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1.
Cochrane Database Syst Rev ; 2: CD007837, 2024 02 28.
Article in English | MEDLINE | ID: mdl-38415871

ABSTRACT

BACKGROUND: Adolescent idiopathic scoliosis (AIS) is a pathology that changes the three-dimensional shape of the spine and trunk. While AIS can progress during growth and cause cosmetic issues, it is usually asymptomatic. However, a final spinal curvature above the critical threshold of 30° increases the risk of health problems and curve progression in adulthood. The use of therapeutic exercises (TEs) to reduce the progression of AIS and delay or avoid other, more invasive treatments is still controversial. OBJECTIVES: To evaluate the effectiveness of TE, including generic therapeutic exercises (GTE) and physiotherapeutic scoliosis-specific exercises (PSSE) in treating AIS, compared to no treatment, other non-surgical treatments, or between treatments. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, four other databases, and two clinical trials registers to 17 November 2022. We also screened reference lists of articles. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing TE with no treatment, other non-surgical treatments (braces, electrical stimulation, manual therapy), and different types of exercises. In the previous version of the review, we also included observational studies. We did not include observational studies in this update since we found sufficient RCTs to address our study aims. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodology. Our major outcomes were progression of scoliosis (measured by Cobb angle, trunk rotation, progression, bracing, surgery), cosmetic issues (measured by surface measurements and perception), and quality of life (QoL). Our minor outcomes were back pain, mental health, and adverse effects. MAIN RESULTS: We included 13 RCTs (583 participants). The percentage of females ranged from 50% to 100%; mean age ranged from 12 to 15 years. Studies included participants with Cobb angles from low to severe. We judged 61% of the studies at low risk for random sequence generation and 46% at low risk for allocation concealment. None of the studies could blind participants and personnel. We judged the subjective outcomes at high risk of performance and detection bias, and the objective outcomes at high risk of detection bias in six studies and at low risk of bias in the other six studies. One study did not assess any objective outcomes. Comparing TE versus no treatment, we are very uncertain whether TE reduces the Cobb angle (mean difference (MD) -3.6°, 95% confidence interval (CI) -5.6 to -1.7; 2 studies, 52 participants). Low-certainty evidence indicates PSSE makes little or no difference in the angle of trunk rotation (ATR) (MD -0.8°, 95% CI -3.8 to 2.1; 1 study, 45 participants), may reduce the waist asymmetry slightly (MD -0.5 cm, 95% CI -0.8 to -0.3; 1 study, 45 participants), and may result in little to no difference in the score of cosmetic issues measured by the Spinal Appearance Questionnaire (SAQ) General (MD 0.7 points, 95% CI -0.1 to 1.4; 1 study, 16 participants). PSSE may result in little to no difference in self-image measured by the Scoliosis Research Society - 22 Patient Questionnaire (SRS-22) (MD 0.3 points, 95% CI -0.3 to 0.9; 1 study, 16 participants) and improve QoL slightly measured by SRS-22 Total score (MD 0.3 points, 95% CI 0.1 to 0.4; 2 studies, 61 participants). Only Cobb angle results were clinically meaningful. Comparing PSSE plus bracing versus bracing, low-certainty evidence indicates PSSE plus bracing may reduce Cobb angle (-2.2°, 95% CI -3.8 to -0.7; 2 studies, 84 participants). Comparing GTE plus other non-surgical interventions versus other non-surgical interventions, low-certainty evidence indicates GTE plus other non-surgical interventions may reduce Cobb angle (MD -8.0°, 95% CI -11.5 to -4.5; 1 study, 80 participants). We are uncertain whether PSSE plus other non-surgical interventions versus other non-surgical interventions reduces Cobb angle (MD -7.8°, 95% CI -12.5 to -3.1; 1 study, 18 participants) and ATR (MD -8.0°, 95% CI -12.7 to -3.3; 1 study, 18 participants). PSSE plus bracing versus bracing alone may make little to no difference in subjective measurement of cosmetic issues as measured by SAQ General (-0.2 points, 95% CI -0.9 to 0.5; 1 study, 34 participants), self-image score as measured by SRS-22 Self-Image (MD 0.1 points, 95% CI -0.3 to 0.5; 1 study, 34 participants), and QoL measured by SRS-22 Total score (MD 0.2 points, 95% CI -0.1 to 0.5; 1 study, 34 participants). None of these results were clinically meaningful. Comparing TE versus bracing, we are very uncertain whether PSSE allows progression of Cobb angle (MD 2.7°, 95% CI 0.3 to 5.0; 1 study, 60 participants), changes self-image measured by SRS-22 Self-Image (MD 0.1 points, 95% CI -1.0 to 1.1; 1 study, 60 participants), and QoL measured by SRS-22 Total score (MD 3.2 points, 95% CI 2.1 to 4.2; 1 study, 60 participants). None of these results were clinically meaningful. Comparing PSSE with GTE, we are uncertain whether PSSE makes little or no difference in Cobb angle (MD -3.0°, 95% CI -8.2 to 2.1; 4 studies, 192 participants; very low-certainty evidence). PSSE probably reduces ATR (clinically meaningful) (MD -3.0°, 95% CI -3.4 to -2.5; 2 studies, 138 participants). We are uncertain about the effect of PSSE on QoL measured by SRS-22 Total score (MD 0.26 points, 95% CI 0.11 to 0.62; 3 studies, 168 participants) and on self-image measured by SRS-22 Self-Image and Walter Reed Visual Assessment Scale (standardised mean difference (SMD) 0.77, 95% CI -0.61 to 2.14; 3 studies, 168 participants). Further, low-certainty evidence indicates that 38/100 people receiving GTE may progress more than 5° Cobb versus 7/100 receiving PSSE (risk ratio (RR) 0.19, 95% CI -0.67 to 0.52; 1 study, 110 participants). None of the included studies assessed adverse effects. AUTHORS' CONCLUSIONS: The evidence on the efficacy of TE is currently sparse due to heterogeneity, small sample size, and many different comparisons. We found only one study following participants to the end of growth showing the efficacy of PSSE over TE. This result was weakened by adding studies with short-term results and unclear preparation of treating physiotherapists. More RCTs are needed to strengthen the current evidence and study other highly clinically relevant outcomes such as QoL, psychological and cosmetic issues, and back pain.


Subject(s)
Drug-Related Side Effects and Adverse Reactions , Scoliosis , Female , Adolescent , Humans , Child , Scoliosis/therapy , Exercise Therapy , Exercise , Behavior Therapy , Back Pain , Observational Studies as Topic
2.
J Interv Cardiol ; 2022: 9609970, 2022.
Article in English | MEDLINE | ID: mdl-35418809

ABSTRACT

Objectives: To investigate the safety and clinical efficacy of tirofiban during primary percutaneous coronary interventions (pPCI). Background: Gp IIb/IIIa inhibitors (GPI) use during pPCI has declined over years, mainly for the increased hemorrhagic risk associated to their use and for the availability of potent, fast-acting oral antiplatelet drugs. However, several pharmacodynamic studies showed suboptimal platelet inhibition with P2Y12-blockers, such as prasugrel or ticagrelor. Methods: Patients with ST-segment elevation myocardial infarction (STEMI) undergoing pPCI were prospectively enrolled in a multicenter registry conducted in high-volume centers in Italy. All patients received intraprocedural tirofiban. The primary safety endpoint was the occurrence of in-hospital bleedings according to the Bleeding Academic Research Consortium definition. In-hospital major adverse coronary events (MACE, defined as death, reinfarction, stent thrombosis, and target vessel revascularization), final TIMI flow, myocardial blush grade, and ST-segment resolution were also evaluated. Results: A total of 472 patients (mean age 61 ± 11 years, 83% males) were enrolled in 16 Italian centers from October 2015 to June 2018. Mean basal thrombus grade score was 3.47 ± 1.25. PCI was performed by transradial approach in 88% of patients. We observed a very low rate of 30 days BARC bleedings (2.1%) and MACE (0.8%). Complete (>70%) ST-segment resolution was observed in 67% of patients. Conclusions: In the FASTER registry, the use of tirofiban during primary PCI, performed with a transradial approach in most cases, in patients with high thrombus burden was associated with high rates of complete ST-segment resolution and low rates of in-hospital bleeding and MACE.


Subject(s)
Percutaneous Coronary Intervention , Thrombosis , Aged , Female , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Registries , Reperfusion , Thrombosis/etiology , Tirofiban/adverse effects , Treatment Outcome , Tyrosine/adverse effects
3.
Eur Spine J ; 31(11): 2994-2999, 2022 11.
Article in English | MEDLINE | ID: mdl-36083351

ABSTRACT

PURPOSE: The association between idiopathic scoliosis (IS) and sports activities remains vague. We aimed to analyse their effect on full-time braced adolescents with IS. METHODS: We retrospectively recruited all the consecutive patients of a tertiary referral Institute of age ≥ 10 (adolescents), with a juvenile (JIS) or adolescent (AIS) IS diagnosis, Risser 0-2, TLSO brace prescription and self-reported adherence ≥ 20 h per day, and follow-up out-of-brace X-rays 18 months after brace prescription. We divided participants into two groups: SPORT (sport twice or more per week) and CONTROL (sport once per week or less). We calculated odds ratio (OR) to compare the outcome of subjects performing to those not performing sport. We ran a logistic regression with covariate adjustment to assess if sports frequency affected the outcomes. RESULTS: Out of 33,311 participants assessed for eligibility, 785 satisfied the inclusion criteria (693 females, age 12.7 ± 1.3 and 40 ± 11° Cobb). The SPORT group consisted of 290 participants and the CONTROL group of 495. The SPORT group showed higher odds of improvement (OR = 1.59, 95%CI = 1.17-2.16, p = 0.0018). The odds of improving increased with the frequency of sports activity (OR = 1.20, 95%CI 1.08-1.34). CONCLUSION: This study shows that sports activities increase the odds of improvement at 18-month follow-up in adolescents with IS treated with a full-time brace. The odds of improvement increase with sports week frequency.


Subject(s)
Awards and Prizes , Scoliosis , Female , Adolescent , Humans , Child , Scoliosis/diagnostic imaging , Scoliosis/epidemiology , Scoliosis/therapy , Retrospective Studies , Prospective Studies , Braces
4.
Arch Phys Med Rehabil ; 101(11): 2027-2032, 2020 11.
Article in English | MEDLINE | ID: mdl-32800748

ABSTRACT

OBJECTIVES: To investigate the feasibility and acceptability of telemedicine as a substitute for outpatient services in emergency situations such as the sudden surge of the COVID-19 pandemic in Italy. DESIGN: Observational cohort study with historical control. SETTING: Tertiary referral outpatient institute. PARTICIPANTS: Consecutive services provided to patients with spinal disorders (N=1207). INTERVENTIONS: Telemedicine services included teleconsultations and telephysiotherapy, and lasted as long as usual interventions. They were delivered using free teleconference apps, caregivers were actively involved, and interviews and counseling were performed as usual. Teleconsultations included standard, but adapted, measurements and evaluations by video and from photographs and videos sent in advance according to specific tutorials. During telephysiotherapy, new sets of exercises were defined and recorded as usual. MAIN OUTCOME MEASURES: We compared the number of services provided in 3 phases, including corresponding periods in 2018 and 2019. During the control (30 working d) and COVID-19 surge (13d) only usual consultations and physiotherapy were provided; during the telemed phase (15d), only teleconsultations and telephysiotherapy were provided. If a reliable medical decision was not possible during teleconsultations, usual face-to-face interventions were prescribed. Continuous quality improvement questionnaires were also evaluated. RESULTS: During telemed, 325 teleconsulations and 882 telephysiotherapy sessions were provided in 15 days. We found a rapid decrease (-39%) of outpatient services from the control to the COVID-19 phase (R2=0.85), which partially recovered in the telemed phase for telephysiotherapy (from -37% to -21%; P<.05) and stabilized for teleconsultation (from -55% to -60%) interventions. Usual face-to-face interventions were required for 0.5% of patients. Patients' satisfaction with telemedicine was very high (2.8 out of 3). CONCLUSIONS: Telemedicine is feasible and allows medical professionals to continue providing outpatient services with a high level of patient satisfaction. During the current pandemic, this experience can provide a viable alternative for many outpatient services while reducing the need for travel and face-to-face contact to a minimum.


Subject(s)
Ambulatory Care/psychology , COVID-19 , Outpatients/psychology , Patient Satisfaction/statistics & numerical data , Rehabilitation/psychology , Spinal Diseases/rehabilitation , Telemedicine/methods , Adult , Ambulatory Care/methods , Cohort Studies , Feasibility Studies , Female , Humans , Italy , Male , Middle Aged , Referral and Consultation , Rehabilitation/methods , SARS-CoV-2 , Spinal Diseases/psychology
5.
J Craniofac Surg ; 30(4): 1214-1220, 2019 Jun.
Article in English | MEDLINE | ID: mdl-30817521

ABSTRACT

BACKGROUND: The purpose of this study was to prospectively test the accuracy of computer-aided orthognathic surgery comparing the virtual surgical planning with the three-dimensional (3D) outcome. METHODS: Patients that underwent computer-assisted orthognathic surgery were retrospectively evaluated. The postoperative results were compared with the surgical plan, superimposing the postoperative computed tomography (CT) scan onto the virtual plan. Surface-based superimpositioning of the postoperative CT scan onto the 3D preoperative plan was carried out to visualize the discrepancy between preoperative virtual plan and postoperative 3D CT result. RESULTS: A total of 17 consecutive patients that underwent two-jaw computer-assisted orthognathic surgery were enrolled in the study.The average linear differences for selected points were <1 mm in 12 patients out of 17. In 5 patients out of 17, the average differences for selected points were <2 mm. CONCLUSIONS: An overall high degree of accuracy between the virtual plan and the postoperative result was found.


Subject(s)
Computer-Aided Design , Mandible , Maxilla , Patient Care Planning , Adult , Dimensional Measurement Accuracy , Female , Humans , Imaging, Three-Dimensional/methods , Italy , Male , Mandible/diagnostic imaging , Mandible/surgery , Maxilla/diagnostic imaging , Maxilla/surgery , Orthognathic Surgical Procedures/methods , Orthognathic Surgical Procedures/standards , Outcome and Process Assessment, Health Care , Preoperative Care , Retrospective Studies , Surgery, Computer-Assisted/methods
6.
Gut ; 66(3): 454-463, 2017 03.
Article in English | MEDLINE | ID: mdl-26681737

ABSTRACT

OBJECTIVE: Patient-specific (unique) tumour antigens, encoded by somatically mutated cancer genes, generate neoepitopes that are implicated in the induction of tumour-controlling T cell responses. Recent advancements in massive DNA sequencing combined with robust T cell epitope predictions have allowed their systematic identification in several malignancies. DESIGN: We undertook the identification of unique neoepitopes in colorectal cancers (CRCs) by using high-throughput sequencing of cDNAs expressed by standard cancer cell cultures, and by related cancer stem/initiating cells (CSCs) cultures, coupled with a reverse immunology approach not requiring human leukocyte antigen (HLA) allele-specific epitope predictions. RESULTS: Several unique mutated antigens of CRC, shared by standard cancer and related CSC cultures, were identified by this strategy. CD8+ and CD4+ T cells, either autologous to the patient or derived from HLA-matched healthy donors, were readily expanded in vitro by peptides spanning different cancer mutations and specifically recognised differentiated cancer cells and CSC cultures, expressing the mutations. Neoepitope-specific CD8+ T cell frequency was also increased in a patient, compared with healthy donors, supporting the occurrence of clonal expansion in vivo. CONCLUSIONS: These results provide a proof-of-concept approach for the identification of unique neoepitopes that are immunogenic in patients with CRC and can also target T cells against the most aggressive CSC component.


Subject(s)
CD4-Positive T-Lymphocytes/immunology , CD8-Positive T-Lymphocytes/immunology , Colorectal Neoplasms/genetics , Colorectal Neoplasms/immunology , DNA, Complementary/analysis , Epitopes, T-Lymphocyte/genetics , Adenomatous Polyposis Coli Protein/genetics , Cell Cycle Proteins/genetics , Class I Phosphatidylinositol 3-Kinases , DNA Mutational Analysis , Epitopes, T-Lymphocyte/immunology , F-Box Proteins/genetics , F-Box-WD Repeat-Containing Protein 7 , Gene Expression , HLA Antigens/genetics , HLA Antigens/immunology , High-Throughput Screening Assays , Humans , Neoplastic Stem Cells/immunology , Phosphatidylinositol 3-Kinases/genetics , Proto-Oncogene Proteins p21(ras)/genetics , Smad4 Protein/genetics , Smad4 Protein/immunology , Tumor Cells, Cultured , Tumor Suppressor Protein p53/genetics , Ubiquitin-Protein Ligases/genetics
7.
Cochrane Database Syst Rev ; (6): CD006850, 2015 Jun 18.
Article in English | MEDLINE | ID: mdl-26086959

ABSTRACT

BACKGROUND: Idiopathic scoliosis is a three-dimensional deformity of the spine. The most common form is diagnosed in adolescence. While adolescent idiopathic scoliosis (AIS) can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. OBJECTIVES: To evaluate the efficacy of bracing for adolescents with AIS versus no treatment or other treatments, on quality of life, disability, pulmonary disorders, progression of the curve, and psychological and cosmetic issues. SEARCH METHODS: We searched CENTRAL, MEDLINE, EMBASE, five other databases, and two trials registers up to February 2015 for relevant clinical trials. We also checked the reference lists of relevant articles and conducted an extensive handsearch of grey literature. SELECTION CRITERIA: Randomized controlled trials (RCTs) and prospective controlled cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces for adolescent with AIS. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by The Cochrane Collaboration. MAIN RESULTS: We included seven studies (662 participants). Five were planned as RCTs and two as prospective controlled trials. One RCT failed completely, another was continued as an observational study, reporting also the results of the participants that had been randomized.There was very low quality evidence from one small RCT (111 participants) that quality of life (QoL) during treatment did not differ significantly between rigid bracing and observation (mean difference (MD) -2.10, 95% confidence interval (CI) -7.69 to 3.49). There was very low quality evidence from a subgroup of 77 adolescents from one prospective cohort study showing that QoL, back pain, psychological, and cosmetic issues did not differ significantly between rigid bracing and observation in the long term (16 years).Results of the secondary outcomes showed that there was low quality evidence that rigid bracing compared with observation significantly increased the success rate in 20° to 40° curves at two years' follow-up (one RCT, 116 participants; risk ratio (RR) 1.79, 95% CI 1.29 to 2.50). There was low quality evidence that elastic bracing increased the success rate in 15° to 30° curves at three years' follow-up (one RCT, 47 participants; RR 1.88, 95% CI 1.11 to 3.20).There is very low quality evidence from two prospective cohort studies with a control group that rigid bracing increases the success rate (curves not evolving to 50° or above) at two years' follow-up (one study, 242 participants; RR 1.50, 95% CI 1.19 to 1.89) and at three years' follow-up (one study, 240 participants; RR 1.75, 95% CI 1.42 to 2.16). There was very low quality evidence from a prospective cohort study (57 participants) that very rigid bracing increased the success rate (no progression of 5° or more, fusion, or waiting list for fusion) in adolescents with high degree curves (above 45°) (one study, 57 adolescents; RR 1.79, 95% CI 1.04 to 3.07 in the intention-to-treat (ITT) analysis).There was low quality evidence from one RCT that a rigid brace was more successful than an elastic brace at curbing curve progression when measured in Cobb degrees in low degree curves (20° to 30°), with no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace (43 girls; risk of success at four years' follow-up: RR 1.40, 1.03 to 1.89). Finally, there was very low quality evidence from one RCT (12 participants) that a rigid brace with a pad pressure control system is no better than a standard brace in reducing the risk of progression.Only one prospective cohort study (236 participants) assessed adverse events: neither the percentage of adolescents with any adverse event (RR 1.27, 95% CI 0.96 to 1.67) nor the percentage of adolescents reporting back pain, the most common adverse event, were different between the groups (RR 0.72, 95% CI 0.47 to 1.10). AUTHORS' CONCLUSIONS: Due to the important clinical differences among the studies, it was not possible to perform a meta-analysis. Two studies showed that bracing did not change QoL during treatment (low quality), and QoL, back pain, and psychological and cosmetic issues in the long term (16 years) (very low quality). All included papers consistently showed that bracing prevented curve progression (secondary outcome). However, due to the strength of evidence (from low to very low quality), further research is very likely to have an impact on our confidence in the estimate of effect. The high rate of failure of RCTs demonstrates the huge difficulties in performing RCTs in a field where parents reject randomization of their children. This challenge may prevent us from seeing increases in the quality of the evidence over time. Other designs need to be implemented and included in future reviews, including 'expertise-based' trials, prospective controlled cohort studies, prospective studies conducted according to pre-defined criteria such as the Scoliosis Research Society (SRS) and the international Society on Scoliosis Orthopedic and Rehabilitation Treatment (SOSORT) criteria. Future studies should increase their focus on participant outcomes, adverse effects, methods to increase compliance, and usefulness of physiotherapeutic scoliosis specific exercises added to bracing.


Subject(s)
Braces , Scoliosis/therapy , Adolescent , Braces/adverse effects , Child , Cohort Studies , Disease Progression , Female , Humans , Male , Prospective Studies , Quality of Life , Randomized Controlled Trials as Topic
8.
Phys Eng Sci Med ; 47(2): 643-649, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38294678

ABSTRACT

CT angiography prior to endovascular aortic surgery is the standard non-invasive imaging method for evaluation of aortic dimensions and access sites. A detailed report is crucial to a proper planning. We assessed Artificial Intelligence (AI)-algorithm accuracy to measure vessels diameters at CT prior to transcatheter aortic valve implantation (TAVI). CT scans of 50 patients were included. Two Radiologists with experience in vascular imaging together manually assessed diameters at nine landmark positions according to the American Heart Association guidelines: 450 values were obtained. We implemented TOST (Two One-Sided Test) to determine whether the measurements were equivalent to the values obtained from the AI algorithm. When the equivalence bound was a range of ± 2 mm the test showed equivalence for every point; if the range was equal to ± 1 mm the two measurements were not equivalent in 6 points out of 9 (p-value > 0.05), close to the aortic valve. The time for automatic evaluation (average 1 min 47 s) was significantly lower compared with manual measurements (5 min 41 s) (p < 0.01). In conclusion, our results indicate that AI-algorithms can measure aortic diameters at CT prior to endovascular surgery with high accuracy. AI-assisted reporting promises high efficiency, reduced inter-reader variabilities and time saving. In order to perform optimal TAVI procedure planning aortic root analysis could be improved, including annulus dimensions.


Subject(s)
Artificial Intelligence , Computed Tomography Angiography , Endovascular Procedures , Humans , Female , Male , Aged , Aged, 80 and over , Algorithms , Transcatheter Aortic Valve Replacement , Aorta/diagnostic imaging , Aorta/surgery
9.
J Immunol Methods ; 529: 113679, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38679364

ABSTRACT

The type II autoimmune subtype of Chronic Spontaneous Urticaria (CSU) is characterized by the presence of IgG autoantibodies targeting IgE or the IgE high-affinity receptor (FcεRI) on mast cells and basophils. In evaluation of CSU patients, indirect basophil activation testing (BAT), has been utilized, involving the mixing of patient serum with heterologous peripheral blood donors, followed by flow cytometric assessment of basophil markers. However, the reliability of the indirect BAT results hinges on the quality of the donor basophils utilized. In this study, we introduce an innovative approach where multiple potential basophil donors undergo rigorous BAT characterization alongside control samples. By selecting and pooling donors with optimal performance, we significantly enhance the inter-assay reproducibility of the indirect BAT test.


Subject(s)
Basophils , Chronic Urticaria , Flow Cytometry , Humans , Basophils/immunology , Chronic Urticaria/immunology , Chronic Urticaria/diagnosis , Chronic Urticaria/blood , Flow Cytometry/methods , Reproducibility of Results , Basophil Degranulation Test/methods , Adult , Female , Immunoglobulin E/blood , Immunoglobulin E/immunology , Male , Autoantibodies/blood , Autoantibodies/immunology , Immunoglobulin G/blood , Immunoglobulin G/immunology , Middle Aged , Receptors, IgE/immunology , Blood Donors
10.
Catheter Cardiovasc Interv ; 80(3): 395-405, 2012 Sep 01.
Article in English | MEDLINE | ID: mdl-22109961

ABSTRACT

BACKGROUND: Bleeding has emerged as a predictor of early and late mortality after percutaneous coronary interventions. However, the prevalence and predictors of long-term bleeding events in patients on prolonged dual antiplatelet therapy (DAPT) after drug-eluting stent (DES) implantation has been poorly explored. METHODS: A total of 1,437 patients undergoing DES implantation discharged on DAPT with aspirin and clopidogrel for 1 year were studied. Patients were followed for up to 4 years (34.3 ± 14.4 months) and the prevalence and predictors of in-hospital and long-term thrombolysis in myocardial infarction (TIMI) major and minor bleeding events evaluated. The impact of bleeding events on major adverse cardiac events (MACE), overall death, and stent thrombosis (ST) was also assessed. RESULTS: The incidences of 30 days major and minor bleeding were 1.3 and 3.3%, respectively. The incidences of 1-year major and minor bleeding were 3.0 and 5.6%, respectively. The incidences of major and minor bleeding up to 4-year follow-up were 3.6 and 6.9%, respectively. At multivariable analysis, 1-year major bleeding was positively predicted by use of oral anticoagulants at hospital discharge [odds ratio (OR) = 13.4, 95% confidence interval (CI) 3.0-59.2, P = 0.001], anemia at admission (OR = 6.7, 95% CI = 2.7-16.5, P < 0.001) and use of glycoprotein IIb/IIIa inhibitors (OR = 2.7, 95% CI = 1.1-6.5, P = 0.03) and negatively predicted by male gender (OR = 0.39, 95% CI = 0.16-0.97, P = 0.042). Overall, major bleeding at 1 year and at long-term follow-up was associated with an increased risk of MACE, cardiac death and ST. Patients who had any bleeding event were more likely to prematurely discontinue antiplatelet therapy (50% vs. 9.6%, P < 0.001). CONCLUSIONS: In DES-treated patients on prolonged DAPT, major bleeding occurring at 1 year and up to 4 years following DES implantation in patients on prolonged DAPT is associated with poor long-term prognosis.


Subject(s)
Aspirin/adverse effects , Coronary Artery Disease/therapy , Coronary Thrombosis/prevention & control , Drug-Eluting Stents , Hemorrhage/chemically induced , Percutaneous Coronary Intervention/instrumentation , Platelet Aggregation Inhibitors/adverse effects , Ticlopidine/analogs & derivatives , Aged , Aspirin/administration & dosage , Chi-Square Distribution , Clopidogrel , Coronary Artery Disease/mortality , Coronary Thrombosis/etiology , Coronary Thrombosis/mortality , Drug Therapy, Combination , Female , Hemorrhage/mortality , Humans , Incidence , Italy , Kaplan-Meier Estimate , Logistic Models , Male , Middle Aged , Multivariate Analysis , Odds Ratio , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Platelet Aggregation Inhibitors/administration & dosage , Prevalence , Prosthesis Design , Registries , Risk Assessment , Risk Factors , Severity of Illness Index , Ticlopidine/administration & dosage , Ticlopidine/adverse effects , Time Factors , Treatment Outcome
11.
Cochrane Database Syst Rev ; (8): CD007837, 2012 Aug 15.
Article in English | MEDLINE | ID: mdl-22895967

ABSTRACT

BACKGROUND: Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine . While AIS can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. The use of scoliosis-specific exercises (SSE) to reduce progression of AIS and postpone or avoid other more invasive treatments is controversial. OBJECTIVES: To evaluate the efficacy of SSE in adolescent patients with AIS. SEARCH METHODS: The following databases (up to 30 March 2011) were searched with no language limitations: CENTRAL (The Cochrane Library 2011, issue 2), MEDLINE (from January 1966), EMBASE (from January 1980), CINHAL (from January 1982), SportDiscus (from January 1975), PsycInfo (from January 1887), PEDro (from January 1929). We screened reference lists of articles and also conducted an extensive handsearch of grey literature. SELECTION CRITERIA: Randomised controlled trials and prospective cohort studies with a control group comparing exercises with no treatment, other treatment, surgery, and different types of exercises. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risk of bias and extracted data. MAIN RESULTS: Two studies (154 participants) were included. There is low quality evidence from one randomised controlled study that exercises as an adjunctive to other conservative treatments increase the efficacy of these treatments (thoracic curve reduced: mean difference (MD) 9.00, (95% confidence interval (CI) 5.47 to 12.53); lumbar curve reduced:MD 8.00, (95% CI 5.08 to 10.92)). There is very low quality evidence from a prospective controlled cohort study that scoliosis-specific exercises structured within an exercise programme can reduce brace prescription (risk ratio (RR) 0.24, (95% CI 0.06 to1.04) as compared to usual physiotherapy (many different kinds of general exercises according to the preferences of the single therapists within different facilities). AUTHORS' CONCLUSIONS: There is a lack of high quality evidence to recommend the use of SSE for AIS. One very low quality study suggested that these exercises may be more effective than electrostimulation, traction and postural training to avoid scoliosis progression, but better quality research needs to be conducted before the use of SSE can be recommended in clinical practice.


Subject(s)
Physical Therapy Modalities , Scoliosis/therapy , Adolescent , Disease Progression , Electric Stimulation Therapy/methods , Exercise Therapy/methods , Humans , Posture , Randomized Controlled Trials as Topic , Traction/methods
12.
Stud Health Technol Inform ; 176: 361-4, 2012.
Article in English | MEDLINE | ID: mdl-22744530

ABSTRACT

INTRODUCTION: SpineCor is a dynamic brace that showed good results in scoliosis treatment. But data suggest that its efficacy is reduced as curves magnitude increase, and no comparisons exist versus exercise alone. The objective of this double study is to compare the short term results of the SpineCor versus SEAS exercises and versus rigid SpoRT brace for AIS. STUDY DESIGN: 2 retrospective controlled studies. Population 1: 56 consecutive AIS patients (39 female; age 13±1, Cobb 21±4°; ATR 11±4°): 28 patients (19 females; age 13±1; TRACE 6; Cobb angle 22±4°; ATR 12±4°, Risser 0-3) treated by SpineCor 20/24 hours; 28 patients (20 females; age 13±1; TRACE 5; Cobb angle 20±4°; ATR 9±3°, Risser 0-3) treated by SEAS exercises. Population 2: 103 consecutive AIS patients from our prospective database (85 females; age 13±1, Cobb 24±5°; ATR 8±4°): 29 patients (19 females; age 13±1; TRACE 6; Cobb angle 22±5°; ATR 9±3°, Risser 0-3) treated by SpineCor 20/24 hours per day; 74 patients (66 females; age 13±1; TRACE 5; Cobb angle 25±4°; ATR 8±4°, Risser 0-3) treated by SPoRT Brace 18 to 23 hours per day. The short term results of treatment, both clinical and radiographic, were evaluated after 18 months. OUTCOME MEASURES: N° of rigid brace prescribed, TRACE, Cobb angle (changes > ±5), ATR (changes > ±2). RESULTS: Study 1: the N° of patients prescribed with a rigid brace was not significantly different in the 2 groups. TRACE was stable for SEAS while decreased for SpineCor (p<0.05). Considering the number of patients changed > ±5° Cobb in the SEAS Group we found 39.3% improved and 14.3% worsened vs 25% and 21.4% in SpineCor (NS); no differences for ATR. Study 2: Both the treatment showed to be effective in improving the TRACE. Considering the other parameters, the SPoRT brace seems to be slightly more effective than the SpineCor both for the Cobb angle and the ATR. CONCLUSION: Short term results showed the SpineCor's efficacy to be between rigid brace and exercise for treatment efficacy for AIS.


Subject(s)
Braces/statistics & numerical data , Exercise Therapy/statistics & numerical data , Scoliosis/epidemiology , Scoliosis/rehabilitation , Adolescent , Female , Humans , Male , Prevalence , Recovery of Function , Retrospective Studies , Risk Assessment , Scoliosis/diagnosis , Treatment Outcome
13.
Stud Health Technol Inform ; 176: 437-40, 2012.
Article in English | MEDLINE | ID: mdl-22744548

ABSTRACT

INTRODUCTION: In our Institute for many years we have asked patients to perform sport activities freely while in treatment, wearing braces or not, because of the physical and psychological advantages. Our aim was to verify whether it is really possible for patients to perform sport with the brace on, and if they complied with this proposal. MATERIAL AND METHODS: Retrospective cohort study nested in a prospective clinical database. INCLUSION CRITERIA: Adolescent Idiopathic Scoliosis (AIS), start of brace treatment, never treated before, Risser 0-3, age 10-16 years. POPULATION: 607 patients, 13.0±2.1 of age, 33.1°±12.0° Cobb. The sport practice in the first six months of bracing was evaluated, searching for changes in the number of patients performing sport activities and in the average sport activity in the considered subgroups. Groups considered included type of brace (Lyon, LSO, Sforzesco, Sibilla, others) and hours of bracing: 22-24 (sport in brace), 19-21, 18 (sport without the brace). RESULTS: Patients with worst curves (and more hours of bracing prescribed) at the baseline practiced less sport then the others. Sport behaviour did not change with treatment: number of patients performing sport were 51.3% at start, 49.9% at the end. The hours of sport per week had a slightly but statistically significant reduction from 1.3±1.6 to 1.2±1.5 (P<0.05), mainly due to the decreased number of patients performing two sports (22.4% before, 18.1% after). General results were confirmed in the different subgroups, with no difference between groups performing in-brace or out-of-brace sport. CONCLUSION; It is possible to undergo brace treatment and continue normally practicing sport, if this is explained to patients and parents and if braces are designed in a way to allow it.


Subject(s)
Braces/statistics & numerical data , Scoliosis/epidemiology , Scoliosis/rehabilitation , Sports/statistics & numerical data , Adolescent , Cohort Studies , Female , Humans , Italy/epidemiology , Male , Prevalence , Retrospective Studies
14.
Urologia ; 88(3): 206-211, 2021 Aug.
Article in English | MEDLINE | ID: mdl-33565363

ABSTRACT

BACKGROUND: Nowadays, the partial nephrectomy (PN) not only is considered oncological equivalent to radical nephrectomy as renal tumor's treatment, but has also give benefits in quality of life and overall survival of patients. OBJECTIVES: The primary objective of the present study was to report our single center experience with NSS, predominantly performed by a robot assisted access, in a high-volume center with large experience with minimally invasive surgery. METHODS: Between June 2018 and January 2020, a consecutive series of 109 patients (pts) with a renal mass suspicious of renal cell carcinoma, feasible of NSS, detected by ultrasound and abdominal computed tomography (CT), underwent NSS and they were included in a prospectively maintained institutional database. Baseline demographics and clinical characteristics, perioperative and postoperative parameters, pathological data were recorded. RESULTS: The mean clinical maximum CT tumor diameter was 37.3 ± 19.6 mm (median 31.5 mm; interquartile range 25-45 mm). PADUA risk was low in 54 pts (49.5%), intermediate in 48 pts (44.0%), high in seven pts (6.4%). The clinical T stage was mostly pT1a (70.6%). NSS was performed by open surgery in nine pts (8.3%), laparoscopy in one pts (0.9%) and was robot assisted in 99 pts (90.8%). A simple enucleation was performed in 67 pts (61.5%), an enucleoresection was performed in 37 pts (33.9%) and a partial nephrectomy was performed in five pts (4.6%). Warm ischemia was performed in 41 pts (37.6%), with a mean warm ischemia time of 5.1 ± 7.1 min. The mean pathological maximum tumor diameter was 35.5 ± 21.7 mm (median 30 mm; interquartile range 22-40 mm). Overall PSM rate was 11.9% (13 pts). In 78% of cases no complication was recorded. No major complications (grade III-IV-V) were noted. CONCLUSION: Our findings suggest that NSS is a safe, reproducible and minimally invasive approach as treatment of small renal masses. NSS permits to achieve a fine oncological management without any worsening of renal function.


Subject(s)
Kidney Neoplasms , Quality of Life , Humans , Kidney Neoplasms/surgery , Nephrectomy , Nephrons/surgery , Retrospective Studies
15.
J Craniomaxillofac Surg ; 49(1): 1-8, 2021 Jan.
Article in English | MEDLINE | ID: mdl-33277160

ABSTRACT

PURPOSE: This study compared two transferring methods for virtually planned orthognathic surgery - the CAD/CAM intermediate splint and the customized surgical guide with fixation plates. METHODS: This was a prospective clinical study in which participants were consecutively recruited and underwent bimaxillary orthognathic surgery. They were divided into two groups based on the transferring method used. The pre- and postoperative CBCTs were aligned using voxel-based landmark-free registration, and the discrepancies for selected points were compared with the planned displacement of the virtually planned surgery. The maxilla and mandible were analyzed separately, and translation and rotation movements were considered. RESULTS: A total of 16 patients, divided into two groups of eight patients each, were included in this study. The splintless group was significantly more accurate for the translation movement along the x-axes for points A (p = 0.008; mean absolute error 0.527 ± 0.387 for the splint group and 0.137 ± 0.067 for the splintless group) and Ans (p = 0.045; mean absolute error 0.535 ± 0.446 for the splint group and 0.156 ± 0.002 for the splintless group). For the mandible there was a significant difference in accuracy along the x-axes for points B (p = 0.049; mean absolute errors 1.728 ± 1.181 and 0.697 ± 0.519 for the splint and splintless groups, respectively), LL3 (p = 0.049; mean absolute error 1.629 ± 0.912 and 0.851 ± 0.797 for the splint and splintless groups, respectively), LR3 (p = 0.049; mean absolute error 1.711 ± 0.906 and 0.844 ± 0.780 for the splint and splintless groups, respectively), with the splintless group being more accurate. For the rotation the splintless group was significantly more accurate along the y-axes (p = 0.04; mean absolute error 1.62 ± 0.78 and 0.49 ± 0.31 for the splint and splintless groups, respectively) and z-axes (p = 0.04; mean absolute error 0.63 ± 0.45 and 0.17 ± 0.05 for the splint and splintless groups, respectively) for the maxilla, while no significant difference was found for the mandible. CONCLUSIONS: Overall, the customized fixation plate system is more accurate than the intermediate CAD/CAM splint for transferring the virtual plan into the operation room.


Subject(s)
Orthognathic Surgery , Orthognathic Surgical Procedures , Surgery, Computer-Assisted , Humans , Imaging, Three-Dimensional , Maxilla , Prospective Studies , Splints
16.
J Cardiovasc Dev Dis ; 8(9)2021 Sep 15.
Article in English | MEDLINE | ID: mdl-34564131

ABSTRACT

BACKGROUND: TAVR is a safe alternative to surgical aortic valve replacement (SAVR); however, sex-related differences are still debated. This research aimed to examine gender differences in a real-world transcatheter aortic valve replacement (TAVR) cohort. METHODS: All-comer aortic stenosis (AS) patients undergoing TAVR with a Medtronic valve across 19 Italian sites were prospectively included in the Italian Clinical Service Project (NCT01007474) between 2007 and 2019. The primary endpoint was 1-year mortality. We also investigated 3-year mortality, and ischemic and hemorrhagic endpoints, and we performed a propensity score matching to assemble patients with similar baseline characteristics. RESULTS: Out of 3821 patients, 2149 (56.2%) women were enrolled. Compared with men, women were older (83 ± 6 vs. 81 ± 6 years, p < 0.001), more likely to present severe renal impairment (GFR ≤ 30 mL/min, 26.3% vs. 16.3%, p < 0.001) but had less previous cardiovascular events (all p < 0.001), with a higher mean Society of Thoracic Surgeons (STS) score (7.8% ± 7.1% vs. 7.2 ± 7.5, p < 0.001) and a greater mean aortic gradient (52.4 ± 15.3 vs. 47.3 ± 12.8 mmHg, p < 0.001). Transfemoral TAVR was performed more frequently in women (87.2% vs. 82.1%, p < 0.001), with a higher rate of major vascular complications and life-threatening bleeding (3.9% vs. 2.4%, p = 0.012 and 2.5% vs. 1.4%, p = 0.024). One-year mortality differed between female and male (11.5% vs. 15.0%, p = 0.002), and this difference persisted after adjustment for significant confounding variables (Adj.HR1yr 1.47, 95%IC 1.18-1.82, p < 0.001). Three-year mortality was also significantly lower in women compared with men (19.8% vs. 24.9%, p < 0.001) even after adjustment for age, STS score, eGFR, diabetes and severe COPD (Adj.HR3yr 1.42, 95%IC 1.21-1.68, p < 0.001). These results were confirmed in 689 pairs after propensity score matching. CONCLUSION: Despite higher rates of peri-procedural complications, women presented better survival than men. This better adaptive response to TAVR may be driven by sex-specific factors.

17.
Cochrane Database Syst Rev ; (1): CD006850, 2010 Jan 20.
Article in English | MEDLINE | ID: mdl-20091609

ABSTRACT

BACKGROUND: Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine. While AIS can progress during growth and cause a surface deformity, it is usually not symptomatic. However, in adulthood, if the final spinal curvature surpasses a certain critical threshold, the risk of health problems and curve progression is increased. Braces are traditionally recommended to stop curvature progression in some countries and criticized in others. They generally need to be worn full time, with treatment extending over years. OBJECTIVES: To evaluate the efficacy of bracing in adolescent patients with AIS. SEARCH STRATEGY: The following databases (up to July 2008) were searched with no language limitations: the Cochrane Central Register of Controlled Trials, MEDLINE (from January 1966), EMBASE (from January 1980), CINHAL (from January 1982) and reference lists of articles. An extensive handsearch of the grey literature was also conducted. SELECTION CRITERIA: Randomised controlled trials and prospective cohort studies comparing braces with no treatment, other treatment, surgery, and different types of braces. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. MAIN RESULTS: We included two studies. There was very low quality evidence from one prospective cohort study with 286 girls that a brace curbed curve progression at the end of growth (success rate 74% (95% CI: 52% to 84%)), better than observation (success rate 34% (95% CI:16% to 49%)) and electrical stimulation (success rate 33% (95% CI:12% to 60%)). There is low quality evidence from one RCT with 43 girls that a rigid brace is more successful than an elastic one (SpineCor) at curbing curve progression when measured in Cobb degrees, but there were no significant differences between the two groups in the subjective perception of daily difficulties associated with wearing the brace. AUTHORS' CONCLUSIONS: There is very low quality evidence in favour of using braces, making generalization very difficult. Further research could change the actual results and our confidence in them; in the meantime, patients' choices should be informed by multidisciplinary discussion. Future research should focus on short and long-term patient-centred outcomes, in addition to measures such as Cobb angles. RCTs and prospective cohort studies should follow both the Scoliosis Resarch Society (SRS) and Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) criteria for bracing studies.


Subject(s)
Braces , Scoliosis/therapy , Adolescent , Child , Cohort Studies , Female , Humans , Randomized Controlled Trials as Topic
19.
JACC Case Rep ; 2(14): 2173-2175, 2020 Nov 18.
Article in English | MEDLINE | ID: mdl-34317132

ABSTRACT

Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is an effective treatment for aortic bioprosthetic valve degeneration. ViV-TAVI could lead to coronary occlusion. We describe the case of a patient treated with double chimney technique to protect coronary ostia followed by post-dilation for high residual transvalvular gradient using "three-kissing balloon" approach. (Level of Difficulty: Advanced.).

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