Analysis of Italian regulations on pathways of care for patients in a vegetative or minimally conscious state.

Different rehabilitation models for persons diagnosed with disorders of consciousness have been proposed in Europe during the last decade. In Italy, the Ministry of Health has defined a national healthcare model, although, to date, there is a lack of information on how this has been implemented at regional level. The INCARICO project collected information on different regional regulations, analysing ethical aspects and mapping care facilities (numbers of beds and medical units) in eleven regional territories. The researchers found a total of 106 laws; differences emerged both between regions and versus the national model, showing that patients with the same diagnosis may follow different pathways of care. An ongoing cultural shift from a treatment-oriented medical approach towards a care-oriented integrated biopsychosocial approach was found in all the welfare and healthcare systems analysed. Future studies are needed to explore the relationship between healthcare systems and the quality of services provided.

FMRI activation with an "affective speech" paradigm in vegetative and minimally conscious States: applicability and prognostic value.

Vegetative state (VS) and minimally conscious state (MCS) are considered different clinical entities but their differential diagnosis remains challenging. Some VS patients can show an MCS-like activation in functional magnetic resonance imaging (fMRI) studies that seems to predict recovery from VS. We studied fMRI activation with an affective speech paradigm in a cohort of non-communicative brain-injured individuals consecutively admitted to a post-acute neurorehabilitation facility in five years. Among 93 eligible subjects, 65 met the clinical criteria for VS and 28 for MCS. Because of exclusion criteria, activation studies were performed in only 30 cases out of 93 and analysed in only 24 (about » of the eligible cases): 19 VS and five MCS patients. The passive acoustic stimulus consisted in a familiar voice narrating a significant episode in the patient's life, administered by nonmagnetic earphones. All the MCS patients showed an activation spread to secondary associative cortices but also 52.7% of the VS patients displayed an "atypical" large-scale activation pattern. Regarding the clinical outcome, 80% of the patients with large-scale network activation (LSNA) had some recovery of consciousness. Our results confirm that the VS patients with LSNA at fMRI study have potential for further recovery of consciousness, whereas no patient without activation or only typical activation improved. fMRI study with an affective speech paradigm, when applicable, seems to have a valuable prognostic value in VS patients, even if there are major limitations in terms of applicability.

The Morfeo Study: A 1-year follow-up of complications of vegetative state in a dedicated facility.

OBJECTIVES: Vegetative State (VS) implies significant issues. The aim of the MORFEO study is to identify the most relevant complications in VS patients and to supply clinicians and policy-makers with data derived from the analysis of a cohort of patients treated in a dedicated long-term facility setting. METHODS: A cohort of 22 VS patients treated between 2003 and 2007 were enrolled and followed up for 1 year. The information recorded were: Disability Rating Scale (DRS), Levels of Cognitive Functioning (LCF), pressure sores, nutritional status, neurological complications, articular complications (passive range of motion-ROM), deep-vein thrombosis and infections. The Kolmogorov-Smirnov test was used to verify the normal distribution of the variables. The indicators of complications were analysed with the Friedman test (continuous variables) and with the Cochran Q test (dichotomous variables). RESULTS: DRS and LCF values showed no significant variation. The number of pressure sores decreased. The nutritional status remained satisfying. The ROM worsened in lower limb joints; a trend (p = ns) towards an improved range was observed in shoulders and elbows. Fifteen infections were recorded. CONCLUSIONS: The data that proved significant suggest a minimum set of quality-of-care indicators in VS patients: pressure sores follow-up, nutritional status, ROM and incidence of infections.

Preemptive therapy for the prevention of cytomegalovirus disease in renal transplant recipients: our preliminary experience.

BACKGROUND: Cytomegalovirus (CMV) disease represents an important cause of morbidity in renal transplant recipients. We report our preliminary evaluation of the efficacy and security of preemptive therapy to manage renal transplant recipients with evidence of active CMV replication. METHODS: Preemptive therapy with gancyclovir and/or valgancyclovir (VGCV) was recently substituted for CMV antiviral prophylaxis at our institution. Between May 2006 and December 2007, all patients undergoing renal transplantation were included in a CMV infection surveillance program. Blood samples to determine CMV viral load were obtained weekly during the first 4 months. Asymptomatic patients, with a viral load determined using polymerase chain reaction (PCR) with CMV DNA >100,000 copies/mL, were treated with VGCV for 3 months or until resolution of viral replication. Until April 2006, patients undergoing renal transplantation received CMV prophylaxis with oral acyclovir and pp65 antigenemia was the test for CMV infection surveillance. The group on preemptive therapy was compared with a historical group on prophylaxis therapy: 100 renal patients who underwent transplantation between April 2004 and 2006. RESULTS: Among 96 recipients, quantitative determination of viral DNA in blood was elevated in 14 asymptomatic patients, who were treated with oral VGCV for 3 months. The patients were followed up for a median time of 13.3 months. None of the 14 patients who received VGCV developed CMV disease. CONCLUSION: VGCV administered as preemptive therapy was safe and efficacious to prevent CMV disease.

Treadmill exercise in early mutiple sclerosis: a case series study.

AIM: The effect of specific exercise therapy programs on the management of balance and walking disorders in multiple sclerosis (MS) patients have not been fully explained yet. Reproducible measurement systems are especially required to show their efficacy. The aim of the present case series study was to explore the feasibility of an aerobic treadmill rehabilitation protocol (endurance training protocol) and its effects on walking parameters, muscular activity and postural balance. An adequate instrumental measure set was adopted to provide evidence of minimal motor dysfunction, not quantifiable by means of standard clinical examination. METHODS: Three minimally impaired MS patients were enrolled. The patients underwent endurance training on a treadmill for four weeks. Posturographic assessment, energy cost measurement and gait analysis by basography and surface electromyography recordings were used as outcome measures. RESULTS: Energy cost during treadmill walking was generally reduced in the three patients after exercise. Indexes of both sway path and sway area used for postural stability measurement were reduced after exercise in two patients, particularly with eyes closed. Minor changes were observed in gait pattern in terms of foot placement. Muscular activity pattern tended to normalize after training. CONCLUSION: The aerobic treadmill exercise is feasible, safe and it may improve early anomalies of posture and gait in early MS patients. In the context of an impairment oriented rehabilitation approach, the set of instrumental measurements proposed seems to be able to identify subclinical anomalies in a very low degree of functional involvement on an individual basis.

Donor characteristics can influence transplant activities and the access to transplant for some age groups.

In recent years Italy has experienced a remarkable increase in organ donation and transplant rates for kidney transplantation. The organ donation rate has placed Italy among the European leaders, but a careful comparative evaluation of Italian and international registries data demonstrates that renal transplantations have not shared the same significant growth. In a decisive way donor characteristics have influenced not only the number of renal transplantations, but also the access to transplant for some age groups. We investigated the probability of transplantation from different age groups using the Kaplan-Meier method and the log-rank test. The 7-year probability of transplant was 72% for the 15 to 45 age group, 85.7% for the 46 to 55 age group, and 88.5% for the over 55 years group (P = .0029). Ethical considerations suggest new approaches of innovative promotion of living donor transplants and a revision of organ allocation criteria.

Immunosuppression in renal transplantation: viral diseases and chronic allograft nephropathy.

Chronic allograft dysfunction after renal transplantation can be ascribed to different causes, among which are viral infections. The aim of this work was to show the various ways by which different kinds of viruses affect transplant structure and function. Polyoma virus is an example of viruses directly affecting the kidney because of a specific tropism to the uroepitelial cells. Cytomegalovirus (CMV) has been chosen both because of the frequency of this infection and because CMV (as other viruses) can produce transplant vascular sclerosis. Finally, we describe hepatitis C virus (HCV) because of its capacity to induce renal lesions independently from chronic allograft nephropathy. Indeed HCV is likely to determine immunologically mediated nephritis in the transplanted kidney as well in the native one.

Efficacy and safety of Palmaz stent implantation in the treatment of renal artery stenosis in renal transplantation.

To verify the long-term efficacy and safety of Palmaz stent implantation in the treatment of transplant renal artery stenosis (TRAS), we reviewed the charts of 26 patients affected by TRAS and treated by percutaneous transluminal angioplasty (PTA) followed by permanent insertion of a Palmaz stent. The mean follow-up period was 43.31 +/- 33.6 months. The mean blood pressure fell significantly at 1 month after stenting (118 +/- 8.1 vs 101 +/- 7.8 mmHg; P < .0001); then remained stable. Renal artery blood flow, as determined by Doppler ultrasonography, was reduced from 352.5 +/- 56.5 to 157.3 +/- 53.7 cm/sec at 1 month after stenting (P < .0001). Renal function improved after stenting (serum creatinine 2.2 +/- 1.4 mg/dL preinsertion versus 1.72 +/- 1.05 at 3 years). In conclusion, in cases of severe or recurrent TRAS, stenting of the renal artery has proved to be an effective therapeutic tool. This method, which has low procedure costs and an extremely low complication rate has proved to be safe and to offer the potential of preserving luminal patency, improving the long-term efficacy of percutaneous angioplasty.

Efficacy and safety of Palmaz stent insertion in the treatment of renal artery stenosis in kidney transplantation.

The aim of this study was to verify the safety and long-term efficacy of Palmaz stent insertion in the treatment of transplant renal artery stenosis (TRAS) in kidney transplantation. Nine of our transplanted patients were submitted to Palmaz stent insertion because of recurrence of renal artery stenosis after previous percutaneous transluminal angioplasty or because of severe ostial stenosis. The post-stenting results were excellent in all patients, with a follow-up period ranging from 1 to 3 years. The mean blood pressure (one-third systolic pressure plus two-thirds diastolic pressure) fell from 118.11 +/- 7.44 to 103.21 +/- 9.25 mmHg; P < 0.001. Renal artery peak blood flow velocity as determined by Doppler sonography fell from 352 +/- 73.24 cm/s to 169.8 +/- 23.35 cm/s; P < 0.001. The serum creatinine 1-year after stenting was 1.3 +/- 0.3 mg/dl with a slight reduction with respect to the pre-stenting values (1.5 +/- 0.3 mg/dl; NS). As no complication occurred, we conclude that insertion of the Palmaz stent is a safe and effective way to treat recurrence of artery stenosis or ostial stenosis in renal transplanted patients.

Mycophenolate mofetil (MMF) in the treatment of chronic renal rejection.

BACKGROUND: Experimental studies suggest the efficacy of MMF in the treatment of chronic renal rejection in rats. Studies on the efficacy of MMF in chronic renal rejection in man are scarce and controversial. AIM: The aim of this study was to verify in a prospective non-randomized study the efficacy of MMF given at the dose of 2 g/day in substitution of azathioprine (AZA) in the chronic rejection of cadaveric kidney transplantation. PATIENTS AND METHODS: Twelve patients with histologically proven chronic renal rejection were enrolled. The patients were 5 males and 7 females. Mean age 38.3 +/- 13.8 years, with a mean duration of transplant of 39 +/- 19 months. Mean serum creatinine values at -6, -3, 0, +3, +6, +12 months were respectively 1.72 +/- 0.33, 1.84 +/- 0.36, 2.15 +/- 0.50, 1.88 +/- 0.54, 1.81 +/- 0.71, 1.73 +/- 0.58 mg/dl. Mean creatinine clearance values were 58.85 +/- 10.06,48.8 +/- 13.3,45.8 +/- 10.2, 54.7 +/- 13.3, 51 +/- 12.7, 57.7 +/- 18.5 ml/min. Mean deltaGFR before MMF was -2.15 ml/month. RESULTS: After MMF introduction, the overall GFR decrease attenuated. In particular in seven patients after MMF administration, we obtained a significant reduction of mean serum creatinine value (1.84 +/- 0.55 vs. 1.38 +/- 0.41mg/dl; p = 0.004). In three patients, we obtained a stabilization in GFR. Two patients were slowly progressing even after MMF introduction. After a switch to MMF in almost all patients, we obtained an improvement of renal function. In three patients, we obtained a stabilization of renal function without regression. In particular, seven patients showed a remarkable improvement of renal function. CONCLUSIONS: In conclusion our data even if concerning a small number of patients, confirm the efficacy of MMF in the treatment of renal allograft chronic dysfunction.

Gait abnormalities in minimally impaired multiple sclerosis patients.

Subclinical evidence of gait abnormalities were identified in a group of seven patients with multiple sclerosis, EDSS scored 0 - 2, without functional limitations. A movement analysis technique was used to identify gait parameters indicative of impaired motor function during walking. Abnormalities related primarily to time-distance parameters (reduced speed of progression, shorter strides, prolonged double support phase) and muscular function (premature recruitment of gastrocnemius and late relaxation of tibialis anterior during stance phase) were identified regardless the severity of the clinical score. The gait analysis procedure was able to provide the clinician with evidence of motor abnormalities prior to functional disturbance observable by a trained physician. These minimal dysfunctions may have resulted from reflex mechanisms impaired by delayed transmission through long loop pathways or else as a result of a nonspecific protective gait strategy to improve balance control. The technique described in this study may be useful to identify earlier starting points for follow-up and physiotherapy.

Limits of clinical signs and non-invasive techniques in detecting severe acute rejection.

We describe a cadaveric renal transplant patient with an early post-transplant period characterized by normal urine output, normal clinical and biological signs, and a slow decrease of serum creatinine; repeated ultrasonography, color doppler ultrasonography and renal angioscintigraphy were normal or consistent with a clinical diagnosis of mild acute tubular necrosis. Nevertheless a core renal biopsy revealed severe steroid-resistant acute rejection with diffuse infiltrates of lymphocytes and initial transmural arteritis.

Walking with the advanced reciprocating gait orthosis (ARGO) in thoracic paraplegic patients: energy expenditure and cardiorespiratory performance.

The aim of this study was to quantify the energy cost and the cardiorespiratory response while walking at free speed with an Advanced Reciprocating Gait Orthosis (ARGO). The study was conducted on a group of six male paraplegic patients, age range 16-31 years (median = 22.50), with complete traumatic injuries ranging from T3 to T12 and a median time lapse from the trauma of 21 months. The data was recorded 6-8 weeks after the patients were fitted and trained to use the orthosis. Maintaining a standing position produced a significant increase of both the heart rate (HR) and the respiratory rate (RR), whilst the increase of energy consumption was not significant. The data for median speed, energy consumption and energy cost observed during free walking was similar to that of the Reciprocating Gait Orthosis (RGO) in thoracic level paraplegic individuals. This study indicates that in the utilisation of the ARGO the workload is not excessive when it is limited to maintaining a standing position. In contrast, walking results in early anaerobic conditions and unsustainable fatigue after short distances. The great energy cost recorded is considered to be a main reason for the frequent abandonment or the low utilisation of the orthosis at follow-up.