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To evaluate clinical outcomes and volumetric changes following endoscopic endonasal approach (EEA) for tuberculum sellae (TS) and planum sphenoidale (PS) meningiomas. Key objectives included evaluating pre- and postoperative tumor volumes, visual assessments and EEA-related complications.
Methods:
A single-center retrospective study was conducted at Foothills Medical Centre, University of Calgary, Canada, from 2009 to 2022 including 24 patients meeting inclusion criteria for midline skull base tumors, confirmed as WHO Grade I or II meningiomas with optic canal extension.
Results:
EEA achieved gross total resection in 87.5% of cases, with a mean tumor volume reduction of 92.24%. Postoperatively, 91.67% exhibited visual improvement or stability. Cerebrospinal fluid leaks occurred in 12.5% of cases, necessitating revision surgery in one case. Persistent postoperative endocrine dysfunction affected 4.17%. Preoperative tumor volume did not demonstrate a correlation with complications.
Conclusions:
This study delivers reproducible data for pre- and postoperative tumor volume following the EEA after TS or PS meningiomas. The EEA demonstrated favorable radiographic and clinical outcomes in TS and PS meningiomas, achieving gross total resection with minimal morbidity.
Edited by
David Kingdon, University of Southampton,Paul Rowlands, Derbyshire Healthcare NHS foundation Trust,George Stein, Emeritus of the Princess Royal University Hospital
Mental health services are intended to provide the means to deliver interventions and care to people experiencing mental health problems. This can only be achieved if the staff and resources to provide interventions and care are available. Unfortunately, the current design and resourcing of services can seriously interfere with this happening. Services have evolved over centuries, and many practices are determined by convention and limited by resources, particularly availability of staff in sufficient numbers and with appropriate skills. Mental Health Service provision, commissioning and funding in the NHS, and the evidence base are rapidly developing. Community mental health services, early intervention, assertive outreach, inpatient, outpatient, intensive care units and home treatment teams form key components, but clinical and patient-rated outcomes are still too infrequently measured to guide service development. The complexity of these services and their interfaces with primary care and specialist mental health teams are discussed in this chapter.
There are limited studies with medium-term follow-up following percutaneous pulmonary valve implantation and no studies with a gender-specific analysis.
Aims:
To report clinical outcomes up to five years following percutaneous pulmonary valve implantation using the two most common balloon expandable valves in a mixed population of paediatric and adult patients with an age and gender-specific analysis.
Methods:
This was a single-centre retrospective observation study. Relevant data were obtained retrospectively from the case files. Age and gender- specific analysis was performed using SPSS.
Results:
Totally, 58 patients (13 children, 45 adults) underwent percutaneous pulmonary valve implantation. Statistically significant reduction in median right ventricular outflow tract flow velocity following valve implantation was maintained for the whole five years in adults but not in children. There were no gender-specific differences despite the study being adequately powered. Independent of valve type used, there was significant reduction of the right ventricular outflow tract flow velocity in the immediate post valve implantation period (Edwards P = 0.001, Melody P = 0.013). There was a significant negative correlation between implanted valve Z-score and subsequent right ventricular outflow tract gradient during the first two years following valve implantation.
Conclusion:
Gender does not significantly affect valve function following percutaneous pulmonary valve implantation. It is important to consider patients’ age and body surface area in relation to existing right ventricular outflow tract size during decisions for percutaneous pulmonary valve implantation.
Abnormalities in the zona pellucida (ZP) adversely affect oocyte maturation, embryo development and pregnancy outcomes. However, the assessment of severity is challenging. To evaluate the effects of different degrees of ZP abnormalities on embryo development and clinical outcomes, in total, 590 retrieval cycles were scored and divided into four categories (control, mild, moderate and severe) based on three parameters: perivitelline space, percentage of immature oocytes and percentage of oocytes with abnormal morphology. As the severity of abnormal ZP increased, both the number of retrieved oocytes and mature oocytes decreased. The fertilization rate did not differ significantly among groups. The rates of embryo cleavage and day-3 high-quality embryos in the mild group and the moderate group did not vary significantly between the two groups but were significantly higher than those in the severe group. The blastulation rates of the abnormal ZP groups were similar; however, they were lower than those of the control group. Moreover, the cycle cancellation rate of the severe abnormal ZP group was as high as 66.20%, which was significantly higher than that of the other three groups. Although the rates of cumulative clinical pregnancy and live births were lower than those in the control group, they were comparable among the abnormal ZP groups. There were no differences in the neonatal outcomes of the different groups. Together, ZP abnormalities show various degrees of severity, and in all patients regardless of the degree of ZP abnormalities who achieve available embryos, there will be an opportunity to eventually give birth.
Somatic symptom disorders (SSD) and functional somatic syndromes (FSS) are often regarded as similar diagnostic constructs; however, whether they exhibit similar clinical outcomes, medical costs, and medication usage patterns has not been examined in nationwide data. Therefore, this study focused on analyzing SSD and four types of FSS (fibromyalgia, chronic fatigue syndrome, irritable bowel syndrome, functional dyspepsia).
Methods
This population-based matched cohort study utilized Taiwan's National Health Insurance (NHI) claims database to investigate the impact of SSD/FSS. The study included 2 615 477 newly diagnosed patients with SSD/FSS and matched comparisons from the NHI beneficiary registry. Healthcare utilization, mortality, medical expenditure, and medication usage were assessed as outcome measures. Statistical analysis involved Cox regression models for hazard ratios, generalized linear models for comparing differences, and adjustment for covariates.
Results
All SSD/FSS showed significantly higher adjusted hazard ratios for psychiatric hospitalization and all-cause hospitalization compared to the control group. All SSD/FSS exhibited significantly higher adjusted hazard ratios for suicide, and SSD was particularly high. All-cause mortality was significantly higher in all SSD/FSS. Medical costs were significantly higher for all SSD/FSS compared to controls. The usage duration of all psychiatric medications and analgesics was significantly higher in SSD/FSS compared to the control group.
Conclusion
All SSD/FSS shared similar clinical outcomes and medical costs. The high hazard ratio for suicide in SSD deserves clinical attention.
Multiple studies have endeavoured to define the role of steroids in paediatric congenital heart surgery; however, steroid utilisation remains haphazard. In September, 2017, our institution implemented a protocol requiring that all neonates undergoing cardiac surgery with the use of cardiopulmonary bypass receive a five-day post-operative hydrocortisone taper. This single-centre retrospective study was designed to test the hypothesis that routine post-operative hydrocortisone administration reduces the incidence of capillary leak syndrome, leads to favourable postoperative fluid balance, and less inotropic support in the early post-operative period. Data were gathered on all term neonates who underwent cardiac surgery with the use of bypass between September, 2015 and 2019. Subjects who were unable to separate from bypass, required long-term dialysis, or long-term mechanical ventilation were excluded. Seventy-five patients met eligibility criteria (non-hydrocortisone group = 52; hydrocortisone group = 23). For post-operative days 0–4, we did not observe a significant difference in net fluid balance or vasoactive inotropic score between study groups. Similarly, we saw no major difference in secondary clinical outcomes (post-operative duration of mechanical ventilation, ICU/hospital length of stay, and time from surgery to initiation of enteral feeds). In contrast to prior analyses, our study was unable to demonstrate a significant difference in net fluid balance or vasoactive inotropic score with the administration of a tapered post-operative hydrocortisone regimen. Similarly, we saw no effect on secondary clinical outcomes. Further long-term randomised control studies are necessary to validate the potential clinical benefit of utilising steroids in paediatric cardiac surgery, especially in the more fragile neonatal population.
This chapter simplifies the complex multi-payer healthcare reimbursement market and explains how to position your product for successful reimbursement. The best time to bring reimbursement planning into the product development process is discussed here. The U.S. healthcare system is used as a baseline and the healthcare systems of other countries are reviewed briefly. Reimbursement for devices and administered drugs is based on many factors, and this chapter shows the steps a biomedical product company can take to maximize revenues in the US Healthcare system. The basics of reimbursement – coverage, coding, and payment – are explained in simple terms with diagrams. Case studies help show how individual companies have addressed the reimbursement process for novel breakthrough technologies.
Over the last decade there has been a significant increase in the utilization of mechanical circulatory support (MCS) devices. Advanced MCS devices are commonplace in the cardiothoracic intensive care. The indications for their use have broadened to include the prophylactic use in high-risk percutaneous coronary interventions or surgery, as an adjunct to cardiopulmonary and as part of the routine management of intractable cardiogenic shock. MCS are typically classified as either temporary or durable and will be discussed in this chapter.
The present study examined the differential effect of the brain-derived neurotrophic factor (BDNF) Val66Met polymorphism on neuropsychological functioning in children with traumatic brain injury (TBI) relative to orthopedic injury (OI).
Methods:
Participants were drawn from a prospective, longitudinal study of children who sustained a TBI (n = 69) or OI (n = 72) between 3 and 7 years of age. Children completed a battery of neuropsychological measures targeting attention, memory, and executive functions at four timepoints spanning the immediate post-acute period to 18 months post-injury. Children also completed a comparable age-appropriate battery of measures approximately 7 years post-injury. Parents rated children’s dysexecutive behaviors at all timepoints.
Results:
Longitudinal mixed models revealed a significant allele status × injury group interaction with a medium effect size for verbal fluency. Cross-sectional models at 7 years post-injury revealed non-significant but medium effect sizes for the allele status x injury group interaction for fluid reasoning and immediate and delayed verbal memory. Post hoc stratified analyses revealed a consistent pattern of poorer neuropsychological functioning in Met carriers relative to Val/Val homozygotes in the TBI group, with small effect sizes; the opposite trend or no appreciable effect was observed in the OI group.
Conclusions:
The results suggest a differential effect of the BDNF Val66Met polymorphism on verbal fluency, and possibly fluid reasoning and immediate and delayed verbal memory, in children with early TBI relative to OI. The Met allele—associated with reduced activity-dependent secretion of BDNF—may confer risk for poorer neuropsychological functioning in children with TBI.
The clinical outcomes of individuals at clinical high risk of psychosis (CHR-P) who do not transition to psychosis are heterogeneous and inconsistently reported. We aimed to comprehensively evaluate longitudinally a wide range of outcomes in CHR-P individuals not developing psychosis.
Methods
“Preferred Reporting Items for Systematic reviews and Meta-Analyses” and “Meta-analysis Of Observational Studies in Epidemiology”-compliant meta-analysis (PROSPERO: CRD42021229212) searching original CHR-P longitudinal studies in PubMed and Web of Science databases up to 01/11/2021. As primary analysis, we evaluated the following outcomes within CHR-P non-transitioning individuals: (a) change in the severity of attenuated psychotic symptoms (Hedge's g); (b) change in the severity of negative psychotic symptoms (Hedge's g); (c) change in the severity of depressive symptoms (Hedge's g); (d) change in the level of functioning (Hedge's g); (e) frequency of remission (at follow-up). As a secondary analysis, we compared these outcomes in those CHR-P individuals who did not transition vs. those who did transition to psychosis at follow-up. We conducted random-effects model meta-analyses, sensitivity analyses, heterogeneity analyses, meta-regressions and publication bias assessment. The risk of bias was assessed using a modified version of the Newcastle-Ottawa Scale (NOS).
Results
Twenty-eight studies were included (2756 CHR-P individuals, mean age = 20.4, 45.5% females). The mean duration of follow-up of the included studies was of 30.7 months. Primary analysis: attenuated psychotic symptoms [Hedges’ g = 1.410, 95% confidence interval (CI) 1.002–1.818]; negative psychotic symptoms (Hedges’ g = 0.683, 95% CI 0.371–0.995); depressive symptoms (Hedges’ g = 0.844, 95% CI 0.371–1.317); and functioning (Hedges’ g = 0.776, 95% CI 0.463–1.089) improved in CHR-P non-transitioning individuals; 48.7% remitted at follow-up (95% CI 39.3–58.2%). Secondary analysis: attenuated psychotic symptoms (Hedges’ g = 0.706, 95% CI 0.091–1.322) and functioning (Hedges’ g = 0.623, 95% CI 0.375–0.871) improved in CHR-P individuals not-transitioning compared to those transitioning to psychosis, but there were no differences in negative or depressive symptoms or frequency of remission (p > 0.05). Older age was associated with higher improvements of attenuated psychotic symptoms (β = 0.225, p = 0.012); publication years were associated with a higher improvement of functioning (β = −0.124, p = 0.0026); a lower proportion of Brief Limited Intermittent Psychotic Symptoms was associated with higher frequencies of remission (β = −0.054, p = 0.0085). There was no metaregression impact for study continent, the psychometric instrument used, the quality of the study or proportion of females. The NOS scores were 4.4 ± 0.9, ranging from 3 to 6, revealing the moderate quality of the included studies.
Conclusions
Clinical outcomes improve in CHR-P individuals not transitioning to psychosis but only less than half remit over time. Sustained clinical attention should be provided in the longer term to monitor these outcomes.
While the efficacy and guidelines for implementation of rapid response systems are well established, limited information exists about rapid response paradigms for paediatric cardiac patients despite their unique pathophysiology.
Methods:
With endorsement from the Paediatric Cardiac Intensive Care Society, we designed and implemented a web-based survey of paediatric cardiac and multidisciplinary ICU medical directors in the United States of America and Canada to better understand paediatric cardiac rapid response practices.
Results:
Sixty-five (52%) of 125 centres responded. Seventy-one per cent of centres had ∼300 non-ICU beds and 71% had dedicated cardiac ICUs. To respond to cardiac patients, dedicated cardiac rapid response teams were utilised in 29% of all centres (39% and 5% in centres with and without dedicated cardiac ICUs, respectively) [p = 0.006]. Early warning scores were utilised in 62% of centres. Only 31% reported that rapid response teams received specialised training. Transfers to ICU were higher for cardiac (73%) compared to generalised rapid response events (54%). The monitoring and reassessment of patients not transferred to ICU after the rapid response was variable. Cardiac and respiratory arrests outside the ICU were infrequent. Only 29% of centres formally appraise critical deterioration events (need for ventilation and/or inotropes post-rapid response) and 34% perform post-event debriefs.
Conclusion:
Paediatric cardiac rapid response practices are variable and dedicated paediatric cardiac rapid response systems are infrequent in the United States of America and Canada. Opportunity exists to delineate best practices for paediatric cardiac rapid response and standardise practices for activation, training, patient monitoring post-rapid response events, and outcomes evaluation.
This study analyzed the effects of the day of trophectoderm (TE) biopsy and blastocyst grade on clinical and neonatal outcomes. The results showed that the implantation and live birth rates of day 5 (D5) TE biopsy were significantly higher compared with those of D6 TE biopsy. The miscarriage rate of the former was lower than that of the latter, but there was no statistically significant difference. Higher quality blastocysts can achieve better implantation and live birth rates. Among good quality blastocysts, the implantation and live birth rates of D5 and D6 TE biopsy were not significantly different. Among fair quality and poor quality blastocysts, the implantation and live birth rates of D5 TE biopsy were significantly higher compared with those of D6 TE biopsy. Neither blastocyst grade nor the day of TE biopsy significantly affected the miscarriage rate. Neonatal outcomes, including newborn sex, gestational age, preterm birth, birth weight and low birth weight in the D5 and D6 TE biopsies were not significantly different. Both blastocyst grade and the day of TE biopsy must be considered at the same time when performing preimplantation genetic testing–frozen embryo transfer.
Purported superior outcomes for treatment of psychosis in low- and middle-income (LMICs) compared with high-income (HICs) countries have not been examined in the context of early intervention services (EIS).
Aims
To compare 2-year clinical outcomes in first-episode psychosis (FEP) treated in EIS in Chennai (LMIC) and Montreal (HIC) using a similar EIS treatment protocol and to identify factors associated with any outcome differences.
Method
Patients with FEP treated in EIS in Chennai (n = 168) and Montreal (n = 165) were compared on change in level of symptoms and rate and duration of positive and negative symptom remission over a 2-year period. Repeated-measures analysis of variance, and logistic and linear regression analyses were conducted.
Results
Four patients died in Chennai compared with none in Montreal. Family support was higher for Chennai patients (F = 14.05, d.f. = 1, P < 0.001, ƞp2 = 0.061) and increased over time at both sites (F = 7.0, d.f. = 1.915, P < 0.001, ƞp2 = 0.03). Negative symptom outcomes were significantly better in Chennai for level of symptoms (time × site interaction F = 7.36, d.f. = 1.49, P = 0.002, ƞp2 = 0.03), duration of remission (mean 16.1 v. 9.78 months, t = −7.35, d.f. = 331, P < 0.001, Cohen's d = 0.80) and the proportion of patients in remission (81.5% v. 60.3%, χ2 = 16.12, d.f. = 1, P < 0.001). The site differences in outcome remained robust after adjusting for inter-site differences in other characteristics. Early remission and family support facilitated better outcome on negative symptoms. No significant differences were observed in positive symptom outcomes.
Conclusions
Patients with FEP treated in EIS in LMIC contexts are likely to show better outcome on negative symptoms compared with those in HIC contexts. Early remission and family support may benefit patients across both contexts.
To explore the relationships between dose changes to antipsychotic and/or benzodiazepine medications and resident outcomes, including variations in neuropsychiatric symptoms, quality of life (QoL), and social withdrawal, within a multicomponent, interdisciplinary antipsychotic and benzodiazepine dose reduction program.
Design:
Prospective, observational, longitudinal study.
Intervention:
The Reducing Use of Sedatives (RedUSe) project involved 150 Australian Long-Term Care Facilities (LTCFs) incorporating auditing and benchmarking of prescribing, education, and multidisciplinary sedative reviews.
Setting:
A convenience sample of LTCFs (n = 28) involved in RedUSe between January 2015 and March 2016.
Participants:
Permanent residents (n = 206) of LTCFs involved in RedUSe taking an antipsychotic and/or benzodiazepine daily. Residents were excluded if they had a severe psychiatric condition where antipsychotic therapy should generally be maintained long-term (e.g., bipolar disorder, schizophrenia) or were considered end-stage palliative.
Measurements:
Neuropsychiatric symptoms (Neuropsychiatric Inventory, Cohen-Mansfield Agitation Inventory (CMAI)), QoL (Assessment of Quality of Life-4D), and social withdrawal (Multidimensional Observation Scale for Elderly Subjects-withdrawal subscale) were measured at baseline and 4 months where nursing staff completed psychometric tests as proxy raters.
Results:
There was no evidence that psychometric measures were worsened following dose reductions. In fact, dose reduction was associated with small, albeit non-statistically significant, improvements in behavior, particularly less physically non-aggressive behavior with both drug groups (−0.36 points per 10% reduction in antipsychotic dose, −0.17 per 10% reduction in benzodiazepine dose) and verbally agitated behavior with benzodiazepine reduction (−0.16 per 10% dose reduction), as measured with the CMAI. Furthermore, antipsychotic reduction was associated with non-statistically significant improvements in QoL and social withdrawal.
Conclusions:
Antipsychotic and benzodiazepine dose reduction in LTCFs was not associated with deterioration in neuropsychiatric symptoms, QoL, or social withdrawal. Trends toward improved agitation with antipsychotic and benzodiazepine dose reduction require further evaluation in larger, prospective, controlled studies.
Although stroke rates in Canada are expected to increase dramatically over the next decade, time-driven hyperacute stroke care with thrombolysis increases the likelihood of a good clinical outcome. Following a period of suboptimal performance results for stroke care, our tertiary care center undertook a door-to-needle (DTN) quality improvement initiative. The purpose of our study was to determine if the resulting improved median DTN times and greater proportion of patients treated within 60 minutes of arrival at our emergency department were associated with improved clinical outcomes.
Methods:
Guided by the Donabedian quality framework, we retrospectively reviewed charts of consecutive patients (n = 324) who received thrombolysis pre- and post-quality improvement initiative. Data on patient characteristics, and process and outcome measures were collected. Primary study outcomes included mortality, adverse events, discharge location, and independence at discharge. Data analysis compared proportions with Chi Square and means using the two-tailed t-test and a 0.05 level of significance.
Results:
Median DTN times and the percentage of cases with a DTN ≤60 minutes improved significantly post-intervention (p < 0.001). In-hospital mortality decreased (p = 0.013), and the proportion of favorable versus unfavorable discharge locations improved (p = 0.005). Mortality rates for all study patients with DTN ≤60 versus >60 minutes were also significantly lower (p = 0.044) post-intervention.
Conclusions:
Our quality improvement initiative resulted in timelier care and positively influenced clinical outcomes. This study highlights the need for ongoing, innovative investment strategies to ensure timely hyperacute stroke care and optimal patient outcomes.
Nutrition therapy is considered an important treatment of burn patients. The aim of the study was to delineate the nutritional support in severe burn patients and to investigate association between nutritional practice and clinical outcomes. Severe burn patients were enrolled (n 100). In 90 % of the cases, the burn injury covered above 70 % of the total body surface area. Mean interval from injury to nutrition start was 2·4 (sd 1·1) d. Sixty-seven patients were initiated with enteral nutrition (EN) with a median time of 1 d from injury to first feed. Twenty-two patients began with parenteral nutrition (PN). During the study, thirty-two patients developed EN intolerance. Patients received an average of about 70 % of prescribed energy and protein. Patients with EN providing <30 % energy had significantly higher 28- d and in-hospital mortality than patients with EN providing more than 30 % of energy. Mortality at 28 d was 11 % and in-hospital mortality was 45 %. Multiple regression analysis demonstrated that EN providing <30 % energy and septic shock were independent risk factors for 28- d prognosis. EN could be initiated early in severe burn patients. Majority patients needed PN supplementation for energy requirement and EN feeding intolerance. Post-pyloric feeding is more efficient than gastric feeding in EN tolerance and energy supplement. It is difficult for severe burn patients to obtain enough feeding, especially in the early stage of the disease. More than 2 weeks of underfeeding is harmful to recovery.
Breast intraoperative radiotherapy (IORT) is a partial irradiation technique that delivers a single fraction of radiation dose to the tumour bed during surgery. The use of this technique is increasing (especially in the Middle East), and therefore, it is essential to have a comprehensive approach to this treatment modality. The aim of this study is to conduct a literature review on available IORT modalities during breast irradiation as well as dedicated IORT machines and associated treatment procedures. The main IORT trials and corresponding clinical outcomes are also studied.
Materials and Methods
A computerised search was performed through MEDLINE, PubMed, PubMed Central, ISI web of knowledge and reference list of related articles.
Results
IORT is now feasible through using two main modalities, including low-kilovolt IORT and intraoperative electron radiotherapy (IOERT). The dedicated machines employed and treatment procedure for mentioned modalities are quite different. The outcomes of implemented clinical trials showed that IORT is not inferior to external beam radiotherapy (EBRT) in specifically selected and well-informed patients and can be considered as an alternative to EBRT.
Conclusion
Although the clinical outcomes of introduced IORT methods are comparable, but based on the review results, it could be said that IOERT is the most effective technical method, in view of the treatment time and dose uniformity concepts. The popularity of IORT is mainly due to the distinguished obtained results during breast cancer treatment. Despite the presence of some technical challenges, it is expected that the IORT technique will become more widespread in the immediate future.
Background: Subthalamic nucleus deep brain stimulation (STN–DBS) has become a standard treatment for many patients with Parkinson’s disease (PD). The reported clinical outcome measures for procedures done under general anesthesia (GA) compared to traditional local anesthetic (LA) technique are quite heterogeneous and difficult to compare. The aim of this systematic review and metaanalysis was to determine whether the clinical outcome after STN–DBS insertion under GA is comparable to that under LA in patients with Parkinson’s disease. Methods: The databases of Medline Embase, Cochrane library and Pubmed were searched for eligible studies (human trials, English language, published between 1946 and January of 2016). The primary outcome of this study was to assess the postoperative improvement in the symptoms, evaluated using either Unified Parkinson’s Disease Rating Scale (UPDRS) scores or levodopa equivalent dosage (LEDD) requirement. Results: The literature searches yielded 395 citations and six retrospective cohort studies with a sample size of 455 (194 in GA and 261 in LA) were included in the analysis. Regarding the clinical outcomes, there were no significant differences in the postoperative Unified Parkinson’s disease rating scale and levodopa equivalent drug dosage between the GA and the LA groups. Similarly, the adverse events and target accuracy were also comparable between the groups. Conclusions: This systematic review and meta-analysis shows that currently there is no good quality data to suggest equivalence of GA to LA during STN-DBS insertion in patients with PD, with some factors trending towards LA. There is a need for a prospective randomized control trial to validate our results.
To analyse sociodemographic, viroimmunological and clinical parameters in different HIV-transmission categories at baseline and during treatment, 3039 patients were followed up for 12 months after the initiation of a nelfinavir-based regimen. Multiple baseline parameters were significantly different in the diverse categories, including CD4 counts (P<0·0001) and viral load (P=0·02). There were differences in the groups regarding the CD4 response (P=0·01), but not the virological response (P=0·4), to therapy over time. Multivariate analyses revealed that transmission categories were significantly related to baseline CD4 counts (P=0·01), viral load at 12 months (P=0·0006), poorer adherence to therapy of injecting drug users (IDUs) vs. each of the other groups (P<0·001) and failure to complete the 12-month evaluation of IDU vs. heterosexual (P=0·003) and men who have sex with men (MSM) groups (P=0·02). We conclude that transmission categories had a significant influence on several baseline parameters and viroimmunological outcomes following highly active antiretroviral therapy (HAART), as well as on adherence to therapy and to medical appointments.
Despite improvements in outcomes after completion of the Fontan circulation, long-term functional state varies. We sought to identify pre- and postoperative characteristics associated with overall function.
Methods and Results
We analyzed data from 476 survivors with the Fontan circulation enrolled in the Pediatric Heart Network Fontan Cross-sectional Study. Mean age at creation of the Fontan circulation was 3.4 plus or minus 2.1 years, with a range from 0.7 to 17.5 years, and time since completion was 8.7 plus or minus 3.4 years, the range being from 1.1 to 17.3 years. We calculated a functional score for the survivors by averaging the percentile ranks of ventricular ejection fraction, maximal consumption of oxygen, the physical summary score for the Child Health Questionnaire, and a function of brain natriuretic peptide. The mean calculated score was 49.5 plus or minus 17.3, with a range from 3 to 87. After adjustment for time since completion of the circulation, we found that a lower score, and hence worse functional state, was associated with: right ventricular morphology (p less than 0.001), higher ventricular end-diastolic pressure (p equals 0.003) and lower saturations of oxygen (p equals 0.047) prior to completion of the Fontan circulation, lower income for the caregiver (p equals 0.003), and, in subjects without a prior superior cavopulmonary anastomosis, arrhythmias after completion of the circulation (p equals 0.003). The model explained almost one-fifth (18%) of the variation in the calculated scores. The score was not associated with surgical centre, sex, age, weight, fenestration, or the period of stay in hospital after completion of the Fontan circuit. A validation model, using 71 subjects randomly excluded from initial analysis, weakly correlated (R equals 0.17, p equals 0.16) with the score calculated from the dataset.
Conclusions
Right ventricular morphology, higher ventricular end-diastolic pressure and lower saturations of oxygen prior to completion of the Fontan circuit, lower income for the provider of care, and arrhythmias after creation of the circuit, are all associated with a worse functional state. Unmeasured factors also influence outcomes.