for each cohort. Exposure-outcome association was assessed via the log-rank test and multivariable Cox proportional hazard regression.Results: Of the 206 patients included in the analysis, 104 (51%) achieved CR, 102 (49%) CRi. Forty patients (39%) met criteria for CRi with both ANC <1000/µL and platelets <100,000/µL, 40 (39%) for isolated thrombocytopenia, and 20 (20%) for neutropenia alone. Median age at leukemia diagnosis was 7 years (range 0.2-24), and at CAR T cell infusion was 12 years (range 1-29), with 48% undergoing a prior allogeneic stem cell transplant (HSCT), 32% with high risk cytogenetics, and 10% with prior blinatumomab treatment, none of which differed between the CR and CRi groups (Table 1). The number of relapses prior to CAR T cell referral was different between the groups (p=0.003), with more CR patients having been referred for primary refractory disease (25% vs 9.8%), and more CRi patients for first relapse (34% vs 18%). More CRi patients had >25% bone marrow blasts (43% vs 19%) at infusion, whereas more CR patients were MRD-negative (50% vs 30%) at infusion (p=0.002). CRi patients were also more likely to have Grade 3/4 CRS (38% vs 6.7%). Median length of follow-up for patients with CR was 39 months (range 7-89), which was not statistically significantly different than for those patients with CRi (41 months, 11-98, p=0.875). There was no difference in RFS when stratified by hematologic recovery (Figure 1, p=0.2165), with RFS at 36 months for CR of 57% (47-69) and CRi of 46% (36-59). OS was significantly lower (Figure 2, p=0.0081) for those with CRi, with 36-month OS for CR of 81% (74-89), and for CRi of 63% (54-73). In multivariable analysis adjusting for sex, prior blinatumomab, relapse number, disease burden at infusion, and maximum CRS grade, CR was not associated with either RFS (HR 0.76 [95%CI 0.50-1.17] p=0.2182) or OS (HR 0.74 [95%CI 0.43-1.29] p=0.2908), in comparison to CRi, Table 2.Discussion: Complete remission with incomplete hematologic recovery, manifesting as neutropenia and/or thrombocytopenia, at the first disease assessment following CAR T cell infusion should not be regarded as a harbinger of relapse and demonstrates that patients with CRi have similar probability of durable remission without further therapy. Anticipatory guidance should be provided to patients, and their families, that CRi is more frequently seen in patients who experience high grade CRS, who have high disease burden at infusion, and who are treated in first relapse. [Display omitted] DisclosuresCallahan: Novartis: Speakers Bureau. Rheingold: Optinose: Other: Spouse's current employment; Pfizer: Research Funding. Grupp: Novartis, Roche, GSK, Humanigen, CBMG, Eureka, and Janssen/JnJ: Consultancy; Novartis, Adaptimmune, TCR2, Cellectis, Juno, Vertex, Allogene and Cabaletta: Other: Study steering committees or scientific advisory boards; Novartis, Kite, Vertex, and Servier: Research Funding; Jazz Pharmaceuticals: Consultancy, Other: Steering committee, Research Funding. Maude: Wugen: Consultancy; Novartis Pharmaceuticals Corporation: Consultancy, Research Funding.

Adherence to Long-Term Follow-up in Patients With Sporadic Vestibular Schwannomas Managed With Serial Observation.

ObjectivesTo examine the long-term adherence to serial imaging of patients with sporadic vestibular schwannoma and analyze factors associated with being lost to follow-up.Study DesignRetrospective chart review with telephone interview.SettingSingle tertiary care center.MethodsPatients with a sporadic vestibular schwannoma and started on observational surveillance management between January 2005 and December 2010 were included. Demographic data, tumor size, hearing and vestibular changes, and follow-up length were recorded. Patient factors were analyzed for association with being lost to follow-up.ResultsIn total, 122 patients were included with a median length of follow-up of 5 months (range, 0-146). After initial surveillance, 22.1% (n = 27) of patients had a change in management to either microsurgery or radiosurgery. Of the remaining 77.9% (n = 95), nearly half (44.2%, n = 42) never returned for a second visit, and all but 3 were eventually lost to follow-up. There was no association between sex, race, age at diagnosis, initial tumor size, insurance status, household income, or driving distance to hospital and being lost to follow-up. Of 26 interviewed patients initially lost to follow-up, 11 (42.3%) sought care at another institution, 5 (19.2%) chose to no longer receive care, 1 (3.8%) had transportation difficulties, and 9 (36.4%) had poor understanding of their diagnosis or instructions.ConclusionsThe length of follow-up for patients undergoing surveillance of sporadic vestibular schwannoma varies widely, and patients are commonly lost to follow-up. Further efforts should be made to identify at-risk patients and provide adequate education to improve long-term surveillance.

Active behavior of triple-negative breast cancer with adipose tissue invasion: a single center and retrospective review

BackgroundInteractions between adipocyte and breast cancer (BC) cells have yet to be fully elucidated. Here we investigated the prognostic impact of marginal adipose tissue invasion in both luminal breast cancer (HR+/HER2-) and triple-negative breast cancer (TNBC) (HR−/HER2-).MethodsA total of 735 patients with early-stage invasive BC (1999–2014) were retrospectively registered. Median length of patient follow-up was 8.9 years. Survival curves were calculated using a Kaplan-Meier cumulative survival plot. The prognostic difference between two groups were assessed by the univariate Cox-proportional hazard regression model.ResultsPatients with adipose tissue invasion (n = 614) had a significantly poorer prognosis than those without adipose tissue invasion (n = 121) in overall survival (OS) (hazard ratio, 2.1; 95% Confidence interval [CI], 1.1 to 4.0; P = 0.025). While a poorer prognosis was observed in TNBC (n = 137) than in luminal BC patients (n = 496) (hazard ratio, 0.45; 95% CI, 0.30 to 0.68, P < 0.001), this aggressive nature of TNBC was noted in node-positive disease (hazard ratio, 0.3; 95% CI, 0.18 to 0.5, P < 0.001) but not in node-negative disease (hazard ratio, 0.78; 95% CI, 0.39 to 1.55, P = 0.472), and also noted in adipose tissue invasion-positive patients (hazard ratio, 0.4; 95% CI, 0.26 to 0.6, P < 0.001) but not in adipose tissue invasion-negative patients (hazard ratio, 0.73; 95% CI, 0.16 to 3.24, P = 0.675). In addition, although patients suffering from TNBC with adipose tissue invasion had a poorer outcome than those without adipose tissue invasion (hazard ratio, 3.63; 95% CI, 1.11 to 11.84; P = 0.033), the difference was not observed in luminal BC (hazard ratio, 1.75; 95% CI, 0.64 to 4.82; P = 0.277).ConclusionsAdipose tissue invasion was correlated with poor survival in TNBC. Cancer cell invasion into local fat may be a first step on cancer progression and systemic disease in TNBC.

Changes in Angioarchitecture After Stereotactic Radiosurgery for Dural Arteriovenous Fistula

IntroductionDural arteriovenous fistulae (DAVF) are intracranial vascular abnormalities encountered in neurosurgery practice. Treatment options are microsurgical disconnection, endovascular embolization and/or radiosurgery. Past studies have reported the efficacy, safety, and predictors of success of radiosurgery. In this study, we investigated the angioarchitecture of fistulae at the time of radiosurgery and how the anatomy changed in the time after treatment based on angiogram follow-ups. MethodsA retrospective analysis was performed on patients with angiographic diagnosis of DAVF treated with Gamma Knife radiosurgery (GKRS) between 2013 and 2018. Data collection included demographics, symptoms, grading scores, vascular anatomy, radiation data, treatment strategy, angiographic results, and length of patient follow-up. ResultsOur study reports data on 10 patients with a total of 14 fistulae. On follow-up angiography, 8 (57%) had complete occlusion of the fistula with a median time to follow up of 19.5 months. The remaining 6 (43%) were deemed as near-complete occlusion of fistula with a median time to follow up of 12.0 months. Time from radiosurgery to angiogram revealing incomplete vs. angiogram revealing complete obliteration was significantly different (p=0.045). Nearly all AVFs had decreased feeders over time after treatment with only one AVF developing an additional feeder post-treatment. Arterial feeders, drainage site, sex, Borden type, lesion volume and treatment volume had no predictive value of obliteration outcome. ConclusionsThis study provides data on the angioarchitecture of fistulae treated with GKRS and also serves as an extension of previous studies reporting the safety and efficacy of GKRS treatment for DAVF in a specific patient population.

Postoperative Rheumatic Heart Disease Follow-Up: Creating a National Registry and First Results from Rwanda.

Background:In many developing countries, rheumatic heart disease (RHD) is diagnosed at an advanced stage and requires surgery for patient survival. However, access to cardiac surgery in this context is limited and often provided through partnerships, requiring centralized patient data systems for monitoring and follow-up.Objectives:This study used data from a national postoperative RHD registry to analyze clinical outcomes of Rwandan patients who received surgery between 2006 and 2017.Methods:The RHD registry was created in 2017 using data compiled from Rwanda Ministry of Health and RHD surgery partners. We extracted pre- and post-operative data on patients who were alive and in care. We excluded patients who died or were lost to follow-up, as their data was not collected in the registry. We evaluated the association between demographic, surgical, and follow-up characteristics and most recent patient symptoms, categorized by New York Heart Association (NYHA) class.Findings:Among the 191 patients eligible for inclusion in this study, 107(56.0%) were female, 110(57.6%) were adults at the time of surgery (>15 years), and 128(67.4%) had surgery in Rwanda. Most patients (n = 166, 86.9%) were on penicillin prophylaxis. Of the patients with mechanical valves, 47(29.9%) had therapeutic International Normalized Ratio values. 90% of patients were asymptomatic (NYHA I) at the time of most recent visit. NYHA class was not significantly associated with any of the considered variables. The median length of follow-up for patients was four years (IQR: 2, 5 years).Conclusion:This study shows both the feasibility and challenges of creating a RHD registry 11 years after the national initiation of RHD surgeries. Most patients captured in the registry are asymptomatic; however, collecting details on patients who had died or were lost to follow-up has proven difficult. Implementing strategies to maintain a complete and up-to-date registry will facilitate follow-up for pre- and postoperative patients.

Non-communicable diseases units: continuity of care factors

Continuity of care in healthcare systems is one of the success measures for improvement of health across communities, especially due to the increasing prevalence of non-communicable diseases in the current century. This study aimed to investigate the factors affecting the continuity of care in non-communicable diseases (NCDs) units. A total of 418 patients from NCD prevention and control units at the Southern Tehran Healthcare Center were selected through systematic random sampling, of whom 189 were contacted successfully and interviewed about their satisfaction with the services received and distance from their place of residence to the health center. About two-thirds of the participants were women. Nearly half of the service receivers were illiterate and educated to elementary level, and only 6 % had a high school diploma or higher. 94% were satisfied with the services provided. There was a positive linear correlation between the number of visits and the number of contacts during the period of observation (r = 0.53, P value < 0.001). Also, the length of patient follow-up by the health center and the number of visits during follow-up for patients with active records were significantly more than for those with inactive records (P value < 0.001). This study showed that satisfaction with services alone was not a principal factor affecting continuity of care. Indeed, we conclude that free screening care should be designed for men, the employed, and educated people. More studies are needed to find out the reasons for non-attendance and the provision of solutions to reduce existing deficiencies.

Outcomes of Halo Immobilization for Cervical Spine Fractures.

Study Design:Retrospective.Objectives:To evaluate complications and outcomes of halo immobilization in patients with cervical spine fractures treated at a level I trauma center.Methods:A retrospective evaluation of patients treated at a single institution with halo immobilization from August 2000 to February 2016 was performed. Demographic information, mechanism of injury, level and type of spine fracture, length of halo immobilization, complications associated with halo immobilization, and length of patient follow-up were collected.Results:A total of 189 patients treated with halos were identified. Of the 189 patients, 121 (64%) received halos for the management of cervical spine fractures and were included in the study. A total of 49.6% were males and 50.4% were females. The average age was 50.8 years (range 1-89 years). Overall, 10.7% sustained C1 fractures, 71.1% C2 fractures, and 18.2% subaxial spine (C3-C7) fractures. In all, 47.1% of the upper cervical fractures were either odontoid or hangman-type fractures. A total of 25.1% of patients had multiple cervical fractures. At latest follow-up, 81% had healed fractures with good alignment, minimal pain, and return to normal activities. There was an 8.3% mortality rate. The mortality group had an average age of 64.7 years (range 19-84 years). A total of 10.7% of patients failed halo immobilization and 46.3% of patients had complications such as pin site infections (5.8%), loose pins (1.7%), neck pain (20.7%), decreased range of motion (14%), thoracic skin ulcers (2.4%), and dysphagia (1.7%).Conclusions:The use of halo immobilization for cervical spine fractures resulted in clinical success in 81% of patients. Complication rates in geriatric patients were lower than previously reported in the literature.

Optimal Length of Follow-up for the Detection of Unsuccessful Pediatric Pyeloplasty: A Single-Center Experience.

To assess the optimal length of follow-up for patients undergoing both open and minimally invasive pyeloplasties to ensure prompt detection of a recurrent obstruction. There are no standard guidelines on ideal follow-up and imaging post-pediatric pyeloplasty currently. A retrospective chart review identified 264 patients (<18 years old) who underwent pyeloplasty for ureteropelvic junction obstruction between April 2002 and December 2014. Ultrasound was obtained every 3-4 months for the first year following pyeloplasty and thereafter at discretion of treating physician. Patient characteristics including symptoms and imaging were reviewed. Of the 264 patients, 72% were male with mean age of 51 months and follow-up of 26.8 months. Approximately 73% followed up to 3 years. Fourteen patients (5.3%) had a recurrent obstruction. Among the failures, 85% were diagnosed and underwent successful redo pyeloplasty within 3 years. Six infants had a recurrence (43% of all unsuccessful surgeries) and were diagnosed within 3 years of the initial surgery. Patients undergoing a minimally invasive procedure were less likely to be followed for more than 3 years compared to an open procedure (p < 0.001). Patients with severe hydronephrosis preoperatively were followed longer (p = 0.031). Age at surgery and type of surgical approach (p < 0.01) were significant predictors of length of follow-up in a negative binomial regression. Based on the results, a minimum of 3 years of follow-up is necessary to detect the majority of recurrent obstructions. Those patients who have higher than average lengths of follow-up tend to be younger and/or underwent an open surgical approach.

Patterns and Predictors of Adherence to Statin Therapy Among Older Patients: Protocol for a Systematic Review.

BackgroundThe benefits of statin therapy are significantly compromised by noncompliance. Although elderly patients may have particular challenges with medication adherence and persistence, previous reviews on statin adherence have not focused on this population. Additionally, comparisons of adherence and persistence specific to statin indication (primary or secondary prevention) have not been thoroughly explored.ObjectiveWe aim to assess the extent of, and factors associated with, adherence and persistence to statin therapy among older populations (aged ≥65 years).MethodsA systematic review will be undertaken according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses recommendations. Searches will be performed using multiple electronic databases (Ovid MEDLINE, EMBASE, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, Database of s of Reviews of Effects, and the National Health Service Economic Evaluation Database) to identify relevant randomized trials and observational studies that evaluated statin adherence and/or persistence as an outcome. Eligible studies will include those involving community-living or outpatient elderly individuals. The methodological quality of randomized controlled trials (RCTs) will be assessed via the Joanna Briggs Institute’s critical appraisal checklist for RCTs, and the quality assessment of observational studies will be undertaken using a set of questions formulated with resort to the National Institute of Health Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. When possible, meta-analyses will be conducted using random-effect modeling and generic inverse variance analyses for adjusted-effect estimates. Heterogeneity across studies will be quantified using the I2 statistic. The presence of publication bias will be assessed using funnel plots and Egger’s regression tests. A leave-one-out sensitivity analysis will also be conducted to assess the impact of individual study results on pooled estimates. To explore possible sources of heterogeneity across studies, subgroup analyses will be performed based on covariates such as study design, statin indication, country of study, and length of patient follow-up.ResultsThe electronic database searches were completed in December 2016. Retrieved articles are currently being screened and the entire study is expected to be completed by June 2017.ConclusionsThis systematic review will provide further understanding of the patterns of, and barriers to, statin adherence and persistence among older patients. The findings will inform clinical practice and the design of appropriate interventions.Trial RegistrationPROSPERO CRD42016053191

Survival Outcomes and Patterns of Recurrence in Patients with Stage III or IV Oropharyngeal Cancer Treated with Primary Surgery or Radiotherapy

PurposeTo compare and contrast the patterns of failure in patients with locally advanced squamous cell oropharyngeal cancers undergoing curative-intent treatment with primary surgery or radiotherapy +/- chemotherapy.Methods and materialsTwo hundred and thirty-three patients with stage III or IV oropharyngeal squamous cell carcinoma who underwent curative-intent treatment from 2006-2012, were reviewed. The median length of follow-up for patients still alive at the time of analysis was 4.4 years. Data was collected retrospectively from a chart review.ResultsOne hundred and thirty-nine patients underwent primary surgery +/- adjuvant therapy, and 94 patients underwent primary radiotherapy +/- chemotherapy (CRT). Demographics were similar between the two groups, except primary radiotherapy patients had a higher age-adjusted Charleston co-morbidity score (CCI). Twenty-nine patients from the surgery group recurred; 15 failed distantly only, seven failed locoregionally, and seven failed both distantly and locoregionally. Twelve patients recurred who underwent chemoradiotherapy; ten distantly alone, and two locoregionally. One patient who underwent radiotherapy (RT) alone failed distantly. Two and five-year recurrence-free survival rates for patients undergoing primary RT were 86.6% and 84.9% respectively. Two and five-year recurrence-free survival rates for primary surgery was 80.9% and 76.3% respectively (p=0.21). There was no significant difference in either treatment when they were stratified by p16 status or smoking status.ConclusionsOur analysis does not show any difference in outcomes for patients treated with primary surgery or radiotherapy. Although the primary pattern of failure in both groups was distant metastatic disease, some local failures may be preventable with careful delineation of target volumes, especially near the base of skull region.

Risk factors for infection after operative fixation of Tibial plateau fractures

IntroductionTibial plateau fractures are challenging to treat due to the high incidence of postoperative infections. Treating physicians should be aware of risk factors for postoperative infection in patients who undergo operative fixation. Patients and methodsA retrospective review was undertaken to identify all patients with tibial plateau fractures over a 10 year period (2003–2012) who underwent open reduction internal fixation. A total of 532 patients were identified who met the inclusion criteria. Several patient and clinical characteristics were recorded, and those variables with a significant association (p<0.05) with postoperative infection after a univariate analysis were further analyzed using a multivariate analysis. ResultsFifty-nine (11.1%) of the 532 patients developed a deep infection. The average length of follow-up for patients was 19.5 months. Methicillin-resistant Staphylococcus aureus was the most common species, and it was isolated in 26 (44.1%) patients. Open fractures, the presence of compartment syndrome, and a Schatzker type IV−VI were found to be independent risk factors for deep infection. ConclusionsThe rate of deep infection remains high after operative fixation of tibial plateau fractures. Patients with risk factors for infection should be counseled on the possibility of reoperation, and surgeons should consider MRSA prophylaxis in those patients who are at higher risk.

The Natural History of the Benign Thyroid Nodule: What Is the Appropriate Follow-Up Strategy?

Long-term monitoring of benign thyroid nodules is not addressed in the present American Thyroid Association guidelines. The objective of this study was to determine the appropriate nature and length of follow-up for patients with a benign thyroid nodule. A retrospective review was performed of all patients referred to single endocrine surgeon for evaluation of thyroid nodules between 2006 and 2012. The review included 263 patients who had benign fine needle aspiration (FNA) cytology and either underwent thyroidectomy or had at least a 1-year follow-up ultrasound. Main outcomes measures were repeat FNA and pathology results. There were 231 women and 32 men. Forty-eight patients underwent immediate thyroidectomy, with pathology showing 2 papillary thyroid cancers (PTC), and 215 patients were followed with annual ultrasounds. During follow-up, 89 (41.3%) nodules underwent repeat FNA after initial biopsy. The repeat FNA cytology showed 91% benign, 7% follicular neoplasm, and 2% PTC. During follow-up, 81 (37.6%) patients underwent thyroidectomy after 3.3±2.8 years. Reasons for surgery included development of symptoms in 58 (71.6%), a non-benign repeat FNA in 8 (9.8%), or patient preference in 15 (18.5%). Surgical pathology identified 70 (86.4%) benign, 7 (8.6%) PTC, 3 (4%) follicular thyroid cancers, and 1 (1.2%) lymphoma. Median time from initial FNA to thyroidectomy in patients who had malignancy was 4.3 years. The maximum initial nodule size and average increase in nodule size did not differ between benign and malignant nodules (p=0.54 and p=0.75, respectively). Significant numbers of benign thyroid nodules enlarge more than 5 mm over 3 years, triggering repeat FNA or thyroidectomy. Larger diameter nodules and more rapidly growing nodules were not predictive of malignancy. The practice of annually obtaining ultrasound for benign thyroid nodules should be discouraged.

Acceptance of standardized ultrasound classification, use of albendazole, and long-term follow-up in clinical management of cystic echinococcosis: a systematic review.

Cystic echinococcosis is a chronic, complex, and neglected disease. The need for a simple classification of cyst morphology that would provide an accepted framework for scientific and clinical work on cystic echinococcosis has been addressed by two documents issued by the WHO Informal Working Group on Echinococcosis in 2003 (cyst classification) and in 2010 (Expert consensus for the diagnosis and treatment of echinococcosis). Here we evaluate the use of the WHO Informal Working Group on Echinococcosis classification of hepatic cystic echinococcosis, the acceptance by clinicians of recommendations regarding the use of albendazole, and the implementation of the long-term follow-up of patients with hepatic cystic echinococcosis in the scientific literature since the WHO Informal Working Group on Echinococcosis recommendations were issued. Of the publications included in our review, 71.2% did not indicate any classification, whereas 14% used the WHO Informal Working Group on Echinococcosis classification. Seventy-four percent reported the administration of peri-interventional albendazole, although less than half reported its modality, and 51% the length of patient follow-up. A joint effort is needed from the scientific community to encourage the acceptance and implementation of these three key issues in the clinical management of cystic echinococcosis.

Surgical management of breast cancer liver metastases

IntroductionSelected patients with isolated breast cancer liver metastases (BCLM) may benefit from surgical management; however, indications remain unclear and the risks may outweigh the benefits in patients with a generally poor prognosis. MethodsBetween 1998 and 2006, 17 patients diagnosed with BCLM were considered for surgical management (<4 tumours, tumour <4cm in diameter and no/stable extrahepatic metastases). Peri-operative and outcomes data were analysed and compared. ResultsEight patients were found to have extensive or untreatable disease on staging laparoscopy and intra-operative ultrasound (SL/IOUS). The remaining nine patients underwent surgical management [seven laparoscopic radiofrequency ablations (RFA) and two hepatic resections]. Median length of follow-up for patients treated surgically was 40.0 months, median disease-free survival (DFS) was 32.2 months and median time to disease progression was 17.7 months. Of the eight patients not amenable to surgery, median length of follow-up was 21.8 months. ConclusionSL/IOUS prevented unnecessary laparotomy in half of the patients taken to the operating room for surgical treatment of BCLM. In patients with BCLM, SL/IOUS should be considered standard of care before surgical intervention. The small number of patients and short follow-up may be inadequate to determine the true value of surgical management in this group of patients with BCLM.

Does High Tibial Osteotomy Affect the Success or Survival of a Total Knee Replacement?

Whether a previous high tibial osteotomy (HTO) influences the long-term function or survival of a total knee arthroplasty (TKA) is controversial. We compared long-term functional scores and survival of bilateral TKAs in patients who had a previous HTO in one of the knees. From 1980 to 1995, we performed 5043 primary TKAs; 39 of these patients had bilateral TKAs at an average of 8.7 years after unilateral HTO. Surgery was simultaneous in 32 patients and staged in seven. There were 12 women and 27 men with an average age of 66.9 years at the time of surgery. At last followup, 19 of the 39 patients were living and had been reevaluated since our previous study. We determined function with Knee Society scores. The length of followup for patients who had HTOs averaged 14 years (range, 3-21 years); for patients without HTOs, the average followup was 13.9 years (range, 3-22 years). We observed no differences in Knee Society function and radiographic and pain scores between the knees without and with previous HTO. Terminal extension and flexion, arc of motion, and knee alignment were similar between the knees. There were no femorotibial revisions in either group of knees. Survival at 15 years was 100% for knees without previous HTO and 97% for knees with previous HTO. Our observations suggest a previous high tibial osteotomy does not influence the function or survival of a knee long term. Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

Endoscopic and Endosonographic Predictors of Cancer in Patients with Barrett's Esophagus and High Grade Dysplasia

Background: Barrett's esophagus (BE) with high grade dysplasia (HGD) may have co-existent esophageal carcinoma and as a result traditional treatment has been esophagectomy. There has been increasing interest in endoscopic therapy as a viable alternative to esophagectomy in the management of HGD but little data exists to correctly guide patients between these treatment options. Aim: We studied patients referred for Endoscopic Ultrasound (EUS)/EGD who had BE with HGD to evaluate the ability of EGD and EUS to determine the presence of co-existing malignancy in HGD before therapy is instituted. Methods: All patients referred for evaluation of HGD in BE from October 2001 to November 2008 for EUS were included. Patients with prior biopsy proven carcinoma were excluded. A total of 53 patients met the above entry criteria. Analysis was performed to see if the findings of endoscopic nodularity, ulcer, stricture, length of BE, focal vs. multifocal HGD, or lesion seen on EUS staging predicted the presence of cancer. Cancer diagnosis was determined by histologic specimen and/or follow-up without evidence of cancer development. Mortality was confirmed for all patients as of November 2008. Results: A total of 30 out of 53 (57%) underwent esophagectomy. 5 patients had continued surveillance, 6 underwent photodynamic therapy, 6 endoscopic mucosal resection, 5 radiofrequency ablation, and 1 chemotherapy and radiation. The average length of follow-up for patients was 43 months (range 1 month to 84 months) with no new cases of adenocarcinoma. 11 patients out of 53 (20%) with HGD had proven esophageal cancer by histology. The mortality rate for the cohort was 2/53 (3.77%), both patients with proven carcinoma. Endoscopic findings of nodularity (p=0.004) and ulceration (p=0.01) predicted the presence of carcinoma. Other findings on endoscopy did not predict carcinoma including stricture (p=0.79), length of BE (p=0.11) or multifocal HGD (p=0.36). EUS stage greater than T0N0 significantly predicted cancer with an odds ratio of 49.4 and p value <0.0000001. One patient with flat HGD and a normal EUS exam was found to have intramucosal carcinoma. Conclusion: 1. The findings of nodularity and ulceration in patients with BE and HGD significantly predicts a co-existent cancer diagnosis. 2. EUS stage is the greatest independent predictor of carcinoma in patients with BE/HGD 3. Patients with flat HGD and negative EUS exam are very unlikely to have invasive cancer present and are thus are the best candidates for endoscopic therapy.

Ectropion following excision of lower eyelid tumours and full thickness skin graft repair

A retrospective review was performed to define the incidence of post operative lower eyelid ectropion after excision and full thickness grafting of lower eyelid tumours. In a 7-year period (1995-2001) 106 consecutive patients were identified who had undergone such surgery with mean follow-up period of 7.4 months (median 5 months, range 1-41.5 months). The majority of lesions were basal cell carcinomas 89/106 (84%). A total of 15/106 (14.2%) patients developed ectropion. The length of follow-up for patients with ectropion was on average 11.7 months (median 10 months, range 2-34 months). Ten patients underwent corrective surgery with five of these showing cosmetic and symptomatic improvement. Of five patients treated conservatively, three showed spontaneous improvement. The incidence of lower eyelid ectropion after lower eyelid skin grafting is defined and this does not seem to have been reported before for a consecutive series of patients. We offer a classification for eyelid zones with regard to ectropion and anatomical and pathological factors that may be important for ectropion formation are discussed. Finally we suggest a new classification of ectropion based on cosmetic and functional consequences.

Risk factors for uncontrolled hypertension in Italy.

To identify factors related to poor control of blood pressure in primary care, we designed a retrospective case-control analysis of clinical and demographic data recorded in the General Practitioners (GP) database. Study data were provided on a voluntary basis by 21 GPs from a practice-based network in primary care. The study included 2519 hypertensive patients enrolled between January 1 and December 31, 2000. The interventions were antihypertensive medication, and the main outcome measures were control of systolic and diastolic blood pressure (BP). The independent variables considered were: age of patient and GP; patient gender, body mass index, history of smoking, diabetes mellitus, or cholesterol tests; family history of hypertension; previous visits for cardiologic, nephrologic, or vascular surgery evaluation; prior hospitalizations for myocardial infarction or heart failure, and number of admissions for surgery; length of patient follow-up, type of antihypertensive medication, mean daily dosage, adherence to the drug regimen, and number of other medications currently being taken by the patient. Blood pressure was uncontrolled (>140/90 mmHg) in 1525 (60%) of the 2519 hypertensive patients enrolled. The presence of diabetes mellitus, increasing patient age, and increasing GP age significantly increased the risk of uncontrolled BP. Factors significantly associated with a reduced risk of uncontrolled BP were the number of other medications currently being taken by the patient and a prior history of MI. We conclude that the failure of antihypertensive medication to adequately control BP is determined by both the patient's characteristics and factors related to the patient-doctor relationship. Successful treatment of hypertension requires patient adherence to the regimen that has been agreed on by the patient and the physician.

Alternatives to the hazard ratio in summarizing efficacy in time-to-event studies: an example from influenza trials.

Estimates of the efficacy of new medicines are key to the investigation of their clinical effectiveness. The most widely recommended approach to summarizing time-to-event data from clinical trials is to use a hazard ratio. When the proportional hazards assumption is questionable, a hazard ratio depends on the length of patient follow-up. Hazard ratios do not directly translate into differences in times to events and therefore can present difficulties in interpretation. This paper describes an area where summary by hazard ratio would seem unsuitable and explores alternative estimates of efficacy. In particular, the difference in median time to event between treatments can provide a useful and consistent measure of efficacy. Methods of calculating confidence intervals for differences in medians for censored time-to-event will be described. Accelerated failure time models provide a useful alternative approach to proportional hazards modelling. Estimates of the ratio of the median time to event between treatments are directly available from these models. One of the reasons given for summarizing time-to-event studies by a hazard ratio is to facilitate meta-analyses. The bootstrap estimate of standard error for difference in median in each trial can provide a method for combining results based on summary statistics.